Mean Fluoroscopy Time Research Articles

Safety profile, electrical performances and clinical outcomes of a novel leadless pacemaker; first results from real-world clinical practice in Saudi Arabia

Abstract Introduction Leadless pacemakers (LP) are emerging as an effective and safe alternative to transvenous pacemakers to reduce lead-related and pocket-related complications and to improve patient experience. A new LP system, the Aveir VR, has been approved in 2022 for US and other countries, and in 2023 for Europe, and features innovative characteristics such as the active fixation helix mechanism and the possibility to measure sensing/pacing parameters before LP deployment. Purpose Evaluate safety, electrical performances and clinical outcomes associated with the first Aveir VR LP implants in 2 Hospitals in Saudi Arabia. Methods We performed a prospective evaluation of all-comer patients who received Aveir VR LP. Decision for LP implant was based on conditions such as cardiac pacing indication, lack of upper extremity venous access, risk of device infection, and life expectancy, and using shared decision-making. Clinical and electrical data were collected at implant and at 1st and 6th month visits. Results A total of 54 patients (25 female, mean age 69 years) were included between December 2022 and October 2023. Pacemaker implant indication was AV block in 25 (46%) patients, sinus node disease in 19 (35%) patients, atrial fibrillation and slow ventricular response in 9 (17%) patients and left bundle branch block in 1 (2%) patient. Implant was successful in all attempted cases. Final device position was lower septum in 51/54 (94.4%) patients and mid-septum in 3/54 (5.6%) patients. Mean procedure time was 48±22 minutes and showed a decreasing trend as a function of operator experience with a mean of 55, 50 and 36 minutes in the first, second and third group of consecutive implants, respectively. Mean fluoroscopic time was 11±8 minutes and showed a decreasing trend as a function of operator experience with a mean of 13, 13 and 6 minutes in the first, second and third group of consecutive implants, respectively. Final device position was achieved at first attempt in 42/54 (77.8%) cases and at first or second attempt in 51/54 (94.4%) cases. At implant mean R wave sensing was 7.6±3.7 mV, mean impedance was 724±335 Ohm, mean threshold was 1.0±0.6 V at 0.4 ms. During implant there was one patient with pericardial effusion treated with pericardiocentesis. In a mean follow-up of 73 days there were no procedure-related or device-related complications, electrical parameters showed acceptable values, and all implanted devices performed as expected. Median longevity, estimated at last follow-up visit, was 19 years (interquartile range: 12-20 years). Conclusion First real-world cases of use of a novel leadless pacemaker in Saudi Arabia show optimal feasibility and good safety profile and electrical performances. Procedure and fluoroscopic times were acceptable and decreased as a function of operator experience. Longevity estimations predict very long service life-times.

Open Surgical Implantation of Lumbosacral Dorsal Root Ganglion Stimulators for Chronic Pain: Analysis of Patient Outcomes and Operative Technique

ObjectiveDorsal root ganglion (DRG) stimulator leads were designed to be placed percutaneously, yet open surgical placement via laminectomy is an option. We present the largest series to date of surgically-placed DRG stimulators and the first series where open surgical implantation was the chosen technique and not a salvage procedure. MethodsA retrospective review of a prospective database of DRG implants identified 17 patients who had open lumbosacral DRG lead placement performed by a single surgeon (NDT) between October 2021 and April 2023. Descriptive statistics, fluoroscopy exposure times, and complications were reported. The window of data collection was 1 month pre-operatively to 12 months post-operatively. Phone interviews were conducted to collect information on pain outcomes and patient satisfaction. ResultsWe identified 17 patients (12 women, 5 men) who had lumbosacral DRG placement. Phone interviews were conducted for 10/17 patients, with mean follow-up of 11.9 months. 53% reduction in mean pain score was achieved (n=10, p<0.001). There were no infections, hematomas, or symptomatic lead migrations. 1/17 experienced a superficial dehiscence and 2/17 had an intra-operative repairable durotomy with no post-operative sequelae. Mean fluoroscopy time per lead was 15.4±9.9s (n=10). ConclusionOpen DRG lead placement via laminotomy/laminectomy is reported as a salvage procedure but may have comparable safety and efficacy profile to percutaneous implantation when utilized as the primary implantation method. Before establishing open DRG as an alternative permanent implantation method, more studies are needed to determine whether such benefits as less migration outweigh the risks of a more invasive implantation procedure.

Comparison of supine and prone mini percutaneous nephrolithotomy in obese patients: a retrospective study.

