Francesco Pollari

Better Short-Term Outcome by Using Sutureless Valves: A Propensity-Matched Score Analysis

BACKGROUND Sutureless aortic valve prostheses have the potential of shortening ischemic time. However, whether shorter operative times may also result in improved patient outcomes and have an effect on hospital costs remains to be established. METHODS From March 2010 to April 2013, 566 patients underwent aortic valve replacement with bioprostheses; of these, 166 received a sutureless valve, and 400 received a stented valve. Redo and associated procedures were included. A propensity-score analysis was used to create two groups (sutureless and stented) with 82 matched pairs with comparable preoperative characteristics. Hospital outcome, follow-up, and health care resource consumption were compared. RESULTS There were 3 hospital deaths in the stented group and 2 in the sutureless group (p=0.65). Aortic cross-clamp, cardiopulmonary bypass, and operation times were significantly shorter in the sutureless group (p<0.001). Patients in the sutureless group required blood transfusion less frequently (1.2±1.3 vs 2.5±3.7 units, p=0.005), with a similar need for reexploration for bleeding (2 vs 5, p=0.221). The sutureless group had a shorter intensive care unit stay (2.0±1.2 vs 2.8±1.3 days, p<0.001), hospital stay (10.9±2.7 vs 12.4±4.4 days, p=0.001) and intubation time (9.5±4.6 vs 16.6±6.4 hours, p<0.001), and a lower incidence of postoperative atrial fibrillation (p=0.015), pleura effusions (p=0.024), and respiratory insufficiency (p=0.016). Pacemaker implantation and occurrence of neurologic events were similar between groups (p>0.05). A lower rate of postoperative complications resulted in reduced resource consumption in the sutureless group for diagnostics (€2,153 vs €1,387), operating room (€5,879 vs €5,527), and hospital stay (€9,873 vs €6,584), with a total cost saving of approximately 25% (€17,905 vs €13,498). CONCLUSIONS A shorter procedural time in the sutureless group is associated with better clinical outcomes and reduced hospital costs.

Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: Results of a multicenter study

OBJECTIVE The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy). METHODS This is a retrospective analysis of 314 patients (mean age, 77.9 ± 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% ± 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers. RESULTS The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 ± 20 minutes (isolated procedure, 39 ± 15 minutes; concomitant coronary surgery, 52 ± 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2% (1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively (P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively. CONCLUSIONS The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis.

Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis

OBJECTIVES The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy with a sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis. METHODS Patients who underwent primary isolated non-emergent AVR at six European centres were included in the study. Of these, 182 (32%) underwent a ministernotomy with a sutureless bioprosthesis (ministernotomy sutureless group) and 383 (68%) a full sternotomy with a stented bioprosthesis (full sternotomy stented group). Propensity score matching was used to reduce selection bias. RESULTS In the overall cohort, 30-day mortality was 1.6 and 2.1%, and 2-year survival was 92 and 92% in the ministernotomy sutureless group and in the full sternotomy stented group, respectively. Propensity score matching resulted in 171 pairs with similar characteristics and operative risk. Aortic cross-clamp (40 vs 65 min, P < 0.001) and cardiopulmonary bypass time (69 vs 87 min, P < 0.001) were shorter in the ministernotomy sutureless group. Patients undergoing ministernotomy received less packed red blood cells but the risk for postoperative permanent pacemaker implantation was higher. There were no differences regarding 30-day mortality or 2-year survival between the two groups. CONCLUSIONS AVR through a ministernotomy with implantation of a sutureless bioprosthesis was associated with shorter aortic cross-clamp and cardiopulmonary bypass time and less transfusion of packed red blood cells, but a higher risk for postoperative permanent pacemaker implantation compared with a full sternotomy with a stented bioprosthesis.

Ministernotomy Versus Full Sternotomy Aortic Valve Replacement With a Sutureless Bioprosthesis: A Multicenter Study

BACKGROUND The aim of this study was to analyze early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) with the sutureless Perceval bioprosthesis (Sorin Biomedica Cardio Srl, Salluggia, Italy) performed through ministernotomy compared with full sternotomy. METHODS This was a study of 267 consecutive patients who underwent isolated AVR with the sutureless Perceval bioprosthesis between 2007 and 2014 at 6 European centers. Of these, 189 (70.8%) were performed through ministernotomy and 78 through a full sternotomy. Propensity score matching was used to reduce selection bias. RESULTS In the overall cohort of ministernotomy and full sternotomy patients, in-hospital mortality was 1.1% and 2.6% and 2-year survival was 92% and 91%, respectively. Propensity score matching resulted in 56 pairs with similar characteristics and operative risk. Aortic cross-clamp (44 minutes in both groups, p = 0.931) and cardiopulmonary bypass time (69 vs 74 minutes, p = 0.363) did not differ between the groups. Apart from higher values in the ministernotomy group for postoperative peak gradients (28.1 vs 23.3 mm Hg, p = 0.026) and mean aortic valve gradients (15.2 vs 11.7 mm Hg, p = 0.011), early postoperative outcomes did not differ in the propensity-matched cohort. There were no differences in the in-hospital mortality rate or 2-year survival between the groups. CONCLUSIONS AVR with the sutureless Perceval bioprosthesis through a ministernotomy was a safe and reproducible procedure that was not associated with prolonged aortic cross-clamp or cardiopulmonary bypass time compared with a full sternotomy. Early postoperative outcomes and 2-year survival were comparable between patients undergoing ministernotomy and full sternotomy.

