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1.
Lancet ; 402(10408): 1147-1157, 2023 09 30.
Article in English | MEDLINE | ID: mdl-37634520

ABSTRACT

BACKGROUND: Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. METHODS: This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2-4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. FINDINGS: Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45-72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3-25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5-27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78-1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. INTERPRETATION: Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. FUNDING: Medtronic.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure , Humans , Male , Female , Bundle-Branch Block/etiology , Bundle-Branch Block/therapy , Prospective Studies , Treatment Outcome , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/methods , Stroke Volume , Electrocardiography
2.
J Cardiovasc Electrophysiol ; 35(3): 583-591, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37811553

ABSTRACT

BACKGROUND: Height, left ventricular (LV) size, and sex were proposed as additional criteria for patient selection for cardiac resynchronization therapy (CRT) but their connections with the QRS complex in left bundle branch block (LBBB) are little investigated. We evaluated these. METHODS: Among patients with "true" LBBB, QRS duration (QRSd) and amplitude, and LV hypertrophy indices, were correlated with patient's height and LV mass, and compared between sexes. RESULTS: In this study cohort (n = 220; 60 ± 12 years; left ventricular ejection fraction [LVEF] 21 ± 7%; mostly New York Heart Association II-III, QRSd 165 ± 19 ms; 57% female; 70% responders [LVEF increased ≥5%]), LV mass was increased in all patients. QRS amplitude did not correlate with LV mass or height in any individual lead or with Sokolow-Lyon or Cornell-Lyon indices. QRSd did not correlate with height. In contrast, QRSd correlated strongly with LV mass (r = .51). CRT response rate was greater in women versus men (84% vs. 58%, p < .001) despite shorter QRSd [7% shorter (p < .0001)]. QRSd normalized for height resulted in a 2.7% and for LV mass 24% greater index in women. CONCLUSION: True LBBB criteria do not exclude HF patients with increased LV mass. QRS amplitudes do not correlate with height or LV mass. Height does not affect QRSd. However, QRSd correlates with LV size. QRSd normalized for LV mass results in 24% greater value in women in the direction of sex-specific responses. LV mass may be a significant nonelectrical modifier of QRSd for CRT.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure , Male , Humans , Female , Bundle-Branch Block/diagnosis , Bundle-Branch Block/therapy , Stroke Volume/physiology , Ventricular Function, Left/physiology , Treatment Outcome , Electrocardiography , Heart Failure/diagnosis , Heart Failure/therapy , Cardiac Resynchronization Therapy/methods
3.
J Cardiovasc Electrophysiol ; 35(4): 832-842, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38448797

ABSTRACT

INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. METHODS AND RESULTS: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. CONCLUSIONS: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Heart Injuries , Pulmonary Veins , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/epidemiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cryosurgery/adverse effects , Cryosurgery/methods , Heart Injuries/etiology , Prospective Studies , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
4.
Ann Noninvasive Electrocardiol ; 29(1): e13097, 2024 01.
Article in English | MEDLINE | ID: mdl-37997698

ABSTRACT

The ECG diagnosis of LVH is predominantly based on the QRS voltage criteria. The classical paradigm postulates that the increased left ventricular mass generates a stronger electrical field, increasing the leftward and posterior QRS forces, reflected in the augmented QRS amplitude. However, the low sensitivity of voltage criteria has been repeatedly documented. We discuss possible reasons for this shortcoming and proposal of a new paradigm. The theoretical background for voltage measured at the body surface is defined by the solid angle theorem, which relates the measured voltage to spatial and non-spatial determinants. The spatial determinants are represented by the extent of the activation front and the distance of the recording electrodes. The non-spatial determinants comprise electrical characteristics of the myocardium, which are comparatively neglected in the interpretation of the QRS patterns. Various clinical conditions are associated with LVH. These conditions produce considerable diversity of electrical properties alterations thereby modifying the resultant QRS patterns. The spectrum of QRS patterns observed in LVH patients is quite broad, including also left axis deviation, left anterior fascicular block, incomplete and complete left bundle branch blocks, Q waves, and fragmented QRS. Importantly, the QRS complex can be within normal limits. The new paradigm stresses the electrophysiological background in interpreting QRS changes, i.e., the effect of the non-spatial determinants. This postulates that the role of ECG is not to estimate LV size in LVH, but to understand and decode the underlying electrical processes, which are crucial in relation to cardiovascular risk assessment.


