Periprocedural Period Research Articles

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.

Cerebral Embolic Protection: Is There a Benefit for Left Atrial and Mitral Valve Procedures?

This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

Incidence and clinical impact of inappropriate periprocedural and perioperative management of antiplatelet therapy

Background and aimsThere is little evidence on the impact of current recommendations on the use of antiplatelet therapy during the perioperative and periprocedural period in our setting. The aim of this study was to analyze the incidence and clinical impact of inappropriate use of antiplatelet therapy in a population of patients undergoing surgery or a diagnostic or therapeutic procedure in “real life” in Spain. MethodsA prospective multicenter observational study of patients treated with antiplatelet agents requiring intervention was conducted. The incidence of thrombotic and hemorrhagic events at 30 days was analyzed according to peri-intervention management of antiplatelet therapy. ResultsWe included 643 patients (31.9% women, 39.0% over 75 years of age), most of them (87.7%) receiving aspirin as antiplatelet therapy at a dose of 100mg/day. Indications for antiplatelet therapy were ischemic heart disease (44.9%), cerebrovascular disease (21.7%), and peripheral vascular disease (23.0%). Ischemic risk was low in 74.3%, while 51.6% had a low bleeding risk of the intervention. Periprocedural management was considered appropriate in 61.7% of cases. 30-day incidence of the combined primary endpoint of thrombotic events and major bleeding (12.1% versus 5.0%; p=0.002) and 30-day mortality (5.2% versus 1.5%; p=0.008) were significantly higher in patients with inappropriate periprocedural management of antiplatelet agents. ConclusionsDespite current recommendations for the use of antiplatelet drugs in the perioperative/periprocedural period, their implementation in the “real world” remains low. Inappropriate use is associated with an increased incidence of adverse events, both thrombotic and hemorrhagic.

Missed Opportunities for use of Advanced Care Planning and Palliative Care in Open Aortic Surgery

Major vascular surgery, including open aortic procedures, is associated with having a 30-day mortality rate greater than 6% and a perioperative complication rate greater than 50%. Published literature suggests that patients undergoing high-risk procedures benefit from having a care plan in place to not only maximize quality of life but also to ensure medical interventions align with care goals. Currently, there is a paucity of published data on the prevalence of goals of care conversations, advance care planning documentation, and palliative care evaluations in patients undergoing high-risk vascular operations. A retrospective chart review of all patients who underwent open aortic surgery at a tertiary care academic medical center from July 2014 to March 2023 was performed. Patient demographics, comorbidities, type and timing of advanced care planning (ACP), palliative care evaluations, and clinical outcomes during the periprocedural period were recorded. For patients who died during the study period, the use of palliative care prior to death were noted. Patients who received ACP or palliative care were compared with those who did not. The cohort consisted of 192 patients who underwent major open aortic surgery. The mean age was 63 years (SD 12.3) and the majority of patients were male (73.4%) and white (64.1%). Thirty-nine (20.6%) operations were classified as emergent. At the time of their operation, 16.7% (n=32) of patients had an ACP document on file. Of the 38 documents on file, most were durable power of attorney (DPOA) (86.8%) documents while a smaller percentage were physician orders for life-sustaining treatment (POLST) (13.2%). There were no patients with Do Not Resuscitate and/or Intubate (DNR/DNI), living will, or organ/tissue donation orders noted in their chart prior to surgery. One percent (n=2) of patients had a palliative evaluation prior to their operation. During the perioperative period, an additional 2 (1%) of patients had advanced care planning documentation and 7 (3.7%) of patients underwent palliative care evaluation. Fifteen percent of patients (n=28) died during the perioperative period and an additional 21 patients died by the end of the study period for a total mortality of 25.2% in the study population. Among patients that died during the perioperative period, 28.6% (n=8 out of 28) received palliative care. Overall, 28.6% of all study patients that died (n=14 out of 49) received a palliative care evaluation prior to or during their terminal hospitalization. Patients who had ACP documents or who received palliative care consultations prior to surgery were older (p=0.01), more likely to be on Medicare or Medicaid (p=0.004), and more likely to have a history of solid organ malignancy (p=0.03). The median interval between surgery and receiving palliative care was 20 (IQR 3-71) days. The median interval between palliative care and death was 5 (IQR 2-13) days. Patients who utilized ACP or PC were more likely to die at home (p=0.05). Despite a high mortality and morbidity rate, ACP documentation is poor for patients undergoing major open aortic surgery. Palliative care interventions tend to be performed closer to the end of life, suggesting a missed opportunity to define goals of care.

