W.R. Eric Jamieson

Prediction of operative mortality after valve replacement surgery

OBJECTIVES We sought to develop national benchmarks for valve replacement surgery by developing statistical risk models of operative mortality. BACKGROUND National risk models for coronary artery bypass graft surgery (CABG) have gained widespread acceptance, but there are no similar models for valve replacement surgery. METHODS The Society of Thoracic Surgeons National Cardiac Surgery Database was used to identify risk factors associated with valve surgery from 1994 through 1997. The population was drawn from 49,073 patients undergoing isolated aortic valve replacement (AVR) or mitral valve replacement (MVR) and from 43,463 patients undergoing CABG combined with AVR or MVR. Two multivariable risk models were developed: one for isolated AVR or MVR and one for CABG plus AVR or CABG plus MVR. RESULTS Operative mortality rates for AVR, MVR, combined CABG/AVR and combined CABG/ MVR were 4.00%, 6.04%, 6.80% and 13.29%, respectively. The strongest independent risk factors were emergency/salvage procedures, recent infarction, reoperations and renal failure. The c-indexes were 0.77 and 0.74 for the isolated valve replacement and combined CABG/valve replacement models, respectively. These models retained their predictive accuracy when applied to a prospective patient population undergoing operation from 1998 to 1999. The Hosmer-Lemeshow goodness-of-fit statistic was 10.6 (p = 0.225) for the isolated valve replacement model and 12.2 (p = 0.141) for the CABG/valve replacement model. CONCLUSIONS Statistical models have been developed to accurately predict operative mortality after valve replacement surgery. These models can be used to enhance quality by providing a national benchmark for valve replacement surgery.

Risk stratification for cardiac valve replacement. National Cardiac Surgery Database

BACKGROUND The Society of Thoracic Surgeons National Database Committee is committed to risk stratification and assessment as integral elements in the practice of cardiac operations. The National Cardiac Surgery Database was created to analyze data from subscribing institutions across the country. We analyzed the database for valve replacement procedures with and without coronary artery bypass grafting to determine trends in risk stratification. METHODS The database contains complete records of 86,580 patients who had valve replacement procedures at the participating institutions between 1986 and 1995, inclusive. The 1995 harvest of data was conducted in late 1996 and available for evaluation in 1997. These records were used to conduct an in-depth analysis of risk factors associated with valve replacement and to provide prediction of operative death by using regression analysis. Regression models were made for six subgroups. RESULTS Adverse patient risk factors, including diabetes, hypertension and reoperation, but not ventricular function, increased over time. There were trends with regard to increasing age of the various population subsets. The types of prostheses used remained similar over time, with more mechanical prostheses than bioprostheses used for both aortic and mitral valve replacement. There was a trend toward increased use of bioprostheses in aortic replacements and decreased use in mitral replacements between 1991 and 1995 than between 1986 and 1990. The mortality rate was determined by patient subset for primary operation and reoperation and by urgency status. The modeling showed that the predicted and observed mortality correlated for all age groups and within patient subsets. CONCLUSIONS Risk modeling is a valuable tool for predicting the probability of operative death in any individual patient. This large, multiinstitutional database is capable of determining modern operative risk and should provide standards for acceptable care. The study illustrates the importance of risk stratification for early death both for the patient and the surgeon.

Transapical transcatheter aortic valve implantation: follow-up to 3 years.

BACKGROUND We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients. METHODS Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up. RESULTS Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively). CONCLUSION Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.

Patient outcome after aortic valve replacement with a mechanical or biological prosthesis: Weighing lifetime anticoagulant-related event risk against reoperation risk

