Combining echocardiographic and anatomic variables to predict outcomes of mitral valve repair with the NeoChord procedure.

BACKGROUND: Trans-apical, echo-guided NeoChord mitral valve (MV) repair is an innovative procedure to treat degenerative mitral regurgitation (MR) without concomitant annuloplasty. Recently, leaflet-to-annulus index (LAI) has been identified as a positive prognostic predictor of outcomes at 1-year follow up. The aim of this study is to develop a pre-operative predictor tool to assess probability of success with NeoChord procedure utilizing multi-factor echocardiographic and anatomic variables. METHODS: We included ninety-one consecutive patients with prolapse/flail of the posterior mitral leaflet, who subsequently underwent NeoChord MV repair between November 2013 and October 2016. All patients completed post-operative echocardiographic follow-up assessments for up to 2 years. A random forest regression algorithm identified and ranked the most relevant predictors of moderate-severe MR. A multi-variable Cox regression model was performed at follow-up intervals, to assess variables associated with residual MR that was classified as mild or less. Bootstrapping re-samples were used to validate an estimated survival model. Predictive accuracy was assessed using a discrimination index that corrected for over-optimism. RESULTS: We developed a nomogram which used the results of a multi-variable model to predict the probability of mild or less residual MR at follow-up periods (discharge, 1, 3, 6 months, 1 and 2 years). Identified predictors included LAI, systolic pulmonary artery pressure, indexed left ventricle end-systolic volume (iLVESV), prolapse/flail width (FW), systolic antero-posterior (AP) annulus diameter, systolic latero-lateral (LL) annulus diameter and presence of calcification. CONCLUSIONS: A NeoChord MV repair prediction tool would be helpful in clinical decision-making and in the identification of patients who may benefit from a ringless mitral valve repair using the NeoChord procedure.

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes.

BACKGROUND: The NeoChord echo-guided transapical beating heart repair is a promising early-stage minimally invasive surgical procedure for degenerative mitral valve (MV) regurgitation (DMR) correction. The technique has been improved since its inception following procedure standardization, patient selection optimization, and learning curve stabilization. We hereby present the mid-term clinical results through three years of our large single center experience. METHODS: All consecutive patients with severe symptomatic DMR due to prolapse or flail of one or both mitral leaflets that underwent the NeoChord procedure between November 2013 and June 2019 were included. Patients were categorized according to MV anatomy; Type A isolated central posterior leaflet prolapse and/or flail, Type B posterior multi-segment prolapse and/or flail, Type C anterior and/or bi-leaflet prolapse or flail, Type D paracommissural prolapse and/or flail and/or significant leaflet and/or annular calcifications. Patients underwent clinical and echocardiographic follow-up at one, three, six, twelve months and yearly thereafter. Clinical outcomes and the composite primary endpoint (patient success) were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria. Mitral regurgitation (MR) severity was graded as absent, mild, moderate and severe according to American Society of Echocardiography (ASE) and European Society of Cardiology (ESC) guidelines. RESULTS: Two hundred and three patients were included; median follow-up was 24 months [interquartile range (IQR), 9-36]. Median age was 64 years (IQR, 54-74 years), median Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) was 0.60% (IQR, 0.32-1.44%). There were 106 Type A patients (52.2%), 68 Type B (33.5%), 16 Type C (7.9%), and 13 Type D (6.4%). Kaplan-Meier estimate of survival was 99.0%±0.7% at one and two years and 94.0%±2.9% at three years. At one-year follow-up patient success was 91.2%±2.0% and 111 patients (74%) presented a residual MR mild or less (1+). At three-year follow-up patient success was 81.2%±3.8% and 32 patients (64%) had a residual MR mild or less (1+). Patient success was significantly different according to anatomical type (P=0.001). Echocardiographic analysis showed a significant acute left ventricle and left atrial reverse remodeling that was maintained up to three years. CONCLUSIONS: The NeoChord echo-guided transapical beating heart repair procedure demonstrated good clinical outcomes and echocardiographic results up to three-year follow-up.

Mechanisms of recurrent regurgitation after transapical off-pump mitral valve repair with neochord implantation†.

