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Heart, Lung & Circulation May 2024Although there are evolving techniques and technologies for treating ventricular tachycardia (VT), the current landscape of clinical trials for managing VT remains...
BACKGROUND
Although there are evolving techniques and technologies for treating ventricular tachycardia (VT), the current landscape of clinical trials for managing VT remains understudied.
OBJECTIVE
The objective of this study was to provide a systematic characterisation of the interventional management of VT through an analysis of the ClinicalTrials.gov, clinicaltrialsregister.eu, anzctr.org.au and chictr.org.cn databases.
METHODS
We queried all phase II to IV interventional trials registered up to November 2023 that enrolled patients with VT. Published, completed but unpublished, terminated, or ongoing trials were included for final analysis.
RESULTS
Of the 698 registered studies, 135 were related to VT, with 123 trials included in the final analysis. Among these trials, 25 (20%) have been published, enrolling a median of 35 patients (interquartile range [IQR] 20-132) over a median of 43 months (IQR 19-62). Out of the published trials, 14 (56%) were randomised, and 12 (48%) focused on catheter ablation. Twenty-two (18%) have been completed but remain unpublished, even after a median of 36 months (IQR 15-60). Furthermore, 27 (22%) trials were terminated or withdrawn, with the most common cause being poor enrolment. Currently, 49 (40%) trials are ongoing and novel non-ablative technologies, such as radioablation and autonomic modulation, account for 35% and 8% of ongoing trials, respectively.
CONCLUSIONS
Our analysis revealed that many registered trials remain unpublished or incomplete, and randomised controlled trial evidence is limited to only a few studies. Furthermore, many ongoing trials are focused on non-catheter ablation-based strategies. Therefore, larger pragmatic trials are needed to create stronger evidence in the future.
PubMed: 38821759
DOI: 10.1016/j.hlc.2024.01.041 -
Clinical Cardiology Jan 2024Hypertrophic cardiomyopathy (HCM) is a common contemporary, treatable, genetic disorder that can be compatible with normal longevity. While current medical therapies are... (Review)
Review
Hypertrophic cardiomyopathy (HCM) is a common contemporary, treatable, genetic disorder that can be compatible with normal longevity. While current medical therapies are ubiquitous, they are limited by a lack of solid evidence, are often inadequate, poorly tolerated, and do not alter the natural disease course. As such, there has long been a need for effective, evidence-based, and targeted disease-modifying therapies for HCM. In this review, we redefine HCM as a treatable condition, evaluate current strategies for therapeutic intervention, and discuss novel myosin inhibitors. The majority of patients with HCM have elevated left ventricular outflow tract gradients, which predicts worse symptoms and adverse outcomes. Conventional pharmacological therapies for symptomatic HCM can help improve symptoms but are often inadequate and poorly tolerated. Septal reduction therapies (surgical myectomy and alcohol septal ablation) can safely and effectively reduce refractory symptoms and improve outcomes in patients with obstructive HCM. However, they require expertise that is not universally available and are not without risks. Currently, available therapies do not alter the disease course or the progressive cardiac remodeling that ensues, nor subsequent heart failure and arrhythmias. This has been regarded as an unmet need in the care of HCM patients. Novel targeted pharmacotherapies, namely cardiac myosin inhibitors, have emerged to reverse key pathophysiological changes and alter disease course. Their favorable outcomes led to the early Food and Drug Administration approval of mavacamten, a first-in-class myosin modulator, changing the paradigm for the pharmacological treatment of HCM.
Topics: United States; Humans; Cardiomyopathy, Hypertrophic; Heart; Disease Progression; Heart Failure; Myosins
PubMed: 38269637
DOI: 10.1002/clc.24207 -
Indian Pacing and Electrophysiology... 2024While atrial fibrillation (AF) ablation has proven beneficial for heart failure (HF) patients, most reports were performed with radiofrequency ablation. We aimed to...
INTRODUCTION
While atrial fibrillation (AF) ablation has proven beneficial for heart failure (HF) patients, most reports were performed with radiofrequency ablation. We aimed to evaluate the efficacy and safety of cryoballoon AF ablation in patients with HFrEF.
