Significant Difference In Fluoroscopy Time Research Articles

Leadless pacemaker implantation versus conventional transvenous cardiac pacing early after transcatheter aortic valve replacement: a safe and relevant option?

Abstract Background Leadless pacemakers (LPM) are known to have lower postoperative complications than conventional transvenous cardiac pacing especially in frail patients (pts) with many comorbidities. The aim of this study was to assess the "real-life" feasibility and outcomes of LPMs compared to transvenous pacemakers (TPMs) in patients who underwent transcatheter aortic valve replacement (TAVR). Methods This is a retrospective single center study including all consecutive patients who received LPM or TPM (either single or double chamber) implantation early after a TAVR over a one-year period since September 2022 with a follow up period of at least 3 months. Results 71 pts were included (mean age 82,56 ± 7,1 years old). 16 pts underwent LPM implantation (22,5%). Leadless system pacing was preferred in pts with history of active systemic infection 43,8%, complex conventional vascular approach 12,5 %, deterioration of general condition and clinical frailty 18,8% and history of breast cancer in 25 % pts. Mean time between appearance of conductive disorders and pacemaker implantation was longer (2,9± 2,8 vs 1,5 ± 1,3 days; p=0,06) in the LPM group probably due to organizational issues. Procedure duration was significantly shorter in the LPM group (46 ±20,5 vs 69 ± 21,1 min; p = 0,01). There was no statistically significant difference in fluoroscopy time between the 2 groups even though this parameter was longer in the LPM group (6,8 min vs 5,6 min; p = 0,413). Significantly lower thresholds were observed in pts with LPM implantation (0,45 ± 0,33 vs 0,66 ± 0,25 V; p = 0,017) with no statistically significant difference between the 2 groups concerning the per-operative impedance value. Median time from pacemaker implantation to discharge was 3,12 ± 3,26 vs 4,78 ±7,16 days after LPM and TPM implantation respectively (p = 0,195). There were less complications in the LPM group (1,4 % vs 9,9 %; p = 0,471). Complications were: arteriovenous fistula for 1 pt with LPM vs 2 pocket hematomas, 1 pneumothorax, 1 per-operative cardiac arrest and 3 leads dislodgements in pts with TPM. The mortality rate was significantly higher in the LPM group (4,2 % vs 2,8 %; p = 0,038) although no pacemaker related deaths were reported in both groups and no significant difference between the 2 groups was noted concerning rehospitalisations for cardiovascular cause (p= 0,407). Conclusion Early LPM implantation after TAVR is a feasible alternative to conventional pacing with significantly shorter procedure durations and better pacing thresholds. Our experience confirms the global clinical frailty of patients receiving LPM after TAVR but underlines the favorable safety profile of leadless system pacing with a low rate of complications.

Safety and feasibility of zero-fluoroscopy technique in ablation-index guided pulmonary vein isolation: a prospective, single center trial

Abstract Introduction Pulmonary vein isolation (PVI) represents the cornerstone of catheter ablation procedures in patients with symptomatic paroxysmal/persistent atrial fibrillation (AF). Conventionally, PVI is performed using fluoroscopy, but it can also be performed using the zero-fluoroscopy (ZF) technique with the assistance of electroanatomical mapping systems and intracardiac ultrasound, achieving fluoroscopy-free procedures. Purpose Our study aimed to compare procedural data of ablation-index guided point-by-point radiofrequency (RF) PVI performed with non-zero-fluoroscopy (NZF) vs. ZF approaches. Methods We enrolled 100 consecutive patients undergoing PVI for antiarrhythmic drug- refractory AF in our prospective observational study. In the first 50 cases, PVI was performed using the NZF technique, and in the other 50 cases, the ZF technique was applied. Procedural time, fluoroscopy exposure, ablation parameters, and the occurrence of complications were compared between the two groups. Results Compared to the NZF group, procedural time (59.6±10.7 min vs. 74.6±13.2 min, p<0.0001) was significantly shorter in the ZF group. This difference was mainly driven by the time from puncture to the beginning of left atrial mapping, which was significantly longer in the NZF group (17 [16; 20] min vs. 31 [23; 34.5] min, p<0.001). No differences were found between the two approaches in the number of RF applications (81 [73; 103] vs. 83 [71; 91], p=0.67), total ablation energy (54986 ± 13093 Ws vs. 55500 ± 11907 Ws, p=0.48), and the left atrial dwelling time (41.5 [36; 52.5] min vs. 40.5 [35; 46], p=0.14). No complications occurred in either group. In the ZF group, complete elimination of fluoroscopy was achieved in all cases, resulting in significant differences in fluoroscopy time (0 [0; 0] sec vs. 132 [100; 160] sec, p<0.0001] and dose (0 [0; 0] mGy vs. 4.8 [4.1; 8.2] mGy, p<0.0001) compared to the NZF technique. The acute success rate was 100% in the study population, and no complications occurred during the study period. Conclusion Ablation-index guided ZF PVI is feasible and safe. Using this technique, the procedure time can be shortened besides achieving a similar acute success rate without increasing complications.

