Holmes, David R.

Abstract Aims To assess the contemporary trends in aortic stenosis (AS) interventions in the USA before and after the introduction of transcatheter aortic valve implantation (TAVI). Methods and results We utilized the National-Inpatient-Sample to assess temporal trends in the incidence, cost, and outcomes of AS interventions between 1 January 2003 and 31 December 2016. During the study’s period, AS interventions increased from 96 to 137 per 100 000 individuals > 60 years old, P < 0.001. In-hospital expenditure on AS interventions increased from $2.28 billion in 2003 to $4.33 in 2016 P < 0.001. Among patients who underwent aortic valve replacement, the proportion of TAVI increased from 11.9% in 2012 to 43.2% in 2016 (P < 0.001). Males and Hispanics had lower proportions of TAVI compared with females and White patients. Adjusted in-hospital mortality of isolated SAVR decreased from 5.4% in 2003 to 3.3% in 2016 (P < 0.001), whereas adjusted in-hospital mortality of TAVI decreased from 4.7% in 2012 to 2.2% in 2016, P < 0.001. The incidence of new dialysis, permanent pacemaker implantation, and blood transfusion decreased after both TAVI and SAVR between 2012 and 2016. However, the rate of post-operative stroke did not significantly decrease. Length of stay and cost of hospitalization decreased after both SAVR and TAVI, although the later remained higher with TAVI. Rates of non-home discharge decreased over time after TAVI but remained stable after isolated SAVR. Conclusion This nationwide survey documents the increasing incidence of AS interventions, the rising cost of modern AS care, and the paradigm shift in aortic valve replacement practice in the USA.

There are contrasting data on concomitant Impella device in cardiogenic shock patients treated with venoarterial extracorporeal membrane oxygenation (VA ECMO) (ECPELLA). This study sought to compare early mortality in patients with cardiogenic shock treated with ECPELLA in comparison to VA ECMO alone. We reviewed the published literature from 2000 to 2018 for randomized, cohort, case-control, and case series studies evaluating adult patients requiring VA ECMO for cardiogenic shock. Five retrospective observational studies, representing 425 patients, were included. Venoarterial extracorporeal membrane oxygenation with concomitant Impella strategy was used in 27% of the patients. Median age across studies varied between 51 and 63 years with 59–88% patients being male. Use of ECPELLA was associated with higher weaning from VA ECMO and bridging to permanent ventricular assist device or cardiac transplant in three and four studies, respectively. The studies showed moderate heterogeneity with possible publication bias. The two studies that accounted for differences in baseline characteristics between treatment groups reported lower 30 day mortality with ECPELLA versus VA ECMO. The remaining three studies did not adjust for potential confounding and were at high risk for selection bias. In conclusion, ECPELLA is being increasingly used as a strategy in patients with cardiogenic shock. Additional large, high-quality studies are needed to evaluate clinical outcomes with ECPELLA.

Background This study sought to evaluate the 15‐year national utilization, trends, predictors, disparities, and outcomes of palliative care services ( PCS ) use in cardiogenic shock complicating acute myocardial infarction. Methods and Results A retrospective cohort from January 1, 2000 through December 31, 2014 was analyzed using the National Inpatient Sample database. Administrative codes for acute myocardial infarction–cardiogenic shock and PCS were used to identify eligible admissions. The primary outcomes were the frequency, utilization trends, and predictors of PCS . Secondary outcomes included in‐hospital mortality and resources utilization. Multivariable regression and propensity‐matching analyses were used to control for confounding. In this 15‐year period, there were 444 253 acute myocardial infarction–cardiogenic shock admissions, of which 4.5% received PCS . The cohort receiving PCS was older, of white race, female sex, and with higher comorbidity and acute organ failure. The PCS cohort received fewer cardiac procedures, but more noncardiac organ support therapies. Older age, female sex, white race, higher comorbidity, higher socioeconomic status, admission to a larger hospital, and admission after 2008 were independent predictors of PCS use. Use of PCS was independently associated with higher in‐hospital mortality (odds ratio 6.59 [95% CI 6.37–6.83]; P <0.001). The cohort with PCS use had >2‐fold higher in‐hospital mortality, 12‐fold higher use of do‐not‐resuscitate status, lesser in‐hospital resource utilization, and fewer discharges to home. Similar findings were observed in the propensity‐matched cohort. Conclusions PCS use in patients with acute myocardial infarction–cardiogenic shock is low, though there is a trend towards increased adoption. There are significant patient and hospital‐specific disparities in the utilization of PCS .

Background Data on race‐ and ethnicity‐based disparities in the utilization and outcomes of structural heart disease interventions in the United States are scarce. Methods and Results We used the National Inpatient Sample (2011‐2016) to examine racial and ethnic differences in the utilization, in‐hospital outcomes, and cost of structural heart disease interventions among patients ≥65 years of age. A total of 106 119 weighted hospitalizations for transcatheter aortic valve replacement, transcatheter mitral valve repair, and left atrial appendage occlusion were included. The utilization rates (defined as the number of procedures performed per 100 000 US people >65 years of age) were higher in whites compared with blacks and Hispanics for transcatheter aortic valve replacement (43.1 versus 18.0 versus 21.1), transcatheter mitral valve repair (5.0 versus 3.2 versus 3.2), and left atrial appendage occlusion (6.6 versus 2.1 versus 3.5), respectively ( P <0.001). Black and Hispanic patients had distinctive socioeconomic and clinical risk profiles compared with white patients. There were no significant differences in the adjusted in‐hospital mortality or key complications between patients of white race, black race, and Hispanic ethnicity following transcatheter aortic valve replacement, transcatheter mitral valve repair, or left atrial appendage occlusion. No difference in cost was observed between white and black patients following any of the 3 procedures. However, Hispanic patients incurred modestly higher cost with transcatheter mitral valve repair and left atrial appendage occlusion compared with white patients. Conclusions Racial and ethnic disparities exist in the utilization of structural heart disease interventions in the United States. Nonetheless, adjusted in‐hospital outcomes were comparable among white, black, and Hispanic patients. Further studies are needed to understand the reasons for these utilization disparities.