To compare the safety and effectiveness of Mini Percutaneous Nephrolithotomy (m-PNL) operations performed in the supine and prone positions in obese patients. We retrospectively analysed data from obese patients (BMI ≥ 30) who underwent prone or supine mPCNL between January 2014 and June 2021 in our clinic. Kidney anomalies, coagulopathy, solitary kidney, skeletal deformity, and patients under 18 were excluded. Outcomes measures included operation time, fluoroscopy time, duration of hospitalisation, stone-free rate, and complications classified by Clavien-Dindo. Statistical analysis was performed using SPSS version 26. The study included 338 patients (100 supine, 238 prone). Supine mPCNL had a shorter mean operation time (89.6 vs. 100.3 minutes, p=0.001), fluoroscopy time, and duration of hospitalisation (60.7 vs. 112.0 hours, p=0.001). Overall complication rates were comparable, but major complications were higher in the prone group (p=0.041). Logistic regression identified stone size >25 mm and prone position as significant risk factors for major complications. Supine and prone mPCNL are both effective for treating kidney stones in obese patients. Supine mPCNL offers benefits, such as shorter operation time, reduced radiation exposure, and fewer major complications. Careful monitoring is recommended for patients with high CCI scores or larger stones due to increased complication risks.

Robotic spinal angiography: A single-center experience.

Robotic neurointervention enhances procedural precision, reduces radiation risk, and improves care access. Originally for interventional cardiology, the CorPath GRX platform has been used in neurointerventions. Recent studies highlight robotic cerebral angiography benefits, but information on spinal angiography is limited. While a new generation of robotic solutions is on the horizon, this series evaluates our experience with the CorPath GRX in spinal angiographic procedures, addressing a key gap in neurointerventional research. In this single-center retrospective case series, we analyzed 11 patients who underwent robotic-assisted diagnostic procedures with the CorPath GRX system from February 2022 to March 2023 at our institution. A descriptive synthesis was performed on the demographic, baseline, surgical, and postoperative data collected. The average age of the 11 patients was 54 ± 20.34 years, with six (54.55%) female. The mean body mass index was 29.58 ± 7.86, and 7 (63.64%) were non-smokers. Of the 11 procedures using the CorPath GRX system, four (36.36%) were partially converted to manual technique. General anesthesia was used in nine cases (81.82%), and right-side femoral access in ten (90.91%) patients. Mean fluoroscopy time was 24.81 ± 10.19 min, contrast dose 174.09 ± 57.31 mL, dose area product 472.23 ± 437.57 Gy·cm², and air kerma 2438.84 ± 2107.06 mGy. No robot-related complications and minimal procedure-related complications were reported. The CorPath GRX system, a robotic-assisted platform, has proven reliable and safe in spinal angiography, evidenced by its enhanced procedural accuracy and reduced radiation exposure for operators.

Safety and Effectiveness of Large-Bore Percutaneous Cholangioscopy–Assisted Gallstone Retrieval for Inoperable Calculous Cholecystitis: A Multi-Institutional Retrospective Study

PurposeTo evaluate the safety and effectiveness of large-bore percutaneous biliary access techniques for cholangioscopy-assisted gallstone extraction in patients with a history of acute calculous cholecystitis who are poor surgical candidates. Materials and MethodsA retrospective analysis was conducted on patients who underwent percutaneous cholangioscopy for gallstone extraction using large-bore access (24 or 30 F) at 2 large academic centers from September 2020 and August 2022. Technical success, procedure duration, fluoroscopy time, immediate postprocedural symptom reduction, 3-month symptom-free outcomes, and adverse events (AEs) were assessed. ResultsThirty consecutive patients were included. Gallstone removal in a single cholangioscopy session was successful in 93.3% of cases. Large-bore access facilitated the removal of gallstones ranging from 0.5 to 4 cm in diameter, with mean procedure and fluoroscopy times of 105.4 minutes and 21.7 minutes, respectively. All patients who presented for 3-month follow-up remained symptom-free without gallstone recurrence on imaging. The overall AE rate was 6.7%, one Grade 2 and one Grade 3 based on the Society of Interventional Radiology (SIR) AE grading system, both managed successfully, leading to patient discharge home. ConclusionsLarge-bore percutaneous biliary access for cholangioscopy-assisted gallstone extraction is a safe and effective technique for managing symptomatic cholelithiasis in poor surgical candidates.

Leadless pacemaker implantation via the internal jugular vein.

Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker systems. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation via the femoral vein. The records of the first consecutive 100 patients undergoing Micra™ leadless pacemaker implantation via the right internal jugular vein from two centres were included in this study. Peri-procedural safety and efficacy of the jugular approach were compared to the first 100 patients using a femoral implantation approach at the University Hospital Zurich. One hundred patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 patients, and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing the jugular approach were of similar age and had similar comorbidities. Mean procedure (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 min, both P < 0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries, and 13 major groin haematomas). The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.

Contact-force local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from an international multicenter clinical setting.

