New York Heart Association Research Articles

Left bundle branch area pacing versus endocardial resynchronization in patients with heart failure

AbstractBackgroundLeft bundle branch area pacing (LBBAP) and endocardial resynchronization (Endo‐CRT) are alternatives to biventricular pacing for cardiac resynchronization therapy (CRT).ObjectiveTo compare the outcomes of LBBAP versus Endo‐CRT using conventional pacing leads.MethodsPatients with heart failure (HF) undergoing CRT with LBBAP or Endo‐CRT were included. The primary efficacy outcome was a composite of HF‐related hospitalization and all‐cause mortality. The primary safety outcome was any procedure‐related complication. Secondary outcomes included procedural characteristics, electrocardiographic, and echocardiographic parameters.ResultsA total of 223 patients (LBBAP n = 197, Endo‐CRT n = 26; mean age 69 ± 10.3 years, 32.3% female) were included. Patients in the LBBAP group had lower NYHA class, shorter preprocedural QRS durations (161 [142–183] vs. 180 [170–203] msec, p < .001), and a lower preprocedural spironolactone use (57.4% vs. 84.6%, p = .009) than patients in the Endo‐CRT group. Fluoroscopy time was significantly shorter in patients undergoing LBBAP (11.4 [7.2–20] vs. 23 [14.2–34.5] min; p < .001). There was no significant difference in the primary efficacy outcome between both groups (Cox proportional HR 1.21, 95% CI 0.635–2.31; p = .56). During follow‐up, patients undergoing LBBAP had a lower incidence of stroke than patients in the Endo‐CRT group (0% vs. 11.5%, p = .001). Postprocedural LVEF (35% [25–45] vs. 40% [20–55]; p = .307) and change in LVEF (7% [0–20] vs. 11% [2–18]; p = .384) were similar between the LBBAP and the Endo‐CRT groups, respectively.ConclusionLBBAP and Endo‐CRT using conventional leads are associated with similar mortality and HF‐related hospitalization, as well as improvements in LVEF. Endo‐CRT is associated with longer fluoroscopy times and a higher risk of stroke.

Association of daily physical activity with pulmonary artery pressure in HFpEF and HFmrEF NYHA class III patients: a pilot trial—feasibility and first results

Abstract Introduction Supervised physical exercise has been shown to benefit patients with heart failure with preserved/mildly reduced ejection fraction (HFpEF/HfmrEF) by improving symptoms and diastolic function. This study aimed to investigate the correlation between unsupervised daily physical activity and changes in daily pulmonary artery pressure (PAP) in patients with stable NYHA class III heart failure (HF) and left ventricular ejection fraction (LVEF) of 45% or higher. Methods Daily physical activity was monitored over a 3-month period using a Holter-ECG with an accelerometer that calculated an activity-associated, heart rate-derived metabolic equivalent of task (MET) score. PAP was measured using an implanted sensor in 17 patients. Results During 3 months of PAP monitoring in parallel with Holter ECG in our HF patients (median age 77 [IQR 72–79.5] years, LVEF 55 [49–56] %, mean cardiac index 1.9 ± 0.3), mean, diastolic, and systolic PAP remained unchanged. Patients engaged in unsupervised daily activity with a mean MET score of 5.0 ± 1.2 and a median daily duration of 41 [13–123] minutes. Intensity of daily activity was associated with a higher diastolic PAP on the following day (R2 = 0.017, p = 0.003), particularly in female patients and those with pulmonary hypertension (PH) (female: R2 = 0.044, p = 0.002; PH: R2 = 0.024, p = 0.004). Patients with longer daily activity durations had lower systolic and mean PAP (p = 0.038 and p = 0.048) and a similar diastolic PAP (p = 0.053) after 3 months. Conclusions Tracking changes in daily PAP based on intensity and duration of unsupervised daily activity using implanted sensors and a PocketECG® is feasible. While daily activity duration was not directly linked to diastolic PAP on the first day after daily activity, intensity, especially in female and PH patients, was associated with increased diastolic PAP. In addition, longer daily activity, rather than higher intensity, might be more important for lowering PAP in the long term. Further research in larger trials is warranted to confirm these findings.

Prognosis of patients with wild-type transthyretin cardiac amyloidosis and non-sustained ventricular tachycardia.

