Thirst and factors associated with frequent thirst in patients with heart failure in Spain

BackgroundThirst is a troublesome symptom in patients with Heart Failure (HF) and one that might be perceived differently in different countries depending on climate, food and cultural habits. The aims of the study were to describe thirst frequency, duration and intensity and to identify factors associated with frequent thirst in outpatients with HF in a Mediterranean country.MethodsData was collected in a cross-sectional study involving 302 patients diagnosed with HF (age 67±12 years, 74% male, LVEF 43%±14) in Spain on thirst frequency and duration, and thirst intensity by patient self-report (VAS, 0-100 mm). Clinical variables were collected from the medical files. Regression analysis was used to identify factors independently associated with frequent thirst.ResultsOf all the patients, 143 (47%) were frequently thirsty, and their median (25^th and 75^th percentiles) thirst intensity was higher (VAS 50 mm [20-67] vs 7 [0-20], p<.001). Their thirst lasted longer compared to those who never/sometimes were thirsty (p<.001). Less treatment with angiotensin receptor blockers (Odds Ratio [OR] 2.72; 95% Confidence Interval [CI] 1.33–5.58), diuretics >40 mg/day (OR 1.92; 95% CI 1.02-3.64), depression (OR 2.99; CI 1.17–7.62), male gender (OR 1.98; CI 1.08–3.64) and worse New York Heart Association functional class (OR 1.92; 95% CI 1.05-3.52) were independently associated with frequent thirst.ConclusionsAbout half of patients with HF and fluid restriction experienced frequent thirst in a Mediterranean area of Spain, and their thirst duration and intensity were significantly increased. Frequent thirst was associated with demographic, clinical and therapeutic variables. The results may help to identify patients with a higher risk of frequent thirst and might suggest therapeutic changes in order to diminish this troublesome symptom.     

Simple Renal Cysts Are Associated With 24-Month Prognosis of Patients With Type B Aortic Dissection and Hypertension

BackgroundThe association of simple renal cyst (SRC) with type B aortic dissection (BAD) has recently been established. However, no studies have examined adverse events after BAD hospitalization among patients with SRC. In this study, we assessed the prognostic value of SRC in BAD patients with hypertension after thoracic endovascular aortic repair (TEVAR).MethodsWe studied all BAD patients with hypertension who were admitted for TEVAR (n = 238; age 56.1 ± 9.8 years, 84.0% male). Aortic-related adverse events (ARAE) were evaluated as outcomes at 3 months and 24 months after TEVAR.ResultsAmong the total number of patients, 104 (43.7%) had at least 1 SRC. Patients with SRC were significantly older than those without (59.6 ± 8.8 vs 53.3 ± 9.7; P < 0.001). Patients with SRC were also more likely to suffer from peripheral arterial disease (55.8% vs 40.3%; P = 0.018) and cerebrovascular accidents (47.1% vs 29.9%; P = 0.006) than those without. Median follow-up for the 238 patients was 18.5 (range 6.4-24.0) months. Cumulative ARAE-free rates were 94.5 ± 1.5% at the 3-month follow-up and 81.5 ± 2.8% at the 24-month follow-up. Independent predictors of 3-month ARAE were found to be insertion of ≥ 2 stents (hazard ratio [HR] 3.977, 95% confidence interval [CI] 1.224-12.920; P = 0.022). For 24-month follow-up, SRC (HR 1.962, 95% CI 1.023-3.764; P = 0.043) was evaluated as the only independent predictive factor. SRC (HR 8.841, 95% CI 1.726-45.294; P = 0.009) was also evaluated as an independent predictive factor for 24-month ARAEs in the chronic group, but not in the acute or the subacute group.ConclusionsSRC could predict 24-month ARAE in BAD patients with hypertension after TEVAR, especially in the chronic group.     

