High Procedural Success Rate Research Articles

Pulsed field ablation for atrial fibrillation: acute procedural efficacy and safety of an initial German multicenter experience

Abstract Background Pulsed field ablation (PFA) is a novel non-thermal energy source to conduct catheter ablation of atrial fibrillation (AF). However, real-world multi-center data regarding acute procedural efficacy and safety is sparse. Purpose To study acute procedural success and safety in patients undergoing PFA for catheter ablation of AF in a multicenter registry. Methods Consecutive paroxysmal and persistent AF patients undergoing PFA-based catheter ablation using a multispline catheter were enrolled. The cohort included first and repeat ablation procedures. Procedural parameters, acute success and in-hospital safety were evaluated. A follow-up of all patients was conducted. Results Five German centers enrolled a total of 154 patients undergoing PFA in this study. Mean age was 68±12 years, median CHA2DS2-VASc Score was 3 (Q1-Q3: 2–4). Patients suffered from paroxysmal AF (n=55; 36%), persistent AF (n=93; 60%) and consecutive atrial tachycardias (AT) due to previous CA (n=6; 4%). The median left atrial (LA) PFA and total procedure times were 33 (Q1-Q3: 24–53) and 90 (Q1-Q3: 73–116) minutes, respectively. Mean LA PFA fluoroscopy and total fluoroscopy times were 12.1±5.5 and 20.2±8.7 minutes. Of all 154 procedures, 130 (84%) were index ablation procedures with isolation of pulmonary veins (PVI) only and 24 (16%) were repeat procedures (including re-PVI and ablation of consecutive AT). Acute PV reconnection following primary PVI and the initial set of PFA-applications was found in 20/130 (15%) patients, necessitating additional PFA ablation. Finally, successful PFA-guided PVI was achieved in all patients. Additional PFA lesion sets (including LA posterior wall isolation, anterior ablation, mitral isthmus ablation) were applied in 17/154 (11%) patients. Complications occurred in a total of 6/154 (3.8%) patients (including three groin site complications, two pericardial tamponades, one transient coronary spasm without sequela). The follow up data is still being assessed and will be provided by the time of the ESC 2022 meeting. Conclusion PFA performed in patients with atrial fibrillation demonstrates high acute procedural success rates and a favorable safety profile in this first real-world multicenter registry. Funding Acknowledgement Type of funding sources: None.

Syncope recurrence and long-term heart rate variability after cardioneuroablation for vasovagal syncope: a systematic review and meta-analysis

Abstract Background Cardioneuroablation (CNA) has emerged as a promising therapy in patients with refractory vasovagal syncope (VVS). Well-designed randomized clinical trials (RCT) are lacking. Purpose To provide an estimate of the procedural success rate of CNA, including subgroup analysis by method and target of ablation, as well as serial measurements of autonomic tone after CNA with heart rate variability (HRV). Methods A systematic search of studies was performed in MEDLINE and EMBASE according to the PRISMA guidelines, from inception to 14 February 2022. Observational studies and clinical trials reporting success rates were included. Quality assessment was performed using the CONSORT and STROBE recommendations. The primary outcome was freedom from syncope after CNA. Meta-analysis was performed with a random-effects model. The secondary outcome was serial HRV analysis (heart rate, SDNN, rMSSD and LF/HF ratio) analysed with one-way ANOVA with Bonferroni's correction for multiple testing. Results A total of 465 patients were included across 14 studies (mean age 40±4 years; 54% females). All included studies were of intermediate quality (median 17, IQR 16–18). Procedural approach to CNA was variable: 50 patients (10.8%) by mapping of fractionated electrograms, 73 patients (15.7%) with the spectral method, 210 (45.2%) with high frequency stimulation, 73 (15.7%) with a purely anatomically guided method, and 59 patients (12.6%) with a combination. The target was bi-atrial in 168 patients (36.1%), left atrium only in 259 patients (55.7%), and right atrium only in 38 patients (8.2%). The freedom from syncope was 91.9% (95% CI 88.1–94.6%; I2=6.9%, p=0.376; Figure 1). CNA limited to right atrial ablation was associated with a significantly lower success rate (p<0.0001; 81.5%, 95% CI 51.9–94.7%) versus left atrial ablation only (94.0%, 95% CI 88.6–96.9%) and bi-atrial ablation (92.7%, 95% CI 86.8–96.1%). Subgroup analysis according to the technique used to identify GPs did not show any significant difference in success rate (p=0.206). Ten studies (n=317, 68.2%) reported at least one HRV parameter. Results are presented in Figure 2 with the mean and standard deviations. There were significant increases in heart rate, and significant decrease in SDNN, rMSSD and LF/HF ratios for each follow-up timepoint available (p<0.0001 for all analyses). Recovery of these parameters was observed in 2 studies, but these were not associated with an increased risk in syncope recurrence. Conclusion This meta-analysis suggests a high procedural success rate of CNA in VVS of 92%. CNA induces long-term changes in HRV, however some studies reported recovery of these parameters without an association with syncope recurrence. Therefore, HRV changes may not be an appropriate surrogate endpoint for clinical response. Well-designed double-blind, multi-center sham controlled RCTs are needed to provide evidence for future treatment guidelines. Funding Acknowledgement Type of funding sources: Foundation.

