Transient Phrenic Nerve Palsy Research Articles

Feasibility and efficacy assessment of a novel size-adjustable cryoballoon for ablation of atrial fibrillation in a multicenter clinical setting

Abstract Background The POLARx-FIT cryoballoon (CB) system introduces a unique feature, allowing the selection of two distinct balloon sizes within a single catheter. This innovation holds promise for treating larger pulmonary veins (PV), providing increased flexibility to achieve optimal occlusions. However, there is a scarcity of clinical data supporting its application in this context. Purpose To compare the benefits and safety of the new POLARx-FIT system to those of the existing POLARx system currently in use for PV isolation (PVI) in patients with atrial fibrillation (AF). Methods The first 140 consecutive patients who underwent CB-based PVI with the POLARx-FIT system were retrospectively compared with 300 consecutive patients treated with the POLARx system. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. In the POLARx-FIT group the choice of balloon size (28 or 31 mm) was determined during the procedure while attempting to occlude each vein. Results Two-thousand one-hundred fifty-five cryo-applications (CBA) from 440 patients were analysed (300, 68.2% POLARx; 140, 31.8% POLARx-FIT). PVI was achieved with cryoablation only in all patients. The mean number of freeze applications per patient was similar between groups (5.0±1.4 in the POLARx-FIT vs 5.3±1.8 in the POLARx group, p=0.207) whereas the number of PVs treated in a single-shot fashion was higher in the POLARx-FIT group (444, 80.7% with one shot; 75, 13.7% with 2 shots; 31, 5.6% with more than 2 shots) than in the POLARx one (1168, 70.2% with one shot, p=0.0002; 294, 17.7% with two shots and 143, 8.6% with more than two shots). Among the POLARx-FIT cases, in 54.2% (n=298) of applications, the 31-mm diameter was employed as a first choice, while in the remaining 45.8% (n=252) of applications, the 28-mm diameter was adopted. A switch to a different balloon diameter was applied in 11.6% of cases. The first pass isolation (i.e. a single shot CBA to achieve PVI) was slightly higher when using a 31 mm diameter (n=250, 83.9%) than a 28 mm diameter (n=194, 77.0%, p=0.05). Three (0.7%) transient phrenic nerve palsy were observed (all in the POLARx group, 0.9%, p=0.554), with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, this novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. The intraprocedural flexibility of balloon size contributed to its versatility, leading to a variation in balloon diameter in about 12% of freeze applications.

Real-world evidence demonstrates an appropriate atrial fibrillation population for hybrid convergent approach versus stand-alone cryoballoon ablation: A long-term safety and efficacy study.

A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.

One shot "fire & 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 < 0.008)]. The DAP (dose area product) was lower in RFB Group [7 Gy*cm2 ( 5-10) vs CB Group 11 ( 7-18), p<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

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<0.001). Total radiation dose (447.4±485.0 vs. 133.9±166.2 mGy, p<0.001) and contrast administration (131.8±28.3 vs. 40.8±26.5 ml, p<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.

Impact of pulmonary vein variant anatomy during cryo-ablation in paroxysmal and persistent AF patients: 1-year outcome from a nationwide multicenter clinical setting

Abstract Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). While contrast findings exist regarding the influence of variant pulmonary vein (PV) anatomy on predicting AF recurrence, limited data are currently available specifically for cases involving the POLARx cryoablation system during PVI. Purpose We report the real-world experience of POLARx in the context of de novo AF ablation in a multicenter Italian registry. Methods Consecutive patients undergoing AF ablation from the CHARISMA registry at 10 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. All patients were followed-up for at least 12 months after the procedure. Results Four-hundred twenty-nine patients were included (n=358, 83.4% paroxysmal AF, n=71, 16.6% persistent AF, mean age 60.7±10 years, 28.3% female, mean LVEF 58±8%). PVI was achieved in all pts using only cryoablation. Twenty-eight (6.6%) patients exhibited an anatomical variant: 17 (4.0%) a common ostium and 11 (2.6%) an adjunctive PV. The mean number of freeze applications per patient was 5.1 (1.2 for LSPV, 1.3 for LIPV, 1.2 for RSPV and 1.3 for RIPV). Over a median of 398[370-461] days of follow-up, 14 (3.2%) patients experienced an early recurrence of AF during the 90-day blanking period. Overall, 63 patients (14.7%) suffered an AF recurrence after the 90-day blanking period (median time to recurrence 342[171-381] days). The proportion of patients exhibiting AF/AT recurrences was higher in the persistent AF group (17 out 71, 23.9%) than in the paroxysmal AF group (46 out 358, 12.8%, p=0.026), with a hazard ratio of 2.02 (95%CI: 1.2 to 3.5, p=0.0137) whereas patients with anatomy variant showed a similar AF/AT recurrence rate (5 out 28, 17.9%) than in the standard anatomy group (58 out of 401, 14.5%) with a hazard ratio of 1.43 (0.6 to 3.6, p=0.441). Four (0.9%) transient phrenic nerve palsy were observed, both with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported. Conclusion In this multicenter study, the cryo-balloon system demonstrated safety and efficacy in treating both paroxysmal and persistent AF patients, yielding a low incidence of AF/AT recurrence during follow-up, regardless of the presence of variant PV anatomy.

