Microembolizations in the arterial cerebral circulation during atrial fibrillation ablation: cryoballoon technique advantages and neurocognitive safety-results of a prospective observational study.

AIMS: The significance of micro-embolic signals (MESs) during atrial fibrillation (AF) ablation is unclear. Previous studies had limitations, and cryoballoon (CB) ablation patients were under-represented. Minimizing MESs is recommended due to their uncertain neurocognitive impact. METHODS AND RESULTS: This prospective observational study included AF patients from a German centre between February 2021 and August 2022. Patients were equally divided into paroxysmal (Group A) and persistent (Group B) AF. Group A received cryoballoon-pulmonary vein isolation only, while Group B also had left atrial roof ablation. MESs were detected using transcranial Doppler ultrasonography during ablation. Neurocognitive status was assessed pre- and post-procedure and at 3 months using the CERAD Plus battery. The study analyzed 100 patients with a median age of 65.5 years. A total of 19 698 MESs were observed, with 80% being gaseous and 20% solid in origin, primarily occurring during pulmonary vein angiography and the balloon freeze and thawing phase. The median MES per patient was 130 (IQR: 92-256) in total, 298 (IQR: 177-413) in bilateral (36%), and 110 (IQR: 71-130) in unilateral (64%) recordings. No significant difference in total MES counts was found between the groups. None of the 11 neuropsychological tests showed cognitive decline post-procedure or at 3 months. CONCLUSION: Our observations confirm that neurocognitive abilities are not affected either 24 h or 3 months after AF ablation using the CB technique. However, despite the low MES burden associated with the CB, more work is needed to reduce small embolic events during AF ablation.

Impact of atrial fibrillation phenotype and left atrial volume on outcome after pulmonary vein isolation.

AIMS: Pulmonary vein isolation (PVI) is increasingly performed in patients with atrial fibrillation (AF). Both AF phenotype and left atrial (LA) volume have been shown to influence ablation outcome. The inter-relationship of the two is incompletely understood. We aimed to investigate the impact of AF phenotype vs. LA volume on outcome after PVI. METHODS AND RESULTS: In a retrospective analysis of a prospective registry of patients undergoing a first PVI, the association of AF phenotype and LA volume index (LAVI) was assessed as well as their impact on AF recurrence during follow-up. Overall, 476 patients were enrolled (median age 63 years, 29% females, 65.8% paroxysmal AF). Obesity, hypertension, chronic kidney disease, and heart failure were all significantly more frequent in persistent AF. After 1 year, single-procedure, freedom from arrhythmia recurrence was 61.5%. Patients with paroxysmal AF had better outcomes compared with patients with persistent AF (65.6 vs. 52.7%, P = 0.003), as had patients with no/mild vs. moderate/severe LA dilation (LAVI <42 mL/m2 67.1% vs. LAVI ≥42 mL/m2 53%, P < 0.001). The combination of both parameters refined prediction of 1-year recurrence (P < 0.001). After adjustment for additional clinical risk factors in multivariable Cox proportional hazard analysis, both AF phenotype and LAVI ≥42 mL/m2 contributed significantly towards the prediction of 1-year recurrence. CONCLUSION: Atrial fibrillation phenotype and LA volume are independent predictors of outcome after PVI. Persistent AF with no/mild LA dilation has a similar risk of recurrence as paroxysmal AF with a moderate/severe LA dilation and should be given similar priority for ablation.

Differences in postablation cardiac MRI scar between radiofrequency and cryoballoon ablation: A DECAAF II subanalysis.

