Alkhouli, Mohamad

ImportanceRacial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials.ObjectiveTo identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies.Design, Setting, and ParticipantsThis cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022.ExposuresMultivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals.Main Outcome and MeasuresThe main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies.ResultsA total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code–based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, −2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials.Conclusions and RelevanceIn this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.

Objective: Limited data exist around the receipt of palliative care (PC) in patients hospitalized with common chronic conditions. We studied the independent predictors, temporal trends in rates of PC utilization in patients hospitalized with acute exacerbation of common chronic diseases. Methods: Population-based cohort study of all hospitalizations with an acute exacerbation of heart disease (HD), cerebrovascular accident (CVA), cancer (CA), and chronic lower respiratory disease (CLRD). Patients aged ≥18 years or older between January 1, 2004, and December 31, 2017, referred for inpatient PC were extracted from the National Inpatient Sample. Poisson regression analyses were used to estimate temporal trends. Results: Between 2004 and 2017, of 91,877,531 hospitalizations, 55.2%, 13.9%, 17.2%, and 13.8% hospitalizations were related to HD, CVA, CA, and CLRD, respectively. There was a temporal increase in the uptake of PC across all disease groups. Age-adjusted estimated rates of PC per 100,000 hospitalizations/year were highest for CA (2308 (95% CI 2249–2366) to 10,794 (95% CI 10,652–10,936)), whereas the CLRD cohort had the lowest rates of PC referrals (255 (95% CI 231–278) to 1882 (95% CI 1821–1943)) between 2004 and 2017, respectively. In the subgroup analysis of patients who died during hospitalization, the CVA group had the highest uptake of PC per 100,000 hospitalizations/year (4979 (95% CI 4918–5040)) followed by CA (4241 (95% CI 4189–4292)), HD (3250 (95% CI 3211–3289)) and CLRD (3248 (95% CI 3162–3405)). Conclusion: PC service utilization is increasing but remains disparate, particularly in patients that die during hospital admission from common chronic conditions. These findings highlight the need to develop a multidisciplinary, patient-centered approach to improve access to PC services in these patients.

Abstract Aims Cardiac computed tomography (CT) is increasingly utilized during follow-up after left atrial appendage closure (LAAC). Hypoattenuated thickening (HAT) is a common finding and might represent either benign device healing or device-related thrombosis (DRT). The appearance and characteristics of HAT associated with the Watchman FLX have not been previously described. Therefore, we sought to investigate cardiac CT findings during follow-up after Watchman FLX implantation with a focus on HAT and DRT. Methods and results Retrospective single-centre, observational study including all patients with successful Watchman FLX implantation and follow-up cardiac CT between March 2019 and September 2021 (n = 244). Blinded analysis of CT images was performed describing the localization, extent, and morphology of HAT and correlated to imaging and histology findings in a canine model. Relevant clinical and preclinical ethical approvals were obtained. Overall, HAT was present in 156 cases (64%) and could be classified as either subfabric hypoattenuation (n = 59), flat sessile HAT (n = 78), protruding sessile HAT (n = 16), or pedunculated HAT (n = 3). All cases of pedunculated HAT and five cases of protruding sessile HAT were considered as high-grade HAT (n = 7). Subfabric hypoattenuation and flat sessile HAT correlated with device healing and endothelialization in histological analysis of explanted devices. Conclusion Subfabric hypoattenuation and flat sessile HAT are frequent CT findings for Watchman FLX, likely representing benign device healing and endothelialization. Pedunculated HAT and protruding HAT are infrequent CT findings that might represent DRT.

