Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis

Kodali, Susheel; Thourani, Vinod H.; White, Jonathon; Malaisrie, S. Chris; Lim, Scott; Greason, Kevin L.; Williams, Mathew; Guerrero, Mayra; Eisenhauer, Andrew C.; Kapadia, Samir; Kereiakes, Dean J.; Herrmann, Howard C.; Babaliaros, Vasilis; Szeto, Wilson Y.; Hahn, Rebecca T.; Pîbarot, Philippe; Weissman, Neil J.; Leipsic, Jonathon; Blanke, Philipp; Whisenant, Brian; Suri, Rakesh M.; Makkar, Rajendra; Ayele, Girma Minalu; Svensson, Lars G.; Webb, John G.; Mack, Michael J.; Smith, Craig R.; Leon, Martin B.

doi:10.1093/eurheartj/ehw112

Cited by 320 publications

(151 citation statements)

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“…Second, further technological advances may favorably influence the outcomes with TAVR in the future, and the SAPIEN XT valve that was used in this trial has already been replaced by the SAPIEN 3 valve system. 35,36 Third, in this trial, multislice computed tomography was not used consistently to assess aortic annulus dimensions for appropriate valve sizing. 37 Also, the recent finding of subclinical valveleaflet thrombosis with the use of high-resolution imaging techniques was not systematically evaluated in the current trial.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

et al. 2016

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BACKGROUNDPrevious trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aorticvalve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODSWe randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTSThe rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P = 0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P = 0.25). In the transfemoralaccess cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P = 0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONSIn intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.) a bs tr ac t

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Section: Discussionmentioning

confidence: 99%

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

et al. 2016

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“…Further studies should be performed as the field begins to address TAVR in the lower risk patient population who are also at lower risk for GA complications and whose expected outcomes are significantly better than patients treated in these registries. 58,59 Many of the steps of the procedure are primarily guided by fluoroscopy with TEE as an adjunct or confirmatory tool that could reduce fluoroscopic time. Recommendations for intraprocedural TEE imaging throughout TAVR have been extensively reviewed and are summarized in Table 1.…”

Section: Intraprocedural Imaging For Specific Valvular Interventions mentioning

confidence: 99%

Transcathether Valve Replacement and Valve Repair

Hahn

2016

Circulation Research

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Transcatheter aortic valve replacement for treatment of aortic stenosis has now become an accepted alternative to surgical valve replacement for some patients. In addition, transcatheter mitral valve repair is also routinely used in high surgical risk patients with mitral regurgitation. Other transcatheter procedures are in rapid development. The current review attempts to summarize the procedures and echocardiographic imaging used for transcatheter valve replacement or valve repair.

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“…In addition, newer generation transcatheter heart valves have an outer skirt or adaptive seal, and some systems are even retrievable to optimize the implantation position. These improvements have resulted in low singledigit moderate-to-severe PVL rates in the latest TAVR studies (3,16,17). Due to the proximity between the transcatheter valve frame extending into the left ventricular outflow tract and the conduction system, heart block with need for permanent pacemaker implantation has been frequent after TAVR.…”

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confidence: 99%

Rapid adoption of transcatheter aortic valve replacement in intermediate- and high-risk patients to treat severe aortic valve stenosis

Cesna

Søndergaard

2017

J. Thorac. Dis.

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Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis

Abstract: ClinicalTrials.gov #NCT01314313.

Cited by 320 publications

References 25 publications

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

Transcathether Valve Replacement and Valve Repair

Rapid adoption of transcatheter aortic valve replacement in intermediate- and high-risk patients to treat severe aortic valve stenosis

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