Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study.

AIMS: Pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared with thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first-generation PFA systems. In this study, we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation. METHODS AND RESULTS: The VOLT CE Mark Study is a pre-market, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA system for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest computed tomography, and cerebral magnetic resonance imaging. Study endpoints were the rate of primary serious adverse event within 7 days and acute procedural effectiveness. A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed a 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 min, respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or oesophageal lesions causally related to the PFA system and three subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events. CONCLUSION: The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry.

AIMS: Phrenic nerve injury (PNI) is the most common complication during cryoballoon ablation. Currently, two cryoballoon systems are available, yet the difference is unclear. We sought to compare the acute procedural efficacy and safety of the two cryoballoons. METHODS: This prospective observational study consisted of 2,555 consecutive atrial fibrillation (AF) patients undergoing pulmonary vein isolation (PVI) using either conventional (Arctic Front Advance) (AFA-CB) or novel cryoballoons (POLARx) (POLARx-CB) at 19 centers between January 2022 and October 2023. RESULTS: Among 2,555 patients (68.8 ± 10.9 years, 1,740 men, paroxysmal AF[PAF] 1,670 patients), PVIs were performed by the AFA-CB and POLARx-CB in 1,358 and 1,197 patients, respectively. Touch-up ablation was required in 299(11.7%) patients. The touch-up rate was significantly lower for POLARx-CB than AFA-CB (9.5% vs. 13.6%, p = 0.002), especially for right inferior PVs (RIPVs). The touch-up rate was significantly lower for PAF than non-PAF (8.8% vs. 17.2%, P < 0.001) and was similar between the two cryoballoons in non-PAF patients. Right PNI occurred in 64(2.5%) patients and 22(0.9%) were symptomatic. It occurred during the right superior PV (RSPV) ablation in 39(1.5%) patients. The incidence was significantly higher for POLARx-CB than AFA-CB (3.8% vs. 1.3%, P < 0.001) as was the incidence of symptomatic PNI (1.7% vs. 0.1%, P < 0.001). The difference was significant during RSPV (2.5% vs. 0.7%, P < 0.001) but not RIPV ablation. The PNI recovered more quickly for the AFA-CB than POLARx-CB. CONCLUSIONS: Our study demonstrated a significantly higher incidence of right PNI and lower touch-up rate for the POLARx-CB than AFA-CB in the real-world clinical practice.

Can phrenic nerve injury be anticipated by larger cryoballoons?

Recently, a novel size-adjustable cryoballoon has been introduced in clinical practice, which can be inflated to two different diameters (28 and 31 mm). The 31 mm cryoballoon is specifically designed to achieve better contact with remodeled pulmonary veins (PVs) that have wider ostia while avoiding deep cannulation, thereby potentially reducing the risk of phrenic nerve injury (PNI) associated with deep balloon cannulation. However, we encountered two cases of PNI during cryoballoon ablation using the novel system among our initial 25 consecutive case series. Herein, we present two cases that exhibited PNI during freezing of the right superior PV with a size-adjustable balloon. While larger balloons are expected to create a larger area of isolation, the safety of this novel balloon system needs to be evaluated in a large-scale clinical study.

Contrast-enhanced computed tomography in the venous rather than the arterial phase is essential for the evaluation of the right phrenic nerve.

BACKGROUND: Preprocedural detection of the running course of the right pericardiophrenic bundles (PBs) is considered to be useful in preventing phrenic nerve (PN) injury during catheter ablation for atrial fibrillation (AF). However, previous studies using the arterial phase of contrast-enhanced computed tomography (CT) reported a relatively low right PBs detection rate. METHODS: This study included 63 patients with AF who underwent catheter ablation and preoperative contrast-enhanced CT imaging of the venous and arterial phases (66.7 ± 10.2 years; 44 male). The venous phase of contrast-enhanced CT significantly improved the detection rate of PBs compared to the arterial phase (96.8% vs. 60.3%, p < .001), and PBs were detected in the venous phase only in 23 (36.7%) patients. No significant differences were observed between the right PBs detection rate using non-contrast CT versus the arterial phase of contrast-enhanced CT (p = .37). Patients without visualization of the right PBs during the arterial phase had a higher frequency of chronic heart failure (p = .0083), lower left ventricular ejection fraction (p = .021), and a higher CHADS2 score (p = .048) than those with visualization. In five patients whose right PBs could only be detected during the venous phase of contrast-enhanced CT, the reconstructed running course of the right PBs corresponded with the PN generated by electrical high-output pacing. CONCLUSION: Contrast-enhanced CT images of the venous phase, rather than the arterial phase, are useful in detecting the right PBs, especially in patients with heart failure or reduced left ventricular ejection fraction.

