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Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†.

ABSTRACT: OBJECTIVES:The Edwards INTUITY Valve System is a balloon-expandable bioprosthesis, inspired from the Edwards Magna valve and transcatheter technology, with a subvalvular stent frame to enable rapid deployment. We report a single-centre experience of aortic valve replacement with this novel bioprosthesis. METHODS:Five hundred consecutive patients, of whom 45.6% were female with a mean age of 73.5 [standard deviation (SD) 7.9?years], with severe aortic stenosis who received a rapid deployment aortic valve between May 2010 and July 2017 were included in a prospective and ongoing database. The median follow-up time was 12?months, and the total accumulated follow-up time was 818 patient years. Preoperative characteristics, operative parameters, survival, valve-related adverse events and valve haemodynamics were assessed. RESULTS:Thirty-day mortality was 0.8% (4/500), and overall survival at 1, 3 and 5 years was 94%, 89% and 81%, respectively. A minimally invasive surgical approach was chosen in 236 patients (47%), of which 122 (24%) were operated on through an anterior right thoracotomy. Cross-clamp and cardiopulmonary bypass times for isolated aortic valve replacement were 53 (SD 17) and 89 (SD 29) min for full sternotomy as well as 75 (SD 23) and 110 (SD 31) min for minimally invasive surgery approaches (P?

SUBMITTER: Andreas M

PROVIDER: S-EPMC6381385 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†.

Andreas Martin M Coti Iuliana I Rosenhek Raphael R Shabanian Shiva S Mahr Stephane S Uyanik-Uenal Keziban K Wiedemann Dominik D Binder Thomas T Kocher Alfred A Laufer Guenther G

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20190301 3

<h4>Objectives</h4>The Edwards INTUITY Valve System is a balloon-expandable bioprosthesis, inspired from the Edwards Magna valve and transcatheter technology, with a subvalvular stent frame to enable rapid deployment. We report a single-centre experience of aortic valve replacement with this novel bioprosthesis.<h4>Methods</h4>Five hundred consecutive patients, of whom 45.6% were female with a mean age of 73.5 [standard deviation (SD) 7.9 years], with severe aortic stenosis who received a rapid ...[more]

PMID: 30137264

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Project description:Degenerative aortic stenosis is the most frequent valvular heart disease in industrialized countries. Conservative treatment may beneficially influence symptoms but is never successful. Surgical aortic valve replacement (SAVR) was the only recognized treatment option to provide substantially prolonged survival until 2008. Operative mortality of isolated SAVR has been reported as low as 0.5% to 1% in experienced institutions, while long-term survival is close to that observed in a control healthy population of similar age. A multitude of studies have demonstrated the beneficial effects of SAVR with regard to improvement in quality of life and physical performance in the majority of symptomatic patients. In the last decade, transcatheter aortic valve implantation (TAVI) has emerged as an equal treatment modality, first in patients with high surgical risk and more recently in patients with intermediate and low surgical risk. Paravalvular regurgitation and the higher rate of pacemaker implantation remain points of consideration. Additionally, the long-term durability of TAVI devices and occurrence of stroke late after TAVI require additional analyses. Sutureless (SU-SAVR) and rapid deployment valve (R-SAVR) were designed to simplify and accelerate a conventional or less invasive surgical procedure while allowing complete excision of the calcified native valve. From 3 different implants tested more than 10 to 15 years ago, only two are available on the market today: the Perceval® valve from Liva Nova and the Intuity® sutureless prosthesis from Edwards Lifesciences. There has been extensive experience with these two devices in previous years and the results obtained are comparable to those observed following the use of conventional implants. The sutureless devices may be of particular interest for more complex and combined surgical procedures. This review summarizes the sutureless (SU-SAVR) and rapid deployment valve technologies and presents a clinical outlook for the patient population managed with these devices.

Project description:ObjectivesSutureless and rapid-deployment valves were recently introduced into clinical practice. The Edwards INTUITY valve system is a combination of the Edwards Magna pericardial valve and a subvalvular stent-frame to enable rapid deployment. We performed a parallel cohort study for comparison of the two valve types.MethodsAll patients receiving either an Edwards Magna Ease valve or an Edwards INTUITY valve system due to aortic stenosis from May 2010 until July 2014 were included. Patients undergoing bypass surgery, an additional valve procedure, atrial ablation surgery or replacement of the ascending aorta were excluded. Preoperative characteristics, operative specifications, survival, valve-related adverse events and transvalvulvar gradients were compared.ResultsOne hundred sixteen patients underwent rapid-deployment aortic valve replacement [mean age 75 years (SD: 8); 62% female] and 132 patients underwent conventional aortic valve replacement [70 years (SD: 9); 31% female; P < 0.001]. Conventional valve patients were taller and heavier. The mean EuroSCORE II was 3.1% (SD: 2.7) and 4.4% (SD: 6.0) for rapid-deployment and conventional valve patients, respectively (P = 0.085). The mean implanted valve size was higher in the conventional group [23.2 mm (SD: 2.0) vs 22.5 mm (SD: 2.2); P = 0.007], but postoperative transvalvular mean gradients were comparable [15 mmHg (SD: 6) vs 14 mmHg (SD: 5); P = 0.457]. A subgroup analysis of the most common valve sizes (21 and 23 mm; implanted in 63% of patients) revealed significantly reduced mean postoperative transvalvular gradients in the rapid-deployment group [14 mmHg (SD: 4) vs 16 mmHg (SD: 5); P = 0.025]. A significantly higher percentage received minimally invasive procedures in the rapid-deployment group (59 vs 39%; P < 0.001). The 1- and 3-year survival rate was 96 and 90% in the rapid-deployment group and 95 and 89% in the conventional group (P = 0.521), respectively. Valve-related pacemaker implantations were more common in the rapid-deployment group (9 vs 2%; P = 0.014) and postoperative stroke was more common in the conventional group (1.6 vs 0% per patient year; P = 0.044).ConclusionsWe conclude that this rapid-deployment valve probably facilitates minimally invasive surgery. Furthermore, a subgroup analysis showed reduced transvalvular gradients in smaller valve sizes compared with the conventionally implanted valve of the same type. The favourable haemodynamic profile and the potentially different spectrum of valve-related adverse events should be addressed in further clinical trials.

Dataset Information

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†.

Publications

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†.

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