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  • Temporal Occurrence of Arrhythmic Complications After Alcohol Septal Ablation
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-24
    Bassim El-Sabawi; Rick A. Nishimura; Gregory W. Barsness; Yong-Mei Cha; Jeffrey B. Geske; Mackram F. Eleid

    Background:The temporal occurrence of arrhythmic complications after alcohol septal ablation (ASA) is unclear. As a result, the appropriate time to monitor patients after ASA is controversial. The purpose of this study is to determine the temporal occurrence of complete heart block (CHB) and ventricular tachyarrhythmia (VT) after ASA to better understand when patients can be safely discharged.Methods:Consecutive patients treated with ASA for hypertrophic cardiomyopathy from 2003 to 2019 at a tertiary referral center were reviewed retrospectively. The incidence and timing of CHB or sustained VT within 30 days post-ASA were assessed.Results:A total of 243 patients were included in this study. Mean maximal septal thickness was 19.0±3.9 mm, and total volume of ethanol injected was 1.7±0.6 mL. CHB occurred in 59 (24.3%) patients, including transient CHB in 33 (13.6%) and permanent in 26 (10.7%). The initial episode of CHB occurred within 24 hours post-ASA in 51 (21.0%) patients, between 24 and 48 hours in 3 (1.2%), between 48 and 72 hours in 3 (1.2%), and after 72 hours in 2 (0.8%). New permanent pacemaker was placed in 46 (18.3%). Presence of baseline bundle branch block and age ≥70 were significantly associated with CHB but not CHB presenting after 24 hours. VT occurred in 3 (1.2%) patients, including 1 (0.4%) within 24 hours, 1 (0.4%) between 24 and 48 hours, and 1 (0.4%) after 72 hours. VT required cardioversion in 2 patients and new implantable cardioverter-defibrillator placement in 2.Conclusions:The incidence of CHB or VT presenting after 72 hours post-ASA was low. These findings suggest that timely discharge of patients without evidence of early conduction disturbances after ASA can be considered as a potentially safe management strategy, especially in patients without preexisting conduction abnormalities.

    更新日期:2020-01-24
  • Trends in Usage and Clinical Outcomes of Coronary Atherectomy
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-24
    Nirat Beohar; Lisa A. Kaltenbach; Daniel Wojdyla; Andrés M. Pineda; Sunil V. Rao; Gregg W. Stone; Martin B. Leon; Kintur A. Sanghvi; Jeffrey W. Moses; Ajay J. Kirtane

    Background:Adjunctive coronary atherectomy (CA) can be utilized in treating severely calcified coronary lesions; however, the temporal trends, patient selection, and variation in use of CA have not been well described. We sought to assess the trends in usage, interhospital variability, and outcomes with CA among patients undergoing percutaneous coronary intervention (PCI).Methods:All patients undergoing PCI in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2016 (N=3 864 377) were analyzed based on utilization of either rotational or orbital CA. Intervals using date of index CA grouped into 2009 Q3 to 2010, 2011 to 2012, 2013 to 2014, and 2015 to 2016 and hospital-level quartiles based on annual CA volumes were evaluated. The primary outcome measure was in-hospital major adverse cardiac events defined as a composite of all-cause mortality, periprocedural myocardial infarction, or stroke. Independent variables associated with outcomes were determined.Results:CA represented 1.7% (n=65 033) of the total PCI volume. Among hospitals performing PCI (n=1672), 577 (34.5%) did not perform any CA. Patients treated with CA were elderly, more often male, and had a history of diabetes, prior myocardial infarction, PCI, and coronary artery bypass grafting. The utilization of CA increased from 1.1% in Q3 2009 to 3.0% in Q4 of 2016 (5% quarterly increase in odds of CA; OR [95% CI], 1.05 [1.04–1.06], P<0.001). Among patients undergoing CA, there was a temporal decline in major adverse cardiac events (0.98 [0.97–0.99], P<0.001) and myocardial infarction (0.97 [0.96–0.98], P<0.001). In adjusted analyses, increasing hospital CA volume was associated with lower mortality (0.85 [0.76–0.96], P=0.01) and lower rates of PCI failure or complication requiring coronary artery bypass grafting (0.67 [0.56–0.79], P<0.001) but was associated with small increase in coronary perforation (1.18 [1.04–1.35], P<0.01).Conclusions:Although CA is performed infrequently, its use has increased over time. After accounting for potential confounders, higher CA volume was associated with lower risk of major adverse events counterbalanced by small risk of coronary perforation.

    更新日期:2020-01-24
  • Endovascular Versus Surgical Revascularization for Acute Limb Ischemia
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-17
    Dhaval Kolte; Kevin F. Kennedy; Mehdi H. Shishehbor; Shafiq T. Mamdani; Lars Stangenberg; Omar N. Hyder; Peter Soukas; Herbert D. Aronow

    Background:The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking.Methods:We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs.Results:Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P=0.002), myocardial infarction (1.9% versus 2.7%; P=0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P<0.001), acute kidney injury (10.5% versus 11.9%; P=0.043), fasciotomy (1.9% versus 8.9%; P<0.001), major bleeding (16.7% versus 21.0%; P<0.001), and transfusion (10.3% versus 18.5%; P<0.001), but higher vascular complications (1.4% versus 0.7%; P=0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P=0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization.Conclusions:In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.

    更新日期:2020-01-17
  • Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-15
    Henrik Djerf; Johan Millinger; Mårten Falkenberg; Lennart Jivegård; Mikael Svensson; Joakim Nordanstig

    Background:The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach.Methods:The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint.Results:Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02).Conclusions:After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.

    更新日期:2020-01-15
  • Impact of Valvulo-Arterial Impedance on Long-Term Quality of Life and Exercise Performance After Transcatheter Aortic Valve Replacement
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-15
    Rutger-Jan Nuis; Jeannette A. Goudzwaard; Marjo J.A.G. de Ronde-Tillmans; Herbert Kroon; Joris F. Ooms; Maarten P. van Wiechen; Marcel L. Geleijnse; Felix Zijlstra; Joost Daemen; Nicolas M. Van Mieghem; Francesco U.S. Mattace-Raso; Mattie J. Lenzen; Peter P.T. de Jaegere

    Background:In aortic stenosis, valvulo-arterial impedance (Zva) estimates the overall left ventricular afterload (valve and arterial component). We investigated the association of Zva (≥5 versus <5 mm Hg mL−1 m−2) on quality of life (QOL) and exercise performance (EP) ≥1 year after transcatheter aortic valve replacement (TAVR).Methods:The study population consists of 250 TAVR patients in whom baseline Zva and follow-up QOL was prospectively assessed using EuroQOL-5-dimensions instruments; EP was assessed in 192 patients who survived ≥1 year after TAVR using questionnaires related to daily activities. In 124 patients, Zva at 1-year was also available and was used to study the change in Zva (baseline to 1 year) on QOL/EP.Results:Elevated baseline Zva was present in 125 patients (50%). At a median of 28 (IQR, 17–40) months, patients with elevated baseline Zva were more limited in mobility (88% versus 71%; P=0.004), self-care (40% versus 25%; P=0.019), and independent daily activities (taking a shower: 53% versus 38%, P=0.030; walking 100 meter: 76% versus 54%, P=0.001; and walking stairs: 74% versus 54%, P=0.011). By multivariable analysis, elevated Zva predicted unfavorable QOL (lower EuroQOL-5-dimensions-Utility Index, odds ratio, 1.98; CI, 1.15–3.41) and unfavorable EP (any limitation in ≥3 daily activities, odds ratio, 2.55; CI, 1.41–4.62). After TAVR, the proportion of patients with elevated Zva fell from 50% to 21% and remained 21% at 1 year and was found to be associated with more limitations in mobility, self-care, and daily activities compared with patients with Zva <5 mm Hg mL−1 m−2.Conclusions:Elevated Zva was seen in half of patients and predicted unfavorable long-term QOL and EP. At 1 year after TAVR, the prevalence of elevated Zva was 21% but remained associated with poor QOL/EP.

    更新日期:2020-01-15
  • Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-15
    Matthew W. Sherwood; Katelyn Xiang; Roland Matsouaka; Zhuokai Li; Sreekanth Vemulapalli; Amit N. Vora; Alexander Fanaroff; J. Kevin Harrison; Vinod H. Thourani; David Holmes; Ajay Kirtane; Andres M. Pineda; Eric D. Peterson; Sunil V. Rao

    Background:Vascular and bleeding complications were commonly reported in transcatheter aortic valve replacement clinical trials. Little is known about complication rates in contemporary US clinical practice or clinical outcomes associated with these complications.Methods:In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we evaluated patients undergoing transcatheter aortic valve replacement from November 1, 2011 to June 30, 2016. The primary outcomes were in-hospital vascular complications and bleeding events. Secondary outcomes included all-cause mortality, stroke, and rehospitalization at 1 year. P values for trends were calculated for rates over time, and multivariable logistic regression was used to determine the association between vascular/bleeding complications and in-hospital clinical outcomes.Results:Overall, 34 893 patients undergoing transcatheter aortic valve replacement at 445 hospitals were analyzed. Of these, 9.3% (n=3257) experienced a vascular complication while 7.6% (n=2651) had an in-hospital bleeding event. Rates of both vascular complications and bleeding events decreased over time (P value for trend test <0.0001); however, there was significant variation in rates across hospital sites (adjusted median rate, 11.4%; IQR, 8.9–14.5). Vascular complications were independently associated with 30-day death (adjusted HR, 2.23 [95% CI, 1.80–2.77]) and death (adjusted HR, 1.17 [95% CI, 1.05–1.30]) and rehospitalization (adjusted HR, 1.14 [95% CI, 1.07–1.22]) at 1 year. Bleeding events were also associated with 30-day death (adjusted HR, 3.71 [95% CI, 2.94–4.69]), and with death (adjusted HR, 1.39 [95% CI, 1.23–1.56]) and hospital readmission (adjusted HR, 1.19 [95% CI, 1.11–1.27]) at 1 year.Conclusions:In patients undergoing transcatheter aortic valve replacement in the US, vascular complications and in-hospital bleeding events were common, but rates have declined over time with significant variation in complication rates across hospital sites. Vascular and bleeding complications are both associated with worse short- and long-term clinical outcomes including all-cause mortality. Further innovation to reduce sheath sizes and optimize antithrombotic therapy is necessary to reduce the incidence of these detrimental complications.

    更新日期:2020-01-15
  • Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-09
    Lee N. Benson; Matthew J. Gillespie; Lisa Bergersen; Sharon L. Cheatham; Kan N. Hor; Eric M. Horlick; Shicheng Weng; Brian T. McHenry; Mark D. Osten; Andrew J. Powell; John P. Cheatham

    Background:The Harmony transcatheter pulmonary valve (TPV) was designed for treatment of postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts.Methods:The Native TPV EFS (Early Feasibility Study) is a prospective, multicenter, nonrandomized feasibility study. Three-year outcomes are reported.Results:Of 20 implanted patients, 17 completed 3-year follow-up (maximum: 4.1 years). There were no deaths and 2 early explants. One patient did not complete the 3-year visit. In patients with available 3-year echocardiographic data, 1 had a mild paravalvular leak and the rest had none/trace; 1 patient had mild pulmonary valve regurgitation and the remainder had none/trace. The 3-year mean right ventricular outflow tract echocardiographic gradient was 15.7±5.5 mm Hg. Radiographically, no late frame fractures or erosions were identified. At 2 years, 2 patients presented with an increased echocardiographic outflow gradient (1 mixed lesion with moderate/severe pulmonary valve regurgitation). Computed tomography scans identified neointimal tissue ingrowth within the stent frame in both patients, and they were treated successfully with a transcatheter valve-in-valve procedure (Melody TPV). Additional follow-up computed tomography scans performed at 3.2±0.5 years after implant were obtained in 16 patients and revealed luminal tissue thickening at the inflow and outflow portion of the frame with no significant alteration of the valve housing.Conclusions:Three-year results from the Native TPV EFS revealed stable Harmony TPV device position, good valve function in most, and the absence of moderate/severe paravalvular leak and significant late frame fractures. Two patients developed significant neointimal proliferation requiring valve-in-valve treatment, while all others had no clinically significant right ventricular outflow tract obstruction.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01762124.