Retrograde recanalization of radial artery occlusion via the distal transradial artery: A single-center experience.

BackgroundRadial artery occlusion (RAO) often occurs after catheterization when using a transradial artery approach.ObjectiveThis prospective study assessed the success and feasibility of accessing the distal transradial artery (dTRA) for retrograde recanalization of RAO.MethodsFrom June 2019 to December 2021, 44 consecutive patients who had undergone cardiac catheterization resulting in RAO were given retrograde recanalization via the dTRA. According to the result of the procedure (primary endpoint), patients' cases were analyzed as successful or failed. Rates of post-operative patency and adverse events were calculated up to 12 months.ResultsThe procedural success rate was 88.6%. Compared with the successful group, a significantly higher percentage of patients in the failed group were current smokers and/or suffered from diabetes mellitus (each, 80.0% cf. 33.3%, P = 0.046); had undergone at least 3 previous cardiac catheterizations (60.0% cf. 12.8%, P = 0.011), lower rate of anticoagulation (30.77% cf. 0%, P = 0.048) and exhibited chronic total occlusion (100.0% cf. 51.28%, P = 0.041). In each group, one patient each had minor bleeding at the access site and hematoma. The patency rates in the successful group at postoperative 3, 6, and 12 months were 48.7, 43.6, and 35.9%, respectively.ConclusionThe dTRA approach for retrograde recanalization of RAO showed a high procedural success rate, but with patency rates of <50% at follow-up.

Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale

Atrial low voltage area (LVA) catheter ablation has emerged as a promising strategy for ablation of persistent atrial fibrillation (AF). It is unclear if catheter ablation of atrial LVA increases treatment success rates in patients with persistent AF. The primary aim of this trial is to assess the potential benefit of adjunctive catheter ablation of atrial LVA in addition to pulmonary vein isolation (PVI) in patients with persistent AF, when compared to PVI alone. The secondary aims are to evaluate safety outcomes, the quality of life and the healthcare resource utilization. A multicenter, prospective, parallel-group, 2-arm, single-blinded randomized controlled trial is under way (NCT03347227). Patients who are candidates for catheter ablation for persistent AF will be randomly assigned (1:1) to either PVI alone or PVI+atrial LVA ablation. The primary outcome is 18-month documented event rate of atrial arrhythmia (AF, atrial tachycardia or atrial flutter) post catheter ablation. Secondary outcomes include procedure-related complications, freedom from atrial arrhythmia at 12 months, AF burden, need for emergency department visits/hospitalization, need for repeat ablation for atrial arrhythmia, quality of life at 12 and 18 months, ablation time, and procedure duration. Characterization of Arrhythmia Mechanism to Ablate Atrial Fibrillation (COAST-AF) is a multicenter randomized trial evaluating ablation strategies for catheter ablation. We hypothesize that catheter ablation of atrial LVA in addition to PVI will result in higher procedural success rates when compared to PVI alone in patients with persistent AF.

Percutaneous Closure of Mitral Paravalvular Leak: Long-Term Results in a Single-Center Experience.

