FRAMINGHAM, Mass., April 20, 2015 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today commented on results from multi-center commercial HVAD® System registries presented and discussed at the 35th International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting in Nice, France.
"Data from large, multi-center registries add to the growing commercial experience and reflect the positive evolution in understanding how to optimize patient outcomes on the HeartWare® Ventricular Assist System," said Doug Godshall, President and CEO at HeartWare. "The volume and variety of data presented at ISHLT involving the HeartWare System reinforce the benefits of mechanical circulatory support in the treatment of advanced heart failure patients around the world."
Post-Approval INTERMACS Registry of the HVAD System in Commercial Use
Simon Maltais, M.D., Ph.D., of Vanderbilt University Medical Center, Nashville, Tennessee discussed data on the HeartWare Post-Approval Study (PAS) demonstrating high survival outcomes and Quality of Life improvements in the early U.S. commercial experience during a poster session on Wednesday, April 15. The PAS is a multi-center, prospective registry designed to determine if the outcomes of commercial use of the HeartWare® System in the United States are comparable to the ADVANCE Bridge to Transplant (BTT) clinical trial and Continued Access Protocol (CAP) results. Between late 2012 and 2013, 600 commercial patients intended for bridge-to-transplant were enrolled and followed for at least six months until device explant, transplantation or death. The registry showed similar survival (Kaplan-Meier 81.4% at 12 months versus 84.1% in ADVANCE and CAP) and a comparable adverse event rate profile, despite 21 new-enrolling commercial centers added to the existing 48 centers from the clinical trial and a sicker commercial population (54% of patients were INTERMACS 1 and 2, compared to 40% of clinical trial patients). The investigators concluded that HVAD® continues to provide excellent outcomes and quality of life improvements in commercial use.
ReVOLVE Registry (Registry to Evaluate the HeartWare® Left Ventricular Assist System)
Jan Schmitto, M.D., Ph.D., MBA, of the Hannover Medical School, in Hannover, Germany, presented long-term follow up results from the ReVOLVE Registry on Thursday, April 16. The registry is an investigator-initiated, multi-center, prospective, single-arm database established to collect post-CE Mark clinical information on patients implanted with the HVAD System. Data was collected from 254 commercial implants performed between February 2009 and March 2012 from nine centers in Europe (seven) and Australia (two) and patients were followed to device explant, heart transplantation or death. The outcomes of patients who remained on support longer than two years were analyzed in a secondary follow-up investigation. ReVOLVE included a higher percentage of female patients (24.6% vs 14.4%) and an older patient population (52.1 years vs 48.5 mean years at age of implant) compared to the CE Mark trial. The mean time on support was 790 days, while 31% of patients in ReVOLVE were still on support at the time of the analysis. Results demonstrated long-term survival of 68%, 63% and 59% at three, four and five years following HVAD implant, respectively, with eight patients exceeding five years of support, seven on the original device. Adverse event rates continued to compare favorably with CE Mark clinical trial results, especially stroke (combined ICVA and HCVA) occurring at 0.07 events per patient year and exchange for pump thrombus at 0.04 events per patient year. The study showed that real-world use of the HVAD Pump continues to support favorable outcomes experienced with the device, and, due to the low rate of transplantation, successful long-term support is observed in a significant cohort of patients receiving the device.
The HeartWare HVAD Pump in Clinical Practice: Results from 1,035 Patients Analyzed in a Retrospective European Multi-Center Study
The European, multi-center retrospective registry podium presentation was given by Thomas Krabastch, M.D., Ph.D., German Heart Center Berlin, in Berlin, Germany, on Thursday, April 16 with results from four, large-volume implant centers in Germany and Austria. This investigator-led registry collected data on 1,035 patients implanted with the HVAD System. In this study, before implantation, 61% of patients were classified as INTERMACS class 1 or 2; 15% were supported with extracorporeal support (life assistance); and 3.0% required hemodialysis. The analysis reflected comparable long-term survival among commercially-available LVADs, and despite the severe fragility of this sicker patient population, low transplant rate of 16% over five years, and long-term use of right and bi-ventricular support (RVAD and BIVAD) in 5% of the patients, survival was 67.2% at one year and 58.5% at two years. Additionally, the adverse event profile was comparable to less sick patient populations, with driveline infections occurring at 0.115 events per patient year, stroke events occurring at 0.108 events per patient year and pump thrombosis at 0.078 events per patient year. The investigators concluded that the HeartWare System has found broad acceptance in recent years, offers great versatility in implant strategies, and shows an acceptably-low complication profile.
Mechanical Circulatory Support Research Network – U.S. Multi-Center Registry
Also on Thursday, Dr. Maltais presented results from the Mechanical Circulatory Support Research Network, a consortium of implanting centers in the United States. This investigator-led registry collected neurological event data on 183 patients implanted with the HVAD® Pump for a bridge to transplant indication with minimum, median and maximum follow-up time of 91, 190 and 413 days, respectively. Reflecting the use of currently-available pumps with sintered inflow cannulas and surgical tools, strict outpatient INR monitoring, and close blood pressure management (many patients sent home with monitoring equipment), the total stroke incidence was 15%, (ischemic 10%, hemorrhagic 5%). Investigators concluded that the risk of neurological complications is comparable between the HeartMate II and HVAD devices in a contemporary cohort of patients bridged to transplantation with a CF-LVAD, with advanced age remaining the primary determinant of neurological events.
"HeartWare's experience supporting mechanical circulatory support patients is growing with more than 8,000 patients implanted around the world. We have come a long way since the early clinical trials and have strengthened our training and education programs to continue to improve patient outcomes and strengthen our partnerships with our clinicians," added Mr. Godshall. "In particular, based on the data presented at ISHLT, we look forward to confirming the benefits of more consistent blood pressure monitoring through our second cohort in destination therapy, which is nearing full enrollment."
Enrollment in Second Destination Therapy Cohort Nearing Completion
In the second destination therapy cohort, HeartWare is enrolling up to 310 HVAD patients, as well as up to 155 control patients, in a 2:1 randomization at 50 centers. The trial protocol approved by the U.S. Food and Drug Administration was designed to confirm observations from ENDURANCE, that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events. Enrollment for the destination therapy supplemental cohort commenced in October 2013, and with more than 80% of the study enrolled, HeartWare expects enrollment to be completed in mid-2015.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 41 countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at www.heartware.com.
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to progress and outcomes of clinical trials and registries, regulatory status, research and development activities and commercialization of the HeartWare® Ventricular Assist System. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by federal securities laws and the rules and regulations of the Securities and Exchange Commission. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A. "Risk Factors" in HeartWare's Annual Report on Form 10-K filed with the Securities and Exchange Commission. HeartWare may update risk factors from time to time in Part II, Item 1A "Risk Factors" in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.
For additional information:
HeartWare International, Inc.
Phone: +1 508 739 0864
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SOURCE HeartWare International, Inc.