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Background: Patients with heart failure (HF) have a high burden of symptoms and physical limitations, regardless of ejection fraction (EF). Whether the benefits of SGLT2 (sodium-glucose cotransporter-2) inhibitors on these outcomes vary across the full range of EF remains unclear. Methods: Patient-level data were pooled from the DEFINE-HF trial (Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction) of 263 participants with reduced EF (≤40%), and PRESERVED-HF trial (Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With Preserved Ejection Fraction Heart Failure) of 324 participants with preserved EF (≥45%). Both were randomized, double-blind 12-week trials of dapagliflozin versus placebo, recruiting participants with New York Heart Association class II or higher and elevated natriuretic peptides. The effect of dapagliflozin on the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at 12 weeks was tested with ANCOVA adjusted for sex, baseline KCCQ, EF, atrial fibrillation, estimated glomerular filtration rate, and type 2 diabetes. Interaction of dapagliflozin effects on KCCQ-CSS by EF was assessed using EF both categorically and continuously with restricted cubic spline. Responder analyses, examining proportions of patients with deterioration, and clinically meaningful improvements in KCCQ-CSS were conducted using logistic regression. Results: Of 587 patients randomized (293 dapagliflozin, 294 placebo), EF was ≤40, >40-≤60, and >60% in 262 (45%), 199 (34%), and 126 (21%), respectively. Dapagliflozin improved KCCQ-CSS at 12 weeks (placebo-adjusted difference 5.0 points [95% CI, 2.6–7.5]; P P =0.01), >40 to ≤60 (4.9 points [95% CI, 0.8–9.0]; P =0.02) and >60% (6.8 points [95% CI, 1.5–12.1]; P =0.01; P interaction =0.79). Benefits of dapagliflozin on KCCQ-CSS were also consistent when analyzing EF continuously ( P interaction =0.94). In responder analyses, fewer dapagliflozin-treated patients had deterioration and more had small, moderate, and large KCCQ-CSS improvements versus placebo; these results were also consistent regardless of EF (all P interaction values nonsignificant). Conclusions: In patients with HF, dapagliflozin significantly improves symptoms and physical limitations after 12 weeks of treatment, with consistent and clinically meaningful benefits across the full range of EF. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT02653482 and NCT03030235.

Aims Peripheral artery disease (PAD) is a global disease. Understanding variability in patient profiles and PAD-specific health status outcomes across health system countries can provide insights into improving PAD care. We compared these features between two high-income countries, the USA and The Netherlands. Methods and results Patients were identified from the patient-centred outcomes related to treatment practices in peripheral arterial disease: investigating trajectories study—a prospective, international registry of patients presenting to vascular specialty clinics for new onset, or exacerbation of PAD symptoms. PAD-specific health status was measured with the peripheral artery questionnaire. General linear mixed models for repeated measures were used to study baseline, 3, 6, and 12-month PAD-specific health status outcomes (peripheral artery questionnaire summary score) between the USA and The Netherlands. Out of a total of 1114 patients, 748 patients (67.1%) were from the USA and 366 (32.9%) from The Netherlands. US patients with PAD were older, with more financial barriers, higher cardiovascular risk factor burden, and lower referral rates for exercise treatment (P Conclusion Compared with the Dutch cohort, US patients had worse adjusted PAD-specific health status scores at all time point, improving less over time, despite treatment. Leveraging inter-country differences in care and outcomes could provide important insights into optimizing PAD outcomes. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT01419080? term=portrait&rank=1 NCT01419080.

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Summary Background COVID-19 can lead to multiorgan failure. Dapagliflozin, a SGLT2 inhibitor, has significant protective benefits for the heart and kidney. We aimed to see whether this agent might provide organ protection in patients with COVID-19 by affecting processes dysregulated during acute illness. Methods DARE-19 was a randomised, double-blind, placebo-controlled trial of patients hospitalised with COVID-19 and with at least one cardiometabolic risk factor (ie, hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease). Patients critically ill at screening were excluded. Patients were randomly assigned 1:1 to dapagliflozin (10 mg daily orally) or matched placebo for 30 days. Dual primary outcomes were assessed in the intention-to-treat population: the outcome of prevention (time to new or worsened organ dysfunction or death), and the hierarchial composite outcome of recovery (change in clinical status by day 30). Safety outcomes, in patients who received at least one study medication dose, included serious adverse events, adverse events leading to discontinuation, and adverse events of interest. This study is registered with ClinicalTrials.gov , NCT04350593 . Findings Between April 22, 2020 and Jan 1, 2021, 1250 patients were randomly assigned with 625 in each group. The primary composite outcome of prevention showed organ dysfunction or death occurred in 70 patients (11·2%) in the dapagliflozin group, and 86 (13·8%) in the placebo group (hazard ratio [HR] 0·80, 95% CI 0·58–1·10; p=0·17). For the primary outcome of recovery, 547 patients (87·5%) in the dapagliflozin group and 532 (85·1%) in the placebo group showed clinical status improvement, although this was not statistically significant (win ratio 1·09, 95% CI 0·97–1·22; p=0·14). There were 41 deaths (6·6%) in the dapagliflozin group, and 54 (8·6%) in the placebo group (HR 0·77, 95% CI 0·52–1·16). Serious adverse events were reported in 65 (10·6%) of 613 patients treated with dapagliflozin and in 82 (13·3%) of 616 patients given the placebo. Interpretation In patients with cardiometabolic risk factors who were hospitalised with COVID-19, treatment with dapagliflozin did not result in a statistically significant risk reduction in organ dysfunction or death, or improvement in clinical recovery, but was well tolerated. Funding AstraZeneca.

