Fausto Biancari

Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty

BACKGROUND The aim of this meta-analysis was to evaluate the safety and efficacy of vascular closure devices (VCDs). METHODS This meta-analysis was performed in accordance with the Cochrane Handbook for Systematic Reviews. RESULTS The literature search yielded 31 prospective, randomized studies including 7,528 patients who were randomized to VCDs or manual/mechanical compression after diagnostic angiography and/or endovascular procedures. Most of these studies have excluded patients at high risk of puncture site complications. Meta-analysis showed similar results in the study groups in terms of groin hematoma, bleeding, pseudoaneurysm, and blood transfusion. Lower limb ischemia and other arterial ischemic complications (0.3% vs 0%, P = .07) as well as need of surgery for vascular complications (0.7% vs 0.4%, P = .10) were somewhat more frequent with arterial puncture closure devices. The incidence of groin infection was significantly more frequent with VCDs (0.6% vs 0.2%, P = .02). The use of VCD was uniformly associated with a significantly shorter time to hemostasis. Such differences where more evident in patients undergoing percutaneous coronary intervention, whereas these methods were associated with similar rates of adverse events among patients undergoing diagnostic coronary angiography. CONCLUSIONS The use of VCDs is associated with a significantly shorter time to hemostasis and thus may shorten recovery. However, the use of VCDs is associated with a somewhat increased risk of infection, lower limb ischemia/arterial stenosis/device entrapment in the artery, and need of vascular surgery for arterial complications. Further studies are needed to get more conclusive results, particularly in patients at high risk of femoral puncture-related complications.

Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis.

Introduction:Recently, endovascular revascularization (percutaneous transluminal angioplasty [PTA]) has challenged surgery as a method for the salvage of critically ischemic legs (CLI). Comparison of surgical and endovascular techniques in randomized controlled trials is difficult because of differences in patient characteristics. To overcome this problem, we adjusted the differences by using propensity score analysis. Materials and Methods:The study cohort comprised 1023 patients treated for CLI with 262 endovascular and 761 surgical revascularization procedures to their crural or pedal arteries. A propensity score was used for adjustment in multivariable analysis, for stratification, and for one-to-one matching. Results:In the overall series, PTA and bypass surgery achieved similar 5-year leg salvage (75.3% vs 76.0%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%) rates and similar freedom from any further revascularization (77.3% vs 74.4%), whereas freedom from surgical revascularization was higher after bypass surgery (94.3% vs 86.2%, P < 0.001). In propensity-score–matched pairs, outcomes did not differ, except for freedom from surgical revascularization, which was significantly higher in the bypass surgery group (91.4% vs 85.3% at 5 years, P = 0.045). In a subgroup of patients who underwent isolated infrapopliteal revascularization, PTA was associated with better leg salvage (75.5% vs 68.0%, P = 0.042) and somewhat lower freedom from surgical revascularization (78.8% vs 85.2%, P = 0.17). This significant difference in the leg salvage rate was also observed after adjustment for propensity score (P = 0.044), but not in propensity-score–matched pairs (P = 0.12). Conclusions:When feasible, infrapopliteal PTA as a first-line strategy is expected to achieve similar long-term results to bypass surgery in CLI when redo surgery is actively utilized.

Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study.

OBJECTIVES This study sought to explore the incidence and risk factors of thromboembolic complications after cardioversion of acute atrial fibrillation. BACKGROUND Anticoagulation therapy is currently recommended after cardioversion of acute atrial fibrillation in patients with risk factors for stroke, but the implementation of these new consensus-based guidelines has been slow. METHODS A total of 7,660 cardioversions were performed in 3,143 consecutive patients with atrial fibrillation lasting <48 h in 3 hospitals. For this analysis, embolic complications were evaluated during the 30 days after 5,116 successful cardioversions in 2,481 patients with neither oral anticoagulation nor peri-procedural heparin therapy. RESULTS There were 38 (0.7%; 95% confidence interval [CI]: 0.5% to 1.0%) definite thromboembolic events (31 strokes) within 30 days (median 2 days, mean 4.6 days) after cardioversion. In addition, 4 patients suffered transient ischemic attack after cardioversion. Age (odds ratio [OR]: 1.05; 95% CI: 1.02 to 1.08), female sex (OR: 2.1; 95% CI: 1.1 to 4.0), heart failure (OR: 2.9; 95% CI: 1.1 to 7.2), and diabetes (OR: 2.3; 95% CI: 1.1 to 4.9) were the independent predictors of definite embolic events. Classification tree analysis showed that the highest risk of thromboembolism (9.8%) was observed among patients with heart failure and diabetes, whereas patients with no heart failure and age <60 years had the lowest risk of thromboembolism (0.2%). CONCLUSIONS The incidence of post-cardioversion thromboembolic complications is high in certain subgroups of patients when no anticoagulation is used after cardioversion of acute atrial fibrillation. (Safety of Cardioversion of Acute Atrial Fibrillation [FinCV]; NCT01380574).