Background: Paravalvular leak occurs in 5–17% of patients following surgical valve replacement, more often in mitral position. The prognosis without treatment is poor. Percutaneous device closure represents an alternative to repeat surgery. The objective of this work is to evaluate the medium and long-term results in the percutaneous closure of PVL in mitral prosthesis. Methods: This observational study is based on a retrospective registry including consecutive mitral PVL cases undergoing percutaneous closure at a single tertiary-care center from April 2010 to December 2020. The safety and efficacy results of the procedure, at 90 days and in the long term, were analyzed. Also, predictors of procedure failure and long-term events were identified. Results: A total of 128 consecutive mitral paravalvular leak closure procedures were included. Technical success was achieved in 115 (89.8%) procedures. The presence of multiple PVLs was the sole factor that independently predicted procedural failure. Median follow-up of our sample was 41.8 months (mean 47.7 ± 35.7 months). Underlying hemolytic anemia as the indication for PVL closure, a recent admission for decompensated HF, and lack of improvement in functional class emerged as consistent predictors of MACE and death during long-term follow-up, while lack of procedural success during the first PVL procedure and chronic kidney disease were also associated with MACE during follow-up. Conclusions: Percutaneous mitral PVL closure displayed high technical and procedural success rates, with an acceptable safety profile, in a high-risk population. Percutaneous mitral PVL closure achieved an improvement in short- and long-term functional class and a reduction of hemolysis in the vast majority of patients. In addition, long-term survival in our study was good, in particular for patients undergoing successful PVL closure procedures.

Experiencia ibérica con PASCAL para la reparación percutánea borde a borde en insuficiencia mitral

Introduction and objectivesThe PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. MethodsProcedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. ResultsWe included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). ConclusionsTranscatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.

Dual guidewire balloon antegrade fenestration and re-entry technique for coronary chronic total occlusions percutaneous coronary interventions.

To describe the experience of coronary chronic total occlusions (CTOs) percutaneous coronary interventions (PCI) using antegrade fenestration and re-entry (AFR) technique with a dedicated dual guidewire balloon (DGB). Antegrade dissection and re-entry (ADR) techniques has been emphasized in recent worldwide CTO consensus documents. We investigated the feasibility and safety of DGB as a dedicated device to perform guidewire-based AFR. Fourteen consecutive patients with complex CTO (J-CTO score: 3.1 ± 0.9) underwent DGB-AFR in the years 2020-2021. DGB-AFR consists in advancing the DGB over a guidewire that reached the vessel distal to the CTO in an extra plaque fashion, inflating/deflating the DGB to create fenestration between subintimal space and the true lumen and advancing a proximal re-entry guidewire through fenestration in the true lumen. DGB-AFR alone was successful in 10 of 14 (71%) cases, a rescue wire-based ADR was needed in two cases for re-entry into the true lumen with a total success rate in 12 of 14 (86%) cases. Among all DGB-AFR cases, four (28%) were performed as a first-line strategy while the remaining 10 (71%) cases were performed as a bail-out strategy after failure of other antegrade crossings for 30 min of procedural time. No DGB-related complications were observed. DGB-AFR is a user-friendly reliable strategy for the treatment of many CTO lesions. It can be used as bail-out after failure of conventional antegrade wiring techniques, achieving high procedural success rate and low occurrence of procedural adverse events.

The Role of High-output His-bundle Pacing During Atrioventricular Node Ablation.

Atrioventricular (AV) junction ablation (AVJA) is an acceptable strategy to control the heart rate in atrial fibrillation (AF) with a high procedural success rate. However, a small subset of patients pose a technical challenge with the standard right-sided approach. High-output His-bundle pacing has been shown to help localize the His bundle in a difficult-to-ablate AV junction. We report a case series of patients with difficult-to-ablate AVJA and present strategies to troubleshoot them. In this small series of patients, we found that high-output His pacing can be an effective alternative for successfully localizing the AVJA site. In this series, we also observed that an inability to achieve His capture from the right side can predict failure of ablation using the standard right-sided approach and the consequent need for a left-sided approach.

6-Month Outcomes of the TricValveSystem in Patients With Tricuspid Regurgitation: The TRICUS EURO Study.

Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients. The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava. TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up. Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P=0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6months (P=0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively. The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6months follow-up.

Multicenter Experience With the Transcatheter Leaflet Repair System for Symptomatic Tricuspid Regurgitation.

