Between August 1978 and September 1984, 440 patients were implanted with the Omniscience cardiac valve at three North American medical centers (210 aortic, AVR; 165 mitral, MVR; and 65 double valve replacements). Total follow-up was 1056 patient years; survivors were followed up to 76 months (mean 32), with 99% accountability. One hundred and eighty-six (42%) also underwent prior or concomitant major cardiac surgical procedures. Mean age was 56 +/- 12 years. Preoperatively, 3% were in New York Heart Association (NYHA) Class I, 18% II, 54% III, 26% IV. The 5 1/2 year actuarial survival rate for death from valve-related causes (thromboembolism, valve thrombosis, perivalvular leak) was 97% overall. The 5 1/2 year actuarial survival rate from all death causes was 78%. The complication rates, expressed as %/patient-year (endocarditis 0.7; anticoagulant-related hemorrhage 1.0; perivalvular leak 1.5; pannus/tissue overgrowth 0.6; and transient ischemic episode 1.2) demonstrate that advanced age at implant and additional major cardiac surgical procedures do not affect occurrence. Actuarial freedom from thrombotic complications (thromboembolism with residual deficit and valve thrombosis) at 5 1/2 years was 95% overall. Postoperatively, of 348 patients with known NYHA, 65% were in NYHA I, 28% II, 5% III, and 2% IV.

Clinical data on the Omniscience cardiac valve prosthesis (sizes 19 to 31 mm) were obtained from 326 patients (155, aortic valve replacement [AVR]; 125, mitral valve replacement [MVR]; and 46, double-valve replacement) during a five-year period (650 patient-years) with 96% accountability. Mean age was 56 +/- 12 years, and 40% (130) of the patients were 61 years old or older. Thirty-one percent (101) had prior or concomitant coronary artery bypass grafting procedures, 9% (28) had a previous malfunctioning prosthesis, and 17% (57) had other cardiac surgical procedures. Eighty percent were in New York Heart Association (NYHA) Functional Class III or IV preoperatively. Early mortality was 10% (34). Five-year actuarial thrombus-free rate is 96% for patients who underwent AVR and 95% for patients having MVR. Postoperatively, 89% (172/193) were in NYHA Class I or II, and 84% (163/193) improved by at least one Functional Class. A significantly high proportion of the postoperative hematological values fall within normal ranges: red blood cell count, 94% (176/187); hematocrit, 88% (166/188); and hemoglobin, 93% (176/190). Ninety-eight percent (287/292) are free from clinical anemia. Four of the 5 patients with clinical anemia had a preoperative history of this condition. Levels of lactic dehydrogenase in 3 patients suggested the probable presence of clinically significant hemolysis, although all 3 have normal hematological values. Actuarial five-year survival for patients who underwent AVR or MVR are similar (82% and 80%, respectively), indicating satisfactory and comparable levels of safety and performance.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical data were gathered over five years (650 patient-years) for all 155 aortic valve replacement, 125 mitral valve replacement and 46 double valve replacement patients implanted with the Omniscience cardiac valve prosthesis at three North American medical cent es. Mean age was 56 +/- 12 years, 80% were preoperatively in NYHA class III or IV, and 57% had previous or concomitant cardiac surgery. Data were evaluated for the incidence of thromboembolic complications. During the late postoperative period, transient ischaemic episodes occurred in six patients (0.92% per patient-year). The five-year actuarial thrombus-free rate for serious thromboembolic complications (valve thrombosis or thromboembolism with residual effects) for aortic valve replacement patients is 96% and 95% for mitral valve replacement patients. For patients experiencing any transient or serious thromboembolic complication, 35% had a compromise of coumadin anticoagulation shortly before the thromboembolic event, 60% had a history of atrial fibrillation, and 76% a history of rheumatic heart disease. Statistically, these rates are significantly higher compared with the original valve population. The low incidence of thromboembolic complications over this five-year clinical study demonstrates a commendable degree of safety and performance for the Omniscience valve.

Cardiac work and power, defined as the wall stress-velocity product per unit volume, have been derived with respect to a circumferential, radial and longitudinal component for the human left ventricle during a complete cardiac cycle. Thirty-nine patients, comprising five clinical groups, were evaluated using pressure and volume data acquired from single-plane cineangiography. The results indicate that work and power are divided into approximately 60% circumferential, 23% radial and 17% longitudinal components for normals. Characteristic variations from normal are presented for selected pathological case studies. With a compensated volume overload patient, diastolic work and power are uniformly reduced in all three directions and systolic radial power approximately equals longitudinal power. With a decompensated volume overload patient, systolic radial power is greater than longitudinal power. With a compensated pressure overload patient, systolic radial work and power are greatly elevated as compared to the normals and represent about 30% of the total work and power, while longitudinal work and power represent only about 8% of the total. With a congestive cardiomyopathy patient, systolic work and power are greatly reduced in all three directions as compared to normals.

A mathematical model of the left ventricle has been developed which describes the muscle element work and power including the contractile filament stress actually borne by the contractile element (CE) and series elastic element (SE). The muscle element work and power are then defined in terms of standard cineangiographic pressure and geometry measurements. For a normal left ventricle, the time variations of the CE and SE power for the circumferential direction at the mid-wall has been determined. There is a rapid initial rise of CE power coincident with isovolumic systole, due to the rapid contractile filament stress development. The SE is rapidly stretched during this period and energy is stored, resulting in a negative value of SE power. CE power falls away during systolic ejection and SE power falls away becoming slightly positive, due to (a) the fall in CE power and (b) circumferential fiber shortening. During diastole, CE power falls to zero and energy stored in the SE is released. Consequently, SE recoils with a rapid velocity of shortening and exhibits a peak positive power. The CE (which is now passive) is rapidly stretched during this period and exhibits a peak negative power value. Finally, both CE and SE return to their original lengths, velocities fall to zero and there is no further power produced during the latter phase of diastole.

The Lillehei-Kaster valve was used in 215 patients over a 7-year period. The aortic valve was replaced in 81 of them. Hospital mortality was 21% (17 patients). Ten patients were lost to follow-up and long-term mortality was 5% (3 patients). The incidence of thromboembolism was 2.6 per 100 patient-years, and actuarial survival was 96% at 5 and 87% at 7 years. Mitral valve replacement was performed in 108 patients. Hospital mortality was 20% (22 patients), 24 patients were lost to follow-up, and long-term mortality was 13% (11 patients). The combined incidence of thromboembolism was 5.0 per 100 patient-years, and actuarial survival was 81% at 5 years and 75% at 7 years. In both groups, the majority of patients improved clinically. Fifteen patients had double-valve replacement, and 11 had coronary revascularization in addition to valve replacement.

A case of congenital complete heart block with atrial flutter without associated cardiac defects is reported. The arrhythmia dating from intra-uterine life has persisted up to the date of this report, almost five years. Although the possibility of primary myocardiopathy exists, we have no reason to believe that any is present in this case. The clinical course has been excellent.