Procedure Time Research Articles

Case Volume Is Not Associated With Outcomes After Adrenalectomy Performed by Urologic Surgeons.

Our goal was to compare outcomes of adrenalectomy performed by low-volume and high-volume academic urologists with extensive experience in renal surgery. A single-center retrospective review identified patients undergoing adrenalectomy by urologists from 2009 to 2023. Data were gathered on demographics, tumor characteristics, surgeon volume, surgical outcomes including length of procedure, estimated blood loss, length of stay, and complications identified by the Clavien-Dindo complication classification system. Bivariable and multivariable analyses adjusting for BMI, size of mass, age, and surgical approach compared outcomes between low- and high-volume adrenalectomy surgeons. A total of 304 adrenalectomies were performed by 7 urologic surgeons during the study period. One surgeon was high volume, with an average of 15 adrenalectomies per year during the study period. The remaining 6 surgeons ranged from < 1 to 4 adrenalectomies per year on average during the study period and were considered low volume. On multivariable analysis, the rate of any complication was found to be significantly different between the groups (5.3% vs 13.5%, P = .01). However, on analysis of Clavien 3 or higher complications, the rate was not found to be different (1% vs 4%, P = .22). Procedure time (130 vs 134 minutes, P = .33), estimated blood loss (30 vs 50 mL, P = .86), positive margin rate (11% vs 7%, P = .35), and length of stay (2 days vs 2 days, P = .22) were not different when the surgery was performed by a high-volume or low-volume urologist. Surgical volume may not affect outcomes of adrenalectomy when performed by urologists experienced in retroperitoneal surgery at a high-volume, specialized center.

Perioperative Management of Pediatric Combined Heart and Liver Transplantation: A 17 year single center experience.

An increasing number of centers are undertaking combined heart and liver transplantation in adult and pediatric patients with congenital heart disease. The primary aim of this study was to describe the perioperative management of a single center cohort, identifying challenges and potential solutions. We conducted a retrospective review of all patients undergoing combined heart and liver transplantation at Stanford Children's Hospital from 2006 to 2022. Preoperative information included cardiac diagnosis, hemodynamics, and severity of liver disease. Intraoperative data included length of surgery, cardiopulmonary bypass time, and blood products transfused. Postoperative data included blood products transfused in the intensive care unit, time to extubation, length of intensive care unit stay, survival outcomes and 30-day adverse events. Eighteen patients underwent en bloc combined heart and liver transplantation at Stanford Children's Hospital from 2006 to 2022, and the majority 15 (83%) were transplanted for failing Fontan circulation with Fontan Associated Liver Disease. Median surgical procedure time was 13.4 [11.5, 14.5] h with a cardiopulmonary bypass time of 4.3 [3.9, 5.8] h. Median total blood products transfused in the operating room post cardiopulmonary bypass was 89.4 [63.9, 127.0] mLs/kg. Nine patients (50%) had vasoplegia during cardiopulmonary bypass. Activated prothrombin complex concentrates were used post cardiopulmonary bypass in 15 (83%) patients with a 30-day thromboembolism rate of 22%. Median time to extubation was 4.0 [2.8, 6.5] days, median intensive care unit length of stay 20.0 [7.8, 48.3] days and median hospital length of stay 54.0 [30.5, 68.3] days. Incidence of renal replacement therapy was 11%; however, none required renal replacement therapy by the time of hospital discharge. Neurological events within 30 days were 17% and the 30 day and 1 year survival was 89%. Perioperative challenges include major perioperative bleeding, unstable hemodynamics, and end organ injury including acute kidney injury and neurological events. Successful outcomes for en bloc combined heart and liver transplantation are possible with careful multidisciplinary planning, communication, patient selection, and integrated peri-operative management.

Development of a Novel Airway-Exchange Broncholaryngoscope.

The purpose of this project was to develop a novel airway-exchange broncholaryngoscope (AEBLScope) to improve the efficiency and accuracy of airway-exchange procedures. The AEBLScope was designed to combine a bronchoscope and airway-exchange catheter (AEC) into a single device and to reduce the blind placement of AECs. The prototype was constructed by modifying an existing distal-chip bronchoscope. A custom AEC was procured to fit concentrically over the flexible portion of the scope. The catheter was connected to the scope handpiece by a customized push-pull locking attachment. The AEBLScope was used to perform airway-exchange procedures with both tracheostomy and endotracheal tubes using two different airway models. Experimental procedures were recorded with still photography to evaluate the exchange of tubes and placement of AECs. In two airway models using the AEBLScope, both tracheostomy and endotracheal tubes were successfully exchanged on first-pass attempt, and AECs were accurately placed under visual guidance. The AEBLScope combines a bronchoscope and AEC into a single tool. Based on these first results, this novel scope has the potential to perform airway-exchange procedures more safely compared with standard procedures by increasing the accuracy of placement, decreasing procedural time, and reducing the morbidity and mortality that can occur from blind placement of AECs. NA Laryngoscope, 134:4488-4493, 2024.

The effects of maternal voice on pain during placement of peripherally inserted central catheter in neonates

BackgroundPeripherally inserted central catheter (PICC) are a necessary procedure for preterm newborns care. Despite the use of analgesic treatments, its insertion can be painful. Our objective was to study the effect of maternal voice on pain during PICC insertion.MethodWe conducted a pre post study for 2 years. Pain was compared between the two groups (with/without maternal presence) using a neonatal pain scale (FANS). Infection rate, procedure time, number of failures, mothers’ anxiety and caregivers’anxiety were compared between the two groups.ResultsNinety neonates were eligible. Finally, 63 neonates were included. Thirty-four placements were realized without maternal voice (first period) and 29 with maternal voice (second period). Mean FANS during PICC placement was lower in the maternal voice group than in the control group (1.15 ± 1.27 vs. 1.41 ± 1.49, p = 0.033). The FANS was also lower in the maternal voice group during the time of the first cutaneous effraction (p = 0.032). There was no significant difference between the two groups concerning the other outcomes.ConclusionMaternal voice added to conventional care decreased acute pain during PICC insertion without increasing infection rate, number of failures or procedure time.

