Improvement In New York Heart Association Class Research Articles

Efficacy and safety of mavacamten for the treatment of hypertrophic cardiomyopathy: an updated systematic review and meta-analysis of randomized controlled trials

The efficacy and safety profile of mavacamten, a cardiac myosin inhibitor for the treatment of hypertrophic cardiomyopathy (HCM) is not well-established, prompting the need for an updated meta-analysis. The authors conducted an extensive search across multiple electronic databases, including Embase, MEDLINE (via Pubmed), and CENTRAL, to identify randomized controlled trials (RCTs) assessing the efficacy and safety of mavacamten in HCM. Review Manager 5.4 (Revman) was employed to pool risk ratios (RR) and mean differences (MD). Our literature search yielded 4 RCTs with a total of 503 patients. Mavacamten was found to be associated with higher rates of greater than or equal to 1 New York Heart Association (NYHA) class improvement (RR 2.20, 95% CI: 1.48–3.28; I2=51%) and change from baseline in the Kansas City Cardiomyopathy Questionnaire- Clinical Summary Score (KCCQ-CSS) (MD 7.50, 95% CI: 3.44–11.55; I2 =50%). Mavacamten was also associated with improved resting left ventricular outflow tract (LVOT) gradient (MD −38.33, 95% CI: −49.38 to −27.28; I2 =75%), Valsalva LVOT gradient (MD −48.08, 95% CI: −62.21 to −33.96; I2 =78%), post-exercise LVOT gradient (MD −37.1, 95% CI: −44.37 to −29.84; I2 =0%), LVMI (MD −16.91, 95% CI: −28.29 to −5.54; I2 =88%), and lower rates of septal reduction therapy (SRT) (RR 0.30, 95% CI: 0.22–0.40; I2 =0%). There were no significant differences between mavacamten and placebo regarding the composite functional outcome, greater than or equal to 1 treatment-emergent adverse event, greater than or equal to 1 serious adverse event, and atrial fibrillation. The authors; findings suggest that mavacamten contributes to improvements in NYHA class, KCCQ-CSS scores, and LVOT gradients while reducing the incidence of SRT in patients with HCM.

Role of Dietary Patterns in the Progression and Management of Heart Failure in Pakistani Patients: A Multicenter Study.

Heart failure (HF) is a chronic condition with increasing prevalence in Pakistan due to common cardiovascular risk factors. Dietary interventions are known to influence HF outcomes, but data specific to Pakistani patients are limited. This study aimed to evaluate the impact of dietary patterns on HF progression and management in Pakistani patients, alongside the effects on quality of life and biochemical markers. A prospective cohort study was conducted across four medical centers in Pakistan, enrolling 170 HF patients. Dietary patterns were assessed using a validated Food Frequency Questionnaire (FFQ) tailored to the South Asian population. The primary outcomes measured were changes in the ejection fraction, New York Heart Association (NYHA) class, and hospitalization rates. Secondary outcomes included changes in quality of life and biochemical markers. Multivariate logistic regression was used to adjust for confounding variables, and Bonferroni corrections were applied to account for multiple comparisons. Adherence to a heart-healthy diet significantly improved the ejection fraction (from 35% to 38%, p = 0.04), reduced hospitalization rates (22%, p = 0.03), and improved NYHA class (45%, p = 0.05). Subgroup analysis showed a 10% reduction in mortality among patients over the age of 65 (p = 0.01) and 18% in diabetic patients (p = 0.02). Dietary interventions play a critical role in HF management among Pakistani patients. Culturally tailored dietary guidelines should be integrated into clinical practice to improve patient outcomes.

Changes in 6-min walk test is an independent predictor of death in chronic heart failure with reduced ejection fraction.

