Survival and valve failure after aortic valve replacement.

A prospective evaluation of 412 consecutive patients undergoing isolated aortic valve replacement between January 1982 and December 1985 was performed in an attempt to identify the determinants of survival and valve failure. A variety of valves were inserted to permit a prospective evaluation of alternative valves including: Bj?rk-Shiley mechanical (n = 37), Ionescu-Shiley pericardial (n = 261), Hancock pericardial (n = 78), and Carpentier-Edwards porcine (n = 36). Thirteen patients died in the hospital (3.2%) and 47 patients died in the follow-up period producing an actuarial survival of 81% +/- 3% at 48 months. Survival was independently predicted by advancing age, preoperative New York Heart Association functional class, and the presence of endocarditis (p less than 0.05 by Cox regression analysis). The majority of patients were symptomatically improved (New York Heart Association class I or II: 21% preoperative, 88% postoperative). Freedom from structural valve dysfunction, prosthetic valve endocarditis, and reoperation for valve-related complications were 95% +/- 2%, 95% +/- 2%, and 92% +/- 2% at 48 months, respectively. These valve-related complications occurred more frequently in younger patients and in those with a Hancock pericardial valve (freedom from structural valve dysfunction, 89% +/- 5%; prosthetic valve endocarditis, 84% +/- 9%; reoperation, 78% +/- 10%; p less than 0.05 by Cox regression). Freedom from thromboembolism was 88% +/- 2% at 48 months; it was significantly lower in patients with a preoperative thromboembolic event and was not influenced by the type of prosthesis inserted. Freedom from anticoagulant-related hemorrhage was 85% +/- 8% at 48 months and was not influenced by any preoperative factors.(ABSTRACT TRUNCATED AT 250 WORDS)     

Long-term results of mitral valve replacement using glutaraldehyde-treated porcine bioprostheses--comparison of the Hancock and the Liotta valves

Long-term results of mitral valve replacement using glutaraldehyde-treated porcine bioprostheses were evaluated. The subjects were 77 patients with the Hancock valve (Hancock group) and 60 with the Liotta valve (Liotta group) who survived operation. The maximum follow-up was 14 years and 8 years, and the cumulative follow-up was 631 patient-year (p-y) and 301 p-y in the Hancock and Liotta groups. The actuarial survival rate at 8 years was 80.1 +/- 4.6% for the Hancock group and 88.1 +/- 4.2% for the Liotta group, and there was no significant difference in survival rate between the both groups. The actuarial survival rate at 14 years was 74.3 +/- 5.9% for the Hancock group. The valve-related complications in the Hancock and the Liotta groups were as follow; thromboembolism 1.9%/p-y vs 1.3%/p-y, bleeding 0 vs 0.7%/p-y, perivalvular leak 0.3% vs 0, infection 0.3%/p-y vs 0.7%/p-y, primary tissue failure (PTF) 3.3%/p-y and all valve-related complications 5.9%/p-y vs 6.0%/p-y. There was no significant difference in valve-related complications between the both groups. However, the actuarial event free rate of PTF was significantly lower in the Liotta group than the Hancock group between 4 and 7 years after operation (100% vs 88.8 +/- 4.3% in the 4th year p less than 0.01, 87.7 +/- 4.4% vs 73.5 +/- 8.0% in the 7th year, p less than 0.05). Although the both anti-thrombogenicity and anti-inflammation were acceptable in the porcine bioprostheses, this prosthesis is now used only in the selected patients because of the limited long term durability of this valve.     

More than ten years' follow-up of the Hancock porcine bioprosthesis in Japan.

From February 1975 through October 1981, 256 Hancock porcine bioprostheses (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) (60 aortic, 169 mitral, and 27 pulmonary/tricuspid position) were implanted in 220 patients (104 male and 116 female, aged 9 to 67 years; mean 43.3) at Kyushu University Hospital in Japan. The procedures include 41 aortic valve replacements, 121 mitral valve replacements, 4 pulmonary valve replacements, 6 tricuspid valve replacements, and 48 combined valve replacements (31 aortic plus mitral, 13 mitral plus tricuspid, and 4 aortic plus mitral plus tricuspid). Hospital mortality was 6.4%. Follow-up was 98% during 8 to 14 (mean 10.5) years. Cumulative follow-up was 1836 patient-years and 2078 valve-years. At 10 years the overall actuarial survival rate, including hospital morality, was 70% +/- 3%, and freedom from valve-related mortality with sudden death was 87% +/- 3%. More than half of the current survivors required no anticoagulant therapy. Freedom from thromboembolism or anticoagulant-related hemorrhage (or both) and prosthetic valve endocarditis was common. Freedom from structural valve failure and reoperation declined more than 9 years after replacement of left-sided heart valves but not after replacement of right-sided heart valves. Sixty-seven patients underwent 68 repeat operations, and there were four deaths (5.9%). The rate of freedom from overall valve-related complications at 10 years was 62% +/- 8% for aortic valve replacement, 53% +/- 5% for mitral valve replacement, 80% +/- 13% for pulmonary/tricuspid valve replacement, and 42% +/- 9% for combined valve replacement. There was a significant difference between pulmonary/tricuspid valve replacement and combined valve replacement (p less than 0.05). The Hancock bioprosthesis is suitable for the replacement of valves in the right side of the heart but not for combined valve replacement.     