Safety and efficacy of brachial approach for coronary angiography and percutaneous coronary intervention

Abstract Background There are many feasible ways to reach the coronary arteries through a percutaneous technique. Till now, the most commonly used approach is the radial artery approach because it has the lowest risk of known vascular adverse events. However, it could not be an option in some situations as congenital radial artery hypoplasia and radial artery spasm. In these cases, the second most common access is the femoral artery access. The current literature over the brachial artery access is controversial. Our study's objective is to verify the brachial artery approach's effectiveness and safety. Methods We studied 300 patients who underwent elective coronary angiography and percutaneous angioplasty in our institution with failed radial access between August 2022 and February 2023. They were classified into two groups; 150 patients in a group with brachial access and 150 in a group with femoral access. Baseline clinical and demographic traits of all enrolled patients were obtained from hospital records and the cardiovascular risk factors were identified. Venous blood samples, resting 12-lead electrocardiogram and transthoracic echocardiography were done before the coronary angiography. Access, procedural and fluoroscopy times were recorded. Doppler evaluations of both brachial and femoral arteries were done the day after the procedure. All patients were examined carefully immediately after the procedure and before discharge to assess any complications. Results Our data showed that no statistically significant difference between the studied groups regarding the cardiovascular risk factors, demographic, clinical and laboratory characteristics. Left brachial access was used more frequently than left femoral access (32.7% vs. 22.7%, p= 0.05), but no significant difference regarding right sided or bilateral access. Procedure time, fluoroscopy time, and contrast volume did not differ significantly (p=0.19, 0.06 and 0.1 respectively). However, brachial group had shorter access time (2.6 ±1.1 vs. 3.4 ± 0.7 minutes, p=0.05) and shorter hospital stay (3.5 ± 1.1 vs. 5.9 ± 1.3 days, p&amp;lt;0.001). Regarding complications, both major and minor complications were significantly lower in the brachial arm (p=0.04 and 0.05, respectively). Conclusion Brachial artery access is a safe, efficient alternative and non-inferior to the femoral route for coronary intervention whenever radial access is not an option.

Single versus double transseptal puncture for pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation - insights from "Go for Zero Fluoroscopy" registry

Abstract Background Transseptal puncture is one of the most challenging steps in catheter ablation of atrial fibrillation (AF) because of the potential risk of complication. While single TSP reduces the puncture-related risk, double TSP simplifies the procedure (immediate signal visualization in pulmonary veins, avoidance of multiple changes of catheters through the single sheath). The purpose of this study was to analyze the impact of single versus double TSP during pulmonary vein isolation (PVI) with radiofrequency (RF) catheter ablation for AF on the fluoroscopy usage and procedure time. Methods Data reported from the international, multicenter prospective „Go For Zero Fluoroscopy Registry" performed in years 2018–2019 were analyzed. Overall 25 European electrophysiology centers from 14 countries and up to 5 operators from each center were enrolled. Only isolated PVI procedures were analyzed. Results A total data of 393 PVI RF procedures were collected from 25 centers. The median dose-area-product (DAP), fluoroscopy time and overall procedure time were: 810 (325 – 1839) cGy*cm2, 8 (4 – 14) minutes and 124 (92 – 168) minutes, respectively. Single TSP was associated with significantly higher DAP: 984 (459 – 1939) vs 667 (227 – 1469) cGy*cm2 (p=0.002), longer fluoroscopy time: 11 (6 – 19) vs 6 (3 – 11) minutes (p&amp;lt;0.001) and longer overall procedure time: 133 (103 – 168) vs 110 (90 – 168) minutes (p=0.003) as compared with double TSP. Single and double TSP group did not differ significantly in regards of general anesthesia usage, circular and multipolar mapping catheter use (p&amp;gt;0.05). However, single TSP was performed by operators with longer EP lab experience: 10 (4 – 15) vs 3 (0 – 10) years (p&amp;lt;0,001). Conclusions Double TSP is related with lower fluoroscopy usage and shorter overall procedure time of pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation.

Posterior wall isolation for persistent atrial fibrillation catheter ablation: an updated systematic review and meta-analysis

