Procedure-related Events Research Articles

Glycopyrrolate Premedication and Procedure-Related Events in Pediatric Upper Endoscopy.

Glycopyrrolate premedication is used for pediatric upper endoscopy procedures, with limited clinical evidence for efficacy. We investigated whether glycopyrrolate use is associated with lower incidence of procedure-related events and serious adverse events (SAEs) using the Pediatric Sedation Research Consortium registry. Pediatric upper endoscopy procedures performed between April 27, 2020 and February 3, 2022 were included (N = 1046). The primary outcome was the incidence of any procedure-related events during induction, maintenance, or recovery, and the secondary outcome was incidence of SAEs. The event rate was 15%, including 30 SAEs (3%). On multivariable analysis, glycopyrrolate was not associated with the overall event rate (odds ratio [OR]: 1.08; 95% confidence interval [CI]: 0.72, 1.61), but was associated with lower odds of SAEs (OR: 0.34; 95% CI: 0.13, 0.91). Although glycopyrrolate was associated with lower odds of SAEs after accounting for patient and procedure characteristics, validation through prospective trials is needed to support its routine use in clinical practice.

Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.

Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in both the presence and absence of medication. This is the first sham-controlled trial investigating the safety and efficacy of RDN in China. This prospective, multicenter, randomized, patient- and outcome-assessor-blinded, sham-controlled trial investigated radiofrequency RDN in patients with hypertension on standardized triple antihypertensive therapy. Eligible patients were randomized 1:1 to undergo RDN using a multi-electrode radiofrequency catheter (Iberis; AngioCare, Shanghai, China) or a sham procedure. The primary efficacy outcome was the between-group difference in baseline-adjusted change in mean 24-hour ambulatory systolic BP from randomization to 6 months. Of 217 randomized patients (mean age, 45.3±10.2 years; 21% female), 107 were randomized to RDN and 110 were randomized to sham control. At 6 months, there was a greater reduction in 24-hour systolic BP in the RDN (-13.0±12.1 mm Hg) compared with the sham control group (-3.0±13.0 mm Hg; baseline-adjusted between-group difference, -9.4 mm Hg [95% CI, -12.8 to -5.9]; P<0.001). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mm Hg ([95% CI, -7.5 to -2.4]; P<0.001) 6 months after RDN, and office systolic and diastolic BP was lowered by -6.4 mm Hg ([95% CI, -10.5 to -2.3]; P=0.003) and -5.1 mm Hg ([95% CI, -8.2 to -2.0]; P=0.001), respectively. One patient in the RDN group experienced an access site complication (hematoma), which resolved without sequelae. No other major device- or procedure-related safety events occurred through follow-up. In this trial of Chinese patients with uncontrolled hypertension on a standardized triple pharmacotherapy, RDN was safe and reduced ambulatory and office BP at 6 months compared with sham. URL: https://clinicaltrials.gov; Unique identifier: NCT02901704.

Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry.

PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

Carotid artery stenting in unfavorable vascular anatomy: Effect of embolic protection filter use on periprocedural complications

ObjectiveTo investigate the effect of embolic protection device (EPD) use on periprocedural complications in patients with carotid artery stenosis with anatomical variations. MethodThe study retrospectively evaluated 185 patients who consecutively underwent carotid artery stenting between November 2020 and December 2023. Forty-four patients with difficult anatomical structures, anatomical variations in the common carotid artery (CCA) and internal carotid artery (ICA) (tortuosity, kinking, or coiling), and a CCA-ICA angle of >60 degrees were included in the sample. The patients were divided into two groups according to the use of EPD filters during the procedure and compared in terms of periprocedural events. ResultsOf the 44 patients included in the study, 24 (54.5 %) were male, and the mean age of all patients was 68.7 ± 8.7 years. Comorbidities were present in 93.2 % (n = 41) of the patients. The most common comorbidity was hypertension (n = 32, 72.8 %). The CCA-ICA angle was ≥60 degrees in 45.4 % (n = 20) of all patients. ICA tortuosity was detected in 27.2 % (n = 12) of the patients, ICA kinking in 13.6 % (n = 6), ICA coiling in 6.8 % (n = 3), and CCA tortuosity in 6.8 % (n = 3). Procedure-related periprocedural events developed in 38.6 % (n = 17) of the patients. Postprocedural mortality occurred in two patients, secondary to myocardial infarction in one and COVID-19 pneumonia in the other. There was no significant difference between the filter and non-filter groups in relation to periprocedural events (p = 0.638). Major stroke did not occur in either group. Minor neurological events occurred in 15 % (n = 3/20) of the patients in the filter group and 16.7 % (n = 4/24) of those in the non-filter group. The incidence of vasospasm was statistically higher in patients using filters compared to those without filters (30 % vs. 0 %; P = 0.005, respectively). ConclusionEvaluation of vascular anatomy before carotid artery stenting is important to decide on the technical procedure to be applied in the procedure. The use of EPD in unfavorable anatomy does not reduce periprocedural neurological events. Instead, it results in technical difficulties, prolongs the duration of procedure, and leads to arterial vasospasm. Considering the high periprocedural events in this study, carotid endarterectomy may be a better alternative to endovascular treatment in patients with unfavorable carotid artery anatomy.

Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate/High-Risk Pulmonary Embolism: Design of the Multicenter USAT IH-PE Registry and Preliminary Results.

Catheter-based revascularization procedures were developed as an alternative to systemic thrombolysis for patients with intermediate-high- and high-risk pulmonary embolisms. USAT IH-PE is a retrospective and prospective multicenter registry of such patients treated with ultrasound-facilitated, catheter-directed thrombolysis, whose preliminary results are presented in this study. The primary endpoint was the incidence of pulmonary hypertension (PH) at follow-up. Secondary endpoints were short- and mid-term changes in the echocardiographic parameters of right ventricle (RV) function, in-hospital and all-cause mortality, and procedure-related bleeding events. Between March 2018 and July 2023, 102 patients were included. The majority were at intermediate-high-risk PE (86%), were mostly female (57%), and had a mean age of 63.7 ± 14.5 years, and 28.4% had active cancer. Echocardiographic follow-up was available for 70 patients, and in only one, the diagnosis of PH was confirmed by right heart catheterization, resulting in an incidence of 1.43% (CI 95%, 0.036-7.7). RV echocardiographic parameters improved both at 24 h and at follow-up. In-hospital mortality was 3.9% (CI 95%, 1.08-9.74), while all-cause mortality was 11% (CI 95%, 5.4-19.2). Only 12% had bleeding complications, of whom 4.9% were BARC ≥ 3. Preliminary results from the USAT IH-PE registry showed a low incidence of PH, improvement in RV function, and a safe profile.

Safety and risk factors for bleeding complications of radial probe endobronchial ultrasound-guided transbronchial biopsy.

Radial probe endobronchial ultrasound (radial EBUS) is widely used to diagnose pulmonary lesions; however, the diagnostic value of radial EBUS-guided transbronchial biopsy (TBB) varies, and its complications (especially the risk of bleeding) are not properly understood. In this study, we evaluated the diagnostic performance and rate of complication of this procedure, and investigated the risk factors associated with the procedure-related bleeding events. A retrospective cohort study. This was a retrospective study that included consecutive patients who underwent radial EBUS-guided TBB. Radial EBUS was performed under moderate sedation in inpatients or outpatients. The severity of bleeding was graded using the standardized definitions of bleeding. Of 133 patients (median age, 69 years; men 57.1%) included, 41 were outpatients (30.8%). The diagnostic accuracy, sensitivity, and specificity for malignancy were 76.1% (89/117), 71.1% (69/97), and 100% (20/20), respectively. The diagnostic accuracy ranged from 66.9% to 79.0%, depending on the classification of undiagnosed cases as either false negatives or true negatives. Twenty-seven patients (20.3%) developed complications (pneumothorax, 3; pneumonia, 5; complicated pleural effusion, 2; bleeding event grade 2 or higher, 21). Of the 41 outpatients, two developed complications (pneumothorax without intervention, 1; grade 2 bleeding event, 1). Of the 21 patients (15.8%) with procedure-related bleeding events, 18 had grade 2, and three had grade 3 bleeding complications. In multivariate analysis, a large size of ⩾30 mm (adjusted odds ratio (OR), 5.09; p = 0.03) and central lesion (adjusted OR, 3.67; p = 0.03) were significantly associated with the risk of grade 2 or higher bleeding events. Our results suggest that radial EBUS-guided TBB is an accurate and safe method for diagnosing pulmonary lesions. Clinically significant procedure-related bleeding was rare. The central location and larger size (⩾30 mm) of pulmonary lesions were risk factors for grade 2 or higher bleeding events.

