Procedure-related Adverse Events Research Articles

Therapeutic apheresis in kidney transplantation: Emerging trends.

The use of therapeutic apheresis (TA) either as stand-alone or adjunctive treatment in kidney transplantation has increased over the years to become a leading indication. This study shows recent trends in indications for TA related to kidney transplantation, adverse events, and patient outcome in this cohort. This is a retrospective cohort review of adults who received TA for kidney transplant-related indications from January 1, 2017, to December 31, 2022, at the University of Virginia Medical Centre, Charlottesville, VA, USA. Data extracted include basic demographics, indication for apheresis, number of procedures, procedure characteristics, procedure-related adverse events (complications), and serum ionized calcium and serum creatinine. Data were analyzed using statistical package for social sciences (SPSS 2022 IBM Inc). Data from a total of 131 patients who received 860 TA procedures were analyzed. Indications for TA were antibody-mediated rejection (65.5%), recurrent focal segmental glomerulosclerosis (15%), thrombotic microangiopathy (5%), desensitization for ABO incompatibility (4.5%) and for HLA-incompatibility (4.5%), and recurrent IgA nephropathy (1%). Some adverse events were encountered in 16.7% of the procedures and include hypocalcemia (7%), vascular access malfunction (0.7%), hypotension (1.2%), arrhythmia (0.6%), and depletion coagulopathy (0.6%). The overall case mortality rate was 8.4% over the 6-year period. There was one death recorded on machine during TA resulting in a procedure-mortality rate of 0.12%. Antibody-mediated rejection was the most common indication for TA related to kidney transplantation. Adverse events were minor and patient survival over the time was within usual limits.

Outcomes of tine-based leadless pacemakers retrieval: a multicenter study

Abstract Background Leadless cardiac pacemakers (LCP) are well established in daily practice and comparable in safety as well as efficacy to conventional transvenous pacemakers. With increasing implant volumes, more patients may need extraction and retrieval of these devices. Data on extractability of LCPs is however scare. Purpose The aim of this study is to analyze indication, techniques, efficacy and safety of LCP extractions in a multicenter international registry. Methods This is an international, multicenter retrospective registry. Demographic parameters, indication of LCP extraction, success and complication rate were analyzed. Results A total of 50 patients (median age 71 years (IQR 64-81), 34% female) were included in this study. 52% of patients received the LCP for complete AV block. The primary underlying cardiac condition was coronary artery disease in 42%. The main indication for LCP extraction was rise in threshold with loss of capture (32%), upgrade to biventricular pacemaker (26%) or upgrade to transvenous dual-chamber device (14%) (Figure 1). The overall success rate of device extraction was 96% with a mean dwell time of the LCP of 715 days (range 0-1477 days). In most cases, a steerable sheath with a single loop snare (71%) was used (Figure 2). Procedure related adverse events were low and included two pericardial effusion (not requiring any intervention) and one case of a device embolization that was retrieved successfully in the same setting. Overall mortality at 7 days was 0 %. Conclusion Retrieval/extraction of chronically implanted LCP appear to be safe and feasible in centers with expertise in femoral snaring.Indication for LCP retrievalTools used for LCP extraction

Atrial fibrillation cryoablation guided by pressure waveform: a prospective multicentre registry

Abstract Background Cryoballoon ablation (CA) procedures require optimal occlusion of the pulmonary veins (PV), which is conventionally evaluated by iodine contrast injection through the catheter tip. This technique has some weaknesses such as risk of allergic reactions, nephrotoxicity, requirement of fluoroscopy (sometimes at high doses), requirement of a second operator, among others. PV pressure waveform assessment is an alternative method for confirming occlusion, however, multicentre assessment of periprocedural efficacy and safety is lacking. Purpose To describe the intra-procedural performance and safety of routine pressure-based CA. Methods In this independent prospective multicentre observational study, baseline and procedure data from consecutive pressure-guided CB ablations were collected. Operators were not required to have experience in pressure-guided CA for participating in the registry. They were asked to classify the pressure waveform curves into type 1 (presence of "a-wave" and/or symmetric "v-wave", meaning incomplete PV occlusion) and type 2 (absence of "a-wave" and asymmetric "v-wave", meaning complete PV occlusion), Figure 1. The primary endpoint was PV isolation in all veins without use of contrast. Procedure performance and adverse events were also analyzed. Results A total of 150 patients (mean age: 61 ± 10 y.) with paroxysmal (62%) or persistent AF (38%) were included and underwent pressure-guided CA in 9 centres from Spain. Complete PV isolation was achieved in 148 patients (98%). The operators switched to contrast use in 14 cases (9%), mainly to double check the occlusion. Total procedure and fluoroscopy time were 97 ± 39 and 19 ± 10 min respectively. There were 7 (4.7%) procedure related adverse events: 4 phrenic nerve palsy (3 of them were transient), 1 transient coronary ST elevation (before ablation), 1 gastroparesis and 1 femoral pseudoaneurysm. Most relevant results are summarized in Figure 2. Conclusion In this multicentre and multi-brand assessment, CA guided by pressure waveforms provided outstanding procedural outcomes, which were equivalent to those reported with the conventional approach. All operators could easily obtain and identify the waveform without a specific learning curve, avoiding the use of iodine contrast in most cases. The long-term efficacy of this approach will be presented in future analyses.Pressure waveforms types in cryoablationProcedural data

