Factors influencing survival and postoperative quality of life after mitral valve reconstruction.

OBJECTIVE: Mitral valve reconstruction (MVR) is the preferred treatment for regurgitant lesions. Clinical benefit is well documented, but comparative data scrutinising factors influencing survival and postoperative quality of life (QOL) in different subsets of patients are missing. We hypothesised that mitral valve reconstruction for mitral regurgitation benefits the patients, regardless of the valve pathology. METHODS: In this study, 663 consecutive patients undergoing mitral valve reconstruction using Carpentier techniques were assigned to four different groups. Aetiology of mitral regurgitation was degenerative (DEG) in 372 (56.1%) patients and ischaemic (ISC) in 157 (23.6%). Cardiomyopathy (CMP) was present in 23 (3.4%) cases and combined degenerative regurgitation plus coronary artery disease (DEG+CAD) in 111 (16.7%) patients. Survival was evaluated using a Cox proportional hazards model. Postoperative QOL was assessed using the short form (SF)-36 questionnaire in a multivariate analysis of covariance. RESULTS: The overall 30-day mortality was 1.1% (0.3%, 1.9%, 0% and 2.7% for groups DEG, ISC, CMP and DEG+CAD, respectively). The median preoperative NYHA class and grade MI was 3 and evenly distributed between groups. After a mean follow-up of 4.1+/-3.4 years, MVR proved to be effective in all groups with 90.3% of patients in the NYHA classes I and II (p<0.001). At 5 years, unadjusted survival was 90.3%, 69.7%, 50.5% and 86.2%. However, after correcting for age, ejection fraction, chronic obstructive pulmonary disorder (COPD), renal insufficiency and the preoperative NYHA class, survival in groups ISC and DEG+CAD was comparable. Group allocation was not a predictor for late death. Postoperative QOL was inferior in female patients in all SF-36 scales (p<0.01) and was impaired by co-morbidities. QOL scores were best for patients in group DEG and worst in group CMP. In a multivariate model correcting for gender, age and co-morbidities (COPD, treated diabetes, renal insufficiency, subjective heart rhythm, preoperative NYHA class and previous myocardial infarction), postoperative QOL was comparable between groups. For the majority of patients with degenerative MR, postoperative life expectancy as well as QOL is similar to a normal population. CONCLUSIONS: MVR was safely and effectively accomplished in all groups. Survival and postoperative QOL was determined by left ventricular function and co-morbidities rather than MR aetiology.

Hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis up to ten years.

BACKGROUND: The Mosaic bioprosthesis (Medtronic, Minneapolis, MN) is a third-generation stented porcine bioprosthesis combining physiologic fixation and amino oleic acid antimineralization treatment to improve hemodynamic performance and durability. The findings of this single-center experience with this valve were evaluated to determine the clinical and hemodynamic performance. METHODS: Between February 1994 and October 1999, we enrolled 255 patients with aortic valve replacement (AVR) with a mean age of 67 years (range, 23 to 82 years) and 47 patients with mitral valve replacement (MVR) with a mean age of 67 years (range, 41 to 84 years) in this post-United States Food and Drug Administration approval prospective and nonrandomized clinical trial. Patients were followed-up, including serial echocardiographic assessment, within 30 days, at 6 months, and annually thereafter. The cumulative follow-up was 1540 patient-years for AVR (mean, 6.1 years; maximum, 10 years) and 250 patient-years for MVR (mean, 5.4 years, maximum; 10 years). RESULTS: Early mortality after AVR (<30 days) was 0.8%; late mortality per patient-year was 3.5%, including a valve-related/unexplained mortality of 1.1%. Early mortality after MVR (<30 days) was 0.0%; late mortality per patient-year was 2.8%, including a valve-related/unexplained mortality of 1.2%. Median postoperative gradient and effective orifice area for all valves after AVR were (early, n = 252; 5 years, n = 161; 9 years, n = 43) 13.7, 12.3, and 11.7 mm Hg and 1.9, 1.8, and 1.8 cm2 at early, 5 years, and 9 years, respectively. With MVR respective data were (early, n = 46; 5 years, n = 25; 7 years, n = 13) 4.6, 4.1, and 3.9 mm Hg and 1.8, 2.2, and 2.3 cm2. At 10 years, freedom from adverse events in the AVR group and MVR group was, respectively, thromboembolism, 86.6% +/- 6.6% and 86.3% +/- 9.8%; permanent neurologic event, 91.2% +/- 6.8% and 90.9% +/- 8.7%; valve thrombosis, 98.2% +/- 0.8% and 100%; structural valve deterioration, 87.1% +/- 6.7% and 100%. CONCLUSIONS: Our midterm results demonstrate clinical safety and good performance of the Mosaic bioprosthesis. Continued follow-up will determine if this new design will provide increased durability.

