Phrenic Research Articles

Efficacy and Safety of Laser Balloon Versus Irrigated Radiofrequency Ablation as Initial Therapies for Atrial Fibrillation: A Meta-Analysis.

Catheter ablation (CA) is an effective therapy for atrial fibrillation (AF) and, although radiofrequency ablation (RFA) is the standard treatment for pulmonary vein isolation (PVI), it is complex and time-consuming. Laser balloon ablation (LBA) has been introduced to simplify the conventional RFA; however, results of studies comparing LBA and RFA remain controversial. As such, this investigation aimed to comprehensively evaluate the efficacy and safety of LBA versus RFA. The PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched for relevant studies. The primary endpoints were the freedom from atrial tachyarrhythmia (ATA) and procedure-related complications. Twelve studies including 1274 subjects were included. LBA and RFA yielded similar rates of freedom from ATA (72.5% vs. 68.7%, odds ratio [OR] = 1.26, 95% confidence interval [CI] 1.0-1.7, p = 0.11) and procedure-related complications (7.7% vs. 6.5%, OR = 1.17, 95% CI 0.72-1.90, p = 0.536). LBA with the second- and third-generation laser balloons (LB2/3) yielded remarkably higher rates of freedom from ATA than RFA using contact-force technology (RFA-CF) (OR = 1.91, p = 0.013). Significantly lower pulmonary vein (PV) reconnection rates (OR = 0.51, p = 0.021), but higher phrenic nerve palsy (PNP) rates (OR = 3.42, p = 0.023) were observed in the LBA group. LBA had comparable procedure (weighted mean difference [WMD] = 8.43 min, p = 0.337) and fluoroscopy times (WMD = 3.09 min, p = 0.174), but a longer ablation time (WMD = 12.57 min, p = 0.00) than those for RFA. LBA and RFA treatments were comparable in terms of freedom from ATA and postprocedural complications in patients with AF. Compared with RFA, LBA was associated with significantly lower PV reconnection rates, but a higher incidence of PNP and longer ablation time.

Fluoroscopic sniff test as a diagnostic tool for phrenic nerve injury in patients with traumatic brachial plexus injury

OBJECTIVE Traumatic brachial plexus injury (BPI) is a high-morbidity condition with an escalating incidence. One of the treatment options is neurotization using the ipsilateral phrenic nerve. Therefore, diagnosis of nerve dysfunction is a crucial step in preoperative planning. This study aimed to assess the accuracy and reliability of the fluoroscopic sniff test for preoperative diagnosis of phrenic nerve injury in patients with traumatic BPI. METHODS The study was conducted from June 2019 to August 2023 at a tertiary care hospital. A preoperative fluoroscopic sniff test was performed. During brachial plexus surgery, direct phrenic nerve stimulation was conducted as a gold standard of phrenic nerve function. Two nonoperating orthopedic surgeons interpreted the accuracy and reliability of the test. RESULTS Seventy-four patients with traumatic BPI (66 males and 8 females) with a median age of 26 years were enrolled. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the fluoroscopic sniff test were 90.9% (95% CI 75.7%−98.1%), 100% (95% CI 91.4%−100%), 100% (95% CI 88.4%−100%), 93.2% (95% CI 82.3%−97.6%), and 95.9% (95% CI 88.6%−99.2%), respectively. Interobserver reliability showed excellent agreement (κ = 1, p < 0.001). CONCLUSIONS The fluoroscopic sniff test was proven to be an accurate, reliable, and simple tool to evaluate phrenic nerve function in patients with traumatic BPI. Preoperative testing should be performed to reduce operative time to identify the phrenic nerve as a donor for nerve transfer surgery in cases in which no function is detected from the fluoroscopic sniff test.

Surgical treatment of thymic epithelial tumors: a narrative review.

Thymic epithelial tumors (TETs) are scarce neoplasms of the prevascular mediastinum. Included in this diverse category of lesions are thymomas and thymic carcinomas (TCs). Surgery is the mainstay of treatment of tumors that are deemed resectable. However, up till now, optimal surgical access has been a subject of debate. The advent of new techniques, such as video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS), challenged the median sternotomy which was traditionally considered the access of choice. This review aims to demonstrate the current evidence concerning the surgical treatment of TET and to enlighten other controversial issues about surgery. PubMed research was conducted using the terms [surgery] AND [thymic epithelial tumors] OR [thymomas] and [surgical treatment] AND [thymic epithelial tumors] OR [thymomas]. Papers concerning pediatric cases and non-English literature papers were excluded. Individual case reports were also excluded. Minimally invasive surgical techniques (MIST) such as VATS and RATS are increasingly applied in early-stage TET. Although numerous published studies have demonstrated better perioperative outcomes in early-stage TET, long-term follow-up data are still required to demonstrate the oncological equivalent of MIST to open surgery. Resection of stage III TET is more challenging. Thymectomy can be expanded en bloc to include the major vascular structures, lung, pleura, phrenic, or vagus nerve in these individuals. There is no agreement on the ideal surgical access and traditionally these patients underwent open sternotomy, sometimes combined with a thoracic access. Evidence concerning the treatment of stage IVA disease is mainly derived from retrospective case series which are highly heterogeneous in terms of the number of enrolled patients, histology, degree of pleural involvement, and timing of presentation. New techniques in the field of minimally invasive surgery are gaining acceptance for early-stage TET but longer follow-up periods are warranted to prove their oncological outcomes. On the contrary, these techniques should be used cautiously in case of locally advanced tumors. Surgeons must not forget that the main objective is the complete resection of the lesion, which is one major predictive factor for increased survival.

Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial

IntroductionSingle-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel pulsed-field ablation (PFA) device (FARAPULSE, Boston Scientific) has been introduced with the aim to improve procedural safety and efficacy. ObjectiveThis study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF. MethodsSINGLE SHOT CHAMPION is a multicentre, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor (ICM) is performed in all patients. ResultsThe primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the ICM within 91 and 365 days post-ablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity Troponin on day 1 post-ablation, (2) analysis of post-ablation 3D electro-anatomical mapping (first 25 patients per study group), (3) AF burden, and (4) quality of life changes ConclusionSINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.

Association of Paroxysmal Versus Persistent Atrial Fibrillation with In-hospital Outcomes and 30-day Readmission After Inpatient Atrial Fibrillation Ablation.

Knowledge of the impact of paroxysmal and persistent atrial fibrillation (AF) after catheter ablation on in-hospital outcomes and 30-day readmission remains limited. This study aimed to evaluate the procedural outcomes and 30-day readmission rates among patients with paroxysmal or persistent AF who were hospitalized for AF ablation. Using the Nationwide Readmissions Database, our study included patients aged ≥18 years with AF who were hospitalized and underwent catheter ablation during 2017-2020. Then, we compared the in-hospital procedural outcomes and 30-day readmission rates between patients with paroxysmal and persistent AF, respectively. Our study included 7310 index admissions for paroxysmal AF ablation and 9179 index admissions for persistent AF ablation. According to our analysis, there was no significant difference in procedural complications-namely, cerebrovascular accident, vascular complications, major bleeding requiring blood transfusion, phrenic nerve palsy, pericardial complications, and systemic embolization-between the persistent and paroxysmal AF groups. There was also no significant difference in early mortality between these groups (0.5% vs. 0.7%; P = .22). Persistent AF patients had significantly higher rates of prolonged index hospitalization (9.9% vs. 7.2%; P < .01) and non-home discharge (4.8% vs. 3.1%; P < .01). The 30-day readmission rates were comparable in both groups (10.0% vs. 9.5%; P = .34), with recurrent AF and heart failure being two of the most common causes of cardiac-related readmissions. Catheter ablation among hospitalized patients with paroxysmal or persistent AF resulted in no significant difference in procedural complications, early mortality, or 30-day readmission. This suggests that catheter ablation of AF can be performed with a relatively similar safety profile for both paroxysmal and persistent AF.

Bilateral Diaphragm Paralysis in Deep Neck Infection: Mimicking Respiratory Distress in Sepsis

Background: This case report highlights an occurrence of bilateral diaphragm paralysis following surgical drainage for deep neck infection. Case: A 56-year-old male underwent surgical drainage and tracheostomy for a deep neck infection. Before the second surgical drainage, he exhibited tachypnea (&gt;30 bpm), although his general condition was not significantly compromised. Following a successful drainage procedure, he was transferred to the intensive care unit and placed on mechanical ventilation. Despite attempts at spontaneous breathing trials (SBT), he failed each trial, leading to a deterioration in his general condition. Subsequently, he was diagnosed with diaphragm paralysis. Conclusion: The clinical manifestations of bilateral diaphragm paralysis closely resemble the common symptoms of sepsis. Therefore, it is crucial to recognize that surgical interventions for deep neck infections may pose a risk of developing diaphragm paralysis, likely associated with phrenic nerve palsy.

