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PubMed2006

[Surgical treatment of aortic valve disease with stentless bovine pericardium prosthesis: immediate results].

OBJECTIVE: To present the immediate results and assess the clinical and hemodynamic performance of stentless bovine pericardial bioprostheses in aortic position. METHODS: Twenty patients were operated who were indicated for surgery for valve replacement with biological prosthesis. Eleven patients were male; sixteen had aortic stenosis; four, insufficiency; the mean age was 66.3 +/- 8.8 years. The surgical technique used was subcoronary implant. Associated procedures were performed in five patients. Postoperative morbidity, mortality and hemodynamic performance were assessed on transthoracic echocardiogram. RESULTS: Mean time of cardiopulmonary bypass was 136.5 +/- 24.41 minutes and mean anoxic time was 105.2 +/- 21.62 minutes. Hospital mortality was 5% (one patient). Mean time of intensive care unit stay was 3.65 +/- 3.23 days. Mean postoperatively transvalvular gradient was was 25.39 +/- 7.82 mmHg. Left ventricle ejection fraction was 67 +/- 13.49% preoperatively and 63.24 +/- 16.06% postoperatively (p = 0.45). Eleven patients did not present any degree of valve regurgitation, eight presented mild regurgitation and one ,mild to moderate regurgitation. CONCLUSION: Stentless prostheses can be used for the surgical treatment of aortic valve diseases, with in hospital mortality and morbidity similar to the mortality and morbidity described in the literature for similar procedures, with satisfactory hemodynamic performance.

Adult↗

PubMed1998

Enlargement of the aortic annulus with glutaraldehyde-fixed bovine pericardium during aortic valve replacement.

BACKGROUND AND AIMS OF THE STUDY: Aortic valve replacement in patients with a small aortic annulus may represent a surgical challenge. We have evaluated a simplified technique to enlarge the aortic annulus which consists of extending the aortotomy incision to divide the commissure between the left and non-coronary cusps into the interleaflet triangle without opening the left atrium. METHODS: This technique was used in 16 patients (15 women, one man; mean age 66 +/- 9 years) who underwent aortic valve replacement between August 1994 and February 1996. Aortic stenosis was the predominant valvular lesion. A mechanical prosthesis was implanted in 13 patients (81%) (21 mm in six, 23 mm in seven) while three received a bioprosthesis (21 mm in one, 23 mm in two). In all patients it was possible to insert a prosthesis at least one size larger than the original aortic annulus diameter. RESULTS: There were no operative deaths and no late deaths. Mean follow up was 20 +/- 6 months (range: 12 to 30 months). Echocardiographic controls at 12 months postoperatively showed no evidence of periprosthetic leaks or mitral regurgitation. Comparison with preoperative data showed no significant variations of mean aortic diameter at the sinus level (30.7 +/- 2.2 mm versus 31.3 +/- 2.6 mm) or at the sinotubular junction (33.6 +/- 2.7 mm versus 34.3 +/- 2.9 mm) (p = NS). Significant reduction of left ventricular mass was observed (314 +/- 57 g versus 260 +/- 45 g; p < 0.001). CONCLUSIONS: This technique is simple, reproducible and effective in allowing adequate enlargement of the aortic annulus and provides excellent clinical and hemodynamic results. Glutaraldehyde-fixed bovine pericardium used as a patch material showed no tendency to aneurysmal dilatation with progression of time at a maximum follow up of 30 months.

Aged↗

PubMed2000

Early and long-term (one-year) effects of the association of aspirin and oral anticoagulant on thrombi and morbidity after replacement of the mitral valve with the St. Jude medical prosthesis: a clinical and transesophageal echocardiographic study.