Risk-scoring Method for Prediction of 30-Day Postoperative Outcome after Infrainguinal Surgical Revascularization for Critical Lower-limb Ischemia: a Finnvasc Registry Study

BackgroundThe aim of the present study was to develop a risk-scoring method for prediction of immediate postoperative outcome after infrainguinal surgical revascularization for critical limb ischemia.MethodsThe Finnvasc registry included data on 3,925 infrainguinal surgical revascularization procedures. This database was randomly divided into a derivation and a validation data set of similar sizes.ResultsIn the overall series, 30-day postoperative mortality and major amputation rates were 3.1% and 6.3%, respectively. The 30-day postoperative mortality and/or limb-loss rate was 9.2%. Diabetes, coronary artery disease, foot gangrene, and urgent operation were independent predictors of 30-day postoperative mortality and/or major lower-limb amputation. A risk score was developed by assigning 1 point each to the latter risk factors. In the derivation data set, the 30-day postoperative mortality/amputation rates in patients with scores of 0, 1, 2, 3, and 4 were 7.7%, 6.4%, 11.1%, 20.4%, and 27.3%, respectively, (P < 0.0001); mortality rates were 1.3%, 2.3%, 4.1%, 7.7%, and 12.1%, respectively, (P < 0.0001); and major amputation rates were 6.4%, 4.3%, 7.1%, 12.7%, and 18.2%, respectively, (P < 0.0001). In the validation data set, the 30-day postoperative mortality/amputation rates in patients with scores of 0, 1, 2, 3, and 4 were 4.8%, 7.5%, 10.1%, 15.9%, and 22.2%, respectively, (P < 0.0001); mortality rates were 0.7%, 2.3%, 4.2%, 5.5%, and 14.8%, respectively, (P < 0.0001); and major amputation rates were 4.6%, 5.3%, 6.4%, 11.0%, and 14.0%, respectively (P = 0.011).ConclusionsThis simple risk-scoring method can be useful to stratify the immediate postoperative outcome of patients undergoing infrainguinal surgical revascularization for critical lower-limb ischemia.

Validation of EuroSCORE II in Patients Undergoing Coronary Artery Bypass Surgery

BACKGROUND The European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) has been recently developed to improve the performance of the original EuroSCORE. Herein we evaluated its discriminatory ability in predicting the immediate and late outcome after coronary artery bypass grafting (CABG). METHODS Complete data on 1,027 patients who underwent isolated CABG were available for validation of EuroSCORE II and to compare its discriminatory ability with the original EuroSCORE and its Finnish modified version. RESULTS EuroSCORE II performed somewhat better (area under the curve [AUC] 0.852, Brier score 0.031) than the original logistic EuroSCORE (AUC 0.838, Brier score 0.034) and its Finnish modified version (AUC 0.825, Brier score 0.034) in predicting operative mortality. The overall expected-to-observed operative mortality ratio for the original logistic EuroSCORE was 1.8, for its Finnish modified version was 0.6, and for EuroSCORE II was 1.2. EuroSCORE II showed expected-to-observed ratios ranging from 1.05 to 1.17 in its highest third quintiles. The best cutoff of EuroSCORE II in predicting operative postoperative mortality was 10% (21.5% vs 1.6%, p<0.0001; sensitivity 91.5%, specificity 60.5%, negative predictive value 98.4%, accuracy of 90.3%). The EuroSCORE II was predictive of de novo dialysis (AUC 0.805), prolonged use of inotropes (AUC 0.748), and intensive care unit stay 5 days or greater (AUC 0.793). The risk of late mortality significantly increased across increasing quintiles of EuroSCORE II (p<0.0001). CONCLUSIONS The EuroSCORE II performs better than its original version in predicting operative mortality and morbidity after isolated CABG. Its ability to predict 30-day mortality in high-risk patients is of particular importance. The EuroSCORE II is also a good predictor of late postoperative survival.

