Springer Science and Business Media LLC

The ThermoCool STSF catheter is used for ablation of ischemic ventricular tachycardia (VT) in routine clinical practice, although outcomes have not been studied and the catheter does not have Food and Drug Administration (FDA) approval for this indication. We used real-world health system data to evaluate its safety and effectiveness for this indication. Among patients undergoing ischemic VT ablation with the ThermoCool STSF catheter pooled across two health systems (Mercy Health and Mayo Clinic), the primary safety composite outcome of death, thromboembolic events, and procedural complications within 7 days was compared to a performance goal of 15%, which is twice the expected proportion of the primary composite safety outcome based on prior studies. The exploratory effectiveness outcome of rehospitalization for VT or heart failure or repeat VT ablation at up to 1 year was averaged across health systems among patients treated with the ThermoCool STSF vs. ST catheters. Seventy total patients received ablation for ischemic VT using the ThermoCool STSF catheter. The primary safety composite outcome occurred in 3/70 (4.3%; 90% CI, 1.2–10.7%) patients, meeting the pre-specified performance goal, p = 0.0045. At 1 year, the effectiveness outcome risk difference (STSF-ST) at Mercy was − 0.4% (90% CI: − 25.2%, 24.3%) and at Mayo Clinic was 12.6% (90% CI: − 13.0%, 38.4%); the average risk difference across both institutions was 5.8% (90% CI: − 12.0, 23.7). The ThermoCool STSF catheter was safe and appeared effective for ischemic VT ablation, supporting continued use of the catheter and informing possible FDA label expansion. Health system data hold promise for real-world safety and effectiveness evaluation of cardiovascular devices.

Implantable cardioverter-defibrillator (ICD) is highly effective in treating life-threatening ventricular arrhythmias, but it can also have proarrhythmic effect in some cases. We report the case of a 72 years old patient with an ischemic cardiomyopathy in whom an ICD was implanted for a poorly tolerated ventricular tachycardia (Profiles MD—Ventritex). Forty-eight hours after implantation, the patient suddenly received 15 successive shocks. ECG tracings and intracardiac EGM showed the presence of several VT episodes, all induced by the antibradycardia pacing of the ICD: the automatic gain control function of the device failed to detect ventricular premature beats in this patient, leading to a bradycardia pacing falling on the T wave and inducing multiple VTs and shocks.

Cardiac resynchronization therapy (CRT) is an effective treatment for heart failure (HF) with left ventricular systolic dysfunction and prolonged QRS interval. However, one third of patients do not benefit from treatment. This study compares the heart failure hospitalization (HFH) rates and corresponding costs between responders and non-responders to CRT. At a single center in New Jersey, we enrolled patients with de novo CRT-D implants between January 2011 and July 2013. Medical history at implant and all subsequent hospitalizations were collected. A retrospective chart review of the cardiology visit at or closest to 12 months post-CRT implant was performed, and patients were classified into responders and non-responders. Universal billing records (UB-04), ICD-9-CM diagnoses, and procedure codes were used to determine whether each hospitalization was due to HF. For each heart failure hospitalization (HFH), an MS-DRG-based US national average Medicare reimbursement was determined. HFH rates and associated payor costs were compared between responders and non-responders using negative binomial regression and non-parametric bootstrapping (×10,000), respectively. CRT response was determined in 135 patients (n = 103 responders, n = 32 non-responders, average follow-up 1.4 years). Demographics, pre-implant HF characteristics, NYHA Class, QRS duration, ejection fraction (EF), left bundle branch block (LBBB) status, and co-morbidities were not statistically different between the two groups. The HFH rate was significantly lower in responders (0.43/patient year) compared to non-responders (0.96/patient year, IRR = 0.45, 95 % CI (0.23 0.90), P = 0.0197). Average US national Medicare reimbursement for the responder group (US$7205/patient year) was 48 % lower than that for the non-responder group (US$13,861/patient year, P = 0.035). In this single-center retrospective study, responders to CRT had significantly lower rates of post-implant heart failure hospitalization rate and reduced associated payor costs compared to non-responders. Therapies that increase CRT response rates can substantially reduce healthcare utilization.

We aimed to analyze the rate of visualization of real-time (RT) recordings and dual fascicle electrograms in our first series of patients treated with the fourth-generation cryoballoon (CB) device. All consecutive patients who underwent CB ablation using the fourth-generation technology were included in the analysis. In all procedures, we used a 28-mm CB placed via a single transseptal puncture guided by intracardiac ultrasound. A 20-mm octapolar intraluminal circular catheter was used for intracardiac recordings. A single 180-s freeze strategy was employed. A total of 129 patients (72.9% male, mean age 60.1 ± 10.9 years) were enrolled in the study. RT recordings were detected in 445 (86.2%) pulmonary veins (PVs). Specifically, RT recordings were visualized in 115 left superior PVs (89.2%), 107 left inferior PVs (82.9%), 118 right superior PVs (91.4%), and 105 right inferior PVs (81.3%). Dual fascicle electrograms could be observed only in patients in sinus rhythm, in 23 of 396 PVs (5.8%). They were most commonly observed in the left superior PV (8.1%), somewhat less in both inferior veins (6.1%), while this phenomenon was least frequent in the right superior PV (3.0%). By using the fourth-generation CB, we report a specific pattern of isolation represented by a sequential isolation of two apparently distinct PV fascicles during a single CB freeze delivery. This phenomenon occurred in 5.8% of PV ablations. Of note, the rate of visualization of RT isolation with this novel CB was very high and could be documented in 86.2% of PVs.