INTRODUCTION: Pulmonary vein isolation (PVI) using radiofrequency (RF) and cryoballoon (Cryo) ablation are standard approaches for rhythm control in patients with symptomatic atrial fibrillation. Both strategies create scars in the left atrium (LA). There have been few studies investigating the difference in scar formation between patients undergoing RF and Cryo using cardiac magnetic resonance (CMR) imaging. METHODS: The current study is a subanalysis of the control arm of the Delayed-Enhancement MRI Determinant of Successful Catheter Ablation of Atrial Fibrillation study (DECAAF II). The study was a multicenter, randomized, controlled, single-blinded trial that evaluated atrial arrhythmia recurrence (AAR) between PVI alone and PVI plus CMR atrial fibrosis-guided ablation. Preablation CMR and 3- to 6-month postablation CMR were obtained to assess baseline LA fibrosis and scar formation, respectively. RESULTS: Of the 843 patients randomized in the DECAAF II trial, we analyzed the 408 patients in the primary analysis control arm that received standard PVI. Five patients received combined RF and Cryo ablations, so they were excluded from this subanalysis. Of the 403 patients analyzed, 345 underwent RF and 58 Cryo. The average procedure duration was 146 min for RF and 103 min for Cryo (p = .001). The rate of AAR at ~15 months occurred in 151 (43.8%) patients in the RF group and 28 (48.3%) patients in the Cryo group (p = .62). On 3-month post-CMR, the RF arm had significantly more scar (8.8% vs. 6.4%, p = .001) compared to Cryo. Patients with ≥6.5% LA scar (p < .001) and ≥2.3% LA scar around the PV antra (p = .01) on 3-month post-CMR had less AAR independent of the ablation technique. Cryo caused a greater percentage of right and left pulmonary vein (PV) antral scar (p = .04, p = .02) and less non-PV antral scar (p = .009) compared to RF. On Cox regression, Cryo patients free of AAR had a greater percentage of left PV antral scar (p = .01) and less non-PV antral scar (p = .004) compared to RF free of AAR. CONCLUSION: In this subanalysis of the control arm of the DECAAF II trial, we observed that Cryo formed a more significant percentage of PV antral scar and less non-PV antral scar compared to RF. Post ablation LA scar ≥6.5% predicted freedom from AAR, independent of ablation technique. These findings may have prognostic implications in ablation technique selection and freedom from AAR.

Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study.

INTRODUCTION: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. METHODS: POLAR ICE, a prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. RESULTS: Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged -56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. CONCLUSION: This real-world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long-term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon.

A Novel Endovascular Robotic System for Treatment of Lower Extremity Peripheral Arterial Disease: First-in-Human Experience.

BACKGROUND: To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD). METHODS: Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2-5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure. RESULTS: In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 µGy. CONCLUSIONS: This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table. CLINICAL IMPACT: There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD).To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials.The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.

Visualization of fibroblast activation using 68Ga-FAPI PET/CT after pulmonary vein isolation with pulsed field compared with cryoballoon ablation.

BACKGROUND: Pulsed-field ablation (PFA) is a novel ablation modality for atrial fibrillation (AF) ablating myocardium by electroporation without tissue-heating. With its different mechanism of tissue ablation, it is assumed that lesion creation is divergent to thermal energy sources. 68Ga-fibroblast-activation protein inhibitor (FAPI) PET/CT targets FAP-alpha expressed by activated fibroblasts. We aimed to assess 68Ga-FAPI uptake in pulmonary veins as surrogate for ablation damage after PFA and cryoballoon ablation (CBA). METHODS: 26 patients (15 PFA, 11 CBA) underwent 68Ga-FAPI-PET/CT after ablation. Standardized uptake values (SUV) and fibroblast-activation volumes of localized tracer uptake were assessed. RESULTS: Patient characteristics were comparable between groups. In PFA, focal FAPI uptake was only observed in 3/15 (20%) patients, whereas in the CBA cohort, 10/11 (90.9%) patients showed atrial visual uptake. We observed lower values of SUVmax (2.85 ± 0.56 vs 4.71 ± 2.06, P = 0.025) and FAV (1.13 ± 0.84 cm3 vs 3.91 ± 2.74 cm3, P = 0.014) along with a trend towards lower SUVpeak and SUVmean in PFA vs CBA patients, respectively. CONCLUSION: Tissue response with respect to fibroblast activation seems to be less pronounced in PFA compared to established thermal ablation systems. This functional assessment might contribute to a better understanding of lesion formation in thermal and PFA ablation potentially contributing to better safety outcomes.

Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry.

INTRODUCTION: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. METHODS: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively). CONCLUSION: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019.

Role of perfusion index and plethysmography variability index for predicting outcomes in neonatal sepsis.