Transcatheter treatment techniques for tricuspid regurgitation (TR) have evolved in recent years, with leaflet repair being the most commonly used, but thus far evidence on the PASCAL and PASCAL Ace system is based mainly on compassionate use data. This is the first report on commercial use in a multicenter study with a large patient cohort investigating the safety and efficacy of the PASCAL and PASCAL Ace system in the treatment of TR. In a retrospective, multicenter, observational setting, data from all consecutive patients undergoing leaflet repair for TR at 8 centers was collected, including a centralized analysis of echocardiographic data. A total of 235 high-risk patients (mean age 78 ± 8 years, 49% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality score 8.6% ± 6.8%) were included. TR was functional in 87% of patients and graded severe or higher in 91%. TR was successfully reduced to moderate or less in 78% of patients (P< 0.001). Procedural success was 78% (n=153). At the latest available follow-up (median 173days), TR reduction was sustained (78% with TR moderate orless; P< 0.001), and echocardiography showed indications of right ventricular remodeling (mean right ventricular end-diastolic diameter 56 ± 9mm vs 53 ± 9mm; P< 0.001). Patients' symptoms diminished significantly (63% were inNew York Heart Association functional class I or II at follow-up; P< 0.001). In a device-specific analysis, the PASCAL andPASCAL Ace showed no difference in TR reduction (postprocedural TR moderate or less in 77% vs 78%; P=0.82). In early clinical experience, the PASCAL (Ace) leaflet repair system has high technical and procedural success rates with efficient TR reduction and significant clinical and echocardiographic improvement at follow-up.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

BackgroundVarious randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively.AimsThe prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety.Methods and resultsThe total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent.ConclusionsThe ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers.Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803.

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation

Introduction and objectivesThe PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. MethodsProcedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. ResultsWe included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). ConclusionsTranscatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.

Periprocedural Outcomes Associated With Use of a Left Atrial Appendage Occlusion Device in China

Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for patients with atrial fibrillation. However, the performance of LAAO among East Asian patients is unknown. To document the procedural success rate and configurations, major adverse event rates, and antithrombotic medication regimens during and after LAAO procedures among patients in China. In this cohort study, consecutive patients from 39 Chinese centers undergoing LAAO were prospectively enrolled between April 1, 2019, and October 31, 2020. Periprocedural and intraprocedural techniques and postprocedural medications were left to the surgeon's discretion. Data were analyzed from July 1 to November 1, 2021. LAAO for patients with atrial fibrillation. The main outcomes were procedural success and complication rates periprocedure and major adverse event rates of death, stroke, systemic embolism, and bleeding events at 30 days postprocedure; the composite end point of death, stroke, and systemic embolism was also analyzed. Unadjusted and multivariable-adjusted logistic regression analyses were performed to assess the associations of periprocedural techniques (types of anesthesia, intraprocedural imaging modalities, and combined ablation procedure) with 30-day adverse events. Among 3096 enrolled participants, 1782 participants (57.6%) were men, and the mean (SD) age was 69 (9) years. Participants had a high risk of stroke (mean [SD] cardiovascular risk score, 4.0 [1.8]) and a moderate-to-high risk of bleeding (mean [SD] bleeding risk score, 2.4 [1.2]). A total of 1287 procedures (41.6%) were performed under local anesthesia, while 493 procedures (15.9%) used only fluoroscopy guidance. In 1297 procedures (41.9%), LAAO implantation was combined with radiofrequency ablation or cryoablation for atrial fibrillation. Procedural success was achieved in 3032 patients (97.9%). At 30-day follow-up, the rate of the composite end point of death, stroke, or systemic embolism was 0.52% (95% CI, 0.32%-0.84%), and the rate of any life-threatening or major bleeding was 1.23% (95% CI, 0.90%-1.68%). No significant associations were observed between the procedural success or 30-day adverse events and the types of anesthesia (general or local), intraprocedural imaging (transesophageal echocardiography, fluoroscopy, or intracardiac echocardiography), or whether a combined ablation procedure was performed or not. In centers performing at least 40 procedures per year, compared with those performing fewer than 40 procedures per year, procedural success was significantly higher (adjusted odd ratio [aOR], 1.97; 95% CI, 1.01-3.53; P = .02) and risk of life-threatening or major bleeding was significantly lower (aOR, 0.42; 95% CI, 0.21-0.87; P = .02). These findings suggest that patients with a high risk of stroke and moderate to high risk of bleeding who underwent implantation of a LAAO device in Chinese centers had high rates of procedural success and low rates of short-term ischemic and bleeding events.

Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry.

The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise. We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included. According to mean CHAD2 DS2 -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage(LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-relatedstroke and 0.6% fatal bleeding. Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period.

