Procedure-related Stroke Research Articles

Association between perforator stroke after middle cerebral artery elective stenting and arterial remodeling patterns: a high-resolution MRI-based retrospective cohort study.

Patterns of arterial remodeling may be associated with outcomes in patients with severe middle cerebral artery (MCA) stenosis after endovascular treatment (EVT). This study aims to investigate the potential correlation between arterial remodeling patterns in patients with severe MCA stenosis, and plaque characteristics and procedure-related perforator stroke (PS). Consecutive patients with MCA atherosclerotic disease who underwent EVT at the First Affiliated Hospital of Zhengzhou University from January 2018 to June 2023 were retrospectively enrolled in this study. The clinical and surgical data of the patients were evaluated. Remodeling index values >1.05, 0.95-1.05, and <0.95 indicated positive remodeling (PR), intermediate remodeling (IR), and negative remodeling (NR), respectively. Based on the remodeling index values calculated by high-resolution magnetic resonance imaging (HR-MRI), the arterial remodeling patterns were classified as NR or non-NR; non-NR was defined as both PR and IR. The primary endpoint was procedure-related PS. Plaque characteristics included the plaque area, plaque burden, contrast-enhancement ratio, and plaque distribution. Plaque features and the incidence of procedure-related PS were compared between the NR and non-NR groups. Differences in the categorical variables between the patients with NR and non-NR were assessed using the Chi-square test (χ2) or Fisher's exact test. Differences in the continuous variables between the two groups were assessed using the Student t-test or Mann-Whitney U-test. A total of 65 patients (mean age: 57.6 years) were enrolled in the study. Of the patients, 45 (69.2%) showed NR and 20 (30.8%) showed non-NR. The primary endpoint of procedure-related PS occurred in 3 patients (3/65, 4.6%). On HR-MRI, the entire cohort had a mean plaque area of 10.0 mm2, a mean plaque burden of 92.0 %, and a mean enhancement ratio of 1.3. Compared to the non-NR group, the NR group had a smaller plaque area (9.2 vs. 11.6 mm2, P=0.001). The probability of the primary end point was 15.0% in the non-NR group and 0.0% in the NR group (P=0.026). PS after MCA elective stenting may be related to non-NR based on HR-MRI. Further prospective and multicenter studies need to be conducted to confirm these findings.

Outcome of tailored antiplatelet therapy in carotid stenting: a retrospective comparative study

BackgroundCarotid stenting requires dual antiplatelet therapy to effectively prevent thromboembolic complications. However, resistance to clopidogrel, a key component of this therapy, may lead to persistent risk of these complications. The aim of this study was to determine, if the implementation of routine platelet function testing and adjusting therapy was associated with lower incidence of thromboembolic complications and death.MethodsAll consecutive patients treated with carotid artery stenting in a single institution over 8 years were enlisted in a retrospective study. Platelet function testing was performed, and efficient antiplatelet therapy was set before the procedure. Incidence of procedure-related stroke or death within periprocedural period (0–30 days) was assessed. The results were evaluated in relation to the findings of six prominent randomized control trials.ResultsA total of 241 patients were treated for carotid stenosis, seven patients undergo CAS on both sides over time. There was 138 symptomatic (55,6%) and 110 asymptomatic stenoses (44,4%). Five thromboembolic complications (2,01%) occurred, four of them (1,61%) was procedure-related. Two patients died because of procedure-related stroke (0,82%). Incidence of procedure-related stroke or death was significant lower compared to the results of CREST study (2,01% vs. 4,81%, P = 0,0243) in the entire cohorts, and to the results of ICSS study in the symptomatic cohorts (2,86% vs. 7,37%, P = 0,0243), respectively.ConclusionsTailored antiplatelet therapy in carotid stenting is safe and seems to be related with lower incidence of procedure-related death or stroke rate. Larger prospective studies to assess whether platelet function testing-guided antiplatelet therapy is superior to standard dual antiplatelet should be considered.

Catheter ablation for atrial fibrillation in patients with prior left atrial appendage occlusion device.

