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1.
Artif Organs ; 2024 Jul 11.
Artículo en Inglés | MEDLINE | ID: mdl-38989991

RESUMEN

BACKGROUND: Significant tricuspid regurgitation (TR) is a predictor of right heart failure (RHF) and increased mortality following left ventricular assist device (LVAD) implantation, however the benefit of tricuspid valve surgery (TVS) at the time of LVAD implantation remains unclear. This study compares early and late mortality and RHF outcomes in patients with significant TR undergoing LVAD implantation with and without concomitant TVS. METHODS: A systematic search of four electronic databases was conducted for studies comparing patients with moderate or severe TR undergoing LVAD implantation with or without concomitant TVS. Meta-analysis was performed for primary outcomes of early and late mortality and RHF. Secondary outcomes included rate of stroke, renal failure, hospital and ICU length of stay. An overall survival curve was constructed using aggregated, reconstructed individual patient data from Kaplan-Meier (KM) curves. RESULTS: Nine studies included 575 patients that underwent isolated LVAD and 308 patients whom received concomitant TVS. Both groups had similar rates of severe TR (46.5% vs. 45.6%). There was no significant difference seen in risk of early mortality (RR 0.90; 95% CI, 0.57-1.42; p = 0.64; I2 = 0%) or early RHF (RR 0.82; 95% CI, 0.66-1.19; p = 0.41; I2 = 57) and late outcomes remained comparable between both groups. The aggregated KM curve showed isolated LVAD to be associated with overall increased survival (HR 1.42; 95% CI, 1.05-1.93; p = 0.023). CONCLUSIONS: Undergoing concomitant TVS did not display increased benefit in terms of early or late mortality and RHF in patients with preoperative significant TR. Further data to evaluate the benefit of concomitant TVS stratified by TR severity or by other predictors of RHF will be beneficial.

2.
Transplantation ; 2024 Jul 18.
Artículo en Inglés | MEDLINE | ID: mdl-39020464

RESUMEN

BACKGROUND: Coronary allograft vasculopathy (CAV) remains a significant cause of morbidity and mortality after heart transplantation. The use of aspirin for CAV prophylaxis has recently garnered interest as a possible therapeutic adjunct in this setting. METHODS: This 2-center retrospective cohort study included 372 patients who underwent heart transplantation between January 2009 and March 2018 and were stratified according to the commencement of aspirin during their index transplant admission. The primary outcome was the development of moderate or severe CAV (International Society for Heart and Lung Transplantation grade ≥2) at surveillance coronary angiography. Secondary endpoints included mortality at follow-up. RESULTS: There were no differences in age, sex, and cause of heart failure. In the early aspirin group, the preponderant risk factors included use of ventricular assist devices, pretransplant smoking, and mild or moderate rejection. Multivariable analyses to assess for independent predictors of CAV development and mortality demonstrated that aspirin was associated with reduced mortality (adjusted hazard ratio = 0.19; 95% confidence interval, 0.08-0.47, P < 0.01) and a trend toward a protective effect against the development of moderate or severe CAV (adjusted hazard ratio = 0.24; 95% confidence interval, 0.54-1.19; P = 0.08). CONCLUSIONS: In this retrospective risk-adjusted 2-center cohort study, early aspirin administration was associated with reduced risk of death and a trend toward a protective effect against CAV development. These findings warrant validation in prospective randomized trials.

3.
Ann Thorac Surg ; 2023 Sep 17.
Artículo en Inglés | MEDLINE | ID: mdl-37717882

RESUMEN

BACKGROUND: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. METHODS: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. RESULTS: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). CONCLUSIONS: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

