Publications by Year: 2021

BACKGROUND: Characteristics of tricuspid valve prolapse (TVP) on transthoracic echocardiography are not well defined. As tricuspid valve interventions are increasingly considered, information on the definition and clinical significance of TVP is needed.

METHODS: At the authors' institution, between January 26, 2000, and September 20, 2018, 410 patients (0.3%) were determined to have suspected TVP. These transthoracic echocardiograms and those of 97 age- and sex-matched normal control subjects were reviewed. Interrater agreement on TVP by visual inspection was assessed in a blinded subset. Leaflet atrial displacement (AD) > 2 SDs above the mean in normal control subjects was used to identify an empiric definition of TVP Features of patients meeting this definition were evaluated.

RESULTS: Three hundred twelve transthoracic echocardiograms with available and interpretable images (76.1%) were included. Interrater agreement on TVP diagnosis by visual inspection was moderate. Normal values of AD were up to 4 mm in the right ventricular inflow view and 2 mm in all other views. AD > 2 mm in the parasternal short-axis view had the best accuracy against suspected TVP to identify TVP. Those with TVP by this definition more frequently had 3 to 4+ tricuspid regurgitation (22.2% vs 3.1%; P < .001), mitral valve prolapse (MVP; 75.0% vs 3.1%; P < .001), and more clinically significant MVP (greater prevalence of 3 to 4+ mitral regurgitation). No difference in mortality was observed in those with isolated TVP versus TVP and MVP (log-rank P = .93).

CONCLUSIONS: In the largest study of TVP to date, interrater agreement on TVP diagnosis by visual inspection was moderate. A cutoff of >2-mm AD in the parasternal short-axis view was optimal to define TVP. Those with TVP by this definition had more significant tricuspid regurgitation, larger right ventricles, and more clinically significant MVP. Overall, these results suggest an increased role for surveillance for TVP and the need for clear diagnostic criteria in updated guidelines.

BACKGROUND: Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease.

METHODS: We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with International Classification of Diseases, Ninth Revision codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics.

RESULTS: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; P=0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; P<0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively.

CONCLUSIONS: Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.

In response to the coronavirus disease 2019 (COVID-19) pandemic, the Cardio-Oncology and Imaging Councils of the American College of Cardiology offers recommendations to clinicians regarding the cardiovascular care of cardio-oncology patients in this expert consensus statement. Cardio-oncology patients-individuals with an active or prior cancer history and with or at risk of cardiovascular disease-are a rapidly growing population who are at increased risk of infection, and experiencing severe and/or lethal complications by COVID-19. Recommendations for optimizing screening and monitoring visits to detect cardiac dysfunction are discussed. In addition, judicious use of multimodality imaging and biomarkers are proposed to identify myocardial, valvular, vascular, and pericardial involvement in cancer patients. The difficulties of diagnosing the etiology of cardiovascular complications in patients with cancer and COVID-19 are outlined, along with weighing the advantages against risks of exposure, with the modification of existing cardiovascular treatments and cardiotoxicity surveillance in patients with cancer during the COVID-19 pandemic.

With aging of the population, cardiovascular conditions (CC) are increasingly common in individuals undergoing PCI for stable angina pectoris (AP). It is unknown if the overall burden of CCs associates with diminished symptom improvement after PCI for stable AP. We prospectively administered validated surveys assessing AP, dyspnea, and depression to patients undergoing PCI for stable AP at our institution, 2016-2018. The association of CC burden and symptoms at 30-days post-PCI was assessed via linear mixed effects models. Included individuals (N = 121; mean age 68 ± 10 years; response rate = 42%) were similar to non-included individuals. At baseline, greater CC burden was associated with worse dyspnea, depression, and physical limitations due to AP, but not AP frequency or quality of life. PCI was associated with small improvements in AP and dyspnea (p ≤ 0.001 for both), but not depression (p = 0.15). After multivariable adjustment, including for baseline symptoms, CC burden was associated with a greater improvement in AP physical limitations (p = 0.01) and depression (p = 0.002), albeit small, but not other symptom domains (all p ≥ 0.05). In patients undergoing PCI for stable AP, increasing CC burden was associated with worse dyspnea, depression, and AP physical limitations at baseline. An increasing number of CCs was associated with greater improvements, though small, in AP physical limitations and depression. In conclusion, the overall number of cardiovascular conditions should not be used to exclude patients from PCI for stable AP on the basis of an expectation of less symptom improvement.