Failure of Hancock pericardial xenografts: is prophylactic bioprosthetic replacement justified?

The incidence of major valve-related complications was evaluated in a series of patients in whom the Hancock pericardial xenograft was used for aortic (AVR; n = 84), mitral (MVR; n = 17) and mitral-aortic (MAVR; n = 13) valve replacement. At 7 years actuarial survival is 66% +/- 8% after AVR, 64% +/- 13% after MVR, and 41% +/- 15% after MAVR, whereas actuarial freedom from valve-related death is 79% +/- 7% after AVR, 78% +/- 13% after MVR, and 81% +/- 12% after MAVR. Actuarial freedom from thromboemboli and anticoagulant-related hemorrhage at 7 years is 93% +/- 4% and 98% +/- 2% after AVR and 83% +/- 10% and 88% +/- 11% after MVR; no such complications occurred after MAVR. Structural valve deterioration determined at reoperation, at autopsy, or by clinical investigation was observed in 34 patients with AVR (10.0 +/- 0.2%/patient-year), in 10 with MVR (10.6 +/- 3.3%/patient-year), and in 9 with MAVR (16.6 +/- 5.5%/patient-year). After AVR, 19 patients underwent reoperation and 2 died before reoperation; 4 patients with MVR underwent reoperation, and 7 patients with MAVR underwent reoperation and 1 died before reoperation. Seventy-eight percent of the current survivors (13 patients with AVR, 7 with MVR, and 1 with MAVR) have clinical evidence of valve failure. At 7 years actuarial freedom from structural deterioration of the Hancock pericardial xenograft is 25% +/- 7% after AVR, 29% +/- 14% after MVR, and 0% after MAVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Intermediate results of isolated mitral valve replacement with a Biocor porcine valve

BACKGROUND: We analyzed the intermediate experience, survival, and prosthetic complications of patients who received the Biocor valve, a new-generation porcine valve, in the mitral position. METHODS: At the University of Padua, between May 1992 and January 2004, 154 consecutive patients (102 female and 52 male patients; mean age, 72.3 +/- 6 years; age range, 37-86 years) received 158 mitral Biocor prostheses (Biocor Industria e Pesguisa Ltda, Belo Horizonte, Brazil). Thirty-five percent of the patients had previous mitral operations, 24% had coronary artery bypass grafting, and 34.6% had other procedures. Median preoperative New York Heart Association class was III. Echocardiography was performed in 75% of the long-term survivors. Follow-up included 609.4 patient-years and was 100% complete, with a median time of 4 patient-years (range, 0.02-11.3 years). At 8 years, 20 (14%) of 142 operative survivors were still at risk. RESULTS: Early mortality was 13.6%. According to univariate analysis, New York Heart Association class III to IV, ejection fraction of less than 40%, urgency, male sex, and coronary artery bypass grafting were significant perioperative risk factors. Eight- and 10-year actuarial survival was 51.1% +/- 5.6% (40 deaths). Eight-year actuarial freedom from valve-related death, thromboembolism, anticoagulant-related hemorrhage, endocarditis, paravalvular leak, and valve-related complications were 85.2% +/- 5%, 85.7% +/- 4.4%, 92.6% +/- 3.7%, 94.1% +/- 3%, 91.8% +/- 3%, and 70.2% +/- 5.7%, respectively. Freedom from structural valve deterioration was 100%. Actual freedom from reoperation was 93.2% +/- 2.2%. By Doppler echocardiography, the peak and mean transprosthetic gradients were 15 +/- 5 mm Hg and 6.3 +/- 3 mm Hg, respectively (mean follow-up, 4.2 +/- 2.7 years). CONCLUSION: At intermediate follow-up, the Biocor prosthesis in the mitral position showed excellent results in terms of valve durability when compared with other second-generation tissue valves.     