    更新日期:2020-01-09
  • Optical Coherence Tomography for Coronary Bioresorbable Vascular Scaffold Implantation
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2020-01-09
    Seung-Yul Lee; Do-Yoon Kang; Sung-Jin Hong; Jung-Min Ahn; Chul-Min Ahn; Duk-Woo Park; Jung-Sun Kim; Byeong-Keuk Kim; Young-Guk Ko; Donghoon Choi; Yangsoo Jang; Seung-Jung Park; Myeong-Ki Hong

    Background:We investigated whether optical coherence tomography (OCT) guidance would reduce nonoptimal bioresorbable vascular scaffold (BVS) deployment.Methods:This was a randomized controlled trial. Patients who required percutaneous coronary intervention for ischemic heart disease were recruited from 2 centers in Korea. The enrolled patients were randomly assigned to receive either OCT-guided BVS (Absorb; Abbott Vascular) implantation or angiography-guided BVS implantation using an optimized technique. The primary outcome was nonoptimal deployment, which was a composite outcome of the following parameters assessed by OCT: a minimal scaffold area <5 mm2, residual area stenosis >20%, incomplete apposition of the scaffold struts >5%, major edge dissection, or scaffold disruption. The secondary outcome was a procedural complication defined by the occurrence of no reflow, coronary perforation, or flow-limiting dissection.Results:Between September 2016 and January 2018, 88 patients (90 lesions) were assigned to OCT guidance, while 88 patients (89 lesions) were assigned to angiography guidance. The recruitment was prematurely terminated in March 2018 because the manufacturer stopped supplying BVS. Postprocedural OCT data were available for 88 lesions with OCT guidance and for 88 lesions with angiography guidance. There was nonoptimal BVS deployment postprocedurally in 35.2% of patients in the OCT-guidance group and in 38.6% in the angiography-guidance group (absolute difference, −3.7% [95% CI, −19.0% to 11.6%]; P=0.64). There were no procedural complications in either group.Conclusions:OCT-guided BVS implantation did not reduce the incidence of nonoptimal deployment compared to that of angiography-guided BVS implantation (using optimized techniques).Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02894697.

    更新日期:2020-01-09
  • Routine Continuous Electrocardiographic Monitoring Following Percutaneous Coronary Interventions
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-30
    Mohammed A. Al-Hijji; Rajiv Gulati; Malcolm Bell; Revelee J. Kaplan; Jeanna L. Feind; Bradley R. Lewis; Bijan J. Borah; James P. Moriarty; Jae Yoon Park; Abdallah El Sabbagh; Ardaas Kanwar; Gregory Barsness; Thomas Munger; Samuel Asirvatham; Amir Lerman; Mandeep Singh

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    更新日期:2019-12-30
  • Two-Year Outcomes After Deferral of Revascularization Based on Fractional Flow Reserve
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-30
    Shoichi Kuramitsu; Hitoshi Matsuo; Tomohiro Shinozaki; Kazunori Horie; Hiroaki Takashima; Hidenobu Terai; Yuetsu Kikuta; Takayuki Ishihara; Tatsuya Saigusa; Tomohiro Sakamoto; Nobuhiro Suematsu; Yasutsugu Shiono; Atsushi Mizuno; Kenichi Tsujita; Katsuhiko Masamura; Hiroyoshi Yokoi; Nobuhiro Tanaka; on behalf of the J-CONFIRM Registry Investigators

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    更新日期:2019-12-30
  • Individual Lesion-Level Meta-Analysis Comparing Various Doses of Intracoronary Bolus Injection of Adenosine With Intravenous Administration of Adenosine for Fractional Flow Reserve Assessment
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-24
    Gilbert W.M. Wijntjens; Ellen L. van Uffelen; Mauro Echavarría-Pinto; Lorena Casadonte; Valérie E. Stegehuis; Tadashi Murai; Koen M.J. Marques; Myeong-Ho Yoon; Seung-Jea Tahk; Gianni Casella; Antonio M. Leone; Ramón López Palop; Christian Schlundt; Fernando Rivero; Ricardo Petraco; William F. Fearon; Nils P. Johnson; Allen Jeremias; Bon-Kwon Koo; Jan J. Piek; Tim P. van de Hoef

    Background:Intravenous infusion of adenosine is considered standard practice for fractional flow reserve (FFR) assessment but is associated with adverse side-effects and is time-consuming. Intracoronary bolus injection of adenosine is better tolerated by patients, cheaper, and less time-consuming. However, current literature remains fragmented and modestly sized regarding the equivalence of intracoronary versus intravenous adenosine. We aim to investigate the relationship between intracoronary adenosine and intravenous adenosine to determine FFR.Methods:We performed a lesion-level meta-analysis to compare intracoronary adenosine with intravenous adenosine (140 µg/kg per minute) for FFR assessment. The search was conducted in accordance to the Preferred Reporting for Systematic Reviews and Meta-Analysis statement. Lesion-level data were obtained by contacting the respective authors or by digitization of scatterplots using custom-made software. Intracoronary adenosine dose was defined as; low: <40 µg, intermediate: 40 to 99 µg, and high: ≥100 µg.Results:We collected 1972 FFR measurements (1413 lesions) comparing intracoronary with intravenous adenosine from 16 studies. There was a strong correlation (correlation coefficient =0.915; P<0.001) between intracoronary-FFR and intravenous-FFR. Mean FFR was 0.81±0.11 for intracoronary adenosine and 0.81±0.11 for intravenous adenosine (P<0.001). We documented a nonclinically relevant mean difference of 0.006 (limits of agreement: −0.066 to 0.078) between the methods. When stratified by the intracoronary adenosine dose, mean differences between intracoronary and intravenous-FFR amounted to 0.004, 0.011, or 0.000 FFR units for low-dose, intermediate-dose, and high-dose intracoronary adenosine, respectively.Conclusions:The present study documents clinically irrelevant differences in FFR values obtained with intracoronary versus intravenous adenosine. Intracoronary adenosine hence confers a practical and patient-friendly alternative for intravenous adenosine for FFR assessment.

    更新日期:2019-12-25
  • Utility of 30-Day Continuous Ambulatory Monitoring to Identify Patients With Delayed Occurrence of Atrioventricular Block After Transcatheter Aortic Valve Replacement
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-13
    Ying Tian; Deepak Padmanabhan; Christopher J. McLeod; Pei Zhang; Peilin Xiao; Gurpreet S. Sandhu; Kevin L. Greason; Rajiv Gulati; Vuyisile T. Nkomo; Charanjit S. Rihal; Lynn E. Polk; Carrie Sanvick; Xing-Peng Liu; Paul A. Friedman; Yong-Mei Cha

    Background:Mechanical injury in the conduction system requiring permanent pacemaker (PPM) associated with transcatheter aortic valve replacement (TAVR) procedure is a common complication. The objective of this study was to use ambulatory monitor BodyGuardian to assess late occurrence of atrioventricular block (AVB) after TAVR.Methods:This prospective study evaluated 365 patients who underwent TAVR at Mayo Clinic, Rochester, Minnesota between June 2016 and August 2017. Patients who received PPM for bradycardia after TAVR before discharge were considered as the PPM group. Those not requiring PPM received a BodyGuardian system (BodyGuardian group) for 30 days of continuous monitoring. Primary end point was Mobitz II or third-degree atrioventricular block (II/III AVB) at 30-day follow-up.Results:Of 365 patients, 74 who had a PPM or an implantable cardioverter-defibrillator before TAVR and 94 who were enrolled in other studies were excluded. Of 197 patients enrolled in the study, 70 (35.5%) received PPM and 127 had BodyGuardian before the hospital dismissal. Eleven of 127 (8.6%) BodyGuardian group required PPM within 30 days after TAVR for late occurrence of symptomatic bradycardia. In total, 33 of 197 (16.7%) patients developed II/III AVB (24 before and 9 after discharge). Thirty-four patients had preexisting right bundle branch block. Of them, 16 (47%) developed II/III AVB. Of 53 patients who developed new left bundle branch block after TAVR, 14% progressed to II/III AVB within 30 days.Conclusions:In patients without a standard post-TAVR pacing indication, yet a potential risk to develop AVB, a strategy of 30-day monitoring identifies additional patients who require permanent pacing.

    更新日期:2019-12-13
  • Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-13
    Daniele Andreini; Rodrigo Modolo; Yuki Katagiri; Saima Mushtaq; Jeroen Sonck; Carlos Collet; Stefano De Martini; Maurizio Roberto; Kaoru Tanaka; Yosuke Miyazaki; Jens Czapla; Danny Schoors; Andre Plass; Francesco Maisano; Philipp Kaufmann; Xavier Orry; Pierre-Adrien Metzdorf; Thierry Folliguet; Gloria Färber; Ioannis Diamantis; Marc Schönweiß; Giorgia Bonalumi; Marco Guglielmo; Cristina Ferrari; Paolo Olivares; Laura Cavallotti; Ingrid Leal; Wietze Lindeboom; Yoshinobu Onuma; Patrick W. Serruys; Antonio L. Bartorelli; for the SYNTAX III REVOLUTION Investigators

    Background:Fractional flow reserve (FFR) is a reliable tool for the functional assessment of coronary stenoses. FFR computed tomography (CT) derived (FFRCT) has shown to be accurate, but its clinical usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the impact of FFRCT on heart team’s treatment decision-making and selection of vessels for revascularization in patients with 3-vessel coronary artery disease.Methods:The trial was an international, multicenter study randomizing 2 heart teams to make a treatment decision between percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography. The heart teams received the FFRCT and had to make a treatment decision and planning integrating the functional component of the stenoses. Each heart team calculated the anatomic SYNTAX score, the noninvasive functional SYNTAX score and subsequently integrated the clinical information to compute the SYNTAX score III providing a treatment recommendation, that is, coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention. The primary objective was to determine the proportion of patients in whom FFRCT changed the treatment decision and planning.Results:Overall, 223 patients were included. Coronary computed tomography angiography assessment was feasible in 99% of the patients and FFRCT analysis in 88%. FFRCT was available for 1030 lesions (mean FFRCT value 0.64±13). A treatment recommendation of coronary artery bypass grafting was made in 24% of the patients with coronary computed tomography angiography with FFRCT. The addition of FFRCT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as reference, FFRCT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile.Conclusions:In patients with 3-vessel coronary artery disease, a noninvasive physiology assessment using FFRCT changed heart team’s treatment decision-making and procedural planning in one-fifth of the patients.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02813473.