The comparison of efficacy and safety between transradial and transfemoral approach for chronic total occlusions intervention: a meta-analysis

This meta-analysis compared the outcomes of transradial access (TRA) and transfemoral access (TFA) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in recent decades. We searched multiple databases for articles published between January 1, 2015, and December 31, 2020. Six observational studies with 11,736 patients were analyzed. Data included baseline demographics, Japan-chronic total occlusion (J-CTO) score, sheath size, PCI vessel, retrograde method, procedural time, fluoroscopy time, and contrast volume. The more prevalent target CTO vessel was the left coronary artery in the TRA group and the right coronary artery in the TFA group. Higher J-CTO score, longer procedural time, and more contrast volume were seen in the TFA group. In comparison, the TRA group had better procedural success rate (odds ratio (OR), 0.846; 95% confidence interval (CI) 0.749–0.956) and less vascular complications (OR, 0.323; 95% CI 0.203–0.515), but similar retrograde success rate (OR, 0.965; 95% CI 0.382–2.435). In-hospital death (OR, 0.527; 95% CI 0.187–1.489) and major adverse cardiovascular events (OR, 0.729; 95% CI 0.504–1.054) did not differ between the groups. Overall, fewer vascular complications and higher procedural success rates were noted in the TRA CTO PCI population. However, similar retrograde success rates and clinical outcomes were noted between the groups.

Bypassing the intensive care unit for patients with acute ischemic stroke secondary to large-vessel occlusion.

Endovascular mechanical thrombectomy is safe and effective for the treatment of acute ischemic stroke (AIS) due to large-vessel occlusion (LVO). Still, despite high rates of procedural success, it is routine practice to uniformly admit postthrombectomy patients to an intensive care unit (ICU) for postoperative observation. Predictors of ICU criteria and care requirements in the postmechanical thrombectomy ischemic stroke patient population are lacking. The goal of the present study is to identify risk factors associated with requiring ICU-level intervention following mechanical thrombectomy. The authors retrospectively analyzed data from 245 patients undergoing thrombectomy for AIS from anterior circulation LVO at a comprehensive stroke and tertiary care center from January 2015 to March 2020. Clinical variables that predicted the need for critical care intervention were identified and compared. The performance of a binary classification test constructed from these predictive variables was also evaluated using a validation cohort. Seventy-six patients (31%) required critical care interventions. A recanalization grade lower than modified Thrombolysis in Cerebral Infarction (mTICI) scale grade 2B (odds ratio [OR] 3.625, p = 0.001), Alberta Stroke Program Early Computed Tomography Score (ASPECTS) < 8 (OR 3.643, p < 0.001), and presence of hyperdensity on postprocedure cone-beam CT (OR 2.485, p = 0.005) were significantly associated with the need for postthrombectomy critical care intervention. When applied to a validation cohort, a clearance classification scheme using these three variables demonstrated high positive predictive value (0.88). A recanalization grade lower than mTICI 2B, ASPECTS < 8, and postprocedure hyperdensity on cone-beam CT were shown to be independent predictors of requiring ICU-level care. Routine admission to ICU-level care can be costly and confer increased risk for hospital-acquired conditions. Safely and reliably identifying low-risk patients has the potential for cost savings, value-based care, and decreasing hospital-acquired conditions.

Upgrades from Previous Cardiac Implantable Electronic Devices Compared to De Novo Cardiac Resynchronization Therapy Implantations: Results from CRT Survey-II in the Turkish Population.

Cardiac resynchronization therapy is the guideline-directed treatment option in selected heart failure with reduced left ventricular ejection fraction patients. Data regarding the contemporary clinical practice of cardiac resynchronization therapy in Turkey have been published recently. This sub-study aims to compare clinical and periprocedural characteristics between cardiac resynchronization therapy upgrade and de novo implantations. Turkish arm of the Cardiac Resynchronization Therapy Survey-II was conducted between October 1, 2015, and December 31, 2016, at 16 centers. All consecutive patients who underwent an upgrade to cardiac resynchronization therapy system (n=60) or de novo cardiac resynchronization therapy implantation (n=335) were eligible. Distribution of age, gender, and heart failure etiology were similar in the 2 groups. Atrial fibrillation, valvular heart disease, and chronic kidney disease were more common in cardiac resynchronization therapy upgrade patients. Narrow intrinsic QRS duration and left ventricular ejection fraction being 75% in both groups, and only beta-blockers were prescribed at rates of >90% in both groups. Cardiac resynchronization therapy upgrades are performed with high procedural success rates and without excess periprocedural complication risk. Feared complications of cardiac resynchronization therapy upgrades due to the pre-existing device should not delay the procedure if indicated.