양측 성대 마비의 치료

Laryngeal reinnervation has been investigated as a treatment option for bilateral vocal fold paralysis (BVFP) that can restore laryngeal function while preserving laryngeal anatomy. Traditionally, BVFP treatment involves irreversible structural changes to the larynx, such as tracheostomy, arytenoidectomy, or cordectomy, which often result in impaired voice and swallowing. In contrast, laryngeal reinnervation aims to restore laryngeal muscle tone and function by providing new neural input to the paralyzed larynx. Reinnervation techniques can be broadly categorized into non-selective and selective methods. Non-selective reinnervation, such as recurrent laryngeal nerve (RLN) end-to-end anastomosis or ansa cervicalis-to-RLN anastomosis, primarily focuses on maintaining muscle bulk and tone. Selective reinnervation techniques, including nerve-muscle pedicle with the ansa cervicalis, selective reinnervation using the phrenic nerve, and bilateral selective laryngeal reinnervation, aim to restore both abduction and adduction function of the larynx. This review summarizes the current laryngeal reinnervation techniques for BVFP treatment.

Transient phrenic nerve stimulation in a patient with single chamber pacemaker: case report

The article presents a clinical observation of a patient with episodes of phrenic nerve stimulation after inadvertent permanent ventricular pacing from the middle cardiac vein. The methods of early diagnosis of this complication and techniques for its prevention are described.

Safety and efficacy of very high-power short ablation in superior vena cava isolation in patients with atrial fibrillation

Abstract Backgrounds The superior vena cava (SVC) plays an important role in non-pulmonary vein (PV) foci to trigger atrial fibrillation (AF) and thus are occasionally isolated. A major complication in SVC isolation is phrenic nerve injury, and a shallower ablation depth might be less likely to cause complications. Recently, very high power short ablation (vHPSD) has been demonstrated to be effective in PV isolation. On the other hand, vHPSD has been reported to have shallower depth than the low-power ablation strategies, suggesting concerns about insufficient ablation in thicker myocardial sites. The vHPSD might be effective and safe in SVC isolation thinner than myocardium, however, the details were not elucidated. Purpose This study was aimed to examine the safety and efficacy of vHPSD strategy in SVC isolation, compared retrospectively with low power ablation strategies. Methods Patients with AF who were undergoing first-time SVC isolation were included. An activation map was performed from the SVC to the right atrium during sinus rhythm, and a circumferential isolation line was designed by the CARTO system at a height of 1.5cm above the earliest site. The site and extent of capture of the phrenic nerve by pacing on the circumferentially designed ablation line were recorded. The first step was to perform circumferential ablation except for the sites where the phrenic nerve was captured. If the SVC isolation was completed, the procedure was completed. If the isolation was inadequate, the sites of capture of the phrenic nerve were also ablated. Two groups of patients were analyzed: those performing vHPSD (n=27, vHPSD group) with a power of 90 watts for 3 seconds or those using lower-power (n=20, LP group) limited to 20-40 watts. Results Forty-seven patients who underwent the initial SVC isolation were evaluated. We analyzed all 351 points in the vHPSD group and all 364 points in the LP group with ablation of SVC. No differences were found in the distance of the SVC circumference on the isolation line (vHPSD: 71±10 vs. LPLD: 71±11mm, p=0.95) or the extent of phrenic nerve capture (12±7 vs. 12±9mm, p=0.82). All patients in the vHPSD group were successfully isolated first-pass; the first-pass isolation rate tended to be higher than in the LP group (100% vs. 85%, p=0.07). Differences were observed in temperature rise (49±4 vs. 28±4 degrees, p&amp;lt;0.001) and impedance drop (12±4 vs. 7±5Ω, p&amp;lt;0.001), although there were no differences in the contact force (15±8 vs. 15±7g, p= 0.73). The vHPSD group achieved SVC isolation with a shorter procedure time (9±4 vs. 17±5 min, p&amp;lt;0.001) and fewer ablation points (13±4 vs. 18±4, p&amp;lt;0.001) compared to the LP group. In the vHPSD cases, ATP was administered after isolation, but no dormant conduction was observed. Only in one case in the LP group, transient phrenic nerve injury was observed. Conclusion The vHPSD for SVC isolation might be safe and result in shorter procedure time and fewer ablation points.

Superior vena cava isolation in paroxysmal atrial fibrillation - mind the phrenic