Abstract Background The ability of catheter ablation (CA) to prevent arrhythmic recurrences in patients with persistent atrial fibrillation (PeAF) remains suboptimal. In this context, the results of studies conducted with both thermal and non-thermal technologies, that evaluated the effect of adding electrical isolation of the posterior wall of the left atrium (PWI) to isolation of the pulmonary veins alone (PVI) have provided conflicting data. Purpose To compare the efficacy and safety of an ablative strategy with the addition of PWI to PVI versus PVI alone in patients with PeAF undergoing a first ablation procedure. Methods We searched electronic databases for observational studies and randomized controlled trials (RCTs) comparing PVI+PWI versus PVI alone as first CA procedure for PeAF, regardless of the technologies used. The efficacy outcomes were recurrence of any atrial tachyarrhythmias lasting more than 30 seconds, recurrence of atrial fibrillation (AF) and atrial flutter/atrial tachycardia (AFlu/AT). The safety outcome was relevant procedural complications defined as a composite of vascular complications, pericardial effusion or tamponade, phrenic nerve palsy, stroke, atrio-esophageal fistula, and death. The procedural time was compared between the ablation strategies studied. The software RevMan 5.4 was used to estimate the risk ratio (RR) and mean difference (MD) with the relative confidence intervals (CI), using a random-effect model. Results Thirteen studies (8 RCTs and 5 observational studies) counting a total of 2994 PeAF patients (1304 treated with PVI+PWI and 1690 with PVI alone; 1847 RF, 600 cryo and 547 PFA) were included in the analysis. Mean age was 65.2±4.1 years, and 26% were female. Mean follow-up period was 14.5±4.8 years. There were no significant differences in the risk of recurrence of any atrial tachyarrhythmias (RR 0.88; 95% CI 0.68-1.14) between the ablation strategies studied. Patients treated with PWI+PVI experienced a reduced risk of recurrence of AF (RR 0.67; 95% CI 0.48-0.94; p = 0.02) balanced by a trend towards increased risk of AFlu/AT (RR 1.74; 95% CI 0.99-3.06; p = 0.06) as compared with PVI alone strategy. No statistically significant differences in the risk of relevant procedural complication were identified between the studied groups (RR 0.94; 95% CI 0.50-1.78 – Fig. 2A). Procedural time was longer in the PWI+PVI group as compared with PVI alone (MD 30.63 min; 95% CI 8.60-52.65 min; p=0.006 – Fig. 2B). Conclusions Our metanalysis shows that, in patients with PeAF treated for the first time with CA, PWI+PVI versus PVI alone was not associated with a reduction of atrial tachyarrhythmias recurrence and required longer procedural times. Nonetheless, a reduction in the risk of AF recurrence and a trend towards an increased risk of AFlu/AT were identified. No differences in the risk of relevant procedural complications were found between the ablation strategies studied.Figure 2

Comparison of procedural analgosedation in patients undergoing pulsed field ablation or cryoballoon ablation for atrial fibrillation

Abstract Background Pulsed field ablation (PFA) has emerged as a novel technology that is increasingly applied for the catheter ablation (CA) of atrial fibrillation (AF) with similar efficacy to established, thermal energy sources. Data solely focussing on analgosedation compared to established single-shot modalities, such as cryoballoon (CB) ablation are scarce. Aim The aim of this study was to assess differences of analgosedation requirement, procedural cardiopulmonary stability, and analgosedation-associated complications between PFA and CB ablation. Methods This study was a retrospective single-centre comparison of analgosedation in patients with paroxysmal, persistent, and long-standing persistent AF undergoing pulmonary vein isolation (PVI) with either PFA or CB from March 2021 until April 2022. The primary study endpoints were the requirements of analgosedation medications (propofol, midazolam and sufentanyl), cardiorespiratory stability measured as decreases in oxygen saturation and systolic blood pressure and analgosedation-associated complications. Secondary endpoints were acute procedural success, procedure time and overall complication rates. Results A total of 100 patients were included {PFA n=50, CB n=50, mean age 66 ± 10.6, 61% male patients, 65% paroxysmal AF). The body weight – and procedure time-adjusted requirement of all analgosedation medications was significantly higher in the PFA group compared to CB {Propofol 0.14 ± 0.04 mg/kg/min in PFA versus 0.11 ± 0.04 mg/kg/min in CB (p=0.001); midazolam 0.00086 ± 0.0004 mg/kg/min in PFA versus 0.00063 ± 0.0003 mg/kg/min in CB (p=0.002) and sufentanyl 0.0013 ± 0.0007 µg/kg/min in PFA versus 0.0008 ± 0.0004 µg/kg/min in CB (p&amp;lt;0.0001)}. Procedural cardiorespiratory stability did not differ between groups (maximum blood pressure decrease PFA 53.4 ± 20.9 mmHg, CB 50.3 ± 18.6 mmHg, P=0.28 and maximum decrease in oxygen saturation: PFA group 4.8 ± 5.3 %, CB group 3.5 ± 2.6 %, P=0.12). Analgosedation-associated complications did not differ between both groups (PFA n=1/50 mild aspiration pneumonia, CB n=0/50, p=0.99). There was no significant difference in acute procedural success (100% n=50/50 in both groups, p&amp;gt;0.99), non-analgosedation associated complications (PFA: n=2/50, 4%, CB: n=1/50, 2%, p=0.99) and procedure times (PFA 75 ± 31, CB 84 ± 32 mins, p=0.18) between groups. Conclusions Pulsed field ablation is associated with higher sedation and especially analgesia requirement compared to cryoballoon ablation, however, the safety of analgosedation does not differ significantly to cryoballoon ablation.

Comparative effectiveness of pulsed field ablation and cryoballoon ablation for atrial fibrillation: a systematic review and meta-analysis