Association between body mass index and results of cryoballoon ablation in Korean patients with atrial fibrillation: an analysis from the Korean Heart Rhythm Society Cryoablation registry.

Pulmonary vein isolation using cryoablation is effective and safe in patients with atrial fibrillation (AF). Although both obesity and underweight are associated with a higher risk for incident AF, there is limited data on the efficacy and safety following cryoablation according to body mass index (BMI) especially in Asians. Using the Korean Heart Rhythm Society Cryoablation registry, a multicentre registry of 12 tertiary hospitals, we analysed AF recurrence and procedure-related complications after cryoablation by BMI (kg/m2) groups (BMI < 18.5, underweight, UW; 18.5-23, normal, NW; 23-25, overweight, OW; 25-30, obese Ⅰ, OⅠ; ≥30, obese Ⅱ, OⅡ). A total of 2648 patients were included (median age 62.0 years; 76.7% men; 55.6% non-paroxysmal AF). Patients were categorized by BMI groups: 0.9% UW, 18.7% NW, 24.8% OW, 46.1% OI, and 9.4% OII. Underweight patients were the oldest and had least percentage of non-paroxysmal AF (33.3%). During a median follow-up of 1.7 years, atrial arrhythmia recurred in 874 (33.0%) patients (incidence rate, 18.9 per 100 person-years). After multivariable adjustment, the risk of AF recurrence was higher in UW group compared with NW group (adjusted hazard ratio, 95% confidence interval; 2.55, 1.18-5.50, P = 0.02). Procedure-related complications occurred in 123 (4.7%) patients, and the risk was higher for UW patients (odds ratio, 95% confidence interval; 2.90, 0.94-8.99, P = 0.07), mainly due to transient phrenic nerve palsy. Underweight patients showed a higher risk of AF recurrence after cryoablation compared with NW patients. Also, careful attention is needed on the occurrence of phrenic nerve palsy in UW patients.

Efficiency and safety in AF ablation using a novel loop-shaped cryoablation catheter

Abstract Background Different single shot ablation systems are under development to improve the efficiency and safety of pulmonary vein isolation for the treatment of atrial fibrillation (AF). Purpose Evaluation of effectiveness and safety of a novel cryoloop catheter (figure 1) for pulmonary vein isolation. Methods In a single centre prospective registry, patients with drug-refactory AF underwent pulmonary vein isolation (PVI) using a novel loop-shaped cryoablation catheter. For efficiency assessment the following parameters were registered: 1: the number of successfully isolated pulmonary veins (PV) confirmed by entrance- and exit block; 2: total procedure time, left atrial dwell time, total cryoablation time and applications as well as total fluoroscopy time; 3: freedom from atrial arrhythmia after 6 months. For safety assessment the following parameters were studied: 1: periinterventional adverse events like pericardial effusion, thromboembolic events and bleedings according to BARC classification; 2: endoscopic detected esophageal lesions (EDEL); 3: phrenic nerve palsy; 4: computed tomography angiography (CTA) detected PV stenosis until 6 months after PVI. Results In total, 25 subjects were enrolled in the current registry and received PVI with the loop-shaped cryoablation catheter. In terms of efficiency, successful acute PVI could be achieved in 91/100 treated PVs. Total procedure, atrial dwell, cryoablation and total fluoroscopy times were 130.5 ± 24.2 min, 101.4 ± 19.8 min, 40.8 ± 11.0 min and 22.5 ± 5.5 min, respectively. On average, 4.5 cryoenergy applications per PV were required for acute PVI. Out of the blanking period of 3 months, after 6 months 18/25 subjects (72%) were free from any atrial arrhythmia. With respect to safety, no pericardial effusion, thromboembolic event or bleeding complication occurred. 2/25 subjects experienced a transient phrenic nerve palsy. Additionally, no EDEL or PV stenosis could be detected. Conclusion The present single centre registry confirmed the effectiveness and safety of the novel loop-shaped cryoablation catheter for the treatment of atrial fibrillation.Figure 1: cryoloop catheter

Pulmonary vein anatomy evaluated prior to atrial fibrillation ablation through multicentre electronic medical records: clinical decision support from a real-world multicentre observational study

