Periprocedural Complication Rate Research Articles

Assessment of safety and effectiveness after percutaneous closure for decannulation of Veno-Arterial Extracorporeal Membrane Oxygenation: A systematic review and meta-analysis.

Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) has emerged as a crucial component of critical care medicine, mainly as a lifesaving intervention for patients experiencing refractory cardiac arrest and respiratory failure. In the past, VA-ECMO decannulation was surgical and often associated with a high rate of periprocedural complications, such as surgical site infection, bleeding, and patient mobilization costs. To reduce the rate of these adverse events, many percutaneous techniques utilizing suture-mediated closing devices have been adopted. One of those devices is the Perclose Proglide® (PP). This study's goal was to perform a systematic review to evaluate PP devices' success and complication rates for VA-ECMO decannulation. To analyze the outcomes of PP in VA-ECMO decannulation, a systematic review of the most recent literature was conducted. The Medline, Web of Science, and Cochrane databases were systematically searched up to September 2023. The National Health, Blood, and Lung Institute Study quality assessment tools were used. The final analysis included 10 observational studies comprising 418 patients. The efficacy of PP in VA-ECMO decannulation was 93.0% (95% CI 90.1%-96.0%). In 381 patients, the incidence of acute limb ischemia after VA-ECMO decannulation was 2.5% (95% CI 0.9%-4.%), the infection of the puncture site after decannulation was 1% (95% CI 0%-2%) in 385 patients. The incidence of patients with pseudoaneurysm after decannulation was 1.1% (95% CI 0.1%-2.1%). This systematic review and meta-analysis demonstrate the safety and efficacy of the PP for achieving hemostasis after VA-ECMO decannulation, with a high success rate and low rate of major complications.

Effects of aortic valve calcification on transcatheter aortic valve replacement for low-flow, low-gradient aortic stenosis.

Patients with low-flow, low-gradient (LFLG) aortic stenosis (AS) have precarious hemodynamics and are a fragile population for intervention. Quantification of aortic valve calcification (AVC) severity is a critical component of the evaluation for transcatheter aortic valve replacement (TAVR); this study aims to further clarify its utility for risk stratification in LFLG AS. This retrospective study evaluated 467 patients with LFLG AS undergoing TAVR at a large quaternary-care hospital from January 2019 to December 2021. AVC was quantified with Agatston scores using pre-operative computed tomography angiograms. Primary endpoint was a composite of all-cause mortality and heart failure rehospitalization rates. 51 patients (10.9%) had mild calcification, 137 (29.3%) had moderate, and 279 (59.7%) had severe. Increased AVC severity correlated with increased AS severity by aortic valve area (0.69cm2 for mild AVC vs. 0.63cm2 for severe; p≤0.001), peak velocity (3.1m/s vs. 3.9m/s; p≤0.001), and mean gradient (21mmHg vs. 36mmHg; p≤0.001). Kaplan-Meier analysis showed increased reductions in the primary composite endpoint (p=0.023) and heart failure rehospitalization rates (p=0.005) for patients with greater AVC severity undergoing TAVR. Multivariate adjustments confirmed a significant reduction in heart failure rehospitalizations when comparing TAVR outcomes between mild and severe AVC (HR 0.40, 95% CI 0.18-0.91; p=0.028). Between the 3 groups, there were no significant differences in adjusted rates of paravalvular leak or other periprocedural complications. Increased AVC in LFLG AS does not correlate clinically with more severe AS by echocardiography. Patients with more severe AVC have less heart failure rehospitalizations and derive greater benefit from TAVR.

Steerable Delivery Sheath for Optimized LAA Closure: First Experience and Procedural Outcomes.

The new Amplatzer Steerable Delivery Sheath is a delivery system designed to improve ease-of-use and procedural results of left atrial appendage closure (LAAC). We aimed to compare procedural results after switching our LAAC program at a tertiary care center with the Amulet device to the Steerable Delivery Sheath, with a control group of LAAC employing the standard sheath. The first n = 32 consecutively treated patients at our site using the Amulet device with the Steerable Delivery Sheath were included in this retrospective analysis. As a control-group, n = 39 consecutive patients treated with the Amulet device before the switch to the new sheath were used. LAAC was successful in all patients in both groups (100%). Contrast use and fluoroscopy time were numerically higher in the steerable sheath group (steerable sheath vs. control group: contrast use 70 ± 23 vs. 55 ± 50 mL, p = 0.09, fluoroscopy time 12.7 ± 4.6 vs. 10.2 ± 6.6 min, p = 0.3). Fluoroscopy time and dose decreased after 3 months while contrast use remained unchanged. Complete sealing rate was high in both groups (steerable sheath vs. control group 97% vs. 95%, p > 0.9) and periprocedural complication rate was low, without any periprocedural stroke, vascular complications, or death in both cohorts. LAAC with the Amplatzer Amulet steerable delivery sheath is feasible and safe. Fluoroscopy time and dose suggest a learning curve with the new sheath.

