Edwards sapien valve

Manufactured by Edwards Lifesciences

Sourced in United States

The Edwards SAPIEN valve is a prosthetic heart valve designed for the treatment of aortic stenosis. It is a transcatheter aortic valve replacement (TAVR) device that is delivered through a minimally invasive procedure. The valve is made of bovine pericardial tissue supported by a stainless steel frame.

Automatically generated - may contain errors

Lab products found in correlation

Melody valve, by Medtronic (1 mentions) Corevalve revalving system, by Medtronic (1 mentions) Corevalve, by Medtronic (1 mentions)

5 protocols using edwards sapien valve

PARTNER Trial: TAVR Outcomes Analysis

Check if the same lab product or an alternative is used in the 5 most similar protocols

The design of the PARTNER trial has been previously described.^{21 (link), 22 (link)} Briefly, it enrolled patients with severe aortic stenosis who were deemed to be either high risk for surgical AVR (cohort A) or non-surgical candidates (cohort B). Patients in cohort A were randomized to either SAVR or AVR by the transfemoral (TF) or transapical (TA) approach. Patients in cohort B with adequate femoral access were randomized to TF TAVR or standard medical therapy. After completion of the randomized trial enrollment, patients were enrolled in a continued access registry for either TA or TF TAVR. All patients who underwent TAVR had implantation of an Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA, USA). The date of data extraction was February 2013.
Patients in the PARTNER Trial had ECG, echocardiogram, and clinical evaluation performed at baseline, discharge, 30 days, 6 months and 1 year post TAVR. Patients were included in this analysis only if they had undergone TAVR as part of either the randomized trial or the non-randomized continued access registry and had baseline and discharge ECGs available for analysis.
The study was approved by the Institutional Review Board at each participating site and all patients provided written informed consent.

Biviano A.B., Nazif T., Dizon J., Garan H., Fleitman J., Hassan D., Kapadia S., Babaliaros V., Xu K., Parvataneni R., Rodes-Cabau J., Szeto W.Y., Fearon W.F., Dvir D., Dewey T., Williams M., Mack M.J., Webb J.G., Miller D.C., Smith C.R., Leon M.B, & Kodali S. (2016). Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights from the PARTNER Trial. Circulation. Cardiovascular interventions, 9(1), e002766.

+ Open protocol

+ Expand

Percutaneous Pulmonary Valve Implantation Outcomes

Check if the same lab product or an alternative is used in the 5 most similar protocols

Data regarding the type and size of the pulmonary valve and hemodynamic measurements were tabulated. Available percutaneous valves at our institution were the Melody® valve (Medtronic Inc, Minneapolis, MN), the Edwards Sapien® valve (Edwards Lifesciences LLC, Irvine, CA) and the Venus P-valve® (Venus MedTech, Shanghai, China) (Fig. 1A). Information on major intraoperative adverse events were collected (i.e., coronary compression, tamponade, and major bleeding requiring medical/or surgical intervention).Fig. 1

A Three models of percutaneous valve implanted in the pulmonary position in our population: the Melody® valve (left panel,

reproduced with permission from Medtronic Inc), the Edwards Sapien® valve (middle panel, reproduced with permission from Edwards Inc) and the Venus P-valve® (right panel, reproduced with permission from Medtech). B 12-lead ECG recorded in patient #1 who presented to the emergency department for sustained palpitations and demonstrating spontaneous monomorphic ventricular tachycardia (cycle length 250 ms). C 12-lead ECG recorded in patient #2 during programmed ventricular stimulation. A rapid sustained monomorphic ventricular tachycardia (cycle length 200 ms) was induced during apical right ventricular pacing at a drive train of 600 ms with three extra-stimuli

Veillette P.O., Miro J., Khairy P., Abadir S, & Le Bloa M. (2022). Ventricular Arrhythmias and Sudden Death Following Percutaneous Pulmonary Valve Implantation in Pediatric Patients. Pediatric Cardiology, 43(7), 1539-1547.