Abstract Background Pulmonary vein isolation (PVI) is the standard of care for patients with atrial fibrillation (AF), but medium-term success rates are far from ideal. Therefore, new methods are being developed, with emphasis on ectopic foci outside the pulmonary veins. Superior vena cava (SVC) is one of the most important non-pulmonary origins of AF and some studies suggested that empiric SVC isolation could improve outcomes in ablation of paroxysmal atrial fibrillation (PAF). Although complications have been reported in SVC ablation, most studies found complication rates of SVC ablation similar to conventional cryoballoon PVI. Aim This prospective, single-center study aimed to assess the complication rate and success rate of PVI followed by SVC isolation by cryoballoon application in comparison with conventional cryoballoon PVI. Methods We designed an unblinded, randomized clinical trial and recruited consecutive patients with PAF who were randomized to a conventional cryoballoon PVI or PVI and additional SVC cryoballoon isolation using single 180 s freeze. Results A total of 140 patients (61.4% male, mean age 62.1 years) with PAF were included and 67 (47.9%) were randomized to SVC isolation in addition to conventional ablation. Planned 180-s freeze in the SVC could be completed in 15 (22.4%) patients, while 27 (40.3%) patients received at least 120-s freeze. The mean time to SVC isolation was 40.2 ± 37.9 s. Real-time recording of SVC isolation was observed in 39 (58.2%) patients. Right phrenic nerve palsy (PNP), impending or transient, occurred in 6 (8.2%) patients in the PVI-only group and in 25 (37.3%) patients in the SVC-group (Chi-square test p &amp;lt; 0.001). There were no persistent PNP cases. Bradycardia or junctional rhythm was observed during a procedure in 15 (22.4%) patients who received SVC isolation. One patient eventually received a permanent AAI pacemaker due to a sinus node injury. Conclusion Our data suggest that SVC isolation can be successfully achieved in the majority of PAF patients using conventional cryoballoon. However, this significantly increases the rate of transient or impending PNP and sinus node injury in comparison to conventional cryoballoon PVI. Therefore, careful phrenic nerve function monitoring and attention to sinus bradycardia or junctional rhythm are important to mitigate this risk. Follow-up data are being collected to determine whether this risk could be outweighed by a lower rate of PAF recurrence.

Comparative analysis of pulsed-field and cryoballoon ablation in octogenarians with atrial fibrillation: a multicenter study

Abstract Background The prevalence of atrial fibrillation (AF) increases with advancing age, and AF contributes to higher rates of stroke, dementia, heart failure, and mortality. Catheter ablation is recognized as an effective treatment for AF; however, data regarding its efficacy in octogenarians are limited. Cryoballoon ablation (CBA) has been reported to be safe and effective in this age group. Recently, single-shot devices using pulsed-field energy have been developed, offering a tissue-specific effect. However, data on the safety and effectiveness of this novel pulsed-field ablation (PFA) in octogenarians are still insufficient. Purpose This study aims to evaluate the procedural outcomes and complications of PFA in octogenarians with AF, in comparison to CBA, from 3 high-volume European centers. Methods We retrospectively enrolled patients who underwent PFA via the FarapulseTM system from January 2022 to June 2023, and those who underwent second-generation CBA from January 2015 to June 2023. Results A total of 176 patients (PFA group: 63, CBA group: 113) were included. The PFA group had a higher proportion of patients with persistent AF (p=0.03) and undergoing a repeat procedure (p&amp;lt;0.01). (Table 1) Unlike CBA, PFA procedures involved additional extrapulmonary targets, such as posterior wall and mitral isthmus. Nonetheless, procedure time was similar between groups. There were no significant differences in complications but phrenic nerve palsy was not observed in the PFA group (Table 2). Conclusions PFA for octogenarians provides the possibility to target additional extrapulmonary sites with equivalent procedural times and safety compared to CBA, without the concern of phrenic nerve palsy.Table 1Table 2

Pulsed field ablation of atrial fibrillation using a large area focal catheter with a novel contact detection algorithm. A first-in-human experience using the QuickShot catheter

Abstract Background/Introduction Pulsed field ablation (PFA) is emerging as a safe and effective alternative energy modality for cardiac ablation. Data have shown that while tissue contact is critical for PFA, the amount of contact force is less important. Single-shot catheters have shown comparable results to current thermal methods for pulmonary vein isolation (PVI), however, are limited to anatomical-based ablation strategies and have limited ability to detect tissue contact. The investigational QuickShot™ large-area focal catheter (Galvanize Therapeutics, Redwood City, CA) combines high-density mapping with large-area focal ablation guided by contact detection. Purpose The QuickShot PEF-AF study was a prospective, single-arm, first-in-human study performed at a single European center to evaluate the safety and performance of the QuickShot catheter (see Figure 1, panel A) combined with the CE-marked CENTAURI™ System (Galvanize Therapeutics, Figure 1, panel B) for catheter ablation of atrial fibrillation (AF). Methods Subjects with paroxysmal or persistent AF underwent a PVI procedure under deep sedation (fentanyl, midazolam, propofol) guided by Rhythmia™ HDx (Boston Scientific, Marlborough, MA, Figure 1, panel D). Irrigation was set to a constant 6 mL/min during the procedure. Focal, monopolar, biphasic PFA lesions were delivered asynchronously at 33 Amps and a 10 mm inter-lesion spacing (center to center with 10 mm lesion tag size). Catheter-tissue contact was confirmed by ICE/fluoroscopy and a novel impedance-based contact detection system (Figure 1, panel C). The acute performance endpoint was PVI, assessed by entrance and exit block using high-density mapping. Procedural safety assessments included microbubble detection via ICE, induction of VT/VF, muscle stimulation, phrenic nerve function, and NIHSS post-procedure. Results Twenty (20) subjects (60% PAF, 60 ± 12 years, 75% male, 4.3 ± 0.52 cm LA AP diameter) were enrolled and treated. Acute PVI was achieved in 100% of patients and targeted PVs (82/82), with first-pass isolation in 88% of targeted PVs. The PVI time was 31 ± 10 min with 46.7 ± 11.4 PFA applications. There were no device- or procedure-related adverse events, and no documented incidence of microbubble formation, arrhythmia induction, muscle stimulation, phrenic nerve dysfunction, esophageal injury, or change in NIHSS post-procedure. Conclusion The QuickShot catheter enables safe and effective large-area focal PFA for subjects requiring PVI. The catheter design enables efficient and flexible focal lesion placement with the ability to ensure adequate apposition to targeted tissues using its novel contact detection algorithm. Future studies will investigate the use of this novel catheter for PFA strategies beyond PVI.

