Postprocedure Day Research Articles

Abstract 4134594: More than One Way to Catch a Fish: Micra Extraction Case Series

Description of Cases: Case 1: A 72 year old male with atrial fibrillation (AF) and tachy-brady syndrome underwent Micra implantation. On post-procedure day 2, pacing thresholds were unacceptably elevated. A new Micra device was deployed; subsequently, a microsnare was placed through the Micra delivery catheter and the docking button of the old Micra was successfully snared (Figure A). The old Micra was then captured over the delivery catheter and removed from the body. Case 2: A 76 year old male underwent Micra implantation and AV node ablation for AF with persistent tachycardia. One month later, he presented with heart failure and interval decrease in ejection fraction from 66% to 33%. After biventricular leads were implanted, an Agilis catheter was advanced towards the Micra. The docking button was successfully snared with a gooseneck snare (Figure B), and the Micra was extracted with gentle traction. Case 3: A 76 year old male with complete heart block and longstanding persistent AF received a Micra. Nine months later, he presented with heart failure and interval decrease in ejection fraction from 55% to 25%. A defibrillator lead was implanted but no suitable CS branch was identified. The Aveir retrieval catheter was advanced and the Micra docking button was captured with the triloop snare (Figure C). The protective sleeve was advanced over the Micra and it was successfully removed. Subsequently, a left bundle area lead was placed. Discussion: Although uncommon, extraction of the tined leadless pacemaker (Micra) may be indicated at times. As rates of implantation continue to increase, establishing uniform procedures for extraction becomes increasingly important. These three cases highlight unique options for Micra extraction, and the feasibility of each approach. However, a dedicated tool and protocol would be ideal for patient safety and consistency. No complications occurred with the above cases.

A pilot intervention trial to reduce the use of post-procedural antimicrobials after common endourologic surgeries.

Post-procedural antimicrobial prophylaxis is not recommended by professional guidelines but is commonly prescribed. We sought to reduce use of post-procedural antimicrobials after common endoscopic urologic procedures. A before-after, quasi-experimental trial with a baseline (July 2020-June 2022), an implementation (July 2022), and an intervention period (August 2022-July 2023). Three participating medical centers. We assessed the effect of a bundled intervention on excess post-procedural antimicrobial use (ie, antimicrobial use on post-procedural day 1) after three types of endoscopic urologic procedures: ureteroscopy and transurethral resection of bladder tumor or prostate. The intervention consisted of education, local champion(s), and audit-and-feedback of data on the frequency of post-procedural antimicrobial-prescribing. 1,272 procedures were performed across all 3 sites at baseline compared to 525 during the intervention period; 644 (50.6%) patients received excess post-procedural antimicrobials during the baseline period compared to 216 (41.1%) during the intervention period. There was no change in the use of post-procedural antimicrobials at sites 1 and 2 between the baseline and intervention periods. At site 3, the odds of prescribing a post-procedural antimicrobial significantly decreased during the intervention period relative to the baseline time trend (0.09; 95% CI 0.02-0.45). There was no significant increase in post-procedural unplanned visits at any of the sites. Implementation of a bundled intervention was associated with reduced post-procedural antimicrobial use at one of three sites, with no increase in complications. These findings demonstrate both the safety and challenge of guideline implementation for optimal perioperative antimicrobial prophylaxis.This trial was registered on clinicaltrials.gov, NCT04196777.

Safe transition home after transcatheter aortic valve implantation feasibility (START-F) study: Very early self-reported function and recovery status after early discharge

Abstract Background Despite significant excellent outcomes and significant improvements in rapid recovery protocols and early discharge, rates of 30-day readmission after transcatheter aortic valve implantation (TAVI) remain stubbornly high. There can be numerous drivers for readmission in older people with valvular heart disease; the time of transition home is the period of greatest risk when patients are most vulnerable to repeat hospitalization. We sought to assess patients’ early recovery (< post-procedure day 3) to inform the evaluation of a nurse-led telephone intervention to mitigate the risks of 30-day readmission after early (1 day) discharge TAVI. Methods We conducted a prospective observational cohort feasibility study in five Canadian TAVI programs to ascertain acceptability, compliance, delivery of the intervention, recruitment and retention. In this preliminary report, we assessed key indicators of patients’ status at the time of discharge and functional status in their early recovery. Results We recruited 188 participants, mean age 81.6 years (SD=7.0), 41.5% women with baseline mean KKCQ 53.4 (SD=20.1). Patients were admitted on the day of the procedure, and underwent TAVI with a balloon-expandable (n=146, 77.6%) or self-expanding (n=30, 16.0%) device, with local anaesthesia +/- light sedation (n=171, 90.1%) or general anaesthesia (n=17, 9.0%). There was 1 in-hospital death (0.5%) and 182 (97.4%) were discharged home. At the time of the 3-day telephone follow-up, 168 (95.5%) reported that an individual had stayed with them during the first 24 hours [spouse: 85 (48.9%); friend: 77 (44.3%)], and 165 (93.3%; missing: 11) were able to complete all activities of daily living, including cooking their own meals (n=80, 45.5%). Self-reported energy was low/very low for 49 participants (26.1%), moderate for 93 (52.8%), and high/very high for 34 (18.1%), with 104 (55.3%) describing feeling somewhat or quite a bit better than before TAVI, and 24 (12.8%) somewhat or quite a bit worse. Bruising was present in 120 participants (68.6%) and 137 (78.8%) had removed their bandage as instructed. 18 participants were readmitted within 30 days, including 14 cardiac-related events. Conclusion This is one of the first reports of TAVI patients’ self-reported function following next-day discharge, providing novel evidence that most patients describe safe self-care and very early improved functional status. Research is needed to identify and support patients who are at higher risk of poorer trajectories of recovery and readmission, and report the feasibility of a nurse-led intervention to mitigate these risks.