Sutureless Valve Implantation via Mini J-Sternotomy: A Single Center Experience with 2 Years Mean Follow-up.

INTRODUCTION Despite increased operative time, minimally invasive cardiac surgery is associated with a lower morbidity than conventional aortic valve replacement (AVR). On the other hand, sutureless aortic bioprostheses have the potential of simplifying implantation, as it reduces the ischemic time. Our aim was to investigate the outcome of a sutureless AVR through a mini-sternotomy. MATERIALS AND METHODS Since March 2010, a total of 262 patients affected by aortic valve stenosis underwent AVR with a sutureless bioprosthesis (Perceval, Sorin Group, Saluggia, Italy). Of these, 145 patients (mean age 77.8 ± 4.7 years, 80 women) underwent surgical AVR through a mini J-sternotomy. Clinical and echocardiographic data were evaluated. RESULTS Patients received a size: S(12), M(49), L(67), or XL(17) prostheses, either as isolated (131) or combined procedures (14) including 2 redo patients who had undergone coronary artery bypass grafting via full sternotomy previously. Mean logistic EuroSCORE (I) was 9.9 ± 5.9%, and mean aortic cross-clamp time was 38 ± 12 minutes (35 ± 11 minutes in isolated procedures). Two conversions to full sternotomy were necessary because of bleeding. Thirty-day mortality was 2.1% (all noncardiac deaths); mean hospital stay was 11.6 ± 4.9 days. We recorded 11 pacemaker implantations (7.6%). At follow-up (23.5 ± 14.4 months), five patients were dead (three noncardiac and two cardiac deaths). At echocardiographic control, mean transprosthetic gradients were as follows: 12.8 ± 4.9, 12.5 ± 4.5, 11.8 ± 4.7 mm Hg, postoperatively at 6 months, 1 year, and 2 years, respectively. No paravalvular leaks were recorded. CONCLUSION The sutureless bioprosthesis shows satisfactory clinical and hemodynamic results. Owing to its simple implantation technique, it represents a good support for minimally invasive access surgery via J-sternotomy.

Left ventricular mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis: preliminary results

OBJECTIVES Left ventricular (LV) hypertrophy in aortic stenosis (AS) is considered a compensatory response helping maintain systolic function, but constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to assess the degree of LV mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis (Sorin Group, Saluggia, Italy). METHODS Between March 2010 and July 2012, 78 patients with symptomatic AS underwent isolated aortic valve replacement (AVR) with the Perceval bioprosthesis. Mean age was 77.1 ± 5.3 years, 46 patients were female (59%) and mean logistic EuroSCORE was 11 ± 7.5%. Echocardiography was performed preoperatively, at discharge, and at follow-up (mean 13.5 ± 7.3 months). LV mass was calculated using the Devereux formula and indexed to body surface area. RESULTS There was 1 in-hospital non-cardiac death and 3 late deaths. LV mass index decreased from 148.4 ± 46 g/m(2) at baseline to 119.7 ± 38.5 g/m(2) at follow-up (P = 0.002). No significant changes were observed in LV hypertrophy and/or relative wall thickness >0.42 as well as in LV ejection fraction. Mean aortic gradient decreased from 49.5 ± 15.8 mmHg at baseline to 11.6 ± 5.1 mmHg at discharge and 8.3 ± 4.4 mmHg at follow-up (P < 0.001), resulting in significant clinical improvement. No moderate or severe paravalvular leakage was observed at discharge and at follow-up. CONCLUSIONS In AS patients, isolated AVR with the Perceval sutureless bioprosthesis is associated with significant LV mass regression at 1-year follow-up. However, longer-term follow-up is necessary to confirm these findings.

