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Should LVAD Implantation Be the New Gold Standard for Terminal Heart Disease?


THOMAS KRABATSCH, MD, PhD
CHRISTOPH KNOSALLA, MD, PhD
EVGENIJ V POTAPOV, MD, PhD
ROLAND HETZER, MD, PhD
Deutsches Herzzentrum Berlin, Germany


Due to a significant improvement in survival rates after ventricular assist device (VAD) implantations during the last years, the number of LVAD systems implanted worldwide has increased considerably. The 6-month survival in bridge-to-transplant patients, for example, rose to 93% [1], whereas in 2008 a rate of 82% had been reported [2]. Several factors have contributed to this improvement in the results. The systems are easier to implant than their predecessors, they are more durable and relatively easy to exchange in an emergency and, in the case of HeartMate II, the postoperative anticoagulation can be less intensive.

Although heart transplantation (HTx) is still regarded as the gold standard in the surgical treatment of terminal heart failure, this solution has been ailing progressively in recent years. In Europe, and especially in Germany, the number of organs available for heart transplantation falls significantly short of the needs of the growing number of patients with end-stage heart disease.

It is not only that far too few donor hearts become available to be able to offer transplantation to even the patients with the most urgent indication, but also far more patients die on the waiting list for a heart transplantation than is generally assumed.

It is true that the long-term results after HTx, with a survival rate of almost 50% after 15 years and more than 20% after 20 years, are unbeaten up to now [3]. However, when assessing these figures, it is mostly overlooked that during the waiting time for a donor organ, which in Germany is over 1 year with normal urgency status and over 100 days even with highest urgency [4], approximately 20%-30% of the patients die [5, 6]. And in Europe, increasingly liberal donor criteria have led to a mortality rate of over 22% in the first year after HTx [7].

Therefore it seems to be time to give some thought to alternatives to our current practice.

Should we perhaps declare LVAD implantation to be the primary therapy for terminal heart failure? This treatment is always available and is suitable for about 90% of the patients so far considered candidates for transplantation (around 10% of the patients, in our experience, need biventricular assist device implantation for a variety of reasons).

If one adds the reported 1-year mortality rate for HTx of 22% to the mortality on the HTx waiting list of approximately 20%-30% in the first year and compares these figures with the current survival rates after LVAD implantation, there should be a survival benefit for the LVAD patients at least for the first 3 to 5 years. Changing our treatment strategy as described above would tend to further improve the results after VAD implantation in comparison with today's situation, since currently most patients are selected for VAD implantation when their condition makes it improbable that they will survive the time on the HTx waiting list.

Such a change in treatment strategy for Germany, as an example, would probably lead to twice as many VAD implantations being performed every year.

Subsequently the patients could live for as long as possible with the LVAD. Failures of the VAD pumps or pump thrombosis could be treated in the long-term course by surgical pump exchanges. If, after years of VAD treatment, complications such as recurrent cable or even systemic infection or secondary right-sided heart failure occur, heart transplantation could be regarded as a "bail-out" solution. The latter, however, would probably apply to only a small percentage of patients.

Our aim is to kick off the discussion on how studies could be planned and performed to elucidate whether such a change in our policy would be beneficial.

We feel that the situation in Europe, and especially in Germany, demands that the medical community seriously considers ways of alleviating the current problems.



Disclosure Statements: The authors have no conflicts of interest to disclose.


References:

  1. Slaughter MS, Aaronson K, Najjar S, et al. Results of the HeartWare ADVANCE Bridge to Transplant Trial and CAP Update. Presented at the EACTS conference in Lisbon 2011. Interact CardioVasc Thorac Surg 2011;13(suppl 2) http://icvts.oxfordjournals.org/content/13/Supplement_2/iii.full
  2. Pagani F, Miller LW, Russell SD, et al. Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device. J Am Coll Cardiol 2009;54:312-21
  3. Taylor DO, Edwards LB, Boucek MM, et al. Registry of the International Society for Heart and Lung Transplantation: twenty-third official adult heart transplantation report--2006. J Heart Lung Transplant 2006;25:869-79
  4. Eurotransplant International Foundation. Annual report 2010 / ed. by Arie Oosterlee and Axel Rahmel. ISBN-13: 978-90-71658-30-3
  5. Deng MC, De Meester JM, Smits JM, et al. Effect of receiving a heart transplant: analysis of a national cohort entered on to a waiting list, stratified by heart failure severity. Commentary: Time for a controlled trial? BMJ 2000;321:540
  6. Kherani AR, Oz MC. Ventricular assistance to bridge to transplantation. Surg Clin North Am. 2004 Feb;84(1):75-89
  7. ISHLT transplant registry quarterly reports for heart in Europe. Characteristics for transplants performed between January 1, 2010 and September 30, 2011 and survival rates for transplants performed between April 1, 2007 and March 31, 2011. Based on UNOS/ISHLT data as of March 30, 2012. http://www.ishlt.org/registries/quarterlyDataReportResults