METHOD
We comprehensively searched the databases of MEDLINE, EMBASE, and Cochrane database from inception to December 2022. Studies that reported the outcomes of freedom from atrial arrhythmia, complications, NYHA functional class (NYHA FC), and left ventricular ejection fraction (LVEF) after Cryoballoon AF ablation in HF patients were included. Data from each study were combined with a random-effects model.
RESULT
A total of 9 studies observational studies with 1414 HF patients were included. Five studies had only HF with reduced ejection fraction (HFrEF), 1 study with HF with preserved ejection fraction (HFpEF), and others with mixed HF types. Freedom from AA in HFrEF at 12 months was 64% (95% CI 56-71%, I 58%). There was a significant improvement of LVEF in these patients with a standard mean difference of 13% (95% CI 8.6-17.5%, I 99% P < 0.001. The complication rate in HFrEF group was 6% (95% CI 4-10%, I 0%). The risk of recurrence of atrial arrhythmia was not significantly different between HF and no HF patients (RR 1.34, 95% CI 0.8-2.23, I2 76%).
CONCLUSION
Cryoballoon AF ablation is effective in HFrEF patients comparable to radiofrequency ablation. The complication rate was low.
PubMed: 38218450
DOI: 10.1016/j.ipej.2024.01.001 -
Journal of Interventional Cardiac... Jun 2024Left atrial appendage closure (LAAC) is a treatment modality for stroke prevention in patients with atrial fibrillation (AF). One of the potential complications of LAAC... (Review)
Review
BACKGROUND
Left atrial appendage closure (LAAC) is a treatment modality for stroke prevention in patients with atrial fibrillation (AF). One of the potential complications of LAAC is a peri-device leak (PDL), which could potentially increase the risk of thromboembolism formation.
METHODS
This systematic review was done according to PRISMA guidelines. Using four databases, all primary studies through April 2022 that met selection criteria were included. Outcomes of interest were studies reporting on PDL characteristics, risk factors and management.
RESULTS
A total of 116 studies met selection criteria (97 original studies and 19 case reports/series). In the original studies (n = 30,133 patients), the weighted mean age was 72.0 ± 7.4 years (57% females) with a HAS-BLED and CHA2DS2-VASc weighted means of 2.8 ± 1.1 and 3.8 ± 1.3, respectively. The most common definition of PDL was based on size; 5 mm: major, 3-5 mm: moderate, < 1 mm minor, or trivial. Follow up time for PDL detection was 7.15 ± 9.0 months. 33% had PDL, irrespective of PDL severity/size, and only 0.9% had PDL of greater than 5 mm. The main risk factors for PDL development included lower degree of over-sizing, lower left ventricular ejection fraction, device/LAA shape mismatch, previous radiofrequency ablation, and male sex. The most common methods to screen for PDL included transesophageal echocardiogram and cardiac CT. PDL Management approaches include Amplatzer Patent Foramen Ovale occluder, Hookless ACP, Amplatzer vascular plug II, embolic coils, and detachable vascular coils; removal or replacement of the device; and left atriotomy.
CONCLUSION
Following LAAC, the emergence of a PDL is a significant complication to be aware of. Current evidence suggests possible risk factors that are worth assessing in-depth. Additional research is required to assess suitable candidates, timing, and strategies to managing patients with PDL.
Topics: Humans; Atrial Appendage; Atrial Fibrillation; Risk Factors; Postoperative Complications; Septal Occluder Device; Female; Stroke; Male; Left Atrial Appendage Closure
PubMed: 38182966
DOI: 10.1007/s10840-023-01729-z -
Journal of Arrhythmia Dec 2023Inherited Primary Arrhythmias Syndromes (IPAS), especially Brugada syndrome (BrS), have been associated with arrhythmogenic substrates that can be targeted through...
BACKGROUND
Inherited Primary Arrhythmias Syndromes (IPAS), especially Brugada syndrome (BrS), have been associated with arrhythmogenic substrates that can be targeted through ablation. This meta-analysis evaluated the outcomes of catheter ablation (CA) in different types of IPAS based on procedural guidance and location.
