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

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

Políticas públicas fundamento para la despenalización del aborto sentimental y eugenésico previsto en el art. 120° del Código Penal Peruano vigente en la Región Ucayali-2016

TesisLa investigación titulada: POLITICAS PÚBLICAS FUNDAMENTO PARA LA DESPENALIZACIÓN DEL ABORTO SENTIMENTAL Y EUGENÉSICO PREVISTO EN EL ART. 120° DEL CÓDIGO PENAL PERUANO VIGENTE EN LA REGIÓN UCAYALI-2016, se plantea en base a que, en el Perú y el resto del mundo, pocos temas son tan controversiales como el aborto. En los países euro-asiáticos como: Rusia, China; Norteamérica y países latinoamericanos como: Brasil, Argentina y Uruguay, mantienen una posición liberal respecto al tema. Por el contrario, nuestro código penal prohíbe el aborto, salvo cuando la vida de la madre corre peligro. En nuestro país la figura jurídica del aborto, es considerado a nivel del derecho penal como delito, esta debe ser en forma sistémica, es decir, no solamente a nivel legal, sino tomando en cuenta principalmente la realidad de nuestra sociedad; ya que el derecho no puede ser desligado de la misma, como también con la política demográfica, la planificación familiar, el estado y la familia. Sin embargo, nuestra legislación peruana al respecto (Código Penal de 1991) estipula que se penaliza todas las formas de aborto con excepción del terapéutico, e incluye como figuras atenuantes el aborto ético o sentimental y el aborto eugenésico. Las voces de protesta de un sector de la población obligó al legislador a cambiar su planteamiento tipificando como aborto privilegiado o atenuado estas dos modalidades, tal como aparece en la redacción del artículo 120 del Código Penal. La investigación ha planteado como Problema: ¿De qué manera las políticas públicas influyen en la despenalización del Aborto sentimental y eugenésico previsto en el art.120 del código penal peruano vigente en la región Ucayali? El Objetivo es: Determinar de qué manera las políticas públicas influye en la despenalización del Aborto del art.120 del código penal peruano vigente en la región Ucayali. La Hipótesis es: Las políticas públicas que influyen significativamente en la despenalización del Aborto del art.120 del Código Penal Peruano vigente en la Región Ucayali. Los principales resultados son las siguientes: Según los datos procesados del ítem N° 08 se muestra que 40 de las personas jurídicas y naturales que representan el 37.7%, afirmaron que la ciudadanía participa de manera regular en términos de políticas públicas. Por otro lado 8 de las personas jurídicas y naturales que representan un 7.5%, estimaron que es bueno en términos de políticas públicas. Consecuentemente según los datos procesados del ítem N° 17 se muestra que 40 de las personas jurídicas y naturales que representan el 37.7%, calificaron como regular en términos generales despenalización del aborto del art. 120° del código penal peruano. Por otro lado 9 de las personas jurídicas y naturales que representan un 8.5%, calificaron como bueno dicho ítem

Beating heart implantation of transventricular artificial cordae: How can access site selection and leaflet insertion improve mitral regurgitation correction?

NeoChord-DS1000-System (NC) and The Harpoon-Mitral-Repair-System (H-MRS) are two trans-apical chordal implantation devices developed for the treatment of degenerative mitral valve (MV) regurgitation (DMR) either if as Fibroelastic-Deficiency (FED), Forma-Frusta (FF), or Barlow (B) presentation. The aim of this study is to evaluate some of the advantages and disadvantages of these two different devices by performing numerical simulation analyses focused on different transventricular access sites in all subsets of DMR presentations. By applying a novel approach for the development of patient-specific MV domains we worked out a set of numerical simulations of the artificial chordae implantation. Different leaflet insertions and ventricle access sites were investigated, and resulting contact-area (CA), tensioning-forces (F) and leaflet's stress (LS) were calculated. The analyses showed that: i) NC-approach maintains low LS when performed with a posterior access site and optimizes the overlap between the leaflets at the systolic peak; ii) H-MRS-system presents better results in case of a more anterior ventricular entry site; however, for FED prolapse large variation of F and LS with respect to NC-approach are found; iii) an accidental contact between artificial sutures and the anterior leaflet may occur when valve function is restored through an excessive anterior access site. Present findings set light on specific technical aspects of transapical off-pump chords implantation, either performed with NC and H-MRS systems and highlight the advantages and disadvantages proper to the two devices. Our study also paves the basis for a systematic application of computational methodology, in order to plan a patient-specific mini-invasive approach thus maximizing the outcomes

Beating heart implantation of transventricular artificial cordae: How can access site selection and leaflet insertion improve mitral regurgitation correction?

NeoChord-DS1000-System (NC) and The Harpoon-Mitral-Repair-System (H-MRS) are two trans-apical chordal implantation devices developed for the treatment of degenerative mitral valve (MV) regurgitation (DMR) either if as Fibroelastic-Deficiency (FED), Forma-Frusta (FF), or Barlow (B) presentation. The aim of this study is to evaluate some of the advantages and disadvantages of these two different devices by performing numerical simulation analyses focused on different transventricular access sites in all subsets of DMR presentations. By applying a novel approach for the development of patient-specific MV domains we worked out a set of numerical simulations of the artificial chordae implantation. Different leaflet insertions and ventricle access sites were investigated, and resulting contact-area (CA), tensioning-forces (F) and leaflet's stress (LS) were calculated. The analyses showed that: i) NC-approach maintains low LS when performed with a posterior access site and optimizes the overlap between the leaflets at the systolic peak; ii) H-MRS-system presents better results in case of a more anterior ventricular entry site; however, for FED prolapse large variation of F and LS with respect to NC-approach are found; iii) an accidental contact between artificial sutures and the anterior leaflet may occur when valve function is restored through an excessive anterior access site. Present findings set light on specific technical aspects of transapical off-pump chords implantation, either performed with NC and H-MRS systems and highlight the advantages and disadvantages proper to the two devices. Our study also paves the basis for a systematic application of computational methodology, in order to plan a patient-specific mini-invasive approach thus maximizing the outcomes

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

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 1 year 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 1 year 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 3 months, 1.30 at 6 months and 1.25 at 1 year. At 30 days 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