Outcomes in World Health Organization Group II Pulmonary Hypertension: Mortality and Readmission Trends With Systolic and Preserved Ejection Fraction–Induced Pulmonary Hypertension

BackgroundHeart failure with preserved ejection fraction (HFpEF) has been increasingly recognized as a leading cause of pulmonary hypertension (HFpEF-PH). It remains unknown how HFpEF-PH fares in relation to systolic HF (reduced ejection fraction)–induced PH (HFrEF-PH). Therefore, we sought to determine the long-term morbidity and mortality of HFpEF-PH and HFrEF-PH.Methods and ResultsWe studied all patients over a 6-year period with symptomatic HF and severe PH (PASP ≥65 mm Hg) in The Bronx, New York. We classified patients as having either preserved (≥50%) or reduced (≤35%) left ventricular ejection fraction. Trends in mortality and HF readmission rates were defined in 650 patients (HFrEF-PH: n = 277; HFpEF-PH: n = 373). HFpEF-PH patients were older and more often female and white. HFrEF-PH patients were more often black, had ischemic cardiomyopathy, and were on typical HF drug regimens. Patients with HFpEF-PH had a significantly increased all-cause 5-year mortality (52% vs 42%; P = .024). HFpEF-PH was a significant predictor of mortality (adjusted hazard ratio 1.70; P = .012). Patients with HFrEF-PH had more HF readmissions (≥1) than patients with HFpEF-PH (28.6% vs 15%; P = .003), especially within the 1st year (9.1% vs 1.7%; P = .005).ConclusionsPatients with HFrEF-PH and HFpEF-PH have a significantly elevated long-term mortality, with HFpEF-PH having a higher 5-year mortality rate. These findings testify to the overall poor prognosis of World Health Organization Group II PH, especially HFpEF-PH.     

Thirst in the elderly with and without heart failure

Elderly patients with heart failure (HF) may be troubled by thirst, despite the fact that elderly have an impaired ability to sense thirst. The present study was undertaken to compare the intensity of thirst in patients with and without HF and to evaluate how this symptom relates to the health-related quality of life and indices of the fluid balance. Forty-eight patients (mean age 80 years) admitted to hospital with worsening HF (n = 23) or with other acute illness (n = 25) graded their thirst and estimated their health-related quality of life (HRQoL). Serum sodium was measured and urine samples were assessed for color and electrolyte content. The HF patients reported significantly more intensive thirst (median = 75 mm) compared with those in the control group (median = 25 mm; p < 0.0001). There was no statistically significant relationship between thirst and HRQoL, which was low overall. Serum sodium and urine color did not differ significantly between the groups, but the urine of the HF patients had a lower sodium concentration and osmolality. We conclude that elderly patients with worsening HF have considerably increased thirst and, hence, intense thirst should be regarded as a symptom of HF.     

Fluid REStriction in Heart Failure vs Liberal Fluid UPtake: Rationale and Design of the Randomized FRESH-UP Study

AimsIt is common practice for clinicians to advise fluid restriction in patients with heart failure (HF), but data from clinical trials are lacking. Moreover, fluid restriction is associated with thirst distress and may adversely impact quality of life (QoL). To address this gap in evidence, the Fluid REStriction in Heart failure vs liberal fluid UPtake (FRESH-UP) study was initiated.MethodsThe FRESH-UP study is a randomized, controlled, open-label, multicenter trial to investigate the effects of a 3-month period of liberal fluid intake vs fluid restriction (1500 mL/day) on QoL in outpatients with chronic HF (New York Heart Association Classes II--III). The primary aim is to assess the effect on QoL after 3 months using the Overall Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Thirst distress, as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient-reported fluid intake and safety (ie, death, HF hospitalizations) are secondary outcomes. The FRESH-UP study is registered at ClinicalTrials.gov (NCT04551729).ConclusionThe results of the FRESH-UP study will add substantially to the level of evidence concerning fluid management in chronic HF and may impact the QoL of these patients.     

Reduced Handgrip Strength as a Marker of Frailty Predicts Clinical Outcomes in Patients With Heart Failure Undergoing Ventricular Assist Device Placement

BackgroundHeart failure (HF) is associated with the derangement of muscle structure and metabolism, contributing to exercise intolerance, frailty, and mortality. Reduced handgrip strength is associated with increased patient frailty and higher morbidity and mortality. We evaluated handgrip strength as a marker of muscle function and frailty for prediction of clinical outcomes after ventricular assist device (VAD) implantation in patients with advanced HF.Methods and ResultsHandgrip strength was measured in 72 patients with advanced HF before VAD implantation (2.3 ± 4.9 days pre-VAD). We analyzed dynamics in handgrip strength, laboratory values, postoperative complications, and mortality. Handgrip strength correlated with serum albumin levels (r = 0.334, P = .004). Compared with baseline, handgrip strength increased post-VAD implantation by 18.2 ± 5.6% at 3 months (n = 29) and 45.5 ± 23.9% at 6 months (n = 27). Patients with a handgrip strength <25% of body weight had an increased risk of mortality, increased postoperative complications, and lower survival after VAD implantation.ConclusionPatients with advanced HF show impaired handgrip strength indicating a global myopathy. Handgrip strength <25% of body weight is associated with higher postoperative complication rates and increased mortality after VAD implantation. Thus, the addition of measures of skeletal muscle function underlying the frailty phenotype to traditional risk markers might have incremental prognostic value in patients undergoing evaluation for VAD placement.     