Pulmonary vein isolation versus PVI + adjunctive strategy (substrate modification and renal denervation therapy) for the reduction of 12-month AF recurrence

Abstract Background of the Study This meta-analysis assessed the latest evidence on the use of adjunct ablation strategies to standard pulmonary vein isolation (PVI) for treating atrial fibrillation (AF). Adjunct treatments were further classified as substrate modification (posterior wall isolation, linear ablation and ablation of complex fractionated atrial electrograms) or renal denervation (RDN). Purpose While ablation maintains sinus rhythm more effectively than antiarrhythmic drug therapy, recurrent AF remains common after 12 months, occurring in up to 40-60% of patients undergoing standard PVI ablation. Treatment strategies have diversified in a response to these challenges. These include reduction of the arrhythmogenic substrate, modulation of autonomic inputs and improvement of risk factors, such as hypertension. Methods A systematic literature search from MEDLINE and PubMed electronic databases was performed until November 2022. The primary outcome was 12-month AF recurrence defined as AF lasting ≥30 seconds on follow-up. The secondary outcome was incidence of procedure-related major adverse events (MAEs), defined as death, clinical strokes, acute heart failure decompensation, pericardial effusion causing tamponade, arteriovenous fistulas, and atrioesophageal fistulas. Results Nine studies comprising 1686 patients were included in the final analysis. AF recurrence was 487/1082 (45%) in the PVI + Adjunct group and 204/604 (33.8%) in PVI Alone. Pooled analysis showed that PVI + adjunct was inconclusively associated with less incidence of 12-month AF recurrence (RR 0.79, 95% CI 0.60–1.04, I2 = 70%, p-value 0.09). Subgroup analyses of six RCTs under the PVI with substrate modification arm showed non-significant increase in 12-month AF recurrence in PVI + substrate modification (RR 0.85, 95% CI 0.6-1.21, p-value 0.38). Subgroup analyses of the 3 RCTs on hypertensive AF patients showed strong evidence of decreased 12-month AF recurrence in PVI + RDN compared to PVI alone (RR 0.65, 95% CI 0.48-0.89, p-value 0.007). Secondary outcome of major adverse procedure-related events in overall pooled analysis showed 8 events in 604 patients undergoing PVI alone, and 23 events in 1082 patients undergoing PVI + adjunct ablation. There is no significant difference in the number of reported MAE in PVI alone over PVI + adjunct (RR 1.16 [0.49-2.75], p = 0.73). Conclusion Overall, PVI with adjunctive strategies did not significantly reduce 12-month AF recurrence after ablation. Among these strategies, RDN demonstrated a significant reduction in the primary endpoint, whereas substrate modification did not. There was no significant difference in MAEs reported between standard therapy versus those with adjunctive treatment. We conclude that PVI ablation strategies should be individualized, and modification of both triggers and risk factors for AF show better rhythm control on follow-up.

Individualized Periprocedural and Intraprocedural Management for Coil Embolization of Unruptured Cerebral Aneurysm in a Patient with Severe Thrombocytopenia due to Liver Cirrhosis

A female patient in her early 60's with advanced liver cirrhosis and thrombocytopenia having a platelet count under 30,000/µL, visited an outpatient clinic. Computed tomography angiography revealed an unruptured aneurysm on the left middle cerebral artery bifurcation with 6.0 mm of maximal diameter. Endovascular coiling was planned, considering the patient's medical condition. Eight pints of platelet concentrate were transfused 6 hours before the procedure, and a platelet count of 57,000/ µL was achieved 3 hours before the procedure. No antiplatelet premedication and intraprocedural heparin was administered. A bail-out use of intra- or postoperative Tirofiban (Aggrastat®) was prepared for inadvertent thromboembolic events. The aneurysm was successfully occluded with no procedure-related event. The patient’s hospital course was uneventful, and she was discharged without complications. Despite the potential hemorrhagic risk caused by hemostatic failure in patients with cirrhosis, successful endovascular coiling can be performed with highly individualized management.

