Holmes, David R.

Introduction: Left atrial appendage closure (LAAC) device for stroke prevention is a safe and effective alternative to oral anticoagulation (OAC) in patients with atrial fibrillation (AF). The safety of performing LAAC on uninterrupted warfarin (UW) compared to interrupted warfarin (IW) is currently unknown. Hypothesis: Complication rates of performing LAAC on UW vs. IW will be similar. Methods: We reviewed the data from the second half of PROTECT-AF trial, PREVAIL trial, CAP and CAP2 registries. Patients were categorized to the UW group if INR on the day of the procedure was ≥2 and to the IW group if INR was <2. Procedural complications within 7 days of LAAC were reviewed. An association between complications and AC strategy was analyzed. Results: Data from 1580 patients were reviewed and 294 patients (18.6%) received LAAC on UW. The UW group had a mean INR of 2.4±0.4 and IW group had a mean INR of 1.3±0.3. There were several differences in baseline characteristics: lower BMI in the UW group (28.6±5.3 vs 29.5±6.0, p=0.01), fewer patients with hypertension in the UW group (87.1% vs 91.1%, p=0.04), lower HAS-BLED score in the UW group (2.0±1.0 vs 2.1±1.0, p<0.01), and more patients with persistent AF in the UW group (37.1% vs 26.4%, p<0.01). Overall, there were no significant differences in total or individual complication rates between the two groups (UW 5.1% vs IW 6.1%, p=0.59). Although not statistically significant, lower event rates were noted in the UW group for the following: stroke (0% vs 0.3%, p>0.99), pericardial effusion requiring intervention (1.7% vs 1.8%, p>0.99), pseudoaneurysm (0% vs 0.4%, p=0.59), hematoma (0% vs 0.2%, p>0.99), and device embolism (0% vs 0.2%, p=1.0). The UW group had statistically insignificant higher events rates of AV fistula (0.3% vs 0%, p=0.19) and major bleeding requiring transfusion (1% vs 0.5%, p=0.38). In addition, there was no significant difference in periprocedural ischemic stroke (0% vs 0.3%, p>0.99). Conclusion: In this retrospective analysis, no significant difference was observed in procedural complication rates when performing LAAC on UW vs. IW. These results suggest that LAAC can be safely performed without interruption of OAC.

Introduction: Atrial fibrillation (AF) is a serious complication, which occurs in 30% to 40% of patients after surgical aortic valve replacement (SAVR) and contributes to adverse outcomes. Advanced technology has enabled transcatheter aortic valve replacement (TAVR) in patients with High-risk Severe Aortic Stenosis (HRSAS). In these patients, the compliance of the systemic vasculature is an independent predictor of diastolic dysfunction, a known predictor of postoperative AF (POAF). We hypothesize that patients with HRSAS undergoing TAVR represent a population at increased risk for POAF. METHODS: The medical records of 195 TAVR patients at the Mayo Clinic from November 2008 to January 2013 were analyzed. All patient demographic, clinical, pre- and post-procedural outcomes were collected from the patients’ medical records, and reviewed to ascertain all cases of POAF (AF ≤30 days of surgery). Patients with a prior history of AF (n= 75 (38.5%)) were excluded. Logistic regression analysis was used to identify clinical predictors of POAF after TAVR. Results: The mean age of the study population was 80.8±7.8 years and 60.8% (n=73) were men. The mean STS risk score was 8.9±5.1. Of the 120 patients without prior AF, 20.8% (n=25) developed new-onset POAF after TAVR. Patients who developed POAF were more likely to have undergone a transapical or transaortic TAVR approach (OR 3.20; 95% CI (1.3-8.0), had a higher incidence of renal complications (52.0% vs 21.5%; p= 0.003), greater hospital length of stay (7.4±2.58 vs 5.0±2.6 days; p= 0.0003, and a trend toward higher 30-day mortality (28.0% vs 13.7%; p= 0.09) and pulmonary complications (16.0% vs 5.4%; p= 0.08) compared with those who did not develop POAF, respectively. Neurologic complications were not different between the 2 group (4.0% vs 3.2%; p= 0.85). Conclusions: Patients with High-risk Severe Aortic Stenosis undergoing TAVR have increased risk of POAF, primarily associated with a transapical or aortic surgical approach. Patients who develop POAF had higher incidence of post-procedural complications and longer hospitalizations. Therefore, perioperative strategies aimed at prevention of POAF are as important in TAVR patients as in those undergoing SAVR.

