Considerations for prostheses choice in multiple valve surgery.

OBJECTIVES: The prosthesis type for multiple valve surgery (replacement of two or more diseased native or prosthetic valves, replacement of two diseased valves with repair/reconstruction of a third, or replacement of a single diseased valve with repair/reconstruction of a second valve) remains inadequately evaluated. The clinical performance of multiple valve surgery with bioprostheses (BP) and mechanical prostheses (MP) was assessed to compare patient survival and composites of valve-related complications. METHODS: Between 1975 and 2000, 1245 patients had multiple valve surgery (BP 785, mean age 62.0 ± 14.7 years; and MP 460, mean age 56.9 ± 12.9 years). There were 1712 procedures performed [BP 969(56.6%) and MP 743(43.4%). Concomitant coronary artery bypass (conCABG) was BP 206(21.3%) and MP 105(14.1%) (p = 0.0002). The cumulative follow-up was BP 5131 years and MP 3364 years. Independent predictors were determined for mortality, valve-related complications and composites of complications. RESULTS: Unadjusted patient survival at 12 years was BP 52.1 ± 2.1% and MP 54.8 ± 4.6% (p = 0.1127), while the age adjusted survival was BP 48.7 ± 2.3% and MP 54.4 ± 5.0%. The predictors of overall mortality were age [Hazard Ratio (HR) 1.051, p < 0.0001], previous valve (HR 1.366, p = 0.028) and conCABG (HR 1.27, p = 0.021). The actual freedom from valve-related mortality at 12 years was BP 85.6 ± 1.6% and MP 91.0 ± 1.6% (actuarial p = 0.0167). The predictors of valve-related mortality were valve type (BP > MP) (2.61, p = 0.001), age (HR 1.032, p = 0.0005) and previous valve (HR 12.61, p < 0.0001). The actual freedom from valve-related reoperation at 12 years was BP 60.8 ± 1.9% and MP85.6 ± 2.1% (actuarial p < 0.001). The predictors of valve-related reoperation were valve type (MP > BP) (HR 0.32, p < 0.0001), age (HR 0.99, p = 0.0001) and previous valve (HR 1.38, p = 0.008) CONCLUSIONS: Overall survival (age adjusted) is differentiated by valve type over 10 and 12 years and valve-related mortality and valve-related reoperation favours the use of mechanical prostheses, overall for multiple valve surgery.

Mitral valve disease: if the mitral valve is not reparable/failed repair, is bioprosthesis suitable for replacement?

OBJECTIVE: The durability of mitral bioprostheses has long been known to be inferior to aortic bioprostheses. Mitral valve reconstruction/repair is currently recommended for most mitral valve procedures. The choice of prostheses for non-reparable or failed mitral valve repairs has not been specified or given appropriate attention within the literature. The objective of this study is to address the role of bioprostheses in the specific subset of non-reparable or failed repair patients by using the knowledge of the general durability of mitral porcine bioprostheses, inclusive of the Carpentier-Edwards mitral porcine bioprosthesis. METHODS: The CE-SAV was implanted in 1135 patients (1175 operations) for mitral valve replacement (MVR) from 1982 to 2000. The mean age was 65.0+/-12.1 years (range 13-86 years). The mean follow-up was 6.4+/-4.5 years, 7555.9 patient-years and 98.3% complete. The evaluation considered freedom from structural valve deterioration (SVD) and freedom from composites of complications, as well as risk assessment. RESULTS: For the 51-60 year age group, the actual and actuarial freedom from SVD was, at 18 years, 56.0+/-4.1% and 14.7+/-5.8%; for the 61-70 year age group was, at 18 years, 69.6+/-2.6% and 26.5+/-5.9%, respectively. For the >70 group, at 15 years was 92.2+/-2.0% and 69.0+/-9.7%, respectively. There were a total of 256 SVD events with 31 fatalities and 226 reoperations with 10 fatalities (4.42%). The predictors of SVD were age (hazard ratio [HR] 0.98, p=0.0002), concomitant CAB (HR 0.66, p=0.020) and valve size (HR 1.08, p=0.034). The overall actual freedom, at 15-18 years, for >70 age group was, for valve-related reoperation, 94.3+/-1.5%; and for valve-related mortality was 87.8+/-2.3%. CONCLUSIONS: The CE-SAV mitral porcine bioprosthesis cannot be recommended as representative of prosthesis-type of choice for non-reparable or failed repair of native mitral valves for ages 70 years of age. The clinical performance of the CE-SAV is similar to other mitral bioprostheses.

Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 20 years.

OBJECTIVE: Experience with the Carpentier-Edwards supra-annular porcine bioprosthesis (Edwards Lifesciences, Irvine, Calif) has been evaluated longitudinally over 20 years. Clinical performance was evaluated by actuarial and actual analysis. Hemodynamic performance was evaluated by echocardiographic/Doppler assessment. Morphology of structural failure was evaluated from pathologic examinations. METHODS: From 1981 through 1999, 1823 patients (mean age, 68.9 +/- 10.9 years; range, 19-89 years) underwent 1847 procedures. Concomitant coronary artery bypass was performed in 788 (42.7%) patients. Previous valve procedures were performed in 107 (5.8%) patients, and other cardiac procedures were performed in 87 (4.7%) patients. RESULTS: The overall valve-related complication rate was 4.36% per patient-year (630 patients), with a fatality rate of 0.96% per patient-year (139 patients). Patient survival at 18 years was 15.8% +/- 1.6%. Overall late mortality rate was 6.3% per patient-year. Overall actual cumulative freedom at 18 years from reoperation was 85.0% +/- 1.2%, valve-related mortality was 88.7% +/- 1.1%, and valve-related residual morbidity was 96.3% +/- 5.0%. Actual freedom from structural valve deterioration at 18 years was 86.4% +/- 1.2% overall, 90.5% +/- 1.8% for age 61 to 70 years, and 98.2% +/- 0.6% for age greater than 70 years. Structural valve deterioration presented with pathologic evidence consistent with stenosis in 27.6% and insufficiency in 72.4%. Hemodynamic performance at 1 year revealed normal effective orifice area indexes for sizes 23 to 27 mm and mild-to-moderate reduction for size 21 mm. CONCLUSIONS: The Carpentier-Edwards supra-annular aortic porcine bioprosthesis continues to provide excellent freedom from structural valve deterioration and overall freedom from valve-related residual morbidity, mortality, and reoperation up to 18 years. Hemodynamic performance is satisfactory. The prosthesis remains recommended for patients older than 70 years and for patients 61 to 70 years of age, especially when comorbid risk factors are not anticipated to provide extended survival.

Medtronic mosaic porcine bioprosthesis: investigational center experience to six years.

BACKGROUND AND AIM OF THE STUDY: The findings of this single-center experience with the Medtronic Mosaic porcine bioprosthesis were evaluated to determine the clinical performance of the valve. METHODS: Between 1994 and 2000, a total of 657 patients was implanted with the prosthesis. Aortic valve replacement (AVR) was performed in 415 patients (mean age 70.5+/-10.7 years; range: 26-89 years) and mitral valve replacement (MVR) in 242 patients (mean age 70.5+/-9.5 years; range: 19-86 years). Concomitant coronary artery bypass (CAB) was performed in 51.1% and 46.7% of AVR and MVR patients, respectively. The majority of patients were aged over 70 years (59.8% AVR, 58.7% MVR). RESULTS: Survival at six years was 73.0+/-2.4% after AVR, and 74.0+/-5% after MVR (p = NS). Actual freedom from valve-related mortality at six years was 98+/-1% for AVR and 96+/-1% for MVR; freedom from overall thromboembolism (TE) was 86+/-3% for AVR and 89+/-2% for MVR. After AVR, 42 thromboembolic events occurred in 39 patients (23 minor; 14 major; three reversible ischemic neurologic deficits (RIND); two thrombosis). After AVR, the late TE rate was 2.1% per pt-yr, and the major rate 0.6% per pt-yr (exclusive of thrombosis). The overall TE rate after AVR was 2.9% per pt-yr (major rate 1% per pt-yr). After MVR, 25 events occurred in 24 patients (10 minor; eight major; five RIND; two thrombosis). After MVR, the late TE rate was 2.6% per pt-yr, and the major rate 0.7% per pt-yr (exclusive of thrombosis). The overall TE rate after MVR was 3.5% per pt-yr (major rate 1.1% per pt-yr). There were four cases of structural valve deterioration (SVD) (two each after AVR and MVR). Reoperation was performed in three of four cases of thrombosis, and in two of four cases of SVD. CONCLUSION: The Medtronic Mosaic porcine bioprosthesis is safe and effective. The rate of SVD after six years was low, being zero in the aortic position of patients aged >60 years, and zero also in the mitral position of patients aged <60 years. The incidence of early and late thromboembolism was contributed to by the advanced age of the patient population.