Subject(s)
Heart Conduction System , Hypertrophy, Left Ventricular , Humans , Hypertrophy, Left Ventricular/diagnosis , Electrocardiography , Arrhythmias, Cardiac , Bundle-Branch Block
5.
Europace ; 25(9)2023 08 02.
Article in English | MEDLINE | ID: mdl-37622591

ABSTRACT

This reviews the transition of remote monitoring of patients with cardiac electronic implantable devices from curiosity to standard of care. This has been delivered by technology evolution from patient-activated remote interrogations at appointed intervals to continuous monitoring that automatically flags clinically actionable information to the clinic for review. This model has facilitated follow-up and received professional society recommendations. Additionally, continuous monitoring has provided a new level of granularity of diagnostic data enabling extension of patient management from device to disease management. This ushers in an era of digital medicine with wider applications in cardiovascular medicine.


Subject(s)
Cardiovascular Agents , Humans , Electronics , Heart , Technology , Disease Management
6.
Europace ; 26(1)2023 12 28.
Article in English | MEDLINE | ID: mdl-38170474

ABSTRACT

AIMS: The increasing use of insertable cardiac monitors (ICM) produces a high rate of false positive (FP) diagnoses. Their verification results in a high workload for caregivers. We evaluated the performance of an artificial intelligence (AI)-based ILR-ECG Analyzer™ (ILR-ECG-A). This machine-learning algorithm reclassifies ICM-transmitted events to minimize the rate of FP diagnoses, while preserving device sensitivity. METHODS AND RESULTS: We selected 546 recipients of ICM followed by the Implicity™ monitoring platform. To avoid clusterization, a single episode per ICM abnormal diagnosis (e.g. asystole, bradycardia, atrial tachycardia (AT)/atrial fibrillation (AF), ventricular tachycardia, artefact) was selected per patient, and analyzed by the ILR-ECG-A, applying the same diagnoses as the ICM. All episodes were reviewed by an adjudication committee (AC) and the results were compared. Among 879 episodes classified as abnormal by the ICM, 80 (9.1%) were adjudicated as 'Artefacts', 283 (32.2%) as FP, and 516 (58.7%) as 'abnormal' by the AC. The algorithm reclassified 215 of the 283 FP as normal (76.0%), and confirmed 509 of the 516 episodes as abnormal (98.6%). Seven undiagnosed false negatives were adjudicated as AT or non-specific abnormality. The overall diagnostic specificity was 76.0% and the sensitivity was 98.6%. CONCLUSION: The new AI-based ILR-ECG-A lowered the rate of FP ICM diagnoses significantly while retaining a > 98% sensitivity. This will likely alleviate considerably the clinical burden represented by the review of ICM events.


Subject(s)
Artificial Intelligence , Atrial Fibrillation , Humans , Electrocardiography, Ambulatory/methods , Atrial Fibrillation/diagnosis , Electrocardiography , Algorithms
7.
Europace ; 25(4): 1458-1466, 2023 04 15.
Article in English | MEDLINE | ID: mdl-36857597