AIM: (i) To compare perfusion index (PI) and plethysmography variability index (PVI) between neonates with proven or probable sepsis versus no-sepsis, (ii) to examine an association of PI and PVI with in-hospital mortality. METHODS: We enrolled neonates with clinically presumed sepsis. Culture-proven or probable sepsis were categorised as 'cases' and no-sepsis as 'controls'. PI and PVI were recorded hourly for 120 h and averaged in 20-time epochs (0-6 h to 115-120 h). RESULTS: We analysed 148 neonates with sepsis (proven sepsis = 77, probable sepsis = 71) and 126 with no-sepsis. Neonates with proven/probable sepsis and no-sepsis had comparable PI and PVI values. Among 148 neonates with sepsis, 43 (29%) died. Non-survivors had significantly lower PI values than survivors (mean difference 0.21 [95% CI 0.14-0.29], p-value <0.001). PI had a significant but modest discriminative ability to identify non-survivors. However, PI did not independently predict mortality. CONCLUSION: Neonates with proven/probable sepsis and no-sepsis had comparable PI and PVI values in the first 120 h of sepsis. PI but not PVI values were significantly lower in non-survivors than survivors. PI did not independently predict in-hospital mortality. Due to modest discriminative ability, PI should be interpreted along with other vital signs to take clinical decisions.

Comparative efficacy of finger versus forehead Plethysmographic Variability Index monitoring in pediatric surgical patients.

INTRODUCTION: The Plethysmographic Variability Index can be measured by both finger and forehead probes. Vasoconstriction may jeopardize the reliability of finger PVI measurements in pediatric patients undergoing surgery. However, forehead vasculature exhibits more marked resistance to alterations in the vasomotor tonus. OBJECTIVE: Our aim was to compare the Plethysmographic Variability Index measured via finger or forehead probes in mechanically ventilated pediatric surgery patients in terms of their ability to predict fluid responsiveness as well as to determine the best cut-off values for these two measurements. MATERIALS AND METHODS: A total of 50 pediatric patients undergoing minor elective surgery were included after provision of parental consent and ethics committee approval. Perfusion index measured at the finger or forehead and Plethysmographic Variability Index monitoring comprised the primary assessments. Hemodynamic parameters monitored included perfusion index, Plethysmographic Variability Index, and cardiac output. A ≥ 15% increase in cardiac output following passive leg raise maneuver was considered to show fluid responsiveness. Two groups were defined based on fluid responsiveness: Group R (responsive) and Group NR (non-responsive). Student's t-test, Mann-Whitney U test, DeLong test, and ROC were used for statistical analysis. RESULTS: The area under curve for finger and forehead Plethysmographic Variability Index prior to passive leg raise maneuver were 0.699 (p = .011) and 0.847 (p < .001), respectively. The sensitivity for finger and forehead measurements at a cut-off value of ≤14% was 92.9% and 96.4%, and 45.4% and 72.7%, respectively. CONCLUSION: Although forehead and finger Plethysmographic Variability Index monitoring were similarly sensitive in predicting fluid responsiveness in pediatric surgical patients, the former method provided higher specificity. The best cut-off value for PVI measurements with forehead and finger probes was found to be 14%.

Can Satellites Predict Yield? Ensemble Machine Learning and Statistical Analysis of Sentinel-2 Imagery for Processing Tomato Yield Prediction.

In this paper, we propose an innovative approach for robust prediction of processing tomato yield using open-source AutoML techniques and statistical analysis. Sentinel-2 satellite imagery was deployed to obtain values of five (5) selected vegetation indices (VIs) during the growing season of 2021 (April to September) at 5-day intervals. Actual recorded yields were collected across 108 fields, corresponding to a total area of 410.10 ha of processing tomato in central Greece, to assess the performance of Vis at different temporal scales. In addition, VIs were connected with the crop phenology to establish the annual dynamics of the crop. The highest Pearson coefficient (r) values occurred during a period of 80 to 90 days, indicating the strong relationship between the VIs and the yield. Specifically, RVI presented the highest correlation values of the growing season at 80 (r = 0.72) and 90 days (r = 0.75), while NDVI performed better at 85 days (r = 0.72). This output was confirmed by the AutoML technique, which also indicated the highest performance of the VIs during the same period, with the values of the adjusted R2 ranging from 0.60 to 0.72. The most precise results were obtained with the combination of ARD regression and SVR, which was the most successful combination for building an ensemble (adj. R2 = 0.67 ± 0.02).

Esophageal safety in CLOSE-guided 50 W high-power-short-duration pulmonary vein isolation: The PREHEAT-PVI-registry.