The safety and efficacy of CA for AF and left-sided atrial arrhythmias (AA) in patients with left atrial appendage occlusion (LAAO) devices are lacking. This is a single-center retrospective registry that included all patients with prior LAAO who underwent catheter ablation for AF or left-sided atrial arrhythmia from January 2020-January 2023. The primary outcomes were procedure-related complications, device-related complications, AA recurrence, and stroke. A total of 30 patients with prior LAAO were included in the analysis (mean age 75.1 ± 7.1years old, 50% male, mean CHA2DS2-VASc score 4 ± 1.6, 46.7% paroxysmal AF, 73.3% had prior AF ablation, mean time to ablation 475 ± 365days). 93.3% (n = 28) and 6.6% (n = 2) patients had ablation for AF (46.7% paroxysmal, 36.7% persistent, 10% long-standing persistent) and left-sided atrial tachycardia, respectively. 16.7% (n = 5) patients underwent ablation along the left atrial appendage ostium, and 3.3% (n = 1) underwent Vein of Marshall alcohol ablation. There were 3 (10%) peri-procedural complications (1 access hematoma and two pericardial effusions requiring intervention-none related to left atrial appendage ostium or alcohol ablation). During the mean follow-up of 440 ± 379days, 40% (n = 12) patients had AA recurrence (91.6% AF, 8.3% atrial tachycardia), of which five patients needed repeat ablation, and two patients were readmitted for heart failure. There was no stroke or any device-related complications, including new peri-device leaks or device-related thrombosis in patients who had follow-up imaging studies (n = 11, 36.7%). Catheter ablation for AF (including VoM alcohol ablation) in patients with prior LAAO devices is feasible and safe with favorable outcomes.

Trends in safety of catheter-based electrophysiology procedures in the last 2 decades: A meta-analysis

BackgroundRapid technologic development and expansion of procedural expertise have led to widespread proliferation of catheter-based electrophysiology procedures. It is unclear whether these advances come at cost to patient safety. ObjectiveThis meta-analysis aimed to assess complication rates after modern electrophysiology procedures during the lifetime of the procedures. MethodsA comprehensive search was performed to identify relevant data published before May 30, 2023. Studies were included if they met the following inclusion criteria: prospective trials or registries, including comprehensive complications data; and patients undergoing atrial fibrillation ablation, ventricular tachyarrhythmia ablation, leadless cardiac pacemaker implantation, and percutaneous left atrial appendage occlusion. Pooled incidences of procedure-related complications were individually assessed by random effects models to account for heterogeneity. Temporal trends in complications were investigated by clustering trials by publication year (2000–2018 vs 2019–2023). ResultsA total of 174 studies (43,914 patients) met criteria for analysis: 126 studies of atrial fibrillation ablation (n = 24,057), 25 studies of ventricular tachyarrhythmia ablation (n = 1781), 21 studies of leadless cardiac pacemaker (n = 8896), and 18 studies of left atrial appendage occlusion (n = 9180). The pooled incidences of serious procedure-related complications (3.49% [2000–2018] vs 3.05% [2019–2023]; P < .001), procedure-related stroke (0.46% vs 0.28%; P = .002), pericardial effusion requiring intervention (1.02% vs 0.83%; P = .037), and procedure-related death (0.15% vs 0.06%; P = .003) significantly decreased over time. However, there was no significant difference in the incidence of vascular complications over time (1.86% vs 1.88%; P = .888). ConclusionDespite an increase in cardiac electrophysiology procedures, procedural safety has improved over time.

Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths. Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Efficacy and safety of low profile stents in Y-stent assisted coil embolization of wide-necked bifurcation aneurysms: a systematic review and meta-analysis.

Low-profile stents may provide significant advantages in Y-stent-assisted coiling due to their miniaturized design and capability to be delivered through a 0.0165-inch microcatheter. We aim to investigate the safety and efficacy of using these newer versions of stents in Y-stent-assisted coiling for the treatment of wide-necked bifurcation aneurysms. We conducted a systematic review of the PubMed, Embase, Cochrane Library, and Web of Science databases up to September 2023, following the PRISMA guidelines. Eligible studies included ≥ 5 patients with intracranial wide-necked bifurcation aneurysms treated with Y-stent-assisted coiling using low-profile stents, providing angiographic and clinical outcomes. Two authors independently handled the search and selection. Primary outcomes were immediate and follow-up aneurysm occlusion, procedure-related complications, aneurysm recanalization, and retreatment. Secondary outcomes included technical success, procedure-related morbidity, procedure-related mortality, procedure-related stroke, and in-stent stenosis at follow-up. We analyzed the data using random-effects meta-analysis. In total, 19 studies including 507 patients with 509 aneurysms were included. 95% of the treated aneurysms were managed using the crossing Y-configuration. Technical success rate was 99%. Immediate adequate aneurysm occlusion was 90%. Follow-up angiographies were available for 443 aneurysms. The mean angiographic follow-up duration was 15.6 ± 1.9 months. The rates for follow-up adequate aneurysm occlusion and complete occlusion were 98% and 89%, respectively. After a mean clinical follow-up of 15 ± 2.4 months, a good clinical outcome was observed in 98% of patients. Overall, procedure-related morbidity and mortality rates were 1.3%, and 0.4%, respectively. Low-profile stents in Y-stent-assisted coiling outperform previous stent versions in terms of safety, efficacy, and technical success rates.