The combination of highly localized impedance (LI) and contact force (CF) may improve tissue characterization and lesion prediction during radiofrequency (RF) pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). We report the outcomes of our acute and long-term clinical evaluation of CF-LI-guided PVI in consecutive AF ablation cases from an international multicenter clinical setting. Three hundred twenty-four consecutive patients from 20 European centers undergoing RF catheter ablation with the Stablepoint™ catheter were enrolled in the CHARISMA registry. Of these, 275 had a minimum follow-up of 1year and were included in the primary analysis. The mean procedure duration was 115 ± 47min, and the mean fluoroscopy time was 9.9 ± 6min. At the end of the procedures, all PVs had been successfully isolated in all study patients. Minor complications were reported in 12 patients (4.4%). At 1year, 36 (13.1%) patients had had an AF recurrence, and freedom from antiarrhythmic drugs and AF recurrence was achieved in 228 (82.9%) patients. The recurrence rate was higher in patients with persistent AF (21/116, 18.1%) than in those with paroxysmal AF (15/159, 9.4%; p = 0.0459). On multivariate logistic analysis adjusted for baseline confounders, only time > 6months from first diagnosis of AF to ablation (HR = 2.93, 95%CI 1.03 to 8.36, p = 0.0459) was independently associated with recurrences. An ablation strategy for PVI guided by CF-LI technology proved safe and effective and resulted in a low recurrence rate of AF over 1-year follow-up, irrespective of the underlying AF type. Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice. (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Comparison of two methods for treatment of 1-2cm kidney stones in pediatric patients: mini PCNL and RIRS.

This study aimed to compare the results of retrograde intrarenal surgery (RIRS) and mini-percutaneous nephrolithotomy (mini-PCNL) for the treatment of 1-2cm kidney stones in pediatric patients. The records of patients under the age of 18 years who were diagnosed with unilateral 1-2cm kidney stones for the first time and underwent endoscopic surgery between February 2008 and April 2022 were retrospectively examined. The patients were divided into two groups: mini-PCNL and RIRS surgery. Parameters such as age, gender, number of stones, side, size and localization were examined. The main endpoint of the study was to compare stone-free rates (SFR) one month after both surgeries. Surgery and fluoroscopy times, postoperative hospital stay, hemoglobin decrease and complication rates were compared between the groups. SFR was evaluated one month after surgery by direct urinary system radiography and USG or CT. A total of 58 patients were included in the study. There were 35 patients in the mini-PCNL group and 23 patients in the RIRS group. Table1 shows the demographic and clinical characteristics of both groups. There was no significant difference between the groups in terms of age, gender, stone size, location, side and density. Calcium oxalate stones were observed at a higher rate in both groups. Mean fluoroscopy time was higher in the mini-PCNL group (p = 0.001). The mean surgery time was lower in the mini-PCNL group (p = 0.024). The mean hemoglobin decrease was greater in the percutaneous group (p = 0.039). There were no differences between the groups in terms of postoperative hospital stay, complication rates, and SFR one month after surgery. Although mini-PCNL seems to be more advantageous in terms of operation time compared to RIRS, it is disadvantageous in terms of average fluoroscopy time, radiation received and average hemoglobin decrease.

Effect of Filtered Blood Return on Outcomes of Pulmonary Aspiration Thrombectomy

ObjectivesTo assess the effects of filtered blood reinfusion (FBR) on procedural outcomes of aspiration thrombectomy for pulmonary embolism (PE). Materials and MethodsA total of 171 patients who underwent aspiration thrombectomy for intermediate-high–risk or high-risk PE between December 2018 and September 2022 were included, 84 of whom underwent thrombectomy with FBR and 87 without. Demographic data, vital signs, laboratory values, procedural details, pulmonary arterial pressures, transfusion needs, length of hospital stay, and procedure-related adverse events were recorded. ResultsThe groups did not differ at baseline, other than the FBR cohort having a higher percentage of women. There was no significant difference in postprocedural vital signs or pulmonary arterial pressure. Mean fluoroscopy time and volume of contrast medium used were lower in the FBR cohort. The drop in hemoglobin level was lower in the FBR group at both 12 (FBR, −1.065; No FBR, −1.742; P > .001) and 24 hours (FBR, −1.526; No FBR, −2.380; P > .001) after procedure; accordingly, fewer patients required transfusions in the FBR cohort (FBR, 8 (9.5%); No FBR, 20 (23.0%); P = .016). There was no difference in the number or severity of adverse events or duration of intensive care unit or hospital admission. ConclusionsFBR use during aspiration pulmonary thrombectomy reduced blood loss and transfusion requirements but had no significant effect on procedural success or adverse event rates.