Comparison of radial artery occlusion between traditional radial access and distal radial access for coronary angiography and intervention: A prospective cohort study

BackgroundThe radial approach is now recommended as the default strategy in diagnostic coronary angiography and percutaneous coronary intervention. Radial artery occlusion (RAO) is the most common complication that limits subsequent angiographic procedures through this access. Recently, distal radial access (DRA) has been recommended as an alternative access site. Despite lower RAO rates in DRA in some recent clinical trials, concerns remain regarding possible complications and limitations due to the small size of the distal radial artery. ObjectiveThe present study aimed to compare traditional radial access (TRA) and DRA concerning RAO in percutaneous coronary procedures. MethodsIn the present prospective cohort study, percutaneous coronary procedures were performed via DRA or TRA in 2 study groups. All consecutive participants underwent DRA from September 2021 to March 2022 and TRA from April 2022 to June 2022. Ultrasonography was performed preprocedurally in the DRA group, and patients with small distal artery diameters (<2 mm) were excluded. The same 6-Fr sheaths and standard air-filled compression devices were used in both groups. The primary endpoint was RAO in ultrasound sonography on the first postprocedural day, and the secondary endpoints were the success rate, access time, angiography time, radial artery spasms, and vascular access complications. ResultsA total of 298 patients were assigned to the DRA group and 278 to the TRA group. The RAO rate was significantly higher in the TRA group than in the DRA group (10.1 % vs 0.9 %; P = 0.0001; OR, 0.08, 95 % CI, 0.01–0.27). The success rate was significantly higher in the TRA group (96 % vs 90.2 %; P = 0.009). Access crossovers were done on 12 patients (4.0 %) in the TRA group and 24 patients (9.8 %) in the DRA group (P < 0.001). The mean access time was significantly lower in the TRA group than in the DRA group (1.9 min vs 2.9 min; P < 0.001). The mean angiography time did not significantly differ between the groups (10.2 min in the TRA group vs 9.9 min in the DRA group). The rate of radial artery spasms was not significantly different between the 2 groups (13.8 % in the TRA group vs 14.5 % in the DRA group). The rates of access site hematoma (12.4 % vs 2.3 %; P < 0.001) and bleeding (10.7 % vs 4.1; P = 0.005) were significantly higher in the TRA group. ConclusionsDRA was safe and feasible with lower rates of RAO and access site complications than TRA. Thus, it could be used as an alternative approach in percutaneous coronary procedures. However, the trade-off for these advantages of DRA is an increase in cross-over rate, and a decrease in puncture success rate.

The effects of mouth rinsing and gargling with mouthwash containing povidone-iodine and hydrogen peroxide on the cycle threshold value of Severe Acute Respiratory Syndrome Coronavirus 2: A randomized controlled trial of asymptomatic and mildly symptomatic patients.

Coronavirus disease 2019 can spread rapidly. Surgery in the oral cavity poses a high risk of transmission of severe acute respiratory syndrome coronavirus 2. The American Dental Association and the Centers for Disease Control and Prevention recommend the use of mouthwash containing 1.5% hydrogen peroxide (H 2O 2) or 0.2% povidone iodine (PI) to reduce the viral load in the upper respiratory tract and decrease the risk of transmission. The aim of the present study was to analyze the effect of mouth rinsing and gargling with mouthwash containing 1% PI, 0.5% PI, 3% H 2O 2, or 1.5% H 2O 2 and water on the cycle threshold (CT) value obtained by real-time reverse transcription polymerase chain reaction (RT-PCR). This study is a randomized single blind controlled clinical trial which has been registered in the International Standard Randomized Controlled Trial Number (ISRCTN) registry on the 3 rd February 2022 (Registration number: ISRCTN18356379). In total, 69 subjects recruited from Persahabatan General Hospital who met the inclusion criteria were randomly assigned to one of four treatment groups or the control group. The subjects were instructed to gargle with 15 mL of mouthwash for 30 s in the oral cavity followed by 30 s in the back of the throat, three times per day for 5 days. CT values were collected on postprocedural days 1, 3, and 5. The results of the Friedman test significantly differed among the groups (n=15). The CT values increased from baseline (day 0) to postprocedural days 1, 3, and 5. Mouth rinsing and gargling with mouthwash containing 1% PI, 0.5% PI, 3% H 2O 2, or 1.5% H 2O 2 and water increased the CT value.

