Bridget M. Bailey

Early and late-phase events after valve replacement with the St. Jude Medical prosthesis in 1200 patients

From May 1982 to August 1991, 1200 patients underwent valve replacement with the St. Jude Medical (St. Jude Medical, Inc., St. Paul, Minn.) valve: 615 men (51%) and 585 women, mean age 58 years. Preoperatively, 830 patients (69%) were in functional class III or IV. A total of 611 patients (51%) had the aortic valve replaced, 490 (41%) the mitral valve, 2 (0.2%) the tricuspid valve, and 97 (8%) multiple valves. There were 81 hospital deaths (6.8%). Risk factors included older age (p = 0.0001), female gender (p = 0.02), higher preoperative left ventricular end-diastolic pressure (p = 0.05), previous cardiac operation (p = 0.003), longer aortic crossclamp time (p = 0.0001), and longer cardiopulmonary bypass time (p = 0.0001). Follow-up was 98% complete (3153 patient-years). There were 152 late deaths; 32 (21%) were considered valve-related: six thromboembolism, four valve thrombosis, five anticoagulant-related hemorrhage, eight prosthetic valve endocarditis, one paravalvular leak, and seven sudden death. The 5-year actuarial survival was 75%. Risk factors for late death included older age (p = 0.03), lower preoperative ejection fraction (p = 0.005), longer aortic crossclamp time (p = 0.001), longer cardiopulmonary bypass time (p = 0.0001), previous cardiac operation (p = 0.02), and higher preoperative functional class (p = 0.0001). Actuarial freedom at 5 years from major thromboembolic events and anticoagulant-related hemorrhage was 97% and 95%, respectively. This value for valve thrombosis was 99%, for reoperation 96%, for prosthetic valve endocarditis 98%, and for paravalvular leak 96%. Actuarial freedom from all valve-related events and valve-related death at 5 years was 74% and 94%, respectively. We conclude that the low incidence of valve-related events and low mortality supports the continued use of the St. Jude Medical valve.

Early and late phase events following bioprosthetic tricuspid valve replacement.

From 1961 through 1987, 9, 247 patients underwent an intracardiac repair for valvular heart disease. Five hundred thirty patients had a procedure that included a tricuspid valve operation (6%), with tricuspid valve replacement performed in 175 patients (2%), of whom 154 had a bioprosthetic valve implanted (1.7%). These 154 patients with a bioprosthetic valve in the tricuspid position are the subject of this review. There were 27 males and 127 females. Ages ranged from 10 to 75 years. There was tricuspid valve insufficiency in 139 patients (90%), and stenosis plus insufficiency in 15 (10%). Carpentier‐Edwards prostheses were implanted in 83 (54%), lonescu‐Shiley in 55 (35%), Hancock in 12 (8%), and Mitroflow in 4 (3%). Concomitant procedures were performed in 146 patients (95%). At least one previous operation had been performed in 86 patients (56%). Preoperatively, 139 patients were in functional Class III or IV (90%). Hospital death occurred in 20 patients (13%). Logistic regression analysis revealed that incremental risk factors for hospital death included increasing peripheral edema preoperatively (p = 0.04), and use of a Hancock prosthesis in the tricuspid position (p = 0.03). All 134 hospital survivors were followed at a mean of 66.01 months, range 1 to 162 months. There were 70 late deaths (52%). Log‐rank test indicated that incremental risk factors for late death were: longer cross‐clamp time at repair (p = 0.0007); higher pulmonary artery systolic pressure preoperatively (p = 0.01); earlier date of surgery (p = 0.03); and larger tricuspid prosthesis size (p = 0.06). The incidence of valve‐related events for bioprostheses implanted in the tricuspid position was: paravalvular leak (0%), thrombosis (1%), and endocarditis (2%). Seventeen patients (12.7%) had structural failure of a bioprosthesis in the tricuspid position, with 15 having a reoperation performed at a mean of 74 months post repair. Fourteen of the patients undergoing reoperation required tricuspid valve re‐replacement, and one a tricuspid valve thrombectomy. Actuarial freedom from tricuspid valve re‐replacement was 70% at 10 years. Different bioprosthesis type was the sole incremental risk factor for the requirement for late tricuspid valve re‐replacement (p = 0.0001). We conclude that bioprostheses in the tricuspid position are at relatively low risk of valve‐related events. However, there is an important hazard for decreased overall survival in these patients. Risk factors for premature late death are related to earlier date of surgery, more complex repairs requiring prolonged aortic occlusion to accomplish, and signs of increasing right heart failure.

Events associated with rupture of intra-aortic balloon counterpulsation devices

Nineteen intra-aortic balloon (IAB) ruptures occurred in sixteen patients during a three-year period. Perforation occurred secondary to abrasion with material failure or mishandling of the device during insertion. To avoid serious sequelae, it is important to be aware of the possibility of IAB rupture and to remove any defective device immediately upon recognition of an event.