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1.
NEJM Evid ; : EVIDoa2400147, 2024 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-39217453

RESUMEN

BACKGROUND: Sodium-glucose cotransporter 2 inhibitors (SGLT2is) have beneficial pleiotropic effects, contributing to improved cardiovascular and renal outcomes for patients with and without diabetes. The impact of SGLT2is on arrhythmic burden remains largely unexplored through randomized trials. METHODS: In this multicenter, double-blind, randomized, placebo-controlled trial, we investigated the effects of ertugliflozin on arrhythmic burden among patients with heart failure with an ejection fraction less than 50%. All patients had an implantable cardioverter-defibrillator (ICD) with or without a cardiac resynchronization therapy device (CRT-D) and were randomized (1:1) to receive either ertugliflozin 5 mg once daily or placebo. The primary end point was the number of incident sustained (>30 seconds) ventricular tachycardia or ventricular fibrillation events from baseline to week 52. Secondary end points included the total number of non-sustained ventricular tachycardias, appropriate ICD therapies, changes in N-terminal pro-brain-type natriuretic peptide (NTproBNP) levels, and the number of heart failure hospitalizations. RESULTS: Randomization was prematurely terminated, after class IA guideline recommendations were published for SGLT2is in patients with heart failure regardless of the ejection fraction. The final analysis included 46 patients (11% of the originally planned sample size). The yearly rate of the primary end point was 3.5 (95% confidence interval [CI] 2.8 to 4.4) with ertugliflozin compared with 13.3 with placebo (95% CI 11.8 to 14.8; rate ratio 0.16, 95% CI 0.04 to 0.61; P<0.001). There were no apparent differences in appropriate ICD therapies, hospitalizations, NTproBNP levels, or predefined adverse and serious adverse events. CONCLUSIONS: Ertugliflozin reduced sustained ventricular tachycardia or ventricular fibrillation events in adults with heart failure and an ICD compared with placebo; however, our trial ended early and thus results should be interpreted with caution. (Funded by Investigator-initiated Studies Program of Merck Sharp & Dohme Corp and Pfizer; EudraCT number, 2020-002581-14; ClinicalTrials.gov number NCT04600921.).

3.
Europace ; 2024 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-39148456

RESUMEN

Indications and clinical impact of genetic testing for cardiac diseases have increased significantly over the past years. The aim of this physician-based EHRA survey was to assess current clinical practice and access to genetic testing for cardiac diseases across ESC countries and to evaluate adherence to the 2022 EHRA/HRS/APHRS/LAHRS Expert Consensus Statement on genetic testing. An online questionnaire composed of 28 questions was submitted to the EHRA Research Network and European Reference Network GUARD-Heart healthcare partners and promoted via dedicated social media channels. There were 357 respondents from 69 countries, 40% working in a hospital setting with a cardiac genetic service and/or a dedicated clinic focusing on inherited cardiac diseases and 27% with an onsite genetic laboratory. No genetic testing or low annual rate (<10/y) was declared by 39% of respondents. The majority of respondents (78%) declared issues or limitations to genetic testing access in their clinical practice. The main reasons for not providing or limited access to genetic testing were no availability of dedicated unit or genetic laboratory (35%) or reimbursement issues (25%). The most frequently reported indication for genetic testing was diagnostic purpose (55%). Most respondents (92%) declared offering genetic testing preceded by genetic counselling and 42% regular multidisciplinary evaluations for patients with cardiac genetic diseases. The perceived value of genetic testing in the diagnostic, prognostic, and therapeutic assessment was variable (67%, 39%, and 29%, respectively) and primarily based on the specific inherited disease. The majority of respondents recommended cascade genetic testing for the first-degree family members in case of pathogenic/likely pathogenic (P/LP) variant in the proband. This survey highlights a significant heterogeneity of genetic testing access and provision and issues attributable to the availability of dedicated unit/genetic laboratory and reimbursement. However, adequate adherence to indications in the current recommendations for genetic testing in patients with cardiac diseases was observed.