METHODS
A systematic search was conducted across multiple databases to identify studies reporting on ventricular arrhythmia (VA) events before and after CA in IPAS, including BrS, Long-QT syndrome (LQTS), Early repolarization syndrome (ERS), and Idiopathic ventricular fibrillation (IVF). The primary outcomes were VA recurrence and VA burden, evaluated through conditional subgroup analysis. Procedural data were collected as secondary outcomes.
RESULTS
A total of 21 studies involving 584 IPAS patients who underwent CA were included. Following a mean follow-up duration of 33.5 months, substrate-based ablation demonstrated efficacy in reducing VA recurrence across all types of IPAS [RR 0.23; 95% CI (0.13-0.39); < .001; = 74%]. However, activation guidance ablation was found to be effective only in IVF cases. Although recurrences still occurred, CA was successful in reducing VA burden [MD -4.70; 95% CI (-6.11-(-3.29); < .001; = 74%]. The mean size of arrhythmogenic substrate was 15.70 cm [95% CI (12.34-19.99 cm)], predominantly distributed in the epicardial right ventricular outflow tract (RVOT) in BrS cases and LQTS [Proportion 0.99; 95% CI (0.96-1.00) and Proportion 0.82; 95% CI ( 0.59-1.00), respectively].
CONCLUSION
Substrate-based CA has demonstrated effective prevention of VA and reduction in VA burden in IPAS cases.
PubMed: 38045449
DOI: 10.1002/joa3.12947 -
Clinical Cardiology Jan 2024The coexistence of atrial fibrillation (AF) with heart failure (HF) is prevalent, leading to severe complications. This review aimed to investigate the success rate and... (Meta-Analysis)
Meta-Analysis Review
The coexistence of atrial fibrillation (AF) with heart failure (HF) is prevalent, leading to severe complications. This review aimed to investigate the success rate and efficacy of cryoballoon ablation (CBA) by measuring the improvement in the New York Heart Association (NYHA) classification and the effect on the left ventricular systolic function in patients with AF accompanied by heart failure with reduced ejection fraction (HFrEF). Electronic databases search included PubMed, Web of Science, and Scopus in January 2023. Outcomes addressed the following: left ventricular ejection fraction (LVEF) improvement, AF recurrence, NYHA classification improvement, and mortality. STATA 17.0 software was used for data analysis. The effect size for the studies was a standard mean difference (SMD) with a 95% confidence interval (CI) for outcomes. Proportion analysis with 95% CI was used for freedom from early AF and AF after 2 years and all-cause death. We included six studies, including 1699 HF patients with 365 HFrEF patients. The SMD of postoperative LVEF compared to preoperative LVEF in HFrEF was 0.99 ([95% CI: 0.60, 1.39], p = .00), and for NYHA was -1.12 ([95% CI: -1.36, -0.87], p = .00). The analysis results in HFrEF patients for freedom from AF after 1 year was 65% ([95% CI: 0.55, 0.75], and after 2 years was 39% ([95% CI: 0.10, 0.67]). Proportional analysis was conducted for all-cause death, resulting in 3% mortality ([95% CI: -0.01, 0.07]). Cryoablation of AF accompanied by HFrEF appeared safe as it reduced AF recurrence and enhanced clinical outcomes.
Topics: Humans; Atrial Fibrillation; Stroke Volume; Ventricular Function, Left; Heart Failure; Treatment Outcome; Catheter Ablation
PubMed: 37877802
DOI: 10.1002/clc.24177 -
American Journal of Cardiovascular... Jan 2024Atrial fibrillation (AF) and/or atrial flutter (AFL) with rapid ventricular response (RVR) is a condition that often requires urgent treatment. Although guidelines have... (Meta-Analysis)
Meta-Analysis
Intravenous Diltiazem Versus Metoprolol in Acute Rate Control of Atrial Fibrillation/Flutter and Rapid Ventricular Response: A Meta-Analysis of Randomized and Observational Studies.