Little is known regarding the prevalence and prognostic implications of non-sustained ventricular tachycardia (NSVT) in patients with wild-type transthyretin cardiac amyloidosis (ATTRwt-CA). We aimed to investigate the prevalence of NSVT in patients with ATTRwr-CA, and the association of NSVT with sustained ventricular arrhythmias (VA) and all-cause mortality. In a cohort of ATTRwt-CA patients from 2011 to 2022 without prior sustained VA, we ascertained the presence and characteristics of NSVT during clinically indicated ambulatory Holter monitoring. Patients were stratified based on the presence of NSVT at baseline. The primary and secondary endpoints of sustained VA and all-cause mortality, respectively, were assessed during follow-up. The cohort included 217 patients with ATTRwt-CA (95% males, median age 75 years; median NYHA class 2). Baseline Holter monitoring demonstrated NSVT in 116 (53%) patients. During a median follow-up of 27 months (IQR 16-45) after the index Holter monitor, 11 (5.1%) patients reached the primary endpoint of sustained VA (incidence 1.8 per 100 person-years, all monomorphic VT), and 46 (21%) patients died. In univariable Cox proportional hazard model, NYHA class 3 or 4 heart failure (p = .048), the presence of NSVT (p = .04), the duration of longest NSVT run (p = .029), and the percentage of ventricular ectopy (p < .001) were associated with the primary outcome. When adjusting for age and NYHA class 3 or 4 heart failure, the presence of NSVT remained associated with the primary outcome (p = .03). All-cause mortality was not significantly different between patients with and without NSVT. A cutoff for ventricular ectopy burden of 0.5%, the median for all patients in this study, was associated with increased risk in sustained VA (log-rank p = .004) and mortality (log-rank p = .02). NSVT is highly prevalent among ATTRwt-CA patients undergoing clinically indicated Holter monitoring and may confer an increased risk of incident sustained VA.

Real-world characteristics and treatment of cardiac transthyretin amyloidosis: A multicentre, observational study.

Data on the clinical profiles of patients with transthyretin amyloidosis cardiomyopathy (ATTR-CM) in the post-approval era of tafamidis 61mg are lacking. Study aims were characterization of contemporary ATTR-CM patients, analysis of potential eligibility for the 'Transthyretin Amyloidosis Cardiomyopathy Clinical Trial' (ATTR-ACT) and identification of factors associated with the decision on tafamidis 61mg treatment. This retrospective study analysed ATTR-CM patients seen at eight University Hospitals in the first year after approval of tafamidis 61mg for ATTR-CM in Germany (April 2020 to March 2021). The cohort comprised 366 patients (median age 79 [74; 82] years, 84% male), with 47% and 45% of the cohort being in National Amyloidosis Centre ATTR stage≥II and NYHA class≥III, respectively. Sixty-four per cent of patients met key eligibility criteria of the pivotal ATTR-ACT. In recently diagnosed patients (58% with diagnosis ≤6months), the rate of variant ATTR was significantly lower than in patients diagnosed more than 6months ago (9.3% vs. 19.7%). Of the 293 patients without prior ATTR specific treatment, tafamidis 61mg was newly initiated in 77%. Patients with tafamidis 61mg treatment were significantly younger, were more often eligible for ATTR-ACT, had lower NYHA class and higher serum albumin levels. These variables explained 16% of the variance of treatment decision. Unadjusted survival was higher in patients with than those without treatment (1-year survival 98.6% vs. 87.3%, P<0.001). Wild-type ATTR was the primary aetiology amongst contemporary ATTR-CM patients and almost two-thirds of patients were in an advanced disease stage. Clinical profiles of 64% of patients in routine care matched those of the ATTR-ACT. Further effort is needed to detect patients at an earlier disease stage and to validate criteria justifying treatment initiation.

