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Alcohol-Mediated Renal Denervation Using the Peregrine System Infusion Catheter for Treatment of Hypertension.
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2020-02-24 , DOI: 10.1016/j.jcin.2019.10.048 Felix Mahfoud 1 , Jean Renkin 2 , Horst Sievert 3 , Stefan Bertog 4 , Sebastian Ewen 1 , Michael Böhm 1 , Jean-Philippe Lengelé 2 , Wojciech Wojakowski 5 , Roland Schmieder 6 , Markus van der Giet 7 , Helen Parise 8 , Nicole Haratani 9 , Atul Pathak 10 , Alexandre Persu 2
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2020-02-24 , DOI: 10.1016/j.jcin.2019.10.048 Felix Mahfoud 1 , Jean Renkin 2 , Horst Sievert 3 , Stefan Bertog 4 , Sebastian Ewen 1 , Michael Böhm 1 , Jean-Philippe Lengelé 2 , Wojciech Wojakowski 5 , Roland Schmieder 6 , Markus van der Giet 7 , Helen Parise 8 , Nicole Haratani 9 , Atul Pathak 10 , Alexandre Persu 2
Affiliation
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OBJECTIVES
The aim of this multicenter, open-label trial was to evaluate the safety and efficacy of alcohol-mediated renal denervation using a novel catheter system (the Peregrine System Infusion Catheter) for the infusion of dehydrated alcohol as a neurolytic agent into the renal periarterial space.
BACKGROUND
The number of hypertensive patients with uncontrolled blood pressure (BP) remains unacceptably low. The renal sympathetic nervous system has been identified as an attractive therapeutic target.
METHODS
Forty-five patients with uncontrolled hypertension on ≥3 antihypertensive medications underwent bilateral renal denervation using the Peregrine Catheter with 0.6 ml alcohol infused per renal artery.
RESULTS
All patients were treated as intended. Mean 24-h ambulatory BP reduction at 6 months versus baseline was -11 mm Hg (95% confidence interval [CI]: -15 to -7 mm Hg) for systolic BP and -7 mm Hg (95% CI: -9 to -4 mm Hg) for diastolic BP (p < 0.001 for both). Office systolic BP was reduced by -18/-10 mm Hg (95% CI: -25 to -12/-13 to -6 mm Hg) at 6 months. Antihypertensive medications were reduced in 23% and increased in 5% of patients at 6 months. Adherence to the antihypertensive regimen remained stable over time. The primary safety endpoint, defined as the absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within 1 month, was met in 96% of patients (95% CI: 85% to 99%). Two patients had major adverse events of periprocedural access-site pseudoaneurysms, with major bleeding in one. There were no deaths or instances of myocardial infarction, stroke, transient ischemic attack, or renal artery stenosis. Transient microleaks were noted in 42% and 49% of the left and right main renal arteries, respectively. There were 2 cases of minor vessel dissection that resolved without treatment.
CONCLUSIONS
Primary results from this trial suggest that alcohol-mediated renal denervation using the Peregrine Catheter safely reduces blood pressure and as such may represent a novel approach for the treatment of hypertension.
中文翻译：
使用百富勤系统输注导管进行酒精介导的肾脏去神经支配治疗高血压。
目的这项开放性试验的目的是评估使用新型导管系统（Peregrine System输液导管）将脱水酒精作为神经溶解剂输注到肾动脉的酒精介导的肾脏去神经的安全性和有效性。空间。背景技术血压不受控制的高血压患者的数量仍然低得令人无法接受。肾交感神经系统已被确定为有吸引力的治疗靶标。方法对45例使用3种以上降压药物的高血压患者进行控制，使用Peregrine导管行双侧肾神经支配，每支肾动脉注入0.6 ml酒精。结果所有患者均按预期治疗。与基线相比，在6个月时平均24小时动态血压降低为-11 mm Hg（95％置信区间[CI]：-15至-7 mm Hg）和-7 mm Hg（95％CI：-9至9 -4 mm Hg）舒张压（两者均p <0.001）。在6个月时，办公室收缩压降低了-18 / -10 mm Hg（95％CI：-25至-12 / -13至-6 mm Hg）。在6个月时，降压药物的使用率降低了23％，而增加了5％。随着时间的推移，对降压方案的依从性保持稳定。96％的患者达到了主要安全终点，定义为无围手术期主要血管并发症，大出血，急性肾损伤或1个月内死亡。（95％CI：85％至99％）。2例患者有严重的围手术期假性动脉瘤不良事件，其中1例发生大出血。没有死亡或心肌梗塞，中风，短暂性脑缺血发作或肾动脉狭窄的病例。分别在左和右主肾动脉的42％和49％中观察到短暂的微渗漏。有2例未进行治疗的小血管夹层情况得以解决。结论该试验的主要结果表明，使用百富勤导管进行酒精介导的肾神经去神经术可安全降低血压，因此可能代表了一种治疗高血压的新方法。
更新日期：2020-02-20
中文翻译：
使用百富勤系统输注导管进行酒精介导的肾脏去神经支配治疗高血压。
目的这项开放性试验的目的是评估使用新型导管系统（Peregrine System输液导管）将脱水酒精作为神经溶解剂输注到肾动脉的酒精介导的肾脏去神经的安全性和有效性。空间。背景技术血压不受控制的高血压患者的数量仍然低得令人无法接受。肾交感神经系统已被确定为有吸引力的治疗靶标。方法对45例使用3种以上降压药物的高血压患者进行控制，使用Peregrine导管行双侧肾神经支配，每支肾动脉注入0.6 ml酒精。结果所有患者均按预期治疗。与基线相比，在6个月时平均24小时动态血压降低为-11 mm Hg（95％置信区间[CI]：-15至-7 mm Hg）和-7 mm Hg（95％CI：-9至9 -4 mm Hg）舒张压（两者均p <0.001）。在6个月时，办公室收缩压降低了-18 / -10 mm Hg（95％CI：-25至-12 / -13至-6 mm Hg）。在6个月时，降压药物的使用率降低了23％，而增加了5％。随着时间的推移，对降压方案的依从性保持稳定。96％的患者达到了主要安全终点，定义为无围手术期主要血管并发症，大出血，急性肾损伤或1个月内死亡。（95％CI：85％至99％）。2例患者有严重的围手术期假性动脉瘤不良事件，其中1例发生大出血。没有死亡或心肌梗塞，中风，短暂性脑缺血发作或肾动脉狭窄的病例。分别在左和右主肾动脉的42％和49％中观察到短暂的微渗漏。有2例未进行治疗的小血管夹层情况得以解决。结论该试验的主要结果表明，使用百富勤导管进行酒精介导的肾神经去神经术可安全降低血压，因此可能代表了一种治疗高血压的新方法。
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