Percutaneous left atrial appendage closure using a novel occlusion device for thromboembolic prevention: 3-year procedural experience

Abstract Background Stroke due to atrial fibrillation has been associated with a high risk of disability and mortality. Percutaneous left atrial appendage (LAA) closure has been established as a treatment strategy for stroke prevention in patients not eligible for oral anticoagulation as well as in patients after electrical isolation of the LAA and subsequent increased risk of thrombus formation. The aim of this study was to evaluate the feasibility and initial experience of LAA closure using a novel nitinol-based, self-expanding system in an unselected patient cohort. Methods and Results One hundred and two patients (39% female, median age 75 [71;80], median CHA2DS2-VASc score 5 [4;6]) underwent LAA closure with the novel system between October 2020 and October 2023. 61/102 (61%) patients underwent previous electrical LAA isolation, 30/102 (29%) patients had high bleeding risk as an indication for LAA closure. Median procedure time was 45 [38;59] minutes and median fluoroscopy time was 10 [7;12] minutes. Successful LAA closure was achieved in all patients, despite different LAA anatomies. Median umbrella and cover disc diameter were 22 [20;24] millimeter and 28 [20;24] millimeter, respectively. Procedure-related adverse events occurred in 2/111 (1.8%) patients. One patient had a vascular complication at the puncture site and another patient had non-hemodynamically significant pericardial effusion. Overall, the patients stayed for a median of 2 [1;4] days in hospital. Conclusion Left atrial appendage closure with a novel nitinol-based, self-expanding system is feasible and safe. LAA isolation was the most common indication for LAA closure at our institution. Further studies are needed, to identify differences and potential advantages of different LAA closure systems.

Cryoballoon ablation for atrial fibrillation in young adults: a propensity-score matching comparison with an older cohort

Abstract Background Cryoballoon ablation (CB-A) has proven to be a valid technology for achieving pulmonary vein isolation (PVI) in patients affected by symptomatic atrial fibrillation (AF). Data regarding CB-A in young adults are still scarce and mainly derived from studies performed without balancing comorbidities and echocardiographic parameters between the groups. The present study aimed to focus on the outcomes and complications of CB-A PVI in young adults (< 50 years) compared to a propensity score-matched population of older individuals, seeking also to understand the true role of "age" as potential risk factor for arrhythmia recurrences. Methods and results We retrospectively enrolled 172 consecutive patients aged < 50 years who underwent PVI employing the second-generation cryoballoon (CB-2). A 1:1 propensity score matching comparison with an older cohort of patients was performed and 290 patients (145 subjects aged < 50 years vs. 145 patients aged ≥ 50 years) were then selected. The mean age was 43.3 ± 4.9 years in the younger group and 64.7 ± 8.7 years in the control group (p < 0.001). After an overall median follow-up of 18 [12 - 29] months, the Kaplan-Meier curves showed a similar rate of freedom from arrhythmia relapses between the younger and the older cohorts (85.5% vs. 77.2% respectively, log-rank p = 0.31). The rate of major complications was low (2.8 %) and did not significantly differ between the groups, being 2.1% for the younger cohort and 3.5% for the older group (p = 0.50). Vascular complications and phrenic nerve palsy appeared to be the most common procedure-related adverse events, occurring in 8 (2.8%) patients. Arrhythmia recurrences during blanking period (ERAF) was found to be the only independent predictor of late AT/AF relapses. Conclusions Our propensity-score model demonstrates that CB-A PVI is equally safe and effective in young adults as it is in older individuals. Furthermore, our findings suggest that "age" itself does not appear to play a significant role in predicting recurrences after CB-A PVI. This result underscores the importance of controlling the modifiable risk factors (comorbidities) and emphasizes the value of early AF diagnosis and intervention.Survival Curve

Substrate characterization and outcomes of ventricular tachycardia ablation in amyloid cardiomyopathy: a worldwide study