    更新日期:2019-12-13
  • Ischemia and No Obstructive Coronary Artery Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-13
    Thomas J. Ford; Eric Yii; Novalia Sidik; Richard Good; Paul Rocchiccioli; Margaret McEntegart; Stuart Watkins; Hany Eteiba; Aadil Shaukat; Mitchell Lindsay; Keith Robertson; Stuart Hood; Ross McGeoch; Robert McDade; Peter McCartney; David Corcoran; Damien Collison; Christopher Rush; Bethany Stanley; Alex McConnachie; Naveed Sattar; Rhian M. Touyz; Keith G. Oldroyd; Colin Berry

    Background:Determine the prevalence and correlates of microvascular and vasospastic angina in patients with symptoms and signs of ischemia but no obstructive coronary artery disease (INOCA).Methods:Three hundred ninety-one patients with angina were enrolled at 2 regional centers over 12 months from November 2016 (NCT03193294). INOCA subjects (n=185; 47%) had more limiting dyspnea (New York Heart Association classification III/IV 54% versus 37%; odds ratio [OR], 2.0 [1.3–3.0]; P=0.001) and were more likely to be female (68% INOCA versus 38% in coronary artery disease; OR, 1.9 [1.5 to 2.5]; P<0.001) but with lower cardiovascular risk scores (ASSIGN score median 20% versus 24%; P=0.003). INOCA subjects had similar burden of angina (Seattle Angina Questionnaire) but reduced quality of life compared with coronary artery disease; subjects (EQ5D-5 L index 0.60 versus 0.65 units; P=0.041).Results:An interventional diagnostic procedure with reference invasive tests including coronary flow reserve, microvascular resistance, and vasomotor responses to intracoronary acetylcholine (vasospasm provocation) was performed in 151 INOCA subjects. Overall, 78 (52%) had isolated microvascular angina, 25 (17%) had isolated vasospastic angina, 31 (20%) had both, and 17 (11%) had noncardiac chest pain. Regression analysis showed inducible ischemia on treadmill testing (OR, 7.5 [95% CI, 1.7–33.0]; P=0.008) and typical angina (OR, 2.7 [1.1–6.6]; P=0.032) were independently associated with microvascular angina. Female sex tended to associate with a diagnosis of microvascular angina although this was not significant (OR, 2.7 [0.9–7.9]; P=0.063). Vasospastic angina was associated with smoking (OR, 9.5 [2.8–32.7]; P<0.001) and age (OR, 1.1 per year, [1.0–1.2]; P=0.032].Conclusions:Over three quarters of patients with INOCA have identifiable disorders of coronary vasomotion including microvascular and vasospastic angina. These patients have comparable angina burden but reduced quality of life compared to patients with obstructive coronary artery disease. Microvascular angina and vasospastic angina are distinct disorders that may coexist but differ in associated clinical characteristics, symptoms, and angina severity.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT03193294.

    更新日期:2019-12-13
  • Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-13
    Mahmood K. Razavi; Stephen Black; Paul Gagne; Richard Chiacchierini; Phillipe Nicolini; William Marston; on behalf of the VIRTUS Investigators

    Background:Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction.Methods:The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction. Patients included those with ≥50% obstruction on venography and Clinical, Etiology, Anatomic, Pathophysiology clinical classification ≥3, or at least moderate leg pain with a Venous Clinical Severity Score of 2 or greater. All patients were treated with a self-expanding nitinol stent developed for dedicated use in the venous system (Vici Venous Stent System, Veniti, Inc/Boston Scientific, Marlborough, MA). Patients returned for clinical and imaging follow-up visits at 1 month, 6 months, and 1 year. The primary safety outcome was freedom from major adverse events at 30 days. The primary effectiveness outcome was venographic primary patency at 1-year. Adverse events were adjudicated by a Clinical Events Committee, and all imaging including venograms, intravascular ultrasound, and Doppler examinations were assessed by respective core laboratories.Results:Between March 2015 and November 2016, 170 patients (127 chronic post-thrombotic, mean age 54 years, 56.4% female) at 22 sites underwent endovenous stent placement. Mean diameter stenosis was 78%, with 31.2% total occlusions. Mean lesion length was 111.3 mm, range 10 to 260 mm (mean 125.3 mm for post-thrombotic patients and 70.2 mm for nonthrombotic patients). Freedom from a major adverse event through 30 days was 98.8%. The 1-year primary patency rate for the entire group was 84.0%. Venographic patency rates for the nonthrombotic and chronic post-thrombotic groups were 96.2% and 79.8%, respectively. At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score.Conclusions:Twelve-month safety and effectiveness were demonstrated with the use of a dedicated venous stent to treat symptomatic iliofemoral venous obstructions, with reductions in clinical symptoms and improvements in quality of life, through 1-year follow-up.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02112877.

    更新日期:2019-12-13
  • Polyvascular Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-12-13
    J. Antonio Gutierrez; Aaron W. Aday; Manesh R. Patel; W. Schuyler Jones

    Atherosclerosis within 2 or more arterial beds has been termed polyvascular disease. Although polyvascular disease has long been associated with heightened cardiovascular risk, much is still unknown regarding its pathophysiology and management. In this past decade, the field of cardiovascular disease has experienced exponential growth in terms of antithrombotic and lipid-lowering therapies aimed at mitigating ischemic events. This review describes the inherent risk associated with polyvascular disease in contemporary observational and clinical trial populations and summarizes novel therapies in this high-risk population.

    更新日期:2019-12-13
  • Predictive Model for Mortality Risk Including the Wound, Ischemia, Foot Infection Classification in Patients Undergoing Revascularization for Critical Limb Ischemia
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-27
    Nobuyoshi Azuma, Mitsuyoshi Takahara, Akio Kodama, Yoshimitsu Soga, Hiroto Terashi, Junichi Tazaki, Terutoshi Yamaoka, Atsuhiro Koya, Osamu Iida

    Background:The aim of this study was to develop a predictive model for mortality risk based on preoperative risk factors, including the Wound, Ischemia, Foot Infection (WIfI) classification, in patients undergoing revascularization for critical limb ischemia.Methods:We analyzed a database of the Surgical reconstruction versus Peripheral Intervention in Patients With Critical Limb Ischemia registry, a multicenter, prospective, observational study that included 520 critical limb ischemia patients (192 surgical and 328 endovascular patients).Results:Multivariate Cox regression analysis identified old age, impaired mobility, low body mass index, renal failure, heart failure, and high WIfI grade as independent risk factors for all-cause mortality (all P<0.05). The risk score comprising these risk factors discriminated the mortality risk well; the 2-year survival rate was >90% in the first quantile of the risk score and ≈20% in the fifth quantile. The area under the time-dependent receiver operating characteristics curve was 0.829 for thirty-day mortality and 0.811 for 2-year mortality. Adding more detailed preoperative information to the predictive model revealed that cystatin C-based estimated glomerular filtration rate, left ventricular ejection fraction, and cholinesterase levels were additional independent risk factors, but the predictive accuracy of the model was not significantly improved, according to the time-dependent receiver operating characteristics curve and net reclassification improvement.Conclusions:The current study developed a risk score for mortality using preoperative risk factors, including the WIfI classification, in critical limb ischemia patients undergoing revascularization.

    更新日期:2019-11-28
  • Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-22
    Anish Badjatiya, Peter Merrill, John B. Buse, Shaun G. Goodman, Brian Katona, Nayyar Iqbal, Neha J. Pagidipati, Naveed Sattar, Rury R. Holman, Adrian F. Hernandez, Robert J. Mentz, Manesh R. Patel, W. Schuyler Jones

    Background:Recent trials have identified anti–diabetes mellitus agents that lower major adverse cardiovascular event (MACE) rates, although some increase rates of lower-extremity amputation (LEA). Patients with peripheral artery disease (PAD) have greater incidence of diabetes mellitus and risk for LEA, prompting this investigation of clinical outcomes in patients with diabetes mellitus and PAD in the EXSCEL trial (Exenatide Study of Cardiovascular Event Lowering).Methods:EXSCEL evaluated the effects of once-weekly exenatide (a GLP-1 [glucagon-like peptide-1] receptor agonist) versus placebo on the rates of the primary composite MACE end point (cardiovascular death, myocardial infarction, or stroke) among patients with type 2 diabetes mellitus. In this post hoc analysis, we assessed the association of baseline PAD with rates of MACE, LEA, and the effects of exenatide versus placebo in patients with and without PAD.Results:EXSCEL included 2800 patients with PAD (19% of the trial population). These individuals had higher unadjusted and adjusted rates of MACE compared with patients without PAD (13.6% versus 11.4%, respectively) as well as a higher adjusted hazard ratio (adjusted hazard ratio, 1.13 [95% CI, 1.00–1.27]; P=0.047). Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20–1.60]; P<0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16–7.22]; P<0.001). Patients treated with exenatide or placebo had similar rates of MACE and LEA, regardless of PAD status.Conclusions:EXSCEL participants with PAD had higher rates of all-cause mortality and LEA compared with those without PAD. There were no differences in MACE or LEA rates with exenatide versus placebo.Clinical Trial Registration URL:https://www.clinicaltrials.gov. Unique identifier: NCT01144338.

    更新日期:2019-11-22
  • Patients’ Willingness to Accept Mitral Valve Procedure-Associated Risks Varies Across Severity of Heart Failure Symptoms
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-22
    Shelby D. Reed, Angelyn O. Fairchild, F. Reed Johnson, Juan Marcos Gonzalez, Robert J. Mentz, Mitchell W. Krucoff, Sreekanth Vemulapalli

    Background:The Food and Drug Administration’s Center for Drugs and Radiological Health issued Guidance in 2016 on generating patient preference information to aid evaluation of medical devices. Consistent with this guidance, we aimed to provide quantitative patient preference evidence on benefit-risk tradeoffs relevant to transcatheter mitral valve repair versus medical therapy for patients with heart failure and symptomatic secondary mitral regurgitation.Methods:A discrete-choice experiment survey was designed to quantify patients’ tolerance for 30-day mortality or serious bleeding risks to achieve improvements in physical functioning or reductions in heart failure hospitalizations. Two samples were recruited: an online US panel of individuals reporting a diagnosis of heart failure (n=244) and patients with heart failure treated at Duke University Health System (n=175). Random-effects logit regression was used to model treatment choices as a function of benefit and risk levels.Results:Across both samples, approximately one-quarter (23.5%) consistently chose device profiles offering the higher level of physical functioning despite mortality and bleeding risks as high as 10%. Among respondents who at least once chose a device profile offering a lower level of functioning, improvement in physical functioning equivalent to a change from New York Heart Association class IV to III was ≈6 times more preferred than a change from New York Heart Association class III to II. Estimated discrete-choice experiment utility gains and losses revealed that respondents would accept up to a 9.7 percentage-point (95% CI, 8.2%–13.3%) increase in risk of 30-day mortality with devices that could improve functioning from New York Heart Association class IV to III, or up to 2.0% (95% CI, 1.4%–2.7%) for an improvement from New York Heart Association class III to II.Conclusions:Severity of heart failure symptoms influences patients’ willingness to accept risks associated with mitral valve medical devices. These findings can inform shared decision-making discussions with patients who are being evaluated for transcatheter mitral valve repair.

    更新日期:2019-11-22
  • Determining the Predominant Lesion in Patients With Severe Aortic Stenosis and Coronary Stenoses
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-22
    Yousif Ahmad, Jeroen Vendrik, Ashkan Eftekhari, James P. Howard, Christopher Cook, Christopher Rajkumar, Iqbal Malik, Ghada Mikhail, Neil Ruparelia, Nearchos Hadjiloizou, Sukhjinder Nijjer, Rasha Al-Lamee, Ricardo Petraco, Takayuki Warisawa, Gilbert W.M. Wijntjens, Karel T. Koch, Tim van de Hoef, Guus de Waard, Mauro Echavarria-Pinto, Angela Frame, Nilesh Sutaria, Gajen Kanaganayagam,, Ben Ariff, Jon Anderson, Andrew Chukwuemeka,, Michael Fertleman, Sasha Koul, Juan F. Iglesias, Darrel Francis, Jamil Mayet, Patrick Serruys, Justin Davies, Javier Escaned, Niels van Royen, Matthias Götberg, Christian Juhl Terkelsen, Evald Høj Christiansen, Jan J. Piek, Jan Baan Jr, Sayan Sen

    Background:Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation.Methods:Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2).Results:Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s−1 versus post-TAVI 3.04±1.6 mm Hg·cm·s−1 [P=0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [P=0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74.Conclusions:TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values <0.74. Future trials of physiology-guided revascularization in severe AS may consider using this value to guide treatment of concomitant coronary artery disease.

