Major Procedure-related Complications Research Articles

Judicious use of coronary computed tomography angiography reduces major procedure-related complications in patients aged <65 years with stable chest pain

Judicious use of coronary computed tomography angiography reduces major procedure-related complications in patients aged <65 years with stable chest pain

Comparison between catheter ablation versus permanent pacemaker implantation as an initial treatment for tachycardia–bradycardia syndrome patients: a prospective, randomized trial

BackgroundClinical outcomes after catheter ablation (CA) or pacemaker (PM) implantation for the tachycardia–bradycardia syndrome (TBS) has not been evaluated adequately. We tried to compare the efficacy and safety outcomes of CA and PM implantation as an initial treatment option for TBS in paroxysmal atrial fibrillation (AF) patients.MethodsSixty-eight patients with paroxysmal AF and TBS (mean 63.7 years, 63.2% male) were randomized, and received CA (n = 35) or PM (n = 33) as initial treatments. The primary outcomes were unexpected emergency room visits or hospitalizations attributed to cardiovascular causes.ResultsIn the intention-to-treatment analysis, the rates of primary outcomes were not significantly different between the two groups at the 2-year follow-up (19.8% vs. 25.9%; hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.25–2.20, P = 0.584), irrespective of whether the results were adjusted for age (HR 1.12, 95% CI 0.34–3.64, P = 0.852). The 2-year rate of recurrent AF was significantly lower in the CA group compared to the PM group (33.9% vs. 56.8%, P = 0.038). Four patients (11.4%) in the CA group finally received PMs after CA owing to recurrent syncope episodes. The rate of major or minor procedure related complications was not significantly different between the two groups.ConclusionCA had a similar efficacy and safety profile with that of PM and a higher sinus rhythm maintenance rate. CA could be considered as a preferable initial treatment option over PM implantation in patients with paroxysmal AF and TBS.Trial registrationKCT0000155.

Augmented fluoroscopy-guided dye localization for small pulmonary nodules in hybrid operating room: intrathoracic stamping versus transbronchial marking.

We developed a novel augmented fluoroscopy-guided intrathoracic stamping technique for localizing small pulmonary nodules in the hybrid operating room. We conducted an observational study to investigate the feasibility of this technique and retrospectively compared two augmented fluoroscopy-guided approaches: intrathoracic and transbronchial. From August 2020 to March 2023, consecutive patients underwent single-stage augmented fluoroscopy-guided localization under general anaesthesia. This included intrathoracic stamping and bronchoscopic lung marking, followed by thoracoscopic resection in a hybrid operating room. Comparative analyses were performed between the two groups. The data of 50 patients in the intrathoracic stamping and 67 patients in the bronchoscopic lung marking groups were analysed. No significant difference was noted in demographic data between the groups, except a larger lesion depth in the bronchoscopic lung marking group (14.7 ± 11.7 vs 11.0 ± 5.8mm, p = 0.029). Dye localization was successfully performed in 49 intrathoracic stamping group patients (98.0%) and 67 bronchoscopic lung marking group patients (100%). No major procedure-related complications occurred in either group; however, the time flow (total anaesthesia time/global operating room time) was longer, and the radiation exposure (fluoroscopy duration/total dose area product) was larger in the bronchoscopic lung marking group. Augmented fluoroscopic stamping localization under intubated general anaesthesia is feasible and safe, providing an alternative with less global operating room time and lower radiation exposure for image-guided thoracoscopic surgery in the hybrid operating room.

Clinical outcomes of radiofrequency catheter ablation guided by intracardiac echocardiography for Chinese atrial fibrillation patients: a single-center, retrospective study.