Background: Randomized clinical trials are often criticized for not reflecting real-world practice. To understand the effect of site and patient selection on trial generalizability, we examined US patient and hospital participation within the Dual Antiplatelet Therapy (DAPT) Study, a broadly inclusive trial of PCI patients, using a linked analysis with the CathPCI Registry®. Methods: Within the CathPCI Registry, we identified patients undergoing PCI between September 1, 2009 and July 1, 2011 - the period of DAPT Study enrollment. We compared US patients enrolled in DAPT to CathPCI Registry patients meeting DAPT inclusion criteria. Characteristics of US DAPT sites were also compared to those of hospitals not participating in DAPT. Standardized differences (%) for all variables were estimated, with those greater than 10% considered significant. Results: Among 1,139,932 NCDR patients undergoing PCI, 748374 (65.7%) met the enrollment criteria for DAPT, and 23495 (2.1%) were enrolled. Enrolled patients were younger and had lower rates of prior stroke, CHF and peripheral vascular disease, but were similar with respect to race and gender compared with eligible patients (Table). Of the 1276 hospitals within the NCDR, 309 (24.2%) participated in DAPT. Hospital characteristics differed markedly, with DAPT-participating hospitals being larger (mean beds 468 vs. 311), more often located in urban settings (61.2% vs. 42.6%), more often affiliated with training programs (53.7% vs. 34.1%), and with higher annual PCI volumes (mean annual hospital volume 858 vs. 378 PCIs) compared with non-DAPT hospitals. Conclusions: While liberal inclusion criteria may allow randomized trials to better simulate “real-world” clinical practice, the process of site selection may encourage participation of higher volume, urban hospital settings. These findings are relevant to clinical trial interpretation and implementation of evidence-based practice throughout the healthcare system.

Objective: To evaluate outcomes of acute spontaneous coronary artery dissection (SCAD) managed with percutaneous coronary intervention (PCI) or conservative therapy. Background: SCAD is a non-atherosclerotic acute coronary syndrome that typically affects young otherwise healthy females. Whether SCAD with normal vessel flow at presentation should be managed with PCI or conservative therapy remains unknown. Methods: We performed a retrospective study of patients after a first SCAD episode (n=142). We excluded those treated with fibrinolysis (n=12) or coronary artery bypass grafting (CABG, n=8). We evaluated in-hospital and late outcomes in three SCAD groups: Vessel occlusion at presentation treated with PCI (Occ-PCI, n=30); normal vessel flow treated with PCI (NF-PCI, n=34) and those managed conservatively (CON, n=58). Results: Overall mean age was 42+9 years, 91% were female and 41% presented with STEMI. Outcomes are shown in the table below. In Occ-PCI, technical failure occurred in 8/30 (27%), of whom 5 required emergency CABG with one in-hospital death. Comparing NF-PCI with CON, there were no differences in clinical characteristics. Technical failure occurred in 16/34 (47%) of NF-PCI due to failure to cross with wire/device (8/34) or final loss of flow (8/34). Emergency CABG was required in 5 (15%). In CON, 54/58 had an uneventful in-hospital course. Four (7%) exhibited early dissection progression of whom two received PCI and one CABG. Long-term rates of target vessel revascularization, but not recurrent SCAD, were higher in NF-PCI vs CON (26% vs 9%, p=0.02; 24% vs 14%, p=0.23). Conclusions: PCI for acute SCAD is associated with high rates of technical failure and adverse clinical outcomes. In SCAD with normal vessel flow, conservative management may be preferable, with close early observation due to a hazard of progression of dissection. These findings underscore the importance of tailoring therapy to etiology of coronary obstruction.

