Management of Heart Failure with the Use of Ventricular Assist Devices

The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on the use of ventricular assist devices (VADs), a clinical strategy for the management of heart failure. VADs are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood.

Medicare currently provides coverage for VADs for three indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (when patients are not candidates for heart transplantation). Patients must meet eligibility criteria which vary based on the indication for use. In addition, devices can only be implanted in facilities and by operators meeting criteria intended to ensure optimal health outcomes for Medicare beneficiaries.

This meeting will focus on how outcomes can be optimized for patients with heart failure, especially the appropriate selection of those who are likely to benefit from the placement of VADs and the facility and operator characteristics which predict improved health outcomes for patients receiving a VAD. It will also serve to identify areas where further research may be warranted, and include an evaluation of the generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of VADs in section 20.9 of the national coverage determination (NCD) manual (Pub. 100-03) entitled National Coverage Determination (NCD) for Artificial Hearts and Related Devices (20.9). The NCD is available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246

August 2, 2012

August 30, 2012

September 4, 2012

November 9, 2012

November 13, 2012

November 27, 2012

February 11, 2013

• Webcast of meeting
• Registration
• Information about visiting CMS
• Driving directions to CMS
• Recommended hotels

Rita Redberg, MD, MScC, Chair
Art Sedrakyan, MD, PhD, Vice Chair
Jyme Schafer, MD, MPH, Division Director, Division of Medical and Surgical Services, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 – 8:00 AM

8:00 – 8:15 AM

8:15 - 8:25 AM

8:25 – 8:35 AM

8:35 – 8:45 AM

8:45 – 9:15 AM

9:15 – 10:00 AM

10:00 – 10:15 AM

10:15 – 10:25 AM

10:25 – 11:00 AM

Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

11:00 – 11:05 AM

Public Attendees who wish to address the panel will be given that opportunity

11:05 – 12:00 PM

12:00 – 1:00 PM

1:00 – 2:00 PM

2:00 – 3:00 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

3:00 – 4:00 PM

4:00 – 4:30 PM

Download meeting minutes. [PDF, 117KB]

The primary focus of this MEDCAC meeting is the consideration of evidence that may support prospective identification of patients who are likely to experience clinically meaningful changes in outcomes from placement of a ventricular assist device (VAD.) We also seek the panel's input on whether or not the published evidence identifies facility and/or operator characteristics that predict clinically meaningful improvements in outcomes of patients who receive a VAD.

Among outcomes, CMS is most interested in mortality, adverse events, patient function and quality of life.

For the purposes of this meeting, optimal medical therapy is defined as treatment of contributing comorbidities, standard lifestyle modifications including dietary interventions, optimization of pharmacotherapy, and appropriate use of other devices such as implantable cardiac resynchronization devices, cardioverter-defibrillators or pacemakers.

For the purposes of this meeting, the heart team concept is defined as a cohesive, multi-disciplinary team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.

Instructions: For the voting questions, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence.

1. How confident are you that there is adequate evidence that specific patient criteria can be used to prospectively identify clinically meaningful changes in the health outcomes listed above (improved, equivalent or worsened) that are likely to be experienced by patients who receive a VAD in addition to optimal medical therapy compared with optimal medical therapy alone?

Discussion


1. If there is at least intermediate confidence (mean score ≥ 2.5 in question 1), what prospective patient criteria predict:
   
   
   1. clinically meaningful improvements in health outcomes,
   2. equivalent health outcomes, and/or
   3. clinically meaningful worsening of health outcomes?
   
   
2. Do these criteria vary if the intended use of the VAD at the time of implantation is:
   
   
   1. bridge-to-transplantation, or
   2. destination therapy?

2. How confident are you that there is adequate evidence that one or more facility and/or operator characteristics predict clinically meaningful improvements in the health outcomes listed above for patients who receive a VAD in addition to optimal medical therapy compared with optimal medical therapy alone?

3. How confident are you that these conclusions are generalizable to the Medicare beneficiary population?

Discussion
Which conclusions are likely or unlikely to be generalizable to the Medicare beneficiary population?

4. How confident are you that clinically significant evidentiary gaps remain regarding the use of VADs?

Discussion

If there is at least intermediate confidence (mean score ≥ 2.5 in question 4), please discuss any significant gaps identified and how CMS might support their closure.

Download scoresheet [PDF, 21KB]