Left atrial appendage occlusion in the absence of intraprocedural product specialist monitoring: is it time to proceed alone? Results from a multicenter real-world experience.

Percutaneous left atrial appendage occlusion (LAAO) presents many technical complex features, and it is often performed under the intraprocedural surveillance of a product specialist (PS). Our aim is to assess whether LAAO is equally safe and effective when performed in high-volume centers without PS support. Intraprocedural results and long-term outcome were retrospectively assessed in 247 patients who underwent LAAO without intraprocedural PS monitoring between January 2013 and January 2022 at three different hospitals. This cohort was then matched to a population who underwent LAAO with PS surveillance. The primary end point was all-cause mortality at 1 year. The secondary end point was a composite of cardiovascular mortality plus nonfatal ischemic stroke occurrence at 1 year. Of the 247 study patients, procedural success was achieved in 243 patients (98.4%), with only 1 (0.4%) intraprocedural death. After matching, we did not identify any significant difference between the two groups in terms of procedural time (70 ± 19 min vs. 81 ± 30 min, p = 0.106), procedural success (98.4% vs. 96.7%, p = 0.242), and procedure-related ischemic stroke (0.8% vs. 1.2%, p = 0.653). Compared to the matched cohort, a significant higher dosage of contrast was used during procedures without specialist supervision (98 ± 19 vs. 43 ± 21, p < 0.001), but this was not associated with a higher postprocedural acute kidney injury occurrence (0.8% vs. 0.4%, p = 0.56). At 1 year, the primary and the secondary endpoints occurred in 21 (9%) and 11 (4%) of our cohort, respectively. Kaplan-Meier curves showed no significant difference in both primary (p = 0.85) and secondary (p = 0.74) endpoint occurrence according to intraprocedural PS monitoring. Our results show that LAAO, despite the absence of intraprocedural PS monitoring, remains a long-term safe and effective procedure, when performed in high-volume centers.

The WATCHMAN Device Review: A New Era for Stroke Prophylaxis.

Atrial fibrillation (AF) is a major risk factor for ischemic stroke, accounting for more than 37 million cases worldwide. In AF, the left atrial appendage (LAA) is the most common site of thrombus formation, and its ligation/closure with the WATCHMAN device is a good alternative to long-term oral anticoagulation, especially in patients with contraindications to warfarin. However, the implantation procedure is associated with various risks and complications. A short-term anticoagulant and antithrombotic administration are essential after implantation. However, no consensus has been reached on the optimal regimen. The WATCHMAN device is non-inferior to warfarin and is a safe alternative for the prevention of stroke and systemic embolization related to non-valvular atrial fibrillation (NVAF). Important procedure-related complications include pericardial effusion (PE), device embolization, procedure-related ischemic stroke, and device-related thrombosis (DRT) formation. It is essential to optimize post-implantation therapy according to individual patient bleeding risk, DRT formation, and contraindication to direct oral anticoagulants (DOACs). Recent studies have also shown that DOACs are a convenient and non-inferior substitute for warfarin. Furthermore, patients with absolute contraindications to OACs/DOACs can only be managed with dual antiplatelet therapy (DAPT). Transesophageal echocardiography (TEE) should be used to assess residual peridevice flow and possible DRT formation at days 45 and 12 months. Low molecular weight heparin (LMWH) and OAC are excellent choices for DRT treatment if detected. This review summarizes the most important complications of the WATCHMAN device in the existing literature and discusses various anticoagulation strategies and challenges post-implementation.