Functional capacity provides important clinical information in patients with heart failure (HF) and reduced ejection fraction (HFrEF). The 6-min walk test (6MWT) is a simple and inexpensive tool for assessing functional capacity and risk. Although change in 6MWT is frequently used as a surrogate outcome in HF trials, the association with mortality is unclear. We aimed to assess the prognostic importance of changes in 6MWT. Patients with chronic HFrEF referred to HF outpatient clinics in Norway completed a 6MWT at the first visit (baseline) and at a stable follow-up visit after treatment optimization (follow-up). Absolute and relative changes in 6MWT were analysed in association with mortality risk using Cox regression models and flexible cubic splines. The study included 3636 HFrEF patients aged 67.3 ± 11.6 years, 23% women, with left ventricular ejection fraction 30 ± 7%. At baseline, mean 6MWT was 438 ± 125 m, median N-terminal pro-B-type natriuretic peptide (NT-proBNP) 1574 (732-3093) ng/L, and 27% had New York Heart Association (NYHA) class III/IV. After optimization of guideline-directed medical therapy (median 147 [86-240] days), 6MWT increased by mean 40 ± 74 m, NT-proBNP decreased by median 425 (14-1322) ng/L, and NYHA class improved in 38% of patients. Patients with greater improvements in 6MWT were younger, with greater improvements in NYHA class (r = 0.27, p < 0.001) and larger reductions in NT-proBNP concentrations (r = 0.19, p < 0.001). After mean 845 ± 595 days, 419 (11.5%) patients were dead. Both absolute and relative changes in 6MWT were non-linearly associated with survival, attenuating as 6MWT increased. A 50 m increase in 6MWT was associated with a 17% lower mortality risk (hazard ratio 0.84, 95% confidence interval 0.77-0.90, p < 0.001) in the fully adjusted model, including changes in NYHA class, NT-proBNP concentrations, and other established risk factors. The associations were more pronounced in patients with lower baseline 6MWT and higher age. Improvement in 6MWT in patients with HFrEF is associated with increased survival, independent of changes in NT-proBNP and NYHA class. These findings support 6MWT change as a surrogate outcome in HF trials.

Radiofrequency ablation in patients with obstructive hypertrophic cardiomyopathy: An updated comprehensive review and meta-analysis.

Radiofrequency catheter ablation (RFCA) has emerged as a therapeutic option for surgical myectomy and alcohol septal ablation (ASA) in patients with hypertrophic obstructive cardiomyopathy (HOCM), but its efficacy remains unclear. Due to limited research on RFCA for HCM, there is an ongoing attempt to assess its efficacy and safety. PubMed, Embase, and Scopus were systematically searched for studies assessing the efficacy outcomes for patients with HOCM who underwent RFCA. Mean differences (MDs) with 95% confidence intervals (CIs) were computed using a random-effects model and heterogeneity was assessed using I2 statistics. We included 11 studies comprising 470 patients, of whom 34.6% were female. The mean patient age ranged from 43.7 to 60.7 years. During the follow-up after RFCA, there was a significant decrease in the left ventricular outflow tract (LVOT) gradient at rest (MD -60.25 mmHg; 95% CI [-70.53;-59.14 mmHg]; p < 0.01) and during stimulation (MD -83.56 mmHg; 95% CI [-100.36;-66.76 mmHg]; p < 0.01). Moreover, RFCA reduced interventricular septum (IVS) thickness (MD -3.61 mm; 95% CI [-5.64; -1.59 mm]; p = 0.01) and New York Heart Association (NYHA) class (MD -1.46; 95% CI [-1.69; -1.24]; p < 0.01). In patients with HOCM, RFCA was associated with an improved NYHA class, reduced IVS thickness, and decreased LVOT gradient at rest and with stimulation.

A predictive model of super response to cardiac resynchronization therapy in short-term period.

The left bundle branch block, nonischemic heart failure (HF) and female gender are the most powerful predictors of a super response to cardiac resynchronization therapy (CRT). It is important to identify super responders who can derive most benefits from CRT. We aimed to establish a predicting model that could be used for prognosis of a super response to CRT in short-term period. Patients with QRS ≥ 130ms, New York Heart Association (NYHA) II-III class of HF, left ventricle ejection fraction (LVEF) ≤ 35% and indications for CRT were included in the study. Before and 6month after CRT the electrocardiography, echocardiography and cardiac scintigraphy were performed. The study's primary endpoint was the NYHA class improvement ≥ 1 and left ventricle end systolic volume decrease > 30% or LVEF improvement > 15% after 6month CRT. Based on collected data, we developed a predictive model regarding a super response to CRT. Of 49 (100.0%) patients, 32 (65.3%) had a super response to CRT. Patients with a super response were likelier to have a lower cardiac index (p = 0.007), higher rates of interventricular delay (IVD) (p = 0.003), phase standard deviation of left ventricle anterior wall (PSD LVAW) (p = 0.009) and ∆QRS (p = 0.02). Only IVD and PSD LVAW were independently associated with a super response to CRT in univariate and multivariate logistic regression. We created a logistic equation and calculated a cut-off value. The resulting ROC curve revealed a discriminative ability with AUC of 0.812 (sensitivity 90.62%; specificity 70.59%). Our predictive model is able to distinguish patients with a super response to CRT.

