Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland.

BACKGROUND: Mitral regurgitation (MR) is the most common valvular disease in the United States and increases the risk of death and hospitalization. The economic burden of MR in the United States is not known. METHODS AND RESULTS: We analyzed inpatient hospitalization data from the 1 221 173 Maryland residents who had any in-state admissions from October 1, 2015, to September 30, 2019. We assessed the total charges for patients without MR and for patients with MR who underwent medical management, transcatheter mitral valve repair or replacement, or surgical mitral valve repair or replacement. During the study period, 26 076 inpatients had a diagnosis of MR. Compared with patients without MR, these patients had more comorbidities and higher inpatient mortality. Patients with medically managed MR incurred average total charges of $23 575 per year; MR was associated with $10 559 more in charges per year and an incremental 3.1 more inpatient days per year as compared with patients without MR. Both surgical mitral valve repair or replacement and transcatheter mitral valve repair or replacement were associated with higher charges as compared with medical management during the year of intervention ($47 943 for surgical mitral valve repair or replacement and $63 108 for transcatheter mitral valve repair or replacement). Annual charges for both groups were significantly lower as compared with medical management in the second and third years postintervention. CONCLUSIONS: MR is associated with higher mortality and inpatient charges. Patients who undergo surgical or transcatheter intervention incur lower charges compared with medically managed MR patients in the years after the procedure.

Hierarchical Development of Physical Frailty and Cognitive Impairment and Their Association With Incident Cardiovascular Disease.

BACKGROUND: Frailty and cognitive impairment (CI) are geriatric conditions that lead to poor health outcomes among older adults with cardiovascular disease. The association between their temporal patterns of development and cardiovascular risk is unknown. OBJECTIVES: This study aims to examine the 5-year cardiovascular outcomes by the pattern of development of frailty and CI in older adults without a history of coronary artery disease. METHODS: We used the National Health and Aging Trends Study, linked to Medicare data. Frailty was measured using the physical frailty phenotype. CI was measured using the AD8 Dementia Screening Interview, measured cognitive performance, or self-report by patient or caregiver for a diagnosis given by a physician. The primary outcome was incident major adverse cardiovascular event at 5 years. RESULTS: Of a total 2,189 study participants aged 65 and older, 38.5% were male. In this study population, 154 (7%) participants developed frailty first, 829 (38%) developed CI first, and 195 (9%) participants developed both simultaneously (frail-CI group). Those who developed frailty and CI simultaneously were older, more likely to be female, and had multiple chronic conditions. The frail-CI group had the highest risk of major adverse cardiovascular event (hazard ratio [HR]: 1.81; 95% CI: 1.47-2.23) followed by frail first (HR: 1.46; 95% CI: 1.17-1.81) and CI first (HR: 1.31; 95% CI: 1.15-1.50). Frailty first was associated with the greater risk of stroke (HR: 1.49; 95% CI: 1.06-2.09) compared to the intact group. CONCLUSIONS: The simultaneous development of frailty and CI is associated with an increased risk of adverse cardiovascular outcomes including death compared with the development of each syndrome alone. Diagnostics to detect frailty and CI are critical in assessment of cardiovascular risk in the older population.

Outcomes among patients undergoing transcatheter aortic valve replacement with very low baseline gradients.

