Mattia Glauber

Diabetic and Nondiabetic Patients With Left Main and/or 3-Vessel Coronary Artery Disease: Comparison of Outcomes With Cardiac Surgery and Paclitaxel-Eluting Stents

OBJECTIVES This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease. BACKGROUND Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial. METHODS The SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG. RESULTS The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001). CONCLUSIONS Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972).

Minimally Invasive and Conventional Aortic Valve Replacement: A Propensity Score Analysis

BACKGROUND The study aimed to compare the short-term results of aortic valve replacement through minimally invasive and sternotomy approaches. METHODS This is a retrospective, observational, cohort study of prospectively collected data on 709 patients undergoing isolated primary aortic valve replacement between 2004 and 2011. Of these, 338 were performed through either right anterior minithoracotomy or upper ministernotomy. With propensity score matching, 182 patients (minimally invasive group) were compared with 182 patients in conventional sternotomy (control group). RESULTS After propensity matching, the 2 groups were comparable in terms of preoperative characteristics. Cardiopulmonary bypass time (117.5 vs 104.1 min, p<0.0001) and aortic cross-clamping time (83.8 vs 71.3 min, p<0.0001) were longer in the minimally invasive group, with no difference in length of stay (median 6 vs 5 days, p=0.43), but shorter assisted ventilation time (median 8 vs 7 hours, p=0.022). Overall in-hospital mortality was identical between the groups (1.64 vs 1.64%, p=1.0). No difference in the incidence of major and minor postoperative complications and related morbidity was observed. Minimally invasive aortic valve replacement was associated with a lower incidence of new onset postoperative atrial fibrillation (21% vs 31%, p=0.04). Reduction of the complication rate was observed. Median transfusion pack per patient was higher in the control group (2 vs 1 units, p=0.04). CONCLUSIONS Our experience shows that mini-access isolated aortic valve surgery is a reproducible, safe, and effective procedure and reduces assisted ventilation duration, the need for blood product transfusion, and incidence of post-surgery atrial fibrillation.

Minimally invasive aortic valve replacement with Perceval S sutureless valve: early outcomes and one-year survival from two European centers.

OBJECTIVE The aim of our study was to evaluate the early outcomes and 1-year survival of patients undergoing minimally invasive aortic valve replacement with the Perceval S sutureless valve for severe aortic stenosis. METHODS From March 2010 to March 2013, 281 high-risk patients underwent minimally invasive aortic valve replacement with the Perceval S sutureless valve through either right anterior minithoracotomy (n = 164) or upper ministernotomy (n = 117) at 2 cardiac centers. RESULTS The overall in-hospital mortality was 0.7% (2 patients). The overall median cardiopulmonary bypass and crossclamp time was 81 minutes (interquartile range, 68-98) and 48 minutes (interquartile range, 37-60), respectively. Postoperative stroke occurred in 5 patients (1.8%). The incidence of paravalvular leak greater than 1 of 4 and atrioventricular block requiring pacemaker implantation was 1.8% (5 patients) and 4.2% (12 patients), respectively. No migration occurred, and the mean postoperative gradient was 13 ± 4 mm Hg. At a median follow-up of 8 months (interquartile range, 4-14), the overall survival was 90%. CONCLUSIONS Minimally invasive aortic valve replacement with the Perceval S sutureless valve in high-risk patients is a safe and reproducible procedure associated with excellent hemodynamic results, postoperative outcomes, and 1-year survival.

Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone” between transcatheter aortic valve implantation and conventional surgery: A propensity-matched, multicenter analysis

OBJECTIVE The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. METHODS We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. RESULTS Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). CONCLUSIONS This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

Minimally invasive aortic valve replacement via right anterior minithoracotomy: Early outcomes and midterm follow-up

FIGURE 1. A, Axial plane shows the right position of the aorta with respect t feasibility of cannulating the ascending aorta and replacing the aortic valve throu ment. AC, Aortic cannula; AT, aortic tourniquet; XC, crossclamp; LVV, left ven From the Department of Cardiothoracic Surgery, Fondazione G. Monasterio, CNR—Regione Toscana, Massa, Italy. Disclosures: Authors have nothing to disclose with regard to commercial support. Received for publication Jan 28, 2011; revisions received April 26, 2011; accepted for publication May 17, 2011; available ahead of print July 4, 2011. Address for reprints: Antonio Miceli, MD, Fondazione G. Monasterio, CNR-regione Toscana, 54100 Massa, Italy (E-mail: antoniomiceli79@alice.it). J Thorac Cardiovasc Surg 2011;142:1577-9 0022-5223/

Sutureless aortic valve replacement: a systematic review and meta-analysis.