Comparative analysis of Hancock and St. Jude Medical valve after mitral valve replacement]

Long term results were compared in 81 operative survivors with MVR using Hancock valve (Hancock group) and 83 using St. Jude Medical valve (SJM group). The cumulative follow-up was 709.0 patients-year (p-y) and 175.2 p-y in the Hancock and SJM groups. Twenty-four percent of the patients in the Hancock group was permanently anticoagulated, while 100% of patients in the SJM group anticoagulated. The 7-year actuarial survival rate including early mortality was 79.3 +/- 4.6% for the Hancock and 93.9 +/- 3.0% for the SJM group (p less than 0.01). The survival rate was significantly higher in the SJM group than that in the Hancock group. The 7-year actuarial event free rate of the valve-related complications in the Hancock and SJM groups were as follows; thromboembolism 88.6 +/- 3.8% vs 95.0 +/- 2.8% (NS), hemorrhage, 94.0 +/- 3.0% vs 98.7 +/- 1.8% (NS), paravalvular leak 92.6 +/- 3.2% vs 97.4 +/- 1.8% (NS), infection 93.9 +/- 3.0% vs 100% (p less than 0.05), valve malfunction 78.0 +/- 5.2% vs 100% (p less than 0.001), overall valve related complications 58.9 +/- 5.9% vs 91.1 +/- 3.5% (p less than 0.001), reoperation for valve-related complication 83.1 +/- 4.6% vs 100% (p less than 0.01). The event free rate of reoperation for valve related complication in the Hancock group was significantly lower than that in the SJM group. The Hancock valve had the acceptable antithrombogenicity, but had the limited long-term durability.(ABSTRACT TRUNCATED AT 250 WORDS)     

Porcine versus pericardial bioprostheses: a comparison of late results in 1,593 patients

From 1976 to 1988, 1,593 patients underwent valve replacement with a porcine (878 patients) or a pericardial bioprosthesis (715 patients). There were 701 aortic, 678 mitral, and 214 multiple-valve replacements. Follow-up was obtained for 1,559 patients (98%). Early mortality was 9% (79 patients) in the porcine valve group and 5% (37 patients) among patients with a pericardial valve (p less than 0.01). Late survival after replacement with porcine valves was 80% +/- 1% and 62% +/- 3% at 5 and 10 years, respectively. With pericardial valves, 5-year survival was 79% +/- 2%. Among valve-related complications, rates of freedom from thromboembolism, endocarditis, and hemorrhage after 6 years were similar for both valve groups. Freedom from reoperation at 6 years was also similar after aortic (96% versus 91%) or multiple-valve replacement (95% versus 88%). However, for mitral valve replacement, freedom from reoperation was significantly better with porcine valves than with pericardial valves at 6 years (92% versus 68%; p less than 0.001). This difference was mainly due to the Ionescu-Shiley valve, which accounted for 83% of primary tissue failures among pericardial bioprostheses implanted in the mitral position (10/12 patients). After 6 years, freedom from primary tissue failure of mitral valves was 92% +/- 2% with porcine and 70% +/- 11% with pericardial bioprostheses (p less than 0.0001). The degree of clinical improvement among survivors was similar with both valve types. Thus, in the aortic position, pericardial valves compare with porcine valves up to 6 years, whereas in the mitral position, the durability of the former is significantly less, mainly because of the suboptimal performance of the Ionescu-Shiley pericardial bioprosthesis.     

复杂性感染性心内膜炎的外科治疗

目的评价瓣周脓肿、心肌脓肿以及瓣膜严重毁损等复杂性感染性心内膜炎手术治疗的近、远期疗效.方法回顾性分析1988年12月至2002年6月手术治疗的复杂性心内膜炎患者57例临床资料,均为原发性心内膜炎,其中感染侵犯主动脉瓣25例、二尖瓣16例、二尖瓣和主动脉瓣16例.术中发现瓣叶严重毁损32例、主动脉瓣周脓肿19例、主动脉根部环形脓肿导致左心室-主动脉连接破坏4例、二尖瓣后瓣环脓肿11例、心肌脓肿6例、瓣膜赘生物形成55例.脓肿清除后遗留残腔采用间断褥式缝合6例、自体心包片修补19例、牛心包片修补6例、聚四氟乙烯膨体补片修补4例;施行以带瓣管道作升主动脉根部替换和左、右冠状动脉移植术4例,主动脉瓣替换术21例,二尖瓣替换术16例,主动脉瓣及二尖瓣双瓣替换术16例.结果早期死亡6例(11%),死亡主要原因为低心输出量综合征、人造心脏瓣膜性心内膜炎和多脏器功能衰竭.随访4个月至14年,平均(5.93±0.20)年.晚期死亡5例,晚期主要并发症为人造瓣膜性心内膜炎.术后1年心功能恢复NYHA分组Ⅰ～Ⅱ级占96%(44/46);5年再手术免除率为(84±3)%,5年实际生存率为(61±9)%.结论复杂性心内膜炎局部组织破坏较多,应限期手术或急症手术,清创后残腔的处理是影响手术本身能否成功以及术后近、远期效果的关键.     

