ACQUIRED CARDIOVASCULAR DISEASE

ACQUIRED CARDIOVASCULAR DISEASE 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 Augusto D’Onofrio, MD,a Antonio Messina, MD,b Roberto Lorusso, MD,c Ottavio R. Alfieri, MD,d Melissa Fusari, MD,e Paolo Rubino, MD,f Mauro Rinaldi, MD,g Roberto Di Bartolomeo, MD,h Mattia Glauber, MD,i Giovanni Troise, MD,b and Gino Gerosa, MDa 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 SUAVRs 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 ¼ .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 ¼ 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 ¼ 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 ¼ .001), but there were no differences in terms of mean transprosthetic gradient (10.3 5 mm Hg vs 11 3.7 mm Hg, P ¼ .59). Conclusions: This preliminary experience showed that, in patients at high risk for conventional surgery, SUAVR is assafe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak. (J Thorac Cardiovasc Surg 2012;144:1010-8) Surgical aortic valve replacement (SAVR) is the treatment of choice in patients with severe symptomatic aortic valve a stenosis (SSAVS) because it provides excellent early and long-term clinical outcomes as well as good results in terms of hemodynamics, valve durability, and freedom from valve-related complications.1 Transcatheter aortic valve imFrom the Division of Cardiac Surgery, University of Padova, Padova, Italy; the Division of Cardiac Surgery,b Poliambulanza Hospital, Brescia, Italy; the Division of Cardiac Surgery,c Community Hospital, Brescia, Italy; the Department of Cardiac Surgery,d San Raffaele University Hospital, Milan, Italy; Department of Cardiovascular Sciences,e Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy; the Invasive Cardiology Laboratory,f Cardiology Division, Montevergine Clinic, Mercogliano, Italy; the Division of Cardiac Surgery,g University of Turin, Turin, Italy; the Division of Cardiac Surgery,h University of Bologna, Bologna, Italy; and Department of Adult Cardiac Surgery,i G. Pasquinucci Heart Hospital, Massa, Italy. Disclosures: Authors have nothing to disclose with regard to commercial support. Read at the 92nd Annual Meeting of The American Association for Thoracic Surgery, San Francisco, California, April 28-May 2, 2012. A.O. and A.M. contributed equally to this manuscript. plantation (TAVI) has shown excellent early and mid-term clinical and hemodynamic results in inoperable or highrisk patients with SSAVS.2,3 In particular, TAVI with balloon-expandable bioprostheses has demonstrated better results than medical therapy alone in inoperable patients4 as well as noninferiority to SAVR in high-risk elderly patients.5 TAVI using balloon-expandable valves can be accomplished with either an antegrade transapical access or with a retrograde approach. The latter is usually performed via a transfemoral access, but recently a transaortic approach has been described6,7; the transsubclavian access is used less frequently. The transfemoral access is generally considered the first choice because it is less invasive and there is no need for general anesthesia and tracheal intubation. However, transapical TAVI (TATAVI) provides good results with a low incidence o Sutureless Valve We collected and analyzed data prospectively of 51 patients who underwent SU-AVR with the Perceval S bioprosthesis (Sorin Biomedica Cardio, Saluggia, Italy) at 3 Italian centers from March to September 2011. These patients represent the entire experience of the 3 participating institutions. Sutureless valve data were collected using the same data set of the I-TA to obtain homogeneous, comparable, and, most important, reliable data. The Perceval S is made of 3 bovine pericardium leaflets mounted on a self-expandable metallic stent. SU-AVR was performed with either full sternotomy, mini sternotomy or mini thoracotomy, according to the type of intervention, the associated procedures, and, ultimately, the surgeon’s preferences. In particular, full sternotomy, mini sternotomy, and mini right thoracotomy in the second intercostal space12 were performed in 36 (70.6%), 4 (7.8%), and 11 (21.6%) patients, respectively. All SU-AVR procedures were performed under moderately hypothermic (32◦C) cardiopulmonary bypass with aortic crossclamping and cardioplegic arrest of the heart. A transverse aortotomy was performed around 3 to 3.5 cm above the aortic annulus, the native valve was removed, and annular decalcification was performed. Annular decalcification is not as extensive as for conventional surgery, but it is aimed at removing bulky calcifications to obtain a homogeneous, round-shaped annulus for sutureless valve implantation. After decalcification, the aortic annulus wassized and the correct prosthesis was selected. Prosthesis size ‘‘small’’ was selected, with an annulus diameter between 19 mm and 21 mm. Size ‘‘medium’’ was selected, with an annulus diameter between 21 mm and 23 mm. During the study period, size ‘‘large’’ wasstill not available. Three 4-0 prolene guiding sutures are passed through the aortic annulus at the nadir of each sinus. The delivery system was guided in its correct position using these sutures and the valve was deployed. After deployment, the delivery system and sutures were removed, and a balloonwasinserted in thevalve and expanded for 30 seconds at a pressure of 3 atm. The ascending aorta was then closed according to the usual technique (Figure 1). Further details about Perceval S implantation technique have been described previously.9,13 Indications for SU-AVR were asfollows: SSAVS defined by a valve area lessthan 0.8 cm2 and mean transaortic gradient more than 40 mm Hg, and a high surgical risk profile for advanced age (75 years), comorbidities, and patient frailty.Because there are no guidelines and/or recommendations for SU-AVR and experience is still limited, we did not use strict EuroSCORE or Society of Thoracic Surgeons score cutoff values as inclusion criteria. The decision to perform SU-AVR instead of SAVR or TAV... C0NTINUES...