Periprocedural Adverse Events Research Articles

First-in-human experience of high-energy ElectroPulse pulsed field ablation: Acute results for pulmonary veins and posterior wall isolation

BackgroundDifferent iterations of catheter and energy delivery system configurations are evolving for pulsed field ablation (PFA); however, some have used large and complex catheters, required large sheaths, and had a recognized risk of hemolysis. ObjectiveThe purpose of this study was to evaluate the acute safety and efficacy of a custom designed 8F variable loop multielectrode mapping and PFA catheter with contact sensing. MethodsThis acute feasibility study recruited 30 patients undergoing de novo ablation of paroxysmal or persistent atrial fibrillation (AF). The ElectroPulse Study is a first-in-human, nonrandomized, prospective study of a novel PFA system that utilizes an 8F, 10-electrode variable loop steerable mapping and ablation catheter with 2800-V biphasic bipolar waveform. All patients had pulmonary vein isolation (PVI) and posterior wall isolation (PWI) using the PFA system. The main outcomes were the acute success of PV/PWI and periprocedural serious adverse events. ResultsComplete PVI/PWI was successfully achieved in all 30 patients using 59.7 ± 7.2 applications. Total procedural time was 113.6 ± 26.3 minutes, fluoroscopy time 8.0 ± 5.5 minutes, and left atrial dwell time 78.7 ± 18.6 minutes. There was no esophageal injury, phrenic nerve palsy, clinical stroke, or death. Brain magnetic resonance imaging detected 2 new but transient silent cerebral lesions. Two patients (6.7%) had vascular access complications. Although there were changes in the biomarkers for hemolysis, none of the patients experienced clinical hemolysis or related acute kidney injury. ConclusionThis first-in-human study demonstrated that PFA using a novel variable loop catheter with a contact sensing system safely achieved 100% acute PVI/PWI with safety profile comparable to existing PFA systems.

How to decide appropriate percutaneous coronary intervention (PCI) technique for managing heavy calcified coronary lesions: serial case-report

Background: Coronary artery calcification (CAC) is still challenging for interventional cardiologists. Their contribution to major adverse cardiac events occurs from the high risk of stent thrombosis or in-stent restenosis and target lesion revascularization. Optimal preparation, such as coronary plaque modification before stenting, is required to reduce the risk of periprocedural adverse events. This case presentation aimed to describe the appropriate management of heavy calcified coronary lesions. Case Presentation: Two cases of heavy calcified coronary lesions with different baselines as Acute Coronary Syndromes (ACS) and elective PCI were presented. In our ACS patients, the Primary PCI was done by coronary angioplasty without stenting because of the complexity of the heavily calcified lesion. A referral to tertiary health care was made for further PCI procedures using a combination of calcium-ablation and balloon-based techniques. A treatable complication occurred after the orbital atherectomy was performed with good results. The second case was an elective PCI patient with heavy calcified lesions findings from coronary angiography. The balloon-based technique was performed using non-compliant and scoring balloons without complication and showed good results. Conclusion: The challenging points in managing heavy calcified coronary lesions are procedure complexity and the higher stent failure rate. Many modifying coronary calcification algorithms using advanced modalities have been proposed, which could be used to select the appropriate technique as experienced and increase the success rate. Keyword: balloon-based technique, calcium-ablation technique, heavy calcified coronary lesion, orbital atherectomy