4.
Comput Methods Programs Biomed ; 254: 108299, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38959599

RESUMEN

BACKGROUND AND OBJECTIVE: Data from electro-anatomical mapping (EAM) systems are playing an increasingly important role in computational modeling studies for the patient-specific calibration of digital twin models. However, data exported from commercial EAM systems are challenging to access and parse. Converting to data formats that are easily amenable to be viewed and analyzed with commonly used cardiac simulation software tools such as openCARP remains challenging. We therefore developed an open-source platform, pyCEPS, for parsing and converting clinical EAM data conveniently to standard formats widely adopted within the cardiac modeling community. METHODS AND RESULTS: pyCEPS is an open-source Python-based platform providing the following functions: (i) access and interrogate the EAM data exported from clinical mapping systems; (ii) efficient browsing of EAM data to preview mapping procedures, electrograms (EGMs), and electro-cardiograms (ECGs); (iii) conversion to modeling formats according to the openCARP standard, to be amenable to analysis with standard tools and advanced workflows as used for in silico EAM data. Documentation and training material to facilitate access to this complementary research tool for new users is provided. We describe the technological underpinnings and demonstrate the capabilities of pyCEPS first, and showcase its use in an exemplary modeling application where we use clinical imaging data to build a patient-specific anatomical model. CONCLUSION: With pyCEPS we offer an open-source framework for accessing EAM data, and converting these to cardiac modeling standard formats. pyCEPS provides the core functionality needed to integrate EAM data in cardiac modeling research. We detail how pyCEPS could be integrated into model calibration workflows facilitating the calibration of a computational model based on EAM data.


Asunto(s)
Simulación por Computador , Programas Informáticos , Humanos , Calibración , Electrocardiografía , Modelos Cardiovasculares , Corazón/fisiología , Electrofisiología Cardíaca
5.
Artículo en Inglés | MEDLINE | ID: mdl-38864809

RESUMEN

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

6.
Artículo en Inglés | MEDLINE | ID: mdl-38869506

RESUMEN

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: To assess the outcomes of pulsed-field ablation (PFA) in HF. METHODS: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HFPEF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HFMR/REF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively. RESULTS: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HFPEF, and 8.6% (n=120) were HFMR/REF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HFPEF or HFMR/REF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HFMR/REF and HFPEF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFPEF vs HFMR/REF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HFPEF and HFMR/REF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSION: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

7.
Europace ; 26(7)2024 Jul 02.
Artículo en Inglés | MEDLINE | ID: mdl-38875490

RESUMEN

AIMS: Superior vena cava (SVC) isolation during atrial fibrillation catheter ablation is limited by the risk of collateral damage to the sinus node and/or the phrenic nerve. Due to its tissue-specificity, we hypothesized the feasibility and safety of pulsed-field ablation (PFA)-based SVC isolation. METHODS AND RESULTS: One hundred and five consecutive patients undergoing PFA-based AF catheter ablation were prospectively included. After pulmonary vein isolation (±posterior wall isolation and electrical cardioversion), SVC isolation was performed using a standardized workflow. Acute SVC isolation was achieved in 105/105 (100%) patients after 6 ± 1 applications. Transient phrenic nerve stunning occurred in 67/105 (64%) patients but without phrenic nerve palsy at the end of the procedure and at hospital discharge. Transient high-degree sinus node dysfunction occurred in 5/105 (4.7%) patients, with no recurrence at the end of the procedure and until discharge. At the 3-month follow-up visit, no complication occurred. CONCLUSION: SVC isolation using a pentaspline PFA catheter is feasible and safe.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Estudios de Factibilidad , Vena Cava Superior , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/métodos , Ablación por Catéter/instrumentación , Masculino , Femenino , Vena Cava Superior/cirugía , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Estudios Prospectivos , Venas Pulmonares/cirugía , Catéteres Cardíacos , Diseño de Equipo , Nervio Frénico/lesiones
8.
Europace ; 26(6)2024 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-38758963