Long-term outcomes with medical therapy, transcatheter repair, or surgery for isolated tricuspid regurgitation: a systematic review and network meta-analysis.

Several transcatheter tricuspid valve (TV) repair devices for tricuspid regurgitation (TR) have emerged. However, few studies have compared transcatheter TV repair with medical therapy (MT) alone or isolated TV surgery. PubMed and EMBASE were searched in February 2024. Studies comparing at least any of the following 2 were included: MT, surgical TV repair, surgical TV replacement, or transcatheter TV repair. The primary outcome was long-term mortality (≧ 1year). The secondary outcomes were short-term mortality (30-day or in-hospital mortality) and periprocedural complications. We performed a network meta-analysis using a random effects model. A total of 25,831 patients from 22 studies (one randomized trial and 21 observational studies) were included. MT alone was associated with higher long-term mortality compared to surgical TV repair (HR [95% CI] 1.72 [1.34-2.23]), surgical TV replacement (HR [95% CI] 1.49 [1.14-1.96]), and transcatheter TV repair (HR [95% CI] 1.52 [1.30-1.78]). Long-term mortality was comparable between transcatheter and surgical interventions. Transcatheter TV repair had a lower risk of short-term mortality (versus surgical TV repair; RR [95% CI] 0.40 [0.22-0.72], versus surgical TV replacement; RR [95% CI] 0.35 [0.19-0.66]) and lower rates of periprocedural complications, including new pacemaker implantation, renal complications, cardiogenic shock than surgical interventions. MT alone for TR was associated with higher long-term mortality compared to surgical or transcatheter TV interventions. Transcatheter TV repair had better periprocedural outcomes compared to surgical interventions with similar long-term mortality. Despite the possibility of selection bias, transcatheter TV repair appears to be an attractive option for TR treatment.

Clinical Outcomes and Risk Factors for Viabahn Stent Graft Occlusion in the Treatment of Visceral Arterial Injuries in Cancer Patients.

This study aimed to evaluate the clinical outcomes of placing Viabahn stent grafts in visceral arterial injuries and identify the risk factors associated with stent graft occlusion. This multicenter, retrospective study included 29 procedures performed on 26 patients who underwent Viabahn stent graft placement between December 2017 and November 2022. We evaluated technical and clinical success rates, periprocedural complications, and stent graft patency using contrast-enhanced computed tomography. We conducted univariate analysis to examine the risk factors associated with Viabahn stent graft occlusion. The technical success rate was 96.6% (28 of 29), and the clinical success rate was 86.2% (25 of 29). The periprocedural complication rate was 17.2% (5 of 29), consisting of 4 mild adverse events and 1 patient death. The stent graft patency rates at 1, 3, 6, 12, and 24 months were 85%, 84.2%, 77.8%, 66.7%, and 50%, respectively. Univariate analysis indicated significant correlations between the lack of antiplatelet medication (P = .00074) and SG oversize ≥ 20% (P = .047). This trial demonstrated the safety and effectiveness of Viabahn stent graft placement for visceral arterial injuries with high patency rates. Additionally, this study identified the lack of antiplatelet treatment and Viabahn oversize ≥ 20% as significant risk factors for Viabahn stent graft blockage in visceral arterial injuries.

Clinical characteristics and predictors of in-hospital mortality of patients hospitalized with myocardial infarction before and during COVID-19 pandemic.

The COVID-19 pandemic has impacted many acute coronary syndrome (ACS) care aspects. The aim was to compare the patient profile, ACS characteristics, and the outcomes in patients referred to the invasive cardiology department before (March 2019 - February 2020) and during the COVID-19 pandemic (March 2020 - February 2021). Clinical and demographic features, comorbidities, laboratory parameters at admission, and periprocedural data were recorded. The relationship of these parameters with in-hospital mortality was assessed. Before the COVID-19 pandemic, 664 patients were admitted due to ACS (mean age 67.16 ± 11.94 years, females 32.1%), and during the COVID-19 pandemic 545 ACS patients were recorded [mean age 66.02 ± 12.02 years (p = 0.463), females 31% (p = 0.706)]. A 17.8% decrease in the ACS rate was observed. During the pandemic, there were more STEMI patients (44.3% vs. 52.1%, p < 0.001) and fewer patients treated conservatively (24.9% vs. 8%, p < 0.001). Most lesions were located in the left anterior descending artery (53.4% vs. 54.7%), but post-percutaneous coronary intervention TIMI 3 was observed more frequently before the pandemic (83.9% vs. 75.1%, p < 0.001). Periprocedural complication rates did not differ between the groups. In-hospital outcomes did not differ between analyzed periods regarding all-cause death nor cardiac death rates, 5.3% vs. 4.6% (p = 0.598) and 4.5% vs. 3.7% (p = 0.473), respectively. Based on the analysis of 1209 patients, a decrease in ACS patients admitted during the pandemic was recorded, but in-hospital mortality remained similar.

