Quantitative comparison of the isolation lesions between conventional- and larger-sized visually guided laser balloon ablation.

BACKGROUND: The importance of a wider circumferential isolation of the pulmonary veins (PV), which includes a large portion of the left atrial posterior wall (LAPW), has been suggested in several studies. However, the extended isolation area using a larger inflated visually guided laser balloon (VGLB) ablation remains to be elucidated. METHODS: Seventy-eight patients with atrial fibrillation (AF) who underwent VGLB ablation were enrolled in this prospective study. An electroanatomic map of the left atrium was obtained before and after PV isolation (PVI) using a conventional-sized VGLB. The isolation areas were extended by the largest-sized VGLB ablation and remapped in the same manner. After the ablation, isolation areas were calculated with CARTO-3 system. The one-year atrial arrhythmia (Ata) recurrence was assessed.  RESULTS: The largest-sized VGLB ablation yielded statistically greater areas of isolation in left-sided PV antrum (PVA) (11.5 ± 2.3 cm2 vs. 15.9 ± 3.5 cm2, P < .001) and right-sided PVA (14.2 ± 3.3 cm2 vs. 20.6 ± 4.4 cm2, P < .001) than the conventional-sized VGLB. Further, non-ablated LAPW (12.3 ± 4.4 cm2 vs. 7.8 ± 3.9 cm2, P < .001) was significantly reduced after largest-sized VGLB ablation, compared to the conventional-sized VGLB ablation. The one-year Ata freedom was 83.7% in patients with paroxysmal AF and 96.4% in those with persistent AF. CONCLUSION: The largest-sized VGLB ablation technique can create a significantly wider isolation area of PVA and debulk a large amount of LAPW than the conventional-sized VGLB ablation. The one-year outcome was similarly high in paroxysmal and persistent AF.

Left atrial roof region ablation using a visually guided laser balloon.

Balloon-based catheter ablation including visually guided laser balloon (VGLB) has been adopted a first line therapeutic strategy for the patients with atrial fibrillation (AF). Recently, the roof area ablation beyond pulmonary vein (PV) isolation (PVI) using cryoballoon has been described as an effective therapy for the patients with persistent AF. However, the roof area ablation performed with a VGLB remains unknown. In this case, we report the case of roof area ablation for the patient with persistent AF using a VGLB.

Initial multicenter clinical experience with the first-generation endoscopic guided laser balloon in Japan.

BACKGROUND: Isolation of the pulmonary veins (PVs) is the golden standard for atrial fibrillation (AF) ablation. To achieve a permanent PV isolation, the endoscopic guided HeartLight laser balloon system was invented. We analyzed the safety and efficacy of this laser balloon system. METHODS AND RESULTS: Three hundred four patients from 21 investigational sites inside Japan were enrolled in this study. One thousand sixty-two out of 1175 PVs (90.4%) were isolated using the HeartLight laser balloon. The isolation rate of the left superior, left inferior, right superior, and right inferior PVs was 87.8%, 91.3%, 91.6%, and 92.1%, respectively. The procedure time, defined as the time from the venous access to taking out the balloon, was 155 ± 39 min. The fluoroscopic time was 44 ± 25 min. The mean follow-up period was 309 ± 125 days. The freedom from AF recurrence at 3 months was 89.0% and at 12 months 82.1%. Adverse events occurred in 22 patients (7.2%) including phrenic nerve injury lasting more than 3 months in 1.6% and strokes in 1.0% of the patients. CONCLUSIONS: This initial experience demonstrated that the laser balloon ablation was feasible for PV isolation in Japanese AF patients.

The impact of home electrocardiograph measurement rate on the detection of atrial fibrillation recurrence after ablation: A prospective multicenter observational study.

Background: This multicenter prospective observational study examined the impact of additionally using a home electrocardiograph (ECG) to detect atrial fibrillation (AF) recurrence after ablation. Methods: Between May 2019 and December 2020, 128 patients undergoing ablation were enrolled in the study. After performing ablation, they were instructed to measure their ECGs at home using Complete (ECG paired with a blood pressure monitor; Omron Healthcare, Japan) every day and to visit the hospital every 3 months until after 12 months for 24-hour Holter ECG and 12-lead ECG as usual care (UC). Results: After ablation, 94 patients were followed up, and AF recurrence at 12 months was detected more commonly in adjudicators-interpreted Complete (31 [33 %]) than in UC (18 [9 %]) (hazard ratio 1.95, 95 % confidence interval [95 %CI] 1.35-2.81, P < 0.001). In patients with recurrent AF found via both modalities (n = 16), the time to first AF detection by Complete was 40.9 ± 73.9 days faster than that in UC (P = 0.04). Notably, when the adherence to Complete measurement was divided by 80 %, the add-on effect of Complete on the detection of recurrent AF in UC indicated the hazard ratio (HR) of 1.71 (95 %CI 0.92-3.18, P = 0.09) for the low adherence (<80 %) group, but it was significant for the high adherence (≥80 %) group, with HR of 2.19 (95 %CI 1.43-3.36, P < 0.001). Conclusions: Despite a shorter measurement time, Complete detected recurrent AF more frequently and faster compared with UC after AF ablation. A significant adherence-dependent difference of Complete was found in detecting AF recurrence.