MP-453083-11 SAFETY AND OUTCOMES OF VENTRICULAR TACHYCARDIA ABLATION ACROSS AGE GROUPS

A pharmacotherapy approach to the treatment of ventricular tachycardia (VT) is frequently complicated by poor tolerance, persistent ICD shocks and impartial rhythm control. This can be burdensome in an elderly population who frequently have significant comorbidities complicating medical care. Catheter ablation for ventricular tachycardia has been increasingly employed to treat VT, however a paucity of data on the safety and outcomes of VT ablation in octogenarians exists. To examine the safety and outcomes of ventricular tachycardia ablation therapy in octogenarians. The data used was obtained from the National Inpatient Sample (NIS) database from 2016 to 2019. We identified patients ≥ 21 years old with VT as primary diagnoses and underwent ablation during index hospitalization. Patients were divided into 4 age subgroups 20-39, 40-59, 60-79 and ≥ 80 years old. Primary outcome was all-cause mortality and secondary outcomes were transfer to rehab, hospital length-of-stay and in-hospital complications. Univariate and multivariate logistic regression analyses were used to study the association between catheter ablation and primary and secondary outcomes. A total of 23,900 patients undergoing VT ablation were identified. Most patients were between ages of 50-69 years of age (60.3%), followed by 40-59 (25%), ≥ 80 (9.5%), and 20-39 (5.6%). No significant differences in complications including procedure-related pericardial effusion, pericarditis, tamponade, stroke, hemorrhage, or respiratory failure were seen between all age groups. Similarly, no significant differences in hospital length of stay were appreciated across all ages. However, mortality rates were significantly higher in octogenarians (4.2%), compared to those between 60-79 years old (3.2%), 40-59 years (1.5%) and 20-39 years (2.3%) (p-value 0.023). Rehab transfer was also significantly higher in the elderly (p-value <0.001). In this large, real-world database study, we found no significant differences in procedure related complications or hospital length of stay across all age groups undergoing VT ablation. However, in-hospital mortality rates and transfer to rehab were significantly higher in octogenarians compared to younger subgroups. Despite procedural safety, a decision to pursue VT ablation in octogenarians must be carefully weighed against modest increased risks of mortality in this delicate population.

Transradial Carotid Artery Stenting Using Walrus Balloon Guide Catheter: Technical Aspects and Clinical Outcome.

Despite an overall surge in transradial access (TRA) for neurointerventional procedures, the feasibility and safety of TRA carotid artery angioplasty and stenting using balloon guide catheters (BGCs) through a short 8-Fr sheath have not been studied. In this study, we present our experience of using Walrus BGC through TRA for carotid artery stent placement. To define the safety and efficacy of using a balloon guide catheter for carotid stenting by a transradial approach. Our prospectively maintained retrospective database was reviewed, and consecutive patients were identified who underwent elective carotid artery stenting through TRA using Walrus BGC between January 2021 and June 2022. Demographics, procedural details including access site complications, the rate of radial to groin conversion, and procedure-related transient ischemic attack or stroke were reviewed. Twenty patients were identified who underwent carotid artery angioplasty and stenting through TRA Walrus BGC use; the mean age was 66 years (range 42-89), and 67% were male. A short 8-Fr sheath was used in all patients without any complications. Two of 20 patients required TRA conversion to transfemoral access, both secondary to severe spasm of the radial artery after initial access inhibiting further advancement of the Walrus BGC. Use of Walrus BGC by TRA through an 8-Fr sheath for carotid artery stenting is safe and feasible with a low rate of conversion to transfemoral access and no access site complications.