Patient-tailored low-voltage-guided ablation of atrial fibrillation: initial experience using a novel ultra-low-temperature cryoablation system

Abstract Introduction The ideal ablation strategy for patients (pts) with persistent atrial fibrillation (PersAF) is still debated. In recent randomized studies, strategies of ablating electrically abnormal atrial regions in addition to pulmonary vein isolation (PVI) have shown promise, and a novel ultra-low-temperature cryoablation (ULTC) system might overcome the limitations of radiofrequency (RF) energy to create transmural lesions in diseased tissue. Purpose Aim of this study is to report procedural aspects, acute efficacy, and safety of our initial experience in treating AF pts with this novel ULTC system. Methods Patients scheduled for catheter ablation who had a high likelihood of having left atrial (LA) low voltage zones (LVZ) underwent ablation with the ULTC system. A detailed high-density LA 3D-electronatomical map was created in sinus rhythm using a multi-electrode catheter. Bipolar LVZs were defined as at least 1cm2 surface of bipolar voltage &amp;lt;0.5mV. The ablation strategy consisted of PVI and linear ablation of the LVZs, transecting (if narrow) or isolating (if broad) the areas of abnormal signals and anchoring these lines to electrically silent structures (PVs or mitral valve ring). Electrical isolation and block across linear ablations were tested as universally accepted. Continuous variables are expressed as median (and interquartile ranges). Results From April to September 2023, 25 pts (10 female) were included (see table for patients´ and procedural characteristics). Procedure duration was 210 (135-270) min, and diminished over time from initially (in the first 12 pts) 260 (203.75-302.50) min to 190 (135-235) min (p=0.047). PVI was achieved in 15/18 pts (83%) using the ULTC, in the remaining 3 pts RF energy touch-up was needed. Linear ablation and isolation of LVZs were always (41/41 in 22pts, 100%) successfully achieved with the ULTC (see figure for an example). Except for 1 right phrenic nerve palsy, no major acute complications were observed. Post-procedural chest pain was not reported by any patient, in 1 patient mild pericardial effusion was detected and treated conservatively. During the 48h post-procedural ECG-monitoring, no sustained atrial arrhythmias occurred. Conclusions This is the first report of patient-tailored low-voltage-guided AF-ablation using a novel ULTC system. Despite representing our initial clinical experience, acute efficacy was very good (95% of acute bidirectional block across lines). Procedure-duration decreased over time, indicating an initial learning curve. Acute safety was reassuring but particular attention should be paid for phrenic nerve function during ablation of the right PVs. The absence of post-procedural pain, pericardial effusion, or acute post-procedural arrhythmias indicates limited ablation-induced inflammation.Result of ULTC ablation in a diseased LA

Effectiveness of a novel integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures

Abstract Background In cryoballoon ablation (CBA) procedures, left atrial (LA) access is generally achieved using a standard sheath and needle system that is exchanged for the cryoballoon delivery sheath and dilator over a long wire. Sheath exchange has been related with air embolic events in CBA procedures. A novel integrated dilator-needle system, that can be combined with the cryoballoon delivery sheath allowing direct LA transseptal access, was recently introduced. Figure. Objective The purpose of this study is to evaluate the efficacy and safety of this new integrated transseptal access tool compared with the traditional approach in CBA procedures. Methods In this prospective single-center study, consecutive patients who underwent AF CBA procedures were randomly assigned 1:1 to undergo traditional transseptal access (t-TSA) or integrated transseptal access (i-TSA). Patients with foramen ovale or interatrial communication, detected on transesophageal echocardiogram prior to the procedure, were excluded. Transseptal access time was defined as time from superior vena cava to LA insertion of the cryoballoon delivery sheath, after sheath exchange (t-TSA) or directly (i-TSA). Results We evaluated 82 patients (63 males, mean age 59 ± 10 years) indicated to CBA of atrial fibrillation, 42 patients underwent t-TSA and 40 i-TSA. The baseline characteristics of the study population were comparable between groups. Table. Mean CBS transseptal access time was 5 min 6 sec ± 2 min 5 sec in the t-TSA group and 3 min 5 sec ± 2 min 23 sec in the i-TSA group, P &amp;lt; 0.001. Challenging interatrial septa were noted in 3 patients: 1 in t-TSA (1 aneurysmal/elastic) and 2 in i-TSA group (1 lipomatous hypertrophy, and 1 abnormally thickened/fibrotic). No acute complications related to transseptal access were noted in both cohorts. The CBA procedure time and fluoroscopy time were lower in the i-TSA group. Table. There were 1 temporary phrenic nerve injury and 1 vascular complication, both in the t-TSA group. Importantly, no signs of clinical air embolism were noted in both groups. Conclusion This is the first randomized study comparing the traditional approach and the use of a new integrated dilator-needle system. Transseptal crossing in CBA procedures using this integrated tool enables a safe and more efficient workflow, reducing time for transseptal access and avoiding sheath exchange.FigureTable

Long-term follow-up of pulmonary vein cryoballoon isolation using a double 120s vs single 240s standard freeze protocol

Abstract Background Recently, pulmonary vein isolation (PVI) using a double 120s freeze protocol has demonstrated to be non-inferior to a single 240s protocol despite a potentially increased procedural safety. Main advantages of a double 120s protocol are a reduction of phrenic nerve injury and an increase of the mean minimal esophageal temperature during the procedure. Methods We performed a long-term follow-up comparison between groups of patients with history of symptomatic atrial fibrillation undergoing PVI with second generation cryoballoon (CB) between 2019 and 2020. Our usual energy dosing protocol was modified including 2 times 120 seconds applications instead of a single 240 seconds application. Of A total of 160 consecutive patients, 80 were treated with double 120s (CB120) and 80 with single 240s (CB240) freeze protocol. 107 patients were, successfully, followed-up. The primary end-point was freedom from atrial tachyarrhythmia. Results Before PVI a total of 11/52 patients (21%) had persistent AF and 41/52 (79%) had paroxysmal AF in the CB120 group; a total of 20/55 patients (36%) had persistent AF and 35/55 (64%) had paroxysmal AF in the CB240 group. On a mean follow-up time of 17 months, freedom from atrial tachyarrhythmia was 63% in those patients undergoing CB240 and 74% with CB120 (log-rank P=0.255). Conclusions The double 120s freeze protocol is not-inferior as compared to the standard 240s in terms of freedom from recurrences on a long term follow-up, but with a more favorable procedural safety profile.

Intra-procedural three-dimensional rotational angiography in cryoballoon ablation of atrial fibrillation - results from a randomised clinical trial

Abstract Introduction There are a variety of approaches for pre-procedural imaging to facilitate atrial fibrillation (AF) ablation. Intra-procedural three-dimensional rotational angiography (3DRA) is the least employed method and it can be advantageous regarding efficiency and procedural logistics (1). There is an open question whether LA imaging could improve safety and outcomes of cryoballoon (CB) ablation. Purpose The aim of this study is to evaluate possible benefits of 3DRA for procedural success, safety and long-term outcomes of CB ablation. Methods We designed a single-centre unblinded randomised clinical trial and recruited 134 patients (64.2% male, 59.0±11.6 years) with paroxysmal (93.3%) and early-persistent AF. Patients were randomised to no imaging or 3DRA which was performed intra-procedurally after trans-septal puncture. Angiographic images were segmented and overlaid to the fluoroscopy screen to guide the ablation procedure. Patients were scheduled for follow-up visits and twenty-four hour ECG recordings at 3, 6 and 12 months, and every 6 months thereafter. Results Of all the patients recruited, 66 (49.3%) were randomised to 3DRA and angiography was successfully performed in all but one patient (1.5%). Procedure time was significantly longer when 3DRA was performed (86.7±27.8 min compared to 67.2±22.1 in non-3DRA group, p&amp;lt;0.001). Total radiation dose (447.4±485.0 vs. 133.9±166.2 mGy, p&amp;lt;0.001) and contrast administration (131.8±28.3 vs. 40.8±26.5 ml, p&amp;lt;0.001) were significantly higher in the 3DRA group (Table 1). In patients who received no imaging one pulmonary vein (PV) couldn’t be isolated in 2 patients while this occurred in 3 patients in the 3DRA group (OR 1.57, 95% CI 0.25-9.72). Only minor complications were reported in both groups. Five patients developed large haematoma (4 in the 3DRA group vs. 1 in the control group). In each group there were 3 incidents of impending or transient phrenic nerve palsy. During 12 months of follow-up, 88.2% of patients in the control group and 81.8% in the 3DRA group were free of atrial fibrillation (OR 1.67, 95% CI 0.63-4.38). Two patients from the control group developed atrial flutter and were treated by ablation. In total, 10 patients underwent redo procedures (7 in the control and 3 in the 3DRA group respectively) and PV reconnections were detected in 9 cases. Conclusion 3DRA is a safe and efficient intra-procedural imaging method to guide CB ablation of AF. However, it significantly increases procedure duration, total radiation dose and contrast expenditure. In our trial it did not have any impact on the acute success rate of PV isolation or freedom from atrial fibrillation during 12-month follow-up.