Upgrades from Previous Cardiac Implantable Electronic Devices Compared to De Novo Cardiac Resynchronization Therapy Implantations: Results from CRT Survey-II in the Turkish Population.

Cardiac resynchronization therapy is the guideline-directed treatment option in selected heart failure with reduced left ventricular ejection fraction patients. Data regarding the contemporary clinical practice of cardiac resynchronization therapy in Turkey have been published recently. This sub-study aims to compare clinical and periprocedural characteristics between cardiac resynchronization therapy upgrade and de novo implantations.Turkish arm of the Cardiac Resynchronization Therapy Survey-II was conducted between October 1, 2015, and December 31, 2016, at 16 centers. All consecutive patients who underwent an upgrade to cardiac resynchronization therapy system (n=60) or de novo cardiac resynchronization therapy implantation (n=335) were eligible.Distribution of age, gender, and heart failure etiology were similar in the 2 groups. Atrial fibrillation, valvular heart disease, and chronic kidney disease were more common in cardiac resynchronization therapy upgrade patients. Narrow intrinsic QRS duration and left ventricular ejection fraction being 75% in both groups, and only beta-blockers were prescribed at rates of >90% in both groups.Cardiac resynchronization therapy upgrades are performed with high procedural success rates and without excess periprocedural complication risk. Feared complications of cardiac resynchronization therapy upgrades due to the pre-existing device should not delay the procedure if indicated.

Mitral valve edge-to-edge repair versus indirect mitral valve annuloplasty in atrial functional mitral regurgitation.

We aimed to compare indirect mitral annuloplasty using the Carillon Mitral Contour System and edge-to-edge repair via MitraClip in atrial functional mitral regurgitation (aFMR). In patients with left ventricular dilation, both edge-to-edge repair and indirect mitral annuloplasty are effective in reducing mitral regurgitation, while no clinical trial has compared both interventional methods in aFMR. In a retrospective single-center analysis, 41 patients with aFMR underwent either edge-to-edge mitral valve repair (MitraClip group, n = 20) or indirect annuloplasty (Carillon group, n = 21). Both treatment groups showed high procedural success (100%) and low complication rates. Both treatment groups showed a comparable reduction of New York Heart Association (NYHA) classification postimplantation, after 3- and 12-months follow-up. Quantitative reduction in echocardiographic FMR parameters was significantly pronounced in the MitraClip group (reduction in vena contracta MitraClip vs. Carillon: postimplantation -74.6 ± 25.8 vs. -29.1 ± 17.8%, 3-months follow-up -65.8 ± 31.2 vs. -33.9 ± 17.5%, 12-months follow-up -50.8 ± 27.9 vs. -23.9 ± 17.0%, p < 0.05). Qualitative mitral valve assessment showed improved FMR class postimplantation, at 3-and 12-months follow-up in both treatment groups. Edge-to-edge repair revealed better results with lower average FMR classification compared to indirect coronary sinus-based annuloplasty. After 12-months left atrial (LA) volume was significantly reduced in the Carillon group, while in the MitraClip group no LA remodeling was found (reduction in LA volume MitraClip vs. Carillon at 12 months: +9.6 ± 25.1% vs. -12.3 ± 12.7%, p < 0.05). Both indirect mitral valve annuloplasty and edge-to-edge repair are feasible and safe in patients with aFMR, while the reduction in FMR was pronounced in the edge-to-edge repair group.

Longterm surveillance and reintervention are key to successful fenestrated repair of aortic aneurysms

Although the utilization of fenestrated endovascular repair for juxtarenal and pararenal aortic aneurysms has increased significantly over the past decade, there exists a paucity of data assessing long-term outcomes. As such, Sveinsson et al should be congratulated on their efforts in demonstrating high rates of procedural success and safety of the Zenith Fenestrated Device (Cook Medical Inc, Brisbane, Australia) for the treatment of juxtarenal aneurysms.1 Moreover, this study represents the best published data to date on long-term outcomes after fenestrated endovascular repair in the real-world clinical practice with comprehensive assessment of target vessel (TV) patency, and reintervention-free and overall survival among a patient population with near complete follow-up.