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BackgroundVisually guided laser balloon (VGLB) ablation allows for pulmonary vein isolation (PVI) under direct endoscopic control. Short- and midterm clinical outcomes are in accordance with results of radiofrequency current (RFC) ablation for the treatment of paroxysmal atrial fibrillation (PAF).ObjectiveThe current study sought to assess the long-term clinical outcomes of VGLB-based PVI for PAF.MethodsA total of 90 patients [60 ± 10 years; 33 (37%) female, left atrial diameter 42 ± 4 mm] with drug-refractory PAF underwent VGLB ablation. The median duration of PAF until VGLB ablation was 36 (interquartile range 12; 84) months. Follow-up was based on outpatient clinic visits including Holter ECGs and telephone interviews. Repeat ablation due to arrhythmia recurrences was performed using RFC ablation.ResultsAfter a single VGLB procedure, 5-year freedom from arrhythmia recurrence was 51% [95% confidence interval (CI) 39–62%]. Thirty-three patients underwent repeat RFC ablation procedures, resulting in multiple procedure freedom from arrhythmia recurrence of 78% (95% CI 68–88%). Major periprocedural complications occurred in four patients (4%).ConclusionsVGLB ablation for the treatment of drug-refractory PAF is safe and results in 5-year single and multiple procedure arrhythmia-free survival of 51 and 78%, respectively.

Pulmonary vein isolation (PVI) is the basis of all ablation techniques for paroxysmal atrial fibrillation. Performing conventional radiofrequency ablation for PVI is time consuming and sometimes challenging when using point-by-point applications to create continuous lesions. Small electrically conducting gaps evolving in the ablation lines may cause recurrences of atrial fibrillation or regular atrial re-entry tachycardias. Development of novel anatomically designed ablation catheters for PVI aim to facilitate the ablation procedure, to produce continuous and durable lesions with a limited number of ablation impulses and to reduce the complication rate. The endoscopic laser balloon ablation system (HeartLight® EAS, Cardiofocus Inc.) is the first system that allows direct visual guidance of energy delivery at the antral level of each pulmonary vein and uses a completely new energy source for ablation.

[...]there are published data showing that it is probably the most successful approach to paroxysmal atrial fibrillation (PAF) so-far invented. 2 Acute success was achieved in over 98% of 924 patients.

Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty. We tested the hypothesis that remote ischaemic conditioning during evolving ST-elevation myocardial infarction, and done before primary percutaneous coronary intervention, increases myocardial salvage. 333 consecutive adult patients with a suspected first acute myocardial infarction were randomly assigned in a 1:1 ratio by computerised block randomisation to receive primary percutaneous coronary intervention with (n=166 patients) versus without (n=167) remote conditioning (intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff). Allocation was concealed with opaque sealed envelopes. Patients received remote conditioning during transport to hospital, and primary percutaneous coronary intervention in hospital. The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention, measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment; analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00435266. 82 patients were excluded on arrival at hospital because they did not meet inclusion criteria, 32 were lost to follow-up, and 77 did not complete the follow-up with data for salvage index. Median salvage index was 0·75 (IQR 0·50–0·93, n=73) in the remote conditioning group versus 0·55 (0·35–0·88, n=69) in the control group, with median difference of 0·10 (95% CI 0·01–0·22; p=0·0333); mean salvage index was 0·69 (SD 0·27) versus 0·57 (0·26), with mean difference of 0·12 (95% CI 0·01–0·21; p=0·0333). Major adverse coronary events were death (n=3 per group), reinfarction (n=1 per group), and heart failure (n=3 per group). Remote ischaemic conditioning before hospital admission increases myocardial salvage, and has a favourable safety profile. Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes. Fondation Leducq.

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.

BackgroundPhrenic nerve injury (PNI) is one of the common complications in atrial fibrillation (AF) ablation, which often recovers spontaneously. However, the course of its recovery has not been examined fully, especially in regard to the different ablation methods. We sought to compare the recovery course of PNI in cryoballoon, laser balloon, and radiofrequency ablation.MethodsThis multicenter retrospective study analyzed 355 patients who suffered from PNI during AF ablation. PNI occurred during cryoballoon ablation (CB group) and laser balloon ablation (LB group) for a pulmonary vein isolation in 288 and 20 patients, and radiofrequency ablation for a superior vena cava (SVC) isolation (RF-SVC group) in 47 patients, respectivelyResultsThere was a significant difference in the estimated probability of PNI recovery after the procedure between the methods (p = 0.01). PNI recovered significantly earlier in the CB group, especially within 24 h and 3 months post-procedure (the percentage of the recovery within 24 h and 3 months: 49.7% and 71.5% in the CB group, 15.0% and 22.2% in the LB group, and 23.4% and 41.9% in the RF-SVC group, respectively). Persistent PNI after 12 months was observed in only seven patients in the CB group, one in the LB group, and four in the RF-SVC group, respectively.ConclusionPNI rarely persists over 12 months after AF ablation; however, there is a difference in the timing of its recovery. PNI recovers quicker with cryoballoon ablation than with laser balloon ablation or radiofrequency ablation of the SVC.