Clinical Care for Cardiovascular Disease in Patients With Williams-Beuren Syndrome.

Williams-Beuren syndrome (WBS) is a congenital multisystem disorder affecting the cardiovascular, central nervous, and musculoskeletal systems. Cardiovascular abnormalities, which consist principally of vascular stenoses, occur in approximately 80% of people with WBS and are the predominant cause of early morbidity and mortality. Supravalvar aortic stenosis and peripheral pulmonary artery stenosis are the most common stenotic lesions in WBS, though other stenoses often occur, including stenoses of the coronary arteries. Approximately one-third of people with WBS undergo cardiovascular interventions. The risk of sudden cardiac death is markedly higher than the general population, with most events occurring in the periprocedural period. Because of the rarity of WBS and the often-complex nature of the cardiovascular abnormalities, most physicians, including cardiologists, have limited experience in caring for patients with WBS. Further, heretofore, clinical cardiovascular management guidelines based on international expert consensus have not been available. This state-of-the-art review provides a comprehensive synopsis of the cardiovascular abnormalities in WBS and presents clinical management guidelines based on the authors' expert consensus.

Sex and outcomes after stenting and endarterectomy in asymptomatic severe carotid stenosis patients

ObjectivesTo determine if sex was an effect modifier in a pooled analysis of asymptomatic patients from CREST and ACT I. Materials and MethodsWe analyzed data from 2544 patients aged <80 with ≥70 % asymptomatic carotid stenosis randomized to CAS or CEA (nCREST = 1091; nACT-1 = 1453). The pre-specified primary endpoint in both trials was any stroke, myocardial infarction or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. The secondary endpoint was any stroke or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. ResultsThere was no significant difference in the frequency of events for men or women between CAS and CEA for the primary or secondary endpoints. When assessing for an interaction of sex and risks between procedures, the treatment-by-sex interaction was not significant for either primary or secondary endpoints in the four-year period or the peri-procedural period. However, women had significantly fewer post-procedural events (ipsilateral stroke) with CAS than CEA (HR = 0.33, 95 % CI: 0.09–1.18) compared to men (HR = 2.09, 95 % CI: 0.78–5.61), p = 0.02 for interaction. ConclusionsIn this large, pooled analysis of asymptomatic patients comparing CAS to CEA, sex did not act as an effect modifier of treatment differences in the four-year primary stroke-MI-or-death endpoint or the secondary stroke-or-death endpoint. However, during the post-procedural period men treated with CAS were at higher risk than their female counterparts.

Initial Experience with the Derivo 2Heal Flow Diverter under Standard or Reduced-Dose Single Antiplatelet Therapy.

Flow diverters with surface modifications or coatings have been recently introduced to clinical practice with the expectation that they can reduce the rate of thromboembolic complications and residual aneurysms. The purpose of this study is to evaluate the utility of the Derivo 2Heal (D2H) device, a new fibrin and heparin-coated flow diverter. Patients treated by a single operator by using the D2H were retrospectively evaluated for demographic data, aneurysm characteristics, procedural variables, and follow-up data. All patients were treated by using a single D2H, monitored by platelet function testing and kept under single antiplatelet therapy with regular or half-dose clopidogrel or prasugrel after the procedure. Twenty patients with 26 aneurysms were treated. Three presented acutely with subarachnoid hemorrhage. Adjunctive devices were used in 6 patients. There were no technical failures and 2 periprocedural self-limited nonthrombotic minor adverse events. During follow-up, 1 of the acutely ruptured aneurysms reruptured, and 1 patient had a visual TIA. All patients were doing well clinically (19 with mRS of 0 and 1 with 1) at the last follow-up after discharge. The rates of total occlusion on very early angiographic (MRA/CTA or DSA, mean: 2.4 months), DSA (mean: 5.8 months), and midterm angiographic (mean: 14.5 months) follow-up for all versus uncoiled aneurysms were 68% versus 70%, 77.8% versus 90.0%, and 91.7% versus 90.1%, respectively. The absence of permanent neurologic deficits in the periprocedural period and favorable occlusion rates in this preliminary study suggest that the novel coating comprising fibrin and heparin may have the potential to increase the safety and efficacy of flow diversion and needs to be further studied by comparing the D2H device with its bare counterpart and other coated or surface-modified flow diverters.

