Durability of the Mitroflow Pericardial Prosthesis: Influence of Patient-Prosthesis Mismatch and New Anticalcification Treatment.

BACKGROUND: The Mitroflow pericardial bioprosthesis (MPB) has been recently associated with a high incidence of early structural failures, questioning its validity as cardiac valve substitute. We have therefore reviewed our experience with this device. MATERIALS AND METHODS: A total of 398 patients with a mean age of 75 ± 7 years (58% above the age of 75 years) had aortic valve replacement with a Mitroflow prosthesis (2005-2015). Most patients had calcific aortic stenosis (86%) and were in sinus rhythm (89%). Mean EuroSCORE II was 5.5 ± 6.2. Mean follow-up was 4 ± 2 years (range: 4 months to 10 years), which was 100% complete. RESULTS: Hospital mortality was 6.5%; at discharge, 25% of patients had a moderate patient-prosthesis mismatch and none had a severe mismatch. Cumulative incidence of structural valve deterioration in the entire series was 2% (95% confidence interval [CI]: 1-4) at 5 years and 7% (95% CI: 4-14) at 8 years. Significant factors influencing MPB durability were age ≤ 65 years (p < 0.001) and the presence of patient-prosthesis mismatch (p = 0.01). No cases of structural valve deterioration were observed in patients with the new prosthetic model incorporating an anticalcification treatment the first 4 years of follow-up. CONCLUSIONS: The Mitroflow prosthesis has shown satisfactory results in the first decade of use. Durability appears adversely influenced by patient age and patient-prosthesis mismatch. Thus, a careful valve size selection and implantation in patients >65 years of age appears to be associated with excellent valve durability in the aortic position. Whether the new anticalcification treatment will provide a more durable prosthesis must be verified at a longer follow-up.

Excellent Durability of the Mosaic Porcine Aortic Bioprosthesis at Extended Follow Up.

BACKGROUND: Biological prostheses are widely employed for aortic valve replacement (AVR). The study aim was to evaluate the performance of the Mosaic porcine bioprosthesis in the aortic position over two decades. METHODS: Between November 1995 and December 2016, a total of 254 patients (194 males, 60 females; mean age 74 ± 9 years) underwent AVR with a Mosaic bioprosthesis at the authors' institution. Among the patients, 14% were aged ≥80 years and 86% had pure or prevalent calcific aortic stenosis. Preoperatively, the mean NYHA functional class was 2.5 ± 1.0. RESULTS: Overall hospital mortality was 5%. A total of 107 late deaths occurred, but only 15 were valve-related (0.72 ± 0.19% per patient-year). Actuarial survival at 15 years was 34 ± 7%. Fourteen embolic episodes occurred, with no cases of bioprosthetic thrombosis; freedom from thromboemboli was 88 ± 4% at 15 years. Eight cases of endocarditis occurred, with a freedom of 95 ± 2% at 15 years. Structural valve deterioration (SVD) was observed in four patients, all of whom were successfully reoperated. Freedom from SVD was 97 ± 2% at 15 years and 96 ± 2% at 20 years. At the last follow up, 23 mm and 25 mm prostheses showed mean gradients of 17 ± 6 mmHg and 15 ± 4 mmHg, respectively. A significant reduction in left ventricular mass was noted in patients with aortic stenosis. CONCLUSIONS: The Mosaic bioprosthesis has shown excellent durability over two decades of clinical use, with a negligible incidence of valve degeneration and need for reoperation. Thus, it may be considered a valid option for AVR, especially in elderly patients.

Cell differentiation in cardiac myxomas: confocal microscopy and gene expression analysis after laser capture microdissection.