Visualization and mapping of the right phrenic nerve by intracardiac echocardiography during atrial fibrillation ablation.

OBJECTIVE: This study aimed to evaluate the feasibility of real-time visualization and mapping of the right phrenic nerve (RPN) by using intracardiac echocardiography (ICE) during atrial fibrillation (AF) ablation. BACKGROUND: RPN injury is a complication associated with the ablation of AF. Multiple approaches are currently being used to prevent and detect RPN injuries. However, none of these approaches can directly visualize the RPN in real-time during the ablation procedure. METHODS AND RESULTS: The RPN was detected using ICE. The RPN and its adjacent structures were analysed. The relationship between the RPN's distance from the superior vena cava (SVC) and its pacing capture threshold was quantified. The safety of SVC isolation guided by the ICE-visualized RPN was evaluated. Thirty-eight people were enrolled in this study. The RPN was visualized by ICE in 92% of patients. It ran through the space between the SVC and the mediastinal pleura and had a 'straw'-like appearance upon ICE imaging. The course of the RPN was close to the SVC (minimum 1.0 ± 0.4 mm) and the right superior pulmonary vein (minimum 14.1 ± 7.3 mm). There was a positive linear correlation between the RPN's capture threshold and its distance from the SVC (Spearman's correlation coefficient = 0.728, < 0.001). SVC isolation was guided by the RPN; none of the patients developed an RPN injury. CONCLUSIONS: RPN can be visualized by ICE in most patients, thus providing a novel approach for the real-time detection of RPN during AF ablation.

The phrenic nerve; the forgotten nerve in head and neck surgery.

BACKGROUND: Neck dissection is a commonly performed procedure for oncologic control of head and neck malignancy. With contemporary modified radical and selective neck dissections, haematoma, wound infection, tissue necrosis, chyle leak and injury involving the marginal mandibular, hypoglossal, vagus or accessory nerves are commonly described complications. Although the phrenic nerve courses within the surgical planes explored during a neck dissection and has a vital function in innervating the diaphragm, few studies have been performed to investigate the exact incidence of post-operative phrenic nerve paresis. This study aims to review the literature as to the rate of phrenic nerve injury following neck dissection. METHODS: A systematic literature review was conducted from 2000 to 2022 including studies reporting on phrenic nerve paresis following neck dissection. RESULTS: In total, 11 studies were included. The reported rate of immediate post-operative phrenic nerve paresis ranged from 0% to 5.3%, with an average rate of 0.613% (12/1959). The reported rate of phrenic nerve paresis at follow-up (1 month-127 months) ranged from 0% to 4.7%, with an average rate of 1.035% (5/483). There were no cases of bilateral phrenic nerve paresis reported in this period. CONCLUSIONS: Phrenic nerve paresis is an uncommon complication following neck dissection, often asymptomatic and potentially underreported. Bilateral phrenic nerve paresis is exceedingly rare. Injury can be avoided by staying superficial to the prevertebral fascia when dissecting around the anterior scalene muscle. Routine phrenic nerve integrity monitoring is not commonly utilized but may aid intra-operative phrenic nerve identification or confirmation of function.

Effect of respiratory training on respiratory failure secondary to unilateral phrenic nerve injury: A case report.

INTRODUCTION: Diaphragm is one of the most important respiratory muscles dominated by the phrenic nerve. Phrenic nerve injury would induce a series of clinical symptoms, including respiratory failure. Respiratory training could assist in regular treatment in improving the respiratory function and daily ability of respiratory failure patients. CASE PRESENTATION: A 71-years-old female was enrolled for the disorders of consciousness of 4.5 hours observed by her family and was diagnosed with respiratory failure secondary to unilateral phrenic nerve injury. The patient received basic therapy combined with rehabilitation training, including the training of aspirate muscle, limb resistance, thoracic loosening, aerobic training, electrical stimulation on respiratory nerves, and airway clearance. The combining therapeutic strategy significantly improved the daily ability and respiratory of the patient. The ultrasound showed that after therapy, the diaphragmatic muscles were thickened and the range of diaphragmatic movement was also enhanced. The pulmonary function was also improved after therapy. CONCLUSION: The combination of rehabilitation is suitable for the treatment of respiratory failure patients with clear causes of phrenic nerve injury. For patients with unexplained causes, rehabilitation could also be performed before the diagnosis. Patients with irreversible injury need long-term and family rehabilitation prescriptions.