Ten-year echocardiographic and clinical follow-up of aortic Carpentier-Edwards pericardial and supraannular prosthesis: a case-match study

BACKGROUND: There are little comparative data on Carpentier-Edwards supraannular and pericardial second-generation bioprostheses. The aim of this work was to compare their hemodynamic and clinical outcomes in patients with aortic stenosis. METHODS: We conducted a retrospective study including 150 patients operated on for aortic stenosis between 1989 and 1993. Patients undergoing aortic valve replacement with either a Carpentier-Edwards supraannular or pericardial prosthesis were matched for sex (49% male), age (72 +/- 8 years), body surface area, valve size, associated procedures, and left ventricular ejection fraction. RESULTS: Mean follow-up was 6.5 +/- 3.3 years, giving a total follow-up of 983 patient-years. Thirty-day mortality and 10-year actuarial survival were, respectively, 8% and 51% in the supraannular group and 6.7% and 43.4% in the pericardial group. At 10 years, freedom from thromboembolism, structural failure, and all valve-related events were, respectively, 88.7%, 88.9%, and 68.7% in the supraannular group and 85%, 100%, and 82.2% in the pericardial group. There were four (5.3%) structural failures, and four (5.3%) reoperations for degeneration (n = 3) and endocarditis (n = 1) in the supraannular group. Freedom from structural dysfunction or reoperation was 87.3% in the supraannular group and 100% (p < 0.05) in the pericardial group. Echocardiographic review of 62 of 76 survivors (81.5%) demonstrated a trend toward a better hemodynamic profile of pericardial valves at the end of follow-up. CONCLUSIONS: Ten years after aortic valve replacement for aortic stenosis, Carpentier-Edwards pericardial prostheses give comparable and probably better results than Carpentier-Edwards supraannular prostheses.     

Comparative analysis of mechanical and bioprosthetic valves after aortic valve replacement

Comparative long-term performance characteristics of Bj?rk-Shiley mechanical and bioprosthetic valves were analyzed for patients undergoing aortic valve replacement between 1976 and 1981. A total of 419 patients received either a standard Bj?rk-Shiley (n = 266) or bioprosthetic (porcine, n = 126, or pericardial, n = 27) aortic valve. Cumulative patient follow-up was 1,705 patient-years; the average patient follow-up was 4.1 +/- 2.7 years. Survival data were obtained for all but 11 patients (97% complete follow-up) up to 9 years after operation. Survival at 5 years was 81% +/- 4% (+/- standard error) for Bj?rk-Shiley and for bioprosthetic valve recipients. Valve failure in the Bj?rk-Shiley group was predominantly due to valve-related mortality and did not result from structural failure. Patients with bioprosthetic valves experienced valve failure as a result of prosthetic valve endocarditis and intrinsic valve degeneration. Although patients with bioprostheses experienced a lower incidence of valve-related morbidity than Bj?rk-Shiley valve recipients (p less than 0.03), no difference could be demonstrated in the incidence of valve-related mortality or valve failure at 5 years between bioprosthetic and Bj?rk-Shiley valves. Mortality rate from valve failure was higher for Bj?rk-Shiley (86%, 12/14) than bioprosthetic valves (36%, 5/14) (p less than 0.01).     