Conduction-System pacing Italian Network Group (C-SING): insights from a Nationwide Multicenter Observational Study

Abstract Background/Introduction Conduction system pacing (CSP), encompassing His bundle pacing (HBP) and left bundle branch area pacing (LBBAP), has gained prominence in treating bradycardia and heart failure in recent years. Despite its increasing utilization, data on real-world adoption of CSP are limited. Purpose The C-SING study aimed at assessing patient characteristics, implant success, procedural details, and safety of CSP when performed in routine clinical practice. Methods Periprocedural data from 27 experienced CSP centers across Italy were collected on patients undergoing CSP implantation for various indications between January 2021 and January 2024. Results The study comprised 1,317 patients (median age 78 years [interquartile range, 71-83], male 66.2%). Leading indications included atrioventricular (AV) block (40.8%), sinus node dysfunction (12.1%), atrial fibrillation with bradycardia (9.7%), AV node ablation (9.5%), and heart failure (12.5%). Pacemakers were implanted in 77.3% of patients, cardiac resynchronization devices in 21.7%, and implantable cardioverter-defibrillators in 1.0%. Stylet-driven and lumenless CSP leads were utilized in 64.7% and 35.3% of procedures, respectively. Final 12-lead ECG assessment revealed LBBAP capture in 88.7% patients, HBP in 8.4% (selective 4.2%, non-selective 4.2%), and no CSP capture in 3.0%, resulting in a 97.0% CSP lead implantation success rate. In patients with LBBAP, predominant capture types were left bundle branch pacing (19.6%), left posterior fascicular pacing (19.2%), and left septal fascicular pacing (14.8%). Comparing HBP to LBBAP, the latter showed shorter procedural time (60 minutes [45-80] vs. 70 minutes [60-95], p=0.003), but similar fluoroscopy time (6.0 minutes [3.3-10.8] vs. 6.1 minutes [4-10], p=0.735). Paced QRS duration was longer in LBBAP (118 ms [105-130]) compared to HBP (110 ms [101-122], p&amp;lt;0.001). LBBAP showed lower capture thresholds (0.6 V [0.5-0.9] @0.4 ms vs. 0.8 V [0.5-1.5] @1.0 ms, p&amp;lt;0.001) and higher R-wave sensing (10.7 mV [8-16] vs. 4.5 mV [2.4-9.9], p&amp;lt;0.001). The rate of periprocedural complications was higher in patients with LBBAP than HBP (7.3% vs. 1.8%, p=0.03), with the most frequent events being intraprocedural perforation into the left ventricular cavity during lead screwing (2.6%) and CSP lead dislodgment before hospital discharge (1.4%). These occurrences necessitated lead repositioning without additional complications. Conclusion CSP demonstrated feasibility as a primary pacing strategy for various indications in a real-world, multicenter setting. LBBAP, more frequently used than HBP, exhibited shorter procedural time and superior acute electrical parameters. LBBAP revealed a higher rate of minor procedural complications than HBP. Further investigations, supported by additional long-term outcome data, are essential to comprehensively assess CSP performance.

Transcatheter mitral edge-to-edge repair in patients with prior cancer diagnosis

Abstract Background Transcatheter edge-to-edge repair (TEER) is a safe and effective therapy for mitral regurgitation (MR). Despite oncological patients have an increased risk of functional and organic MR due to cardiotoxic treatment exposure, the use of TEER in this setting remains underexplored. Purpose To evaluate the safety and efficacy of TEER in patients with MR and prior cancer diagnosis. Methods Observational, retrospective, multicenter study based on the Spanish national TEER registry. Patients from those centers providing oncological specific data were included in this analysis. Patients with and without history of cancer were propensity score matched (PSM) in a 1:1 ratio. The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 1 year. Results A total of 1237 patients with MR who underwent TEER between 2010 and 2022 across 14 centers in Spain were included. The mean age was 73 ± 11 years and 34% were female. MR etiology was functional in 58%, organic in 27% and mixed in 15%. Of them, 164 had a history of cancer. Baseline characteristics of the unmatched cohort are shown in Figure 1. Median time from cancer diagnosis to TEER was 7 (3-17) years and the most common cancer types were breast (20%), leukemia/lymphoma (19%) and colorectal (11%). PSM resulted in 163 pairs with a good balance of baseline characteristics (Figure 1). Procedural success rate was high and similar between the groups (93% vs 96%, p=0.217), as were periprocedural complication rates (Figure 2A). The primary efficacy endpoint occurred in 38 (23%) patients in the cancer group and 29 (18%) patients in the control group (Hazard ratio 1.36, CI 95% 0.84 to 2.20, p= 0.214) (Figure 2B). Conclusion In routine practice, a notable proportion of patients undergoing mitral TEER have a prior cancer diagnosis. Immediate and 1-year clinical outcomes appear comparable to those observed in non-cancer patients. These findings suggest that mitral TEER should not be withheld from this growing population.

