Alessandro Frigiola

Early and late complications associated with transcatheter occlusion of secundum atrial septal defect

OBJECTIVES The goal of this study was to report the early and late complications experienced in atrial septal defect (ASD) transcatheter closure. BACKGROUND Atrial septal defect transcatheter occlusion techniques have become an alternative to surgical procedures. A number of different devices are available for transcatheter ASD closure. The type and rate of complications are different for different devices. METHODS Between December 1996 and January 2001, 417 patients (mean age: 26.6 +/- 19 years) underwent transcatheter occlusion of secundum type ASD. Complications were categorized into major and minor. Two different devices were used: the CardioSEAL/STARFlex in 159 patients and the Amplatzer septal occluder in 258 patients. RESULTS Thirty-four patients experienced 36 complications during the hospitalization (8.6%, 95% confidence interval: 6.1% to 11.1%). Ten patients underwent elective surgical repair because of device malposition (three patients) or device embolization (seven patients). Twenty-four patients experienced 25 minor complications: unsatisfactory device position or embolization. Devices were retrieved using a gooseneck snare and/or a basket; 11 patients experienced arrhythmic problems. Other complications were: pericardial effusion, thrombus formation on the left atrial disc, right iliac vein dissection, groin hematoma, hemorrhage in the retropharynx and sizing balloon rupture. Two patients had late complications: peripheral embolization in the left leg one year after implantation of an Amplatzer device and sudden death 1.5 year later. CONCLUSIONS Our series of patients with ASD by transcatheter occlusion shows that the procedure is safe and effective in the vast majority of cases. To further reduce the complications rate, the criteria of device selection according to ASD morphology and some technical tips during implantation are discussed.

Risk of assessing mortality risk in elective cardiac operations: age, creatinine, ejection fraction, and the law of parsimony.

Background— Several mortality risk scores exist in cardiac surgery. All include a considerable number of independent risk factors. In elective cardiac surgery patients, the operative mortality is low, the number of events recorded per year is limited, and the risk model may be overfitted. The present study aims to develop and validate an operative mortality risk score for elective patients based on a limited number of factors. Methods and Results— The development series included 4557 adult patients who had undergone an elective cardiac operation at our institution from 2001 to 2003; the validation series includes the 4091 patients who subsequently underwent an operation. Three independent factors were included in the mortality risk model: age, creatinine, and left ventricular ejection fraction (ACEF). The ACEF score was computed as follows: age (years)/ejection fraction (%)+1 (if serum creatinine value was >2 mg/dL). The ACEF score was compared with 5 other risk scores in the validation series. Discriminatory power (accuracy) was defined with a receiver-operating characteristics analysis. The best accuracy was achieved by the Cleveland Clinic score (0.812), with ACEF score just below it (0.808). In coronary operations, the 2 scores performed equally well (0.815 versus 0.813), and in isolated coronary operations, the best accuracy was achieved by ACEF (0.826), with the Cleveland Clinic score at 0.806. Conclusion— A risk model limited to 3 independent predictors has similar or better accuracy and calibration compared with more complex risk scores if applied to elective cardiac operations.

Transcatheter closure of perimembranous ventricular septal defects. Early and long-term Results

OBJECTIVES We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of perimembranous ventricular septal defects (pmVSD). BACKGROUND Results of pmVSD transcatheter closure have been reported in the literature; however, follow-up data are still limited. METHODS Between January 1999 and June 2006, 104 patients underwent percutaneous closure of a pmVSD at our institution. An Amplatzer VSD device (muscular or eccentric) (AGA Medical Corp., Golden Valley, Minnesota) was used in all subjects. RESULTS The mean age at closure was 14 years (range 0.6 to 63 years). The attempt to place a device was successful in 100 patients (96.2%). The median device size used was 8 mm (range 4 to 16 mm). No deaths occurred. Total occlusion rate was 47% at completion of the procedure, rising to 84% at discharge and 99% during the follow-up. A total of 13 early complications occurred (11.5%), but in all but 2 subjects (1.9%) these were transient. The median follow-up was 38.5 months. The most significant complication was complete atrioventricular block (cAVB), which required pacemaker implantation in 6 subjects (5.7%; 2 in the early phase and 4 during the follow-up). Cox proportional hazards regression analysis showed that the only variable significantly associated with the occurrence of this complication was age at the time of the procedure (p = 0.028; relative risk 0.25). All subjects experiencing this problem were <6 years old. CONCLUSIONS In the current era and in experienced hands, pmVSD closure can be performed safely and successfully. The major concern is the occurrence of cAVB; therefore, very careful monitoring of rhythm is mandatory during follow-up.