    更新日期:2019-11-22
  • Outcomes With Deferred Versus Performed Revascularization of Coronary Lesions With Gray-Zone Fractional Flow Reserve Values
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-22
    Michael Megaly, Charl Khalil, Marwan Saad, Iosif Xenogiannis, Mohamed Omer, Mahesh Anantha Narayanan, Ashish Pershad, Santiago Garcia, Arnold H. Seto, M. Nicholas Burke, Emmanouil S. Brilakis

    Background:Management of coronary lesions with fractional flow reserve values in the gray zone (0.75–0.80) remains controversial due to conflicting data on the performance versus deferral of revascularization.Methods:We performed a systematic review and meta-analysis of 7 observational studies including 2683 patients that compared the outcomes of deferred versus performed revascularization of coronary lesions with gray-zone fractional flow reserve values.Results:During a mean follow-up of 31±9 months, the incidence of major adverse cardiovascular events (12.54 % versus 11.25%; odds ratio [OR], 1.64 [95% CI, 0.78–3.44]; P=0.19, I2=84%), cardiac mortality (1.25% versus 0.72%; OR, 1.78 [95% CI, 0.58–5.46]; P=0.31, I2=18%), and myocardial infarction (1.28% versus 2.66%; OR, 0.79 [95% CI, 0.22–2.79]; P=0.71, I2=65%) was similar with deferral versus performance of revascularization in coronary lesions with gray-zone fractional flow reserve. Deferral of revascularization was associated with a higher incidence of target vessel revascularization (9.12% versus 5.78%; OR, 1.85 [95% CI, 1.03–3.33]; P=0.04, I2=62%). When the analysis was limited only to studies that used percutaneous coronary intervention for revascularization, deferred revascularization remained associated with a higher risk of target vessel revascularization (18% versus 7.3%; OR, 3.04 [95% CI, 1.53–6.02]; P<0.001) and was associated with a higher risk of major adverse cardiovascular event (23.2% versus 13.4%; OR, 3.38 [95% CI, 1.92–5.95]; P<0.001).Conclusions:In lesions with gray-zone fractional flow reserve, revascularization was associated with a similar incidence of major adverse cardiovascular event but a lower incidence of target vessel revascularization over a mean follow-up of approximately 2.5 years.Clinical Trial Registration:URL: https://www.crd.york.ac.uk/prospero/. Unique identifier: CRD42019128076.

    更新日期:2019-11-22
  • Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-11
    Mathieu Kerneis, Megan K. Yee, Roxana Mehran, Tarek Nafee, Christoph Bode, Jonathan L. Halperin, Eric D. Peterson, Freek W.A. Verheugt, Peter Wildgoose, Martin van Eickels, Gregory Y.H. Lip, Marc Cohen, Keith A.A. Fox, C. Michael Gibson

    Background:Among stented patients with atrial fibrillation, double therapy with a novel oral anticoagulant plus single antiplatelet therapy (SAPT) reduces bleeding or cardiovascular rehospitalizations compared with a vitamin K antagonist (VKA) based triple therapy regimen. A recent study demonstrated that apixaban based double therapy reduced bleeding compared with VKA based double therapy. However, it remains unknown whether rivaroxaban based double therapy is superior to a VKA based double therapy.Methods:Patient with stented atrial fibrillation (n=2124) were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y12 inhibitor (Group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT; Group 2, n=709); and warfarin plus DAPT (Group 3, n=706). Before randomization, subjects were stratified according to a prespecified duration of DAPT (1, 6, or 12 months). After the prespecified DAPT duration, subjects in Group 2 were switched to rivaroxaban 15 mg plus low dose aspirin, and those in Group 3 were switched to VKA plus low dose aspirin. The Wei, Lin, and Weissfeld time to multiple events method was used to compare the occurrence of all bleeding and cardiovascular rehospitalizations among subjects on a novel oral anticoagulant versus VKA based double therapy.Results:A total of 906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug. Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to VKA+SAPT experienced multiple rehospitalizations. In total, 124 (20.3%) events occurred among subjects on novel oral anticoagulant+SAPT compared with 87 (29.6%) among subjects on VKA+SAPT (hazard ratio=0.65 [95% CI, 0.45–0.93], P=0.008).Conclusions:Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01830543.

    更新日期:2019-11-11
  • Intravascular Lithotripsy in Calcified Coronary Lesions
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-11
    Adem Aksoy, Carlos Salazar, Marc Ulrich Becher, Vedat Tiyerili, Marcel Weber, Felix Jansen, Alexander Sedaghat, Sebastian Zimmer, Jürgen Leick, Eberhard Grube, Nieves Gonzalo, Jan-Malte Sinning, Javier Escaned, Georg Nickenig, Nikos Werner

    Background:Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort.Methods:Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event).Results:Seventy-eight calcified lesions were treated using the Shockwave C2 balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae.Conclusions:IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.

    更新日期:2019-11-11
  • Application of the Academic Research Consortium High Bleeding Risk Criteria in an All-Comers Registry of Percutaneous Coronary Intervention
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-11
    Masahiro Natsuaki, Takeshi Morimoto, Hiroki Shiomi, Kyohei Yamaji, Hirotoshi Watanabe, Satoshi Shizuta, Takao Kato, Kenji Ando, Yoshihisa Nakagawa, Yutaka Furukawa, Tomohisa Tada, Kazuya Nagao, Kazushige Kadota, Mamoru Toyofuku, Takeshi Kimura

    Background:Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice.Methods:We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group.Results:Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, P<0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors: 49.9%, 2 majors: 30.6%, 1 major: 18.5%, ≥2 minors: 14.7%, and no-HBR: 6.6%, P<0.0001).Conclusions:ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry.

    更新日期:2019-11-11
  • Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-07
    Benoit Lattuca, Johanne Silvain, Yan Yan, Christophe Pouillot, Thomas Cuisset, Guillaume Cayla, Patrick Henry, Abdourahmane Diallo, Simon Elhadad, Grégoire Rangé, Thibault Lhermusier, Ziad Boueri, Pascal Motreff, Didier Carrié, Eric Vicaut, Gilles Montalescot, Jean-Philippe Collet

    Background:In the ARCTIC trial (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting), treatment adjustment following platelet function testing failed to improve clinical outcomes. However, high-on-treatment platelet reactivity (HPR) is considered as a predictor of poor ischemic outcome. This prespecified substudy evaluated clinical outcomes according to the residual platelet reactivity status after antiplatelet therapy adjustment.Methods:We analyzed the 1213 patients assigned to the monitoring arm of the ARCTIC trial in whom platelet reactivity was evaluated by the VerifyNow P2Y12 test before percutaneous coronary intervention and during the maintenance phase (at 14 days). HPR was defined as platelet reaction unit≥235U. The primary ischemic end point, a composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization and the safety end point of major bleeding were assessed according to the platelet reactivity status.Results:Before percutaneous coronary intervention, 35.7% of patients displayed HPR (n=419). During the acute phase, between percutaneous coronary intervention and the 14-day platelet function testing, ischemic (adjusted hazard ratio, 0.94 [95% CI, 0.74–1.18]; P=0.58) and safety outcomes (hazard ratio, 1.28 [95% CI, 0.22–7.59]; P=0.78) were similar in HPR and non-HPR patients. During the maintenance phase, the proportion of HPR patients (n=186, 17.4%) decreased by 56%. At 1-year, there was no difference for the ischemic end point (5.9% versus 6.0%; adjusted hazard ratio, 0.79 [95% CI, 0.40–1.58]; P=0.51) and a nonsignificant higher rate of major bleedings (2.7% versus 1.0%, hazard ratio, 2.83 [95% CI, 0.96–8.41]; P=0.06) in HPR versus non-HPR patients.Conclusions:The proportion of HPR was halved after platelet function testing and treatment adjustment but without significant ischemic benefit at 1 year. HPR seems more as a modifiable risk marker than a risk factor of ischemic outcome.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT00827411.

    更新日期:2019-11-07
  • Infective Endocarditis Following Transcatheter Aortic Valve Replacement
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-07
    Ander Regueiro

    Background:No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems.Methods:Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV.Results:A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2–15] months versus BEV, 5.3 [1.7–11.4] months; P=0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; P<0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; P=0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; P=0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04–5.82, P=0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; P=0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; P=0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died (P=0.66).Conclusions:The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field.

    更新日期:2019-11-07
  • Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-07
    Jordan B. Strom, Yuansong Zhao, Kamil F. Faridi, Hector Tamez, Neel M. Butala, Linda R. Valsdottir, Jeptha Curtis, J. Matthew Brennan, Changyu Shen, Mike Boulware, Jeffrey J. Popma, Robert W. Yeh

    Background:Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials.Methods:Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of International Classification of Diseases,Ninth andTenthRevisions, Clinical Modification billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared.Results:Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4 International Classification of Diseases, Ninth Revision, Clinical Modification codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3 International Classification of Diseases, Tenth Revision, Clinical Modification codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%.Conclusions:In linked clinical trial and Medicare claims data, 4 International Classification of Diseases, Ninth Revision, Clinical Modification and 3 International Classification of Diseases, Tenth Revision, Clinical Modification billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.

    更新日期:2019-11-07
  • Impact of Smoking on Platelet Reactivity and Clinical Outcomes After Percutaneous Coronary Intervention
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-01
    Rajesh Gupta, Ajay J. Kirtane, Yangbo Liu, Aaron Crowley, Bernhard Witzenbichler, Michael J. Rinaldi, D. Christopher Metzger, Giora Weisz, Thomas D. Stuckey, Bruce R. Brodie, Roxana Mehran, Ori Ben-Yehuda, Gregg W. Stone

    Background:Smoking is a potent risk factor for coronary artery disease; however, prior studies describe increased platelet inhibition with clopidogrel among smokers, and some studies report improved outcomes among smokers, a finding described as the smoker’s paradox. This study assessed the relationship between platelet reactivity and clinical outcomes after percutaneous coronary interventions among current smokers and nonsmokers.Methods:ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. Platelet reactivity was assessed by the VerifyNow point-of-care assay; high on-treatment platelet reactivity (HPR) was defined as P2Y12 reaction units >208. A propensity-adjusted multivariable analysis was performed to determine the relationship between current smoking, platelet reactivity, and subsequent adverse events.Results:Among 8582 patients, 22.6% were active smokers at the time of their percutaneous coronary intervention procedure. Current smokers were younger and had fewer comorbidities compared with nonsmokers. Current smokers had lower mean P2Y12 reaction units and lower rates of HPR compared with nonsmokers. Current smokers had similar rates of adverse events compared with nonsmokers. HPR was associated with higher rates of adverse events for both smokers and nonsmokers; however, there was evidence of interaction between smoking status and the effect of HPR. Smokers with HPR had significantly higher rates of stent thrombosis. Adverse event rates were highest among current smokers with HPR.Conclusions:Current smoking was associated with lower P2Y12 reaction units and lower rates of HPR on average; however, the combination of current smoking and HPR was associated with high rates of stent thrombosis.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794.