OBJECTIVE Although the results of aortic valve replacement with different valve prostheses are well documented in terms of survival, the risks of (valve-related) events are less well explored. METHODS We used a dataset of 3934 patients who underwent aortic valve replacement with either a bioprosthesis (73%) or a mechanical prosthesis (27%) between 1982 and 2003 to simulate the outcome of patients after aortic valve replacement with either valve type. With the use of microsimulation, we compared total age and gender-specific life expectancy, event-free life expectancy, reoperation-free life expectancy, lifetime risks of reoperation, and valve-related events for both valve types. RESULTS The total follow-up was 26,467 patient-years. The mean follow-up was 6.1 years in the biological arm and 8.5 years in the mechanical arm. The mean age at implantation was 70 and 58 years for biological and mechanical prostheses, respectively, and the percentage of concomitant coronary artery bypass grafting was 47% and 28%, respectively. For a 60-year-old man, simulated life expectancy in years for biological versus mechanical prostheses was 11.9 versus 12.2, event-free life expectancy was 9.8 versus 9.3, and reoperation-free life expectancy was 10.5 versus 11.9. Lifetime risk of reoperation was 25% versus 3%. Lifetime risk of bleeding was 12% versus 41%. CONCLUSION Even for patients aged 60 years, event-free life expectancy is better with a bioprosthesis. Although the chance of reoperation is higher, the lifetime risk of bleeding is lower compared with a mechanical prosthesis. Comparing lifetime event risks between different types of valve prostheses provides more insight into patient outcome after aortic valve replacement and aids patient selection and counseling.

Effect of Prosthesis-Patient Mismatch on Long-Term Survival With Aortic Valve Replacement: Assessment to 15 Years

BACKGROUND The effect of prosthesis-patient mismatch on long-term survival after aortic valve replacement has received considerable attention but there remains controversy. This study was performed to determine the predictors of mortality after aortic valve replacement and influence of prosthesis-patient mismatch on survival. METHODS Contemporary mechanical prostheses and bioprostheses were implanted in 3,343 patients with aortic valve replacement between 1982 and 2003. The mean age was 68.06 +/- 11.20 years (median 70.06; range, 19 to 94), and the mean follow-up was 6.18 +/- 4.96 years, for a total of 20,666 years of follow-up. Prosthesis-patient mismatch was classified by effective orifice area index categories: normal (> 0.85 cm(2)/m(2)), 1,547 (46.3%); mild-to-moderate (> 0.65 cm(2)/m(2) to < or = 0.85 cm(2)/m(2)), 1,584 (47.4%); and severe (< 0.65 cm(2)/m(2)), 212 (6.3%). RESULTS The predictors of overall mortality were age, age categorization, New York Heart Association functional class III/IV, concomitant coronary artery bypass graft surgery, prosthesis type, preoperative congestive heart failure, diabetes mellitus, renal failure, and chronic obstructive pulmonary disease. All categories of effective orifice area indexes were not predictive of overall mortality, late mortality, or early mortality. The 15-year overall survival was differentiated by effective orifice area index categories: 38.1% +/- 2.1%, 37.0% +/- 2.2%, and 22.1% +/- 6.5%, respectively, for the three categories. Survival adjusted for the covariates (effective orifice area index, age, basal mass index, and ejection fraction) determined no effect except severe effective orifice area index when adjusted for ejection fraction more than 50% (p = 0.049). CONCLUSIONS Prosthesis-patient mismatch is not a predictor of overall standard unadjusted mortality to 15 years after aortic valve replacement, regardless of the category of effective orifice area index.

Carpentier-Edwards standard porcine bioprosthesis: a 21-year experience

BACKGROUND The Carpentier-Edwards standard porcine bioprosthesis experience to 21 years has been evaluated to determine the influence of structural valve deterioration by valve position in various age groupings. METHODS From 1975 to 1988, 1,181 patients had the prosthesis implanted in 1,198 procedures. The mean age of the population was 57.9+/-12.5 years (range, 21 to 85 years). Aortic valve replacement was performed in 564 patients (47.8%); mitral valve replacement, 478 (40.5%); and multiple valve replacement, 132 (11.2%). Concomitant procedures were performed in 337 patients (28.5%), and 140 (11.9%) had previous operations. RESULTS The early mortality was 8.1% (97), only 0.4% (5) of which were valve-related. The total follow-up was 10,405 years (mean, 8.8+/-5.2 years). The late mortality was 5.7%/patient-year (591), with the valve-related component 1.6%/patient-year (168) with a 13% reoperative mortality (56). The linearized rate of structural valve deterioration was 3.8%/patient-year (395), with overall complications of 7.1%/patient-year (737). The overall survival at 20 years was 17.2%+/-3.1% (p < 0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration was, at 18 years, 25.8%+/-2.8% overall, AVR 40.6%+/-4.2%, and MVR 8.5%+/-3.4% (p < 0.05, aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 15 years, for patients older than 70 years, 82.9%+/-9.1%; 61 to 70 years, 73.2%+/-4.7%; 51 to 60 years, 58.8%+/-5.4%; 41 to 50 years, 41.7%+/-8.2%; and 21 to 40 years, 25.5%+/-7.8%. The freedom from structural valve deterioration for mitral valve replacement was, at 15 years, for patients older than 70 years, 89.8%+/-7.6%; 61 to 70 years, 22.8%+/-6.3%; 51 to 60 years, 26.3% +/- 5.7%; 41 to 50 years, 11.7%+/-5.6%; and 21 to 40 years, 7.0%+/-4.7%. CONCLUSIONS The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extended longevity is not anticipated) and for mitral valve replacement for patients older than 70 years.

