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1.
Artigo em Inglês | MEDLINE | ID: mdl-38970733

RESUMO

Coronary obstruction remains a primary concern for redo transcatheter aortic valve implantation (TAVI) due to supra-annular leaflets. Hereby, we present two valve-in-valve-in-valve cases, initially incorporating a surgical valve implanted to clarify our concept that the surgical valve serves to safeguard against the coronary ostium obstruction.

2.
Sci Rep ; 14(1): 12526, 2024 05 31.
Artigo em Inglês | MEDLINE | ID: mdl-38822074

RESUMO

Transcatheter aortic valve replacement (TAVR) is a widely used intervention for patients with severe aortic stenosis. Identifying high-risk patients is crucial due to potential postprocedural complications. Currently, this involves manual clinical assessment and time-consuming radiological assessment of preprocedural computed tomography (CT) images by an expert radiologist. In this study, we introduce a probabilistic model that predicts post-TAVR mortality automatically using unprocessed, preprocedural CT and 25 baseline patient characteristics. The model utilizes CT volumes by automatically localizing and extracting a region of interest around the aortic root and ascending aorta. It then extracts task-specific features with a 3D deep neural network and integrates them with patient characteristics to perform outcome prediction. As missing measurements or even missing CT images are common in TAVR planning, the proposed model is designed with a probabilistic structure to allow for marginalization over such missing information. Our model demonstrates an AUROC of 0.725 for predicting all-cause mortality during postprocedure follow-up on a cohort of 1449 TAVR patients. This performance is on par with what can be achieved with lengthy radiological assessments performed by experts. Thus, these findings underscore the potential of the proposed model in automatically analyzing CT volumes and integrating them with patient characteristics for predicting mortality after TAVR.


Assuntos
Estenose da Valva Aórtica , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/métodos , Tomografia Computadorizada por Raios X/métodos , Feminino , Masculino , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/diagnóstico por imagem , Idoso
3.
Artigo em Inglês | MEDLINE | ID: mdl-38683812

RESUMO

INTRODUCTION: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is characterized by progressive myocardial dysfunction and associated with an increased risk of major cardiovascular events. AIMS: To determine right heart strain (ventricular and atrial global longitudinal strain (RVGLS and RAGLS)) in patients with definite ARVC and its association with adverse events during follow-up. METHODS: RVGLS and RAGLS were analysed in focused right heart apical views from 70 patients using TomTec ImageArena and association with a composite endpoint (sustained ventricular arrhythmia and cardiovascular death) was determined. RESULTS: Over a median follow-up duration of 4.9 years, 26 (37%) patients met the endpoint. RVGLS was significantly impaired in the event group (-11.5 [-13.3 - -10.2]%) versus the no-event group (-15.8 [-17.1 - -14.5]%, P < 0.001), and so was RAGLS (22.8 [21.4 - 27.4]% vs. 31.5 [25.1 - 39.6]%, respectively, P < 0.001). In Cox regression, RVGLS (HR 1.36, P < 0.001) and RAGLS (HR 0.92, P = 0.002) were associated with higher risk of adverse events. In multivariable Cox regression models, RVGLS and RAGLS remained independent of and were incremental to age, gender, and conventional RV parameters, and model fit was improved when RVGLS and RAGLS were applied together rather than alone. CONCLUSIONS: RVGLS and RAGLS are more impaired in patients with adverse events and associated with adverse events independent of age, gender, and conventional RV parameters. When RVGLS and RAGLS are applied together, prediction models are improved suggesting that right heart strain may form part of the echocardiographic routine protocol in patients with ARVC.