Predictive Factors for Stroke and TIA Following Carotid Artery Stenting

Purpose: Carotid artery stenting (CAS) is an effective and minimally invasive method for the treatment of extracranial carotid artery stenosis. The aim of the present study was to explore independent risk factors to predict cerebrovascular events following CAS to identify high-risk patients and improve the safety of CAS in this population. Materials and Methods: HISPANIAS is a national prospective multicenter study that included 14 hospitals that collected data from patients who underwent CAS. We analyzed morbidity and mortality within 30 days after CAS, looking for factors that might be associated with cerebrovascular events (stroke and transient ischemic attack [TIA]). Results: The HISPANIAS cohort included 757 patients: 80.32% were men, the mean age was 70.73 years, and 82.96% underwent symptomatic CAS. Cerebrovascular complications occurred in 42 patients (5.6%), including TIA in 24 patients (70.8% ipsilateral; mean 2.79 days after CAS) and stroke in 18 patients (72.2% ipsilateral; mean 6.72 days after CAS). The main independent clinical predictors of stroke/TIA identified by logistic regression were female sex (odds ratio [OR] 2.29, 95% CI 1.15–4.54) and diabetes (OR 3.29, 95% CI 1.71–6.40). Survival analysis showed that diabetic women, compared with the rest of the patients, had a higher number of events concentrated mainly in the first days after the intervention (p=0.003). Conclusion: Cerebrovascular ischemic complications after CAS continue to be a challenge for the management of these patients. Although there are other factors, female sex and the presence of diabetes are emerging as strong risk factors for the development of complications after symptomatic CAS. Clinical Impact Carotid artery stenting (CAS) is an effective and minimally invasive method for the treatment of extracranial carotid artery stenosis. Although CAS has been regarded as a reliable and safety approach, some studies reported that CAS was associated with a higher risk of procedure-related stroke. Cerebrovascular complications after CAS continue to be a main problem and a challenge for the management of these patients. Therefore, it is essential to identify the factors involved in the development of these complications. Our study shows that the combination of female sex and diabetes is associated with a clearly worse outcome, with a greater number of events concentrated mainly in the first days. This is different from other studies that have explored each factor separately. It would be interesting to perform separate interventions for this group given the increased risk of complications.

Transcarotid Revascularization Timing and Early Postoperative Outcomes in Symptomatic Patients.

Carotid endarterectomy (CEA) performed several days after onset of symptoms has been shown to be optimal in preventing procedure-related stroke. Transcarotid artery revascularization (TCAR) is an alternative hybrid procedure to treat high-risk for CEA patients. In this investigation, our aim is to determine the effect of timing of TCAR in symptomatic patients. Procedures were captured prospectively at 2 independent health systems from 2016-2022 within a carotid intervention database. A retrospective analysis of this database was performed to generate cohorts by time to revascularization from onset of symptoms, with the short-interval revascularization (SIR) group defined as having a time to revascularization between 2-5days; and long-interval revascularization (LIR) group having a time to revascularization of 6-180days. Univariate analysis was performed comparing the cohorts at an α of .05. During the study period, 875 TCARs were captured, including 321 procedures performed in symptomatic patients. Of these, 84 had revascularization performed within 6days after onset of symptoms (SIR) while 237 additional cases were completed 6 or more days after onset of symptoms (LIR). Baseline comorbidities were grossly similar between cohorts. Intraoperatively, SIR patients were less likely to develop bradycardia (4.8% vs 22.2%, P = .01) and experienced a shorter operative time (58minutes vs 65minutes, P = .02). Estimated blood loss, flow reversal time, radiation exposure, fluoroscopic time and contrast volume were identical between the groups. Length of stay in SIR patients was longer (1, IQR [1-3] vs 1, IQR [1-2] days, P < .01). Additionally, SIR patients seemed to trend toward a higher rate of reinterventions (3.6% vs .4%, P = .06). The incidence of ipsilateral or contralateral stroke, cranial nerve palsy, myocardial infarction, hematoma, stent thrombosis and death were statistically identical between the 2 groups. Like the previous results established for CEA, symptomatic patients undergoing TCAR demonstrate similar outcomes if the procedure is performed 48hours after the neurologic event.

1066 THE USEFULNESS OF CEREBRAL PROTECTION DURING TAVR: A METANALYSIS

Abstract Introduction although transcatheter aortic valve replacement (TAVR) represents a milestone in the treatment of degenerative aortic stenosis, stroke remains an important complication compared to surgical aortic valve replacement (SAVR). Multiple magnetic resonance imaging (MRI) studies demonstrated a substantial rate of new cerebral ischemic lesions after TAVR. In order to avoid debris passage into the circulation and to prevent procedure-related embolic stroke, cerebral embolic protection (CEP) devices were developed. However, their safety and efficacy remain controversial. Very recently, new studies provided additional evidence on this topic. Aim to assess the entire body of evidence from randomized controlled studies about neurological outcomes after TAVR. Materials and Methods a systematic meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched MEDLINE, Scopus, and Google Scholar for randomized controlled studies. The following keywords were used for the search: “transcatheter aortic valve implantation” or “stroke prevention” or “embolic protection” and “cerebral protection”. Study groups were defined as a the “CEP group” and the “control group”. Non-randomized studies reporting outcomes with cerebral embolic protection (CEP) during TAVR were excluded to reduce the selection and confounding bias of observational pilot studies. The primary outcome was post-procedural stroke. Secondary outcomes included total lesion volume on MRI and new ischemic lesions on MRI. Results nine trials including 4077 patients were eligible for analysis and included to the meta-analysis. Of those, 2203 patients were randomized to cerebral embolic protection and 1874 patients to control group. Despite the rate of post-procedural stroke was higher in the CEP arm (2.27%) compared to the control arm (2.87%, p&amp;lt;0.001), the use of cerebral embolic protection was not associated with a significantly lower risk of stroke (OR=0.82, 95% CI 0.59-1.15; p=0.255). Cumulative meta-analysis revealed a trend towards a lower impact on stroke prevention with more recent trials. Conclusions use of cerebral embolic protection devices during TAVR is a safe procedure. However, the current outline of results from all randomized controlled trials available does not support its routine use, as no significant reduction of stroke risk was evident. The use of these devices might be considered in selected high-risk patients, such as in the setting of heavy calcified cusps or atherosclerotic aortic lesions.