Intracardiac echocardiography (ICE) is a novel technology with certain advantages in treatment of atrial fibrillation (AF), yet there is limited research on the use of ICE in radiofrequency ablation for AF treatment in China. The aim of this study was to investigate the total fluoroscopy time and dose, safety, and effectiveness of ICE guided vs. traditional fluoroscopy (non-ICE) guided radiofrequency ablation for AF in China. We conducted a single-center retrospective analysis of patients who underwent ICE or traditional fluoroscopy-guided radiofrequency ablation for AF. The primary endpoint of this study was total fluoroscopy time, and the secondary endpoints included total fluoroscopy dose, acute surgery failure, transseptal puncture time, ablation time, total procedure time, and 6-month surgery success (no AF recurrence or atrial flutter). As an exploratory analysis, outcomes of interest by different types of AF were examined. A total of 97 patients were included in the analysis. Forty-eight were in the ICE group and 49 were in the non-ICE group with comparable demographic and clinical characteristics at the baseline. None of patients experienced acute surgery failure with no major procedure-related complications occurred. The fluoroscopic time and dose were significantly lower in the ICE group compared to the non-ICE group (0.00 vs. 9.67±4.88 min, P<0.001; 0.00 vs. 77.10±44.28 mGy/cm2, P<0.001, respectively). There were no statistically significant differences in transseptal puncture time, ablation time and total procedure time between the two groups. There were two AF recurrences observed during the 6-month follow-up in each group (P>0.99). ICE significantly reduced the fluoroscopic time and dose for radiofrequency catheter ablation in AF patients. There were no significant differences in safety or effectiveness outcomes between the ICE and non-ICE groups.

Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry.

Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models. 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6-64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%-5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR: .47, 95% CI: .36-.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%-6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001). Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.

Ten-year single-center outcomes following endovascular repair for abdominal aortic aneurysm using the INCRAFT device

ObjectiveThis study aimed to report the long-term outcomes beyond 10 years of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms using the low-profile INCRAFT device. MethodsThis was a single-center, retrospective cohort study of all patients undergoing EVAR using the INCRAFT device as part of the regulatory trial between 2012 and 2013. Primary endpoint was aneurysm-related death. Secondary endpoints were all-cause death, reintervention, late open conversion, and aneurysm status (shrinkage, stable, and growth). ResultsThirty patients with a mean age of 71.8 ± 7.7 years were included in this study. The median aneurysm diameter at EVAR was 54.5 mm (interquartile range, 53-56.8 mm). All abdominal aortic aneurysms in this study were treated following the device’s instructions for use. At index EVAR, the INCRAFT device was successfully implanted in all patients using a percutaneous approach under local anesthesia. No patients experienced major adverse events or procedure-related complications 30 days after EVAR. During the median follow-up of 125 months (interquartile range, 98-131 months) with follow-up rates of 100% at 5 years and 96.7% at 10 years, aneurysm-related mortality was 0%, and freedom from all-cause mortality was 82.9% at 5 years and 75.3% at 10 years. Reintervention was required in 10 patients with 15 procedures. Sac growth was observed in 11 patients (36.7%), six of whom eventually required late open conversion; five of these patients underwent open aneurysmorrhaphy with stent graft preservation, and one underwent open surgical repair with endograft explantation. Late rupture was identified in one case, where type Ia endoleak led to rupture at 69 months, and open repair was successfully performed. Freedom from reintervention was 89.0% at 5 years but declined to 60.9% at 10 years; freedom from late open conversion was 100% at 5 years but declined to 70.8% at 10 years. ConclusionsLong-term outcomes of the INCRAFT stent graft showed no aneurysm-related deaths. However, sac growth occurred persistently throughout the follow-up period, resulting in a relatively high rate of reinterventions in the later periods, which highlights the importance of lifelong postoperative surveillance and appropriate reinterventions when indicated.

Age and Computed Tomography and Invasive Coronary Angiography in Stable Chest Pain

The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown. To determine the association of age with outcomes of CT and ICA in patients with stable chest pain. The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023. Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy. MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years. Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients. Age did not modify the effect of randomization group on the primary outcome of MACE but did modify the effect on major procedure-related complications. Results suggest that CT was associated with a lower risk of major procedure-related complications in younger patients. ClinicalTrials.gov Identifier: NCT02400229.

