Virtual visits to optimize research trial offerings to heart failure patients.

Background: Clinical trials are crucial for development of new treatments that impact outcomes. Assessments used in heart failure trials include the 6-minute hallway walk test (6MWT) and timed up and go test (TUG). Objectives: We hypothesized that 6MWT and TUG performed virtually would be feasible and comparable to in-person functionality testing for heart failure patients. Methods: This pilot study explored the use of virtual visits to collect functional information on patients living with heart failure. Patients were enrolled in an outpatient setting. Informed consent was obtained. Baseline testing consisted of patient-reported New York Hospital Association class, quality-of-life surveys (EQ-5D-5L, Kansas City Cardiomyopathy Questionnaire [KCCQ], Frailty Index for Elders), and cognitive assessments (Mini-Cog). Patients also completed an in-person TUG and 6MWT at baseline. Patients were issued supplies to set up TUG/6MWT courses at home. Follow-up video visits occurred 7 days and 14 days (± 3 days) postbaseline. Surveys (EQ-5D-5L, KCCQ, Frailty Index), TUG, and 6MWT were completed. Study staff reviewed 6MWT/TUG course set-up for accuracy and supervised patients during testing. Results: Of the 94 patients enrolled, 74 patients completed all 6MWT assessments. One-way repeated measures ANOVA found no statistical difference between mean in-person and virtual 6MWT (P = .45). One-way repeated measures ANOVA found a statistical difference between mean TUG scores (P = .03). Patients were comfortable with the use of virtual visits (56%), would participate in research studies through telemedicine (98.7%), and found completing a virtual research visit to be not difficult (77.3%). Conclusion: Virtual administration of the 6MWT was shown to be feasible and acceptable to heart failure patients as compared to in-person functionality testing. This approach could be implemented into clinical care pathways for evaluation of heart failure patients, as well as adopted by industry-sponsored and investigator-initiated research studies in heart failure cohorts for data collection.

Cardiac resynchronisation therapy in anthracycline-induced cardiomyopathy.

INTRODUCTION: Chemotherapy-induced cardiomyopathy has been increasingly recognised as patients are living longer with more effective treatments for their malignancies. Anthracyclines are known to cause left ventricular (LV) dysfunction. While heart failure medications are frequently used, some patients may need consideration for device-based therapies such as cardiac resynchronisation therapy (CRT). However, the role of CRT in anthracycline-induced cardiomyopathy (AIC) is not well understood. METHODS: We performed a retrospective review of all patients undergoing CRT implantation at our centre from 2003 to 2019 with a diagnosis of AIC. The LV remodelling and survival outcomes of this population were obtained and then compared with consecutive patients with other aetiologies of non-ischaemic cardiomyopathy (NICM). RESULTS: A total of 34 patients underwent CRT implantation with a diagnosis of AIC with a mean age of 60.5±12.7 years, left ventricular ejection fraction (LVEF) of 21.7%±7.4%, and 11.3±7.5 years and 10.2±7.4 years from cancer diagnosis and last anthracycline exposure, respectively. At 9.6±8.1 months after CRT implantation, there was an increase of LVEF from 21.8%±7.6% to 30.4%±13.0% (p<0.001). Patients whose LVEF increased by at least 10% post-CRT implant (42.5% of cohort) survived significantly longer than patients who failed to improve their LVEF by that amount (p=0.01). A propensity matched analysis between patients with AIC and 369 consecutive patients with other aetiologies of NICM who underwent CRT implantation during the same period revealed no significant differences in improvement in LVEF or long-term survival. CONCLUSIONS: Patients with AIC undergo LV remodelling with CRT at rates similar to other aetiologies of NICM. Furthermore, AIC post-CRT responders have a favourable long-term mortality compared with non-responders.

Prognostic implications and outcomes of cardiac arrest among contemporary patients with STEMI treated with PCI.

BACKGROUND: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI). METHODS: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI. RESULTS: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56-1.82, p = 0.97). CONCLUSIONS: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA.

