The Concerted Action 'Heart' European registry on clinical application of mechanical circulatory support systems: bridge to transplant. The Registry Scientific Committee.

OBJECTIVE: The goal of this paper is to identify in the field of mechanical support as bridge to transplant, by statistical analysis, variables influencing survival during support (transplanted patients) and the overall survival (discharged after transplant). METHODS: Clinical factors are analysed in 258 patients in the period 1986-1993. All variables were analyzed by a univariate and multivariate analysis. RESULTS: The indications for mechanically circulatory support were hemodynamic deterioration before transplantation in 177 (69%), post acute myocardial infarction in 40 (15%), postcardiotomy cardiogenic shock in 20 (8%), graft failure in 12 (5%) and cardiac rejection 9 (3%). The devices implanted have been: pneumatic VAD in 145 cases (56%), electromechanical LVAS in 15 cases (6%), TAH in 78 cases (30%) and centrifugal pumps in 20 cases (8%). The patients were supported for period ranging from 2 h to 623 days (mean 18.3 days +/- 43.2). The type of support was: LVAD 50 cases (20%), RVAD 3 cases (1%), BVAD 127 cases (49%), and TAH 78 cases (30%). Bleeding occurred in 84 patients (32.5%), infections in 83 patients (32.1%); 21 embolic complications were reported in 16 patients (6%). Renal failure occurred in 64 cases (25%) requiring dialysis in 33 (13%); respiratory failure in 47 cases (18%); neurological impairment was noted in 22 patients (9%). One hundred-sixty patients were transplanted (62%) and 104 ultimately discharged (40% out of total 258 patients and 65% out of 160 transplanted patients). Among postoperative parameters, renal failure, TAH, neurological impairment and infection shown statistical power. Some pre- and post-operative variables were identified as independent risk factors for overall mortality: age, indication for graft failure, all indications different from cardiomyopathy, neurological impairment, renal insufficiency, infection, bleeding and any type of support different from LVAD. The improvement in the success rate in the last 2 years is statistically significant (P = 0.0282) considering both the percentage of transplanted patients and of discharged patients. CONCLUSIONS: The results are encouraging if mechanical support is performed in patients with deterioration while awaiting transplant, when LVAD is feasible and effective, when an ideal timing of transplant during support period is identified.

The Italian Artificial Heart Program.

In Italy, artificial heart development was promoted by virtue of a special program on technological and industrial development in areas related to cardiology and cardiosurgery. A first prototype series of electromechanical total artificial hearts (TAHs) and ventricular assist devices (VADs), with ball-screw-based actuation technology, has been developed, and preliminary bench tests and short-term animal implant experiments were performed. The project started with analysis and development of existing TAH and VAD models, and it included a fill-sensor-free control scheme and anatomical fitting studies using a three-dimensional computer model of the chest cavity. Second-generation prototypes are currently being developed, and they are scheduled for medium-term bench and in vivo testing by early 1994.