Marco Vola

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

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.

Biaxial rupture properties of ascending thoracic aortic aneurysms.

UNLABELLED Although hundreds of samples obtained from ascending thoracic aortic aneurysms (ATAA) of patients undergoing elective surgical repair have already been characterized biomechanically, their rupture properties were always derived from uniaxial tensile tests. Due to their bulge shape, ATAAs are stretched biaxially in vivo. In order to understand the biaxial rupture of ATAAs, our group developed a novel methodology based on bulge inflation and full-field optical measurements. The objective of the current paper is threefold. Firstly, we will review the failure properties (maximum stress, maximum stretch) obtained by bulge inflation testing on a cohort of 31 patients and compare them with failure properties obtained by uniaxial tension in a previously published study. Secondly, we will investigate the relationship between the failure properties and the age of patients, showing that patients below 55years of age display significantly higher strength. Thirdly, we will define a rupture risk based on the extensibility of the tissue and we will show that this rupture risk is strongly correlated with the physiological elastic modulus of the tissue independently of the age, ATAA diameter or the aortic valve phenotype of the patient. STATEMENT OF SIGNIFICANCE Despite their medical importance, rupture properties of ascending thoracic aortic aneurysms (ATAA) subjected to biaxial tension were inexistent in the literature. In order to address this lack, our group developed a novel methodology based on bulge inflation and full-field optical measurements. Here we report rupture properties obtained with this methodology on 31 patients. It is shown for the first time that rupture occurs when the stretch applied to ATAAs reaches the maximum extensibility of the tissue and that this maximum extensibility correlates strongly with the elastic properties. The outcome is a better detection of at-risk individuals for elective surgical repair.

First human totally endoscopic aortic valve replacement: An early report

FIGURE 1. A, Preoperative computed tomographic images of patient 2 demonst patients with insufficient periaortic working space (<2 cm between the inferior mar distance between the aortic clamp, the cardioplegia needle, and the aortotomy, an should also be excluded (the central line of the ascending aorta should be longer t avoided; the central axis of the proximal aortic root (bottom left, red line), togethe should create anangle not exceeding45 , to avoidany tractiononto themargins of th The last panel (bottom right) shows a 3-dimensional reconstruction of the computed operative photograph of patient 2 shows operating field and trocar positioning. The ative trocar (15mm) is in the third, a percutaneous transthoracic aortic clamp is in th vein venting line and purse-string with carbon dioxide insufflation line are in the fi From the Department of Cardiovascular Surgery, Centre Hospitalier Universitaire de SaintEtienne, Saint-Etienne, France. Disclosures: Marco Vola reports consulting and lecture fees from Medtronic. JeanFrancois Fuzellier reports lecture fees from Medtronic. All other authors have nothing to disclose with regard to commercial support. Received for publication Aug 12, 2013; revisions received Sept 29, 2013; accepted for publication Oct 6, 2013; available ahead of print Dec 2, 2013. Address for reprints: Marco Vola, MD, PhD, Cardiovascular Surgery Unit, Centre Hospitalier Universitaire de SaintEtienne Nord, 42055 Saint-Etienne cedex, France (E-mail: marco.vola@univ-st-etienne.fr). J Thorac Cardiovasc Surg 2014;147:1091-3 0022-5223/

Sutureless Prostheses and Less Invasive Aortic Valve Replacement: Just an Issue of Clamping Time?

36.00 Copyright 2014 by The American Association for Thoracic Surgery http://dx.doi.org/10.1016/j.jtcvs.2013.10.010

Sutureless Aortic Valve Replacement International Registry (SU-AVR-IR): design and rationale from the International Valvular Surgery Study Group (IVSSG)

BACKGROUND Recently, sutureless aortic bioprostheses have been increasingly adopted to facilitate minimally invasive aortic valve replacement. We aimed at evaluating the impact of the transition from conventional bioprostheses to the routine use of the 3f Enable prosthesis (Medtronic ATS Medical, Minneapolis, MN) for aortic valve replacement through ministernotomy. METHODS Between November 2009 and November 2012, 83 consecutive minimally invasive aortic valve replacement procedures were performed in our institution by the same surgeon through an upper T-shaped ministernotomy. The earliest 42 patients (group A) received a conventional bioprosthesis, and the later 41 patients (group B) received the sutureless 3f Enable valve. Aortic clamping and cardiopulmonary bypass times, early outcomes, and valve hemodynamics were compared. RESULTS There was no statistical intergroup difference in baseline characteristics. In-hospital mortality was 1% (a single nonvalve-related death). Average aortic clamping times in group A and group B were, respectively, 85 ± 17 and 47 ± 11 minutes (p < 0.0001); the cardiopulmonary bypass time was 108 ± 21 and 69 ± 15 minutes, respectively (p < 0.0001). There were three paravalvular leakages in group A (grade I) and four in group B (two grade I, and two grade II); three pacemaker implantations occurred in group B (p = 0.07); mean transvalvular gradient at discharge was 16.9 ± 9.1 mm Hg in group A and 11.4 ± 4.3 mm Hg in group B (p = 0.0007). During follow-up (average 25.5 ± 12.9 months), one structural valve deterioration was registered in group A, and was treated with a valve-in-valve procedure. CONCLUSIONS In our initial experience, the sutureless 3f Enable technology significantly reduced the clamping and cardiopulmonary bypass times, as well as the mean transvalvular gradient in aortic valve replacement through ministernotomy.