Impact of the type of anesthesia on adverse events during transcarotid artery revascularization

ObjectiveThe use of local or regional anesthesia (LRA) is encouraged during transcarotid artery revascularization (TCAR) because the procedure is performed through a small incision. LRA permits neurologic evaluation during the procedure and may reduce periprocedural cardiac morbidity compared with general anesthesia (GA). There is limited and conflicting information regarding the preferred anesthesia to use during TCAR. We compared periprocedural clinical and technical complications, and intraprocedural performance metrics of TCAR performed under GA vs LRA. MethodsPatient, lesion, physician, and procedural information was collected in a worldwide quality assurance program of consecutive TCAR procedures. A composite clinical adverse event rate (death, stroke, transient ischemic attack, myocardial infarction) and a composite technical adverse event rate (aborted procedure, conversion to carotid endarterectomy, bleeding, dissection, cranial-nerve injury, device failure) in the periprocedural period were computed. Four intraprocedural performance measures (flow-reversal time, fluoroscopy time, contrast volume, and skin-to-skin time) were recorded. Deidentified data were analyzed independently at the Center for Vascular Research, University of Maryland. Poisson regressions were used to assess the impact of anesthesia type on adverse event rates. Linear regressions were used to compare performance measures. ResultsA total of 27,043 TCARs were performed by 1456 physicians between 2012 and 2021. A majority of patients (83%) received GA, and this proportion increased over time (R2 = 0.74; P < .0001). Some physicians (33.4%) used LRA in some of their procedures; only 2.7% used LRA in all of their procedures. Clinical risk factors were more common in the LRA group (P < .0001) and anatomic risk factors in the GA group (P < .0001); these differences were adjusted for in subsequent analyses. LRA was more likely to be used by vascular surgeons and by physicians with higher prior transfemoral carotid stenting experience (P < .0001). When comparing GA vs LRA, clinical adverse events (1.49%; 95% confidence interval [CI], 1.3-1.8 vs 1.55%; 95% CI, 1.2-2.0; P = .78), technical adverse events (5.6%; 95% CI, 5.2-6.2 vs 5.3%; 95% CI, 4.5-6.3; P = .47), and intraprocedural performance measures did not differ by type of anesthesia. ConclusionsAlmost two-thirds of physicians performed TCAR exclusively under GA, and the overall proportion of procedures performed under GA increased over time. A larger fraction of patients with severe medical risk factors received LRA vs GA, whereas a larger fraction of patients with anatomic risk-factors received GA. Periprocedural clinical and technical adverse events did not differ by type of anesthesia. Intraprocedural performance metrics that drive procedural cost were similar between groups; potential differences in procedural cost driven by anesthetic choice require further study.

PDA Stenting for Ductal-Dependent Pulmonary Blood Flow: Management of Prostaglandin E1 Infusion.

Newborns with ductal-dependent pulmonary blood flow require PGE1 infusion prior to ductal stenting to ensure patency of the PDA. There is no consensus, however, on management of PGE in the peri-procedural period in terms of timing of discontinuation of the drug. This review will focus on the rationale for continuing or discontinuing PGE, a brief review of some of the published recommendations, and will make some final recommendations regarding PGE management. Reasons to continue PGE include ensuring the patient is stable and has adequate oxygenation prior to the stenting procedure. In addition, continuation of PGE makes the procedure logistically easier since the timing for the intervention is not dependent upon ductal constriction. The rationale for discontinuation of PGE is to ensure there is adequate ductal constriction to securely place a stent and minimize the risk of stent embolization. Decision-making regarding the discontinuation of PGE must be individualized and is primarily dependent upon PDA morphology.

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.