Comparison of long-term results of Carpentier-Edwards and Hancock bioprosthetic valves

The long-term survival following valve replacement with Carpentier-Edwards or Hancock bioprostheses was compared between the two valve models and between the two groups totaling 407 patients who were discharged after valve replacement beginning in 1974. The two groups of patients were treated in a nonrandomized fashion. The actuarial survival for 299 patients with Carpentier-Edwards valves was 94 +/- 1.5% (+/- standard error) and 93 +/- 1.7% after 5 and 8 years of follow-up, respectively. Comparable figures for 108 patients undergoing valve replacement with Hancock valves were 89 +/- 3.0% and 83 +/- 3.7%, respectively (p = not significant [NS]). The probability of freedom from death and valve removal after 5 and 8 years of follow-up was 91 +/- 1.8% and 79 +/- 4.6%, respectively, with the Carpentier-Edwards valve and 84 +/- 3.5% and 75 +/- 4.3%, respectively, with the Hancock valve (p = NS). An accelerated rate of attrition for both valves was observed in the mitral position. There were no significant differences in actuarial survival between the two valves in the mitral or the aortic position or in the incidence of major valve-related complications.     

Clinical assessment of prosthetic valve replacement of the right-sided cardiac valves: mechanical or bioprosthesis?

Clinical results with mechanical and bioprosthetic valve replacements for tricuspid and/or pulmonary positions were reviewed. Between February 1975 and December 1985, 34 bioprostheses (B) (22 Hancock, 9 Ionescu-Shiley and 3 Carpentier-Edwards pericardial) and 18 mechanical prostheses (M) (St. Jude Medical) were implanted in our institute excluding hospital death. Group with B included 29 tricuspid valve replacements and 5 pulmonary valve replacements. Group with M included 9 tricuspid valve replacements, 7 pulmonary valve replacements and 1 both valve replacements. The cumulative follow-up period was 207.2 patient-years (p-t) in group B and 55.0 p-y in group M. The incidence of valve failure was 0.48 +/- 0.48% per p-y in group B and 7.27 +/- 3.64% per p-y in group M (p less than 0.001). The incidence of valve-related events was 1.93 +/- 0.97% per p-y in group B and 9.09 +/- 4.07% per p-y in group M (p less than 0.001). At 3 years, the percent free of valve failure was 100 +/- 0% in group B and 76.8 +/- 10.2% in group M (p less than 0.05). Fourteen bioprosthetic valves (B') and 10 mechanical valves (M') were implanted at the right-sided cardiac valve position alone. The cumulative follow-up period was 94.2 p-y in group B' and 32.3 p-y in group M'. The incidence of valve-related events was 1.06 +/- 1.06% per p-y in group B' and 12.4 +/- 6.19% per p-y in group M' (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Long-term durability of the Hancock II porcine bioprosthesis

BACKGROUND: Survival and prosthetic complications of patients receiving the Hancock II second-generation bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in the aortic, mitral, mitral-aortic, and tricuspid positions were analyzed at 15 years' follow-up. METHODS: Between May 1983 and December 1993, 212 patients (104 men and 108 women; mean age, 63 +/- 9 years; age range, 29-81 years) received 66 aortic, 114 mitral, 26 mitral-aortic, and 6 tricuspid Hancock II valves. Thirty-one percent of patients had previous valve operations, 15% had concomitant cardiac procedures, and 87% were in New York Heart Association class III or IV. Follow-up included 1704 patient-years and was 98% complete, with a median of 9 patient-years (range, 0.013-17.4 years). Forty-six patients were at risk at 14 to 15 years, and 30 were at risk after 15 years. RESULTS: One hundred twenty-two (57%) of 212 patients died, 20 of them perioperatively. Fifteen-year actuarial Kaplan-Meier survival was 35.2% +/- 3.8%, and freedom from valve-related mortality was 84% +/- 3.5%, with no difference on the basis of position or age (<65 or >or=65 years). Percentages for freedom from thromboembolism, anticoagulant-related hemorrhage, endocarditis, and paravalvular leak were, respectively, 78.2% +/- 4%, 83.5% +/- 3.6%, 95.7% +/- 2%, and 97.3% +/- 1.4%, with no significant difference between the aortic and mitral positions. Freedom from structural valve deterioration was 71.8% +/- 5.6%: 88.9% +/- 6.2% in the aortic position versus 59.5% +/- 3.9% in the mitral position (P =.01) and 64.3% +/- 3% in the mitral-aortic position. In patients younger than 65 years, actual freedom from structural valve deterioration was less than that seen in older patients (84.5% +/- 3.5% vs 95% +/- 3.0%) and was better in the aortic versus the mitral position (92% +/- 4.5% vs 82% +/- 4.2%). CONCLUSION: The Hancock II porcine valve showed excellent 15-year durability. We recommend its use in patients 65 years of age, as well as in younger patients undergoing aortic replacement.     