Background: Left ventricular outflow tract obstruction may occur following transcatheter mitral valve replacement in the setting of mitral annular calcification. Methods: We present a case series whereby preemptive septal radiofrequency ablation (RADIO-TMVR) was used to augment the left ventricular outflow tract for transcatheter mitral valve replacement in 4 patients at risk for left ventricular outflow tract obstruction despite alcohol septal ablation. Results: All patients were female, average age of 74.9 (68.8–80.4) years. Baseline ejection fraction was 71% (63%–75%). Mean mitral valve area was 1.28 (range, 1.0–1.59) cm 2 . Mean mitral valve gradient at rest was 9.5 (range, 7–11) mm Hg. New York Heart Association symptoms were III to IV at baseline. Patients underwent preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement a range between 69 and 154 days after alcohol septal ablation. Procedural time was 384 (337–424) minutes with a fluoroscopic time of 31 (14–71) minutes. Radiofrequency ablation time was 132 (100–175) minutes. As anticipated, 3 patients developed complete heart block and underwent pacemaker implantation, whereas 1 had a preexisting pacemaker. One patient developed groin hematoma and heart failure exacerbation. There were no peri-procedural deaths. Preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement resulted in septal end-diastolic wall thickness reduction compared with baseline (28.6%, 30.4%, 30.3%, and 11.1%) and following alcohol septal ablation (23.1%, 12%, 8.5%). Valve replacement in the setting of mitral annular calcification was performed in all patients 89 (range, 38–45) days after preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement. Two patients had concomitant laceration of the anterior mitral leaflet to further augment the neo-left ventricular outflow tract. Postprocedure, New York Heart Association symptoms improved to class I (3 patients) and class II (1 patient). Conclusions: In at-risk individuals, preemptive septal radiofrequency ablation may be an effective strategy at preventing left ventricular outflow tract obstruction with transcatheter mitral valve replacement.

Background The management of severe mitral regurgitation (MR) after transcatheter edge‐to‐edge repair (TEER) remains a clinical conundrum. Considering the growing volume of TEER, more outcomes data for mitral surgery in this cohort are needed. Methods and Results Symptomatic patients with persistent or recurrent severe MR after TEER evaluated between May 2014 and June 2021 were included. The primary outcome was all‐cause mortality in patients who were treated with surgery versus medical therapy. The Kaplan–Meier and Cox regression methods were used to report risk‐adjusted survival analyses. Among the 142 included patients, 44 (31.0%) underwent mitral surgery. Patients who underwent surgery were younger than those treated medically (74.1±8.9 versus 78.6±10.5 years, P =0.01). Major comorbidities were similar except obesity, sleep apnea, left ventricular dimensions, and ejection fraction. Society of Thoracic Surgeons Predicted Risk of Operative Mortality was 9.0±4.7 versus 7.9±4.9 in the surgical versus medical therapy groups, respectively, P =0.22. Time from TEER to detection of severe MR was similar in both groups (median [interquartile range] 97.5 [39.5–384] versus 93.5 [40–389] days in the surgical versus medical groups, respectively [ P >0.05]). In the surgical group, valve replacement was performed in all patients. Operative mortality was 4.5% (observed/expected ratio 0.55), and major complications were uncommon. After risk‐adjustment, surgery was associated with significantly lower all‐cause mortality (adjusted hazard ratio, 0.33 [95% CI, 0.12–0.92], P =0.001) compared with medial therapy. Conclusions Compared with medical therapy, mitral surgery in patients with severe persistent or recurrent MR after TEER is associated with lower mortality despite the high‐risk profile of these patients. Patients with severe MR after TEER should be considered for surgery at a referral mitral surgical center.

Atrial septal pouch is a common anatomic variant of the interatrial septum and a nidus for thrombus formation. Left-sided atrial septal pouch has been associated with an increased risk of cryptogenic stroke. We described a case of left-sided atrial septal pouch thrombus, incidentally found prior to transseptal puncture during Watchman device placement. This case highlights the importance of a thorough echocardiographic evaluation of the atrial septum prior to transseptal access and recognition of this finding as a potential cardiac source of embolism.

