Days at Home After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

BACKGROUND: Days at home (DAH) represents an important patient-oriented outcome that quantifies time spent at home after a medical event; however, this outcome has not been fully evaluated for low-surgical-risk patients undergoing transcatheter aortic valve replacement (TAVR). We sought to compare 1- and 2-year DAH (DAH365 and DAH730) among low-risk patients participating in a randomized trial of TAVR with a self-expanding bioprosthesis versus surgical aortic valve replacement (SAVR). METHODS: Using Medicare-linked data from the Evolut Low Risk trial, we identified 619 patients: 606 (322 TAVR/284 SAVR) and 593 (312 TAVR/281 SAVR) were analyzed at 1 and 2 years, respectively. DAH was calculated as days alive and spent outside a hospital, inpatient rehabilitation, skilled nursing facility, long-term acute care hospital, emergency department, or observation stay. Mean DAH was compared using the t test. RESULTS: The mean (SD) age and female sex were 74.7 (5.1) and 74.3 (4.9) years and 34.6% (115/332) and 30.3% (87/287) in TAVR and SAVR, respectively. Postprocedural discharge to rehabilitation occurred in ≤3.0% (≤10/332) in TAVR and 4.5% (13/287) in SAVR. The mean DAH365 was comparable in TAVR versus SAVR (352.2±45.4 versus 347.8±39.0; difference in days, 4.5 [95% CI, 2.3-11.2]; P=0.20). DAH730 was also comparable in TAVR versus SAVR (701.6±106.0 versus 699.6±94.5; difference in days, 2.0 [-14.1 to 18.2]; P=0.81). Secondary outcomes DAH30 and DAH90 were higher in TAVR (DAH30, 26.0±3.6 versus 20.7±6.4; difference in days, 5.3 [4.5-6.2]; P<0.001; DAH90, 85.1±8.3 versus 78.7±13.6; difference in days, 6.4 [4.6-8.2]; P<0.001). CONCLUSIONS: In the Evolut Low Risk trial linked to Medicare, low-risk patients undergoing TAVR spend a similar number of days at home at 1 and 2 years compared with SAVR. Days spent at home at 30 and 90 days were higher in TAVR. In contrast to higher-risk patients studied in prior work, there is no clear advantage of TAVR versus SAVR for DAH in the first 2 years after AVR in low-surgical-risk patients.

Days at home after transcatheter or surgical aortic valve replacement in high-risk patients.

BACKGROUND: Days at home (DAH) quantifies time spent at home after a medical event but has not been fully evaluated for TAVR. We sought to compare 1- and 5-year DAH (DAH365, DAH1825) among high-risk patients participating in a randomized trial of transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis versus surgical aortic valve replacement (SAVR). METHODS: We linked data from the U.S. CoreValve High Risk Trial to Medicare Fee-for-Service claims in 456 patients with 450 (234 TAVR/216 SAVR) and 427 (222 TAVR/205 SAVR) analyzed at 1 and 5 years. DAH was calculated as the number of days alive and spent outside of a hospital, skilled nursing facility, rehabilitation, long-term acute care hospital, emergency department, or observation stay. RESULTS: Mean DAH365 was higher in patients who underwent TAVR compared with SAVR (295.1 ± 106.9 vs 267.8 ± 122.3, difference in days 27.2 [95% CI 6.0, 48.5], P = .01). Compared with SAVR, TAVR patients had a shorter index length of stay (LOS) (7.4 ± 4.5 vs 12.5 ± 9.0, difference in days -5.1 [-6.5, -3.8], P < .001). The largest contributions to decreased DAH365 were mortality days and total facility days after discharge from the index hospitalization (mortality days-TAVR: 34.7 ± 93.1 vs SAVR: 48.0 ± 108.8, difference in days -13.3 [95% CI -32.1, 5.5], P = .17; total facility days-TAVR: 27.9 ± 47.4 vs SAVR: 36.7 ± 48.9, difference in days -8.8 [95% CI -17.8, 0.1], P = .05). Mean DAH1825 was numerically but not statistically significantly higher in TAVR (TAVR: 1154.2 ± 659.0 vs SAVR: 1067.6 ± 697.3, difference in days 86.6 [95% CI -42.3, 215.6], P = .19). Landmark analysis showed no difference in DAH from years 1 to 5 (TAVR: 1040.4 ± 477.5 vs SAVR: 1022.9 ± 489.3, P = .74). CONCLUSIONS: In the U.S. CoreValve High Risk Trial linked to Medicare, high-risk patients undergoing TAVR spend an average of 27 additional DAH compared with SAVR in the first year after the procedure due to a shorter index LOS and the additive effect of fewer but nonsignificantly different mortality and total facility days after discharge from the index hospitalization compared with SAVR. After the first year, both groups spend a similar number of DAH. These results describe the postprocedural course of high-risk patients from a patient-centered perspective, which may guide expectations regarding longitudinal health care needs and inform shared decision-making.