Pharmacotherapy of acute ST-elevation myocardial infarction and the pharmacist's role, part 1: Patient presentation through revascularization.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Key pharmacotherapeutic modalities and considerations for the patient with ST-elevation myocardial infarction (STEMI) across the critical initial phases of care are reviewed. Despite established value in the emergency department (ED), cardiac care, and intensive care settings, there is currently little published literature describing or supporting clinical pharmacist roles in the acute management of STEMI. The high-risk period from hospital presentation through revascularization and stabilization involves complex pharmacotherapeutic decision points, many operational medication needs, and multiple layers of quality oversight. While rife with opportunities for pharmacists to optimize care, this timeframe appears inconsistently targeted by clinical pharmacy services, which may halt after ED evaluation and then resume upon postcatheterization cardiac unit admission. Herein we review the key pharmacotherapeutic modalities and considerations for the patient with STEMI across the critical initial phases of care. These include supportive therapies prior to revascularization, the host of antithrombotics involved in revascularization by percutaneous coronary intervention and/or fibrinolysis, and other periprocedural medications. Important practice guidelines and clinical resources are summarized from the clinical pharmacist perspective, and roles and responsibilities of the responding pharmacist are suggested. A companion article will extend the review to periprocedural adverse event management, key early decision-making regarding long-term risk reduction, and pharmacist involvement in institutional quality improvement efforts. We aim to support inpatient pharmacy departments in advancing clinical services for this critical patient population, and we call for further research delineating pharmacist impact on patient and institutional STEMI outcomes. Patients presenting with STEMI rapidly traverse multiple phases of care and receive a host of antithrombotic and supportive medications during acute management, presenting many important pharmacotherapeutic decision points and roles for pharmacists.

A Randomized Trial of Cardiac Catheterization With Fasting Versus Liberal Oral Intake: The CALORI Trial

BackgroundRoutine preprocedural fasting before cardiac catheterization remains common practice, despite a lack of robust evidence to support this practice. We investigated the impact of a liberal nonfasting strategy vs a standardized nil per os (NPO) regimen prior to cardiac catheterization. MethodsAdult inpatients undergoing elective or urgent cardiac catheterization were randomized (1:1 ratio) to either NPO past midnight or ad libitum intake of liquids and solids (without dietary constraints) until immediately prior to the procedure. Only patients at high risk of aspiration or undergoing complex interventions were excluded. The primary end point was preprocedural patient-reported well-being scores (scaled 0-5, with 0 signifying absence of ailment and 5 the most extreme form), for variables including hunger, fatigue, anxiety, and nausea. A composite score summed the individual scores for hunger and fatigue. Other end points were periprocedural adverse events including emesis, aspiration, or intubation, in addition to postprocedural satisfaction. ResultsA total of 198 patients (65% male and 42% Black) were included in the final analysis. There were no differences in baseline characteristics between groups. Time from most recent oral intake (liquid or solid) to the start of the procedure averaged 148 minutes for the nonfasting group and 970 minutes for the NPO strategy (P < .001). The composite preprocedural well-being score was significantly better in the nonfasting arm (2.4 ± 2.4 nonfasting vs 6.0 ± 2.5 NPO, P < .001), as were the individual components of hunger (0.9 ± 1.5 vs 3.7 ± 1.5, P < .001), fatigue (1.5 ± 1.6 vs 2.3 ± 1.8, P < .001), and nausea (0.1 ± 0.5 vs 0.5 ±1.2, P = .006). There were no significant differences in adverse events between groups. Overall postprocedural satisfaction scores were significantly better in the nonfasting vs NPO group (0.3 ± 0.7 vs 1.0 ± 1.3, respectively, P < .001). ConclusionsIn this single-center randomized trial, a liberal nonfasting strategy prior to cardiac catheterization significantly improved patient well-being and satisfaction without compromising safety. Given the findings of this and other studies, routine fasting prior to cardiac catheterization should be reconsidered.

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.

Midterm Outcomes of Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Cardiomyopathy: A Single-Center, Observational Study.

Percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) has been reported to be safe and effective at midterm follow-up to treat drug-refractory hypertrophic obstructive cardiomyopathy in a single center. However, data from other centers are lacking. This retrospective cohort study aimed to investigate the efficacy and safety of PIMSRA from another independent center. PIMSRA was performed in 76 patients with hypertrophic obstructive cardiomyopathy in our center from April 2020 to June 2023. The primary outcome was the reduction of left ventricular outflow tract gradient after 6 months or more post-PIMSRA. Secondary outcomes were periprocedural major adverse clinical events. Sixty-one patients returned to the hospital for follow-up 6 to 30 (median, 14) months after the procedure. At the last follow-up of the 61 patients, the maximum septal thickness decreased from a median of 23.6 (interquartile range, 20.5-26.4) to 19.1 (interquartile range, 16.0-22.1) mm (P<0.001) and the left ventricular outflow tract peak gradient at rest decreased from a median of 70.0 (interquartile range, 29.1-107.5) to 20.0 (interquartile range, 10.8-48.8) mm Hg (P<0.001). The percentage of patients with symptoms of New York Heart Association functional class III/IV decreased from 51% to 0%. Of all 76 patients, there was no in-hospital or 30-day death, no right or left branch block, and no permanent pacemaker implantation. Six (8%) patients had pericardial effusion, with 1 experiencing cardiac tamponade and ventricular fibrillation, and 1 (1%) patient developed septal branch aneurysm that was treated with coil occlusion. PIMSRA allows for the reduction in the left ventricular outflow tract gradient and enhances symptomatic improvement, with a limited incidence of adverse events and complications among patients with hypertrophic obstructive cardiomyopathy.