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulmonary vein (PV) isolation is a cornerstone ablation strategy in the management of patients with atrial fibrillation (AF). PV frequently display anatomical variants, which may compromise the results of cryoballoon ablation (CBA). Purpose We aimed to determine PV variation patterns in real-world patients undergoing CBA for AF and their impact on procedural success using a multicentre electronic medical records (Casiopea) sharing cardiac computed tomography (CT) scan studies performed in the referring centres and evaluated prior to the procedure in the EP reference hospital. Methods We included consecutive patients with paroxysmal or persistent AF who referred for CBA to a EP reference hospital in Spain from 2017 to 2021. All patients underwent systematic standardized CBA. Prior to the procedure, PV variation and left atrium (LA) size were evaluated in all patients by CT- scan. Blinded data were analysed by a imaging Core Lab. PV and LA anatomy were evaluated in 3-dimensional reconstructions using EnSite NavX electroanatomic mapping system. Ablation procedure was performed using either 23 or 28 mm cryoballoon according to the operator's criteria and potential predictors for AF recurrence were recorded. Results 104 patients were included (mean age 58±8 year-old, 85% male). 76 patients (73%) had recurrent paroxysmal AF, failure of antiarrhythmic drugs was present in 96% and prior radiofrequency ablation in 4%. Conventional PV anatomy consisting in 4 veins was present in 83 patients (80%), left or right common vein in 13 (13%) and accessory veins in 8 (7%). Figure. 61 patients (59%) showed left atria enlargement (&amp;gt; 40 mm or area &amp;gt; 20 cm2). CBA was performed using a 28 mm cryoballoon in 98 patients (94%). Temperature achieved during ablation was below -40°C in all the veins in 80% of the procedures. Procedural-related complications occurred in 6 patients (5%), transient phrenic nerve palsy in 2 patients and vascular damage in 4. All patients were under antiarrhythmic drugs and continued for at least 6 months after the procedure. After 19±9 months of follow-up, freedom from AF recurrence after the blanking period was 73%. Univariate analyses identified the following baseline characteristics predicted AF recurrence: prior ablation (OR = 3.6 p=0.03; 95% CI 1.1-12.3), complete PV isolation with temperature below -40°C (OR = 0.16 p = 0.001; 95% CI 0.05-0.48) and AF recurrence during the blanking period (OR = 6.3, p &amp;lt;0.001; 95% CI 2.9-13.8). PV anatomy was not a limitation nor a predictor for AF recurrences in the long-term follow-up (OR = 0.56 p = 0.17; 95% CI 0.24-1.28). Conclusion This evaluation of multicentre electronic medical records sharing CT scan studies prior CBA showed that the procedure was safe and effective with regard to the PV anatomy. The presence of anatomical variants of PV should not discourage about efficacy and it is not a limitation for CBA.

Pulsed field ablation based pulmonary vein isolation utilizing a simplified approach

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulsed field ablation (PFA) is a novel non-thermal energy source with promising safety and efficacy advantages compared to standard ablation technologies. Purpose We aimed to develop a safe, effective and fast pulmonary vein isolation (PVI) utilizing a single shot PFA catheter via a single femoral vein puncture and a venous closure system approach. Methods Forty-eight consecutive AF patients underwent first-time PVI via PFA under deep sedation. A single ultrasound guided femoral vein puncture and a single transseptal puncture was utilized for left atrial access. After pulmonary vein (PV) angiography eight pulse trains (2kV/2.5 sec, bipolar, biphasic, each 4x basket/flower configuration) were delivered to each PV. Extra pulse trains in the flower configuration (8x) were added to the posterior wall for very wide antral circumferential ablation (vWACA). Continuous intraluminal esophageal temperature (TESO) was monitored with a s-shaped esophageal temperature probe. A venous closure system was utilized on the single access site. A Donati suture was performed. The pressure bandage was removed after 1h. Results Patients (mean age: 64 +/-11 years) presented with AF (paroxysmal 58% or persistent AF (42%). A total of 192 PV were identified and isolated via PFA (100%). A mean of 40 pulse trains for PVI and vWACA have been used. The mean procedural time was 27 +/- 7 minutes, the mean catheter dwell time was 14 +/- 6 minutes and the median fluoroscopy time was 6 +/- 2 minutes. No relevant esophagus temperature rise occurred. One patient (2%) experienced a transient phrenic nerve palsy which recovered until the end of the procedure. Two patients (4%) experienced a superficial bleeding which was treated by a figure of eight suture. No severed hematoma, transfusion or intervention was necessary. No pericardial effusion or tamponade occurred. Conclusion The combination of a single vein single transseptal puncture approach resulted in a 100% rate of acute PVI and an extraordinary fast procedure and dwell time. The rate of periprocedural complications was low.