Five-year outcomes of transcarotid transcatheter aortic valve replacement

BackgroundTranscarotid transcatheter aortic valve replacement (TC-TAVR) has emerged as an alternative access route for transcatheter aortic valve replacement (TAVR). However, scarce data exist on long-term outcomes following TC-TAVR. This study aimed to evaluate clinical outcomes at 5 years after TC-TAVR. MethodsA total of 110 consecutive patients who underwent TC-TAVR were included. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. The primary endpoint was the incidence of a composite outcome of all-cause mortality, stroke, and repeat hospitalization at 5-year follow-up. Echocardiography results, New York Heart Association (NYHA) class, and quality of life (QoL) as assessed with the EuroQol visual analog scale (EQ-VAS) were examined over the 5-year follow-up. ResultsThe median patient age was 77 years (interquartile range [IQR], 72-82.2 years), 42.3% were women, and the median Society of Thoracic Surgeons (STS) risk score was 5.02% (IQR, 3.4%-7.5%). The incidence of the composite primary endpoint was 54.5%. Death from any cause occurred in 45.6% of patients (11.9 per 100 patient-years); stroke in 8.2% (1.9 per 100 patient-years); disabling stroke in 2.7% (0.7 per 100 patient-years); and rehospitalization in 27.2%. The improvements in valve hemodynamics, NYHA class, and EQ-VAS following the procedure persisted at 5-year follow-up (P < .001). The incidence of bioprosthetic valve failure was 0.9%. ConclusionsAbout half of the moderate-to high-risk patients undergoing TC-TAVR survived with no major cardiovascular events at the 5-year follow-up. The yearly incidence of stroke events was low, and early improvements in valve hemodynamics, functional status, and QoL persisted at 5 years. These results suggest the long-term safety and efficacy of TC-TAVR and would support this approach as an alternative to surgery in non-transfemoral candidates.

Tricuspid regurgitation and heart failure: the fate of treated vs. untreated cohort in the percutaneous era.

Tricuspid regurgitation (TR) is associated with heart failure (HF) and reduced survival. Within a short-time period, transcatheter tricuspid valve repair or replacement (TTVR/TTVr) for TR has evolved from innovation to clinical reality. The present study's aim is to provide 1-year results between TR patients treated with TTVR and TTVr compared with untreated patients, in terms of cardiac survival, rehospitalization, right-side HF symptom development, and New York Heart Association (NYHA) improvement. Seventy-seven patients (pts) have been prospectively inserted into a dedicated database from January 2020 till January 2023. Twenty-six patients (33.8%) have been treated with TTVR/r [treated group (TG)], and 51 pts (66.2%) have been left untreated with medical therapy optimization [untreated group (UNTG)]. Analysing the cardiac death between the two groups, there was a significant statistical difference since TG has less incidence of exitus in the general population (P = 0.05). Concerning HF hospitalization, TG has a lower incidence with a P = 0.005. In TG, there was a significant improvement in NYHA class at follow-up (FUP) (P = 0.001) as well as an improvement in right-side HF symptoms (P = 0.001). This study shows that treatment in the case of TR with right-side HF has a positive impact on cardiac death and HF hospitalization at 1 year. And there is a significant improvement in clinical and echocardiographic status at FUP in the TG.