Cardiac myxomas are rare tumors with a heterogeneous cell population including properly neoplastic (lepidic), endothelial and smooth muscle cells. The assessment of neoplastic (lepidic) cell differentiation pattern is rather difficult using conventional light microscopy immunohistochemistry and/or whole tissue extracts for mRNA analyses. In a preliminary study, we investigated 20 formalin-fixed and paraffin-embedded cardiac myxomas by means of conventional immunohistochemistry; in 10/20 cases, cell differentiation was also analyzed by real-time RT-PCR after laser capture microdissection of the neoplastic cells, whereas calretinin and endothelial antigen CD31 immunoreactivity was localized in 4/10 cases by double immunofluorescence confocal microscopy. Gene expression analyses of α-smooth muscle actin, endothelial CD31 antigen, alpha-cardiac actin, matrix metalloprotease-2 (MMP2) and tissue inhibitor of matrix metalloprotease-1 (TIMP1) was performed on cDNA obtained from either microdissected neoplastic cells or whole tumor sections. We found very little or absent CD31 and α-Smooth Muscle Actin expression in the microdissected cells as compared to the whole tumors, whereas TIMP1 and MMP2 genes were highly expressed in both ones, greater levels being found in patients with embolic phenomena. α-Cardiac Actin was not detected. Confocal microscopy disclosed two different signals corresponding to calretinin-positive myxoma cells and to endothelial CD31-positive cells, respectively. In conclusion, the neoplastic (lepidic) cells showed a distinct gene expression pattern and no consistent overlapping with endothelial and smooth muscle cells or cardiac myocytes; the expression of TIMP1 and MMP2 might be related to clinical presentation; larger series studies using also systematic transcriptome analysis might be useful to confirm the present results.

The Modified Bentall Procedure: A Single-Institution Experience in 249 Patients with a Maximum Follow Up of 21.5 Years.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate the long-term clinical outcomes of the modified Bentall procedure (MBP) with a mechanical conduit. METHODS: Between 1993 and 2014, a total of 249 patients (mean age 62 ± 12 years; range: 25-87 years) underwent a MBP at the authors' institution. The main indication was annuloaortic ectasia in 102 patients (41%), followed by acute aortic dissection in 82 patients (33%); moderate to severe aortic regurgitation was present in 79% of cases. A bicuspid aortic valve was found in 17% of patients, and Marfan syndrome in 7%. The mean NYHA functional class was 2.5 ± 1.1. Concomitant procedures were performed in 36 patients (14%). The mean follow up was 8.7 ± 5.0 years (range: 0.3-21.5 years) and was 99% complete. The total follow up was 6.475 patient-years (pt-yr). RESULTS: Operative mortality was 3% in elective cases. Age, prolonged cardiopulmonary bypass times and mechanical ventilation >96 h were independent risk factors for early mortality. Actuarial survival at 15 and 20 years was 62% and 60%, respectively. Risk factors for late mortality were age and emergency operation. Actuarial freedom from thromboembolism (linearized incidence 0.93%/pt-yr) was 82% at 15 years, and 74% at 20 years. Seven patients required reoperation (0.38%/pt-yr), with an actuarial freedom from reoperation of 91% at 15 years and 87% at 20 years. The incidence of overall valve-related complications was 0.32%/pt-yr, with actuarial freedoms of 94% at 15 and 20 years. CONCLUSIONS: The MBP has shown excellent long-term results with a low incidence of procedure-related complications up to 20 years postoperatively. For this reason, it is considered to be a valid option for the treatment of aortic root disease, whenever valvesparing procedures are not indicated.

Management of Prosthetic Thrombosis During Pregnancy: Importance of a Multidisciplinary Approach.

A 40-year-old female of African origin presented in the 32nd week of her second pregnancy with thrombosis of a bileaflet mechanical prosthesis implanted in the mitral position. After an emergency cesarean section, she was successfully treated by means of a multidisciplinary approach.

Enlargement of the aortic annulus during aortic valve replacement: a review.

The main goal of aortic valve replacement (AVR) is to obtain relief from the fixed left ventricular (LV) obstruction by replacing the aortic valve with a prosthesis, either mechanical or biological, of adequate size. Most currently available prostheses provide satisfactory hemodynamic performance, but small-sized prostheses may be associated with high transvalvular gradients and suboptimal effective orifice area that result in prosthesis-patient mismatch (PPM), and thus are far from ideal for use in young, active patients. The avoidance of PPM is advisable as it has been repeatedly associated with increased mortality, decreased exercise tolerance and an impaired regression of LV hypertrophy after AVR for severe aortic stenosis. Enlargement of the aortic annulus (EAA) has proved to be a valuable method to prevent PPM in the presence of a diminutive aortic root. This review outlines the various techniques described for EAA, presenting technical details, long-term results and major procedure-related complications, and discussing the current role of EAA in patients requiring AVR.

Recurrent mitral regurgitation due to ruptured artificial chordae: case report and review of the literature.