INTRODUCTION: Pulmonary vein isolation (PVI) using high-power-short-duration (HPSD) radiofrequency ablation (RF) is emerging as the standard of care for treatment of atrial fibrillation (AF). While procedural short-term to midterm efficacy and efficiency are very promising, this registry aims to investigate esopahgeal safety using an optimized ablation approach. METHODS: In a single-center experience, 388 consecutive standardized first-time AF ablation were performed using a CLOSE-guided-fixed-50 W-circumferential PVI and substrate modification without intraprocedural esophageal temperature measurement. Three hundred patients underwent postprocedural esophageal endoscopy to diagnose and grade endoscopically detected esophageal lesions (EDEL) and were included in the analysis. RESULTS: EDEL were detected in 35 of 300 patients (11.6%), 25 of 35 were low-grade Kansas-city-classification (KCC) 1 lesions with fast healing tendencies. Six patients suffered KCC 2a lesions, 4 patients had KCC 2b lesions (1.3% of all patients). No esophageal perforation or fistula formation was observed. Patient baseline characteristics, especially patients age, gender, and body mass index did not influence EDEL incidence. Additional posterior box isolation did not increase the incidence of EDEL. In patients diagnosed with EDEL, mean catheter contact force during posterior wall ablation was higher (11.9 ± 1.8 vs. 14.7 ± 3 g, p < .001), mean RF duration was shorter (11.9 ± 1 vs. 10.7 ± 1.2 s, p < .001), while achieved ablation index was not different between groups (434 ± 4.9 vs. 433 ± 9.5, n.s.). CONCLUSION: Incidence of EDEL after CLOSE-guided-50 W-HPSD PVI is lower compared to historical cohorts using standard-power RF settings. Catheter contact force during posterior HPSD ablation should not exceed 15 g.

Contemporary treatment of below-the-knee peripheral arterial disease in patients with chronic limb threatening ischemia: Observations from the Vascular Quality Initiative.

OBJECTIVE: We sought to determine trends in percutaneous transluminal angioplasty (PTA) versus non-PTA interventions over time, as well as factors that influence the decision for non-PTA intervention. BACKGROUND: Although the optimal strategy for revascularization in patients with below-the-knee (BTK) chronic limb-threatening ischemia (CLTI) remains under investigation, PTA has been the preferred endovascular approach. Recently, there has been an increase in the use of non-PTA approaches for revascularization. METHODS: We performed a retrospective analysis of the Vascular Quality Initiative. Between 2011 and 2020, a total of 23,850 procedures corresponding to 33,098 arteries in 19,404 patients with CLTI were included. After application of exclusion criteria and removal of missing variables, 18,644 arteries were included in the study cohort. The primary analysis was factors associated with receiving non-PTA intervention. Secondary analysis included trends in PTA versus non-PTA intervention over time. RESULTS: Throughout the study period, the majority of interventions (72%) were PTA alone. The percentage of non-PTA interventions, on a per-artery basis, increased over the study period from 18% to 33%, p < 0.01. Advanced age, increasing TransAtlantic Inter-Society Consensus classification, and concomitant above-the-knee disease were associated with an increased likelihood for non-PTA intervention. In contrast, longer lesion length, insulin-dependent diabetes mellitus, bilateral disease, and discharge to location other than home were associated with an increased likelihood of PTA. CONCLUSIONS: We observed a significant increase in the percentage of non-PTA interventions for patients with CLTI requiring BTK interventions over the last decade, with lesion- and patient-specific characteristics associated with the type of endovascular approach.

High anatomical accuracy of a novel high-resolution wide-band dielectric imaging system in cryoballoon-based ablation.

