Feature | September 19, 2014

New Study Compares Cost-effectiveness of TAVR With Surgical Valve Replacement in High-risk Patients

Results of U.S. CoreValve High Risk trial Reported at TCT 2014

U.S. CoreValve High Risk trial TCT 2014

September 19, 2014 — According to a new study, transcatheter aortic valve replacement (TAVR) provided meaningful clinical benefits relative to surgical aortic valve replacement (SAVR) in high risk patients with incremental costs considered acceptable from a U.S. perspective. Findings from the cost-effectiveness analysis of the U.S. CoreValve High Risk Trial were reported Sept. 13 at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

Previous studies have shown that among patients with severe aortic stenosis who are unsuitable for conventional aortic valve surgery, TAVR provides substantial clinical benefits at a reasonable incremental cost. However, there has previously been less consensus about the cost effectiveness of TAVR relative to SAVR for high-risk surgical candidates.

Findings from the U.S. CoreValve High Risk trial, published earlier this year in the New England Journal of Medicine, found that in patients with severe, symptomatic aortic stenosis who were deemed to be at high operative risk, TAVR using a self-expanding prosthesis was associated with lower 12-month mortality compared with SAVR (14.2 percent vs. 19.1 percent).

The cost-effectiveness analysis of the U.S. CoreValve High Risk Trial compared the costs of TAVR and SAVR for this high risk population from the perspective of the US healthcare system. To assess cost effectiveness, inpatient and outpatient medical resource utilization was collected for all patients. Hospital bills were collected for 80 percent of the index hospital admissions and health state utilities were measured using the EQ-5D questionnaire at one, six and 12 months. The primary effectiveness measure was quality adjusted life years (QALY) and the secondary effectiveness measure was life years (LY).

In the as-treated population (n=747), the mean cost for the initial valve implant procedure was $23,661 higher per patient with TAVR than with SAVR ($37,920 vs. $14,258, respectively p<0.001). TAVR reduced the initial hospital length of study by 4.4 days relative to SAVR (8.1 vs. 12.5 days p<0.001) and reduced the need for rehabilitation services at discharge (23 percent vs. 44 percent, respectively p<0.001). Despite this, initial hospital costs were higher with TAVR ($69,000 vs. $58,000, including physician fees) and projected lifetime costs were also higher by approximately $13,700 per patient.

TAVR patients reported significantly better quality of life than SAVR patients at one month, but not at six or 12 months. In lifetime projections, TAVR patients were estimated to gain 0.24 life years and 0.20 quality adjusted life years relative to SAVR patients.

Projected lifetime incremental cost-effectiveness ratios for TAVR were approximately $67,000 per QALY gained and $57,000 LY gained. Results were slightly better among patients suitable for iliofemoral access (n=623) at approximately $55,500 per QALY gained and $48,300 per LY gained. Sensitivity analysis indicated that a reduction in the cost of initial TAVR hospitalizations of approximately $2,000-4,000 per patient would lower the cost effectiveness ratios to less than $50,000 per QALY or LY.

“In this high risk population, TAVR provided meaningful clinical benefits relative to SAVR, with acceptable incremental costs in the U.S.,” said lead investigator Matthew R. Reynolds, M.D., MSc. Reynolds is director, economics and quality of life research at the Harvard Clinical Research Institute.

“With modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high.” 

The U.S. CoreValve High Risk trial was funded by Medtronic. Reynolds reported receiving grant and research support from Medtronic and Edwards Lifesciences. He also received honoraria from Medtronic.

For more information: www.crf.org, www.tctconference.com

Related Content

Boston Scientific, Edwards Lifesciences Agree To Global Litigation Settlement
News | Heart Valve Technology | January 15, 2019
Boston Scientific Corp. and Edwards Lifesciences Corp. announced that the companies have reached an agreement to settle...
The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as a arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital. Dr. Dominick Wiktor. The TEE is from a Philips Epiq system.

The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as an arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital.

Feature | Heart Valve Technology | January 14, 2019 | Allen Atchley, M.D., FACC, The Chattanooga Heart Institute
Mitral regurgitation (MR) is one of the most common types of heart valve diseases in the United States, affecting app
JC Medical Announces First U.S. Treatment With J-Valve TAVR Device
News | Heart Valve Technology | January 07, 2019
January 7, 2019 — JC Medical announced the successful treatment of the first U.S.
Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Technology | Heart Valve Technology | January 02, 2019
Edwards Lifesciences Corp. announced that the Sapien 3 Ultra system has received U.S. Food and Drug Administration (FDA...
Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation
Feature | Heart Valve Technology | December 12, 2018
A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S....
First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.
News | Heart Valve Technology | November 06, 2018
4Tech Inc. initiated its U.S. Early Feasibility Study of the TriCinich Coil System following U.S. Food and Drug...
Valve Replacement Volume Key to Successful Patient Outcomes
News | Heart Valve Technology | November 02, 2018
Hospitals that routinely perform a heart valve replacement procedure requiring open heart surgery are more likely to...
Prosthetic Valve Mismatches Common in TAVR Procedures
News | Heart Valve Technology | October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and...
Local Anesthesia Safe and Effective for Intermediate- and High-Risk TAVR Patients
News | Heart Valve Technology | September 28, 2018
The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (...
Overlay Init