Sapien 3

Manufactured by Medtronic

Sourced in Ireland

The SAPIEN 3 is a transcatheter aortic valve replacement (TAVR) system designed for the treatment of severe aortic stenosis. The device is used to replace a patient's diseased aortic valve without open-heart surgery. The SAPIEN 3 system includes a bioprosthetic aortic valve and a delivery catheter system that allows for minimally invasive implantation.

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Lab products found in correlation

Corevalve, by Medtronic (3 mentions) Corevalve evolut r, by Medtronic (1 mentions) Evolut r pro, by Medtronic (1 mentions) Sapien xt, by Medtronic (1 mentions) Sapien, by Edwards Lifesciences (1 mentions) Evolut r, by Medtronic (1 mentions) Evolut pro, by Medtronic (1 mentions) Evolut, by Boston Scientific (1 mentions) Acurate neo, by Boston Scientific (1 mentions)

7 protocols using sapien 3

Transcatheter Aortic Valve Implantation Outcomes

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Patients with severe symptomatic AS who were treated with TAVI at our institution between December 2014 and September 2016 were deemed eligible for inclusion. All patients were considered to have a moderate-to-high surgical risk according to common risk scores and other clinical parameters (e.g., frailty, presence of porcelain aorta, and sequelae of chest irradiation). Patients were excluded if they were undergoing TAVI because of a degenerated aortic bioprosthesis (valve-in-valve procedure) or an extra-aortic valve treatment (i.e., mitral or tricuspid valve). Patients who died during the periprocedural period were not included. Three different types of prosthesis were investigated in the current study: (1) Edwards Sapien 3^® (S3), (2) Medtronic Corevalve^® (CV), and (3) Medtronic CoreValve Evolut^® R (EVR). The optimal prosthesis size was selected based on anatomical data obtained from computed tomography (CT), which was performed according to the current recommendations for CT imaging before TAVI [6 (link)]. All of the study patients were included in the French TAVI registry and provided their written informed consent.

Kanso M., Kibler M., Hess S., Rischner J., Plastaras P., Kindo M., Hoang M., De Poli F., Leddet P., Petit H., Zeyons F., Trinh A., Matsushita K., Morel O, & Ohlmann P. (2021). Effective Orifice Area of Balloon-Expandable and Self-Expandable Transcatheter Aortic Valve Prostheses: An Echo Doppler Comparative Study. Journal of Clinical Medicine, 10(2), 186.

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TAVR at Certified German Centre

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TAVR was performed at the TAVR centre of the University Medical Center Göttingen, which is certified according to quality requirements of the German Society of Cardiology.¹⁷In most of the study participants, an Edwards SAPIEN 3™ (90%) or a Medtronic CoreValve (7%) prosthesis was implanted.

Evertz R., Hub S., Beuthner B.E., Backhaus S.J., Lange T., Schulz A., Toischer K., Seidler T., von Haehling S., Puls M., Kowallick J.T., Zeisberg E.M., Hasenfuß G, & Schuster A. (2023). Aortic valve calcification and myocardial fibrosis determine outcome following transcatheter aortic valve replacement. ESC Heart Failure, 10(4), 2307-2318.

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TAVI Protocol for Severe Aortic Stenosis

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Between February and October 2016, we recruited subjects with severe AS from patients undergoing clinical TAVI for standard indications. Inclusion criteria demanded use of general anaesthesia, implantation of an Edwards SAPIEN 3 or Medtronic CoreValve Evolut valve, and native AS (no valve-in-valve). Exclusion criteria included moderate or severe aortic insufficiency, mitral regurgitation, or tricuspid insufficiency; hypertrophic cardiomyopathy; unrevascularized, severe coronary disease; myocardial infarction within the preceding 3 weeks; history of significant ventricular arrhythmia; or a prior severe reaction to dobutamine. All subjects gave written informed consent as approved by the medical ethics committee of the hospital.

Johnson N.P., Zelis J.M., Tonino P.A., Houthuizen P., Bouwman R.A., Brueren G.R., Johnson D.T., Koolen J.J., Korsten H.H., Wijnbergen I.F., Zimmermann F.M., Kirkeeide R.L., Pijls N.H, & Gould K.L. (2018). Pressure gradient vs. flow relationships to characterize the physiology of a severely stenotic aortic valve before and after transcatheter valve implantation. European Heart Journal, 39(28), 2646-2655.