Comparison of maximum-sized visually guided laser balloon and cryoballoon ablation.

Balloon ablation therapy has recently been used for atrial fibrillation (AF) ablation. Laser balloons possess the property in which the balloon size can be changed. Standard laser balloon ablation (Standard LBA) was followed by additional ablation using a maximally extended balloon (Extended LBA) and its lesion characteristics were compared to cryoballoon ablation (CBA), another balloon technology. From June 2020 to July 2021, patients with paroxysmal AF who underwent an initial pulmonary vein (PV) isolation were enrolled. Sixty-five patients with paroxysmal AF were included, 32 in the LBA and 33 in the CBA group. To measure the isolated surface area after the ablation procedures, left atrial voltage mapping was performed after Standard LBA, Extended LBA, and CBA. The baseline patient characteristics did not differ between LBA and CBA. Extended LBA could successfully increase the isolated area more than Standard LBA for all four PVs. Compared to CBA, the isolated area of both superior PVs was significantly greater with Extended LBA (left superior PV: 8.5 ± 2.1 vs 7.3 ± 2.4, p = 0.04, right superior PV: 11.4 ± 3.7 vs 8.7 ± 2.7, p < 0.01), and thus the non-isolated posterior wall (PW) was smaller (8.5 ± 3.4 vs 12.4 ± 3.3, p < 0.01). Nevertheless, changes in the cardiac injury markers were significantly lower with LBA than CBA. There was no significant correlation between the cardiac injury level and isolated area in both groups. In conclusion, Extended LBA exhibited a significantly greater isolation of both superior PVs and resulted in a smaller non-isolated PW, but the cardiac injury markers were significantly suppressed as compared to CBA.

Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial.

BACKGROUND: Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias. METHODS: In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software. RESULTS: Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae. CONCLUSIONS: In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03639597.

Diagnostic Value of Atrial Fibrillation by Built-in Electrocardiogram Technology in a Blood Pressure Monitor.

Background: Hypertension in patients with atrial fibrillation (AF) is a known independent risk factor for stroke. The Complete blood pressure (BP) monitor (Omron Healthcare, Kyoto, Japan) was developed as the first BP monitor with electrocardiogram (ECG) capability in a single device to simultaneously monitor ECG and BP readings. This study investigated whether the Complete can accurately differentiate sinus rhythm (SR) from AF during BP measurement. Methods and Results: Fifty-six consecutive patients with persistent AF admitted for catheter ablation were enrolled in the study (mean age 65.8 years; 83.9% male). In all patients, 12-lead ECGs and simultaneous Complete recordings were acquired before and after ablation. The Complete interpretations were compared with physician-reviewed ECGs, whereas Complete recordings were reviewed by cardiologists in a blinded manner and compared with ECG interpretations. Sensitivity, specificity, and κ coefficient were also determined. In all, 164 Complete and ECG recordings were simultaneously acquired from the 56 patients. After excluding unclassified recordings, the Complete automated algorithm performed well, with 100% sensitivity, 86% specificity, and a κ coefficient of 0.87 compared with physician-interpreted ECGs. Physician-interpreted Complete recordings performed well, with 99% sensitivity, 85% specificity, and a κ coefficient of 0.85 compared with physician-interpreted ECGs. Conclusions: The Complete, which combines BP and ECG monitoring, can accurately differentiate SR from AF during BP measurement.

Takayasu arteritis and ulcerative cutaneous sarcoidosis.

A 67-year-old woman was referred to our hospital due to a refractory lower extremity ulcer. Occlusion of the bilateral superficial femoral arteries and a difference (>50 mmHg) in blood pressure between the bilateral upper limbs were noted. In addition to occlusion of the left subclavian artery and stenosis at the ostium of the right coronary artery, these findings led to a diagnosis of Takayasu arteritis. Furthermore, a biopsy of the ulcerated skin lesion localized on the fibular surface showed a non-caseating cutaneous granulomatous lesion resulting in the diagnosis of cutaneous sarcoidosis. The simultaneous occurrence of cutaneous sarcoidosis and Takayasu arteritis, albeit rare, should not be overlooked.