OBJECTIVES: The aim of the study was to test the value of low dose aspirin associated with standard oral anticoagulants (OAC) after mechanical mitral valve replacement (MMRV) to reduce strands, thrombi and thromboembolic events. BACKGROUND: Strands and thrombi are thought to increase the risk of embolic events after MMVR, particularly in the immediate postoperative period. METHODS: Two hundred twenty-nine patients were prospectively recruited: 109 patients (group A+) were randomly assigned to aspirin (200 mg per day) with OAC and 120 patients (group A-) to OAC alone (international normalized ratio 2.5 to 3.5). All patients were subjected to multiplane transesophageal echocardiography at nine days and five months and were followed up for one year. RESULTS: At nine days and five months, there was a high and comparable incidence of strands in the two groups (group A+: 44%, 58%; group A-: 49%, 63%). However, the incidence of nonobstructive periprosthetic valve thrombi was significantly lower in group A+ at 9 days: 5% versus 13%, p = 0.03. Total thromboembolic events were reduced in group A+ (9% vs. 25%, p = 0.004) although there was an increased incidence of gastrointestinal hemorrhage (7% vs. 0%). Overall mortality was 9% in group A+ and 4% in group A-. Valve-related events were similar in both groups. Early thrombi, but not strands, were associated with higher morbidity, especially thromboembolic events (30% vs. 13%, p = 0.003). CONCLUSIONS: One year after MMVR, the association of aspirin with OAC reduced thrombi and thromboembolic events, but not morbidity, due to an increase in hemorrhagic complications.

Administration, Oral↗

PubMed2001

Influence of technique of coronary artery implantation on long-term results in composite aortic root replacement.

BACKGROUND: Long-term results after composite graft aortic root replacement may depend on the insertion technique. The aim of this study is to assess the influence of the technique of coronary artery implantation on long-term results in composite aortic root replacement. METHODS: One hundred fifty consecutive patients (mean age, 55 years; 119 men) with different disorders of the ascending aorta who underwent aortic root replacement with a composite graft prosthesis between January 1985 and December 1999 were retrospectively studied. Thirteen patients had previously undergone cardiovascular surgery. The open button technique was performed in 65 patients (43.3%, group 1) and the inclusion technique in 85 patients (56.7%, group 2). Mean follow-up was 70.5 months. Surgery was elective in 110 procedures (73%). RESULTS: Global actuarial survival was 76.1% +/- 4.3% for group 1 and 73.7% +/- 3.9% for group 2 at 10 years (p = 0.22). Freedom from reoperation excluding early deaths was 81% +/- 3% for group 1 and 86% +/- 2.2% for group 2 at 10 years (p = 0.62). Group 2 demonstrated a statistically significantly higher occurrence of pseudoaneurysm formation versus group 1 (p = 0.04). CONCLUSIONS: Composite graft aortic root replacement is a safe and effective therapy for proximal aortic aneurysm and dissection, resulting in good early and long-term results irrespective of the anastomotic technique. However, the open button technique seems to avoid late false aneurysm formation at the anastomotic sites.

Adolescent↗

PubMedDate not supplied

Aortic valve replacement with the St. Jude Medical prosthesis and fixed dose anticoagulation.

Over a 10-year period, between 1986 and 1996, 865 patients underwent primary aortic valve replacement (AVR) with the St. Jude Medical mechanical prosthesis. Patients who had undergone valve replacement with a different type of prosthesis previously were excluded from this study. Patient age ranged from 11 to 79 years. The mean age was 42.9 +/- 14.54. The gender distribution was 396 men (45.8%) and 469 women (54.2%). All patients received 2.5 mg/day Coumadin after extubation. A combination of the antiaggregant therapy (Dypridamole 3X 75 mg/day, Asprine 100 mg/day) was added after removal of the chest tubes. The dosage of Coumadin was maintained constant regardless of the prothrombin time (PT) or cardiac rhythm. There were 101 valve-related complications (4.2% per patient year [ppy]) occurring in the late follow-up period. Of these complications; 38 were anticoagulant-related hemorrhage (1.58% ppy), 3 were paravalvular leak (0.12% ppy), and 36 were thromboembolism (1.4% ppy). There were 24 reoperations (0.99% ppy) and 17 late deaths. The linearized late mortality rate was 0.7% ppy. Long-term survival estimates at 5 and 10 years were 97.14 +/- 0.82% and 94.86 +/- 1.54%, respectively. We conclude from the data that the St. Jude Medical valve may allow the use of a low level of anticoagulation. This study shows that fixed dose oral anticoagulation does not increase the rate of thromboembolism in patients with the St. Jude aortic valve. This protocol does not result in reduction of bleeding complications, however.