36.00 Copyright 2011 by The American Association for Thoracic Surgery doi:10.1016/j.jtcvs.2011.05.011

Clinical and hemodynamic outcomes of ''all-comers'' undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

BACKGROUND Sutureless aortic valve replacement (SU-AVR) has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to reduce cross-clamp and cardiopulmonary bypass (CPB) duration and thereby improve surgical outcomes and facilitate a minimally invasive approach suitable for higher risk patients. The present systematic review and meta-analysis aims to assess the safety and efficacy of SU-AVR approach in the current literature. METHODS Electronic searches were performed using six databases from their inception to January 2014. Relevant studies utilizing sutureless valves for aortic valve implantation were identified. Data were extracted and analyzed according to predefined clinical endpoints. RESULTS Twelve studies were identified for inclusion of qualitative and quantitative analyses, all of which were observational reports. The minimally invasive approach was used in 40.4% of included patients, while 22.8% underwent concomitant coronary bypass surgery. Pooled cross-clamp and CPB duration for isolated AVR was 56.7 and 46.5 minutes, respectively. Pooled 30-day and 1-year mortality rates were 2.1% and 4.9%, respectively, while the incidences of strokes (1.5%), valve degenerations (0.4%) and paravalvular leaks (PVL) (3.0%) were acceptable. CONCLUSIONS The evaluation of current observational evidence suggests that sutureless aortic valve implantation is a safe procedure associated with shorter cross-clamp and CPB duration, and comparable complication rates to the conventional approach in the short-term.

Traversing the learning curve in minimally invasive heart valve surgery: a cumulative analysis of an individual surgeon's experience with a right minithoracotomy approach for aortic valve replacement

OBJECTIVE The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). METHODS From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). RESULTS All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. CONCLUSIONS TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

Aortic Valve Replacement Through Right Anterior Minithoracotomy: Can Sutureless Technology Improve Clinical Outcomes?

OBJECTIVE Cumulative sum (CUSUM) analysis, first developed to assess industrial quality control, was then used to monitor cardiac surgery performance more than 10 years ago. This analysis may be more sensitive than the standard statistical tools to analyse surgical results. The aim of this study is to assess a single surgeons learning curve with right anterior minithoracotomy (RAMT) for aortic valve replacement (AVR) using risk-adjusted CUSUM curves and to compare the short- and medium-term results of these patients with a propensity-matched cohort of patients who had standard AVR (SAVR). METHODS The first 100 patients who underwent RAMT by a single surgeon were analysed, using risk-adjusted CUSUM curves. Predicted risks of failure for individual patients were derived from our institutional database, using logistic regression modelling. Perioperative death or one or more of 10 adverse events constituted failure. Finally, RAMT patients were matched to 100 SAVR patients operated by the same surgeon in the same period, using a propensity score analysis. RESULTS The authors RAMT experience was associated with a low risk of cumulative failures from the outset, and no learning curve effect was observed. A cluster of surgical failure was individuated at the end of the CUSUM curve (between patients 90 and 100). The predicted risk of failure for the study population constantly increased over the time. After propensity score matching, no baseline differences were observed between RAMT and SAVR patients. The mortality rate was similar between groups (P = 0.8). However, the RAMT group had a lower need for mechanical-assisted ventilation (P = 0.02), transfusion requirements (P = 0.001), post-operative atrial fibrillation (P = 0.01) and post-operative intensive care unit and hospital stay (P = 0.001). Three-year survival was similar between groups (RAMT 94.5% vs. SAVR 92.8%). CONCLUSIONS AVR can be safely performed through an RAMT with results comparable with the standard sternotomy technique. Patients undergoing this technique are not exposed to an increased operative risk also during the surgeons initial experience. CUSUM analysis is a valuable tool to assess the learning curve of new surgical techniques and to implement continuous performance monitoring.

Biological features (inflammation and neoangiogenesis) and atherosclerotic risk factors in carotid plaques and calcified aortic valve stenosis: two different sites of the same disease?

BACKGROUND The impact of sutureless prosthesis on the clinical outcome in minimally invasive aortic valve replacement is still unclear. We assessed mid-term outcomes of the sutureless and conventional valves implanted through right anterior minithoracotomy. METHODS Five hundred fifteen patients undergoing primary aortic valve replacement through a right anterior minithoracotomy (269 conventional versus 246 sutureless prostheses) between 2004 and 2014 were reviewed. The most common sutured prostheses were Carpentier-Edwards Perimount and Medtronic Mosaic, and the Sorin Perceval S mainly composed the sutureless prosthesis group. One hundred thirty-three pairs of patients were propensity matched and retrospectively analyzed. RESULTS Cardiopulmonary bypass (p<0.0001) and cross-clamping (p<0.0001) times were shorter in the sutureless group (S group). We observed the same in-hospital mortality (1 versus 2; p=0.62) and incidence of postoperative stroke and pacemaker implant between the groups, but shorter duration of mechanical ventilation (6 versus 7 hours; p=0.001) in the S group. Generally, larger prostheses were implanted in the S group (p<0.0001). Follow-up was longer (p<0.0001) for sutured valves: 52 versus 15 months (overall median, 21 months). Overall Kaplan-Meier survival rate was 87.2% versus 97.0% (p=0.33) and 50% versus 100% (p=0.02) in elderly patients for sutured versus sutureless prostheses, respectively. Freedom from reoperation at follow-up (p=0.64) and transaortic gradients (12 versus 11 mm Hg; p=0.78) did not differ in the two groups. CONCLUSIONS In the present limited cohort of patients, sutureless prostheses reduced operative times for aortic valve replacement and the duration of mechanically assisted ventilation and might have influenced early and mid-term survival. Larger studies are needed to confirm our data and compare long-term outcomes.