4.
Transplantation ; 107(6): 1390-1397, 2023 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-36872474

RESUMEN

BACKGROUND: Tricuspid regurgitation (TR) is common following heart transplantation and has been shown to adversely influence patient outcomes. The aim of this study was to identify causes of progression to moderate-severe TR in the first 2 y after transplantation. METHODS: This was a retrospective, single-center study of all patients who underwent heart transplantation over a 6-y period. Transthoracic echocardiogram (TTE) was performed at month 0, between 6 and 12 mo, and 1-2 y postoperatively to determine the presence and severity of TR. RESULTS: A total of 163 patients were included, of whom 142 underwent TTE before first endomyocardial biopsy. At month 0, 127 (78%) patients had nil-mild TR before first biopsy, whereas 36 (22%) had moderate-severe TR. In patients with nil-mild TR, 9 (7%) progressed to moderate-severe TR by 6 mo and 1 underwent tricuspid valve (TV) surgery. Of patients with moderate-severe TR before first biopsy, by 2 y, 3 had undergone TV surgery. The use of postoperative extracorporeal membrane oxygenation (ECMO) in the latter group was significant (78%; P < 0.05) as was rejection profile ( P = 0.02). Patients with late progressive moderate-severe TR had a significantly higher 2-y mortality than those who had moderate-severe TR immediately. CONCLUSIONS: Overall, our study has shown that in the 2 main groups of interest (early moderate-severe TR and progression from nil-mild to moderate-severe TR), TR is more likely to be the result of significant underling graft dysfunction rather than the cause of it.


Asunto(s)
Trasplante de Corazón , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/etiología , Insuficiencia de la Válvula Tricúspide/cirugía , Estudios Retrospectivos , Trasplante de Corazón/efectos adversos , Ecocardiografía/efectos adversos , Factores de Riesgo , Resultado del Tratamiento
5.
Gen Thorac Cardiovasc Surg ; 71(4): 258-260, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36271221

RESUMEN

This report describes a novel modification of a self-assembled composite graft to replace the aortic root and left ventricular outflow tract (LVOT). This technique enables the implantation of a larger valve than conventional ways and simultaneous reconstruction of LVOT. This technique comprises Inspiris Resilia aortic valve and Gelweave Valsalva graft. By placing the valve in the sinus portion of the graft, the bioprosthesis that is 1 mm smaller than the graft can be accommodated, providing a proper length of the collar for LVOT reconstruction. This technique is useful for patients who require redo-aortic root replacement and have restricted LVOT.


Asunto(s)
Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Aorta/cirugía , Reimplantación , Resultado del Tratamiento
6.
Perfusion ; 37(2): 152-161, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33482711

RESUMEN

BACKGROUND: Vasoplegia has been shown to be associated with increased morbidity and mortality in patients undergoing cardiac surgery. It has been previously stated that low pulsatile states as seen with current left ventricular assist devices (LVADs) may contribute to vasoplegia post LVAD-explant and heart transplant. We sought to examine the literature regarding vasoplegia in the post-operative setting for patients undergoing LVAD explant and heart transplant. METHOD: A literature review was conducted to firstly define vasoplegia in the setting of LVAD patients, and secondly to better understand the relationship between vasoplegia and LVAD explantation in the postoperative heart transplant patient cohort. A keyword search of 'vasoplegia' OR 'vasoplegic' AND 'transplant' was used. Search engines used were PubMed, Cochrane Library, ClinicalTrials.gov, Ovid, Scopus and grey literature. RESULTS: 17 studies met the selection criteria for review. Three key themes emerged from the literature. Firstly, there is limited consensus regarding the definition of vasoplegia. Secondly, patients with LVADs experienced higher rates of vasoplegia following heart transplant than their counterparts and thirdly, increased cardiopulmonary bypass time was associated with a higher rate of vasoplegia. CONCLUSION: Vasoplegia is not clearly defined in the literature as it pertains to the LVAD patient cohort. Patients bridged with LVADs appear to have higher rates of vasoplegia, however the aetiology of this is unclear and may be associated with continuous flow physiology or prolonged cardiopulmonary bypass time. A universal definition will aid in risk stratification, early recognition and management.


Asunto(s)
Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Vasoplejía , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/cirugía , Trasplante de Corazón/efectos adversos , Corazón Auxiliar/efectos adversos , Humanos , Estudios Retrospectivos , Resultado del Tratamiento , Vasoplejía/complicaciones
7.
J Am Coll Cardiol ; 78(19): 1847-1859, 2021 11 09.
Artículo en Inglés | MEDLINE | ID: mdl-34736561

RESUMEN

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported. OBJECTIVES: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR. METHODS: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years. RESULTS: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005). CONCLUSIONS: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514).