Prosthesis-related complications: first-year annual rates.

The rates of valve-related complications determine the clinical performance of biological and mechanical heart valve prostheses by valve position. The crude rates of valve-related complications within the first year after implantation have not been previously reported. The Food and Drug Administration (FDA) of the United States guidance document for the performance of new heart valve prostheses uses objective performance criteria (OPC) as target values for valve-related complications. The FDA requirement for each valve-related complication is that the rate cannot be greater than twice the OPC. This report provides the first-year rates of valve-related complications from a university database of over 7,000 implants, followed longitudinally between 1982 and 1999, of currently marketed biological and mechanical heart valve prostheses. The aim of this report was to provide an additional method for consideration by regulatory authorities in determination of the standards of performance for pre-market approval of new prosthetic valves for heart valve replacement surgery.

Traumatic rupture of the thoracic aorta: third decade of experience.

BACKGROUND: Traumatic rupture of the thoracic aorta is a relatively common injury of deceleration accidents, usually high-speed motor vehicle accidents. Spinal cord injury has been a well-documented complication of surgical management. The use of nonheparinized partial bypass with a centrifugal pump was evaluated for protection against spinal cord injury and reduction of risk of associated injuries. METHODS: From 1989 to 1999, the third decade of the authors' experience, traumatic rupture was diagnosed in 58 patients (male 46 and female 12; mean age 39.9 years, range 17 to 85). Associated injuries were documented in 98.3% (57 patients). In all, 45 patients (77.6%) had the opportunity for definitive surgical management; 42 (93.3%) were managed with partial cardiopulmonary bypass, 35 without the use of heparin. Full cardiopulmonary bypass was utilized in 1 patient while 2 had repair without cardiopulmonary bypass support. Thirteen patients did not have the opportunity for definitive surgical management, 1 death on arrival, 8 (61.5%) suspected, and 4 (30.8%) diagnosed. RESULTS: There were 6 deaths in the surgical group, 5 in nonheparinized patients. The causes were intraoperative hypovolemia (2), anoxic brain death after intraoperative cardiac arrest (1), sepsis (1), and adult respiratory distress syndrome (1). The other was in the simple aortic cross-clamp group from intraoperative pulmonary compromise. There was one spinal cord injury, paraparesis in 1 of the 2 patients managed without bypass support. The total hospital stay ranged from 8 to 112 days, primarily owing to management of associated injuries. Of the 13 patients who did not have the opportunity for definitive surgical management, 5 had unsuccessful emergency thoracotomy and 3 survived the hospital course without surgery. Of the total population, the overall mortality was 27.6%, whereas the mortality of the potentially operable patients was 25.8%. Of the surgical group, the intraoperative mortality was 6.7% and 30-day mortality was 13.3%. CONCLUSIONS: Spinal cord injury was prevented by the use of partial cardiopulmonary bypass. Nonheparinized bypass was likely to be a contributory factor to lack of mortality directly related to associated injuries.