Artificial Hearts

The NCD for Artificial Hearts, released by CMS in May 2008, concluded that additional clinical research would be appropriate under the Coverage with Evidence Development aspect of CMS’ coverage authority.  The NCD specifies that artificial heart devices are covered only when provided to Medicare beneficiaries when the device is implanted as part of a CMS approved study.  An artificial heart is an implanted prosthetic device that replaces the heart. As part of the artificial heart implantation, a substantial part of the biological heart is removed.

A clinical study must address one or more aspects of the following questions:

Were there unique circumstances such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?

What will be the average time to device failure when the device is made available to larger numbers of patients?

Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more widespread use?

The NCD may be found at:

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246&ncdver=5

CMS will maintain a list of all approved studies:

Study Title: A post-approval study to monitor the clinical performance of the AbioCor in severe end-stage heart disease
Sponsor: Abiomed, Inc.
ClinicalTrials.gov Number:  http://www.clinicaltrials.gov/ct2/results?term= NCT00669357&rank=1
CMS Approval Date: 5/14/08

Study Title: The SynCardia CardioWest TAH-t postmarket surveillance study
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: http://www.clinicaltrials.gov/ct2/results?term=NCT00614510&rank-1
CMS Approval Date: 5/14/08

Study Title: SynCardia Freedom Driver System Study
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: http://www.clinicaltrials.gov/ct2/results?term=NCT00733447&rank=1
CMS Approval Date: 4/20/10