The mosaic valve clinical performance at seven years: results from a multicenter prospective clinical trial.

BACKGROUND AND AIM OF THE STUDY: The Mosaic valve is a third-generation stented porcine bioprosthesis built upon the historical durability of the Hancock II valve in an attempt to improve hemodynamic performance and durability. METHODS: This multicenter trial was prospective and non-randomized in design. Between February 1994 and October 1999, six centers following a common study protocol enrolled 797 patients (mean age 70 years: range: 21-88 years) who underwent aortic valve replacement (AVR), and 232 patients (mean age 68 years; range: 17-84 years) who underwent mitral valve replacement (MVR). The cumulative follow up was 3,442 patient-years (pt-yr) for AVR (mean 4.3 years; maximum 8 years), and 870 pt-yr for MVR (mean 3.7 years; maximum 7 years). Follow up was complete for 95% of AVR patients, and for 97% of MVR patients. RESULTS: The mean gradient and calculated effective orifice area average across all valve sizes remained stable at one, four and six years. Freedom from valve-related adverse events (mean +/- SE) at one, four and seven years after AVR were, respectively: Antithromboembolic-related hemorrhage (ARH) 97.0 +/- 0.6, 95.6 +/- 0.9, and 94.6 +/- 5.1%; primary hemolysis 100, 100, and 100%; and structural valve deterioration (SVD) 100, 100 and 100%. Freedom at one, four and seven years after MVR were: ARH 96.9 +/- 1.2, 95.6 +/- 2.0, and 95.6 +/- 7.6%; primary hemolysis 100, 100, and 100%; and SVD 100, 100, and 100%. CONCLUSION: These mid-term results demonstrate the clinical safety and excellent performance of the Mosaic valve. Continued follow up will determine if this new-design, third-generation bioprosthesis will provide increased durability.

Off-Pump Arterial Revascularization Using a New Reusable Device for Coronary Occlusion and Local Stabilization.

Abstract Background: Optimal local stabilization, an unobstructed view, and a free field for operation are of most importance during off-pump surgery to facilitate high-quality anastomoses. We report on a new reusable stabilizing platform for complete off-pump coronary revascularization. Methods: From May 2001 until June 2002, 118 consecutive patients (82 men, 36 women) with coronary artery disease (61 with 1-vessel, 42 with 2-vessel, and 15 with 3-vessel disease) and a mean age of 63. 6 +/- 10. 0 years (range, 41-88 years) were scheduled for complete off-pump arterial revascularization. The mean left ventricular ejection fraction was 56. 5% +/- 12. 5%(range, 25%-85%). Exposure of the coronary vessels was facilitated with deep pericardial slings. The target coronary vessel was snared twice with air-cushioned silicone loops and fixed to the platform, which was connected to a flexible steel arm. The platform is available in 3 versions with different connector angles to accommodate various anatomical conditions. Together with its flat design, the platform provides an unobstructed view and a free field of operation. Results: All operations were performed without any intraoperative complications, and all planned bypasses were carried out. The mean number of bypass grafts was 1. 7 +/- 0. 8 (range, 1-5). There was no early (30 days) mortality. The postoperative course was uneventful in all patients except for 1 reexploration for retrosternal bleeding, 10 patients with temporary atrial fibrillation, and 1 patient with reintubation after early extubation in the operating room because of respiratory insufficiency. Patients were discharged from the hospital in good condition 8. 7 +/- 2. 6 days (range, 5-18 days) after surgery. Conclusions: Our data indicate that complete arterial off-pump revascularization can be performed safely and effectively with a new reusable platform that provides excellent stabilization and an unobstructed view to the target coronary vessels.