Adolescent↗

PubMed2001

Silzone coating and paravalvular leak: an independent, randomized study.

BACKGROUND AND AIM OF THE STUDY: The study aim was to address independently, in a randomized patient cohort, the impact of Silzone coating on the prevalence and impact of paravalvular leak in patients undergoing mechanical valve replacement. METHODS: Randomized implantation of the uncoated St. Jude Medical Masters, and the Silzone-coated prosthesis was performed in 95 patients, excluding those with suspected or diagnosed infective endocarditis. The company did not support the study; this cohort is not contained in the AVERT trial. Following recall of the Silzone-coated valves, all patients in this cohort were invited to undergo control transthoracic echocardiography and plasma LDH determination. RESULTS: Silzone-coated valves were implanted in 46 patients (57 valves; 34 aortic, 20 mitral, three tricuspid), and uncoated valves in 49 patients (55 valves; 38 aortic, 16 mitral, one tricuspid). One patient with an uncoated mitral valve died from left ventricular dissection. In total, 73 patients returned for specifically planned echocardiography (mean interval 478+/-78 days). Sixteen patients underwent echocardiography on another occasion (mean interval 113+/-202 days). Six hospital survivors did not undergo any postoperative echocardiography. In total, 51 Silzone-coated valves (31 aortic, 18 mitral, two tricuspid), and 53 uncoated valves (37 aortic, 15 mitral, one tricuspid) were evaluated. No patients were reoperated for intrinsic or extrinsic valve dysfunction. No major paravalvular leaks were seen. Five of 51 Silzone-coated valves showed minimal (grade <1+; four aortic, one mitral) paravalvular leak when specifically sought; two showed minimal (grade <1+; one aortic, one mitral), and one slight (grade 1+; one mitral) paravalvular leak in the uncoated group (p = 0.55). The LDH level was 654+/-163 U/I in the Silzone group, and 598+/-124 U/l in the control group (p = 0.10). CONCLUSION: No differences were detected in the incidence of paravalvular leak between Silzone-coated and uncoated mechanical St. Jude Medical valves. The incidence of major paravalvular leaks appears to be lower in the present cohort than was reported in the AVERT trial.

Aged↗

PubMed2005

A novel approach to tricuspid valve replacement: the upside down stentless aortic bioprosthesis.

BACKGROUND: Tricuspid valve replacement (TVR) is a rarely needed operation. Choices between mechanical and biological prosthesis still generate controversy. We present our initial clinical experience with a stentless aortic root placed inverted in the tricuspid annulus. METHODS: Between August 2000 and September 2003, TVR for severe tricuspid insufficiency was performed in 8 patients. Indications were infective endocarditis (7) and iatrogenic damage (1). Mean age was 42.2 years old (20 to 58 years old). Five patients were male and 3 patients had a concomitant procedure (mitral valvuloplasty, coronary bypass grafting, and aortic valve replacement). A stentless aortic root, size 27 mm (n = 5) or 29 mm (n = 3) was placed inverted in the tricuspid position after the valsalva sinuses were scalloped. Interrupted 4-0 polypropylene sutures were used between the tricuspid valve annulus and the sewing ring. The struts equivalent on the stentless valve were anchored to the septal, anterior and posteroinferior wall of the right ventricle using 5-0 PTFE pledgeted sutures. RESULTS: Hospital survival was 100% and mean hospital stay was 12.5 days (3 to 18 days). Intraoperative and follow-up echocardiograms revealed no stenosis or insufficiency. Mean follow-up was 17.2 months (1-38 months). There were 3 late deaths due to continued IV drug use (n = 2) and end-stage renal failure (n = 1). CONCLUSIONS: This is a novel surgical alternative for a very high risk population. Potential advantages over current options include minimization of blood contact with nonbiological surfaces, preservation of annular motion, freedom from anticoagulation, and a theoretical lower rate of calcification.

Adult↗

PubMed2006

Long-term neurocognitive function after mechanical aortic valve replacement.