Background: While there is evidence that patients with low-flow, low-gradient aortic stenosis (AS) benefit from transcatheter aortic valve replacement (TAVR), data are lacking regarding outcomes of patients with a very low gradient (VLG). Methods: In this retrospective, single-center study of patients with severe AS who underwent TAVR, three groups were defined using baseline mean aortic valve gradient: VLG (≤25 mmHg), low gradient (LG, 26-39 mmHg), and high gradient (HG, ≥40 mmHg). The primary outcome was the composite of Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 of <45, decrease in KCCQ-12 of ≥10 compared with baseline, or death at 1 year. Results: One-thousand six patients were included: 571 HG, 353 LG, and 82 VLG. The median age was 82.1 years [interquartile range (IQR) 76.3-86.9]; VLG patients had more baseline comorbidities compared with the other groups. The primary outcome was highest at 1 year in the VLG group (VLG, 46.7%; LG, 29.9%; HG, 23.1%; p = 0.002), with no difference between groups after adjustment for baseline characteristics. At baseline, <30% of VLG patients had an excellent or good (50-100) KCCQ-12, whereas more than 75% and 50% had an excellent or good KCCQ-12 at 30-day and 1-year follow-up, respectively. Conclusion: Although patients with VLG undergoing TAVR have a higher rate of poor outcomes at 1 year compared with patients with LG and HG severe AS, this difference is largely attributable to baseline comorbidities. Patients with severe AS undergoing TAVR have significant improvement in health status outcomes regardless of resting mean gradient.

The impact of a statewide payment reform on transcatheter aortic valve replacement (TAVR) utilization and readmissions.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an increasingly used but relatively expensive procedure with substantial associated readmission rates. It is unknown how cost-constrictive payment reform measures, such as Maryland's All Payer Model, impact TAVR utilization given its relative expense. This study investigated the impact of Maryland's All Payer Model on TAVR utilization and readmissions among Maryland Medicare beneficiaries. METHODS: This was a quasi-experimental investigation of Maryland Medicare patients undergoing TAVR between 2012 and 2018. New Jersey data were used for comparison. Longitudinal interrupted time series analyses were used to study TAVR utilization and difference-in-differences analyses were used to investigate post-TAVR readmissions. RESULTS: During the first year of payment reform (2014), TAVR utilization among Maryland Medicare beneficiaries dropped by 8% (95% confidence interval [CI]: -9.2% to -7.1%; p < 0.001), with no concomitant change in TAVR utilization in New Jersey (0.2%, 95% CI: 0%-1%, p = 0.09). Longitudinally, however, the All Payer Model did not impact TAVR utilization in Maryland compared to New Jersey. Difference-in-differences analyses demonstrated that implementation of the All Payer Model was not associated with significantly greater declines in 30-day post-TAVR readmissions in Maryland versus New Jersey (-2.1%; 95% CI: -5.2% to 0.9%; p =0.1). CONCLUSIONS: Maryland's All Payer Model resulted in an immediate decline in TAVR utilization, likely a result of hospitals adjusting to global budgeting. However, beyond this transition period, this cost-constrictive reform measure did not limit Maryland TAVR utilization. In addition, the All Payer Model did not reduce post-TAVR 30-day readmissions. These findings may help inform expansion of globally budgeted healthcare payment structures.

Radial versus femoral secondary access for transcatheter aortic valve replacement: A systematic review and meta-analysis.

OBJECTIVES: We aimed to evaluate the risk of procedural complications after TAVR using secondary radial access (RA) versus femoral access (FA) through a systematic review and meta-analysis of the published literature. BACKGROUND: Transcatheter aortic valve replacement (TAVR) entails both large-bore arterial access for device delivery and secondary arterial access for hemodynamic and imaging assessments. It is unknown whether RA versus FA for this secondary access reduces the risk of procedural complications. METHODS: We searched PubMed, Embase, the Cochrane Library, and Web of Science for observational studies comparing TAVR procedural complications in RA versus FA. Event rates were compared via weighted summary odds ratios using the Mantel-Haenszel method. RESULTS: Six manuscripts encompassing 6132 patients were included. Meta-analysis showed that RA reduced the risk of major vascular complications (OR 0.58, 95% CI 0.43-0.77, p < 0.001, I2 0%) and major/life-threatening bleeding (OR 0.46, 95% CI 0.36-0.59, p < 0.001, I2 0%) as compared to FA for secondary TAVR access. We also observed a reduction 30-day mortality (OR 0.55, 95% CI 0.38-0.79, p = 0.001, I2 0%), acute kidney injury (OR 0.45, 95% CI 0.34-0.60, p < 0.001, I2 0%), and stroke and transient ischemic attack (OR 0.43, 95% CI 0.27-0.67, p < 0.001, I2 0%). CONCLUSIONS: RA reduced the risk of major vascular and bleeding complications when compared to FA for secondary access in TAVR. RA is associated with reduced risk of other adverse outcomes including mortality, but these associations may be related to selection bias and confounding given the observational study designs.

