J Thorac Cardiovasc Surg 2008;135:1360-1361
© 2008 The American Association for Thoracic Surgery
Cardiopulmonary Support and Physiology |
Discussion
Dr Cleveland
(Denver, Colo). Jim, I congratulate you and your coauthors at the Utah artificial heart program for achieving exemplary outcomes with a complex and challenging group of patients undergoing LVAD therapy as sole therapy for advanced heart failure. Again, Jim did a good job emphasizing and placing this group of patients and the results of the study in the context of the fact that these are critically ill patients. All had class IV congestive heart failure for at least 90 days. All had an ejection fraction less than 25%. All had a VO2 max less than 12 mL/kg/min, and most important all had no other therapy (ie, heart transplantation). The principle finding of the present study in this cohort of 23 patients undergoing DT in Utah is a 1-year survival of 77% versus 52% in the surgically implanted destination group in the REMATCH trial. Particularly noteworthy is the subsequent 2-year survival of 77% in Dr Long's cohort versus only 30% in the REMATCH cohort.
If one considers the nature of this therapy for heart failure, there are 3 main mechanisms that could be offered to explain the improved outcomes seen in your study. First is earlier patient implant. Obviously these are sick but not moribund patients, and you alluded to that, perhaps if their sodium was a little higher, perhaps if their blood pressure was a little higher. Second is improvement in the HeartMate or LVAD technology itself. Third is improvement in patient management. Which of these 3 to do you believe is most operant in providing for these results?
Dr Long. In this era I think patient management is the most critical step by which we can improve this field. Certainly as devices improve we are going to see added reliability and durability, but we have not yet been able to identify that in the limited numbers we've seen. Reduction in mortality because of device failure is largely the result of managing patients better through the perioperative period. We think the reduction in infection, the first leading cause of mortality in the REMATCH trial, is also largely the result of infection, but clearly as devices improve, get smaller with percutaneous leads that are smaller, it will be much easier to reduce infections, much easier to implant these, and have a more durable device, moving beyond 2-year devices into the 4+ range. Patient selection is critical. Now we are constrained to the REMATCH-like patients largely because of Centers for Medicare and Medicaid Services constraints and the regulatory approval process. I think if we are going to do this effectively we have to move beyond that, but we really can't move beyond that until we get some good results with those kinds of patients. I think it is important for centers across this country to set targets of 50% 2-year survivorship, and if we do achieve that across this field I think we earn the right to move to a less ill patient population analogous to those who were in the REMATCH trial.
Dr Cleveland. Second, as discussed in your article, and it's really a well-written and clear article, DT has been offered only to a small number of patients. I think a reason for this is cost. Eric Rose and colleagues published subsequent cost data from the REMATCH trial suggesting that with DT if the patient incurs complications perioperatively, particularly that of sepsis or bleeding, the cost of this therapy increases to near-prohibitive levels. Do you have associated data? I know you didn't present here today, but do you have data suggesting that with your improved outcomes the cost of the therapy is less and therefore it may make this more approachable by many centers?
Dr Long. Your observation is right on. The destination field really didn't begin picking up post-REMATCH until Centers for Medicare and Medicaid Services approval was in place, so that gives you some indication how important reimbursement is to this. In more recent studies yet to be released, we're finding that we can decrease this to the $140,000 range and to the $130,000 range in those without complications.
Related Article
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Improving outcomes with long-term "destination" therapy using left ventricular assist devices
- James W. Long, Aaron H. Healy, Brad Y. Rasmusson, Cris G. Cowley, Karl E. Nelson, Abdallah G. Kfoury, Stephen E. Clayson, Bruce B. Reid, Stephanie A. Moore, Douglas U. Blank, and Dale G. Renlund
J. Thorac. Cardiovasc. Surg. 2008 135: 1353-1361.
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