Impact of the use of plaque modification techniques on coronary microcirculation using an angiography-derived index of microcirculatory resistance.

Many lesions in patients undergoing percutaneous coronary intervention (PCI) exhibit significant calcification. Several techniques have been developed to improve outcomes in this setting. However, their impact on coronary microcirculation remains unknown. The aim of this study is to evaluate the influence of plaque modification techniques on coronary microcirculation across patients with severely calcified coronary artery disease. In this multicenter retrospective study, consecutive patients undergoing PCI with either Rotablation (RA) or Shockwave-intravascular-lithotripsy (IVL) were included. Primary endpoint was the impairment of coronary microvascular resistances assessed by Δ angiography-derived index of microvascular resistance (ΔIMRangio) which was defined as the difference in IMRangio value post- and pre-PCI. Secondary endpoints included the development of peri procedural PCI complications (flow-limiting coronary dissection, slow-flow/no reflow during PCI, coronary perforation, branch occlusion, failed PCI, stroke and shock developed during PCI) and 12-month follow-up adverse events. 162 patients were included in the analysis. Almost 80% of patients were male and the left descending anterior artery was the most common treated vessel. Both RA and IVL led to an increase in ΔIMRangio (22.3 and 10.3; p = 0.038, respectively). A significantly higher rate of PCI complications was observed in patients with ΔIMRangio above the median of the cohort (21.0% vs. 6.2%; p = 0.006). PCI with RA was independently associated with higher ΔIMRangio values (OR 2.01, 95% CI: 1.01-4.03; p = 0.048). Plaque modification with IVL and RA during PCI increases microvascular resistance. Evaluating the microcirculatory status in this setting might help to predict clinical and procedural outcomes and to optimize clinical results.

Deep sight: enhancing periprocedural adverse event recording in endoscopy by structuring text documentation with privacy-preserving large language models

Background and aimsThe assessment of adverse events from endoscopic procedures is essential for successful interventions, ensuring accurate follow-up, adverse event management and processing for quality control. Despite the critical need for structured documentation, the current practice often relies on free-text recordings, which poses challenges for scalable intervention analysis; however, the introduction of Large Language Models (LLMs) offers a promising solution by enabling the automatic extraction of adverse event details from procedural reports, without altering existing documentation practices. MethodsWe analyzed 672 endoscopy reports, using OpenAI’s GPT-4 and Llama-2 based models to structure the data in JSON for efficient analysis. We used an automated LLM-pipeline to extract adverse events such as bleeding, perforation, and aspiration. The dataset was divided into a proof of concept set (PoC-S) with n=171 reports, on which we explored prompt engineering to improve the performance of the models. The final analysis was run on an additional external test set of 501 reports (TS). ResultsGPT-4 showed high accuracy, with a sensitivity of 97% and specificity of 92% in the PoC-S and 91% and 96% respectively in the TS. GPT-4 use in real-world settings is limited by privacy concerns. Conversely, Llama-2 based models, especially the Llama-2 variants fine-tuned for German language, demonstrated comparable performance (PoC-S: sensitivity 94%, specificity 92%, CS: sensitivity 89%, specificity 93%) and offered a viable, privacy-compliant alternative. These models' effectiveness was further influenced by the method of prompt engineering, with experiments showing that the specificity and sensitivity could vary substantially based on the inclusion of specific prompt features, underscoring the importance of tailored prompt design. ConclusionApplying LLMs to extract structured medical information, particularly from endoscopy reports, offers an efficient, scalable, and adaptable documentation method that captures adverse events accurately with low error rate. It facilitates immediate quality reporting and reduces manual documentation efforts.