Outcomes of endovascular repair of aortic aneurysms with the GORE thoracic branch endoprosthesis for left subclavian artery preservation.

Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA. Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion. More than one-half of the patients were male (63%). Their average age was 70± 11years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2mm. The mean follow-up was 30months (range, 2.6-50.7months). Reported here are the patient outcomes at 1 and 12months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n= 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6months. Type I (n= 3) and III (n= 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention. Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.

Sex difference in clinical and procedural outcomes in patients undergoing coronary atherectomy: a systematic review and meta-analysis.

Rotational and orbital coronary atherectomy (CA) are commonly utilized to treat complex calcified coronary lesions. We conducted a meta-analysis to evaluate sex differences in procedural complications and clinical outcomes after CA. PubMed, Google Scholar, and Cochrane databases were searched for all studies comparing sex differences in procedural and clinical outcomes following CA. The outcomes of interest were procedural complications (coronary dissection, stroke, major bleeding, coronary perforation, cardiac tamponade, and slow or no flow in target vessel) and the clinical outcomes (including early mortality, mid-term all-cause mortality, stroke, myocardial infarction, and target vessel revascularization). Pooled risk ratios (RRs) with their corresponding 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel random-effects model. Six observational studies with 3517 patients (2420 men and 1035 women) were included in this meta-analysis. While there was no significant difference in the early mortality (RR, 1.14; 95% CI, 0.37-3.53; P = 0.83) between men and women, at a mean follow-up of 2.9 years, all-cause mortality was significantly higher in women (RR, 1.29; 95% CI, 1.11-1.49; P = 0.0009). Women had an increased risk of procedure-related stroke (RR, 3.98; 95% CI, 1.06-14.90; P = 0.04), coronary dissection (RR, 2.10; 95% CI, 1.23-3.58; P = 0.006), and bleeding (RR, 2.26; 95% CI, 1.30-3.93; P = 0.004), whereas the rates of coronary perforation, cardiac tamponade, and the risk of slow or no flow in the revascularized artery were similar in both. In our analysis, women undergoing CA are at increased risk of mid-term mortality and procedure-related complications including stroke, coronary dissection, and major bleeding.

Outcomes of stroke events during transcatheter aortic valve implantation.

Despite improvements in the safety of transcatheter aortic valve implantation (TAVI), ~4% of patients experience a procedure-related stroke. Understanding long-term health and healthcare implications of these events may motivate the development and adoption of preventative strategies. Aims: We aimed to assess the association of TAVI-related ischaemic stroke with subsequent clinical outcomes and healthcare utilisation. We used Medicare fee-for-service claims to identify patients who underwent their first TAVI between January 2012 and December 2017. Previously used ICD-9-CM and ICD-10-CM codes were used to identify TAVI-related ischaemic stroke. Among those with and without TAVI-related ischaemic stroke, we compared the risk of a composite endpoint that included all-cause mortality, acute myocardial infarction, and subsequent stroke using inverse probability treatment weighted Cox regression. We also performed a difference-in-difference analysis to compare 1-year Medicare expenditures and days spent at home during the first year after TAVI. Among 129,628 primary TAVI patients, 5,549 (4.3%) had a procedure-related stroke. These patients were more likely to be female and have had prior stroke, peripheral vascular disease, ischaemic heart disease, or renal failure. After adjustment, TAVI-related ischaemic stroke was associated with a higher risk of the 1-year composite outcome (HR 1.67, 95% CI: 1.56-1.78), higher 1-year Medicare expenditures (difference $9,245 [standard error 790], p<0.001), and fewer days at home during the first year (difference 16 days [standard error 1], p<0.001). Among Medicare beneficiaries undergoing TAVI, procedure-related ischaemic stroke was associated with worse outcomes, increased Medicare expenditures, and less time spent at home. Procedure-related ischaemic stroke during TAVI remains a critically important and potentially preventable source of patient mortality, morbidity and healthcare utilisation.