Age is a predictor of elbow stiffness after type III or IV supracondylar humerus fractures

PurposeSupracondylar humerus (SCH) fractures account for approximately 30% of injuries for those younger than 7 years of age (Cheng et al. in J Pediatr Orthop 19:344–350, 1999). Recent studies examining the association of patient age and SCH fracture outcomes have provided conflicting findings. The purpose of this study is to investigate SCH fracture outcomes in children at different ages of skeletal development.MethodsRetrospective review of a Level I pediatric trauma center between 2010 and 2014 was conducted. 190 patients with SCH fractures, age < 14 years, fracture type Gartland III or IV (AO/OTA 13-M 3.1 III and IV) were included. Patients were sorted into age groups: < 2 years, 4–6 years, and > 8 years. Patients were treated with either a closed or open reduction with percutaneous fixation. Clinical outcomes including postoperative elbow range of motion, nerve palsy, compartment syndrome, infection, and cubitus varus were assessed.ResultsPatients in younger age groups were more likely to obtain postoperative full elbow flexion (< 2 years = 77%; 4–6 years = 66%; > 8 years = 43%) and full elbow extension (< 2 years = 96%; 4–6 years = 88%; > 8 years = 64%). Age was a significant predictor of nerve palsy on admission, mean operative time (< 2 years = 21.8 min; 4–6 years = 43.0 min; > 8 years = 80.7 min), and mean fluoroscopy time (< 2 years = 22.9 s; 4–6 years = 59.5 s; > 8 years = 171.9 s). There were no differences in rates of open reduction, compartment syndrome, pin tract infection, cubitus varus, or reoperation among groups.ConclusionIncreasing age is associated with increased elbow stiffness after percutaneous fixation of Gartland Type III and Type IV SCH fractures. Older patients with SCH fractures may benefit from formal rehabilitation.Level of evidenceIII.

Robotic-Assisted Endovascular Treatment for Transplant Renal Artery Stenosis: A Feasibility Study.

To describe a single-center experience with robotic-assisted endovascular treatment for transplant renal artery stenosis. This is a single-center, retrospective, feasibility study of 4 consecutive cases of robotic-assisted endovascular surgery for transplant renal artery stenosis from October 2021 to August 2022. All lesions were identified, and stenting was performed with no complications. Conversion to manual control was not necessary. The mean fluoroscopy time was 25.25min (range 12-60.9). A control Doppler ultrasound was routinely performed, demonstrating no residual lesions in all cases. There was no reintervention during the follow-up period. The operator learning curve was felt to be acceptable. Robotic-assisted endovascular treatment is a feasible technique for transplant renal artery stenosis.

Radiation dose during transarterial chemoembolization and associated factors.

To provide detailed reports on radiation doses during transarterial chemoembolization (TACE) in the cone-beam computed tomography (CBCT) era and to identify the associated factors. This retrospective study included 385 consecutive patients who underwent initial conventional TACE for hepatocellular carcinoma (HCC) between January 2016 and December 2017. In most cases, CBCT was performed at the common hepatic artery or celiac axis to confirm the location of the tumor and the three-dimensional hepatic artery anatomy. Superselective TACE was performed for all technically feasible cases. Information on total dose area product (DAP), total cumulative air kerma (CAK), fluoroscopy time, and DAP and CAK of each digital subtraction angiography (DSA) and CBCT scan was recorded. Multiple linear regression analysis was performed to identify the factors associated with increased DAP during TACE. The mean values of total DAP and CAK were 165.2 ± 81.2 (Gy·cm²) and 837.1 ± 571.0 (mGy), respectively. The mean fluoroscopy time was 19.1 ± 10.3min. The mean DAP caused by fluoroscopy, DSA, and CBCT was 51.8 ± 43.9, 28.0 ± 24.1, and 83.9 ± 42.1Gy·cm², respectively. Male sex, a high body mass index, largest tumor size > 3cm, presence of aberrant right and left hepatic arteries, and superselective TACE were identified as independent predictors of increased total DAP during TACE. We were able to provide detailed reports on radiation doses during TACE and associated factors.

Midterm Outcomes for Funnel-EVAR.

The funnel technique, the hybrid assembly of a thoracic and abdominal aortic endograft, is advantageous for frail patients where efficient oversizing is not possible for infrarenal wide aortic necks over 34 mm. We sought to determine the advantages and disadvantages of the Funnel-endovascular aneurysm repair (EVAR) technique using 60 mm length thoracic endograft. This retrospective study included 22 patients, all frail with high comorbidities, who were operated on with the Funnel technique using the 60 mm Lifetech Ankura thoracic endograft, in 7 urgent and 15 elective cases from January 2018. There were no exclusion criteria except having an age 60 years. Primary endpoints were the technical success and early mortality and morbidity; secondary endpoints were late outcomes such as endoleak, migration, late open surgical conversion, successful sac shrinkage, and enlargement at the infrarenal aortic neck diameter. The patients' mean age was 72.6 7.3 years (62-86 years), with a mean aneurysm diameter of 83.2 16.8 mm and mean infrarenal aortic diameter of 38.7 2.4 mm. There was no early mortality. Technical success was 100%. 21 standard bifurcated and one aorto-uni-iliac abdominal endograft were deployed. The mean fluoroscopy time was 14.3 5.2 minutes. Mean follow-up was 32.8 19.6 months, with no endovascular complications. There was no Type-1a or Type-3 endoleak, migration, infrarenal aortic neck diameter enlargement, or aneurysm sac enlargement. During the follow-up, three patients died, but there was no aneurysm-related mortality. Funnel-EVAR is effective and safe for patients with a wide infrarenal aortic neck diameter when assessing midterm outcomes. Therefore, it should be part of the armamentarium of a vascular surgeon in patients with wide aortic necks 34 mm.