Inequities in Aortic Stenosis and Aortic Valve Replacement Between Black/African-American, White, and Hispanic Residents of Maryland.

Background Racial and ethnic inequities exist in surgical aortic valve replacement for aortic stenosis (AS), and early studies have suggested similar inequities in transcatheter aortic valve replacement. Methods and Results We performed a retrospective analysis of the Maryland Health Services Cost Review Commission inpatient data set from 2016 to 2018. Black patients had half the incidence of any inpatient AS diagnosis compared with White patients (incidence rate ratio [IRR], 0.50; 95% CI, 0.48-0.52; P<0.001) and Hispanic patients had one fourth the incidence compared with White patients (IRR, 0.25; 95% CI, 0.22-0.29; P<0.001). Conversely, the incidence of any inpatient mitral regurgitation diagnosis did not differ between White and Black patients (IRR, 1.00; 95% CI, 0.97-1.03; P=0.97) but was significantly lower in Hispanic compared with White patients (IRR, 0.36; 95% CI, 0.33-0.40; P<0.001). After multivariable adjustment, Black race was associated with a lower incidence of surgical aortic valve replacement (IRR, 0.67; 95% CI, 0.55-0.82 P<0.001 relative to White race) and transcatheter aortic valve replacement (IRR, 0.77; 95% CI, 0.65-0.90; P=0.002) among those with any inpatient diagnosis of AS. Hispanic patients had a similar rate of surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients. Conclusions Hospitalization with any diagnosis of AS is less common in Black and Hispanic patients than in White patients. In hospitalized patients with AS, Black race is associated with a lower incidence of both surgical aortic valve replacement and transcatheter aortic valve replacement compared with White patients, whereas Hispanic patients have a similar incidence of both. The reasons for these inequities are likely multifactorial.

Frailty and cardiovascular outcomes in the National Health and Aging Trends Study.

AIMS: Physical frailty is a commonly encountered geriatric syndrome among older adults without coronary heart disease (CHD). The impact of frailty on the incidence of long-term cardiovascular outcomes is not known.We aimed to evaluate the long-term association of frailty, measured by the Fried frailty phenotype, with all-cause-mortality and MACE among older adults without a history of CHD at baseline in the National Health and Aging Trends Study. METHODS AND RESULTS: We used the National Health and Aging Trends Study, a prospective cohort study linked to a Medicare sample. Participants with a prior history of CHD were excluded. Frailty was measured during the baseline visit using the Fried physical frailty phenotype. Cardiovascular outcomes were assessed during a 6-year follow-up.Of the 4656 study participants, 3259 (70%) had no history of CHD 1 year prior to their baseline visit. Compared to those without frailty, subjects with frailty were older (mean age 82.1 vs. 75.1 years, P < 0.001), more likely to be female (68.3% vs. 54.9%, P < 0.001), and belong to an ethnic minority. The prevalence of hypertension, falls, disability, anxiety/depression, and multimorbidity was much higher in the frail and pre-frail than the non-frail participants. In a Cox time-to-event multivariable model and during 6-year follow-up, the incidences of death and of each individual cardiovascular outcomes were all significantly higher in the frail than in the non-frail patients including major adverse cardiovascular event (MACE) [hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.53, 2.06], death (HR 2.70, 95% CI 2.16, 3.38), acute myocardial infarction (HR 1.95, 95% CI 1.31, 2.90), stroke (HR 1.71, 95% CI 1.34, 2.17), peripheral vascular disease (HR 1.80, 95% CI 1.44, 2.27), and coronary artery disease (HR 1.35, 95% CI 1.11, 1.65). CONCLUSION: In patients without CHD, frailty is a risk factor for the development of MACEs. Efforts to identify frailty in patients without CHD and interventions to limit or reverse frailty status are needed and, if successful, may limit subsequent adverse cardiovascular events.