Machine Learning of 12-Lead QRS Waveforms to Identify Cardiac Resynchronization Therapy Patients With Differential Outcomes.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves heart failure outcomes but has significant nonresponse rates, highlighting limitations in ECG selection criteria: QRS duration (QRSd) ≥150 ms and subjective labeling of left bundle branch block (LBBB). We explored unsupervised machine learning of ECG waveforms to identify CRT subgroups that may differentiate outcomes beyond QRSd and LBBB. METHODS: We retrospectively analyzed 946 CRT patients with conduction delay. Principal component analysis (PCA) dimensionality reduction obtained a 2-dimensional representation of preCRT 12-lead QRS waveforms. k-means clustering of the 2-dimensional PCA representation of 12-lead QRS waveforms identified 2 patient subgroups (QRS PCA groups). Vectorcardiographic QRS area was also calculated. We examined following 2 primary outcomes: (1) composite end point of death, left ventricular assist device, or heart transplant, and (2) degree of echocardiographic left ventricular ejection fraction (LVEF) change after CRT. RESULTS: Compared with QRS PCA Group 2 (n=425), Group 1 (n=521) had lower risk for reaching the composite end point (HR, 0.44 [95% CI, 0.38-0.53]; P<0.001) and experienced greater mean LVEF improvement (11.1±11.7% versus 4.8±9.7%; P<0.001), even among patients with LBBB with QRSd ≥150 ms (HR, 0.42 [95% CI, 0.30-0.57]; P<0.001; mean LVEF change 12.5±11.8% versus 7.3±8.1%; P=0.001). QRS area also stratified outcomes but had significant differences from QRS PCA groups. A stratification scheme combining QRS area and QRS PCA group identified patients with LBBB with similar outcomes to non-LBBB patients (HR, 1.32 [95% CI, 0.93-1.62]; difference in mean LVEF change: 0.8% [95% CI, -2.1% to 3.7%]). The stratification scheme also identified patients with LBBB with QRSd <150 ms with comparable outcomes to patients with LBBB with QRSd ≥150 ms (HR, 0.93 [95% CI, 0.67-1.29]; difference in mean LVEF change: -0.2% [95% CI, -2.7% to 3.0%]). CONCLUSIONS: Unsupervised machine learning of ECG waveforms identified CRT subgroups with relevance beyond LBBB and QRSd. This method may assist in objective classification of bundle branch block morphology in CRT.

Midterm outcomes of subclavian artery revascularization in the setting of thoracic endovascular aortic repair.

OBJECTIVE: The outcomes of subclavian artery revascularization (SAR) have been examined extensively in the setting of atherosclerotic occlusive disease but have been poorly characterized in the setting of thoracic endovascular aortic repair (TEVAR). As trials for branched thoracic endovascular stent grafts materialize, the outcomes of the subclavian artery branched prosthesis will need to be compared with TEVAR with SAR by carotid-subclavian bypass or subclavian transposition. METHODS: A database of 1516 patients undergoing TEVAR from 2000 to 2015 was queried. Of those undergoing TEVAR, 19% (282 patients) also underwent SAR. Patient demographics, TEVAR indication, 30-day morbidity and mortality, and midterm patency and survival were analyzed. RESULTS: During the study period, 282 patients underwent 288 SARs in the setting of TEVAR. A total of 269 (93%) carotid-subclavian bypasses and 19 (7%) subclavian artery transpositions were performed; 76% of the SARs occurred before TEVAR, 14% occurred concurrently with TEVAR, and 10% occurred after TEVAR. The most common indications for TEVAR was aortic aneurysm (56%), chronic aortic dissection with aneurysmal degeneration (23%), and aortic dissections (13%). The 30-day ipsilateral stroke rate was 3.5%. Eight patients (2.8%) underwent an unplanned return to the operating room (2.1% for hematoma evacuation and 0.7% for management of chyle leak). Six patients (2.1%) sustained a nerve injury. The mean follow-up was 4.2 years. All-cause 30-day mortality was 4.6%. The overall survival rates at 1 year, 5 years, and 10 years were 82%, 60%, and 42%, respectively. The median survival was 7.2 years. Four patients were found to have a failure in primary patency during follow-up. All four patients had undergone a carotid-subclavian bypass. The 1-, 2-, and 5-year primary patency rates were 99.5%, 98.9%, and 98.0%, respectively, for carotid-subclavian bypass and 100% for carotid-subclavian transposition. CONCLUSIONS: During our 16-year study, we found SAR in the setting of TEVAR to be associated with low morbidity, durable long-term patency, and infrequent need for reintervention.

