Preoperative risk assessment in cardiac surgery: comparison of predicted and observed results.

In the present climate of quality-assurance policies, rigorous requirements for informed consent, and a constantly changing patient population, a system of preoperative risk assignment and postoperative correlation was developed to monitor and evaluate surgical performance. Patients were categorized by operation, priority (emergent, urgent, elective), New York Heart Association Functional Class, and risk. Risk was assigned before operation using data from the Coronary Artery Surgery Study (CASS) and the recent literature. Data were collected by a full-time data manager and were stored and analyzed by computer. From January 1, 1984, to July 1, 1985, 1,303 patients underwent operation for acquired disease. This group included 913 patients undergoing isolated primary coronary artery bypass grafting (CABG). The comparison of predicted and observed results showed: (Table: see text). For patients undergoing isolated primary CABG, the elective group had an operative mortality of 0.6% (2/329); the urgent group, 1.1% (5/450); and the emergent group, 5.2% (7/134). Preoperative risk assignment is an effective method of quality assurance. Female sex and age older than 60 years, which predicted an operative mortality of 2 to 5% in the CASS study and other recent series, did not predict a similar risk in our series.

Performance of the Smeloff aortic valve beyond ten years.

The Smeloff aortic valve has remained unchanged in design and material since 1966. To assess the long-term performance of this prosthesis, we reviewed 394 consecutive patients undergoing elective aortic valve replacement. Concomitant coronary artery bypass grafting was performed in 26.4% of these patients. Follow-up was complete in 96%; maximum follow-up was 13.1 years (mean 4.3 years). The operative mortality was 7.4%. Actuarial survival rate, including operative mortality, was 66.3% +/- 2.8% at 5 years and 48.7% +/- 4.5% at 10 years. Thromboembolism for the entire group occurred at a rate of 3.8% per patient-year. Patients who underwent anticoagulation continuously had a rate of embolision of 1.8% per patient-year. All patients had a 5 year embolus-free rate of 91% +/- 2% and a 10 year embolus-free rate of 85% +/- 3%. Patients receiving anticoagulants had a 5 year embolus-free rate of 92% +/- 2% and a 10 year embolus-free rate of 89% +/- 3%. There was no mechanical failure or prosthetic thrombosis in 1,690 patient-years of follow-up. The Smeloff aortic valve has excellent long-term durability and thromboembolism is low in patients receiving anticoagulants.

Modification of the Smeloff mitral prosthesis.

The simplicity of the ball valve with its random seating capabilities coupled with its durability, reliability, and predictability has made it the attractive choice of many surgeons. A low incidence of embolic phenomena with the Smeloff full-orifice, double-caged, bare-strutted ball valve has made us reluctant to alter the design over 17 years. Recent evaluation of the reasons for reoperation on the Smeloff mitral valve implantation in 376 cases revealed 16 cases in which development of fibrous subvalvular pannus with signs and symptoms of mitral stenosis occurred. The mean occurrence time was 7.5 years for adults and 4.6 years for children under age 8 years. No such problem has been encountered with the valve in the aortic position. Many of these patients are maintained on aspirin and Persantine alone. Valve design was explored as a possible cause of mitral subvalvular stenosis. Alterations of the design were examined in the engineering laboratory and in dog implantations by catheterization, electrophysiologic evaluation, and echocardiography. The results were encouraging.

Long-term survival after single aortic or mitral valve replacement with the present model of Smeloff-Cutter valves.

Two hundred fourteen survivors of single aortic (AVR) or mitral valve replacement (MVR) were evaluated. The present model of the Smeloff-Cutter prosthesis was used in these patients, and the series was started in September, 1966, following the last structural change in the valve. Clinical follow-up ended in September, 1976. Bleeding, thromboembolism, and peristent left ventricular dysfunction were the major complications. Thromboembolism occurred at a rate of 0.13 percent per month of patient follow-up. Late deaths occurred in 19.2 percent of patients, half of these within the first year. Acturarial data indicated a 5 year survival rate of approximately 75 percent after both mitral and aortic replacements. Bleeding and thromboembolism were more frequent causes of death after mitral replacement. Myocardial function was of greatest importance in long-term survival after replacement of either valve. Variations in warfarin dosage significantly affected both bleeding and thromboembolic complications.

Development of a cardiac valve substitute: the Smeloff-Cutter prosthesis.

Several criteria were used for the development of the Smeloff-Cutter prosthesis: (a) the valve must permit adequate pulsatile forward flow with minimal gradients and regurgitation; (b) materials used must be inert or compatible with tissue and blood; (c) the prosthesis must be durable; (d) attachment must be easy and secure; (e) the valve must be nonhemolytic and nonthrombogenic; (f) its geometry must not impinge on surrounding structures; (g) testing must be in vitro as well as in vivo; and (h) its use must result in an acceptable long-term clinical response. Application of these criteria to the design of the Smeloff-Cutter valve is described.

Complications of heart valve replacement. Embolism bleeding and hemolysis.

Fifty-two patients surviving single heart valve replacement since September 1962 were reviewed in order to detail the incidence of post-operative embolism, bleeding and hemolysis. A substantial decrease in the occurrence of embolism has been seen with newer prosthetic devices paralleling the improvement in cardiac catheterization dynamics. The frequency of embolism appears also to be affected by the degree and adequacy of anticoagulant control although a higher morbidity from bleeding must be accepted. The tendency to deformation and destruction of red cells by rigid prosthetic valves is apparent since shortened red cell survival indicative of hemolysis was found in all patients studied. Hemolytic anemia of importance was uncommon.