The use of expanded polytetrafluoroethylene (ePTFE) sutures has become an established method to correct mitral regurgitation due to elongated or ruptured mitral chordae. Mitral valve repair using artificial chordae has demonstrated excellent long-term results, particularly as ePTFE retains its flexibility with time and is highly resistant to mechanical stress. On conducting a literature review, four cases were found of recurrent mitral regurgitation due to the late (6-14 years postoperatively) rupture of ePTFE chordae. Herein, the case is described of artificial chordal rupture that required reoperation at 11 years after the initial mitral valve repair. In all previously reported cases, chordal rupture was related to the calcification of ePTFE, whereas in the present case only minimal calcification was observed at histology, and chordal rupture was most likely due to ePTFE fatigue-induced lesion. Although rare, rupture of the artificial chordae may cause recurrent mitral regurgitation; hence, the continuous monitoring of these patients, especially when the follow up extends beyond 10 years, appears mandatory.

Reduction in platelet count after aortic valve replacement: comparison of three bioprostheses.

BACKGROUND AND AIM OF THE STUDY: Concerns have recently been raised regarding postoperative decreases in platelet count (PC) after aortic valve replacement (AVR) with the Sorin Freedom Solo (SFS) stentless bioprosthesis. In order to assess the relevance and the clinical impact of this phenomenon, variations in PC were monitored in patients with SFS valves, and compared to changes of PC in patients after AVR with two other bioprostheses, the Medtronic Mosaic (MOS) porcine valve and the Sorin Mitroflow (MIT) pericardial valve. METHODS: Three groups of patients (25 in each group) who had undergone AVR with a biological prosthesis were compared. The patients were similar in terms of their preoperative characteristics, including mean age, NYHA functional class, risk factors, EuroSCORE, and mean PC. The PC was monitored on postoperative days 1, 3, and 5, and again at discharge. Thrombocytopenia was considered to be 'present' when the PC was < 150,000/microl, and 'severe' when the PC was < 30,000/microl. RESULTS: No significant inter-group differences were observed in the duration of extracorporeal circulation or cross-clamp times. The mean postoperative PCs for MOS valves were 154,000 +/- 56,000/microl, 154,000 +/- 54,000/microl, 161,000 +/- 85,000/microl, and 228,000 +/- 95,000/microl at days 1,3, and 5, and at discharge, respectively. For MIT valves, these values were 126,000 +/- 37,000/microl, 113,000 +/- 38,000/microl, 130,000 +/- 46,000/microl, and 170,000 +/- 50,000/microl, respectively. For SFS valves, the values were 99,000 +/- 27,000/microl, 67,000 +/- 9000/microl, 78,000 +/- 54,000/microl, and 96,000 +/- 32,000/microl, respectively. Severe thrombocytopenia was never observed in any patient. A significant decrease in PC occurred with SFS when compared to MOS valves (on days 1, 3, 5, and at discharge, p < 0.001) and to MIT valves (on days 3, 5, and at discharge, p < 0.005). Multivariate analysis showed older age (p = 0.001) and the SFS valve (p = 0.0002) to be incremental risk factors for developing severe or moderate thrombocytopenia after AVR. CONCLUSION: A reduction in PC occurred with all bioprostheses on postoperative day 1, while a significant reduction in PC was continued for SFS valves on postoperative days 3 and 5, when compared to MOS and MIT valves. A normalization of PC at discharge was observed only with MOS valves. Thrombocytopenia after AVR with biological prostheses was not associated with any major postoperative complication.

Surgical revascularization for stable coronary syndrome: the ISCHEMIA trial versus a single-centre matched population-a real-world analysis of patients undergoing surgical revascularization.

OBJECTIVES: The aim of this study was to test if the current general practice of surgical revascularization is comparable to the setting of International Study of Comparative Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate the comparative risk of cardiovascular events or death after coronary artery bypass grafting. METHODS: We selected patients undergoing surgical revascularization and matching ISCHEMIA inclusion criteria. Chronic coronary syndrome patients were included if diagnosis of myocardial ischaemia by functional testing and coronary artery disease at angiography were detected. The primary end point was a composite of cardiovascular death, myocardial infarction, rehospitalization for unstable angina, heart failure and resuscitated cardiac arrest. Secondary end points were death by any cause, cardiovascular death, myocardial infarction and rehospitalization. RESULTS: Among 353 patients, the primary outcome occurred in 62 (17.6%) patients. At 6 months, cumulative event-free survival was 97%, at 1 year 96%, at 5 years 89% and at 10 years 80%. Cumulative risk of the primary composite outcome at 5 years was 11%, 18% in the conservative arm of ISCHEMIA and 16% in the revascularization arm of ISCHEMIA (P < 0.001). Risk of myocardial infarction at 5 years was 7% in surgical patients and 12% and 10% in the conservative and invasive arms of the trial, respectively (P < 0.001). CONCLUSIONS: Long-term results in surgical patients treated for chronic coronary syndromes showed that ISCHEMIA trial findings are not transferable in a 'real-world' scenario and have not changed previous medical practice. A patient-tailored approach, especially with diabetes and reduced left ventricle function, offers the best results in patients with stable coronary artery disease.