BACKGROUND
Atrial fibrillation (AF) and/or atrial flutter (AFL) with rapid ventricular response (RVR) is a condition that often requires urgent treatment. Although guidelines have recommendations regarding chronic rate control therapy, recommendations on the best choice for acute heart rate (HR) control in RVR are unclear.
METHODS
A systematic search across multiple databases was performed for studies evaluating the outcome of HR control (defined as HR less than 110 bpm and/or 20% decrease from baseline HR). Included studies evaluated AF and/or AFL with RVR in a hospital setting, with direct comparison between intravenous (IV) diltiazem and metoprolol and excluded cardiac surgery and catheter ablation patients. Hypotension (defined as systolic blood pressure less than 90 mmHg) was measured as a secondary outcome. Two authors performed full-text article review and extracted data, with a third author mediating disagreements. Random effects models utilizing inverse variance weighting were used to calculate odds ratios (OR) and 95% confidence intervals (CI). Heterogeneity was assessed using the I test.
RESULTS
A total of 563 unique titles were identified through the systematic search, of which 16 studies (7 randomized and 9 observational) were included. In our primary analysis of HR control by study type, IV diltiazem was found to be more effective than IV metoprolol for HR control in randomized trials (OR 4.75, 95% CI 2.50-9.04 with I = 14%); however, this was not found for observational studies (OR 1.26, 95% CI 0.89-1.80 with I = 55%). In an analysis of observational studies, there were no significant differences between the two drugs in odds of hypotension (OR 1.12, 95% CI 0.51-2.45 with I = 18%).
CONCLUSION
While there was a trend toward improved HR control with IV diltiazem compared with IV metoprolol in randomized trials, this was not seen in observational studies, and there was no observed difference in hypotension between the two drugs.
Topics: Humans; Atrial Fibrillation; Atrial Flutter; Diltiazem; Hypotension; Metoprolol; Observational Studies as Topic
PubMed: 37856044
DOI: 10.1007/s40256-023-00615-3 -
JACC. Clinical Electrophysiology Jun 2023There is variability in treatment modalities for premature ventricular complexes (PVCs), including use of antiarrhythmic drug (AAD) therapy or catheter ablation (CA).... (Review)
Review
There is variability in treatment modalities for premature ventricular complexes (PVCs), including use of antiarrhythmic drug (AAD) therapy or catheter ablation (CA). This study reviewed evidence comparing CA vs AADs for the treatment of PVCs. A systematic review was performed from the Medline, Embase, and Cochrane Library databases, as well as the Australian and New Zealand Clinical Trials Registry, U.S. National Library of Medicine ClinicalTrials database, and the European Union Clinical Trials Register. Five studies (1 randomized controlled trial) enrolling 1,113 patients (57.9% female) were analyzed. Four of five studies recruited mainly patients with outflow tract PVCs. There was significant heterogeneity in AAD choice. Electroanatomic mapping was used in 3 of 5 studies. No studies documented intracardiac echocardiography or contact force-sensing catheter use. Acute procedural endpoints varied (2 of 5 targeted elimination of all PVCs). All studies had significant potential for bias. CA seemed superior to AADs for PVC recurrence, frequency, and burden. One study reported long-term symptoms (CA superior). Quality of life or cost-effectiveness was not reported. Complication and adverse event rates were 0% to 5.6% for CA and 9.5% to 21% for AADs. Future randomized controlled trials will assess CA vs AADs for patients with PVCs without structural heart disease (ECTOPIA [Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment]), with impaired LVEF (PAPS [Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy] Pilot), and with structural heart disease (CAT-PVC [Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease]). In conclusion, CA seems to reduce recurrence, burden, and frequency of PVCs compared with AADs. There is a lack of data on patient- and health care-specific outcomes such as symptoms, quality of life, and cost-effectiveness. Several upcoming trials will offer important insights for management of PVCs.