Physical Frailty Phenotype and the Development of Geriatric Syndromes in Older Adults with Coronary Heart Disease.

BACKGROUND: Frailty, a clinical state of vulnerability, is associated with subsequent adverse geriatric syndromes in the general population. We examined the long-term impact of frailty on geriatric outcomes among older patients with coronary heart disease. METHODS: We used the National Health and Aging Trends Study, a prospective cohort study linked to a Medicare sample. Coronary heart disease was identified by self-report or International Classification of Diseases (ICD) codes 1-year prior to the baseline visit. Frailty was measured using the Fried physical frailty phenotype. Geriatric outcomes were assessed annually during a 6-year follow-up. RESULTS: Of the 4656 participants, 1213 (26%) had a history of coronary heart disease 1-year prior to their baseline visit. Compared to those without frailty, subjects with frailty were older (ages ≥75: 80.9% vs 68.9%, P < 0.001), more likely to be female, and belong to an ethnic minority. The prevalence of hypertension, stroke, falls, disability, anxiety/depression, and multimorbidity were much higher in the frail, than nonfrail, participants. In a discrete time survival model, the incidence of geriatric syndromes during 6-year follow-up including 1) dementia, 2) loss of independence, 3) activities of daily living disability, 4) instrumental activities of daily living disability, and 5) mobility disability were significantly higher in the frail than in the nonfrail older patients with coronary heart disease. CONCLUSION: In patients with coronary heart disease, frailty is a risk factor for the accelerated development of geriatric outcomes. Efforts to identify frailty in the context of coronary heart disease are needed, as well as interventions to limit or reverse frailty status for older patients with coronary heart disease.

Myocardial Injury in Severe COVID-19 Compared With Non-COVID-19 Acute Respiratory Distress Syndrome.

BACKGROUND: Knowledge gaps remain in the epidemiology and clinical implications of myocardial injury in coronavirus disease 2019 (COVID-19). We aimed to determine the prevalence and outcomes of myocardial injury in severe COVID-19 compared with acute respiratory distress syndrome (ARDS) unrelated to COVID-19. METHODS: We included intubated patients with COVID-19 from 5 hospitals between March 15 and June 11, 2020, with troponin levels assessed. We compared them with patients from a cohort study of myocardial injury in ARDS and performed survival analysis with primary outcome of in-hospital death associated with myocardial injury. In addition, we performed linear regression to identify clinical factors associated with myocardial injury in COVID-19. RESULTS: Of 243 intubated patients with COVID-19, 51% had troponin levels above the upper limit of normal. Chronic kidney disease, lactate, ferritin, and fibrinogen were associated with myocardial injury. Mortality was 22.7% among patients with COVID-19 with troponin under the upper limit of normal and 61.5% for those with troponin levels >10 times the upper limit of normal (P<0.001). The association of myocardial injury with mortality was not statistically significant after adjusting for age, sex, and multisystem organ dysfunction. Compared with patients with ARDS without COVID-19, patients with COVID-19 were older and had higher creatinine levels and less favorable vital signs. After adjustment, COVID-19-related ARDS was associated with lower odds of myocardial injury compared with non-COVID-19-related ARDS (odds ratio, 0.55 [95% CI, 0.36-0.84]; P=0.005). CONCLUSIONS: Myocardial injury in severe COVID-19 is a function of baseline comorbidities, advanced age, and multisystem organ dysfunction, similar to traditional ARDS. The adverse prognosis of myocardial injury in COVID-19 relates largely to multisystem organ involvement and critical illness.