Clinical results of 30 consecutive patients of carotid artery stenosis treated with CASPER stent placement: 1-year follow-up and in-stent findings on intravascular ultrasound examination immediately and 6 months after treatment

BackgroundThe CASPER stent is expected to reduce periprocedural ischemic complications, but there is concern about restenosis in the early period. One-year follow-up results of CASPER stenting and findings on intravascular...

Focal pulsed field ablation for organised atrial tachyarrhythmias: one to rule them all

Abstract Background Focal pulsed field ablation (fPFA) has emerged as a versatile and innovative strategy for ablating atrial tachyarrhythmias (1). The primary objective of this study is to present the short-term safety characteristics, feasibility and procedural outcomes of fPFA in the management of organised atrial tachyarrhythmias. This report focuses on the commercial use of an innovative pulsed field ablation (PFA) generator, utilized in conjunction with commercially available focal, solid-tip ablation catheters, and complemented by 3D electro-anatomical mapping (3D-EAM). Methods Patients with organised atrial tachycardia treated using fPFA between August 2022 and September 2023 at our center were included in this retrospective analysis. Tachycardia mechanisms were identified with high-definition, multi-electrode mapping catheter paired with 3D-EAM system. Ablation lines, when targeting macro-reentrant arrhythmias were strategicaly positioned to adress critical isthmi when recognised or they were empirically placed between the anatomical obstacles ( including LA roof, anterior, mitral isthmus, upper septal and cavotricuspid line as deemed appropriate). Positioning of the fPFA catheter was guided by 3D-EAM, intracardiac ultrasound, and fluoroscopy (Figure 1). Bidirectional block verification was performed using standard criteria to assess acute procedural success. Glyceryl trinitrate boluses were administered prior to ablation in proximity to coronary arteries. Results In a cohort of 36 patients (median age 62 years; 12 females), we effectively mapped and treated a total of 51 distinct organised atrial tachyarrhythmias. These included 18 typical flutters, 3 roof-dependent macro-reentries, 4 posterior-wall micro-reentries, 15 peri-mitral macro-reentries, 8 anterior-wall micro-reentries and 3 biatrial macro-reentries via Bachman bundle. Our ablation strategy involved creating 21 cavotricuspid isthmus lines, 3 roof lines, 18 posterior wall lines, 11 anterior lines, 8 septal lines, and 15 mitral isthmus lines (Figure 2). Impressively, first-pass acute isolation with bidirectional block was achieved in 93% (54 of 58) of isthmus ablations and 94% (17 of 18) of left posterior wall lines. No ST segment alterations or other complications were observed during the periprocedural period. Conclusion In our cohort fPFA proved as a feasible, effective, and safe approach for treating organised atrial tacharrhythmias. The primary reason for designating this setup as our preferred choice for redo procedures lies in its versatility in addressing a wide range of arrhythmias. As ultra-fast pulmonary vein isolation (PVI) procedures become more prevalent with the expansion of PFA, the demand for an ideal setup capable of effectively targeting various substrates will become even more pronounced (2). Notably, our findings suggest superior suitability and efficacy when compared to bulkier, single-shot design PFA devices (3).Figure 1Figure 2

Association of preprocedural antiplatelet use with decreased thromboembolic complications for intracranial aneurysms undergoing intrasaccular flow disruption.

This study was conducted to investigate the impact of antiplatelet administration in the periprocedural period on the occurrence of thromboembolic complications (TECs) in patients undergoing treatment using the Woven EndoBridge (WEB) device for intracranial wide-necked bifurcation aneurysms. The primary objective was to assess whether the use of antiplatelets in the pre- and postprocedural phases reduces the likelihood of developing TECs, considering various covariates. A retrospective multicenter observational study was conducted within the WorldWideWEB Consortium and comprised 38 academic centers with endovascular treatment capabilities. Univariable and multivariable logistic regression analyses were performed to determine the association between antiplatelet use and TECs, adjusting for covariates. Missing predictor data were addressed using multiple imputation. The study comprised two cohorts: one addressing general thromboembolic events and consisting of 1412 patients, among whom 103 experienced TECs, and another focusing on symptomatic thromboembolic events and comprising 1395 patients, of whom 50 experienced symptomatic TECs. Preprocedural antiplatelet use was associated with a reduced likelihood of overall TECs (OR 0.32, 95% CI 0.19-0.53, p < 0.001) and symptomatic TECs (OR 0.49, 95% CI 0.25-0.95, p = 0.036), whereas postprocedural antiplatelet use showed no significant association with TECs. The study also revealed additional predictors of TECs, including stent use (overall: OR 4.96, 95% CI 2.38-10.3, p < 0.001; symptomatic: OR 3.24, 95% CI 1.26-8.36, p = 0.015), WEB single-layer sphere (SLS) type (overall: OR 0.18, 95% CI 0.04-0.74, p = 0.017), and posterior circulation aneurysm location (symptomatic: OR 18.43, 95% CI 1.48-230, p = 0.024). The findings of this study suggest that the preprocedural administration of antiplatelets is associated with a reduced likelihood of TECs in patients undergoing treatment with the WEB device for wide-necked bifurcation aneurysms. However, postprocedural antiplatelet use did not show a significant impact on TEC occurrence.