Performance of a fabricated trileaflet porcine bioprosthesis. Midterm follow-up of the Hancock modified-orifice valve

The fabrication of the Hancock modified-orifice valve raised questions about its long-term durability. Since 1976, 315 patients (206 male, 109 female) with a mean age of 63 years underwent aortic valve replacement with 21 mm (n = 120), 23 mm (n = 153), 25 mm (n = 36), and 27 mm (n = 6) Hancock modified-orifice valves. There were five operative deaths (1.6% mortality). Two hundred sixty-two patients are alive 2 to 117 (mean 53) months postoperatively. Actuarial probability of survival at 96 months was 78% +/- 3%. Two hundred twenty-two survivors are in Functional Class I or II. Forty-three patients have had valve-related complications: thromboembolism in 25 (1.9%/pt-yr), primary valve dysfunction in eight (0.6%/pt-yr), and endocarditis in 11 (0.8%/pt-yr). Twelve patients have required reoperation (0.8%/pt-yr) for primary valve dysfunction (four patients), for endocarditis (five patients), and for perivalvular leak (three patients). At 96 months the actuarial probability of freedom from thromboembolism was 87% +/- 3%, from primary valve dysfunction 97% +/- 2%, and from endocarditis 92% +/- 3%. The probability of freedom from all valve-related complications was 78% +/- 4% and from reoperation 94% +/- 2%. The performance of this prosthesis justifies its continued use for aortic valve replacement.     

Early mechanical failures of the Hancock pericardial xenograft

From August 1981 to July 1984, a total of 97 Hancock pericardial xenografts were implanted in 84 patients, whose ages ranged from 13 to 75 years (mean 55.7 +/- 13). Mitral value replacement was performed in 17, aortic valve replacement in 54, and mitral-aortic valve replacement in 13. Operative survivors were reevaluated from July to September 1985. Cumulative duration of follow-up is 167 patient-years (range 0.5 to 4.1 years), and follow-up is 99% complete. The overall late mortality (at 4 years) is 3.6% +/- 1.4% per patient year, and the actuarial survival rate is 95.4% +/- 3% for aortic valve replacement, 74.7% +/- 16.5% for mitral valve replacement, and 67.1% +/- 20.7% for mitral-aortic valve replacement. One patient sustained a thromboembolic event after mitral valve replacement, but no such complications occurred after aortic or mitral-aortic valve replacement. Actuarial freedom from embolism at 4 years is 100% for aortic and mitral-aortic valve replacement and 93.3% +/- 6.4% for mitral valve replacement. Reoperation for Hancock pericardial xenograft dysfunction was performed in seven patients (five aortic and two mitral-aortic). In the aortic valve replacement group the causes were endocarditis in one, paravalvular leak in one, and primary tissue failure in three; all survived reoperation. The two patients with mitral-aortic valve replacement required reoperation because of primary tissue failure of both Hancock pericardial xenografts, and one died. All values explanted because of primary tissue failure showed commissural tears causing severe prosthetic regurgitation. Calcium deposits were severe in one and mild but unrelated to the cusp rupture in another. Collagen disarray was seen only at the site of the tears, whereas the collagen structure was well preserved in the intact parts of the cusps. Four patients with aortic valve replacement and one with mitral valve replacement show evidence of Hancock pericardial xenograft failure and are awaiting reoperation. The actuarial freedom from primary tissue failure at 4 years is 74.3% +/- 9.8% for aortic and 78.9% +/- 13.2% for mitral Hancock pericardial xenografts. At medium-term follow-up, the Hancock pericardial xenograft has shown poor durability and an extremely high rate of early mechanical failure, especially in the aortic position. These observations suggest the need for a close follow-up of Hancock pericardial xenograft recipients and possibly elective reoperation in asymptomatic patients with clinical evidence of prosthetic failure. These results have led us to discontinue the clinical use of this pericardial xenograft.     

