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BackgroundSingle-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown.Methods/designIn this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first 30 days after radiosurgery. Secondary endpoints are the assessment of VT burden, reduction of implantable cardioverter defibrillator (ICD) interventions [shock, anti-tachycardia pacing (ATP)], mid-term side effects and quality-of-life (QoL) in the first year after radiosurgery. The planned sample size is 20 patients with the goal of demonstrating safety and feasibility of cardiac radiosurgery in ≥ 70% of the patients. Quality assurance is provided by initial contouring and planning benchmark studies, joint multi-center treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.DiscussionRAVENTA will be the first study to provide the initial robust multi-center multi-platform prospective data on the therapeutic value of cardiac radiosurgery for ventricular tachycardia.Trial registration numberNCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.Graphic abstract

Introduction Ventricular arrhythmias (VAs) in patients with chronic heart failure (CHF) are sometimes refractory to antiarrhythmic drugs and cardiac ablation. This study aimed to investigate catheter-based renal sympathetic denervation (RDN) as antiarrhythmic strategy in refractory VA. Methods These are the first data from a pooled analysis of 13 cases from five large international centers (age 59.2 ± 14.4 years, all male) with CHF (ejection fraction 25.8 ± 10.1 %, NYHA class 2.6 ± 1) presented with refractory VA who underwent RDN. Ventricular arrhythmias, ICD therapies, clinical status, and blood pressure (BP) were evaluated before and 1–12 months after RDN. Results Within 4 weeks prior RDN, a median of 21 (interquartile range 10–30) ventricular tachycardia (VT) or fibrillation (VF) episodes occurred despite antiarrhythmic drugs and prior cardiac ablation. RDN was performed bilaterally with a total number of 12.5 ± 3.5 ablations and without peri-procedural complications. One and 3 months after RDN, VT/VF episodes were reduced to 2 (0–7) ( p  = 0.004) and 0 ( p  = 0.006), respectively. Four (31 %) and 11 (85 %) patients of these 13 patients were free from VA at 1 and 3 months. Although BP was low at baseline (116 ± 18/73 ± 13 mmHg), no significant changes of BP or NYHA class were observed after RDN. During follow-up, three patients died from non-rhythm-related causes. Conclusions In patients with CHF and refractory VA, RDN appears to be safe concerning peri-procedural complications and blood pressure changes, and is associated with a reduced arrhythmic burden.

Background Patients undergoing cardiac resynchronization therapy with a defibrillator (CRT‐D) often experience improvements in the left ventricular ejection fraction (LVEF). This study aimed to identify predictors of ventricular tachyarrhythmias (VTA) in patients with CRT‐D devices and LVEF improvement beyond guideline recommendations for a defibrillator. Methods Patients randomized to the CRT‐D arm of the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy trial who improved their LVEF to > 35% at 12 months following CRT‐D implant were included in this analysis (N = 651). Predictors of an appropriate implantable cardioverter defibrillator (ICD) Rx VTA were evaluated by Cox proportional hazards regression modeling. Results We identified three predictors of VTA among patients treated with CRT‐D subsequent to LVEF improvement > 35%: Lower range improvement in LVEF 36%–40% versus improvement to > 40% (HR, 1.97; 95% CI, 1.21–3.20; p = 0.006); Baseline non‐LBBB ECG morphology (hazard ratio [HR], 1.93; 95% confidence interval [CI], 1.23–3.04; p = 0.004); Occurrence of VTA during the first year post‐CRT‐D (HR, 4.91; 95% CI, 2.99–8.07; p < 0.001). Conclusions We identified a sub‐group of patients with risk factors who remain at high risk of VTA despite improvement in LVEF following CRT implant. These patients require close monitoring despite improvement in LVEF beyond guideline recommendations for an ICD. In CRT‐D patients with LVEF above guideline indications, LVEF 36%–40%, absence of LBBB, and a history of VTA increase the risk for future VTA. These patients require close monitoring despite improvement beyond guideline recommendations.