Abstract Background Cryoballoon ablation (CBA) is a well-established technique for treating atrial fibrillation (AF), with a low complication rate related to cryoenergy-induced lesions. Pulsed Field Ablation (PFA) has emerged as a non-thermal alternative, with promising potential to further reduce complications. Purpose We aim to conduct a systematic review and meta-analysis comparing the efficacy and safety of PFA versus CBA in patients with AF. Methods We conducted a systematic search across PubMed, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials (RCTs) or observational studies published between 2013 and 2024 that compared PFA and CBA ablation techniques in patients with AF. Statistical analysis was carried out utilizing RevMan 5.1.7. Heterogeneity was assessed with I² statistics; p-values inferior to 0.05 and I²&amp;gt;25% were considered as significant heterogeneity. Results A total of 840 studies were screened in the initial search, and 26 studies were selected for full-text review based on inclusion criteria. Out of these, 8 observational studies involving 3,113 patients were included. Among these, 1,088 (34.9%) underwent PFA, while 2,025 (65.0%) underwent CBA. Periprocedural complications were significantly lower in patients who underwent PFA compared with the CBA group (RR 0.46; 95% CI 0.29 to 0.74; p=0.001; I²=1%; Fig. 1A). Furthermore, there was a significant reduction in procedure time in the PFA group (MD -8.21 min; 95% CI -13.74 to -2.69; p=0.004; I²=96%; Fig. 1B). However, no statistically significant difference was observed among groups regarding fluoroscopy time (MD 1.63 min; 95% CI -0.22 to 3.48; p=0.08; I²=92%; Fig. 2A), or recurrence of atrial arrhythmias after the blanking period (RR 0.84; 95% CI 0.68 to 1.04; p=0.12; I²=6%; Fig. 2B). Additionally, a subgroup analysis involving only propensity score-matched cohorts was conducted but didn’t show any statistical difference for any outcomes evaluated. Conclusion In this systematic review and meta-analysis, PFA was associated with a lower risk of periprocedural complications and a shorter procedure duration, compared to CBA in patients with AF. Additionally, it didn’t show a potential for reducing the recurrence of atrial arrhythmias, and the data regarding fluoroscopy time were inconclusive.Primary outcomesSecondary outcomes

Interventional treatment of patients with hypertrophic obstructive cardiomyopathy: the immediate and long-term results

Abstract Background Alcohol septal ablation (ASA) is a widely accepted and effective procedure for reducing septal thickness in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) who do not respond to medical treatment and have significant outflow tract gradients. Despite numerous studies confirming its safety and efficacy, as well as current guidelines from 2020 recommending ASA as a class 1 treatment option alongside surgical myectomy[1], the decision between these methods is still a subject of debate. Methods From 2009 to 2022 154 ASA performed in 145 patients (91 males, 54 females) with HOCM at our centre. Mean age of pts. was 42 [6;77] years. All pts. had right ventricle pacing lead with pacemaker backup and myocardial contrast ECHO(MCE) before procedure. Mean peak pressure gradient (PG) on LVOT was 93,5 ± 8,2 mm. Hg. Mitral valve regurgitation (MR) from moderate to severe was in all pts. Mean interventricular septum thickness was 2,5сm [1,6; 3,8]. Results Mean PG on LVOT decreased from 93,5 ± 8,2 mmHg to 31,7±4,3 mmHg. The grade of MR reduced from at least moderate to mild or even trivial. The procedure – related mortality was 1,3%. In 3 cases (2%) the procedure was aborted by he MCE data. Mean follow up for 145pts (100%)was 91±4,6 months. 112(77,3%) pts had PG reduction (to ≤30 mtmHg) – regarded as good result of procedure. 19 (13,1%) pts had PG &amp;gt; 30mmHg, but significant improvement in symptoms. Long term mortality in ASA pts. was 2.7%. 10(6.9%) pts needed redo procedure due to residual LVOTO, which was effective. 13(8,9%) patients had complete AV block and required permanent pacemaker. Mean interventricular wall thickness decreased from 2,5±0,3сm to 1,8±0,2cm. MR decreased from at least moderate to mild or complete disappearance. NYHA class reduced from 2,9 to 1,2. Conclusions ASA is effective and safe method of HOCM treatment. Accumulation of the experience can lead to a reduction in procedure time, a decrease in the number of complications, and an overall improvement in the outcomes of interventional HOCM treatment.

Ultrasound-guided versus palpation-guided techniques for vessel catheterization in children undergoing cardiac surgery. A systematic review and meta-analysis of randomized controlled trials

Abstract Background Pediatric heart surgery is the first treatment option for congenital heart disease, which is the leading cause of death in Children. Arterial cannulation (AC) and Central venous catheter (CVC) are required in pediatric cardiac surgery for continuous monitoring of the central venous pressure (CVP), replacement of fluid and blood products, close hemodynamic monitoring, and frequent sampling for arterial blood gases (ABG). Purpose We aim to assess the efficacy and safety of the ultra-sound guided technique compared to the traditional palpation-guided technique for vessel catheterization in children undergoing cardiac surgery. Methods A systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) studies obtained from PubMed, Embase Cochrane, Scopus, and WOS until February 2024. We used the fixed-effects model to report dichotomous outcomes using risk ratio (RR) and continuous outcomes using mean difference (MD) with a 95% confidence interval (CI). Results Thirteen RCTs with 1060 children were included. Regarding arterial cannulation, ultrasound-guided technique was associated with a statistically significant increase in successful cannulation [RR: 1.31 with 95% CI (1.10, 1.56), P&amp;lt; 0.0001], and first-attempt success [RR: 1.88 with 95% CI (1.35, 2.63), P&amp;lt; 0.0001]; however, it was not associated with any statistically significant difference in venous cannulation in both outcomes with [RR: 1.13 with 95% CI (0.98, 1.30), P= 0.10], [RR: 1.53 with 95% CI (0.86, 2.71), P= 0.15] respectively. Moreover, ultrasound-guided technique was associated with a statistically significant decrease in the number of attempts either in arterial cannulation with [MD: -0.73 with 95% CI (-1.00, -0.46), P&amp;lt; 0.0001] or in venous cannulation with [MD: -1.34 with 95% CI (-2.55, -0.12), P= 0.03], and the time of attempted cannulation also either in arterial cannulation with [MD: -2.27 with 95% CI (-3.38, -1.16), P&amp;lt; 0.0001] or in venous cannulation with [MD: -4.13 with 95% CI (-7.06, -1.19), P&amp;lt; 0.0001]. Finally, ultrasound-guided technique was associated with a statistically significant decrease in the incidence of any complications either in arterial cannulation with [RR: 0.36 with 95% CI (0.18, 0.71), P&amp;lt; 0.001] or in venous cannulation with [RR: 0.30 with 95% CI (0.11, 0.84), P= 0.02]. Conclusion Ultrasound-guided arterial catheterization increases the number of successful catheterizations and first-attempt success rate; however, there was no significant difference in venous cannulation, while both arterial and venous cannulation were associated with decreased number of attempts, reduced overall procedure time, and decreased incidence of complications.