Preliminary results of intracranial aneurysm treatment with derivo2heal embolization device

IntroductionThe Derivo 2 Heal Embolization Device (D2HED) is a novel flow diverter (FD) providing a fibrin-/heparin-based surface coating aiming at lower thrombogenicity. We evaluate periprocedural aspects and preliminary aneurysm occlusion efficacy for intracranial aneurysm treatment.MethodsThirty-four D2HEDs deployments (34 aneurysms, 32 patients) between 04/2021 and 10/2023 were analyzed. All patients were under dual antiplatelet therapy (dAPT). Periprocedural details, adverse events, and follow-up (FU) imaging were reviewed by consultant-level neuroradiologists. Complication rates and aneurysm occlusion efficacy are compared with performance data of other FDs based on literature research.ResultsEach intervention succeeded in the deployment of one D2HED. Significant and/or increased intraaneurysmal contrast stagnation immediately after D2HED deployment was seen in 73.5% of cases according to O’Kelly-Marotta (OKM) grading scale. Clinically relevant early adverse events occurred in three patients: Among them two cases with fusiform aneurysms in the posterior circulation (ischemic events, early in-stent-thrombosis) and one patient (ischemic event) out of the majority of 31 treated internal carotid artery aneurysms (3,2%). Regarding mid-term FU (> 165 days), one aneurysm did not show progressive occlusion presumably caused by a prominent A1 segment arising from the terminal ICA aneurysm itself. Apart from that, mid-term complete / partial occlusion rates of 80% / 20% could be demonstrated.ConclusionOur case series - although suffering from restricted sample size - suggests a potential effectiveness of D2HED in managing intracranial aneurysms. Further studies with larger samples are warranted to quantify long-term occlusion efficacy and the impact of antithrombogenic surface coating on the necessary (d)APT.

Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study.

Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm2) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated. We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm2) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism. One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler. Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).

Adverse events and sedation characteristics of propofol and dexmedetomidine during magnetic resonance imaging: An observational study in neuropsychiatric population

Objectives: Propofol and dexmedetomidine are the most commonly used sedative drugs during magnetic resonance imaging (MRI) studies. However, data regarding peri-procedural adverse events, and the profile of these drugs concerning the quality of sedation, imaging, and recovery is limited in neurological and psychiatric populations. This study aimed to compare adverse events and sedation characteristics of propofol and dexmedetomidine during MRI studies in patients with neurological and psychiatric illnesses. Materials and Methods: This prospective observational study was conducted between March 2020 and September 2021 after the Ethics Committee’s approval and informed consent. Patients of all ages and genders undergoing elective MRI studies for neurological, neurosurgical, or psychiatric illness under sedation with either dexmedetomidine or propofol infusion were included in the study. Results: The patients in the dexmedetomidine group were older, had higher body mass index, and had more pre-procedure risk factors than the propofol group. Pre-medication use (midazolam or ketamine) was more in the propofol group. There was no difference in respiratory adverse events, but cardiovascular events (bradycardia and hypotension) were more with dexmedetomidine. There was no difference in the quality of sedation (patient movement, image quality, and need for repeating the imaging sequence). Recovery time from anesthesia was faster, and Aldrete score and Observer Assessment of Alertness/Sedation Scale scores in the post-anesthesia care unit were higher with propofol. Conclusion: Cardiovascular but not respiratory adverse events were more with dexmedetomidine, recovery profile was better with propofol, and both the drugs were similar regarding the quality of sedation and images in neurological and psychiatric patients undergoing MRI study.

Outcomes of patients with cardiac amyloidosis undergoing percutaneous left atrial appendage occlusion.