Depression, health-related quality of life and life satisfaction in patients with heart failure

Background: The Patient Health Questionnaire 9 (PHQ9) has been recognized as an effective tool for identification of patients with heart failure (HF) at risk for lower health-related quality of life (HRQoL). We aimed to compare HRQoL levels, overall satisfaction with health and life, disease severity variables, sociodemographic variables and behavioural risk factors between patients with HF with different levels of depressive symptomatology. Methods: In a &gt;55 years-old general population cross-sectional HF prevalence study, 1851 subjects were screened and those with NTproBNP ≥125 pg/mL (n=930) underwent detailed diagnostic visit to confirm or rule out HF as per 2016 European Society of Cardiology guidelines. HRQoL (the ShortForm 12 Health Survey, SF12; EQ5D3L), depressive symptoms (Patient Health Questionnaire, PHQ9) and satisfaction with life (Satisfaction With Life Scale, SWLS) were also assessed. Patient with HF (75±8 years, 54 % male, New York Heart Association (NYHA) functional class IIII, with mean left ventricular ejection fraction (LVEF) 56±13) were divided into three groups based on the severity of depressive symptomatology as per PHQ9 score (none: score 04, mild: score 59, and moderate-to-severe: score 1027). Multiple group comparisons and pairwise post hoc analyses were performed. Results: Results indicated significant between group differences in NYHA status (p&lt;0.001), number of comorbidities (p=0.006), functional capacity (p=0.01), as well as HRQoL variables (p=0.05 to 0.001) and SWLS score (p&lt;0.05), with nondepressed group generally showing better physical and subjective indicators of health and wellbeing compared with the mild and moderate-to-severe group. Conclusions: Results indicate that even patients with HF with clinically non-significant levels of depressive symptomatology show significantly impaired psychosocial status (diminished HRQoL, lower life satisfaction).

In-hospital bioimpedance-derived total body water predicts short-term cardiovascular mortality and re-hospitalizations in acute decompensated heart failure patients.

Hospital re-admissions in heart failure (HF) patients are mostly caused by an acute exacerbation of their chronic congestion. Bioimpedance analysis (BIA) has emerged as a promising non-invasive method to assess the volume status in HF. However, its correlation with clinically assessed volume status and its prognostic value in the acute intra-hospital setting remains uncertain. In this single-center observational study, patients (n = 49) admitted to the cardiology ward for acute decompensated HF (ADHF) underwent a daily BIA-derived volume status assessment. Median hospital stay was 7 (4-10) days. Twenty patients (40%) reached the composite endpoint of cardiovascular mortality or re-hospitalization for HF over 6months. Patients at discharge displayed improved NYHA class, lower body weight, plasma and blood volume, as well as lower NT-proBNP levels compared to the admission. Compared to patients with total body water (TBW) less than or equal to that predicted by body weight, those with higher relative TBW levels had elevated NT-proBNP and E/e´ (both p < 0.05) at discharge. In the Cox multivariate regression analysis, the BIA-derived delta TBW between admission and discharge showed a 23% risk reduction for each unit increase (HR = 0.776; CI 0.67-0.89; p = 0.0006). In line with this finding, TBW at admission had the highest prediction importance of the combined endpoint for a subgroup of high-risk HF patients (n = 35) in a neural network analysis. In ADHF patients, BIA-derived TBW is associated with the increased risk of HF hospitalization or cardiovascular death over 6months. The role of BIA for prognostic stratification merits further investigation.

Transapical Transcatheter Aortic Valve Implantation with the J-Valve System in Aortic Regurgitation

BackgroundAortic regurgitation (AR) is a condition associated with significant morbidity and mortality, particularly in severe cases. The J-valve system, next-generation transcatheter heart valve (THV), may overcome the procedural challenges associated with treating pure AR. This study reported the outcome of J-valve for treatment of AR. MethodsThis study observed 47 patients undergoing transcatheter aortic valve implantation (TAVI) with the J-Valve system. Diagnostic evaluation included transthoracic echocardiography and multislice computed tomography to assess AR severity and anatomical characteristics essential for TAVI. Follow-ups were conducted at various intervals post-operation to evaluate outcomes. ResultsThe patients had a mean age of 73.0±9.0 years and a median ejection fraction (EF) of 58.0% (IQR, 45.0%-64.0%). The median EuroSCORE II was 3.0% (IQR, 2.0%-6.7%).The procedural success rate was 100%, with no need for a second valve implantation or conversion to sternotomy. Short-term outcomes showed significant improvements in the New York Heart Association (NYHA) functional classification (P<0.001), left ventricular ejection fraction (LVEF) (P=0.009) and left ventricular end-diastolic diameter (LVEDD) (P<0.001). A singular case of valve migration and severe perivalvular leakage (PVL) due to Behçet's disease prompted a revised approach incorporating immunomodulation therapy. ConclusionsTAVI with the J-Valve system presents a viable alternative for managing severe AR, demonstrating high procedural success and substantial clinical improvement. However, the case of valve migration due to Behçet's disease highlights the need for careful preoperative screening and consideration of autoimmune disorders in differential diagnoses.

