HeartMate

HeartMate is a series of left ventricular assist devices (LVADs) designed, manufactured, and marketed by Thoratec Corporation and trademarked for this purpose. Since the introduction of the HeartMate IP in 1986 to the approval of the Heartmate II as a bridge-to-transplant therapy in 2007, the HeartMate products have evolved through several generations of changes designed to improve efficacy, safety, cost-effectiveness, and practicality of VADs as a treatment option for end-stage heart failure.

Overview of products

HeartMate series

Product	First trial	BTT approval	DT approval	Status
HeartMate IP	1986	1994	NA	active
HeartMate VE	1991	1998	2003	superseded by XVE
HeartMate XVE	1991	1998	2003	active
HeartMate II	2000	2007	2010	active
HeartMate III	2001	N/A	N/A	in testing

HeartMate IP

The HeartMate IP was first implanted on an experimental basis in 1986, when clinical trials started for the VAD. It received final approval for BTT therapy in 1994. It is used in a hospital setting, as it requires continutous monitoring and a panel on wheels.

HeartMate VE/XVE (also known as HeartMate I)

Trials for the HeartMate VE started in 1991. The device was approved for BTT by the FDA in 2001, and by the Conformité Européenne (CE) in 2003. It was approved for destination therapy (DT) by the FDA and CE in the spring and summer of 2003, respectively. The HeartMate XVE was the successor to the HeartMate VE by reducing mechanical failure.

Heartmate II

The HeartMate II pivotal trial began in 2005 and included the evaluation of HeartMate II for two indications: Bridge to Transplantation (BTT) and Destination Therapy (DT), or long-term, permanent support. It was the first time the FDA had approved a clinical trial to include both indications in one protocol.

The FDA approval of HeartMate II for BTT was based on six months follow-up data from the first 194 patients enrolled in the trial. Clinical evidence supports positive survival outcomes and improved quality of life for a broad range of patients. Key outcomes of the trial included:

• Eighty-four percent of the patients survived to hospital discharge or transplantation.
• The median duration of device support was 132 days, and the cumulative patient support in the trial was 109 years.
• Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one-year.
• Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status.
• The incidence of major adverse events with comparable definitions-including infections, strokes and bleeding requiring surgery – was significantly lower than what was clinically observed in the BTT study of the HeartMate VE LVAS.
• The majority of patients demonstrated vast improvement progressing from severe heart failure symptoms - even at rest - to being able to resume normal activities with little or no limitation; with 85 percent of the patients improving to NYHA Class I or II and 15 percent improving to NYHA Class III.

At 18-months, the HeartMate II Trial reported the following results on 281 consecutive NYHA Class IV patients who were listed for cardiac transplantation, but at an imminent risk of dying:

• 33 sites enrolled patients from march 2005 to April 2008. To date, this has been the fastest enrolling LVAD trial.
• At six months post-implantation, 83% of patients improved to NYHA Class I or II.
• Average distance covered in a six-minute walk improved 163 meters after one month of support, and 305 meters by six months.
• Patients demonstrated significant improvement in quality of life as demonstrated by both the Kansas City Cardiomyopathy and the Minnesota Living With Heart Failure questionnaires.* Greater than 90% reduction in percutaneous lead infection
• Nearly 70% reduction in bleeding requiring surgery
• More than 65% reduction in stroke
• More than 80% reduction in nonstroke neurological events
• The most common adverse event was bleeding, primarily in the early postoperative period. The leading cause of death were sepsis (11), ischemic stroke (5), hemorrhagic stroke (5), and right heart failure (7).
• Actuarial survival of 281 patients observed in a prospective, multicenter study (based on Kaplan-Meier analysis) was 82% at six months, 73% at 12 months, and 72% at 18 months.
• The conclusion: a continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplantation, with improved functional status and quality of life.

HeartMate III (future)

The HeartMate III LVAD is being tested in vivo bovine subjects. It is based on a centrifugal pump. There is no projected date for further trials, approval, or marketing .