Prospective Comparative Analysis of Colour-Doppler Ultrasound, Contrast-enhanced Ultrasound, Computed Tomography and Magnetic Resonance in Detecting Endoleak after Endovascular Abdominal Aortic Aneurysm Repair

OBJECTIVES To assess the accuracy of colour-Doppler ultrasound (CDUS), contrast-enhanced ultrasonography (CEUS), computed tomography angiography (CTA) and magnetic resonance angiography (MRA) in detecting endoleaks after endovascular abdominal aortic aneurysm repair (EVAR). DESIGN Prospective, observational study. MATERIALS AND METHODS From December 2007 to April 2009, 108 consecutive patients who underwent EVAR were evaluated with CDUS, CEUS, CTA and MRA as well as angiography, if further treatment was necessary. Sensitivity, specificity, accuracy and negative predictive value of ultrasound examinations were compared with CTA and MRA as the reference standards, or with angiography when available. RESULTS Twenty-four endoleaks (22%, type II: 22 cases, type III: two cases) were documented. Sensitivity and specificity of CDUS, CEUS, CTA, and MRA were 58% and 93%, 96% and 100%, 83% and 100% and 96% and 100% respectively. CEUS allowed better classification of endoleaks in 10, two and one patients compared with CDUS, CTA and MRA, respectively. CONCLUSIONS The accuracy of CEUS in detecting endoleaks after EVAR is markedly better than CDUS and is similar to CTA and MRA. CEUS seems to be a feasible tool in the long-term surveillance after EVAR, and it may better classify endoleaks missed by other imaging techniques.

Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: A systematic review and meta-analysis of 48 studies

OBJECTIVE This study was planned to evaluate the outcome of patients ≥80 years old undergoing isolated conventional aortic valve replacement (AVR). METHODS Systematic review of the literature and meta-analysis of data on octogenarians and nonagenarians who underwent isolated AVR were performed. RESULTS The literature search yielded 48 observational studies reporting on 13 216 patients ≥80 years old. Pooled proportion of immediate postoperative mortality was 6.7 % (95% CI 5.8-7.5, 47 studies, 13,092 patients), and it was 5.8% (95% CI 4.8-6.9) in 18 studies with a mid-date from 2000 to 2006 and 7.5% (95% CI 6.8-8.2) in 30 studies with a mid-date from 1982 to 1999 (P = .004). Pooled proportion of postoperative stroke was 2.4% (95% CI 2.1-2.7, 21 studies, 8,436 patients), that of postoperative dialysis was 2.6% (95% CI 1.6-3.8, 10 studies, 1,945 patients), and that of postoperative implantation of a pacemaker was 4.6% (95% CI 3.6-5.8, 6 studies, 1,470 patients). Pooled survival rates at 1, 3, 5, and 10 years after isolated AVR were 87.6%, 78.7%, 65.4%, and 29.7%, respectively. CONCLUSIONS Immediate postoperative mortality and morbidity after isolated AVR in patients ≥80 years old are rather low. Postoperatively mortality decreased even further in the most recent series. Importantly, isolated AVR in these high-risk patients was associated with good late survival. These findings suggest that advanced age alone cannot be considered as a contraindication to conventional isolated AVR and that any new valve prosthesis implanted in these patients should be durable enough to guarantee the results so far offered by conventional surgery.

Meta-analysis of randomised trials comparing the effectiveness of miniaturised versus conventional cardiopulmonary bypass in adult cardiac surgery