Risk Factors for Reduced Long-term Survival Following Isolated Surgical Aortic Valve Replacement in Different Age Groups.

According to recent guidelines, the selection of transcatheter vs. surgical aortic valve replacement (TAVR vs SAVR) in low-risk patients depends on age and life expectancy. Our objective was to understand independent risk factors for reduced life expectancy following isolated SAVR and the rate of re-do aortic valve (AV) intervention in different age groups, to delineate optimal intervention depending on patient characteristics. Between 2000-2015, 2026 patients underwent isolated SAVR with Edwards pericardial tissue valves. Multivariable models were conducted to determine independent risk factors for long-term survival in three age groups. The 10-year survival rates were 83.4±2.3%, 72.7± 2.6% and 39.8±3.0% in Group I (age <65 years, n=577), II (age 65 - <75 years, n=693) and III (age ≥75 years, n=756), respectively. Independent factors for the reduced long-term survival were pulmonary hypertension (PH), renal failure, peripheral vascular disease, diabetes, and NYHA class IV in Group I; PH, diabetes, current smoking, and atrial arrhythmia in Group II; and PH, anemia, and NYHA class IV in Group III. The re-do AV intervention rate at 10 years was much higher in Group I than in Groups II and III (14.7±2.5% vs. 3.4±1.1% and 0.8±0.4%, P<0.001). We identified risk factors for reduced long-term survival following isolated SAVR in different age groups and PH being the only risk factor across all ages, which should assist in decision-making for SAVR vs. TAVR. Our results also support the current recommendation of bioprostheses in patients aged >65 years given extremely low rate of re-do AV intervention.

LEFT VENTRICULAR NON COMPACTION CARDIOMYOPATHY ASSOCIATED WITH MITRAL VALVE PROLAPSE

Left ventricular non compaction (LVNC) is a rare condition characterized by prominent ventricular trabeculations and intertrabecular recesses,Mitral regurgitationwhen present is usually a result of annular dilation, mitral valve prolapse due to chordae tendinae rupture is quite rare.We present the case of a 48 year old male with no medical history who presented with worsening exertional dyspnea classified as NYHA class III. The physical examination found a systolic murmur heard at the apex. Transthoracic echocardiography and cardiac magnetic resonance confirmed the diagnosis of Left ventricular non compaction associated with posterior mitral valve prolapse with severe mitral regurgitation and preserved ventricular function who was successfully operated and found asymptomatic during the follow up.

Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.

Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).

Effect of Intravenous Iron on Functional Capacity in Patients with Ischemic Cardiomyopathy

Background: Iron deficiency is common in heart failure with reduced ejection fraction. Intravenous (IV) iron supplementation has been found to reduce morbidity in heart failure. However, the effect of IV iron on Bangladeshi patients with heart failure are not known. Objects: The study was done to see the effect of IV iron on functional capacity in Bangladeshi patients with ischaemic cardiomyopathy (ICM) and iron deficiency. Methodology: In this quasi-experimental study, out of 80 hospitalized patients with ICM and iron deficiency, 40 were given IV ferric carboxymaltose (FCM) in addition to standard therapy of heart failure, while another 40 were randomized to standard therapy alone. Primary outcome measure was changes in six-minute walk test (6MWT) distance, while secondary outcome measures were changes in New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF) and plasma NT-proBNP at Weeks 4 and 12. Results: 6MWT distance improved significantly in patients receiving IV iron therapy compared to the patients not receiving IV iron. LVEF improved and plasma NT-proBNP decreased significantly in IV irontreated patients than in patients receiving standard therapy. However, improvement in NYHA functional class was not statistically significant. Conclusion: In Bangladeshi patients with ICM and iron deficiency, IV FCM on top of standard heart failure therapy was associated with improved functional capacity. J Inv Clin Cardiol 2023; 5(2): 32-37

Large-bore Mechanical Thrombectomy Versus Catheter-directed Thrombolysis in the Management of Intermediate-risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial.