BACKGROUND Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. METHODS Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model. RESULTS Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p

The association of invasive versus noninvasive treatment and physical activity level in patients with claudication remains unclear. Participants with claudication were enrolled from US vascular clinics. Treatment was categorized as invasive (surgical or endovascular treatment3 months of initial visit) versus noninvasive. Self-reported leisure time (LTPA) and work related physical activity (WRPA) (sedentary, mild, moderate/strenuous), and health status (peripheral artery questionnaire summary score [PAQ SS]) was measured at baseline and 12 months. Change in PA was also categorized as increased, decreased, persistent sedentary [reference] and persistent active based on activity status at baseline and 12 months. Multivariable logistic regression assessed the association of treatment with 12-month LTPA and WRPA. Multivariable linear regression examined the association between 12-month change in PA with a 12-month change in PAQ. A total of 196of 656 patients (29.9%) underwent invasive treatment. There was no association between treatment and 12-month LTPA (p = 0.77) or WRPA (p = 0.26). Compared with being persistently sedentary, increased LTPA was associated with increased PAQ SS (OR 11.1 95% CI [4.4 to 17.7], p0.01). In conclusion, there was no association between invasive treatment and physical activity at follow up despite a greater health status change in the invasive group. As increased physical activity was associated with more health status gains than remaining sedentary, additional ways to improve physical activity levels could potentially improve PAD outcomes.

Background Improvement of symptoms and functional status is one of the main peripheral artery disease (PAD) treatment goals but pharmacological options are limited. The objective of this study was to assess the use of cilostazol and its association with patient-reported health status quantified by the Peripheral Artery Questionnaire (PAQ). Methods Initiation of cilostazol therapy was assessed in 567 patients in the US cohort of PORTRAIT between June 2011 and December 2015. Patients with heart failure history, on cilostazol prior to enrollment, with no baseline or follow-up PAQ scores were excluded. Health status over time was quantified using linear mixed models adjusting for baseline PAQ scores and patient characteristics. Results Of the 567 cilostazol-naive patients, 65 (11%) were started on cilostazol. Mean age was 68.5 ± 9.6 years, 43% were female and 71.1% white. There was no significant difference in the mean PAQ score changes from baseline to 12 months between the cilostazol and non-cilostazol group, with difference of 3.8 [CI (−2.6, 10.1), p = .24] for summary scores, 1.6 [CI (−5.5, 8.6), p = .66] for quality of life, 3.6 [CI (−4.3, 11.6), p = .37] for symptoms, 6.2 [CI (−3.1, 15.5), p = .19] for physical limitation and 3.2 [CI (−3.9, 10.2), p = .38] for social limitation scores. Conclusions We found a low rate of cilostazol use and while there was no significant association between cilostazol initiation and subsequent health status, the ability to define small differences in health status was limited due to the small sample size.

BACKGROUND The effect of body mass index (BMI) on the procedural outcomes and health status (HS) change after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is largely unknown. METHODS Thousand consecutive patients enrolled in a 12-center prospective CTO PCI study (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures [OPEN-CTO]) were categorized into three groups by baseline BMI (obese ≥30, overweight 25-30, and normal 18.5-25), after excluding seven patients with BMI

