Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves.

Binder, Ronald K; Stortecky, Stefan; Heg, Dik; Tueller, David; Jeger, Raban; Toggweiler, Stefan; Pedrazzini, Giovanni; Amann, Franz W; Ferrari, Enrico; Noble, Stephane; Nietlispach, Fabian; Maisano, Francesco; Räber, Lorenz; Roffi, Marco; Grünenfelder, Jürg; Jüni, Peter; Huber, Christoph; Windecker, Stephan; Wenaweser, Peter Martin (2015). Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves. Circulation: Cardiovascular interventions, 8(10), e002653. Lippincott Williams & Wilkins 10.1161/CIRCINTERVENTIONS.115.002653

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BACKGROUND New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27). CONCLUSIONS The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Kardiologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Kardiologie

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Stortecky, Stefan; Heg, Dierik Hans; Räber, Lorenz; Jüni, Peter; Windecker, Stephan and Wenaweser, Peter Martin

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1941-7632

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

15 Oct 2015 14:52

Last Modified:

09 Sep 2017 05:52

Publisher DOI:

10.1161/CIRCINTERVENTIONS.115.002653

PubMed ID:

26453687

Additional Information:

Authors Binder and Stortecky contributed equally to this work.

Uncontrolled Keywords:

aortic valve stenosis; bleeding; transcatheter aortic valve replacement; transcatheter heart valve; transcutaneous aortic valve implantation; vascular complications

BORIS DOI:

10.7892/boris.72391

URI:

https://boris.unibe.ch/id/eprint/72391

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