Lisa Salberg
03-26-2004, 05:31 PM
FDA advisory panel recommends approval of total artificial heart as bridge to transplantation
Rockville, MD - The FDA's Circulatory System Devices panel has voted 10 to 1 in favor of recommending approval of the world's first total artificial heart as a bridge to transplantation. The advisory panel spent most of St Patrick's Day grappling over whether the data presented by the sponsor were sufficient to unequivocally demonstrate that the benefits of device implantation outweighed the risks.
As luck would have it for the sponsor, the vote swung in favor of the artificial heart. "People are dying who don't have any good alternative," Dr Judah Weinberger (Columbia University, New York, NY) said in support of the yes vote.
Representatives from SynCardia Systems Inc, manufacturer of the CardioWest Total Artificial Heart, presented data on 81 patients who received the device, 79% of whom survived long enough to receive a heart transplant. The average amount of time on the device was 11 weeks, while one patient lived on the artificial heart for 414 days. One month after receiving their heart transplant, 69% of the original group was out of bed and recovering well. Unlike ventricular assist devices (VADs), which support and reduce the workload of a ventricle only, the CardioWest device actually replaces the left and right ventricles and heart valves and is attached to a washing-machine-sized pump, relegating the device to hospital use only.
Hamstrung for data
Adverse events were not infrequent, an FDA review observed: 22% of the patients developed infections related to the device, 8% developed clots, a full 40% had serious bleeding episodes, and in 18% of the patients, the device malfunctioned.
The major bone of contention for the panel, however, was the company's attempts to demonstrate improvements in the CardioWest group as compared with a historical control group: people who had awaited heart transplantation during the early 1990s. The issue was also a primary concern of FDA spokespeople, who pointed out that patients with VADs were not used as comparators. VADs are used more frequently in patients who still have one ventricle functioning, but survival rates in patients waiting for transplants who are on VAD support are typically similar to those reported today for the CardioWest device, with similar side effects, despite being a less radical form of cardiac support.
"This leaves all of us in a hamstrung position," Dr Mitchell Krucoff (Duke University, Durham, NC) grumbled. "Where are the data?"
SynCardia maintains that there are approximately 4000 people awaiting heart transplantation in the US in any given year and that up to half of these have double-chamber heart failure that would render them poor candidates for a VAD. Ultimately, the advisory panel appeared to be swayed by data showing that patients who received the artificial heart appeared to have improvements in liver and kidney function, changes that would make them better candidates for heart transplantation.
Related links
1. FDA labels AbioCor artificial heart a "humanitarian use device" [HeartWire > News; Sep 29, 2003 ]
2. FDA approves AB5000 heart-assist ventricle from Abiomed [HeartWire > News; Sep 25, 2003 ]
3. Jarvik 2000 safe as a bridge-to-transplant [HeartWire > News; May 27, 2002 ]
4. First patient to receive permanent Jarvik 2000 implant shows improved quality of life at 20-month follow-up. [HeartWire > News; May 14, 2002 ]
By: Shelley Wood The HEART.org
Rockville, MD - The FDA's Circulatory System Devices panel has voted 10 to 1 in favor of recommending approval of the world's first total artificial heart as a bridge to transplantation. The advisory panel spent most of St Patrick's Day grappling over whether the data presented by the sponsor were sufficient to unequivocally demonstrate that the benefits of device implantation outweighed the risks.
As luck would have it for the sponsor, the vote swung in favor of the artificial heart. "People are dying who don't have any good alternative," Dr Judah Weinberger (Columbia University, New York, NY) said in support of the yes vote.
Representatives from SynCardia Systems Inc, manufacturer of the CardioWest Total Artificial Heart, presented data on 81 patients who received the device, 79% of whom survived long enough to receive a heart transplant. The average amount of time on the device was 11 weeks, while one patient lived on the artificial heart for 414 days. One month after receiving their heart transplant, 69% of the original group was out of bed and recovering well. Unlike ventricular assist devices (VADs), which support and reduce the workload of a ventricle only, the CardioWest device actually replaces the left and right ventricles and heart valves and is attached to a washing-machine-sized pump, relegating the device to hospital use only.
Hamstrung for data
Adverse events were not infrequent, an FDA review observed: 22% of the patients developed infections related to the device, 8% developed clots, a full 40% had serious bleeding episodes, and in 18% of the patients, the device malfunctioned.
The major bone of contention for the panel, however, was the company's attempts to demonstrate improvements in the CardioWest group as compared with a historical control group: people who had awaited heart transplantation during the early 1990s. The issue was also a primary concern of FDA spokespeople, who pointed out that patients with VADs were not used as comparators. VADs are used more frequently in patients who still have one ventricle functioning, but survival rates in patients waiting for transplants who are on VAD support are typically similar to those reported today for the CardioWest device, with similar side effects, despite being a less radical form of cardiac support.
"This leaves all of us in a hamstrung position," Dr Mitchell Krucoff (Duke University, Durham, NC) grumbled. "Where are the data?"
SynCardia maintains that there are approximately 4000 people awaiting heart transplantation in the US in any given year and that up to half of these have double-chamber heart failure that would render them poor candidates for a VAD. Ultimately, the advisory panel appeared to be swayed by data showing that patients who received the artificial heart appeared to have improvements in liver and kidney function, changes that would make them better candidates for heart transplantation.
Related links
1. FDA labels AbioCor artificial heart a "humanitarian use device" [HeartWire > News; Sep 29, 2003 ]
2. FDA approves AB5000 heart-assist ventricle from Abiomed [HeartWire > News; Sep 25, 2003 ]
3. Jarvik 2000 safe as a bridge-to-transplant [HeartWire > News; May 27, 2002 ]
4. First patient to receive permanent Jarvik 2000 implant shows improved quality of life at 20-month follow-up. [HeartWire > News; May 14, 2002 ]
By: Shelley Wood The HEART.org