ABSTRACT

AIMS: Pacing remote from the latest electrically activated site (LEAS) in the left ventricle (LV) may diminish response to cardiac resynchronization therapy (CRT). We tested whether proximity of LV pacing site (LVPS) to LEAS, determined by non-invasive three-dimensional electrical activation mapping [electrocardiographic Imaging (ECGI)], increased likelihood of CRT response. METHODS AND RESULTS: Consecutive CRT patients underwent ECGI and chest/heart computed tomography 6-24 months of post-implant. Latest electrically activated site and the distance to LVPS (dp) were assessed. Left ventricular end-systolic volume (LVESV) reduction of ≥15% at clinical follow-up defined response. Logistic regression probabilistically modelled non-response; variables included demographics, heart failure classification, left bundle branch block (LBBB), ischaemic heart disease (IHD), atrial fibrillation, QRS duration, baseline ejection fraction (EF) and LVESV, comorbidities, use of CRT optimization algorithm, angiotensin-converting enzyme inhibitor(ACE)/angiotensin-receptor blocker (ARB), beta-blocker, diuretics, and dp. Of 111 studied patients [64 ± 11 years, EF 28 ± 6%, implant duration 12 ± 5 months (mean ± SD), 98% had LBBB, 38% IHD], 67% responded at 10 ± 3 months post CRT-implant. Latest electrically activated sites were outside the mid-to-basal lateral segments in 35% of the patients. dp was 42 ± 23 mm [31 ± 14 mm for responders vs. 63 ± 24 mm non-responders (P < 0.001)]. Longer dp and the lack of use of CRT optimization algorithm were the only independent predictors of non-response [area under the curve (AUC) 0.906]. dp of 47 mm delineated responders and non-responders (AUC 0.931). CONCLUSION: The distance between LV pacing site and latest electrical activation is a strong independent predictor for CRT response. Non-invasive electrical evaluation to characterize intrinsic activation and guide LV lead deployment may improve CRT efficacy.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure , Humans , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/methods , Heart Ventricles/diagnostic imaging , Angiotensin Receptor Antagonists , Angiotensin-Converting Enzyme Inhibitors , Electrocardiography/methods , Bundle-Branch Block/diagnosis , Bundle-Branch Block/therapy , Arrhythmias, Cardiac/therapy , Heart Failure/diagnosis , Heart Failure/therapy , Treatment Outcome , Ventricular Function, Left
8.
Europace ; 25(5)2023 05 19.
Article in English | MEDLINE | ID: mdl-37208301

ABSTRACT

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.


Subject(s)
Monitoring, Physiologic , Telemetry , Humans
9.
Ann Noninvasive Electrocardiol ; 28(1): e13035, 2023 01.
Article in English | MEDLINE | ID: mdl-36630149

ABSTRACT

BACKGROUND: Sudden cardiac death (SCD) risk is elevated following acute myocardial infarction (MI). The time course of SCD susceptibility post-MI requires further investigation. METHODS: In this observational cohort study, we employed state-of-the-art noninvasive ECG techniques to track the daily time course of cardiac electrical instability and autonomic function following ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI). Preventice BodyGuardian MINI-EL Holters continuously recorded ECGs for 7 days at hospital discharge and at 40 days for STEMI (N = 5) or at 90 days for NSTEMI patients (N = 5). Cardiac electrical instability was assessed by T-wave alternans (TWA) and T-wave heterogeneity (TWH); autonomic tone was determined by rMSSD-heart rate variability (HRV). RESULTS: TWA was severely elevated (≥60 µV) in STEMI patients (80 ± 10.3 µV) at discharge and throughout the first recording period but declined by 50% to 40 ± 2.3 µV (p = .03) by Day 40 and remained in the normal range (<47 µV). TWH, a related phenomenon analyzed from 12-lead ECGs, was reduced by 63% in the five STEMI patients from discharge to normal (<80 µV) at follow-up (105 ± 27.3 to 39 ± 3.3 µV, p < .04) but increased by 65% in a STEMI case (89 to 147 µV), who received a wearable defibrillator vest and later implantable cardioverter defibrillator. In NSTEMI patients, TWA was borderline abnormal (47 ± 3.3 µV) at discharge and declined by 19% to normal (38 ± 1.2 µV) by Day 90 (p = .05). An overall reciprocal increase in rMSSD-HRV suggested recovery of vagal tone. CONCLUSIONS: This study provides proof-of-principle for tracking post-MI SCD risk in individual patients with implications for personalized therapy.


Subject(s)
Myocardial Infarction , Non-ST Elevated Myocardial Infarction , ST Elevation Myocardial Infarction , Humans , Electrocardiography , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , Electrocardiography, Ambulatory , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/therapy , Syndrome
10.
J Electrocardiol ; 81: 85-93, 2023.
Article in English | MEDLINE | ID: mdl-37647776

ABSTRACT

The ECG diagnosis of LVH is predominantly based on the QRS voltage criteria, i.e. the increased QRS complex amplitude in defined leads. The classical ECG diagnostic paradigm postulates that the increased left ventricular mass generates a stronger electrical field, increasing the leftward and posterior QRS forces. These increased forces are reflected in the augmented QRS amplitude in the corresponding leads. However, the clinical observations document increased QRS amplitude only in the minority of patients with LVH. The low sensitivity of voltage criteria has been repeatedly documented. We discuss possible reasons for this shortcoming and proposal of a new paradigm.