Outcomes of stroke events during transcatheter aortic valve implantation.

BACKGROUND: Despite improvements in the safety of transcatheter aortic valve implantation (TAVI), ~4% of patients experience a procedure-related stroke. Understanding long-term health and healthcare implications of these events may motivate the development and adoption of preventative strategies.  Aims: We aimed to assess the association of TAVI-related ischaemic stroke with subsequent clinical outcomes and healthcare utilisation. METHODS: We used Medicare fee-for-service claims to identify patients who underwent their first TAVI between January 2012 and December 2017. Previously used ICD-9-CM and ICD-10-CM codes were used to identify TAVI-related ischaemic stroke. Among those with and without TAVI-related ischaemic stroke, we compared the risk of a composite endpoint that included all-cause mortality, acute myocardial infarction, and subsequent stroke using inverse probability treatment weighted Cox regression. We also performed a difference-in-difference analysis to compare 1-year Medicare expenditures and days spent at home during the first year after TAVI. RESULTS:  Among 129,628 primary TAVI patients, 5,549 (4.3%) had a procedure-related stroke. These patients were more likely to be female and have had prior stroke, peripheral vascular disease, ischaemic heart disease, or renal failure. After adjustment, TAVI-related ischaemic stroke was associated with a higher risk of the 1-year composite outcome (HR 1.67, 95% CI: 1.56-1.78), higher 1-year Medicare expenditures (difference $9,245 [standard error 790], p<0.001), and fewer days at home during the first year (difference 16 days [standard error 1], p<0.001). CONCLUSIONS: Among Medicare beneficiaries undergoing TAVI, procedure-related ischaemic stroke was associated with worse outcomes, increased Medicare expenditures, and less time spent at home. Procedure-related ischaemic stroke during TAVI remains a critically important and potentially preventable source of patient mortality, morbidity and healthcare utilisation.

Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Variation in Practice and Outcomes.

OBJECTIVES: The aims of this study were to examine variation in the use of conscious sedation (CS) for transcatheter aortic valve replacement (TAVR) across hospitals and over time and to evaluate outcomes of CS compared with general anesthesia (GA) using instrumental variable analysis, a quasi-experimental method to control for unmeasured confounding. BACKGROUND: Despite increasing use of CS for TAVR, contemporary data on utilization patterns are lacking, and existing studies evaluating the impact of sedation choice on outcomes may suffer from unmeasured confounding. METHODS: Among 120,080 patients in the TVT (Transcatheter Valve Therapy) Registry who underwent transfemoral TAVR between January 2016 and March 2019, the relationship between anesthesia choice and TAVR outcomes was evaluated using hospital proportional use of CS as an instrumental variable. RESULTS: Over the study period, the proportion of TAVR performed using CS increased from 33% to 64%, and CS was used in a median of 0% and 91% of cases in the lowest and highest quartiles of hospital CS use, respectively. On the basis of instrumental variable analysis, CS was associated with decreases in in-hospital mortality (adjusted risk difference: 0.2%; p = 0.010) and 30-day mortality (adjusted risk difference: 0.5%; p < 0.001), shorter length of hospital stay (adjusted difference: 0.8 days; p < 0.001), and more frequent discharge to home (adjusted risk difference: 2.8%; p < 0.001) compared with GA. The magnitude of benefit for most endpoints was less than in a traditional propensity score-based approach, however. CONCLUSIONS: In contemporary U.S. practice, the use of CS for TAVR continues to increase, although there remains wide variation across hospitals. The use of CS for TAVR is associated with improved outcomes (including reduced mortality) compared with GA, although the magnitude of benefit appears to be less than in previous studies.

Extracorporeal Membrane Oxygenation Use in Cardiogenic Shock: Impact of Age on In-Hospital Mortality, Length of Stay, and Costs.