The Singapore Heart Failure Outcomes and Phenotypes (SHOP) Study and Prospective Evaluation of Outcome in Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PEOPLE) Study: Rationale and Design

BackgroundHeart failure (HF) with preserved ejection fraction (EF) accounts for a substantial proportion of cases of HF, and to date no treatments have clearly improved outcome. There are also little data comparing HF cohorts of differing ethnicity within the Asia-Pacific region.MethodsThe Singapore Heart Failure Outcomes and Phenotypes (SHOP) study and Prospective Evaluation of Outcome in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction (PEOPLE) study are parallel prospective studies using identical protocols to enroll patients with HF across 6 centers in Singapore and 4 in New Zealand. The objectives are to determine the relative prevalence, characteristics, and outcomes of patients with HF and preserved EF (EF ≥50%) compared with those with HF and reduced EF, and to determine initial data on ethnic differences within and between New Zealand and Singapore. Case subjects (n = 2,500) are patients hospitalized with a primary diagnosis of HF or attending outpatient clinics for management of HF within 6 months of HF decompensation. Control subjects are age- and gender-matched community-based adults without HF from Singapore (n = 1,250) and New Zealand (n = 1,073). All participants undergo detailed clinical assessment, echocardiography, and blood biomarker measurements at baseline, 6 weeks, and 6 months, and are followed over 2 years for death or hospitalization. Substudies include vascular assessment, cardiopulmonary exercise testing, retinal imaging, and cardiac magnetic resonance imaging.ConclusionsThe SHOP and PEOPLE studies are the first prospective multicenter studies defining the epidemiology and interethnic differences among patients with HF in the Asia-Oceanic region, and will provide unique insights into the pathophysiology and outcomes for these patients.     

A Randomized Controlled Pilot Study of Outcomes of Strict Allowance of Fluid Therapy in Hyponatremic Heart Failure (SALT-HF)

BackgroundCurrently, fluid restriction recommendations in heart failure (HF) are based on expert opinion. After implementing a 1,000-mL/d fluid restriction for 60 days after discharge, outcomes were examined.Methods and ResultsIn a randomized controlled design, hyponatremic patients (serum sodium ≤137 mg/dL) received usual care (UC; n = 26) or 1,000 mL/d fluid restriction (n = 20) at discharge. Quality of life (QoL), thirst, difficulty following fluid recommendations, adherence to fluid restriction, HF emergency care, HF rehospitalization, and all-cause death were examined. Mean age was 62.8 ± 12.8 years; 46% were white. There were no differences by group in baseline demographics, comorbidities, and QoL, except that more UC patients had New York Heart Association (NYHA) functional class III/IV status (P = .019). Median [interquartile range] QoL scores were better in the 1,000 mL/d group for symptom burden (83.3 [68.8–91.7] vs 50 [29.2–79.2]; P = .018), total symptoms (77.1 [58.1–91.7] vs 54.2 [30.2–73.9]; P = .022), overall QoL summary (72.6 [52.2–86.3] vs 51.0 [37.7–68.5]; P = .038), and clinical QoL summary (75.5 [57.8–92.9] vs 59.1 [35.7–77.3]; P = .039). There were no group differences in thirst, difficulty adhering to fluid recommendations, adherence to fluid restriction, or health care consumption.ConclusionsThe 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge. Future research in a larger more heterogeneous sample is needed.     