TRLS-17. INTERIM CLINICAL, PHARMACOKINETIC, AND TECHNICAL REPORT OF A PHASE 2 STUDY OF SONODYNAMIC THERAPY (SDT) USING SONALA-001 TOGETHER WITH MR-GUIDED LOW-INTENSITY FOCUSED ULTRASOUND (MRGFUS) IN CHILDREN WITH DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG)

Abstract BACKGROUND Children with DIPG have limited treatment options and poor prognosis with median survival of 9-12 months. Preclinical studies reveal that sonodynamic therapy (SDT) via MR-guided focused ultrasound (MRgFUS) activates SONALA-001 (ALA) metabolite, protoporphyrin IX (PpIX), inducing tumor cell death and extending survival in glioma models. METHODS We present preliminary data from an ongoing first-in-child drug-device trial (NCT05123534) of SONALA-001 SDT in children with DIPG aged ≥ 5 years post-radiation therapy. The trial evaluates the safety of ALA-SDT, preliminary efficacy and pharmacokinetics (PK) of SONALA-001 at 5mg/kg administered 6-12 hours before SDT and establishes the RP2D. Each cohort involves three subjects: the first receiving half-pons treatment 30-days apart; the others receiving entire pons treatment. Single-treatment approach was amended to allow up to 12 monthly-treatments. RESULTS Six patients (4M:2F, 5-12 years) in 2 cohorts received 22 SDT-treatments between August 2022 and February 2023. Sonication duration averaged 147 minutes. Five of 6 patients received repeated treatments. All were discharged post-procedure day 1 with no DLTs or related AE grade ≥ 3. For SONALA-001, the Cmax occurred at end of infusion, followed by rapid clearance (15.7 mL/min/kg); plasma half-life of &amp;lt; 1 hour, indicating rapid distribution. The PpIX-Cmax occurred 4-6 hours post-dose, declining with a longer mean half-life than SONALA-001 of 6 hours. Both Cmax and AUCall demonstrate circulating-PpIX and systemic exposure were significantly lower than for SONALA-001. Two of 6 patients achieved a partial response per RAPNO central-review, and 2 continue in the study treatment for 11 and 15 months, respectively. CONCLUSION SDT is an innovative and to-date well-tolerated strategy for children with DIPG post-initial radiotherapy. Sonications did not result in any adverse procedural effects. SONALA-001 exhibits rapid distribution and clearance, while PpIX PK align with metabolite formation. After dose escalation completion, dose-expansion at R2PD will offer insights into safety, PK, and efficacy.

Morbidity and neurodevelopmental outcomes at 2 years in preterm infants undergoing percutaneous transcatheter closure vs. surgical ligation of the PDA.

Review a cohort of preterm infants ≤29 weeks of gestation at birth and compare morbidities and neurodevelopmental outcomes based on PDA status and type of PDA closure. Single center observational retrospective-prospective case control study of premature infants who had no hsPDA, underwent surgical ligation or percutaneous transcatheter closure of the PDA. Neurodevelopmental testing was done using the Bayley Scales of Infant Development 3rd ed. The percutaneous transcatheter closure group had an older post menstrual age and greater weight at the time of procedure, and started enteral feeds and achieved room air status at an earlier post procedure day. Infants in the surgical ligation group were more likely to experience vocal cord paralysis. There was no difference in neurodevelopmental outcomes between groups. Waiting for infants to achieve the appropriate size for percutaneous transcatheter closure of the PDA may lead to reduced short-term complications without increasing the risk of neurodevelopmental impairment.