Abstract Background the electrophysiological substrate underpinning ventricular tachycardia (VT) in cardiac amyloidosis (CA) remains elusive, and outcomes of catheter ablation in this peculiar population are currently unknown. Purpose we sought to describe the electrophysiological substrate and clinical outcomes of VT ablation in a cohort of patients with CA. Methods we included 19 consecutive patients (mean age, 69±10 years; male sex, 89%) with CA (ATTR, n=13; AL, n=6) undergoing catheter ablation for VT/ventricular fibrillation (VF) between 2013 and 2023 in a retrospective, observational, international study, involving 7 referral European and North American electrophysiology units. The primary efficacy outcome was recurrent VT/VF during follow-up, while the primary safety outcome included major procedure-related adverse events. Results the indication for ablation was drug-refractory VT in 16 patients (84%), and PVC-initiated polymorphic VT/VF in 3 (16%). Catheter ablation was performed using endocardial (n=14, 74%) or endo-epicardial approaches (n=5, 26%). Complete endocardial electroanatomical voltage maps of the left and right ventricles were obtained in 14 (74%) and 6 (32%) patients, respectively. Each patient had evidence of low-voltage areas, most commonly involving the interventricular septum (n=12); late potentials were recorded in 13 patients (68%). A median of 1 (1-2) VTs were inducible per patient; in 10 subjects (43% of mappable VTs), activation mapping was consistent with septal VT origin. Complete procedural success was obtained in 13 patients (68%), at the expense of 4 (21%) major procedure-related adverse events. After a median follow-up of 36 (18-54) months, sustained VT/VF recurrence was observed in 9 patients (47%); survival free from VT/VF recurrence was 74% (95%CI, 56-96%) at 12 months, and 53% (95%CI, 34-94%) at 36-month follow-up; the majority of patients remained on antiarrhythmic drugs (Figure). Low-voltage QRS (HR,21.96; p=0.022) and complete procedural success (HR,0.08; p=0.029) were associated with recurrent VT/VF at multivariable analysis (Figure). Conclusions catheter ablation of VT/VF is associated with favorable acute and mid-term arrhythmia control, yet with substantial risk of procedure-related complications and long-term recurrences. Septal substrate and frailty challenge successful management of patients with CA and VT/VF.Multimodality evaluation of LV substrateMain Study Outcomes

Pulsed-field ablation of atrial fibrillation in patients with multiple cardiovascular comorbidities: acute safety and efficacy from a large nationwide multicenter experience

Abstract Background Patients with multiple cardiovascular (CV) comorbidities are increasing users of health care globally. The decision to perform ablation of atrial fibrillation (AF) may be challenging in this population, due to the difficulty in evaluating their life expectancy and the associated procedural risk. In addition, no data have been reported on the efficiency, effectiveness, and safety outcomes for non-thermal ablation, such as electroporation with pulsed-field ablation (PFA). Purpose To evaluate procedural workflow and safety for AF ablation in these patients through a novel PFA technology (Farapulse) in a large, nationwide clinical practice. Methods Consecutive patients who had undergone PFA of AF from 10 Italian centers were included. Patients were stratified according to the numbers of several comorbidities, assigning 1 point each, including: advanced age (≥80 years), LVEF≤35%, structural heart disease, coronary artery disease, chronic kidney disease, chronic obstructive pulmonary disease, previous stroke/TIA, hyperthyroidism, cancer history, cancer ongoing, severe sleep apnea, diabetes, hypertension, dyslipidemia. Results We included 634 patients (age 62±9 years, 73% male, 67% paroxysmal AF, 88% de novo ablation procedure, LVEF 57±8%). Two-hundred-nine (33%) patients had no risk-factors, 179 (28.2%) patients had at least 1, 137 (21.6%) two, 63 (9.9%) patients 3 risk-factors and 46 (7.3%) patients more than 4 comorbidities. Patients with accumulated risk factors (≥4) had a higher percentage of long-standing AF (17.4% vs 5.4%, p=0.005) and more often underwent de novo ablation procedure (93.5% vs 81.3%, p=0.04). In these cases, operators decided to adopt more frequently, albeit not significantly, advanced diagnostic such as 3D mapping system (30.4% vs 21.9%, p=0.20) or intracardiac echocardiography (41.3% vs 29.8%, p=0.13), a general anesthesia sedation strategy (41.3% vs 32.1%, p=0.88) and a more extensive lesion set beyond PVI (i.e. left atrial posterior wall area, 32.6% vs 23.1%, p=0.15). Procedures in which patients with accumulated risk factors are involved required longer support (preparation plus skin-to-skin) time (90[65-120] min vs 72[60-100] min, p=0.02) and skin-to-skin time (70[60-100] min vs 60[55-85] min, p=0.03) compared to patients with <4 risk factors, whereas time to PVI (19[14-25] min vs 20[14-25] min, p=0.81) and total number of PFA deliveries to achieve PVI (32[32-38] vs 32[32-36], p=0.55) were similar. PVI was achieved in all patients. No major procedure-related adverse events were reported. Conclusion In this preliminary experience, the use of Farapulse PFA system for AF ablation in patients with accumulated risk factors was safe and effective and resulted in similar and fast time to PVI.