6-Month Outcomes in Patients With Implantable Cardioverter-Defibrillators Undergoing Renal Sympathetic Denervation for the Treatment of Refractory Ventricular Arrhythmias

ObjectivesThis study aimed to assess 6-month outcomes in patients with implantable cardioverter-defibrillators (ICDs) undergoing renal sympathetic denervation (RSD) for refractory ventricular arrhythmias (VAs).BackgroundICDs are generally indicated for patients at high risk of malignant VAs. Sympathetic hyperactivity plays a critical role in the development, maintenance, and aggravation of VAs.MethodsA total of 10 patients with refractory VA underwent RSD. Underlying conditions were Chagas disease (n = 6), nonischemic dilated cardiomyopathy (n = 2), and ischemic cardiomyopathy (n = 2). Information on the number of ventricular tachycardia (VT)/ventricular fibrillation (VF) episodes and device therapies (antitachycardia pacing/shocks) in the previous 6 months as well as 1 and 6 months post-treatment was obtained from ICD interrogation.ResultsThe median number of VT/VF episodes/antitachycardia pacing/shocks 6 months before RSD was 28.5 (range 1 to 106)/20.5 (range 0 to 52)/8 (range 0 to 88), respectively, and was reduced to 1 (range 0 to 17)/0 (range 0 to 7)/0 (range 0 to 3) at 1 month and 0 (range 0 to 9)/0 (range 0 to 7)/0 (range 0 to 3) at 6 months afterward, respectively. There were no major procedure-related complications. Two patients experienced sustained VT within the first week; in both cases, no further episodes occurred during follow-up. Two patients were nonresponders: 1 with persistent idioventricular rhythm and 1 with multiple renal arteries and incomplete ablation. Three patients died during follow-up. None of the deaths was attributed to VA.ConclusionsIn patients with ICDs and refractory VAs, RSD was associated with reduced arrhythmic burden with no procedure-related complications. Randomized controlled trials investigating RSD for treatment of refractory VAs in patients with increased sympathetic activity are needed.     

Ticagrelor Monotherapy Versus Ticagrelor With Aspirin in Patients With ST-Segment Elevation Myocardial Infarction

ObjectivesThe aim of this study was to assess whether the effects of ticagrelor monotherapy after 3-month dual-antiplatelet therapy (DAPT) are consistent among patients presenting with ST-segment elevation myocardial infarction (STEMI), non–ST-segment elevation myocardial infarction, and unstable angina treated with drug-eluting stents.BackgroundTicagrelor monotherapy after short-term DAPT has not been investigated in patients with STEMI.MethodsThis was a pre-specified, stratified, subgroup analysis of the STEMI cohort from the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome) trial, which constituted 36% of the total population. The primary outcome was a composite of major bleeding and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, stent thrombosis, stroke, or target vessel revascularization). The secondary outcomes were major bleeding and MACCE.ResultsThe incidence of the primary outcome was 4.4% in patients with STEMI (n = 1,103), 6.0% in those with non–ST-segment elevation myocardial infarction (n = 1,027), and 4.1% in those with unstable angina (n = 926), without statistical significance (p = 0.09). Compared with ticagrelor-based 12-month DAPT, ticagrelor monotherapy after 3-month DAPT showed consistent effects on the primary outcome across clinical presentations (p for interaction [p_int] = 0.64). Furthermore, the effect of ticagrelor monotherapy on the reduction of major bleeding was consistent across clinical presentations (p_int = 0.36). The effect of ticagrelor monotherapy on MACCE was also consistent in patients with STEMI, without evidence of a higher risk for MACCE (p_int = 0.14).ConclusionsThis pre-specified subgroup analysis revealed no heterogeneity in the effects of ticagrelor monotherapy after 3-month DAPT, compared with 12-month DAPT, for the primary outcome, major bleeding, and MACCE across clinical presentations including STEMI, though larger studies are needed to demonstrate these findings with adequate power. (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome [TICO Study]; NCT02494895)     

Noncardiovascular Death,Especially Infection,Is a Significant Cause of Death in Elderly Patients With Acutely Decompensated Heart Failure

BackgroundDespite marked improvements in treatment strategies for heart failure (HF), the mortality rate of elderly patients with HF is still high. Detailed causes of death have not been fully understood.Methods and ResultsWe studied 459 consecutive patients with acute decompensated HF (ADHF) emergently admitted to our hospital from 2007 to 2011. Patients were divided into 2 groups: <75 years old (younger group; n = 225) and ≥75 years old (elderly group; n = 234). All-cause death, cardiovascular death, and noncardiovascular death were assessed as adverse outcomes. Compared with the younger group, the elderly group was characterized by a higher proportion of women and hypertensive patients and higher left ventricular ejection fraction. During a mean follow-up of 20.7 months, a total of 174 patients (37.9%) died. All-cause death was significantly higher in the elderly group than in the younger group (46.6% vs 28.9%; P < .0001), and this difference was caused by an increase in noncardiovascular deaths (20.9% vs 9.3%; P < .001), especially deaths due to infection (10.7% vs 4.0%; P < .01). Cardiovascular deaths did not differ between the 2 groups.ConclusionsNoncardiovascular deaths, most of which were caused by infection, were frequent among elderly patients with ADHF.     