4.
Eur Heart J ; 45(18): 1613-1630, 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38596850

RESUMO

BACKGROUND AND AIMS: Increasing data suggest that stress-related neural activity (SNA) is associated with subsequent major adverse cardiovascular events (MACE) and may represent a therapeutic target. Current evidence is exclusively based on populations from the U.S. and Asia where limited information about cardiovascular disease risk was available. This study sought to investigate whether SNA imaging has clinical value in a well-characterized cohort of cardiovascular patients in Europe. METHODS: In this single-centre study, a total of 963 patients (mean age 58.4 ± 16.1 years, 40.7% female) with known cardiovascular status, ranging from 'at-risk' to manifest disease, and without active cancer underwent 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography between 1 January 2005 and 31 August 2019. Stress-related neural activity was assessed with validated methods and relations between SNA and MACE (non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, and cardiovascular death) or all-cause mortality by time-to-event analysis. RESULTS: Over a maximum follow-up of 17 years, 118 individuals (12.3%) experienced MACE, and 270 (28.0%) died. In univariate analyses, SNA significantly correlated with an increased risk of MACE (sub-distribution hazard ratio 1.52, 95% CI 1.05-2.19; P = .026) or death (hazard ratio 2.49, 95% CI 1.96-3.17; P < .001). In multivariable analyses, the association between SNA imaging and MACE was lost when details of the cardiovascular status were added to the models. Conversely, the relationship between SNA imaging and all-cause mortality persisted after multivariable adjustments. CONCLUSIONS: In a European patient cohort where cardiovascular status is known, SNA imaging is a robust and independent predictor of all-cause mortality, but its prognostic value for MACE is less evident. Further studies should define specific patient populations that might profit from SNA imaging.


Assuntos
Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Prognóstico , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Idoso , Europa (Continente)/epidemiologia , Doenças Cardiovasculares/mortalidade , Encéfalo/diagnóstico por imagem , Fluordesoxiglucose F18 , Compostos Radiofarmacêuticos , Coração/diagnóstico por imagem
5.
Int J Cardiol ; 399: 131660, 2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38160913

RESUMO

INTRODUCTION: Echocardiography is used for assessment of patients after transcatheter aortic valve implantation (TAVI). Global work index (GWI) integrates LV deformation throughout the cardiac cycle and LV afterload and may be advantageous for long-term follow-up. METHODS: We analysed 144 patients with severe aortic stenosis who underwent TAVI and echocardiography within two weeks afterwards. GE EchoPAC v2.6 was applied for determining LV ejection fraction, global longitudinal strain (GLS), stroke work (SW), cardiac power output (CPO), and GWI. The endpoint was cardiovascular mortality. RESULTS: During median follow-up of 625 [IQR: 511-770] days, 20 (14%) patients died. Clinical baseline characteristics were comparable between non-survivors and survivors. GWI (p = 0.003) and LVEF (p = 0.039) were lower in non-survivors, while GLS, SW, and CPO were not different. In Kaplan-Meier analysis patients with GWI ≤1234 mmHg% exhibited a lower survival probability (P = 0.006). In univariable Cox regression, a significant mortality association was identified for GWI (P = 0.004), weaker for LVEF (P = 0.014), but not for the other parameters. In multivariable Cox regression, GWI independently improved an LV systolic function model including LVEF and GLS. Similarly, GWI but not LVEF independently improved outcome association of different clinical models. CONCLUSIONS: GWI was lower in non-survivors than survivors, differentiated non-survivors from survivors, was associated with mortality independent of clinical or LV parameters, and improved the fitness of clinical or LV prediction models. In contrast, GLS, SW, and CPO did not show any of these properties. GWI provides added value for follow-up after TAVI possibly by integrating LV deformation throughout the cardiac cycle.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Disfunção Ventricular Esquerda , Humanos , Resultado do Tratamento , Volume Sistólico , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estudos Retrospectivos , Função Ventricular Esquerda , Valva Aórtica/cirurgia
6.
RMD Open ; 9(4)2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37949614