Feasibility study of cryoballoon ablation for atrial fibrillation with KODEX-EPD: a single center experience

To evaluate the feasibility of cryoballoon (CB) ablation of atrial fibrillation (AF) under the guidance of a new three-dimensional (3D) mapping system KODEX-EPD. 40 patients scheduled for CB ablation of AF in the first affiliated Hospital of Xinjiang Medical University from August 2021 to July 2022 were randomly divided into two groups: KODEX-EPD 3D mapping system guidance group (KODEX group, n = 20) and conventional two-dimensional perspective group (standard group, n = 20). The ablation time, operation time, fluoroscopy time, fluoroscopy dose, contrast agent dosage and follow-up data were compared between the two groups. Besides, the feasibility and accuracy of the dielectric sensing system in evaluating pulmonary vein (PV) occlusion in patients with AF during CB ablation were verified. All pulmonary veins were being isolated. The ablation time (36.40 ± 6.72 min vs 35.15 ± 6.29 min, P > 0.05) and the operation time (64.20 ± 11.82 min vs 66.00 ± 13.18 min, P > 0.05) were not statistically different in the two groups. The standard group has longer fluoroscopy time, dose and contrast medium dosage. There were significant differences in fluoroscopy time (532.30 ± 72.83 s vs 676.25 ± 269.33 s, P < 0.05), fluoroscopy dose (110.00 ± 28.64 mGy vs 144.68 ± 66.66 mGy, P < 0.05), and contrast medium dosage (71.90 ± 5.97 ml vs 76.05 ± 5.93 ml, P < 0.05) between the two groups. The learning curves of the first 5 patients and the last 15 patients in the KODEX group were compared. There was no statistical difference in the ablation time (36.80 ± 8.56 min vs 36.27 ± 6.34 min, P > 0.05) or the operation time (69.00 ± 5.00 min vs 62.60 ± 13.10 min, P > 0.05); however, compared to the first 5 patients, fluoroscopy time (587.40 ± 38.34 s vs 513.93 ± 73.02 s, P < 0.05), fluoroscopy dose (147.85 ± 35.19 mGy vs 97.39 ± 8.80 mGy, P < 0.05) and contrast medium dosage (79.60 ± 1.14 ml vs 69.33 ± 4.45 ml, P < 0.05) were significantly decreased. Using pulmonary venography as the gold standard, the sensitivity, specificity of the completely occlusion in KODEX group was 93.6% (95% CI 85–97.6%) and 69.6% (95% CI 54–81.8%); and the sensitivity, specificity of the small leak in KODEX group was 93.1% (95% CI 82.4–97.8%) and 82.0% (95% CI 65.9–91.9%). During an average follow-up of (9.90 ± 1.06) months, there was no statistical difference in arrhythmia recurrence and antiarrhythmic drugs taking after CB ablation between the two groups (P > 0.05). Using the KODEX-EPD system, the CB ablation procedure can correctly evaluate the PV occlusion, and significantly reduce fluoroscopy exposure and contrast medium without significantly increasing the operation time.

Clinical significance of the DUS4ABL strategy for systematically guiding left atrial and ventricular electrophysiological procedures

Abstract Funding Acknowledgements Type of funding sources: None. Background The ultrasound evolved as an indispensable tool to guide electrophysiological (EP) procedures (i.e., gain femoral access, transseptal puncture or exclude pericardial effusion). However, there are no data regarding the course and safety features of ablation procedures in a systematic ultrasound-guided approach. Purpose The aim of this study was to investigate if the systematic use of ultrasound in the course of all ablation procedures with transseptal punction benefits the outcome especially reducing major complication rates and benefitting the process with a reduction of procedure time and fluoroscopy time and dose. This approach consisted of for elements: Firstly the transesophageal echocardiography ruling out left atrial thrombi in the EP laboratory, secondly the ultrasound guided femoral vein puncture, thirdly the transesophageal guided transseptal punction (TSP) and fourthly ruling out pericardial effusion peri and post procedural (TTE), summarized as the DUS4ABL strategy. Methods A cohort of 222 patients undergoing LA or LV electrophysiological ablation guided by the DUS4ABL strategy were compared to a historical cohort of 299 undergoing the same type of procedure using only TTE post procedural to rule out pericardial effusion and in some cases having ruled out left atrial thrombi via TEE in an independent examination up to 7 days prior to the electrophysiological procedure. In the standard group the femoral access was performed by palpation only, the transseptal punction was managed pressure and fluoroscopy guided. Comorbidities, medication and epidemiological data were recorded and analyzed such as major complications specifically: Pericardiac tamponade, strokes, pseudoaneurysms of the femoral vein and artery, atrio-esophageal fistula, phrenic lesions and death. Results All 521 patients (43% female) were included into the final analysis: 43.8% of patients presented with paroxysmal atrial fibrillation, 35.3% had persistent atrial fibrillation, 10.9% had atrial tachycardia and 10% arrhythmias arising from the left ventricle. Baseline characteristics of the patients did not differ significantly between both groups. Results show a significantly lower complication rate in the DUS4ABL group compared to the standard group with 0 major complications occurring in the DUS4ABL group and 11 complications in the standard group (p=.001). Complications included 4 pericardial tamponades and 7 pseudoaneurysms of the femoral artery, all of which were successfully managed. Other complications such as strokes, phrenic lesions and death did not occur in either of the groups. There was no significant difference in procedure time between the groups but a significant difference in fluoroscopy time and dose both of which were significantly lower in the DUS4ABL group (p=0.002 and p=0.013). Conclusion The DUS4ABL strategy significantly reduced the overall complication rate, and also resulted in positive effects for fluoroscopy time and dose.