Background In aortic valve disease, the relationship between claims-based frailty indices (CFIs) and validated measures of frailty constructed from in-person assessments is unclear but may be relevant for retrospective ascertainment of frailty status when otherwise unmeasured. Methods and Results We linked adults aged ≥65 years in the US CoreValve Studies (linkage rate, 67%; mean age, 82.7±6.2 years, 43.1% women), to Medicare inpatient claims, 2011 to 2015. The Johns Hopkins CFI, validated on the basis of the Fried index, was generated for each study participant, and the association between CFI tertile and trial outcomes was evaluated as part of the EXTEND-FRAILTY substudy. Among 2357 participants (64.9% frail), higher CFI tertile was associated with greater impairments in nutrition, disability, cognition, and self-rated health. The primary outcome of all-cause mortality at 1 year occurred in 19.3%, 23.1%, and 31.3% of those in tertiles 1 to 3, respectively (tertile 2 versus 1: hazard ratio, 1.22; 95% CI, 0.98-1.51; P=0.07; tertile 3 versus 1: hazard ratio, 1.73; 95% CI, 1.41-2.12; P<0.001). Secondary outcomes (bleeding, major adverse cardiovascular and cerebrovascular events, and hospitalization) were more frequent with increasing CFI tertile and persisted despite adjustment for age, sex, New York Heart Association class, and Society of Thoracic Surgeons risk score. Conclusions In linked Medicare and CoreValve study data, a CFI based on the Fried index consistently identified individuals with worse impairments in frailty, disability, cognitive dysfunction, and nutrition and a higher risk of death, hospitalization, bleeding, and major adverse cardiovascular and cerebrovascular events, independent of age and risk category. While not a surrogate for validated metrics of frailty using in-person assessments, use of this CFI to ascertain frailty status among patients with aortic valve disease may be valid and prognostically relevant information when otherwise not measured.

Background The optimal treatment strategy for patients with chronic limb-threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record-based frailty measure with treatment choice and long-term outcomes among patients hospitalized with CLTI. Methods and Results We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims-based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75‒0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72‒0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30‒1.38; non-revascularized: adjusted HR, 1.22; CI, 1.17‒1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31‒1.42; endovascular: aHR, 1.29; CI, 1.243‒1.35). Conclusions Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.

BACKGROUND: Frailty is associated with a higher risk for adverse outcomes after aortic valve replacement (AVR) for severe aortic valve stenosis, but whether or not frail patients derive differential benefit from transcatheter (TAVR) versus surgical (SAVR) AVR is uncertain.

METHODS: We linked adults ≥65 years old in the US CoreValve HiR trial (High-Risk) or SURTAVI trial (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) to Medicare claims, February 2, 2011, to September 30, 2015. Two frailty measures, a deficit-based and phenotype-based frailty index (FI), were generated. The treatment effect of TAVR versus SAVR was evaluated within FI tertiles for the primary end point of death and nondeath secondary outcomes, using multivariable Cox regression.

RESULTS: Of 1442 (linkage rate =60.0%) individuals included, 741 (51.4%) individuals received TAVR and 701 (48.6%) received SAVR (mean age 81.8±6.1 years, 44.0% female). Although 1-year death rates in the highest FI tertiles (deficit-based FI 36.7% and phenotype-based FI 33.8%) were 2- to 3-fold higher than the lowest tertiles (deficit-based FI 13.4%; hazard ratio, 3.02 [95% CI, 2.26-4.02], P<0.001; phenotype-based FI 17.9%; hazard ratio, 2.05 [95% CI, 1.58-2.67], P<0.001), there were no significant differences in the relative or absolute treatment effect of SAVR versus TAVR across FI tertiles for all death, nondeath, and functional outcomes (all interaction P>0.05). Results remained consistent across individual trials, frailty definitions, and when considering the nonlinked trial data.

CONCLUSIONS: Two different frailty indices based on Fried and Rockwood definitions identified individuals at higher risk of death and functional impairment but no differential benefit from TAVR versus SAVR.