Assessment and Management of Older Adults Undergoing PCI, Part 1: A JACC: Advances Expert Panel.

As the population ages, older adults represent an increasing proportion of patients referred to the cardiac catheterization laboratory. Older adults are the highest-risk group for morbidity and mortality, particularly after complex, high-risk percutaneous coronary interventions. Structured risk assessment plays a key role in differentiating patients who are likely to derive net benefit vs those who have disproportionate risks for harm. Conventional risk assessment tools from national cardiovascular societies typically rely on 3 pillars: 1) cardiovascular risk; 2) physiologic and hemodynamic risk; and 3) anatomic and procedural risks. We propose adding a fourth pillar: geriatric syndromes, as geriatric domains can supersede all other aspects of risk.

Impact of Transcatheter Mitral Valve Repair Availability on Volume and Outcomes of Surgical Repair.

BACKGROUND: The impact of transcatheter edge-to-edge repair (TEER) on national surgical mitral valve repair (MVr) volume and outcomes is unknown. OBJECTIVES: This study aims to assess the impact of TEER availability on MVr volumes and outcomes for degenerative mitral regurgitation. METHODS: MVr volume, 30-day and 5-year outcomes, including mortality, heart failure rehospitalization and mitral valve reintervention, were obtained from the Society of Thoracic Surgeons database linked with Medicare administrative claims and were compared within TEER centers before and after the first institutional TEER procedure. A difference-in-difference approach comparing parallel trends in coronary artery bypass grafting outcomes was used to account for temporal improvements in perioperative care. RESULTS: From July 2011 through December 2018, 13,959 patients underwent MVr at 278 institutions, which became TEER-capable during the study period. There was no significant change in median annualized institutional MVr volume before (32 [IQR: 17-54]) vs after (29 [IQR: 16-54]) the first TEER (P = 0.06). However, higher-risk (Society of Thoracic Surgeons predicted risk of mortality ≥2%) MVr procedures declined over the study period (P < 0.001 for trend). The introduction of TEER was associated with reduced risk-adjusted odds of mortality after MVr at 30 days (adjusted OR: 0.73; 95% CI: 0.54-0.99) and over 5 years (adjusted HR: 0.75; 95% CI: 0.66-0.86). These improvements in 30-day and 5-year mortality were significantly greater than equivalent trends in coronary artery bypass grafting. CONCLUSIONS: The introduction of TEER has not significantly changed overall MVr case volumes for degenerative mitral regurgitation but is associated with a decrease in higher-risk surgical operations and improved 30-day and 5-year outcomes within institutions adopting the technology.

Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use.

Importance: In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018. Objective: To evaluate the association between CMS TAVR reimbursement rates and EPD use. Design, Setting, and Participants: This cohort study used the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry to identify patients who underwent TAVR between January 2018 and September 2019. Analysis took place between July 2020 and February 2022. Main Outcomes and Measures: The association between EPD use and CMS reimbursement was assessed using multivariable logistic regression models adjusted for patient characteristics (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2). Results: Among 511 institutions, CMS reimbursement for TAVR ranged from $28 062 to $111 280 with a median (IQR) of $45 884 ($40 331-$53 627). Among 84 353 patients (median [IQR] age, 81.0 [75.0-86.0] years; 46 247 male individuals [54.8%]; 3958 [4.7%] of Hispanic or Latino ethnicity; 78 170 White individuals [92.7%]) treated at the sites, 6012 (7.1%) underwent TAVR with EPD. Patient characteristics associated with EPD use included prior stroke (adjusted odds ratio [aOR], 1.13 [95% CI, 1.00-1.27]; P = .048), female sex (aOR, 0.85 [95% CI, 0.78-0.93]; P < .001), hemodialysis (aOR, 0.52 [95% CI, 0.40-0.68]; P < .001), and shock (aOR, 0.62 [95% CI, 0.41-0.94]; P = .03). Higher CMS reimbursement up to $50 000 per TAVR was associated with greater likelihood of EPD use in model 1 (per $1000; aOR, 1.08 [95% CI, 1.01-1.16]; P = .02). However, this association was no longer apparent after adjusting for site characteristics (model 2; aOR, 1.03 [95% CI, 0.96-1.11]; P = .38). Higher TAVR volume was associated with increased EPD use (per 25 TAVRs; aOR, 1.15 [95% CI, 1.09-1.21]; P < .001). There was no significant change in the odds of EPD uptake before vs after institution of the CMS new technology add-on payment across tertiles of CMS TAVR reimbursement (Wald χ2 = 3.59; P = .17). Conclusions and Relevance: EPD use during TAVR remains infrequent and is associated with multiple patient and site characteristics. While CMS reimbursement varies significantly across institutions, TAVR case volume, rather than CMS TAVR reimbursement or the CMS new technology add-on payment, appears to be the predominant factor associated with EPD use. Ongoing work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use.