An international two-centre experience with the third generation laser balloon system: safety, efficiency, and efficacy

Abstract Funding Acknowledgements Type of funding sources: None. Background Endoscopic laser balloon systems (ELBS) are a new tool for pulmonary vein isolation (PVI). The third generation ELBS underwent significant structural improvements compared to its predecessors. These include a novel feature (RAPID mode), potentially allowing an automized and high-speed circumferential energy delivery for PVI. However, there is a lack of data on its use. Objective We analyzed the safety, efficiency, and efficacy of the third-generation ELBS in a cohort of patients who underwent ablation of atrial fibrillation in a German and an Italian centre. Methods We prospectively enrolled all consecutive patients who underwent PVI using the third-generation ELBS between June 2019 and November 2022. All the procedures were performed by four operators. For each pulmonary vein (PV), we always attempted to obtain a complete circumferential lesion using only the RAPID mode. When this was not feasible, the operator treated the remaining gaps with point-by-point laser delivery. Results We included 163 patients in our study (mean age 61.9 ± 11.4, persistent atrial fibrillation 30.6%, female patients 30.6%). The operators identified and successfully isolated 655 pulmonary veins. There was an anatomical variation of the PVs in 41 (25.1%) patients, of whom 19 had either a left or a right common trunk, and 23 had a supernumerary right PV. 424 PVs (64%) were isolated for at least 80% of their circumference using the RAPID mode, 389 (59.4%) were treated using it for a minimum of 90% of their circumference, and finally, 289 (44%) were isolated using only RAPID. The operators could perform the procedure using only the RAPID mode in 35 (21.5%) patients. We observed a mean total procedural and fluoroscopic times of 95.7 ± 44.5 min and 13.9 ± 8.4, respectively. 5 (3%) periprocedural complications occurred. There were three episodes of transient phrenic nerve palsy (the most extended episode resolved two months after discharge). One episode of pericardial tamponade occurred, with a subsequent need for pericardiocentesis. Finally, there was one periprocedural transient ischaemic attack (TIA). During energy delivery, eight pinhole balloon ruptures occurred. Eighty-five patients were followed up for at least six months (mean follow-up 12.2 ± 4.4 months). Among these, 26 (30.5%) presented a recurrence after the blanking period. Among baseline features, persistent AF was not a predictor of recurrence. Conclusion This is one of the largest cohorts of patients treated with third-generation ELBS. In our two-centre experience, the system proved efficient, safe, and effective and the RAPID mode showed good applicability.

PO-04-060 FOUND WITH SOUND: INTRACARDIAC ECHOCARDIOGRAPHY CORRELATED WITH MEDIUM-OUTPUT PACING TO AVOID PHRENIC NERVE INJURY WITH RIGHT ATRIAL ABLATION

Catheter ablation within the right atrium can be limited by proximity to the phrenic nerve and potential for hemi diaphragmatic paralysis. High output pacing is frequently employed to map phrenic position relative to endocardium, particularly in relation to the superior vena cava and the right superior pulmonary vein. The use of intracardiac echocardiography (ICE) in correlation with lower output pacing to rigorously map the course of the right phrenic nerve along the right atrium has not been previously described. We describe a case of incessant right atrial tachycardia successfully mapped and ablated close to the phrenic nerve using a combination of ICE imaging and medium-output pacing to rigorously map the phrenic nerve. n/a An 18-year-old man with incessant atrial tachycardia was referred for repeat ablation following unsuccessful attempt at ablation at an outside institution. Prior ablation was limited by proximity to the phrenic nerve and transient phrenic nerve palsy with cryoablation at the mid crista terminalis. Epicardial access to deflect the phrenic nerve was anticipated. Atrial tachycardia was mapped endocardially prior to obtaining epicardial access. An ICE catheter was advanced to the SVC and used to identify the phrenic nerve. The course of the phrenic nerve was rigorously mapped with ICE and integrated into the CARTO navigational system (Biosense Webster). Pacing along the course of the phrenic nerve was performed at 10 mA to further refine the course of the phrenic nerve within the SVC and right atrium. Regions in close anatomic proximity to the phrenic nerve with loss of pace-capture correlated with sites of physiologic effusion, where pericardial fluid was concentrated and separation of the phrenic nerve from the visceral epicardium was noted. After mapping the phrenic nerve, endocardial ablation of atrial tachycardia was successfully performed in the absence of phrenic nerve injury without the need for epicardial access. Phrenic nerve injury may be prevented by rigorous mapping of the phrenic nerve within the right atrium using intracardiac ultrasound with medium-output pacing.