Optimal prevention method of phrenic nerve injury in superior vena cava isolation: efficacy of high-power, short-duration radiofrequency energy application on the risk points.

BACKGROUND OR PURPOSE: Superior vena cava isolation (SVCI) is widely performed adjunctively to atrial fibrillation (AF) ablation. Right phrenic nerve injury (PNI) is a complication of this procedure. The purpose of the study is to determine the optimal PNI prevention method in SVCI. METHODS: A total of 1656 patients who underwent SVCI between 2009 and 2022 were retrospectively examined. PNI was diagnosed based on the diaphragm position and movement in the upright position on chest radiographs before and after SVCI. RESULTS: With the introduction of various PN monitoring systems over the years, the incidence of SVCI-associated PNI has decreased. However, complete PNI avoidance has not been achieved. PNI incidence according to fluoroscopy-guided PN monitoring, high-output pace-guided, compound motor action potential-guided, and 3-dimensional electro-anatomical mapping (EAM) systems was 8.1% (38/467), 2.7% (13/476), 2.4% (4/130), and 2.8% (11/389), respectively. However, a high-power, short-duration (50 W/7 s) radiofrequency (RF) energy application only on PNI risk points tagged by a 3-dimensional EAM system completely avoids PNI (0%; 0 /160 since April 2021). PNI showed no symptoms and recovered within an average of 188 days post-SVCI, except for a few patients who required > 1 year. CONCLUSIONS: Although PNI incidence decreased annually with the introduction of various monitoring systems, these monitoring systems did not prevent PNI completely. Most notably, the delivery of a high-power, short-duration RF energy only on risk points tagged by EAM prevented PNI completely. PNI recovered in all patients. The application of higher-power, shorter-duration RF energy on risk points tagged by EAM appears to be an optimal PNI prevention maneuver.

Comparison of phrenic nerve injury and its effect on the extrapulmonary vein structures with cryoballoon and hot-balloon ablation systems: considering the lesion created on the superior vena cava as a surrogate marker.

Preventing phrenic nerve injury (PNI) during balloon-based ablation is essential. The superior vena cava-right atrial (SVC-RA) junction is located just opposite the balloon position during right superior pulmonary vein (RSPV) ablation, and the phrenic nerve runs nearby on the lateral side. We compared the occurrence of PNI between the two balloon-based ablation systems and also the lesions created at the SVC-RA junction, which were expected to represent the effect on extra-PV structures. Cryoballoon ablation (CBA, n = 110) and hot-balloon ablation (HBA, n = 90) were performed in atrial fibrillation patients. High-density maps of the SVC-RA junction were created in 93 patients (CBA = 53, HBA = 40), and the damaged area (< 1.0 mV) was determined as an "SVC lesion". CBA had a higher occurrence of transient PNI (7.3% vs 1.1%, p = 0.035), but all recovered during the 6-month follow-up. An apparent SVC lesion was documented in 43% of the patients (40/93), and all patients with PNI had this lesion. CBA created a frequent (CBA vs HBA = 55% vs 28%, p = 0.008) and wider (0.8[0.4-1.7] cm2 vs 0.5[0.3-0.7] cm2, p = 0.005) SVC lesion than HBA. A multivariate analysis revealed that the use of a CBA system was a predictive factor of the occurrence of SVC lesions. CBA had a higher occurrence of transient PNI but not a permanent form. Every patient with PNI had lesions on the SVC-RA junction, and CBA revealed more substantial ablation effects at the SVC-RA junction than HBA. This may be caused by the different characteristics of the two balloon-based ablation systems and their balloon positions.

3D mapping of phrenic nerve course for radiofrequency pulmonary vein isolation.

