Fabio Zucchetta

Transapical off-pump mitral valve repair with Neochord implantation: Early clinical results

BACKGROUND This prospective study aims to assess early clinical outcomes in patients undergoing Transapical Off-Pump Mitral Valve Intervention with Neochord Implantation (TOP-MINI). METHODS AND RESULTS Forty-nine patients with severe symptomatic degenerative mitral regurgitation (MR) were treated. Median age was 72 years (IQR 58-78) and median Euroscore-I was 3.26% (IQR 0.88-8.15). Forty-four patients (89.8%) presented with posterior leaflet prolapse (LP), 4 (8.2%) with anterior LP and 1 (2%) with combined disease. Acute procedure success (defined as successful placement of at least 3 neochords with reduction of residual MR to less than 2+) was achieved in all patients. In-hospital mortality was 2%. At 30 days major adverse events included one AMI (2%) successfully treated percutaneously and one sepsis (2%), no stroke or bleeding events occurred. At 3 months overall survival was 98%. MR was absent in 16 patients (33.4%), was grade 1+ in 15 (31.2%), and was grade 2+ in 12 (25%). Five patients (10.4%) developed recurrent severe MR due to anterior native chordae rupture. Four of them were successfully re-operated. At 3 months follow-up freedom from reoperation was 91.7 ± 4%. CONCLUSIONS Early results with Neochord procedure indicate that TOP-MINI is feasible and safe. Efficacy is maintained up to 3 months follow-up with significant clinical benefit for the patients.

Acute safety and efficacy of the NeoChord procedure

OBJECTIVES Transapical off-pump mitral valve repair using the NeoChord device has been proposed to treat degenerative mitral valve regurgitation. This prospective study sought to evaluate acute safety and efficacy of this innovative, minimally invasive, transcatheter mitral valve repair approach. METHODS Symptomatic patients with severe mitral regurgitation (MR) were selected if they presented a favourable valve anatomy (the presence of leaflet flail/prolapse with consistent overlap of tissue). Early device success was defined as placement of at least two neochordae with residual mitral regurgitation ≤ 2+ after the procedure. The primary acute safety and efficacy end points were evaluated at 30 days. RESULTS Between February 2013 and June 2014, in Padua and Vilnius University Hospitals, a total of 62 patients were treated, with a median age of 66 years (IQR 52-76) and a median EuroSCORE I of 1.9% (IQR 0.9-6). Fifty-six patients (88.9%) presented with a posterior leaflet prolapse, 4 (6%) with an anterior leaflet prolapse and 3 (5%) with a combined disease. Early procedural success was achieved in all patients. Two neochordae were implanted in 2 patients (3%), 3 in 20 (32%), 4 in 28 (44%), 5 in 10 (16%), 6 in 2 (3%) and 7 in 1 (2%). At 30 days, major adverse events included only 1 acute myocardial infarction (2%) successfully treated percutaneously and 2 cases of sepsis (3%). Mitral regurgitation at 30 days was absent in 29 patients (46%), Grade 1+ in 16 (25%), Grade 2+ in 10 (16%), Grade 3+ in 7 (11%) and Grade 4+ in 1 (2%). All 8 patients with MR >2+ were successfully reoperated with conventional surgery or NeoChord reintervention. CONCLUSIONS Initial results with the NeoChord procedure in a small number of patients indicate that transapical off-pump mitral valve repair is feasible and safe. Efficacy is maintained up to the 30-day follow-up with significant clinical benefit for patients.

The TRIBECA study: (TRI)fecta (B)ioprosthesis (E)valuation versus (C)arpentier Magna-Ease in (A)ortic position

OBJECTIVE To determine whether the Trifecta bioprosthetic aortic valve produces postoperative haemodynamic results comparable with or better than those of the Magna Ease aortic valve bioprosthesis. METHODS We retrospectively reviewed the medical records of patients who had undergone aortic valve replacement with Trifecta or Magna Ease prostheses at eight European institutions between January 2011 and May 2013, and analysed early postoperative haemodynamic performance by means of echocardiography. RESULTS A total of 791 patients underwent aortic valve replacement (469 Magna Ease, 322 Trifecta). Haemodynamic variables were evaluated on discharge and during the follow-up (minimum 6 months, maximum 12 months). The mean gradient and the indexed effective orifice area (IEOA) were as follows: 10 mmHg [interquartile range (IQR): 8-13] and 1.10 cm(2)/m(2) (IQR: 0.95-1.27) for Trifecta; 16 mmHg (IQR: 11-22) and 0.96 cm(2)/m(2) (IQR: 0.77-1.13) for Magna Ease (P < 0.001). These significant differences were maintained across all valve sizes. Similar statistically significant differences were found when patients were matched and/or stratified for preoperative characteristics: body-surface area, ejection fraction, mean gradients and valve size. Severe prosthesis-patient mismatch (IEOA: <0.65 cm(2)/m(2)) was detected in 2 patients (0.6%) with Trifecta and 40 patients (8.5%) with Magna Ease (P < 0.001). CONCLUSIONS The haemodynamic performance of the Trifecta bioprosthesis was superior to that of the Magna Ease valve across all conventional prosthesis sizes, with almost no incidence of severe patient-prosthesis mismatch. The long-term follow-up is needed to determine whether these significant haemodynamic differences will persist, and influence clinical outcomes.