Medial and Lateral Burns With Concomitant Infection After Genicular Nerve Radiofrequency Ablation: A Case Report

BACKGROUND: Knee osteoarthritis management might include medication, intraarticular injections, physical therapy, and surgical intervention. Genicular nerve radiofrequency ablation (RFA) is an effective therapy for patients who do not receive benefit from conservative medical management and are not surgical candidates (secondary to medical comorbidity, patient preference, and other factors). Genicular nerve RFA is generally safe and has a low complication rate. However, there have been case reports of minor and major complications after RFA. We report a case of burns after genicular nerve RFA. CASE REPORT: A 49-year-old man (92 kg; body mass index [kg/m2] 28.3), with a history of coronary artery disease and chronic tobacco use, presented with 20 years of chronic knee pain. He previously had short-term relief with an intraarticular steroid knee injection. He was found to be a suitable candidate for genicular nerve RFA and underwent the procedure successfully without any immediate complications. His pain decreased from 9/10 before the procedure to 5/10 after his RFA. On postprocedure day 33, a 1 cm circular lesion with drainage was noted on the medial aspect of his knee. A lateral lesion was discovered at a subsequent follow-up appointment. He was treated with antibiotics, chlorhexidine cleansing, and dressing changes which resolved the lesions without any long-term sequelae. CONCLUSION: Our case represents an instance of full thickness skin burns with concomitant infection post genicular RFA, uniquely in both the medial and lateral sites. Our patient’s risk factors of low body mass index, smoking, and vascular disease may have led to a delayed healing response. In addition, needle depth may also have contributed to his injury. Ensuring adequate needle depth and patient selection can minimize these complications. KEY WORDS: Radiofrequency ablation, knee pain, osteoarthritis, chronic pain, genicular nerve, RFA, adverse event, complication

Original Article--Clinical and Procedural Characteristics of Successful Transcatheter Device Closure of Ostium Secundum Atrial Septal Defect in Symptomatic Children Weighing

This retrospective study sought to determine the feasibility of transcatheter atrial septal defect device closure in patients less than 15 kg, as well as to assess complication rates and the reasons for unsuccessful device closure. In general, the risks associated with transcatheter atrial septal defect device closure are believed and reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend atrial defect closure in device closure in children <15 kg, due to limited data available for feasibility and safety of device closure in this group of patients. Retrospective review of all patients who underwent elective transcatheter closure of ostium secundum atrial septal defect between September 2013 to February 2022. We excluded all children above 15 kg, as well as those with complex congenital heart defects. Major and minor complications were predefined and indications for referral were evaluated. We identified 81 patients meeting criteria with a median procedural age of 3 years (1 year-8 years), and median weight of 12 kg (4-15 kg). Successful device closure was achieved in 95.1% (77/81) and in 4.9% (4/81), the procedure was aborted. There was 1 major (1.2%) and 1 minor (1.2%) complication, total complication rate (2.4%). 100% of the referrals had right heart enlargement and exertional dyspnoea, 18.5% had recurrent lower respiratory tract infection and 9.9% had failure to thrive. Rate of resolution of residual shunt was 95.1%. at post-procedure day 1 and 98.8% at post-procedure 3 and 6 months respectively. Percutaneous atrial septal defect closure can be done effectively and safely in symptomatic children weighing less than 15 kg in experienced centres. However, deferral for closure until the historically established timeline of around 4-5 years of age should be strongly considered in asymptomatic children.

Therapeutic effectiveness of high-intensity focused ultrasound (HIFU) ablation in patients with unresectable hepatocellular carcinoma.

490 Background: High-intensity focused ultrasound (HIFU) ablation is a new therapeutic method for treatment of solid tumor. To determine the efficacy and safety of HIFU, we report our experience for local therapy of primary or metastatic hepatocellular carcinoma (HCC). Methods: From January 2015 to December 2022, forty- eight patients with unresectable HCC underwent single or two therapeutic sessions of HIFU under general anesthesia. Ten patients with liver metastasis from colon cancer and three patients with liver metastasis from stomach cancer were included. We used HIFU, ultrasound-guided extracorporeal system (HIFU Technology Company, Chongqing, China). Thirty-three patients received transarterial embolization before HIFU. Thirteen patients were treated with chemotherapy before HIFU. Technical effectiveness per patient and per masses was assessed according to clinical findings and MR imaging at follow-up. Complications were also recorded. Results: We treated total 78 tumors in 48 patients. The tumor size ranged from 1.3 cm to 12 cm in diameter. Small (&lt; 3 cm), intermediate (3-5 cm) and large tumors (&gt;5 cm) are 44, 24 and 10 patients, respectively. Average procedure time was 4 hours 10 minutes with 68 minutes treatment time. We made the artificial pleural effusion to get treatment field in 25 patients. Mean follow-up period was 52 weeks. For the technical effectiveness per patient as follows: complete ablation with no evidence of recurrence on follow up in 18%, apparent complete ablation of target mass with progression of new lesions on follow up in 29%, recurrence after apparent complete ablation in 26%, and incomplete ablation at 2 week follow up in 27%. Average post-procedure hospital day was 5.4 days. No severe complication except mild right upper quadrant pain was observed after treatment. Conclusions: HIFU is an effective and safe treatment option for local image-guided tumor ablation in patients with unresectable HCC. Although further study is necessary, these results show that HIFU may be helpful in treating unresectable HCC.