Increased serum IgG4 levels and intimal IgG4-positive cell infiltration in rapidly growing aortic aneurysm.

A 67-year-old Japanese man had been complaining of discomfort in the chest and back and feeling febrile for 2 weeks. Chest computed tomography indicated a thoracic aortic aneurysm. He occasionally showed a high fever (up to 38.0°C), even after hospital admission, irrespective of antibiotic therapy. The patient was found to have elevated serum IgG4 levels (366 mg/dL). The aneurysm demonstrated rapid growth; therefore, rifampicin-soaked woven Dacron synthetic graft replacement was performed 22 days after admission. Immunohistostatining of the resected aorta segment showed an IgG4-positive plasma cell infiltrate within the intimal layer neighboring the cholesterol-rich atheromatous plaque. After surgery, the patient's serum IgG4 level dropped acutely; however, it did not reach the normal range. The possible role of IgG4 in the development or suppression of aortic remodeling, as well as in atherogenesis, among patients with rapidly growing aortic aneurysm requires further investigation.

Impact of atrial fibrillation termination on clinical outcome after ablation in relation to the duration of persistent atrial fibrillation.

BACKGROUND: Whether procedural termination of persistent atrial fibrillation (AF) is necessary for optimal clinical efficacy still remains controversial. We sought to characterize the patients with persistent AF in whom procedural AF termination impacted an improved clinical outcome after ablation. METHODS: We retrospectively assessed 132 patients (61.0 ± 9.3 years, 114 males) undergoing catheter ablation of persistent AF (duration 3 years, median). A stepwise ablation approach including pulmonary vein isolation and atrial substrate ablation targeting complex fractionated and high-frequency electrograms was performed with desired endpoint of AF termination. RESULTS: Overall, 90 patients (68%) were free from recurrent arrhythmias at 20 ± 11 months of follow-up after one or two procedures. The left atrial diameter and continuous AF duration according to medical history were associated with the outcome (P = 0.002 and P< 0.001, respectively). In multivariate Cox regression analysis, the continuous AF duration was the only independent predictor of recurrent arrhythmias (hazard ratio 1.17, 95% confidence interval 1.10-1.23, P < 0.001). In patients with AF duration of ≥ 3 years, the clinical success was comparable regardless of whether AF termination was achieved or not (log-rank, P = 0.27). In the remaining patients with AF duration of <3 years, procedural AF termination was associated with a higher arrhythmia-free rate than when AF was sustained after ablation (log-rank, P = 0.023). CONCLUSION: Extensive ablation to terminate AF might not be warranted in patients with a longer AF duration. On the contrary, procedural AF termination could be associated with maintenance of sinus rhythm in patients with a shorter AF duration with a less proarrhythmic substrate. (PACE 2012;35:1436-1443).

Two distinct electrocardiographic forms of idiopathic ventricular arrhythmia originating in the vicinity of the His bundle.

AIM: The objective is to assess electrocardiographic characteristics predicting the precise location of ventricular arrhythmia (VA) origin within the right ventricle (RV) close to the His bundle (HB) region. METHODS AND RESULTS: Twenty-five patients (14 men, age 65 ± 14 years) underwent successful catheter ablation of para-Hisian VA. Ventricular arrhythmias were considered to arise in the vicinity of the HB region based on the criteria that mapping exhibited the earliest RV activation before QRS onset in the HB region. Surface 12-lead electrocardiogram during the para-Hisian VAs was analysed. Of the 25 patients, 8 originated from the RV antero-septum just above the HB region, and 17 arose from the RV mid-septum just below the HB region. There was no significant difference in precedence of the local ventricular electrogram of the HB region from the onset of surface QRS during VAs. Surface electrocardiographic findings were characterized according to R-wave amplitude in lead I (0.43 ± 0.18 vs. 0.67 ± 0.19 mV, P = 0.005), mean R-wave amplitude in inferior leads (1.12 ± 0.32 vs. 0.71 ± 0.24 mV, P = 0.002), R-wave amplitude ratio of leads III/II (0.77 ± 0.10 vs. 0.50 ± 0.23, P = 0.005), incidence of S-wave in lead III [1/8 (13%) vs. 16/17 (94%), P < 0.001], and QS morphology in lead V1 [3/8 (38%) vs. 17/17 (100%), P = 0.001]. CONCLUSIONS: Despite their adjacent locations, para-Hisian VAs could be classified into two subgroups with distinctive electrocardiographic characteristics according to origin either above or below the HB region. The present findings can be helpful for planning catheter ablation of para-Hisian VAs, and can reduce the risk of inadvertent atrioventricular block.