RESUMO

BACKGROUND: Cardiovascular involvement is one of the leading causes of mortality in systemic sclerosis (SSc) and is reported to be higher in men as compared with women. However, the cause of this difference is largely unknown. The objective of this study was to assess sex differences in echocardiographic characteristics, including left ventricular global longitudinal strain (LV GLS), as a potential explanation of sex differences in outcomes. METHODS: A total of 746 patients with SSc from four centres, including 628 (84%, 54±13 years) women and 118 (16%, 55±15 years) men, were evaluated with standard and advanced echocardiographic examinations. The independent association of the echocardiographic parameters with the combined endpoint of cardiovascular events-hospitalisation/death was evaluated. RESULTS: Men and women with SSc showed significant differences in disease characteristics and cardiac function. After adjusting for the most important clinical characteristics, while LV ejection fraction and diastolic function were not significantly different anymore, men still presented with more impaired LV GLS as compared with women (-19% (IQR -20% to -17%) vs -21% (IQR: -22% to -19%), p<0.001). After a median follow-up of 48 months (IQR: 26-80), the combined endpoint occurred in 182 patients. Men with SSc experienced higher cumulative rates of cardiovascular events-hospitalisation/mortality (χ2=8.648; Log-rank=0.003), and sex differences were maintained after adjusting for clinical confounders, but neutralised when matching the groups for LV GLS. CONCLUSION: In patients with SSc, male sex is associated with worse cardiovascular outcomes even after adjusting for important clinical characteristics. LV GLS was more impaired in men as compared with women and potentially explains the sex difference in cardiovascular outcomes.


Assuntos
Escleroderma Sistêmico , Disfunção Ventricular Esquerda , Humanos , Masculino , Feminino , Função Ventricular Esquerda , Caracteres Sexuais , Disfunção Ventricular Esquerda/etiologia , Ecocardiografia/efeitos adversos , Escleroderma Sistêmico/complicações
7.
Front Cardiovasc Med ; 10: 1252872, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37745112

RESUMO

Introduction: This study aims at exploring biventricular remodelling and its implications for outcome in a representative patient cohort with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). Methods and results: Pre-interventional echocardiographic examinations of 100 patients with severe AS undergoing TAVI were assessed by speckle tracking echocardiography of both ventricles. Association with mortality was determined for right ventricular global longitudinal strain (RVGLS), RV free wall strain (RVFWS) and left ventricular global longitudinal strain (LVGLS). During a median follow-up of 1,367 [959-2,123] days, 33 patients (33%) died. RVGLS was lower in non-survivors [-13.9% (-16.4 to -12.9)] than survivors [-17.1% (-20.2 to -15.2); P = 0.001]. In contrast, LVGLS as well as the conventional parameters LV ejection fraction (LVEF) and RV fractional area change (RVFAC) did not differ (P = ns). Kaplan-Meier analyses indicated a reduced survival probability when RVGLS was below the -14.6% cutpoint (P < 0.001). Lower RVGLS was associated with higher mortality [HR 1.13 (95% CI 1.04-1.23); P = 0.003] independent of LVGLS, LVEF, RVFAC, and EuroSCORE II. Addition of RVGLS clearly improved the fitness of bivariable and multivariable models including LVGLS, LVEF, RVFAC, and EuroSCORE II with potential incremental value for mortality prediction. In contrast, LVGLS, LVEF, and RVFAC were not associated with mortality. Discussion: In patients with severe AS undergoing TAVI, RVGLS but not LVGLS was reduced in non-survivors compared to survivors, differentiated non-survivors from survivors, was independently associated with mortality, and exhibited potential incremental value for outcome prediction. RVGLS appears to be more suitable than LVGLS for risk stratification in AS and timely valve replacement.

8.
JACC Case Rep ; 17: 101900, 2023 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-37496718

RESUMO

A 62-year-old man experienced embolization of a patent foramen ovale (PFO) occlusion device in the pulmonary artery. The device was successfully retrieved using "puncture to loop" technique, without the need of specific materials. This is a challenging retrieval situation, confirming the feasibility and flexibility of the technique. (Level of Difficulty: Advanced.).