Pulsed field ablation using additional mapping and substrate modification to treat atrial fibrillation - one year outcome comparison

Abstract Background Pulsed field ablation (PFA) is a relatively new non-thermal form of ablation employing irreversible cell electroporation as an alternative to radio-frequency ablation. Conventional use of PFA relies on fluoroscopy. Electro-anatomical and voltages mapping (EAM) may potentially provide refinement of PFA via ablation of non-PV targets and accurate localisation of catheter placement. Currently there is limited data on the efficacy of the use of voltages criteria of EAM in conjunction PFA in the treatment of atrial fibrillation. Objective The aim of our study was to determine the effect on atrial arrhythmia recurrence with the use of EAM with PFA in patients requiring atrial fibrillation ablation. Methods This single centre retrospective observational analysis included one hundred patients with symptomatic AF (paroxysmal and persistent) undergoing ablation for the first time. Fifty patients underwent PFA-PVI alone and fifty patients underwent PFA-PVI with EAM. Data were obtained on patient characteristics, outcomes, procedure details and complications up to one year. A blanking period of three months was used post-ablation. For rhythm monitoring we utilised ECGs and holters at three, six, nine and twelve months and twenty-four hour holter monitoring at six and nine months. We also used remote monitoring in between these periods to record any symptomatic episodes atrial arrhythmias. Results Baseline patient characteristics are represented in Table 1. Despite having no significant difference in category of AF between groups (Paroxysmal, persistent, longstanding persistent) the mapping group were significantly older (68.2 years ± 10.2 vs 60.1 ± 11.11; p=0.01), longer duration of documented atrial fibrillation (45.9 ± 50 vs 28.6 ± 38 months; p=0.038), higher risk for CV events with CHA2DS2-VASc score (2.2 ± 1.5 vs 1.42 ± 1.2; p=0.04), however, procedure times were greater in the PVI and mapping group (72.8 ± 6.2 vs 41.1 ± 17 minutes; p=0.03). Successful PVI was achieved acutely in all patients upon voltage guided mapping validation and most importantly 1 year follow up revealed comparable outcome in both groups (Fig 1). Conclusion Patients who underwent PFA with mapping were older, greater co-morbidity and longer duration of AF burden. Yet, the addition of EAM with PFA did demonstrate equivalent achievement of sinus rhythm and was relatively high as higher than 80 % at one year follow up. This study may suggest a preference to using EAM in patients who may be deemed to be older and have a greater co-morbidity. It emerges as a great hope to safer approach and successful intervention to reduce AF burden.mapping vs PVI onlyGraph showing one year follow up

Enhancing guidewire efficacy for transradial access: the EAGER randomised controlled trial

Abstract Background and Purpose The standard J tip peripheral guidewire used to perform coronary angiography was originally designed for transfemoral access and large vascular interventions over 70 years ago. The 3mm J tip on the standard wire is larger than the typical radial artery diameter and has limited ability to navigate smaller tortuous peripheral arteries increasing the risk of vessel spasm, and potentially reducing procedural success. We compared the efficacy and safety of a hydrophilic 1.5mm J tip guidewire (intervention - ‘baby J wire’) upfront versus the standard fixed core 0.035" J wire (‘control wire’). Methods Investigator initiated, blinded multicentre randomised trial conducted in Australia. Patients undergoing clinically indicated transradial coronary angiography were randomized 1:1 to either control or baby J peripheral guidewire use upfront. The primary endpoint was technical success defined as gaining access to the aortic root with the randomised guidewire. Secondary endpoints included total procedural time, time to aorta and coronary intubation, crossover rates to alternate wire or access site, fluoroscopy times, radial artery spasm, haematoma (EASY criteria), bleeding complications (BARC criteria) and vascular complications (VARC 2 criteria). Major adverse cardiac events (MACE) and clinical endpoints were adjudicated by a blinded independent clinical events committee. Results 330 patients were enrolled over a 9-month period from October 2022 to June 2023. The median age was 69 years (36% female), BMI 29kg/m2. The primary efficacy endpoint of technical success was achieved more frequently in the intervention group (96% v 85%; ARR 10.9% (95% CI 4.6 -17.2); P &amp;lt;0.001). Women were significantly more likely to benefit from the intervention related to higher failure rates with the control wire (69% vs 93% in men; P = &amp;lt; 0.001). Overall procedure times were similar between the groups (median 1135 vs 1354 seconds; P=0.094) but fluoroscopy time was lower in the baby J wire group (median 344 vs 491 seconds; P = 0.024). Radial completion of procedures was high and did not differ between groups (100% v 98%; P=0.2). Clinically significant bleeding (BARC2+) was more common in the control wire group (3% v 0%; P=0.017). There were no differences in MACE or vascular complications. Conclusion The hydrophilic 1.5mm J tip Baby J peripheral guidewire leads to greater upfront technical success and reduced fluoroscopy time for transradial coronary angiography compared to the standard 3mm J tip guidewire. The baby J hydrophilic guidewire is safe and may have key incremental benefits for the transradial approach particularly in patients with smaller diameter radial arteries including women.Primary Outcome