Enhancing transvenous lead extraction risk prediction: Integrating imaging biomarkers into machine learning models

BackgroundMachine learning (ML) models have been proposed to predict risk related to transvenous lead extraction (TLE). ObjectiveThe purpose of this study was to test whether integrating imaging data into an existing ML model increases its ability to predict major adverse events (MAEs; procedure-related major complications and procedure-related deaths) and lengthy procedures (≥100 minutes). MethodsWe hypothesized certain features—(1) lead angulation, (2) coil percentage inside the superior vena cava (SVC), and (3) number of overlapping leads in the SVC—detected from a pre-TLE plain anteroposterior chest radiograph (CXR) would improve prediction of MAE and long procedural times. A deep-learning convolutional neural network was developed to automatically detect these CXR features. ResultsA total of 1050 cases were included, with 24 MAEs (2.3%) . The neural network was able to detect (1) heart border with 100% accuracy; (2) coils with 98% accuracy; and (3) acute angle in the right ventricle and SVC with 91% and 70% accuracy, respectively. The following features significantly improved MAE prediction: (1) ≥50% coil within the SVC; (2) ≥2 overlapping leads in the SVC; and (3) acute lead angulation. Balanced accuracy (0.74–0.87), sensitivity (68%–83%), specificity (72%–91%), and area under the curve (AUC) (0.767–0.962) all improved with imaging biomarkers. Prediction of lengthy procedures also improved: balanced accuracy (0.76–0.86), sensitivity (75%–85%), specificity (63%–87%), and AUC (0.684–0.913). ConclusionRisk prediction tools integrating imaging biomarkers significantly increases the ability of ML models to predict risk of MAE and long procedural time related to TLE.

Efficacy and safety of catheter ablation for atrial fibrillation in elderly patients: a systematic review and meta-analysis.

Catheter ablation (CA) is a well-established therapy for patients with atrial fibrillation (AF); however, there is paucity of data for elderly patients. We aimed to assess long-term efficacy and safety of CA for elderly patients with AF. Medline, BVS, Cochrane, and Embase were searched through April 2023 to investigate comparative outcomes between elderly patients > 75 or 80years, as per-study cutoff, and individuals ≤ 75/80years, undergoing CA. Primary efficacy and safety endpoints (AF recurrence and procedure-related major complications) were pooled with the Comprehensive Meta-Analysis 3.0 software. Subgroup analyses were performed by age groups and type of procedure (radiofrequency vs. cryoballoon). Four thousand eight hundred twenty-nine titles were screened, and 27 studies were included, being 26 observational and 1 randomized trial, comprising 117,869 patients, being 8714 (7.4%) elderly > 75/80years, with follow-up from 11.7 to 72.3months. In comparative studies (N = 17 studies), elderly > 75/80years had a higher risk of AF recurrence compared to those ≤ 75/80: relative risk (RR) 1.16 (95% CI 1.05-1.27, p = 0.002. However, funnel plot indicated publication bias, and after imputation of 5 studies, the groups were similar (RR 1.07 (95% CI 0.97-1.19)). The rates of major complications (N = 14 studies) were higher in elderly > 75/80years (RR 1.30 (95% CI 1.10-1.54), I2 = 0, p = 0.002), but were similar in cryoablation studies (N = 7) (RR 1.10, 95% CI 0.94-1.29, p = 0.24, I2 = 0.0). Results were similar when individual study arms (N = 27 studies) were pooled. AF ablation is feasible in elderly patients > 75/80years, with success rates compared to younger individuals. Complication rates, however, were higher.

Treatment of atrial fibrillation with second-generation cryoballoon followed by contact-sensing radiofrequency catheter ablation for arrhythmia recurrences-results of a 5-year follow-up.