Which is the best way for patients with ureteral obstruction? Percutaneous nephrostomy versus double J stenting.

Percutaneous nephrostomy (PCN) and Double J stenting (DJS) are the 2 main treatment options of ureteral obstruction. We evaluate which of these 2 methods is superior concerning the course of procedure, postoperative complication and quality of life. A detailed review of electronic databases including PubMed, Embase, Cochrane Library, China Biology Medicine disc, China National Knowledge Infrastructure up to February 21st, 2021 was searched. Continuous data were evaluated using mean difference (MD) with 95% confidence interval (CI), while nominal data were analyzed by risk ratio (RR) with 95% CI. Meanwhile, we performed the subgroup analysis based on study design, disease type, sample size, sepsis, DJ diameter, nephrostomy diameter, anesthesia type and guidance under X-ray or ultrasound. There were 18 previous studies included in current study. As a result, we found that there were significant differences in fluoroscopy time (MD = 0.31; 95% CI, 0.14-0.48, P < .001) and hospital stay (MD = 1.23; 95% CI, 0.60-1.85, P < .001). However, no statistic difference was detected in operative time (MD = 5.40; 95% CI, -1.78 to 12.58, P = .140) between the paired groups. Although DJS showed a higher rate of postoperative complications (25.19% vs 17.61%), there was no significant difference in the incidence of complications following DJS and PCN (RR = 0.92; 95% CI, 0.60-1.43; P = .720). Based on the EuroQol analysis, the 2 main treatment options had different impacts on quality of life. The pooled results showed that PCN patients reported more difficulties in self-care compared to DJS patients (RR = 3.07; 95% CI, 1.32-7.14; P = .009). DJS is a safe and better method of temporary urinary diversion than PCN for management of ureteral obstruction with shorter fluoroscopy time and hospital stay. As for quality of life, patients receiving PCN had a distinct difficulty in self-care compared to those receiving DJS. However, these 2 treatment options often depends on the individual situation.

Initial Safety and Feasibility of Steerable Ureteroscopic Renal Evacuation: A Novel Approach for the Treatment of Urolithiasis.

Background:There is a need to reliably render urolithiasis patients completely stone free with minimal morbidity. We report on the initial safety and feasibility with steerable ureteroscopic renal evacuation (SURE) in a prospective study using basket extraction as a comparison.Materials and Methods:A pilot randomized controlled study was conducted comparing SURE with basket extraction postlaser lithotripsy. SURE is performed using the CVAC™ Aspiration System, a steerable catheter (with introducer). The safety and feasibility of steering CVAC throughout the collecting system under fluoroscopy and aspirating stone fragments as it was designed to do were evaluated. Fluoroscopy time, change in hemoglobin, adverse events through 30 days, total and proportion of stone volume removed at 1 day, intraoperative stone removal rate, and stone-free rate (SFR) at 30 days through CT were compared.Results:Seventeen patients were treated (n = 9 SURE, n = 8 Basket). Baseline demographics and stone parameters were not significantly different between groups. One adverse event occurred in each group (self-limiting ileus for SURE and urinary tract infection for Basket). No mucosal injury and no contrast extravasation were observed in either group. The CVAC catheter was steered throughout the collecting system and aspirated fragments. There was no significant difference in fluoroscopy time, procedure time, change in hemoglobin, or stone removal rate between groups. SURE removed more and a greater proportion of stone volume at day 1 vs baskets (202 mm3 vs 91 mm3, p < 0.01 and 84% vs 56%, p = 0.022). SURE achieved 100% SFR at 30 days vs 75% for baskets, although this difference was not statistically significant (p = 0.20).Conclusions:This initial study suggests SURE is safe, feasible, and may be more effective in stone removal postlaser lithotripsy compared to basketing. More development is needed, and larger clinical studies are underway.

Hybrid ablation procedure for the treatment of nonparoxysmal atrial fibrillation: A systematic review and meta-analysis.

Hybrid ablation combines the advantages of surgical and catheter ablation. Many studies have explored the efficiency and safety of hybrid ablation in patients with nonparoxysmal AF. We systematically searched for prospective controlled trials that compared hybrid ablation with catheter/surgical ablation in PubMed, Web of Science, Wiley Library, and CNKI. Our main assessment indicators included maintenance of sinus rhythm (SR) without antiarrhythmic drugs for more than 12 months, major adverse events (MAEs), procedure time and fluoroscopy time. Of 1214 identified studies, five were eligible and were included in our analysis (N=451 participants). The pooled results showed that hybrid ablation was more effective in maintaining SR than a single procedure (surgical ablation or catheter ablation) (OR=2.52, 95% confidence interval [CI]: 1.63-3.89, p<.001). Little significant heterogeneity was revealed (p=.32 for heterogeneity, I2 =14%). More MAEs occurred in the hybrid group than in the single procedure group (OR=7.47, 95% CI: 1.90-29.41, p=.004; I2 =0%). Two trials reported the procedure and fluoroscopy times, and the procedure time for hybrid ablation was significantly longer than that of a single procedure (mean difference=107.42, 95% CI: 88.62 to 126.22, p<.001; I2 =82%). There was no significant difference in fluoroscopy time between the 2 groups (mean difference=-1.00, 95% CI: -5.37 to 3.36, p=.65; I2 =12%). Hybrid ablation was more effective than catheter ablation and was as effective as surgical ablation in patients with nonparoxysmal AF. Meanwhile, hybrid ablation, especially concomitant hybrid ablation, increases the incidence of MAEs and prolongs the procedure time.

