Background

In the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India).

Materials and methods

A total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study.

Results

The mean age of the study population was 83 (75–87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3–7) days.

Conclusion

Based on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves.

中文翻译：

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新型球囊扩张型 Myval 经导管主动脉瓣的初步体验：初步研究

背景

在本文中，我们介绍了我们对新型球囊扩张型 Myval 瓣膜（Meril Life Sciences，Gujarat，印度）的首次体验。

材料和方法

该研究共纳入 25 例从 2020 年 6 月至 2020 年 11 月连续接受经导管主动脉瓣植入术（TAVI）的患者。

结果

研究人群的平均年龄为 83（75-87）岁；17 人（68%）为女性，20 人（80%）患有高血压。该组胸外科医师协会（STS）评分为5.4%±3.5%。所有患者均通过经股动脉途径进行 TAVI。在 19 例 (76%) 病例中，我们在没有预扩张的情况下开始了手术。在未进行预扩张的两个 (10.5%) 病例中，假体未通过天然瓣膜。我们不得不在一名 (4%) 患者中从降主动脉植入瓣膜。我们为 6 名 (24%) 患者使用 Prostar XL (Abbott Vascular, Santa Clara, CA, USA)，为 19 名 (76%) 患者使用 ProGlide (Abbott Vascular) 进行血管闭合。在我们的研究中发生了两例 (8%) 住院死亡，但在 30 天和 90 天的随访中没有死亡。一名（4%）患者出现血管并发症。我们研究中的患者均未出现严重的瓣周漏 (PVL)，而两名 (8%) 患者出现中度 PVL。两名 (8%) 患者需要永久性起搏器 (PPM) 以指示完全房室传导阻滞。整个组的平均住院时间为 4 (3-7) 天。

结论

根据我们的经验，新型球囊扩张瓣膜 Myval 易于使用、高效，并且只有几个可忽略的缺点，例如需要对鞘管进行预扩张。虽然轴的灵活性在某些情况下可能具有优势，包括在非常曲折的动脉中，但它可能会导致瓣膜对齐方面的一些困难。