9.
J Clin Med ; 12(11)2023 May 26.
Artigo em Inglês | MEDLINE | ID: mdl-37297892

RESUMO

AIMS: Association of two-(2D) and three-dimensional (3D) left atrial strain (LAS) and low-voltage area (LVA) with recurrence of atrial fibrillation (AF) after pulmonary vein isolation (PVI) was assessed. METHODS AND RESULTS: 3D LAS, 2D LAS, and LVA were obtained in 93 consecutive patients undergoing PVI and recurrence of AF was analyzed prospectively. AF recurred in 12 patients (13%). The 3D left atrial reservoir strain (LARS) and pump strain (LAPS) were lower in patients with recurrent AF than without (p = 0.008 and p = 0.009, respectively). In univariable Cox regression, 3D LARS or LAPS were associated with recurrent AF (LARS: HR = 0.89 (0.81-0.99), p = 0.025; LAPS: HR = 1.40 (1.02-1.92), p = 0.040), while other values were not. Association of 3D LARS or LAPS with recurrent AF was independent of age, body mass index, arterial hypertension, left ventricular ejection fraction, and end-diastolic volume index and left atrial volume index in multivariable models. Kaplan-Meier curves revealed that patients with 3D LAPS < -5.9% did not exhibit recurrent AF, while those >-5.9% had a significant risk of recurrent AF. CONCLUSIONS: 3D LARS and LAPS were associated with recurrent AF after PVI. Association of 3D LAS was independent of relevant clinical and echocardiographic parameters and improved their predictive value. Hence, they may be applied for outcome prediction in patients undergoing PVI.

10.
ERJ Open Res ; 9(2)2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37057079

RESUMO

Background: COPD may predispose to symptomatic pulmonary hypertension at high altitude. We investigated haemodynamic changes in lowlanders with COPD ascending to 3100 m and evaluated whether preventive acetazolamide treatment would attenuate the altitude-induced increase in pulmonary artery pressure (PAP). Methods: In this randomised, placebo-controlled, double-blind, parallel-group trial, patients with COPD Global Initiative for Chronic Obstructive Lung Disease grades 2-3 who were living <800 m and had peripheral oxygen saturation (S pO2 ) >92% and arterial carbon dioxide tension <6 kPa were randomised to receive either acetazolamide (125-250 mg·day-1) or placebo capsules, starting 24 h before ascent from 760 m and during a 2-day stay at 3100 m. Echocardiography, pulse oximetry and clinical assessments were performed at 760 m and after the first night at 3100 m. Primary outcome was PAP assessed by tricuspid regurgitation pressure gradient (TRPG). Results: 112 patients (68% men, mean±sd age 59±8 years, forced expiratory volume in 1 s (FEV1) 61±12% pred, S pO2 95±2%) were included. Mean±sd TRPG increased from 22±7 to 30±10 mmHg in 54 patients allocated to placebo and from 20±5 to 24±7 mmHg in 58 patients allocated to acetazolamide (both p<0.05) resulting in a mean (95% CI) treatment effect of -5 (-9 to -1) mmHg (p=0.015). In patients assigned to placebo at 760/3100 m, mean±sd S pO2 was 95±2%/88±3%; in the acetazolamide group, the respective values were 94±2%/90±3% (both p<0.05), resulting in a treatment effect of +2 (1 to 3)% (p=0.001). Conclusions: In lowlanders with COPD travelling to 3100 m, preventive acetazolamide treatment attenuated the altitude-induced rise in PAP and improved oxygenation.