Topics: Female; United States; Male; Humans; Anti-Arrhythmia Agents; Prospective Studies; Quality of Life; Ventricular Premature Complexes; Australia; Heart Diseases; Catheter Ablation
PubMed: 37380322
DOI: 10.1016/j.jacep.2023.01.035 -
Clinical Oncology (Royal College of... Sep 2023Reports of stereotactic arrhythmia radioablation (STAR) in patients with refractory ventricular tachycardia after catheter ablation are limited to small series. Here, we... (Meta-Analysis)
Meta-Analysis
AIMS
Reports of stereotactic arrhythmia radioablation (STAR) in patients with refractory ventricular tachycardia after catheter ablation are limited to small series. Here, we carried out a systematic review and meta-analysis of studies to better determine the efficacy and toxicity of STAR for ventricular tachycardia.
MATERIALS AND METHODS
Following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) and the Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines, eligible studies were identified on Medline, Embase, Cochrane Library and the proceedings of annual meetings to 10 February 2023. Efficacy was defined as a ventricular tachycardia burden reduction >70% at 6 months; safety was defined as <10% of any grade ≥3 toxicity.
RESULTS
Seven observational studies with a total of 61 patients treated were included. At 6 months, the ventricular tachycardia burden reduction was 92% (95% confidence interval 85-100%) and use of fewer than two anti-arrhythmic drugs was seen in 85% (95% confidence interval 50-100). Six months after STAR, an 86% reduction (95% confidence interval 80-93) in the number of implantable cardioverter-defibrillator shocks was observed. The rates for improved, unchanged and decreased cardiac ejection fraction were 10%, 84% and 6%, respectively. Overall survival at 6 and 12 months was 89% (95% confidence interval 81-97) and 82% (95% confidence interval 65-98). The cardiac-specific survival at 6 months was 87%. Late grade 3 toxicity occurred in 2% (95% confidence interval 0-5%) with no grade 4-5 toxicity.
CONCLUSION
STAR demonstrated both satisfactory efficacy and safety for the management of refractory ventricular tachycardia and was also associated with a significant decline in anti-arrhythmic drugs consumption. These findings support the continued development of STAR as a treatment option.
Topics: Humans; Anti-Arrhythmia Agents; Tachycardia, Ventricular; Heart; Catheter Ablation; Defibrillators, Implantable; Treatment Outcome
PubMed: 37365062
DOI: 10.1016/j.clon.2023.04.004 -
International Journal of Cardiology Jun 2023Sick sinus syndrome (SSS) and atrial fibrillation (AF) frequently coexist and show a bidirectional relationship. This systematic review and meta-analysis aimed to... (Meta-Analysis)
Meta-Analysis
AIMS
Sick sinus syndrome (SSS) and atrial fibrillation (AF) frequently coexist and show a bidirectional relationship. This systematic review and meta-analysis aimed to decipher the precise relationship between SSS and AF, further exploring and comparing different therapy strategies on the occurrence or progression of AF in patients with SSS.
METHODS AND RESULTS
A systematic literature search was conducted until November 2022. A total of 35 articles with 37,550 patients were included. Patients with SSS were associated with new-onset AF compared to those without SSS. Catheter ablation was associated with a lower risk of AF recurrence, AF progression, all-cause mortality, stroke and hospitalization of heart failure compared to pacemaker therapy. Regarding the different pacing strategies for SSS, VVI/VVIR has higher risk of new-onset AF than DDD/DDDR. No significant difference was found between AAI/AAIR and DDD/DDDR, as well as between DDD/DDDR and minimal ventricular pacing (MVP) for AF recurrence. AAI/AAIR was associated with higher risk of all-cause mortality when compared to DDD/DDDR, but lower risk of cardiac death when compared to DDD/DDDR. Right atrial septum pacing was associated with a similar risk of new-onset AF or AF recurrence compared to right atrial appendage pacing.
CONCLUSION
SSS is associated with a higher risk of AF. For patients with both SSS and AF, catheter ablation should be considered. This meta-analysis re-emphasizes that high percentage of ventricular pacing should be avoided in patients with SSS in order to decrease AF burden and mortality.
Topics: Humans; Atrial Fibrillation; Sick Sinus Syndrome; Cardiac Pacing, Artificial; Pacemaker, Artificial; Heart Atria
PubMed: 37023861
DOI: 10.1016/j.ijcard.2023.03.066