Left atrial posterior wall isolation during catheter ablation with the pulsed field ablation in patients with persistent atrial fibrillation

Abstract Background Few data are available on pulsed-field ablation (PFA) targeting left atrial posterior wall (LAPW) in persistent atrial fibrillation (PeAF) patients. Purpose We sought to explore the role of PFA in persistent AF patients beyond pulmonary vein isolation (PVI), extending the lesion set to obtain LAPW isolation. Methods We enrolled consecutive patients referred for persistent AF catheter ablation using the Farapulse PFA system at nine Italian centers. Complete 3D mapping was performed before and immediately after LAPW isolation to validate our workflow in all cases. To analyze lesions' formation and residual gaps, the line around each pair of PVs was divided into 7 distinct sections in accordance with the literature, while the roof line, the floor line, and the two longitudinal posterior wall lines were equally divided into three parts. The PW was overall divided into nine regions. This scheme has been illustrated in Figure 1, Panel A. Results Fifty patients meeting inclusion criteria were included. PVI was achieved in all 202 (100%) PVs (1 patient exhibited a left common trunk, 2 patients exhibited a right middle cardiac PV). One-hundred ninety-eight (98.0%) PVs were acutely isolated on first pass, as confirmed by both entrance and exit block on subsequent 3D-mapping with the mapping catheter. A total of 7 PV gaps were detected through 3D mapping: 4 at the RSPV, 2 at the RIPV and 1 at the LSPV. When considering LAPWI, overall LAPW ablated area was 20.0±6 cm2 with lesions being deployed with the PFA catheter maneuvered in the flower configuration from one LAPW area to another. First-pass roof area (sectors #1 to #3) block was achieved in 44 (88%), first-pass floor area (sectors #7 to #9) block in 43 (86%) and inner-area (sectors #3 to #6) block in 45 (90%). A total of 23 residual LAPW activity gaps were detected through validation using high-output pacing and 3D mapping. Remapping examples has been reported in Figure 1, panel B-C-D. Evaluation of individual segments of the LAPW via signals’ assessment from the PFA splines demonstrated an accuracy of 94.9% (437 out of 450 sectors), compared to the results of subsequent high-output pacing and 3D mapping. Following PFA consolidation in these areas, LAPW isolation was successfully achieved in all cases (100%) using PFA alone, with no need for radiofrequency touch-ups. No major procedure-related adverse events were reported. Conclusion A structured workflow with the novel Farapulse PFA system allowed for a reliable, safe, and fast LAPW isolation, as confirmed by ultra-high-density 3D mapping.

Acute safety and efficacy of ablation for atrial fibrillation in elderly patients by means of pulsed field ablation

Abstract Background It is well known that age affects the efficacy of pharmacological treatment for atrial fibrillation (AF). Thermal ablation (radiofrequency or cryoballoon) is an established strategy for AF. However, there is no evidence evaluating efficiency, effectiveness, and safety outcomes in elderly patients in the context of the novel pulsed-field ablation (PFA) technology. Purpose We aimed to analyze the efficacy and safety of PFA in elderly (age≥75 years) patients with AF compared to non-elderly (age<75 years) patients with AF. Methods All consecutive patients undergoing AF ablation with the Farapulse system at 10 centers were included. Protocol-directed PVI was delivered using 2000 V with eight applications per vein, that is, four applications each in the basket and flower poses. Additional lesions were performed at the operator’s discretion. Results A total of 851 consecutive patients were included: 83 (9.8%) had ≥75 years (median of 77[75-78] years) whereas 768 (90.2%) had <75 years (median of 62[56-68] years, p<0.0001). Older patients had more comorbidities compared to younger patients (kidney disease: 9.6% vs 1.2%, p<0.0001; chronic obstructive pulmonary disease: 8.4% vs 3%, p=0.021; cancer history: 18.1% vs 6.1%, p=0.0004; hypertension: 61.4% vs 43.8%, p=0.002), whereas they exhibited a higher LVEF (60±6% vs 57±8%, p=0.0243). No differences between older and younger patients were found in terms of underlying AF type (paroxysmal AF: 66.3% vs 68.9%, p=0.62), procedure type (repeat ablation: 8.4% vs 13.4%, p=0.29), more extensive lesion set than PVI only (28.9% vs 22.5%, p=0.22) and the use of 3D mapping system (22.9% vs 21.1%, p=0.67). By looking at procedural metrics, no differences were also found between groups: 73±28 min vs 72±32 min for skin-to-skin time, p=0.41; 93±41 min vs 88±43 min for preparation plus skin-to-skin time, p=0.11; 18±9 min vs 17±9 min for fluoroscopy time, p=0.61 and 32[32-40] vs 32[32-38] PFA spots to achieve PVI, p=0.29. PVI was achieved in all patients. No major procedure-related adverse events were reported. Conclusion In our experience, the use of Farapulse PFA system for AF ablation in elderly patients was rapid, safe and effective, with no differences compared to the younger population.