Predictors of long-term outcomes greater than 10 years after cardiac resynchronization therapy implantation.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in patients with medically refractory heart failure and wide QRS duration. While much is known about predictors of left ventricular (LV) remodeling after CRT implantation and short-term mortality, limited data exist on long-term outcomes after CRT placement. METHODS: We retrospectively reviewed all patients undergoing CRT implantation at our center between 2003 and 2008 and examined mortality using institutional electronic records, social security death index, and online obituary search. We included only patients with preimplant echoes with LV ejection fraction (LVEF) 35% or below. Variable selection was performed using stepwise regression and models were compared using goodness-of-fit criteria. A final model was validated with the bootstrap regression method. RESULTS: Out of the 877 CRT patients undergoing implantation during this time, 287 (32.7%) survived longer than 10 years. Significant (P < .05) predictors of survival in our multivariate model were age, left ventricular diastolic diameter, sex, presence of nonischemic vs ischemic cardiomyopathy, QRS duration, atrial fibrillation, BNP levels, and creatinine levels at the time of CRT implantation. A model using the odds ratios from these variables had a receiver operating curve with an area under the curve score of 0.816 (standard error, 0.019) at predicting survival or freedom from LVAD or heart transplant for longer than 10 years after CRT implantation. The specificity for factors 3 or above and 5 or above was 68% and 77%, respectively. CONCLUSION: A large proportion of patients are still alive 10 years after CRT implantation. Variables at the time of CRT implant can help provide prognostic information to patients and electrophysiologists to determine the long-term benefit and survival of patients after CRT implantation.

Cardiac resynchronization therapy-heart failure (CRT-HF) clinic: A novel model of care.

BACKGROUND: Post-implant care of patients with heart failure (HF) undergoing cardiac resynchronization therapy (CRT) is not addressed in current HF or CRT guidelines and is often fragmented with poor communication between specialties. We sought to develop a new model of post-CRT care which could be implemented in busy clinical settings. METHODS AND RESULTS: We designed a novel, multidisciplinary approach to standardizing post CRT care. All patients receiving a CRT device at the Cleveland Clinic between March 2017 and August 2018 were invited to be seen in the clinic 6 months post implant. A one-time collaborative visit encompassing cardiac imaging, heart failure, and electrophysiology care was performed. We recorded the operational feasibility of the clinic in terms of patient throughput as well as patient characteristics, interventions, and new diagnoses made. Between September 2017 and February 2019, 150 patients were seen in the clinic. Of these, 125 patients had their index CRT implanted for standard indications and were included in the current analysis. Approximately 45 minutes were dedicated for each patient visit. Interventions in care were made in 95% of patients, with CRT non-responders offered a higher number of interventions as compared to responders (median 3 versus 2 interventions). Types of interventions were device-related (26% of population), medication-related (74%), and referral for alternate medical services (80%). CONCLUSIONS: Multidisciplinary post-implant care of patients with HF receiving CRT devices, regardless of CRT response status, is feasible and results in frequent medical interventions.

Effect of Cardiac Resynchronization Therapy on Left Ventricular Remodeling in Patients With Cardiac Sarcoidosis.

Cardiac resynchronization therapy (CRT) has been shown to be beneficial in patients with medically refractory heart failure. Although it has been found to be effective in a wide range of etiologies for nonischemic cardiomyopathy, its role in improving remodeling and survival of patients with cardiac sarcoidosis (CS) remains undefined. We performed a retrospective review of all patients at our institution with CS who underwent implantation of a CRT device from 2007 to 2017. The outcomes of this population were compared with the outcomes of a cohort of patients with nonischemic cardiomyopathy with an etiology other than sarcoidosis. Nineteen patients in our institution with CS underwent CRT implantation during the time period. This group was compared with 311 consecutive patients with other etiologies of nonischemic cardiomyopathy who underwent CRT implantation. CRT improved left ventricular ejection fraction (LVEF) from 28.8% to 35.9% (p <0.05) in CS, whereas it improved LVEF from 25% to 36.6% (p <0.01) in non-CS group (difference in means of 0.13). CRT significantly improved diastolic and systolic LV diameters, mitral regurgitation, and right ventricular systolic function in non-CS patients but failed to improve same parameters in CS patients. In conclusion, CRT significantly improved LVEF in patients with CS. There is no significant evidence that survival outcomes of CRT patients with CS are significantly worse than other etiologies of nonischemic cardiomyopathy.

Vascular disease patient information page: Abdominal aortic aneurysm (AAA).

Abdominal aortic aneurysm is a silent but often fatal disease. AAA is most common in older people, with both modifiable (such as smoking) and hereditary (family history of AAA) risk factors influencing disease development. Screening for AAA can aid in the early diagnosis and treatment of the disease, reducing complications and death amongst those affected. Advancements in screening techniques, surgical innovations, and graft development strive to further improve patient outcomes and disease management.