Real-world outcomes and management considerations following surgical aortic valve replacement with the Trifecta valve.

IF 1.6 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Cardiovascular Revascularization Medicine Pub Date : 2024-10-28 DOI:10.1016/j.carrev.2024.10.011

Dan Gutfinger, Ibrahim Sultan, Gorav Ailawadi, Danny Ramzy, Tsuyoshi Kaneko, Yang Yu, Geetanjali Meka, Julie B Prillinger, Joseph E Bavaria

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Abstract

Background: Bioprosthetic surgical aortic valve replacement (SAVR) using the Trifecta valve was frequently chosen because of its large opening area and low transvalvular gradient. However, long-term follow-up revealed the potential for early structural valve deterioration. To further assess the long-term clinical outcomes and management considerations for patients implanted with the Trifecta valve, a real-world study using Medicare fee-for-service claims data was conducted with a focus on Trifecta valve reintervention.

Methods: De-identified patients undergoing SAVR with the Trifecta™ valve (Abbott) in the U.S. between 1/1/2011-12/31/2021 were selected by ICD-9/10 procedure codes and then linked to a manufacturer device tracking database. All-cause mortality and freedom from Trifecta valve reintervention with repeat SAVR or valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) were evaluated at 10-years using the Kaplan Meier method. Independent predictors for reintervention and clinical outcomes following reintervention were assessed.

Results: Among 242,160 Medicare beneficiaries undergoing SAVR during the study period, 23,197 were implanted with the Trifecta valve. Mean age was 75.2 ± 7.4 years. At 10-years survival was 32.3 % (95 % CI, 31.4 %-33.3 %) and the freedom from valve reintervention was 82.4 % (95 % CI, 81.1 %-83.5 %). Independent predictors for reintervention included younger age, female, obesity, and implants with a small valve size (19 mm, 21 mm). Reintervention with ViV-TAVI (N = 796) was associated with better operative survival (3.8 % vs. 12.5 %, p < 0.001) than repeat SAVR (N = 577).

Conclusion: This real-world nationwide study of Medicare beneficiaries receiving the Trifecta valve demonstrates >80 % freedom from all-cause valve reintervention at 10-years post-implant with reintervention using ViV-TAVI having improved operative survival compared to repeat SAVR.

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使用 Trifecta 瓣膜进行主动脉瓣置换手术后的实际效果和管理注意事项。

背景：使用Trifecta瓣膜的生物人工主动脉瓣置换术（SAVR）因其开口面积大、跨瓣梯度低而经常被选用。然而，长期随访发现，瓣膜结构有可能出现早期退化。为了进一步评估植入Trifecta瓣膜患者的长期临床结果和管理注意事项，我们利用医疗保险付费服务理赔数据进行了一项真实世界研究，重点关注Trifecta瓣膜再介入：方法：根据 ICD-9/10 手术代码筛选出 2011 年 1 月 1 日至 2021 年 12 月 31 日期间在美国接受 Trifecta™ 瓣膜（雅培）SAVR 手术的身份不明患者，然后将其与制造商设备跟踪数据库相连。采用 Kaplan Meier 法评估了 10 年后的全因死亡率和通过重复 SAVR 或瓣中瓣经导管主动脉瓣植入术（ViV-TAVI）进行 Trifecta 瓣膜再介入的自由度。评估了再介入的独立预测因素和再介入后的临床结果：在研究期间接受 SAVR 手术的 242,160 名医疗保险受益人中，23,197 人植入了 Trifecta 瓣膜。平均年龄为 75.2 ± 7.4 岁。10年生存率为32.3%（95% CI，31.4%-33.3%），瓣膜再介入率为82.4%（95% CI，81.1%-83.5%）。再介入的独立预测因素包括年龄较小、女性、肥胖以及植入的瓣膜尺寸较小（19 毫米、21 毫米）。使用 ViV-TAVI 进行再介入（N = 796）与较高的手术存活率相关（3.8% 对 12.5%，P 结论：这项针对接受Trifecta瓣膜治疗的医保受益人进行的全国性真实研究表明，在植入瓣膜后10年，80%以上的患者不会因各种原因再次进行瓣膜介入治疗，与再次进行SAVR相比，使用ViV-TAVI进行再次介入治疗的手术生存率更高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cardiovascular Revascularization Medicine CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

3.30

自引率

5.90%

发文量

687

审稿时长

36 days

期刊介绍： Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.