Citations

Abstract Background and Aims Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. Methods All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine–Gray competing risk models. Results 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6–64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%–5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR: .47, 95% CI: .36–.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%–6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001). Conclusions Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.

AbstractINTRODUCTIONPatients with dementia with Lewy bodies (DLB) may have Alzheimers disease (AD) pathology that can be detected by plasma biomarkers. Our objective was to evaluate plasma biomarkers of AD and their association with positron emission tomography (PET) biomarkers of amyloid and tau deposition in the continuum of DLB, starting from prodromal stages of the disease.METHODSThe cohort included patients with isolated rapid eye movement (REM) sleep behavior disorder (iRBD), mild cognitive impairment with Lewy bodies (MCI‐LB), or DLB, with a concurrent blood draw and PET scans.RESULTSAbnormal levels of plasma glial fibrillary acidic protein (GFAP) were found at the prodromal stage of MCI‐LB in association with increased amyloid PET. Abnormal levels of plasma phosphorylated tau (p‐tau)‐181 and neurofilament light (NfL) were found at the DLB stage. Plasma p‐tau‐181 showed the highest accuracy in detecting abnormal amyloid and tau PET in patients with DLB.DISCUSSIONThe range of AD co‐pathology can be detected with plasma biomarkers in the DLB continuum, particularly with plasma p‐tau‐181 and GFAP.

Purpose To evaluate return to play (RTP) and return to same level of play (RTSP) rates as well as preoperative and postoperative in‐game performance metrics in baseball pitchers who underwent ulnar collateral ligament reconstruction (UCLR). Secondarily, this review sought to assess outcomes based on primary versus revision UCLR as well as level of competition. Methods This review was performed using Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. PubMed/MEDLINE, Embase, Web of Science, and Cochrane Database of Systematic Reviews were queried to identify articles evaluating UCLR in baseball players between January 2002 and October 2022. Data included RTP, RTSP, and performance metrics including earned run average, innings pitched, walks and hits per inning pitched, batting average against, strikeouts per 9 innings, walks per 9 innings, percentage of fastballs thrown, and average fastball velocity. The Methodological Index for Non‐randomized Studies criteria were used for quality assessment. Results Analysis included 25 articles reporting on 2,100 elbows. After primary UCLR, RTP ranged from 336 to 615 days (57% to 100% achieved) and RTSP ranged from 330 to 513 days (61% to 95%). After revision UCLR, RTP ranged from 381 to 631 days (67% to 98%) and RTSP ranged from 518 to 575 days (42% to 78%). When stratifying primary UCLR outcomes by competitive level, RTP and RTSP ranged respectively from 417 to 615 days (75% to 100%) and 513 days (73% to 87%) for Major League Baseball only, 409 to 615 days (57% to 100%) and 470 to 513 days (61% to 95%) for Major League Baseball plus Minor League Baseball, and 336 to 516 days (73% to 85%) and 330 days (55% to 74%) for college plus high school. Heterogeneity was seen in postoperative sports performance metrics. Conclusions Although more than half of baseball players appear able to RTP after primary and revision UCLR, RTSP rates after revision UCLR were as low as 42% in the literature. Preoperative and postoperative performance metrics varied. Level of Evidence Level IV, systematic review of Level II‐IV studies.