A steel band in addition to 8 wire cerclages reduces the risk of sternal dehiscence after median sternotomy.

BACKGROUND: Sternal dehiscence after full median sternotomy may result in wound-healing disorders, including osteomyelitis. The consequences are extended hospitalization, plastic surgery, stress for the patient, and increased costs. Stable closure of the median sternotomy plays a crucial role in the avoidance of sternal dehiscence and osteomyelitis. METHODS: All patients who underwent full sternotomy from January 1999 until December 2001 were investigated with respect to the incidence of sternal dehiscence. Since January 2000, patients supposed to be at risk for sternum dehiscence were more frequently treated with an Ethicon steel band at the third intercostal space in addition to standard osteosynthesis with 8 wire cerclages. RESULTS: Since the introduction of this method, the incidences of sternal dehiscence and sternal wound infections decreased from 2.9% and 0.9 %, respectively, in 1999 to 0.3% and 0.2%, respectively, in 2001. This decline resulted in shorter postoperative hospital stays, less stress for the patients, and substantial reductions in postsurgical costs. CONCLUSIONS: A steel band used in addition to standard osteosynthesis with 8 wire cerclages is a safe and effective procedure resulting in a statistically significant decrease in the frequency of sternal dehiscence.

Surgical treatment of interrupted aortic arch with extraanatomical bypass simultaneous to coronary artery bypass grafting and aortic valve replacement.

An interrupted aortic arch accompanied by further surgically reparable cardiac lesions is a rare combination in adult patients. We describe treatment of an interrupted aortic arch, coronary artery bypass grafting (CABG), and aortic valve replacement (AVR) performed simultaneously through median sternotomy in a 64-year-old man. The patient underwent surgery performed using standard cardiopulmonary bypass with cannulation of the ascending aorta and the right atrium, hypothermia (24.6degreesC), and blood cardioplegic arrest. Four aortocoronary vein grafts and pericardial aortic valve replacement were carried out. Finally, the posterior pericardium was opened, and a 16-mm prosthesis was anastomosed to the descending aorta during side clamping using a 4-0 monofilament continuous suture. Optimal placement of the prosthesis was obtained by guiding it to the ascending aorta laterally to the right atrium and passing it between the inferior vena cava and right inferior lung vein. The operation was carried out without complications, and the postoperative course was uneventful. Magnetic resonance imaging showed competent aortic valve prosthesis and highly decreased collateral flow via the internal mammary arteries. Postoperatively both inguinal pulses were present, and the patient was free of angina. In the presence of an interrupted aortic arch, extraanatomical bypass via the posterior pericardium between the ascending and descending aorta can safely be performed at the same time as CABG and AVR through a median sternotomy.

Congenital fistula between the left internal mammary artery (LIMA) and the pulmonary artery: cause of LIMA bypass occlusion?

Congenital fistulas from the left internal mammary artery to the pulmonary artery are rare. We describe a 49-year-old patient with severe aortic valve regurgitation and coronary artery disease. Percutaneous transluminal coronary angioplasty and left anterior descending artery (LAD) stenting had been performed because of a significant proximal LAD lesion. Repeated coronary angiogram 3 months later revealed a patent stent but severe sclerosis up to a 40% stenosis of the LAD after the area of stenting. An aortic valve replacement and a left internal mammary artery (LIMA) bypass to LAD were performed during standard cardiopulmonary bypass (CPB). Because of patient chest pain, a control angiogram was carried out 2 years after surgery and revealed a LIMA-bypass occlusion and a large fistula deriving from the proximal part of the LIMA to the pulmonary artery. The fistula was occluded by coils during an interventional cardiological procedure. Diminished flow in the LIMA bypass due to the fistula in combination with a nonsignificant proximal LAD stenosis are possible reasons for IMA-bypass occlusion. From this case we conclude that angiography of the IMA to detect malformations preoperatively should be mandatory in all cases of arterial coronary revascularization using IMA bypasses.