    更新日期:2019-11-01
  • Impact of Specific Crossing Techniques in Chronic Total Occlusion Percutaneous Coronary Intervention on Recovery of Absolute Myocardial Perfusion
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-01
    Stefan P. Schumacher, Wijnand J. Stuijfzand, Roel S. Driessen, Pepijn A. van Diemen, Michiel J. Bom, Henk Everaars, Marly Kockx, Pieter G. Raijmakers, Ronald Boellaard, Peter M. van de Ven, Albert C. van Rossum, Maksymilian P. Opolski, Alexander Nap, Paul Knaapen

    Background:Multiple crossing techniques in chronic total occlusion (CTO) percutaneous coronary intervention have been developed. This study compared recovery of quantitative myocardial blood flow (MBF) after different CTO percutaneous coronary intervention techniques.Methods:Consecutive patients with [15O]H2O positron emission tomography perfusion imaging before and 3 months after successful CTO percutaneous coronary intervention between 2013 and 2018 were included. Changes in hyperemic MBF, coronary flow reserve, and perfusion defect size were compared between antegrade wire escalation, retrograde wire escalation, antegrade dissection and reentry (ADR), and retrograde dissection and reentry.Results:One hundred ninety-three patients were treated with antegrade wire escalation (N=90), retrograde wire escalation (N=24), ADR (N=35), and retrograde dissection and reentry (N=44). Increase in hyperemic MBF (1.19±0.77, 0.94±0.65, 1.09±0.63, and 1.02±0.75 mL·min-1·g-1, respectively; P=0.40) and coronary flow reserve (1.34±1.08, 1.14±1.09, 1.31±0.96, and 1.24±0.99, respectively; P=0.84) and decrease in defect size (3.2±2.1, 3.0±2.2, 2.7±2.1, and 2.9±1.9 segments, respectively; P=0.77) were comparable between the 4 approaches. In addition, recovery of hyperemic MBF was less pronounced after subintimal crossing with knuckle-wire-technique compared with CrossBoss in controlled ADR and retrograde dissection and reentry (0.93±0.69 versus 1.54±0.65 mL·min-1·g-1, P=0.02), and less after reentry using subintimal tracking and reentry in ADR compared with controlled ADR (Stingray) or limited antegrade subintimal tracking (0.60±0.53 versus 1.18±0.54 [P=0.04] and versus 1.49±0.57 mL·min-1·g-1, [P<0.01]).Conclusions:Recovery of hyperemic MBF, coronary flow reserve, and perfusion defect size after CTO percutaneous coronary intervention was comparable between different approaches. Although sometimes necessary to cross a complex CTO lesion, subintimal knuckle wiring and subintimal tracking and reentry resulted in less hyperemic MBF improvement compared with other subintimal crossing and reentry techniques.

    更新日期:2019-11-01
  • Transradial Artery Access Complications
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-11-01
    Yader Sandoval, Malcolm R. Bell, Rajiv Gulati

    Transradial access (TRA) is favored over transfemoral access for performing coronary angiography and percutaneous coronary intervention due to the reduced risk for vascular and bleeding complications and the documented survival benefit in ST-segment–elevation myocardial infarction patients who undergo primary percutaneous coronary intervention. TRA complications can be categorized as intra- or postprocedural and further categorized as related to bleeding or nonbleeding issues. Major intra- and postprocedural complications such as radial artery perforation and compartment syndrome are rare following TRA. Their occurrence, however, can be associated with morbid consequences, including requirement for surgical intervention if not identified and treated promptly. Nonbleeding complications such as radial artery spasm and radial artery occlusion are typically less morbid but occur much more frequently. Strategies to prevent TRA complications are essential and include the use of contemporary access techniques that limit arterial injury. This document summarizes contemporary techniques to prevent, identify, and manage TRA complications.

    更新日期:2019-11-01
  • Comparison of Outcomes at Time of Superior Cavopulmonary Connection Between Single Ventricle Patients With Ductal-Dependent Pulmonary Blood Flow Initially Palliated With Either Blalock-Taussig Shunt or Ductus Arteriosus Stent
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-10-14
    Jeffery J. Meadows, Athar M. Qureshi, Bryan H. Goldstein, Christopher J. Petit, Courtney E. McCracken, Michael S. Kelleman, Varun Aggarwal, Holly Bauser-Heaton, Christine S. Combs, Ari J. Gartenberg, R. Allen Ligon, George T. Nicholson, Andrew C. Glatz

    Background:Patients with single ventricle anatomy and ductal-dependent pulmonary blood flow may be initially palliated with either modified Blalock-Taussig shunt (BTS) or ductus arteriosus stent (DAS). Comparisons of outcomes during the interstage period and at the time of superior cavopulmonary connection (SCPC) are lacking and may differ between palliation strategies.Methods:Infants with single ventricle anatomy and ductal-dependent pulmonary blood flow palliated with either DAS or BTS from 2008 to 2015 were reviewed across 4 centers. Interstage outcomes, and for those who had SCPC, anatomy, hemodynamics, and perioperative clinical outcomes were compared. Thirty-five patients with DAS and 136 patients with BTS were included.Results:At initial palliation, demographic, clinical variables, and pulmonary artery size were similar. Interstage death, transplant, or unplanned reintervention to treat cyanosis occurred in 25.7% of DAS and 35.8% of BTS, P=0.27. Reintervention was more common with DAS (48.6% versus 2.2%; P<0.001). Twenty-three DAS patients and 111 BTS patients underwent SCPC. Preoperative hemodynamics and overall pulmonary atresia growth were similar, although right pulmonary artery growth was better with DAS (change in z-score: 1.57 versus 0.65, P=0.026). SCPC intraoperative and postoperative courses were similar.Conclusions:In patients with single-ventricle anatomy and ductal-dependent pulmonary blood flow, interstage outcomes, hemodynamics before SCPC, and acute postoperative outcomes were similar. Overall reintervention was more common in the DAS group, driven by more frequent planned reintervention. Unplanned reintervention, death, and transplant were similar. Both groups demonstrated good pulmonary atresia growth. DAS is a reasonable initial palliative alternative to BTS in select patients.

    更新日期:2019-10-14
  • Optimizing the Technique for Invasive Fractional Flow Reserve to Assess Lesion-Specific Ischemia
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-10-14
    Brian M. Renard, Elvis Cami, Monica R. Jiddou-Patros, Ahmad Said, Herman Kado, Justin Trivax, Aaron Berman, Akhil Gulati, Maher Rabah, Steven Timmis, Mazen Shoukfeh, Amr E. Abbas, George Hanzel, Ivan Hanson, Simon Dixon, Robert D. Safian

    Background:Invasive fractional flow reserve (FFRINV) is the standard technique for assessing myocardial ischemia. Pressure distortions and measurement location may influence FFRINV interpretation. We report a technique for performing invasive fractional flow reserve (FFRINV) by minimizing pressure distortions and identifying the proper location to measure FFRINV.Methods:FFRINV recordings were obtained prospectively during manual hyperemic pullback in 100 normal and diseased coronary arteries with single stenosis, using 4 measurements from the terminal vessel, distal-to-the-lesion, proximal vessel, and guiding catheter. FFRINV profiles were developed by plotting FFRINV values (y-axis) and site of measurement (x-axis), stratified by stenosis severity. FFRINV≤0.8 was considered positive for lesion-specific ischemia.Results:Erroneous FFRINV values were observed in 10% of vessels because of aortic pressure distortion and in 21% because of distal pressure drift; these were corrected by disengagement of the guiding catheter and re-equalization of distal pressure/aortic pressure, respectively. There were significant declines in FFRINV from the proximal to the terminal vessel in normal and stenotic coronary arteries (P<0.001). The rate of positive FFRINV was 41% when measured from the terminal vessel and 20% when measured distal-to-the-lesion (P<0.001); 41.5% of positive terminal measurements were reclassified to negative when measured distal-to-the-lesion. Measuring FFRINV 20 to 30 mm distal-to-the-lesion (rather than from the terminal vessel) can reduce errors in measurement and optimize the assessment of lesion-specific ischemia.Conclusions:Meticulous technique (disengagement of the guiding catheter, FFRINV pullback) is required to avoid erroneous FFRINV, which occur in 31% of vessels. Even with optimal technique, FFRINV values are influenced by stenosis severity and the site of pressure measurement. FFRINV values from the terminal vessel may overestimate lesion-specific ischemia, leading to unnecessary revascularization.

    更新日期:2019-10-14
  • Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction in Clinical Practice
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-10-14
    Kevin R. Bainey, Paul W. Armstrong, Yinggan Zheng, Neil Brass, Benjamin D. Tyrrell, Raymond Leung, Cynthia M. Westerhout, Robert C. Welsh

    Background:Recent clinical trial data support a pharmacoinvasive strategy as an alternative to primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction. We evaluated whether this is true in a real-world prehospital ST-segment elevation myocardial infarction network using ECG assessment of reperfusion coupled with clinical outcomes within 1 year.Methods:Of the 5583 ST-segment elevation myocardial infarction patients in the Alberta Vital Heart Response Program (Cohort 1 [2006–2011]: n=3593; Cohort 2 [2013–2016]: n=1990), we studied 3287 patients who received a pharmacoinvasive strategy with tenecteplase (April 2013: half-dose tenecteplase was employed in prehospital patients ≥75 years) or pPCI. ECGs were analyzed within a core laboratory; sum ST-segment deviation resolution ≥50% was defined as successful reperfusion. The primary composite was all-cause death, congestive heart failure, cardiogenic shock, and recurrent myocardial infarction within 1 year.Results:The pharmacoinvasive approach was administered in 1805 patients (54.9%), (493 [27.3%] underwent rescue/urgent percutaneous coronary intervention and 1312 [72.7%] had scheduled angiography); pPCI was performed in 1482 patients (45.1%). There was greater ST-segment resolution post-catheterization/percutaneous coronary intervention with a pharmacoinvasive strategy versus pPCI (75.8% versus 64.3%, IP-weighted odds ratio, 1.59; 95% CI, 1.33–1.90; P<0.001). The primary composite was significantly lower with a pharmacoinvasive approach (16.3% versus 23.1%, IP-weighted hazard ratio, 0.84; 95% CI, 0.72–0.99; P=0.033). Major bleeding and intracranial hemorrhage were similar between a pharmacoinvasive strategy and pPCI (7.6% versus 7.5%, P=0.867; 0.6% versus 0.6%; P=0.841, respectively). In the 82 patients ≥75 years with a prehospital pharmacoinvasive strategy, similar ST-segment resolution and rescue rates were observed with full-dose versus half-dose tenecteplase (75.8% versus 88.9%, P=0.259; 31.0% versus 29.2%, P=0.867) with no difference in the primary composite (31.0% versus 25.0%, P=0.585).Conclusions:In this large Canadian ST-segment elevation myocardial infarction registry, a pharmacoinvasive strategy was associated with improved ST-segment resolution and enhanced outcomes within 1 year compared with pPCI. Our findings support the application of a selective pharmacoinvasive reperfusion strategy when delay to pPCI exists.

    更新日期:2019-10-14
  • Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-10-14
    Harold L. Dauerman, G. Michael Deeb, Daniel P. O’Hair, Ron Waksman, Steven J. Yakubov, Neal S. Kleiman, Stanley J. Chetcuti, James B. Hermiller Jr, Tanvir Bajwa, Kamal Khabbaz, Eduardo de Marchena, Tomas Salerno, Jessica L. Dries-Devlin, Shuzhen Li, Jeffrey J. Popma, Michael J. Reardon

    Background:Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR.Methods:The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch.Results:From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01).Conclusions:Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up.Clinical Trial Registration:URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.

    更新日期:2019-10-14
  • Use of Coronary Computed Tomographic Angiography to Facilitate Percutaneous Coronary Intervention of Chronic Total Occlusions
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-10-14
    Gerald S. Werner

    Chronic total coronary occlusions (CTO) are found frequently in coronary artery disease; however, the technical challenge to open the occlusion by percutaneous coronary intervention is considerably higher than for nonocclusive lesions. The angiographic analysis is limited by the inability to visualize the occluded segment and requires a dual injection approach from donor and recipient vessel to assess the CTO. Therefore, imaging of the CTO by computed tomographic angiography can provide additional information on the vessel course within the CTO segment, specifically the degree and extent of calcification, and maybe even be superior to angiography to analyze the proximal cap morphology. This had been integrated in a score to predict the interventional success. This information provides a valuable means to better plan the procedure and the required strategy. In addition, an integration of the computed tomographic angiography is possible by synchronization with the gantry position and movement of the angiography system during percutaneous coronary intervention, illustrating the course of the occluded segment and possible obstacles in the way. It remains to be established which patient will most likely profit from this additional preprocedural examination involving increased radiation and contrast media exposure and institutional expenses.