Intravascular lithotripsy in the management of underexpanded stents

Abstract Introduction Stent underexpansion significantly heightens the risk of major adverse cardiac events (MACE), and available treatment options for this condition remain limited. Intravascular Lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, emerges as a promising tool for underexpanded stents. Methods Following PRISMA guidelines, we systematically explored PubMed, SCOPUS, and Cochrane databases up to September 3, 2023, for studies evaluating IVL's safety and efficacy in treating underexpanded stents. We gathered angiographic (QCA) and intracoronary imaging (OCT or IVUS) data, examining the stent's minimal diameter stenosis (MDS), minimal lumen diameter (MLD), minimal stent area (MSA), and minimal lumen area (MLA) pre- and post-IVL application. Procedural success constituted the efficacy endpoint, while peri-procedural complications, in-hospital-30-days and long-term mortality, and MACE were safety endpoints Results This meta-analysis comprised 21 studies including 669 patients and 673 treated lesions in underexpanded stent. The mean age was 73.2 ± 2.1 years, with an overall IVL procedural success rate of 93% [(95% Confidence Interval (CI): 88%-96%, I2=29%), while the in-hospital-30-days and long-term mortality incidence were 1% (95% CI: 1%-3%, I2=0%) and 3% (95% CI: 2%-6%, I2=0), respectively. The 30-days target lesion revascularization (TLR) was approximately 6% (95% CI: 3%-12%, I2=50%). There was a significant increase in the MDS [Standardized Mean Difference (SMD): +50.52%, 95% CI: 39.4-61.6, I2=94%)] and in MSA (SMD: +3.52, 95% CI: 2.47 to -4.58, I2=83%) immediately after IVL application. It was observed a significant increase in MLD (SMD: +1.54, 95% CI: 1.09 to 1.98, I2=95%) and in the MLA (SMD: +3.64, 95% CI: 2.62-4.66, I2=5%). Major procedural and device related complications were 3% (95% CI: 1%-6%, I2=0%) and 1% (95% CI: 0%-2%, I2=85%) respectively. Notably low rates were observed for stent thrombosis (0%, 95% CI: 0%-2%, I2=0%), dissections (1%, 95% CI: 1%-4%, I2=0%), perforations (1%, 95% CI: 1%-3%, I2=0%) and no-reflow (0%, 95% CI: 0%-1%, I2=0%). Conclusions IVL demonstrates promise as a safe and effective strategy for underexpanded stent treatment, characterized by low rates of periprocedural complications. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.30day All-Cause Mortality after IVL use.Minimum Stent Diameter after IVL use.

Nationwide trends in utilization and safety of ventricular arrythmia ablation in patients with hypertrophic cardiomyopathy

Abstract Background Catheter ablation for ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVC) is increasingly utilized across the nation, while data on its safety in Hypertrophic Cardiomyopathy (HCM) patients is sparse. Purpose To analyze the nationwide trends in utilization and complications of inpatient ventricular arrhythmia ablations in patients with HCM. Methods This study is a retrospective analysis of hospitalizations, in HCM patients 18 years of age and older, who underwent an inpatient VA ablation in the U.S., between 2016 and 2020. We drew data from the National Inpatient Sample (NIS) database. Patients without HCM undergoing the CA for VA were used as controls. Baseline sociodemographic and clinical data, procedural complications, mortality and length of stay were analyzed. Multivariable analysis was performed to identify independent predictors of procedural complications. Results Among a weighted total of 2880 patients hospitalized between 2016 and 2020, who underwent VA ablations, the median age was 67 years (IQR 56-74), 60% were male, and 73% were white. The HCM group had similar age distribution but more women (64.5% vs 33.6%, p&amp;lt;0.001) and more African Americans (13.2% vs. 7.3%, p=0.03). The non-HCM cohort had significantly higher rates of prior myocardial infarction (22% vs 12.4%, p=0.026), ischemic cardiomyopathy (30.1% vs 0.8%, p&amp;lt;0.001), heart failure (70.5% vs 39.7%, p&amp;lt;0.001), and peripheral vascular disease (PVD, 42.9% vs 18.2%, p&amp;lt;0.001). This was reflected in higher Deyo Comorbidity Index in the non-HCM cohort (score of ≥ 2 in 66.6% vs 43%, p&amp;lt;0.001). Overall, the real-world peri-procedural complication rate in the entire cohort was 15.3%, including 6.4% hemorrhagic, 4.5% pericardial, and 2.3% vascular complications. There was a trend for lower complication rate in the HCM group (9.9% vs. 16.7%, p = 0.08). The in-hospital mortality didn’t defer (1.7% vs. 4.2%, p=0.28) and the length of stay was shorter in the HCM group (3.5 vs. 6.4 days, p &amp;lt; 0.001). Multivariable logistic regression analysis showed obesity (OR 2.06; 95%CI: 1.59 - 2.67; p&amp;lt;0.001) and PVD (OR 2.19; 95%CI: 1.34-3.53; p=0.001) to be independent predictors of complications while HCM was not (OR 0.76, 95% CI 0.51-1.14, p = 0.195). Conclusion Real-world data from a nationwide inpatient database shows comparable safety for VA ablation in HCM patients with similar mortality and lower length of stay, compared to non-HCM patients.