A single-center experience of type B aortic intramural hematoma

ObjectiveThe outcomes of the best medical treatment (BMT) and intervention treatment (INT) in a single-center experience were reported in type B intramural hematoma (IMH). MethodsFrom February 2015 to February 2021, a total of 195 consecutive patients with type B IMH were enrolled in the study. The primary end point was mortality, and the secondary end points included clinical and imaging outcomes. The clinical outcomes were aortic-related death, retrograde type A aortic dissection, stent graft-induced new entry tear, endoleak, and reintervention. The imaging outcome was evaluated through the latest follow-up computed tomography angiography, which included aortic rupture, aortic dissection, aortic aneurysm, rapid growth of aortic diameter, newly developed or enlarged penetrating aortic ulcer or ulcer-like projection (ULP) and increased aortic wall thickness. Kaplan-Meier curves were used to assess the association between different treatments. ResultsAmong the enrolled patients, 115 received BMT, and 80 received INT. There was no significant difference in early (1.7% vs 2.5%; P = 1.00) and midterm all-cause death (8.3% vs 5.2%; P = .42) between the BMT and INT groups. However, patients who underwent INT were at risk of procedure-related complications such as stent graft-induced new entry tear and endoleaks. The INT group was associated with a profound decrease in the risk of ULP, including newly developed ULP (4.3% vs 26.9%; P < .05), ULP enlargement (6.4% vs 31.3%; P < .05), and a lower proportion of high-risk ULP (10.9% vs 45.6%; P < .05). Although there was no significant difference in the incidence of IMH regression between the two groups, the maximum diameter of the descending aorta in patients receiving INT was larger compared with those treated with BMT. ConclusionsBased on our limited experience, patients with type B IMH treated with BMT or INT shared similar midterm clinical outcome. Patients who underwent INT may have a decreased risk of ULPs, but a higher risk of procedure-related events and patients on BMT should be closely monitored for ULP progression.

Comparison of treatment outcomes and complications of coil embolization in elderly and very elderly patients with cerebral aneurysms: a propensity score matching analysis.

This single center study aims to compare the treatment outcomes and procedure-related complications of coil embolization in elderly patients (60-79 years) and very elderly patients (aged 80 years or older) with cerebral aneurysms. Data was collected from 504 elderly patients aged 60 years or older who underwent coil embolization for intracranial aneurysms from 2018 to 2021. The study evaluated patient-related and anatomical factors and assessed various outcomes, comparing results between groups using statistical analysis and propensity score matching. A total of 503 cerebral aneurysms were analyzed from individuals aged 60-79 years (n = 472) and those aged 80 years or older (n = 31). The majority of the aneurysms were unruptured with an average size of 3.5 mm in height and 3.4 mm in width. The patients were compared using 1:1 propensity score matching, and no significant differences were found in factors other than age and aortic elongation. Logistic analysis revealed that being over 80 years old and having a severe aortic arch elongation were identified as risk factors for procedure-related events in both total and unruptured cases. The study compared coil embolization treatment for cerebral aneurysms in patients aged 60-79 and over 80, finding no significant difference in treatment outcomes except for procedure-related events. Procedure-related events were associated with severe aortic arch elongation and being over 80 years old. Coil embolization can be considered safe and effective for patients over 80, but further trials are needed for accurate conclusions.

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial

ObjectiveSpinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery. Methods and MaterialsPatients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis—yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function. ResultsIntention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a <one-point change in the CMM arm. Three serious and 14 non–serious device- or procedure-related events were reported. ConclusionsThis study found substantial improvement at six months in back pain, back pain-related disability, pain-related emotional suffering, PGIC, pain interference, and physical function in a population with severe, debilitating back pain for more than a decade. These improvements were reported in conjunction with reduced opioid use, injection, and ablation therapy. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT04479787.

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams

ObjectiveThis study describes 3-year follow-up of 200 infants weighing ≥ 700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder.Study DesignBetween June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study.ResultsThe implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and tricuspid regurgitation (5), for which no interventions were required.ConclusionsThis follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants. ClinicalTrials.gov identifier: NCT0305585.

Snaring Self-Expanding Devices to Facilitate Transcatheter Aortic Valve Replacement in Patients with Complex Aortic Anatomies.