Abstract 10829: Biradial Access Results in Lower Contrast Use and Fewer Complications Than Transfemoral Access in Alcohol Septal Ablation

Introduction: Transradial cardiac catheterization has equivalent efficacy, reduced vascular complications, and is more comfortable and convenient for patients than transfemoral catheterization. The biradial approach for alcohol septal ablation (ASA) has not been well studied. Since 2013, the biradial approach has become the standard approach for alcohol septal ablation at MUSC. This project tested the hypothesis that the biradial approach is equally efficacious and results in fewer complications than the transfemoral approach in ASA. Methods: In this study 274 consecutive patients were retrospectively analyzed from the MUSC alcohol septal ablation database (137= biradial approach, 137=femoral approach) and the changes in left ventricular outflow tract gradient (LVOTG), amount of contrast, fluoroscopy time, and complications were recorded. Groups were not significantly different in pre-ASA LVOTG (p=0.88 and 0.06 for resting and provoked LVOTG respectively). Results: The procedures were equally efficacious at reducing LVOTG with a mean reduction of resting LVOTG of 91.24% (SEM=1.21) in biradial access and 92.37% (SEM=1.14) in femoral access (p=0.5), and a mean reduction of provoked LVOTG of 80.31% (SEM=1.90) in biradial access and 82.17% (SEM=1.74) in femoral access (p=.47). The biradial approach was associated with significantly less contrast use than the femoral approach (mean of 98.1 ccs, SEM of 3.60, and 110.89 ccs, SEM of 4.84, respectively; p=.035). There were statistically significant differences in fluoroscopy time and incidence of complications between the procedures (fluoroscopy time mean of 17.42 min. (SEM=0.93) biradial and 13 min. (SEM=0.72) femoral; (p= 0.00028). Incidence of cardiac complications of .13 biradial and .23 femoral; (p= 0.04)). Conclusions: In this largest study to date, the transradial approach is equally efficacious and is associated with significantly lower contrast use, and fewer complications, albeit with increased fluoroscopy time, than the transfemoral approach in ASA.

Use of a 2 Dimensional Vessel Navigator Roadmap Decreases Patient Radiation Dose Compared to Standard 3D Mapping for Fenestrated Endovascular Aneurysm Repair

For fenestrated endovascular aneurysm repair (FEVAR), the implementation of the VesselNavigator (Philips Healthcare, Best, The Netherlands) to provide a 3-dimensional vessel roadmap has been shown to reduce patient radiation exposure. Unfortunately, FEVAR radiation doses remain substantial despite utilization of this technology. Traditionally, registration of the live fluoroscopy with the pre-operative CTA is performed via the acquisition of a low-dose cone-beam CT scan. However, this registration can also be accomplished with the acquisition of 2D X-rays using the c-arm in 2 different projection angles. We hypothesized that the 2D image acquisition for vessel roadmap development would result in a significant reduction in patient radiation dose in comparison to the 3D CT registration without compromising image quality or increasing procedural length. This single-center, retrospective study included FEVARs performed from January 2015 to May 2019. For patient data, the cumulative reference air kerma (RAK) was presented as geometric mean and standard deviation. A general linear model with log-normal distribution was used to test the difference in patient RAK between 2D X-ray and 3D CT VesselNavigator registration after adjusting for BMI and the number of vessel fenestrations (1 to 2 vs. 3 to 4). Fluoroscopy time was recorded and used as a surrogate for case complexity. All analyses were done in SAS 9.4 (SAS Institute, Inc., Cary, North Carolina). One hundred and sixty four FEVARs were performed on a Philips Allura Xper FD 20 fluoroscopy system equipped with clarity technology. The VesselNavigator registration was completed using 3D CT mapping in 99 cases and 2D X-rays in 65 procedures. On average, utilization of 2D mapping versus 3D mapping for the VesselNavigator resulted in a 20.4% reduction in patient RAK after controlling for BMI and number of vessel fenestrations, P = 0.0135. There was no significant difference in fluoroscopy time between the 2 study groups (P= 0.81) suggesting that image quality was not compromised by the use of 2D mapping leading to the need for additional fluoroscopy. Acquisition of 2D films rather than a 3D CT scan for VesselNavigator registration allows for a significant reduction in patient radiation dose during FEVAR without increasing the case complexity or compromising image quality.

A Novel Measurement Using Digital Radiography to Minimize Fluoroscopy in Total Hip Arthroplasty