BACKGROUND: Mechanical aortic valves are a possible source of microemboli potentially causing cerebral injury. Therefore, the long-term impact of mechanical aortic valve replacement on neurocognitive function is uncertain. METHODS: In this prospective, contemporary study, we followed 32 consecutive patients (aged 51 +/- 8 years; range, 38 to 70; EuroSCORE [European System for Cardiac Operative Risk Evaluation] 4.4 +/- 1.7) undergoing isolated aortic valve replacement with a mechanical prosthesis. A cohort of age- and sex-matched patients (n = 28, aged 50 +/- 7 years) served as nonsurgical controls. After aortic valve replacement, neurocognitive function was serially reevaluated at 7-day (n = 32), 4-month (n = 31), and 3-year (n = 29) follow-up. Neurocognitive function was measured by means of P300 auditory evoked potentials. RESULTS: Before the operation, P300 peak latencies were comparable between surgical patients (361 +/- 32 ms) and nonsurgical controls (365 +/- 33 ms, p = 0.783). In patients undergoing aortic valve replacement, P300 peak latencies were prolonged 7 days after surgery (380 +/- 32 ms) as compared with before the operation (361 +/- 32 ms, p < 0.0001) and as compared with nonsurgical controls (364 +/- 34 ms, p = 0.002). At 4-month (369 +/- 30 ms, p = 0.752) and 3-year (370 +/- 31 ms, p = 0.825) follow-up, P300 peak latencies normalized as compared with before operation and as compared with nonsurgical controls (4-month follow-up 363 +/- 31 ms, p = 0.832; 3-year follow-up 366 +/- 32 ms, p = 0.432). We found no difference in patients with different valve types. CONCLUSIONS: Despite previous assumptions based on the potential occurrence of microemboli in patients with mechanical valves, mechanical aortic valve replacement has no adverse long-term impact on neurocognitive function. This finding is only valid for patients with a comparable age range undergoing isolated aortic valve replacement.

Adult↗

PubMed2000

Long-term follow-up of morbidity and mortality after aortic valve replacement with a mechanical valve prosthesis.

AIMS: The aim of this study was to determine the incidence of valve-related complications in patients with a mechanical aortic valve prosthesis and to identify risk factors for an adverse outcome. METHODS AND RESULTS: In the 424 patients, event-free survival rates 5 and 10 years after aortic valve replacement were 62% and 37%, respectively. The linearized incidence of thromboembolic events was 4.4% per patient-year, and of anticoagulant-related haemorrhage 8.5% per patient-year. Advanced NYHA functional class, atrial fibrillation, pure aortic regurgitation and thromboembolism prior to surgery decreased event-free survival. A history of pre-operative thromboembolism increased the risk for a first embolic event after aortic valve replacement (relative hazard [RH] 3.2), but was even more strongly associated with the risk for repeated events (> or =2 events, RH 5.4). After each thromboembolic episode that occurred, the risk for a subsequent one was increased. The risk for at least one, and up to three or more haemorrhages was increased in patients with a pre-operative history of bleeding (RH 3.3-5.1) and of atrial fibrillation (RH 1.8-3.9). The risk for a subsequent event was increased by a history of repeated haemorrhages, a short interval since previous bleeding, and high age. CONCLUSIONS: There were few factors strongly related to valve related morbidity. However, previous bleedings and previous thromboembolism were powerful risk factors for repeated events.

Adolescent↗

PubMed1999

Aortic valve replacement with the freestyle stentless bioprosthesis: five-year experience.