Background Multiple studies have demonstrated the importance of adequate catheter–tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact force (CF)-sensing catheters has contributed significantly to improve clinical outcomes in atrial fibrillation. However, CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia (PSVT). The possible reason for this is that PSVT ablation with the conventional approach (i.e. nonirrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rates (short and long term). The aim of this study is to determine whether CF sensing can further improve the outcomes of PSVT ablation. Methods/design The COBRA-PATH study is a single-center, two-armed, randomized controlled trial. Patients without structural heart disease being referred for electrophysiology study, because of PSVT and potential treatment with radiofrequency (RF) catheter ablation, will be randomly assigned to either manual ablation with standard nonirrigated ablation catheters or manual ablation with an open-irrigated ablation catheter equipped with CF sensing (used in a virtual nonirrigated modus). The primary study endpoint is the difference in the number of RF applications during the ablation of atrioventricular nodal re-entry tachycardia, and that of Wolff–Parkinson–White syndrome and atrioventricular re-entrant tachycardia. Secondary outcome parameters include acute and long-term procedural success rates, overall duration of RF applications, procedure/fluoroscopy durations and safety parameters. Discussion We expect to see a reduced number/duration of RF applications required to achieve effective lesion creation, and consequently a decrease in total procedure/fluoroscopy times. Although a significant improvement in procedural success rates (acute/long term) might not be feasible to demonstrate (given the relatively high success rate of the standard ablation method), the possible decrease in procedure duration and the consequential reduction of radiation exposure has important clinical implications for both operators and patients undergoing the procedure. Trial registration ClinicalTrials, NCT04078685 . Retrospectively registered on 2 September 2019.

IntroductionCatheter ablation (CA) has shown to effectively reduce the burden of ventricular tachycardia in patients with implanted cardioverter-defibrillator (ICD). However, in patients with ICD implantation for secondary prevention of ventricular tachycardia (VT), the appropriate time point of CA and its effect on mortality and heart failure progression remains a matter of debate.Methods and analysisWe present the design of the ongoing preventive aBlation of vEntriculartachycaRdia in patients with myocardiaLINfarction (BERLIN VT) study that aims to prospectively enrol 208 patients with a stable ischaemic cardiomyopathy, a left ventricular ejection fraction of 30% to 50% and documented ventricular tachycardia. Patients will be 1:1 randomised to undergo CA at the time of ICD implantation or CA after the third appropriate ICD shock for ventricular tachycardia. ICD implantation will be performed in all patients. The primary endpoint is defined as the time to first event comprising all-cause mortality and unplanned hospital admission for congestive heart failure or for symptomatic VT/ventricular fibrillation. The patients will be followed until study termination according to the event driven design. Completion of enrolment is expected for mid of 2019.Ethics and disseminationThe study had been approved by the “Ethik-kommission der Landesärztekammer Hamburg” as well as the local institutional review boards for each of the participation sites. The results of the trial will be published in peer-reviewed journalsTrial registration numberNCT02501005.

Background Intravenous adenosine is the recommended treatment for paroxysmal supraventricular tachycardia (PSVT). There is no official recommended method of giving adenosine. We compared the success rates between a standard and alternative method of first dose intravenous adenosine in PSVT. Methods A pilot parallel randomized controlled study was conducted in the emergency department of a tertiary care hospital. Eligible patients were stable PSVT adult patients. We used block randomization and divided them into two groups, the standard method (double syringe technique of 6 mg of adenosine), and the alternative method (similar to the standard method, then immediately followed by elevating the arm to 90° perpendicular to a horizontal plane for 10 s). The primary outcome was the success rate of electrocardiogram (ECG) response which demonstrated termination of PSVT (at least two-fold of the RR-interval widening or sinus rhythm conversion). Secondary outcomes were complications within one minute after the injection. Results We allocated 15 patients in each group and analyzed them as intention-to-treat. The success rate was 86.7% in the alternative group and 80% in the standard group (risk difference 6.7%, 95% confidence interval − 19.9 to 33.2%, P 1.00). Complications within one minute after adenosine injection were also similar in both groups, 14 of 15 patients (93%) in each group had no complications, without significant difference. Conclusions No evidence of the difference between alternative and standard methods occurred, in terms of the success rate of ECG response and complications within one minute after adenosine injection. The standard method of adenosine injection is a safe, easy-to-administer, and widely available treatment for PSVT. Trial Registration : TCTR20200609001.

Novel implantable cardioverter defibrillator (ICD) discrimination algorithms and programming strategies have significantly reduced the incidence of inappropriate shocks, but there are still gains to be made with respect to reducing appropriate but unnecessary antitachycardia pacing (ATP) and shocks. We examined whether programming a number of intervals to detect (NID) of 60/80 for ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) detection was safe and the impact of this strategy on (1) adverse events related to ICD shocks and syncopal events; (2) ATPs/shocks; and (3) patient-reported outcomes. The “ENHANCED Implantable Cardioverter Defibrillator programming to reduce therapies and improve quality of life” study (ENHANCED-ICD study) was a prospective, safety-monitoring study enrolling 60 primary and secondary prevention patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technology and aged 18 to 80 years were eligible to participate. In all patients, a prolonged NID 60/80 was programmed. The cycle length for VT/fast VT/VF was 360/330/240 ms, respectively. Programming a NID 60/80 proved safe for ICD patients. Because of the new programming strategy, unnecessary ICD therapy was prevented in 10% of ENHANCED-ICD patients during a median follow-up period of 1.3 years. With respect to patient-reported outcomes, levels of distress were highest and perceived health status lowest at the time of implantation, which both gradually improved during follow-up. In conclusion, the ENHANCED-ICD study demonstrates that programming a NID 60/80 for VT/VF detection is safe for ICD patients and does not negatively impact their quality of life.