11.
JACC Cardiovasc Imaging ; 16(3): 332-341, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36889849

RESUMO

BACKGROUND: Left ventricular ejection fraction (LVEF) demonstrates limited prognostic value for post-transcatheter aortic valve replacement (TAVR) outcomes. Evidence regarding the potential role of left ventricular global longitudinal strain (LV-GLS) in this setting is inconsistent. OBJECTIVES: The aim of this systematic review and meta-analysis of aggregated data was to evaluate the prognostic value of preprocedural LV-GLS for post-TAVR-related morbidity and mortality. METHODS: The authors searched PubMed, Embase, and Web of Science for studies investigating the association between preprocedural 2-dimensional speckle-tracking-derived LV-GLS and post-TAVR clinical outcomes. An inversely weighted random effects meta-analysis was adopted to investigate the association between LV-GLS vs primary (ie, all-cause mortality) and secondary (ie, major cardiovascular events [MACE]) post-TAVR outcomes. RESULTS: Of the 1,130 identified records, 12 were eligible, all of which had a low-to-moderate risk of bias (Newcastle-Ottawa scale). On average, 2,049 patients demonstrated preserved LVEF (52.6% ± 1.7%), but impaired LV-GLS (-13.6% ± 0.6%). Patients with a lower LV-GLS had a higher all-cause mortality (pooled HR: 2.01; 95% CI: 1.59-2.55) and MACE (pooled odds ratio [OR]: 1.26; 95% CI: 1.08-1.47) risk compared with patients with higher LV-GLS. In addition, each percentage point decrease of LV-GLS (ie, toward 0%) was associated with an increased mortality (HR: 1.06; 95% CI: 1.04-1.08) and MACE risk (OR: 1.08; 95% CI: 1.01-1.15). CONCLUSIONS: Preprocedural LV-GLS was significantly associated with post-TAVR morbidity and mortality. This suggests a potential clinically important role of pre-TAVR evaluation of LV-GLS for risk stratification of patients with severe aortic stenosis. (Prognostic value of left ventricular global longitudinal strain in patients with aortic stenosis undergoing Transcatheter Aortic Valve Implantation: a meta-analysis; CRD42021289626).


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Disfunção Ventricular Esquerda , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Função Ventricular Esquerda , Prognóstico , Volume Sistólico , Deformação Longitudinal Global , Estudos Retrospectivos , Valor Preditivo dos Testes , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia
12.
J Clin Med ; 12(3)2023 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-36769561

RESUMO

Cardiocutaneous syndrome (CCS) is often caused by genetic variants in desmoplakin (DSP) in the presence of thick calluses on the hands and soles of the feet (palmoplantar keratoderma) in combination with arrhythmogenic cardiomyopathy. In this case report, we describe a 58-year-old man presenting with a history of cardiomyopathy with recurrent sustained ventricular tachycardia and palmoplantar keratosis. The cardiological evaluation showed biventricular cardiomyopathy, and repeated genetic testing identified a novel DSP variant. Repeated genetic testingis clinically meaningful in patients with a high probability of a specific inherited cardiac disease, such as CCS, particularly if molecular screening has been performed in the pre-NGS era with an incomplete NGS panel or outdated technology as presented in this case report.

15.
J Clin Med ; 11(24)2022 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-36556128

RESUMO

Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is a hereditary condition that can cause sudden cardiac death in young, frequently athletic individuals under the age of 35 due to malignant arrhythmias. Competitive and endurance exercise may hasten the onset and progression of ARVC, leading to right ventricular dysfunction and potentially fatal ventricular arrhythmias earlier in life. In this article, we present a novel, pathogenic, early truncating heterozygous variant in the PKP2 gene that causes biventricular arrhythmogenic cardiomyopathy and affects a family, of which the only member with the positive phenotype is a competitive endurance athlete.

16.
Int J Cardiol ; 368: 86-93, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-35970442

RESUMO

AIMS: This study aimed at investigating whether tissue Doppler imaging (TDI) is associated with adverse events in arrhythmogenic right ventricular cardiomyopathy (ARVC). METHODS AND RESULTS: Transthoracic echocardiography was performed in 72 patients with definite (n = 63) or borderline (n = 9) ARVC diagnosed according to the 2010 Task Force Criteria and included in the prospective Zurich ARVC registry. Myocardial peak systolic tissue velocity (S') was measured by TDI at lateral tricuspid (tricuspid S'), medial mitral (septal S'), and lateral mitral annulus (lateral S'). Association of echocardiographic parameters with outcome was assessed by univariable Cox regression. During a median follow-up of 4.9 ± 2.6 years, 6 (8.3%) patients died of cardiovascular cause or received heart transplantation and 21 (29.2%) patients developed sustained ventricular arrhythmia. Tricuspid, septal, and lateral S' were lower in patients who died (p = 0.001; p < 0.001; p = 0.008; respectively), while tricuspid and septal S' were lower in those with ventricular arrhythmia (p = 0.001; p = 0.008; respectively). There was a significant association of tricuspid, septal, and lateral S' with mortality (HR = 1.61, p = 0.011; HR = 2.15, p = 0.007; HR = 1.67, p = 0.017; respectively), while tricuspid and septal S' were associated with ventricular arrhythmia (HR = 1.20, p = 0.022; HR = 1.37, p = 0.004; respectively). Kaplan-Meier analyses demonstrated a higher freedom from mortality with tricuspid S' >8 cm/s (p = 0.001) and from ventricular arrhythmia with S' >10.5 cm/s (p = 0.021). CONCLUSIONS: This study demonstrates that TDI provides information on the ARVC phenotype, is associated with adverse events in ARVC patients, and differentiates between patients with and without adverse events.


