Initial clinical experience of pulmonary vein isolation using the ultra-low temperature cryoablation catheter for patients with atrial fibrillation.

BACKGROUND: The iCLAS ultra-low temperature cryoablation (ULTC) system has recently been brought to the market. A combination of a newly exploited cryogen and interchangeable stylet enables flexible and continuous lesion creation in atrial fibrillation (AF) ablation. The use of an esophageal warming balloon is recommended when using the system to reduce the potential for collateral esophageal injury. OBJECTIVE: To describe the initial clinical experience when using ULTC in the AF treatment without general anesthesia (GA). METHODS: Consecutive patients undergoing AF ablation using ULTC under deep sedation without GA were enrolled. We assessed the procedural data focusing on "single-shot isolation" defined as successful pulmonary vein (PV) isolation after the first application. Esophagogastroduodenoscopy was systematically performed the day after ablation. RESULTS: A total of 27 AF patients (67% paroxysmal AF) were analyzed. Onehundred four out of 106 PVs (98.1%) were isolated solely using ULTC. The mean procedure time was 79 ± 30 min. The mean number of applications per PV was 2.6 ± 1.0. Single-shot isolation was achieved in 57 PVs (54%) varying across PVs from left superior to inferior PVs (40%-64%). The single procedure 6-month recurrence-free rate was 84%. No major complication (cerebrovascular event, pericardial effusion/tamponade, esophageal damage on esophagogastroduodenoscopy) occurred. A single transient phrenic nerve palsy occurred during the right superior PV ablation, which had recovered by the 3-month follow-up appointment. CONCLUSIONS: AF ablation using the novel ULTC system seemed feasible without GA and enabled a >50% single-shot isolation rate. The promising safety profile has to be confirmed in large-scale studies.

Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis.

To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double ('bonus') freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98-1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53-0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37-1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double ('bonus') freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696).

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation.

AIMS: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). METHODS AND RESULTS: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. CONCLUSIONS: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

Tissue oedema following pulsed field ablation recognized during a concomitant left atrial appendage closure procedure: a case report.

Background: In patients with non-valvular atrial fibrillation (AF), at high stroke risk, and who are ineligible for long-term oral anticoagulation, the left atrial appendage closure (LAAC) could be an alternative to anticoagulation. Pulsed field ablation (PFA) is a new non-thermal method for cardiac ablation modality based on high-voltage electrical energy for irreversible electroporation. We first report a case of a concomitant PFA pulmonary vein isolation (PVI) and LAAC. Case summary: A 74-year-old female patient was referred to our department for PVI for persistent AF (CHA2DS2-VASc score 5). A concomitant percutaneous LAAC was proposed because of a history of previous cerebellar transient ischaemic attack despite continuous oral anticoagulation therapy. Pulmonary vein isolation was achieved with a pentaspline PFA catheter, and LAAC was performed with a WATCHMAN FLX™ device (Boston Scientific, Plymouth, MN, USA). After PVI, a swelling of the left atrial ridge was observed, yet a 27 mm LAAC device was successfully implanted. The follow-up transesophageal echo (TEE) after 6 weeks showed complete resolution of the oedema, no device-related thrombus, but a slight proximal tilting of the LAAC device without leakage could be observed. The 6-month follow-up demonstrated a stable sinus rhythm, no stroke, or bleeding events were recorded. Discussion: In this case of synchronous PFA-PVI procedure in AF and WATCHMAN FLX™ device implantation, the electroporation created an acute oedema at the ridge level which at the TEE follow-up after 6 weeks was resolved. This resulted in a slightly tilted WATCHMAN device position which was nevertheless stable and showed no leakage.

Severe ST-segment elevation and AV block during pulsed-field ablation due to vasospastic angina - a novel observation.

Catheter ablation of atrial fibrillation using non-thermal electroporation represents a promising ablation modality due to its believed superior safety profile. Still, if electroporation is delivered in proximity to a coronary artery, vasospasms can occur. We report the first case of severe right coronary artery vasospasm resulting in ST-segment elevation and AV block despite a remote distance from the ablation site to the right coronary artery, indicating a different mechanism. In this case, electroporation most likely triggered a previously unknown Prinzmetal vasospastic angina in the patient, resulting in the coronary vasospasm. Thus, meticulous monitoring of ST-segment changes following PFA delivery even from regions remote to coronary arteries is required.

Hot or cold? Feasibility, safety, and outcome after radiofrequency-guided versus cryoballoon-guided left atrial appendage isolation.