Asunto(s)
Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Efectos Adversos a Largo Plazo/mortalidad , Insuficiencia de la Válvula Mitral , Válvula Mitral , Complicaciones Posoperatorias , Disfunción Ventricular Izquierda , Anciano , Ecocardiografía/métodos , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/cirugía , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Índice de Severidad de la Enfermedad , Volumen Sistólico , Resultado del Tratamiento , Disfunción Ventricular Izquierda/diagnóstico , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/fisiopatología
8.
Int J Cardiol Heart Vasc ; 32: 100687, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33365382

RESUMEN

BACKGROUND: Transapical transcatheter mitral valve implantation (TMVI) may be a therapeutic option for patients with severe mitral regurgitation (MR) excluded from cardiac surgery due to excessive risk. Exclusion criteria frequently include pulmonary hypertension and right ventricular (RV) dysfunction. The effect of TMVI on RV function has not previously been well-characterized. The aim of this study was to examine the procedural and 3-month impact of TMVI on RV hemodynamics and function. METHODS: This was a multi-center, retrospective, observational cohort study of patients with >3+MR undergoing TMVI. Pre- and post-TMVI hemodynamics were assessed with right heart catheterization. RV function was assessed at baseline, pre-discharge and at 3-months by echocardiography. RESULTS: Forty-six patients (age 72±9 years; 34 men) with ≥3+MR underwent TMVI over a 5-year period. Successful device implantation was achieved in all patients with abolition of MR (p < 0.001) and reduction in left-ventricular end-diastolic volume (p = 0.001). RV stroke work index (RVSWI) increased intra-operatively (7 ± 4 g/m/beat/m2 vs 11 ± 5 g/m/beat/m2; p < 0.001). At 3-months there were reductions in severity of tricuspid regurgitation (TR) (p < 0.001) and pulmonary artery systolic pressure (PASP) (49 ± 16 mmHg vs 36 ± 12 mmHg; p < 0.001), and improvements in RV fractional area change (28 ± 7% vs 34 ± 9%, p<0.001), tricuspid annular plane systolic excursion (TAPSE) (1.0 ± 0.3 vs 1.5 ± 0.5cm, p = 0.03), and RV free wall longitudinal strain (-14.2±5.0 vs -17.6±7.3, p = 0.05). CONCLUSIONS: Transapical TMVI results in significant improvement of RV function that is sustained to 3-months as evidenced by improvements in RVSWI and RV fractional area change, as well as reductions in PASP and TR severity.

9.
Catheter Cardiovasc Interv ; 95(1): E37-E39, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-30919551

RESUMEN

A 73-year-old man with severe, symptomatic secondary mitral regurgitation (MR) underwent successful transcatheter mitral valve replacement using the Tendyne™ mitral valve system. The device was deployed from the left ventricular (LV) apex and secured in position by a tether attached to an epicardial pad. Three days postoperatively, the patient developed hemolytic anemia and a paravalvular leak (PVL) associated with indentation of the LV apex. Adjustment of the tether tension and placement of an epicardial disc under the pad resulted in reduction in the PVL, and resolution of the hemolytic anemia.


Asunto(s)
Migración de Cuerpo Extraño/cirugía , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anemia Hemolítica/etiología , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/etiología , Migración de Cuerpo Extraño/fisiopatología , Humanos , Masculino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Diseño de Prótesis , Reoperación , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
10.
Eur Heart J Case Rep ; 3(1): yty152, 2019 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31020228

RESUMEN

BACKGROUND: The inter-arterial anomalous course of the left main coronary artery (LMCA) originating from the right coronary sinus of Valsalva is a rare, though potentially lethal pathology. Coronary artery bypass grafting is a potential surgical therapy with previously reported success, however, there is concern for the possibility of graft occlusion in the setting of competitive native vessel flow. CASE SUMMARY: A 48-year-old gentleman presented to our facility with a non-ST elevation acute coronary syndrome. A malignant anomalous course of the LMCA was confirmed using invasive coronary angiography and computed tomography (CT). The patient underwent surgical revascularization of the left anterior descending artery with a left internal mammary artery (LIMA) graft, which was found to be atretic on follow-up CT. Seven years later the patient underwent repeat CT imaging, which confirmed recanalization of the previously atretic LIMA. DISCUSSION: We present the first documented case of a patient with spontaneous recanalization of an occluded LIMA following bypass surgery for an inter-arterial anomalous course of the LMCA. We postulate that the dynamic obstruction of the anomalous LMCA led to variable flow dependence on the bypass graft and subsequent atresia of the LIMA, due to the favourable native flow conditions in the absence of significant obstructive coronary disease. The exact mechanism of LIMA recanalization remains unclear, but in our case may have been partly mediated by a small increase in left main plaque.