The aim of this study was to report the long-term follow-up results of cryoballoon (CB) ablation in patients with atrial fibrillation. All consecutive patients who underwent second-generation CB ablation from February 2015 to December 2017 were included in our study. In all procedures, we used a 28-mm CB placed via a single transseptal puncture guided by intracardiac ultrasound. A 20-mm octapolar intraluminal circular catheter was used for intracardiac recordings. A single 180-s freeze strategy was employed. Repeated procedures were performed with a 3D mapping system and radiofrequency catheters. A total of 126 patients (69.8% male, mean age 57 ± 11years), of which 77.0% had paroxysmal atrial fibrillation (PAF), were included in the study. After a 5-year period, 52.4% of patients were in sinus rhythm without AF recurrence, off antiarrhythmic drugs. A total of 61.9% of patients were free of AF recurrence when redo PVI procedures were performed. When accounting for redo pulmonary vein isolation and antiarrhythmic drugs, a total of 73.8% of the patients were without AF recurrence in long-term follow-up. The patients who underwent redo pulmonary vein isolation procedures had statistically significant lower rates of AF recurrence (p = 0.006). In patients with PAF, long-term success rates improved from 62.9 to 79.4% for patients who underwent the redo procedure (p = 0.020). In patients with persistent atrial fibrillation (PersAF), success rates went up from 41.4 to 55.1% for patients with single or repeated PVI procedure (p = 0.071). In the whole cohort, a total of 3 (2.4%) procedure-related major complications occurred which included persistent PNP, arterial pseudoaneurysm, and arteriovenous fistula. Our data suggest a favorable long-term safety and efficacy profile of second-generation CB ablation. In the mixed paroxysmal and persistent population, up to 73.8% of patients remained free of AF recurrence in the 5-year follow-up, when accounting for redo procedures and AADs. Only 2.4% of patients experienced major complications of the ablation procedure, none with permanent sequelae.

Safety, risk stratification, and cost of ERCP in patients with cirrhosis: a prospective controlled study

IntroductionGiven that ERCP has major procedure-related complications in non-cirrhotic patients, the complications and the cost of therapeutic ERCP were not studied in cirrhotic patients.AimWe aimed to study the complications and cost of ERCP compared to patients without cirrhosis.Patients and methodsOutcome and complications of therapeutic ERCP were prospectively studied in patients with cirrhosis and compared to patients without cirrhosis undergoing ERCP. Patients with cirrhosis were evaluated using the Child-Pugh classification, MELD, MELD Na, and APRI scores. Safety was assessed up to 30 days following the procedure.ResultsPancreatitis, perforation, bleeding, and cardiopulmonary complications were not different in both groups (8% vs. 9.3, 0% vs. 2%, 3.3% vs. 4%, and 4% vs. 2% respectively), while cholangitis occurred more frequently in cirrhosis (13.3% vs. 1.3% respectively). Hospital stay was longer, and mortality and costs were significantly higher among patients with cirrhosis. Patients with Child C cirrhosis developed more complications and had higher mortality. A MELD score cut-off of ≥ 11.5 separated all mortalities. Similarly, MELD-Na and APRI separated patients with cirrhosis who had more frequent complications and mortalities.ConclusionsPatients with cirrhosis experienced more complications and costs, and cirrhotic patients who developed moderate to severe complications were more likely to die.