The snare-assisted technique has been described to facilitate transcatheter aortic valve replacement (TAVR) delivery system advancement in complex aortic anatomies. However, the evidence is limited to case reports. To evaluate the safety profile of the snare-facilitated approach and its impact on self-expanding (SE) TAVR outcomes, we collected consecutive patients who underwent transfemoral SE-TAVR for aortic stenosis, using propensity score matching (PSM) separately in tricuspid and type-0 and type-1 bicuspid aortic valve morphology between the snare and non-snare groups. In 766 patients, despite the snare group having significantly larger annulus angulation and maximal ascending aortic diameter, both groups achieved comparable 30-day device success rates, regardless of first-generation or new-generation valve use. After PSM, the snare group had a significantly lower new permanent pacemaker implantation rate among 193 type-0 patients (3.3% vs. 18.3%, p = 0.01). The ipsilateral group used new-generation valves less frequently (23.0% vs. 75.4%, p < 0.001), but there were no significant inter-group differences in procedure-related events, except for a lower incidence of PVL ≥ mild in the ipsilateral group (14.9% vs. 32.3%, p = 0.01). In conclusion, the snare-assisted technique appears useful in SE-TAVR with angulated aortic root anatomy, and the benefits were comparable between ipsilateral and contralateral snare techniques.

Benefits and harms of gastric suction or lavage at birth for gastrointestinal outcomes: A systematic review and meta-analysis.

The benefits of routine gastric suctioning or lavage in neonates remain uncertain, despite the common practice worldwide. To investigate the potential advantages and harms, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) examining the effects of these procedures in healthy or meconium-stained neonates at birth. We systematically searched PubMed, Scopus, Embase, Ovid, and the Cochrane Library databases from inception to February 9, 2023. We included only RCTs assessing the outcomes of gastric suction or lavage in neonates at birth. We calculated risk ratio (RR) and weighted mean differences with 95% confidence intervals (CIs) using a random-effects model. The primary outcomes were gastrointestinal symptoms including vomiting, retching, feeding intolerance, and secondary aspiration. The secondary outcomes included time to initiation of breastfeeding and potential adverse procedure-related events. Twelve RCTs with a total of 4,122 neonates were analyzed. All the studies compared neonates who received gastric suction or lavage with those who received usual care. Gastrointestinal symptoms were significantly reduced in neonates receiving gastric suction or gastric lavage compared with the control group (RR, 0.75; 95% CI, 0.63-0.89). Gastric lavage was beneficial for infants with meconium-stained amniotic fluid (RR 0.71; 95% CI, 0.60-0.84), while gastric suction had no significant benefit in reducing gastrointestinal symptoms in infants without meconium-stained amniotic fluid (RR 0.91; 95% CI, 0.61-1.37). Our findings suggest that gastric suction or lavage may reduce gastrointestinal symptoms in neonates; however, these procedures may only benefit infants born with meconium-stained amniotic fluid. Vigorous newborns without meconium-stained amniotic fluid may not benefit from these procedures. Furthermore, gastric suction may lead to adverse outcomes such as apnea and bradycardia. Registration: This study was registered in the PROSPERO International prospective register of systematic reviews in health and social care (CRD42023247780).

Safety and feasibility of oesophageal ultrasound for the work-up of thoracic malignancy in patients with respiratory impairment.

Biopsying lung tumours with endobronchial access in patients with respiratory impairment is challenging. However, fine needle aspiration with the endobronchial ultrasound-endoscope via the oesophagus (EUS-B-FNA) makes it possible to obtain tissue samples without entering the airways. Safety of EUS-B-FNA in these patients has not earlier been investigated prospectively. Therefore, this study aimed at assessing feasibility and safety of EUS-B-FNA from centrally located tumours suspected of thoracic malignancy in patients with respiratory insufficiency. The study is a prospective observational study. Patients with indication of EUS-B-FNA of centrally located tumours and respiratory impairment defined as modified Medical Research Council (mMRC) dyspnoea scale score of ≥3, saturation ≤90% or need of continuous oxygen supply were included prospectively in three centres. Any adverse events (AEs) were recorded during procedure and 1-hour recovery. AEs were defined as hypoxemia (saturation <90% or need for increased oxygen supply) or any kind of events needing intervention. Late procedure-related events were recorded during 30-day follow-up. Between April 1, 2020 and January 30, 2021, 16 patients were included. No severe AEs (SAEs) occurred, but AEs were seen in 50% (n=8) and 13% (n=2) of the patients during procedure and recovery respectively. AEs included hypoxemia corrected with increased oxygen supply and in two cases reversal of sedation. Late procedure-related events were seen in 13% (n=2) and included prolonged need of oxygen and one infection treated with oral antibiotics. In this cohort, EUS-B-FNA of centrally located tumours was safe and feasible in patients with respiratory impairment, when examined in the bronchoscopy suite. A variety of mostly mild and manageable complications may occur, a few even up to 30 days post-procedure.