+ Open protocol

+ Expand

Transcatheter Aortic Valve Implantation Procedure

Check if the same lab product or an alternative is used in the 5 most similar protocols

The TAVI procedure has previously been reported in detail.12 (link)
15 (link)
20 (link) In brief, the procedure consists in the following: the preferred access route was the femoral artery; other access sites (subclavian or carotid artery, transaortic, or transapical) were considered when femoral access was not suitable due to severe femoral artery disease; the femoral artery was punctured percutaneously and closed using a suture device, while the other access sites were managed surgically. Two commercially available systems were used: a self-expandable prosthesis, namely the Medtronic CoreValve Revalving System (Medtronic, Minneapolis, Minnesota, USA); a balloon-expandable prosthesis, the Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California, USA). All patients provided written informed consent before the TAVI procedure.

Dijos M., Reynaud A., Leroux L., Réant P., Cornolle C., Roudaut R., Dos Santos P, & Lafitte S. (2015). Efficacy and follow-up of transcatheter aortic valve implantation in patients with radiation-induced aortic stenosis. Open Heart, 2(1), e000252.

+ Open protocol

+ Expand

TAVR Outcomes in Severe Aortic Stenosis

Check if the same lab product or an alternative is used in the 5 most similar protocols

All consecutive patients with severe AS who underwent TAVR between June 2015 and December 2018 at two cardiovascular centers were enrolled. Included patients had symptomatic severe AS, defined as an aortic valve area <1.0 cm² with a mean aortic valve gradient of ≥40 mmHg or a peak aortic jet velocity of 4.0 m/s. Risk for surgery was evaluated using the Society of Thoracic Surgeons (STS) score [18 (link)] and the logistic European System for Cardiac Operative Risk evaluation (euroSCORE) method [19 (link)]. The treatment modality decision was made by a heart team including cardiac surgeons, interventional cardiologists, imaging specialists, and radiologists who considered age, comorbidities, performance status, comprehensive risk assessment by STS score, and anatomical suitability of cardiac, aortic, and major vascular structures. TAVR was performed using either the self-expandable Medtronic CoreValve (Medtronic, Inc., Minneapolis, MN, USA) or the balloon-expandable Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA, USA). Cardiac rhythm was continuously monitored using an in-hospital ECG telemonitoring system during the index hospitalization for TAVR. The study was approved by the Institutional Review Board of the Catholic Medical Center of Korea. All subjects provided written informed consent.

Choi Y., Hwang B.H., Oh G.C., Kim J.J., Choo E., Kim M.C., Kim J., Jung H.O., Youn H.J., Chung W.S, & Chang K. (2022). Long-Term Maintenance of Sinus Rhythm Is Associated with Favorable Echocardiographic Remodeling and Improved Clinical Outcomes after Transcatheter Aortic Valve Replacement. Journal of Clinical Medicine, 11(5), 1330.

+ Open protocol

+ Expand

Transcatheter Aortic Valve Replacement Outcomes

Check if the same lab product or an alternative is used in the 5 most similar protocols

The study population consisted of 262 consecutive patients who underwent TAVR at a single center from March 2012 to October 2016. Prior to TAVR, all patients underwent coronary angiography, computed tomographic angiography of the chest, abdomen, and pelvis, and 2D echocardiography. A multidisciplinary team consisting of at least two cardiothoracic surgeons and an interventional cardiologist then evaluated the patients and accepted them for TAVR. All patients received a balloon-expandable Edwards SAPIEN valve (Edwards Life Sciences, Inc.). Three different generations of the SAPIEN valves were used in this study: SAPIEN, SAPIEN XT and SAPIEN III (Table 1). Thirty-six patients with PPM implantation prior to the TAVR were excluded from the study cohort. No patients met guideline indications for permanent pacing prior to TAVR.

Sharma E., McCauley B., Ghosalkar D.S., Atalay M., Collins S., Parulkar A., Sheikh W., Ahmed M.B, & Chu A. (2020). Aortic Valve Calcification as a Predictor of Post-Transcatheter Aortic Valve Replacement Pacemaker Dependence. Cardiology Research, 11(3), 155-167.

+ Open protocol

+ Expand

About PubCompare

Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.

We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.

However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.

Ready to get started?

Revolutionizing how scientists
search and build protocols!