Differences in Intraoperative Fluoroscopic Radiation Exposure During Ankle Fracture Open Reduction and Internal Fixation Between Orthopaedic Surgery and Podiatry.

Surgical ankle fractures pose a unique situation because both podiatrists and orthopaedic surgeons manage these injuries. Intraoperative fluoroscopy is routinely used; however, excessive radiation can be harmful to both the patient and the surgical team. The primary goal of this study was to determine whether there is a difference in the amount of intraoperative radiation exposure during ankle fracture open reduction and internal fixation (ORIF) when performed by orthopaedic surgeons versus podiatrists. This is a retrospective review of patients who underwent ankle fracture ORIF at an urban level I trauma center between January 1st, 2018, and April 1st, 2023. The electronic health record was queried using International Classification of Diseases nine and 10 codes associated with ankle fractures. Patients aged older than 18 years with an ankle fracture managed surgically were included. Subjects were then stratified by procedure. The mean total radiation dose (mRad) and mean total fluoroscopic time (seconds) were then compared between those performed by orthopaedic surgeons and podiatrists. Of the 333 included procedures, 186 were done by orthopaedic surgeons and 147 were done by podiatrists. Using multiple linear regression analysis to control for age, sex, race, ethnicity, and body mass index, patients undergoing isolated malleolus ORIF with syndesmosis repair performed by orthopaedic surgery were found to have a significantly lower mean fluoroscopic time compared with those performed by podiatry (68.4 s versus 104.8 s; P = 0.028). In addition, trimalleolar ORIF with syndesmotic repair performed by orthopaedic surgery had a significantly lower mean total radiation dose compared with those performed by podiatry (244.6 mRad v 565.6 mRad; P = 0.009). Patients and surgical teams are exposed to markedly less radiation in isolated malleolar and trimalleolar fracture ORIF with syndesmosis repair when performed by an orthopaedic surgeon as compared with those performed by a podiatrist.

Clinical efficacy of mini-percutaneous nephrolithotomy versus retrograde intrarenal surgery for the management of upper urinary tract calculus (1–2.5 cm) in children ≤10 years of age

With improvements in endoscopic surgery, open surgical procedures for urinary system stones have cleared the path for the use of less invasive treatment modalities in patients with pediatric kidney stone disease. Extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL), and retrograde intrarenal surgery (RIRS) are among the treatment options available. To prospectively evaluate the outcomes of mini-percutaneous nephrolithotomy and retrograde intrarenal surgery (RIRS) for children ≤10 years of age with upper urinary tract calculus (1-2.5cm). Sixty pediatric patients with single or multiple renal stones (1-2.5cm in diameter) were collected prospectively and equally divided into two groups to undergo RIRS or mini-PCNL. The operative and postoperative outcomes of both groups were analyzed. The groups' mean ages and genders were comparable. The mean stone size for the RIRS group was 1.86cm and 1.69cm for the PCNL group (P=0.449). The PCNL group had statistically longer mean fluoroscopy and hospitalization times. The stone-free rates (SFRs) after a single procedure were 27 (90%) in the PCNL group and 25 (83.33%) in the RIRS group (P=0.706). The UAS was placed in 13 (43.33%) patients in the RIRS group. In the RIRS group, 14 (46.67%) children required preoperative DJ stent application to passively dilate the ureteric orifice. As regard post DJ stenting, 13 (46%) cases applied DJ in the mini PCNL group. major complications were observed in either group. Minor complication (Clavien 1-3) rates were 16.66% and 13.33% for the PCNL and RIRS groups, respectively. There were no differences found between the RIRS and mini-PCNL groups regarding operative time. The mean cost of RIRS was $703.96 and $537.03 for the mini-PCNL. According to the results of this study, mini-PCNL and RIRS are effective procedures for treating renal stones in children up to 2.5cm with comparable success and complication rates. Hospital stay, radiation exposure, and fluoroscopy time are significantly lower in RIRS than in the mini PCNL technique. Although RIRS is effective, a major disadvantage is the greater requirement for JJ stent insertion either before or after the procedure and the consequent need for a second procedure for removal.