Unusual complication after aortic valve replacement with the Freedom Solo stentless bioprosthesis.

The case is presented of an unusual complication after aortic valve replacement with a Freedom Solo bioprosthesis. Excision of the aortic valve created a discontinuity of the aortic annulus that was missed intraoperatively and left uncorrected after supra-annular placement of the bioprosthesis; this created a pseudoaneurysm with direct communication to the pericardial cavity. When implanting the Freedom Solo bioprosthesis, care must be taken to exclude the presence of any aortic annular discontinuity. Implantation of the Freedom Solo bioprosthesis is not precluded by this possible complication, provided that any annular disruption is promptly recognized and adequately closed before placement of the supra-annular sutures.

Mitral Valve Replacement With a Third-Generation Porcine Valve: An Italian Multicentered Study.

BACKGROUND: Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis. METHODS: From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 ± 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%). RESULTS: Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patient-years. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3% (95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structural valve degeneration and reoperations were 5.8% (95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively. CONCLUSIONS: This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis for MVR provides satisfactory results in terms of both early and long-term outcomes up to 14 years from its implantation.

Repair of a giant left ventricular pseudoaneurysm with rupture of the interventricular septum.

Presence of two combined mechanical complications of acute myocardial infarction is extremely rare and still associated with a high-operative mortality. We describe a 73-year-old male patient who presented with a giant left ventricular pseudoaneurysm associated with rupture of the interventricular septum. Surgical repair of both lesions was successfully accomplished.

Modified Bentall procedure: Mechanical vs biological valved conduits in patients older than 65 years.

BACKGROUND: The modified Bentall procedure is still the treatment of choice for patients requiring combined replacement of the ascending aorta and aortic valve. We compared the long-term outcome of patients >65 years of age undergoing Bentall procedure with biological vs mechanical valved conduits in a multi institutional study. METHODS: A total of 282 patients, undergoing a Bentall operation (January 1994-May 2015), with a biological (Group 1, 173 patients) or a mechanical (Group 2, 109 patients) conduit were reviewed, the primary outcome being analysis of late survival and freedom from major adverse events. RESULTS: Hospital mortality was 5% (9 patients) and 2% (2 patients) for Group 1 and Group 2 (p = 0.2). Median follow-up was 77 months (range Q1-Q3: 49-111) for Group 1 vs 107 months (range Q1-Q3: 63-145) for Group 2 (p < 0.001). A not statistically significant advantage in late survival was found in patients receiving mechanical valved conduits (36% for Group 1 vs 58% for Group 2 at 12 years; p = 0.09), although freedom from major adverse events was similar between the 2 groups (33% in Group 1 vs 50% in Group 2 at 12 years; p = 0.3). CONCLUSIONS: In conclusion, mechanical-valved conduits employed for the modified Bentall procedure show a trend towards an improved late survival in patients ≥65 years of age and particularly in those between 65 and 75 years, despite a higher incidence of major adverse events. Our results indicate the need for specific guidelines to better define the ideal age limit for each type of valved conduit.

Patient blood management in cardiac surgery: The "Granducato algorithm".