Prasugrel vs Ticagrelor for DAPT in Patients with ACS Undergoing PCI: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor added to aspirin is considered the standard of care for patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Prasugrel and ticagrelor are commonly used P2Y12 inhibitors, and a few head-to-head randomized control trials (RCTs) have been performed. We performed a systematic review and meta-analysis of these RCTs to compare the efficacy and adverse effects between these two agents when used in patients with ACS undergoing PCI. METHODS: We searched PubMed/MEDLINE and Cochrane library for RCTs comparing prasugrel to ticagrelor in ACS. The primary endpoint was major adverse cardiovascular events (MACE). Secondary outcomes were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stent thrombosis, major bleeding, and all bleeding event. Estimates were calculated as random effects risk ratios (RRs) with 95% confidence intervals (CI). RESULTS: Six trials with 6807 patients were included. There were no significant difference of MACE (RR 0.93; 95% CI [0.72-1.20]; p = 0.59; I2 = 26%), all-cause mortality (RR 0.92; 95% CI [0.73-1.17]; p = 0.51; I2 = 0%), cardiovascular mortality (RR 0.99; 95% CI [0.75-1.31]; p = 0.96; I2 = 0%), MI (RR 0.87; 95% CI [0.60-1.27]; p = 0.48; I2 = 27%), stent thrombosis (RR 0.64; 95% CI [0.39-1.04]; p = 0.07; I2 = 0%), major bleeding (RR 0.94; 95% CI [0.70-1.26]; p = 0.68; I2 = 6%), and all bleeding event (RR 0.92; 95% CI [0.77-1.09]; p = 0.32; I2 = 0%) for prasugrel compared with ticagrelor. CONCLUSION: There are no significant difference of MACE, all-cause mortality, cardiovascular mortality, MI, stent thrombosis, and bleeding between prasugrel and ticagrelor when added to aspirin among patients with ACS undergoing PCI.

Dual Versus Triple Therapy for Atrial Fibrillation After Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis.

Background: The safety and effectiveness of dual therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) versus triple therapy (vitamin K antagonist plus aspirin and P2Y12 inhibitor) in patients with nonvalvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) is unclear. Purpose: To examine the effects of dual versus triple therapy on bleeding and ischemic outcomes in adults with AF after PCI. Data Sources: Searches of PubMed, EMBASE, and the Cochrane Library (inception to 31 December 2019) and ClinicalTrials.gov (7 January 2020) without language restrictions; journal Web sites; and reference lists. Study Selection: Randomized controlled trials that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events in adults with AF after PCI. Data Extraction: Two independent investigators abstracted data, assessed the quality of evidence, and rated the certainty of evidence. Data Synthesis: Four trials encompassing 7953 patients were selected. At the median follow-up of 1 year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], -0.013 [95% CI, -0.025 to -0.002]). Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004 [CI, -0.010 to 0.017]), cardiovascular mortality (RD, 0.001 [CI, -0.011 to 0.013]), myocardial infarction (RD, 0.003 [CI, -0.010 to 0.017]), stent thrombosis (RD, 0.003 [CI, -0.005 to 0.010]), and stroke (RD, -0.003 [CI, -0.010 to 0.005]). The upper bounds of the CIs for these effects were compatible with possible increased risks with dual therapy. Limitation: Heterogeneity of study designs, dosages of DOACs, and types of P2Y12 inhibitors. Conclusion: In adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear. Primary Funding Source: None.

In-Hospital Management and Outcomes of Patients With Acute Myocardial Infarction and Influenza.