Internal hematoma architecture predicts subdural hematoma responsiveness to standalone middle meningeal artery embolization.

Subdural hematoma (SDH) is quickly becoming the most common neurosurgical pathology due to the aging population. Middle meningeal artery embolization (MMAE) has recently emerged as an effective adjunct to surgical SDH evacuation by decreasing recurrence risk. MMAE has also shown promise as a standalone SDH intervention, but clinical and radiographic predictors of successful MMAE remain ill-defined. Retrospective chart review from 2020 to 2023 at a single center identified all MMAE cases performed as primary SDH treatment. Cases were classified by hematoma internal architecture as homogeneous, separated, laminar, or trabecular. SDH maximal thickness was assessed on all follow-up imaging and any recurrences or expansions requiring surgery were denoted as treatment failures. 164 standalone MMAE cases were reviewed. Most cases were in male patients (75.0%) with a mean age of 73.2 years. The overall MMAE treatment failure rate was 6.7% with a 4.9% periprocedural complication rate. The cases with trabecular and laminar collections were slightly larger than those with homogeneous and separated collections (16.2mm vs. 14.2mm, p = 0.008*), but other baseline characteristics were similar. The MMAE failure rate was significantly lower in the laminar and trabecular subgroup (1.2%) compared to the homogeneous and separated subgroup (12.4%) (p = 0.005*). Homogeneous and separated internal hematoma architecture was the only predictor of MMAE failure in multivariate analysis (OR 10.5, p = 0.027*) and was also associated with delayed SDH resorption (ANOVA: F = 4.8, p = 0.0025*). Standalone MMAE is an effective, safe, and durable treatment for non-acute SDHs, and is especially effective for SDHs with more membranous internal architecture.

Catheter ablation alone versus catheter ablation with combined percutaneous left atrial appendage closure for atrial fibrillation: a systematic review and meta-analysis.

Combined catheter ablation (CA) with percutaneous left atrial appendage closure (LAAC) may produce comprehensive treatment for atrial fibrillation (AF) whereby rhythm control is achieved and stroke risk is reduced without the need for chronic oral anticoagulation. However, the efficacy and safety of this strategy is still controversial. This meta-analysis was reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Medline, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies. The risk of bias was assessed using the Modified Newcastle-Ottawa scale and Cochrane risk of bias tool. Eligible studies reported outcomes in patients with AF who underwent combined CA and LAAC vs CA alone. Studies performing CA without pulmonary vein isolation were excluded. Eight studies comprising 1878 patients were included (2 RCT, 6 observational). When comparing combined CA and LAAC vs CA alone, pooled results showed no difference in arrhythmia recurrence (risk ratio (RR) 1.04; 95% confidence interval (CI) 0.82-1.33), stroke or systemic embolism (RR 0.78; 95% CI 0.27-2.22), or major periprocedural complications (RR 1.28; 95% CI 0.28-5.89). Total procedure time was shorter with CA alone (mean difference 48.45 min; 95% CI 23.06-74.62). Combined CA with LAAC for AF is associated with similar rates of arrhythmia-free survival, stroke, and major periprocedural complications when compared to CA alone. A combined strategy may be as safe and efficacious for patients at moderate to high risk for bleeding events to negate the need for chronic oral anticoagulation.

Kidney disease, diabetes, and diameter stenosis predict Rotablation bailout in modified balloon application for severely calcified coronary lesions.