Impact of pulmonary vein variant anatomy during cryo-ablation in paroxysmal and persistent AF patients: 1-year outcome from a nationwide multicenter clinical setting

Abstract Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). While contrast findings exist regarding the influence of variant pulmonary vein (PV) anatomy on predicting AF recurrence, limited data are currently available specifically for cases involving the POLARx cryoablation system during PVI. Purpose We report the real-world experience of POLARx in the context of de novo AF ablation in a multicenter Italian registry. Methods Consecutive patients undergoing AF ablation from the CHARISMA registry at 10 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. All patients were followed-up for at least 12 months after the procedure. Results Four-hundred twenty-nine patients were included (n=358, 83.4% paroxysmal AF, n=71, 16.6% persistent AF, mean age 60.7±10 years, 28.3% female, mean LVEF 58±8%). PVI was achieved in all pts using only cryoablation. Twenty-eight (6.6%) patients exhibited an anatomical variant: 17 (4.0%) a common ostium and 11 (2.6%) an adjunctive PV. The mean number of freeze applications per patient was 5.1 (1.2 for LSPV, 1.3 for LIPV, 1.2 for RSPV and 1.3 for RIPV). Over a median of 398[370-461] days of follow-up, 14 (3.2%) patients experienced an early recurrence of AF during the 90-day blanking period. Overall, 63 patients (14.7%) suffered an AF recurrence after the 90-day blanking period (median time to recurrence 342[171-381] days). The proportion of patients exhibiting AF/AT recurrences was higher in the persistent AF group (17 out 71, 23.9%) than in the paroxysmal AF group (46 out 358, 12.8%, p=0.026), with a hazard ratio of 2.02 (95%CI: 1.2 to 3.5, p=0.0137) whereas patients with anatomy variant showed a similar AF/AT recurrence rate (5 out 28, 17.9%) than in the standard anatomy group (58 out of 401, 14.5%) with a hazard ratio of 1.43 (0.6 to 3.6, p=0.441). Four (0.9%) transient phrenic nerve palsy were observed, both with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported. Conclusion In this multicenter study, the cryo-balloon system demonstrated safety and efficacy in treating both paroxysmal and persistent AF patients, yielding a low incidence of AF/AT recurrence during follow-up, regardless of the presence of variant PV anatomy.

First-in-man clinical implantation and acute pacing performance of a novel subxiphoidal pacemaker system.

Intravascular cardiac pacemakers are an established therapy for bradycardic indications. Recently, a new class of leadless pacemakers have mitigated some of the complications related to pacemaker leads. In this study, we evaluate the implantation and performance of a novel extravascular technology that delivers epicardial pacing through a subxiphoidal approach. Fifteen patients undergoing non-emergent open-heart surgery were enrolled. A midline incision was made just below the xiphoid process, and substernal tunneling was used to create a pocket for the device and to access the anterior pericardium over the right ventricle. The test device (Calyan Technologies, Oakdale, MN) was temporarily inserted underneath the ribcage and clipped to the xiphoid process. The sensing and pacing electrode (FlexArm) was positioned on the anterior pericardium. Ventricular sensing and pacing capture thresholds were measured. The test device was successfully implanted in all 15 patients. There were no device or procedure-related adverse events. The first five implanted patients had no pacing capture at maximum stimulation intensity. Design changes were made to the device, including different electrode size and shape, and successful ventricular capture was achieved in 9 of the subsequent 10 patients. In these patients, pacing threshold was 3.8 ± 1.6mA with a pulse width of 0.5 ms. All devices were successfully explanted at the end of the procedure. In a first-in-human experience with a novel extravascular pacemaker, this study demonstrated the feasibility of pericardial ventricular pacing via a subxiphoidal approach. Further chronic studies are required to evaluate the safety and performance of this novel pacing technology.