As opposed to fundamental investigations into the nature of atrial fibrillation (AF) current clinical studies of AF ablation techniques sometimes only contain sparse information about the underlying electrophysiological properties. The purpose of this prospective, pilot study was to evaluate acute therapeutic success and clinical outcome after 6 month of segmental ostial ablation (SOA) using the High Density Mesh Mapper catheter (HDMM, BARD Electrophysiology, Lowell, MA, USA) for an electrophysiological guided approach. The HDMM is a novel, single expandable basket electrode catheter for high resolution recordings at the left atrium/pulmonary vein (PV) junction. SOA was performed by irrigated radiofrequency (RF) application around the HDMM. Entry- and exit conduction block, as well as decreased local electrode amplitude, were endpoints for short-term successful ablation. Seventy-two patients with highly symptomatic paroxysmal AF (PAF; 47, 65.2%), persistent AF (12, 16.7%) and permanent AF (13, 18.1%) were studied. Entrance conduction block was obtained in 93%, exit conduction block in 81% of all PV. After 6 month no PV stenosis was observed, 62 patients (86.1%) improved clinically, whereas 52 patients (72.2%) were free from arrhythmias and sinus rhythm was present favoring patients with PAF. In this first prospective study of PV isolation using the HDMM, our findings suggest, that this method is safe and yields good primary success rates and favourable clinical outcome at 6 month. The new technology based on high resolution recordings, offers beside good anatomical orientation a direct electrophysiological control for monitoring of bidirectional conduction block.

Atrial fibrillation (AF) ablation is a common procedure to reduce cardiovascular morbidity but is limited by recurrence. The objective of this study was to determine if post-ablation acute surface P wave morphology and other electrocardiographic parameters correlate with AF recurrence. The Avoiding Bladder Catheters During AF ablation (ABCD-AF) trial was a randomized, prospective trial in 160 subjects undergoing AF ablation. The present study examined correlation between AF recurrence in follow-up and acute post-ablation electrocardiographic P wave parameters. Median follow-up was 255 (188, 306) days. The ABCD-AF cohort had a mean age of 62.7 ± 12.8 with 32.1% being females. Rate of recurrent AF was 35.8%, with a median time to AF of 135 (109, 182) days. There was no baseline demographic associated with AF recurrence. There was more AF recurrence in those with longer follow-up (p = 0.001). Lead 2 PR interval, lead 2 P wave duration/PR (Pdur/PR), lead V1 PR interval, and lead V1 Pdur/PR were all significantly associated with recurrent AF (p = 0.03, 0.02, 0.01, 0.01). Longer PR and shorter Pdur/PR predicted AF recurrence. In a multivariable model, lead V1 Pdur/PR provided the best predictor of AF recurrence, with an odds ratio of 0.018 (p = 0.016) per standard deviation change. Shorter P wave duration combined with longer AV node delay, as measured by proportion of the PR that the P wave occupies, was the best predictor of AF recurrence post-ablation.

Although catheter ablation targeting the pulmonary vein (PV) is a well-known therapy for patients with paroxysmal atrial fibrillation (PAF), ectopic firings from the superior vena cava (SVC) can initiate PAF. The purpose of this study was to investigate predictors of SVC firing. The subjects included 336 consecutive PAF patients (278 males, age 56.1 ± 10.8 years) undergoing atrial fibrillation (AF) ablation. The appearance of SVC firing was monitored throughout the procedure using a decapolar catheter with multiple electrodes to record electrograms of the coronary sinus and SVC. In addition to PV isolation, SVC isolation was performed only in patients with documented SVC firing. SVC firing was observed in 43/336 (12.8 %) of the patients, among whom complete isolation of the SVC was achieved in 40/43 (93 %) patients. A lower body mass index (BMI) (22.8 ± 2.8 vs 24.1 ± 3.1 kg/m2, p = 0.007) and higher prevalence of prior ablation procedures (58 vs 18 %, p = 0.0001) were related to the presence of SVC firing. In a multivariate analysis, a lower BMI (p = 0.012; odds ratio 0.83, 95 % CI 0.72 to 0.96) and history of prior ablation procedures (p < 0.0001; odds ratio 5.37, 95 % CI 2.71 to 10.63) were found to be independent predictors of the occurrence of SVC firing. Among 96 patients undergoing repeat ablation procedures, less PV-left atrial re-conduction was observed in patients with SVC firing than in those without (2.7 ± 1.2 vs 3.2 ± 0.8, p = 0.02). The presence of SVC firing in patients with PAF is associated with a history of repeat ablation procedures and lower BMI values.

To evaluate whether catheter ablation is superior to conventional therapy for atrial fibrillation (AF) in patients with heart failure with reduced ejection fraction (HFrEF). Electronic databases were searched for randomized, controlled trials of AF ablation compared with conventional therapy in adults with AF and HFrEF. Odds ratio (OR), standard mean difference (SMD), and 95% confidence intervals (CIs) were measured using the Mantel-Haenszel method. There were seven trials including 856 patients (mean age 62 years, male 86%). All-cause mortality in patients who underwent ablation was 10% vs. 19% in those who received conventional treatment (four trials, 668 patients, 47% relative reduction, 9% absolute reduction; OR 0.46, 95% CI 0.29–0.72). Improvement in the left ventricular ejection fraction was significantly higher for patients undergoing ablation (+ 9 ± 10%) compared to conventional treatment (+ 2 ± 7%) (seven trials, 856 patients, SMD 0.68, 95% CI 0.28–1.08). Freedom from AF was higher in patients undergoing ablation (seven trials, 856 patients, 70% vs. 18%, respectively; 64% relative reduction, 52% absolute reduction; OR 0.03 95% CI 0.01–0.11). There was no significant difference in major complications between both strategies (OR 1.13, 95% CI 0.58–2.20). Catheter ablation for AF in patients with HFrEF decreases mortality and AF recurrence and improves left ventricular function, functional capacity, and quality of life, when compared to conventional management, without increasing complications.