Influence of patient gender on mortality after aortic valve replacement for aortic stenosis.

OBJECTIVE: To assess the influence of gender on mortality after aortic valve replacement for aortic stenosis. METHODS: A retrospective analysis was performed on data prospectively collected from all patients undergoing aortic valve replacement for aortic stenosis. Multivariate regression analysis was performed to evaluate the effect of 22 preoperative and operative variables on early, late, and overall mortality. RESULTS: Aortic valve replacement was performed in 3343 patients with aortic stenosis between 1982 and 2003. The female patients were older, with a smaller body mass index. The women were less likely to have diabetes, chronic obstructive pulmonary disease, previous myocardial infarction, or left ventricular ejection fraction <35% but were more likely to have hypertension or a New York Heart Association III-IV classification. The female patients received a smaller prosthetic valve, with a smaller effective orifice area index (EOAI). The mean follow-up period was 6.18 ± 4.96 years, with a total of 2066.142 years of follow-up. The independent predictors of early mortality for the male patients included age, concomitant surgical revascularization, congestive heart failure, and valve size of ≤21 mm. The independent predictors of late mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, chronic obstructive pulmonary disease, congestive heart failure, and a bioprosthetic valve. The independent predictors of overall mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, heart failure, and valve size of ≤21 mm. For the female patients, the risk factors for early mortality included body mass index <25 kg/m(2); for late mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and diabetes; and for overall mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and renal failure. Furthermore, male gender was an independent predictor of late (but not early or overall) mortality. CONCLUSIONS: The independent predictors of mortality after aortic valve replacement for aortic stenosis differed between the male and female patients. Male gender increased the risk of late mortality, and a valve size of ≤21 mm increased the risk of early and overall mortality among the male patients only. These differences need to be taken into consideration preoperatively and require consideration during operative management.

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.

Effect of prosthesis-patient mismatch on long-term survival with mitral valve replacement: assessment to 15 years.

BACKGROUND: The effect of prosthesis-patient mismatch on long-term survival after mitral valve replacement (MVR) has received limited attention. This study was performed to determine the predictors of mortality after MVR and influence of prosthesis-patient mismatch on survival. METHODS: Contemporary mechanical prostheses and bioprostheses were implanted in 2,440 patients with MVR between 1982 and 2002. The mean age was 63.9 +/- 12.1 years and the mean follow-up was 6.1 +/- 4.6 years, a total of 14,797.7 years of follow-up. Prosthesis-patient mismatch was classified by effective orifice area index categories: normal, greater than 1.2 cm(2)/m(2) (345, 14.2%); mild-to-moderate, equal to or less than 1.2 to greater than 0.9 cm(2)/m(2) (1,696, 69.5%); and severe, equal to or less than 0.9 cm(2)/m(2) (399, 16.4%). RESULTS: The predictors of overall mortality were age, age categorization, New York Heart Association III-IV, concomitant coronary artery bypass, ventricular dysfunction, prosthesis type, body mass index, and pulmonary hypertension. All categories of effective orifice area indices (EOAIs) were not predictive of overall mortality, late mortality, or early mortality. The 15-year survival was not differentiated by EOAI categories; 32.0 +/- 4.4%, 32.9 +/- 2.1%, and 36.6 +/- 6.3%, respectively, for the three categories. Pulmonary hypertension influenced mortality by EOAI categories; normal versus mild-to-moderate (p = 0.0317) and normal versus severe (p = 0.0320). The EOAI was not an independent predictor of mortality in the consideration of patients with pulmonary hypertension but there is an interaction between pulmonary hypertension and mild-to-moderate (p = 0.023) and severe (p = 0.031) EOAI. CONCLUSION: Prosthesis-patient mismatch is not a predictor of overall mortality to 15 years after MVR regardless of the category of effective orifice area index. The preoperative variable, pulmonary hypertension, influences overall mortality in the presence of mild-to-moderate and severe prosthesis-patient mismatch in the survival analysis.

Predictors of recurrence and reoperation for prosthetic valve endocarditis after valve replacement surgery for native valve endocarditis.