Abstract 11905: Dexmedetomidine for Sedation During Epicardial Ablation for Ventricular Tachycardia: A Single-Center Experience

Introduction: Epicardial ablation of ventricular tachycardia (VT) is mainly performed under general anesthesia (GA). However, GA lowers blood pressure, may interfere with arrhythmia induction, and the use of muscle relaxants precludes identification of the phrenic nerve. Moreover, an anesthesiologist's is required during GA for the whole procedure, which may not always be possible. Hypothesis: The aim of there study was to evaluate the feasibility and safety of epicardial VT ablations under conscious sedation using dexmedetomidine. Methods: Between 2018 and 2022, all patients who underwent epicardial VT ablation under dexmedetomidine infusion were prospectively enrolled. All patients received premedication with paracetamol 1 g (acetaminophen 10 mg/ml) and ketorolac 30 mg. Sedation protocol included an i.v. bolus of midazolam (0.03-0.05 mg/kg) followed by continuous infusion of dexmedetomidine (0.2-0.7 mcg/kg/h). In addition, an i.v. fentanyl bolus (0.7-1.4 mcg/kg) was given for short-term analgesia, followed by a second dose after 30-45 minutes. Sedation-related complications were: hypoxia (S02&lt;90%), severe hypotension (MAP&lt;60 mmHg), and bradycardia (HR &lt;45 b/m). Results: Seventy-one patients with drug-refractory recurrent VT underwent epicardial or endo-epi ablation under conscious sedation. Standard percutaneous sub-xiphoid access was attempted in all patients. in 2 patients the procedure was switched to GA because of intractable pain during epicardial catheter's manipulation. Data from 69 patients were analyzed. Mean age was 65.4±12.1 years and 66.6% of patients were males. Forty-seven patients (68.1%) had non-ischemic cardiomyopathy, 13 patients (18.9%) had ischemic-cardiomyopathy, and 9 patients (13%) had myocarditis. Procedural-related complications occurred in five patients (7.2%), one transient phrenic nerve palsy, two pericarditis, and two vascular complications. No severe adverse events related to the sedation occurred. Conclusions: Prompt availability of anesthesia support remains crucial for epicardial VT ablation. Continuous infusion of dexmedetomidine in addition to midazolam and fentanyl seems to be a safe and effective sedation protocol in patients undergoing epicardial VT ablation.

Protocolized nurse-guided intravenous conscious sedation for cryoballoon ablation of paroxysmal and persistent atrial fibrillation

Abstract Background Nursing staff is playing an increasingly important role in arrhythmia units and it entails acquiring more specialized knowledge. Intravenous conscious sedation is being administered more frequently in a wide variety of cardiac procedures including cryoballoon ablation (CBA). Nurses and physicians have distinct yet collaborative roles in the management and care of the patient receiving conscious sedation. It is imperative that the nurse be aware of her/his role in caring for the patient before, during, and after the administration of intravenous conscious sedation. Purpose We aimed to evaluate the nurse's role, working in coordination with the medical staff, in intravenous conscious sedation for CBA following a standardized protocol ensuring proper handling and administration of the different drugs, monitorization of vital signs and management of drug infusion in order to avoid pain but also complications inherent to the procedure and sedation. Method We included consecutive patients with paroxysmal or persistent AF who underwent a CBA from 2017 to 2021. We evaluated a nurse-guided sedation, under medical surveillance, in CBA procedures using propofol. The dosage was based on the patient's weight, starting sedation with a bolus of 1 ml (1% solution) for every 20 kg of weight, and starting a perfusion at 10 ml/h (2% solution), monitoring constantly patient's vital signs, especially blood pressure and O2saturation. This infusion was adjusted according to the patient's response. During the procedure, on a stable hemodynamic situation, booster bolus of 1 ml (1% solution) could be administered approximately every 15 minutes when needed for sedation. When systolic blood pressure was under 100 mmHg, a solution of midazolam (1mg/ml) and fentanyl (0.05mg/ml) in a mixture of 1cc + 1cc was preferred as booster. Saline and colloid solutions andephedrine (30mg/ml) bolus could be used when severe hypotension to revert propofol's hypotensive effect. Systematic standardized CBA was performed and intraprocedural and periprocedural complications were recorded. Results 104 patients were included (mean age 58±8 year-old, 85% male). Of these patients, 76 (73%) had recurrent paroxysmal AF, failure of antiarrhythmic drugs was present in 96% and prior radiofrequency ablation in 4%, 61 (59%) showed left atria enlargement (&amp;gt;40 mm or area &amp;gt;20 cm2), and 11 (10%) had structural heart disease. Mean CHA2DS2VASc score was 1. Baseline characteristics in Table 1. Procedural-related complications occurred in 6 patients (5%), transient phrenic nerve palsy in 2 patients and vascular damage in 4. All sedations were performed without complications. Conclusions In our experience, protocolized nurse-guided intravenous conscious sedation under medical surveillance in CBA procedures is safe and really useful. It contributes to help medical operators to focus on the procedure sharing the patient's sedation management with trained nurses. Funding Acknowledgement Type of funding sources: None.