Abstract Background Pulmonary vein stenosis (PVS), which is often unrecognized, may arise from a variety of conditions resulting in major morbidity and mortality. In some patients, pharmacological therapy may help but more often in advance stages, mechanical treatment must be considered. Transcatheter approaches, both balloon angioplasty (BA) and stent implantation have been applied. While both may be effective, they continue to be limited by restenosis. Herein, we compare the outcomes following BA and stenting for PVS. Purpose PVS presents a challenge for both diagnosis and therapy, with BA and stenting being primarily limited by restenosis. Stenting is performed in most cases and is associated with improved patency rates. Historical comparisons of BA and stenting for PVS have yielded similar results. Our analysis incorporates more conventional studies (2010–2021) and provides a larger stent (N=361) versus BA (N=229) contemporary analysis of the current state of PV intervention practice. Methods From January 1, 2010 to August 2, 2021, studies, limited to English language and humans, were assessed in Ovid MEDLINE®, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Two independent reviewers screened articles including those in which balloon angioplasty or stenting was performed for pulmonary vein stenosis with reporting of restenosis outcomes and data was independently extracted. Systematic review was performed, and overall restenosis rates were reported across all included studies. Meta-analysis was then performed using RevMan 5.4 assessing rates of restenosis and restenosis requiring repeat intervention. Results Our systematic review yielded 34 studies reporting on BA and/or stenting for PVS. Of these, 7 studies (1–7), treating a total of 343 patients with 590 PV interventions (229 BA and 361 Stents) reported restenosis rates with mean follow-up ranging from 10 to 60 months. Stenting was associated with a lower risk of restenosis compared to balloon angioplasty [risk ratio 0.35, 95% CI (0.18, 0.64), p=0.0008] (Figure 1). Restenosis requiring repeat intervention was reported in 5 studies, including 303 patients with 502 PV interventions (160 BA and 342 Stents) with stenting similarly associated with a lower risk of restenosis requiring re-intervention [risk ratio 0.34, 95% CI (0.16, 0.72), p=0.005]. Conclusion Stenting for pulmonary vein stenosis is associated with reduced risk of restenosis and re-intervention as compared to balloon angioplasty. Funding Acknowledgement Type of funding sources: None.

Background This study aimed to compare percutaneous left atrial appendage occlusion (LAAO) with non‐vitamin K antagonist oral anticoagulants among patients with atrial fibrillation. Methods and Results Using a US administrative database, 562 850 patients with atrial fibrillation were identified, among whom 8397 were treated with LAAO and 554 453 were treated with non‐vitamin K antagonist oral anticoagulants between March 13, 2015 and December 31, 2018. Propensity score overlap weighting was used to balance baseline characteristics. The primary outcome was a composite end point of ischemic stroke or systemic embolism, major bleeding, and all‐cause mortality. The mean age was 76.4±7.6 years; 280 097 (49.8%) were female. Mean follow‐up was 1.5±1.0 years. LAAO was associated with no significant difference in the risk of the primary composite end point (hazard ratio [HR], 0.93 [0.84–1.03]), or the secondary outcomes including ischemic stroke/systemic embolism (HR, 1.07 [0.81–1.41]), and intracranial bleeding (HR, 1.08 [0.72–1.61]). LAAO was associated with a higher risk of major bleeding (HR, 1.22 [1.05–1.42], P =0.01) and a lower risk of mortality (HR, 0.73 [0.64–0.84], P <0.001). The lower risk of mortality associated with LAAO was most pronounced in patients with a prior history of intracranial bleeding. Conclusions In comparison to non‐vitamin K antagonist oral anticoagulants, LAAO was associated with no significant difference in the risk of the composite outcome and a lower risk of mortality, which suggests LAAO might be a reasonable option in select patients with atrial fibrillation. The observation of higher bleeding risk associated with LAAO highlights the need to optimize postprocedural antithrombotic regimens as well as systematic efforts to assess and address bleeding predispositions.

Background Despite improvements in the management and prevention of stroke, increasing hospitalizations for stroke and stagnant mortality rates have been described in young adults. However, there is a paucity of contemporary national mortality estimates in young adults. Methods and Results Trends in mortality related to stroke in young adults (aged 25–64 years) were assessed using the Centers for Disease Control and Prevention Wide‐Ranging Online Data for Epidemiologic Research database. Age‐adjusted mortality rates per 100 000 people with associated annual percentage change were calculated. Joinpoint regression was used to assess the trends in the overall sample and different demographic (sex, race and ethnicity, and age) and geographical (state, urban‐rural, and regional) subgroups. Between 1999 and 2019, a total of 566 916 stroke‐related deaths occurred among young adults. After the initial decline in mortality in the overall population, age‐adjusted mortality rate increased from 2013 to 2019 with an associated annual percentage change of 1.5 (95% CI, 1.1–2.0). Mortality rates were higher in men versus women and in non‐Hispanic Black people versus individuals of other races and ethnicities. Non‐Hispanic American Indian or Alaskan Native people had a marked increase in stroke‐related mortality (annual percentage change 2010–2019: 3.3). Furthermore, rural (nonmetropolitan) counties experienced the greatest increase in mortality (annual percentage change 2012–2019: 3.1) compared with urban (metropolitan) counties. Conclusions Following the initial decline in stroke‐related mortality, young adults have experienced increasing mortality rates from 2013 to 2019, with considerable differences across demographic groups and regions.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P &amp;lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &amp;lt; .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P &amp;lt; .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.