Multicentre safety of adding Focal Impulse and Rotor Modulation (FIRM) to conventional ablation for atrial fibrillation.

AIMS: Focal Impulse and Rotor Modulation (FIRM) uses 64-electrode basket catheters to identify atrial fibrillation (AF)-sustaining sites for ablation, with promising results in many studies. Accordingly, new basket designs are being tested by several groups. We set out to determine the procedural safety of adding basket mapping and map-guided ablation to conventional pulmonary vein isolation (PVI). METHODS AND RESULTS: We collected 30 day procedural safety data in five US centres for consecutive patients undergoing FIRM plus PVI (FIRM-PVI) compared with contemporaneous controls undergoing PVI without FIRM. A total of 625 cases were included in this analysis: 325 FIRM-PVI and 300 PVI-controls. FIRM-PVI patients were more likely than PVI-controls to be male (83% vs. 66%, P < 0.001) and have long-standing persistent AF (26% vs. 13%, P < 0.001) reflecting patients referred for FIRM. Total ablation time was greater for FIRM-PVI (62 ± 22 min) vs. PVI-controls (52 ± 18 min, P = 0.03). The complication rate for FIRM-PVI procedures (4.3%) was similar to controls (4.0%, P = 1) for both major and minor complications; no deaths were reported. The rate of complications potentially attributable to the basket catheter was small and did not differ between basket types (Constellation 2.8% vs. FIRMap 1.8%, P = 0.7) or between cases in which basket catheters were and were not used (P = 0.5). Complication rates did not differ between centres (P = 0.6). CONCLUSIONS: Procedural complications from the use of the basket catheters for AF mapping are low, and thus procedural safety appears similar between FIRM-PVI and PVI-controls in a large multicentre cohort. Future studies are required to determine the optimal approach to maximize the efficacy of FIRM-guided ablation.

Organized Sources Are Spatially Conserved in Recurrent Compared to Pre-Ablation Atrial Fibrillation: Further Evidence for Non-Random Electrical Substrates.

INTRODUCTION: Recurrent atrial fibrillation (AF) after ablation is associated with reconnection of initially isolated pulmonary vein (PV) trigger sites. Substrates are often targeted in addition to PVI, but it is unclear how substrates progress over time. We studied if substrates in recurrent AF are conserved or have developed de novo from pre-ablation AF. METHODS AND RESULTS: Of 137 patients undergoing Focal Impulse and Rotor Mapping (FIRM) at their index procedure for AF, 29 consecutive patients (60 ± 8 years, 79% persistent) recurred and were also mapped at repeat procedure (21 ± 20 months later) using carefully placed 64-pole baskets and RhythmView(TM) (Topera, Menlo Park, CA, USA) to identify AF sources and disorganized zones. Compared to index AF, recurrent AF had a longer cycle length (177 ± 21 vs. 167 ± 19 milliseconds, P = 0.01). All patients (100%) had 1 or more conserved AF rotors between procedures with surrounding disorganization. The number of sources was similar for recurrent AF post-PVI versus index AF (3.2 ± 1.4 vs. 3.1 ± 1.0, P = 0.79), but was lower for recurrent AF after FIRM+PVI versus index AF (4.4 ± 1.4 vs. 2.9 ± 1.7, P = 0.03). Overall, 81% (61/75) of AF sources lay in conserved regions, while 19% (14/75) were detected de novo. CONCLUSION: Electrical propagation patterns for recurrent AF after unsuccessful ablation are similar in individual patients to their index AF. These data support temporospatial stability of AF substrates over 1-2 years. Trials should determine the relative benefit of adding substrate mapping and ablation to PVI for recurrent AF.

Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device.