PURPOSE: Recently, a novel cardiac imaging system based on a wide-band dielectric technology (KODEX-EPD) was introduced to guide catheter ablation. The aim of the study was to evaluate this 3D wide-band dielectric imaging system (WDIS) during cryoballoon (CB)-based atrial fibrillation (AF) ablation focusing on accuracy of pulmonary vein (PV)-anatomy. METHODS: In consecutive patients with symptomatic AF, CB-based ablation was performed in conjunction with the 3D WDIS. Selective PV-angiographies were performed, and 3D anatomy of the left atrium (LA) and PVs using the 3D WDIS was created. The ostial diameters of the ipsilateral right-sided and left-sided PVs and ostial diameters of the right-/left-sided upper/lower PVs demonstrated by selective angiographies were analyzed and compared to 3D WDIS-based PV visualization. RESULTS: In 65 patients (42/65 (65%) male, age 65 ± 9 years, 29/65 (45%) paroxysmal AF) a total of 260 PVs were identified. Median ostial PV-diameters for the ipsilateral left- and right-sided PVs were 38 [34; 43] and 37 [34; 40.3] mm when assessed fluoroscopically and 40 [35.7; 43] and 39 [35.0; 43] mm as demonstrated by 3D WDIS. There was no statistically significant difference between both methods regarding PV-diameter measurements. KODEX-EPD overestimated fluoroscopy measurements by 1.08 mm (95% limits of agreement of -1.93 mm and 4.1 mm). CONCLUSION: The novel wide-band dielectric 3D-imaging system is feasible to create high-resolution images of cardiac structures during CB ablation procedures and accurately visualizes PV-anatomy.

Plethysmography variability index (PVI) changes in preterm neonates with shock-an observational study.

Shock is an acute state of circulatory dysfunction. The diagnosis of shock is complex in neonates. The relative sensitivity of current clinical or laboratory findings for detecting shock is largely unknown, especially for preterm neonates. For preload assessment, inferior vena cava (IVC) collapsibility can be a useful bedside echocardiography parameter. plethysmography variability index (PVI) is a marker of fluid responsive shock in adults and children, but not well defined in neonates. In this prospective observational study, we evaluated the changes in PVI in preterm neonates with shock. Among the 37 infants enrolled in the study, the mean blood pressure (MAP) was 45 (± 4 mm of Hg) and none of infants had hypotension. The mean pulse pressure was 28 mm of Hg, the mean PVI was 28% (±5), the mean arterial blood gas pH was 7.20 (±0.07), and the mean base deficit was 9.9 (±2.53) at the onset of shock. Thirty (96.77%) of the 31 infants with resolution of shock showed decrease in PVI with an average decrease of 11% (±5).Conclusion: Significant proportion of neonates show an increase in PVI at the onset of shock. What is Known: • Plethysmography Variability Index (PVI) is commonly used as a marker of volume status in paediatric population. • Changes in PVI may guide in giving volume boluses in patients with shock. What is New: • This study provides information of changes in PVI in preterm neonates with shock. • PVI may become a valuable tool to be used at bedside in preterm infants with shock.

Influence of ablation index on the incidence of cardiac tamponade complicating pulmonary vein isolation.

BACKGROUND: Cardiac tamponade (CT) complicating pulmonary vein isolation (PVI) for atrial fibrillation (AF) is a complication that can increase morbidity and mortality. Radiofrequency energy is a known cause of CT. Ablation Index (AI) is a novel ablation quality marker. We hypothesized that use of AI reduces the incidence of CT. METHODS: All AF procedures between 10/2014 and 06/2019 were included. Three ablation groups were defined: group A, RF ablation with non-contact force (CF) catheter; group B, RF ablation with CF catheter; and group C, RF ablation with CF catheter using AI. All episodes of CT were analyzed. RESULTS: In total, 1222 consecutive AF patients underwent PVI. Group A consisted of 100 (8%) procedures, while group B included 432 (35%) procedures and group C 690 (57%) procedures. The overall risk for CT in all patients was 2.1% (26/1222). The risk in group A was 2.9% (3/100), in group B 2.5% (11/432), and in group C 1.7% (12/690), including all 1222 patients in the analysis (p < 0.05). Univariate analysis identified no further specific predictors for CT. With the exception of one patient (1/26; 3.8%), who needed surgical treatment, all CT could be successfully drained. CONCLUSIONS: In a high-volume center, the use of AI decreased the risk of CT in patients undergoing RF ablation for AF by 32%.

Catheter ablation vs. thoracoscopic surgical ablation in long-standing persistent atrial fibrillation: CASA-AF randomized controlled trial.