Clinical ResearchCongenital Heart DiseaseTranscatheter Closure of Perimembranous Ventricular Septal Defects: Early and Long-Term Results

OBJECTIVES We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of perimembranous ventricular septal defects (pmVSD). BACKGROUND Results of pmVSD transcatheter closure have been reported in the literature; however, follow-up data are still limited. METHODS Between January 1999 and June 2006, 104 patients underwent percutaneous closure of a pmVSD at our institution. An Amplatzer VSD device (muscular or eccentric) (AGA Medical Corp., Golden Valley, Minnesota) was used in all subjects. RESULTS The mean age at closure was 14 years (range 0.6 to 63 years). The attempt to place a device was successful in 100 patients (96.2%). The median device size used was 8 mm (range 4 to 16 mm). No deaths occurred. Total occlusion rate was 47% at completion of the procedure, rising to 84% at discharge and 99% during the follow-up. A total of 13 early complications occurred (11.5%), but in all but 2 subjects (1.9%) these were transient. The median follow-up was 38.5 months. The most significant complication was complete atrioventricular block (cAVB), which required pacemaker implantation in 6 subjects (5.7%; 2 in the early phase and 4 during the follow-up). Cox proportional hazards regression analysis showed that the only variable significantly associated with the occurrence of this complication was age at the time of the procedure (p = 0.028; relative risk 0.25). All subjects experiencing this problem were <6 years old. CONCLUSIONS In the current era and in experienced hands, pmVSD closure can be performed safely and successfully. The major concern is the occurrence of cAVB; therefore, very careful monitoring of rhythm is mandatory during follow-up.

Role of age in acute type A aortic dissection outcome: report from the International Registry of Acute Aortic Dissection (IRAD).

OBJECTIVE The increasing life expectancy of the population will likely be accompanied by a rise in the incidence of acute type A aortic dissection. However, because of an increased risk of cardiac surgery in an elderly population, it is important to define when, if at all, the risks of aortic repair outweigh the risk of death from unoperated type A aortic dissection. METHODS We analyzed 936 patients with type A aortic dissection enrolled in the International Registry of Acute Aortic Dissection from 1996 to 2004. Patients with type A aortic dissection were categorized according to patient age by decade and by surgical versus medical management, and outcomes of both management types were investigated in the different age groups. RESULTS The rate of surgical aortic repair decreased progressively with age, whereas surgical mortality significantly increased with age. Age 70 years or more was an independent predictor for mortality (38.2% vs 26.0%; P < .0001, odds ratio 1.73). The in-hospital mortality rate was significantly lower after surgical management compared with medical management until the age of 80 years. For patients aged 80 to 90 years, the in-hospital mortality appeared to be lower after surgical management (37.9% vs 55.2%; P = .188); however, this failed to reach clinical significance owing to the limited patient number in this age group. CONCLUSIONS Although the surgical mortality significantly increased with increased age, surgical management was still associated with significantly lower in-hospital mortality rates compared with medical management until the age of 80 years. Surgery may decrease the in-hospital mortality rate for octogenarians with type A aortic dissection and might be considered in all patients with type A aortic dissection regardless of age.

Treatment of isolated secundum atrial septal defects: Impact of age and defect morphology in 1,013 consecutive patients

BACKGROUND Percutaneous closure of atrial septal defect (ASD) is a valid alternative to surgical approach. Current device has significantly improved the success rate also in complex cases. The aim of this study is to assess the impact of age, defect size, and morphologic features on successfully percutaneous ASD closure. METHODS Between January 2000 and September 2004, 1,013 consecutive patients underwent closure of an isolated type II ASD at our institution. The following outcomes have been evaluated: (1) role of percutaneous ASD closure as alternative to surgical repair, in current daily practice; (2) impact of age on the selected closure approach; (3) analysis of morphologic variety of ASD and its effect on the closure technique; (4) possible role of specific device selection according to ASD morphology to improve procedural success. RESULTS During the study period, up to 80% of secundum ASDs were suitable for percutaneous closure with the currently available devices. Need for surgical ASD closure was more common in pediatric patients, likely reflecting the more frequent diagnosis of larger and complex defects at a young age. Accurate ADS morphology assessment and appropriate device selection are key elements to obtain procedural success. In particular, among all the ASD characteristics, the rim absence is the main limiting factor to a successful percutaneous ASD closure. A trend of reduction in peri-procedural adverse events was observed during the study period, with complications needing immediate cardiac surgery occurred only in 1% of cases. CONCLUSIONS Percutaneous ASD closure is feasible and associated with low complication rate. A thorough analysis of morphologic aspects is mandatory in order to select the appropriate device and the optimal approach. Surgical closure remains the treatment of choice in selected patients.