OBJECTIVE: Surgical treatment of native valve endocarditis remains challenging, especially in cases with paravalvular destruction. Basic principles include complete debridement and reconstruction. This study is designed to evaluate the outcomes of surgical reconstruction of complex annular endocarditis using standard techniques and materials, including autologous and bovine pericardium. METHODS: From 1975 to 2000, 358 cases (357 patients, mean age 49 +/- 16 years, range 18-88 years) of native valve endocarditis were surgically managed. Bioprosthetic valves were implanted in 189 cases, and mechanical prostheses were implanted in 169 cases. A total of 78 cases of paravalvular destruction were identified: 62 annular abscesses, 8 fistulas, and 8 combined abscesses/fistulas. These were managed with 46 pericardial patches and 32 isolated suture reconstructions after radical debridement and prosthetic valve replacement. RESULTS: The overall early mortality was 8.4% (n = 30). The mortality with paravalvular destruction was 17.9%, and the mortality with simple leaflet infection was 5.7% (P = .001). The unadjusted survival at 20 years was 26.4% +/- 4.9% for bioprosthetic valves and 56.5% +/- 8.1% for mechanical prostheses (P = .007). The freedom from recurrent prosthetic valve endocarditis was 78.9% +/- 4.4% at 15 years. The freedom from reoperation for recurrent prosthetic valve endocarditis was 85.8% +/- 4.2% at 15 years. The freedom from reoperation after reconstruction for paravalvular destruction was 88.2% +/- 6.9% at 15 years. The freedom from mortality for recurrent prosthetic valve endocarditis was 92.7% +/- 3.4% at 15 years. The independent predictors of reoperation were age (hazard ratio 0.930, P = .005) and intravenous drug use/human immunodeficiency virus plus surgical technique (hazard ratio 12.8, P = .003 for patch reconstruction plus valve and hazard ratio 3.6, P = .038 for valve replacement only). Prosthesis type was not predictive when separated from intravenous drug use/human immunodeficiency virus (hazard ratio 3.268, P = .088). CONCLUSION: Paravalvular destruction is associated with a higher operative mortality. Native valve endocarditis can be managed with reasonable long-term survival and low rates of reinfection with radical debridement and pericardial reconstruction with bioprostheses and mechanical prostheses. The type of prosthesis implanted does not influence long-term outcome. Patients with a history of intravenous drug use and human immunodeficiency virus are at increased risk for recurrent infection and reoperation.

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.

Aortic and mitral prosthetic valve replacement in age groups 61-65 & 66-70 years.

Prosthesis choice for aortic and mitral valve replacements in patients aged 61-70 years is difficult. We evaluated prostheses in age groups 61-65 and 66-70 years. Freedom from major thromboembolism and hemorrhage was greater for bioprostheses than mechanical prostheses in both age groups after aortic valve replacement, but only in the younger age group after mitral valve replacement. Freedom from valve-related re-operation was greater after mitral valve replacement with mechanical prostheses in both age groups, but no difference after aortic valve replacement. Valve type was predictive of major thromboembolism and hemorrhage, except in older patients undergoing mitral valve replacement. Bioprostheses are favored for aortic valve replacement in both age groups, but the risk of re-operation with a bioprosthesis in the mitral position in patients aged 61-65 years favors a mechanical prosthesis. Prosthesis choice is less definite in those aged 66-70 years.

Early antithrombotic therapy for aortic valve bioprostheses: is there an indication for routine use?