Subject(s)
Electrocardiography, Ambulatory , Hypertrophy, Left Ventricular , Humans , Hypertrophy, Left Ventricular/diagnosis , Electrocardiography , Heart Conduction System
11.
J Cardiovasc Electrophysiol ; 33(2): 234-240, 2022 02.
Article in English | MEDLINE | ID: mdl-34911148

ABSTRACT

OBJECTIVE: To test whether a high defibrillation threshold (DFT) marks patients with poor outcomes which are improved when DFT is decreased by system modification (subcutaneous coil implant; SM). BACKGROUND: The electrical substrate generating fast ventricular arrhythmias may generate poor outcomes among patients treated with implantable cardioverter-defibrillators (ICDs), even when arrhythmias are treated successfully. Since patients with high DFTs have increased mortality, we contrasted survival among patients with high DFT treated with and without SM. METHODS: We studied consecutive patients undergoing ICD implantation and DFT testing at Cleveland Clinic over a 14-year period. High DFT was defined as successful defibrillation by shock strength >25 J or ≤10 J of maximal device output. Mortality was recorded using the Social Security Death Index. Survival was compared among those high DFT patients receiving SM versus the remainder. RESULTS: Out of 6353 patients tested, 191 (3%) had high DFT (32.1 ± 3.7 J) versus 13.9 ± 4.9 J in the remainder ("acceptable DFT," p < .001). One hundred twenty-one high DFT patients (63%; 33.3 ± 3.4 J) underwent SM, which significantly decreased DFT (24.8 ± 5.9 J; p < .001). Seventy patients (37%; 30.3 ± 3.3 J) did not undergo SM. During follow-up, 38% (2363/6162; 7.8 yrs) patients with acceptable DFT died versus 48% high DFT patients (91/191; 5.6 yrs.; p < .001). Concomitantly, 48% patients with SM (58/121) died, as compared to 47% patients (33/70) without SM (p = .91); median follow-up 4.9 yrs). CONCLUSION: Patients with high DFT have a higher mortality than those with acceptable DFT. The additional subcutaneous coil implant decreases DFT to an acceptable range but does not appear to improve survival. The electrical substrate underlying high DFT appears to determine survival.


Subject(s)
Defibrillators, Implantable , Electric Countershock , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/therapy , Defibrillators, Implantable/adverse effects , Electric Countershock/adverse effects , Humans , Ventricular Fibrillation/diagnosis , Ventricular Fibrillation/etiology , Ventricular Fibrillation/therapy
12.
Europace ; 24(1): 165-172, 2022 01 04.
Article in English | MEDLINE | ID: mdl-34455442

ABSTRACT

AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing. METHODS AND RESULTS: Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy. CONCLUSION: By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers.


Subject(s)
Cardiac Resynchronization Therapy , Cardiology , Pacemaker, Artificial , Adult , Advisory Committees , Cardiac Resynchronization Therapy/adverse effects , Humans , Quality Indicators, Health Care
13.
J Cardiovasc Electrophysiol ; 32(8): 2228-2237, 2021 08.
Article in English | MEDLINE | ID: mdl-34191359

ABSTRACT

INTRODUCTION: Circuits underlying ventricular tachycardias (VTs) accompanying remote inferior myocardial infarction (IMI) are regarded to be located in the scar. Rotation around the mitral annulus (MA) had also been postulated. We tested whether entrainment mapping could confirm whether MA rotation in VTs post-IMI represented a "driving circuit." METHODS: Three patients with IMI (male, left ventricular ejection fraction range 13%-40%) with hemodynamically tolerated VT (cycle length 365-690 ms) were studied with activation and entrainment mapping of the MA. RESULTS: Patients showed QRS morphologies reported for VTs following IMI: LBBB (left bundle branch block) pattern and/or right bundle pattern. Entrainment revealed the entire MA perimeter constituted the circuit, that is, macroreentry (path length greater than 13 cm in one case). Areas showing prolonged fractionated electrograms (accounting for over 50% of tachycardia cycle length) demonstrated concealed entrainment indicative of slow conduction through (and not around) the scar. Concealed entrainment was observed along the MA, with similar stimulus-QRS intervals when pacing during normal sinus rhythm. Radiofrequency ablation of the inferior isthmus from scar to MA (epicardially in one case) abolished tachycardia. In follow-up, two patients had no VT recurrence and maintained NYHA Class 1 functional status during several years of follow-up. The other patient continued to deteriorate with rapidly progressive HF, had recurrent VT within 3 months, proceeding to transplant within 9 months. Our findings confirm a single-loop perimitral circuit, which is largely (if not exclusively) protected by anatomical barriers. This differs from the established "figure-of-8" VT model. CONCLUSION: Single-loop macroreentrant mitral annular circuits may underlie some VTs following inferior wall infarcts.


