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Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor.

ABSTRACT: Sutureless 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.All 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.One 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).We 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.

SUBMITTER: Andreas M

PROVIDER: S-EPMC4986793 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor.

Andreas Martin M Wallner Stephanie S Habertheuer Andreas A Habertheuer Andreas A Rath Claus C Schauperl Martin M Binder Thomas T Beitzke Dietrich D Rosenhek Raphael R Loewe Christian C Wiedemann Dominik D Kocher Alfred A Laufer Guenther G

Interactive cardiovascular and thoracic surgery 20160313 6

<h4>Objectives</h4>Sutureless 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.<h4>Methods</h4>All 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 incl ...[more]

PMID: 26976130

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Project description:ObjectivesThis study was designed to describe Doppler-echocardiography values of Carpentier-Edwards Perimount Standard (CEPS) and Carpentier-Edwards Perimount Magna (CEPM) aortic prosthetic valves, evaluated by a single, experienced echo-laboratory, early in the postoperative phase.MethodsThree-hundred-seventy-seven consecutive patients, who had had a CEPS or a CEPM implanted in our Hospital due to aortic stenosis and/or insufficiency, underwent baseline Doppler echocardiography evaluation within 7 days after surgery. Hemodynamic performances of CEPS and CEPM were accurately described, evaluating flow-dependent (transprosthetic velocities and gradients) and flow-independent (effective orifice area, indexed effective orifice area and Doppler velocity index) Doppler-echocardiography parameters.ResultsOut of the 377 patients 48.8% were men (n = 184), mean age was 74.63 ± 6.77 years, mean BSA was 1.78 ± 0.18 m2, mean ejection fraction was 57.78 ± 8%. Two-hundred and sixty two CEPS and 115 CEPM were implanted. Comparing size-by-size CEPS with CEPM, both prostheses showed a good hemodynamic profile, with fairly similar values of pressure gradients (PGmax and mean, in mmHg, = 37,18 ± 11.57 and 20.81 ± 7.44 in CEPS n°19 compared to 32,47 ± 7,76 and 17,67 ± 4.63 in CEPM n°19 and progressively lower in higher sized prostheses, having PGmax and mean 15 ± 3,16 and 9.15 ± 1,29 in CEPS n°29 compared to 15,67 ± 1,53 and 9 ± 1 in CEPM n°29) and EOAi (being 0,65 ± 0,33 cm²/m² in CEPS n°19 compared to 0,77 ± 0,29 cm²/m² in CEPM n°19 and progressively higher in higher sized prostheses, being 1,28 ± 0,59 cm²/m² in CEPS n°29 compared to 1,07 ± 0,18 cm²/m² in CEPM n°29), the latter resulting, however, basically less flow obstructive.ConclusionsOur data confirm the good hemodynamic performance of both aortic bioprostheses and the more favourable hemodynamic profile of CEPM compared to CEPS, pointing out the need to perform routinely an accurate baseline Doppler-echocardiography evaluation early after surgery to allow an adequate interpretation of data at follow-up.

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:Background:Although sutureless and rapid deployment aortic valve replacement (SURD-AVR) has been associated with an increased rate of permanent pacemaker (PPM) implantation compared to conventional AVR (c-AVR), the predictors of new conduction abnormalities remain to be clarified. This study aimed to identify risk factors for conduction disorders in patients undergoing AVR surgery. Methods:Data from 243 patients receiving minimally invasive AVR were prospectively collected. SURD-AVR was performed in 103 (42.4%) patients and c-AVR in 140 (57.6%). The primary endpoint was the occurrence of new-onset conduction disorders, defined as first degree atrioventricular (AV) block, advanced AV block requiring PPM implantation, left anterior fascicular block (LAFB), left bundle branch block (LBBB) and right bundle branch block (RBBB). Results:The unadjusted comparison revealed that SURD-AVR was associated with a higher rate of advanced AV block requiring PPM when compared with c-AVR (10.5% vs. 2.1%, P=0.01). After adjusting for other measured covariates (OR: 1.6, P=0.58) and for the estimated propensity of SURD-AVR (OR: 5.1, P=0.1), no significant relationship between type of AVR and PPM implantation emerged. On multivariable analysis, preoperative first-degree AV block (OR: 6.9, P=0.04) and RBBB (OR: 6.9, P=0.03) were independent risk factors for PPM. Subgroup analysis of patients with normal preoperative conduction revealed similar incidence of PPM between SURD-AVR and c-AVR (1.3% vs. 1.9%, P=0.6). When compared with c-AVR, SURD-AVR was associated with a greater incidence of postoperative new onset LBBB (18.1% vs. 3.2%, P<0.001). This finding was confirmed after adjusting for the estimated propensity of SURD-AVR (OR: 6.3, P=0.009). Conclusions:Our study revealed that the risk of PPM implantation in patients receiving surgical AVR is heavily influenced by the presence of pre-existing conduction disturbances rather than the type of valve prosthesis. Conversely, SURD-AVR emerged as an independent predictor for LBBB and was associated with an increased risk of PPM in patients presenting with RBBB.

Project description: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?<?0.001). Mean gradients at discharge, 1, 3 and 5 years were 13 (SD 5), 11 (SD 4), 12 (SD 5) and 11 (SD 3) mmHg, respectively. New pacemaker implantation was necessary in 8.6% of patients. A single case (0.2%) of structural degeneration was registered after 6 years. Valve explantation for non-structural dysfunction or endocarditis occurred in 9 patients (1.8%). CONCLUSIONS:This rapid deployment aortic valve has shown excellent results concerning haemodynamic performance, durability and safety. Implantation requires specific training, and the rate of pacemaker implantation remains a matter of concern. This novel valve also facilitates minimally invasive approaches and may be beneficial in complex combined procedures.

Dataset Information

Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor.

Publications

Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor.

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