BACKGROUND: Consensus reports over the past 10 years from the United States, Europe, United Kingdom, and Canada have not provided consistent guidelines for antithrombotic therapy of aortic valve bioprostheses for the three-month period after surgery. This study was conducted to determine if antithrombotic therapy was protective against TE with aortic bioprostheses 30 days or less after aortic valve replacement (AVR). METHODS: From 1994 to 2000, 1,372 patients implanted with three currently marketed aortic bioprostheses, Medtronic Mosaic (Medtronic, Inc, Minneapolis, MN) (415 patients), Carpentier-Edwards SAV (462), and Carpentier-Edwards PERIMOUNT (495) (Edwards Lifesciences, Irvine, CA), with a mean age of greater than 70 years were evaluated. Patient populations were comparable, inclusive of concomitant coronary artery bypass grafting (CABG) for the overall populations and for patients greater than 70 years. RESULTS: There were 37 thromboembolic (TE) events: major TE, 14; reversible ischemic neurologic deficit (RIND), 12; and minor TE, 11. There were 4 TE deaths. Multivariate (stepwise logistic regression) analysis revealed no predictive risk factors for overall TE. For the combination of major TE plus RIND there were two predictive risk factors with analysis of 12 risk variables: preoperative cerebrovascular accident (odds ratio [OR] 4.45, 95% confidence interval [CI] 1.17 to 16.87, p = 0.028); and concomitant CABG (OR 3.19, 95% CI 1.16 to 8.76, p = 0.025). Neither anticoagulant nor antiplatelet therapies gave significant protection. CONCLUSIONS: There does not appear to be an indication for routine antithrombotic management. The study supports the potential use of antithrombotic therapy for comorbidities of preoperative cerebrovascular accident and concomitant CABG but not atrial fibrillation, left ventricular dysfunction, or elderly age greater than 70 years. Vascular burden and advanced age are likely contributing factors to these independent predictors. There may still be a need for, or at least consideration of, a randomized trial for AVR with bioprostheses.

What prosthesis should be used at valve re-replacement after structural valve deterioration of a bioprosthesis?

BACKGROUND: The fate of bioprostheses (BP) and mechanical prostheses (MP) after valve re-replacement for bioprostheses is not well-documented. This research compares the late fate of these two valve types after valve re-replacement for structural valve deterioration (SVD) of a bioprosthesis. METHODS: Between 1975 and 2000, 298 patients had successful aortic valve re-replacements (AVRR) (BP n = 149, average age = 67.1 +/- 12.3 years; MP 149, 58.9 +/- 10.9) and 442 patients had successful mitral valve re-replacements (MVRR) (BP 155, 65.8 +/- 14.1; MP 287, 60.8 +/- 11.7) after SVD of a previous BP. Follow-up was five years in all groups. RESULTS: (1) Aortic position (AVRR): Survival favored MP over BP overall, at 10 years (70.3 +/- 5.4% vs 56.7 +/- 5.7%, p = 0.0220). This survival advantage was seen to be significant only in patients less than 60 years of age (at 10 years, 85.3 +/- 4.9% vs 59.2 +/- 9.8%, p = 0.038). No significant difference in survival between the two valve types was observed in patient age groups greater than 60 years of age. Freedoms from valve-specific complications, including reoperation for SVD-thrombosis, major thromboembolism and hemorrhage, and valve-related mortality were not significantly different between the two groups overall. (2) Mitral position (MVRR): Survival favored MP over BP overall (58.6 +/- 4.2% vs 42.1 +/- 5.2%, p = 0.0011), and in patients greater than 70 years of age (32.8 +/- 8.9% vs 16.7 +/- 7.1%, p = 0.008). Freedoms from valve-specific complications and valve-related mortality favored MP over BP. CONCLUSIONS: There was no clinical performance difference between mechanical and bioprosthetic valves in patients greater than 60 years of age upon AVRR. Mechanical valves generally outperformed bioprosthetic valves in all age groups in MVRR.

15-year comparison of supra-annular porcine and PERIMOUNT aortic bioprostheses.

The second-generation Carpentier-Edwards bioprostheses, the supra-annular porcine valve and the PERIMOUNT pericardial valve, have been evaluated longitudinally for several years. This study compared clinical performance over 15 years. Aortic valve replacement was performed with a supra-annular porcine valve in 1,823 patients (group 1) aged 19-89 years (mean, 68.9 +/- 10.9 years) and with a PERIMOUNT pericardial bioprosthesis in 1,430 patients (group 2) aged 16-90 years (mean, 69.5 +/- 10.4 years). The groups were similar except for concomitant coronary artery bypass in 43% of group 1 and 18% of group 2 ( p < 0.001). Overall survival at 15 years was 29.3% +/- 1.5% for group 1 and 35.2% +/- 3.1% for group 2 ( p = 0.0009). The actual freedom from valve-related mortality was 88.5% +/- 0.9% for group 1 and 84.9% +/- 1.7% for group 2. The actual freedom from structural valve deterioration at 15 years was similar overall, and for patients aged > 60 years, between the groups, but was dissimilar (group 2 > group 1) for age group 2), sex (male > female), age, and concomitant coronary artery bypass. Both bioprostheses provided satisfactory clinical performance at 15 years after aortic valve replacement.