BACKGROUND: Stentless aortic valves were designed to provide a more physiological flow pattern and lower transvalvular gradient, which may have an important bearing on postoperative left ventricular function and remodeling. In this study, we prospectively analyzed the 5-year clinical results with the Freestyle valve (Medtronic, Inc) and its hemodynamic performance by serial echocardiography. METHODS AND RESULTS: Between January 1993 and August 1997, 95 patients with a mean age of 75 years underwent aortic valve replacement with the Freestyle prosthesis. Sixty-four percent of patients received valves </=23 mm, and 37% had concomitant coronary artery bypass grafting. Average follow-up was 44+/-18 months (mean+/-SD), and echocardiography was performed preoperatively, at discharge, at 3 to 6 months, and annually thereafter. The 30-day operative mortality rate was 3%, with an overall actuarial survival rate of 80+/-6% (mean+/-SEM) at 5 years. Of the 10 late deaths, only 2 were cardiac related, thereby yielding a freedom from cardiac mortality of 94+/-3% after 5 years. No patient required reoperation on the aortic valve for any reason, including structural degeneration, nonstructural dysfunction, or prosthetic valve endocarditis. There were 9 thromboembolic and 3 anticoagulant-related bleeding events, none of which was fatal. The actuarial freedom from valve-related morbidity and mortality was 79+/-4% at 5 years. Hemodynamically, the mean transvalvular gradient significantly decreased after valve replacement and was reduced further by 41% by 6 months with a corresponding increase in effective orifice area. Left ventricular mass index fell to 75% of the preoperative value by 2 years. CONCLUSIONS: The Freestyle stentless valve can be implanted safely in the elderly with excellent midterm clinical results. It has superb hemodynamics in terms of residual transvalvular gradient, effective orifice area, and regression of left ventricular hypertrophy.

Aged↗

PubMed2003

[Valvular replacement with the Bicarbon mechanical valve. Results after 7 years in 104 patients].

OBJECTIVE: Study of the medium term results of aortic and mitral valve replacement with the Bicarbon' prosthesis. METHOD: From 1990 to 1996, 109 valves were implanted (70 in aortic position, 31 in mitral position and 4 double replacements). The average age was 61 years and 75% were male. According to the NYHA, 59% of patients were stage III or IV. The average pre-operative ejection fraction was 59.6%. There was re-intervention in 21.1% of patients and 35.3% had an associated procedure during the intervention. RESULTS: The average follow up was 5.4 +/- 1.98 years in 98 patients (that is 522 patient years). One patient died post-operatively and 19 died later. The overall survival at 7 years was 69.4 +/- 6.3%. Complications, expressed in patient years, were 1.15% for thrombo-embolic complications, 2.1% for haemorrhagic complications. 0.38% for endocarditis, 1.72% for non-infectious peri-prosthetic leaks, and 0.76% for re-interventions. At 7 years, the absence of thrombo-embolic, haemorrhagic, endocarditis, and re-intervention complications was 91.8 +/- 4.2%, 85.3 +/- 4.8%, 95.8 +/- 3.2%, 93.8 +/- 3.5% respectively. According to the NYHA, 95% of patients were in stage 1 or II (p < 0.001). CONCLUSION: Valvular replacement in the aortic or mitral position with the Bicarbon' valve is satisfactory as much in terms of survival as of clinical complications.

Aortic Valve↗

PubMed1998

Mechanical versus biological isolated aortic valvular replacement after the age of 70: equivalent long-term results.

OBJECTIVE: In order to evaluate the long-term outcome of valvular substitutes in the elderly, we retrospectively analyzed two comparative groups of patients consecutively operated on by the same team for an isolated valvular aortic replacement using either a mechanical or a pericardial prosthesis. METHODS: From 1982 to 1996, 206 patients over 70 years (mean 76.5+/-4.4) underwent an isolated aortic valvular replacement using either a St. Jude Medical (Group I, n = 93) or a Mitroflow (Group II, n= 113) prosthesis depending on the surgeon's preference at the time of surgery. Both groups matched for the following pre-operative variables: sex ratio, type of aortic valve disease, NYHA status, cardiac rhythm, mean pulmonary arterial pressure, left ventricular end-diastolic pressure, LV-AO gradient, cardiac index and ejection fraction. RESULTS: Given an early mortality rate of 6.4% in Group I and 4.4% in Group II (NS), follow-up (mean 4.4+/-3.7 years in Group I and 5.3+/-3.1 years in Group II) was 100% complete. Actuarial survival was 69.9+/-6 and 70.2+/-4.6% at 5 years for Group I and Group II, respectively, and 49.6+/-7.7 vs. 51.4+/-6.3% at 10 years (NS). Freedom from valve-related death was 86.5+/-4.8% in Group I vs. 82.7+/-4% in Group II at 5 years (NS) and 66.7+/-8.7 vs. 66.3+/-7% at 10 years (NS). There were no anticoagulant-related deaths or severe accidents in Group 1. A secondary valvular replacement was necessary in 4 patients in Group II vs. none in Group I. CONCLUSION: The study shows a similar late survival in both groups, with a strikingly low incidence of anticoagulant-related deaths in this population. Given a higher rate of reoperation after biological valve replacement, the use of mechanical valve in this aging population seems to be a valid option.

