After more than six months of experience with human clinical trials, top officials of Abiomed (Danvers, Massachusetts) said last month that they are "more confident than ever" concerning the operation of the company's AbioCor artificial heart.In a press conference presentation marked by a high level of confidence concerning the future of the AbioCor, company chairman and CEO David Lederman proclaimed that the device "works – and it works well." Lederman and Edward Berger, the company's vice president for strategic policy and planning, gave the most complete review yet of the ongoing clinical trial of the AbioCor, the company's flagship product, and Abiomed's policy concerning dissemination of information.
In summary of the clinical perspective, Lederman used the "more confident than ever" line to describe both the operation of the AbioCor heart and its prospects for eventual market clearance.
As of the Jan. 23 press conference, three of the five patients in the first cohort of a 15-patient clinical trial remained alive and supported by AbioCor hearts. Lederman emphasized the characterization of the AbioCor as a "replacement heart" to distinguish it from heart assist devices, he said. Those three patients, plus a fourth recipient who died late last year, all were supported more than 60 days, that period defined as a key endpoint of the trial. As reported the day prior to the Abiomed presentation, one of those patients, James Quinn, had been discharged from Hahnemann University Hospital (Philadelphia, Pennsylvania) and moved to a transitional facility.
Another endpoint of the trial is good quality of life, with the press conference featuring short video clips showing some of the patients in various social settings.
Thus far, the AbioCor has produced more than a year's worth of days supporting these patients, Lederman noted. This experience has indicated the need for some minor changes in one of the plastic parts of the heart's internal components, he said, as well as some adjustments in the external components that power the heart and are worn by the patient. But he emphasized that none of these changes offered "a major technological challenge."
Also underlining a point that the company has made throughout the trial, Lederman stressed the debilitated condition of the implanted patients. Without citing specific patients, he reviewed their multiple difficulties, such as breathing and liver and kidney failures, as well as heart function losses and, in some cases, bypass surgeries. In every case, he noted, the patients had achieved a degree of rehabilitation as a result of the AbioCor implant.
In what he characterized as a somewhat surprising finding, the heart had even supported symptoms that a healthier patient might not have tolerated as well. Those conditions included temperatures of up to 107 degrees or higher and "severe acidosis" in some, Lederman said. Additionally, he noted the ability of the heart to support those patients who could not tolerate anticoagulation medication, a normal part of the implant protocol. The plastic components of the device, he said, had been "very well tolerated" by the patients.
Berger focused more on the somewhat controversial public relations aspect of the trial and the company's policy of releasing information sparingly to avoid compromising patient care, a policy that he said will remain in place. While giving the media high marks for being "respectful and responsible" concerning patient privacy, Berger said that there had been "an excessive focus on individual patients to the detriment of a clear and comprehensive understanding of the trial." He called this the "natural fallout, that we have worked so hard not to compromise confidentiality."
Thus, one purpose of last month's press conference, he said, was "to shift the focus of information flow from individual patients to the trial as a whole. We're hoping to provide the media and public with information based on larger experience, rather than anecdotes." The trial has now produced a "critical mass" of information, he said, and he promised "negative events disclosed very rapidly, if anything," as well as continuing updates "no less than every three months."
Berger also reviewed the impact of the trial's use of independent patient advocacy councils (IPACs) at each trial site, funded by a trust and with no control by Abiomed. He defined an IPAC as "focused on the patient, as opposed to academic interests and ethics" and functioning to make sure that the patients and families understand every part of the trial and the decisions made. "I'm pleased to report that the contribution of the IPAC is very well accepted and strongly supported by the clinicians at the site," he said. As an "informal advisory body," the IPAC had been "a very rich source of ideas and perception about what's going on in the psycho-social arena with patients."
Lederman also reported during the press conference that Abiomed is developinga smaller version of the replacement heart, with completion of that device set for 2004.