Valve replacement surgery in end-stage renal failure: mechanical prostheses versus bioprostheses.

BACKGROUND: The 1998 American College of Cardiology/American Heart Association Guidelines recommend mechanical prostheses for valve replacement in patients with end-stage renal disease requiring dialysis. The aim of the study is to evaluate the combined experience at two academic centers. METHODS: Sixty-nine valve replacements (aortic 40; mitral 22; multiple 7; 47 bioprostheses, 22 mechanical prostheses) were performed. Total follow-up was 128.7 patient-years (bioprostheses, 68.4; mechanical prostheses, 60.4). RESULTS: Patient populations were homogeneous, except for age (bioprostheses greater than mechanical prostheses, p = 0.012), previous myocardial infarction (bioprostheses greater than mechanical prostheses, p = 0.040), and concomitant CABG (bioprostheses greater than mechanical prostheses, p = 0.019). A survival advantage was observed in favor of mechanical prostheses (p = 0.0299) at 5 years. Freedom from valve-related complications at 5 years was calculated for thromboembolism plus thrombosis plus hemorrhage (bioprostheses, 93.0% +/- 3.9%; mechanical prostheses, 76.4% +/- 12.7%), thromboembolism excluding thrombosis (bioprostheses, 93.0% +/- 3.9%; mechanical prostheses, 88.9% +/- 10.5%), and hemorrhage (bioprostheses, 100%; mechanical prostheses, 95.2% +/- 4.7%). One case of structural valve deterioration occurred in the bioprostheses group at 95 months after surgery. Five-year freedom from all valve-related complications was 82.8% +/- 8.1% for bioprostheses and 76.4% +/- 12.7% for mechanical prostheses. CONCLUSIONS: Overall survival was poor. Differences between populations were related to age at operation and coronary artery disease. Structural valve deterioration was not accentuated with bioprostheses. Considering lack of homogeneity between prostheses groups there was no superiority of mechanical prostheses over bioprostheses in terms of freedom from composites of complications. Bioprostheses should be considered in the management of valvular disease in end-state renal disease patients.

Mitral valve reconstruction: experience related to early and late mortality and reoperation.

BACKGROUND AND AIM OF THE STUDY: The present authors' experience with mitral valve reconstruction was reviewed to determine the influence of anatomical and functional abnormalities on mortality and reoperation. METHODS: Between 1991 and 2001, a total of 397 patients (mean age 59.0 +/- 13.4 years) underwent mitral valve reconstruction at the authors' institution. Patients were grouped according to the Carpentier functional classification as follows: type I, n = 88 (mean age 57.4 years; range: 24-81 years); type II, n = 169 (mean age 59.8 years; range: 16-81 years); type IIIa, n = 44 (mean age 52.8 years; range: 22-78 years); type IIIb, n = 85 (mean age 65.1 years; range: 33-82 years); and congenital (C), n = 11 (mean age 36.2 years; range: 18-65 years). RESULTS: The total follow up was 1,485.8 patient-years (pt-yr). Early mortality was: type I, 3.4% (n = 3); type II, 0; type IIIa; 2.3% (n = 1); type IIIb, 9.4% (n = 8); and C, 0 (p = 0.0028, IIIb > II and C). The late mortality was: type I, 2.1%/pt-yr (n = 6); type II, 1.1%/pt-yr (n = 7); type IIIa, 1.8%/pt-yr (n = 4); type IIIb, 4.3%/pt-yr (n = 12); and C, 1.7%/pt-yr (n = 1) (p = 0.0035 IIIb > II). The overall survival at 10 years was 79.6 +/- 4.2% (p <0.001, II > IIIb; p = 0.029, I > IIIb; p = 0.046, II > I). The reoperations were: type I, 1.4%/pt-yr (n = 4); type II, 1.9%/pt-yr (n = 12); type IIIa, 0.9%/pt-yr (n = 2); type IIIb, 0.4%/pt-yr (n = 1); and C, 0 (p = 0.0435 II > IIIb). Among the 19 reoperations there were 17 replacements, one re-repair, and one annuloplasty. The failures were predominantly type II, posterior (n = 5) and anterior (n = 5), or a combination (n = 2). The overall freedom from reoperation was 92.0 +/- 2.2% (p = NS between groups). CONCLUSION: Mitral valve reconstruction can be performed in all four functional categories with generally satisfactory results, except possibly for functional ischemic disease. The results of surgery for degenerative disease afford the opportunity for early surgical management, if proven techniques are adhered to in order to minimize the risk of reoperation. The repair of ischemic disease due primarily to ventricular dysfunction is in a state of evolution.

