Sapien and sapien xt

Manufactured by Edwards Lifesciences

Sourced in United States, Mongolia

The SAPIEN and SAPIEN XT are medical devices developed by Edwards Lifesciences for the treatment of aortic valve disease. These devices are designed for transcatheter aortic valve replacement (TAVR) procedures, where a new valve is implanted without open-heart surgery.

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Lab products found in correlation

Corevalve, by Medtronic (2 mentions) Corevalve revalving system, by Medtronic (1 mentions)

4 protocols using sapien and sapien xt

Comparative Analysis of TAVR Approaches

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This was a multicentre, observational study involving 15 tertiary-care hospitals from Europe and North America. Consecutive patients with at least grade II obesity (i.e. BMI >35 kg/m²) who underwent TF- or TC-TAVR between March 2015 and July 2020 were included. Patients who underwent TAVR by other approach beyond TF or TC and those in whom TF-TAVR was performed with the use of a surgical cut-down approach were not included in the study. In addition, those patients receiving early-generation transcatheter heart valves (THVs) were excluded, aiming to improve comparability between groups and to include predominantly a contemporaneous subset of patients. The following THVs were considered to be early-generation devices: the balloon-expandable SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA, USA) and the self-expandable CoreValve (Medtronic Inc., Minneapolis, MN, USA). A list of inclusion/exclusion criteria is presented in Supplementary Material, Table S1.

Alperi A., McInerney A., Modine T., Chamandi C., Tafur-Soto J.D., Barbanti M., Lopez D., Campelo-Parada F., Cheema A.N., Toggweiler S., Saia F., Amat-Santos I., Oteo J.F., Serra V., Dabrowski M., Abi-Akar R., Echavarria N.G., Valvo R., Lopez-Pais J., Matta A., Arif M., Moccetti F., Compagnone M., Mohammadi S., Nombela-Franco L, & Rodés-Cabau J. (2021). Transcatheter aortic valve replacement in obese patients: procedural vascular complications with the trans-femoral and trans-carotid access routes. Interactive Cardiovascular and Thoracic Surgery, 34(6), 982-989.

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Hybrid Operating Room Optimized TAVR

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All TAVRs were performed in a dedicated hybrid operating room offering full functionality for cardiac catheterization, anesthesiology, and cardiac operations, and a cardiopulmonary bypass circuit and clinical perfusion team were kept on standby. Competences of the interdisciplinary heart team, consisting of cardiac surgeons, cardiologists, anesthesiologists, and perfusionists, complemented in optimal support during the TAVR procedure. TAVR was performed with different currently commercially available transcatheter heart valves: SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA), the CoreValve ReValving System (Medtronic Inc, Minneapolis, MN), and the ACURATE-TA (Symetis S.A., Ecublens, Switzerland). TAVR was performed by transapical, transaortic, or transfemoral access. Technical aspects of the different TAVR procedures and access sites have been described previously by our group [8] [9] [10] .

Wendt D., Kahlert P., Canbay A., Knipp S., Thoenes M., Cremer G., Al-Rashid F., Jánosi R.A., El-Chilali K., Kamler M., El Gabry M., Marx P., Dohle D.S., Tsagakis K., Benedik J., Gerken G., Rassaf T., Jakob H, & Thielmann M. (2017). Impact of Liver Indicators on Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation. The Annals of thoracic surgery, 104(4).

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Minimalist Transfemoral TAVR Approach

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All TAVR procedures were performed using a balloonexpandable valve (Sapien and Sapien XT, Edwards Lifesciences, Irvine, CA). The procedural approach was left to the discretion of the attending physicians and the multispecialty heart team. An overview of a decision algorithm allocating patients to different TAVR access in our institution, including details of each procedure, has been previously described [5, 6] . Our institution uses a TF-first strategy, and all eligible patients are performed as minimalist-TF-TAVR [7, 8] .

Jensen H.A., Thourani V.H., Forcillo J., Condado J.F., Binongo J.N., Babaliaros V., Lasanajak Y., Leshnower B., Devireddy C., Guyton R., Mavromatis K., Block P., Simone A., Keegan P., Stewart J., Tsai L.L., Rajaei M.H., Lerakis S, & Sarin E.L. (2016). Does a Higher Society of Thoracic Surgeons Score Predict Outcomes in Transfemoral and Alternative Access Transcatheter Aortic Valve Replacement?. The Annals of thoracic surgery, 102(2).

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Long-term Outcomes of TAVI in France

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This study was conducted in 5 centers in France: (1) Rouen University Hospital-Charles Nicolle, (2) Paris University Hospitals-Bichat Claude Bernard, (3) Jacques Cartier private hospital (Massy), (4) Brest University Hospital, and (5) Saint Gatien private hospital (Tours).
Patients included were those treated with TAVI, from the first implantation in each center until December 2011, to reach a minimum follow-up of 5 years. All patients were prospectively included in trials or registries approved by an institutional review committee and had given their signed informed consent to participate.
All patients were implanted for symptomatic severe aortic stenosis, and indication of TAVI was systematically discussed by the local heart team according to recommendations. TAVI procedure was performed in each center at the discretion of the operator using either the self-expandable Corevalve (Medtronic Inc, Minneapolis, MN) or the balloon-expandable Sapien and Sapien XT prostheses (Edwards Lifesciences, Irvine, CA) valves. In rare cases, a JenaValve (JenaValve technology, Munich, Germany) was used. Data collected on the procedure were the approach (femoral or other), the type and size of the valve, the malposition of the valve, and the need for a second valve.

Durand E., Sokoloff A., Urena-Alcazar M., Chevalier B., Chassaing S., Didier R., Tron C., Litzler P.Y., Bouleti C., Himbert D., Hovasse T., Bar O., Avinée G., Iung B., Blanchard D., Gilard M., Cribier A., Lefevre T, & Eltchaninoff H. (2019). Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition. Circulation. Cardiovascular interventions, 12(4).

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