Bedside Ultrasound-Guided Percutaneous Cholecystostomy in Critically Ill Patients—Outcomes in 51 Patients

Abstract Purpose The aim of this study was to report technical and clinical success of bedside ultrasound-guided percutaneous cholecystostomy (PC) tube placement in intensive care unit (ICU). Materials and Methods This is a retrospective study of 51 patients (36 males:15 females, mean age: 67 years) who underwent ultrasound-guided PC from May 2015 to January 2020. The indication for cholecystostomy tube placement, comorbidities, imaging finding, technical success, clinical success, timing of surgery post-cholecystostomy tube placement, indwelling catheter time, complications, and follow-up were recorded. Results Indications for cholecystostomy tube placement were acute calculous cholecystitis (n = 43; 84.3%), perforated cholecystitis (n = 5; 9.8%), and emphysematous cholecystitis (n = 3; 5.9%). Most of the patients had multiple comorbidities; these were diabetes mellitus, hypertension, cardiovascular disease, chronic renal disease, underlying malignancy, and multisystem disease with sepsis. All patients had undergone PC through transhepatic approach under ultrasound guidance in ICU. Technical success rate of the procedure was 100%. Clinical success rate was 92.1% (47/51) and among these 44/51 (86.2%) patients underwent definitive elective cholecystectomy, 3/51 (5.9%) patients had elective tube removal. Three of fifty-one (5.9%) patients did not improve; among these two underwent emergency surgery, while there was 1/51 (1.9%) mortality due to ongoing sepsis and multiorgan dysfunction. There were no procedure-related mortalities or procedure-related major complications. One patient had bile leak due to multiple attempts for cholecystostomy placement. Mean tube indwelling time was 13 days (range: 3–45 days). Conclusion Ultrasound-guided PC can be safely performed in ICU in critically ill patients unfit for surgery with high technical and clinical success rates. Early laparoscopic cholecystectomy should be preferred after stabilization of clinical condition following cholecystostomy.

High-risk Brugada syndrome: factors associated with arrhythmia recurrence and benefits of epicardial ablation in addition to implantable cardioverter defibrillator implantation.

This study aims to evaluate the prognostic impact of the arrhythmogenic substrate size in symptomatic Brugada syndrome (BrS) as well as to validate the long-term safety and effectiveness of epicardial radiofrequency ablation (RFA) compared with no-RFA group. In this prospective investigational long-term registry study, 257 selected symptomatic BrS patients with implantable cardioverter defibrillator (ICD) implantation were included. Among them, 206 patients underwent epicardial RFA and were monitored for over 5 years post-ablation (RFA group), while 51 patients received only ICD implantation declining RFA. Primary endpoints included risk factors for ventricular fibrillation (VF) events pre-ablation and freedom from VF events post-ablation. In the RFA group, BrS substrates were identified in the epicardial surface of the right ventricle. During the pre-RFA follow-up period (median 27 months), VF episodes and VF storms were experienced by 53 patients. Independent risk factors included substrate size [hazard ratio (HR), 1.13; 95% confidence interval (CI), 1.08-1.18; P < 0.001], aborted cardiac arrest (HR, 2.98; 95% CI, 1.68-5.28; P < 0.001), and SCN5A variants (HR, 2.22; 95% CI, 1.15-4.27; P = 0.017). In the post-RFA follow-up (median 40 months), the RFA group demonstrated superior outcomes compared with no-RFA (P < 0.001) without major procedure-related complications. Our study underscores the role of BrS substrate extent as a crucial prognostic factor for recurrent VF and validates the safety and efficacy of RFA when compared with a no-RFA group. Our findings highlight the importance of ajmaline in guiding epicardial mapping/ablation in symptomatic BrS patients, laying the groundwork for further exploration of non-invasive methods to guide informed clinical decision-making.