Assuntos
Displasia Arritmogênica Ventricular Direita , Displasia Arritmogênica Ventricular Direita/diagnóstico por imagem , Ecocardiografia , Ecocardiografia Doppler/métodos , Humanos , Estudos Prospectivos , Sístole
17.
Eur J Cardiothorac Surg ; 62(3)2022 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-35920768

RESUMO

The retrograde valve-crossing of a stenotic aortic valve is a crucial step in the transcatheter aortic valve implantation procedure. In addition to being time-consuming and associated with an increased stroke risk, inappropriate valve-crossing may cause devastating complications. This tutorial review summarizes systematic and detailed techniques to cross the aortic valve. First, the main challenges in retrograde valve-crossing are depicted. Next, a step-by-step guidance on valve-crossing is provided, along with an in-depth description of the three-dimensional anatomy under a two-dimensional fluoroscopy view. Finally, modified techniques for different anatomies are described.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Algoritmos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Fluoroscopia , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
19.
J Card Surg ; 37(10): 3396-3402, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35842798

RESUMO

We report the case of a 78-year-old female with Sapien 3 transcatheter heart valve implantation in the transcaval approach. In this setting, we describe the step-by-step management and technique of the transcaval transcatheter aortic valve implantation.


Assuntos
Estenose da Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
20.
ESC Heart Fail ; 9(4): 2207-2214, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35619238

RESUMO

AIMS: Synchronized diaphragmatic stimulation (SDS) modulates intrathoracic and intra-abdominal pressures with favourable effects on cardiac function for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure (HFrEF). VisONE-HF is a first-in-patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device. METHODS AND RESULTS: The SDS system comprises a pulse generator and two laparoscopically delivered, bipolar, active-fixation leads on the inferior diaphragmatic surface. Fifteen symptomatic men with HFrEF and ischaemic heart disease receiving guideline-recommended therapy were enrolled (age 60 [56, 67] years, New York Heart Association class II [53%] /III [47%], LVEF 27 [23, 33] %, QRSd 117 [100, 125] ms, & N terminal pro brain natriuretic peptide [NT-proBNP] 1779 [911, 2,072] pg/mL). Implant success was 100%. Patients were evaluated at 3, 6, and 12 months for device-related or lead-related complications, quality of life (SF-36 QOL), 6 min hall walk distance (6MHWd), and by echocardiography. No implant procedure or SDS-related adverse event occurred, and patients were unaware of diaphragmatic stimulation. By 12 months, left ventricular end-systolic volume decreased (136 [123, 170] mL to 98 [89, 106] mL; P = 0.05), 6MHWd increased (315 [300, 330] m to 340 [315, 368] m; P = 0.004), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], P = 0.006; emotional scale 0 [0, 33] to 33 [33, 67], P = 0.001). Although neither reached statistical significance, LVEF decreased (28 [23, 40]% vs. 34 [29, 38]%; P = ns) and NT-proBNP was lower (1784 [920, 2540] pg/mL vs. 1492 [879, 2028] pg/mL; P = ns). CONCLUSIONS: These data demonstrate the feasibility of laparoscopic implantation and delivery of SDS without raising safety concerns. These encouraging findings should be investigated further in adequately powered randomized trials.


Assuntos
Insuficiência Cardíaca , Isquemia Miocárdica , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/complicações , Qualidade de Vida , Volume Sistólico , Função Ventricular Esquerda
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