SHOULD WE BE CONCERNED ABOUT USING INTRAVASCULAR LITHOTRIPSY ON THE LEFT MAIN? INSIGHT FROM ROLLING STONE RETROSPECTIVE REGISTRY

Abstract Background The use of rotational atherectomy is currently prevalent in the treatment of left main coronary artery lesions. However, it often necessitates the use of a large burr to achieve adequate debulking, which, in turn, demands highly experienced operators. Intravascular lithotripsy (IVL) is a promising, user–friendly and increasingly employed technique for calcific plaque modification before percutaneous coronary intervention. Although in many cath labs it is now routinely used to treat lesions of the three main coronary arteries, there are still concerns regarding its use in the left main, primarily due to prolonged inflations required for its optimal efficacy. Methods We conducted a retrospective analysis using data from the multicenter retrospective Rolling Stone registry. The analysis involved data from 474 patients, with a stratification between IVL procedures involving left main coronary artery (46 patients) and those that did not (428 patients). The primary effectiveness endpoint was procedural success (defined as achieving residual stenosis < 20% with TIMI III flow); secondary endpoints included the rate of procedural related adverse events, in hospital adverse events and MACE rate at 30 days and 6 months. Results Between April 2018 and January 2023, a total of 474 underwent IVL procedures. Most patients presented with calcific lesion requiring lithotripsy in non–left main segments, while IVL was performed on the left main artery in 46 patients. No significative differences were found on baseline characteristics between LM and non–LM groups. Treatment of IVL–LM lesion was marked by a high procedural success rate (97.8%) and a low incidence of procedural and peri–procedural complications. However, there was a higher rate of contrast–induced acute kidney injury in patients treated in LM (6.5% vs. 1.6%, p=0.030), although no other differences for in–hospital outcomes were observed. Furthermore, there were no differences in 30–day and 6–month follow–up outcomes between the two groups. Conclusions This study suggests that employing intravascular lithotripsy in the left main coronary artery is not only a safe procedure but also produces excellent results comparable to its application in other coronary branches. This provides a substantial level of confidence in the safety and effectiveness of IVL when used in this specific context.

Comparison between Endoscopic Ultrasound-Guided Antegrade and Transluminal Stent Implantation in Distal Malignant Biliary Obstruction after Failed ERCP.

Distal malignant biliary obstruction (DMBO) can result in obstructive jaundice. Endoscopic ultrasound- (EUS-) guided biliary drainage (EUS-BD) has been an alternative for DMBO after failed ERCP. To compare the efficacy and safety between antegrade and transluminal approaches in patients with unresectable DMBO when ERCP failed. Patients with DMBO leading to obstructive jaundice after failed ERCP were enrolled in this study. We retrospectively evaluated the safety and efficacy between EUS-guided transluminal stenting (TLS group) and antegrade stenting (AGS group). 82 patients were enrolled, of which 45 patients were in TLS group and 37 in AGS group. There were no statistical differences in the malignancy type, baseline common bile duct diameter, total bilirubin level, reason for EUS-BD, and history of biliary drainage between TLS and AGS groups. The technical success rate was statistically higher in TLS group than in AGS group (97.8 vs. 81.1%, P = 0.031). There were no statistical differences in clinical success rate, procedure-related adverse events, stent migration rate, stent dysfunction rate, reintervention rate, and overall patient survival time between TLS and AGS groups. The median time to stent dysfunction or patient death in TLS and AGS groups was 53 and 81 days, respectively (P = 0.017). Although AGS had a lower technical success rate than TLS, it was superior to TLS in stent patency in patients with DMBO.

A phase I/II clinical trial of ex-vivo expanded human bone marrow derived allogeneic mesenchymal stromal cells in adult patients with perianal fistulizing Crohn’s Disease

BackgroundPerianal fistulas (PF) affect one-third patients with Crohn’s disease (CD) with limited therapeutic options. There is dearth of literature on safety and efficacy of bone marrow-derived mesenchymal stromal cells (BMSCs) in this population.MethodsAn open-label, phase I/II, single-arm study was conducted involving local administration of human allogeneic bone marrow-derived mesenchymal stromal cells in perianal fistula of patients with Crohn’s disease refractory to standard therapies. Clinical severity and biomarkers were assessed at baseline and periodically until week 104 , and MRI at week 24 and 104. Primary and secondary objectives were to assess safety and efficacy respectively. Fistula remission was complete closure of fistula openings with < 2 cm perianal collection on MRI, and fistula response was decrease in drainage by ≥ 50%. Change in perianal disease activity index, quality-of-life and Van Assche index on MRI over time was assessed using mixed-effect linear regression model.ResultsTen patients (male:8, mean age:27.4 ± 12.0years) were recruited. Self-resolving procedure-related adverse events occurred in three patients, with no follow-up adverse events. In intention to treat analysis at week 24, two patients (20%) achieved fistula remission and seven (70%) had fistula response. At week 52, two (20%) patients were in remission and seven (70%) maintained response. At 104 weeks, two (20%) patients maintained response and one (10%) was in remission. Statistically significant decrease in perianal disease activity index (P = 0.008), Van Assche Index (P = 0.008) and improvement in quality-of-life (P = 0.001) were observed over time.ConclusionsAllogeneic BMSCs are safe and effective for the treatment of perianal fistulizing CD with significant improvement in clinical severity and radiological healing.Trial registrationThe study was prospectively registered on Clinical trials registry – India (CTRI), CTRI/2020/01/022743 on 14 January 2020, http://ctri.nic.in.