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Outcomes of TAVR in AS Subgroups

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This is a retrospective, observational study performed at a single center in the United States. The study was approved by the local institutional review board and exempted from needing an informed consent. All patients who underwent TAVR using a transfemoral approach and using newer generation balloonexpandable or self-expanding bioprostheses (Edwards Sapien 3, Medtronic Evolut R/Pro) at Hartford Hospital between September 2015 and November 2019 were screened for inclusion. Patients with LVEF <50%, low surgical risk, undergoing valve-in-valve procedures, patients with prior MV surgery, and patients with incomplete records were excluded from the analysis. From this cohort, 595 patients were grouped according to their MG determined by resting transthoracic echocardiography. Patients with a MG >40 mm Hg were included in the HG-AS group (n=395). The remaining patients (n=200) were further screened based on their Vmax (transaortic peak velocity) and stroke volume index (SVi to body surface area) where only patients with Vmax <4.0 m/s and SVi ≤35 mL/m 2 where included in the pLFLG-AS group.

Mosleh W., Amer M.R., Ding Y., Megaly M., Mather J.F., McMahon S., Pershad A., McKay R.G, & Arora B. (2021). Benefit of Transcatheter Aortic Valve Replacement in Patients With Paradoxical Low-Flow Low-Gradient Versus High-Gradient Aortic Stenosis and Preserved Left Ventricular Function. Circulation. Cardiovascular interventions, 14(3).

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Anesthesia Strategies in Transcatheter Aortic Valve Replacement

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Among TF-TAVR patients, general anesthesia was used in 242 (42%) and conscious sedation/local anesthesia in 333 (58%). Characteristics of patients undergoing both strategies were generally similar (standardized differences within ±10%), as shown in Supplemental Table E2.
TAVR valves implanted included Sapien (Edwards Lifesciences, Irvine, CA; n = 112, 19%), Sapien XT (n = 354, 63%), Sapien 3 (n = 41, 6.0%), CoreValve (Medtronic, Dublin, Ireland; n = 29, 5.1%), Direct Flow (Direct Flow Medical, Santa Rosa, CA; n = 11, 1.9%), Boston Scientific/Lotus (n = 3, 0.52%), and other (n = 25, 4.3%). SAVR was performed via reoperative full sternotomy in 304 (97%) of the 315 cases.

Hasan S.M., Cikach F., Toth A.J., Blackstone E.H., Krishnaswamy A., Kapadia S., Roselli E.E., Gillinov A.M., Svensson L.G, & Mick S.L. (2022). Comparison of Outcomes and Discharge Location After Transcatheter vs. Surgical Aortic Valve Replacement With Prior Coronary Artery Bypass Grafting. Structural Heart, 7(1), 100120.

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Prospective TAVI Cohort Study

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We conducted a prospective single-center cohort study. Consecutive patients with severe symptomatic aortic stenosis undergoing workup for TAVI with either balloon-expandable (Edwards SAPIEN 3) or self-expandable (Medtronic Evolut R or Evolut Pro) valves between November 2016 and December 2020 were eligible for inclusion at Hôpital Sacré Coeur de Montréal, an intermediate-volume TAVI center in Montreal, Quebec. Excluded patients had either not undergone all imaging modalities or images were not interpretable (i.e., artefacts, no valve section). Patients with a prior bioprosthetic aortic valve were also excluded. The study was approved by the ethics committee and consent was obtained for all participants.

Massie C., Parent M., Berthelot-Richer M., Kouz R., Palisaitis D., Le V, & Poulin F. (2023). Automated and semi-automated 3D echocardiographic software for aortic annulus sizing in transcatheter aortic valve implantation helps bridge the gap between expert and novice operators. The International Journal of Cardiovascular Imaging, 39(9), 1707-1717.

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Retrospective Analysis of Transcatheter Aortic Valve Implantation

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This retrospective analysis included transfemoral TAVI procedures performed between 2012 and 2019 with balloon-expanding (BE: Edwards Lifesciences Sapien-3), self-expanding (SE: Medtronic Evolut/Evolut-R/Pro, Boston Scientific Acurate-Neo, Abbott Vascular Portico) and mechanically expanding (ME: Boston Scientific Lotus) devices at four high-volume centers in Germany: University Heart Center Hamburg, Kerckhoff Heart and Thorax Center Bad Nauheim, University Heart Center Bonn and University hospital Cologne. In accordance with previous studies [8 (link), 9 (link)], patients with a SAA (defined as annulus area < 400 mm², measured by multidetector computed tomography (MDCT)) were included. Patients with valve-in-valve procedures, treatment of predominant aortic regurgitation and procedures via non-transfemoral access routes were excluded. Patients were divided into five groups according to the implanted THV (Sapien-3, Evolut, Acurate-Neo, Portico and Lotus).

Voigtländer L., Kim W.K., Mauri V., Goßling A., Renker M., Sugiura A., Linder M., Schmidt T., Schofer N., Westermann D., Reichenspurner H., Nickenig G., Blankenberg S., Hamm C., Conradi L., Adam M., Sinning J.M, & Seiffert M. (2021). Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves. Clinical Research in Cardiology, 110(12), 1957-1966.

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