Author + information
- Received December 18, 2017
- Revision received April 20, 2018
- Accepted April 23, 2018
- Published online July 16, 2018.
- E. Murat Tuzcu, MDa,∗ (, )@ClevelandClinic,
- Samir R. Kapadia, MDb,
- Sreekanth Vemulapalli, MDc,
- John D. Carroll, MDd,
- David R. Holmes Jr., MDe,
- Michael J. Mack, MDf,
- Vinod H. Thourani, MD, MPHg,
- Frederick L. Grover, MDh,i,
- J. Matthew Brennan, MD, MPHc,
- Rakesh M. Suri, MD, DPhila,
- David Dai, PhDc and
- Lars G. Svensson, MD, PhDb
- aCleveland Clinic, Abu Dhabi, United Arab Emirates
- bCleveland Clinic, Cleveland, Ohio
- cDuke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina
- dUniversity of Colorado, Anschutz Medical Campus, School of Medicine, Aurora, Colarado
- eMayo Clinic, Rochester, Minnesota
- fBaylor Scott and White Health, Plano, Texas
- gMedstar Washington Hospital Center, Washington, DC
- hDepartment of Surgery, School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado
- iDenver Department of Veterans Affairs Medical Center, Denver, Colorado
- ↵∗Address for correspondence:
Dr. E. Murat Tuzcu, Department of Cardiovascular Medicine, Cleveland Clinic Abu Dhabi, PO Box 112412, Al Maryah Island, Abu Dhabi, United Arab Emirates.
Background Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been shown to be feasible, yet the safety and efficacy in relation to native valve (NV) TAVR are not known.
Objectives This study sought to evaluate the safety and effectiveness of ViV TAVR for failed surgical aortic valve replacement (SAVR) by comparing it with the benchmark of NV TAVR.
Methods Patients who underwent ViV-TAVR (n = 1,150) were matched 1:2 (on sex, high or extreme risk, hostile chest or porcelain aorta, 5-m-walk time, and Society of Thoracic Surgeons Predicted Risk of Mortality for reoperation) to patients undergoing NV-TAVR (n = 2,259). Baseline characteristics, procedural data, and in-hospital outcomes were obtained from the Transcatheter Valve Therapy Registry. The 30-day and 1-year outcomes were obtained from linked Medicare administrative claims data.
Results Unadjusted analysis revealed lower 30-day mortality (2.9% vs. 4.8%; p < 0.001), stroke (1.7% vs. 3.0%; p = 0.003), and heart failure hospitalizations (2.4% vs. 4.6%; p < 0.001) in the ViV-TAVR compared with NV-TAVR group. Adjusted analysis revealed lower 30-day mortality (hazard ratio: 0.503; 95% confidence interval: 0.302 to 0.839; p = 0.008), lower 1-year mortality (hazard ratio: 0.653; 95% confidence interval: 0.505 to 0.844; p = 0.001), and hospitalization for heart failure (hazard ratio: 0.685; 95% confidence interval: 0.500 to 0.939; p = 0.019) in the ViV-TAVR group. Patients in the ViV-TAVR group had higher post-TAVR mean gradient (16 vs. 9 mm Hg; p < 0.001), but less moderate or severe aortic regurgitation (3.5% vs. 6.6%; p < 0.001). Post-TAVR gradients were highest in small SAVRs and stenotic SAVRs.
Conclusions Comparison with the benchmark NV-TAVR shows ViV-TAVR to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery.
Dr. Vemulapalli has received research grants from the American College of Cardiology, Society of Thoracic Surgeons, Abbott Vascular, Patient Centered Outcomes Research Institute, and Boston Scientific; is a consultant for Premiere, Janssen, Zafgen, and Novella; and has served on the speakers bureau for Boston Scientific. Dr. Carroll is an investigator in research trials sponsored by Edwards LifeSciences, Abbott Vascular, and Direct Flow; and an investigator in a research trial sponsored by Medtronic. Dr. Mack is a co-principal investigator for the Partner 3 Trial, Edwards Lifesciences, uncompensated. Dr. Thourani is a consultant for Edwards Lifesciences. Dr. Brennan is a consultant for Edwards LifeSciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 18, 2017.
- Revision received April 20, 2018.
- Accepted April 23, 2018.
- 2018 American College of Cardiology Foundation
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