Outcome of Transarterial Radioembolization in the Treatment of Hepatocellular Carcinoma: Glass Versus Resin Microsphere.

To compare the treatment outcomes of glass and resin microspheres for the treatment of hepatocellular carcinoma (HCC) and evaluate the prognostic factors that influence the outcomes. We retrospectively reviewed 251 consecutive patients who underwent radioembolization for the treatment of HCC at a single tertiary center. Imaging responses after radioembolization were evaluated using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method. Univariate and multivariate Cox proportional hazard models were used to identify the prognostic factors. A total of 195 patients were included in this study (glass microsphere, n = 75; resin microsphere, n = 120). The complete and objective response rates were 16.0% and 50.7% in the glass microsphere group and 17.5% and 58.3% in the resin microsphere group, respectively. Median PFS was 241days in the glass microsphere group and 268days in the resin microsphere group (p = 0.871). Median OS was 29months in the glass microsphere group and 40months in the resin microsphere group (p = 0.669). The only significant prognostic factor was bilobar tumor distribution, which favored resin microspheres (p = 0.023). Procedure-related adverse events occurred more frequently in the resin microsphere group (glass, 2.7% vs. resin, 5.0%; p < 0.001). Glass and resin microspheres for the treatment of HCC did not show a significant difference in survival, though major adverse events occurred more frequently with the use of resin microspheres.

Endoscopic resection in subepithelial lesions of the upper gastrointestinal tract; experience of a tertiary referral hospital in The Netherlands.

Objectives Histological confirmation of subepithelial lesions (SELs) in the upper gastrointestinal tract remains challenging. Endoscopic resection of SELs is increasingly used for its excellent diagnostic yield and opportunity to do away with continued surveillance. In this study, we aimed to evaluate the indications, success-rates and complications of different endoscopic resections techniques for SELs in a large, tertiary referral hospital in Rotterdam, The Netherlands. Methods Data between October 2013 and December 2021 were retrospectively collected and analyzed. Main outcomes are R0-resection rate, en bloc resection rate, recurrence rate and procedure-related adverse events (Clavien-Dindo). Secondary outcomes are procedure time, need for surgical intervention and clinical impact on patient management. Results A total of 58 patients were referred for endoscopic resection of upper gastro-intestinal SELs. The median diameter of lesions was 20 mm (range 7-100mm). Median follow-up time was 5 months (range 0.4-75.7). Forty-eight (83%) procedures were completed successfully leading to en bloc resection in 85% and R0-resection in 63%. Procedure-related adverse events occurred in 6 patients (13%). Severe complications (CD grade 3a) were seen in 3 patients. Local recurrence rate for (pre)malignant diagnosis was 2%. Additional surgical intervention was needed in 7 patients (15%). A total of 32 patients (67%) could be discharged from further surveillance after endoscopic resection. Conclusions Endoscopic resection is a safe and effective treatment for SELs and offers valuable information in undetermined SELs in which repeated sampling attempts have failed to provide adequate tissue for diagnosis.

Dedicated Echoendoscope for Interventional Endoscopic Ultrasound: Comparison with a Conventional Echoendoscope.

Background/Objective: Interventional endoscopic ultrasound (I-EUS) is technically difficult and has risks of severe adverse events due to the scarcity of dedicated endoscopes and tools. A new EUS scope was developed for I-EUS and was modified to increase the puncture range, reduce the blind area, and overcome guidewire difficulties. We evaluated the usefulness and safety of a new EUS scope compared to a conventional EUS scope. Methods: All I-EUS procedures were performed at Juntendo University Hospital from April 2020 to April 2022. The primary outcomes included the procedure time and fluoroscopy time. The secondary outcomes included the technical success rate and the rates of procedure-related adverse events. Clinical data were retrospectively reviewed and statistically analyzed between the new and conventional EUS scopes. Results: In total, 143 procedures in 120 patients were analyzed. The procedure time was significantly shorter with the new EUS scope, but the fluoroscopy time was not different. Among the patients only undergoing EUS-guided biliary drainage (EUS-BD), 79 procedures in 74 patients were analyzed. Both the procedure time and fluoroscopy time were significantly shorter with the new EUS scope. Multivariate analysis revealed that a new EUS scope and use of covered metal stents could reduce the fluoroscopy time. The technical success rate and the adverse event rate were not significantly different between the total I-EUS and the EUS-BD only groups. However, the conventional scope showed stent deviation during stent placement, which did not happen with the new scope. Conclusions: The new EUS scope reduced procedure time for total I-EUS and fluoroscopy time for EUS-BD compared to a conventional EUS scope because of the improvement suitable for I-EUS.