There is limited data on the safety and efficacy of left atrial appendage occlusion (LAAO) devices in patients with cardiac amyloidosis. We examined the outcomes of patients with cardiac amyloidosis undergoing LAAO device implantation in a nationally representative cohort of patients. The National Readmissions Database (NRD) was analyzed from 2016 to 2019 to identify patients ≥ 18 years old with atrial fibrillation (AF) undergoing LAAO. Patients were divided into those with cardiac amyloidosis and those without cardiac amyloidosis. A multivariable logistic regression model was utilized to assess the independent association of cardiac amyloidosis with in-hospital, 30-day/90-day/180-day outcomes after adjusting for confounders. Our cohort included 54,900 LAAO implantation procedures, of which 220 (0.4%) had cardiac amyloidosis. Patients with cardiac amyloidosis had a lower proportion of women and a lower prevalence of comorbidities including anemia, obesity, diabetes, and peripheral vascular disorders but a higher prevalence of stroke, as compared to those without cardiac amyloidosis. On multivariable analysis, cardiac amyloidosis was associated with significantly higher odds of peri-procedural major adverse events (adjusted odds ratio [aOR]: 2.69; 95% confidence interval [CI]: 1.41-5.14; p<0.01) and neurological complications (aOR: 5.48; 95% CI: 2.47-12.8; p<0.01). There was no difference in the odds of other peri-procedural complications, in-hospital mortality, hospital resource utilization, and 30/90/180-day all-cause/bleeding/stroke-related readmissions between both groups. Patients with cardiac amyloidosis undergoing LAAO device implantation have an increased risk of peri-procedural complications without any difference in bleeding/stroke-related readmissions. These hypothesis-generating findings need validation in future prospective studies.

Transperineal Laser Ablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: Long-Term Follow-Up in 40 Patients

PurposeTo evaluate the durability, effectiveness, and safety of transperineal laser ablation (TPLA) of the prostate. Materials and MethodsPatients with symptomatic benign prostatic hyperplasia (BPH) underwent TPLA with a 1,064-nm continuous-wave diode laser. International Prostate Symptom Score (IPSS), quality of life (QoL), postvoid residual (PVR), and prostate volume were evaluated at baseline and successive timepoints. ResultsForty prospectively enrolled patients had follow-up of ≥36 months; median duration of follow-up was 57 months (range, 36–76 months). Compared with baseline, the median reduction in IPSS at 12-month follow-up was 74% (interquartile range [IQR], 60%–81%) (P < .001). Median QoL score at 12 months was improved from 5 (IQR, 4–5) at baseline to 1 (IQR, 0–1) (P < .001). Median PVR at 12 months decreased from 108 mL (IQR, 38–178 mL) to 13.5 mL (IQR, 0–40.5 mL) (P < .001), a median reduction of 88% (IQR, 61%–100%). At 12 months, median prostate volume was significantly reduced from 66 mL (IQR, 48.5–86.5 mL) to 46 mL (IQR, 36–65 mL) (P < .001), a median reduction of 32% (IQR, 21%–45%). For all of these parameters, the benefit of TPLA persisted at last follow-up, and all changes were statistically significant compared with baseline. There were no intraprocedural adverse events; periprocedural adverse events consisted of 1 case of prostatitis and 1 case of urinary tract infection (both Society of Interventional Radiology [SIR] Grade I). ConclusionsTPLA for symptomatic BPH produced durable benefits across a range of clinical outcomes and was well tolerated in follow-up at median duration of 57 months.

Adjunctive low-voltage area ablation for patients with atrial fibrillation: An updated meta-analysis of randomized controlled trials.

The efficacy and safety of adjunctive low-voltage area (LVA) ablation on outcomes of catheter ablation (CA) for atrial fibrillation (AF) remains uncertain. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) comparing CA with versus without LVA ablation for patients with AF. Risk ratios (RR) with 95% confidence intervals (CI) were pooled with a random-effects model. Our primary endpoint was recurrence of atrial tachyarrhythmia (ATA), including AF, atrial flutter, or atrial tachycardia. We used R version 4.3.1 for all statistical analyses. Our meta-analysis included 10 RCTs encompassing 1780 patients, of whom 890 (50%) were randomized to LVA ablation. Adjunctive LVA ablation significantly reduced recurrence of ATA (RR 0.76; 95% CI 0.67-0.88; p < .01) and reduced the number of redo ablation procedures (RR 0.54; 95% CI 0.35-0.85; p < .01), as compared with conventional ablation. Among 691 (43%) patients with documented LVAs on baseline substrate mapping, adjunctive LVA ablation substantially reduced ATA recurrences (RR 0.57; 95% CI 0.38-0.86; p < .01). There was no significant difference between groups in terms of periprocedural adverse events (RR 0.78; 95% CI 0.39-1.56; p = .49). Adjunctive LVA ablation is an effective and safe strategy for reducing recurrences of ATA among patients who undergo CA for AF.

