Does the Ross operation fulfil the objective performance criteria established for new prosthetic heart valves?

BACKGROUND AND AIM OF THE STUDY: Objective Performance Criteria (OPC) were established to compare a new heart valve prosthesis with fixed standards of linearized complication rates for morbid events: thromboembolism, thrombosis, hemorrhage, leakage and endocarditis. Although the pulmonary autograft operation provides optimal hemodynamic performances, the morbidity of both the autograft and homograft remain topics of controversy. METHODS: Valve-related morbid events and echocardiography in 109 patients who have undergone the Ross operation since 1991 were evaluated at annual follow up examination (mean 2.8 years; range: 1 month to 8 years). Linearized rates (number of events per 100 years patient exposure) were calculated to establish the safety and efficacy of this operation (288.7 years cumulative patient-years). RESULTS: Three patients died perioperatively (2.8%); two patients were reoperated due to autograft incompetence (1.8%, both valve repairs). No patient is currently on anticoagulation therapy, and no events of thromboembolism, valve thrombosis or bleeding were observed during follow up. Two patients had homograft endocarditis but were asymptomatic with moderate incompetence at the last follow up examination. There was no significant increase in aortic incompetence (AI) or pulmonary incompetence (PI) between discharge and follow up (AI, 0.4 +/- 0.5 versus 0.6 +/- 0.6; PI, 0.2 +/- 0.4 versus 0.4 +/- 0.6). In comparing the OPC (events per patient-year) for the Ross operation with those for tissue and mechanical valves, the results were: thromboembolism 0% (tissue 2.5%, mechanical 3%), valve thrombosis 0% (0.2% and 0.8%), all bleeding 0% (1.4% and 3.5%), major bleeding 0% (0.9% and 1.5%), all leakage 0.7% (1.2% and 1.2%), major leakage 0.7% (1.2% and 1.2%) and endocarditis 0.7% (1.2% and 1.2%). CONCLUSION: The pulmonary autograft procedure provides optimal hemodynamics and echocardiographic performance, and low valve-related complication rates; thus, the OPC for tissue and mechanical heart valve prostheses can be fulfilled by this technically demanding operation. These results confirm that the autograft is an ideal aortic valve replacement device.