Thromboembolism prophylaxis practices of pediatric and congenital electrophysiologists during invasive electrophysiology studies: A PACES survey.

Thromboembolic events related to invasive electrophysiology studies, while rare, can have devastating consequences. Use of systemic anticoagulation for a pediatric or adult-congenital invasive electrophysiology study is recommended, however there is no established standard of practice in this population. To report on procedural practices for thromboembolism prophylaxis during invasive electrophysiology studies for pediatric patients and adults with congenital heart disease. An anonymous web-based survey was sent to the members of the Pediatric and Congenital Electrophysiology Society. The survey focused on pre-procedural, intra-procedural, and post-procedural thromboembolism prophylaxis practices during invasive electrophysiology studies. Significant practice variation was defined as <90% concordance among respondents. Survey was completed by 73 members; 52 (71%) practicing in the United States, 65 (89%) practicing in an academic institution, and 14 (19%) in an institution that performs more than 200 invasive electrophysiology procedures annually. Responses showed significant variation in practice. Prior to an invasive electrophysiology procedure, 25% discontinue aspirin while 47% discontinue anticoagulants. Heparin is given for all procedures by 32%. When heparin is administered, the first dose is given by 32% after sheaths are placed, 42% after crossing into the systemic atrium, and 26% just prior to systemic-side ablation. Most target an activated clotting time between 200-300 seconds. Post systemic-side ablation, 58% do not initiate a heparin infusion. Post-procedural oral agents were initiated on day of procedure by 34% of respondents and on post-procedure day 1 by 53%. If treating with aspirin, 74% use low-dose (3-5mg/kg or 81mg daily), and 68% treat for 4-6weeks. There is significant variation in thromboembolism prophylaxis for invasive EP studies among pediatric and congenital electrophysiologists. Further studies are needed to optimize the management of thromboembolism prophylaxis in this population.

Comparison of Outcomes of the Open and Plastibell Methods in 600+ Boys Circumcised by a Single Surgeon-A Quasi-experimental Study from Pakistan (A Lower-middle Income Country)

Background: Circumcision is the most common elective surgical procedure amongst Muslims. The Plastibell method is gaining popularity as it is being considered safer with a lower complication rate. Objective: To compare the Open and Plastibell methods of circumcision in terms of procedural time, outcomes, and parental satisfaction in our cohort of boys up to 5 years of age. Methods: This quasi-experimental study of boys aged ≤5 years was conducted from July 2018 to October 2020 at THQ Ferozewala, Punjab. Boys meeting the inclusion criteria were circumcised, based on parental preference, by the Open method or the Plastibell technique after administering age-appropriate local or general anesthesia. Follow-up was conducted on the 5th, 10th, and 30th post-procedural days. Basic demographic data, procedural duration, and outcomes were documented. Results: Of 646 boys brought for circumcision, 608 met the inclusion criteria with equal participants in both groups. The median age in the Open and Plastibell groups was 3.0 (IQR=1.0-12.2) and 5.0 (IQR=2.0-9.0) months respectively. The Plastibell group had a significantly shorter median operating time compared to the Open method (4.2 min vs. 13 min; p-value: 0.008). Complications were recorded in 15% of children (n=91) and were more frequent but comparatively trivial in nature in the Plastibell group. Comparison of complications between the two methods revealed that the association of over-removal of skin was statistically significant (p-value: 0.007) with the Open method while under-removal of skin (p-value: 0.002) and post-operative phimosis (p-value: 0.037) were significantly associated with the Plastibell technique; the latter two complications being significantly associated with age of the boys in the ≥2 months to 1-year group. No serious adverse outcomes were reported for both groups. The open method was preferred by parents for cosmesis and Plastibell for ease of care. Follow-up contact was established with all families. Conclusion: Plastibell, compared to the Open method, is a quicker and safer method of circumcision for boys up to 5 years of age, under appropriate anesthesia. Follow-up ensures patient safety.

A 5-Year Statewide Analysis of Unplanned Hospital Visits for EGD, Colonoscopy, Combined EGD/Colonoscopy, and ERCP