Magnetic Resonance-Guided Focused Ultrasound without Anesthesiologist Support

Introduction: Magnetic resonance-guided focused ultrasound (MRgFUS) is an effective treatment option for essential tremor (ET) and tremor dominant Parkinson’s disease (TDPD), which is often performed with sedation or in the presence of an anesthesiologist in an effort to minimize adverse events and maximize patient comfort. This study explores the safety, feasibility, and tolerability of performing MRgFUS without an anesthesiologist. Methods: This is a single academic center, retrospective review of 180 ET and TDPD patients who underwent MRgFUS treatment without anesthesiologist support. Patient demographics, intra-procedural treatment parameters, peri-procedural adverse events, and 3-month Clinical Rating Scale for Tremor Part B (CRST-B) scores were compared to MRgFUS studies that utilized varying degrees of anesthesia. Results: There were no anesthesia related adverse events or unsuccessful treatments. There were no early treatment terminations due to patient discomfort, regardless of skull density ratio. 94.6% of patients would repeat the procedure again. The most common side effects during treatment were facial/tongue paresthesia (26.3%), followed by nausea (22.3%), dysarthria (8.6%), and scalp pain (8.0%). No anxiolytic, pain, or antihypertensive medications were administered. The most common early adverse event after MRgFUS procedure was gait imbalance (58.3%). There was a significant reduction of 83.1% (83.4% ET and 80.5% TDPD) of the mean CRST-B scores of the treated hand when comparing 3-month and baseline scores (1.8 vs. 10.9, n = 109, p < 0.0001). Conclusion: MRgFUS without intra-procedural anesthesiologist support is a safe, feasible, and well-tolerated option, without an increase in peri-procedural adverse events.

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

The Efficacy of Coronary Sinus Reducer in Patients with Refractory Angina: A Systematic Review and Meta-Analysis.

Refractory angina is a frequently encountered phenomenon in patients with coronary artery disease, often presenting therapeutic challenges to the clinical cardiologist. Novel treatment methods have been explored in this direction, with the coronary sinus reducer (CSR) being among the most extensively-investigated. We conducted a systematic review of the literature for studies assessing the efficacy of CSR in patients with refractory angina. The primary endpoints of interest were procedural success and the improvement in angina according to the Canadian Cardiovascular Society (CCS) by at least one class. Secondary endpoints were the rate of periprocedural adverse events, the improvement by at least 2 CCS classes, and the mean change in CCS class. A random-effects meta-analysis of proportions (procedural success, improvement by 1 or 2 classes, periprocedural adverse events) or means (mean CCS class change) were performed. was chosen as the metric for between-study heterogeneity. Publication bias was assessed by the inspection of funnel plots and Egger's regression test. We examined the risk of bias according to the Newcastle-Ottawa Scale. From a total of 515 studies identified from the original search, 12 studies were finally included for data extraction. Based on their meta-analysis, we observed a high CSR procedural success (98%, 95% confidence interval (CI) 96 to 99%) with a low rate of periprocedural complications (6%, 95% CI 5 to 7%), while most patients exhibited an improvement by at least 1 CCS class (75%, 95% CI 66 to 83%) after the intervention. A significant proportion of patients demonstrated an improvement by at least 2 CCS classes (39%, 95% CI 34 to 45%), with a mean change of -1.24 CCS class (95% CI -1.40 to -1.08). CSR is associated with high implantation success rates and significant improvements in angina symptoms for patients with refractory angina.

Effectiveness of endoscopic ultrasound (EUS)-guided choledochoduodenostomy vs. EUS-guided gallbladder drainage for jaundice in patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography: Retrospective, multicenter study (GALLBLADEUS Study).

