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.
Forward-Looking Statements
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:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com
Phone: +1 508 739 0864
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SOURCE HeartWare International, Inc.