RESUMEN

AIMS: Pulmonary vein isolation (PVI) is the corner stone of modern rhythm control strategies in patients with atrial fibrillation (AF). Sleep-disordered breathing (SDB) is prevalent in more than 50% of patients undergoing AF ablation, and studies have indicated a greater recurrence rate after PVI in patients with SDB. Herein, we study the effect of catheter-based PVI on AF in a pig model for SDB. METHODS AND RESULTS: In 11 sedated spontaneously breathing pigs, obstructive apnoeas were simulated by 75 s of intermittent negative upper airway pressure (INAP) applied by a negative pressure device connected to the endotracheal tube. Intermittent negative upper airway pressures were performed before and after PVI. AF-inducibility and atrial effective refractory periods (aERPs) were determined before and during INAP by programmed atrial stimulation. Pulmonary vein isolation prolonged the aERP by 48 ± 27 ms in the right atrium (RA) (P < 0.0001) and by 40 ± 34 ms in the left atrium (LA) (P = 0.0004). Following PVI, AF-inducibility dropped from 28 ± 26% to 0% (P = 0.0009). Intermittent negative upper airway pressure was associated with a transient aERP-shortening (ΔaERP) in both atria, which was not prevented by PVI (INAP indued ΔaERP after PVI in the RA: -57 ± 34 ms, P = 0.0002; in the LA: -42 ± 24 ms, P < 0.0001). Intermittent negative upper airway pressure was associated with a transient increase in AF-inducibility (from 28 ± 26% to 69 ± 21%; P = 0.0008), which was not attenuated by PVI [INAP-associated AF-inducibility after PVI: 58 ± 33% (P = 0.5)]. CONCLUSION: Transient atrial arrhythmogenic changes related to acute obstructive respiratory events are not prevented by electrical isolation of the pulmonary veins, which partially explains the increased AF recurrence in patients with SDB after PVI procedures.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Modelos Animales de Enfermedad , Venas Pulmonares , Animales , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/cirugía , Fibrilación Atrial/prevención & control , Fibrilación Atrial/diagnóstico , Porcinos , Ablación por Catéter/métodos , Apnea Obstructiva del Sueño/fisiopatología , Insuficiencia del Tratamiento , Frecuencia Cardíaca , Atrios Cardíacos/fisiopatología , Atrios Cardíacos/cirugía
9.
Europace ; 26(5)2024 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-38666444

RESUMEN

Stereotactic arrhythmia radioablation (STAR) is a treatment option for recurrent ventricular tachycardia/fibrillation (VT/VF) in patients with structural heart disease (SHD). The current and future role of STAR as viewed by cardiologists is unknown. The study aimed to assess the current role, barriers to application, and expected future role of STAR. An online survey consisting of 20 questions on baseline demographics, awareness/access, current use, and the future role of STAR was conducted. A total of 129 international participants completed the survey [mean age 43 ± 11 years, 25 (16.4%) female]. Ninety-one (59.9%) participants were electrophysiologists. Nine participants (7%) were unaware of STAR as a therapeutic option. Sixty-four (49.6%) had access to STAR, while 62 (48.1%) had treated/referred a patient for treatment. Common primary indications for STAR were recurrent VT/VF in SHD (45%), recurrent VT/VF without SHD (7.8%), or premature ventricular contraction (3.9%). Reported main advantages of STAR were efficacy in the treatment of arrhythmias not amenable to conventional treatment (49%) and non-invasive treatment approach with overall low expected acute and short-term procedural risk (23%). Most respondents have foreseen a future clinical role of STAR in the treatment of VT/VF with or without underlying SHD (72% and 75%, respectively), although only a minority expected a first-line indication for it (7% and 5%, respectively). Stereotactic arrhythmia radioablation as a novel treatment option of recurrent VT appears to gain acceptance within the cardiology community. Further trials are critical to further define efficacy, patient populations, as well as the appropriate clinical use for the treatment of VT.