Radiofrequency balloon ablation: 1-year outcomes of the AURORA registry

Abstract Background and Objectives A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into 3D mapping system was recently launched. Methods Patients ablated for paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (persAF) at two German high-volume electrophysiology centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180 and 360 days following ablation including 24h Holter ECGs. Results A total of 101 patients were enrolled (50 from centre A, 51 from centre B) and 86 patients (48% male, 65 ± 11 years, 55% PAF, 59 ± 7% left ventricular ejection fraction (LVEF)) completed the follow-up. Mean ablation and procedure times were 26 ± 13 min and 71 ± 20 min, respectively. Dose area product was 1501 ± 1634 mGycm2. Acute PVI was achieved in 100%. Atrial fibrillation (AF) free survival after a mean FU of 361 (219-375) days was 78.4% for PAF and 75.4% for persAF. (p= 0.828). A multiple regression analysis did not reveal any clinical or procedural predictors of AF recurrence among sex, age, BMI, left atrial diameter, LVEF, ablation time, procedure time and single shot PVI. However, early recurrence of atrial tachyarrhythmia (ERAT) was an independent predictor for AF recurrence at 1-year (Hazard Ratio [HR]: 3.198; 95% confidence interval [95% CI]: 1.036 - 10.32, p value = 0.0433). Primary adverse events occurred in 3.5% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke or phrenic nerve paralysis were observed. Conclusions RFB-based PVI is clinically effective and safe. ERAT at the first follow-up visit is an independent predictor of late AF recurrence.

One shot "fire &amp; ice"

Abstract Introduction Pulmonary vein isolation (PVI) is the best and first strategies during ablation of atrial fibrillation (1-4). Short- and long-term effectivity as well as procedure time are important parameters during PVI-ablation. New efforts are made to find longer effectivity, low risk of the procedure and shorter procedure. Purpose The aim of our study is to compare the two "balloon - one shot" methods (radiofrequency balloon "RFB" and cryoballoon "CB") in terms of speed, efficacy and safety. Methods Prospective, randomized, pilot single-center trial including 74 consecutive patients with paroxysmal, persistent or long lasting persistent atrial fibrillation who undergo for the first time PVI-ablation between December 2022 and October 2023. Patient were randomized 1:1 according type of AF, Sex, Hypertension, left ventricular ejection fraction e left atrial volume in a multi-electrode radiofrequency balloon catheter Heliostar ablation or in cryoballoon system ablation. Both groups had comparable clinical characteristics. Results Median Age of the population was 64 year (iq range 57-70), 19 were female (25,7%), 31 patients (42%) had paroxysmal atrial fibrillation, median EF was 60% (iq range 55-65) and median left atrial volume 36 ml/mq (iq 28-40). 37 patients undergo cryoballoon PVI and 37 patients undergo RF balloon Ablation. Compared with the RFB group, the CB group showed a shorter procedure time [65 minutes (55-75) vs. 75 minutes (65-90) (P &amp;lt; 0.008)]. The DAP (dose area product) was lower in RFB Group [7 Gy*cm2 ( 5-10) vs CB Group 11 ( 7-18), p&amp;lt;0,001]. First-pass isolation was comparable. We had 5 complications in RFB group (1 pericardial effusion without pericardiocentesis, 3 transitory ST-elevation on ECG due to air embolism, 1 transient phrenic nerve palsy) and 3 complications in CB group (3 transient phrenic nerve palsy) P=ns. During the procedures in 3 cases of RF group and in 1 case of CB group (p=ns) we had to change the balloon due to technical issues. Conclusion The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. CB has shorter procedural times but with a higher X-Ray exposure.Figure 1Figure 2

Cryoballoon ablation for atrial fibrillation in young adults: a propensity-score matching comparison with an older cohort