A cost-consequence analysis comparing three distinct cardiac ablation strategies for the treatment of paroxysmal atrial fibrillation

Abstract Background Cardiac ablation is a well-established treatment option for preventing atrial fibrillation (AF). While radiofrequency, cryo-energy, and laser energies are commonly employed in catheter ablation, they present the risk of potential damage to adjacent organs such as the oesophagus and phrenic nerve. To address these concerns, new technologies are being explored including pulsed field ablation (PFA), a non-thermal energy approach that employs high-voltage, short-duration pulses to selectively destroy target cells. Purpose The present analysis aims at: i) quantifying the short-term costs related to three ablation strategies for paroxysmal AF (PFA, radiofrequency ablation -RFA-, and cryo-balloon ablation -CRYO-), identify the cost drivers, and assess potential variations in resource consumption for each treatment alternative; ii) comparing the medium-term (1-year) economic implications of adopting the three alternatives, in terms of redo procedures (effectiveness) and complications (safety). Methods A cost-consequence model was developed to compare economic outcomes of the three ablation strategies for paroxysmal AF in the short- (during procedure) and medium-term (1-year). Resource consumption data during the procedure were collected by two European medical centres specialized in cardiac ablation (N=61 patients). For the medium-term analysis, costs were correlated to the effectiveness and safety of the procedures. The clinical data (i.e., redo and complication rates) considered in the model were retrieved from published literature. Costs and tariffs were collected from economic formularies of the respective hospitals. A scenario analysis was conducted to evaluate economic outcomes under various hypothetical difference in the prices of treatment kits. Results A significant difference was registered in terms of pre-procedural (mean±SD: 13.9±4.4 min for PFA, 20.1±7.6 min for CRYO and 20.5±7.7 min for RFA; ANOVA test p=0.003) and procedural time (skin-to-skin), favouring PFA over RFA and CRYO (53.6±26.8 min for PFA, 72.4±28.1 min for CRYO and 149.9±99.9 min for RFA; p&amp;lt;0.0001; Table 1). PFA was associated with lower procedural costs vs CRYO (-€400) and RFA (-€827). A similar economic advantage was observed in the medium-term (Table 2). The scenario analysis showed that PFA would be cost-saving vs CRYO (Δtotal costs ≤ 0) up to a price difference of +€881 (i.e., PFA kit is more expensive than CRYO kit), and similarly, up to a price difference of +€1,306 vs RFA. Above these thresholds, PFA would be considered cost-effective vs CRYO or RFA, due to its efficacy despite being more expensive. Conclusion In summary, PFA emerges as cost-effective or even cost-saving over CRYO and RFA, thanks to its faster execution, lower redo, and complications rate. Moreover, PFA time predictability would facilitate hospital planning. For a complete analysis, these benefits should be evaluated against the difference in acquisition costs among treatments.Procedural time by phase and techniqueCumulative savings per technique

Characterization of sedation strategies in real-world use of pulsed field ablation: sub-analysis of the EU-PORIA registry

Abstract Background/Introduction With the introduction of pulsed field ablation (PFA) to treat patients with atrial fibrillation (AF), there has been interest in studying workflow and sedation strategies to better understand how this new technology can be integrated into clinical practice. Purpose Characterize the use of general anesthesia (GA) versus deep sedation during real-world use of the pentaspline PFA catheter to treat AF. Methods EU-PORIA is an all-comer AF registry enrolling consecutive patients treated with the pentaspline PFA catheter at seven high-volume centers in Europe. Patients were treated based on institutional standard of care. During follow-up, any episode of atrial tachycardia (AT) or AF lasting longer than 30 seconds was considered an arrhythmia recurrence. Results EU-PORIA enrolled 1233 patients, of which 250 ablation cases were performed under GA and 983 cases were performed with deep sedation. Six out of the 7 participating centers employed a single sedation strategy (2 GA; 4 deep sedation), with one center doing a mix of both sedation and GA. The patient population treated with GA had fewer female patients (30% vs 40%; p=0.04), a lower prevalence of hypertension (43% vs 57%; p&amp;lt;0.01), and fewer paroxysmal AF patients (54% vs 62%; p&amp;lt;0.01). The ablation strategy was performed based on operator’s discretion. In the GA group, 72% of patients received a pulmonary vein isolation (PVI)-only ablation approach versus 90% of patients in the sedation group (p&amp;lt;0.01). The most common additional lesion set performed was posterior wall isolation which accounted for 23% and 7% of cases in the GA and sedation groups, respectively (p&amp;lt;0.01). Procedure times and fluoroscopy times were significantly shorter in the sedation group versus the GA group (51 [36-84] min vs 75[60-90] min; 13 [8-19] min vs 19 [15-26] min; p&amp;lt;0.01 for both). Mapping was used in 60% of cases in the GA group versus only 26% of cases in the sedation group. Overall, there were no differences in the incidence of serious adverse events, and no difference in chronic treatment success. At 1-year follow-up, 74.8% of patients (187/250) in the GA group and 73.8% of patients (725/983) in the sedation group were free from recurrent AF/AT. Conclusion(s) In this registry, the use of deep sedation for AF ablation with the pentaspline PFA catheter demonstrated a safety and efficacy profile consistent with those procedures performed under GA. The majority of the deep sedation procedures were PVI-only and performed in a less progressed AF disease state. It is worth noting that there may be certain patient populations and center restrictions where GA will remain the necessary approach for AF ablation. This characterization of real-world use warrants further evaluation to understand optimal sedation strategies that can be used with PFA technologies.