Reoperation in biological and mechanical valve populations: Fate of the reoperative patient

From 1975 through 1992 inclusive, reoperative valve replacement (REOP) was required by 12.9% of patients (708/5,499). Of 1,355 patients with mechanical prostheses (MP), 46 (3.4%) came to REOP versus 662 of 4,144 patients (16%) with biological prostheses (BP). Early REOP mortality rate was 17.4% (8/46) for MP and 10.6% (70/662) for BP (p = not significant). It was higher with age greater than 75 years (p < 0.05) and trended higher with concomitant procedures and with increasing number of REOPs (p = not significant). The percentage freedom from REOP at 5 and 10 years for all BP was 96.0% +/- 0.4% and 74.9% +/- 1.1% compared with 93.6% +/- 1.2% and 87.9% +/- 2.5% for MP. The most common cause of REOP in the BP patients was structural valve deterioration, which was uncommon in patients with MP (72% versus 2% of REOP but only 15% versus 0.1% of initial implants). Nonstructural dysfunction was the leading cause of REOP in the MP group (65% versus 11%). Prosthetic valve endocarditis (18% versus 10%) and thromboembolic complications (10% versus 1%) were also more frequent causes of REOP in MP patients. However, the increased relative role of these factors with MP is due to the minimal incidence of structural valve deterioration. When related to the original choice of MP versus BP, only thromboembolic complication (3.8 times) was more prevalent as a cause of REOP in patients receiving MP at their previous procedure (p = not significant). For patients who previously received BP, structural valve deterioration (69 times) was more likely to lead to REOP than with MP (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Modern cardiac valve devices--bioprostheses and mechanical prostheses: state of the art.

The choice of bioprostheses and mechanical prostheses as valvular substitutes for cardiac valve replacement surgery has existed for over 20 years. The extensive developments over the past three decades have been introduced to reduce or eliminate valve related complications, namely thromboembolism, anticoagulant related hemorrhage, and structural failure, as well as to optimize hemodynamic performance. The biological valvular prostheses, namely porcine aortic or bovine pericardium, have been developed with tissue preservation, together with stent designs, that contribute to preservation of anatomical characteristics and biomechanical properties of the leaflets. The mechanical prostheses have been developed to eliminate structural failure, to facilitate prevention of blood status and thrombus formation, to facilitate radiopacity for evaluation of prosthesis function, and to facilitate intraoperative leaflet positioning. The implantation of the various present generation bioprostheses and mechanical prostheses requires special considerations to avoid technical complications and support ventricular performance. The studies of biological and mechanical prostheses, both randomized and nonrandomized, as well as specific prosthesis assessments, have contributed to the establishment of indications for types of prostheses. Bioprostheses have a high risk of structural failure and reoperation, while mechanical prostheses have a high risk of thromboembolism and anticoagulant hemorrhage. Within the bioprostheses population, the risk factors for structural valve deterioration are younger age and mitral prosthesis. Older patients (> 65 years of age) have a greater risk of valve related complications with mechanical prostheses, while younger patients (< 40 years of age) are at greater risk with bioprostheses. Comparison of large bioprostheses and mechanical prostheses populations by age groups revealed that regardless of the differences in the freedom from structural valve deterioration, the freedom from treatment failure (valve related mortality and permanent impairment from thromboembolism, anticoagulant hemorrhage, and septal emboli from prosthetic valve endocarditis) is essentially the same for mechanical prostheses and bioprostheses at 10 years. The quality of life is superior with bioprostheses, while patient survival and total valve related morbidity/mortality are similar with both types of prostheses.