Video‐Assisted Minithoracotomy Approach: Technical Developments Towards Totally Endoscopic Sutureless Aortic Valve Replacement

BACKGROUND Sutureless aortic valve replacement (SU-AVR) is an innovative approach which shortens cardiopulmonary bypass and cross-clamp durations and may facilitate minimally invasive approach. Evidence outlining its safety, efficacy, hemodynamic profile and potential complications is replete with small-volume observational studies and few comparative publications. METHODS Minimally invasive aortic valve surgery and high-volume SU-AVR replacement centers were contacted for recruitment into a global collaborative coalition dedicated to sutureless valve research. A Research Steering Committee was formulated to direct research and support the mission of providing registry evidence warranted for SU-AVR. RESULTS The International Valvular Surgery Study Group (IVSSG) was formed under the auspices of the Research Steering Committee, comprised of 36 expert valvular surgeons from 27 major centers across the globe. IVSSG Sutureless Projects currently proceeding include the Retrospective and Prospective Phases of the SU-AVR International Registry (SU-AVR-IR). CONCLUSIONS The global pooling of data by the IVSSG Sutureless Projects will provide required robust clinical evidence on the safety, efficacy and hemodynamic outcomes of SU-AVR.

Robotic total endoscopic sutureless aortic valve replacement: proof of concept for a future surgical setting

Interest in sutureless aortic bioprostheses is growing because of the potential advantages that such devices can bring in facilitating minimally invasive approaches. Video assistance can potentially enhance details of decalcification and sutureless valve sizing. We review the feasibility of sutureless aortic valve replacement (AVR) via a minimally invasive video‐assisted (MIVA) right anterior minithoracotomy.

Right anterior minithoracotomy aortic valve replacement with a sutureless bioprosthesis: Early outcomes and 1-year follow-up from 2 European centers.

Sutureless valves have recently enabled closed chest aortic valve replacement. This paper evaluates the feasibility of a robotic telemanipulation during thoracoscopic sutureless aortic valve implantation in cadavers.

Sutureless 3f Enable valve implantation concomitant with mitral valve surgery

BACKGROUND A sutureless aortic valve can be inserted through a right anterior minithoracotomy (RAMT) with consistent decreased cross-clamping time and ease of insertion. We report the experience of RAMT implantation of the 3f Enable (Medtronic, Inc, Minneapolis, Minn) self-expanding sutureless bioprosthesis, performed in 2 European cardiac surgery centers. METHOD From September 2012 to April 2014, a total of 71 patients with severe aortic stenosis were selected to receive an aortic valve replacement via RAMT using the sutureless valve. Hemodynamic parameters and clinical outcome were assessed at discharge and up to 16 months postoperatively. RESULTS All the patients received the prosthesis with success. One conversion to median sternotomy was necessary, owing to severe pleural adhesions. Overall in-hospital mortality was 2.8%. Mean cardiopulmonary bypass and cross-clamping time were, respectively, 91 ± 29 minutes and 66 ± 19 minutes. Reclamping was necessary in 4 cases (5.6%). Early incidences of grade I or lower paravalvular leakages and pacemaker implantation were, respectively, 4.2% and 5.6%. No paravalvular leakage greater than grade I was registered. The mean follow-up time was 8.1 months; the mean transvalvular gradient was, at discharge and at 6-12 months, respectively, 10.7 ± 4.3 mm Hg and 9.6 ± 3.1 mm Hg. The degree of regurgitation remained stable in all cases. Freedom from all-cause and valve-related mortality was 97% and 99%, respectively, at 1 year. CONCLUSIONS Aortic valve replacement via RAMT with the 3f Enable valve is a reproducible procedure, as it provides satisfactory hemodynamics, and a low valve-related complication rate. Greater experience is needed to compare the performance of the 3f Enable valve with that of other sutureless valves implanted via the same RAMT procedure.

First in Human Totally Endoscopic Perceval Valve Implantation

OBJECTIVE Interest in aortic sutureless bioprostheses is growing. Here, we evaluate the feasibility of performing aortic sutureless valve replacement concomitant with mitral valve surgery using the 3f Enable prosthesis. METHODS Of the 198 3f Enable® valve implantation procedures carried out in our unit between March 2011 and October 2014, 15 were performed concomitant with mitral valve surgery (8 bioprosthetic replacements and 7 annuloplasties). RESULTS The mean age and logistic EuroSCORE were 76 ± 6 years and 10.2 ± 4.8, respectively. The procedural success rate of aortic sutureless valve implantation was 100%. Mean cross-clamping and cardiopulmonary bypass times were 113.9 ± 35 and 150- ± 43 min, respectively. No reclamping in response to a sutureless paravalvular leakage (PVL) was needed. One grade 1 leak was observed at the time of discharge. There was no perioperative mortality. Pacemaker implantation was required in 1 case (6.6%). Initial follow-up (median = 8 months, range 1-6) showed no new aortic PVL; mean and peak transprosthetic gradients and the orifice area were 11.1 ± 2.5 and 18.4 ± 4.9 mmHg and 1.7 ± 0.4 cm(2), respectively. One grade 2 and two grade 1 mitral valve leaks were detected following annuloplasty. CONCLUSIONS 3f Enable® sutureless valve implantation combined with mitral valve surgery appears feasible and the results presented here are encouraging. This procedure has the potential to simplify surgery in a cohort of high-risk patients for whom transcatheter aortic valve replacement is not an effective option. Larger studies should be conducted to confirm these observations.