AIMS: Long-standing persistent atrial fibrillation (LSPAF) is challenging to treat with suboptimal catheter ablation (CA) outcomes. Thoracoscopic surgical ablation (SA) has shown promising efficacy in atrial fibrillation (AF). This multicentre randomized controlled trial tested whether SA was superior to CA as the first interventional strategy in de novo LSPAF. METHODS AND RESULTS: We randomized 120 LSPAF patients to SA or CA. All patients underwent predetermined lesion sets and implantable loop recorder insertion. Primary outcome was single procedure freedom from AF/atrial tachycardia (AT) ≥30 s without anti-arrhythmic drugs at 12 months. Secondary outcomes included clinical success (≥75% reduction in AF/AT burden); procedure-related serious adverse events; changes in patients' symptoms and quality-of-life scores; and cost-effectiveness. At 12 months, freedom from AF/AT was recorded in 26% (14/54) of patients in SA vs. 28% (17/60) in the CA group [OR 1.128, 95% CI (0.46-2.83), P = 0.83]. Reduction in AF/AT burden ≥75% was recorded in 67% (36/54) vs. 77% (46/60) [OR 1.13, 95% CI (0.67-4.08), P = 0.3] in SA and CA groups, respectively. Procedure-related serious adverse events within 30 days of intervention were reported in 15% (8/55) of patients in SA vs. 10% (6/60) in CA, P = 0.46. One death was reported after SA. Improvements in AF symptoms were greater following CA. Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02). CONCLUSION: Single procedure thoracoscopic SA is not superior to CA in treating LSPAF. Catheter ablation provided greater improvements in symptoms and accrued significantly more QALYs during follow-up than SA. CLINICAL TRIAL REGISTRATION: ISRCTN18250790 and ClinicalTrials.gov: NCT02755688.

Novel three-dimensional imaging approach for cryoballoon navigation and confirmation of pulmonary vein occlusion.

BACKGROUND: Cryoballoon apposition is crucial for durable pulmonary vein isolation (PVI) in atrial fibrillation, yet the balloon is difficult to visualize by conventional mapping systems, and pulmonary venography may miss small or out-of-plane leaks. We report a novel imaging system that offers real-time 3D navigation of the cryoballoon within atrial anatomy that may circumvent these issues. METHODS AND RESULTS: A novel overlay guidance system (OGS) registers already-acquired segmented atrial cardiac tomography (CT) with fluoroscopy, enabling real-time visualization of the cryoballoon within tomographic left atrial imaging during PVI. Phantom experiments in a patient-specific 3D printed left atrium showed feasibility for confirming PV apposition and leaks. We applied OGS prospectively to 68 PVs during PVI in 17 patients. The cryoballoon was successfully reconstructed in all cases, and its apposition was compared to concurrent PV venography. The OGS uncovered leaks undetected by venography in nine veins (eight cases), which enabled repositioning, confirming apposition in remaining 68 veins. Concordance of OGS to venography was 83.8% (χ2 , P < .01) CONCLUSIONS: We report a new system for real-time imaging of cryoballoon catheters to ensure PV apposition within the tomography of the left atrium. While providing high concordance with other imaging modalities for confirming balloon apposition or leak, the system also identified leaks missed by venography. Future studies should determine if this tool can provide a new reference for cryoballoon positioning.

Single-center experience of the FIRM technique to ablate paroxysmal and persistent atrial fibrillation.

INTRODUCTION: Focal impulse and rotor modulation (FIRM)-guided ablation has had mixed results of published success, and most studies have had a follow-up for a year or less. We aimed to study a consecutive group of patients followed for at least 1.5 years, subgrouped into those with an initial FIRM ablation and those with a previous, failed ablation who now received a FIRM guided one, to evaluate for success in each group and factors that might affect success. METHODS: Of 181 patients, 167 were available for analysis. Group 1 (n = 122) had a first or primary ablation (paroxysmal atrial fibrillation [PAF] 51; persistent atrial fibrillation [PeAF] 71) and group 2 (n = 45) had a redo ablation (PAF 18; PeAF 27). All patients were done under general anesthesia. FIRM mapping was done in the right atrium first and then the left, and only rotors consistently seen on multiple epochs were ablated, using 15 to 30 W. Rotor ablation was discontinued when remapping showed elimination of rotational activity at the site. Wide area catheter ablation was done for pulmonary vein isolation (PVI). Routine follow-up was at 3, 6, and 12 months of the first year, with a Holter monitor at 6 months, and then every 6 months thereafter. Event recorders were given to patients with potential arrhythmic symptoms. RESULTS: Mean follow-up was 16 months. Nearly 40% of patients had obstructive sleep apnea; mean body mass index was 32; and average left atrial size was 39.7 mm and 46.2 mm for PAF and PeAF patients, respectively. Freedom from atrial arrhythmia recurrence was: in group 1 patients, 82.4% for PAF and 67.6% for PeAF patients; in group 2 patients, 83.3% for PAF, but only 40.7% for PeAF patients. Comparing outcomes for the first 10 patients studied to the next 20 or more done by three operators showed no difference, suggesting no learning curve affecting the ablation results. Furthermore, the univariate analysis did not show any demographic factor to have an independent significance for ablation success or failure. Spontaneous termination during rotor ablation occurred in 76.8% of PAF and 27.6% of PeAF patients but did not affect the long-term outcomes for maintenance of sinus rhythm. CONCLUSIONS: FIRM-guided atrial ablation plus PVI in our patient population resulted in good success from a recurrence of atrial arrhythmias in patients undergoing an initial ablation procedure. For those with persistent AF undergoing a second procedure now using FIRM guidance plus PVI, the results are lower. Further research is needed to define better the appropriate population for FIRM-guided ablation and the degree of ablation needed for success in these patients.