Although contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is performed with high success rates, 10% to 13% of patients presenting with CTOs have chronic kidney disease (CKD), and the comparative safety, efficacy, and health status benefit of CTO PCI in these patients, has not been well defined. We examined the association of baseline renal function with periprocedural major adverse cardiovascular and cerebral events and health status outcomes in 957 consecutive patients (mean age 65.3 ± 10.3 years, 19.4% women, 90.3% white, 23.6 CKD [estimated glomerular filtration rate {eGFR}60]) in the OPEN-CTO (Outcomes, Patients Health Status, and Efficiency in Chronic Total Occlusions Registry) study. Hierarchical multivariable regression models were used to examine the independent association of baseline eGFR with technical success, periprocedural complications and change in health status, using Seattle Angina Questionnaire (SAQ) over 1 year. Crude rates of acute kidney injury were higher (13.5% vs 4.4%, p0.001) and technical success lower (81.8% vs 88.4%, p = 0.01) in patients with CKD. There were no significant differences in other periprocedural complications. After adjustment for confounding factors, there was no significant association of baseline eGFR with technical success or periprocedural major adverse cardiovascular and cerebral events (death, myocardial infarction, emergent bypass surgery, stroke, perforation), whereas patients with lower eGFR had higher rates of acute kidney injury. The difference in SAQ summary score, between patients on the 10th and 90th percentile for baseline eGFR distribution was not clinically significant (1 month: -0.91; 1 year: -3.06 points). In conclusion, CTO PCI success, complication rates, and the health status improvement after CTO PCI are similar in patients across a range of baseline eGFRs.

Compliance with cardiac performance measures for guideline-directed medical therapy remains suboptimal. There is a compelling need to identify modifiable factors that influence compliance rates, so that these factors can be addressed as targets of quality improvement. This study examines the relationship between cardiovascular provider experience and compliance with performance measures for outpatients with coronary artery disease (CAD), heart failure, and atrial fibrillation in the PINNACLE Registry. We hypothesize that providers who have been practicing longer, especially those further out from certification who may not be required to recertify, will have lower compliance rates with key cardiac performance measures. Using clinical data from January 1, 2013 to March 31, 2014 in the PINNACLE Registry, we employed a multilevel hierarchical logistic regression analysis to examine the relationship between cardiac performance measures and provider experience, defined by the number of years since initial cardiology board certification (

Objectives This study sought to examine depression prevalence among chronic total occlusion (CTO) patients and compared symptom improvement among depressed and nondepressed patients after percutaneous coronary intervention (PCI). Background Depression in cardiovascular patients is common, but its prevalence among CTO patients and its association with PCI response is understudied. Methods Among 811 patients from the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated change in health status between baseline and 1-year post-PCI, as measured by the Seattle Angina Questionnaire (SAQ) and the Rose Dyspnea Score. Depression was defined using the Personal Health Questionnaire-8. The independent association between health status and depression following PCI was assessed using multivariable regression. Results Among the 811 patients, 190 (23%) screened positive for major depression, of whom 6.3% were on antidepressant therapy at intervention. Depressed patients experienced more baseline angina, but by 1-year post-PCI they experienced greater improvements than nondepressed patients (change in SAQ Summary: 31.4 ± 22.4 vs. 24.2 ± 20.0; p Conclusions Depression is common among CTO PCI patients, but few were treated with antidepressants at baseline. Depressed patients had more severe baseline angina and significant improvement in health status after PCI. (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion [OPEN-CTO]; NCT02026466)

e13041 Background: PIK3CA mutations occur in about 40% of patients with HR+/HER2- breast cancer. The phase III SOLAR-1 trial demonstrated prolonged progression-free survival with alpelisib and fulvestrant compared to fulvestrant alone among patients with HR+/HER2-/ PIK3CA mutant advanced breast cancer previously treated with endocrine therapy. Hyperglycemia was seen in 64% of patients treated with alpelisib and fulvestrant and was treated with metformin. Inhibition of PI3Kα leads to an on-target effect of hyperglycemia and a secondary hyperinsulinemia. This rebound hyperinsulinemia may lead to escape PI3K pathway activation in breast cancer progression via the insulin and IGF1pathways. Concurrent administration of SGLT2 inhibitors may abrogate the PI3K pathway activation effect and delay disease progression. This study reports time on treatment with alpelisib and PFS among patients who received an SGLT2 inhibitor with alpelisib. Methods: A retrospective review of all metastatic breast cancer patients treated with alpelisib was completed from 8/2019 to 5/2021 at the Saint Luke’s Koontz Center for Advanced Breast Cancer. Results: This review included 22 female patients, 11 received an SGLT2 inhibitor for treatment related hyperglycemia (A+SGLT group) and 11 who received metformin/other diabetic agents (A group). Baseline characteristics were not significantly different between the two groups: median age 63, BMI of 29.1, hemoglobin A1C of 6.3 and fasting blood glucose of 119.1mg/dl. PIK3CA mutations included H1047X (40.9%), E545X (31.8%), E542K (13.6%), other (13.6%). The median number of prior treatments for MBC was 3 (range 1-5). Prior treatments included aromatase inhibitors: 100%, fulvestrant: 77%, CDK 4/6 inhibitors: 82%, everolimus: 32% and chemotherapy: 68%. Hyperglycemia grade 2+ was seen in 72.7% of patients. There were no significant differences between the two groups for emergency room visits, hospitalizations, or endocrinology referrals related to hyperglycemia. Median time to initiation of an SGLT2 inhibitor was 13 days following the first dose of alpelisib. PFS was longer in the A+SGLT compared with the A group with a median time to progression of 6.1 months and 3.9 months respectively (HR 0.51; 95% CI 0.16 to 1.63; p = 0.39). Time on treatment was significantly longer for A+SGLT group compared with the A group, with a median time on treatment of 5.8 months, compared with 3.0 months (HR 0.32; 95% CI 0.11 to 0.92; p = 0.03). The primary reason for discontinuation of alpelisb was disease progression in 73%, with no statistically significant difference in the reason for discontinuation between the groups. Conclusions: This study supports a potential clinical benefit of an SGLT inhibitor along with alpelisib in allowing for a longer time on treatment, without significant adverse events. It also suggests a possible favorable impact on PFS for the combination.