11.
J Thorac Cardiovasc Surg ; 156(6): 2143-2152, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30025607

RESUMEN

OBJECTIVES: We report our experience with temporary postoperative venopulmonary arterial extracorporeal life support as short-term right ventricular support in patients with biventricular failure undergoing HeartWare (HeartWare Inc, Framingham, Mass) left ventricular assist device implantation and compared these outcomes with isolated left ventricular assist device support and long-term biventricular assist device support. METHODS: A total of 112 consecutive patients were studied, 75 with the isolated HeartWare left ventricular assist device, 23 with a concomitant left ventricular assist device and venopulmonary arterial extracorporeal life support, and 14 with durable biventricular assist device support. The decision concerning short-term or durable biventricular support was based on the clinical characteristics, echocardiography, and hemodynamic profile. RESULTS: Patients who required venopulmonary arterial extracorporeal life support after left ventricular assist device insertion required the greatest support preoperatively and were more likely to have Interagency Registry for Mechanical Assisted Circulatory Support level 1 (left ventricular assist device 19%, venopulmonary arterial extracorporeal life support 48%, biventricular assist device 57%, P < .001). They were more likely to require preoperative mechanical support (left ventricular assist device 9%, venopulmonary arterial extracorporeal life support 43%, and biventricular assist device 29%, P < .001) or preoperative ventilation (9%, 38%, and 21%, respectively, P < .05). Preoperative echocardiographic and hemodynamic parameters were more similar to those requiring isolated left ventricular assist device, with patients requiring durable biventricular assist device support more likely to have elevated right atrial pressure (left ventricular assist device 14.3 ± 6.7 vs venopulmonary arterial extracorporeal life support 13.6 ± 4.8 vs biventricular assist device 18.7 ± 6.0 mm Hg, P < .05); right atrial/pulmonary capillary wedge pressure ratio (0.53 ± 0.23 vs 0.51 ± 0.17, vs 0.69 ± 0.22, respectively, P < .02); and tricuspid regurgitation grade (1.7 ± 1.5 vs 1.7 ± 1.6 vs 2.8 ± 1.6, respectively, P < .01). One-year survival was 84% for those with an isolated left ventricular assist device compared with 62% for those with venopulmonary arterial extracorporeal life support and 64.3% for biventricular assist device. CONCLUSIONS: In critically unwell patients requiring temporary biventricular support, planned venopulmonary arterial extracorporeal life support provides acceptable outcomes, similar to durable biventricular assist device support. Requirement for venopulmonary arterial extracorporeal life support is more determined by the level of preoperative acuity than echocardiographic or hemodynamic parameters.


Asunto(s)
Oxigenación por Membrana Extracorpórea , Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Implantación de Prótesis/instrumentación , Función Ventricular Izquierda , Función Ventricular Derecha , Adulto , Anciano , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/mortalidad , Femenino , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/mortalidad , Recuperación de la Función , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
12.
Heart ; 104(12): 1036-1044, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29654097

RESUMEN

CLINICAL INTRODUCTION: A 56-year-old lady with a background of hypertension was admitted to our institution with acute pulmonary oedema. She reported gradual and increasingly severe dyspnoea on exertion over the preceding 12 months and, prior to presentation, her exercise tolerance was restricted to one flight of stairs. On transthoracic echocardiography during the index admission, left ventricular size and systolic function were normal, and peak and mean transaortic gradients were 67 mm Hg and 33 mm Hg, respectively, with a peak velocity of 3.9 m/s. No aortic incompetence or other significant valvular abnormality was noted. A transoesophageal echocardiogram was performed. Figure 1 depicts the mid-oesophageal parasternal long-axis view. What is the explanation behind the significant transaortic gradient?heartjnl;104/12/1036/F1F1F1Figure 1Transoesophageal echocardiogram, mid-oesophageal long-axis view at 135 degrees. QUESTION: What is the explanation behind the significant transaortic gradient?Ventricular septal defect Supravalvular aortic stenosisAortic valvular stenosisSubaortic membraneHypertrophic obstructive cardiomyopathy.


