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The 2013 International Society of Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support: Observations and Future Directions

MCS Council Education Committee Workforce Leader

The field of mechanical circulatory support (MCS) has evolved rapidly over the last two decades in regards to both medical indications and technologic advances. Significant milestones have included the adoption of MCS as an alternative to heart transplantation, known as destination therapy, as well as the move away from devices based on pulsatile flow towards those based on the concept of continuous flow. Over this time frame, competing interests have included physicians and hospitals who want to grow or establish new MCS programs, commercial entities wanting to sell their products, and third party payers who want to limit their financial liability. In contrast to cardiac transplantation where donor availability ultimately limits the number of procedure performed, the availability of MCS devices themselves are theoretically limitless and therefore no barrier to the number of procedures that could be performed. In the milieu of world-wide economic constraints and need for "austerity," the use of expensive technologies such as MCS are vulnerable to scrutiny from outside entities.

Just as the management of advanced heart failure has evolved to broaden the role of MCS, the scope of our Society has changed as well. Today, a significant portion of the Society's scientific efforts are now focused on MCS. In many regards, the ISHLT has been the vanguard for developments in the field. Therefore, rather than having industry, payers or other societies determining best-practices, the time was long overdue for the members of our Society, with our unique multi-disciplinary and international perspective, to put to paper the current state of knowledge in MCS in the form of a guidelines document. The outcome of this effort culminated in the inaugural publication of the "2013 International Society of Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support".

The guidelines are divided into five Task Forces, addressing the management of the patient from the time of evaluation through implantation and over the long-term until transplantation, explantation or death. Two striking observations were apparent during this process. First, despite over two decades of experience with mechanical circulatory support, there is a significant lack of randomized controlled data guiding our management decisions as manifested in the majority of recommendations being "level of evidence C". This is indicative of the difficulty of performing such trials in patient populations that are relatively small and in whom great resources already have been invested. When a patient with MCS presents acutely with medical illness, such as a stroke, the clinician's goal is to resolve the issue as promptly as possible to avoid patient morbidity and mortality. How willing would this clinician be to enroll this patient in a trial randomly assigning one management strategy over another? Similar to heart transplantation, individual clinician's management decisions have traditionally been influenced by experiential and anecdotal evidence with many published research studies being of a retrospective nature.

Despite the lack of controlled data, the second observation worth noting was this: there were far more commonalities in approaching patient management issues than differences. Almost surprisingly, there was relatively little controversy regarding specific recommendations made by these guidelines during the development process. Again, this speaks to the workings of our society. Despite our diversity, the intimacy of our society allows for presentation of research and exchange of ideas at a grassroots level amongst those at the frontlines of the field. As a result, consistencies in patient management strategies have developed through the amalgamation of research and expert consensus.

Tremendous opportunity exists for future research in the field, despite the challenges. It is the hope of the Society that not only will this document be the "go to" guide of the current knowledge base for those caring for patients, but will serve as an inspiration for future research initiatives.

Disclosure Statement: The author has no conflicts of interest to disclose

Salpy Pamboukian is Associate Professor of Medicine at the University of Alabama School of Medicine in Birmingham, Alabama, USA.