Background: Understanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients’ perspectives has ever been published for peripheral artery disease–specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease–specific health status instrument for which we sought to prospectively establish its MCID from patients’ perspectives. Methods and Results: Patients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients’ 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9–14.5) and −11.0 (−18.6 to −3.3), respectively. After multivariable adjustment, these were 8.9 (3.0–14.8) and −11.2 (−18.2 to −4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response ( P =0.75). Conclusions: In patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01419080.

The surgical complexities of our current population have pushed the technological limits of healthcare, urging for minimally invasive approaches. For ventral hernias, in particular, robotic assisted laparoscopic repairs have been met with conflict. Cost and longer operative times are among the arguments against robotic surgery, although thorough evaluation of patient outcomes could potentially advocate for use of this tool. We attempted to approach this by retrospectively reviewing our own data. We reviewed charts between September 2016 and February 2017 of patients receiving complex hernia repairs, either a standard open repair (SOR) or robotic-assisted repair (RAR). Data collected included preoperative, perioperative, and postoperative care. Of the 43 patients reviewed, 16 were SOR, versus 27 RAR. Patients were comparable in age, gender, BMI, diabetes as a comorbidity; average hernia defect size was similar between the two groups. Although operative times were longer in the RAR group, estimated blood loss (EBL) was less. Hospital stay was also shorter in the RAR group, at 3.0 ± 1.9 days versus 9.6 ± 8.4 days for the OAR group. Of those requiring critical care management, only one patient had a robotic assisted repair, versus half of the patients who received an open repair. Of the patients who presented to the emergency department within 30 days of surgery, each group had four patients, and two from the OAR group required admission. Our data is consistent with other literature supporting shorter lengths of stays. Although the robotic approach did required a longer operative time, the resulting improved patient outcomes support this technique for complex ventral hernia repairs.

BACKGROUND Patients with coronary chronic total occlusions (CTO) often have multivessel coronary artery disease. We utilized the OPEN CTO study to evaluate patients who underwent single-vessel versus multivessel percutaneous coronary intervention (PCI) during CTO PCI. METHODS Patients were considered to have undergone single-vessel CTO PCI if they underwent target-vessel only CTO PCI. Patients who underwent multivessel PCI during their index CTO PCI procedure were considered to have undergone multivessel PCI. The additional lesions treated in the multivessel group could be either a separate CTO lesion in a separate epicardial vessel or PCI attempt of any non-CTO stenosis during the same index procedure. Multivariate regression models were used to evaluate predictors of technical success, in-hospital major adverse cardiac and cerebrovascular events (MACCE), and health status measures. RESULTS Eighty hundred twenty-one patients underwent single-vessel CTO PCI and 179 (17.9%) underwent multivessel PCI during their CTO PCI procedure. Baseline comorbidities, index CTO lesion complexity, and successful crossing strategies used were similar between the two groups. Total procedural time (142.6 versus 115.9 minutes, P < 0.01) and contrast administered (293.8 versus 255.0 ml, P < 0.01) were increased in the multivessel CTO PCI group. Single-vessel versus multivessel PCI during these cases did not affect the likelihood of achieving technical success [odds ratio (OR) 1.05, 95% confidence interval (CI) 0.63-1.75] nor the risk for MACCE (OR 1.23, 95% CI 0.72-2.11). Quality of life (QOL) metrics were similar between the two groups at baseline and 30-day follow-up. CONCLUSION There were no significant differences in technical success, in-hospital MACCE rates, or QOL metrics at 30-day follow-up for patients who underwent single-vessel versus multivessel PCI during CTO PCI.