AbstractPreoperative templating for total hip arthroplasty (THA) is fraught with uncertainty. Specifically, the conventional measurement of the lesser trochanter to the center (LTC) of the femoral head used in preoperative planning is easily measured on a template but not measurable intraoperatively. The purpose of this study was to examine the utility of a novel measurement that is reproducible both on templating and in surgery as a more accurate and practical guide. We retrospectively reviewed 201 patients with a history of osteoarthritis who underwent primary THA. For preoperative templating, the distance from the top of the lesser trochanter to the equator (LeTE) of the femoral head was measured on a calibrated digital radiograph with a neutral pelvis. This measurement was used intraoperatively to guide the choice of the trial neck and head. As with any templating technique, the goal was to construct a stable, impingement-free THA with equivalent leg lengths and hip offset. In evaluating this novel templating technique, the primary outcomes measured were the number of trial reductions and the amount of fluoroscopic time, exposures, and radiation required to obtain a balanced THA reconstruction. Using the LeTE measurement, the mean number of trial reductions was 1.21, the mean number of intraoperative fluoroscopy images taken was 2.63, the mean dose of radiation exposure from fluoroscopy was 0.02 mGy, and the mean fluoroscopy time per procedure was 0.6 seconds. In hips templated with the conventional LTC prior to the LeTE, the mean fluoroscopy time was 0.9 seconds. There was a statistically significant difference in fluoroscopy time (p &lt; 0.001). The LeTE is a reproducible measurement that transfers reliably from digital templating to surgery. This novel preoperative templating metric reduces the fluoroscopy time and consequent radiation exposure to the surgical team and may minimize the number of trial reductions.

Adrenal Vein Sampling: Radiation Dose Reduction on New Angiography Platform

Objectives: Primary aldosteronism is one of the most common causes of secondary hypertension. Distinguishing unilateral from bilateral disease is essential as those with unilateral adrenal disease will benefit from adrenalectomy. This is best achieved by adrenal vein sampling (AVS) which may be a difficult procedure with significant radiation to both patient and operator. This study aims to measure the radiation dose during AVS before and after the installation of a new angiography platform. Materials and Methods: The dose area product (DAP), air kerma, and fluoroscopy time were collected retrospectively together with demographic data for the first ten patients who underwent AVS between April and September 2018 following the installation of the Philips Azurion 7 M20 interventional platform. These results were compared with those from ten patients who underwent AVS before the installation of the new machine using the Philips Allura Xper FD20 platform. Mann–Whitney test was used to compare DAP, air kerma, and fluoroscopy time. P &lt; 0.05 was considered statistically significant. Results: Successful bilateral adrenal vein catheterization was achieved in all cases in both groups. There was no significant difference in fluoroscopy time: 5.5 (3.3–10.8) min (new) versus 5.3 (4.5–8.4) min (old) (P = 0.9502). The DAP and air kerma were both significantly lower on the new machine: 11.3 (5.2–26.7) Gy.cm2 versus 45.5 (17.2–56.5) Gy.cm2 (P = 0.0089) and 201.5 (88.1–464.0) mGy versus 682.5 (300.5–998.5) mGy (P = 0.0115), respectively. Conclusion: The installation of the Philips Azurion 7 M20 interventional platform has allowed a significant reduction in radiation dose during AVS.

“Failure-to-Cross” in Patients Undergoing Percutaneous Peripheral Intervention: The Nonreimbursed Procedure

Percutaneous peripheral intervention (PPI) is often the first mode of therapy for patients with symptomatic arterial occlusive disease. Technical success generally remains high although "failure-to-cross" still complicates 5-20% of cases. Extended efforts to cross long, occlusive lesions can utilize significant hospital and practitioner resources. The hospital is typically reimbursed for this effort as facility fees are charged by the hour and materials are charged per use. However, given the lack of a CPT® code for "failure-to-cross," practitioners are rarely appropriately compensated. The purpose of this study is to analyze the predictors, technical details, outcomes, and costs of "failure-to-cross" during PPI. All PPI procedures over a 2-year period at a single institution were retrospectively reviewed. Clinical characteristics, results, costs, and reimbursements obtained from hospital cost accounting were compared among successful therapeutic interventions, crossing failures, and diagnostic angiograms without attempted intervention. A total of 146 consecutive PPIs were identified; the rate of "failure-to-cross" was 11.6% (17 patients). The majority of patients with "failure-to-cross" were male (82%) with single-vessel runoff (53%). Compared to successful interventions, the incidences of chronic limb-threatening ischemia (82% vs. 70%, P=0.34) and infrapopliteal occlusive disease were similar (47% vs. 31%, P=0.20). "Failure-to-cross" procedures were just as long as successful procedures; there were no significant differences in fluoroscopy time (27±10 vs. 24±14min, P=0.52), in-room time (106±98 vs. 103±44min, P=0.84), or contrast dye volume utilization (73±37 vs. 96±54mL, P=0.12). As expected, "failure-to-cross" procedures incurred far higher hospital charges and costs compared to noninterventional diagnostic angiograms (charges $13,311±6,067 vs. $7,690±1,942, P<0.01; costs $5,289±2,099 vs. $2,826±1,198, P<0.01). Despite the additional time and effort spent attempting to cross difficult lesions, the operators were reimbursed at the same low rate as a purely diagnostic procedure (average fee charge $7,360; average reimbursement $992). After 1 year, the 17 patients in whom lesions could not be crossed were treated with advanced interventional procedures with success (n=2), surgical bypass grafting (n=5), extremity amputation (n=4), or no additional intervention in their salvaged limb (n=6). Patients whose lesions cannot be crossed during PPI fare worse than patients undergoing successful interventions. Hospital costs and charges appropriately reflect the high technical difficulty and resource utilization of extended attempts at endovascular therapy. For practitioners, crossing lesions during PPI is truly a "pay-for-performance" procedure in that only successful procedures are reasonably reimbursed.