    更新日期:2019-10-14
  • Impact of Procedural Bleeding in Peripheral Artery Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-10-04
    Aman Kansal, Zhen Huang, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F. Gerry Fowkes, Brian Katona, Kenneth W. Mahaffey, Lars Norgren, William R. Hiatt, Manesh R. Patel, W. Schuyler Jones

    Background:The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure.Methods:EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group.Results:Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%–4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%–5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%–3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation.Conclusions:The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.

    更新日期:2019-10-04
  • Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-26
    Kyungil Park, Young-Rak Cho, Jong-Sung Park, Tae-Ho Park, Moo-Hyun Kim, Young-Dae Kim

    Background:Ticagrelor reduced the rate of myocardial infarction and death compared with clopidogrel in patients with acute coronary syndrome. However, little is understood about chronic treatment of ticagrelor on microvascular dysfunction. The objective of this study was to assess the impact of ticagrelor maintenance treatment on microvascular system and coronary flow in comparison with clopidogrel.Methods:This study was a nonblinded, open-label, parallel-group, prospective, randomized controlled trial that enrolled 120 patients with acute coronary syndrome requiring stent implantation. Patients were randomized into the ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300 to 600 mg loading dose, 75 mg daily thereafter) group. The primary end point was coronary microvascular dysfunction as measured by an index of microcirculatory resistance (IMR) at 6 months after treatment.Results:The baseline clinical characteristics and physiological parameters, such as fractional flow reserve, coronary flow reserve, and IMR, did not differ between the ticagrelor and clopidogrel groups. Six-month follow-up physiological data showed that the IMR value was significantly lower in the ticagrelor group than the clopidogrel group (15.57±5.65 versus 21.15±8.39, P<0.01), and coronary flow reserve was higher in the ticagrelor group than in the clopidogrel group (3.85±0.72 versus 3.37±0.76, P<0.01). However, there was no difference in fractional flow reserve (0.87±0.08 versus 0.87±0.09, P=0.94) between the 2 groups. The improvement in IMR after 6 months of treatment was higher in the ticagrelor group (P<0.01). Analyses of 223 nonculprit vessels of registered patients based on physiological results showed no differences in baseline fractional flow reserve (0.93±0.13 versus 0.92±0.09, P=0.58), coronary flow reserve (3.62±1.27 versus 3.51±1.24, P=0.16), or IMR (21.37±12.37 versus 24.19±21.08, P=0.22) or in follow-up fractional flow reserve (0.91±0.09 versus 0.91±0.08, P=0.67), coronary flow reserve (3.91±1.22 versus 3.75±1.16, P=0.36), or IMR (19.43±10.32 versus 21.52±18.90, P=0.34) between the 2 groups.Conclusions:Compared with clopidogrel, 6 months of ticagrelor therapy significantly improved microvascular dysfunction in acute coronary syndrome patients with stent implantation.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02618733.

    更新日期:2019-09-26
  • Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography–Guided Revascularization in Patients With ST-Segment–Elevation Myocardial Infarction and Multivessel Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-26
    Ramón Calviño-Santos, Rodrigo Estévez-Loureiro, Jesús Peteiro-Vázquez, Jorge Salgado-Fernández, Alejandro Rodríguez-Vilela, Raúl Franco-Gutiérrez, Alberto Bouzas-Mosquera, José Ángel Rodríguez-Fernández, Alejandro Mesías-Prego, Carlos González-Juanatey, Guillermo Aldama-López, Pablo Piñón-Esteban, Xacobe Flores-Ríos, Rita Soler-Martín, Teresa Seoane-Pillado, Nicolás Vázquez-González, Javier Muñiz, José Manuel Vázquez-Rodríguez

    Background:Recent trials suggest that complete revascularization in patients with acute ST-segment–elevation myocardial infarction and multivessel disease is associated with better outcomes than infarct-related artery (IRA)–only revascularization. There are different methods to select non-IRA lesions for revascularization procedures. We assessed the clinical outcomes of complete angiographically guided revascularization versus stress echocardiography–guided revascularization in patients with ST-segment–elevation myocardial infarction.Methods:We performed a randomized clinical trial in patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or stress echocardiography–guided revascularization (n=152) of the non-IRA lesions in an elective procedure before hospital discharge.Results:The trial was prematurely stopped after the inclusion of 77% of the planned study population. As many as 152 (99%) patients in the complete revascularization group and 44 (29%) patients in the selective revascularization group required a percutaneous coronary intervention procedure of a non-IRA lesion before discharge. The primary end point occurred in 21 (14%) patients of the stress echocardiography–guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52–1.72; P=0.85).Conclusions:In patients with ST-segment–elevation myocardial infarction and multivessel disease, stress echocardiography–guided revascularization may not be significantly different to complete angiographically guided revascularization, thereby reducing the need for elective revascularization before hospital discharge.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01179126.

    更新日期:2019-09-26
  • Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-25
    Ziad A. Ali, Holger Nef, Javier Escaned, Nikos Werner, Adrian P. Banning, Jonathan M. Hill, Bernard De Bruyne, Matteo Montorfano, Thierry Lefevre, Gregg W. Stone, Aaron Crowley, Mitsuaki Matsumura, Akiko Maehara, Alexandra J. Lansky, Jean Fajadet, Carlo Di Mario

    Background:The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions.Methods:The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events.Results:Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non–Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length.Conclusions:In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.

    更新日期:2019-09-26
  • The Activated Clotting Time Paradox
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-13
    Andrea Pacchioni, Jayme Ferro, Gabriele Pesarini, Riccardo Mantovani, Antonio Mugnolo, Michele Bellamoli, Carlo Penzo, Giuseppe Marchese, Daniela Benedetto, Riccardo Turri, Alfredo Fede, Giovanni Benfari, Salvatore Saccà, Flavio Ribichini, Francesco Versaci, Bernhard Reimers

    Background:Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, and insufficient anticoagulation are all predictors of RAO. However, excessive anticoagulation can lead to longer time to achieve complete hemostasis and less patent hemostasis rate. This study was designed to assess the relationship among residual anticoagulation at the end of a percutaneous coronary procedure and the risk of RAO.Methods:Eight hundred thirty-seven patients undergoing transradial catheterization were enrolled. Activated clotting time (ACT) was measured before sheath removal. Patients were divided into 3 groups according to ACT values (ACT <150 s, ACT between 150 and 249 s, ACT >250 s), patent hemostasis with reverse Barbeau test was attempted in all patients, and compression device removed as soon as possible. Within 24 hours, patency of radial artery was checked by Doppler using reverse Barbeau technique.Results:Incidence of RAO was higher for the extreme ACT values. Patent hemostasis were less frequently obtained and time to hemostasis significantly longer for increasing ACT values (P=0.004 for trend and <0.0001 for trend, respectively). At logistic regression analysis, ACT values <150 s were an independent predictor of RAO (odds ratio, 3.53; 95% IC, 1.677–7.43; P=0.001) while adjusted probability for RAO confirmed U-shaped relationship with ACT values.Conclusions:The level of anticoagulation is strongly related to incidence of RAO and should be measured objectively by ACT.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02762344.

    更新日期:2019-09-14
  • Detection of Device-Related Thrombosis Following Left Atrial Appendage Occlusion
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-13
    Kasper Korsholm, Jesper Møller Jensen, Bjarne Linde Nørgaard, Jens Erik Nielsen-Kudsk

    Background:Device-related thrombosis (DRT) following left atrial appendage occlusion is a rare but feared complication. The diagnostic value of cardiac compute tomography (CT) for detection of DRT is unknown. This study sought to evaluate the clinical value of cardiac CT for detection of DRT using transesophageal echocardiography (TEE) as the reference standard and to provide insights into the causes, natural history, and risk of DRT.Methods:We reviewed 301 consecutive patients undergoing left atrial appendage occlusion at Aarhus University Hospital, Denmark, between 2010 and 2017. Of these, 248 patients had cardiac CT and TEE imaging available at 8-week follow-up; 139 had complete 12-month imaging. A blinded investigator analyzed all images. On TEE, an echo-dense mass attached to the device was defined as DRT. Cardiac CT was analyzed for presence of hypoattenuated thickening (HAT) on the device, which was subclassified as low grade or high grade. High-grade HAT was considered as definite DRT.Results:At 8 weeks, TEE detected 5 (2%) cases with DRT; and cardiac CT 6 (2.4%) cases with high-grade HAT. At 12 months, both TEE and cardiac CT detected 2 (1.4%) cases with DRT or high-grade HAT, respectively. Cardiac CT demonstrated low-grade HAT in 9 (3.6%) cases at 8 weeks; and 13 cases (9.4%) at 12-months. High-grade HAT/DRT was associated with thromboembolism in 2 cases, whereas low-grade HAT was not related to embolic events. Low-grade HAT resolved spontaneously over time.Conclusions:Cardiac CT seems equally good as TEE for detection of DRT. In addition, cardiac CT demonstrates cases with low-grade HAT, not visualized by TEE. The clinical significance hereof requires further investigation.

    更新日期:2019-09-14
  • Experimental Evaluation of a Novel Percutaneous Transseptal Catheter-Based Mitral Valve Replacement Technology
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-12
    Torsten P. Vahl, Aaron Grogan, Yanping Cheng, Genghua Yi, Randolf von Oepen, Omar K. Khalique, Daniel T. Wallace, Thomas Modine, Juan F. Granada

    Background:Transcatheter mitral valve replacement is a novel therapeutic approach aiming to treat patients with severe mitral regurgitation. This study aimed to evaluate the biological and technical performance of a novel transseptal transcatheter mitral valve replacement system (Cephea Valve Technologies, Santa Cruz, CA) in a preclinical model.Methods:Biological performance and healing response were evaluated following open-heart surgical implantation procedures in 10 sheep utilizing an antegrade transatrial access. Valve performance was assessed with fluoroscopy, echocardiography, and histology at 30 (n=2), 60 (n=3), and 90 days (n=5). Feasibility of transseptal valve delivery and performance was tested acutely in 10 pigs.Results:In the chronic studies, all animals survived without problems until completion of the study. The hemodynamics of the study valves were excellent with low rates of paravalvular leak. There was no left ventricular outflow tract obstruction. Pathological evaluation showed excellent position and condition of the mitral implants without evidence for thrombosis, endocarditis, or excessive calcification. Subsequently, mitral valves were implanted in 10 pigs using a dedicated transseptal delivery system. The implants remained in stable position with excellent hemodynamic profile. Correct valve position and function was confirmed by echocardiography and autopsy.Conclusions:The transseptal delivery of the Cephea transcatheter mitral valve replacement system in an experimental model was feasible and safe. The chronic studies demonstrated a favorable healing response. Further human studies are needed to evaluate the performance of this novel valve system in patients with severe mitral regurgitation.