Background: Left atrial appendage (LAA) isolation (LAAI) has been described as an adjunctive ablation strategy for patients with recurrent atrial tachyarrhythmia (ATa). Objectives: We compared the clinical impact of persistent durable LAAI between radiofrequency (RF)-guided wide-area LAAI and cryoballoon (CB)-guided ostial LAAI. Methods: Consecutive patients who underwent RF- or CB-guided LAAI were retrospectively analyzed. RF-guided LAAI was performed by combining linear ablation. CB-guided LAAI was performed by LAA ostial ablation. Following LAAI, the patients underwent an invasive remapping study. LAA closure was conducted if persistent durability was confirmed. The procedural data, LAAI durability, and ATa recurrence were assessed. Results: A total of 260 patients (RF: n = 201; CB: n = 59) undergoing LAAI were identified. The acute rate of procedural LAAI was higher in the CB group (CB:94.9% vs. RF:82.6%, p = .02) with a lower pericardial effusion incidence (CB:0% vs. RF:7.5%, p = .03). The 6-week durable LAAI was similar between the two groups (RF:78.3% vs. CB:66.0%, p = .103). During follow-up, one gastrointestinal bleeding and four stroke events including one subsequent intracranial bleeding leading to death occurred in the RF group, while one gastrointestinal bleeding occurred in the CB group.The 1-year ATa recurrence-free rate was higher in patients with durable LAAI following RF-guided LAAI (RF:76.3% vs. CB:56.7%, p = .0017). Multivariate analysis revealed RF-guided LAAI as a predictor of freedom from ATa recurrence (HR: 0.478, 95%CI: 0.336-0.823, p = .017). Conclusions: LAAI can be more readily and safely achieved by CB-guided ostial ablation. In patients with confirmed LAAI, however, the freedom from ATa recurrence was higher after RF-guided wide-area isolation.

Current Status of Atrial Fibrillation Ablation with Balloon Strategy.

Catheter ablation of atrial fibrillation (AF) has been established worldwide and is recommended for symptomatic paroxysmal AF patients according to international guidelines. Importantly, the cornerstone of any AF ablation represents pulmonary vein isolation (PVI). Traditional radiofrequency (RF) point by point ablation within a 3D electroanatomic left atrial (LA) map requires profound understanding of LA anatomy and electrophysiology. This ablation strategy can be highly efficient and safe if performed in experienced hands and centers. However, procedural complexity causes a long learning curve and has limited its wide spread utilization. In contrast, balloon based PVI ablation strategies are based on an anatomic principle. Currently, two balloon types (cryoballoon and laserballoon) have been adopted to clinical routine. Both balloons are positioned at the target PV and circumferential energy ablation is enabled. This simplified anatomic approach facilitates reaching the procedural endpoint of PVI and demonstrated less operator dependency. Therefore, balloon PVI appears to be associated with improved procedural reproducibility and safety. Importantly, large scale randomized trials proved non-inferiority of balloon guided AF ablation (cryothermal and laser energy) vs. experienced operators using traditional "gold standard" RF ablation in paroxysmal and persistent AF. Ongoing technological refinements of both balloons as well as the introduction of novel energy dosing strategies and ablation targets may potentially impact the current way of ablating AF in future. This review will summarize current clinical experience of contemporary balloon devices and will look into future developments.

Remote-controlled magnetic ablation of a right anterolateral accessory pathway - the superior caval vein approach.

OBJECTIVE: An 18-year old male patient with recurrent supraventricular tachycardias was admitted for catheter ablation. Baseline ECG was consistent with right anterolateral accessory pathway (AP) conduction. MATERIALS AND METHODS: The novel magnetic navigation system (MNS, Niobe Stereotaxis) in combination with a catheter advancer unit (Cardiodrive, Stereotaxis) allows a complete remote-controlled electrophysiologic study and ablation. RESULTS: Despite accurate identification of the AP insertion site using the MNS, a stable catheter position was not achieved from the inferior caval vein. Therefore, the venous access was switched to the superior caval vein approach using the left subclavian vein. The same magnetic field vector now resulted in a perfectly stable catheter position, and application of radiofrequency current immediately blocked AP conduction. CONCLUSION: This case demonstrates feasibility and safety of a complete remote-controlled ablation of a right-sided anterolateral accessory pathway using the superior approach in conjunction with the novel magnetic navigation system Niobe.

Remote-controlled catheter ablation of accessory pathways: results from the magnetic laboratory.

AIMS: This study evaluates feasibility, safety, and efficacy of magnetic remote-controlled accessory pathway (AP) ablation. METHODS AND RESULTS: The novel magnetic navigation system (MNS) (Niobe, Stereotaxis) creates a steerable magnetic field (0.08 T) controlling the distal magnetic tip of an ablation catheter. In conjunction with a catheter advancer system (Cardiodrive, Stereotaxis) remote catheter ablation is enabled. Conventional electrophysiology study identified AP conduction in 59 patients (37 males, 36+/-14 years, 60 APs). First generation 1-magnet tip (1-M) (group I, n=18), second generation bipolar 3-magnet tip (3-M) (group II, n=27), and third generation quadripolar 3-magnet tip catheters (3-M quad.) (group III, n=14) were used for magnetic remote-controlled ablation. Successful AP ablation was achieved in 67% (group I), 85% (group II), and 92% (group III). A significant decrease of median [IQR: Q1-Q3] fluoroscopy time and dosage was observed: 21.2 [12.1-33.8] min, 1110 [395-3234] microGym2 (group I); 6.5 [4.4-15.4] min, 290 [129-489] microGym2 (group II), and 4.9 [3.4-8.0] min, 129 [74-270] microGym2 (group III). Mean procedure time (217+/-67 min; 182+/-68 min, and 172+/-90 min) significantly decreased in group III. Median number [Q1-Q3] of radiofrequency current applications in groups I, II, and III was 4 [2-9], 4 [2-6], and 2 [2-4], respectively. No complications occurred. CONCLUSION: Remote AP ablation is safe and feasible using the novel MNS. Introduction of the 3-magnet quadripolar ablation catheter significantly improved the efficacy of the procedure.