Shared Care to Destination Therapy Left Ventricular Assist Device Site: a Novel Strategy to Start a Successful Mechanical Circulatory Support Program.

PURPOSE OF REVIEW: Heart failure is an important healthcare issue because of its high prevalence, mortality, and morbidity. Advanced heart failure therapies have improved significantly over the years with improved outcomes. Heart transplantation remains an elusive treatment option for most patients; hence, the need for alternative therapy has given rise to the use of mechanical circulatory support (MCS) devices, initially as bridge to transplantation, but with more recent use as destination therapy. This review focuses on the intricacies of establishing a successful left ventricular assist device (LVAD) program for destination therapy in the setting of a growing anticipated need for wider availability of such treatment options. RECENT FINDINGS: Guidelines have established the role of MCS in patients with advanced HF refractory to optimal guideline-directed medical therapy (GDMT) and cardiac device interventions. Multiple studies have shown generational improvement in the overall safety profile of MCS devices with the use of newer devices for destination therapy showing improved outcomes. Heart failure is a growing cardiovascular problem with an anticipated growing need for advanced HF therapies including MCS devices. A model of shared care LVAD to destination therapy implanting site should be considered as a strategy to start a successful LVAD program.

Prevalence and timing of bend relief disconnection in patients supported by the late version HeartMate II left ventricular assist device.

BACKGROUND: On April 4, 2012, the U.S. Food and Drug Administration issued a Class 1R recall of the HeartMate II (Thoratec Corporation, Pleasanton, CA) left ventricular assist device (LVAD) due to spontaneous detachment of the bend relief from its intended position in patients implanted with the most recent version of the HM II. This study examined the incidence and timing of outflow graft bend relief disconnection in patients implanted with the HM II LVAD. METHODS: All patients supported with the modified version of the HM II LVAD were asked to report for dedicated abdominal X-ray imaging to assess the position of the bend relief. Also performed was a retrospective review of X-ray images of all patients who had previously been supported with this version but had since received a transplant, undergone LVAD explant, or died. RESULTS: Between March 9, 2011, and April 9, 2012, 59 patients underwent primary implant with the modified version HM II. Follow up X-ray images were available for 56 patients (95%). The bend relief was found fully disconnected in 6 of 56 (11%) and partially disconnected in 13 (23%). Two of 6 patients (33%) with full bend relief disconnection and 1 of 13 of the initially partially disconnected patients (7.7%) required urgent surgical intervention due to symptoms of hemolysis and/or heart failure. CONCLUSIONS: Bend relief disconnection is common and may be observed immediately after implant but may also develop over time. Full bend relief disconnect may present with hemolysis and/or heart failure symptoms and often requires surgical revision. Surveillance abdominal X-ray imaging should be performed routinely on all patients who were implanted with the modified version HM II.

A two-round Delphi study examining consensus of recommended clinical practices for patients with ventricular assist devices as destination therapy.

OBJECTIVE: To identify the current clinical practices of Medicare-certified facilities offering ventricular assist devices as destination therapy and to attain a consensus of recommended clinical practices across the United States for the management of adults with ventricular assist devices as destination therapy. METHOD: Sixty ventricular assist device coordinators from Medicare-certified centers were invited to participate in an online, 2-round Delphi survey. The surveys asked whether recommended practices are current practices and whether respondents always/agreed or never/disagreed with performing the recommended practice guidelines. Consensus was defined as 75% agreement. The clinical areas of focus were patient selection, preoperative preparation, postoperative care, infection control, nutrition, and patient discharge preparation. Practices were extracted from the advanced practice guidelines for HeartMate destination therapy and the International Society for Heart and Lung Transplantation's 2006 guidelines for the care of heart transplant candidates. RESULTS: Representing 21 states across the country, the first-round survey had a response rate of 57% (n = 34). The second-round survey had a response rate of 74% (n = 17), representing 28% of the 60 centers. Consensus was obtained for 122 practices. The dimension of patient selection-diagnostic tests and screening had the highest level of consensus (16%, n = 20), and the dimension of postoperative care-intermediate/intensive care unit dimension had the lowest level of consensus (3.3%, n = 4). CONCLUSION: Survey results identify a consensus of practices for the specific group of ventricular assist device coordinators who responded, but that consensus cannot be generalized to all ventricular assist device facilities. These results can, however, provide a foundation for further research leading to the development of standard-of-care practices for patients with ventricular assist devices as destination therapy.

A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial.

BACKGROUND: Cardiac transplantation, a procedure nearly abandoned in the 1970s, has evolved into the standard of care for appropriate patients with end-stage heart failure. Much of this success has been due to improvements in immunosuppression, including the introduction of a triple-drug regimen. Retrospective reports suggested that single-drug immunosuppression with tacrolimus was feasible. As such, a prospective, randomized trial was conducted to test this approach. METHODS AND RESULTS: One hundred fifty adult de novo heart transplant recipients were enrolled in a prospective, randomized, controlled, open-label trial comparing tacrolimus monotherapy (MONO) with tacrolimus and mycophenolate mofetil therapy (COMBO). Corticosteroids were used in the early postoperative period but discontinued in all patients over 8 to 9 weeks. The primary end point was the composite biopsy score at 6 months after transplant. Patients were followed for 1 to 5 years. The composite biopsy score was similar between groups at 6 and 12 months: 6-month MONO, 0.70 ± 0.44 (95% confidence interval, 0.60 to 0.80) versus COMBO, 0.65 ± 0.40 (95% confidence interval, 0.55 to 0.74; P=0.44). Allograft vasculopathy was assessed by angiography and intravascular ultrasound, with no significant differences noted. Three-year survival was also similar (92.4% MONO versus 97% COMBO; P=0.58, log-rank). CONCLUSIONS: Addition of mycophenolate to single-agent immunosuppression did not provide an advantage over single-agent immunosuppression in terms of rejection, allograft vasculopathy, or 3-year survival. Corticosteroids, which have traditionally been a mainstay of therapy, were successfully discontinued in all patients. These conclusions are tempered by the limited statistical power associated with a sample size of only 150 patients. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00299221.