The aim of this study was to compare endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) vs. EUS-gallbladder drainage (EUS-GBD) in cases of failed endoscopic retrograde cholangiopancreatography (ERCP) for jaundice resulting from malignant distal biliary obstruction (MDBO). This multicenter retrospective study included patients with obstructive jaundice secondary to MDBO who underwent EUS-GBD or EUS-CDS with lumen-apposing metal stents after failed ERCP. The primary end-point was clinical success rate. Secondary end-points were technical success, periprocedural adverse events rate (<24 h), late adverse events rate (>24 h), overall survival, and time to recurrent biliary obstruction. A total of 78 patients were included: 41 underwent EUS-GBD and 37 underwent EUS-CDS. MDBO was mainly the result of pancreatic cancer (n = 63/78, 80.7%). Clinical success rate was similar for both procedures: 87.8% for EUS-GBD and 89.2% for EUS-CDS (P = 0.8). Technical success rate was 100% for EUS-GBD and 94.6% for EUS-CDS (P = 0.132). Periprocedural morbidity (<24 h) rates were similar between both groups: 4/41 (9.8%) for EUS-GBD and 5/37 (13.5%) for EUS-CDS (P = 0.368). There was a significantly higher rate of late morbidity (>24 h) among patients in the EUS-CDS group (8/37 [21.6%]) than in the EUS-GBD group (3/41 [7.3%]) (P = 0.042). The median follow-up duration was 4.7 months. Overall survival and time to recurrent biliary obstruction did not significantly differ between the groups. After failed ERCP for MDBO, EUS-GBD and EUS-CDS show comparable clinical success rates and technical success. EUS-GBD appears to be a promising alternative for MDBO, even as a second-line treatment after failed ERCP. Further studies are needed to validate these findings and compare the long-term outcomes of EUS-GBD and EUS-CDS.

Intravitreous aflibercept or vitrectomy for initial treatment of diabetic vitreous hemorrhage? A Systematic Review of Current Evidence

Introduction &amp; Objectives : To assess the efficacy and safety of intravitreous aflibercept versus vitrectomy in patients with diabetic vitreous hemorrhage (VH)&#x0D; Methods : Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE database were searched. No constraints based on language or publication date were applied. Only randomized controlled trials (RCTs) comparing intravitreal aflibercept injection with vitrectomy procedure were included. Search results were screened independently by two authors. Data extraction and synthesis were performed according to The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The primary outcome measures were best-corrected visual acuity obtained at least 6 months following interventions, rate of recurrent hemorrhage, and periprocedural ocular adverse events. The quality of evidence was assessed using the GRADE tools.&#x0D; Results : Two clinical trials that randomized 239 eyes were included in this review. There was no evidence ofa difference in primary outcome of mean visual acuity at six months between randomized groups. However, patients receiving intravitreous aflibercept were more likely to experience recurrent VH than those undergoing vitrectomy (RR 3.12 95% CI 1.95 - 4.99, absolute effect of 32 more people with recurrent VH per 100 people treated with aflibercept). Rates of periprocedural ocular complications were similar in both groups.&#x0D; Conclusion : Intravitreous aflibercept safety and efficacy appear to be non-inferior compared to vitrectomy for initial management of diabetic VH. Further well-designed studies are needed to investigate the long- term effects of treatments.

One-Day Interruption of NOAC Is Associated with Low Risk of Periprocedural Adverse Events during Pulmonary Vein Isolation If Combined with Left Atrial Thrombus Exclusion with Computed Tomography.

Safety, efficacy, and patient comfort are the expectations during pulmonary vein isolation (PVI). We aimed to validate the combined advantages of pre- and periprocedural anticoagulation with non-vitamin K anticoagulants (NOACs) and rigorous left atrial appendage thrombus (LAAT) exclusion with computed tomography (CT). This study included a population of consecutive patients, between March 2018 and June 2020, who underwent cardiac CT within 24 h before PVI to guide the ablation and rule out LAAT. NOAC was omitted 24 h before the ablation. A total of 187 patients (63% male) underwent CT before PVI. None of the patients experienced stroke during or after the procedure. The complication rate was low, with no thromboembolic events and 2.1% of patients experiencing a major bleeding event. Omitting NOAC 24 h before the ablation might be safe if combined with left atrial thrombus exclusion with computed tomography.