BACKGROUND: The purpose of this study was to compare a unique zip-type adjustable coaptive tape-based skin closure device to traditional subcuticular sutures in three domains: time, cosmesis, and wound closure-related outcomes in cardiac implantable electronic device (CIED) procedures. METHODS: A total of 40 patients were enrolled in a prospective randomized controlled trial to assess time to wound closure, as well as cosmesis and wound closure-related outcomes. RESULTS: The adjustable coaptive tape-based skin closure device had shorter overall closure time (78 ± 6.6 seconds vs 216 ± 21.5 seconds; P < 0.001) and mean closure time per centimeter (18.0 ± 2.0 s/cm vs 50.1 ± 6.7 s/cm; P < 0.001) versus sutures, with less intersurgeon and interpatient variability with the use of adjustable coaptive device versus sutures (P < 0.001). There was no difference between groups in postoperative pain or scar cosmesis during the follow-up period. Neither group had any closure-related adverse events. CONCLUSIONS: The adjustable coaptive tape-based skin closure device demonstrated shorter closure times with less variability when compared to sutures. It is a safe and acceptable alternative to sutures for skin closure following CIED implantation.

Compatibility of Radiofrequency Surgical Sponge Detection Technology with Cardiac Implantable Electronic Devices and Temporary Pacemakers.

BACKGROUND: Radiofrequency (RF) technology has improved detection of retained surgical sponges with a reported 100% sensitivity and specificity. However, the potential for interactions of the RF signals emitted by the detection system with cardiac implantable electronic devices (CIEDs) or temporary pacemakers may limit its use in those patients with these devices. This study investigated whether RF detection technology causes interference or clinically significant changes in the programmed settings of implanted pacemakers and defibrillators or temporary epicardial pacemakers. METHODS: Fifty patients who were scheduled either for CIED removal or placement of a temporary epicardial pacemaker (at the time of open heart surgery) were recruited for this study. Device settings and measurements from separate interrogations before and after scanning with the RF detection system were compared. For the temporary pacemakers, we observed for any changes in hemodynamics or signs of pacing interference. RESULTS: Twenty (40%) pacemakers, 20 (40%) implantable cardioverter defibrillators, and 10 (20%) temporary pacemakers were analyzed in this study. During scanning, no signal interference was detected in any permanent device, and there were no significant changes in programmed settings after scanning with the RF detection system. However, pacing inhibition was detected with temporary pacing systems when programmed to a synchronous mode (DDD). CONCLUSIONS: RF detection technology can be safely used to scan for retained surgical sponges in patients with permanent CIEDs and temporary pacemakers set to asynchronous mode.

Modifying Ventricular Fibrillation by Targeted Rotor Substrate Ablation: Proof-of-Concept from Experimental Studies to Clinical VF.

INTRODUCTION: Recent work has suggested a role for organized sources in sustaining ventricular fibrillation (VF). We assessed whether ablation of rotor substrate could modulate VF inducibility in canines, and used this proof-of-concept as a foundation to suppress antiarrhythmic drug-refractory clinical VF in a patient with structural heart disease. METHODS AND RESULTS: In 9 dogs, we introduced 64-electrode basket catheters into one or both ventricles, used rapid pacing at a recorded induction threshold to initiate VF, and then defibrillated after 18±8 seconds. Endocardial rotor sites were identified from basket recordings using phase mapping, and ablation was performed at nonrotor (sham) locations (7 ± 2 minutes) and then at rotor sites (8 ± 2 minutes, P = 0.10 vs. sham); the induction threshold was remeasured after each. Sham ablation did not alter canine VF induction threshold (preablation 150 ± 16 milliseconds, postablation 144 ± 16 milliseconds, P = 0.54). However, rotor site ablation rendered VF noninducible in 6/9 animals (P = 0.041), and increased VF induction threshold in the remaining 3. Clinical proof-of-concept was performed in a patient with repetitive ICD shocks due to VF refractory to antiarrhythmic drugs. Following biventricular basket insertion, VF was induced and then defibrillated. Mapping identified 4 rotors localized at borderzone tissue, and rotor site ablation (6.3 ± 1.5 minutes/site) rendered VF noninducible. The VF burden fell from 7 ICD shocks in 8 months preablation to zero ICD therapies at 1 year, without antiarrhythmic medications. CONCLUSIONS: Targeted rotor substrate ablation suppressed VF in an experimental model and a patient with refractory VF. Further studies are warranted on the efficacy of VF source modulation.

Retrieval of a detached transseptal sheath tip from a right pulmonary artery branch following catheter ablation.