Abstract Background Cryoballoon ablation (CB-A) has proven to be a valid technology for achieving pulmonary vein isolation (PVI) in patients affected by symptomatic atrial fibrillation (AF). Data regarding CB-A in young adults are still scarce and mainly derived from studies performed without balancing comorbidities and echocardiographic parameters between the groups. The present study aimed to focus on the outcomes and complications of CB-A PVI in young adults (&amp;lt; 50 years) compared to a propensity score-matched population of older individuals, seeking also to understand the true role of "age" as potential risk factor for arrhythmia recurrences. Methods and results We retrospectively enrolled 172 consecutive patients aged &amp;lt; 50 years who underwent PVI employing the second-generation cryoballoon (CB-2). A 1:1 propensity score matching comparison with an older cohort of patients was performed and 290 patients (145 subjects aged &amp;lt; 50 years vs. 145 patients aged ≥ 50 years) were then selected. The mean age was 43.3 ± 4.9 years in the younger group and 64.7 ± 8.7 years in the control group (p &amp;lt; 0.001). After an overall median follow-up of 18 [12 - 29] months, the Kaplan-Meier curves showed a similar rate of freedom from arrhythmia relapses between the younger and the older cohorts (85.5% vs. 77.2% respectively, log-rank p = 0.31). The rate of major complications was low (2.8 %) and did not significantly differ between the groups, being 2.1% for the younger cohort and 3.5% for the older group (p = 0.50). Vascular complications and phrenic nerve palsy appeared to be the most common procedure-related adverse events, occurring in 8 (2.8%) patients. Arrhythmia recurrences during blanking period (ERAF) was found to be the only independent predictor of late AT/AF relapses. Conclusions Our propensity-score model demonstrates that CB-A PVI is equally safe and effective in young adults as it is in older individuals. Furthermore, our findings suggest that "age" itself does not appear to play a significant role in predicting recurrences after CB-A PVI. This result underscores the importance of controlling the modifiable risk factors (comorbidities) and emphasizes the value of early AF diagnosis and intervention.Survival Curve

Pulsed field ablation for atrial fibrillation: efficacy, safety and lesion durability in patients with recurrences

Abstract Background Initial findings from feasibility studies regarding pulsed field ablation (PFA) for atrial fibrillation (AF) indicated substantial efficacy and safety of the procedure, including high rates of lesion durability upon systematic remapping. However, data regarding PFA for AF in real-life settings remains scarce. Objective This pooled analysis was conducted to provide insights into PFA’s practical performance and safety profile in real-life settings, as well as information regarding lesion durability in patients with arrhythmia recurrences. Methods MEDLINE/EMBASE databases were searched up to August 31, 2023 for studies including patients undergoing catheter ablation for AF using PFA. Independent searches were performed by 2 investigators (K.B. and K.V.). Feasibility studies, first-in-human studies, small studies with population overlap, and those with a follow-up duration shorter than one year were excluded from the analysis. Authors were contacted for missing information or to confirm the absence of population overlap. Two investigators (K.B. and K.V.) independently extracted data from studies meeting inclusion criteria. Any discrepancies were resolved by a third experienced reviewer. Results We assessed for relevance a total of 952 references. Five studies met the inclusion criteria (comprising of 1 randomized trial, 2 single arm prospective trials, and 2 post-market registries), with a combined cohort of 2,359 patients who underwent PFA for AF. The pooled rate of acute PVI was 99.6% (95%CI 99.2-99.8, I2:7%). The pooled one-year rates of freedom from atrial arrhythmia for individuals with paroxysmal or persistent AF were 79.5% (95%CI 75.7-83.1, I2:70%) and 67.5% (95%CI 60.9-73.7, I2:60%), respectively. Among patients who underwent repeat catheter ablation for AF recurrences (n=197), the pooled rate of durable PVI per patient was 48.9% (95%CI 30.4-67.7, I2:71%), while durable PVI per vein was 74.1% (95%CI 65.1-82.2, I2: 75%). Incidence of overall complications and serious procedure-related complications were 1.8% (95% CI: 0.2-4.8, I2: 92%) and 0.9% (95% CI: 0.3-1.7, I2:59%), respectively. The most prevalent complication types were access site complications (48.6%), pericardial effusions/tamponades (24.8%) and stroke/transient ischemic attack (9.5%). No esophageal damage or PV stenosis were reported . There was one case of persistent phrenic nerve palsy and two cases of reversible coronary spasm (during ablation along the posterior mitral isthmus, and during PVI, both resolving with intracoronary nitroglycerin). Conclusion This pooled analysis confirms that catheter ablation of atrial fibrillation using pulsed field ablation is associated with high rates of atrial arrhythmia-free survival at one year while maintaining low rates of procedure-related complications. Durable pulmonary vein isolation is observed in approximately half of the patients undergoing a repeat procedure for atrial fibrillation recurrence.