There is a lack of randomized controlled trial (RCT) data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism (PE). PEERLESS is a prospective, multicenter, RCT that enrolled 550 intermediate-risk PE patients with right ventricular dilatation and additional clinical risk factors randomized 1:1 to treatment with large-bore mechanical thrombectomy (LBMT) or catheter-directed thrombolysis (CDT). The primary endpoint was a hierarchal win ratio (WR) composite of the following: 1) all-cause mortality, 2) intracranial hemorrhage, 3) major bleeding, 4) clinical deterioration and/or escalation to bailout, and 5) postprocedural intensive care unit (ICU) admission and length of stay, assessed at the sooner of hospital discharge or 7 days post-procedure. Assessments at the 24-hour visit included respiratory rate, mMRC dyspnea score, NYHA classification, right ventricle (RV)/left ventricle (LV) ratio reduction, and RV function. Endpoints through 30 days included total hospital stay, all-cause readmission, and all-cause mortality. The primary endpoint occurred significantly less frequently with LBMT vs CDT (WR 5.01 [95% CI: 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% vs 5.4%; P=0.04) with LBMT vs CDT and less postprocedural ICU utilization (P<0.001), including admissions (41.6% vs 98.6%) and stays >24 hours (19.3% vs 64.5%). There was no significant difference in mortality, intracranial hemorrhage, or major bleeding between strategies, nor in a secondary WR endpoint including the first 4 components (WR 1.34 [95% CI: 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for LBMT patients (18.3±3.3 vs 20.1±5.1; P<0.001) and fewer had moderate to severe mMRC dyspnea scores (13.5% vs 26.4%; P<0.001), NYHA classifications (16.3% vs 27.4%; P=0.002), and RV dysfunction (42.1% vs 57.9%; P=0.004). RV/LV ratio reduction was similar (0.32±0.24 vs 0.30±0.26; P=0.55). LBMT patients had shorter total hospital stays (4.5±2.8 vs 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% vs 7.9%; P=0.03), while 30-day mortality was similar (0.4% vs 0.8%; P=0.62). PEERLESS met its primary endpoint in favor of LBMT vs CDT in treatment of intermediate-risk PE. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural ICU utilization compared with CDT, with no difference in mortality or bleeding.

A Risk Prediction Model for Prolonged Length of Stay After Minimally Invasive Valve Surgery.

Minimally invasive surgery determines shorter postoperative hospital length of stay (LOS) even in cardiac surgery. Potential preoperative factors affecting LOS are still not known in minimally invasive heart valve surgery (MIVS). We aimed to identify preoperative variables influencing prolonged LOS in MIVS. We reviewed 189 patients who underwent MIVS via minithoracotomy at our institution. Prolonged LOS was defined as more than 7 postoperative days. Poisson and logistic regression were used to screen the predictors. The mean postoperative LOS was 9.13 days, and 64 patients (33.9%) experienced a prolonged LOS. These patients were older, more frequently in New York Heart Association (NYHA) class III or IV, showed worse left ventricular ejection function (LVEF), and had a higher incidence of reoperation and chronic kidney disease (CKD). At univariate analysis, the most significant preoperative factors affecting prolonged LOS were age (odds ratio [OR] = 1.04), NYHA class III or IV (OR = 3.03), reduced LVEF (OR = 3.22), CKD (OR = 2.7), and redo surgery (OR = 3.6). After adjustment, the most significant preoperative factors predicting prolonged LOS were age (OR = 1.03, 95% CI: 1.01 to 1.06, P = 0.02) and redo surgery (OR = 3.33, 95% CI: 1.29 to 8.9, P = 0.01). The most important factors affecting prolonged LOS after MIVS were represented by age and redo surgery, although other preoperative characteristics such as reduced LVEF, NYHA class III or IV, and CKD play a significant role in delaying recovery after MIVS. Further larger studies are needed to better identify potential preoperative predictors of prolonged LOS after MIVS.

Palliative care integration into outpatient heart failure management: pilot study

ObjectivesPeople with heart failure have palliative care needs yet services remain underused. The heart failure clinic is a potential setting for initial palliative care delivery though evidence for such services is lacking. We explored the outcomes of an embedded model of palliative medicine within a heart failure clinic.MethodsWe conducted a retrospective cohort study of individuals who received a palliative medicine consultation in a heart failure clinic. Descriptive statistics were used to characterise the cohort and their outcomes, and the McNemar test to compare rates of advance care planning before/after consultation.ResultsMajority of individuals who received a palliative medicine consultation experienced New York Heart Association (NYHA) class II symptoms (65.5%) and had a Palliative Performance Scale score of≥60% (66.8%). While only 17% engaged in advance care planning in the year before consultation, 93% had advance care planning during the first consultation (p&lt;0.001). Care was provided in multiple domains including advance care planning (95%), symptom management (97%) and caregiver support (30%), regardless of the reason for referral.ConclusionsOur embedded model of palliative medicine within the heart failure clinic was associated with increased advance care planning at a time when patients were functional and minimally symptomatic. Further research should substantiate these findings at other sites.