Risk factors for renal dysfunction after coronary surgery: the role of cardiopulmonary bypass technique:

We studied 316 patients undergoing cardiopulmonary bypass for coronary artery surgery in order to determine perioperative risk factors for postoperative renal dysfunction A preliminary univariate analysis was performed by χ2 analysis for categorical data and Mann-Whitney U-test for continuous variables to detect significant correlations between each risk factor and the occurrence of moderate or severe renal dysfunction. Subsequently, a multiple logistic regression was applied to the three risk factors identified as predictive for severe renal dysfunction. Low cardiac output syndrome and need for banked blood transfusions combined with a low haematocrit value during cardiopulmonary bypass increase the probability of severe renal dysfunction in the postoperative course.

Postoperative antithrombin levels and outcome in cardiac operations

Objective:During cardiac operations with cardiopulmonary bypass surgery, antithrombin is consumed and low levels of antithrombin activity are commonly observed at admission to the intensive care unit (ICU). This study investigates the association between antithrombin activity at admission to the ICU (ICU-antithrombin activity) and various outcome variables. Design:The authors conducted a prospective, observational cohort study. Setting:The study was conducted at a university hospital. Patients:The study consisted of 647 consecutive patients who had undergone cardiac surgery with cardiopulmonary bypass. Measurements and Main Results:ICU-antithrombin activity significantly (p < .001) decreased with respect to preoperative values. As seen with univariate analysis, low levels of ICU-antithrombin activity were significantly associated with higher blood loss, prolonged mechanical ventilation time and ICU stay, a higher incidence of allogeneic blood products use, surgical reexploration, low cardiac output syndrome, adverse neurologic events, thromboembolic events, renal dysfunction, and hospital mortality. When corrected for the other explanatory variables, low levels of ICU-antithrombin activity remained independently associated with a prolonged ICU stay (p = .003) and with a higher incidence of surgical reexploration (p = .023), adverse neurologic events (p = .001), and thromboembolic events (p = .036). An ICU-antithrombin activity value of <58% was found to be predictive of prolonged ICU stay, with a sensitivity of 67% and a specificity of 83%. Conclusions:Low levels of ICU-antithrombin activity are associated with a poor outcome in cardiac surgery; ICU-antithrombin activity is predictive of prolonged ICU stay.

Mediterranean Diet and Cardiovascular Risk Factors: A Systematic Review

The aim of this paper was to systematically review and analyze the epidemiological evidence on the role of Mediterranean diet (MD) in the prevention of cardiovascular diseases (CVD). Fifty-eight studies exploring the relation between MD and lipoprotein concentration, antioxidative capacity and inflammatory markers, hypertension, obesity, diabetes, and metabolic syndrome, were identified and selected. These included 33 cross-sectional, 9 cohort, and 16 intervention studies. Most of the studies showed favorable effects of MD on CVD, although a certain degree of controversy remains in the respect of some issues, as obesity. Important methodological differences and limitations in the studies make difficult to compare results, thus further studies, particularly randomized clinical trials, are needed to finally substantiate the benefits of MD and to shed some lights on mechanisms.

Predictors for heparin resistance in patients undergoing coronary artery bypass grafting

Heparin resistance (HR) is a common event in cardiac operations. At present, no clear recognition of the risk factors for HR has been reached. The aim of this study was to determine a predictive model for HR, based on the preoperative patient’s profile. Two hundred consecutive patients scheduled for elective coronary artery bypass operations were enrolled in a prospective trial. Demographics, type of preoperative anticoagulation therapy and preoperative coagulation profile were collected and statistically analysed with respect to the evidence of a HR. Heparin resistance was defined as at least one activated clotting time < 400 s after heparinization and/or the need for purified antithrombin III (AT-III) administration. With a multivariate analysis we could identify five predictors for HR: AT-III ≤ 60%; preoperative subcutaneous heparin therapy; intravenous heparin therapy; platelet count ≥ 300 000 cells/mm3; age ≥ 65 years. We conclude that HR is a predictable event. In the presence of all the risk factors, the likelihood of HR is 99%; in the absence of all of them, it is 10%. Predicting HR allows us to apply many possible therapeutic strategies.