Risk factors for paravalvular leak after transcatheter aortic valve replacement

Objective: To assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation in a large single‐center cohort, including measurement of aortic valve calcification using a reproducible method. Methods: We retrospectively analyzed preoperative contrast‐enhanced multidetector computed tomography scans of patients who underwent transcatheter aortic valve implantation in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve, left ventricular outflow tract, and device landing zone. Results: Overall, 539 patients were included in the study who had experience with 4 prothesis types (SapienXT [Edwards Lifesciences, Irvine, Calif] [n = 192], Sapien3 [Edwards Lifesciences] [n = 206], CoreValve EvolutR [Medtronic, Minneapolis, Minn] [n = 44], and Acurate [Symetis, Ecublens, Switzerland] [n = 97]). Median calcium volume in the device landing zone was 757 mm3, with no significant differences among the 4 prosthesis groups. None of the patients had severe PVL. The overall incidence of mild‐to‐moderate PVL was 15.8% (95% confidence interval [CI], 12.8%‐19.1%). On multivariate logistic regression, device landing zone calcification (P = .00006; odds ratio for an increase of 100 mm3, 1.08; 95% CI, 1.04‐1.13) and use of the CoreValve (P = .0028; odds ratio, 4.1; 95% CI, 1.6‐10 with SapienXT as reference) prosthesis were found to be associated with mild or greater PVL. In contrast, degree of oversizing (P = .002; odds ratio, 0.97; 95% CI, 0.95‐0.99), and use of Sapien3 (P = .00005; odds ratio, 0.23; 95% CI, 0.11‐0.47 with SapienXT as reference) were associated with a lower incidence of mild or greater PVL. Conclusions: Aortic calcification volume in the device landing zone is associated with residual PVL after transcatheter aortic valve implantation. When taking calcification into account, the balloon‐expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL.

[Double mitro-aortic valve replacement in a high-risk patient: the sutureless way].

The mitro-aortic disease in high-risk patients is a challenge for the cardiac surgeon because minimally invasive techniques are difficult to apply. We report the first case in the literature of a 78-year-old woman affected by severe rheumatic steno-insufficiency of aortic and mitral valves at high surgical risk. The patient was successfully treated by mitral valve replacement with a biological prosthesis and concomitant aortic valve replacement with a sutureless prosthesis.

Sutureless Aortic Valve Replacement in Complex Procedures: What Is the Benefit?

Objectives: Sutureless aortic valve replacement (AVR) has been associated with excellent hemodynamic and clinical outcomes, but less is known on the outcomes of the patients operated on for complex surgery. We aimed to evaluate the early outcomes and 1-year follow-up of patients undergoing AVR with a self expandable sutureless valve and concomitant procedures. Methods: Two European centers participated in the study, with a total number of self expandable aortic valve prosthesis implants equal to 682 (time frame May 2010 - May 2014). Of them, 168 (mean age 76.7 ± 6.4 years, female gender 93 (55.4%)) have been operated on for concomitant procedures.. Minimally invasive approach was chosen for 30 (17.9%) patients (14 ministernotomies and 16 right anterior minithoracotomies). 12 (7.1%), 45 (26.8%), 96 (57.1%) and 15 (8.9%) patients received 21 mm, 23 mm, 25 mm and 27 mm size prostheses, respectively. Common implantation technique was implemented in all the patients; coronary artery bypass grafting (if any) and mitral valve repair/replacement (if any) were performed prior to aortotomy and aortic valve replacement. Results: Overall surgical mortality was 7 (4.2%). Cardiopulmonary bypass time and aortic cross-clamp time were 136.3 ± 48 (median and interquartile range: 92 (71–114 minute)) and 94.3 ± 33 (74 (52–98)) min, respectively. Median assisted ventilation time was 10 (range 3–380) h. Revision for bleeding was necessary in 11 (6.5%) patients. 2 (1.2%) patients developed permanent neurological deficit following stroke. In 3 (1.8%) patients transient ischemic attack was observed. In 5 (3.0%) patients acute renal failure developed postoperatively. Permanent pacemaker implant due to advanced atrioventricular block was required in 16 (9.5%). 6/161 (3.7%) patients died during follow-up (mean duration 14 ± 11 months). Mean transprosthetic gradient averaged 13.6 ± 5.4 mm Hg. Conclusion: Good early outcomes, comparable to those of tissue valve prostheses, can be achieved in patients, undergoing sutureless AVR and associated procedures. Shortening the operative times, the self expandable sutureless prosthesis amplifies the armamentarium of aortic valve prostheses and represents a useful tool for associated and complex procedures.

Sorin Perceval S aortic valve implantation through a mini-sternotomy approach.

We describe a case of a 78-year-old female with chronic obstructive pulmonary disease (COPD), diabetes, obesity, impaired renal function and severe aortic valve stenosis with associated insufficiency (Video 1). The patient was symptomatic for dyspnea (class NYHA III). Her medical history included breast cancer treated with mastectomy two years prior. The logistic Euroscore was 19.17%. After echocardiographic evaluation which excluded significant coronary artery disease, a minimally invasive sutureless aortic valve replacement (AVR) was planned.