Aged↗

PubMed2006

Mechanical versus bioprosthetic valve replacement in middle-aged patients.

OBJECTIVE: The current trend towards decreasing the age for selection of a tissue over a mechanical prosthesis has led to a dilemma for patients aged 50-65 years. This cohort study examines the long-term outcomes of mechanical versus bioprosthetic valves in middle-aged patients. METHODS: Patients (N = 659) aged between 50 and 65 years who had first-time aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed prospectively after surgery. The total follow-up was 3,402 patient-years (mean 5.1 +/- 4.1 years; maximum 18.3 years). Outcomes were examined with multivariate actuarial methods. A composite outcome of major adverse prosthesis-related events (MAPE) was defined as the occurrence of reoperation, endocarditis, major bleeding, or thromboembolism. RESULTS: Ten-year survival was 73.2 +/- 4.2% after mechanical AVR, 75.1 +/- 12.6% after bioprosthetic AVR, 74.1 +/- 4.6% after mechanical MVR, and 77.9 +/- 7.4% after bioprosthetic MVR (P=NS). Ten-year reoperation rates were 35.4% and 21.3% with aortic and mitral bioprostheses, respectively. Major bleeding occurred more often following mechanical MVR (hazard ratio [HR]: 3.3; 95% confidence interval [CI] 1.2, 9.0; P = 0.022), and the incidence of any thromboembolic event was more common after mechanical MVR (HR: 4.7; CI 1.4, 13.3; P = 0.01). Overall freedom from MAPE at 10 years was 70.2 +/- 4.1% for mechanical AVR patients, 41.0+/-30.3% for bioprosthetic AVR patients, 53.3 +/- 8.8% for mechanical MVR patients, and 61.2 +/- 9.2% for bioprosthetic MVR patients. Although a trend existed towards more MAPE amongst middle-age patients with tissue valves, multivariate analysis did not identify the presence of a bioprosthesis as an independent risk factor for MAPE (HR: 1.3; CI 0.9, 2.0; P = 0.22). CONCLUSIONS: In middle-aged patients, MAPE may occur more often in patients with bioprosthetic valves, but definitive conclusions necessitate the accumulation of additional follow-up. At present, these data do not support lowering the usual cutoff for implantation of a tissue valve below the age of 65.

Aged↗

PubMed1998

Medtronic intact porcine bioprosthesis: 10 years' experience.

BACKGROUND: The Medtronic Intact porcine bioprosthesis experience was evaluated over a period of 10 years to determine the influence of structural valve deterioration by valve position in various age groupings. METHODS: From 1986 to 1996 inclusive, at three centers, 1,272 patients had the prosthesis implanted in 1,296 procedures. The mean age of the population was 67 years (range, 9 to 91 years). There were 836 aortic valve replacements (AVR) (64.5%), 333 mitral valve replacements (MVR) (25.7%), and 110 multiple valve replacements (MR) (8.5%). RESULTS: The early mortality was 7.3% (94 of 1,296 procedures). The early mortality with concomitant procedures (primarily coronary artery bypass grafting) was 9.8% (52 of 528) and without, 5.5% (42 of 768). The late mortality was 4.25%/patient-year. The linearized rate of major thromboembolism was 0.86%/patient-year. The rate of reoperation was 1.19%/patient-year and valve-related mortality, 1.06%/patient-year. There were 36 cases of structural valve deterioration for aortic valve replacement (16), mitral valve replacement (15), tricuspid valve replacement (2), and multiple valve replacement (3). The freedom from structural valve deterioration for aortic valve replacement was in patients 21 to 40 years, 62.5%+/-25.8% at 7 years; 41 to 50 years, 75.0%+/-15.3% at 7 years; 51 to 60 years, 91.0%+/-4.5% at 8 years; 61 to 70 years, 98.7%+/-0.7% at 10 years; and older than 70 years, 98.3%+/-1.0% at 10 years (p < 0.05). The freedom from structural valve deterioration for mitral valve replacement was for patients 41 to 50 years, 91.7%+/-8.0% at 7 years; 51 to 60 years, 85.9%+/-9.9% at 8 years; 61 to 70 years, 86.3%+/-6.8% at 8 years; and older than 70 years, 93.9%+/-4.8% at 8 years (not significant). CONCLUSIONS: The Medtronic Intact porcine bioprosthesis has acceptable freedom from structural valve deterioration in both the aortic and mitral positions approaching 10 years of evaluation.