Subject(s)
Catheter Ablation , Inferior Wall Myocardial Infarction , Myocardial Infarction , Tachycardia, Ventricular , Electrocardiography , Heart Conduction System/surgery , Humans , Male , Stroke Volume , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/etiology , Tachycardia, Ventricular/surgery , Ventricular Function, Left
14.
Europace ; 23(8): 1237-1243, 2021 08 06.
Article in English | MEDLINE | ID: mdl-33729470

ABSTRACT

AIMS: Cryoballoon pulmonary vein isolation (PVI) is a safe and effective treatment for atrial fibrillation (AF). Current limitations include incomplete vein occlusion due to balloon rigidity and inconsistent electrogram recording, which impairs identification of isolation. We aimed to evaluate the acute safety and performance of a novel cryoballoon system. METHODS AND RESULTS: The system includes a steerable sheath, mapping catheter, and a balloon that maintains uniform inflation pressure and size following initiation of ablation. Protocol-directed cryoablation was delivered for 180 s for isolation documented in ≤60 s, otherwise freeze duration was 240 s. Primary endpoints were acute safety and vein isolation. Pulmonary vein isolation was confirmed at ≥30 min post-isolation. Data were compared across vein locations. Thirty patients with paroxysmal AF were enrolled at two centres and underwent PVI. Pulmonary vein isolation was achieved with cryoablation only in 100% of veins (120/120). Nadir temperature was -53.1 ± 5.3°C. The number of applications to achieve PVI was 1.4 ± 0.4 per vein. Of the 120 veins, 89 were isolated with a single cryothermal application (10/30 patients required only 4 total cryoablations). There were no procedural- or device-related serious adverse events at 30 days post-procedure. A subset (24/30) of patients was followed for 1-year and 71% (17/24) remained free of atrial arrhythmias. Six patients with arrhythmia recurrence were remapped and three had durable PVI for all four veins. CONCLUSION: In this first human experience, the novel cryoballoon platform was safe, efficacious, and demonstrated a high proportion of successful single ablation isolation.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Humans , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
15.
Europace ; 23(10): 1586-1595, 2021 10 09.
Article in English | MEDLINE | ID: mdl-34198334

ABSTRACT

AIMS: The aim of this study is to quantify healthcare resource utilization among non-responders to cardiac resynchronization therapy (CRT-NR) by heart failure (HF) events and influence of comorbidities. METHODS AND RESULTS: The ADVANCE CRT registry (2013-2015) prospectively identified responders/CRT-NRs 6 months post-implant using the clinical composite score. Heart failure event rates and associated cost, both overall and separated for inpatient hospitalizations, office visits, emergency room visits, and observational stays, were quantified. Costs of events were imputed from payments for similar real-world encounters in subjects with CRT-D/P devices in the MarketScan™ commercial and Medicare Supplemental insurance claims databases. Effects of patient demographics and comorbidities on event rates and cost were evaluated. Of 879 US patients (age 69 ± 11 years, 29% female, ischaemic disease 52%), 310 (35%) were CRT-NR. Among CRT-NRs vs. responders, more patients developed HF (41% vs. 11%, P < 0.001), HF event rate was higher (67.0 ± 21.7 vs. 11.4 ± 3.7/100 pt-year, P < 0.001), and HF readmission within 30 days was more common [hazard ratio 7.06, 95% confidence interval (2.1-43.7)]. Inpatient hospitalization was the most common and most expensive event type in CRT-NR. Comorbid HF was increased by diabetes, hypertension, and pulmonary disorders. Over 2 years, compared to CRT responders, each CRT-NR resulted in excess cost of $6388 ($3859-$10 483) to Medicare (P = 0.015) or $10 197 ($6161-$17 394) to private insurances (P = 0.014). CONCLUSION: Healthcare expenditures associated with contemporary CRT non-response management are among the highest for any HF patient group. This illustrates an unmet need for interventions to improve HF outcomes and reduce costs among some CRT recipients.