A Novel System for Transcatheter Aortic Valve Implantation: First-in-Man Study

Transcatheter aortic valve implantation (TAVI) has become a therapeutic treatment for severe symptomatic patients with aortic stenosis. This study aimed to test a novel transcatheter aortic self-expandable bioprosthesis-the ScienCrown system (Lepu Medtech Inc., Beijing, China)-and evaluate the safety of the new device during TAVI. ScienCrown aortic valve implantation was performed on 10 patients. Clinical assessment was performed at baseline, post procedure, and after 1year. Clinical outcomes and adverse events were assessed according to Valvular Academic Research Consortium-3 criteria. The mean age was 75.30 ± 4.78years with a mean Society of Thoracic Surgeons score of 4.64 ± 3.23%. Device success was achieved in all patients (80% transfemoral, 20% transapical). After 1year, there were no deaths, disabling strokes, myocardial infarctions, conversions to surgery, or major procedure-related complications. New pacemaker implantation was required in one patient (10%). ScienCrown implantation resulted in a reduction in mean valve gradient (63.00 ± 18.84 to 9.67 ± 4.97mm Hg, p <0.001) and an increase in effective orifice area (0.57 ± 0.20 to 2.57 ± 0.59cm2, p <0.001) at 1year. Paravalvular leak was absent in 9 patients (90%), and there was a trace in one patient (10%). All patients were in New York Heart Association class I to II at a mean follow-up of 1year. The experience showed that ScienCrown transcatheter aortic valve system was safely and successfully implanted for treatment of severe symptomatic aortic stenosis. The newer-generation device affords a stable implantation while providing optimal hemodynamic performance.

Single-Session Thrombectomy without Thrombolysis for Iliofemoral Deep Vein Thrombosis: A Single-Center Experience of ClotTriever with Evaluation of Predictors for Reocclusion

Abstract Objective The aim of this study was to determine the effectiveness of a mechanical thrombectomy device in treating iliofemoral deep vein thrombosis (DVT) without thrombolysis and factors associated with post-thrombectomy occlusion. Methods A single-institution retrospective study of consecutive patients who underwent mechanical thrombectomy for iliofemoral DVT using the Inari ClotTriever device was performed from August 2019 to July 2022 without thrombolysis or aspiration. Pre- and post-thrombectomy modified Marder score, symptomatic relief, and other baseline characteristics were evaluated. Occlusion rate was evaluated by clinical symptoms and imaging studies during follow-up. Occlusion-free survival (OFS) was calculated. Factors associated with OFS were evaluated with log-rank tests and cox-proportional hazard ratio model. Procedure-related complications were reported. Results Among 32 included patients and 45 limbs, the mean Marder score decreased from 17.5 ± 8.1 to 0.13 ± 0.89 after thrombectomy. Stenting was needed in 13 patients (40.6%). No procedure-related major complication was observed postprocedurally. At initial follow-up, symptomatic improvement and occlusion-free patency were achieved in 80.0 and 72.2%, respectively. Poor venous inflow on post-thrombectomy venogram (p &lt; 0.05) was associated with early occlusion. Suboptimal use of post-thrombectomy anticoagulation (n = 7) was the only independent predictor of clinical and radiological OFS (p = 0.042). Conclusion Mechanical thrombectomy with ClotTriever is safe and effective in the treatment of acute and/or subacute iliofemoral DVT and can mitigate the need for thrombolytic therapy. Poor venous inflow on post-thrombectomy venogram and suboptimal use of anticoagulation were associated with early reocclusion.

Chronic safety and performance of the extravascular ICD: results from the global EV ICD Pivotal study