INTRODUCTION: Phrenic nerve (PN) injury is a rare but severe complication of radiofrequency (RF) pulmonary vein isolation (PVI). The objective of this study was to characterize the typical intracardiac course of the PN with a three-dimensional electroanatomic mapping system, to quantify the need for modification of the ablation trajectory to avoid delivering an ablation lesion on sites with PN capture, and to identify very circumscribed areas of common PNC on the routine ablation trajectory of a RF-PVI, allowing fast and effective PN screening for everyday usage. METHODS: We enrolled 137 consecutive patients (63 ± 9 years, 64% men) undergoing PVI. A detailed high output (20 mA) pace-mapping protocol was performed in the right (RA) and left atrium (LA) and adjacent vasculature. RESULTS: The right PN was most commonly captured in the superior vena cava at a lateral (50%) or posterolateral (23%) position before descending along the RA either straight (29%) or with a posterolateral bend (20%). In the LA, beginning deep within the right superior pulmonary vein (RSPV), the right PN is most frequently detectable anterolateral (31%), then descends to the lateral proximal RSPV (23%), and further towards the lateral antral region (15%) onto the medial LA wall (12%). To avoid delivering an ablation lesion on sites with PN capture, modification of ablation trajectory was necessary in 23% of cases, most commonly in the lateral RSPV antrum (81%). No PN injury occurred. CONCLUSION: PN mapping frequently reveals the close proximity of the PN to the ablation trajectory during PVI, particularly in the lateral RSPV antrum. Routine PN pacing should be considered during RF PVI procedures.

Staged Phrenic Nerve Elongation and Free Functional Gracilis Muscle Transplantation-A Possible Option for Late Reconstruction in Chronic Brachial Plexus Injury.

PURPOSE: In patients with late brachial plexus birth injuries, sequelae after acute flaccid myelitis, or chronic adult brachial plexus injury, donor nerves for functioning muscle transplantation are often scarce. We present the results of a potential strategy using the phrenic nerve with staged free gracilis transplantation for upper extremity reanimation in these scenarios. METHODS: A retrospective review was performed on an institutional database of brachial plexus injury or patients with palsy. All patients underwent a staged reconstruction in which the ipsilateral phrenic nerve was extended by an autogenous nerve graft (PhNG), followed by free-functioning gracilis transplantation (PhNG-gracilis). RESULTS: Nine patients (6 cases of late brachial plexus birth injuries, 2 of acute flaccid myelitis, and 1 of adult chronic brachial plexus injury) were included in this study. The median follow-up period following the PhNG-gracilis procedure was 27 months (range, 12-72 months). The goals of the staged PhNG and PhNG-gracilis were primarily finger extension or finger flexion. In some patients, the technique was used to improve both elbow and finger function, tunneling the muscle through the flexor compartment of the upper arm and under the mobile wad at the elbow. All patients exhibited improvement of muscle strength, including in finger extension (4 patients) from M0 to M2; finger flexion (3 patients) from M0 to M3; elbow extension (1 patient) from M0 to M2; and elbow flexion (1 patient) from M2 to M4. CONCLUSIONS: A 2-stage PhNG-gracilis may restore or enhance the residual elbow and/or finger paralysis in chronic brachial plexus injuries. A minimum follow-up period of 3 years is recommended. This technique may remain useful as one of the last reconstructive options to increase power in patients with scarce donor nerves. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic V.

Characterization of Phrenic Nerve Response to Pulsed Field Ablation.

BACKGROUND: Phrenic nerve palsy is a well-known complication of cardiac ablation, resulting from the application of direct thermal energy. Emerging pulsed field ablation (PFA) may reduce the risk of phrenic nerve injury but has not been well characterized. METHODS: Accelerometers and continuous pacing were used during PFA deliveries in a porcine model. Acute dose response was established in a first experimental phase with ascending PFA intensity delivered to the phrenic nerve (n=12). In a second phase, nerves were targeted with a single ablation level to observe the effect of repetitive ablations on nerve function (n=4). A third chronic phase characterized assessed histopathology of nerves adjacent to ablated cardiac tissue (n=6). RESULTS: Acutely, we observed a dose-dependent response in phrenic nerve function including reversible stunning (R2=0.965, P<0.001). Furthermore, acute results demonstrated that phrenic nerve function responded to varying levels of PFA and catheter proximity placements, resulting in either: no effect, effect, or stunning. In the chronic study phase, successful isolation of superior vena cava at a dose not predicted to cause phrenic nerve dysfunction was associated with normal phrenic nerve function and normal phrenic nerve histopathology at 4 weeks. CONCLUSIONS: Proximity of the catheter to the phrenic nerve and the PFA dose level were critical for phrenic nerve response. Gross and histopathologic evaluation of phrenic nerves and diaphragms at a chronic time point yielded no injury. These results provide a basis for understanding the susceptibility and recovery of phrenic nerves in response to PFA and a need for appropriate caution in moving beyond animal models.