    更新日期:2019-09-12
  • Invasive Management of Out of Hospital Cardiac Arrest
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-12
    Erik M. Kelly, Duane S. Pinto

    Out of hospital cardiac arrest (OHCA) is a major cause of morbidity and mortality worldwide. Clinical decision making is extremely difficult in this understudied patient population with high prevalence of neurological injury and inexorable shock states. As such, there are uncertain benefits from therapies available in the cardiac catheterization laboratory. Fear of futility and public reporting often affects decision making and can result in risk aversion. This review focuses on invasive management in OHCA care, with particular focus on coronary angiography, coronary revascularization, and mechanical support. Guidelines recommend emergency coronary angiography in patients with ST-segment elevations on ECG after OHCA, while the role of coronary angiography in patients without ST-segment elevations is less clear. Similar uncertainty remains in the appropriate revascularization strategy in these patients. As in other areas of cardiology, there is a growing interest in the role of mechanical circulatory support after OHCA, though the available literature shows mixed results. The many uncertainties associated with treating the patient with OHCA highlight the importance of clinical decision support tools and treatment algorithms in the care of this population. This review focuses on invasive management in OHCA care, with particular focus on coronary angiography, coronary revascularization, and mechanical support.

    更新日期:2019-09-12
  • Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-09
    Evan Shlofmitz, Philippe Généreux, Shmuel Chen, Ovidiu Dressler, Ori Ben-Yehuda, Marie-Claude Morice, John D. Puskas, David P. Taggart, David E. Kandzari, Aaron Crowley, Björn Redfors, Ghazaleh Mehdipoor, Arie Pieter Kappetein, Joseph F. Sabik III, Patrick W. Serruys, Gregg W. Stone

    Background:The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial.Methods:The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory–assessed SS using multivariable Cox proportional hazards regression.Results:A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5–74); 24.1% of patients had angiographic core laboratory–assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (Pinteraction=0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (Pinteraction=0.03).Conclusions:In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.

    更新日期:2019-09-09
  • Propensity Score–Adjusted Comparison of Long-Term Outcomes Among Revascularization Strategies for Critical Limb Ischemia
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-09
    Jihad A. Mustapha, Barry T. Katzen, Richard F. Neville, Robert A. Lookstein, Thomas Zeller, Larry E. Miller, Teresa R. Nelson, Michael R. Jaff

    Background:Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia.Methods:In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up.Results:Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent).Conclusions:Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.

    更新日期:2019-09-09
  • Prognostic Value of Coronary Microvascular Function Measured Immediately After Percutaneous Coronary Intervention in Stable Coronary Artery Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-09-06
    Takeshi Nishi, Tadashi Murai, Giovanni Ciccarelli, Sonia V. Shah, Yuhei Kobayashi, François Derimay, Katsuhisa Waseda, Avalon Moonen, Masahiro Hoshino, Atsushi Hirohata, Andy S.C. Yong, Martin K.C. Ng, Tetsuya Amano, Emanuele Barbato, Tsunekazu Kakuta, William F. Fearon

    Background:The prognostic impact of coronary microvascular dysfunction after percutaneous coronary intervention (PCI) remains unclear in patients with stable coronary artery disease. This study sought to investigate the prognostic value of microvascular function measured immediately after PCI in patients with stable coronary artery disease.Methods:We enrolled 572 patients with stable coronary artery disease who underwent PCI and elective measurement of the index of microcirculatory resistance (IMR) immediately after PCI from 8 centers in 4 countries. Impaired microvascular function was defined as IMR≥25 (high IMR). Major adverse cardiac events, including death, myocardial infarction (MI) and target vessel revascularization, were evaluated.Results:During a median follow-up duration of 4.0 years, the cumulative major adverse cardiac events rate was significantly higher in the high IMR group (n=66/148) compared with the low IMR group (n=128/424; hazard ratio [HR], 1.56; 95% CI, 1.16−2.105; P=0.001), primarily due to a higher rate of periprocedural MI (HR, 1.59; 95% CI, 1.11−2.28; P=0.004) but also due to higher rates of mortality (HR, 1.59; 95% CI, 0.76−3.35; P=0.22), spontaneous MI (HR, 2.10; 95% CI, 0.67−6.63; P=0.20) and target vessel revascularization (HR, 1.40; 95% CI, 0.77−2.54; P=0.27). Cumulative risk for death, spontaneous MI, and target vessel revascularization was higher in the high IMR group (HR, 1.55; 95% CI, 0.99−2.43; P=0.056), as was death and spontaneous MI alone (HR, 1.79; 95% CI, 0.96−3.36; P=0.065). On multivariable analysis, high IMR post-PCI was an independent predictor of major adverse cardiac events.Conclusions:IMR measured immediately after PCI predicts adverse events in patients with stable coronary artery disease.

    更新日期:2019-09-06
  • Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-27
    Francesco Costa, Salvatore Brugaletta, Alberto Pernigotti, Eduardo Flores-Ulmanzor, Luis Ortega-Paz, Angel Cequier, Andres Iniguez, Antoni Serra, Pilar Jiménez-Quevedo, Vicente Mainar, Gianluca Campo, Maurizio Tespili, Peter den Heijer, Armando Bethencourt, Nicolás Vazquez, Gerrit Anne van Es, Bianca Backx, Marco Valgimigli, Patrick Serruys, Manel Sabaté

    Background:Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions.Methods:We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated.Results:Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (Pint=0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27–1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34–1.03; P=0.066).Conclusions:Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.

    更新日期:2019-08-27
  • Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-27
    Dean J. Kereiakes, Stephan Windecker, R. Lee Jobe, Shamir R. Mehta, Ian J. Sarembock, Robert L. Feldman, Bernardo Stein, Christophe Dubois, Timothy Grady, Shigeru Saito, Takeshi Kimura, Paul Underwood, Dominic J. Allocco, Ian T. Meredith

    Background:The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY.Methods:Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25–≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS Element Plus (N=846). EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203).Results:The 5-year target lesion failure rate was 14.3% for SYNERGY and 14.2% for PROMUS Element Plus (P=0.91). Landmark analysis demonstrated similar rates of target lesion failure from discharge to 1-year (P=0.90) and from 1 to 5 years (P=0.94). Definite/probable stent thrombosis was infrequent in both arms (SYNERGY 0.7% versus PROMUS Element Plus 0.9%; P=0.75). There were no significant differences in the rates of cardiac death, myocardial infarction, or revascularization. Among patients with diabetes mellitus, the target lesion failure rate to 1-year was noninferior to a prespecified performance goal and to 5 years was 17.0%.Conclusions:SYNERGY demonstrated comparable outcomes to PROMUS Element Plus, with low rates of stent thrombosis and adverse events through 5 years of follow-up. Five-year clinical outcomes were favorable in patients with diabetes mellitus. These data support the long-term safety and effectiveness of SYNERGY in a broad range of patients.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01665053.

    更新日期:2019-08-27
  • Site Variation and Outcomes for Antithrombotic Therapy in Atrial Fibrillation Patients After Percutaneous Coronary Intervention
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-16
    Christoph B. Olivier, Jun Fan, Mariam Askari, Kenneth W. Mahaffey, Paul A. Heidenreich, Alexander C. Perino, George C. Leef, P. Michael Ho, Robert A. Harrington, Mintu P. Turakhia

    Background:Patients with atrial fibrillation (AF) treated with percutaneous coronary intervention (PCI) require multiple antithrombotic therapies. The optimal strategy is debated suggesting increased treatment variation. This study sought to characterize site-level variation in antithrombotic therapies in AF patients after PCI and determine the association with outcomes.Methods:Using the retrospective TREAT-AF study (The Retrospective Evaluation and Assessment of Therapies in AF) from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2015 followed by a PCI with a P2Y12-antagonist prescription were identified. Patients were grouped according to the therapy dispensed 7 days before until 30 days after the PCI: oral anticoagulation plus platelet inhibition (OAC+PI) or platelet inhibition only. A combined outcome of death, myocardial infarction, stroke, or major bleeding was assessed 1 year after PCI and Cox regression was performed to estimate hazard ratios.Results:Of 230 762 patients with newly diagnosed AF, 4042 (1.8%) underwent PCI and received a P2Y12-antagonist during the observation period (age, 67±9 years; CHA2DS2-VASc, 2.7±1.7; HAS-BLED, 2.6±1.2). Among these, 47% were prescribed OAC+PI, and 53% platelet inhibition only 7 days before until 30 days after the PCI. Across 63 sites, the use of OAC+PI ranged from 19% to 66%. Prescription of OAC+PI was independently associated with a reduction in the combined outcome of death, myocardial infarction, stroke, or major bleeding compared with platelet inhibition only (adjusted hazard ratio, 0.85; 95% CI, 0.73–0.99; P=0.033).Conclusions:In patients with established AF undergoing PCI, the use of OAC+PI varied substantially across sites in the 30 days post-PCI. Anticoagulation appeared to be underutilized but was associated with improved outcomes. Strategies to promote OAC+PI and minimize site variation may be useful, particularly in light of recent randomized trials.

    更新日期:2019-08-16
  • Examining the Operator Learning Curve for Percutaneous Coronary Intervention of Chronic Total Occlusions
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-16
    Michael N. Young, Eric A. Secemsky, Lisa A. Kaltenbach, Farouc A. Jaffer, James A. Grantham, Sunil V. Rao, Robert W. Yeh

    Background:Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined.Methods:Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting.Results:Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98–1.03, P=0.7980).Conclusions:Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation.

    更新日期:2019-08-16
  • Coronary Microcirculation in Aortic Stenosis
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-16
    Hannah Z.R. McConkey, Michael Marber, Amedeo Chiribiri, Philippe Pibarot, Simon R. Redwood, Bernard D. Prendergast

    Aortic stenosis is a heterogeneous disorder. Variations in the pathological and physiological responses to pressure overload are incompletely understood and generate a range of flow and pressure gradient patterns, which ultimately cause varying microvascular effects. The impact of cardiac-coronary coupling depends on these pressure and flow effects. In this article, we explore important concepts concerning cardiac physiology and the coronary microcirculation in aortic stenosis and their impact on myocardial remodeling, aortic valve flow patterns, and clinical progression.

    更新日期:2019-08-16
  • Quantification of Myocardial Mass Subtended by a Coronary Stenosis Using Intracoronary Physiology
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-06
    Tadashi Murai, Tim P. van de Hoef, Thomas P.W. van den Boogert, Gilbert W.M. Wijntjens, Valérie E. Stegehuis, Mauro Echavarria-Pinto, Masahiro Hoshino, Taishi Yonetsu, R. Nils Planken, José P.S. Henriques, Javier Escaned, Tsunekazu Kakuta, Jan J. Piek

    Background:In patients with stable coronary artery disease, the amount of myocardium subtended by coronary stenoses constitutes a major determinant of prognosis, as well as of the benefit of coronary revascularization. We devised a novel method to estimate partial myocardial mass (PMM; ie, the amount of myocardium subtended by a stenosis) during physiological stenosis interrogation. Subsequently, we validated the index against equivalent PMM values derived from applying the Voronoi algorithm on coronary computed tomography angiography.Methods:Based on the myocardial metabolic demand and blood supply, PMM was calculated as follows: PMM (g)=APV×D2×π/(1.24×10−3×HR×sBP+1.6), where APV indicates average peak blood flow velocity; D, vessel diameter; HR, heart rate; and sBP, systolic blood pressure. We calculated PMM to 43 coronary vessels (32 patients) interrogated with pressure and Doppler guidewires, and compared it with computed tomography–based PMM.Results:Median PMM was 15.8 g (Q1, Q3: 11.7, 28.4 g) for physiology-based PMM, and 17.0 g (Q1, Q3: 12.5, 25.9 g) for computed tomography–based PMM (P=0.84). Spearman rank correlation coefficient was 0.916 (P<0.001), and Passing-Bablok analysis revealed absence of both constant and proportional differences (coefficient A: −0.9; 95% CI, −4.5 to 0.9; and coefficient B, 1.00; 95% CI, 0.91 to 1.25]. Bland-Altman analysis documented a mean bias of 0.5 g (limit of agreement: −9.1 to 10.2 g).Conclusions:Physiology-based calculation of PMM in the catheterization laboratory is feasible and can be accurately performed as part of functional stenosis assessment.