Safety and efficacy outcomes in 100 consecutive cases of pulsed field ablation

Abstract Background Pulsed field ablation (PFA) an emerging technology for ablation of atrial fibrillation (AF). This non-thermal ablation modality uses ultrarapid electrical pulses to destabilise cell membranes and can selectively ablate myocardial tissue. Successful pulmonary vein isolation (PVI) and reductions in procedure times compared to other modalities have been observed in initial studies. Aim To report initial outcomes and fluoroscopic times in the first 100 consecutive cases using PFA in AF ablation. Methods The first 100 consecutive PFA cases carried out by a single operator in a single centre were examined. All cases were performed under general anaesthesia, using ultrasound-guided vascular access and TOE-guided transseptal puncture. Outcomes were recorded from the first case in June 2022 to the present day. Electroanatomic mapping (EAM) was carried out using two proprietary systems. Results Procedural information and follow-up was achieved in all 100 patients (see table). The majority (77) were male. Mean age 61. Cardiovascular comorbidities included: hypertension (41), heart failure (12), ischaemic heart disease (10), stroke (4), diabetes mellitus (3). Antiarrhythmic drugs were used by 45 patients (Amiodarone in 22, Dronedarone in 18, Flecainide in 10, Sotalol in 8, Mexiletine in 1) with 55 taking beta blockers only or no rhythm control drugs. Persistent AF accounted for 57 cases, and 91 patients had no prior ablation procedure. Median CHA2DS2VASC 1. Warfarin was used on 1 patient, the other 99 patients underwent ablation on uninterrupted DOAC, most commonly Apixaban. EAM was conducted in 59 patients. Stand-alone PVI was carried out in 68, while 30 underwent an additional posterior wall box isolation, and a mitral isthmus line was added in a further 2 who had atrial flutter (AFl) during the procedure following successful PVI. There were no serious peri-procedural complications. (vascular access complications, pericardial effusion, stroke or death). All 100 patients were discharged following a one-night stay. Clinical pericarditis without effusion occurred in 1 patient on day 2, and resolved with a short course of Colchicine. Mean fluoroscopy time was 9minutes, 12seconds, and reductions in fluoroscopy times correlated significantly with case number (see figure). Mean fluoroscopy time was 2mins, 30secs higher where EAM was used. Sinus rhythm was achieved in 100%. Atrial arrhythmia recurred in 12 patients, 7 with AF and 3 atrial flutter, 2 with typical symptoms which could not be documented. Two of the recurrences were within 24 hours of the procedure. Conclusions This registry data shows that PFA was used to achieve PVI safely, with effective additional substrate ablation also demonstrated. There were no serious peri-procedural complications, and procedural improvements in fluoroscopic times were observed throughout the 100 cases. Long term follow-up data is required to validate the safety and efficacy of this new technology.

Impact of magnetic data collection prior to electroanatomic model creation on acute outcomes in de novo AF procedures

Abstract Background As ablation and electroanatomical mapping technology evolve, workflows change to maximize the impact on procedural efficacy, safety, and efficiency. In a magnetic-primary navigation mode, optimization of the magnetic-impedance field links (VoXels) must be considered to provide accurate environments for anatomic modeling, mapping, and lesion placement. To achieve this accuracy and optimize speed of data collection, many operators have adopted the strategy of collecting VoXels using an ablation catheter prior to introduction of a multipolar mapping catheter. However, the impact of this workflow on procedural metrics has not yet been quantified in a multicenter, international cohort. Objective Assess the impact of optimizing the magnetic navigation field using an ablation catheter prior to collecting left atrial (LA) data using a high-density diagnostic tool on acute outcomes in de novo atrial fibrillation (AF) ablation procedures. Methods Acute observational data from 199 de novo pulmonary vein isolation (PVI) cases was prospectively collected from 56 operators at 42 centers in Europe, the US, and Australia. Procedural metrics, modeling workflow, ablation technology used, and acute outcomes were collected. Results Of 199 de novo AF (62.3% PAF) ablation procedures, VoXels were collected with an ablation catheter prior to LA map collection with a multipolar catheter in 65/199 (32.7%) cases; the remainder collected with multipolar catheter first. An irrigated, contact force sensing RF ablation catheter was used in all procedures. Mean procedure duration was similar in procedures in which VoXels were collected prior to map collection (VC) compared to those that did not (nVC) (107.0±46.8 min and 115.4±59.2 min, respectively (p=0.28)). Mean fluoroscopy time was significantly reduced in VC cases compared to nVC cases (3.0±4.5 min and 5.3±5.6 min, respectively (p=0.002)). Total RF duration was significantly reduced in VC cases compared to nVC cases (904±444s and 1063±632s, respectively (p=0.04)). There was also a significant reduction in fluid delivered through the ablation catheter in VC cases, 369±159mL, compared to nVC cases, 520±243mL (p&amp;lt;0.001). Acute success rates were similar between groups: 98.5% for VC cases and 99.2% for nVC cases (p=0.64). Conclusion In this international cohort, cases where VoXels were collected prior to map and model collection had significantly reduced fluoroscopy times, RF durations, and fluid volumes delivered through the ablation catheter, potentially as a result of improved model quality. Despite the introduction of an additional step to the workflow, there was a trend toward shorter procedures when VoXels were collected prior to map and model collection, although it did not achieve statistical significance. Better quantification of the impact of this workflow on model quality, along with analysis of long-term patient outcomes, is warranted.Procedure Duration Comparison_VC vs. nVCFluoroscopy Comparison_VC vs. nVC