Asunto(s)
Radiocirugia , Taquicardia Ventricular , Fibrilación Ventricular , Humanos , Femenino , Masculino , Taquicardia Ventricular/cirugía , Taquicardia Ventricular/fisiopatología , Adulto , Persona de Mediana Edad , Fibrilación Ventricular/cirugía , Fibrilación Ventricular/fisiopatología , Radiocirugia/tendencias , Encuestas de Atención de la Salud , Técnicas Electrofisiológicas Cardíacas , Recurrencia , Resultado del Tratamiento , Pautas de la Práctica en Medicina/tendencias , Pautas de la Práctica en Medicina/estadística & datos numéricos , Cardiólogos/tendencias , Electrofisiología Cardíaca/tendencias
10.
JACC Clin Electrophysiol ; 10(5): 900-912, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38430087

RESUMEN

BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Atrios Cardíacos , Venas Pulmonares , Humanos , Fibrilación Atrial/cirugía , Masculino , Femenino , Anciano , Ablación por Catéter/métodos , Ablación por Catéter/efectos adversos , Persona de Mediana Edad , Estudios Retrospectivos , Atrios Cardíacos/cirugía , Venas Pulmonares/cirugía , Resultado del Tratamiento , Sistema de Registros
12.
Eur Heart J Digit Health ; 5(1): 97-100, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38264695

RESUMEN

Aims: TeleCheck-AF is a novel remote on-demand mobile health infrastructure around teleconsultations for patients with atrial fibrillation. Social media (SoMe) communication on Twitter contributed to the dissemination of this healthcare innovation by using the hashtag #TeleCheckAF. This study aims to analyse the SoMe network behind #TeleCheckAF and determine the key opinion leaders. Methods and results: Publicly available data on actors and interactions around the hashtag #TeleCheckAF were collected by web scraping from the platform Twitter. With tools based on social network analysis, a social network was created, different communities were identified, and key opinion leaders were determined by their centrality in the network. The SoMe network consisted of 413 086 accounts with 636 502 ties in 22 different communities. A total of 287 accounts that diffused information and/or used the TeleCheck-AF infrastructure were analysed in depth. Those accounts involved users from >15 different countries and multidisciplinary professions. Further, 20 opinion leaders were identified, including four official accounts of societies and associated journals among key opinion leaders. Peaks in #TeleCheckAF tweets were seen after (virtual) conferences and other activities involving national and international cardiology societies. Social network analysis of the TeleCheck-AF Twitter hashtag revealed a wide, multidisciplinary potential reach for the diffusion of a healthcare innovation. Conclusion: Official society SoMe accounts can amplify the dissemination of research findings by featuring abstract presentations during conferences and published manuscripts. This underlines the synergistic effects between traditional and SoMe-based research dissemination strategies for novel healthcare approaches, such as the TeleCheck-AF project.

13.
Neth Heart J ; 32(3): 130-139, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38214880

RESUMEN

AIM: To evaluate changes in healthcare utilisation and comprehensive packages of care activities and procedures (referred in the Netherlands to as 'diagnose-behandelcombinatie (DBC) care products) during the implementation of the TeleCheck-AF approach (teleconsultation supported by app-based heart rate/rhythm monitoring) in a Dutch atrial fibrillation (AF) clinic. METHODS AND RESULTS: In the Maastricht University Medical Centre+ AF Clinic, data on healthcare utilisation and DBC care products for patients consulted by both a conventional approach in 2019 and the TeleCheck-AF approach in 2020 were analysed. A patient experience survey was performed. Thirty-seven patients (median age 68 years; 40% women) were analysed. With the conventional approach, 35 face-to-face consultations and 0 teleconsultations were conducted. After the implementation of TeleCheck-AF, the number of face-to-face consultations dropped by 80% (p < 0.001) and teleconsultations increased to 45 (p < 0.001). While 42 electrocardiograms (ECGs) and 25 Holter ECGs or echocardiograms were recorded when using the conventional approach, the number of ECGs decreased by 71% (p < 0.001) and Holter ECGs or echocardiograms by 72% (p < 0.001) with the TeleCheck-AF approach. The emergency department patient presentations showed no statistically significant change (p = 0.33). Overall, 57% of medium-weight DBC care products were changed to light-weight ones during implementation of the TeleCheck-AF approach. Patient satisfaction with the TeleCheck-AF approach was high. CONCLUSION: The implementation of TeleCheck-AF led to a change in healthcare utilisation, a change from medium-weight to light-weight DBC care products and a reduction in patient burden. These results created the basis for a new reimbursement code for the TeleCheck-AF approach in the Netherlands.