Background: Wrestling is a physically demanding sport with young athletes prone to traumatic shoulder instability and a paucity of data evaluating the results of shoulder instability surgery (SIS). Purpose: To assess reoperation rates, patient-reported outcomes, and return to wrestling (RTW) after SIS in a cohort of competitive wrestlers. Study Design: Case series; Level of evidence, 3. Methods: All competitive wrestlers with a history of shoulder instability and subsequent surgery at a single institution between 1996 and 2020 were identified. All directions of shoulder instability (anterior shoulder instability [ASI], posterior shoulder instability [PSI], and traumatic multidirectional shoulder instability [TMDI]) were analyzed. Exclusions included revision SIS and <2 years of follow-up. Athletes were contacted for determination of complications, RTW, and Western Ontario Shoulder Instability Index scores. Results: Ultimately, 104 wrestlers were included with a mean age at initial instability of 16.9 years (range, 12.0-22.7 years), mean age at surgery of 18.9 years (range, 14.0-29.0 years), and a mean follow-up of 5.2 years (range, 2.0-22.0 years). A total of 58 (55.8%) wrestlers were evaluated after a single shoulder instability event, while 46 (44.2%) sustained multiple events before evaluation. ASI was the most common direction (n = 79; 76.0%), followed by PSI (n = 14; 13.5%) and TMDI (n = 11; 10.6%). Surgical treatment was most commonly an arthroscopic soft tissue stabilization (n = 88; 84.6%), with open soft tissue repair (n = 13; 12.5%) and open bony augmentation (n = 3; 2.9%) performed less frequently. RTW occurred in 57.3% of wrestlers at a mean of 9.8 months. Recurrent instability was the most common complication, occurring in 18 (17.3%) wrestlers. Revision SIS was performed in 15 (14.4%) wrestlers. Across the entire cohort, survivorship rates free from recurrent instability and revision surgery were 90.4% and 92.5% at 2 years, 71.9% and 70.7% at 5 years, and 71.9% and 66.5% at 10 years, respectively. Preoperative recurrent instability was an independent risk factor for postoperative recurrent instability (hazard ratio, 3.8; 95% CI, 1.33-11.03; P = .012). Conclusion: Competitive wrestlers with multiple dislocations before initial clinical evaluation were 3.8 times more likely to experience postoperative recurrent instability. Patients should be counseled that despite SIS, only 57.3% returned to wrestling after surgery.

Introduction: Patients diagnosed with ischemic stroke routinely undergo prolonged cardiac telemetry (PCT) to evaluate for occult atrial fibrillation (AF), but this approach is limited by high cost and low yield. Clinical scores including CHA2DS2-VASc and CHARGE-AF can risk stratify patients but lack desired accuracy. Therefore, we aimed to evaluate an artificial intelligence (AI)-enabled ECG algorithm to predict AF detected by PCT after index stroke. Methods: This retrospective study included all adult patients with ischemic stroke evaluated at Mayo Clinic with baseline electrocardiogram (ECG) and PCT between 2018-2020. We recorded demographics, CHA2DS2-VASc score, CHARGE-AF score, stroke etiology, duration of PCT, and if PCT detected AF. ECGs were analyzed using the AI-ECG algorithm to determine AF likelihood. Stroke etiology was adjudicated using TOAST and embolic stroke of undetermined source (ESUS) definitions. The ability of the AI-ECG algorithm, CHA2DS2-VASc, and CHARGE-AF to predict AF detected by PCT was assessed via receiver operating characteristics analysis, calculating the area under curve (AUC) (c-statistic). Sensitivity and specificity analyses were performed for each tool using optimal cutoffs (using maximum Youden indices). Results: 863 patients were included; median age was 69 years, 496 (57.5%) were male, and 561 (65%) patients were categorized as ESUS. PCT detected AF in 85 (9.8%) patients. Median duration of cardiac telemetry was 30 (IQR 25-30) days. Sensitivity and specificity analyses are outlined in Table 1. The AI-ECG algorithm outperformed the CHA2DS2-VASc score (AUC 0.690 vs. 0.597, p=0.013), but was similar to the CHARGE-AF score (AUC 0.690 vs 0.651, p=0.233). Conclusions: Our AI-ECG algorithm demonstrated improved ability to predict AF detection on PCT after index stroke when compared to the CHA2DS2-VASc score, but was similar in performance to the CHARGE-AF score. All three methods had suboptimal accuracy.

