Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry

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• 作者：Vinayak Bapat ; MD^a ; ^{vnbapat@yahoo.com" class="auth_mail" title="E-mail the corresponding author} ; Derk Frank ; MD^b ; Ricardo Cocchieri ; MD^c ; Dariusz Jagielak ; MD^d ; Nikolaos Bonaros ; MD^e ; Marco Aiello ; MD^f ; Joel Lapeze ; MD^g ; Mika Laine ; MD^h ; Sidney Chocron ; MDⁱ ; Douglas Muir ; MD^j ; Walter Eichinger ; MD^k ; Matthias Thielmann ; MD^l ; Louis Labrousse ; MD^m ; Kjell Arne Rein ; MDⁿ ; Jean-Philippe Verhoye ; MD^o ; Gino Gerosa ; MD^p ; Hardy Baumbach ; MD^q ; Peter Bramlage ; MD^r ; Cornelia Deutsch ; MD^r ; Martin Thoenes ; MD^s ; Mauro Romano ; MD^t
• 关键词：access ; TAVR ; transaortic ; transapical ; transcatheter heart valve ; transfemoral
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：12 September 2016
• 年：2016
• 卷：9
• 期：17
• 页码：1815-1822
• 全文大小：309 K

文摘

The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).

Background

TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.

Methods

ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.

Results

A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.

Conclusions

TAo access for TAVR seems to be a safe alternative to the transapical procedure.