Efficacy of left bundle branch area pacing versus biventricular pacing in patients treated with cardiac resynchronization therapy: Select site – cohort study

BackgroundCardiac resynchronization therapy (CRT) is typically attempted with biventricular (BiV) pacing. One-third of patients are nonresponders. Left bundle branch area pacing (LBBAP) has been evaluated as an alternative means. ObjectiveThe purpose of this study was to assess the feasibility and clinical response of permanent LBBAP as an alternative to BiV pacing. MethodsOf 479 consecutive patients referred with heart failure, 50 with BiV-CRT and 51 with LBBAP-CRT were included in this analysis after study exclusions. Quality-of-Life (QoL) assessments, echocardiographic measurements, and New York Heart Association (NYHA) class were obtained at baseline and at 6-monthly intervals. ResultsThere were no differences in baseline characteristics between groups (all P > .05). Clinical outcomes such as left ventricular ejection fraction, left ventricular end-systolic volume, QoL, and NYHA class were significantly improved for both pacing groups compared to baseline. The LBBAP-CRT group showed greater improvement in left ventricular ejection fraction at 6 months (P = .001) and 12 months (P = .021), accompanied by greater reduction in left ventricular end-systolic volume (P = .007). QRS duration < 120 ms (baseline 160.82 ± 21.35 ms vs 161.08 ± 24.48 ms) was achieved in 30% in the BiV-CRT group vs 71% in the LBBAP-CRT group (P ≤ .001). Improvement in NYHA class (P = .031) and QoL index was greater (P = .014). Reduced heart failure admissions (P = .003) and health care utilization (P < .05) and improved lead performance (P < .001) were observed in the LBBAP-CRT group. ConclusionLBBAP-CRT is feasible and effective CRT. It results into a meaningful improvement in QoL and reduction in health care utilization. This can be offered as an alternative to BiV-CRT or potentially as first-line therapy.

Long-Term Survival and Quality of Life Following Transcatheter Aortic Valve Replacement in Nonagenarians

Transcatheter aortic valve replacement (TAVR) has emerged as a successful treatment option for severe aortic stenosis. However, the long-term outcomes of TAVR in nonagenarians is lacking. We aimed to examine the long-term mortality and quality of life in nonagenarians after TAVR. This is a multicenter, retrospective analysis on patients with severe aortic stenosis who underwent TAVR. Patients were divided into 2 groups: nonagenarians (age ≥90years) and age <90years. The Kansas City cardiomyopathy questionnaire (KCCQ) and New York Heart Association (NYHA) scores were compared before and after TAVR. All-cause mortality was compared between both groups at 30days, 1 year, and 5 years after TAVR using the Cox proportional hazard model. A total of 6,896 patients were included, of whom 591 were nonagenarians. Nonagenarians had a higher Society of Thoracic Surgeons perioperative risk of mortality (8.1 ± 4.6% vs 5.4 ± 4.2%, p <0.001) before TAVR. Both groups were similar in KCCQ and NYHA scores at baseline. At 1year after TAVR, there was no significant difference in improvement in the KCCQ overall score between those aged <90 years and nonagenarians (-4.76, 95% confidence interval [CI] -11.4 to 1.9, p=0.161). Similarly, therewas no statistically significant difference in improvement in NYHA class between the 2 groupsat 1year (odds ratio 1.07, 95% CI 0.85 to 1.25), p=0.526). The unadjusted 30-day (3.2% vs 2.7%, hazard ratio 1.11, 95% CI 0.70 to 1.80, p=0.667) and 5-year (28.0% vs 26.6%, hazard ratio 1.05, 95% CI 0.89 to 1.24, p=0.60) all-cause mortality were similar between the 2 groups. In conclusion, this study demonstrates an excellent long-term mortality rate at 5years after TAVR in nonagenarians, comparable to patients younger than 90 years. There is a significant and enduring improvement in functional status in nonagenarians, observed up to 1year after TAVR.

