Holmes, David R.

AbstractBackgroundRandomized studies of intra‐aortic balloon pump (IABP) in cardiogenic shock (CS) have only included on patients with acute coronary syndromes (ACS) without stratification according to shock severity. We examined the association between IABP and mortality in CS patients across the Society for Cardiovascular Angiography and Intervention (SCAI) shock stages.MethodsWe included cardiac intensive care unit patients admitted from 2007 to 2015 with CS from any etiology. In‐hospital mortality associated with IABP was examined in each SCAI shock stage. Multivariable logistic regression was performed using inverse probability of treatment weighting (IPTW) to determine the association between IABP and in‐hospital mortality.ResultsWe included 934 patients, with a mean age of 68 ± 14 years; 60% had ACS. The distribution of SCAI shock stages was: B, 41%; C, 13%; D, 38%; E, 8%. In‐hospital mortality was lower in the 39% of patients who received IABP (27% vs. 43%, adjusted OR with IABP after IPTW 0.53, 95% CI 0.40–0.72, p < .0001). IABP use was associated with lower crude in‐hospital mortality in each SCAI shock stage (all p < .05, except p = .08 in SCAI shock stage E). We did not observe any significant heterogeneity in the association between IABP use and in‐hospital mortality as a function of SCAI shock stage.ConclusionsPatients with CS who were selected to receive an IABP had lower in‐hospital mortality, without differences in this effect across the SCAI shock stages. Future studies should account for the severity and etiology of shock when evaluating the efficacy of IABP for CS.

Background The role of race and ethnicity in the outcomes of cardiac arrest (CA) complicating acute myocardial infarction (AMI) is incompletely understood. Methods and Results This was a retrospective cohort study of adult admissions with AMI‐CA from the National Inpatient Sample (2012–2017). Self‐reported race/ethnicity was classified as White, Black, and others (Hispanic, Asian or Pacific Islander, Native American, Other). Outcomes of interest included in‐hospital mortality, coronary angiography, percutaneous coronary intervention, palliative care consultation, do‐not‐resuscitate status use, hospitalization costs, hospital length of stay, and discharge disposition. Of the 3.5 million admissions with AMI, CA was noted in 182 750 (5.2%), with White, Black, and other races/ethnicities constituting 74.8%, 10.7%, and 14.5%, respectively. Black patients admitted with AMI‐CA were more likely to be female, with more comorbidities, higher rates of non–ST‐segment–elevation myocardial infarction, and higher neurological and renal failure. Admissions of patients of Black and other races/ethnicities underwent coronary angiography (61.9% versus 70.2% versus 73.1%) and percutaneous coronary intervention (44.6% versus 53.0% versus 58.1%) less frequently compared to patients of white race ( p <0.001). Admissions of patients with AMI‐CA had significantly higher unadjusted mortality (47.4% and 47.4%) as compared with White patients admitted (40.9%). In adjusted analyses, Black race was associated with lower in‐hospital mortality (odds ratio [OR], 0.95; 95% CI, 0.91–0.99; P =0.007) whereas other races had higher in‐hospital mortality (OR, 1.11; 95% CI, 1.08–1.15; P <0.001) compared with White race. Admissions of Black patients with AMI‐CA had longer length of hospital stay, higher rates of palliative care consultation, less frequent do‐not‐resuscitate status use, and fewer discharges to home (all P <0.001). Conclusions Racial and ethnic minorities received less frequent guideline‐directed procedures and had higher in‐hospital mortality and worse outcomes in AMI‐CA.

Background: Ten-year all-cause death according to incomplete (IR) versus complete revascularization (CR) has not been fully investigated in patients with 3-vessel disease and left main coronary artery disease undergoing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). Methods: The SYNTAX Extended Survival study (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]) evaluated vital status up to 10 years in patients who were originally enrolled in the SYNTAX trial. In the present substudy, outcomes of the CABG CR group were compared with the CABG IR, PCI CR, and PCI IR groups. In addition, in the PCI cohort, the residual SYNTAX score (rSS) was used to quantify the extent of IR and to assess its association with fatal late outcome. The rSS of 0 suggests CR, whereas a rSS>0 identifies the degree of IR. Results: IR was more frequently observed in patients with PCI versus CABG (56.6% versus 36.8%) and more common in those with 3-vessel disease than left main coronary artery disease in both the PCI arm (58.5% versus 53.8%) and the CABG arm (42.8% versus 27.5%). Patients undergoing PCI with CR had no significant difference in 10-year all-cause death compared with those undergoing CABG (22.2% for PCI with CR versus 24.3% for CABG with IR versus 23.8% for CABG with CR). In contrast, those with PCI and IR had a significantly higher risk of all-cause death at 10 years compared with CABG and CR (33.5% versus 23.7%; adjusted hazard ratio, 1.48 [95% CI, 1.15–1.91]). When patients with PCI were stratified according to the rSS, those with a rSS≤8 had no significant difference in all-cause death at 10 years as the other terciles (22.2% for rSS=0 versus 23.9% for rSS>0–4 versus 28.9% for rSS>4–8), whereas a rSS>8 had a significantly higher risk of 10-year all-cause death than those undergoing PCI with CR (50.1% versus 22.2%; adjusted hazard ratio, 3.40 [95% CI, 2.13–5.43]). Conclusions: IR is common after PCI, and the degree of incompleteness was associated with 10-year mortality. If it is unlikely that complete (or nearly complete; rSS<8) revascularization can be achieved with PCI in patients with 3-vessel disease, CABG should be considered. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00114972. URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03417050.