BACKGROUND: Patients undergoing cardiac surgery are subject to severe alterations of the coagulation system. The four cardiac surgery centers in Tuscany (Italy) structured and shared an algorithm (Granducato Patient Blood Management algorithm, G-PBMa) with predefined interventions for patient blood management. The aim of the study is to analyze the impact of that algorithm on the transfusion needs and bleeding-related outcomes in a large patient population. METHODS: Multicenter retrospective observational study on 3839 patients undergoing cardiac surgery at the four cardiac centers in Tuscany. The G-PBMa was released at the end of 2015 and it was structured in three parts: pre-, intra-, and post-operative. The year 2014, before the G-PBMa (1955 patients) and the year 2016 (1884 patients) after the G-PBMa in place were compared. Logistic regression analyses were used. RESULTS: The main changes introduced were the routine application of viscoelastic tests in bleeding patients (+72%) and the use of fibrinogen and prothrombin complex concentrate (+67%). The G-PBMa resulted in a significant reduction in the overall transfusion rate and in the transfusion rate of the separate blood products (relative risk for transfusions: 0.75, 95% confidence interval 0.65-0.85, P = 0.001). For preoperative hemoglobin values of between 8 and 10 g/dL, the absolute difference in RBC transfusion rate before and after the G-PBMa introduction ranged around 15%-17%. The G-PBMa introduction determined lower (P = 0.02) chest drain blood loss, lower (P = 0.001) postoperative acute kidney injury and shorter (P = 0.001) hospital stay. CONCLUSIONS: The G-PBMa was effective in reducing blood loss, transfusion requirements, and resulted in a better outcome.

Surgical Treatment of Annuloaortic Ectasia - Replace or Repair?

BACKGROUND: Patients with annuloaortic ectasia may be surgically treated with modified Bentall or David I valve-sparing procedures. Here, we compared the long-term results of these procedures. METHODS: A total of 181 patients with annuloaortic ectasia underwent modified Bentall (102 patients, Group 1) or David I (79 patients, Group 2) procedures from 1994 to 2015. Mean age was 62 ± 11 years in Group 1 and 64 ± 16 years in Group 2. Group 1 patients were in poorer health, with a lower ejection fraction and higher functional class. RESULTS: Early mortality was 3% in Group 1 and 2.5% in Group 2. Patients undergoing a modified Bentall procedure had a higher incidence of thromboembolism and hemorrhage, whereas those undergoing a David I procedure had a higher incidence of endocarditis. Actuarial survival was 70 ± 6% at 15 years in Group 1 and 84 ± 7% at 10 years in Group 2. Actuarial freedom from reoperation was 97 ± 2% at 15 years in Group 1 and 84 ± 7% at 10 years in Group 2. In Group 2, freedom from procedure-related reoperations was 98 ± 2% at 10 years. At last follow-up, no cases of moderate or severe aortic regurgitation were observed. CONCLUSIONS: The modified Bentall and David I procedures showed excellent early and late results. The modified Bentall procedure with a mechanical conduit was associated with thromboembolic and hemorrhagic complications, whereas the David I procedure was associated with unexplained occurrences of endocarditis. Thus, the David I procedure appears to be safe, reproducible, and capable of achieving stable aortic valve repair and is therefore our currently preferred solution for patients with annuloaortic ectasia. However, the much shorter follow-up for David I patients limits the strength of our comparison between the two techniques.

The Mosaic Mitral Valve Bioprosthesis: A Long-Term Clinical and Hemodynamic Follow-Up.

We reviewed the cases of 100 patients (mean age, 73 ± 10 yr; 64 men) who had mitral valve replacement with a Medtronic Mosaic porcine bioprosthesis from 1995 through 2011. The mean New York Heart Association (NYHA) class was 3 ± 0.7, and 52 patients were in atrial fibrillation. Prosthetic sizes were chiefly 27 mm (50 patients) and 29 mm (40 patients). Follow-up ended in December 2012 and is 97% complete, with a cumulative duration of 611 patient-years (mean duration, 6 ± 4.6 yr; maximum, 17.7 yr). The early mortality rate was 10% (6% in elective patients); late deaths occurred in 31 patients (5 valve-related). Actuarial survival rates at 5, 10, and 15 years were 74% ± 5%, 50% ± 6%, and 37% ± 8%. The mean NYHA class in survivors was 1.4 ± 0.6 (P <0.0001). Thromboembolic episodes occurred in 4 patients, with an actuarial freedom at 15 years of 91% ± 5%. No cases of endocarditis were observed. Four patients needed reoperation, 2 for structural failure, and 1 each for perivalvular leakage and valve thrombosis. Actuarial freedom from structural failure and from reoperation, respectively, was 93% ± 5% and 91% ± 5% at 15 years. Echocardiographic follow-up in 24 patients with 27-mm prostheses showed a mean gradient of 5 ± 1.7 mmHg and an effective orifice area of 1.57 ± 0.3 cm(2); in 16 patients with 29-mm prostheses, the mean gradient was 4.5 ± 1.9 mmHg, and the effective orifice area, 1.63 ± 0.4 cm(2). During nearly 17 years of follow-up, the Mosaic bioprosthesis has shown good overall clinical and hemodynamic performance after mitral valve replacement.