The Evolution of the Right Anterolateral Thoracotomy Technique for Correction of Atrial Septal Defects: Cosmetic and Functional Results in Prepubescent Patients

BACKGROUND The aim of this study was to evaluate the results of a cosmetic right anterolateral thoracotomy (RALT) in prepubescent girls who underwent repair of atrial septal defect (ASD). METHODS All prepubescent girls who underwent RALT for ASD closure since January 1998 were included. Patient satisfaction with the cosmetic approach and the impact of RALT on breast development were evaluated. One hundred healthy women were used as controls. RESULTS One-hundred forty-one patients were included. Median age at repair was 4.6 years (range, 8 months-12 years). The median length of the surgical incision was 9 cm (range 3-20 cm); it was shorter during the last 5 years of our experience (median, 5 cm; range, 3-10 cm; p = 0.001). Fourteen patients (9.9%) experienced a transitory mild sensitive skin deficit in the mammary area, which was associated with the length of the RALT (p = 0.05). At median follow-up of 10.1 years (range, 1.5-14.5 years), 3/60 patients (5%) who had complete breast development had relevant asymmetrical breast development (indexes of breast symmetry > 2 standard deviations of the median value for controls). Six additional patients who underwent RALT (10%) had mild asymmetrical breast development, which was comparable to the control population (p = 0.1). The satisfaction rate for the cosmetic result of RALT was 97.8% (138/141 patients). Reasons for dissatisfaction were the presence of asymmetrical breast development (n = 2) and the presence of a keloid at the incision level (n = 1). CONCLUSIONS RALT is a reliable surgical technique that combines excellent cosmetic and functional results in almost all patients. With the latest technical refinements, it is our gold standard treatment for ASD in prepubescent girls.

Transapical off-pump mitral valve repair with Neochord Implantation (TOP-MINI): step-by-step guide

A wide variety of surgical approaches for mitral valve repair (MVR) are available. Recent studies have demonstrated that the techniques which “respect rather than resect” the diseased portion of the mitral valve (MV) have comparable clinical outcomes and potentially superior results in terms of physiology (1). Artificial chordal implantation has received increased attention as an MVR strategy during the last few decades, especially when performed through a minimally invasive approach. The Transapical Off-Pump Mitral Valve Repair with Neochord Implantation (TOP-MINI) is a new MVR option that has been approved for patients presenting with severe mitral regurgitation (MR) due to leaflet(s) prolapse or flail (2-4). The procedure is performed using the NeoChord DS1000 system (NeoChord, Inc., Eden Praire, MN) under guidance of direct 2D and 3D transesophageal echocardiography (TEE) (5,6) for both implantation and tension adjustment of the neochordae. The aim of this article is to describe the TOP-MINI procedure in a step-by-step fashion.

SynCardia: the total artificial heart.

The SynCardia total artificial heart (TAH) currently provides the most definitive option for patients with biventricular failure who are not candidates for isolated left ventricular (LV) assist device placement. The techniques for implantation are adaptable to almost all patients with advanced heart failure, including those with severe biventricular cardiomyopathy, complex congenital heart disease, failed LV assist devices, failed transplantations, and acquired structural heart defects that have failed or are not amenable to conventional surgical treatment. Over the years, the implantation technique has evolved in order to minimize the surgical invasiveness of the procedure, in anticipation of additional future surgery. Meticulous hemostasis with double layer sutures, use of Gore-Tex sheets around the TAH and the pericardial cavity, and use of tissue expanders to avoid contraction of pericardial cavity around the device are discussed in detail in the following report. Additionally, we will provide our experience with implantation of TAH in various challenging scenarios, such as patients with a small chest cavity, congenital heart defects, and simultaneous use of extracorporeal membrane oxygenation (ECMO).