Conventional complication rates for gastrointestinal endoscopic procedures may underestimate the broader risk represented by postprocedure unplanned hospital visits (UHVs). We aimed to characterize UHVs for procedures in Maryland and the District of Columbia from 2014 to2018. Data for all esophagogastroduodenoscopies (EGDs), colonoscopies, combined EGDs/colonoscopies, and endoscopic retrograde cholangiopancreatographies (ERCPs) performed between 2014 and 2018 was provided by the Maryland Health Information Exchange (Chesapeake Regional Information System for our Patients'). Patient demographics, timing of UHV within 14 days postprocedure, distance traveled, facility site ("home" vs "away" institution), and International Classification of Diseases codes for the UHV were analyzed. Only UHVs potentially attributable to the endoscopic procedures were included. Among 304,786 endoscopic procedures and 3904 unplanned visits, the 14-day UHV rates were 1.7%, 0.6%, 1.3%, and 5.2% for EGD, colonoscopy, combined EGD/colonoscopy, and ERCP procedures respectively. From 2014 to 2018, the UHV rate on an annual basis remained stable for all procedure types except for ERCPs which increased. Patients who experienced UHVs were statistically different in sex, race, age, and distance traveled. UHVs most often occurred on postprocedure day 1; emergency department visits occurred most commonly. UHVs for all procedures, except ERCPs, were more likely to occur at a "home" institution. Overall, patients were more likely to be admitted postprocedure at an "away" institution. Postendoscopic procedure UHV rates were generally low. However, UHV rates for EGDs and colonoscopies were significantly higher than conventional complication rates. As 30%-60% of all unplanned visits occurred at an "away" institution, endoscopists should consider a broad approach to detecting postprocedure complications and not rely on a single institution for data capture.

Successful Retrieval of Rota Burr After Driveshaft Fracture

Rotational atherectomy is an effective procedure for heavily calcified lesions and those that cannot be crossed using conventional percutaneous coronary intervention (PCI) devices. Here, we report a rare case of intracoronary burr entrapment in the coronary artery due to burr disconnection from the driveshaft. A 67‐year‐old man undergoing hemodialysis for nephrosclerosis presented with exertional chest discomfort. Coronary angiography revealed stenotic lesions in the right coronary artery, and PCI was performed using a Rotawire Floppy. During the procedure, the disconnected burr was successfully removed without surgery using the child‐in‐mother technique with a guide extension catheter. Notably, the patient remained hemodynamically stable throughout the procedure and his recovery was uncomplicated. He was discharged on the second postprocedural day. At the 6‐month follow‐up, the patient remained asymptomatic with no evidence of myocardial ischemia. This report informs clinicians of the possibility of burr disconnection and the non‐surgical intervention used for its removal.

Early in-hospital discontinuation of aspirin on the first post-procedural day after percutaneous coronary stent implantation in patients on direct oral anticoagulation.

Previous trials investigating antithrombotic therapy with a direct oral anticoagulant (DOAC) and a P2Y12 inhibitor after percutaneous coronary intervention (PCI), termed dual therapy, allowed a short period of triple therapy including a DOAC, a P2Y12 inhibitor, and aspirin. This study aimed to determine whether discontinuation of aspirin on the first post-procedural day is safe or causes ischemic events. Ischemic and bleeding events during hospitalization were investigated retrospectively in all patients treated with dual therapy (DOAC + P2Y12 inhibitor, designated as group 1) or triple therapy (DOAC + P2Y12 inhibitor+aspirin, designated as group 2) from day 1 after PCI at our center. Of 4,564 consecutive PCI procedures, 1,059 (23.2%) had an indication for OAC. Of these, 322 met the inclusion criteria for group 1 and 62 for group 2. Baseline characteristics, CHA2DS2-VASc and HAS-BLED scores showed no relevant differences between the two groups, and the main indication for DOAC therapy was atrial fibrillation in both groups. Approximately ¼ of patients were treated for acute coronary syndrome. The mean length of post-procedural hospitalization was 2.1 ± 2.5 and 2.2 ± 3.0 days in group 1 and 2, respectively (p = 0.305). One patient per group suffered a TIA (p = 0.297). There were no other ischemic events and no statistically significant differences in bleeding events. A subgroup analysis of cases hospitalized for ≥2 post-procedural days (group 1: 100 cases, mean 4.4 ± 3.4 days vs. group 2: 25 cases, mean 4.0 ± 4.1 days) confirmed these results. The initiation of dual therapy and thus discontinuation of aspirin on the first postprocedural day appears to be safe with respect to short-term ischemic events in a real-world population. Almost ¼ of patients undergoing PCI have an indication for OAC, highlighting the relevance of this issue.

