34 CARDIOVASCULAR MEDICINE MARCH 1, 2010 • INTERNAL MEDICINE NEWS HeartMate II Approved As Destination

BY ELIZABETH MECHCATIE tor of the FDA’s Center for Devices and Radiological Health, said in the Smaller Device Yields Big Results he approval of the HeartMate agency’s approval statement. II, the continuous-flow left ven- The HeartMate II Destination Ther- ith this approval, the current had cancer recently, are too old, or Ttricular assist device, has been apy study, a randomized trial spon- Wstate-of-the-art nonpulsatile have other comorbidities. expanded to include its use as destina- sored by Thoratec, compared the LVAD can be offered to all Efforts are underway at tion therapy for people with severe HeartMate II with the HeartMate XVE appropriate patients without the NHLBI to study VAD failure who are not acceptable in 200 patients (median age 64 years) the confines of an investiga- therapy in less ill patients, to candidates for . with advanced who were MY TAKE tional study. The approval determine if patients can be The device can now be used in pa- ineligible for cardiac transplanta- validates the concept that identified as candidates for tients with New York Heart Associa- tion.The primary end point—survival the smaller LVAD devices LVAD therapy before they tion class IIIB or IV end-stage left ven- at 2 years free of disabling stroke and confer benefits, compared get desperately ill and need a tricular failure, who have received reoperation to repair or replace the de- with the pulsatile device, and transplant, or before they are optimal medical therapy for at least 45 vice—was met by 62 (46%) of the 134 it opens up the way to their as sick as current LVAD can- of the last 60 days, according to the patients who received the Heart Mate further development. didates. The HeartMate statement issued by the manufacturer, II, compared with 7 (11%) of the 66 Small-stature adults, and XVE has shown wear and Thoratec Corp. who received the HeartMate XVE (N. many women, are too small for the tear after 1-1½ years of use, but there The Food and Drug Administration Engl J. Med. 2009;361:2241-51). HeartMate XVE. The HeartMate II is are people who have had the Heart- and Thoratec Corp. announced the “In addition, data collected in a sep- a smaller, nonpulsatile pump, so more Mate II for more than 3 years. approval of the Heart Mate II left arate registry of smaller-stature patients are eligible candidates. And as Considering how far we have come ventricular assist device (LVAD) in late women and men indicated that the de- the HeartMate II Destination Therapy with cardiac resynchronization thera- January. vice worked well in this specific pop- study showed, there’s less morbidity py devices and implantable car- It was first approved by the FDA in ulation,” the FDA statement said. associated with the surgical operation dioverter defibrillators—which once April 2008 for use as a bridge to trans- As a condition of FDA approval, because of the smaller size, which is a were huge, bulky devices that have plantation in cardiac transplant candi- Thoratec is required to conduct a post- big advantage. gotten smaller and smaller and even- dates at risk of imminent death from marketing study evaluating the de- Despite better survival and fewer in- tually will not even have leads—this is nonreversible left ventricular heart fail- vice’s performance. The data will be fections with the HeartMate II com- certainly what we expect to happen ure. The HeartMate II is markedly entered into the Interagency Registry pared with the HeartMate XVE, the with LVADS as well. smaller than previously available de- of Mechanically Assisted Circulatory stroke rate was not different, and that’s vices, including Thoratec’s HeartMate Support (INTERMACS), which is a concern. Investigators will focus MARIELL L. JESSUP, M.D., is associate XVE, the only other LVAD approved managed by the FDA; the National more on the mechanisms behind chief of clinical affairs of the division of for destination therapy. The Heart- Heart, Lung, and Blood Institute; the stroke and the resultant anticoagula- cardiovascular medicine, and medical Mate XVE, a pulsatile flow LVAD, was Center for Medicare & Medicaid Ser- tion strategies. director of the Penn Heart and Vascular first approved for use as a bridge to vices; and participating hospitals and Typically, destination-therapy pa- Center, University of Pennsylvania, transplantation. manufacturers. The study will follow tients have class IV heart failure, a low Philadelphia. The university was one of “Its smaller size and mobility should 247 patients for 2 years, and will col- ejection fraction, and poor exercise the sites for the study, but Dr. Jessup did allow more patients, including women lect data on outcomes, adverse events, tolerance, but are not transplant can- not contribute to the manuscript and and men of smaller stature, access to functional status, and quality of life, didates—perhaps because they have had no other relevant disclosures. treatment,” Dr. Jeffrey Shuren, direc- according to Thoratec. ■ Newly Approved LVAD Alternative to Heart Transplantation

