Eleonora Bizzotto

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.

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.

Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation

BACKGROUND Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. METHODS From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. RESULTS transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirty-day cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney injury (AKI) rate was higher in the TA group (30.5% versus 11.2%; p < 0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p < 0.001). Mean follow-up was 22.3 ± 17.8 months (range, 1-74 months). Overall survival rates at 1, 3, and 5 years were 85.5% ± 2.1%, 69.9% ± 3.2%, and 61% ± 4.3%, respectively. Independent predictors of all-cause mortality at follow-up were previous myocardial infarction (odds ratio [OR], 2.7), any grade of paravalvular leak (PVL) (OR, 2.5), and AKI (OR, 3.1). Mean gradient and effective orifice area at follow-up were 10.7 ± 12.0 mm Hg and 1.1 ± 0.9 cm(2)/m(2), respectively. CONCLUSIONS Our data show that TAVI has good early and intermediate-term clinical and hemodynamic outcomes in high-risk or inoperable patients with severe symptomatic aortic valve stenosis. PVL of any grade has a significant impact on survival.

Beating heart mitral valve repair with neochordae implantation: real-time monitoring of haemodynamic recovery

Transapical off-pump mitral valve repair with neochord implantation has been approved for patients presenting with severe mitral regurgitation due to leaflet prolapse or flail. The procedure is performed under real-time 2D and 3D transoesophageal echocardiography for both implantation and neochordae tension adjustment allowing real-time monitoring of haemodynamic recovery.

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 …

Patient-Specific Ventricular Access Site Selection for the NeoChord Mitral Valve Repair Procedure

Selecting the ventricular access site on the basis of mitral valve anatomy improves the outcomes for a subgroup of patients undergoing the transapical echocardiographically guided NeoChord (NeoChord, Inc, St. Louis Park, MN) repair procedure to correct mitral regurgitation and who have a leaflet-to-annulus index lower than the recommended efficacy threshold of 1.25.

Prosthetic valve endocarditis: Predictors of early outcome of surgical therapy. A multicentric study

OBJECTIVES Prosthetic valve endocarditis (PVE) is an uncommon yet dreadful complication in patients with prosthetic valves that requires a distinct analysis from native valve endocarditis. The present study aims to investigate independent risk factors for early surgical outcomes in patients with PVE. METHODS A retrospective cohort study was conducted in 8 Italian Cardiac Surgery Units from January 2000 to December 2013 by enrolling all PVE patients undergoing surgical treatment. RESULTS A total of 209 consecutive patients were included in the study. During the study period, the global rate of surgical procedures for PVE among all operations for isolated or associated valvular disease was 0.45%. Despite its rarity this percentage increased significantly during the second time frame (2007‐2013) in comparison with the previous one (2000‐2006): 0.58% vs 0.31% (P < 0.001). Intraoperative and in‐hospital mortality rates were 4.3% and 21.5%, respectively. Logistic regression analysis identified the following factors associated with in‐hospital mortality: female gender [odds ratio (OR) = 4.62; P < 0.001], shock status (OR = 3.29; P = 0.02), previous surgical procedures within 3 months from the treatment (OR = 3.57; P = 0.009), multivalvular involvement (OR = 8.04; P = 0.003), abscess (OR = 2.48; P = 0.03) and urgent surgery (OR = 6.63; P < 0.001). CONCLUSIONS Despite its rarity, PVE showed a significant increase over time. Up to now, in‐hospital mortality after surgical treatment still remains high (>20%). Critical clinical presentation and extension of anatomical lesions are strong preoperative predictors for poor early outcome.

Acute intraoperative echocardiographic changes after transapical off-pump mitral valve repair with NeoChord implantation

OBJECTIVES Our aim is to investigate the acute intraoperative effects of the NeoChord repair procedure on mitral valve (MV) annular geometry and LV function and the impact of these changes on MR at 1-year follow-up. BACKGROUND Recently transapical off-pump mitral valve repair with NeoChord implantation has been demonstrated to be safe and effective in patients with degenerative mitral regurgitation (DMR). METHODS We retrospectively analyzed baseline and early postoperative 3-dimensional transesophageal echocardiography of 66 patients who underwent NeoChord repair for isolated posterior leaflet MV disease using semiautomatic off-line analysis software. RESULTS We observed a significant acute reduction of indexed LV end diastolic volume (Δ% = 14, p < .001), LV ejection fraction (Δ = 5.7%, p = .002), indexed left atrial volume (Δ = 14.7%, p = .045), and pulmonary artery pressure (Δ = 2.1%, p = .026). Among MV geometric parameters, we observed a significant reduction of MV antero-posterior diameter (Δ = 7%, p < .001), sphericity index (Δ = 8%, p < .001), annulus circumference (Δ = 0.9%, p = .021), and annulus area (Δ = 2.7%, p = .018). At 1-year, 53 patients (85.5%) presented MR ≤ mild, while 9 patients (14.5%) had MR ≥ moderate. Reduction of AP diameter (OR = 0.14, CI -3.83; 0.08, p < .001), annulus circumference (OR = 0.27, CI -2.98; 0.37, p = .005), MV area (OR = 0.39, CI -2.46; 0.61, p = .04), aorto-mitral angle (OR = 0.38, CI -2.49; 0.54, p = .002) and iEDV (OR = 0.44, CI -2.44; 0.81, p = .001) were independent protective factors against recurrence of MR greater than mild at 1-year follow-up. CONCLUSIONS Transapical NeoChord repair produces important acute intraoperative changes in MV anatomy in DMR patients. The acute changes observed were associated with procedure durability at 1-year FU.

CT for the Transapical Off-Pump Mitral Valve Repair With Neochord Implantation Procedure

The advent of transapical echocardiography-guided mitral valve (MV) repair with implantation of polytetrafluoroethylene neochordae (NeoChord, St. Louis Park, Minnesota) has identified some critical aspects of the procedure that require accurate understanding of cardiac anatomy [(1,2)][1]. In

TCT-42 Transcatheter echo guided Mitral Valve Repair with Neochord Implantation for posterior leaflet disease: Results from Neochord Independent International Registry

Transapical off-pump mitral valve repair with neochordae implantation (TOP-MINI) is an innovative procedure to treat degenerative mitral valve regurgitation (MR). Assess initial results of the Neochord Independent International Registry (NIIR) for isolated treatment of posterior mitral leaflet (PML