Quantified Metrics of Gastric Emptying Delay by Glucagon-Like Peptide-1 Agonists: A Systematic Review and Meta-Analysis With Insights for Periprocedural Management.

Divergent recommendations for periprocedural management of glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 RA) medications rely on limited evidence. We performed a systematic review and meta-analysis to provide quantitative measures of gastric emptying relevant to mechanisms of weight loss and to periprocedural management of GLP-1 RA. We hypothesized that the magnitude of gastric emptying delay would be low and of limited clinical significance to procedural sedation risks. A protocolized search identified studies on GLP-1 RA that quantified gastric emptying measures. Pooled estimates using random effects were presented as a weighted mean difference with 95% confidence intervals (CIs). Univariate meta-regression was performed to assess the influence of GLP-1 RA type, short-acting vs long-acting mechanism of action, and duration of treatment on gastric emptying. Fifteen studies met the inclusion criteria. Five studies (n = 247) utilized gastric emptying scintigraphy. Mean T 1/2 was 138.4 minutes (95% CI 74.5-202.3) for GLP-1 RA vs 95.0 minutes (95% CI 54.9-135.0) for placebo, with a pooled mean difference of 36.0 minutes (95% CI 17.0-55.0, P < 0.01, I2 = 79.4%). Ten studies (n = 411) utilized the acetaminophen absorption test, with no significant delay in gastric emptying measured by T max , area under the curve (AUC) 4hr , and AUC 5hr with GLP-1 RA ( P > 0.05). On meta-regression, the type of GLP-1 RA, mechanism of action, and treatment duration did not impact gastric emptying ( P > 0.05). While a gastric emptying delay of ∼36 minutes is quantifiable on GLP-1 RA medications, it is of limited magnitude relative to standard periprocedural fasting periods. There were no substantial differences in gastric emptying on modalities reflective of liquid emptying (acetaminophen absorption test), particularly at time points relevant to periprocedural care.

Transcranial Doppler emboli monitoring for stroke prevention after flow diverting stents.

Flow diverting stents (FDS) are increasingly used for the treatment of intracranial aneurysms. While FDS can provide flow diversion of parent vessels, their high metal surface coverage can cause thromboembolism. Transcranial Doppler (TCD) emboli monitoring can be used to identify subclinical embolic phenomena after neurovascular procedures. Limited data exists regarding the use of TCDs for emboli monitoring in the periprocedural period after FDS placement. We evaluated the rate of positive TCDs microembolic signals and stroke after FDS deployment at our institution. We retrospectively evaluated 105 patients who underwent FDS treatment between 2012 and 2016 using the Pipeline stent (Medtronic, Minneapolis, MN, USA). Patients were pretreated with aspirin and clopidogrel. All patients were therapeutic on clopidogrel pre-operatively. TCD emboli monitoring was performed immediately after the procedure. Microembolic signals (mES) were classified as "positive" (<15 mES/hour) and "strongly positive" (>15 mES/hour). Clinical stroke rates were determined at 2-week and 6-month post-operatively. A total of 132 intracranial aneurysms were treated in 105 patients. TCD emboli monitoring was "positive" in 11.4% (n=12) post-operatively and "strongly positive" in 4.8% (n=5). These positive cases were treated with heparin drips or modification of the antiplatelet regimen, and TCDs were repeated. Following medical management modifications, normalization of mES was achieved in 92% of cases. The overall stroke rates at 2-week and 6-months were 3.8% and 4.8%, respectively. TCD emboli monitoring may help early in the identification of thromboembolic events after flow diversion stenting. This allows for modification of medical therapy and, potentially, preventionf of escalation into post-operative strokes.