Simultaneous transapical aortic and mitral valve‐in‐valve implantation for double prostheses dysfunction: Case report and technical insights

Transcatheter “Valve‐in‐Valve” implantation (ViV) has shown promising results in high‐risk patients suffering from structural valve deterioration (SVD) of a previously implanted heart valve bioprosthesis. We present a case of a 68‐year‐old woman with a history of three previous cardiac operations on the aortic and mitral valve. At the time of admission she was severely symptomatic due to a simultaneous SVD of a 23 mm aortic and of a 29 mm mitral St. Jude Biocor bioprosthesis. Because of the history of several cardiac operations and to her comorbidities, the patient was considered with an extremely high surgical risk profile and was therefore scheduled for double concomitant mitral and aortic ViV. Through a trans‐apical approach, the patient underwent 23 and 29 mm Edwards Sapien XT implantation in the aortic and mitral bioprosthesis, respectively. The procedure was uneventful as well as the following hospital stay. At 6‐months follow‐up the patient is in NYHA class I. Echocardiography shows that the aortic bioprosthesis has no leak and the mean gradient is 20 mm Hg while the mitral valve has mild leak and maximum and mean gradients are 21 and 10 mm Hg, respectively. The three main technical aspects that should be carefully considered in double concomitant ViV are: sequence of valve deployment (whether to implant the mitral or the aortic valve first), choice of access and valve sizing. In conclusion, double simultaneous trans‐apical mitral and aortic ViV is technically feasible.

One-Stage Off-Pump Transapical Mitral Valve Repair and Aortic Valve Replacement

Transcatheter aortic valve implantation (TAVI) is routinely performed in high-risk patients presenting with severe symptomatic aortic valve stenosis. The use of TAVI in patients with symptomatic pure aortic regurgitation (AR) is less common1 because of the limited number of devices specifically designed for this pathology. Nowadays, the only device specifically approved for use in pure aortic insufficiency is the Jena Valve (Jena Valve Technology, Munich, Germany), currently available only for the transapical approach.2 Transcatheter mitral valve repair has been also proposed with the use of different technologies. Recently, transapical off-pump mitral valve repair with neochord implantation (TOP-MINI) using the NeoChord DS 1000 device (NeoChord, Eden Praire, MN) has been shown to be feasible and safe for repairing degenerative mitral valve disease.3–5 Unlike TAVI and other percutaneous devices, transapical off-pump mitral valve intervention with Neochord implantation is approved not just for high-surgical-risk candidates. Two-stage treatment of aortic valve stenosis and mitral regurgitation (MR) using transcatheter techniques has already been described. Here, we present the first-in-humans 1-stage transapical off-pump concomitant aortic valve implantation and mitral valve repair in a patient experiencing pure AR and degenerative MR. A 78-year-old man with severe AR and MR in New York Heart Association functional class III despite optimal medical therapy was referred to our institution. He presented systemic arterial hypertension and moderate 2-vessel coronary artery disease. Preoperative transesophageal echocardiography confirmed the presence of severe AR and severe MR with severe calcifications of the posterior mitral annulus and annular portion of the posterior mitral leaflet (Figure 1 and Movies I–III in the online-only Data Supplement). His left ventricular ejection fraction was 67%, with initial signs of ventricular dilatation (left ventricle end-diastolic volume, 86 mL/m2). Figure 1. Preoperative transesophageal echocardiography (TEE). A , Two-dimensional TEE color Doppler showing severe aortic regurgitation (AR) and …

The Jarvik-2000 ventricular assist device implantation: how we do it.

The Jarvik-2000 is a non-pulsatile axial-flow left ventricular assist device (LVAD) that is largely used in patients who present in end-stage heart failure, as a bridge to transplant support or destination therapy. From its first utilization, several implantation techniques have been elaborated, starting from a median sternotomy with cardiopulmonary bypass (CPB) support and moving towards a minimally invasive access with an off-pump strategy. Here we present the favored surgical technique used in our department to implant the Jarvik-2000, in a step-by-step fashion.

Pulmonary valve-sparing techniques during repair of tetralogy of Fallot: The delamination plasty

From the Pediatric and Congenital Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy. Disclosures: Authors have nothing to disclose with regard to commercial support. Received for publication Jan 29, 2016; accepted for publication Feb 7, 2016; available ahead of print March 5, 2016. Address for reprints: Vladimiro L. Vida, MD, PhD, Pediatric and Congenital Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Surgery, University of Padua, Via Giustiniani, 2, 35100 Padua, Italy (E-mail: vladimiro.vida@unipd.it). J Thorac Cardiovasc Surg 2016;151:1757-8 0022-5223/