Abstract Background Implantable cardioverter defibrillators (ICDs) prevent sudden cardiac death in patients at high risk for ventricular arrhythmias, but conventional systems carry a risk of transvenous (TV) lead-related complications. The novel extravascular ICD (EV ICD) may reduce some of these complications, while offering anti-tachycardia pacing (ATP), pause prevention pacing, and a device of similar size and projected battery longevity as a TV ICD, by placing a lead substernally. The EV ICD Pivotal study demonstrated EV ICD safety and performance for termination of ventricular arrythmias at 6 months. Longer-term performance is unknown. Purpose To report the chronic safety and performance of the EV ICD system. Methods The extravascular implantable cardioverter defibrillator (EV ICD) Pivotal study was a prospective, international, single-arm, premarket clinical study. Patients with a class I or IIa indication for a single-chamber ICD per ESC or ACC/AHA/HRS guidelines were enrolled. Freedom from major system- and/or procedure-related complications at 18 mo was evaluated, as well as conversion of arrhythmias by anti-tachycardia pacing (ATP) or shock through all available follow up. Rates of ATP success were evaluated using the generalized estimating equation (GEE) and simple proportions. Results Implantation was attempted in 316 patients: 74.7% male, age 53.8±13.1 years, 82% primary prevention, left ventricular ejection fraction of 38.9%±15.4%, and New York Heart Association Class I (23.4%) or II/III (65.5%). Of 299 implanted patients (average follow up 16.2±7.2 mo), 19 experienced 80 spontaneous, appropriately treated arrhythmic episodes: 37 treated by ATP, 15 by ATP and shock, and 28 by shock alone with a Kaplan-Meier (KM) estimated 6.8% of patients experiencing appropriate therapy by 18 mo (Figure). Of discrete episodes treated with shock, 21/21 (100%) were successfully terminated. ATP was delivered in 12 patients, successfully treating 35/52 episodes (67.3%; GEE adjusted 59.0%). Inappropriate shocks occurred in 35 patients through all follow up, with a rate of 10.2% at 1 year. The KM estimate of freedom from major EV ICD system-or procedure-related complications rate through 18 mo was 91.9% (95% CI: 88.2% to 94.4%). The most common event was lead dislodgment (10 events in 9 patients) identified 0 to 120 days post-implant, predominantly due to anchoring technique. Conclusion The safety and effectiveness of a novel EV ICD system with a substernal lead extends through chronic follow up. Shocks were avoided in nearly half of all spontaneous episodes because of the availability of ATP.Figure

Percutaneous shunt vessel embolisation with Amplatzer vascular plugs II and IV in the treatment of dogs with splenophrenic shunts: four cases (2019-2022).

To describe the treatment of four dogs with splenophrenic shunts using percutaneous shunting vessel embolisation with Amplatzer vascular plugs II and IV and provide information on their clinical outcomes. Dogs with splenophrenic shunts treated at a veterinary hospital from January 2019 to December 2022 were identified through a medical record search. Six dogs with splenophrenic shunts were identified. Two dogs were excluded because they were treated with laparoscopic surgery. Four underwent percutaneous shunting vessel embolization with Amplatzer vascular plugs and were included in the case series. A sheath was placed in the left external jugular vein and a balloon catheter was advanced to the shunting vessel under fluoroscopy. Portal vein pressure was confirmed to be within an acceptable range during temporary balloon occlusion. Based on preoperative CT angiography and intraoperative contrast examination, Amplatzer vascular plugs II were selected for two dogs and IV were selected for two dogs. Under fluoroscopy, the plug was deployed into the shunting vessel, and angiography confirmed occlusion. In all cases, the increase in portal pressure after temporary occlusion was within the acceptable range, and complete occlusion of blood flow was possible with a single plug. There were no major procedure-related complications. No dogs developed post-ligation seizures or signs of portal hypertension. In addition, improvements in ammonia values were observed in all cases. Percutaneous splenophrenic shunt embolisation using Amplatzer vascular plugs II and IV is technically feasible in dogs, and assessed by intra-procedure angiography, a single plug completely obstructed blood flow in all dogs. Based on the literature search, this is the first report describing Amplatzer vascular plugs for the treatment of splenophrenic shunts.

Endovascular treatment as first-line therapy in Spetzler-Martin grade III brain arteriovenous malformations: a multicenter retrospective study.