Background Recently, machine learning algorithms have identified preprocedural γ‐glutamyl transferase (GGT) as a significant predictor of long‐term mortality after coronary revascularization in the SYNTAX (Synergy Between PCI [Percutaneous Coronary Intervention] With Taxus and Cardiac Surgery) trial. The aim of the present study is to investigate the impact of preprocedural GGT on 10‐year all‐cause mortality in patients with complex coronary artery disease after revascularization. Methods and Results The SYNTAX trial was a randomized trial comparing PCI with coronary artery bypass grafting in 1800 patients with complex coronary artery disease. The present report is a post hoc subanalysis of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) trial, an investigator‐driven extended 10‐year follow‐up of the SYNTAX trial. The association between preprocedural GGT and 10‐year all‐cause mortality was investigated. The mean values of GGT for men and women were 43.5 (SD, 48.5) and 36.4 (SD, 46.1) U/L, respectively. In multivariable Cox regression models adjusted by traditional risk factors, GGT was an independent predictor for all‐cause death at 10‐year follow‐up, and each SD increase in log‐GGT was associated with a 1.24‐fold risk of all cause death at 10‐year follow‐up (95% CI, 1.10–1.40). According to previously reported sex‐related GGT thresholds, patients with higher GGT level had a 1.74‐fold risk of all‐cause death at 10‐year follow‐up (95% CI, 1.32–2.29) compared with patients with lower GGT level. Conclusions Preprocedural GGT is an independent predictor of 10‐year mortality after coronary revascularization in patients with complex coronary artery disease. In patients with elevated GGT, strong secondary prevention may be required after revascularization and must be studied prospectively. Registration URL: https://clinicaltrials.gov/study/NCT03417050 .

Abstract Percutaneous Coronary Intervention (PCI) is a widely utilized standard ofcare and efficacious intervention in the management of coronary artery disease,improving prognosis and symptoms for many patients. Prediction of post-PCIoutcomes contributes to effective patient management and quality improvementinitiatives in healthcare. Our study focuses on comparative performance analysisfor state-of-the-art vision transformer (ViT) and convolutional neural network(CNN) on multimodal data analysis in a joint fusion framework. We integrateimages of electrocardiogram (ECG) data and tabular electronic health records(EHR) to predict 3 clinically relevant post-PCI (6 months) endpoints - heart failure hospitalization, all-cause mortality, and ischemic stroke. To design a comparativemodel for ViT, we proposed a new joint fusion architecture that consistsof a convolutional neural network (CNN) with a convolutional block attentionmodule (CBAM). The learned representations are combined at an intermediatelayer followed by processing these representations using a fully connectedlayer. The proposed model demonstrates excellent performance with the highestAUROC scores of 0.849, 0.913, and 0.794 for predicting heart failure hospitalization,all-cause mortality, and stroke, respectively. Surpassing the baseline EHRmodel and ViT, the proposed CNN+CBAM fusion model showcases superiorpredictive capabilities for heart failure prediction.

Introduction: Doppler mean gradient (MG) can underestimate the severity of aortic stenosis (AS) in patients with atrial fibrillation (AF) compared to patients in sinus rhythm (SR). Patients with AF and severe AS may experience delayed diagnosis and more advanced disease at time of referral for transcatheter aortic valve replacement (TAVR). Methods: Patients who underwent TAVR from 2013 to 2017 for native valve severe AS were identified from an institutional database. MG and aortic valve calcium score (AVCS) at time of referral were compared in patients in AF and SR. Retrospective theoretical AVCS in AF patients were derived assuming an average progression of 152 AU/year (published data). Results: There were 820 patients included; mean age was 81.3+/- 8.2 years and 41.6% were female. AF was present in 356 patients at time of referral. Patients in AF were older (82.2 vs. 80.5, p = 0.003), had lower MG compared to SR patients (42.0 vs. 44.9, p = 0.002) and a lower peak velocity (4.1 vs. 4.2, p = 0.010) with a similar indexed aortic valve area (0.4 vs. 0.4, p = 0.17). Stratified by sex, the median calcium score for AF patients was higher (by around 300 AU) among both males (AF 2850.0 vs. SR 2561.0, p = 0.044) and females (AF 1942.0 vs. 1610.5, p = 0.025) ( figure 1 ). A density plot of retrospective theoretical AVCS in AF patients (projected assuming referral to TAVR approximately two years prior) resulted in nearly identical median AVCS between the two cohorts ( figure 2 ). Conclusions: Older age and higher AVCS in patients with AF compared to SR suggests that AS was both underestimated and more advanced at time of referral to TAVR. Patients in AF may have severe AS as early as 2 years prior to TAVR referral.