HeartWare International, Inc. (HTWR): 10-7-11/Heartwire: Followup Article on H...

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Re: cjgaddy post# 385

Tuesday, 10/11/2011 9:28:58 AM

Tuesday, October 11, 2011 9:28:58 AM

10-7-11/Heartwire: Followup Article on HVAD EACTS’11 Data Update, with addl. quotes from Dr. Mark Slaughter, Professor & Chief of the Division of Thoracic & Cardiovascular Surgery and Director of the Mechanical Assist Device & Heart Transplant Program at the Univ. of Louisville.
NOTE: “Dr. Slaughter discloses grant & research support from Thoratec & HeartWare.”

10-7-11: ”Change in Anticoagulation Reduces Thrombi in Heartware Trials”
By Lisa Nainggolan, Heartwire (More of our EACTS 2011 coverage)
http://www.theheart.org/article/1292159.do
…REQUIRES SUBS., but you can access it via Google here:
http://www.google.com/search?hl=en&source=hp&biw=1536&bih=666&q=%22Change+in+anticoagulation+reduces%22&oq=%22Change+in+anticoagulation+reduces%22

10-7-11: Lisbon, Portugal - The latest clinical-trial data with the HeartWare continuous-flow ventricular assist device (VAD) (Framingham, MA) show that modifications made to the anticoagulation regimens of patients are paying off in terms of fewer adverse events, with fewer pump thrombi and strokes without any resultant increase in bleeding [1,2]. Although the results reported from the ADVANCE bridge-to-transplant pivotal trial of the HeartWare VAD in patients with end-stage heart failure and the continued access protocol (CAP) for this study have been encouraging, there have been concerns about a high rate of thrombus development with the device.

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PHOTO: Dr. Mark S Slaughter

Caption: “I think the important thing is, we can demonstrate with two devices a 90% survival rate at a year, and that is incredibly exciting. He believes HeartWare now has "equivalent results" with the latest data on the other continuous-flow VAD on the market, HeartMate 2 (Thoratec). "I think the important thing is, we can demonstrate with two devices a 90% survival rate at a year, and that is incredibly exciting," he told Heartwire, adding that the 2 devices are very similar in terms of cost.”
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As a result, in March of this year, a decision was made to try to adjust the anticoagulation of participating patients, investigator Dr. Mark S Slaughter (Univ. of Louisville, KY) explained to heartwire at the European Association for Cardio-Thoracic Surgery (EACTS) 2011 Annual Meeting earlier this week. "We sat down and decided best practices. The programs that had the best outcomes were maintaining INR levels around 2 to 2.5 and they were giving a whole aspirin (325 mg). So the majority of programs now follow that protocol; not everybody, but the majority. And by doing that, we have shown immediately a decrease in strokes, pump thrombus, and things like that within a 6-month time period," he noted. And there was no trade-off in terms of an increase in bleeding, he noted, adding that the bleeding risk was "virtually unchanged." Slaughter said it's likely some of the improvements seen are simply due to better management of patients. "By raising awareness, people are maybe being a bit more careful."

Survival remains high despite lower transplant rates than prior trials.

Results from ADVANCE were reported last year; outcomes for the 140 patients who received the HeartWare were deemed "noninferior" to those from the prospectively defined control group, which consisted of almost 500 registry patients who received VADs for bridging to transplantation, in most cases the HeartMate 2. Following the last patient enrolled in ADVANCE, a CAP was agreed on that included 3 allotments of additional patients - 54, 54, and 94 - for a total of 202 patients in addition to the 140 in ADVANCE. At the EACTS meeting, Slaughter reported aggregated data on the 140 ADVANCE patients plus 101 of those from the CAP who had at least six months of follow-up, for a total of 241 patients (data cutoff was July 15, 2011, with a database lock on August 25, 2011).

The survival "remains high" at 180 days, despite a lower transplant rate than in prior bridge-to-transplant trials, he noted. Of the 93% of patients who survived, 71% were alive on the device and 22% were transplanted. Adjustments in anticoagulation reduced thrombus events, and reoperations for bleeding, as well as sepsis and driveline infections, were "infrequent," he said. Slaughter noted, however, that results from this trial, including adverse events and outcomes, could possibly change as the trial reaches completion.

ADVERSE EVENTS IN 241 PATIENTS IN ADVANCE OR CAP FOR HEARTWARE
ADVERSE EVENT Patients affected(%) Event rate(per patient-year)
INFECTIONS
• Driveline exit 11.6 0.19
• Sepsis 10.4 0.14
• Bleeding requiring reoperation 11.6 0.16
DEVICE EXCHANGES
• Procedure related 1.2 0.01
• Suspected thrombus 4.1 0.05
• Other 1.7 0.02
NEUROLOGIC EVENTS
• Ischemic cerebrovascular accident <48h 2.9 0.03
• Ischemic cerebrovascular accident >48h 5.0 0.07
• Hemorrhagic cerebrovascular accident 5.4 0.06
• Transient ischemic attack 3.7 0.05

Future trials aim to show benefit of treating patients sooner with VADs

HeartWare is awaiting approval in the US; it is already available in Europe & Australia. As well as ADVANCE and the CAP, another US trial is also under way, called ENDURANCE, which is a randomized, controlled, unblinded, multicenter clinical trial to evaluate the use of HeartWare as a destination therapy vs any VAD FDA approved for destination therapy in 450 advanced heart-failure patients who have not responded to standard medical management and who are ineligible for cardiac transplantation.

Also planned is the REVIVE-IT trial with HeartWare, in non-transplant-eligible patients - "destination therapy in patients who have never been on inotropes, so they are at home, ambulatory. They will go straight to a device, and that will be exciting."

And Slaughter says for HeartMate 2, which is already approved for use in the U.S., a prospective registry is ongoing. "The goal is to demonstrate what we showed in the destination-therapy trial, that there is a significant advantage to treating NYHA 3b patients 3-6 months sooner than you would if you wait until they are a truly bedridden class."
Dr. Slaughter discloses grant & research support from Thoratec & HeartWare.
*end*

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9-29-11 Canaccord reits BUY in prep. for Oct2 EACTS
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67522757

10-2-11/PR: HVAD/BTT Data Update given by Dr. Mark Slaughter (Univ.Louisville)
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67606997

10-2-11: EACTS/Lisbon Breakout Session – Dr. Slaughter’s Slideshow (32 slides)
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67611674

10-2-11: Dr. Mark Slaughter on HVAD-vs-HMII Choice once HVAD is approved in U.S. for BTT
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67640780

10-3-11: Canaccord Reits. BUY on Heartware (PT=101); Positive HVAD Data at EACTS
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67622843

10-3-11: Wedbush Reits. OUTPERFORM on Heartware (PT=105), based on EACTS’11 HVAD Data Update, “groundbreaking nature of HeartWare's HVAD”, the “enthusiastic response from surgeons”…
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67630244

10-3-11/MassDev: Followup article on positive HVAD update at EACTS’11/Lisbon
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67654721

10-4-11: 10-4-11: Wunderlich reits. HOLD on Heartware [PT=$80], following 10-2-11 EACTS/Lisbon HVAD data update that showed “reduced rates of thrombus requiring a pump exchange”…
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67666071

10-7-11: Heartwire Followup article on HVAD EACTS’11 Data Update, with addl. quotes from Dr. Slaughter
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