Efficacy of Superselective Intra-arterial Recanalization of Embolized Arteries Resulting from Facial Hyaluronic Acid Injection.

Arterial embolism is a rare complication caused by hyaluronic acid (HA) injection. However, it is one of the most serious complications. Once it happens, the complication would have a great and long-term impact on patients. Intra-arterial recanalization has been reported for recovering the visual acuity in patients with visual loss caused by hyaluronic acid. There is little report about the benefits of superselective intra-arterial recanalization therapy for skin wounds caused by hyaluronic acid vascular embolization. Eight patients who had received the superselective intra-arterial recanalization therapy were retrospectively reviewed. Hyaluronidasewasinjected into the facialartery by superselective intra-arterial recanalization therapy, followed by symptomatic treatment. The facial artery recanalization was successfully performed and no interventional procedure-related adverse events happened. Arterial embolization accompanies by the interruption or reduction of blood supply, followed by ochrodermia, pain, numbness, swelling, yellowish white secreta and even necrosis on skin wound area. Early detection of skin blood supply disorders and early recovery of blood supply areverycritical to treatfacial artery embolization caused byHA. After superselective intra-arterial recanalization therapy, the blood supply to facial skin was restored and skin wounds recovered in all patients. Only 1 patient was left with small and superficial scars. Superselective intra-arterial recanalization therapy is an effective and safe methodthat can alleviateskin wounds caused by HA vascular embolization. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Novel Retractable Robotic Device for Colorectal Endoscopic Submucosal Dissection.

: Appropriate tissue tension and clear visibility of the dissection area using traction are essential for effective and safe endoscopic submucosal dissection (ESD). In this study, we developed a retractable robot-assisted traction device and evaluated its performance in colorectal ESD. : An experienced endoscopist performed ESD 18 times on an ex vivo porcine colon using the robot and 18 times using the conventional method. The outcome measures were procedure time, dissection speed, procedure-related adverse events, and blind dissection rate. : Thirty-six colonic lesions were resected from ex vivo porcine colon samples. The total procedure time was significantly shorter in robot-assisted ESD (RESD) than in conventional ESD (CESD) (20.1±4.1 minutes vs 34.3±8.3 minutes, p<0.05). The submucosal dissection speed was significantly faster in the RESD group than in the CESD group (36.8±9.2 mm2/min vs 18.1±4.7 mm2/min, p<0.05). The blind dissection rate was also significantly lower in the RESD group (12.8%±3.4% vs 35.1%±3.9%, p<0.05). In an in vivo porcine feasibility study, the robotic device was attached to a colonoscope and successfully inserted into the proximal colon without damaging the colonic wall, and ESD was successfully performed. : The dissection speed and safety profile improved significantly with the retractable RESD. Thus, our robotic device has the potential to provide simple, effective, and safe multidirectional traction during colonic ESD.

Percutaneous endobiliary radiofrequency ablation with stent placement in type IV hilar cholangiocarcinoma: A prospective comparison with stent placement alone

ObjectivesThis study aimed to compare the safety and effectiveness of percutaneous endobiliary radiofrequency ablation with stent placement (RFA group) versus stent placement alone (stent group) in patients with type IV hilar cholangiocarcinoma. MethodsThis prospective nonrandomized study was conducted between October 2021 and April 2023. The study included 56 participants (33 men and 23 women, median age 73 years) who underwent percutaneous endobiliary RFA with stent placement (n = 25) or stent placement alone (n = 31) for type IV hilar cholangiocarcinoma. The primary end point was stent patency, while the secondary end points were procedure-related adverse events (AE) and overall survival. ResultsThe percutaneous endobiliary RFA and/or stent placement were successfully completed in all patients in both groups. The median stent patency rate was higher in the RFA group than the stent group (188 days vs. 155 days, p = 0.048). There were no differences in AEs (grade 1 [5 in RFA group vs. 5 in stent group, p = 0.74] and grade 2 AEs [2 vs. 4, p = 0.68]) and patients’ survival (median 222 days vs. 214 days, p = 0.49) between the two groups. ConclusionsIn patients with type IV hilar cholangiocarcinoma, percutaneous endobiliary RFA with stent placement may improve stent patency without increasing the risk of AEs compared to stent placement alone.