We explored the utility of T-wave alternans (TWA) in predicting mortality in patients with non–ST-segment elevation acute coronary syndrome (NSTEACS). Maximum TWA was calculated using Modified Moving Average method from continuous electrocardiographic recordings in patients with left ventricular ejection fraction <40% and ventricular tachycardia (VT) ≥4 beats during index hospitalization or sudden cardiac death during the follow-up year and age- and sex-matched controls in the Metabolic Efficiency with Ranolazine for Less Ischemia in Non–ST Elevation Acute Coronary Syndrome–Thrombolysis In Myocardial Infarction (MERLIN-TIMI) 36 trial. All patients received standard therapy for NSTEACS plus ranolazine (n = 109) or placebo (n = 101). Median follow-up was 1 year. Baseline clinical characteristics did not differ between patients with elevated TWA (≥47 μV) compared with lower levels. Patients with TWA ≥47 μV at admission had increased risk of total mortality (adjusted odds ratio [ORadj] 2.35, p = 0.04) during follow-up and VT ≥4 beats (ORadj 2.70, p = 0.01) during hospitalization with a trend toward increased cardiovascular death risk (ORadj 2.18, p = 0.07) during follow-up. In patients receiving placebo, TWA ≥47 μV on day 6 was associated with increased risk of total mortality (OR 4.12, 95% confidence interval 1.25 to 13.64, p = 0.02) and cardiovascular death (OR 4.73, p = 0.01) during follow-up. No deaths occurred among patients with TWA ≥47 μV assigned to ranolazine. In conclusion, in patients with NSTEACS and left ventricular ejection fraction <40%, TWA ≥47 μV early after admission is associated with increased risk of mortality at 1 year and with nonsustained VT during hospitalization. TWA may be useful in risk estimation in patients with NSTEACS. The possibility that TWA may serve as a therapeutic target deserves further exploration.

This multicenter, prospective, randomized, controlled, parallel trial compares the efficacy of biventricular (BIV) versus right ventricular (RV) antitachycardia pacing (ATP) in terminating all kinds of ventricular tachycardia (VT). Five hundred twenty-six patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device were enrolled and randomized 1:1 to either BIV (266) or RV (260) ATP (single burst 8 pulse, 88% coupling interval) and were followed up for 12 months. During 12 months' follow-up, 1,077 ventricular episodes in 180 patients were detected and classified: 634 true VTs divided into 69 ventricular fibrillation (VF) (11%), 202 fast ventricular tachycardia (FVT) (32%), and 363 VT (57%). A comparable first ATP efficacy (BIV 65% vs RV 68%, P = .59) was observed in FVT + VT, in VT zone (BIV 62% vs RV 71%, P = .25), and in FVT zone (BIV 71% vs RV 61%, P = .34). A trend toward lower accelerations during ATP applied to FVT was observed in the BIV group (3.5% BIV vs 10.2% RV, P = .163). No syncope/presyncope occurred during ATP for FVT in the BIV group versus 4 events (3.2%) in the RV group ( P = .016). biventricular ATP was more effective in treating FVT in coronary artery disease (CAD) patients ( P = .032), whereas both modalities presented similar efficacy in patients with non-CAD etiology ( P = .549). Antitachycardia pacing is effective in patients implanted with a CRT-D device. No significant differences in efficacy emerged between BIV- and RV-delivered ATP in the general population, whereas BIV ATP seems to present a safer profile in ischemic patients.

Background The role of epicardial substrate ablation of ventricular tachycardia (VT) as a first-line approach in patients with ischemic heart disease is not clearly defined. Epicardial ablation as a first-line option is standard for patients with nonischemic dilated cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Several nonrandomized studies, including studies on patients with ischemic heart disease, have shown that epicardial VT ablation improves outcome but this approach was often used after a failed endocardial approach. The aim of this study is to determine whether a combined endo-epicardial scar homogenization as a first-line approach will improve the outcome of VT ablation. Methods/Design The EPILOGUE study is a multicenter, two-armed, nonblinded, randomized controlled trial. Patients with ischemic heart disease who are referred for VT ablation will be randomly assigned to combined endo-epicardial scar homogenization or endocardial scar homogenization only (control group). The primary outcome is recurrence of sustained VT during a 2-year follow-up. Secondary outcomes include procedural success and safety. Discussion This study is the first randomized trial that evaluates the role of a combined endo-epicardial scar homogenization versus endocardial scar homogenization for the treatment of ischemic scar-related VT. Trial registration NL4816807814v02