Transseptal introducer sheaths are being used with increasing frequency for left-sided arrhythmia ablations and structural heart disease interventions. Sheath tip detachment and embolization is an uncommon but known complication, and several sheaths have been recalled due to such complications. We report a unique case of a fractured transseptal sheath tip that embolized to a branch of the right pulmonary artery in a patient who had undergone ablation of a left-sided atypical atrial flutter. During final removal of one of the two long 8.5-French SL1 transseptal sheaths used routinely as part of the ablation, the radiopaque tip of the sheath fractured and first embolized to the right atrium and subsequently to a secondary right pulmonary artery branch. Using techniques derived from percutaneous interventional approaches, including a multipurpose catheter, coronary guidewire, and monorail angioplasty balloon, the sheath tip was successfully wired through its inner lumen, trapped from the inside with the balloon, and removed from the body via a large femoral vein sheath, without complications. The approach detailed in this case may guide future cases and circumvent urgent surgical intervention.

Percutaneous extraction of inadvertently placed left-sided pacemaker leads with complete cerebral embolic protection.

Lead wire malposition is a known, but rare complication of permanent pacemaker or defibrillator implantation. The actual incidence and prevalence is unknown and management options for inadvertent left ventricular lead malposition have not been uniform. Current recommendations include systemic anticoagulation with warfarin or surgical lead removal with circulatory arrest for compelling clinical scenarios. Percutaneous left-sided lead extraction is contraindicated due to the potentially increased risk of thromboembolic complications associated with this procedure. To our knowledge, this is the first report of percutaneous extraction of inadvertently placed left ventricular and left atrial endocardial pacemaker leads with flow-preserving complete cerebral embolic protection. We also review the current literature regarding the incidence, management, and percutaneous extraction of left-sided cardiac leads.

Rotors as drivers of atrial fibrillation and targets for ablation.

Atrial fibrillation (AF) is the most common arrhythmia targeted by catheter ablation. Despite significant advances in our understanding of AF, ablation outcomes remain suboptimal, and this is due in large part to an incomplete understanding of the underlying sustaining mechanisms of AF. Recent developments of patient-tailored and physiology-based computational mapping systems have identified localized electrical spiral waves, or rotors, and focal sources as mechanisms that may represent novel targets for therapy. This report provides an overview of Focal Impulse and Rotor Modulation (FIRM) mapping, which reveals that human AF is often not actually driven by disorganized activity but instead that disorganization is secondary to organized rotors or focal sources. Targeted ablation of such sources alone can eliminate AF and, when added to pulmonary vein isolation, improves long-term outcome compared with conventional ablation alone. Translating mechanistic insights from such patient-tailored mapping is likely to be crucial in achieving the next major advances in personalized medicine for AF.

Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation.

BACKGROUND: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. A formal analysis of the atrioesophageal fistula (AEF) rate with active esophageal cooling has not previously been performed. OBJECTIVES: The authors aimed to compare AEF rates before and after the adoption of active esophageal cooling. METHODS: This institutional review board (IRB)-approved study was a prospective analysis of retrospective data, designed before collecting and analyzing the real-world data. The number of AEFs occurring in equivalent time frames before and after adoption of cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were quantified across 25 prespecified hospital systems. AEF rates were then compared using generalized estimating equations robust to cluster correlation. RESULTS: A total of 14,224 patients received active esophageal cooling during RF ablation across the 25 hospital systems, which included a total of 30 separate hospitals. In the time frames before adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the preadoption cohort, a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates for procedures using LET monitoring. In the postadoption cohort, no AEFs were found in the prespecified sites, yielding an AEF rate of 0% (P < 0.0001). CONCLUSIONS: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.

Correlation between sinus rhythm deceleration zones and critical sites for localized reentrant atrial flutter: A retrospective multicenter analysis.