Limited data exist that comprehensively describe the practical management, in-hospital outcomes, healthcare resource utilization, and rates of post-hospital readmission among patients with submassive and massive pulmonary embolism (PE). Consecutive discharges for acute PE were identified from a single health system over 3 years. Records were audited to confirm presence of acute PE, patient characteristics, disease severity, medical treatment, and PE-related invasive therapies. Rates of in-hospital major bleeding and death, hospital length of stay (LOS), direct costs, and hospital readmission are reported. From January 2016 to December 2018, 371 patients were hospitalized for acute massive or submassive PE. In-hospital major bleeding (12.1%) was common, despite low utilization of systemic thrombolysis (1.8%) or catheter-directed thrombolysis (3.0%). In-hospital death was 10-fold higher among massive PE compared to submassive PE (36.6% vs 3.3%, p < 0.001). Massive PE was more common during hospitalizations not primarily related to venous thromboembolism, including hospitalizations primarily for sepsis or infection (26.8% vs 8.2%, p = 0.001). Overall, the median LOS was 6.0 days (IQR, 3.0–11.0) and the median standardized direct cost of admissions was $10,032 (IQR, $4467–$20,330). Rates of all-cause readmission were relatively high throughout late follow-up but did not differ between PE subgroups. Despite low utilization of thrombolysis, in-hospital bleeding remains a common adverse event during hospitalizations for acute PE. Although massive PE is associated with high risk for in-hospital bleeding and death, those successfully discharged after a massive PE demonstrate similar rates of readmission compared to submassive PE into late follow-up.

Introduction: Pulmonary hypertension (PH) was shown in multiple studies to be associated with an increased risk of mortality after transcatheter aortic valve replacement (TAVR). However, it is unclear if echocardiogram derived right ventricular systolic pressure (RVSP) is associated with health status outcomes in surviving patients after TAVR. We explored for an association between baseline RVSP and quality of life in patients before and after undergoing TAVR. Methods: We estimated RVSP by echocardiography using the modified Bernoulli equation in a single-center cohort of patients undergoing TAVR from 2012-2017 . Disease-specific health status was assessed at baseline and 1-month and 12-months after TAVR with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS). We then explored the association between baseline RVSP and KCCQ-OS before and after TAVR using a linear mixed model with an interaction for time and baseline RVSP and adjusted for baseline mitral valve regurgitation and systolic blood pressure. Results: Among 485 patients who underwent TAVR (mean age 81.7±7.9 years, 54.8% men), baseline RVSP was 42±15 mmHg, and 73% had RVSP >34 mmHg. After TAVR, mean RVSP decreased to 37±13 mmHg at 1 month and 36±14 mmHg at 12 months. Baseline KCCQ-OS was 46±25 and improved to 66.9±23.6 at 1 month and 69.5± 22.6 at 12 months. In the linear mixed model, there was a significant cross-sectional association between baseline RVSP and baseline KCCQ-OS, with higher RVSP associated with worse health status. However, baseline RVSP was not significantly associated with KCCQ-OS at 1 month or 12 months (Figure). Conclusions: RVSP is not associated with worse health status after TAVR. This suggests that while patients with high RVSP are at an increased risk for mortality after TAVR, surviving patients appear to have similar health status as those with normal RVSP.

Introduction: We assessed the hypothesis that markers of LV wall stress, such as LV sphericity index (SI), may predict appropriate therapy for ventricular arrhythmias (VA) in patients with primary prevention defibrillators, independent of LV ejection fraction. Methods: We performed a retrospective analysis of consecutive patients with new ICD or CRT-D placement for primary prevention at a single hospital from 01/01/2015 to 06/30/2018. TTE images were used for calculating LV SI, which was defined as the ratio of bi-plane LV end-diastolic volume to the volume of a hypothetical sphere with a diameter of LV end-diastolic length in apical 4-chamber view. Device interrogations were reviewed for appropriate therapy for VA and inappropriate therapy for non-VAs. Kaplan-Meier curves stratified by LV SI tertile were constructed, and Cox proportional hazards models were used to evaluate time to appropriate and inappropriate therapy, and all-cause mortality. Results: A total of 282 patients (ICD 154, CRT-D 128) were included. Baseline characteristics are described in the Table. We found a trend towards increased appropriate therapy as LV SI increased in the ICD but not the CRT-D group, but this was non-significant in both (ICD log-rank 0.63, p-value 0.73; CRT-D log-rank 0.07, p-value 0.96). There was no correlation between LV SI and time to all-cause mortality in the ICD (log-rank 0.53, p-value 0.76) or the CRT-D patients (log-rank 0.51, p-value 0.77). LV SI correlated significantly with time to inappropriate therapy in the ICD (log-rank 8.6, p-value 0.01), but not the CRT-D patients (log-rank 2.4, p-value 0.3). Conclusions: LV SI demonstrated a non-significant trend towards increased appropriate device therapy in the ICD but not the CRT-D group. LV SI predicted inappropriate therapy in the ICD but not the CRT-D group. Study power was limited by lower than expected event rates, possibly due to changes in device programming and improvements in heart failure therapies over time.