Gender Differences in the Short and Long-Term Outcomes Following Rotational Atherectomy: A Meta-Analysis

BackgroundRotational atherectomy (RA) is used to address complex calcified coronary lesions but data regarding the association between gender and outcomes of patients undergoing RA remained uncertain. We aimed to investigate the short and long-term outcomes of patients undergoing RA based on sex. MethodsA systematic literature search was performed in PubMed, Embase and Cochrane databases from its inception until August 2023 for relevant studies. Endpoints were pooled using the DerSimonian and Laird random-effects model as odd ratio (OR) with 95% confidence intervals (CI). Results7 studies with 8,490 patients (2,565 women and 5,925 men) undergoing RA were included in the study. In terms of periprocedural outcomes, women had a higher risk of in-hospital mortality (OR 2.00, 95% CI 1.08-3.68, p=0.03), coronary dissection (OR 1.80, 95% CI 1.05-3.10, p=0.03), coronary perforation (OR 1.96, 95% CI 1.19-3.23, p=0.01), and stroke (OR 4.22, 95% CI 1.06-16.82, p=0.04) compared to men. There were no significant differences between women and men in terms of MACE (OR 1.43, 95% CI 0.69-2.94, p=0.33), MI (OR 1.35, 95% CI 0.87-2.08, p=0.18), bleeding (OR 1.71, 95% CI 0.88-3.30, p=0.11), and cardiac tamponade (OR 2.30, 95% CI 0.45-11.68, p=0.32). Over a follow-up period of 3 years, results of meta-analysis showed that women had a higher risk of all-cause mortality (OR 1.45, 95% CI 1.19-1.77, p<0.001), long-term MACE (OR 1.38, 95% CI 1.10-1.74, p=0.01), and long-term stroke (OR 3.41, 95% CI 1.63-7.17, p<0.001). The risk of long-term MI was found to be similar between both gender (OR 1.45, 95% CI 0.95-2.22, p=0.09). ConclusionIn conclusion, female gender is associated with adverse periprocedural and long-term outcome following RA. Women consistently demonstrated higher risk of in-hospital mortality, coronary dissection, coronary perforation, and stroke in the periprocedural period. Long-term follow-up further highlighted a heightened risk for women in terms of all-cause mortality and stroke.

Intermediate and long-term outcomes of transcatheter closure of congenital coronary cameral fistulas in 66 children

Objective: To evaluate the intermediate and long-term outcomes and technical aspects of transcatheter closure (TCC) of coronary cameral fistulas (CCF) in pediatric patients. Methods: This was a case-control study. All pediatric patients with CCF who underwent TCC between January 2005 and December 2019 were retrospectively reviewed. Data was collected from medical records, including demographic characteristics, procedural details, intraoperative and postoperative serious adverse events, follow-up results and prognosis. Patients with serious adverse events and without serious adverse events were compared regarding their clinical features and CCF characteristics. Comparisons between groups were performed with independent sample t test, chi-square test or Fisher exact test. Results: A total of 66 CCF patients (34 boys, 32 girls, 3.9 (1.9, 6.2) years old, 15 (11, 20) kg) underwent attempted TCC. All of the CCF were all medium or large fistulas including 55 proximal fistulas (83%) and 11 distal fistulas (17%). The CCF originated more frequently from the right coronary artery (38 cases (58%)), followed by the left coronary artery (28 cases (42%)). The incidence of coronary artery aneurysms (CAA) was 61% (40/66).Procedural treatment was achieved in 64 patients and procedural success was achieved in 59 patients (92%). Six (9%) serious adverse events occurred in 5 patients during the perioperative period. Acute complications included procedure-related death in one patient and acute myocardial infarction in one patient. Periprocedural complications occurred in 3 patients at one day postoperatively including acute myocardial infarction (2 cases), occluder detachment (1 case), and tricuspid chordae tendinae rupture (1 case). Clinical follow-up data were available in 58 of the 62 patients who underwent initial successful TCC with a follow-up period of 9.3 (6.5, 13.4) years. Ten adverse events occurred in 9 patients including 5 complications consisted of aortic valve perforation (1 case), coronary thrombosis (1 case), progressive aneurysmal dilation after reintervention (1 case), and new-onset tricuspid valve prolapse with significant regurgitation (2 cases) and large residual shunts due to fistula recanalization (5 cases). Therefore, the incidence of intermediate and long-term adverse events was 17% (10/58). During the periprocedural and follow-up period, 16 adverse events occurred in 13 patients, whereas no adverse events occurred in 51 patients. Patients with seriovs adverse events presented with larger proportion of large CCF (11/13 vs. 39% (20/51), P=0.005), giant CAA (10/13 vs.14% (7/51), P=0.030), and higher mean pulmonary artery pressure ((20±9) vs.(16±6) mmHg, 1 mmHg=0.133 kPa, t=2.02, P=0.048) compared to patients without serious adverse events. Conclusions: TCC in CCF children appears to be effective with favorable intermediate and long-term outcomes. Strict indication of TCC is mandatory.