Background: Atypical left atrial flutter (AFL) may be macroreentrant or spatially localized. The relationship between the critical isthmus (CI) for localized reentry with sinus rhythm (SR) conduction slowing has not been systematically examined. Objective: To examine the correlation between CI sites for localized AFL (L-AFL) and deceleration zones (DZ) identified by isochronal late activation mapping (ILAM) during baseline rhythm. Methods: Patients with localized AFL who underwent high-density activation mapping of both SR and AFL were retrospectively analyzed. L-AFL was defined as reentry restricted to 2 wall segments of the left atrium. CI was defined by activation mapping and sites of successful termination during ablation. DZ, defined as >3 isochrones within 1 cm radius during baseline rhythm, were correlated to the locations of the CI. Results: Thirty-one consecutive patients that underwent detailed sinus rhythm and AFL high-density activation maps were analyzed at 3 centers. A mean 4060 ± 3275 and 6209 ± 8656 points were collected in ILAM and AFL activation maps, respectively. At least 1 DZ (1.7 ± 0.77) was identified in all patients. ILAM showed 3.27 ± 0.52 isochrones per DZ (168 ± 32 ms), and co-localized to CI sites at a distance of 6.7 ± 3 mm. A total of 34% ± 14% of the AFL cycle length was contained within 0.5 cm of the DZ. Conclusions: In patients with L-AFL, CI co-localized with DZ during baseline rhythm, suggesting that DZ mapping during SR may yield candidate targets for ablation as an adjunct to pulmonary vein isolation to prevent a subtype of AFL.

Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study.

BACKGROUND: The accuracy of noninvasive arrhythmia source localization using a forward-solution computational mapping system has not yet been evaluated in blinded, multicenter analysis. This study tested the hypothesis that a computational mapping system incorporating a comprehensive arrhythmia simulation library would provide accurate localization of the site-of-origin for atrial and ventricular arrhythmias and pacing using 12-lead ECG data when compared with the gold standard of invasive electrophysiology study and ablation. METHODS: The VMAP study (Vectorcardiographic Mapping of Arrhythmogenic Probability) was a blinded, multicenter evaluation with final data analysis performed by an independent core laboratory. Eligible episodes included atrial and ventricular: tachycardia, fibrillation, pacing, premature atrial and ventricular complexes, and orthodromic atrioventricular reentrant tachycardia. Mapping system results were compared with the gold standard site of successful ablation or pacing during electrophysiology study and ablation. Mapping time was assessed from time-stamped logs. Prespecified performance goals were used for statistical comparisons. RESULTS: A total of 255 episodes from 225 patients were enrolled from 4 centers. Regional accuracy for ventricular tachycardia and premature ventricular complexes in patients without significant structural heart disease (n=75, primary end point) was 98.7% (95% CI, 96.0%-100%; P<0.001 to reject predefined H0 <0.80). Regional accuracy for all episodes (secondary end point 1) was 96.9% (95% CI, 94.7%-99.0%; P<0.001 to reject predefined H0 <0.75). Accuracy for the exact or neighboring segment for all episodes (secondary end point 2) was 97.3% (95% CI, 95.2%-99.3%; P<0.001 to reject predefined H0 <0.70). Median spatial accuracy was 15 mm (n=255, interquartile range, 7-25 mm). The mapping process was completed in a median of 0.8 minutes (interquartile range, 0.4-1.4 minutes). CONCLUSIONS: Computational ECG mapping using a forward-solution approach exceeded prespecified accuracy goals for arrhythmia and pacing localization. Spatial accuracy analysis demonstrated clinically actionable results. This rapid, noninvasive mapping technology may facilitate catheter-based and noninvasive targeted arrhythmia therapies. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04559061.

Open-window mapping of accessory pathways utilizing high-density mapping.

PURPOSE: Accessory pathway (AP) mapping is currently based on point-by-point mapping and identifying if a local electrogram's origin is atrial, pathway, or ventricular, which is time-consuming and prone to insufficient mapping. We sought to determine the feasibility of automated and high-density mapping to define AP location using open-window mapping (OWM), which does not rely on defining the electrogram's origin but simply detects the sharpest local signal at each point. METHODS: We enrolled 23 consecutive patients undergoing catheter ablation for atrioventricular reentrant tachycardia. High-density mapping was performed using OWM and ablation was performed. The successful site of ablation was determined by the loss of pathway function. RESULTS: OWM was 100% effective at identifying the successful site of ablation (average mapping time 7.3 ± 4.3 min.) Permanent AP elimination was achieved using a mean radiofrequency energy time of 18.5 ± 24.5 s/patient. Transiently successful ablations were 4.0 ± 1.8 mm from permanently successful sites and had lower contact force (5.1 ± 2.5 g vs. 11.7 ± 9.0 g; P = 0.041). Unsuccessful sites had similar contact force to permanently successful sites (12.2 ± 9.2 g vs. 11.7 ± 9.0 g; P = 0.856) but were 6.4 ± 2.0 mm away from successful sites. CONCLUSION: A novel technique of high-density, automated, and open-window mapping (OWM) effectively localizes APs without the need to differentiate the signal's site of origin. These findings suggest that OWM can be used to rapidly and successfully map and ablate APs. Both distances from the pathway and contact force were shown to be important for pathway ablation.