Percutaneous Intramyocardial Septal Radiofrequency Ablation in Patients With Drug-Refractory Hypertrophic Obstructive Cardiomyopathy

Patients with hypertrophic obstructive cardiomyopathy (HOCM) and drug-refractory symptoms and outflow gradients have limited nonsurgical treatment options. The feasibility of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) has been reported previously; however, procedural and medium-term outcomes are unknown. To describe the safety and medium-term outcomes of PIMSRA in a large patient cohort with drug-refractory HOCM. This was a single-arm, open-label study of PIMSRA in patients with drug-refractory HOCM. Patients presenting to the Xijing Hospital in Xi'an, China, between October 2016 to June 2020 with hypertrophic cardiomyopathy. Of 1314 patients presenting with HOCM, 244 fulfilled inclusion criteria of severe resting/provoked outflow gradients of 50 mm Hg or higher, and symptoms of New York Heart Association functional class of II or higher refractory to maximum tolerated medications. After discussion among the heart team, 40 patients underwent surgical or alcohol septal reduction therapy and 4 required treatment of significant coronary artery disease. PIMSRA performed in patients. The primary outcome was 30-day major adverse clinical events: death, emergency surgery, severe effusion requiring intervention, procedure-related stroke, bleeding, and stroke. Secondary outcomes included 30-day technical success and 90-day improvement in outflow obstruction. The mean (SD) age of 200 patients was 46.9 (14.0) years, and 125 (62.5%) were men. Resting or provoked left ventricular outflow tract gradients were 50 mm Hg or higher. The median (IQR) follow-up for all patients was 19 (6-50) months. Thirty-day major adverse clinical events rate was 10.5% (n = 21): there were 2 in-hospital/30-day deaths (1.0%), 7 patients (3.5%) with pericardial effusion requiring mini-thoracotomy, 12 patients (6%) with pericardial effusion requiring pericardiocentesis, and no bleeding or strokes. Other periprocedural complications included permanent right bundle branch block in 5 patients (2.5%), resuscitated ventricular fibrillation in 2 (1.0%), and septal branch aneurysm in 2 (1.0%). There were no permanent pacemaker implantations. At follow-up, maximum septal thickness was reduced from a mean (SD) of 24.0 (5.1) mm to 17.3 (4.4) mm (P < .001), and left ventricular outflow tract gradient was decreased from a mean (SD) of 79.0 (53.0) mm Hg to 14.0 (24.0) mm Hg (P < .001). Overall, 190 patients (96%) with HOCM were in New York Heart Association functional class I or II at last follow-up. This study found that PIMSRA in patients with drug-refractory HOCM may be an effective procedure for relief of left ventricular outflow tract obstruction and symptoms with acceptable complication rates. These results are encouraging and support the design of a randomized clinical trial against well-established septal reduction therapies.

Carotid Endarterectomy and Carotid Artery Stenting for Symptomatic Carotid Stenosis: An Experience of a Hybrid Neurosurgeon in a Developing Nation.

Stenosis of the ICA is an important cause of ischemic stroke and associated morbidity and mortality. Carotid artery stenting (CAS) and carotid endarterectomy (CEA) help to prevent impending or subsequent ischemic stroke in such patients. To study the outcome and adverse events associated with CEA and CAS. To determine the generalization of results obtained with multicentric trials such as CREST, etc., by comparing the results obtained by a single neurosurgeon in a community setting. From Jan 2014-Dec 2017, 80 patients presented with symptomatic carotid stenosis. Out of these 80 patients, 65 underwent intervention; 34 patients underwent CEA and 31 patients underwent CAS. Pre-defined variables like age, sex, and degree of stenosis were assessed as potential risk factors, and the patients' clinical features, radiological imaging, and procedural complications were documented. The primary outcome of procedure-related stroke, major adverse events (MAEs), and death at 30 days follow-up and long-term outcomes of restenosis at 1 year were analyzed. Peri-procedural stroke occurred in 2 cases (6.4%) of CAS; one suffered an ischemic stroke and other suffered a hemorrhagic stroke. Three cases of CEA suffered procedure-related events; one (2.9%) suffered TIA while the other two developed postoperative local hematoma without neurological deficit; one was treated conservatively while the other required re-exploration due to pressure symptoms. Restenosis occurred in one case that underwent CAS. CAS and CEA are complementary approaches in treating symptomatic carotid stenosis even when performed by a single hybrid neurosurgeon as results obtained are commensurable to major studies like CREST.