OptiVol for Volume Assessment in Patients With Continuous Flow Left Ventricular Assist Device.

OptiVol (Medtronic PLC, Minneapolis, MN) is a diagnostic feature of some cardiac implantable electronic devices (CIEDs) based on changes in thoracic impedance (TI) over time. Changes in TI can predict heart failure (HF) hospitalizations and mortality in HF populations. However, the utility of this feature is unknown in patients with a left ventricular assist device (LVAD). To determine if OptiVol and TI correlate with clinical HF events in a population of LVAD patients, hospitalization outcomes were collected retrospectively from the electronic health records at a single academic medical center in 80 LVAD patients with an OptiVol-capable CIED. Demographics, medical history, and available clinical data were reviewed and reported. The primary outcomes of interest were TI and OptiVol trends before and after hospitalization, and association of trends before and after these events was evaluated. Most patients had a HeartMate II LVAD and most CIEDs were defibrillators, and 23 (29%) had at least one HF hospitalization during the study period. HF hospitalizations were preceded by signs of volume overload in Optivol (60%) and TI (78%) with recovery of these measures post hospitalization in 33% and 25% of patients, respectively. Monitoring of TI and OptiVol may be one effective component of HF management in LVAD patients as part of a comprehensive program.

Economic Evaluation of Catheter Ablation of Atrial Fibrillation in Patients with Heart Failure With Reduced Ejection Fraction.

BACKGROUND: Randomized clinical trials have demonstrated that catheter ablation for atrial fibrillation in patients with heart failure with reduced ejection fraction may improve survival and other cardiovascular outcomes. METHODS: We constructed a decision-analytic Markov model to estimate the costs and benefits of catheter ablation and medical management in patients with symptomatic heart failure with reduced ejection fraction (left ventricular ejection fraction ≤35%) and atrial fibrillation over a lifetime horizon. Evidence from the published literature informed the model inputs, including clinical effectiveness data from meta-analyses. Probabilistic and deterministic sensitivity analyses were performed. A 3% discount rate was applied to both future costs and benefits. The primary outcome was the incremental cost-effectiveness ratio assessed from the US health care sector perspective. RESULTS: Catheter ablation was associated with 6.47 (95% CI, 5.89-6.93) quality-adjusted life years (QALYs) and a total cost of $105 657 (95% CI, $55 311-$191 934; 2018 US dollars), compared with 5.30 (95% CI, 5.20-5.39) QALYs and $63 040 (95% CI, $37 624-$102 260) for medical management. The incremental cost-effectiveness ratio for catheter ablation compared with medical management was $38 496 (95% CI, $5583-$117 510) per QALY gained. Model inputs with the greatest variation on incremental cost-effectiveness ratio estimates were the cost of ablation and the effect of catheter ablation on mortality reduction. When assuming a more conservative estimate of the treatment effect of catheter ablation on mortality (hazard ratio of 0.86), the estimated incremental cost-effectiveness ratio was $74 403 per QALY gained. At a willingness-to-pay threshold of $100 000 per QALY gained, atrial fibrillation ablation was found to be economically favorable compared with medical management in 95% of simulations. CONCLUSIONS: Catheter ablation in patients with heart failure with reduced ejection fraction patients and atrial fibrillation may be considered economically attractive at current benchmarks for societal willingness-to-pay in the United States.

Management of Atrial Fibrillation in Older Patients by Morbidity Burden: Insights From Get With The Guidelines-Atrial Fibrillation.

Background Knowledge is scarce regarding how multimorbidity is associated with therapeutic decisions regarding oral anticoagulants (OACs) in patients with atrial fibrillation. Methods and Results We conducted a cross-sectional study of hospitalized patients with atrial fibrillation using the Get With The Guidelines-Atrial Fibrillation registry from 2013 to 2019. We identified patients ≥65 years and eligible for OAC therapy. Using 16 available comorbidity categories, patients were stratified by morbidity burden. A multivariable logistic regression model was used to determine the odds of receiving OAC prescription at discharge by morbidity burden. We included 34 174 patients with a median (interquartile range) age of 76 (71-83) years, 56.6% women, and 41.9% were not anticoagulated at admission. Of these patients, 38.6% had 0 to 2 comorbidities, 50.7% had 3 to 5 comorbidities, and 10.7% had ≥6 comorbidities. The overall discharge OAC prescription was high (85.6%). The prevalence of patients with multimorbidity increased from 59.7% in 2014 to 64.3% in 2019 (P trend=0.002). Using 0 to 2 comorbidities as the reference, the adjusted odds ratio (95% CI) of OAC prescription were 0.93 (0.82, 1.05) for patients with 3 to 5 comorbidities and 0.72 (0.60, 0.86) for patients with ≥6 comorbidities. In those with ≥6 comorbidities, the most common reason for nonprescription of OACs were frequent falls/frailty (31.0%). Conclusions In a contemporary quality-of-care database of hospitalized patients with atrial fibrillation eligible for OAC therapy, multimorbidity was common. A higher morbidity burden was associated with a lower odds of OAC prescription. This highlights the need for interventions to improve adherence to guideline-recommended anticoagulation in multimorbid patients with atrial fibrillation.

Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial.

BACKGROUND: Palliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown. METHODS: In a secondary analysis of the PAL-HF trial (Palliative Care in Heart Failure), we analyzed differences in quality of life among men and women with heart failure and assessed for differential effects of the palliative care intervention by sex. Differences in clinical characteristics and quality-of-life metrics were compared between men and women at serial time points. The primary outcome was change in Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks. RESULTS: Among the 71 women and 79 men, there was a significant difference in baseline Kansas City Cardiomyopathy Questionnaire (24.5 versus 36.2, respectively; P=0.04) but not Functional Assessment of Chronic Illness Therapy-Palliative Care scale (115.7 versus 120.3; P=0.27) scores. Among those who received the palliative care intervention (33 women and 42 men), women's quality-of-life score remained lower than that of men after enrollment. Treated men's scores were significantly higher than those untreated (6-month Kansas City Cardiomyopathy Questionnaire, 68.0 [interquartile range, 52.6-85.7] versus 41.1[interquartile range, 32.0-78.3]; P=0.047), whereas the difference between treated and untreated women was not significantly different (P=0.39). Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men. CONCLUSIONS: In the PAL-HF trial, women with heart failure experienced a greater symptom burden and poorer quality of life as compared with men. The change in treated men's Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks was significantly higher than those untreated; this trend was not observed in women. Thus, there may be a sex disparity in response to palliative care intervention, suggesting that sex-specific approaches to palliative care may be needed to improve outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT0158960.

Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair.

BACKGROUND: Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies. METHODS AND RESULTS: Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 2007 to 2013 as part of the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk Registry or the REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued-Access Registry. Each registry adjudicated mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion within 1 year. Concordance of claims-based outcomes with events was assessed in 3 ways: 1-year occurrence, cumulative incidence, and synchrony of first events. For event occurrence, positive predictive value (PPV) of claims versus adjudication was the highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%) but lower for bleeding (PPV=40%) and renal failure (PPV=19%). Whereas claims-based cumulative incidence for mortality, heart failure hospitalization, and renal failure were consistent with clinician-triggered adjudication, incidence curves for bleeding events and ventilation diverged, with claims identifying a greater number of events. When events were detected by both methods, however, over 75% of event dates matched exactly. Mitral valve reinterventions were identified through claims with perfect sensitivity and specificity relative to physician adjudication. CONCLUSIONS: Ascertainment of mortality, heart failure hospitalization, and renal failure was highly concordant between physician adjudication and administrative claims. Further work is necessary to determine the role of administrative claims in event ascertainment in both prospective and retrospective studies of structural heart disease.

Does clinician-reported lipid guideline adoption translate to guideline-adherent care? An evaluation of the Patient and Provider Assessment of Lipid Management (PALM) registry.

BACKGROUND: The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol guideline recommends statin treatment based on patients' predicted atherosclerotic cardiovascular disease (ASCVD) risk. Whether clinician-reported guideline adoption translates to implementation into practice is unknown. OBJECTIVES: We aimed to compare clinician lipid management in hypothetical scenarios versus observed practice. METHODS: The PALM Registry asked 774 clinicians how they would treat 4 hypothetical scenarios of primary prevention patients with: (1) diabetes; (2) high 10-year ASCVD risk (≥7.5%) with high low-density lipoprotein cholesterol (LDL-C; ≥130 mg/dL); (3) low 10-year ASCVD risk (<7.5%) with high LDL-C (130-189 mg/dL); or (4) primary and secondary prevention patients with persistently elevated LDL-C (≥130 mg/dL) despite high-intensity statin use. We assessed agreement between clinician survey responses and observed practice. RESULTS: In primary prevention scenarios, 85% of clinicians reported they would prescribe a statin to a diabetic patient and 93% to a high-risk/high LDL-C patient (both indicated by guidelines), while 40% would prescribe statins to a low-risk/high LDL-C patient. In clinical practice, statin prescription rates were 68% for diabetic patients, 40% for high-risk/high LDL-C patients, and 50% for low-risk/high LDL-C patients. Agreement between hypothetical and observed practice was 64%, 39%, and 52% for patients with diabetes, high-risk/high LDL-C, and low-risk/high LDL-C, respectively. Among patients with persistently high LDL-C despite high-intensity statin treatment, 55% of providers reported they would add a non-statin lipid-lowering medication, while only 22% of patients were so treated. CONCLUSIONS: While the majority of clinicians report adoption of the 2013 ACC/AHA guideline recommendations, observed lipid management decisions in practice are frequently discordant.