Background Patients with peripheral artery disease (PAD) and coexisting diabetes mellitus (DM) have greater PAD progression and adverse limb events. Our aim was to study whether PAD‐specific health status differs by DM. Methods and Results The PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) trial is a 16‐center international registry that includes patients with recent exacerbations or new‐onset symptomatic PAD presenting to specialty clinics. We assessed PAD‐specific health status initially and at 3, 6, and 12 months (Peripheral Artery Questionnaire [PAQ]). We used hierarchical, multivariable, linear regression, and repeated measures analyses to study the association between DM and baseline health status initially and over 3 to 12 months. Models were adjusted for demographics, socioeconomic factors, PAD severity, comorbidities, and psychosocial characteristics. The interaction of DM with PAD revascularization on 3‐ to 12‐month health status was also tested. Of 1204 patients, 398 (33%) had DM (94% type 2). Patients with versus those without DM had lower unadjusted PAQ summary scores at baseline and 3, 6, and 12 months (46.1 versus 50.8, 63.6 versus 68.2, 65.7 versus 71.7, and 65.4 versus 72.6; P ≤0.01). In fully adjusted models, the effect of DM on baseline (mean difference, −0.65; 95% CI, −2.86 to 1.56 [ P =0.56]) and over 3‐ to 12‐month PAQ summary scores (mean difference, −1.59; 95% CI, −4.06 to 0.88 [ P =0.21]) was no longer significant. Twelve‐month health status gains following revascularization were similar in both groups ( P =0.69). Conclusions Patients with PAD with coexisting DM have poorer health status, mostly explained by the differences in their psychosocial and other comorbidity burden. Patients with PAD and DM versus those without DM experience similar health status benefits following PAD revascularization.

Background No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI). Methods In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed. Results Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI. Conclusion CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI).In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed.Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI.CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

Background The association of depressive symptoms with health status in peripheral artery disease (PAD) is understudied. No reports of differential impact on women have been described. Methods and Results The PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Artery Disease Investigating Trajectories) registry enrolled 1243 patients from vascular specialty clinics with new or worsening PAD symptoms. Depressive symptoms were assessed at baseline and 3 months using the 8‐Item Patient Health Questionnaire (score ≥10 indicating clinically relevant depressive symptoms). Disease‐specific and generic health status were measured by Peripheral Artery Questionnaire and EQ‐5D Visual Analogue Scale at baseline and 3, 6, and 12 months. An adjusted general linear model for repeated measures was constructed for baseline and 3‐, 6‐, and 12‐month health status outcomes by depressive symptoms at baseline. Differences by sex were tested with interaction effects. The mean age was 67.6±9.4 years with 38% (n=470) women. More women than men (21.1% versus 12.9%; P P Conclusions Women with PAD have a high burden of depressive symptoms. Depressive symptoms were associated with a strikingly worse disease‐specific health status recovery path over the year following PAD diagnosis in men and women. Developing and testing interventions to address depressive symptoms in PAD are urgently needed. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01419080.

Background/significance The 10-point Adverse Childhood Experiences (ACEs) score measures childhood exposure to traumatic events. An ACEs score of 4 or higher has been associated with long-term physical and mental health problems, and increased mortality. It is unclear if the rates of undergraduate nursing students experiencing ACEs is different from the general population, and what impact ACEs has on nursing students' depression, anxiety and stress. Purpose The purpose of this study was to assess the rate of ACEs in nursing students and to examine the relationship between ACEs and perceived depression, anxiety, and stress among undergraduate nursing students. Methods This is a descriptive correlational study to determine Adverse Childhood Experiences (ACEs) scores and Modified Depression Anxiety and Stress Scale (DASS-21) scores for undergraduate pre-licensure students at a private mid-western college. Students' ACEs scores were correlated with DASS-21 scores and demographic data. Results 409 students volunteered to participate in the study. Seventeen percent of students had high ACEs scores (≥4). Those students with high ACEs scores also scored statically significantly higher on the DASS-21 items relating to depression, anxiety, and stress. Conclusion/implications Results from this study demonstrated that many nursing students have experienced ACEs and nursing students with ACEs scores of 4 or higher had higher rates of depression, anxiety, and stress. These findings should drive faculty in nursing programs to acknowledge the prevalence of ACEs among their nursing students and recognize that impact on the mental health of students.