Procedural outcomes of fluoroscopy-less catheter ablation for atrial fibrillation

Abstract Background Radiofrequency catheter ablation is superior therapy to antiarrhythmic drugs for maintaining sinus rhythm in atrial fibrillation (AF) patients. Traditional fluoroscopy-guided AF ablation poses risks of prolonged radiation exposure for both patients and medical staff. Recent advancements in fluoroscopy-less catheter ablation techniques offer potential solutions, but comprehensive data on their effectiveness and safety are lacking. Purpose To evaluate the procedural outcomes and safety of fluoroscopy-less catheter ablation for AF compared to fluoroscopy-guided ablation. Methods Retrospective observational study of consecutive AF ablations (N=881) conducted at a university teaching hospital (Hamilton Health Sciences, Hamilton, Ontario) from November 2017 to September 2022. An electro-anatomical mapping system and ICE was used in all cases. Baseline characteristics and procedural outcomes between the fluoroscopy-less and fluoroscopy-guided groups were compared. Cases that used &amp;lt;60 seconds of fluoroscopy (occasionally used by operators during the placement of an esophageal probe) were included in the fluoroscopy-less group (N= 68). Results Mean age of individuals was 60.6 ± 11 years, 71.7% were male, 72.6% had paroxysmal AF, mean CHA2DS2-VASc score was 1.6 ± 1.4, 11.1% had prior heart failure, and mean left ventricular ejection fraction was 57.5 ± 15%. There were no significant differences in patient baseline characteristics between the fluoroscopy-less and fluoroscopy groups. Total procedure and fluoroscopy times were lower in the fluoroscopy-less group compared to the fluoroscopy-guided group (169.3 ±42 minutes vs. 192.1 ±54 minutes, p&amp;lt;0.0001 and 0.024 ±0.10 vs. 10.0 ±7.4 minutes , p&amp;lt;0.0001). Fluoroscopy-less AF ablation remained an independent predictor of lower procedure times following adjusting for the use of general anesthesia, high-power short-duration, presence of trainees, AF pattern, redo cases, and type of mapping system. Complication rates were similar between fluoroscopy-less and fluoroscopy-guided ablation (1.9% vs. 3.8%, p=0.11). Conclusion Fluoroscopy-less catheter ablation for AF appears to have similar procedural outcomes and safety than fluoroscopy-guided AF ablation.

Safety and efficacy of leadless pacemaker extraction using a novel retrieval tool: a multicenter analysis

Abstract Background Leadless pacemakers (LP) have emerged as a safe and effective alternative for cardiac pacing, increasingly adopted by the medical community. While rare, complications such as pacemaker syndrome or device dislodgment can occur. In such instances, the extraction of the leadless pacemaker and its replacement with a new device should be considered. Purpose This multicenter study aimed to describe the use of the Aveir retrieval sheath during Micra extraction procedure and to assess the success rates and potential complications associated with the procedure. Methods In this observational study, we analyzed prospectively collected data from 14 patients that underwent leadless pacemaker using Abbott retrieval catheter at three high volume centers for pacemaker extraction and leadless implant in United States. Thought femoral vein the Aveir steerable retrieval catheter is advanced to the right atrium and then across the tricuspid valve. Under TEE and fluoroscopy guidance the snare is advanced over the Micra, and the button is secured. A protective sleeve is advanced over the LP. With application of traction to snare and countertraction with the sleeve against the endocardium, the LP is free from the myocardium and removed via the sheath. (Fig. 1) The procedural duration should be intended as the combined total of the time taken for the extraction of the existing pacemaker and the implantation time of the new device. Extractions performed during the first year were described as early and thereafter as late. Procedural success was described as complete extraction of LP without procedural complication. Results The reason for early explant was LP dislodgment and for late explant was pacemaker syndrome. Median time to extraction was 4±2 months in early explant and 35±9 months in late explant. Procedural time in early and late groups was 68.7 and 72.3 min respectively (P=0.32). Fluoroscopy time in early and late groups was 12.2 and 16.4 respectively (P= 0.18). LP was then replaced with a transvenous pacemaker. Success was 100% in both groups. No complication occurred in both groups. Conclusion Micra pacemaker using Aveir retrieval catheter is an effective tool irrespective of dwell time.

HD grid versus circular mapping catheter for assessment of pulmonary vein (pv) reconnections