14.
Pacing Clin Electrophysiol ; 47(1): 117-120, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37885274

RESUMEN

Pulse field ablation (PFA) is a novel nonthermal ablation modality for treatment of atrial fibrillation. While mostly lacking 3D electroanatomical mapping integration, reported radiation doses in procedures using multielectrode PFA catheters are relatively high. We report a first case series of three patients where a zero-fluoroscopy approach by intracardiac echocardiography was utilized and present a possible workflow for zero-fluoroscopy ablation with the Farapulse PFA system.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Humanos , Terapia de Electroporación Irreversible , Resultado del Tratamiento , Ablación por Catéter/métodos , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Fluoroscopía/métodos
15.
J Cardiopulm Rehabil Prev ; 44(2): 115-120, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-38032261

RESUMEN

PURPOSE: Patients at risk for sudden cardiac death may temporarily need a wearable cardioverter-defibrillator (WCD). Exercise-based cardiac rehabilitation (CR) has a class I recommendation in patients with cardiac disease. The aim of this study was to evaluate the safety and feasibility of undergoing CR with a WCD. METHODS: We performed a retrospective analysis of all patients with a WCD who completed a CR in Austria (2010-2020). RESULTS: Patients (n = 55, 60 ± 11 yr, 16% female) with a median baseline left ventricular ejection fraction (LVEF) of 36 (30, 41)% at the start of CR showed a daily WCD wearing duration of 23.4 (22, 24) hr. There were 2848 (8 [1, 26]/patient) automatic alarms and 340 (3 [1, 7]/patient) manual alarms generated. No shocks were delivered by the WCD during the CR period. One patient had recurrent hemodynamically tolerated ventricular tachycardias that were controlled with antiarrhythmic drugs.No severe WCD-associated adverse events occurred during the CR stay of a median 28 (28, 28) d. The fabric garment and the device setting needed to be adjusted in two patients to diminish inappropriate automatic alarms. Left ventricular ejection fraction after CR increased significantly to 42 (30, 44)% ( P < .001). Wearable cardioverter-defibrillator therapy was stopped due to LVEF restitution in 53% of patients. In 36% of patients an implantable cardioverter-defibrillator was implanted, 6% had LVEF improvement after coronary revascularization, one patient received a heart transplantation (2%), two patients discontinued WCD treatment at their own request (4%). CONCLUSION: Completing CR is feasible and safe for WCD patients and may contribute positively to the restitution of cardiac function.


Asunto(s)
Rehabilitación Cardiaca , Desfibriladores Implantables , Humanos , Femenino , Masculino , Estudios Retrospectivos , Volumen Sistólico , Función Ventricular Izquierda , Cardioversión Eléctrica
16.
JAMA Cardiol ; 8(12): 1142-1151, 2023 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-37910101

RESUMEN

Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs). Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.


Asunto(s)
Fibrilación Atrial , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Adolescente , Fibrilación Atrial/tratamiento farmacológico , Estudios Retrospectivos , Estudios de Cohortes , Factores Sexuales , Resultado del Tratamiento
17.
J Clin Med ; 12(15)2023 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-37568431

RESUMEN

BACKGROUND: After acute myocardial infarction (AMI), patients are at risk of sudden cardiac death. The VEST trial failed to show a reduction in arrhythmic mortality in AMI patients with an LVEF ≤ 35% prescribed with a WCD, having a lower-than-expected WCD wearing compliance. OBJECTIVES: The aim was to investigate on outcomes of patients in a real-world Austrian cohort with good compliance. METHODS: A retrospective analysis of all eligible Austrian WCD patients according to the VEST trial inclusion and exclusion criteria between 2010 and 2020 was performed. RESULTS: In total, 105 Austrian patients (64 ± 11 years, 12% female; LVEF 28 ± 6%) received a WCD for a median of 69 (1; 277) days after AMI (wearing duration 23.5 (0; 24) hours/day). Within the first 90 days, 4/105 (3.8%) patients received 9 appropriate shocks (2 (1; 5) shocks). No inappropriate shocks were delivered, and 3/105 (2.9%) patients died during follow-up. Arrhythmic mortality (1.9% Austria vs. 1.6% VEST, p = 0.52), as well as all-cause mortality (2.9% vs. 3.1%, p = 0.42) was comparable in both cohorts. CONCLUSIONS: The WCD is a safe treatment option in a highly selected cohort of patients with LVEF ≤ 35% after AMI. However, despite excellent WCD wearing duration in our cohort, the arrhythmic mortality rate was not significantly different.