Study design of the VenaSeal Spectrum Program: Two randomized controlled trials and one single-arm prospective study of a cyanoacrylate closure system to treat early to advanced chronic venous disease

Background/ObjectiveChronic venous disease (CVD) affects >25% of adults in developed countries. It is usually a progressive disease; if left untreated, can lead to advanced disease such as venous ulceration. The VenaSeal Spectrum Program compares the VenaSeal closure system (VenaSeal) to the global standards of care for CVD: endothermal ablation and surgical stripping. It also investigates VenaSeal's usefulness for patients with venous leg ulcers (VLUs). A key component of this clinical program was to measure and quantify patient satisfaction with treatments related to discomfort, healing time, and effectiveness, which often has been overlooked in CVD research. This article describes the rationale and design of the VenaSeal Spectrum Program for patients with CVD. MethodsVenaSeal Spectrum is a prospective, postmarket, clinical trial program reporting outcomes from the periprocedural period through 5 years after treatment with VenaSeal. VenaSeal Spectrum has enrolled 506 participants at 32 sites in 10 countries requiring treatment for symptomatic Clinical, Etiological, Anatomical, and Pathophysiological Classification (CEAP) 2-6 CVD involving the truncal saphenous vein(s). The program is composed of three studies. Two randomized controlled trials compare VenaSeal ablation with either surgical stripping or endovenous thermal ablation in patients with symptomatic CEAP 2-5 disease. A single-arm prospective study investigates participants with active VLUs (CEAP 6) treated with VenaSeal. The unique primary end points for both randomized trials include both periprocedural and postprocedural patient treatment satisfaction measured by a new questionnaire (VenousTSQ) at 30 days post procedure and elimination of clinically relevant superficial truncal reflux in the target vein at index procedure. The primary end point for the VLU study is time to ulcer healing through 12 months. Secondary end points, which are more familiar to clinicians in this disease space, include time to return to work, complication rates, patient-reported outcome measures, and closure rates. ConclusionsVenaSeal Spectrum is a rigorously designed clinical study program with a large study population and unique patient-centric end points after treatment with VenaSeal for early to advanced symptomatic CVD. The studies report on the safety, effectiveness, and patient experience outcomes including two new primary end points assessing the specific needs of patients with venous insufficiency from the periprocedural period through 5-year follow-up.

Periprocedural management of patients presenting for neurointerventional procedures using flow diverters for complex intracranial aneurysms: An anesthetist's perspective - A narrative review.