Why Is the Group of Non-responders to Cardiac Resynchronization Therapy so Large? Some Ethical and Medical Aspects of the Topic

The aim of this single centre study (“St. Ekaterina” Hospital) is to assess the effect of a second successful cardiac resynchronization therapy (CRT) in patients who had already had an unsuccessful implantation of a CRT system at other medical centres in Bulgaria and were defined as “non-responders”. This is a prospective observational study. The patients have previously had an unsuccessful implantation of a left ventricular (LV) lead or the latter has not been placed in the target vessel. After the successful implantation of a new LV lead in another target vessel, the post-procedure criteria for echocardiographic (EchoCG) and clinical response were monitored. Over the period 2017–2019, 18 CRT systems have been implanted in 18 patients with an average age 65±1 years with initial heart failure (HF) according to the Classification of the New York Heart Association (NYHA) class III. The average LV ejection fraction (LVEF) was 28±1%. After the successful implantation of a new LV lead, patients presented with HF class II–III and LVEF 36±1%. In the new “upgrading” procedure, 15 patients (83%) had a good clinical and EchoCG response, and two of those 15 patients were “super responders”. The remaining three patients (17%) were “poor responders”. After the good clinical and echocardiographic response to the therapy with a second successful implantation of a LV lead in another target vessel, an important question arises, whether all “non-responders” to the CRT are actually supposed to be defined as such.

Relationship between clinical congestion and worsening renal function after intravenous initiation of furosemide in patients with acute heart failure.

To investigate if worsening renal function (WRF) appearing in some patients with acute heart failure (AHF) after intravenous furosemide initiation is influenced by severity of congestion. We conducted a retrospective secondary analysis of consecutive patients diagnosed with AHF and prospectively included in 10 Spanish emergency departments (EDs) for whom serum creatinine at ED arrival and after 2-7days of intravenous furosemide initiation were available. Congestion was clinically evaluated by identification of 7 signs/symptoms and by chest X-ray. The outcome was WRF, defined as a delta-creatinine ≥ 0.3mg/dL. Risk of WRF according to congestion was estimated in models adjusted by patient baseline characteristics and vitals at ED arrival, and interaction was also investigated. We included 3027 patients (median age 82years, 56% women), and 657 (21.7%) presented WRF after intravenous furosemide initiation. When signs/symptoms were individually considered, only lower limbs edema was associated with decreased risk of WRF (20.1% vs. 24.8%; OR = 0.76, 95%CI = 0.64-0.91). After adjustment, lower limbs edema persisted inversely associated with WRF (aOR = 0.78, 95%CI = 0.65-0.94), with significant lower risk for patients ≤ 80years and without chronic kidney disease, functional limitation, and hypoxemia (p for interaction 0.01, 0.04, 0.02 and 0.03, respectively). Neither degree of clinical congestion (number of signs/symptoms of congestion) nor radiological congestion in chest X-ray were related to WRF. Worsening renal function was associated with a higher 1-year all-cause mortality (40.1% vs 34.6%; HR = 1.27, 1.10-1.46; aHR = 1.331, 1.151-1.540). In patients with WRF, liver cirrhosis, chronic treatment with loop diuretics and renin-angiotensin system inhibitors, age (> 80years), dementia, heart valve disease and NYHA class III-IV were associated with higher mortality. Intravenous furosemide initiation in patients with AHF without lower limbs edema must be cautious, as they are at increasing risk of developing WRF during the next following days, which in turn is associated with a higher 1-year mortality.