Modified balloon (MB) treatment in severely calcified coronary artery lesions is an established technique. However, some lesions require Rotablation (RA) as bailout strategy. This study aimed to assess predictors of switch from MB to RA and its impact on procedural and midterm outcomes. Four hundred and eighty-three consecutive patients were included undergoing MB treatment (n = 204) with a scoring or cutting balloon, or upfront RA treatment (n = 279) serving as control cohort. Strategy switch from MB to RA was performed in 19 of 204 patients. Procedural success was defined as successful stent implantation and TIMI III flow. In the MB cohort, median age was 72 [63-78] years, 75.5% were male and 42.1% had acute coronary syndrome. Procedure success was achieved in 89.4% of the switch group versus 98.4% of the MB only group (p < 0.001) and in 96.4% of the RA cohort. In the switch group, periprocedural complications (31.6% vs. 8.1% vs. 11.8%, p = 0.007), radiation dose (149 [126-252] vs. 59 [30-97] vs. 102 [59-156] Gcm2; p < 0.001) and contrast volume (250 [190-250] vs. 190 [150-250] vs. 195 [190--250] mL; p < 0.001) were significantly higher. Diabetes (OR 3.8, 95%CI 1.1-13.9, p = 0.042), chronic kidney disease stage 4 or 5 (OR 19.0, 95%CI 3.3-108.6, p < 0.001) and pronounced calcification resulting in higher angiographic diameter stenosis (OR 1.13, 95%CI 1.1-1.2, p = 0.001) independently predicted strategy switch. Midterm results were not affected by strategy switch regarding 1-year target lesion revascularization rates (86% vs. 89% vs. 89%; log-rank p = 0.95). Primary RA strategy might be considered in patients with severely calcified coronary artery lesions with high angiographic diameter stenosis, diabetes or impaired renal function due to increased periprocedural complication rates, radiation dose, and contrast volume following strategy switch.

‘Pressure cooker’ and ‘balloon pressure’ techniques significantly increase 3-month complete occlusion rate after spinal arteriovenous fistula embolization as compared to glue: single center evaluation on 38 consecutive patients

BackgroundSpinal arteriovenous fistulas can be treated either by surgery or by endovascular means, using different strategies. The main drawback of embolization is the risk of recurrence. Our objective is to...

Safety and efficacy of flow redirection endoluminal device (FRED) for treatment of intracranial aneurysm; A systematic review and meta-analysis.

Previous research has shown promising results for treating intracranial aneurysms (IAs) with a flow redirection endoluminal device (FRED). In this systematic review and meta-analysis, we aimed to assess the safety and efficacy of this device by providing pooled estimates using the data from previous studies. A systematic literature search of Web of Sciences, PubMed, Scopus, and Embase was performed until October 8th, 2023. After selecting the final articles, relevant data were extracted. Parameters relating to safety and efficacy were pooled using STATA software. Heterogeneity was assessed using I-squared and Cochran's Q. Funnel plots and Egger's regression methods were used to evaluate publication bias. Sensitivity analysis was also performed using the leave-one-out method. The data of 37 studies were used for meta-analysis. The rates of immediate adequate occlusion and complete occlusion were 0.51 (95% CI: 0.31-0.71) and 0.34 (95% CI: 0.16-0.53), respectively, while the rates of the adequate and complete occlusion at the latest follow-up were 0.90 (95% CI: 0.84-0.94) and 0.75 (95% CI: 0.65-0.84), respectively. The periprocedural complications rate was 0.04 (95% CI: 0.03-0.06), and the overall complications rate was 0.12 (95% CI: 0.09-0.15). The rate of good functional outcome was 0.99 (95% CI: 0.99-1.00) and the successful implantation rate was 1.00 (95% CI: 1.00-1.00). There was substantial heterogeneity among the reports for most of the evaluated parameters. FRED had high safety and efficacy in treating IAs, as evidenced by its high occlusion and low complication rates.

Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry

BackgroundNo data have been reported on cooling characteristics and the impact of variant pulmonary vein (PV) anatomy on atrial fibrillation (AF) recurrences after POLARx cryoballoon (CB) ablation. ObjectiveThe purpose of this study was to analyze the impact of PV anatomy variants and cooling characteristics after CB ablation from a large multicenter prospective registry. MethodsThe primary end point was defined as 1-year absence of any atrial tachyarrhythmias (ATAs: AF/atrial flutter/atrial tachycardia). Correlation between ATA recurrences and anatomy variants/cooling characteristics were evaluated. The secondary outcome was the rate of major periprocedural complications. ResultsA total of 429 consecutive patients diagnosed with paroxysmal AF (83.4%) or persistent AF (peAF; 16.6%) were enrolled. Twenty-eight patients (6.6%) exhibited an anatomical variant (common ostium: 4.0%; adjunctive PV: 2.6%). Nadir temperature, thaw time, and total deflation time were different between standard PVs and PV variants. After the blanking period, over a mean of 431 ± 99 days of follow-up, 63 patients (14.7%) suffered an ATA recurrence. Patients with recurrences had both a shorter thaw time (18.5 ± 7 seconds vs 19.8 ± 7 seconds; P = .0012) and a shorter total deflation time, whereas time to isolation was longer (57.4 ± 42 seconds vs 49.1 ± 33 seconds; P = .04). Patients with anatomy variants showed a similar ATA recurrence rate (5 of 28 [17.9%]) to the standard PV anatomy group (58 of 401 [14.5%]) (P = .584), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] 0.49–4.13; log-rank, P = .4384). After adjusting for confounders, heart failure (HR 4.12; 95% CI 1.75–9.73; P = .0013) and peAF (HR 1.81; 95% CI 1.03–3.18; P = .0433) remained associated with ATA recurrence during follow-up. ConclusionThe POLARx CB system demonstrated long-term efficacy, along with a safe profile, in both patients with paroxysmal AF and those with peAF, regardless of the presence PV variants. Time to isolation was longer in patients with ATA recurrences during follow-up. Clinical Trial RegistrationCatheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). ClinicalTrials.gov identifier: NCT03793998. Registration date: January 4, 2019.