OBJECTIVE: A physically active lifestyle reduces the risk of cardiovascular events and functional impairment in patients with peripheral artery disease (PAD). There are limited data on the patterns of physical activity in patients with PAD compared across countries. METHODS: Self-reported physical activity (sedentary vs not) was obtained at enrolment, 3, 6, and 12 months in the US and Netherlands’ cohorts of the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry of patients with new or worsening claudication. Multivariable repeated measures using modified Poisson regression analysis compared the proportion of sedentary participants over time between countries and to identify factors that attenuate intercountry differences. RESULTS: Of 1 098 participants, 743 (67.7%) and 355 (32.3%) were recruited from the USA and the Netherlands respectively. Compared to the Netherlands, participants from the US were older (mean age 68.6 vs 65.3 years; p < .001), more obese (41.3% vs 20.5%; p < .001), and more likely to be female (41.3% vs 31.4%; p = .002). There were fewer current smokers (30.1% vs 52.8%; p < .001) and supervised exercise referrals (1.6% vs 63.9%; p < .001) in the US compared with the Netherlands. US participants were more sedentary at baseline (43.7% vs. 34.1%; p < .001). Sedentary behaviour decreased after 3 months in both countries, then diverged with an increase in sedentary participants in the USA. Risk of sedentary behaviour was significantly greater in the USA compared with the Netherlands at 12 months, after adjustment of sociodemographic, lifestyle factors, and comorbidities (relative risk [RR] 1.56, 95% confidence interval [CI] 1.08 – 2.25; p = .020) but was attenuated after accounting for referral to supervised exercise (RR 1.20, 95% CI 0.67 – 2.16; p =.54). CONCLUSION: Referral to supervised exercise was key in explaining the observed difference in the physical activity levels between patients with PAD in the USA and the Netherlands. Further promotion of supervised exercise for PAD may improve physical activity in patients with PAD and modify cultural norms of inactivity in the US.

Imaging can help guide management in peripheral arterial disease (PAD) with symptoms refractory to medical treatment. However, there are no set guidelines to determine when physicians should seek further imaging in patients with PAD for the assessment of new, persistent or worsening symptoms. This study describes the rates and variability in non-invasive and invasive imaging for patients presenting to vascular specialty clinics for symptomatic PAD.Patients (n=1,275) with a new PAD diagnosis or exacerbation of PAD symptoms were enrolled from 16 vascular clinics. Hierarchical logistic regression models were used to estimate the referral rates for 1) non-invasive and 2) invasive imaging tests, after adjusting for patient demographics, disease characteristics, PAQ summary score, PAD performance measures and country. Median Odds Ratios (MOR) were calculated to examine the variability across sites and providers.Mean ABI was 0.67 ± 0.19. There were 690 (54.1%) patients who had imaging, of which 62 (9.0%) had invasive imaging. Imaging rates ranged from 8.6% to 98.6% across sites. The MOR for use of imaging for site was 3.36 (p0.001) and provider 3.49 (p0.001). The variability was explained primarily by (RThere is wide variation in the use of imaging for patients presenting with new onset or recent exacerbations of their PAD. Country, followed by provider and site, were most strongly associated with this variability after adjusting for patient characteristics.

Background: Comorbid sleep apnea in cardiovascular disease is a predictor of adverse cardiovascular outcomes. It is unknown whether comorbid sleep apnea in PAD is associated with worse PAD-specific health status outcomes. Methods: PORTRAIT is an international (US, Netherlands, Australia), 16-center, prospective PAD registry. Health status was assessed upon PAD diagnosis and at 12 months (disease-specific Peripheral Artery Questionnaire, PAQ Summary scores). Higher PAQ scores indicate better health status. A sequentially adjusted hierarchical linear regression model examined the association between sleep apnea and 1-year PAQ scores (figure). Results: Of the 1204 patients with PAD, 8.3% (n=100) had comorbid sleep apnea. The mean age was 67.6 ± 9.4 with 37.5% women. Patients with vs. without sleep apnea were more from the US; more sedentary, presented with more diabetes, obesity, coronary disease and a history of peripheral interventions, but had higher ankle-brachial index values. They also had lower health status scores at presentation and 12 months (41.2 ± 22.0 vs 49.9±21.6 and 58.6±27.9 vs71.3±24.9, respectively, p Conclusion: In patients presenting with PAD, comorbid sleep apnea clusters with an overall toxic cardiovascular risk profile. Independent of these risk factors, patients with PAD and sleep apnea obtain less favorable PAD-specific 1-year PAD-specific health status outcomes. Figure: The Association Between Sleep Apnea and 1-Year PAQ Summary Scores Following Sequential Adjustment for Demographics, Socioeconomic Factors, PAD severity, Psychosocial Factors and Baseline Health Status Score. Estimates represent Beta coefficients and 95% confidence intervals.