Cox Regression Model with Time-varying Coefficients Applied to Survival Estimation of Heart Failure

This study focuses on survival analysis of heart failure patients. All the patients, who are over 40 years old, have NYHA classes III or IV stages of heart failure. Cox regression model with time-varying coefficients is applied to deal with these data, which is updated in 2015. Kaplan Meier curves are plotted to screen out categorical variables that violates PH assumptions. As for continuous variables violating PH assumption, Schoenfeld residual plot is drawn to realize time stratification. Therefore, for each time period, cox proportional hazard model can be fit to estimate mortality and find out the key factors promoting or inhibiting death event of heart failure. As a result, age, blood pressure, serum creatinine, and ejection fraction are the significant features of hazard of death led by heart failure, which is validated by Wald test, Likelihood ratio test, and Log-rank test. Discrimination ability is also characterized by ROC curves and AUC finally.

The impact of heart failure caregiver burden and patient heart failure severity: analysis of the needs assessment tool: advanced heart failure (NAT: PD-HF)

Abstract Background Not only patients with heart failure (HF), but also their caregivers have reported experiencing distress, depression, anxiety, social isolation, and health problems related to caring for a patient. Needs assessment tools have been used in clinical practice to identify patients' problems and needs from an early stage, however, their relationship with caregiver burden and the severity of the HF patients they care for has not been well investigated. Purpose The purpose of this study is to examine the relationship between distress and HF severity in patients and their caregivers using the Needs Assessment Tool: Progressive Disease-Heart Failure (NAT: PD- HF). Methods We enrolled consecutive 106 chronic HF patients who were admitted to a university hospital and assessed needs by the NAT: PD-HF between February 2023 and July 2023. We also enrolled 95 of their caregivers. The NAT: PD-HF is administered by the health care provider in the form of an interview with the patient and their caregiver. The questionnaire consists of an assessment of the patient's well-being and an assessment of the caregiver's ability to care for the patient. The healthcare provider completes the tool by indicating the level of distress (none, mild, significant) for each section. The severity of the New York Heart Association (NYHA) functional classification is examined in each patient. Results The median age was 72 years (interquartile range 59-81), and 41% were in NYHA class III or IV. The most common relationship between patients and their primary caregivers was partners (53%), followed by children (26%), parents (8%), and siblings (5%). There were 100 patients (94%) with more than mild distress, 57 with NYHA I or II and 43 with NYHA III or IV (P = 0.037). There were also 84 (88%) caregivers with more than mild distress, 47 with NYHA I or II, and 37 with NYHA III or IV of the patients they cared for (P = 0.026). Twenty-four patients (22.6%) were in severe distress, of which 10 were NYHA I or II and 14 were NYHA III or IV (P = 0.044). Among caregivers, 18 (18.9%) were in severe distress, of whom 6 with NYHA I or II and 12 with NYHA III or IV for whom they are caring (P = 0.010). Conclusions Regardless of the severity of HF, caregivers were found to experience distress as similar rate as that in the HF patients they cared for. The proportion of patients and caregivers experiencing distress was found to increase with the severity of HF. It is important to introduce palliative care for HF from the early stage of the disease and to support not only the patient but also the caregivers by using screening tools to identify distress.

Utilization and safety of digoxin in patients with chronic heart failure and atrial fibrillation with rapid ventricular rate

Abstract Background Digoxin can reduce symptoms and the risk of tachycardia-induced cardiomyopathy in patients with heart failure (HF) and concomitant atrial fibrillation (AF) with rapid ventricular rate. The effect of digoxin in HF and AF has not been tested in randomized controlled trials, and observational data have shown conflicting results linking digoxin to increased mortality in AF, though the nature of observational data makes it prone to bias and results difficult to interpret. Purpose To assess the utilization of digoxin in patients with HF and AF, and its association with New York Heart Association (NYHA) functional class and survival. Methods We used data from the Norwegian HF registry that collected data from all Norwegian HF clinics between 2013-2022. Data was collected from the first and last visit during optimizization of HF medical therapy. Associations with mortality status from Statistics Norway were assessed in unadjusted time-to-event analysis, and after adjustment for age, sex, body mass index, estimated glomerular filtration rate, aldosterone antagonists, renin-angiotensin-aldosterone system inhibitors, and beta blockers. Results The study included 4,877 HF patients, consisting of 4,067 (83.4%) with ejection fraction (EF) ≤40% and 810 (16.6%) with EF &amp;gt;40%.. The mean age was 67.7±12.0 years; 25.1% were women, and 27.3% had NYHA functional class III/IV. At the first visit, 1,339 (27.5%) patients had AF and 829 (61.9%) of these were treated with ≥50% of the beta-blocker target dose. AF with a ventricular rate ≥100 bpm was present in 277 (20.1%) patients, and 188 (67.9%) of these were on ≥50% beta-blocker target dose. Similarly, 262 (19.6%) of all AF patients and 44 (15.9%) of those with a ventricular rate ≥100 bpm were treated with digoxin. After optimization of HF medical therapy (median duration 140 [Q1–Q3 82–237] days), 1,039 (21.3%) patients had AF. Among these, 227 (21.9%) were treated with digoxin, including 9 (18.0%) patients with ventricular rate ≥100 bpm. Patients with AF who were started on digoxin experienced during the optimization period a larger decline in heart rate compared to those who were not (mean change -23.7±17.2 vs. -5.7±16.7 bpm, p=0.001), and more often an improvement in NYHA functional class (45% vs 30%, p=0.018). During median 779 [Q1–Q3 386–1,334)] days of follow-up after the last optimization visit, digoxin use was associated with lower mortality in HF patients with AF in unadjusted analysis (HR 0.67 [0.46–0.97]). After adjustment for baseline characteristics and other HF medical therapies, the association with mortality was attenuated and no longer significant (HR 0.96 [0.65–1.42]). Conclusion Digoxin was infrequently used in patients with HF and AF with rapid ventricular rate but was associated with a greater decrease in heart rate and improvement in NYHA functional class. The use of digoxin appears safe and was not associated with increased mortality.