Introduction: Recent randomized control trials suggested that mechanical thrombectomy (MT) was associated with good functional outcomes after acute ischemic stroke (AIS) due to large vessel occlusion (LVO) in patients presenting with low Alberta Stroke Program Early CT Score (ASPECTS) (defined as ASPECTS 2-5). The aim of this study is to develop and validate a stroke prediction tool for outcome in MT for AIS patients with low ASPECTS using data from an ongoing international multicenter registry, the Stroke Thrombectomy and Aneurysm Registry (STAR). Methods: 236 AIS patients with low ASPECTS caused by LVO who undertook MT between January 2010 and December 2022 were retrospectively investigated. Univariate and multivariate logistic regression results were used to screen model predictors and construct nomograms of 90-day modified Rankin Scale scores (mRS) 0-3. The performance of the model was detected by using receiver operating characteristic analysis. The bootstrap resampling method was considered internal validation of the model. Results: Age (< 70 years), premorbid status (mRS 0), National Institutes of Health Stroke Scale (NIHSS) (< 20), and recanalization status after the MT (modified Thrombolysis in Cerebral Ischemia [mTICU] ≥2b) were related to 90-day mRS 0-3. Predictive score was calculated by adding 1 point for age (< 70 years), premorbid status (mRS 0), and NIHSS < 20 and 3 points for a mTICI ≥2b (ranging 0-6). 90-day mRS 0-3 was observed in 0% of patients with a score of 0 or 1, 6.3% with a score of 2, 17.7% with a score of 3, 22.2% with a score of 4, 45.7% with a score of 5, and 73.7% with a score of 6. The score showed relatively high performance in predicting 90-day mRS0-3 (area under the curve: 0.79 [95% CI 0.73-0.79] and 0.78 [95% CI 0.78-0.78] for derivation and validation cohorts, respectively). Conclusions: This study indicates the STAR score can be calculated with baseline and periprocedural characteristics to predict the 90-day outcome after MT in AIS patients with low ASPECTS.

Introduction: The outcomes of mechanical thrombectomy (MT) for patients with acute ischemic stroke (AIS) caused by medium vessel occlusions (MeVOs) in different vessels remains unknown. The aim of this study is to investigate MT outcomes in AIS patients with isolated MeVOs in different occluded vessel segments using the data from an ongoing international multicenter registry, the Stroke Thrombectomy and Aneurysm Registry (STAR). The aim of this study is to investigate MT outcomes in AIS patients with isolated MeVOs in different occluded vessel segments using the data from an ongoing international multicenter registry, the Stroke Thrombectomy and Aneurysm Registry (STAR). Methods: 110 AIS patients with MeVO who undertook MT between January 2010 and December 2022 were retrospectively investigated. MeVO was defined as isolated occlusion of the A2 or A3 (A23O) segment of the anterior cerebral artery, M3 segment of the middle cerebral artery (M3O), and P2 or P3 segment of the posterior cerebral artery (P23O). The primary outcome measure was a 90-day modified Rankin score (mRS) 0-2. The 90-day mRS 0-1, any intracranial hemorrhage, symptomatic intracranial hemorrhage, and 90-day mortality were used as secondary outcomes. Outcomes were compared between A23O, M3O, and P23O. Results: Median (interquartile range) age was 68.3 (58.4-76.0) years and 49 patients were female (46.7%). MeVO included 17 A23O (15.5%), 60 M3O (54.5%), and 33 P23O (30.0%).Compared to patients with A23O (17.7%), those with M3O (56.7%) and P23O (45.5%) had a higher proportion of 90-day mRS 0-2 (M3O, adjusted odds ratio 10.3, 95% confidence interval 1.71-62.2, p = 0.01; P23O adjusted odds ratio 8.86, 95% confidence interval 1.32-59.3, p =0.02). Other outcomes showed no significant differences. Conclusions: This study indicates A2O might be related to poorer outcomes compared to M3O and P23 in MT treatment for AIS patients due to isolated MeVO. Efforts should be aimed at improving outcomes following A23O to match those at other MeVO locations.