Ten-year analysis of the Bj?rk-Shiley standard aortic valve

Long-term performance characteristics of the Bj?rk-Shiley standard aortic valve were determined by analyzing the follow-up of 514 patients undergoing operation between 1971 and 1981. Cumulative follow-up was 2,601 patient-years (average, 5.3 +/- 3.8 years); 53% (238/452) of hospital survivors have been followed more than 5 years. Valve-related complications expressed as both actuarial event-free percents (+/- standard error at 10 years) and first-event linearized determinations (percent per patient-year) occurred at the following rates: thromboembolism, 82 +/- 3 and 2.3 +/- 0.3, respectively; anticoagulant-related hemorrhage, 60 +/- 4 and 5.6 +/- 0.5; prosthetic valve endocarditis, 94 +/- 2 and 0.8 +/- 0.2; valve thrombosis, 97 +/- 1 and 0.4 +/- 0.1; reoperation, 94 +/- 2 and 0.6 +/- 0.2; valve failure, 82 +/- 4 and 1.6 +/- 0.2; and composite valve-related morbidity and mortality, 46 +/- 4 and 8.8 +/- 0.2. Overall survival was 72 +/- 2% at 5 years and 55 +/- 3% at 10 years; valve-related complications accounted for 22% of the late deaths. Although no instance of structural valve failure could be identified, 25% of valve-related complications resulted from valve failure, of which 67% were fatal. By 10 years, 54% of patients had experienced at least one form of major valve-related complication, 16% of which proved fatal. The Bj?rk-Shiley standard aortic valve has late valve-related complications similar to other existing mechanical prostheses that have been subjected to long-term analysis.     

Mitral valve surgery in patients with severe left ventricular dysfunction.

OBJECTIVES: The objectives of this study were to determine (1) survival, (2) functional status and freedom from readmission for heart failure and (3) change in postoperative left ventricular (LV) dimensions and function following mitral valve repair or replacement in patients with severe LV dysfunction and mitral regurgitation. PATIENTS AND METHODS: Between 1990 and 1998, 44 patients with mitral regurgitation and a LV ejection fraction <35% (mean+/-SD, 28+/-6%) underwent isolated mitral repair (n=35) or replacement (n=9). The etiology of regurgitation was valvular in 18 (40%) patients, ischemic in 13 (30%) patients and dilated idiopathic cardiomyopathy in 13 (30%) patients. Every patient had been hospitalized one to six times for symptoms of heart failure (mean+/-SD, 2.3+/-1.5). All patients were receiving maximal drug therapy with 15 (34%) in New York Heart Association (NYHA) class III and 12 (27%) in class IV. Seven (16%) patients were initially referred for consideration of transplantation. The mean+/-SD duration of follow-up was 40+/-21 months. RESULTS: One (2.3%) patient died 9 days postoperatively of acute bronchopneumonia. The mean+/-SD duration of ICU and hospital stay was 41+/-34 h and 9+/-3 days, respectively. The 1-, 2- and 5-year survival rates were 89, 86 and 67%, respectively. Heart failure and sudden death accounted for 62% of the late deaths. The NYHA class improved for survivors from 2.8+/-0.8 preoperatively to 1. 2+/-0.5 at follow-up (P<0.0001). Freedom from readmission for heart failure was 88, 82 and 72% at 1, 2 and 5 years, respectively. No patient has been listed for transplantation. CONCLUSIONS: Mitral valve surgery offers symptomatic improvement and survival benefit in patients with severe LV dysfunction and mitral regurgitation. More liberal use of this surgery for cardiomyopathy patients is warranted.     

Left ventricular reconstruction: Early and late results

OBJECTIVES: In patients with coronary disease and poor left ventricular function, ventricular reconstruction with revascularization is a surgical option. Details of patient selection and optimal surgical technique are still debated. This study reports results achieved with ventricular reconstruction in 285 patients who had akinesia or dyskinesia associated with relative wall thinning. METHODS: Data were prospectively collected. Reconstruction on the beating heart was accomplished by a modified linear closure plus septoplasty, when indicated, (dyskinetic septum). Preoperatively, 237 (83%) were in symptom class III or IV with congestive heart failure (n =174; 61%), angina (n = 157; 55%), or ventricular tachycardia (n = 107; 38%). Average ejection fraction was 24% +/- 11%, and 144 (51%) had preoperative grade 2+ mitral regurgitation. Operative procedures included coronary artery bypass grafting in 262 (92%), septoplasty in 64 (22%), ablation of ventricular tachycardia in 118 (41%), and a mitral valve procedure in 6 (2%). RESULTS: Operating room mortality was 2.8%. Perioperative support included intra-aortic balloon pumping in 49 (17%) and inotropic drugs in 154 (54%). During a mean follow-up of 63 +/- 48 months, 8 patients required transplantation (interval of 49 +/- 41 months), 2 needed mitral valve replacement, and 9 required use of an implantable cardioverter-defibrillator for ventricular tachycardia. At 1, 5, and 10 years actuarial survivals were 92%, 82%, and 62%. Freedom from sudden death was 99%, 97%, and 94%. Among survivors, symptom class improved in 140 of 208 patients (67%), mean improvement 1.3 +/- 1.1 functional class per patient. Average increase in ejection fraction postoperatively was 10% +/- 9%. CONCLUSIONS: Using wall thinning as a criterion for patient selection, left ventricular reconstruction can be performed with low operative mortality, provides good control of symptoms, excellent long-term survival, and freedom from sudden death. This approach should be considered in all patients with coronary disease, poor left ventricular function, and relative wall thinning.     

Factors affecting mitral valve reoperation in 317 survivors after mitral valve reconstruction.

From a very heterogeneous group of 340 patients undergoing mitral valve reconstruction from 1969 through 1988, 313 hospital survivors were analyzed for factors affecting the occurrence of reoperative mitral valve procedures related to native mitral valve dysfunction. Follow-up was 100% and extended from 1 year to 20 years (mean follow-up, 7.2 years). Sixty-three patients (18.5% of the 340) required mitral valve reoperation at a mean postoperative interval of 6 years (range, 1 to 15 years). Incremental risk factors analyzed for the event late mitral valve failure included age, sex, preoperative New York Heart Association class, cause of valvular disease, pathophysiology of the mitral valve, previous mitral valve operation, mitral valve pathology, and estimation of mitral valve function at operation after repair. Mitral valve pathophysiology affected the actuarial freedom from mitral valve replacement (p = 0.023 [log-rank]). Actuarial freedom from mitral valve reoperation was 90% at 5 years and 80% at 8 years in patients who had either pure mitral regurgitation or isolated mitral stenosis compared with 80% and 72% at 5 and 10 years, respectively, in patients who had mixed mitral stenosis and regurgitation (p = 0.023). Patients undergoing late reoperation were younger (51.7 +/- 1.56 years [+/- the standard error of the mean]) than those not having reoperation (p less than 0.0003). Durability of the repair was less in patients with rheumatic heart disease (p less than 0.025) and greater in patients with ischemic heart disease (p less than 0.004). Seventy-three percent of patients undergoing reoperation had concomitant operations compared with 68% of those not having reoperation (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Improved right ventricular function following late pulmonary valve replacement for residual pulmonary insufficiency or stenosis

Residual severe pulmonary insufficiency or stenosis may result in significant myocardial dysfunction late after repair of tetralogy of Fallot. Although pulmonary valve replacement has been advocated for selected patients, objective improvement in right ventricular function has been difficult to demonstrate. We undertook pulmonary valve replacement in 11 patients to treat residual insufficiency (n = 8) or stenosis (n = 3) and evaluated them before and after operation by radionuclide ventriculography and M-mode echocardiography. Patients' age at the original repair was 6.6 +/- 0.6 years (range 2 to 8 years) and at subsequent valve replacement was 14.6 +/- 1.5 years (range 5 to 20 years). Indications for pulmonary valve replacement were conduit stenosis indicated by a gradient greater than or equal to 75 mm Hg (n = 3), symptoms (n = 2), progressive cardiomegaly (n = 3), and new onset of tricuspid insufficiency (n = 3). Prior to pulmonary valve replacement, right ventricular ejection fraction was 0.29 +/- 0.12 (range 0.12 to 0.48) and rose to 0.35 +/- 0.10 (range 0.19 to 0.48) at a mean of 10.5 +/- 2.3 months after operation (p less than 0.05). Improvement (defined as an increase in ejection fraction greater than 0.05) was noted in seven patients whereas four demonstrated no change. Left ventricular ejection fraction before operation (0.55 +/- 0.12) was unchanged after pulmonary valve replacement (0.54 +/- 0.06). M-mode echocardiography demonstrated significant reduction in right ventricular dilatation. Right ventricular/left ventricular end-diastolic dimension fell from 1.03 +/- 0.30 to 0.73 +/- 0.13 after operation (p less than 0.01). Cardiothoracic ratio fell from 0.59 +/- 0.02 to 0.55 +/- 0.02 at a mean of 12 months after pulmonary valve replacement (p less than 0.01). Subjective improvement in exercise tolerance was noted in all seven patients who showed an increase in right ventricular ejection fraction. Of the remaining four patients, two had no improvement, one felt symptomatically improved, and one was too young for evaluation. These data demonstrate objective improvement in right ventricular function following pulmonary valve replacement and confirm the usefulness of this procedure in patients with significant right ventricular dysfunction secondary to residual pulmonary insufficiency and stenosis.