European experience with the Mosaic bioprosthesis.

OBJECTIVE: The purpose of this study was to prospectively evaluate the clinical and hemodynamic performance of the Mosaic bioprosthesis (Medtronic, Inc, Minneapolis, Minn). METHODS: The stented porcine bioprosthesis combines the amino-oleic acid antimineralization treatment and the zero-pressure differential fixation technique for improved tissue durability. From February 1994 to May 1999, a total of 561 patients underwent valve replacement with the Mosaic bioprosthesis at 5 centers in Europe: 461 in the aortic and 100 in the mitral position. There were 261 women and 300 men; mean age at implantation was 70 years (range, 23-89 years). Mean follow-up was 2.9 years (range, 0-6.2 years), with a total follow-up of 1710.1 patient-years. RESULTS: Postoperative mortality was 4.2% per patient-year, including a valve-related mortality of 0.4% per patient-year. The freedom from event rates in the aortic position at 5 years and in the mitral position at 4 years were, respectively, 96.6% +/- 1.1% and 94.9% +/- 3.3% for primary thromboembolism, 96.4% +/- 5.0% and 87.1% +/- 4.8% for antithromboembolic-related hemorrhage, 99.1% +/- 0.5% and 100% for thrombosed prosthesis, 98.8% +/- 1.2% and 100% for structural valve deterioration, 98.8% +/- 0.7% and 100% for nonstructural dysfunction, 98.4% +/- 0.6% and 94.4% +/- 3.8% for endocarditis, and 95.4% +/- 1.6% and 95.3% +/- 3.7% for explant and reoperation. Mean pressure gradient values at 5 years ranged from 7.5 to 15.9 mm Hg in the aortic position and at 4 years from 2.0 to 6.9 mm Hg in the mitral position across all valve sizes. CONCLUSIONS: Clinical and hemodynamic performance of the Mosaic bioprosthesis were very satisfactory during the first 6 years after clinical introduction.

Left ventricular mass regression after aortic valve replacement with the mosaic bioprosthesis.

BACKGROUND AND AIMS OF THE STUDY: The study aim was to evaluate the hemodynamic performance and extent of left ventricular (LV) mass regression after aortic valve replacement (AVR) with the Mosaic bioprosthesis within the first postoperative year. METHODS: Between 1994 and 1999, 366 patients (203 males, 163 females) underwent AVR with the Mosaic bioprosthesis at five centers in Europe. Mean age at implant was 71.1 years (range: 34.5-86.8 years). LV mass assessment and hemodynamic evaluation were performed using transthoracic echocardiography within six days postoperatively, after six months, and at annual intervals thereafter. RESULTS: LV mass index decreased significantly in patients with valve sizes 21 to 27 mm, from 184.4+/-56.2 g/m2 postoperatively to 157.3+/-45.5 g/m2 after one year (14.7% decrease). The 19-mm valve group did not show significant LV mass index reduction (from 210.4+/-39.4 to 195.0+/-59.4 g/m2; 7.3%). Patients with significant LV mass index regression had survival benefits after seven years. Mean pressure gradients after one year were 16.0+/-4.3, 14.2+/-5.4, 12.8+/-5.3, 11.1+/-4.0 and 10.5+/-3.7 mmHg for 19, 21, 23, 25 and 27 mm valves, respectively. CONCLUSION: Implantation of the Mosaic bioprosthesis resulted in a significant regression of LV mass for the valves sizes 21 to 27 mm, corresponding to very low pressure gradients for a stented bioprosthesis.

Coronary hybrid revascularization from January 1997 to January 2001: a clinical follow-up.

BACKGROUND: Hybrid revascularization (HyR), combining minimally invasive left internal mammary artery (LIMA) bypass grafting to the left anterior descending coronary artery (LAD) and catheter interventional treatment of the remaining coronary lesions, avoids the disadvantages associated with cardiopulmonary bypass (CPB). We investigated the clinical follow-up of 57 patients with multivessel disease undergoing this procedure in the last 4 years. METHODS: Between January 1997 and January 2001, 57 consecutive patients (41 men and 16 women, aged 65.7 +/- 7.9 years) with coronary artery disease (two-vessel, n = 34; three-vessel, n = 23) were treated with off-pump LIMA-to-LAD bypass combined with balloon angioplasty and stenting of the remaining significantly obstructed (> 50%) coronary vessels. Clinical follow-up data included a early postoperative and a 6-month control angiography and a patient interview in January 2001. RESULTS: All patients underwent LIMA-to-LAD bypass-grafting and balloon angioplasty in 72 coronary lesions without procedural-related complications. However, one early LIMA bypass occlusion was documented during coronary angiography. Postoperatively no deterioration of preexistent organ dysfunction was observed in any patient. The mean follow-up was 100.7 +/- 37.9 weeks in 55 of 57 patients (97%). Control angiography 6 months after HyR (n = 34) revealed a patent LIMA bypass in 33 patients and 8 in-stent restenoses (> 50%) in the coronary arteries that were treated interventionally by re-PTCA (n = 6) or by conventional CABG (n = 1). In 1 patient medical treatment resulted in significant reduction of angina so no further intervention was considered necessary. After HyR 1 patient died 18 months later of an intracerebral hemorrhage. All other patients are alive and doing well. CONCLUSIONS: Our results indicate that in selected patients with multivessel disease including left main stem stenosis HyR is an effective and secure procedure with excellent early and good midterm results. Especially elderly patients with severe concomitant diseases appear to benefit from this approach by avoiding CPB.

Clinical experience with the CorLink device for proximal anastomosis of the saphenous vein to the aorta: a clinical, prospective, and randomized study.

BACKGROUND: Avoiding tangential clamping of the ascending aorta during coronary bypass operations reduces the trauma to the aorta and may avoid local particulate embolization. METHODS: From December 2000 to May 2001, 21 male patients, mean age 64.1 +/- 7.2 years (range, 46-76 years), with coronary artery 2-vessel (n = 3) and 3-vessel (n = 18) disease were divided randomly into 2 groups and underwent myocardial revascularization. In 11 patients an aorta-saphenous vein graft anastomosis was performed with the CorLink device for anastomosis between the saphenous vein and the ascending aorta. Ten patients served as control subjects. In these patients the central bypass anastomosis was performed with a 6-0 running suture. Clinical follow-up was performed 1 month and 3 months postoperatively. Six months after surgery, multislice computed tomography was performed to evaluate bypass patency for all patients. RESULTS: Mean number of study vessels was 1.2 +/- 0.4 in the CorLink group and 1.5 +/- 0.5 in the control group. In the CorLink group, 13 additional arterial and vein grafts were performed, and in the suture control group 15 additional mammary artery grafts were carried out. No intraoperative complications occurred. In 2 CorLink anastomoses an additional stitch was necessary because of minor bleeding. Follow-up was carried out at 6 months with multislice computed tomography for all patients and showed only 1 study vessel occlusion in the CorLink group. All 62 other bypass grafts were revealed to be patent and had anastomoses of good quality. CONCLUSION: Our experience suggests that the CorLink device is a safe and effective technique for anastomosis between saphenous vein grafts and the ascending aorta. The CorLink device could be used for totally endoscopic coronary bypass operations. Further randomized studies enrolling a larger number of patients are necessary to determine which patients may benefit the most from this procedure.