Erica Manzan

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.

TEE-Guided Transapical Beating-Heart Neochord Implantation in Mitral Regurgitation

Transapical beating-heart neochord (Neochord DS1000, Minnetonka, Minnesota) implantation to repair mitral valve regurgitation has been demonstrated to be a safe and effective minimally invasive alternative to open surgical repair in selected patients with mitral leaflet prolapse (flail/chordae

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.

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.

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.

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