Continuous Ultrafiltration for Congestive Heart Failure: The CUORE Trial

BackgroundThere are limited data comparing ultrafiltration with standard medical therapy as first-line treatment in patients with severe congestive heart failure (HF). We compared ultrafiltration and conventional therapy in patients hospitalized for HF and overt fluid overload.Methods and ResultsFifty-six patients with congestive HF were randomized to receive standard medical therapy (control group; n = 29) or ultrafiltration (ultrafiltration group; n = 27). The primary end point of the study was rehospitalizations for congestive HF during a 1-year follow-up. Despite similar body weight reduction at hospital discharge in the 2 groups (7.5 ± 5.5 and 7.9 ± 9.0 kg, respectively; P = .75), a lower incidence of rehospitalizations for HF was observed in the ultrafiltration-treated patients during the following year (hazard ratio 0.14, 95% confidence interval 0.04–0.48; P = .002). Ultrafiltration-induced benefit was associated with a more stable renal function, unchanged furosemide dose, and lower B-type natriuretic peptide levels. At 1 year, 7 deaths (30%) occurred in the ultrafiltration group and 11 (44%) in the control group (P = .33).ConclusionsIn HF patients with severe fluid overload, first-line treatment with ultrafiltration is associated with a prolonged clinical stabilization and a greater freedom from rehospitalization for congestive HF.     

Right Ventricular–Pulmonary Arterial Coupling in Patients With HF Secondary MR: Analysis From the COAPT Trial

ObjectivesThe aim of this study was to determine the prognostic impact of right ventricular (RV)–pulmonary arterial (PA) coupling in patients with heart failure (HF) with severe secondary mitral regurgitation (SMR) enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.BackgroundRV contractile function and PA pressures influence outcomes in patients with SMR, but the impact of RV-PA coupling in patients randomized to transcatheter edge-to-edge repair (TEER) vs guideline-directed medical therapy (GDMT) is unknown.MethodsRV-PA coupling was assessed by the ratio of RV free wall longitudinal strain derived from speckle-tracking echocardiography and noninvasively measured RV systolic pressure. Advanced RV-PA uncoupling was defined as RV free wall longitudinal strain/RV systolic pressure ≤0.5%/mm Hg. The primary endpoint was a composite of all-cause mortality or HF hospitalization at 24-month follow-up.ResultsA total of 372 patients underwent speckle-tracking echocardiography, and 70.2% had advanced RV-PA uncoupling. By multivariable analysis, advanced RV-PA uncoupling was strongly associated with an increased risk for the primary 24-month endpoint of death or HF hospitalization (HR: 1.87; 95% CI: 1.31-2.66; P = 0.0005). A similar association was present for all-cause mortality alone (HR: 2.57; 95% CI: 1.54-4.29; P = 0.0003). The impact of RV-PA uncoupling was consistent in patients randomized to TEER and GDMT alone. Compared with GDMT alone, the addition of TEER improved 2-year outcomes in patients with (48.0% vs 74.8%; HR: 0.51; 95% CI: 0.37-0.71) and those without (28.8% vs 47.8%; HR: 0.51; 95% CI: 0.27-0.97) advanced RV-PA uncoupling (P_interaction = 0.98).ConclusionsIn the COAPT trial, advanced RV dysfunction assessed by RV-PA uncoupling was a powerful predictor of 2-year adverse outcomes in patients with HF and SMR. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079)     