New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice: results from the international prospective observational SMART Registry.

Insertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx™, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications. The SMART Registry is an international prospective observational study. The main endpoints were ICM safety (incidence of serious adverse device and procedure-related events (SADEs) at 1 month), ICM clinical value (incidence of device-detected true arrhythmias and of clinical diagnoses and interventions), and patient-reported experience measurements (PREMs). A total of 1400 subjects were enrolled. ICM indications included syncope (49.1%), AF (18.8%), unexplained palpitations (13.6%), risk of ventricular arrhythmia (6.6%), and cryptogenic stroke (6.0%). Freedom from SADEs at 1 month was 99.4% (95% Confidence Interval: 98.8-99.7%). In the 6-month monitoring period, the ICM detected true cardiac arrhythmias in 45.7% of patients and led to clinical interventions in a relevant proportion of patients; in particular, a pacemaker implant was performed after bradycardia detection in 8.9% of subjects who received an ICM for syncope and oral anticoagulation therapy was indicated after AF detection in 15.7% of subjects with cryptogenic stroke. PREMs showed that 78.2% of subjects were satisfied with the remote monitoring patient app. The evaluated ICM is associated with an excellent safety profile and high diagnostic yield. Patients reported positive experiences associated with the use of their smartphone for the device remote monitoring.

Evaluation of long-term performance of an intraperitoneal biomaterial in the treatment of ventral hernias

BackgroundOne-year device safety and clinical outcomes of ventral hernia repair with the GORE® SYNECOR Intraperitoneal Biomaterial, a hybrid composite mesh was evaluated.MethodsThis retrospective, multicenter, case review analyzed device/procedure endpoints and patient-reported outcomes in patients treated for hernia repair ≥ 1 year from study enrollment.ResultsIncluded were 459 patients (with 469 ventral hernias) with a mean age of 58 ± 15 years; 77.1% met Ventral Hernia Working Group 2 (VHWG2) classification. Mean hernia size was 18.9 cm2 and 57.3% of hernias were incisional. Laparoscopic or robotic approach was utilized in 95.4% of patients. Mesh location was intraperitoneal for 75.6% and bridging repair was performed in 57.3%. Procedure-related adverse events within 30-days occurred in 5.0% of patients and included surgical site infection (SSI), surgical site occurrence (SSO), ileus, readmission, and re-operation. Procedure-related SSI or SSO events were 3.8% through 12 months. SSO events requiring procedural intervention (SSOPI) were 2.6% through 24 months. Four patients (0.9%) had confirmed hernia recurrence through the study (the mean follow-up was 32-months, range 14–53 months). Subgroup comparisons were conducted for all type recurrence; only diabetes was found to be statistically significant (p = .0506).ConclusionIn this analysis, ventral hernia repair with hybrid, composite mesh results in successful outcomes in most patients. This study represents a heterogeneous patient population undergoing repair using various approaches, mesh fixation, and mesh placement locations. These data appear to confirm long-term acceptable safety and device performance with a low rate of recurrence in a predominantly VHWG2 population.

Impact of previous lumbar spine surgery on the outcome of lumbar total disc replacement: analysis of prospective 5-year follow-up study data.