OBJECTIVES: The aim of this study was to describe possible mechanisms of recurrent mitral regurgitation (MR) in patients who have been treated with the NeoChord procedure. METHODS: Patients presenting with recurrent severe or moderate MR were categorized as Not Expected Surgical-Like Result (NESLR)-Redo and NESLR-MR2 [NESLR reintervention or moderate MR (2+), respectively]. NESLR patients were stratified by onset (intraoperative, perioperative 24 h-30 days, or early 30 days to follow-up), by MR jet direction (central or eccentric) and by jet orientation (anterior or posterior). Specific mechanisms of NESLR were analysed. RESULTS: Fifty-two patients were identified with 13 (25%) categorized as NESLR-Redo, and 39 (75%) as NESLR-MR2. NESLR-Redo patient stratification included: intraoperative = 2 patients (1.2%), both eccentric anteriorly directed jets; perioperative = 7 patients (4.2%), all eccentric with 3 anteriorly and 4 posteriorly directed jets; and early = 4 patients (2.4%), 1 central, 3 eccentric, 2 posteriorly and 1 anteriorly directed jets. NESLR-MR2 patient stratification included: perioperative = 2 patients (5.1%), both eccentric, 1 anteriorly and 1 posteriorly directed jets; and early = 37 patients (94.9%), 4 central, 33 eccentric, 22 anteriorly and 11 posteriorly directed jets. Possible mechanisms of recurrent MR were identified as: patient selection (17.3%), technical issues (28.8%), progression of baseline disease (15.4%), left ventricle reverse remodelling (1.9%), excessive over-tensioning (35.8%) and PML curling (30.8%). CONCLUSIONS: The mechanisms of recurrent MR after the NeoChord procedure can be determined. Understanding recurrent MR mechanisms has led to improvements in procedural standardization and ad hoc prevention strategies that have been widely adopted since our initial clinical experience.

Risk stratification of severe aortic stenosis according to new guidelines: long term outcomes.

BACKGROUND: Current ESC and ACC/AHA guidelines for the management of valvular heart disease assign a class Ia indication for aortic valve replacement (AVR) only to patients with symptomatic severe aortic valve stenosis and asymptomatic patients with depressed left ventricular ejection fraction (LVEF <50%) or positive exercise test. We examined the long-term outcomes for patients undergoing AVR for aortic stenosis over a 11-year period at our institution compared to current international guidelines for AVR. METHODS: Patients who had undergone isolated AVR for severe aortic valve stenosis between January 2001 and December 2012 were selected. The population was divided into subgroups based on preoperative LVEF (< or ≥50%) and on presence/absence of symptoms (NYHA =I or ≥II, respectively). RESULTS: We identified 607 patients with a median follow-up (FU) time of 5.75 years (IQR 3.24-8.00 years). The presence of symptoms did not have a significant impact on cardiovascular mortality (P=0.201). Patients with LVEF <50% displayed a higher long-term cardiovascular mortality rate (P=0.015). Multivariate analysis showed that preserved LVEF was a protective factor for asymptomatic patients (P=0.021), while preoperative LVEF did not affect the mortality rate in symptomatic patients (HR 0.88; 95% CI, 0.54-1.44). Correspondingly, asymptomatic patients with reduced LVEF were found to be at a higher risk of long-term mortality compared to the other groups (P=0.011). The only other independent risk factor for death was age (HR 6.46; 95% CI, 2.22-18.76). CONCLUSIONS: According to our data, current international class I indications for symptomatic patients ensure good long-term survival, while class I indications for asymptomatic patients with reduced LVEF are associated with poor long-term survival. Our results suggest that early surgery should also be considered also for asymptomatic patients with preserved LVEF, particularly in cases of very low operative risk.

Prognostic impact of leaflet-to-annulus index in patients treated with transapical off-pump echo-guided mitral valve repair with NeoChord implantation.

BACKGROUND: The transapical echo-guided NeoChord repair is a procedure to correct mitral regurgitation (MR) without the need for concomitant annuloplasty for degenerative mitral valve (MV) disease. Lacking strict criteria to define normal annular dimensions for patients undergoing MV repair, we consequently missed having precise selection criteria to identify patients who can benefit from a ringless procedure with respect to who would need a combined annular and leaflet repair. The aim of this study is to identify whether a new preoperative echocardiographic index may predict postoperative outcomes after NeoChord repair. METHODS: All consecutive patients with posterior leaflet disease who underwent NeoChord repair between November 2013 and January 2016 presenting complete postoperative echocardiographic assessment up to 1year were included. Leaflet-to-Annulus Index (LAI) was defined as the ratio between the sum of anterior leaflet length (AML) and posterior leaflet length (PML) over antero-posterior length (AP; AML+PML/AP). Measurements were performed with 2D transesophageal echocardiography. RESULTS: Sixty-six patients were enrolled. At 1year MR was absent in (24) 38% of patients, mild in (28) 44%, moderate in (10) 16% and severe in (1) 2%. Logistic regression analysis identified LAI as positive prognostic predictor of MR≤mild for values >1.35 at 3months, 1.30 at 6months and 1.25 at 1year. At 30days LAI was not associated with the grade of residual MR. CONCLUSIONS: LAI is a positive postoperative predictor of MR≤mild at 1-year follow-up and can be used to identify patients who could benefit from a ringless NeoChord repair procedure for the absence of a leaflet-to-annulus mismatch.

Learning curve analysis of transapical NeoChord mitral valve repair.