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.

Use of abdominal quilting sutures for seroma prevention in TRAM flap reconstruction: a prospective, controlled trial.

This study is designed to evaluate the effect of abdominal quilting sutures on the incidence of abdominal seroma formation in patients undergoing pedicled transverse rectus abdominis musculocutaneous (TRAM) flap reconstruction. It is theorized that the use of such sutures during closure of abdominal flaps will collapse dead space, thus preventing abdominal seroma formation. A total of 71 consecutive patients undergoing pedicled TRAM flap breast reconstruction were randomly assigned to receive abdominal quilting sutures or to undergo a standard abdominal closure. Primary outcome measures included: daily drain output for the first 3 postoperative days, time to drain removal, and seroma formation. Drain output per day decreased with the use of abdominal quilting sutures; however, the time to drain removal was not significantly affected. Most importantly, there was no significant decrease in the incidence of seroma formation with the use of abdominal quilting sutures in this series.

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.

Retrospective case review of capsular contracture after two-stage breast reconstruction: is colonization of the tissue expander pocket associated with subsequent implant capsular contracture?

Periprosthetic capsular contracture is a common problem associated with implant-based breast reconstruction. The purpose of this study was to determine if bacterial colonization of the tissue expander contributes to contracture of the permanent implant. Medical records were reviewed for 86 patients (124 tissue expanders) between 1997 and 2001 in 1 institution. Three specimens taken from the expander were cultured. The overall incidence of colonization was 42.7%; 49.4% (38.8-60.0) of immediate and 28.2% (14.1-42.3) of delayed expanders had at least 1 positive culture site (P = 0.043). The most common organisms were Propionibacterium acnes (57.6%), Staphylococcus epidermidis (31.0%), and Peptostreptococcus (5.8%). Statistical analysis revealed no significant difference between colonization of the expander and capsular contracture of the permanent prosthesis (P = 0.59). 45.8% (25.9-65.8) of breasts irradiated preoperatively developed contracture versus 14% (7.2-20.8) with no irradiation (P = 0.0013). These results suggest that colonization of the expander occurs frequently, irradiation predisposes to contracture, and colonization did not contribute to secondary implant contracture in this study population.

Intra-abdominal complications after surgical repair of small bowel injuries: an international review.