It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery. Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration. Clinical outcome measures included the Oswestry Disability Index (ODI), visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events, and re-operations. Radiographic outcomes included flexion/extension range of motion (ROM) and translation of the operated segment. Patients were divided into two groups: Prior Lumbar Surgery (PLS, n = 92) and No Prior Lumbar Surgery (NPLS, n = 284). Baseline demographics were similar in the two groups. ODI, VAS, and SF-36 Physical Component Scale scores improved significantly (p < 0.05) from baseline in both groups with improvements maintained through 5-year post-TDR with no significant differences between groups. There were no statistically significant differences in rates of serious device-related events, procedure-related events, or re-operations. While ROM was significantly less prior to TDR surgery in the PLS group, there was no significant difference in ROM at post-operative points. Prior lumbar spine surgery was not associated with compromised outcomes following TDR. These results are in line with reports from earlier studies with shorter follow-up, finding that non-destabilizing prior surgery is not a contra-indication for TDR provided that selection criteria are met. Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Abstract 13443: Clinical Outcomes Following Primary Prevention Implantable Cardioverter Defibrillator (ICD) Implantation Among Older Patients With Hypertrophic Cardiomyopathy (HCM)

Introduction: The clinical benefit of primary prevention ICDs among older patients (age &gt; 65) with HCM is unclear. This analysis examined procedural complications and post-discharge outcomes among older patients with HCM following initial placement of a primary prevention ICD. Methods: The NCDR ICD Registry was queried to identify patients with HCM who received a primary prevention ICD between 2010-2016. Procedure-related adverse event rates were examined. Direct identifiers were used to link patients &gt; 65 years to CMS claims data. Cox proportional hazard models were used to assess clinical factors associated with post-discharge mortality and hospitalization for cardiac arrest/ventricular arrhythmia (VA). Kaplan Meier curves were generated to depict 5-year outcomes. Results: Of 5571 patients with HCM who were included, 1511 (27.1%) were &gt; 65 years old. Compared with patients &lt; 65 years of age, older patients with HCM were more likely to experience a procedure-related event (2.3% vs 1.5%, p=0.038) and procedure-related death (0.3% vs 0.1%, p=0.024). The variables most strongly associated with post-discharge mortality were older age (aHR 1.8, 95% CI 1.47-2.21), NYHA class (III/IV vs I/II aHR 2.17, 95% CI 1.57-2.98), and LVEF (LVEF &lt; 35% vs &gt;50% aHR 2.34, 95% CI 1.58-3.48; LVEF 36-50% vs &gt;50% aHR 2.98, 95% CI 2.02-4.4). For the endpoint of hospitalization for cardiac arrest/VA, history of NSVT at the time of device implantation (aHR 2.38, 95% CI 1.62-3.51) and NYHA class (NYHA class III/IV vs I/II aHR 1.84, 95% CI 1.22-2.78) were the strongest predictors. The event-free survival rates are shown ( Figure). Conclusions: Procedure-related complication and mortality rates were low, but they occurred more frequently among older patients. Further prospective investigation should focus on whether clinical factors, such as NYHA class and history of NSVT, may be useful in identifying older patients with HCM who are most likely to benefit from a primary prevention ICD.

Imaging intensive care patients: multidisciplinary conferences as a quality improvement initiative to reduce medical error

BackgroundStrategies to identify imaging-related error and minimise its consequences are important in the management of critically ill patients. A new quality management (QM) initiative for radiological examinations has been implemented in an intensive care unit (ICU) setting. In regular multidisciplinary conferences (MDCs), radiologists and ICU physicians re-evaluate recent examinations. Structured bilateral feedback is provided to identify errors early. This study aims at investigating its impact on the occurrence of QM events (imaging-related errors). Standardised protocols of all MDCs from 1st of June 2018 through 31st of December 2019 were analysed with regard to categories of QM events (i.e. indication, procedure, report) and resulting consequences.ResultsWe analysed 241 MDCs with a total of 973 examinations. 14.0% (n = 136/973) of examinations were affected by QM events. The majority of events were report-related (76.3%, n = 106/139, e.g. misinterpreted finding), followed by procedure-related (18.0%, n = 25/139, e.g. technical issue) and indication-related events (5.8%, n = 8/139, e.g. faulty indication). The median time until identification of a QM event (time to MDC) was 2 days (interquartile range = 2). Comparing the first to the second half of the intervention period, the incidence of QM events decreased significantly from 22.9% (n = 109/476) to 6.0% (n = 30/497) (p < 0.0001). Significance of this effect was confirmed by linear regression (p < 0.0001).ConclusionsEstablishing structured discussion and feedback between radiologists and intensive care physicians in the form of MDCs is associated with a statistically significant reduction in QM events. These results indicate that MDCs may be one suitable approach to timely identify imaging-related error.