Clinical characteristics and burden of non-obstructive hypertrophic cardiomyopathy: a real-world survey in Italy and Spain

Abstract Background Research describing non-obstructive hypertrophic cardiomyopathy (nHCM) and the associated burden of illness is sparse. Purpose This research aimed to describe the clinical characteristics of patients with nHCM and the associated clinical and societal burden of illness in Italy (IT) and Spain (ES). Methods Data were from the Adelphi HCM Disease Specific Programme (DSP), a cross-sectional survey with retrospective data collection in IT and ES (July 2022–January 2023). Ethics approval was obtained from the Pearl Institutional Review Board. Cardiologists provided data on patient demographics, employment, clinical characteristics, symptoms, support needs and treatment for up to ten consecutively consulting adult HCM patients. Patients voluntarily completed a survey containing the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ). Analyses were descriptive and the mean [SD] was summarized for continuous variables. Results Overall, 112 cardiologists provided data for 483 patients with nHCM from IT (243) and ES (240). The mean age [SD] was 54.3 [14.1] and 58.0 [16.0], with 66.3% and 61.7% of patients being male, in IT and ES respectively. Eighty-four percent and 92.1% of patients were classified as New York Heart Association (NYHA) II, 14.8% and 7.1% were NYHA III, and 1.2% and 0.8% were NYHA IV, in IT and ES respectively. Among patients who completed the KCCQ, the mean [SD] KCCQ-clinical summary score was 84.9 [12.9] in IT and 81.8 [20.7] in ES. Regarding work-related impact, 30.8% (IT) and 16.7% (ES) of patients had taken time off work due to nHCM in the last three months, and 41.6% (IT) and 48.4% (ES) were not working full-time, of which 5.6% (IT) and 11.0% (ES) were not working full time due to nHCM. Additionally, 17.6% and 18.2% of patients experienced a delayed diagnosis in IT and ES respectively, with 24.0% (IT) and 25.0% (ES) having multiple delays to diagnosis. The most common symptoms reported by physicians were dyspnoea when active (83.7%), palpitations (29.3%) and fatigue (25.7%). The most prevalent concomitant conditions were hypertension (20.5%), anxiety (18.6%), and atrial fibrillation (18.4%). In IT and ES, respectively, 77.8% and 74.2% of patients were currently prescribed treatment for nHCM. The most frequently prescribed treatments were beta-blockers (83.3%), diuretics (32.1%) and angiotensin converting enzyme inhibitors (20.5%), alone or in combination. In IT and ES respectively, 14.4% and 18.8% of patients required caregiver support, at a mean [SD] of 46.3 [52.4] and 44.2 [47.5] hours per week. Conclusions While the majority of patients with nHCM were classified as NYHA II, a considerable clinical and societal burden is evident. Burden was demonstrated by the high prevalence of symptoms, comorbidities, disruptions to employment and the requirement for caregiver support among these patients, highlighting the need for new treatment and management approaches to enhance health outcomes and reduce societal impact.