OBJECTIVES: Transapical off-pump mitral valve intervention with neochordae implantation is a novel, minimally invasive procedure for treatment of degenerative mitral valve regurgitation. The aim of this study was to apply control charts (CUSUM curves) to monitor the performance of NeoChord repair during the initial phase of its adoption. METHODS: The first 112 consecutive patients who underwent NeoChord repair at our institution between November 2013 and March 2016 were included in the analysis. Mitral Valve Academic Research Consortium criteria for 1-year patient success was utilized to determine failed procedures. Control charts had predetermined acceptable and unacceptable failure rates of 5% and 15%, respectively. RESULTS: The actual incidence of 1-year-patient failure was 11% (12 of 112 cases), with a cluster of failures within the first 20 cases. The CUSUM analysis demonstrated an initial learning curve; however, the upper boundary (alarm line) was never crossed. The reassurance line was first crossed after 40 procedures and performance remained stable after 49 procedures. CONCLUSIONS: NeoChord repair is a safe procedure, and the results are maintained through the 1-year follow-up. A relative high number of implants were required to overcome the learning curve at our institution due to the concurrent development of patient selection criteria and the technical refinement of the procedure. Future studies are needed to assess the evolution of the learning curve after the wide adoption of the procedure across European and North American centres.

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.

An early European experience with transapical off-pump mitral valve repair with NeoChord implantation.

OBJECTIVES: Transapical off-pump NeoChord repair is a novel minimally invasive surgical procedure to treat degenerative mitral valve regurgitation. The aim was to evaluate 1-year clinical results of the NeoChord procedure in a consecutive cohort of patients. METHODS: Between February 2013 and July 2016, 213 patients were enrolled in the NeoChord Independent International Registry. All patients presented severe mitral regurgitation due to flail/prolapse of 1 or both leaflets, and they all completed postoperative echocardiographic assessment up to 1 year. We identified the primary end point as composed of procedural success, freedom from mortality, stroke, reintervention, recurrence of severe mitral regurgitation, rehospitalization and decrease of at least 1 New York Heart Association functional class at 1-year follow-up. We also compared outcomes according to the anatomical classification (Type A: isolated central posterior leaflet disease; Type B: posterior multisegment disease; Type C: anterior, bileaflet, paracommissural disease with/without leaflet/annular calcifications). RESULTS: The median age was 68 years (interquartile range 56-77), and the median EuroSCORE II was 1.05% (interquartile range 0.67-1.76). The number of Type A, B and C patients was 82 (38.5%), 98 (46%) and 33 (15.5%), respectively. Procedural success was achieved in 206 (96.7%) patients. At 1-year follow-up, overall survival was 98 ± 1%. Composite end point was achieved in 84 ± 2.5% for the overall population and 94 ± 2.6%, 82.6 ± 3.8% and 63.6 ± 8.4% in Type A, Type B and Type C patients, respectively (P < 0.0001). CONCLUSIONS: These results demonstrate that the NeoChord procedure is safe, effective and reproducible. Clinical and echocardiographic efficacy is maintained up to 1 year with significant differences among the anatomical groups. Specific anatomical selection criteria are necessary to achieve stable results.

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.

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.

Impact of Changes in Left Ventricular Ejection Fraction on Survival After Transapical Aortic Valve Implantation.

BACKGROUND: This single-center retrospective study assessed the variation of left ventricular ejection fraction (LVEF) after transapical transcatheter aortic valve implantation and its effect on survival. We also evaluated the effect of sheath diameter on LVEF. METHODS: We analyzed data of all consecutive patients who underwent transapical transcatheter aortic valve implantation with the Sapien (Edwards Lifesciences, Irvine, CA) device (and its evolutions) between 2009 and 2015. We analyzed the difference between preoperative LVEF and LVEF at discharge (ΔEF = LVEFpost-op - LVEFpre-op) and considered its interquartile range (±5%) as the cutoff. Patients were divided in three groups: (1) improved LVEF (ΔEF ≥ +5%); (2) unchanged LVEF (ΔEF -5% to +5%), and (3) worsened LVEF (ΔEF ≤ -5%). Survival was evaluated with Kaplan-Meier analysis, and logistic regression multivariable analysis was used to determine independent predictors of LVEF improvement. RESULTS: Data of 122 patients were analyzed. Patients in the three groups were distributed as follows: (group 1) 27 patients (22.1%), (group 2) 69 (56.6%), and (group 3) 26 (21.3%). The mean ΔEF was 12.7% ± 4.7% in group 1 and -10.8% ± 3.9% in group 3. The ΔEF was more likely to improve in patients with preoperative LVEF of less than 0.35 (p = 0.014). There were no significant differences in survival (p = 0.41), rehospitalization (p = 0.472), and New York Heart Association Functional Classification (p = 0.307) among the groups. The use of the smallest available sheath (18F) was not associated with a significant change of ΔEF. CONCLUSIONS: LVEF worsened in a small number of patients after transapical transcatheter aortic valve implantation, but this change was not associated with worse postoperative outcomes. Patients with a low LVEF showed better improvement. The progressive reduction of sheath diameter does not have a significant effect on LVEF changes.

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.

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.

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.