Stent Repair for Complex Coarctation of Aorta

ObjectivesThis study sought to determine whether several anatomic or evolving characteristics of the coarctation may create challenging conditions for treatment.BackgroundStent repair of coarctation of aorta is an alternative to surgical correction.MethodsWe analyzed our 21-year experience in the percutaneous treatment of complex coarctation of aorta. Adverse conditions for treatment were as follow: 1) complete interruption of the aortic arch (n = 11); 2) associated aneurysm (n = 18); 3) complex stenosis (n = 30); and 4) the need for re-expansion and/or restenting (n = 21). Twenty patients (33%) belonged to more than 1 group. Ten interruptions were type A and 1 was type B. The mean length of the interrupted aorta was 9 ± 11 mm. The associated aneurysms were native in 8 patients and after previous intervention in 10 patients. Aneurysm shapes were fusiform in 8 patients and saccular in 10. The following characteristics defined complex stenosis as long diffuse stenosis, very tortuous coarctation, or stenosis involving a main branch or an unusual location. Patients previously stented at an early age, required re-expansion and/or restenting after reaching 16 ± 5 years of age.ResultsTwo patients had died by 1-month follow-up. The remaining 58 patients did well and were followed-up for a mean period of 10 ± 6 years. Late adverse events occurred in 3 patients (5%). All remaining patients are symptom-free, with normal baseline blood pressure. Imaging techniques revealed good patency at follow-up without associated aneurysm or restenosis. The actuarial survival free probability of all complex patients at 15 years was 92%.ConclusionsStent repair of complex coarctation of aorta is feasible and safe. Initial results are maintained at later follow-up.     

Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure

BackgroundMore data regarding effects of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes (T2D) and heart failure (HF) are required.ObjectivesThe purpose of this study was to investigate the effects of liraglutide on cardiovascular events and mortality in LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) participants, by HF history.MethodsIn the multinational, double-blind, randomized LEADER trial, 9,340 patients with T2D and high cardiovascular risk were assigned 1:1 to liraglutide (1.8 mg daily or maximum tolerated dose up to 1.8 mg daily) or placebo plus standard care, and followed for 3.5 to 5 years. New York Heart Association (NYHA) functional class IV HF was an exclusion criterion. The primary composite major adverse cardiovascular events outcome was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Post hoc Cox regression analyses of outcomes by baseline HF history were conducted.ResultsAt baseline, 18% of patients had a history of NYHA functional class I to III HF (liraglutide: n = 835 of 4,668; placebo: n = 832 of 4,672). Effects of liraglutide versus placebo on major adverse cardiovascular events were consistent in patients with (hazard ratio [HR]: 0.81 [95% confidence interval (CI): 0.65 to 1.02]) and without (HR: 0.88 [95% CI: 0.78 to 1.00]) a history of HF (p interaction = 0.53). In both subgroups, fewer deaths were observed with liraglutide (HR: 0.89 [95% CI: 0.70 to 1.14] with HF; HR: 0.83 [95% CI: 0.70 to 0.97] without HF; p interaction = 0.63) versus placebo. No increased risk of HF hospitalization was observed with liraglutide, regardless of HF history (HR: 0.98 [95% CI: 0.75 to 1.28] with HF; HR: 0.78 [95% CI: 0.61 to 1.00] without HF; p interaction = 0.22). Effects of liraglutide on the composite of HF hospitalization or cardiovascular death were consistent in patients with (HR: 0.92 [95% CI: 0.74 to 1.15]) and without (HR: 0.77 [95% CI: 0.65 to 0.91]) a history of HF (p interaction = 0.19).ConclusionsBased on these findings, liraglutide should be considered suitable for patients with T2D with or without a history of NYHA functional class I to III HF. (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results [LEADER]; NCT01179048)     

Watchman Occlusion in Long-Standing Persistent Atrial Fibrillation: Larger Left Atrial Appendages With Greater Residual Leak

ObjectivesThis study sought to compare patients with and without long-standing persistent atrial fibrillation (LSPAF) undergoing Watchman left atrial appendage (LAA) occlusion.BackgroundAn increased burden of atrial fibrillation is associated with progressive left atrial remodeling and enlargement.MethodsTransesophageal echocardiography (TEE) measures of LAA ostial diameter and depth, device compression, and residual leak were evaluated in 101 consecutive Watchman cases. The patients were categorized into LSPAF (n = 48) or non-LSPAF (n = 53) groups and compared.ResultsThe average LAA ostial diameter for LSPAF versus non-LSPAF by TEE omniplane at 0° was 21.1 ± 4.1 mm versus 18.2 ± 3.6 mm (p = 0.0002); at 45° was 18.7 ± 3.4 mm versus 16.3 ± 3.1 mm (p = 0.0004); at 90° was 19.6 ± 3.8 mm versus 16.2 ± 3.4 mm (p = 0.00001); and at 135° was 21.0 ± 4.1 mm versus 18.0 ± 4.1 mm (p = 0.0005). The average LAA depth for LSPAF versus non-LSPAF by TEE at 0° was 28.1 ± 6.4 mm versus 25.2 ± 4.9 mm (p = 0.02); at 45° was 27.9 ± 5.8 mm versus 25.1 ± 4.3 mm (p = 0.007); at 90° was 27.2 ± 5.2 mm versus 22.8 ± 3.7 mm (p = 0.0001); and at 135° was 25.6 ± 5.4 mm versus 21.5 ± 3.8 mm (p = 0.0001). In successfully treated patients, 77% of the LSPAF group received larger device (27, 30, or 33 mm) implants versus only 46% in the non-LSPAF group (p = 0.003). While both groups had similar rates of moderate (3 to 5 mm) leaks at implant (2% vs. 0%; p = 0.14), 27% of the LSPAF vs. 4% of the non-LSPAF group had moderate leaks (p = 0.04) on 6-week follow-up TEE.ConclusionsPatients with LSPAF have significantly larger LAA sizes, require larger devices, and have more residual leak on follow-up TEE. LSPAF may represent a higher risk group that warrants more stringent long-term follow-up.     