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia.

BACKGROUND: Stereotactic ablative radiotherapy (SAbR) is an emerging therapy for refractory ventricular tachycardia (VT). However, the current workflow is complicated, and the precision and safety in patients with significant cardiorespiratory motion and VT targets near the stomach may be suboptimal. OBJECTIVE: We hypothesized that automated 12-lead electrocardiogram (ECG) mapping and respiratory-gated therapy may improve the ease and precision of SAbR planning and facilitate safe radiation delivery in patients with refractory VT. METHODS: Consecutive patients with refractory VT were studied at 2 hospitals. VT exit sites were localized using a 3-D computational ECG algorithm noninvasively and compared to available prior invasive mapping. Radiotherapy (25 Gy) was delivered at end-expiration when cardiac respiratory motion was ≥0.6 cm or targets were ≤2 cm from the stomach. RESULTS: In 6 patients (ejection fraction 29% ± 13%), 4.2 ± 2.3 VT morphologies per patient were mapped. Overall, 7 out of 7 computational ECG mappings (100%) colocalized to the identical cardiac segment when prior invasive electrophysiology study was available. Respiratory gating was associated with smaller planning target volumes compared to nongated volumes (71 ± 7 vs 153 ± 35 cc, P < .01). In 2 patients with inferior wall VT targets close to the stomach (6 mm proximity) or significant respiratory motion (22 mm excursion), no GI complications were observed at 9- and 12-month follow-up. Implantable cardioverter-defibrillator shocks decreased from 23 ± 12 shocks/patient to 0.67 ± 1.0 (P < .001) post-SAbR at 6.0 ± 4.9 months follow-up. CONCLUSIONS: A workflow including computational ECG mapping and protocol-guided respiratory gating is feasible, is safe, and may improve the ease of SAbR planning. Studies to validate this workflow in larger populations are required.

Long-term mode and timing of premature ventricular complex recurrence following successful catheter ablation.

PURPOSE: Catheter ablation of premature ventricular contractions (PVCs) is highly successful and has become the hallmark treatment for symptomatic or highly prevalent cases. However, few studies exist that evaluate the outcomes of ablation and likely mechanisms of PVC recurrence beyond 1 year of follow-up. METHODS: This study is a retrospective analysis of patients who underwent catheter ablation for symptomatic PVCs with acute procedural success and had clinical follow-up ≥ 12 months. RESULTS: Forty-four patients (24 women; age 53.5 ± 4.8 years) following acutely successful PVC ablation with long-term follow-up were studied. At a mean of 36 ± 6 months, overall long-term ablation success was 75% (33/44 patients). Notably, recurrence of the targeted PVC focus was low (6.8%, 3/44 patients); the majority of recurrences were from a new source location (18.2%, 8/44 patients). The time course for targeted versus de novo PVC recurrences was significantly different: recurrence of a PVC similar to the targeted PVC morphology occurred at a mean of 5.0 ± 2.0 months, while recurrence of a PVC different from the index case occurred at a mean of 35.8 ± 17.1 months (p = 0.01). Non-ischemic cardiomyopathy was associated with increased risk of PVC recurrence (odds ratio [OR] 14.50 (95% confidence interval [CI] 1.92-109.33, p = 0.01)) and was a significant negative prognostic factor in multivariate analysis for PVC recurrence survival (hazard ratio [HR] 4.63, 95% CI 1.03-20.74, p = 0.04). CONCLUSIONS: The majority of long-term PVC recurrences occur late in follow-up, at locations remote from the targeted PVC source or sources. Such sites may represent ongoing substrate evolution; additional work is required to determine the precise substrate alterations which promote such arrhythmogenic changes.