Actuarial Analysis↗

PubMedDate not supplied

A six-year experience with the omnicarbon valve in North American patients.

AIM: We studied the results of an all-carbon monoleaflet valve prosthesis (the Omnicarbon) in a North American population. METHODS: Patients were recalled to our valve clinic for complete evaluation, including echocardiography, laboratory tests, and physician examination. This experience includes 108 Omnicarbon valve implants. We report the results of single aortic (AVR) or mitral (MVR) valve replacement. RESULTS: Patients' ages ranged from 40 to 83 (mean: 63 +/- 9 years), and most were male (60%, 59/98). Preoperatively, 71% were NYHA Classes III/IV, while most patients are now Classes I/II (86%). AVR predominated (63%, 62/98), and many patients (44%, 43/98) underwent cardiac procedures either previously or concomitant with valve replacement. Hospital mortality was 6.1% (6/98). Predicted hospital mortality using the Parsonnet additive risk model averaged 12.1%. Currently, four patients cannot be located (96% accountability). Overall, hematology indicated low hemolysis-lactate dehydrogenase: 691 +/- 184 IU/L (112%+/- 30% upper normal), reticulocytes: 1.8%+/- 0.7%, and red blood cells (10(6)/mm(3)): 4.41 +/- 0.50 (males)/4.16 +/- 0.50 (females). International normalized ratio averaged 2.67 +/- 0.72. Doppler echocardiography values were acceptable and comparable to other mechanical valves. Five-year survival (hospital death included) is 86%+/- 4%. At 5 years, freedom from any thromboembolic event is 99%+/- 1%, and freedom from bleeding is 97%+/- 2%. Endocarditis and nonstructural dysfuction also occurred at low rates (99%+/- 1% freedom at five years), and no structural failure or hemolytic anemia was observed during the 343 patient-years (mean: 3.7 +/- 1.6 years). CONCLUSIONS: Good hematology and hemodynamics, along with remarkably low complication rates, demonstrate that the Omnicarbon valve meets contemporary performance expectations.

Adult↗

PubMed1999

Mid-term comparative follow-up after aortic valve replacement with Carpentier-Edwards and Pericarbon pericardial prostheses.

BACKGROUND: The first generation of pericardial valves had a high rate of premature deterioration. The aim of this study was to compare the outcome after aortic valve replacement with second generation pericardial prostheses (Pericarbon and Carpentier-Edwards). METHODS AND RESULTS: Between 1987 and 1994, 162 patients underwent aortic valve replacement with either a Pericarbon (n=81, 69+/-11 years) or a Carpentier-Edwards (n=81, 70+/-11 years) pericardial prosthesis. Mean follow-up was 4.4+/-2.7 years for Pericarbon and 4.8+/-2.4 years for Carpentier-Edwards valves (P=0. 27), giving a total follow-up of 745 patient-years. Thirty-day mortality and 5-year actuarial survival were, respectively, 6.2% and 63.2+/-5.7% in the Pericarbon group and 6.2% and 63.5+/-5.6% in the Carpentier-Edwards group. At 8 years, freedom from (and linearized rates per patient-year) thromboembolism, structural failure, and all valve-related events were, respectively, 91.8+/-3.6% (1.4%), 76. 9+/-8.7% (2.5%), and 58.4+/-9.3% (5.6%) in the Pericarbon group and 94.4+/-2.7% (1%), 100% (0%, P<0.01), and 88.8+/-3.7% (2%, P<0.05) in the Carpentier-Edwards group. There were 9 (11.1%) Pericarbon structural failures related predominantly to severe calcification and stenosis. The actual reoperation rate was 7.4% (1.6% per patient-year) in the Pericarbon group for fibrocalcific degeneration (n=3), periprosthetic leak (n=1), endocarditis (n=1), and aortic dissection (n=1). There was neither structural valve failure nor valve reoperation in the Carpentier-Edwards group. Echocardiographic review of 70 patients from 85 survivors (82.3%) found 4 additional Pericarbon valves with signs of early structural failure but no Carpentier-Edwards valve with such changes. CONCLUSIONS: Eight years after aortic valve replacement, Pericarbon pericardial prostheses compared unfavorably with Carpentier-Edwards pericardial prostheses, with a high incidence of structural valve failure and reoperation.

