Mechanical Ventricular Assistance as Destination Therapy for End-Stage Heart Failure: Has it Become a First Line Therapy?

摘要

Patients with end-stage heart failure have poor quality of life and prognosis. Therapeutic options are scarce and are not available for all. Only few patients can be transplanted every year. Several medical and surgical strategies have shown limited ability to influence prognosis and quality of life. In the past years, technological progress has realized devices capable of providing appropriate hemodynamic stabilization and recovery of secondary organ failure. Recently, these devices have been assessed as definitive treatment for patients who do not qualify for transplantation or/and instead to transplantation (“destination therapy”). This indication is increasingly considered following the results of newest clinical study reporting long-term survival without device correlated adverse events using last generation devices, and acceptable quality of life. The current knowledge about destination therapy and some original data from the DAVID Study (an Italian multicenter prospective study designed to evaluate the patient’s survival rate and quality of life of patients implanted with these new devices as long-term support or destination therapy) are summarized herein.Key Points class="first-line-outdent">– End-stage heart failure (NYHA class IV or stage D) is a vastly growing problem, with a poor prognosis and limited therapeutic options.– Heart Transplantation is nowadays the “gold standard” treatment albeit its inability to serve to the current demand let alone the future one.– The REMATCH study has demonstrated that first generation implantable devices, even with their high number of complications (infectious and thromboembolic events), allowed an improvement of quality and duration of life compared to medical therapy. Further studies have shown that the evolution of VAD technology has reduced device-related complications and consequently improved survival and quality of life of patients with results, according to some authors, similar to cardiac transplantation at least at 2 years from the implantation.– Biotechnology advancements have led to the creation of a new generation of implantable mechanical assist devices: the continuous-flow rotary pumps. Recently entered into clinical use, they seem to represent a promising solution to end -stage– heart failure allowing long-term assistance and an adequate standard of living (Destination Therapy/Bridge to Life).– The DAVID Study, an Italian multicenter prospective study, reports encouraging results in terms of late outcome and quality of life in patients implanted with newest continuous-flow devices as destination therapy. More and more numerous studies are needed to confirm our initial data and for laying the foundations for this new therapeutic frontier face to cardiac transplantation. class="kwd-title">Keywords: end-stage heart failure, ventricular assist devices, heart transplantation, destination therapy, quality of life class="head no_bottom_margin" id="S1title">IntroductionAdvanced heart failure is an epidemic contributing considerably to the overall cost of health care in developed nations. The number of people afflicted with this complex syndrome is increasing at an alarming pace with this trend will likely continue for many years.End-stage heart failure may present as an acute event or as the terminal stage of a chronic heart disease. In its acute refractory form, initiating mechanical support relies heavily on the assessment of the recovery potential of cardiac function and the patient’s possibility to be a candidate for transplantation or definitive mechanical assistance.In the case of patients with terminal chronic heart failure, the therapeutic procedure is more complex. We are faced with patients who have poor prognosis and poor quality of life as encumbered by the presence of symptoms even at rest, require frequent hospitalizations and have complex, difficult to manage drug therapies. In this cohort of patients, the quality of life is very poor and mortality rate at 1 year that is approximately 50% (, ). Key treatment is heart transplant: with more than 85% 1-year survival and approximately 70–75% survival at 5 years, according to the registry of the International Society for Heart and Lung Transplantation (). It is now clear that transplantation alone cannot meet all its demand and the availability of hearts for transplantation will always be a limited resource. Furthermore, even after optimizing the rate of donations per million inhabitants with the increase of older donors will not increase the actual availability of transplantable hearts (). Moreover, the transplanted hearts are not immune to complications, with implications in survival and quality of life: this is evident from the data register collected by the International Society of Heart and Lung Transplantation (ISLHT) (see Tables and ) ().>Table 1>Prevalence of complications at 5 and 10 years in patients with heart transplant (modified by 2014 ISHLT Registry).