The Use of Embolic Protection Devices during Lower Extremity Peripheral Vascular Interventions

The use of embolic protection device (EPD) during lower extremity peripheral vascular interventions (PVI) has been reported, but its impact on outcomes is unclear. The goal of this study was to assess the use and outcomes of EPDs during PVI. All PVI between 2010 and 2014 in the Vascular Study Group of New England (VSGNE) database were reviewed. The characteristics of patients and lesions treated with EPD were identified. A propensity-matched control group without EPD was selected. The outcomes of both groups were compared, and a multivariable analysis was performed. There were a total of 10,875 procedures. EPD was used in 2% of the procedures. From 2010 to 2014, EPD use significantly increased from 1.1 to 3.5% (P<0.001). Patients undergoing PVI with EPD were less likely to be white but more likely to have diabetes, chronic obstructive pulmonary disease, coronary artery disease, and history of prior PVI. After propensity matching, there were 182 procedures with EPD and 604 controls with no significant difference in risk factors. There was no difference in indication or anatomic level treated, with claudication (52.7% vs. 49.8%) being most common indication and the superficial femoral artery (65.4% vs. 62.1%), the most commonly treated artery. Patients undergoing PVI with EPD were more likely to be treated with excisional atherectomy (26.4% vs. 12.6%), whereas patients without EPD were more likely to be treated with orbital atherectomy (31.9% vs. 41.6%, P=0.017). There was no significant difference in the incidence of minor distal embolization (DE) (1.1% vs. 1.5%) or DE requiring endovascular treatment (2.8% vs. 2.6%) between the two groups, but EPD use was significantly associated with increased fluoroscopy time (P<0.001). There was no difference in technical success, patency, amputation, or mortality between the two groups. On multivariable analysis, there was no significant association between the use of EPD and patency (incidence relative risk (IRR) [95% CI]=1.1 [0.9-1.3]), amputation (IRR=0.7 [0.2-2.1]), or mortality (IRR=0.8 [0.6-1.2]). However, there was a significant difference in fluoroscopy time (mean ratio [95% CI]=1.2 [1.1-1.3]). The analysis was repeated after eliminating all procedures with DE in the EPD group (assuming that EPD use is 100% effective in preventing DE), and the results were no different. EPD use during PVI has significantly increased. Despite EPDs increasing procedural complexity and time, they do not seem to have any impact on PVI outcomes. Additional studies are needed to characterize which patients would benefit from EPDs.

P1915Time to freeze - An updated meta-analysis on the efficacy and safety of cryoballoon versus radiofrequency ablation for atrial fibrillation

Abstract Background and aim Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Its efficacy to prevent recurrent arrhythmias in patients nonresponsive to antiarrhythmic drugs is proven. This procedure has a higher efficacy rate in patients with paroxysmal AF (PAF) compared with persistent AF (sustained AF - SAF). Radiofrequency (RF) ablation represents a standard of care for PVI, while, cryoballoon (CB) ablation has emerged as a valid alternative therapy. The aim of the present meta-analysis was to explore the comparative efficacy, and safety of CB compared with RF ablation for AF. Methods We searched PubMed and EMBASE for studies that investigated the comparative efficacy and safety of CB versus RF ablation for AF. The efficacy outcome was AF recurrence after the procedure. The safety outcomes were: incidence of pericardial effusion or cardiac tamponade, permanent phrenic nerve palsy, transient phrenic nerve palsy, vascular complications and major bleedings. The performance outcomes were: procedural time and fluoroscopy time. Random-effects Risk Ratios (RRs) were estimated using a DerSimonian-Laird model. Two subgroup sensitivity analyses were performed to stratify the result on the efficacy outcome according to type of AF (PAF versus SAF) and study design (randomized clinical trial (RCT) versus observational study (OS)). Results 12 RCT and 34 OS were included in the analysis (n=13103). Mean follow-up was 14±6 months. 37 studies included only patients with PAF, while, 2 studies included only patients with SAF and the remaining 7 studies included both patients with SAF or PAF. Overall, CB ablation reduced the incidence of AF recurrence compared with RF ablation (RR 0.85; 95% CI 0.77–0.95; P=0.002 - Figure). However, this reduction was not consistent in the RCT subgroup (RR 0.90; 95% CI 0.72–1.13) and it was marginally non-significant in the SAF subgroup (RR 0.76; 95% CI 0.57–1.01). Regarding the safety outcomes, although CB had a significantly higher rate of transient nerve palsy compared with RF procedure (RR 7.46; 95% CI 4.67–11.90) this difference became non-significant when considering permanent phrenic nerve palsy (RR 1.24; 95% CI 0.66–2.34). Moreover, CB was related to a lower incidence of pericardial effusion or cardiac tamponade compared with RF (RR 0.51; 95% CI 0.37–0.69) and there was no significant difference in vascular complications or major bleedings between the two strategies. Focusing on performance outcomes, CB ablation had a shorter procedural time compared with RF (mean difference −20 minutes; 95% CI −30 to −10; P&lt;0.001); whereas, there was no significant difference in fluoroscopy time between the two. CB vs. RF in preventing AF recurrence Conclusions This large study level meta-analysis demonstrates that CB is at least as effective as RF ablation in preventing arrhythmic recurrence both in patients with PAF and SAF. Moreover, our study suggests that CB has a safer profile and shorter procedural time compared with RF ablation.

Radiation exposure in the treatment of pediatric supracondylar humerus fractures.