The procedure value index: a new method for quantifying value in shoulder arthroplasty.

BACKGROUND: The purpose of this study was to introduce the procedure value index (PVI) and apply this value instrument to shoulder arthroplasty. The PVI uses the value equation in units of minimal clinically important difference (MCID) to provide an objective system of quantifying value-driven care. Secondarily, we describe the PVI for both primary anatomic total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) to highlight value differences between these patient populations. METHODS: Patients undergoing primary shoulder arthroplasty with minimum 2-year follow-up were identified retrospectively. MCIDs were determined for the Simple Shoulder Test (SST) score, American Shoulder and Elbow Surgeons (ASES) score, visual analog scale (VAS) score for pain, and Single Assessment Numeric Evaluation (SANE) score. Cost data were reported as total hospitalization costs, total charges, and total reimbursements. The PVI was calculated as the ratio of outcome improvement in units of MCID over the cost of care. Mean PVIs for TSA and RSA were compared. RESULTS: Five hundred thirty-four patients met the inclusion criteria. MCIDs for the SST, ASES, VAS pain, and SANE scores were 3.61, 29.49, 3.28, and 37.05, respectively. With the exception of the ASES score, improvements in units of MCID were not different between TSA and RSA. However, total hospitalization costs and charges were significantly higher for RSA (P < .001). PVIs based on total hospitalization costs and total charges for the SST, ASES, and VAS pain scores were significantly greater for TSA (P < .05). No other PVI was significantly different. CONCLUSIONS: The PVI was greater for TSA when total hospitalization costs and total charges were considered. The PVI helps highlight value differences in shoulder arthroplasty.

Value comparison of humeral component press-fit and cemented techniques in reverse shoulder arthroplasty.

BACKGROUND: Press-fit humeral fixation for reverse shoulder arthroplasty (RSA) has been shown to have loosening rates and outcomes similar to a cemented technique; however, increased value has not been reported. The purpose of this study was to determine whether the press-fit technique could improve the value of RSA using the procedure value index (PVI). METHODS: Primary RSA patients with complete hospitalization cost data, preoperative and minimum 2-year postoperative Simple Shoulder Test (SST) scores, and postoperative satisfaction were included. The PVI was calculated as improvement in the SST score (in units of minimal clinically important difference) divided by total cost and normalized. Itemized cost data were obtained from hospital financial records and categorized. Radiographic complications, infections, and revisions were noted. Comparisons were made between the press-fit and cemented RSA cohorts. RESULTS: A total of 176 primary RSA patients (83 cemented and 93 press fit) met the inclusion criteria (mean follow-up period, 44.6 months). Surgical indications (except failed rotator cuff repair), baseline SST scores, and demographic characteristics were similar. The calculated minimal clinically important difference for the SST score was 3.98. The average PVI was significantly greater in the press-fit cohort (1.51 vs 1.03, P < .001), representing a 47% difference. SST score improvement was not significantly different (P = .23). However, total hospitalization costs were significantly lower for the press-fit cohort ($10,048.89 vs $13,601.14; P < .001). CONCLUSION: Use of a press-fit technique led to a 47% increase in value over a cemented technique. This appeared to be a function of decreased total costs rather than increased outcome scores.