Objectives: The aim of this meta-analysis is to summarise the results of prospective, randomised studies comparing miniaturised (Mini-CPB) versus conventional cardiopulmonary bypass (C-CPB). Design: Meta-analysis of randomised trials. Methods: After retrieval from literature search of 33 comparative studies, 13 studies have been included in this meta-analysis. Results: There were 562 patients in the Mini-CPB group and 599 in the C-CPB group. Mini-CPB was associated with a somewhat lower mortality during the immediate postoperative period (1.1% vs 2.2%, OR 0.58, 95% CI 0.23 to 1.47, p = 0.25). Postoperative stroke rate was significantly lower in the Mini-CPB group (0.2% vs 2.0%, OR 0.25, 95% CI 0.06 to 1.00, p = 0.05). The length of stay in intensive care unit was similar in the study groups (mean difference: −0.01, 95% CI −0.14 to 0.12, p = 0.87). Mini-CPB was associated with a significantly lower amount of postoperative blood loss (mean difference: −96.55, 95% CI −147.48 to −45.62, p = 0.0002) along with a higher platelet count 6 h after surgery (mean difference: 23 480, 95% CI 2 130 to 44 830, p = 0.03). The risk of resternotomy for bleeding was similar in the study groups (OR 1.06, 95% CI 0.32 to 3.57, p = 0.92). Conclusions: This meta-analysis suggests that the use of Mini-CPB may be associated with lower risk of postoperative stroke and blood losses and with a somewhat decreased mortality. However, due to the large heterogeneity of methods and the small number of studies and patients evaluated so far, larger and homogeneous studies should be performed to obtain more conclusive results on the safety and efficacy of Mini-CPB.

Angiosome-targeted lower limb revascularization for ischemic foot wounds: systematic review and meta-analysis.

OBJECTIVE The efficacy of angiosome-targeted revascularization to achieve healing of ischemic tissue lesions of the foot and limb salvage is controversial. This issue has been investigated in this meta-analysis. METHODS A systematic review of the literature and meta-analysis of data on angiosome-targeted lower limb revascularization for ischemic tissue lesions of the foot were performed. RESULTS Nine studies reported on data of interest. No randomized controlled study was available. There were 715 legs treated by direct revascularization according to the angiosome principle and 575 legs treated by indirect revascularization. The prevalence of diabetes was >70% in each study group and three studies included only patients with diabetes. The risk of unhealed wound was significantly lower after direct revascularization (HR 0.64, 95% CI: 0.52-0.8, I2 0%, four studies included) compared with indirect revascularization. Direct revascularization was also associated with significantly lower risk of major amputation (HR 0.44, 95% CI: 0.26-0.75, I2 62%, eight studies included). Pooled limb salvage rates after direct and indirect revascularization were at 1 year 86.2% vs. 77.8% and at 2 years 84.9% vs. 70.1%, respectively. The analysis of three studies reporting only on patients with diabetes confirmed the benefit of direct revascularization in terms of limb salvage (HR 0.48, 95% CI: 0.31-0.75, I2 0%). CONCLUSIONS The results of the present meta-analysis suggest that, when feasible, direct revascularization of the foot angiosome affected by ischemic tissue lesions may improve wound healing and limb salvage rates compared with indirect revascularization. Further studies of better quality and adjusted for differences between the study groups are needed to confirm the present findings.

Elective Endovascular vs. Open Repair for Abdominal Aortic Aneurysm in Patients Aged 80 Years and Older: Systematic Review and Meta-Analysis

OBJECTIVES Endovascular treatment (EVAR) of abdominal aortic aneurysm (AAA) is thought to be of benefit, particularly in patients aged ≥80 years. This issue was investigated in the present meta-analysis. DESIGN The study design involved a systematic review of the literature and meta-analysis. METHODS Systematic review of the literature and meta-analysis of data on elective EVAR vs. open repair of AAA in patients aged ≥80 years were performed. RESULTS Six observational studies reporting on 13,419 patients were included in the present analysis. Pooled analysis showed higher immediate postoperative mortality after open repair compared with EVAR (risk ratio 3.87, 95% confidence interval (CI) 3.19-4.68; risk difference, 6.2%, 95%CI 5.4-7.0%). The pooled immediate mortality rate after open repair was 8.6%, whereas it was 2.3% after EVAR. Open repair was associated with a significantly higher risk of postoperative cardiac, pulmonary and renal complications. Pooled analysis of three studies showed similar overall survival at 3 years after EVAR and open repair (risk ratio 1.10, 95%CI 0.77-1.57). CONCLUSIONS The results of this meta-analysis suggest that elective EVAR in patients aged ≥80 years is associated with significantly lower immediate postoperative mortality and morbidity than open repair and should be considered the treatment of choice in these fragile patients. These results indicate also that, when EVAR is not feasible, open repair can be performed with acceptable immediate and late survival in patients at high risk of aneurysm rupture.