Complex intracranial aneurysms pose significant challenges in the realm of neurointervention, necessitating meticulous planning and execution. This article highlights the crucial roles played by anesthetists in these procedures, including patient assessment, anesthesia planning, and continuous monitoring and maintaining hemodynamic stability, which are pivotal in optimizing patient safety. Understanding these complex procedures and their complications will aid the anesthetist in delivering optimal care and in foreseeing and managing the potential associated complications. The anesthetist's responsibility extends beyond the procedure itself to postprocedure care, ensuring a smooth transition to the recovery phase. Successful periprocedural anesthetic management in flow diverter interventions for complex intracranial aneurysms hinges on carefully orchestrating these elements. Moreover, effective communication and collaboration with the interventional neuroradiologist and the procedural team are emphasized, as they contribute significantly to procedural success. This article underscores the essential requirement for a multidisciplinary team approach when managing patients undergoing neurointerventions. In this collaborative framework, the expertise of the anesthetist harmoniously complements the skills and knowledge of other team members, contributing to the overall success and safety of these procedures. By providing a high level of care throughout the periprocedural period, anesthetists play a pivotal role in enhancing patient outcomes and minimizing the risks associated with these intricate procedures. In conclusion, the periprocedural anesthetic management of neurointervention using flow diverters for complex intracranial aneurysms is a multifaceted process that requires expertise, communication, and collaboration.

Qihuang Zhuyu formula alleviates coronary microthrombosis by inhibiting PI3K/Akt/αIIbβ3-mediated platelet activation

BackgroundCoronary microembolism (CME) is commonly seen in the peri-procedural period of Percutaneous Coronary Intervention (PCI), where local platelet activation and endothelial cell inflammation crosstalk may lead to micro thrombus erosion and rupture, with serious consequences. Qihuang Zhuyu Formula (QHZYF) is a Chinese herbal compound with high efficacy against coronary artery disease, but its antiplatelet mechanism is unclear. Hypothesis/PurposeThis study aimed to elucidate the effects and mechanisms of QHZYF on sodium laurate-induced CME using network pharmacology and in vitro and in vivo experiments. MethodsWe employed high-performance liquid chromatography mass spectrometry to identify the main components of QHZYF. Network pharmacology analysis, molecular docking and surface plasmon resonance (SPR) were utilized to predict the primary active components, potential therapeutic targets, and intervention pathways mediating the effects of QHZYF on platelet activation. Next, we pretreated a sodium laurate-induced minimally invasive CME rat model with QHZYF. In vivo experiments were performed to examine cardiac function in rats, to locate coronary arteries on heart sections to observe internal microthrombi, to extract rat Platelet-rich plasma (PRP) for adhesion assays and CD62p and PAC-1 (ITGB3/ITGA2B) flow assays, and to measure platelet-associated protein expression in PRP. In vitro clot retraction and Co-culture of HUVECs with PRP were performed and the gene pathway was validated through flow cytometry and immunofluorescence. ResultsCombining UPLC-Q-TOF/MS technology and database mining, 78 compounds were finally screened as the putative and representative compounds of QHZYF, with 75 crossover genes associated with CME. QHZYF prevents CME mainly by regulating key pathways of the inflammation and platelets, including Lipid and atherosclerosis, Fluid shear stress, platelet activation, and PI3K-Akt signaling pathways. Five molecules including Calyson, Oroxin A, Protosappanin A,Kaempferol and Geniposide were screened and subjected to molecular docking and SPR validation in combination with Lipinski rules (Rule of 5, Ro5). In vivo experiments showed that QHZYF not only improved myocardial injury but also inhibited formation of coronary microthrombi. QHZYF inhibited platelet activation by downregulating expression of CD62p receptor and platelet membrane protein αIIbβ3 and reduced the release of von Willebrand Factor (vWF), Ca2+ particles and inflammatory factor IL-6. Further analysis revealed that QHZYF inhibited the activation of integrin αIIbβ3, via modulating the PI3K/Akt pathways. In in vitro experiments, QHZYF independently inhibited platelet clot retraction. Upon LPS induction, the activation of platelet membrane protein ITGB3 was inhibited via the PI3K/Akt pathway, revealing an important mechanism for attenuating coronary microthrombosis. We performed mechanistic validation using PI3K inhibitor LY294002 and Akt inhibitor MK-2206 to show that QHZYF inhibited platelet membrane protein activation and inflammation to improved coronary microvessel embolism by regulating PI3K/Akt/αIIbβ3 pathways, mainly by inhibiting PI3K and Akt phosphorylation. ConclusionQHZYF interferes with coronary microthrombosis through inhibition of platelet adhesion, activation and inflammatory crosstalk, thus has potential in clinical anti-platelet applications. Calyson, Oroxin A, Protosappanin A, Kaempferol and Geniposide may be the major active ingredient groups of QHZYF that alleviate coronary microthrombosis.