Purpose: To report a safety and efficacy study of directed excimer laser atherectomy with the Bias Sheath guiding catheter to create larger lumens in the superficial femoral artery (SFA). Methods: Fourteen patients (9 men; mean age 66±9 years, range 46–76) with chronic lower limb ischemia (Rutherford class 2 to 5) referable to SFA stenoses were treated with the 8-F—compatible Bias Sheath and a 1.7- or 2.0-mm laser catheter. Eight (57%) lesions were de novo and 6 (43%) were in-stent restenoses (ISR). Mean diameter stenosis was 96%±8% (range 80%–100%; 10 total occlusions), and mean lesion length was 126±78 mm (range 30–290). The primary study endpoint was laser success, defined as <50% angiographic residual stenosis post-laser, without major perforations. Results: The primary endpoint was achieved in 8 (57%) lesions; all patients underwent additional balloon angioplasty, which achieved an angiographic residual stenosis <30% in all. Three lesions could not be completely traversed with the study device. Two dissections were detected after Bias Sheath application; 1 required stenting. There were 2 embolic events (specific to the antegrade device design); both were treated with aspiration therapy. Intravascular ultrasound (IVUS)–based minimal lumen diameters were 0.23±0.2 mm (range 0–1.0) at baseline and 3.2±0.8 mm after Bias Sheath application. Rutherford category improved at 1 month in 10 (71%) patients. One patient remained unchanged, another worsened (category 2 to 3), 1 died, and the fourth was not examined. The ankle-brachial index improved from 0.41±0.18 at baseline to 0.79±0.19 at discharge and to 0.80±0.19 at 1 month. Primary 1-month patency (<50% restenosis by duplex) was 85% (11/13 lesions). Conclusion: SFA lesions, including ISR, can be treated in the majority of cases with directed laser atherectomy, significantly reducing plaque burden as measured by IVUS. Embolization was attributed to device-specific features of the prototype antegrade sheath design, which was discontinued. Larger studies are mandatory to document the longterm technical and clinical impact of this new device.

Background Visually guided laser balloon (VGLB) ablation is a balloon-based treatment for atrial fibrillation (AF) that uses a titratable laser energy source to perform pulmonary vein isolation (PVI), allowing for real-time visualization of target tissue and ablation lesions through an endoscopic camera. Few long-term data on this technique are currently available. This report presents acute efficacy, procedural data, complication rates, and long-term AF-free survival up to 5 years post-ablation. Methods In this single-center, retrospective, observational report, 152 patients (72.4% male, mean age 60.6 ± 9.7 years, 62.5% paroxysmal AF, 598 pulmonary veins in total) treated with the first-generation VGLB system between 2014 and 2016 were included for analysis. AF ablation consisted of PVI only. Results Acute PVI was achieved in 98.2% of veins, with first-pass isolation in 92.5%. Procedure duration of 129 min [IQR 113–150], fluoroscopy time of 15 min [IQR 11–20], and dose area product of 5016 mGy·cm 2 [IQR 3603–8711] were recorded. During a median follow-up of 51 months [IQR 45–57], 74.3% of patients remained free of AF (78.8% for paroxysmal and 65.3% for persistent AF, p  = 0.108). Freedom of AF at 1, 2, 3, and 4 years follow-up was 88.2%, 82.2%, 78.9%, and 74.8%, respectively. PV reconnections were identified in only 46.9% of redo procedures. The median number of PV reconnections during redo procedures was 0 [IQR 0–2]. Anti-arrhythmic drug use was significantly reduced after ablation ( p  < 0.001). The most commonly reported complications were minor vascular complications (4.6%) and transient phrenic nerve paralysis (3.3%). Conclusions First-generation VGLB ablation demonstrated high acute isolation rates, reasonable procedure times and low complication rates. Long-term freedom from AF was 78.8% for paroxysmal AF and 65.3% for persistent AF, performing PVI only.

BackgroundThe 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.MethodsSeventy-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. ResultsThe 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.ConclusionThe 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.