Introduction: The first-pass effect (FPE), defined as a complete or near-complete recanalization after a single pass of a mechanical thrombectomy (MT) device, has been linked to favorable clinical outcomes. However, its effectiveness in acute ischemic stroke (AIS) patients with low ASPECTS (Alberta Stroke Program Early CT Score 2-5) has not been validated. Method: We utilized data from STAR, a multicenter database of 84 centers worldwide, to conduct a retrospective, cohort study on patients who underwent MT for internal carotid artery (ICA) or M1 occlusion presenting with ASPECTS 2-5. We compared the outcomes of patients who achieved FPE (successful recanalization with an mTICI score of 2c or higher in one pass) to those who did not. The primary outcome was a 90-day favorable outcome, defined as mRS 0-3. Secondary outcomes included any intracranial hemorrhage (ICH), symptomatic ICH (sICH), and 90-day mortality. Results: Out of 10,229 patients in the STAR database, 250 patients met our inclusion criteria. Among those, 60 (24%) achieved FPE. There were no significant differences between the two groups in baseline, imaging, and procedural characteristics. FPE was significantly associated with higher odds of 90-day mRS 0-3 (adjusted odds ratio (aOR): 2.17, 95% confidence interval (CI): 1.04 - 4.20; P-value: 0.04) and lower rates of ICH (OR: 0.49, 95% CI: 0.25 - 0.93, P-value: 0.03). However, there was no significant difference in sICH rates (OR: 0.84, 95% CI: 0.31 - 2.04, P-value: 0.70). Conclusion: Achieving FPE in AIS stroke patients with low ASPECTS was associated with significantly higher rates of good functional outcomes and lower rates of ICH.

Introduction: Real-world data showed that less than half of the acute ischemic stroke (AIS) patients with large vessel occlusion (LVO) presenting with low Alberta Stroke Program Early Computed Tomography Score (ASPECTS) (2-5) achieved favorable outcomes at 90 days after mechanical thrombectomy (MT). In this study, we aim to investigate the relationship between the number of MT passes at which successful recanalization is obtained and outcomes in LVO-related AIS patients with low ASPECTS. Methods: This retrospective cohort study was performed on the data from 31 thrombectomy-capable centers between 2013 to 2022. Successful recanalization was defined as modified Thrombolysis in Cerebral Ischemia Score≥ 2b. The primary outcome was a 90-day modified Rankin Scale (mRS) of 0-3. Secondary outcomes were symptomatic intracranial hemorrhage and intracranial hemorrhage within 24 hours and mortality at 90 days. Outcomes were compared among patients with unsuccessful recanalization, and successful recanalization at first, second, third, and more than four passes. Results: A total of 297 patients with a median age of 70 [IQR 59-78] years were included and 140 (47.1%) were female. In 239 (80.4%) patients, successful recanalization was achieved: 88 patients (29.6 %) with 1 pass, 59 patients (19.9 %) with 2 passes, 35 patients(11.8%) with 3 passes, and 57 patients (19.2%) with more than 4 passes. Compared to unsuccessful recanalization, successful recanalization at first pass (adjusted OR 5.25, 95% CI 1.78 - 17.1), second passes (adjusted OR 5.20, 95% CI 1.68 - 17.6), and passes 4 (adjusted OR 4.90, 95% CI 1.68 - 17.6) was related to 90-day mRS 0-3. Recanalization status and MT attempt number were not related to secondary outcomes except for 90-day mortality. Compared to unsuccessful recanalization, successful recanalization at second and third passes were inversely related to 90-day mortality (adjusted OR 0.37, 95% CI 0.14 - 0.93; adjusted OR 0.33, 95% CI 0.11 - 0.95, respectively). Conclusion: The present results indicated that successful recanalization was related to 90-day good outcome regardless of the number of MT passes but the odds of achieving favorable outcome declines with each pass.