Asunto(s)
Válvula Aórtica/fisiopatología , Estenosis Subaórtica Fija/diagnóstico por imagen , Estenosis Subaórtica Fija/fisiopatología , Cardiopatías Congénitas/diagnóstico por imagen , Cardiopatías Congénitas/fisiopatología , Hemodinámica , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Diagnóstico Diferencial , Estenosis Subaórtica Fija/complicaciones , Estenosis Subaórtica Fija/cirugía , Ecocardiografía Transesofágica , Femenino , Cardiopatías Congénitas/complicaciones , Cardiopatías Congénitas/cirugía , Humanos , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Edema Pulmonar/etiología , Edema Pulmonar/fisiopatología , Resultado del Tratamiento
13.
J Am Coll Cardiol ; 69(4): 381-391, 2017 Jan 31.
Artículo en Inglés | MEDLINE | ID: mdl-28040318

RESUMEN

BACKGROUND: Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. OBJECTIVES: This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. METHODS: Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. RESULTS: Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. CONCLUSIONS: TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Anciano de 80 o más Años , Cateterismo , Ecocardiografía , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
14.
Eur J Cardiothorac Surg ; 50(5): 839-848, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27605222

RESUMEN

OBJECTIVES: Ventricular blood stasis is a concern for continuous flow mechanical support devices and might contribute to the formation of thromboembolic events. The HeartWare® Ventricular Assist System (HVAD®) is equipped with the Lavare™ cycle that is a periodic speed modulation feature designed to alter flow patterns within the left ventricle and reduce areas of potential blood stasis. Here, we report in vitro and clinical findings on the effects of the Lavare cycle. METHODS: The effect of pump speed changes on the intraventricular flow field was examined with an in vitro particle image velocimetry model. The clinical impact of the Lavare cycle was evaluated through a retrospective review of the ReVOLVE study which includes 248 patients implanted with the HVAD following Conformité Européenne Mark in nine centres in Europe and Australia. Baseline characteristics, adverse event profiles and Kaplan-Meier survival estimates were stratified by patients using/not using the Lavare cycle. RESULTS: Particle image velocimetry showed increased ventricular washout with an active Lavare cycle as measured by the fluid velocities and angular dispersion parameters. With the Lavare cycle on, there was also a 22% decrease in the stagnation index compared with when the Lavare cycle was off. In the ReVOLVE registry, patients with the Lavare cycle turned on (n = 215) were supported for 497 patient-years, whereas patients who did not use the speed modulation (n = 33) were supported for 39.3 patient-years. The Lavare cycle did not significantly affect patient survival as both groups had approximately an 80% survival after 1 year. Patients using the Lavare cycle had significantly fewer rates of stroke [0.06 vs 0.20 events per patient-year (EPPY), P = 0.0008], sepsis (0.03 vs 0.15 EPPY, P = 0.0003) and right heart failure (0.03 vs 0.18 EPPY, P < 0.0001) with no difference in the transplant or recovery rates among the two cohorts. CONCLUSIONS: The Lavare cycle effectively generates ventricular washout and the adverse event profiles of ReVOLVE patients with the Lavare cycle on were better than those with the Lavare cycle off. Larger studies are warranted to verify the positive effect of the Lavare cycle and to optimize speed modulation settings, so additional clinically relevant improvements can be realized.