Background: Peripheral artery disease (PAD) prevalence is increasing by age in high-income countries. It is unknown whether patient characteristics, treatment profiles, and 1-year PAD-specific health status outcomes differ across health care contexts in high-income countries such as the ones in the United States (US) vs. the Netherlands. Methods: Patients were identified from the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study which is a prospective, multicenter, international registry of patients presenting to vascular specialty clinics for new onset, or an exacerbation of PAD symptoms. PAD-specific health status was measured by Peripheral Artery Questionnaire (PAQ) at presentation, and at 3, 6 and 12 months follow-up using adjusted generalized repeated measurement models. Results: Out of a total of 1,114 patients,748 patients (67.1%) were from the US and 366 (32.9%) were from the Netherlands. US patients with PAD were significantly older and had a higher cardiovascular risk factor burden including smoking (Table) with more Netherlands patients being referred to supervised vs. unsupervised exercise therapy (SET) as compared with the US cohort after enrollment. US patients presented with significantly lower PAD-specific health status scores (PAQ summary scores) upon presentation (-41.59 vs 49.58, p Conclusion: US patients seeking care for PAD have a different risk profile upon presentation from Dutch patients, including worse health status profiles, and had less exposure to SET. Even after adjustment, worse PAD-specific health status outcomes were seen in the US cohort at baseline throughout 12 months of follow-up. Contrasting risk exposure patterns and health care systems across high-income care settings may highlight mutual learning opportunities to advance the care for PAD.

Background A number of non‐low‐density lipoprotein cholesterol lipid abnormalities are associated with type 2 diabetes and insulin resistance, which may lead practitioners to use medications targeting these abnormal lipid fractions despite a lack of evidence or guideline recommendations. Methods and Results Among 382 921 US patients with type 2 diabetes (69% with cardiovascular disease, 76% on a statin), 95 995 (26%) were on some nonstatin lipid‐lowering medication—19 265 (5%) on niacin, 32 919 (9%) on a fibrate and 69 513 (18%) on fish oil. Use of all three medications was stable over time and higher in patients with cardiovascular disease and with higher triglyceride levels, although even among patients with triglyceride levels, A number of non‐low‐density lipoprotein cholesterol lipid abnormalities are associated with type 2 diabetes and insulin resistance, which may lead practitioners to use medications targeting these abnormal lipid fractions despite a lack of evidence or guideline recommendations. Among 382 921 US patients with type 2 diabetes (69% with cardiovascular disease, 76% on a statin), 95 995 (26%) were on some nonstatin lipid‐lowering medication—19 265 (5%) on niacin, 32 919 (9%) on a fibrate and 69 513 (18%) on fish oil. Use of all three medications was stable over time and higher in patients with cardiovascular disease and with higher triglyceride levels, although even among patients with triglyceride levels

Background Underuse of guideline‐recommended therapy in peripheral artery disease ( PAD ) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy ( SET ) in PAD are lacking. We aimed to document the use of PAD guideline‐recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16‐center PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011–2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET : “2 quality measures” referred to the use of both statin and antiplatelet medications; “4 quality measures” to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET . Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received “2 quality measures” and 19.7% “4 quality measures.” The median odds ratio for 2 quality measures was 2.13 (95% CI , 1.61–3.56; P CI , 2.84–17.91; P SET . The odds for SET referral in The Netherlands (70% referral rate) was nearly 100 times greater than in US sites (2% referral rate). Conclusions Not all patients who have undergone a PAD workup at a specialty care facility are treated with evidence‐based care, especially so for SET .

Supplemental material, sj-pdf-1-vmj-10.1177_1358863X20967415 for Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study by Matthew C Bunte, Kensey Gosch, Ahmed Elkaryoni, Anas Noman, Erin Johnson, Philip Jones, Mahathi B Indaram and Sravanthi Vupputuri in Vascular Medicine