Background There are limited contemporary data on the use of emergent coronary artery bypass grafting (CABG) in acute myocardial infarction. Methods and Results Adult (aged >18 years) acute myocardial infarction admissions were identified using the National (Nationwide) Inpatient Sample (2000–2017) and classified by tertiles of admission year. Outcomes of interest included temporal trends of CABG use; age‐, sex‐, and race‐stratified trends in CABG use; in‐hospital mortality; hospitalization costs; and hospital length of stay. Of the 11 622 528 acute myocardial infarction admissions, emergent CABG was performed in 1 071 156 (9.2%). CABG utilization decreased overall (10.5% [2000] to 8.7% [2017]; adjusted odds ratio [OR], 0.98 [95% CI, 0.98–0.98]; P <0.001), in ST‐segment–elevation myocardial infarction (10.2% [2000] to 5.2% [2017]; adjusted OR, 0.95 [95% CI, 0.95–0.95]; P <0.001) and non–ST‐segment–elevation myocardial infarction (10.8% [2000] to 10.0% [2017]; adjusted OR, 0.99 [95% CI, 0.99–0.99]; P <0.001), with consistent age, sex, and race trends. In 2012 to 2017, compared with 2000 to 2005, admissions receiving emergent CABG were more likely to have non–ST‐segment–elevation myocardial infarction (80.5% versus 56.1%), higher rates of noncardiac multiorgan failure (26.1% versus 8.4%), cardiogenic shock (11.5% versus 6.4%), and use of mechanical circulatory support (19.8% versus 18.7%). In‐hospital mortality in CABG admissions decreased from 5.3% (2000) to 3.6% (2017) (adjusted OR, 0.89; 95% CI, 0.88–0.89 [ P <0.001]) in the overall cohort, with similar temporal trends in patients with ST‐segment–elevation myocardial infarction and non–ST‐segment–elevation myocardial infarction. An increase in lengths of hospital stay and hospitalization costs was seen over time. Conclusions Utilization of CABG has decreased substantially in acute myocardial infarction admissions, especially in patients with ST‐segment–elevation myocardial infarction. Despite an increase in acuity and multiorgan failure, in‐hospital mortality consistently decreased in this population.

Background: Identifying patients at a high risk of mortality post percutaneous coronary intervention (PCI) is of vital clinical importance. We investigated the utility of machine learning algorithms to predict short and intermediate-term risk of all-cause mortality in patients undergoing PCI. Methods: Patient-level demographics, clinical, electrocardiographic ,echocardiographic and angiographic data from January 2006 to December 2017 were extracted from the Mayo Clinic CathPCI registry and clinical records. For patients with multiple PCI events, data collected at the time of the index PCI was used for analysis. Patients who underwent bailout coronary artery bypass graft surgery (CABG) prior to discharge were excluded. 306 variables were incorporated into random forest machine learning model (RF) to predict all-cause mortality at 6 months and 1 year after PCI. Ten-fold cross-validation repeated five times was used to optimize the hyperparameters and estimate its external performance. The National Cardiovascular Data Registry (NCDR) based logistic regression model was used for comparison. The area under receiver operator characteristic curves (AUC) was calculated to assess the ability of the models to predict all-cause mortality. Results: A total of 17356 unique patients were included for the final analysis after excluding 165 patients who underwent CABG surgery during the index hospitalization. The mean age was 66.9 ± 12.5 years;71% were male. Indications for PCI were ST-elevation myocardial infarction (9.4%), non-ST elevation myocardial infarction (12.9%), unstable angina (17.7%), and stable angina (52.8%) in the cohort. In-hospital, 6-month & 1 year mortality rates were 1.9%,4.2% & 5.8% respectively. The RF model was superior to the NCDR model in predicting inhospital, 6-month, 1 year mortality (p<0.0001) ( Figure 1 ). Conclusion: Machine learning is superior to NCDR model in predicting short and intermediate risk of all-cause mortality post PCI.