Obesity paradox in patients with reduced ejection fraction eligible for device implantation - an observational study.

Patients with obesity have an overall higher cardiovascular risk, at the same time obesity could be associated with a better outcome in a certain subgroup of patients, a phenomenon known as the obesity paradox. Data are scarce in candidates for cardiac resynchronization therapy (CRT). We aimed to investigate the association between body mass index (BMI) and all-cause mortality in patients eligible for CRT. Altogether 1,585 patients underwent cardiac resynchronization therapy between 2000-2020 and were categorized based on their BMI, 459 (29%) patients with normal weight (BMI<25kg/m2), 641 (40%) patients with overweight (BMI 25-<30kg/m2) and 485 (31%) with obesity (BMI≥30kg/m2). The primary endpoint was all-cause mortality, heart transplantation, and left ventricular assist device implantation. We assessed periprocedural complications and 6-month echocardiographic response. Normal-weight patients were older compared to patients with overweight or obesity (70years vs. 69years vs. 68years; P ‹0.001), respectively. Sex distribution, ischaemic aetiology, and CRT-D implantation rates were similar in the three patient groups. Diabetes mellitus (BMI<25kg/m2 26% vs. BMI 25-<30kg/m2 37% vs. BMI≥30kg/m2 48%; P ‹0.001) and hypertension (BMI<25kg/m2 71% vs. BMI 25-<30kg/m2 74% vs. BMI≥30kg/m2 82%; P ‹0.001) were more frequent in patients with overweight and obesity. During the mean follow-up time of 5.1years, 973 (61%) reached the primary endpoint, 66% in the BMI<25kg/m2 group, 61% in the BMI 25-<30kg/m2 group and 58% in the BMI≥30kg/m2 group (log-rank P‹0.05). Patients with obesity showed mortality benefit over normal-weight patients (HR 0.78; 95%CI 0.66-0.92; P=0.003). The obesity paradox was present in patients free from diabetes, atrial fibrillation, and ischemic events. Periprocedural complication rates did not differ in the three groups (BMI<25kg/m2 25% vs. BMI 25-<30kg/m2 28% vs. BMI≥30kg/m2 26%; P=0.48). Left ventricular ejection fraction improved significantly in all patient groups (BMI<25kg/m2 median -LVEF 7% vs. BMI 25-<30kg/m2 median -LVEF 7.5% vs. BMI≥30kg/m2 median -LVEF 6%; P<0.0001) with a similar proportion of developing reverse remodeling (BMI<25kg/m2 58% vs. BMI 25-<30kg/m2 61% vs. BMI≥30kg/m2 57%; P=0.48); P=0.75). The obesity paradox was present in our HF cohort at long-term, patients underwent CRT implantation with obesity and free of comorbidities showed mortality benefit compared to normal weight patients. Patients with obesity showed similar echocardiographic response and safety outcomes compared to normal weight patients.

Percutaneous Transluminal Angioplasty for Atherosclerotic Stenosis of Vertebral Artery Origin.

Background: In patients with vertebral artery origin (VAO) stenosis and concomitant stenoses of other cerebral feeding arteries, data on the risk of percutaneous transluminal angioplasty (PTA) alone and with stent placement (PTAS) for VAO stenosis are limited. We aimed to determine how the presence of polystenotic lesions in other cerebral feeding arteries and concomitant carotid artery stenting (CAS) affect the periprocedural risk and long-term effect of PTA/S for atherosclerotic VAO stenosis. Methods: In a retrospective descriptive study, consecutive patients treated with PTA/S for ≥70% VAO stenosis were divided into groups with isolated VAO stenosis and multiple stenoses. We investigated the rate of periprocedural complications in the first 72 h and the risk of restenosis and ischemic stroke (IS)/transient ischemic attack (TIA) during the follow-up period. Results: In a set of 66 patients aged 66.1 ± 9.1 years, polystenotic lesions were present in 56 (84.8%) patients. 21 (31.8%) patients underwent endovascular treatment for stenosis of one or more other arteries in addition to VAO stenosis (15 underwent CAS). During the periprocedural period, no patient suffered from an IS or died, and, in the polystenotic group with concomitant CAS, there was one case of TIA (1.6%). During a mean follow-up period of 36 months, we identified 8 cases (16.3%) of ≥50% asymptomatic VA restenosis, and, in the polystenotic group, 4 (8.9%) cases of IS. Conclusion: The presence of severe polystenotic lesions or concomitant CAS had no adverse effect on the overall low periprocedural risk of PTA/S of VAO stenosis or the risk of restenosis during the follow-up period.