To determine the factors that influence radiation exposure during repair of supracondylar humerus fractures. Medical records of almost 200 children with supracondylar fractures were retrospectively analyzed for variables correlated with fluoroscopy time and radiation dose as measures of radiation exposure. There was no statistically significant difference in fluoroscopy time (27 vs. 22s p = 0.345) or direct radiation dose (0.394 vs. 0.318mSv p = 0.290) between uniplanar and biplanar C-arm use. No statistically significant differences in fluoroscopy time or radiation dose were found for surgical technique, comorbid ipsilateral fractures, preoperative neurovascular compromise, or resident participation. There was a significant 8.3s increase in fluoroscopy time (p = 0.022) and 0.249mSv increase in radiation dose (p = 0.020) as the fracture type increased from II to III. An increase in one pin during CRPP resulted in a statistically significant 10.4s increase in fluoroscopy time and a 0.205mSv increase in radiation dose. There were significant differences between the physician with the lowest fluoroscopy time and radiation dose compared with the physicians with the two highest values for both fluoroscopy time and radiation dose (p < 0.01). We found no significant difference in direct radiation exposure or fluoroscopy time when comparing biplanar to uniplanar C-arm use, resident participation, preoperative neurovascular compromise, or for comorbid ipsilateral fractures. Both outcomes increased significantly as fracture type increased from II to III and as the number of pins used during CRPP increased. Both outcomes were significantly different between the surgeons performing CRPP.

Radiation Exposure to the Surgeon, Surgical Assistant, and Scrub Nurse During Closed Intramedullary Nailing of Long Bones-Does It Vary Depending on the Experience of the Surgeon?

To assess radiation exposure (RE) to the surgical team and fluoroscopy time (FT) during closed nailing of long bone fractures performed under fluoroscopic guidance with regard to surgeon's experience. Prospective observational study. Level-1 trauma center. Surgical team, comprising a surgeon, a surgical assistant, and a scrub nurse, for closed nailing procedures performed in 202 consecutive closed tibial and femoral diaphyseal fractures. Dosimeter provided to each member of surgical team. Surgeon experience level (trainee, senior registrar, and consultant). RE (microsieverts) to the surgical team and FT (minutes) were recorded from the dosimeter and fluoroscopic unit, respectively, and correlated with surgeon's experience. In tibial nailing, mean RE (in µSv) per procedure to surgeon, surgical assistant, and scrub nurse was 15.2, 9.2, and 2.0 for trainees, 14.5, 8.1, and 1.6 for senior registrars, and 13.6, 7.4, and 1.5 for consultants, respectively. In femoral nailing, mean RE per procedure to surgeon, surgical assistant, and scrub nurse was 181.6, 113.6, and 37.1 for trainees, 110.1, 66.7, and 20.4 for senior registrars, and 79.9, 30.9, and 12.5 for consultants, respectively. RE to the surgeon was highest followed by surgical assistant and scrub nurse irrespective of operating surgeon's experience in both tibial and femoral nailing (P < 0.001). In tibial nailing, there was a significant difference in FT only for the stage of guide wire passage (P = 0.041), whereas in femoral nailing, total FT (P < 0.001), nail entry verification (P = 0.02), guide wire passage (P = 0.013), nail introduction (P = 0.006), and distal locking (P < 0.001) showed a significant difference. RE was maximum for operating surgeon and least for scrub nurse irrespective of operating surgeon's experience in both femoral and tibial nailing. FT and RE to the surgical team decreased with increasing experience of the surgeon in femoral nailing. Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Intracardiac vs transesophageal echocardiography for percutaneous left atrial appendage occlusion: A meta-analysis.

Percutaneous left atrial appendage closure (LAAC) is typically performed utilizing transesophageal echocardiography (TEE) and fluoroscopy. Intracardiac echocardiography (ICE) can be a suitable alternative to guide implantation. Given the limited data, we performed a meta-analysis of all studies that compared ICE vs TEE for percutaneous LAAC. A comprehensive literature search was performed in PubMed, Embase, Scopus, Google Scholar, and major scientific conference sessions for published abstracts and manuscripts until 1 August 2018. Studies reporting clinical outcomes comparing TEE vs ICE for endocardial LAAC in human subjects aged greater than or equal to 18 years were included. Two investigators independently extracted the data and individual quality assessment was performed. The analysis was performed using Cochrane Collaboration software, RevMan 5.3. Five eligible studies consisting of 1157 patients (ICE-391 patients and TEE-766 patients) were included. Four studies were retrospective and one was prospective, nonrandomized. Two studies included Watchman, two included the Amplatzer Cardiac Plug/Amulet device, and one included both devices. There was no significant difference in CHA2DS2VASC or HAS-BLED scores between both groups. There was no significant difference in acute procedural success between ICE vs TEE (risk ratio, 1.01; 95% CI, 0.99-1.04; P = 0.24). There was no significant difference in fluoroscopy time (mean difference [MD], 1.84 minutes; 95% CI, 0.59-4.27; P = 0.14) and total procedure time (MD, -5.06 minutes; 95% CI, -24.6-14.4; P = 0.61) between both groups. There was also no significant difference in complications including pericardial tamponade, device embolization, and stroke between both groups. In our meta-analysis, ICE was as effective as TEE during percutaneous LAAC.

