Experimental development of an electrically stimulated biological skeletal muscle ventricle for chronic aortic counterpulsation.

OBJECTIVE: The chronic shortage of donor organs for cardiac transplantation and the high costs for mechanical assist devices demand the development of alternative cardiac assist devices for the treatment of severe heart failure. Cardiac assistance by stimulated skeletal muscles is currently investigated as such a possible alternative. The goal of the presented study was to construct a newly designed biological skeletal muscle ventricle and to evaluate its possible hemodynamic efficacy in an acute sheep model. METHODS: A total of 14 adult sheep were used for acute experiments. The entire thoracic aorta including the aortic root was excised from a donor sheep. An aorto-pericardial pouch conduit (APPC) was created by enlarging the aortic circumference in its middle section with two strips of pericardium. This biological conduit was anastomosed in parallel to the descending aorta of a recipient sheep, using the aortic root as an inflow valve to the conduit. Stimulation electrodes were applicated to the thoracodorsal nerve and the latissimus dorsi muscle was detached from the trunk and wrapped around the pouch. ECG-triggered functional electrical stimulation was applied during cardiac diastole to simulate aortic counterpulsation. Stimulation was performed during various hemodynamic conditions. RESULTS: A standardised surgical procedure suitable for long term studies was established during six experiments. An APPC, with 70-80 mm filling volume, was found to be of optimal size. In another eight experiments, hemodynamic measurements were performed. Under stable hemodynamic conditions the stimulation of the biological skeletal muscle ventricle induced a significant increase of mean arterial pressure by 14% and mean diastolic pressure by 26%. During pharmacologically induced periods of cardiac failure, the stimulation of the APPC increased mean arterial pressure by 13% and mean diastolic pressure by 19%. In all eight experiments, the diastolic peak pressure reached supra-systolic values during stimulation. CONCLUSIONS: The results demonstrate the hemodynamic efficacy of this newly designed biological skeletal muscle ventricle as an aortic counterpulsation device. Chronic experiments using a preconditioned fatigue-resistant muscle will further help to evaluate its possible clinical significance.

The impact of implantable cardioverter-defibrillators on mortality among patients on the waiting list for heart transplantation.

Implantable cardioverter-defibrillators were investigated for their impact on mortality in 228 consecutive heart transplant candidates on the waiting list for transplantation (207 patients without and 21 with implantable cardioverter-defibrillator therapy). The mortality rate in 207 patients without implantable cardioverter-defibrillator therapy was 23.2% and in 21 patients with implantable cardioverter-defibrillator therapy was 4.7%. In a Cox proportional hazards model for all 228 study patients (mortality while on the waiting list: 21.5%; transplantation rate: 54.8%), the absence of an implantable cardioverter-defibrillator was only a marginally significant predictor of mortality (p = 0.079). However, the absence of an implantable cardioverter-defibrillator was a powerful predictor of mortality for a subgroup of 134 patients with high-grade ventricular arrhythmias on Holter electrocardiography (mortality while on the waiting list: 26.1%; transplantation rate: 54.5%; p = 0.022) and for a subgroup of 58 survivors of sudden cardiac death (mortality while on the waiting list: 22.4%; transplantation rate: 56.9%; p = 0.018). Implantable cardioverter-defibrillator therapy can be strongly recommended in transplant candidates with a history of sudden cardiac death. Recommendations for an expanded, prophylactic use of implantable cardioverter-defibrillator therapy in heart transplant candidates cannot be given.