Catheter ablation of ventricular arrhythmias arising from the right ventricular septum close to the His bundle: features of the local electrogram at the optimal ablation site.

INTRODUCTION: The characteristics of the local electrogram at the optimal ablation site of ventricular arrhythmias (VAs) originating from the right ventricle close to the His bundle (HB) region have rarely been described. METHODS AND RESULTS: Among 190 consecutive patients with idiopathic VAs with left bundle branch block morphology and inferior-axis deviation, 16 were found to have successful ablation site in the right ventricle close to the HB region (para-Hisian group). The electrophysiologic data were compared between the patients in the para-Hisian group and those with VAs arising from the right ventricular (RV) outflow tract (RVOT group). The distal bipolar electrogram at the successful ablation sites in the para-Hisian group exhibited a significantly greater R-wave duration, lower R-wave amplitude, and slower upright deflection of the initial R wave than did those in the RVOT group (all P < 0.001). In the para-Hisian group, a total of 56 radiofrequency (RF) energy applications were delivered, of which the local electrograms at 16 successful and 40 unsuccessful ablation sites were reviewed. High-frequency R-wave potentials of the bipolar electrogram were present in 14 (88%) of the successful ablation sites. An R-wave duration of greater than 34 ms had a discriminatory power for indicating the site of a successful ablation (area under the receiver-operator characteristics curve 0.90, sensitivity 94%, specificity 80%). CONCLUSIONS: The successful ablation site of the para-Hisian VAs had distinctive local electrogram characteristics. A longer R-wave duration of the bipolar electrogram with high-frequency potentials could be a novel predictor of a successful ablation.

Atrial defibrillation threshold as a novel predictor of clinical outcome of catheter ablation for persistent atrial fibrillation.

AIMS: Catheter ablation for persistent atrial fibrillation (AF) is currently performed with different procedural endpoints. When AF did not terminate during ablation procedure, electrical cardioversion was performed at different defibrillation threshold (DFT) according to AF characteristics and atrial electrophysiologic substrates. We sought to evaluate the impact of atrial DFT after catheter ablation for persistent AF on clinical outcome. METHODS AND RESULTS: We studied 128 patients with persistent AF (age 63±9 years, 106 men). After completion of circumferential pulmonary vein isolation, the left atrial substrate ablation was performed until AF terminated or all identified complex fractionated electrograms were eliminated. If AF did not terminate during ablation, an internal cardioversion protocol was started at 5J and was increased incrementally in 5 J steps until successful cardioversion was accomplished. Procedural AF termination was achieved in 50 patients (Group A). Atrial fibrillation was terminated by cardioversion with DFT≤10 J in 47 patients (Group B) and with DFT>10 J in 31 patients (Group C). At 14±7 follow-up months after 1.3±0.5 sessions, 47 (94%) Group A patients, 42 (89%) Group B patients, and 14 (45%) Group C patients remained in sinus rhythm. In multivariate analysis of Group B and Group C, DFT (hazard ratio 5.54, P<0.001) and AF duration (hazard ratio 3.74, P=0.011) were independent predictors of recurrent arrhythmia. CONCLUSION: When AF does not terminate after the completion of predetermined stepwise ablation, further extensive ablation to terminate AF might be unnecessary if the AF can be successfully terminated by electrical cardioversion at low DFT.

Assessment of acute injuries and chronic intimal thickening of the radial artery after transradial coronary intervention by optical coherence tomography.

AIMS: Transradial coronary intervention (TRI) introduces a trauma to the radial artery (RA), possibly influencing quality as a bypass conduit if subsequently used. We sought to determine the acute and chronic effects of TRI on the RA by optical coherence tomography (OCT). METHODS AND RESULTS: Immediately after TRI completion, 73 RAs in 69 patients were examined. The sheath was pulled back 2 cm distal to the puncture site, and OCT imaging was performed. The acute injuries and intimal thickening were compared between first-TRI RAs and repeat-TRI RAs. Intimal tears were observed in 49 RAs (67.1%) and were more frequent in the distal than in the proximal RA (P = 0.001). Medial dissections were not uncommon (26 RAs, 35.6%). The frequency of acute injury was significantly higher in repeat-TRI RAs (P < 0.001). Intima/medial area, the maximum intimal thickness/medial thickness ratio, and per cent narrowing were all significantly greater in repeat-TRI RAs in the distal and proximal RA. Multivariate analysis revealed that a repeated TRI procedure was the only independent predictor of intimal thickening. CONCLUSION: Optical coherence tomography clearly demonstrated significant acute injuries and chronic intimal thickening of RA after TRI. Further study should evaluate the impact of these effects when TRI RAs are subsequently used as conduits, on long-term graft patency and on clinical outcomes after bypass surgery.