Radiation doses for endovascular aortic repairs performed on mobile and fixed C-arm fluoroscopes and procedure phase-specific radiation distribution

ObjectiveThe objective of this study was to analyze radiation risk to patients during endovascular aneurysm repair (EVAR) using mobile C-arm (MA) or fixed C-arm (FA) fluoroscopes and to describe the dose distribution during the different phases of the procedure. MethodsPatients treated with EVAR using a single stent graft system between November 2009 and June 2016 were included in this study. The patients were divided into one of two groups (MA or FA) according to the type of C-arm used in the procedure. Data regarding patients' demographics and the total amount of contrast agent (CA) used, dose-area product, and fluoroscopy time for the procedures were prospectively recorded. Based on the dose report from the FA system, five standard and two optional phases of the procedure were identified to determine the dose distribution. ResultsOverall, 160 patients were included (mean age, 73.30 ± 8.97 years; 146 men); of these, 107 were treated with an MA system and 53 were treated with an FA system. The mean amounts of CA used were 108.55 ± 42.28 mL in the MA group and 85.37 ± 38.79 mL in the FA group (P = .0014). The mean total dose-area product values were 49.93 ± 38.06 Gy·cm2 in the MA group and 168.34 ± 146.92 Gy·cm2 in the FA group (P < .0001). There was no significant difference in fluoroscopy time between the groups. Per-phase analysis demonstrated that identification of the proximal landing zone and main body deployment required the most radiation, accounting for 24% of the total radiation dose. Overall, 47.6% of the exposure was due to digital subtraction angiography. ConclusionsUse of an FA system can significantly reduce the amount of CA needed but may also lead to higher radiation doses in EVAR procedures. Dose monitoring remains crucial for the safety of both patients and operators. A detailed analysis of dose distribution is possible with modern systems, which may improve the quality of monitoring in the future.

Abstract 21364: Multicenter Prospective Study Comparing Phased Multipolar versus Traditional Radiofrequency Ablation

Background: Multipolar, phased radiofrequency (RF) catheter ablation (PVAC) has been associated with reduced procedural times compared to traditional RF. We performed a multicenter study to assess the efficacy and efficiency of using this catheter. Methods: This is a multicenter, sequential, prospective, cohort study between 2012 to 2016 in 6 tertiary care centers (NCT01562912). Patients were enrolled if they had symptomatic, paroxysmal AF (less than 7 days) refractory to at least one antiarrhythmic medication. Patients were enrolled in a 2:1 ratio of PVAC (group A) to control point-by-point RF with 3D mapping (group B). ECG and 48 hour Holter monitor were used to assess patients at 3, 6, 9 and 12 months post-ablation follow up. Recurrence was defined as any atrial arrhythmia &gt;30 seconds excluding an initial 3 month blanking period. Results: Overall, 230 patients consisting of 162 males (70.4%) with mean age 57±11 years were analyzed. By Kaplan-Meier analysis, freedom from any atrial arrhythmia at 12 months was 49% and 69.2% in group A and B respectively (p=0.033) (Figure1). Among patients with recurrence, 14.7% (21) in group A and 7.7% (6) in group B had redo procedure within 12 month post procedure(p=0.12). Procedure time was significantly lower in Group A than Group B (P&lt;0.0001). There was no significant difference in fluoroscopy time between the two groups (p=0.49). Stroke was not reported in any of the patients. Pulmonary Embolism, occurred in 1.3% of patients in group B. Pericardial effusion occurred in 1.4% in group A and 2.6% in group B. Tamponade occurred in 3.8% of patients in group B. Conclusion: This study demonstrated that the PVAC catheter is associated with significantly reduced procedure times for AF ablation, however, AF recurrence rates may be higher than contemporary point-by-point RF ablation with 3D mapping technology.

Fluoroscopy Learning Curve in Hip Arthroscopy—A Single Surgeon's Experience

To determine if (1) absorbed radiation dose and (2) fluoroscopy time decreased with experience over the first 100 cases of a single surgeon's hip arthroscopy practice. Subjects who underwent hip arthroscopy for symptomatic femoroacetabular impingement and labral injury were eligible for analysis. Inclusion criteria included the first 100 subjects who underwent hip arthroscopy by a single surgeon (December 2013 to December 2014). Subject demographics, procedure details, fluoroscopy absorbed dose (milligray [mGy]), and time were recorded. Subjects were categorized by date of surgery to one of 4 possible groups (25 per group). One-way analysis of variance was used to determine if a significant difference in dose (mGy) or time was present between groups. Simple linear regression analysis was performed to determine the relation between case number and both radiation dose and fluoroscopy time. Subjects underwent labral repair (n= 93), cam osteoplasty (n= 90), and pincer acetabuloplasty (n= 65). There was a significant (P < .001 for both) linear regression between case number and both radiation dose and fluoroscopy time. A significant difference in mGy was observed between groups, group 1 the highest and group 4 the lowest amounts of radiation (P= .003). Comparing individual groups, group 4 was found to have a significantly lower amount of radiation than group 1 (P= .002), though it was not significantly lower than that of group 2 (P= .09) or group 3 (P= .08). A significant difference in fluoroscopy time was observed between groups, group 1 the highest and group 4 the lowest times (P= .05). Comparing individual groups, group 4 was found to have a significantly lower fluoroscopy time than group 1 (P= .039). Correction for weight, height, and body mass index all revealed the same findings: significant (P < .05) differences in both dose and time across groups. The absorbed dose of radiation and fluoroscopy time decreased significantly over the first 100 cases of a single surgeon's hip arthroscopy practice learning curve. Level IV, therapeutic, retrospective, noncomparative case series.