The significance of excessive supraventricular ectopic activity immediately after catheter ablation in the risk stratification for late recurrence of atrial fibrillation

Abstract Background/Introduction Early recurrence of atrial fibrillation (AF) (&amp;lt;3 months) after ablation is associated with late recurrence (≥3 months). Even absent early AF recurrence, patients frequently experience postprocedural supraventricular ectopic complexes (SVEC). Excessive supraventricular ectopic activity (ESVEA) is a new surrogate marker for new-onset AF and poor stroke prognosis. However, the relationship between ESVEA and late recurrence of AF post-ablation is poorly understood. Purpose We hypothesized that postprocedural ESVEA would be associated with late recurrence of AF. We also investigated use of ESVEA compared to early recurrence of AF for stratifying patients’ risk of late recurrence of AF. Methods Participants were patients with AF who underwent initial radiofrequency catheter ablation and 24-Holter monitoring the day after the procedure between 2014 and 2020. SVEC was defined as supraventricular complexes occurring ≥30% earlier than expected compared with the previous RR interval. ESVEA was defined as at least 30 beats of SVEC per hour, or any episodes of SVEC runs ≥20 beats. Atrial tachyarrhythmia lasting for longer than the 30s was defined as AF recurrence. We analyzed the association between postprocedural Holter monitoring results and late recurrence of AF. Results We enrolled 469 patients with AF (average ± SD 63.6 ± 10.1 years; 32% female; 56% paroxysmal AF). We observed early recurrence of AF (n = 57; 12%) and ESVEA (n = 287; 61%) during postprocedural Holter monitoring in these patients; 125 patients (27%) had no signs of AF or ESVEA. During a median follow-up of 25 months, 152 patients (32%) experienced a late recurrence of AF. Patients who demonstrated early AF recurrence or ESVEA during Holter monitoring were significantly more likely to experience late recurrence of AF, even after adjusting for various clinical parameters and left atrial enlargement. Patients with early recurrence of AF had the worst outcomes, and AF-free survival was significantly worse in patients with ESVEA than patients without early recurrence of AF (Figure). Conclusions ESVEA on post-procedure day 1, even without AF, was associated with worse clinical outcomes following initial AF ablation. Postprocedural 24-Holter monitoring may reveal an increased risk of late recurrence of AF secondary to observation of recurrent AF or ESVEA.

Improved first-pass effect in acute stroke thrombectomy using Solitaire-X compared to Solitaire-FR.

In acute ischemic stroke (AIS), successful endovascular thrombectomy (EVT) of large vessel occlusion (LVO) necessitates the most suited device. Solitaire-X has longer and larger diameter pusher wires than Solitaire-FR.As the role of a larger pusher-wire diameter is uncertain, we aim to compare procedural, clinical, and radiological outcomes for AIS patients undergoing EVT using either type of Solitaire device. Procedures were performed using the Solumbra technique, which combines a large-bore aspiration catheter with a stentriever. The primary outcome was to compare rates of successful first-pass recanalization (defined as TICI 2b/3 score). The secondary objectives were procedural (rates of successful recanalization), clinical (post-procedural NIHSS and days of hospitalization), and radiological (post-procedural ASPECT score and hemorrhagic transformation) outcome measures. Consecutive AIS patients undergoing EVT for LVO were recruited into a prospective multicenter database at our academic center. We have used Solitaire-FR until October 2020 and Solitaire-X ever since. We retrospectively analyzed our prospective consecutive registry. Included in our analysis are patients undergoing EVT using Solitaire only; patients with tandem lesions or underlying stenosis requiring emergent stenting during the procedure were excluded. The cohort of patients treated with Solitaire-X was compared with a cohort consisting of the most recent consecutive cases undergoing EVT with the Solitaire-FR. A total of 182 (71.9 ± 14, 61% male patients) AIS patients were included in the analysis with both groups (n = 91 each) sharing similar demographic characteristics, premorbid conditions, and stroke characteristics (time from symptom-onset, NIHSS, ASPECTS, occlusion site, and rates of intravenous-tPA treatment). The Solitaire-X group had a higher rate of first-pass recanalization (65.9% vs. 50.5%, p = 0.049). On 24-h post-procedural head-CT, the Solitaire-X group had higher ASPECT scores (6.51 ± 2.9 vs. 5.49 ± 3.4, p = 0.042) and lower post-procedural average bleeding volumes (0.67 ± 2.1 vs. 1.20 ± 3.4 mL, p = 0.041). The Solitaire-X group had shorter duration of hospitalization (16.6 ± 13.1 days vs. 25.1 ± 23.2, p = 0.033). On multivariate analysis, using Solitaire-X was the sole independent predictor of first-pass recanalization (OR 2.17, 95% CI 1.12-4.26, p = 0.023). In our study, the use of the Stentriever-X with a larger pusher-wire diameter was associated with a higher likelihood of first-pass effect and improved procedural, clinical, and radiological outcomes in AIS patients.