3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure

BackgroundIn the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone.ObjectivesThis study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit.MethodsThis study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months.ResultsThe annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).ConclusionsAmong patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079)     

Impact of serum uric acid levels on cardiovascular events and quality of life in patients with chronic coronary syndromes: Insights from a contemporary,prospective, nationwide registry

Background and aimsHyperuricemia is a metabolic disorder that has been associated with adverse cardiovascular (CV) events. Using the data from a nationwide, prospective registry on patients with chronic coronary syndromes (CCS), we assessed the impact of serum uric acid (SUA) levels on quality of life (QoL) and major adverse CV events (MACE), a composite of CV death and hospitalization for myocardial infarction, heart failure (HF), angina or revascularization at 1-year.Methods and resultsAmong the 5070 consecutive CCS patients enrolled in the registry, levels of SUA were available for 2394 (47.2%). Patients with SUA levels available at baseline were grouped as low tertile (n = 860; 4.3 [3.7–4.7] mg/dL), middle tertile (n = 739; 5.6 [5.3–5.9] mg/dL) and high tertile (n = 795; 7.1 [6.7–7.9] mg/dL). At 1 year, the incidence of MACE was 3.7%, 4.1% and 6.8% for low, middle and high tertiles, respectively (p = 0.005 for low vs high tertile). Patients in the high tertile of SUA had a significantly higher rate of CV mortality (1.4% vs 0.4%; p = 0.05) and hospital admission for HF (2.8% vs 1.6%; p = 0.03) compared to the low tertile. However, hyperuricemia did not result as an independent predictor of MACE at multivariable analysis [hazard ratio: 1.27; 95% confidence intervals: 0.81–2.00; p = 0.3].ConclusionsIn this contemporary, large cohort of CCS, those in the high tertile of SUA had a greater burden of CV disease and worse QoL. However, SUA did not significantly influence the higher rate of CV mortality, hospitalization for HF and MACE observed in these patients during 1-year follow-up.     

Cardiac resynchronisation therapy optimisation of interventricular delay by the systolic dyssynchrony index: A comparative,randomised, 12-month follow-up study

BackgroundThe aim of our study was to compare the effect of interventricular (VV) delay optimisation in CRT recipients on the basis of systolic dyssynchrony index (SDI) derived from the three-dimensional echocardiography (3DE) versus QRS width assessment on left ventricle volume reduction at the 12-month follow-up.MethodsWe included 63 patients with recently implanted CRT in this randomised, open-label trial. Patients were randomised to VV delay optimisation according to QRS complex width measurement in group 1 (n = 31) to obtain the narrowest QRS complex and SDI in group 2 (n = 32) to achieve its lowest possible value. We evaluated left ventricular end-systolic volume (LVESv), left ventricular ejection fraction (LVEF) and SDI by 3DE before CRT implantation and at a 12-month follow-up in all the patients. We also obtained the New York Heart Association functional class, the 6-minute walk test, the quality of life questionnaire and the level of NT-proBNP.ResultsThe number of volumetric responders was similar in both groups (17 vs. 20, P = 0.786). There were also no significant differences in the reduction of LVESv (−41 ± 55 mL vs. - 61 ± 51 mL, P = 0.111), improvement in LVEF (+10.1 ± 10.6% vs. + 13.0 ± 9.9%, P = 0.213) or differences in clinical outcomes between both groups at the 12-month follow-up.ConclusionCRT optimisation of interventricular delay using SDI compared with QRS width assessment did not reveal any significant difference in terms of volumetric and clinical response at the 12-month follow-up.