Abstract Background Traditionally, circular mapping catheters (CMC) have been considered superior to other designs for mapping pulmonary vein reconnections due to the circular shape of the PV ostium. The grid multipolar catheter produces higher definition maps potentially overcoming the disadvantage of being rectangular. Purpose We assessed the acute procedural results, comparing Grid versus CMC in the setting of PV re-isolation to understand if one was superior to the other. Methods In this multicentre randomised controlled trial, 169 patients (62% male; median age 66 years [22-83) underwent repeat ablation, between July 2021 and March 2023, for recurrent symptomatic atrial arrhythmias. We undertook two LA maps for patients, utilising the Grid and the CMC. Blinded maps were collected with both catheters, followed by randomisation to one map for analysis and ablation. The primary outcome was the radiofrequency time required to isolate the pulmonary veins. Secondary outcomes include LA mapping time and density for both catheters, ability to identify pulmonary vein sleeves and duration of the ablation procedure. Results 126 patients had PV reconnections. 66 patients (64% male; median age 65 years [22-83]) in the Grid arm and 60 patients (68% male; median age 65.5 years [31-83]) in the CMC arm. There was one pericardial effusion and one TIA. There was no significant difference (p=0.202) found in the RF time required to achieve PV isolation in both Grid (mean RF time 200 ± 232 secs) vs CMC (mean RF time 169 ± 298 secs) arms. There was no significant difference (p=0.407) found between LA mapping time for the CMC (mean 1047 ± 454 seconds) and the Grid (Median 1080 ± 440 seconds). There was no significant difference (p=0.411) found in the total procedure time for the CMC (mean 122.7 minutes) and the HD grid (130 minutes). There were significantly more (p&amp;lt;0.001) PV mapping points identified with the grid (mean 354±213 points) than the CMC (mean 234±154 points) arm. There was no significant difference in PV sleeve reconnections found (p=0.106) between the grid (120 PV sleeve reconnections with a mean 1.4±0.71 reconnections) and the CMC (98 PV sleeve reconnections with a mean 1.52±0.72 reconnections). Both maps were analysed to assess reconnections on opposing catheter arms. The grid identified 20 PV sleeve reconnections not visible on the CMC, whilst 9 were visible on the CMC and not the grid. Conclusion There was no significant difference found in RF time, mapping time and overall procedure time. The Grid identified more reconnections not seen with the CMC and had an overall improved mapping density suggesting that this configuration could be superior for LA mapping.

A mcgyvering way to left bundle branch area pacing : using the treadmill test machine ECG system and modified V1 / V6 leads connected to the pacing system analyser for left bundle branch area pacing

Abstract Background Left bundle branch area pacing (LBBaP) is a novel pacing modality which provides physiological synchronisation of both the ventricles. However, its use and adoption requires the presence of a standardised electrophysiological (EP) system with 12 lead ECG to show left bundle branch area capture. Purpose The aim of the study was to assess the feasibility and outcomes of using the conventional treadmill test (TMT) machine 12 lead ECG system and modified V1 and V6 leads connected to the pacing system analyser (PSA) to demonstrate conduction system capture during left bundle branch area pacing (LBBaP). Methods LBBaP was attempted by a single operator in a mixed cohort of patients at peripheral hospitals lacking the standardised EP system. The presence of LBB area capture was tested with the aid of the 12 lead ECG system connected to the standard TMT machine (1). Conduction system capture was also assessed using modified V1 and V6 leads connected to the PSA for measurement of V6 left ventricular activation time (LVAT)(2) . The baseline clinical, procedural, pacing, electrocardiographic parameters, echocardiographic response (&amp;gt; 10% improvement in ejection fraction {EF}) and clinical response to LBBaP were assessed. Results LBBaP was attempted in 19 patients and was successful in 18 patients (94.7%). Patient characteristics include age 66.7 +/- 11.47 years, female 47.37%, male 52.63%, ischaemic cardiomyopathy 10.52% and non-ischaemic cardiomyopathy 5.26% .The mean baseline EF and QRS duration was 45%+/-14% and 130.18 +/-10.45 milliseconds(ms) respectively. LBBaP threshold was 0.59 +/-0.168 volts and R wave amplitude was 12+/-3.5 millimetres , which remained stable during the mean follow up of 15.9 +/-13.67 months. The mean fluoroscopic duration was 11.57 +/-2.58 minutes and procedural time was 108.78+/-29.20 minutes. LBBaP resulted in impressive narrowing of the QRS duration to 102.39 +/-10.55 ms (p&amp;lt;0.001) with LVAT of 68.94 +/-9.94 ms. LVEF improved in the patients with cardiomyopathy from 33.4 +/- 5.77 % to 48.2+/-12.37 % (p=0.028) .Clinical and echocardiographic response was noted in 87.5% of patients with cardiomyopathy. Conclusion The 12 lead ECG system with the standardised TMT machine in conjunction with the modified V1 and V6 leads connected to the PSA is a feasible alternative to the EP system to perform successful left bundle branch area pacing.ECG leads connected during LBBapClinical profile of patients

Retrograde coronary chronic total occlusion intervention (JR-CTO) score: from the Japanese CTO-PCI expert registry

Abstract Background Despite the effectiveness of the retrograde approach for chronic total occlusion (CTO) lesions, there are no standardized tools to predict the success of retrograde percutaneous coronary intervention (PCI). Purpose The objective of this study was to develop a prediction tool to identify CTO lesions that will achieve successful retrograde PCI. Methods This study evaluated data from 2,374 patients who underwent primary retrograde CTO-PCI and were enrolled in the Japanese CTO-PCI Expert Registry between January 2016 and December 2022. All observations were randomly assigned to the derivation and validation cohorts at a 2:1 ratio. The prediction score for guidewire failure in retrograde CTO-PCI was determined by assigning one point for each factor and summing all accrued points. Results The JR-CTO score (moderate–severe calcification, tortuosity, Werner collateral connection grade ≤ 1, and non-septal collateral channel) demonstrated a c statistic for guidewire failure of 0.72 (95% confidence interval: 0.67–0.76) and 0.71 (95% confidence interval: 0.64–0.77) in the derivation and validation cohorts, respectively. Patients with lower scores had higher guidewire and technical success rates and decreased guidewire crossing time and procedural time (P &amp;lt; 0.01). Conclusions The JR-CTO score, a simple four-item score that predicts successful guidewire crossing in patients undergoing retrograde CTO-PCI, has the potential to support clinical decision-making for the retrograde approach.