One year of atrial fibrillation ablation using pulsed-field pentaspline catheter - learning curves based on a single centre experience

Abstract Introduction Pulsed-field ablation (PFA) represents a novel nonthermal strategy for ablation of atrial fibrillation (AF). As the technology has recently emerged in routine clinical praxis, only limited data on learning curves exist so far. Hereby, we present data from our centre regarding learning curves after the first year of using PFA. Methods The ablation procedure was performed under deep sedation or general anaesthesia in patients with paroxysmal or persistent AF. No 3D mapping system was used, procedures were guided by fluoroscopy and intracardiac echocardiography. For ablation itself, a pantaspline over-the-wire catheter with a steerable sheath was used. The following parameters were analysed over the course of time: procedure time, left atrial (LA) catheter dwelling time, total fluoroscopy time, and complications. Patients who received pulmonary vein isolation (PVI) alone and those with another additive set of lesions (PVI+) were analysed separately. Procedural parameters of the first and the last 20 patients of each group were compared for statistical significance. Results A total number of consecutive 159 patients (mean age 63.20 ± 10.51 years, 69.40 % males) were included in the analysis (PVI N = 73 (45.91 %), PVI+ N = 83 (54.09 %)). Procedures were performed by 3 certified electrophysiology specialists usually in random teams of 2 operators. The mean procedure time was 62.59 ± 23.09 min (PVI 59.64 ± 27.27; PVI+ 65.09 ± 18.64 min, P = 0.15). Over time, there was a non-significant decrease in PVI group (60.30 ± 17.44 vs. 52.75 ± 16.33 min, P = 0.16), but no difference in PVI+ cohort (67.85 ± 13.31 vs. 67.65 ± 28.88 min, P = 0.97). The mean LA catheter dwelling time was 39.84 ± 13.52 min (PVI 35.04 ± 10.20 min; PVI+ 44.33 ± 14.72 min, P &amp;lt;0.001). Non-significant shortening of the LA dwelling time was observed in PVI patients (36.56 ± 8.0 vs. 33.37 ± 9.58 min, P = 0.29). In contrast, the LA dwelling time in the PVI+ group became non-significantly longer (42.93 ± 10.62 vs. 48.56 ± 22.28 min, P = 0.39). The mean fluoroscopy time was 9.28 ± 3.66 min (PVI 8.65 ± 3.04; PVI+ 9.80 ± 4.05 min, P = 0.043). Importantly, fluoroscopy time decreased significantly in both groups over time (PVI: 10.63 ± 3.51 vs. 6.95 ± 2.45 min, P &amp;lt;0.001; PVI+: 12.82 ± 4.99 vs. 9.13 ± 4.16 min, P = 0.017). Regarding complications, we observed one pulmonary oedema requiring orotracheal intubation and mechanical ventilation in the early period. Other complications were related to the femoral puncture site. Conclusion Over the course of time with the new PFA technology, we observed a significant decrease in total fluoroscopy time. However, the change in total procedure and LA dwelling time did not reach statistical significance.

Use of a novel, mode-switching electroanatomic mapping function and its effect on procedure and fluoroscopy duration in de novo AF procedures