BY BRUCE JANCIN does now appear to be on the cusp of being able to of- vanced heart failure is typically less than 10%, noted Dr. fer real benefit to at least some patients with severe Yancy, medical director of the Baylor Heart and Vascu- S NOWMASS, COLO. — The Food and Drug Ad- heart failure,” Dr. Lytle said. lar Institute and chief of cardiothoracic transplantation ministration’s recent approval of Thoratec Corp.’s Dr. Yancy explained that the technologic break- at Baylor University Medical Center, Dallas. HeartMate II left ventricular assist device as destination through that has finally brought destination therapy to Dr. Michael B. Fowler cautioned that outcomes with therapy—that is, as an alternative to heart transplan- the fore is the development of small, reliable, totally im- the HeartMate II are not nearly as good as with heart tation—is a landmark development heralding a long- plantable left ventricular assist devices (LVADs) featur- transplantation, which has a 1-year survival of rough- awaited era of lifetime mechanical circulatory support ing continuous-flow rotary pumps. ly 85% and a 10-year survival of 50%. But heart trans- in patients with terminal heart failure, plantation is available to only 2,000 pa- experts said at a conference sponsored by The HeartMate II tients per year because of the very the American College of . is ‘a realistic ‘Outcomes with limited donor organ supply. “This represents a significant step for- option in the the HeartMate II It is clear from observational registry ward and now becomes a realistic option treatment of are not nearly as data that LVADs need to be implanted in the treatment of patients with ad- patients with good as with relatively early in the course of end- vanced heart failure,” said Dr. Clyde W. advanced heart heart stage heart failure to achieve the best Yancy, the president of the American failure.’ transplantation.’ long-term survival. In one large registry, Heart Association, at the conference. older age, shock, and right-heart failure “When I went to the Cleveland Clinic DR. LYTLE DR. FOWLER as reflected in ascites or increased biliru- in 1978, we believed that we were just bin at device implantation were signifi- about ready to have an effective mechanical cardiac re- The HeartMate II is the prototype. It earned FDA ap- cant predictors of shortened survival (J. Heart Lung placement. And, honestly, one of the most disappoint- proval as destination therapy on the strength of a 200- Transplant. 2009;28:44-50), said Dr. Fowler, professor of ing parts of my career is that for a long time we really patient, multicenter, randomized trial in which it was medicine and director of the heart failure program at didn’t make much progress in that area. Basically, the compared with its predecessor, the HeartMate XVE, Stanford (Calif.) University. He noted that the Heart- devices just weren’t good enough. The pumps fell which uses a pulsatile-flow pump. Mate II has not solved the problem of device-associat- apart. There was a high incidence of stroke, bleeding, The primary study end point—survival at 2 years free ed thromboembolism: The rate of disabling stroke in and infection. It made for very poor quality of life,” ob- of disabling stroke or reoperation to replace or repair the randomized trial was 11% in the HeartMate II arm served Dr. Bruce Lytle, professor and chairman of the the pump—was achieved in 46% of HeartMate II re- and 12% with the pulsatile-flow LVAD. ■ department of cardiothoracic surgery at the Cleveland cipients and 11% of those who got the pulsatile-flow de- Clinic Foundation. vice. Two-year actuarial survival was 58% in the Heart- Disclosures: Dr. Yancy and Dr. Lytle indicated they have The HeartMate II has not solved all those problems, Mate II group, compared with 24% on the pulsatile-flow no relevant financial interests. Dr. Fowler disclosed that he but it does represent a great improvement over earlier- device (N. Engl. J. Med. 2009;361:2241-51). Two-year sur- serves as a consultant to Medtronic, AstraZeneca, generation devices. “Mechanical replacement really vival in medically managed patients with similarly ad- GlaxoSmithKline, Merck, and Scios.