The management of Spetzler-Martin grade (SMG) III brain arteriovenous malformations (bAVMs) may be challenging, whatever the exclusion treatment modality chosen. The purpose of this study was to evaluate the safety and effectiveness of endovascular treatment (EVT) as a first-line treatment of SMG III bAVMs. The authors performed a retrospective, two-center, observational cohort study. Cases recorded in institutional databases between January 1998 and June 2021 were reviewed. Patients who were ≥ 18 years of age, had ruptured or unruptured SMG III bAVMs, and received EVT as first-line therapy were included. Baseline characteristics of patients and bAVMs, procedure-related complications, clinical outcome according to the modified Rankin Scale, and angiographic follow-up were assessed. The independent risk factors of procedure-related complications and poor clinical outcome were assessed using binary logistic regression. One hundred sixteen patients with 116 SMG III bAVMs were included. The mean age of the patients was 41.9 ± 14.0 years. The most common presentation was hemorrhage (66.4%). Forty-nine (42.2%) bAVMs were found to be completely obliterated by EVT alone at follow-up. Complications occurred in 39 patients (33.6%), including 5 (4.3%) major procedure-related complications. There was no independent predictor of procedure-related complication. Age > 40 years and poor preoperative modified Rankin Scale score were the independent predictors of poor clinical outcome. EVT of SMG III bAVMs provides encouraging results but needs further improvement. When the embolization procedure performed with intent to cure appears difficult and/or risky, a combined technique (with microsurgery or radiosurgery) may be a safer and more effective strategy. In terms of safety and effectiveness, the benefit of EVT (alone or included in a multimodal management strategy) for SMG III bAVMs needs to be confirmed by randomized controlled trials.

Percutaneous transhepatic biliary drainage (PTBD) in patients with biliary leakage: Technical and clinical outcomes.

The purpose of this study is to evaluate the technical and clinical outcome of percutaneous transhepatic biliary drainage (PTBD) in patients with biliary leakage. All patients who underwent ultrasound-assisted PTBD between January 2017 and December 2021 due to biliary leakage with nondilated biliary systems were retrospectively evaluated for periprocedural characteristics, medical indications, technical success (successful placement of drainage catheter), clinical success (resolved leak without additional procedures), fluoroscopy time, procedure duration, and clinical outcomes. 74 patients with a mean age of 64.1 ± 15.1 years were identified. Surgery was the most common etiology of biliary leak with 93.2% of the cases. PTBD had a 91.8% (68/74) technical success rate and an 80.8% clinical success rate. The mean procedure and fluoroscopy duration were 43.5 and 18.6 minutes. Age > 65 years (P = .027) and left-sided drainage (P = .034) were significant risk factors of clinical failure. Procedure-related major complications were 2 bleedings from the liver and 1 bleeding from an intercostal artery (major complication rate 4%). PTBD is a feasible, safe, and effective treatment option in patients with biliary leakage with low complication rates.

Percutaneous nephrostomy in infants: a 20-year single-center experience.

To investigate the safety and efficacy of the imaging-guided percutaneous nephrostomy (PCN) procedure in infants. A total of 75 (50 boys; 66.7%) patients with a mean age of 121 days (range, 1-351 days) who underwent PCN over a period of 20 years were included in this retrospective study. For each patient, PCN indications, catheter size, the mean duration of catheterization, complications, and the procedure performed following nephrostomy were recorded. Technical success was determined based on the successful placement of the nephrostomy catheter within the pelvicalyceal system. Clinical success was defined as the complete resolution of hydronephrosis and improvement in renal function tests during follow-up. In patients with urinary leakage, technical and clinical success was determined based on the resolution of leakage. The technical success rate was 100%, and no procedure-related mortality was observed. In 11 patients (14.7%), bilateral PCN was performed. The most frequent indication of PCN was ureteropelvic junction obstruction (n = 41, 54.7%). Procedure-related major complications were encountered in two patients (methemoglobinemia and respiratory arrest caused by the local anesthetic agent in one patient and the development of urinoma caused by urinary leakage from the puncture site in the other). Mild urinary leakage was the only minor complication that occurred and only in one patient. Catheter-related complications were managed through replacement or revision surgery in 16 patients (21.3%). Imaging-guided PCN is a feasible and effective procedure with high technical success and low major complication rates, and it is useful for protecting kidney function in infants.