19.
Europace ; 25(9)2023 08 02.
Artículo en Inglés | MEDLINE | ID: mdl-37498147

RESUMEN

AIMS: Electrophysiology (EP) is a growing field in cardiology, with an increasing involvement of young people. Nevertheless, concerns about radiation exposure and its impact on reproduction and pregnancy may discourage the choice of an EP career. The study is aimed at investigating the level of awareness and main sources of concern about the effects of radiation on reproductive potential and pregnancy, exploring the safety measures adopted in different EP labs, and verifying the adherence to the current guidelines. METHODS AND RESULTS: An online survey was conducted using the European Heart Rhythm Association (EHRA) infrastructure from April to June 2022. A total of 252 EP personnel (42% women) participated, from 50 countries and different professional roles. Most participants expressed concerns regarding the effects of radiation on reproductive capacity (67.1%) and offspring diseases (68.2%). Only 37.9% of participants were aware of the EHRA 2017 consensus document about occupational radiation exposure. Most participants (80.9%) considered that occupational radiation during pregnancy is not safe. EP female staff were not allowed to work in the EP lab during pregnancy in 48.1% of cases. Zero-fluoroscopy was the preferred choice to continue working in the EP lab during pregnancy. CONCLUSION: EP staff, including both men and women, have concerns about the effects of radiation on reproductive capacity. Despite the recommendations issued by international bodies, implementation of the policies regarding pregnancy and occupational radiation exposure is heterogeneous. Zero-fluoroscopy is the preferred approach to ensure safety during pregnancy in the EP lab.


Asunto(s)
Exposición Profesional , Exposición a la Radiación , Traumatismos por Radiación , Masculino , Embarazo , Femenino , Humanos , Adolescente , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Encuestas y Cuestionarios , Reproducción , Electrofisiología Cardíaca , Exposición Profesional/efectos adversos , Exposición Profesional/prevención & control , Dosis de Radiación
20.
Front Cardiovasc Med ; 10: 1199630, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37424905

RESUMEN

Aims: To test the feasibility of postprocedural photoplethysmography (PPG) rhythm telemonitoring during the first week after atrial fibrillation (AF) ablation and its predictive value for later AF recurrence. Methods: PPG rhythm telemonitoring during the first week after the ablation procedure was offered to a total of 382 consecutive patients undergoing AF ablation. Patients were instructed to perform 1 min PPG recordings by a mobile health application 3 times per day and in case of symptoms. Clinicians assessed the PPG tracings via a secured cloud and the information was remotely integrated into the therapeutic pathway via teleconsultation (TeleCheck-AF approach). Results: 119 patients (31%) agreed to perform PPG rhythm telemonitoring after ablation. Patients included in the TeleCheck-AF approach were younger compared to those who declined participation (58 ± 10 vs. 62 ± 10 years, p < 0.001). Median follow up duration was 544 (53-883) days. 27% of patients had PPG tracings suggestive of AF in the week following the ablation. In 24% of patients, the integration of PPG rhythm telemonitoring resulted in a remote clinical intervention during teleconsultation. During follow-up of one year, 33% of patients had ECG-documented AF recurrences. PPG recordings suggestive of AF in the week after ablation were predictive of late recurrences (p < 0.001). Conclusion: PPG rhythm telemonitoring during the first week after AF ablation often triggered clinical interventions. Due to its high availability, PPG-based follow-up actively involving patients after AF ablation may close a diagnostic and prognostic gap in the blanking period and increase active patient-involvement.

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