BACKGROUND: The ideal method of repairing serious small bowel injuries remains unknown. Prior reports suggest a higher rate of enteric anastomotic-related complications (EACs) with stapled posttraumatic bowel anastomosis but did not specifically focus on the small bowel or clarify fully the actual anastomotic construction. METHODS: This was a retrospective review of patients requiring surgical repair of small bowel perforations at a Level I urban American center (Detroit Receiving Hospital [DRH]) and a Canadian provincial trauma center (Vancouver Hospital and Health Sciences Center [VHHSC]). All patients requiring a primary repair and/or resection were included. Anastomoses were hand-sewn, stapled, or combined stapling and sewing with mucosal inversion. Leaks, anastomotic fistulae, and intra-abdominal abscesses were considered specific EACs. A sample size of 53 per group was obtained to detect a 17% difference at alpha = 0.05 (one-sided) and beta = 0.2. RESULTS: Full-thickness small bowel injuries were repaired in 232 patients (DRH, 165; VHHSC, 67). Injuries were penetrating at DRH (91.5%) and blunt at VHHSC (65.7%). Anastomotic repairs in 127 patients (158 anastomotic repairs [DRH, 113; VHHSC, 55]) were 64 (40.5%) stapled, 38 (24.1%) hand-sewn, and 56 (35.4%) combined. Also, 105 patients had 349 primary closures of an injury. Overall, there were 24 EACs. After anastomosis, there were 11 intra-abdominal abscesses: 6 after stapling, 3 after being sewn, and 2 after a combined construction. There were four small bowel anastomotic fistulae: three after stapled-only anastomosis and one after hand-sewing. After enteroenterostomy, the EAC rate was 10.2% per patient, or 8.4% per anastomosis. After primary repairs, one patient had an anastomotic fistula, which closed spontaneously, and 11 had intra-abdominal abscesses, yielding an EAC rate of 10.6% per patient or 3.4% per repair. A primary repair was significantly less likely to be associated with an EAC than any anastomosis (p = 0.035). No method of anastomosis was statistically safer in relation to EACs, whether analyzed by patient, by anastomosis, or by considering primarily either the use of a linear stapler or the principle of inverting the mucosal approximation. Only damage control procedures and associated pancreaticoduodenal injuries were identified as statistically significant predictors using multiple logistic regression analysis. CONCLUSION: Anastomotic complications after enteroenterostomy or primary repair for trauma are uncommon regardless of the technique, but surgeons must be especially cautious during or after damage control. Primary repairs are desirable, but when anastomosis is unavoidable, the method of repair should reflect that with which the surgeon is the most comfortable.

Performance of the Carpentier-Edwards SAV and Hancock-II porcine bioprostheses in aortic valve replacement.

BACKGROUND AND AIMS OF THE STUDY: Extended experiences of the Carpentier-Edwards Supra-Annular Valve (CE-SAV) and the Hancock II (H II) porcine bioprostheses were evaluated to determine the freedom from structural valve deterioration (SVD) by reoperation in the aortic position. METHODS: Between 1981 and 1994, 1,524 procedures (mean patient age 67.6+/-11.2 years) with the CE-SAV, and 670 procedures (mean patient age 65.2+/-12.1 years) with the H II were conducted at the University of British Columbia and University of Toronto, respectively. The patient populations were differentiated by mean age, gender and valve size, but not by concomitant coronary artery bypass. The analyses included actuarial and actual freedom from SVD and evaluation of predictors of SVD. RESULTS: Actuarial freedom from SVD at 15 years for patients aged > or =65 years was 91.5+/-2.9% for CE-SAV, and 100% for H II (p = NS), while the actual freedom was 96.4+/-1.0% and 100%, respectively. For the patient population aged 66-70 years, the actuarial freedom from SVD was 87.0+/-6.0% for CE-SAV and 100% for H II (p = NS), while the actual rates were 93.6+/-2.3% and 100%, respectively. For the population aged >70 years, the actuarial freedom from SVD was 96.9+/-1.5% for CE-SAV, and 100% for H II (p = NS), while the actual freedom was 98.8+/-0.5% and 100%, respectively. In the patient population aged <65 years, the actuarial freedom from SVD at 15 years favored the H II (p = 0.04), and the actual freedom showed the same outcome. The valve type was not predictive of SVD for age groups < or =60 years, >60 years, 61-70 years and >70 years, but was predictive for the overall population (p = 0.03), as was age and previous valve replacement. CONCLUSION: The CE-SAV and Hancock II both provide satisfactory clinical performances, with a low incidence of SVD, and no significant difference in SVD was shown in patients aged > or =65, 66-70, or >70 years. There is a trend to less SVD by actual analysis for the Hancock II in patients aged <65 years. This evaluation must be considered as work-in-progress because of the limited number of patients at risk at 15 years, especially with the Hancock II prosthesis.