A prospective evaluation of phrenic nerve injury after lung transplantation: Incidence, risk factors, and analysis of the surgical procedure.

BACKGROUND: Phrenic nerve injury (PNI) is a complication of lung transplantation related to the surgical procedure and associated with increased morbidity. However, the incidence and risk factors, specifically regarding surgical techniques, have not been adequately studied. METHODS: We conducted a prospective single-center study over 4-years, in recipients of lung transplantation with a normal pretransplant phrenic nerve conduction study (PNCS). Diaphragm ultrasound and PNCS were performed in the first 21 postoperative days and PNI was defined when both tests were abnormal. Patients were followed up until hospital discharge. The association between transplant characteristics and PNI was analyzed by using logistic regression models. RESULTS: Two hundred eleven lung grafts implanted in 127 patients were included in the study. After lung transplantation, PNI was diagnosed in 43.3% of the subjects and 29% of the operated hemithorax. Regression logistic model showed that the variables related to PNI were female gender (p = 0.02), bilateral lung transplantation (BLT) (p = 0.001), right lung graft (p = 0.003), clamshell incision (p = 0.01), mediastinal adhesions (p = 0.002), longer operative time (p = 0.003), intraoperative extracorporeal support (p = 0.02), and blood transfusion (p = 0.003). Conversely, age >61 years (p = 0.008) and higher thoracic diameter (p = 0.04) were protective factors. The use of electrocautery, cardiac mechanical retractors, and diaphragmatic traction was not associated with PNI. Morbidity was increased without any difference in mortality. CONCLUSIONS: PNI is a frequent complication after lung transplantation, associated with higher morbidity. Mainly risk factors were age, BLT, female gender, and variables related to surgical difficulties. Lung graft in the right hemithorax and mediastinal adhesiolysis were the most relevant technical variables.

A Multidisciplinary Approach to Penetrating Neck Trauma in a Patient with Self-Inflicted Gunshot Injuries to Zones 1-3 of the Neck.

Penetrating neck trauma comprises 5%-10% of all traumatic injuries in adults and carries up to a 10% mortality rate for those affected. Management of penetrating neck trauma can be challenging and often requires a multidisciplinary approach. A case of penetrating neck trauma via self-inflicted gunshot wound to zones 1-3 of the neck in an intoxicated, suicidal 60-year-old man is presented. Immediately after stabilization by the trauma surgery team, surgical reconstruction using a pectoralis major pedicled myocutaneous flap was completed by the plastic and reconstructive surgery team. The patient's hospital course was complicated by injury to the left phrenic nerve, oropharyngeal swallowing dysfunction, and left diaphragmatic dysfunction. The trauma team initiated prompt multidisciplinary responses to each of these complications as they arose by involving the plastic and reconstructive surgery, otolaryngology, gastroenterology, and speech language pathology teams. Early involvement of the physical medicine and rehabilitation, psychiatry, dietary, and pharmacy teams allowed for early optimization and monitoring of the patient's mobility, psychological, and nutritional statuses. The timely initiation of multidisciplinary care in this patient's case allowed for the patient to not only to survive a potentially fatal penetrating neck trauma, but to be discharged to a rehabilitation facility with an independent level of function. Given the complications due to severe penetrating neck trauma of zones 1-3 in this case, it is essential for early involvement of the appropriate subspecialty teams in order to achieve the best possible outcome for the patient.

The many paths to diagnose diaphragmatic paralysis: Cardiopulmonary ultrasound on stage.

Abnormal diaphragmatic motion (ADM) due to phrenic nerve injury is a recognized complication of cardiac surgery and several diagnostic techniques can be used to determine the diagnosis. Due to its relationship with the diaphragm, cardiac kinetics is affected by the abnormal movement of the diaphragm in cases of left hemidiaphragm paralysis. The authors present a case of diaphragmatic paralysis in which the initial diagnosis is made through echocardiography.

Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry.

BACKGROUND: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce. METHODS: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible. RESULTS: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months. CONCLUSIONS: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.

Phrenic nerve injury after the percutaneous microwave ablation of lung tumors: A single-center analysis.