Patients with influenza infection are at increased risk of acute myocardial infarction (AMI). There are limited data on the short-term prognosis and management of patients with AMI and concomitant influenza. We examined the National Inpatient Sample from 2010 to 2014 for adult patients with a diagnosis of AMI. Patients were stratified into those with or without concomitant influenza. In-hospital therapies and outcomes were compared between groups in unadjusted and adjusted analyses. Standardized differences of >10% and p values <0.05 were considered significant. Propensity matching was performed using a caliper radius of 0.01*sigma. Of 4,285,641 patients with a discharge diagnosis of AMI, 12,830 had concomitant influenza. Patients with influenza were older, had a higher burden of co-morbidities, and more often presented with non-ST elevation AMI (90% vs 74%) as compared with those without influenza. Coronary angiography (23% vs 54%) and revascularization (11% vs 41%) were less often pursued in AMI patients with influenza. Patients with AMI and influenza had elevated in-hospital mortality (14%) and multiorgan failure (33%). In a propensity-matched analysis of 23,415 patients, in-hospital mortality (odds ratio [OR] 1.26; p = 0.01), acute kidney injury (OR 1.36; p <0.01), multiorgan failure (OR 1.81; p <0.01), length-of-stay, and hospital costs were significantly higher in those with influenza. In conclusion, patients with AMI and concomitant influenza have an adverse in-hospital prognosis as compared with those without influenza.

Fibrotic Lung Disease at CT Predicts Adverse Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

PURPOSE: To evaluate the relationship between CT findings of diffuse lung disease and post-transcatheter aortic valve replacement (TAVR) outcomes. MATERIALS AND METHODS: Retrospective review of pre-TAVR CT scans obtained during 2012-2017 was conducted. Emphysema, reticulation, and honeycombing were separately scored using a five-point scale and applied to 10 images per examination. The fibrosis score was the sum of reticulation and honeycombing scores. Lung diseases were also assessed as dichotomous variables (zero vs nonzero scores). The two outcomes evaluated were death and the composite of death and readmission. RESULTS: The study included 373 patients with median age of 84 years (age range, 51-98 years; interquartile range, 79-88 years) and median follow-up of 333 days. Fibrosis and emphysema were present in 66 (17.7%) and 95 (25.5%) patients, respectively. Fibrosis as a dichotomous variable was independently associated with the composite of death and readmission (hazard ratio [HR], 1.54; P = .030). In those without known chronic lung disease (CLD) (HR, 3.09; P = .024) and those without airway obstruction, defined by a ratio of forced expiratory volume in 1 second to the forced vital capacity greater than or equal to 70% (HR, 1.67, P = .039), CT evidence of fibrosis was a powerful predictor of adverse events. Neither emphysema score nor emphysema as a dichotomous variable was an independent predictor of outcome. CONCLUSION: The presence of fibrosis on baseline CT scans was an independent predictor of adverse events after TAVR. In particular, fibrosis had improved predictive value in both patients without known CLD and patients without airway obstruction.Supplemental material is available for this article.© RSNA, 2020.

Principles and Issues for Physical Frailty Measurement and Its Clinical Application.

INTRODUCTION: "Frailty" has attracted attention for its promise of identifying vulnerable older adults, hence its potential use to better tailor geriatric health care. There remains substantial controversy, however, regarding its nature and ascertainment. Recent years have seen a proliferation of frailty assessment methods. We argue that the development of frailty assessments should be grounded in "validation"-the process of substantiating that a measurement accurately and precisely measures what it intends, identify unresolved measurement issues, and highlight measurement-related considerations for clinical practice. METHODS: Principles for validating frailty measures are elucidated. We follow principles-articulated, for example, by Borsboom-in which a construct must be clearly defined and then analyses undertaken to substantiate that a measurement accurately and precisely measures what it intends. Key elements are content validity, criterion validity, and construct validity, with an emphasis on the latter. RESULTS: We illustrate the principles for a physical frailty phenotype construct. CONCLUSIONS: Unresolved conceptual issues include the roles of intersecting concepts such as cognition, disease severity, and disability in frailty measurement, conceptualization of frailty as a state versus a continuum, and the potential need for dynamic measures and systems concepts in furthering understanding of frailty. Clinical considerations include needs to distinguish interventions designed to address frailty "symptoms" versus underlying physiology, improve "prefrailty" measures intended to screen individuals early in their frailty progression, address feasibility demands, and further visioning followed by rigorous efficacy research to address the landscape of potential uses of frailty assessment in clinical practice.