Outcome of high-power short-duration radiofrequency ablation in combination with half-normal saline irrigation for the treatment of atrial fibrillation.

Data regarding the use of high-power short-duration (HPSD) radiofrequency (RF) in combination with half-normal saline irrigation for catheter irrigation are limited. This study investigated the safety and efficacy of using HPSD RF ablation in combination with half-normal saline irrigation for the treatment of AF. One hundred consecutive patients with AF underwent RF ablation using HPSD combined with half-normal saline for catheter irrigation. In addition, the following ablation strategies were used: 1 mm tags for the display of ablation lesions on the mapping system, high-frequency jet ventilation (HFJV), low contact force, pacing after ablation to verify areas of noncapture, atrial/ventricular pacing at 500 to 700ms to aid in catheter stability, use of two skin electrodes to reduce impedance, and postablation adenosine infusion. Power was started at 40 to 45 W and was modulated manually based on impedance changes. The average age of patients was 65.2 years and 70% were male. Forty seven percent had paroxysmal AF and the average CHA2 DS2 -VASc score was 2.1 ± 1.6. The average power and lesion duration were 38.1 ± 3.3 W and 8.1 ± 2.3 s, respectively. During a median follow-up period of 321 ± 139 days, 89% of the patients remained free from any atrial arrhythmias after a single RF ablation procedure. No procedure-related death, stroke, pericardial effusion, or atrioesophageal fistula occurred during follow-up. Catheter ablation using HPSD RF lesions in combination with half-normal saline irrigation and is safe and effective, and results in high rate of freedom from AF.

Pipeline Embolization Device for the Treatment of Ruptured Intracerebral Aneurysms: A Multicenter Retrospective Study.

Background and Purpose: The utilization of flow diversion for ruptured intracerebral aneurysms (IAs) is still limited. We aimed to demonstrate our multicenter experience using the pipeline embolization device (PED) for ruptured IAs that were difficult to treat by clipping and coiling.Methods: Thirty-eight patients with ruptured IAs who underwent PED treatment from 2015 to 2020 were retrospectively reviewed. Factors associated with procedure-related stroke (ischemic and hemorrhagic) and clinical and angiography outcomes were analyzed.Results: There were 14 (36.8%) saccular IAs, 12 (31.6%) blister-like IAs, and 12 (31.6%) dissecting IAs. Perforator involvement was noted in 10 (26.3%) IAs. Early PED placement ( ≤ 15 days) and adjunctive coiling treatment were performed in 27 (71.1%) and 22 (57.9%) cases, respectively. The overall rate of stroke-related complications was 31.6% (12/38) (including rates of 10.5% for procedure-related hemorrhagic complications and 15.8% for procedure-related infarction). The mortality rate was 13.2% (5/38), and 84.2% of patients (32/38) had favorable outcomes. Thirty-two (84.2%) patients underwent follow-up angiographic evaluations; of these, 84.4% (27 patients) had complete occlusion and 15.6% had incomplete obliteration. Multivariate analysis revealed that early PED placement was not associated with a high risk of procedure-related stroke or an unfavorable outcome. Adjunctive coiling exhibited an association with procedure-related stroke (p = 0.073). Procedure-related hemorrhagic complications were significantly associated with an unfavorable outcome (p = 0.003). Immediate contrast stasis in the venous phase was associated with complete occlusion during follow-up (p = 0.050).Conclusion: The PED is a feasible and effective treatment to prevent rebleeding and achieve aneurysm occlusion, but it is associated with a substantial risk of periprocedural hemorrhage and ischemic complications in acute ruptured IAs. Therefore, the PED should be used selectively for acutely ruptured IAs. Additionally, adjunctive coiling might increase procedure-related stroke; however, it may reduce aneurysm rebleeding in acutely ruptured IAs. Patients with immediate contrast stasis in the venous phase were more likely to achieve total occlusion. A prospective study with a larger sample size should be performed to verify our results.