Pregnancy and bioprostheses: Influence on structural valve deterioration**

The long-term performance of bioprostheses was evaluated in women 35 years of age or less to determine the influence of pregnancy on structural valve deterioration. Between 1972 and 1992, 237 female patients received 255 biological prostheses. Of the total operations, 53 were performed in patients who experienced pregnancy (P) and 202 in patients who were never pregnant (nonpregnant [NP]). The mean age of the P group was 23.0 +/- 5.8 years (standard deviation) (12 to 34 years) and of the NP group it was 27.1 +/- 6.3 years (8 to 35 years) (p < 0.05). The mean follow-up for the NP group was 6.8 years and for the P group it was 7.9 years. The late mortality was 2.26%/patient-year overall, 2.71%/patient-year for the NP group and 0.89%/patient-year for the P group (p = not significant [NS]). The P group of 52 patients had 94 pregnancies: 70 deliveries (74.5%) and 24 abortions (25.5%) (therapeutic, 14 [15%]). There were a total of 143 valve-related complications (P, 35; NP, 108); the majority for structural valve deterioration (SVD) 43% (109 patients), P 51% (27 patients) and NP 41% (82 patients) (p = NS). The valve-related reoperation rate paralleled the SVD rate at 42% (107 patients), P 51% (27 patients) and NP 40% (80 patients) (p = NS). The overall reoperative mortality rate was 6.0%. The interval from initial implant to reoperation was 99.6 +/- 3.6 months (p = NS groups P and NP).(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiac valve replacement in the elderly: Clinical performance of biological prostheses

From 1975 to 1987, 1,127 elderly patients underwent 1,223 valve replacements with the Carpentier-Edwards standard or supraannular porcine bioprostheses in 1,147 operations. Of the total patient population seen during these years, 33.5% receiving a standard porcine bioprosthesis and 48.6% receiving a supraannular bioprosthesis were 65 years of age or older. Of this elderly patient population, 465 patients were between 65 and 69 years old; 618 patients, 70 and 79 years old; and 52 patients, 80 years old and older. Aortic valve replacement was performed in 635 patients, mitral valve replacement in 417 patients, tricuspid valve replacement in 2 patients, and multiple-valve replacement in 80 patients. The cumulative follow-up was 3,957 patient-years. Early mortality was 9.5%: 7.3% for the 65- to 69-year-old group, 10.7% for the 70- to 79-year-old group, and 15.4% for the group 80 years old and older. Late mortality was 5.5% per patient-year: 4.2% per patient-year for the 65- to 69-year-old group, 6.3% per patient-year for the 70- to 79-year-old group, and 14.1% per patient-year for the group 80 years old and older. Valve-related causes contributed to 7 early deaths and 33 late deaths. The overall patient survival, including operative deaths, was 70.7% +/- 1.6% at 5 years and 47.8% +/- 3.7% at 10 and 12 years. The freedom from all valve-related complications was 52.1% +/- 6.1% at 10 and 12 years. The overall rate of valve-related complications was 5.0% per patient-year (fatal complications, 1.13% per patient-year). The overall rate of thromboembolism was 2.3% per patient-year and the freedom from thromboembolism, 69.6% +/- 5.2% at 10 and 12 years. The freedom from structural valve deterioration was 80.8% +/- 8.1% at 10 and 12 years: 71.7% +/- 11.0% at 10 and 12 years for the 65- to 69-year-old group, 97.9% +/- 1.2% at 10 years for the 70- to 79-year-old group, and 100% at 12 years for the group 80 years old and older. At 10 and 12 years, the freedom from valve-related death was 83.7% +/- 4.3% and the freedom from reoperation, 73.3% +/- 8.6%. The freedom from valve-related death, residual morbidity from thromboembolism and anticoagulant-related hemorrhage, and reoperation was 61.7% +/- 7.0% at 10 and 12 years. The clinical performance of porcine bioprostheses in the elderly patient population has been excellent. The early mortality increases in patients 70 years old or older.(ABSTRACT TRUNCATED AT 400 WORDS)