Stability of aortic annulus enlargement during aortic valve replacement using a bovine pericardial patch: an 18-year clinical, echocardiographic, and angio-computed tomographic follow-up.

OBJECTIVE: Enlargement of the aortic annulus may be required during aortic valve replacement to avoid patient-prosthesis mismatch. We reviewed patients with enlargement of the aortic annulus with the aim of assessing the stability of the procedure by means of echocardiographic and angio-computed tomography studies. METHODS: A series of 53 consecutive patients underwent aortic valve replacement and enlargement of the aortic annulus from 1994 to 2012. The mean age was 68 ± 11 years (range, 29-84 years), and 85% (45 patients) were female. The predominant valvular lesion was aortic stenosis. The mean logistic European System for Cardiac Operative Risk Evaluation was 11.2 ± 13.0. Enlargement of the aortic annulus was performed by extending the aortotomy incision to separate the commissure between the left and noncoronary sinuses into the anterior mitral leaflet and closing the resulting defect with an adequately tailored patch of bovine pericardium. RESULTS: Hospital mortality was 2%, with 20 late deaths mostly due to noncardiac causes. At a maximum follow-up of 18 years (mean, 8.9 ± 5.0 years), actuarial survival is 37% ± 9%. No cases of severe patient-prosthesis mismatch were observed, and only 2 patients had moderate patient-prosthesis mismatch. At discharge, the mean aortic root diameter was 30.0 ± 2.3 mm and the mean diameter at the sinotubular junction was 31.5 ± 5.0 mm. At follow-up, the mean aortic root diameter was 31.0 ± 3.4 mm and the mean diameter at the sinotubular junction was 31.7 ± 4.5 mm (P = not significant) with no cases of late aneurysm formation on angio-computed tomography. CONCLUSIONS: Enlargement of the aortic annulus is a safe and effective procedure and should be indicated in patients with a small aortic annulus; particularly, it should be considered to prevent patient-prosthesis mismatch and its potential deleterious long-term effects.

Single center experience with the Sorin Bicarbon prosthesis: a 17-year clinical follow-up.

OBJECTIVE: To evaluate the long-term results of aortic valve replacement (AVR) and mitral valve replacement (MVR) with the Sorin Bicarbon prosthesis (SBP). METHODS: Five hundred seven patients (306 men, 201 women), mean age 62±10 years (range, 21-86 years), received an SBP between 1994 and 2000; AVR was performed in 344 (67%) and MVR in 163 (33%). The main concomitant procedure was coronary artery grafting in 79 patients (16%). Follow-up was 99% complete; mean follow-up was 12.7±4.0 years with a cumulative duration of follow-up of 6475 patient-years in the entire group (4348 patient-years for AVR and 2124 patient-years for MVR). RESULTS: Hospital mortality was 2.7% (AVR, 2.03%; MVR, 4.3%). There were 169 late deaths (AVR, 128; MVR, 41). Actuarial survival at 17 years is 49.7%±5.3% for AVR and 62.0%±6.1% for MVR. At the last follow-up, 310 survivors (199 AVR, 111 MVR) are in New York Heart Association functional class I or II. At 17 years, actuarial freedom from valve-related deaths, embolism, and bleeding is 89.8%±4.8%, 85.8%±5.4%, and 96.2%±1.2% after AVR, and 91.9%±3.9%, 96.3%±1.8%, 95.0%±2.9% after MVR. Reoperation was required in 5 patients with AVR (thrombosis in 4 and perivalvular leak in 1). Actuarial freedom from reoperation is 98.1%±0.8% after AVR and 100% after MVR; freedom from endocarditis is 100% after AVR and 99.2%±0.7% after MVR. No cases of intrinsic structural valve failure were observed. CONCLUSIONS: The SBP has shown excellent results in terms of clinical improvement and freedom from valve-related complications, even up to 17 years after AVR and MVR. It therefore seems to be a safe option whenever a mechanical prosthesis is needed.