Dexmedetomidine for sedation during epicardial ablation for ventricular tachycardia: a single-center experience.

Epicardial approach to ventricular tachycardia (VT) ablation is mainly performed under general anesthesia (GA). Although catheter manipulation and ablation in the epicardial space could be painful, GA lowers blood pressure and may interfere with arrhythmia induction and mapping, and the use of muscle relaxants precludes identification of the phrenic nerve (PN). Moreover, an anesthesiologist's presence is required during GA for the whole procedure, which may not always be possible. Therefore, we evaluated the feasibility and safety of epicardial VT ablations performed under conscious sedation using dexmedetomidine in our center. Between January 2018 and January 2022, all patients who underwent epicardial VT ablation under continuous dexmedetomidine infusion were prospectively included in the study. All patients received premedication 30min before the epicardial puncture with paracetamol (acetaminophen 10mg/ml) 1000mg and ketorolac 30mg. Sedation protocol included an intravenous bolus of midazolam hydrochloride (0.03-0.05mg/kg) followed by continuous infusion of dexmedetomidine (0.2-0.7 mcg/kg/h). In addition, an intravenous fentanyl citrate bolus (0.7-1.4 mcg/kg) was given for short-term analgesia, followed by a second dose repeated after 30 to 45min. Sedation-related complications were defined in case of respiratory failure, severe hypotension, and bradycardia requiring treatment. Sixty-nine patients underwent epicardial or endo-epi VT ablation under conscious sedation and were included in the analysis. The mean age was 65.4 ± 12.1years; forty-six patients were males (66.6%). All patients had drug-refractory recurrent VT. Forty-seven patients (68.1%) had non-ischemic cardiomyopathy (NICM), 13 patients (18.9%) had ischemic-cardiomyopathy (ICM), and 9 patients (13%) had myocarditis. Standard percutaneous sub-xiphoid access was attempted in all patients. Non-inducibility of any VT was achieved in 82.6% (9/9 myocarditis, 10/13 ICM, 38/47 NICM, n = 57/69 patients), inducibility of non-clinical VT in 13% (3/13 ICM, 6/38 NICM, n = 9/69 patients), and failure in 4.3% (3/38 NICM, n = 3/69 patients). Although we observed procedural-related complications in five patients (7.2%), one transient PN palsy, two pericarditis, and two vascular complications, those were not related to the conscious sedation protocol. No respiratory failure, severe hypotension, or bradycardia requiring treatment has been observed among the patients. Prompt availability of anesthesiology support remains crucial for complex procedures such as epicardial VT ablation. Continuous infusion of dexmedetomidine and administration of midazolam and fentanyl seem to be a safe and effective sedation protocol in patients undergoing epicardial VT ablation.

Efficacy and safety of cryoballoon pulmonary vein isolation for paroxysmal and persistent atrial fibrillation: A comparison with radiofrequency ablation

BackgroundCryoballoon ablation was established as an effective and safe modality to achieve pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). However, its role in persistent atrial fibrillation (PersAF) remains unclear.ObjectiveThis study aimed to evaluate the efficacy and safety of cryoballoon PVI in PAF and PersAF comparing conventional radiofrequency catheter ablation (RFCA).MethodsTwo hundred patients undergoing cryoballoon ablation for symptomatic AF were consecutively enrolled in this retrospective study. For comparison, 210 patients undergoing RFCA in the same period were included. The primary outcome was a recurrence of any atrial tachyarrhythmias (ATas) after the index ablation. 12-lead ECG and 24-hour Holter monitoring were obtained at 1,3,6 and 9–12 months.ResultsPVI by cryoablation alone was achieved in 197 patients (98.5%). ATas-free survival at 12 months post-ablation was 72.7% in the cryoablation and 80.6% in the RFCA group (P = 0.123), respectively. The cryoablation showed comparable efficacy maintaining sinus rhythm compared with RFCA in PAF (P = 0.539), whereas in PersAF, ATas-free survival was significantly lower in cryoablation (P = 0.039). PV reconnection was observed in the majority of patients (14/16, 87.5%) who receive redo RFCA. Complications were encountered in 10 patients, including femoral arteriovenous fistula (n = 1), transient phrenic nerve palsy (n = 8), and minimal amount pericardial effusion (n = 1).ConclusionThe efficacy of cryoballoon PVI is comparable with conventional RFCA in PAF, whereas PVI alone using cryoballoon may not be insufficient to maintaining sinus rhythm in PersAF. The safety of cryoballlon PVI is tolerable.

Local Infiltration Analgesia Versus Interscalene Block for Pain Management Following Shoulder Arthroplasty: A Prospective Randomized Clinical Trial.

