Czer L S, Chaux A, Matloff J M, DeRobertis M A, Nessim S A, Scarlata D, Khan S S, Kass R M, Tsai T P, Blanche C
Department of Thoracic and Cardiovascular Surgery, Cedars-Sinai Medical Center, Los Angeles, Calif 90048.
J Thorac Cardiovasc Surg. 1990 Jul;100(1):44-54; discussion 54-5.
The St. Jude Medical valve is a bileaflet prosthesis with excellent hemodynamic characteristics, but the long-term surgical experience with this valve, its durability, and its biocompatibility are unknown. During a 10-year period from March 1978 to 1988, 690 prostheses (290 aortic, 252 mitral, and 74 double aortic-mitral) were inserted as the initial valve replacement substitute in 616 patients (mean age 63 years). Coronary atherosclerosis was present in 58%. Follow-up totaled 2031 patient-years (mean 3.3 years) and was 95% complete (32 lost). Early (30-day) mortality rates were 5.2%, 11.9%, and 8.1% after aortic, mitral, and double valve replacement; 5- and 9-year actuarial survival rates were 71% +/- 3% and 51% +/- 8%, 59% +/- 4% and 41% +/- 6%, and 69% +/- 6% and 47% +/- 15%, respectively. Deaths were associated with extensive coronary atherosclerosis (p less than 0.001), older age (p less than 0.001), advanced preoperative New York Heart Association functional class (p less than 0.05), and malignant ventricular arrhythmias (p less than 0.05). No structural failures have been observed. Embolism (40 events) occurred at a rate of 2.0%/pt-yr (2.3% aortic, 1.6% mitral, 2.0% double). There were six cases of valve thrombosis (0.3%/pt-yr; one fatal). Hemorrhage was the most frequent complication (2.6%/pt-yr); 13 (25%) of 52 events were fatal, accounting for 62% of all valve-related deaths. After the target prothrombin time ratio was lowered, the rate of hemorrhage decreased by 44% (2.7% to 1.5%/pt-yr), while the combined rate of embolism and valve thrombosis increased slightly (2.2% to 2.5%/pt-yr, a 14% change). In summary, the St. Jude Medical valve remains a durable valve substitute. Survival was strongly related to the presence of associated coronary atherosclerosis. The most common complication has been hemorrhage; a less intensive warfarin regimen may reduce hemorrhagic risk while maintaining thromboembolic protection.
圣犹达医疗瓣膜是一种双叶人工瓣膜，具有出色的血流动力学特性，但该瓣膜的长期手术经验、耐久性和生物相容性尚不清楚。在1978年3月至1988年的10年期间，690个假体瓣膜（290个主动脉瓣、252个二尖瓣和74个主动脉-二尖瓣联合瓣膜）被作为初始瓣膜置换替代物植入616例患者（平均年龄63岁）体内。58%的患者存在冠状动脉粥样硬化。随访总计2031患者年（平均3.3年），随访完成率为95%（32例失访）。主动脉瓣、二尖瓣和双瓣膜置换术后早期（30天）死亡率分别为5.2%、11.9%和8.1%；5年和9年的精算生存率分别为71%±3%和51%±8%、59%±4%和41%±6%、69%±6%和47%±15%。死亡与广泛的冠状动脉粥样硬化（p<0.001）、高龄（p<0.001）、术前纽约心脏协会心功能分级较高（p<0.05）以及恶性室性心律失常（p<0.05）相关。未观察到结构故障。栓塞（40例事件）发生率为2.0%/患者年（主动脉瓣2.3%、二尖瓣1.6%、双瓣膜2.0%）。有6例瓣膜血栓形成（0.3%/患者年；1例致命）。出血是最常见的并发症（2.6%/患者年）；52例事件中有13例（25%）致命，占所有瓣膜相关死亡的62%。在降低目标凝血酶原时间比值后，出血率下降了44%（从2.7%降至1.5%/患者年），而栓塞和瓣膜血栓形成的综合发生率略有增加（从2.2%升至2.5%/患者年，变化14%）。总之，圣犹达医疗瓣膜仍然是一种耐用的瓣膜替代物。生存率与相关冠状动脉粥样硬化的存在密切相关。最常见的并发症是出血；强度较低的华法林治疗方案可能在维持血栓栓塞保护的同时降低出血风险。