Transcatheter Aortic Valve Replacement in Low-Risk Patients: A Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) has become the standard treatment option for patients with symptomatic severe aortic stenosis (AS) with high surgical risk and a reasonable option for intermediate surgical risk as an alternative to surgical aortic valve replacement (SAVR). The role of TAVR in lower risk patients is less established but has been the focus of recent randomized controlled trials (RCTs). We performed a meta-analysis of RCTs to assess TAVR outcomes among low surgical risk patients. METHODS AND RESULTS: Systematic search of RCTs was done using PubMed, EMBASE, and Cochrane Library databases. Statistical analysis was performed with RevMan v5.3 software using a random effects model to report risk ratio (RR) with 95% confidence interval (CI). A total of three RCTs including 2698 patients (1375 TAVR and 1323 SAVR) were analyzed. Compared to SAVR, TAVR was not associated with all-cause mortality [RR 0.86 (95% CI 0.61-1.19); P = 0.36; I2 = 8%] or stroke [RR 0.82 (0.48-1.43); P = 0.49; I2 = 42%]. However, TAVR was significantly associated with lower risk of acute kidney injury [RR 0.27 (0.13-0.54); P = 0.0002; I2 = 0%], new-onset atrial fibrillation [RR 0.26 (0.18-0.39); P < 0.00001; I2 = 80%], and life-threatening or disabling bleeding [RR 0.35 (0.22-0.55); P < 0.00001; I2 = 57%], but a higher risk of moderate-severe paravalvular leak [RR 4.40 (1.22-15.86); P = 0.02; I2 = 26%] and permanent pacemaker insertion [RR 2.73 (1.41-5.28); P = 0.003; I2 = 83%]. CONCLUSIONS: There is no difference in all-cause mortality or stroke between TAVR and SAVR, but TAVR is associated with lower risk of other perioperative complications except for moderate-severe paravalvular leak and the need for permanent pacemaker implantation.

Comparing Frailty Markers in Predicting Poor Outcomes after Transcatheter Aortic Valve Replacement.

INTRODUCTION: Frailty is an important component of risk prognostication in transcatheter aortic valve replacement (TAVR). Objective markers of frailty, including sarcopenia, the modified Frailty Index (mFI), and albumin levels, have emerged, but little is known how such markers compare to each other in predicting outcomes after TAVR. We sought to define and compare these markers in predicting long-term outcomes after TAVR. METHODS: Patients who underwent TAVR at our institution from 2011 to 2016 were included. Indexed cross-sectional areas of the lumbosacral muscles on preoperative computed tomography scans were used to assess sarcopenia. Optimal cutoffs for sarcopenia were defined using a statistically validated method. mFI was calculated using an 11-point scale of clinical characteristics. The primary outcome was 2-year all-cause mortality. Adjusted survival analysis was used to analyze outcomes. RESULTS: A total of 381 patients were included in this study. Sarcopenia of the psoas muscles was associated with an increased risk of mortality on univariate (HR: 2.3, P = 0.01) and multivariate (HR: 2.5, P = 0.01) analysis. Sarcopenia of the paravertebral muscles was associated with increased risk of mortality only on univariate analysis (HR: 2.1, P = 0.03). Increased preoperative albumin levels were associated with decreased risk of mortality on univariate (HR: 0.3, P < 0.01) and multivariate analysis (HR: 0.3, P < 0.01). The (mFI) was not associated with mortality on univariate or multivariate analysis. DISCUSSION: Novel cutoffs for sarcopenia of the psoas muscles were determined and associated with decreased survival after TAVR. Sarcopenia and albumin levels may be better tools for risk prediction than mFI in TAVR.

Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.

BACKGROUND: We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques. METHODS AND RESULTS: This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques. CONCLUSION: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques.