Twenty-five-year experience with the Medtronic-Hall valve prosthesis in the aortic position: a follow-up cohort study of 816 consecutive patients.

BACKGROUND: The Medtronic-Hall valve was developed and for the first time implanted in Oslo, Norway, in 1977. A total of 1104 patients received this valve at Rikshospitalet from 1977 to 1987. In the present study, we followed up on all 816 patients undergoing aortic valve replacement over a 25-year period. METHODS AND RESULTS: This is a retrospective cohort analysis of 816 consecutive patients undergoing aortic valve replacement with the Medtronic-Hall valve at Rikshospitalet, Oslo, Norway, from 1977 to 1987. All patients were contacted by means of questionnaires or telephone. Data were checked against hospital databases and medical records. Date of death was verified by the Norwegian civil registry. Follow-up was 99.6% complete. Survival analysis included operative deaths as well as late deaths. Survival at 25 years was 24.9%. No mechanical failures were found. Valve thrombosis was seen in 4 patients, in 1 case combined with pannus formation. Small valves (20 mm to 21 mm) were associated with reduced survival; however, when controlled for the confounding effects of age and gender, valve size did not remain a significant risk factor. Patient-related factors were important: Older age, female gender, and the need for concomitant coronary artery bypass surgery significantly reduced survival, whereas surgery of the ascending aorta did not. Linearized rates of thromboembolic complications, warfarin-related bleeding, and endocarditis were 1.5%, 0.7%, and 0.16%/patient-year, respectively. At follow-up, 79% of the patients were in New York Heart Association classes I to II. CONCLUSIONS: This study confirms the excellent long-term outcome for patients with Medtronic-Hall valves in the aortic position.

Continued symptomatic improvement three to five years after transmyocardial revascularization with CO(2) laser: a late clinical follow-up of the Norwegian Randomized trial with transmyocardial revascularization.

OBJECTIVES: The goals of this study were to assess late clinical outcome and left ventricular ejection fraction (LVEF) after transmyocardial revascularization with CO(2) laser (TMR). BACKGROUND: During the 1990s TMR emerged as a treatment option for patients with refractory angina not eligible for conventional revascularization. Few reports exist on clinical effects and LVEF >3 years after TMR. METHODS: One hundred patients with refractory angina not eligible for conventional revascularization were block-randomized 1:1 to receive continued medical treatment or medical treatment combined with TMR. The patients were evaluated at baseline and after 3, 12 and 43 (range: 32 to 60) months with end points to angina, hospitalizations due to acute myocardial infarctions or unstable angina, heart failure and LVEF. Mortality was registered and MOS 36 Short-Form Health Survey answered at baseline and after 3, 6 and 12 months. RESULTS: Forty-three months after TMR, angina symptoms were still significantly improved, and unstable angina hospitalizations reduced by 55% (p < 0.001). Heart failure treatment (p < 0.01) increased, whereas the number of acute myocardial infarctions, LVEF and mortality was not affected. Quality of life was improved 3, 6 and 12 months after TMR. CONCLUSIONS: Forty-three months after TMR, angina symptoms and hospitalizations due to unstable angina were significantly reduced, heart failure treatment increased and LVEF and mortality were seemingly unaffected.

Surgery for left ventricular aneurysm: early and late survival after simple linear repair and endoventricular patch plasty.

OBJECTIVE: Simple linear resection and endoventricular patch plasty are alternative techniques to repair postinfarction left ventricular aneurysm. The aim of the study was to compare these 2 methods with regard to early mortality and long-term survival. METHODS: We retrospectively reviewed 159 patients undergoing operations between 1989 and 2003. The epidemiologic design was of an exposed (simple linear repair, n = 74) versus nonexposed (endoventricular patch plasty, n = 85) cohort with 2 endpoints: early mortality and long-term survival. The crude effect of aneurysm repair technique versus endpoint was estimated by odds ratio, rate ratio, or relative risk and their 95% confidence intervals. Stratification analysis by using the Mantel-Haenszel method was done to quantify confounders and pinpoint effect modifiers. Adjustment for multiconfounders was performed by using logistic regression and Cox regression analysis. Survival curves were analyzed with the Breslow test and the log-rank test. RESULTS: Early mortality was 8.2% for all patients, 13.5% after linear repair and 3.5% after endoventricular patch plasty. When adjusted for multiconfounders, the risk of early mortality was significantly higher after simple linear repair than after endoventricular patch plasty (odds ratio, 4.4; 95% confidence interval, 1.1-17.8). Mean follow-up was 5.8 +/- 3.8 years (range, 0-14.0 years). Overall 5-year cumulative survival was 78%, 70.1% after linear repair and 91.4% after endoventricular patch plasty. The risk of total mortality was significantly higher after linear repair than after endoventricular patch plasty when controlled for multiconfounders (relative risk, 4.5; 95% confidence interval, 2.0-9.7). Linear repair dominated early in the series and patch plasty dominated later, giving a possible learning-curve bias in favor of patch plasty that could not be adjusted for in the regression analysis. CONCLUSIONS: Postinfarction left ventricular aneurysm can be repaired with satisfactory early and late results. Surgical risk was lower and long-term survival was higher after endoventricular patch plasty than simple linear repair. Differences in outcome should be interpreted with care because of the retrospective study design and the chronology of the 2 repair methods.

Repair of left ventricular aneurysm: surgical risk and long-term survival.

BACKGROUND: The aim of the study was to identify predictors for survival after repair of postinfarction left ventricular aneurysm. METHODS: We retrospectively reviewed the records of 149 patients who had an operation for postinfarction left ventricular aneurysm between 1989 and 2001. The following variables were recorded: preoperative clinical, angiographic, and echocardiographic findings and operative procedures. Outcomes were early mortality (<30 days) and long-term survival. Risk factors were pinpointed using t test or Mann-Whitney test, contingency tables, and survival curves. Independent risk factors were identified by logistic regression and Cox regression methods. Mean follow-up was 5.8 years (range, 0 to 13.8 years). RESULTS: The early mortality (<30 days) rate was 8.7% altogether, and the 5-year cumulative survival rate was 77%. Advanced age, history of ventricular arrhythmia, three-vessel disease, and linear repair technique were independent risk factors for early and total mortality. Poor left ventricular function predicted reduced long-term survival but did not increase surgical risk. Survival was not affected by gender, diabetes, type and severity of symptoms, anterior or posterior aneurysm, revascularization of the left anterior descending artery, or number of distal anastomoses. CONCLUSIONS: Postinfarction left ventricular aneurysm can be repaired with acceptable surgical risk and long-term survival. Survival is reduced in cases with advanced age, history of ventricular arrhythmia, three-vessel disease, poor left ventricular function, and linear repair of the aneurysm.

Sternal wound closure in patients undergoing open-heart surgery: a prospective randomized study comparing intracutaneous and zipper techniques.

OBJECTIVE: A prospective, randomized study was undertaken to compare a non-invasive surgical zipper to intracutaneous suture closure in open-heart surgery with respect to postoperative wound infection rate and cosmetic results. METHODS: A total number of 300 patients were included in the study, of which 150 had their skin wound closed with zipper and 150 with intracutaneous suture. The end-points were superficial and deep sternal wound infections within 6 weeks postoperatively. RESULTS: The incidence of total infection after 6 weeks was equal in the two groups (6.7 vs. 6.7%) (P=0.94). The superficial infection rate was 5.3% in the zipper group vs. 6.0% in the intracutaneous, and the deep infection rate was 1.4% in the zipper group and 0.7% in the intracutaneous. There was no statistically significant difference between the groups. Only the cosmetic result differed. On a visual scale from 1 (poorest) to 10 (best), an average score of 8.2 was obtained in the intracutaneous group versus 8.9 in the zipper group (P<0.01). CONCLUSION: The wound infection rate was equal for the intracutaneous group compared with the zipper group; however, the cosmetic result was judged better by the patients in the zipper group.

Surgery of postinfarction ventricular septal rupture: the effect of David infarct exclusion versus Daggett direct septal closure on early and late outcomes.

OBJECTIVE: David infarct exclusion and Daggett direct septal closure are alternative techniques to repair postinfarction ventricular septal rupture. The aim of the present study was to compare the 2 methods with regard to postoperative morbidity, 30-day mortality, and long-term survival. METHODS: From May 1981 to December 2010, 110 patients underwent surgery for postinfarction ventricular septal rupture. Data were collected on the clinical, angiographic, and echocardiographic findings, operative procedures, early morbidity, and survival time. The epidemiologic design was of an exposed (David infarct exclusion, n = 42) versus a nonexposed (Daggett direct closure, n = 68) cohort with 3 endpoints: postoperative morbidity, 30-day mortality, and long-term survival. The crude effect of the repair technique versus the endpoint was estimated using univariate statistics. Stratification analysis using the Mantel-Haenszel method was done to quantify the confounders and pinpoint the effect modifiers. Adjustment for confounders was performed using logistic regression and Cox regression analysis, and with propensity score stratification statistics. Survival curves were analyzed using the Breslow test and log-rank test. RESULTS: The surgical technique had no influence on postoperative morbidity. The 30-day mortality was 16.7% in the David group and 48.5% in the Daggett group (P = .000). Long-term survival was greater after David than after Daggett, with 5- and 10-year survival of 69% versus 38% and 48% versus 27%, respectively (P = .004). Total coronary revascularization improved survival more in the David than in the Daggett group. CONCLUSIONS: David infarct exclusion was superior to Daggett direct septal closure for early and late survival after surgery for postinfarction ventricular septal rupture. Total coronary revascularization improved survival more in the David than in the Daggett group.

Surgical repair of postinfarction ventricular septal rupture: risk factors of early and late death.

OBJECTIVE: The aim of the study was to identify risk factors of early and late death after surgical repair of postinfarction ventricular septal rupture. METHODS: During a 25-year period, from May 1981 to August 2006, 102 patients underwent repair of postinfarction ventricular septal rupture. Data were collected on clinical, angiographic, and echocardiographic findings; operative procedures; early morbidity; and survival time. Univariable and multivariable analyses were performed to identify risk factors of 30-day mortality and total mortality. RESULTS: Thirty-day mortality was 33% altogether and decreased from 45% in the first half to 21% in the second half of the period (P = .01). Follow-up was a mean of 5.2 +/- 6.2 years and a median of 2.9 years (range, 0-26.3 years). Five- and 10-year cumulative survival was 50% and 32%, respectively. Shock at surgical intervention and incomplete coronary revascularization were strong and independent risk factors of both 30-day mortality and poor long-term survival. CONCLUSIONS: Early outcome after repair of ventricular septal rupture improved significantly during time, with 30-day mortality being 21% in the last decade. Five- and 10-year cumulative survival was 50% and 32%, respectively. Shock at surgical intervention and incomplete coronary revascularization were strong and independent predictors of poor early and late survival.