Asunto(s)
Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Adulto , Anciano , Australia/epidemiología , Velocidad del Flujo Sanguíneo/fisiología , Cardiomiopatía Dilatada/diagnóstico por imagen , Cardiomiopatía Dilatada/fisiopatología , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Corazón Auxiliar/efectos adversos , Hemorreología/fisiología , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos Cardiovasculares , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , Sepsis/epidemiología , Sepsis/etiología , Sepsis/prevención & control , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Función Ventricular/fisiología
16.
Eur J Cardiothorac Surg ; 50(5): 834-838, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27412342

RESUMEN

OBJECTIVES: The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated multicentre, prospective, single-arm database established to collect post-Conformité Européenne Mark clinical information on patients receiving the HeartWare® Ventricular Assist System (HVAD®). The number of patients requiring longer periods of mechanical circulatory support is ever increasing and so further investigation into long-term outcomes in bridge-to-transplant populations is necessary. METHODS: Data were collected on 254 commercial implants performed between February 2009 and March 2012 from nine centres in Europe (7 centres) and Australia (2 centres). Patients were followed to device explant, heart transplant or death, and the outcomes of patients who remained on support longer than 2 years were analysed. Summary statistics were used to describe patient demographics, adverse events, length of support and outcomes for this long-term cohort. RESULTS: A total of 124 patients (49% of the original ReVOLVE population) were on support for more than 2 years (range: 731-2108 days), 76 of whom are still alive on support. Overall survival through 5 years was 59%. CONCLUSIONS: Owing to the low rate of heart transplants, a significant number of patients receiving a left ventricular assist device as a bridge to transplant remain on support for prolonged periods, often exceeding 2, 3 and even 4 years. Real-world use of the HVAD system continues to show excellent outcomes for patients on the device, including those on support beyond 2 years.


Asunto(s)
Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Adulto , Anciano , Australia/epidemiología , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/mortalidad , Trasplante de Corazón/estadística & datos numéricos , Corazón Auxiliar/efectos adversos , Humanos , Estimación de Kaplan-Meier , Cuidados a Largo Plazo/métodos , Masculino , Persona de Mediana Edad , Vigilancia de Productos Comercializados/métodos , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento
18.
Lancet ; 385(9987): 2585-91, 2015 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-25888085

RESUMEN

BACKGROUND: Orthotopic heart transplantation is the gold-standard long-term treatment for medically refractive end-stage heart failure. However, suitable cardiac donors are scarce. Although donation after circulatory death has been used for kidney, liver, and lung transplantation, it is not used for heart transplantation. We report a case series of heart transplantations from donors after circulatory death. METHODS: The recipients were patients at St Vincent's Hospital, Sydney, Australia. They received Maastricht category III controlled hearts donated after circulatory death from people younger than 40 years and with a maximum warm ischaemic time of 30 min. We retrieved four hearts through initial myocardial protection with supplemented cardioplegia and transferred to an Organ Care System (Transmedics) for preservation, resuscitation, and transportation to the recipient hospital. FINDINGS: Three recipients (two men, one woman; mean age 52 years) with low transpulmonary gradients (<8 mm Hg) and without previous cardiac surgery received the transplants. Donor heart warm ischaemic times were 28 min, 25 min, and 22 min, with ex-vivo Organ Care System perfusion times of 257 min, 260 min, and 245 min. Arteriovenous lactate values at the start of perfusion were 8·3-8·1 mmol/L for patient 1, 6·79-6·48 mmol/L for patient 2, and 7·6-7·4 mmol/L for patient 3. End of perfusion lactate values were 3·6-3·6 mmol/L, 2·8-2·3 mmol/L, and 2·69-2·54 mmol/L, respectively, showing favourable lactate uptake. Two patients needed temporary mechanical support. All three recipients had normal cardiac function within a week of transplantation and are making a good recovery at 176, 91, and 77 days after transplantation. INTERPRETATION: Strict limitations on donor eligibility, optimised myocardial protection, and use of a portable ex-vivo organ perfusion platform can enable successful, distantly procured orthotopic transplantation of hearts donated after circulatory death. FUNDING: NHMRC, John T Reid Charitable Trust, EVOS Trust Fund, Harry Windsor Trust Fund.