While providing effective analgesia following shoulder arthroplasty, an interscalene block has known complications. Local infiltration analgesia (LIA) using ropivacaine has been successfully employed in other joint arthroplasties, but its efficacy in shoulder arthroplasty has not been studied extensively. The purpose of this study was to compare pain and opioid consumption between LIA and an interscalene block following shoulder arthroplasty. Patients undergoing primary shoulder arthroplasty were prospectively randomized into 2 groups: the block group received an interscalene block using liposomal bupivacaine, and the injection group received an LIA injection intraoperatively. The LIA injection included ropivacaine, epinephrine, ketorolac, and normal saline solution. Postoperative visual analog scale pain scores, opioid consumption in morphine milligram equivalents, and complications were compared between the groups. The mean pain scores during the first 24 hours postoperatively were used to test noninferiority of LIA compared with an interscalene block. The study included 74 patients (52 men and 22 women with a mean age of 69 years; 37 were in the injection group and 37 in the block group). There was no significant difference between the groups with respect to pain scores at any postoperative time points (p > 0.05), except for the 8-hour time point, when the injection group had a significantly higher pain score than the block group (p = 0.01). There was no significant difference in opioid consumption between the groups at any time points postoperatively (p > 0.05). The amount of intraoperative opioid consumption was significantly higher in the injection group (p < 0.001). In noninferiority testing for the mean pain scores during the first 24 hours, the injection group was found to be noninferior to the block group. One patient in the block group developed transient phrenic nerve palsy. One patient in the injection group developed dislocation after reverse arthroplasty related to noncompliance. The mean procedure hospital charge was $1,718 for an interscalene block and $157 for LIA. LIA and an interscalene block provided similar analgesia during the first 24 hours after primary shoulder arthroplasty. LIA was associated with worse pain at 8 hours postoperatively and more intraoperative opioid consumption but was also substantially less costly. Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Novel cryo-balloon technology for a successful pulmonary vein isolation: acute outcome and follow-up from a large multicenter Italian clinical setting

Abstract Funding Acknowledgements Type of funding sources: None. Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). Recently, a new cryoablation system (POLARx) with unique features has been made available for clinical use. To date, limited data exist on acute and follow-up outcome of this system in a multicentric clinical practice. Purpose We reported the preliminary experience of this novel technology in a multicenter Italian registry. Methods Consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 6 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred &amp;gt;60 sec or when time to isolation (TTI) was not available. The ablation endpoint was PV isolation as assessed by entrance and exit block. Rhythm monitoring during the follow-up examinations was performed via the clinical assessment of AF recurrence, ECG and Holter monitoring, according to the clinical practice of each center. All patients were followed-up for at least 6 months after the procedure. Arrhythmia recurrences within the first 3 months (blanking period) were classified as early recurrences and were not considered procedural failures Results Six-hundred twenty-four cryoapplications from 112 pts (439 PVs) were analyzed (n=89, 79.5% paroxysmal AF, n=23, 20.5% persistent AF, mean age 61.5±9 years, 76% male, 22% with an history of AT, mean LVEF 49±10%). PVI was achieved in all pts using only cryoablation. The mean number of freeze applications per pt was 5.6±2.1 (1.4±1.2 for LSPV, 1.5±1.1 for LIPV, 1.3±0.8 for RSPV and 1.3±0.8 for RIPV), with 318 (72.4%) PVs treated with a single cryoablation (92, 21% with 2 cryoablation; 29, 6.6% with more than 2 cryoablations). Fourty-four (39.3%) pts were treated with a single application to each of the PVs. Over a median of 296[245 to 382] days of follow-up, five (4.5%) patients experienced an early recurrence of AF/AT during the 90-day blanking period. Overall, 12 patients (10.7%) suffered an AF/AT recurrence after the 90-day blanking period (median time to recurrence 200[124 to 297] days). Specifically, 8 (7.1%) patients had AF recurrence only, 3 (2.7%) had AT recurrence only and 1 (0.9%) experienced both events. One (0.9%) patient underwent a repeated ablation procedure. The proportion of patients exhibiting AF/AT recurrences was similar between AF types (10 out 89, 11.2% for paroxysmal AF vs 2 out 23, 8.7% for persistent AF, p=1.00) with a hazard ratio of 0.9 (95%CI: 0.2 to 3.9, log-rank p=0.8894). One transient phrenic nerve palsy was observed, with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported. Conclusion In this first multicentric experience, the novel cryo-balloon system proved to be safe and effective and resulted in a very low rate of AF/AT recurrence during follow-up.