Safety and Efficacy of Radial Artery Access for Peripheral Vascular Intervention: A Single-Center Experience

Radial artery (RA) access has been increasingly utilized for coronary procedures due to lower rates of access-site complications and improved patient satisfaction. However, limited data are available for RA access for peripheral vascular intervention (PVI). We performed a retrospective review of 143 patients who underwent PVI via RA access from February 2020 to September 2022 at a single institution. Baseline characteristics and follow-up data were ascertained from a prospectively maintained institutional database. Of 491 PVI, 156 (31.8%) were performed through the RA. Anatomical location for intervention were the femoral (44.8%), iliac (31.1%), popliteal (9.6%) peroneal (2.7%), tibial (9.9%), and subclavian (1.9%) arteries. Procedural access was obtained through the right RA (92.9%), left RA (4.5%), or right ulnar artery (2.6%) using the 6 French R2P Destination Slender sheath in 85 cm, 105 cm, and 119 cm lengths. Atherectomy was used in 34.7%. Mean contrast volume was 105.5 mL and the average fluoroscopy time was 18.5 minutes. Conversion to femoral access occurred in 3 cases (1.9%) due to arterial spasm and non-crossable lesions. Concomitant pedal access occurred in 2 cases (1.3%). Periprocedural complication rate was 3.84%, of which access-site hematoma was most common (3.2%); none required blood transfusion, surgical intervention, or additional hospital stay. There was 1 case (0.64%) of in-hospital stroke. The mortality rate at 30-day, 6-month, and 1-year was 1.4%, 2.8%, and 4.2%, respectively. In conclusion, RA access is feasible for diverse PVI, and future studies are needed to assess safety and benefit compared to femoral artery access.

Standalone transcatheter left atrial appendage closure or combined with cryoballoon pulmonary vein isolation

Abstract Background Head-to-head comparisons between stand-alone left atrial appendage closure (LAAC) and a same-procedure LACC + cryoballoon (CB) pulmonary vein isolation (PVI) (combined procedure) are currently lacking. Purpose To compare acute and long-term outcomes between stand-alone LAAC vs a LAAC+CB-PVI combined procedure. Methods All patients undergoing LAAC at our institution, having at least 2 years follow-up, were analyzed to assess the impact of additional CB-PVI. The primary efficacy and safety endpoints of our study were the acute procedural success rate and the peri-procedural complications rate. As secondary endpoints, major bleeding, and ischemic events, as well as sinus rhythm rate at 2 years follow-up were assessed. Results Among 126 LAAC patients meeting inclusion criteria (males=64.2%), n=55 (43.7%) underwent a combined procedure. LAAC-only patients were older (72.5±7.2 vs 68.9±8.6, p&amp;lt;0.05) and less frequently having paroxysmal AF (23.9% vs 47.3%, p&amp;lt;0.05). Baseline CHA2DS2-VASc was similar among groups (3.3±1.3 vs 2.9±1.1, p=0.07) while LAAC-only patients had higher HAS-BLED at enrollment (3.4±1.1 vs 3.0±1.0, p=0.04). Additional CB-PVI was not a risk factor for incomplete LAA occlusion (OR 0.24–3.78, p=0.96), presence of residual lateral flow (OR 0.26–4.05; p=0.96), intraprocedural need for occluder device resizing compared to pre-procedural assessment (OR 0.27–3.05; p=0.884), and peri-procedural complications (OR 0.25–6.74, p=0.749). At 3-month post-procedural trans-esophageal echocardiography, a combined procedure was not associated with higher risk of incomplete occlusion (OR 0.33–1.59, p = 0.432), nor larger peri-device leakages (coefficient k: -0.65–+0.20, p=0.291). Overall and by-group ischemic (red) and bleeding (blue) relative risk reduction from CHA2DS2-VASc and HAS-BLED predicted yearly rates during follow-up was reported in Figure1. Over a median follow-up of 40 [26–56] months, a combined procedure was not a risk factor for major bleeding (OR 0.31–5.48, p=0.715) or ischemic (OR 0.11–3.56, p=0.599) events. As expected, additional CB-PVI was strongly associated with a reduction of AF recurrences (OR 0.16–0.86, p&amp;lt;0.05), after excluding permanent AF patients from the analysis. Conclusion Combined LAAC + CB-PVI procedure does not appear to be a risk factor for worse LAAC-related outcomes, while reducing AF recurrences in non-permanent AF patients.Figure 1