Asunto(s)
Displasia Ventricular Derecha Arritmogénica/terapia , Cardiomiopatía Dilatada/terapia , Trasplante de Corazón/métodos , Miocarditis/terapia , Preservación de Órganos/métodos , Donantes de Tejidos/clasificación , Obtención de Tejidos y Órganos/métodos , Adulto , Displasia Ventricular Derecha Arritmogénica/fisiopatología , Biopsia , Cardiomiopatía Dilatada/fisiopatología , Femenino , Paro Cardíaco Inducido , Humanos , Masculino , Persona de Mediana Edad , Miocardio/patología , Choque/patología , Resultado del Tratamiento , Virosis/terapia , Isquemia Tibia
19.
J Cardiothorac Vasc Anesth ; 29(2): 288-96, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25655210

RESUMEN

OBJECTIVES: To characterize the longitudinal hemostatic profile during adult ECMO using point-of-care tests (POCT) for coagulation and to compare these parameters to standard laboratory tests. In addition, the clinicians' responses during bleeding episodes using available information were compared to a POCT-based response. DESIGN: Prospective observational cohort study. SETTING: ECMO-referral center in a university teaching hospital. PARTICIPANTS: Ten critically ill adult ECMO patients. INTERVENTIONS: Daily laboratory coagulation profile, transfusion history and near-daily thromboelastometry (ROTEM®) and platelet aggregometry (Multiplate®). MAIN RESULTS: Six male and four female patients, seven with VA- and three with VV-ECMO were studied over 110 days. Seventy-five thromboelastometry (TEM) and 36 platelet aggregometry (MEA) results were analyzed. A majority of TEM values were within the normal range, except for FIBTEM (majority high), which remained consistent over long (>5 days) ECMO runs. In MEA there were low values, particularly in the adenosine diphosphate- and ristocetin-induced assay, implying possibly a vWF-factor or GpIb-receptor defect. There was correlation between laboratory and POCT as well as good correlation between the clot firmness after 10 minutes (A10) and the maximum clot firmness in ROTEM, suggesting that reliable information can be obtained within 15 minutes. Twenty-two bleeding episodes were observed in five patients. When comparing the clinicians' response to a transfusion algorithm based on POCT, there was a concordance in less than 20% of episodes. CONCLUSIONS: POCT for coagulation can provide specific, reliable, and timely information during bleeding episodes and the use of targeted therapy algorithms could improve outcomes and reduce costs.


Asunto(s)
Trastornos de la Coagulación Sanguínea/diagnóstico , Trastornos de la Coagulación Sanguínea/etiología , Plaquetas , Oxigenación por Membrana Extracorpórea/efectos adversos , Sistemas de Atención de Punto , Tromboelastografía/estadística & datos numéricos , Adulto , Trastornos de la Coagulación Sanguínea/sangre , Pruebas de Coagulación Sanguínea/métodos , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recuento de Plaquetas/estadística & datos numéricos , Estudios Prospectivos
20.
Heart Lung Circ ; 23(9): 841-6, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24751512

RESUMEN

BACKGROUND: With improved life expectancy more octogenarians now present with aortic valve disease. Cardiac surgery in this group of patients has previously been considered high risk due to co-morbidities and challenges of rehabilitation. This study seeks to challenge the concept of octogenarian cardiac surgery "unsuitability" by analysing operative outcomes and long term survival following aortic valve replacement. METHODS: Eighty-seven consecutive patients undergoing aortic valve replacement between 2000 and 2009 at St Vincent's Hospital were retrospectively identified. Statistical analysis was performed using SPSS (version 15 and 19). RESULTS: The average age was 82.7 ± 2.4 years. The mean logistic EuroSCORE was 18.86 ± 14.11. Post-operatively, four patients required insertion of a permanent pacemaker (4.6%) and five patients had a myocardial infarction (5.8%). In-hospital mortality was 3.4%. Follow-up was 93.1% complete. One-year survival was 92.9%, three-year survival was 86.7% and five-year survival was 75.0%. At follow-up 98.1% of patients were New York Heart Association (NYHA) Class I or II. CONCLUSIONS: Results were excellent despite reasonable co-morbidities and Euroscore risk. Survival was impressive and the NYHA class reflected the success of the surgery in relieving the pathological aortic valve process. Patient age should not be the primary exclusion for cardiac surgery for aortic valve disease.


Asunto(s)
Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Anciano de 80 o más Años , Cuidados Críticos , Femenino , Mortalidad Hospitalaria , Humanos , Tiempo de Internación , Masculino , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Esternotomía/mortalidad , Tasa de Supervivencia
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