OBJECTIVES: Increasing age is a well-recognized risk factor for in-hospital mortality in patients receiving extracorporeal membrane oxygenation for cardiogenic shock, but the shape of this relationship is unknown. In addition, the impact of age on hospital length of stay, patterns of patient disposition, and costs has been incompletely characterized. DESIGN: Retrospective analysis of the National Inpatient Sample. SETTING: U.S. nonfederal hospitals, years 2004-2016. PATIENTS: Adults with cardiogenic shock treated with extracorporeal membrane oxygenation (3,094; weighted national estimate: 15,415). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The mean age of extracorporeal membrane oxygenation recipients was 54.8 ± 15.4 years (range, 18-90 yr). Crude in-hospital mortality was 57.7%. Median time-to-death was 8 days (interquartile range, 3-17 d). A linear relationship between age and in-hospital mortality was observed with a 14% increase in the adjusted odds of in-hospital mortality for every 10-year increase in age (adjusted odds ratio, 1.14; 95% CI, 1.08-1.21; p < 0.0001). Thirty-four percent of patients were discharged alive at a median time of 30 days (interquartile range, 19-48 d). The median length of stay and total hospitalization costs were 14 days (interquartile range, [5-29 d]) and $134,573 ($71,782-$239,439), respectively, both of which differed significantly by age group (length of stay range from 17 d [18-49 yr] to 9 d [80-90 yr]; p < 0.0001 and cost range $147,548 [18-49 yr] to $105,350 [80-90 yr]; p < 0.0001). CONCLUSIONS: Age is linearly associated with increasing in-hospital mortality in individuals receiving extracorporeal membrane oxygenation for cardiogenic shock without evidence of a threshold effect. Median time-to-death is approximately 1 week. One third of patients are discharged from the hospital alive, but the median time-to-discharge is 1 month. Median length of stay ranges from 9 to 17 days depending on age. Hospitalization costs exceed $100,000 in all age groups.

National trends, predictors of use, and in-hospital outcomes in mechanical circulatory support for cardiogenic shock.

AIMS: Despite rising rates of cardiogenic shock (CS), data on trends and in-hospital outcomes of short-term non-durable mechanical circulatory support (MCS) are limited. Thus, we aimed to identify recent national trends in MCS utilisation in the USA, patient-level predictors of MCS use, and in-hospital outcomes in CS inclusive of extracorporeal membrane oxygenation (ECMO). METHODS AND RESULTS: Hospitalisations of US adults with a discharge diagnosis of CS, from January 2004 to December 2014, in the National Inpatient Sample were included. Rates of MCS were stratified by device type and clinical presentation. Outcomes included in-hospital mortality, hospitalisation costs, and number of procedures. A total of 183,516 hospitalisations with CS (47,636 [25.9%] involving MCS) were included. MCS recipients were younger, less frequently female, received more procedures, had higher costs, and more frequently presented with MI (MCS vs. non-MCS: 71.6% vs. 42.9%; p<0.0001). Growth in CS hospitalisations (214.4%) outpaced annual MCS use (160.0%), with relative declines in intra-aortic balloon pump use starting in 2008. Right heart catheterisation rates for both groups remained low (MCS vs. non-MCS: 5.9% vs. 3.3%; p<0.0001). In-hospital mortality declined but remained high in both groups (MCS vs. non-MCS [2014]: 32.7% vs. 41.5%; p<0.0001). CONCLUSIONS: In-hospital mortality for CS has declined but remains high. Rates of CS have outpaced MCS utilisation which remains uncommon in non-MI hospitalisations with shock. MCS is associated with utilisation of other procedures during hospitalisation.

Genetic effects on carotid intima-media thickness: systematic assessment and meta-analyses of candidate gene polymorphisms studied in more than 5000 subjects.

BACKGROUND: Carotid intima-media thickness (CIMT) is highly heritable and associated with stroke and myocardial infarction, making it a promising quantitative intermediate phenotype for genetic studies of vascular disease. There have been many CIMT candidate gene association studies, but no systematic review to identify consistent, reliable findings. METHODS AND RESULTS: We comprehensively sought all published studies of association between CIMT and any genetic polymorphism. We obtained additional unpublished data and performed meta-analyses for the 5 most commonly studied genes (studied in at least 2 studies in a total of >5000 subjects). We used a 3-step meta-analysis method: meta-analysis of variance; genetic model selection; and random effects meta-analysis of the mean CIMT difference between genotypes. We performed subgroup analyses to investigate effects of ethnicity, vascular risk status, and study size. We accounted for potential reporting bias by assessing qualitatively the possible effects of including unavailable data. Polymorphisms in 3 of the 5 genes (apolipoprotein E, angiotensin I converting enzyme, and 5,10-methylenetetrahydrofolate reductase) had an apparent association with CIMT, but for all these, we found evidence of small study bias. Apolipoprotein E epsilon2/epsilon3/epsilon4 was the only polymorphism with a persistent, statistically significant but modest association when we restricted analysis to larger studies (>1000 subjects). CONCLUSIONS: Of the most extensively studied polymorphisms, apolipoprotein E epsilon2/epsilon3/epsilon4 is the only one so far with a convincing association with CIMT. Larger studies than have generally been performed so far may be needed to confirm the associations identified in future genome-wide association studies, and to investigate modification of effect according to characteristics such as ethnicity and vascular risk status.