Objective: This study aimed to analyze the cases of phrenic nerve injury caused by the percutaneous microwave ablation of lung tumors conducted at our center and to explore the risk factors. Materials and Methods: The data of 455 patients who underwent the percutaneous microwave ablation of lung tumors at the Department of Interventional Radiology, First Affiliated Hospital of Fujian Medical University from July 2017 to October 2021, were retrospectively analyzed. The cases of phrenic nerve injury after the percutaneous ablation were reported to analyze the risk factors involved, such as the shortest distance between tumor margin and phrenic nerve, tumor size, and ablation energy. The groups were divided based on the shortest distance between the tumor edge and the phrenic nerve into group 1, d ≤ l cm; group 2, 1 < d ≤2 cm; and group 3, d >2 cm. Lesions with a distance ≤2 cm were compared in terms of tumor size and ablation energy. Results: Among the 455 patients included in this study, 348 had primary lung cancer, and 107 had oligometastatic cancer. A total of 579 lesions were detected, with maximum diameter of 1.27 ± 0.55 cm, and the ablation energy was 9,000 (4,800-72,000) J. Six patients developed phrenic nerve injury, with an incidence of 1.32%. For these six patients, the shortest distance from the lesion edge to the phrenic nerve was 0.75 ± 0.48 cm, and the ablation energy was 10,500 (8,400-34,650) J. There were statistically significant differences in phrenic nerve injury among groups 1, 2, and 3 (P < 0.05). In patients with a distance (d) ≤ 2 cm, there were no significant differences in tumor diameter and energy between the phrenic nerve injury group and the non-injury group (P = 0.80; P = 0.41). In five out of six patients, the diaphragm level completely recovered to the pre-procedure state, and the recovery time of the phrenic nerve was 9.60 ± 5.60 months. Another one was re-examined 11 months after the procedure, and the level of the diaphragm on the affected side had partially recovered. Conclusions: Phrenic nerve injury is a rare but not negligible complication of thermal ablation and is more likely to occur in lesions with a distance ≤2 cm from the phrenic nerve.

Second-generation cryoballoon versus contact force radiofrequency ablation for atrial fibrillation: an updated meta-analysis of evidence from randomized controlled trials.

Catheter ablation has been recommended for patients with symptomatic atrial fibrillation (AF), with pulmonary vein isolation being the cornerstone of the ablation procedure. Newly developed technologies, such as cryoballoon ablation with a second-generation cryoballoon (CB2) and the contact force radiofrequency (CF-RF) ablation, have been introduced in recent years to overcome the shortcomings of the widely used RF ablation approach. However, high-quality results comparing CB2 and CF-RF remain controversial. Thus, we conducted this meta-analysis to assess the efficacy and safety between CB2 and CF-RF using evidence from randomized controlled trials (RCTs). Databases including Embase, PubMed, the Cochrane Library, and ClinicalTrials.gov were systematically searched from their date of inception to January 2021. Only RCTs that met the inclusion criteria were included for analysis. The primary outcome of interest was freedom from atrial tachyarrhythmia (AT) during follow-up. Secondary outcomes included procedure-related complications, procedure time and fluoroscopy time. Six RCTs with a total of 987 patients were finally enrolled. No significant differences were found between CB2 and CF-RF in terms of freedom from AT (relative risk [RR] = 1.03, 95% confidence interval [CI] 0.92-1.14, p = 0.616) or total procedural-related complications (RR = 1.25, 95% CI 0.69-2.27, p = 0.457). CB2 treatment was associated with a significantly higher risk of phrenic nerve palsy (PNP) than CF-RF (RR = 4.93, 95% CI 1.12-21.73, p = 0.035). The occurrences of pericardial effusion/tamponade and vascular complications were comparable between the CB2 and CF-RF treatments (RR = 0.41, p = 0.398; RR = 0.82, p = 0.632). In addition, CB2 treatment had a significantly shorter procedure time than CF-RF (weighted mean difference [WMD] = - 20.75 min, 95% CI - 25.44 ~ - 16.05 min, P < 0.001), whereas no difference was found in terms of fluoroscopy time (WMD = 4.63 min, p = 0.179). CB2 and CF-RF treatment are comparable for AF patients regarding freedom from AT and procedure-related complications. Compared to CF-RF, CB2 treatment was associated with a shorter procedure time but a higher incidence of PNP. Further large-scale studies are warranted to compare these two techniques and provide an up-to-date recommendation.