Aged↗

PubMed2006

Prediction of valve prosthesis-patient mismatch prior to aortic valve replacement: which is the best method?

BACKGROUND: To predict the occurrence of valve prosthesis-patient mismatch (VP-PM) after aortic valve replacement (AVR), the surgeon needs to estimate the postoperative effective orifice area index (EOAI). AIM: To compare different methods of predicting VP-PM. METHODS: The effective orifice area (EOA) of 383 patients who had undergone AVR between July 2000 and January 2005 with various aortic valve prostheses was obtained echocardiographically 6 months after the operation. We tested the efficacy of (1) EOAI calculated from the echo data obtained in our own laboratory, (2) indexed geometric orifice area, (3) EOAI estimated from charts provided by prosthesis manufacturers (which are based either on in vitro or on echo data) and (4) EOAI estimated from reference echo data published in the literature to predict VP-PM. RESULTS: Sensitivity and specificity to predict VP-PM were 53% and 83% (method 1), 80% and 53% (charts based on echo data, parts of method 3) and 71% and 67% (method 4) using reference data derived from echocardiographic examinations. The sensitivity of method 2 and of charts based on in vitro data (parts of method 3) to predict VP-PM was 0-17%. The incidence of severe VP-PM could be reduced from 8.7% to 0.8% after the introduction of the systematic estimation of the EOAI at the time of operation (p = 0.003, method 1). CONCLUSIONS: The best method of predicting VP-PM is the use of mean (SD) EOAs derived from echocardiographic examinations, whereas the use of in vitro data or the geometric orifice area is unreliable. After the surgeon's anticipation of VP-PM prior to AVR, the incidence of VP-PM could be reduced.

Aged↗

PubMed1999

Experiences with the Toronto SPV bioprosthesis after three years follow-up.

BACKGROUND: Stentless aortic valve prostheses are considered to be hemodynamically superior to mounted bioprostheses. The Toronto SPV bioprosthesis is a Dacron covered stentless porcine aortic prosthesis. METHODS: From March 1993 to October 1997, 175 patients underwent aortic valve replacement with the Toronto SPV bioprosthesis, 126 patients with leading aortic stenosis, 14 with valve insufficiency, and combined lesion in 35 patients. Preoperatively all patients were in NYHA class III-IV. All patients underwent transesophageal echocardiography (TEE) intraoperatively after institution of cardiopulmonary bypass (CPB). The patients underwent clinical and echocardiographic examinations at 1 week, 6 months, 12 months, 24 months, and 36 months postoperatively. RESULTS: Mean age was 71.3 years (range 29-84). Additional coronary artery bypass grafting (CABG) was performed in 74 patients. Mean ischemic time was 58 minutes (range 49-129) for singular aortic valve replacement (AVR) and 86 minutes (range 66-136) with additional CABG. The 30-day mortality was low at 4% (7/175). 139 patients were seen at 2 years and 77 at 3 years follow-up. At 3 years 67% (51/77) of our patients were in NYHA functional class I and 33% (26/77) were in class II. Minimal aortic valve incompetence was seen in 17% (13/77) at 3 years. CONCLUSIONS: The Toronto SPV bioprosthesis shows good results both hemodynamically and clinically. Most patients are in NYHA functional class I or II after 3 years. Perioperative mortality was low and no valve-related complications occurred.

Adult↗