Subject(s)
Cardiac Resynchronization Therapy , Defibrillators, Implantable , Heart Failure , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy Devices , Female , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/therapy , Humans , Male , Medicare , Middle Aged , Treatment Outcome , United States/epidemiology
16.
Pacing Clin Electrophysiol ; 44(11): 1890-1896, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34499749

ABSTRACT

BACKGROUND: Marked QRS widening in patients with left bundle branch block (LBBB) may reduce efficacy of cardiac resynchronization therapy (CRT). We hypothesized that extreme QRS prolongation may accompany right ventricular (RV) dilatation/systolic dysfunction (RVD/RVsD) as well as left ventricular dilatation/systolic dysfunction (LVD/LVsD). METHODS: We assessed rates of both ventricular dilatation and systolic dysfunction according to widening of QRS duration (QRSd) in 100 consecutive cardiomyopathy patients with true LBBB (QRSd ≥ 130 ms in female or ≥140 ms in male, QS or rS in leads V1/V2, and mid-QRS notching/slurring in ≥2 contiguous leads of I, aVL, and V1/V2/V5/V6). Ventricular dimensions and function were measured by cardiac magnetic resonance imaging. RESULTS: There was a trend toward an increase in the prevalence of LVD (13%, 20%, and 90%), LVsD (67%, 77%, and 90%), RVD (23%, 27%, and 50%), RVsD (27%, 27%, and 40%), RVD plus RVsD (13%, 17%, and 40%), or RVD/RVsD (37%, 37%, and 50%) according to the degree of QRS prolongation (<150 ms, n = 30; 150-180 ms, n = 60; and ≥180 ms, n = 10). Similarly, patients in the highest quartile of QRSd (QRSd ≥ 168 ms, n = 26) showed greater rates of RVD (23% vs. 44%, p = .069), RVsD (22% vs. 48%, p = .032), RVD plus RVsD (10% vs. 30%, p = .040), or RVD/RVsD (33% vs. 57%, p = .050) compared to those in the remaining quartiles (n = 74). QRSd ≥ 180 ms was identified as an independent predictor for the presence of RVD plus RVsD. CONCLUSION: The rates of RVD and/or RVsD increased with QRS widening, particularly when QRSd exceeded 180 ms. This may diminish anticipated CRT response rates in cardiomyopathy patients with LBBB.


Subject(s)
Bundle-Branch Block/physiopathology , Cardiomyopathies/physiopathology , Ventricular Dysfunction, Left/physiopathology , Ventricular Dysfunction, Right/physiopathology , Aged , Bundle-Branch Block/diagnostic imaging , Cardiomyopathies/diagnostic imaging , Dilatation , Echocardiography , Female , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Ventricular Dysfunction, Left/diagnostic imaging , Ventricular Dysfunction, Right/diagnostic imaging
17.
Pacing Clin Electrophysiol ; 44(10): 1663-1670, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34319603

ABSTRACT

BACKGROUND: Cardiac resynchronization therapy (CRT) involves stimulation of both right ventricle (RV) and left ventricle (LV). LV pacing from the sites of delayed electrical activation improves CRT response. The RV-LV conduction is typically measured in intrinsic rhythm. The differences in RV-LV conduction patterns and timing between intrinsic rhythm and during paced RV activation, these differences are not fully understood. METHODS: Enrolled patients were implanted with a de novo CRT device and quadripolar LV lead, with lead implant locations at the implanting physician's discretion. QRS duration and conduction delay between the RV lead and each of the four LV electrodes (D1, M2, M3, and P4) were measured during intrinsic conduction and RV pacing. RESULTS: Conduction measurements were collected from 275 patients across 14 international centers (68 ± 13 years of age, 73% male, 45% ischemic, 158 ± 22 ms QRS duration). Mean RV-LV conduction time was shorter during intrinsic conduction versus RV pacing by 59.6 ms (106.5 ± 36.5 versus 166.1 ± 32.1 ms, p < 0.001). The intra-LV activation delay between the latest and earliest activating LV electrode was also shorter during intrinsic conduction versus RV pacing by 6.6 ms (20.6 ± 13.1 vs. 27.2 ± 21.2 ms, p < 0.001). Intrinsic conduction and RV pacing resulted in a different activation order in 72.7% of patients, and the same LV activation order in 27.3%. CONCLUSIONS: Differences in RV-LV conduction time, intra-LV conduction time, and activation pattern were observed between intrinsic conduction and RV pacing. These findings highlight the importance of evaluating intrinsic versus paced ventricular activation to guide LV pacing site selection in CRT patients.