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

Abstract Funding Acknowledgements Type of funding sources: None. Introduction To facilitate atrial fibrillation (AF) ablation procedures there is a variety of approaches for pre-procedural imaging of pulmonary veins (PV) and left atrium (LA), including CT angiography and cardiac MRI. Intra-procedural three-dimensional rotational angiography (3DRA) is the least employed method and it can be advantageous regarding efficiency and procedural logistics. Data supporting different practices is still evolving and there is an open question whether LA imaging could improve safety and outcomes of 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 101 patients (65.3% male, 59.3±11.5 years) with paroxysmal (92%) and early-persistent AF. Patients were randomized 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. All patients are followed for 1 year and data concerning procedural characteristics, safety outcomes and AF recurrence are being collected. Results Of all the patients recruited, 48 (47%) underwent 3DRA. In patients who received no imaging (non-3DRA group) one PV couldn’t be isolated while in 3DRA group isolation of one PV could not be achieved in 3 patients (OR 3.47, 95% CI 0.35-34.51). The occurrence of left common PV, an anatomical variation that could have potential to influence results, was similar in both groups (25,4% in non-3DRA and 25.0% in 3DRA group). Procedure time was significantly longer when 3DRA was performed (87.4±27.7 min compared to 69.9±23.0 in non-3DRA group, p&amp;lt;0.001). Total radiation dose (148.2±177.7 vs 387.7±203.8 mGy, p&amp;lt;0.001) and contrast administration (42.5±27.1 vs 133.8±26.8 ml, p&amp;lt;0.001) were significantly lower in the control group. Only minor complications were reported in both groups. Three patients developed large haematoma (2 in 3DRA group vs 1 in control group). In each group there was one incident of transient phrenic nerve palsy. Conclusion 3DRA is a safe and efficient intra-procedural imaging method to guide CB ablation for 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. One-year follow up data is still being collected and will subsequently be presented.

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

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. To describe the initial clinical experience when using ULTC in the AF treatment without general anesthesia (GA). 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. A total of 27 AF patients (67% paroxysmal AF) were analyzed. Onehundredfour 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 superiorto 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. 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-scalestudies.

Redo surgery for neurogenic thoracic outlet syndrome is useful

ObjectivesSurgery for neurogenic thoracic outlet syndrome (NTOS) has shown good outcome in numerous case series. However, 5% to 30% of patients will have persistent or recurrent symptoms, caused by incomplete first rib resection, reattachment of residual scalene muscle, fibrous scarring around the brachial plexus, or a wrong NTOS diagnosis. In patients with a sound diagnosis of recurrent or persisting NTOS, not responding to conservative measures, a secondary procedure can be considered. We report the results of redo thoracic outlet decompression surgery through the supraclavicular approach (SC-REDO-TOD) for persistent or recurrent NTOS. MethodsA retrospective review of a prospective database was performed. Every patient referred from September 2016 until January 2020 was eligible for inclusion. In an SC-REDO-TOD, we perform complete (cartilage-cartilage) resection of the first rib, any bony and fibrous anomalies, complete anterior and middle scalenectomy, and complete neurolysis of the brachial plexus (complete anatomical decompression of the brachial plexus). Clinical outcomes were assessed by questionnaires including the Disability of Arm, Shoulder and Hand (DASH), Cervico-Brachial Symptoms Questionnaire (CBSQ), and TOS (thoracic outlet syndrome) Disability scale. ResultsIn total, 45 patients had a SC-REDO-TOD. The median duration of hospital admission after SC-REDO-TOD was 1.41 days (interquartile range, 1.00 day). In total, 30 (66.66%) of 45 patients had recurrent NTOS, and 15 (33.33%) of 45 patients had persisting NTOS. Postoperative complications were seen in eight patients (18.18%). One patient had postoperative complications with permanent impairment (Horner syndrome). Seven patients had postoperative complications with full recovery (three patients had a chylous leakage that was treated with a median-chain triglycerides diet for 6 weeks, three patients had transient phrenic nerve palsy with full recovery <6 weeks, and one patient had a discrete Horner syndrome that resolved in 6 weeks). The median time of follow-up was 19.50 months (interquartile range, 14.00 months) and the response rate to the questionnaires was 91.11% at 6 months and 64.44% at 12 months. We found a positive and statistically significant difference for DASH score, CBSQ score, and TOS Disability Scale score comparing scores for all patients. (DASH score: P < .001; CBSQ score: P < .001; TOS Disability Scale: P < .001). Patients with first rib remnants showed a significant better response (lower DASH, CBSQ and TOS Disability Scale scores) compared with patients without first rib remnants (DASH score: P = .004; CBSQ score: P ≤ .014; TOS Disability Scale: P = .009). ConclusionsSC-REDO-TOD after a previous NTOS surgery shows good results with a low risk of permanent impairment. Patients with NTOS with first rib remnants after primary surgery seem to benefit the most from SC-REDO-TOD surgery.