A phase IB/IIA study of ex vivo expanded allogeneic bone marrow–derived mesenchymal stem cells for the treatment of rectovaginal fistulizing Crohn’s disease

BackgroundCrohn-related rectovaginal fistulas are notoriously difficult to treat. Studies of mesenchymal stem cells for the treatment of perianal Crohn fistulizing disease have largely excluded rectovaginal fistulas. The aim of this study was to determine the safety and efficacy of mesenchymal stem cells for refractory rectovaginal fistulizing Crohn disease. MethodsA phase IB/IIA randomized control trial was performed in a 3:1, single-blinded study. Patients included were adult women with an anovaginal/rectovaginal fistula in the setting of Crohn disease. Seventy-five million mesenchymal stem cells were administered with a 22G needle after curettage and primary closure of the fistula tract at day 0 and month 3. Adverse and serious adverse events were recorded at post-procedure day 1, week 2, week 6, month 3, month 6, and month 12, along with clinical healing, magnetic resonance imaging, and patient-reported outcomes. ResultsA total of 19 patients were enrolled and treated—15 treatment and 4 control. There were no adverse or serious adverse events related to mesenchymal stem cell therapy. At 6 months, 50% of the treatment group and 0% of the control had complete clinical and radiographic healing; 91.7% of the treatment group had improvement at 6 months with only one patient having a lack of response, whereas only 50% of the control group had improvement at 6 months. ConclusionBone marrow-derived mesenchymal stem cells offer a safe alternative treatment approach for rectovaginal fistulas in the setting of Crohn disease. Complete healing was achieved in half of the patients.

Intravascular Ultrasound Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation Reduces Laboratory Markers of Acute Liver Injury

PurposeTo compare the laboratory markers of acute liver injury after transjugular intrahepatic portosystemic shunt (TIPS) creation performed using intravascular ultrasound (IVUS) guidance with those using other techniques. Materials and MethodsThis single-center, retrospective study examined 293 TIPS procedures performed between 2014 and 2022 (160 men; mean age, 57.4 years; 71.7% with ascites, 158 with IVUS). Laboratory changes on postprocedural day (PPD) 1 were classified based on Common Terminology Criteria for Adverse Events (CTCAE) grades and were compared between IVUS and non-IVUS cases. ResultsIVUS cases had a lower baseline Model for End-Stage Liver Disease (MELD) score (12.5 vs 13.7, P = .016), higher pre- (16.8 vs 15.2, P = .009), and post-TIPS (6.6 vs 5.4 mm Hg, P < .001) pressure gradient, smaller stent diameter (9.2 vs 9.9 mm, P < .001), and fewer needle passes (2.4 vs 4.2, P < .001). IVUS predicted a lower PPD 1 CTCAE grade for aspartate transaminase (8.0% vs 22.2% grade ≥ 2, P = .010), alanine transaminase (ALT) (2.2% vs 7.1%, P = .017), and bilirubin (9.4% vs 26.2%, P < .001), findings confirmed using multivariable regression and propensity score analysis. IVUS predicted fewer adverse events (1.3% vs 8.1%, P = .008) and an increased likelihood of PPD 1 discharge (81% vs 59%, P = .004). IVUS was not associated with differences in PPD 30 MELD scores or 30-day survival; however, higher PPD 1 ALT (β = 1.96, P = .008) and bilirubin levels (β = 1.38, P = .004) predicted larger PPD 30 MELD score increase. Higher increases in ALT level predicted worse 30-day survival (hazard ratio, 1.93; P = .021). ConclusionIVUS resulted in less laboratory evidence of acute liver injury immediately following TIPS creation.

Immunologic profiles in patients with chronic limb-threatening ischemia undergoing endovascular revascularization.

Inflammation and immune dysregulation have been associated with adverse outcomes in cardiovascular disease. There is limited understanding of the association of different profiles of white blood cell (WBC) subsets and red cell distribution width (RDW) in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI undergoing endovascular revascularization in our single-center, tertiary care hospital from 2017 to 2019, who had a preceding complete blood count (CBC) with WBC differentials (n =213), were included in the analysis. Patient characteristics, laboratory values, and clinical outcomes were collected. Cox proportional hazards regression models were used to assess for associations between all-cause mortality and leukocyte subset; multivariate analysis was used to account for confounders. Kaplan-Meier curves were generated to depict survival censored at 1 year postrevascularization using baseline CBC indices. Adjusting for confounders, elevated RDW was associated with increased mortality (continuous per % increase, adjusted hazard ratio [HR] 1.33, p < 0.001). Baseline lymphopenia was associated with mortality in univariate analysis. Other leukocyte subtypes were not associated with mortality outcomes in our population. Exploratory analysis showed negative deflections in ∆WBC from pre- to postprocedure day 1 were affiliated with increased mortality when adjusted for age, sex, race, chronic kidney disease, and baseline hemoglobin (∆WBC HR 1.16, p = 0.004). Further exploratory analysis showed an association between RDW and all-comers readmission. The utilization of a periprocedural WBC subset differential can be a useful adjunct to risk-stratify patients with CLTI undergoing endovascular revascularization. Further studies are needed to understand potential ways to modulate immune dysregulation so as to improve mortality outcomes.