Subject(s)
Cardiac Resynchronization Therapy/methods , Heart Conduction System/physiopathology , Heart Ventricles/physiopathology , Aged , Cardiac Resynchronization Therapy Devices , Female , Humans , Male , Prosthesis Design
18.
Ann Noninvasive Electrocardiol ; 26(2): e12795, 2021 03.
Article in English | MEDLINE | ID: mdl-33513268

ABSTRACT

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/ Heart Rhythm Society/ European Heart Rhythm Association/ Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.


Subject(s)
Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/therapy , Electrocardiography, Ambulatory/methods , Telemedicine/methods , Arrhythmias, Cardiac/physiopathology , Asia , Consensus , Europe , Humans , Internationality , Societies, Medical
19.
J Cardiovasc Electrophysiol ; 31(2): 544-546, 2020 02.
Article in English | MEDLINE | ID: mdl-31908076

ABSTRACT

This case illustrates that the condition of atrial fibrillation (AF) may harbor site(s) of regular rotational activity, reentry may be an underlying mechanism, high periodicity and wavebreak through areas of the scar may generate fibrillatory conduction, and disintegration of the "rotor" may not abolish AF.


Subject(s)
Action Potentials , Atrial Fibrillation/diagnosis , Electrophysiologic Techniques, Cardiac , Heart Rate , Pulmonary Veins/physiopathology , Aged , Atrial Fibrillation/physiopathology , Atrial Fibrillation/surgery , Catheter Ablation , Female , Humans , Predictive Value of Tests , Pulmonary Veins/surgery , Recurrence , Time Factors , Treatment Outcome
20.
J Cardiovasc Electrophysiol ; 31(8): 1979-1986, 2020 08.
Article in English | MEDLINE | ID: mdl-32510749

ABSTRACT

BACKGROUND: Morbid obesity is associated with prohibitively high arrhythmia recurrence rates following atrial fibrillation (AF) ablation. DESIGN: This was a single-center study comprising 239 patients with morbid obesity and symptomatic paroxysmal or persistent AF undergoing AF ablation compared to 239 patients with a body mass index less than 30 kg/m2 matched based on age, sex, ejection fraction, AF type, presence and type of heart failure, and left atrial volume index. METHODS: Our primary outcome of interest was arrhythmia recurrence. RESULTS: During a mean follow-up of 29 months, arrhythmia recurrence was observed in 65% of the morbidly obese cohort compared to 27% of the control group (P < .0001). Among those with morbid obesity, sleep apnea screening, and treatment (91% vs 40%; P < .0001), blood pressure control (62% vs 53%; P = .001), glycemic control (85% vs 56%; P = .004), and weight loss more than equal to 5% (33% vs 57% in those who lost less than 5% and 83% in those who gained weight, P < .0001) were associated with lower arrhythmia recurrence. Recurrent arrhythmia was observed in one (4%) patient who accomplished all four goals, compared to 36% who achieved 3 of 4, 85% who modified 2 of 4%, and 97% of those who modified zero or one risk-factor. Risk-factor modification (RFM) was also associated with substantial reductions in the need for repeat ablation or direct-current cardioversion and arrhythmia-related hospitalization (P < .0001). CONCLUSION: RFM through pragmatic noninvasive means such as blood pressure and glycemic control, sleep apnea screening and treatment, and weight loss is associated with substantially lower rates of recurrent arrhythmia among morbidly obese patients undergoing AF ablation.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Obesity, Morbid , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Humans , Obesity, Morbid/complications , Obesity, Morbid/diagnosis , Obesity, Morbid/surgery , Recurrence , Risk Factors , Treatment Outcome
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