    更新日期:2019-08-06
  • Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-06
    Juan F. Iglesias, Dik Heg, Marco Roffi, David Tüller, Stéphane Noble, Olivier Muller, Igal Moarof, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Florim Cuculi, Jonas Häner, Peter Jüni, Stephan Windecker, Thomas Pilgrim

    Background:Randomized trials evaluating the Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES; 60 and 80 μm strut thickness for stent diameters ≤3 and >3 mm, respectively) did not stratify according to vessel size and failed to specify the impact of ultrathin-strut thickness on long-term clinical outcomes compared with durable polymer everolimus-eluting stents (DP-EES). We sought to assess the long-term effect of ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES on long-term outcomes in patients undergoing percutaneous coronary revascularization for small vessel disease.Methods:In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years.Results:Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94–1.58; P=0.13). Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis at 5 years were similar in patients treated with ultrathin-strut BP-SES and thin-strut DP-EES. After adjustment for potential confounders, there was no significant interaction between vessel size and treatment effect of BP-SES versus DP-EES.Conclusions:We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

    更新日期:2019-08-06
  • Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-08-05
    Mandy D. Müller, Stefanie von Felten, Ale Algra, Jean-Pierre Becquemin, Richard Bulbulia, David Calvet, Hans-Henning Eckstein, Gustav Fraedrich, Alison Halliday, Jeroen Hendrikse, George Howard, John Gregson, Olav Jansen, Martin M. Brown, Jean-Louis Mas, Thomas G. Brott, Peter A. Ringleb, Leo H. Bonati

    Background:Over the past decades, stroke risk associated with carotid disease has decreased, reflecting improvements in medical therapy and a more rigorous control of vascular risk factors. It is less clear whether the procedural risk of carotid revascularization has declined over time.Methods:We analyzed temporal changes in procedural risks among 4597 patients with symptomatic carotid stenosis treated with carotid artery stenting (n=2326) or carotid endarterectomy (n=2271) in 4 randomized trials between 2000 and 2008, using generalized linear mixed-effects models with a random intercept for each source trial. Models were additionally adjusted for age and other baseline characteristics predicting treatment risk. The primary outcome event was any procedural stroke or death, occurring during or within 30 days after revascularization.Results:The procedural stroke or death risk decreased significantly over time in all patients (unadjusted odds ratio per year, 0.91; 95% CI, 0.85–0.97; P=0.006). This effect was driven by a decrease in the carotid endarterectomy group (unadjusted odds ratio per year, 0.82; 95% CI, 0.73–0.92; P=0.003), whereas no significant decrease was found after carotid artery stenting (unadjusted odds ratio, 0.96; 95% CI, 0.88–1.04; P=0.33). Carotid endarterectomy patients had a lower procedural stroke or death risk compared with carotid artery stenting patients, and the difference significantly increased over time (interaction P=0.031). After adjustment for baseline characteristics, the results remained essentially the same.Conclusions:The risk of stroke or death associated with carotid endarterectomy for symptomatic carotid stenosis decreased over an 8-year period, independent of clinical predictors of procedural risk. No corresponding reduction in procedural risk was seen in patients treated with stenting.Clinical Trial Registration:URL: https://www.clinicaltrials.gov; http://www.isrctn.com. Unique identifier: NCT00190398 (EVA-3S), NCT00004732 (CREST), ISRCTN57874028 (SPACE), and ISRCTN25337470 (ICSS).

    更新日期:2019-08-05
  • Invasive Versus Medical Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-07-31
    Matthew M.Y. Lee, Mark C. Petrie, Paul Rocchiccioli, Joanne Simpson, Colette E. Jackson, David S. Corcoran, Kenneth Mangion, Ammani Brown, Pio Cialdella, Novalia P. Sidik, Margaret B. McEntegart, Aadil Shaukat, Alan P. Rae, Stuart H.M. Hood, Eileen E. Peat, Iain N. Findlay, Clare L. Murphy, Alistair J. Cormack, Nikolay B. Bukov, Kanarath P. Balachandran, Keith G. Oldroyd, Ian Ford, Olivia Wu, Alex McConnachie, Sarah J.E. Barry, Colin Berry, on behalf of the CABG-ACS Investigators

    Background:The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials.Methods:In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function).Results:Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years’ follow-up (median [interquartile range], 744 [570–853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months.Conclusions:More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751.

    更新日期:2019-07-31
  • Transcatheter Aortic Valve Replacement With the HLT Meridian Valve
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-07-31
    Josep Rodés-Cabau, Mathew R. Williams, Harindra C. Wijeysundera, Dean J. Kereiakes, Jean-Michel Paradis, Cezar Staniloae, Muhamed Saric, Sam Radhakrishnan, Robert F. Wilson, Spencer H. Kubo

    Background:While most self-expanding transcatheter valves are repositionable, only one fully retrievable valve is currently available. The Meridian valve is a new self-expanding valve with full retrievability properties. The objective of our study was to evaluate the early feasibility, preliminary safety, and efficacy of transcatheter aortic valve replacement with the HLT Meridian valve (HLT, Inc).Methods:This was a multicenter early feasibility study including patients with severe aortic stenosis at high surgical risk undergoing transfemoral transcatheter aortic valve replacement with the 25-mm Meridian valve. All serious adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiography data were assessed by an independent echocardiography core laboratory.Results:A total of 25 patients (mean age, 85±6 years; 80% of men) were included. The valve was successfully implanted in 22 (88%) patients (annulus too large and extreme horizontal aorta in 2 and 1 unsuccessful cases, respectively). Valve retrieval because of an initial nonadequate positioning was attempted and successfully performed in 10 (40%) patients. Echocardiography post-transcatheter aortic valve replacement showed a low mean residual gradient (10±4 mm Hg) and the absence of moderate-severe aortic regurgitation (none-trace and mild aortic regurgitation in 76% and 24% of patients, respectively). Mortality at 30 days was 8%, with no cases of disabling stroke, valve embolization, or major/life-threatening bleeding complications. At 6-month follow-up, the cumulative mortality rate was 12%, with no changes in echocardiographic parameters and no cases of valve dysfunction. The majority of patients (89%) were in New York Heart Association class I-II at 6 months.Conclusions:Transcatheter aortic valve replacement with the Meridian valve was feasible and associated with acceptable early and 6-month clinical results. Valve retrieval after full valve deployment was successfully performed in all attempted cases, and valve performance was excellent, with low residual gradients, no cases of moderate-severe aortic regurgitation, and none-trace residual aortic regurgitation in the majority of patients.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02838680 (RADIANT-Canada); NCT02799823 (RADIANT-US).

    更新日期:2019-07-31
  • Better Prognosis After Complete Revascularization Using Contemporary Coronary Stents in Patients With Chronic Kidney Disease
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-07-26
    Doyeon Hwang, Jeehoon Kang, Han-Mo Yang, Seokhun Yang, Jiesuck Park, Jung-Kyu Han, Hyun-Jae Kang, Bon-Kwon Koo, Hyo-Soo Kim

    Background:The prognostic value of angiographic complete revascularization in patients with chronic kidney disease (CKD) has not been thoroughly investigated, especially for contemporary coronary stents. We compared the clinical outcomes of complete and incomplete revascularization with second-generation drug-eluting stent, according to the presence of CKD.Methods:From the Grand Drug-Eluting Stent Registry (N=17 286) in Korea, we selected 8471 patients, who were treated with second-generation drug-eluting stent and had glomerular filtration rate and quantitative coronary angiography data (3014 [35.6%] patients with CKD and 5457 (64.4%) patients with preserved renal function). Angiographic complete revascularization was defined as a residual SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) of 0. The primary outcome was the patient-oriented composite outcome at 3 years, including all-cause death, any myocardial infarction, and any revascularization.Results:The patient-oriented composite outcome rate after complete revascularization was significantly lower than that after incomplete revascularization in patients with CKD (14.6% versus 21.8%; adjusted hazard ratio, 0.79; 95% CI, 0.64–0.96; P=0.020) and in patients with preserved renal function (8.0% versus 12.0%; adjusted hazard ratio 0.77; 95% CI, 0.63–0.94; P=0.011). The cutoff values of residual SYNTAX scores for predicting better patient-oriented composite outcomes were different according to the presence of CKD, that is, <3 and <8 in patients with CKD and with preserved renal function, respectively.Conclusions:Angiographic complete revascularization led to better clinical outcomes in patients with CKD and with preserved renal function. However, the residual SYNTAX score to achieve a better outcome was lower in patients with CKD than with preserved renal function, favoring more aggressive revascularization in patients with CKD.

    更新日期:2019-07-26
  • Restenosis of Drug-Eluting Stents
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-07-26
    Evan Shlofmitz, Micaela Iantorno, Ron Waksman

    Despite on-going evolution and iteration of drug-eluting stent (DES) technology, the prevalence of in-stent restenosis (ISR) remains relatively unchanged, encompassing ≈10% of percutaneous coronary interventions. The mechanism of ISR is multifactorial, including biological, mechanical, patient, and operator-related factors. The main mechanical contributors are stent underexpansion or fracture, while biological factors include local inflammation leading to aggressive neointimal proliferation and late neoatherosclerosis. Intracoronary imaging is critical to identify the mechanism of ISR and tailor therapy accordingly. The presentation of DES-ISR is not benign and is challenging for optimal treatment. Among the proposed treatment modalities are scoring and high-pressure balloons, percutaneous coronary intervention with additional DES, atheroablative therapies by laser or mechanical atherectomy, drug-coated balloons, vascular brachytherapy, and surgical revascularization. We propose a new classification for ISR that differentiates among mechanical, biological, and mixed etiologies. Stratifying ISR by mechanism guides individualized treatment of DES-ISR to improve clinical outcomes. An algorithmic approach, guided by intracoronary imaging, for the treatment of DES-ISR, is recommended based on the specific cause of restenosis.

    更新日期:2019-07-26
  • Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-07-01
    Christoph B. Olivier, Deepak L. Bhatt, Sergio Leonardi, Gregg W. Stone, C. Michael Gibson, Ph. Gabriel Steg, Christian W. Hamm, Matthew D. Wilson, Stacey Mangum, Matthew J. Price, Jayne Prats, Harvey D. White, Renato D. Lopes, Robert A. Harrington, Kenneth W. Mahaffey, on Behalf of the CHAMPION PHOENIX Investigators*

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    更新日期:2019-07-12
  • Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device
    Circ. Cardiovasc. Interv. (IF 6.060) Pub Date : 2019-07-01
    David A. Wood, Zvonimir Krajcer, Janarthanan Sathananthan, Neil Strickman, Chris Metzger, William Fearon, Mark Aziz, Lowell F. Satler, Ron Waksman, Marvin Eng, Samir Kapadia, Adam Greenbaum, Molly Szerlip, David Heimansohn, Andrew Sampson, Paul Coady, Roberto Rodriguez, Amar Krishnaswamy, Jason T. Lee, Itsik Ben-Dor, Sina Moainie, Susheel Kodali, Adnan K. Chhatriwalla, Pradeep Yadav, Brian O’Neill, Mark Kozak, John M. Bacharach, Ted Feldman, Mayra Guerrero, Aravinda Nanjundappa, Robert Bersin, Ming Zhang, Srinivasa Potluri, Colin Barker, Nelson Bernardo, Alan Lumsden, Andrew Barleben, John Campbell, David J. Cohen, Michael Dake, David Brown, Nathaniel Maor, Samuel Nardone, Sandra Lauck, William W. O’Neill, John G. Webb, on behalf of the SAFE MANTA Study Investigators

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    更新日期:2019-07-12
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