Background: We aim to study the incidence of major complications related to procedure defined as in-hospital death, myocardial infarction, stroke, pericardial effusion or tamponade, percutaneous coronary intervention due to iatrogenic coronary dissection, or unplanned bypass surgery within 72 hours after diagnostic left heart catheterization (LHC; primary end point). Furthermore, all causes of in-hospital death after LHC were adjudicated and reported (secondary end point). Methods and Results: Diagnostic LHC procedures (aortic angiography; coronary, including graft, angiography; and left ventricular angiography) from January 1, 2002, through December 31, 2013, were identified using the clinical scheduling system at Mayo Clinic, Rochester, and complications were identified through electronic records. International Classification of Diseases, Ninth Revision billing codes were used. Registration was queried to identify all-cause mortality. All events were reviewed and adjudicated. There were 43 786 diagnostic LHC procedures; 97.3% were coronary angiograms. The mean age of patients was 64.5 years (13.6), and the majority were male (61.5%). Primary end point was seen in 36 (0.082%) procedures or 8.2 of 10 000 LHCs. Combined right sided procedures with LHC did not increase the risk of major complications. Cardiogenic and septic shock, cardiac arrhythmia, and postsurgical complication were the most common causes of in-hospital death after LHC. Conclusions: The overall rates of major complications related to diagnostic cardiac catheterization procedures are extremely rare. The majority of the deaths occurring post-diagnostic LHC procedures were secondary to acute illness rather than directly related to diagnostic procedure.

Background Recent publications reached conflicting conclusions about the cost‐effectiveness of left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, Marlborough, MA) for stroke risk reduction in nonvalvular atrial fibrillation (AF). This analysis sought to assess the cost‐effectiveness of LAAC relative to both warfarin and nonwarfarin oral anticoagulants (NOACs) using pooled, long‐term data from the randomized PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long‐Term Warfarin) trials. Methods and Results A Markov model was constructed from a US payer perspective with a lifetime (20‐year) horizon. LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF and PREVAIL trial 5‐year data. Warfarin and NOAC inputs were derived from published meta‐analyses. The model was populated with a cohort of 10 000 patients, aged 70 years, at moderate stroke and bleeding risk. Sensitivity analyses were performed. LAAC was cost‐effective relative to warfarin by year 7 ($48 674/quality‐adjusted life‐year) and dominant (more effective and less costly) by year 10. LAAC became cost‐effective and dominant compared with NOACs by year 5. Over a lifetime, LAAC provided 0.60 more quality‐adjusted life‐years than warfarin and 0.29 more than NOACs. In sensitivity analyses, LAAC was cost‐effective relative to warfarin and NOACs in 98% and 95% of simulations, respectively. Conclusions Using pooled, 5‐year PROTECT AF and PREVAIL trial data, LAAC proved to be not only cost‐effective, but cost saving relative to warfarin and NOACs. LAAC with the Watchman device is an economically viable stroke risk reduction strategy for patients with AF seeking an alternative to lifelong anticoagulation.

Background Patients with symptomatic severe aortic stenosis and a history of chest radiation therapy represent a complex and challenging cohort. It is unknown how transcatheter aortic valve replacement ( TAVR ) compares with surgical aortic valve replacement in this group of patients, which was the objective of this study. Methods and Results We retrospectively reviewed all patients with severe aortic stenosis who underwent either TAVR or surgical aortic valve replacement at our institution with a history of mediastinal radiation (n=55 per group). End points were echocardiographic and clinical outcomes in‐hospital, at 30 days, and at 1 year. Inverse propensity weighting analysis was used to account for intergroup baseline differences. TAVR patients had a higher STS score than surgical aortic valve replacement patients (5.1% [3.2, 7.7] versus 1.6% [0.8, 2.6], P <0.001) and more often ( P <0.01 for all) a history of atrial fibrillation (45.5% versus 12.7%), chronic lung disease (47.3% versus 7.3%), peripheral arterial disease (38.2% versus 7.3%), heart failure (58.2% versus 18.2%), and pacemaker therapy (23.6% versus 1.8%). Postoperative atrial fibrillation was less frequent (1.8% versus 27.3%; P <0.001) and hospital stay was shorter in TAVR patients (4.0 [2.0, 5.0] versus 6.0 [5.0, 8.0] days; P <0.001). The ratio of observed‐to‐expected 30‐day mortality was lower after TAVR as was 30‐day mortality in inverse propensity weighting–adjusted Kaplan–Meier analyses. Conclusions In patients with severe aortic stenosis and a history of chest radiation therapy, TAVR performs better than predicted along with less adjusted 30‐day all‐cause mortality, postoperative atrial fibrillation, and shorter hospitalization compared with surgical aortic valve replacement. These data support further studies on the preferred role of TAVR in this unique patient population.