Mitral regurgitation (MR) is not just a clinical challenge; it is also a quality and economic concern for hospitals as untreated MR can lead to heart failure, one of the 30-day readmissions measures in Hospital Readmissions Reduction Program and an outcome measure in Value-Based Purchasing Program by the Centers for Medicare and Medicaid Services (CMS). The national average readmissions rate due to heart failure (HF) remains higher than other indicators at 24.6%,1 according to CMS Hospital Compare data. As hospitals continue to improve on ways to manage readmissions and quality outcomes, treating conditions that cause HF may have substantial quality and economic impact. The clinical challenge to treating MR, however, is that patients with severe, symptomatic MR who demonstrate HF symptoms are often overlooked as candidates for mitral valve repair due to age and/or comorbidity.2 Adding to the challenge is the prevalence of mitral valve disease (the most frequent form of valvular heart disease) in an aging U.S. population.3

Transcatheter mitral valve therapy is one option to treat MR and manage HF. In 2014, the American Heart Association and American College of Cardiology’s Guideline for the Management of Patients with Valvular Heart Disease addressed the complexity of MR treatment, especially for high-surgical-risk patients, and included transcatheter mitral valve repair as an option for intervention. The importance of treating complex MR patients through safe, minimally invasive procedures is evident in the emergence of technologies being developed to percutaneously treat MR. Leading the transcatheter mitral valve therapy movement is MitraClip therapy—the first-of-its-kind, minimally invasive option for mitral valve repair indicated for select patients with significant, symptomatic degenerative MR who cannot undergo conventional surgical repair. MitraClip therapy is not only the world’s first-in-class transcatheter mitral valve therapy, but also one with proven safety and efficacy. With the use of MitraClip, patients experienced clinically meaningful improvement in NYHA functional class, the proportion of patients in NYHA Class III/IV reduced from 87% to 13% one year after implantation.4 “A typical MitraClip patient would be … somebody who is at high risk for conventional open surgical repair,” said Paul Sorajja, MD, Director of Valve and Structural Heart Disease at Minneapolis Heart Institute. “[MitraClip] is a very efficacious procedure with relatively low risk.”

MitraClip supports hospitals in their readmissions and quality improvement efforts by reducing HF-related hospitalizations. In a clinical trial setting, patients who received MitraClip experienced on average a 73% reduction in HF hospitalization rate4 in the year following the procedure, which may potentially lead to economic savings from minimizing the volume of high-cost HF treatment and avoiding penalties. Having MitraClip also helps complete a hospital’s armamentarium of treatment options for valvular heart disease and become a truly comprehensive heart center. The distinction demonstrates a commitment to the community by treating a previously unmet clinical need. “The addition of transcatheter mitral valve therapy to our current portfolio of valvular disease treatment enables our center to care for a previously underserved patient population, reduce the rate of HF-related readmission, and be a center of choice for complex MR,” said Kevin DiLallo, Chief Executive Officer at Manatee Memorial Hospital. More importantly, MitraClip offers patient-focused benefits that may significantly impact patients’ quality of life. In addition to patients experiencing improved physical function, the average hospital stay for the procedure is less than 3 days,4 and the majority of patients are discharged to home instead of a skilled nursing facility or rehabilitation center.5

With over 25,000 patients treated worldwide, MitraClip therapy delivers a growing body of clinical and real-world experience. Abbott is committed to our vision for focused innovations by pioneering breakthrough therapies, such as MitraClip and meeting unmet clinical needs. As with MitraClip, Abbott is prepared to continue its forward momentum in driving future innovations with a focus on proven safety and support for our hospital partners.

Julie Miller is Divisional Vice President of U.S. Marketing, Tiffany Liu is Manager of U.S. Marketing, and Ellen Lee is Product Manager of U.S. Strategic Marketing, Abbott Vascular in the United States. Ms. Miller may be reached at julie.miller@av.abbott.com, Ms. Liu at tiffany.liu@av.abbott.com, and Ms. Lee at ellen.lee@abbott.com.

1. Boccuti C, Casillas G. Aiming for fewer hospital U-turns (issue brief). http://files.kff.org/attachment/issue-brief-aiming-for-fewer-hospital-u-turns-the-medicare-hospital-readmission-reduction-program. 2015. Accessed September 16, 2015.

2. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28:1358-1365.

3. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005-1011.

4. Lim DS, Reynolds MR, Feldman T, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64:182-192.

5. MitraClip Clip Delivery System Instructions for Use.