Abstract Background Electroanatomical mapping systems utilize either an impedance-primary (IP) or magnetic-primary (MP) coordinate system for navigation. IP systems allow visualization of metal within the impedance field and can be scaled with supplemental magnetic information. MP systems collect information from catheters with a magnetic sensor, and supplementary impedance information is used to visualize catheters without a sensor. One commercially available mapping system offers both IP and MP navigation modes; however, operators must select a mode at procedure start. A novel software function allowing for near-instant transition between modes was recently introduced; its impact on procedural metrics has not yet been quantified. Objective Assess the impact of a mode-switching software function (MS) on acute procedural metrics in de novo paroxysmal atrial fibrillation (PAF) cases in which both the IP and MP modes were used, compared to procedures in which IP or MP was used alone. Methods Observational data was collected from 309 de novo PAF cases performed at 63 centers in Europe, the US, and Australia. Ablation technology used, procedure duration, fluoroscopy time, and acute outcomes were collected. Results Of 309 cases analyzed, 157 (50.8%) used MS, 97 (31.4%) used MP alone, and 55 (17.8%) used IP alone. Radiofrequency ablation (RFA) was used in 291 (94.2%) cases, while the remaining 18 (5.8%) used cryoablation. Irrigated, contact force sensing RFA catheters were used in 153 (97.4%) MS, 89 (91.8%) MP, and 29 (52.7%) IP cases. Mean procedure durations for MS and MP cases were similar: 106.2±51.6 min and 106.8±53.0 min, respectively (p=0.93). However, IP cases were significantly longer than both MS and MP cases, 134.2±53.8 min (p=0.002). Fluoroscopy time was significantly less in the MS group compared to MP and IP groups: 3.9±5.5, 6.1±5.2, and 7.8±6.4 min, respectively (p&amp;lt;0.001). No fluoroscopy was used in significantly more MS compared to MP or IP cases: 72 (45.9%) MS, 10 (10.3%) MP, and 8 (14.5%) IP cases (p&amp;lt;0.001). When these 90 cases were excluded, mean fluoroscopy times were similar between MS, MP, and IP cases (7.1±5.6, 6.8±5.0, and 9.2±5.9 min, respectively (p=0.05)). Acute success rates were not significantly different between modes: 98.6% MS, 100% MP, and 100% IP (p=0.49). Conclusions In this analysis of international usage of a novel software function, cases utilizing MS had significantly shorter fluoroscopy durations with similar acute success rates and procedure durations than those using MP or IP. When zero fluoroscopy cases were excluded, there was no significant difference in fluoroscopy times; however, there were significantly more zero fluoroscopy cases in the MS group, indicating that, while MS supports and may encourage low-fluoroscopy workflows, differences in procedural metrics seen may be biased by operator preference. Future analyses are warranted to provide insight into operator-specific metrics when using MS.Fluoroscopy Duration Comparison

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

Abstract Background Pulmonary vein isolation (PVI) with the use of an endoscopic laser balloon (ELB) is an alternative option for catheter ablation of atrial fibrillation (AF). The third-generation system has several improvements, including the novel RAPID mode (RM), potentially allowing a one-shot, continuous, circumferential laser lesion for PVI. Objective In an international, multicentric cohort, we assessed the third-generation ELB’s safety, efficacy, and long-term effectiveness. We also focused on the learning curve (LC) and the use of RM. Methods Between June 2019 and December 2022, we prospectively obtained data on all the patients who consecutively underwent ablation of AF using the third-generation ELB in eight Italian and one German hospital. Each operator attempted to use the RM to the maximum extent in every procedure. Follow-up (FU) visits were scheduled at 3, 6, 12 and 24 months and included a Holter-ECG of 24 hours or, if the patient was a carrier, a device interrogation (implantable loop recorder or two-chamber/three-chamber pacemaker/defibrillator). For FU analysis, we included patients with data available after the blanking period (the first 90 days after the procedure). We analysed the LC, comparing the outcomes of the first fifteen patients of each centre with the remaining patients. In addition, we investigated the impact of an extensive use of the RM (at least 90% of all PV circumferences) on the procedural and FU outcomes. Results we enrolled 427 patients. Of these, 328 had a FU &amp;gt;90 days. The mean total procedural and fluoroscopic times were 105 (66-150) and 17 (10-28) minutes, respectively. Serious adverse procedural events occurred in 11 patients (2.6 %) as follows: 3 periprocedural transient ischaemic attacks, 4 pericardial tamponades, 1 persistent phrenic nerve palsy and 3 severe vascular complications. The mean FU period was of 365 days (194-533). AF recurrence-free rate was 76.7% (95% CI, 70.8%-81.5%) at 12 months. Median RM use was 94% (81-100) of the PVs circumference. RM could be used for at least 90% of all PV circumferences in 188 (55.8%) patients, and the operators could perform an RM-only procedure in 82 (24.3%) patients. Patients treated after the LC or with extensive use of RM showed significantly reduced procedural times and rates of AF recurrence. In a multivariate analysis, the use of the RM was not an independent predictor of a lower recurrence rate at FU, demonstrating only a tendency toward significance (86.0% [77.3-91.6] vs 71.3% [61.3-79.2], HR 0.52, CI 0.26-1.07, p 0.075). Conclusion In this prospective, multicentre, international registry of patients treated with the third-generation ELB, the system proved efficient, safe, and effective. Completing the LC and using the RM reduced procedural time and arrhythmia recurrence. However, using RM was not an independent predictor of a lower recurrence rate.