Introduction: Watchman has been increasingly used in AF patients who have difficulties taking anticoagulation, but the RCTs only compared Watchman to warfarin. There was also a signal of increased ischemic stroke with Watchman in comparison to warfarin in RCTs, which made some clinicians question the fundamental premise that Watchman can reduce stroke. We aimed to compare Watchman to no anticoagulation in a large national cohort of patients in the US. Methods: We identified AF patients treated with Watchman (N=7,309) or no anticoagulation (N=1,234,543) between 2015-2017 from the OptumLabs Data Warehouse, which is the first to link private insurance, Medicare Advantage, and Medicare Fee-for-Service records at patient level longitudinally. One-to-one propensity score matching was used to balance patients on demographics and medical history. The primary outcomes were ischemic stroke or systemic embolism (hereafter referred to as stroke) and major bleeding. Secondary outcomes included all-cause mortality and intracranial bleeding. Results: In the unmatched cohort, the mean age was 76.6±6.4 yr in the Watchman group and 76.6 ±8.5 yr in the no anticoagulation group, but Watchman patients were more likely to have a history of bleeding (44.9% vs 13.7%) and intracranial bleeding (9.5% vs 2.6%). After matching, the two groups were similar on 18 baseline characteristics. Watchman was associated with a lower risk of stroke and mortality, but a higher risk of major bleeding and a similar risk of intracranial bleeding. The associations were largely consistent across subgroups, including those with relative contraindications to anticoagulation (Figure). Conclusions: In AF patients who had difficulties taking anticoagulation, Watchman offers an alternative approach to reduce stroke and mortality. The results provide important evidence to inform clinical decision making in the absence of RCTs, since 40% of AF patients in routine practice are not on anticoagulation.

Background: Left atrial appendage occlusion (LAAO) devices have successfully provided an alternative therapeutic option in patients with atrial fibrillation and high bleeding risk. However, patients with thrombocytopenia (TP) were underrepresented in the milestone trials, and the optimal strategy of postprocedural antithrombotic therapy in this group of patients remains unclear. Methods: Patients were identified from the National Cardiac Database Registry - LAAO database at all three Mayo Clinic sites in the period from 1/2016-10/2019. Patients were further divided into TP (platelet &lt; 150 x 10^9/L) and control (platelet &gt; 150 x 10^9 /L) groups for clinical outcome analysis. Outcome endpoints include composite of bleeding (GI bleeding, hemorrhagic stroke, and other non-intracranial hemorrhage) and composite thrombotic events (device thrombus, ischemic stroke, TIA and undetermined stroke). Results: A total of 249 consecutive patients were included in the final analysis. The mean age was 76.7 ± 7.2 years, and 169 (67.9%) were male; 242 (97.2%) were white. The mean CHA2DS2-VASc score was 5.3 ±1.5, and the HAS-BLED score was 3.0 ± 1.1. TP at baseline was present in 74 (29.7%) patients. The median follow-up time was 6.8 months. The use of post-procedural antithrombotic regimens was similar between the two groups (Table 1). When comparing the TP group to control, there was no significant difference in composite bleeding events (10.8% vs. 8.0%, P = 0.069) and thrombotic events (2.7% vs. 2.3%, P= 0.170). Conclusions: The presence of baseline TP does not significantly increase post-procedural bleeding risk in atrial fibrillation/atrial flutter patients who underwent an LAAO occlusion procedure with the Watchman device (Boston Scientific). This group of patients can be treated with the same antithrombotic regimen as patients with normal platelet levels. Future studies are still warranted to determine the optimal antithrombotic regimen.

AbstractObjectivesWe investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10‐year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial.BackgroundTSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated.MethodsImpacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients.ResultsTSL as a continuous variable was significantly associated with 10‐year mortality (adjusted hazard ratio [HR], 1.05 [1.01–1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41–2.74]) or not‐ extensive stenting PCI (adjusted HR, 1.94 [1.36–2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85–1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23–2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19–2.53]). Patients treated with not‐extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG.ConclusionsExtensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA 2 DS 2 -VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% ( P <0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% ( P <0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02702271.

Racial disparities in utilization and outcomes of mechanical circulatory support (MCS) in patients with acute myocardial infarction-cardiogenic shock (AMI-CS) are infrequently studied. This study sought to evaluate racial disparities in the outcomes of MCS in AMI-CS. The National Inpatient Sample (2012–2017) was used to identify adult AMI-CS admissions receiving MCS support. MCS devices were classified as intra-aortic balloon pump (IABP), percutaneous left ventricular assist device (pLVAD) or extracorporeal membrane oxygenation (ECMO). Self-reported race was classified as white, black and others. Outcomes included in-hospital mortality, hospital length of stay and discharge disposition. During this period, 90,071 admissions were included with white, black and other races constituting 73.6%, 8.3% and 18.1%, respectively. Compared to white and other races, black race admissions were on average younger, female, with greater comorbidities, and non-cardiac organ failure (all p < 0.001). Compared to the white race (31.3%), in-hospital mortality was comparable in black (31.4%; adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.93–1.05); p = 0.60) and other (30.2%; aOR 0.96 (95% CI 0.92–1.01); p = 0.10). Higher in-hospital mortality was noted in non-white races with concomitant cardiac arrest, and those receiving ECMO support. Black admissions had longer lengths of hospital stay (12.1 ± 14.2, 10.3 ± 11.2, 10.9 ± 1.2 days) and transferred less often (12.6%, 14.2%, 13.9%) compared to white and other races (both p < 0.001). In conclusion, this study of AMI-CS admissions receiving MCS devices did not identify racial disparities in in-hospital mortality. Black admissions had longer hospital stay and were transferred less often. Further evaluation with granular data including angiographic and hemodynamic parameters is essential to rule out racial differences.