Clinical outcomes of left bundle branch area pacing compared with biventricular pacing in patients with heart failure requiring cardiac resynchronization therapy: systematic review and meta-analysis

Abstract Background Biventricular pacing (BVP) is recommended from the most recent ESC guidelines as the first line pacing strategy in patients with heart failure (HF) that require cardiac resynchronization therapy (CRT). (1) Many studies have shown its beneficial effects regarding morbidity and mortality in this population. (2, 3) However, 10% of patients cannot be treated by BVP due to unsuitable coronary sinus vein, while 30-40% are non-responders to BVP and experience no benefit from this treatment.(4) Left bundle branch area pacing (LBBAP) is a new pacing modality (5) that can achieve narrow QRS and improve left ventricular function in patients with HF, by engaging the intrinsic conduction pathway of the heart. Also, it appears to have better results in electrical and mechanical synchrony compared with BVP. Purpose We conducted a systematic review and meta-analysis to compare the two pacing modalities in terms of hard clinical outcomes, in patients with heart failure that require CRT. Methods Medline, Embase, Cochrane Central Register of Controlled Trials and Web of Science databases were systematically searched for studies comparing LBBAP with BVP for CRT in patients with HF. Outcomes of interest were all-cause mortality, Heart Failure Hospitalizations (HFH) and New York Heart Association (NYHA) class improvement. Two independent investigators identified studies, extracted data, and assessed the risk of bias using the Cochrane Risk of Bias 2 tool for randomized clinical trials and the Newcastle-Ottawa-Scale for observational studies. Pairwise meta-analysis was conducted using random and fixed effects models. Risk Ratios (RRs) and weighted mean difference (WMD) with 95% confidence intervals (CIs) were used to report dichotomous and continuous variables respectively. Heterogeneity was assessed with the I² statistic. Results In total, 764 studies were retrieved and finally 9 trials with 992 individuals (365 in LBBAP and 627 in BVP group) were included in the analysis. The mean follow-up duration was 13 ± 5.82 months and the average procedural success rate in the LBBAP group was 89.8%. The baseline characteristics were similar between the two groups. Pooled analysis showed that the two methods had no difference in terms of all-cause mortality (RR:0.87 CI 95%:0.38 to 2.02; I²=0%; p=0.750, Figure 1) with 8 (2.4%) vs 17 (2.9%) events occurring in LBBAP and BVP group respectively. However, LBBAP was found to have significantly lower risk for HFH (RR:0.58 CI 95%:0.38 to 0.91; I²=0%; p=0.020, Figure 2A) and to achieve more improvement in NYHA class compared with BVP (WMD: -0.40, CI 95%: -0.68 to -0.12; I²=72%; p=0.005; Figure 2B). Conclusions To the best of our knowledge this is the first meta-analysis that assesses exclusively the clinical outcomes of LBBAP compared to BVP in such an important number of patients. LBBAP presents better outcomes in HFH and NYHA class improvement, but it has no difference in all-cause mortality in comparison with BVP.Figure 1.All-cause mortalityFigure 2.A.HFH B.NYHA class improvement

Clinical Outcomes of Left Bundle Branch Area Pacing Compared with Biventricular Pacing in Patients with Heart Failure Requiring Cardiac Resynchronization Therapy: Systematic Review and Meta-Analysis.

Biventricular pacing (BVP) is recommended for patients with heart failure (HF) who require cardiac resynchronization therapy (CRT). Left bundle branch area pacing (LBBAP) is a novel pacing strategy that appears to ensure better electrical and mechanical synchrony in these patients. Our aim was to systematically review and meta-analyze the existing evidence regarding the clinical outcomes of LBBAP-CRT compared with BVP-CRT. Medline, Embase, Cochrane Central Register of Controlled Trials and Web of Science databases were searched for studies comparing LBBAP-CRT with BVP-CRT. Outcomes were all-cause mortality, heart failure hospitalizations (HFH) and New York Heart Association (NYHA) class improvement. We included randomized controlled trials (RCTs) and observational studies with participants that had left ventricular ejection fraction (LVEF) 40% and (i) symptomatic HF or (ii) expected ventricular pacing 40%. Random and fixed effects models pairwise meta-analysis was conducted. Cochrane Risk of Bias 2 assessment tool (ROB 2.0) and the Newcastle-Ottawa scale (NOS) were used to assess the quality of the studies. Eleven studies (10 observational studies and 1 RCT) with 3141 patients were included in the analysis. Compared with BVP-CRT, LBBAP-CRT was associated with lower risk of all-cause mortality (risk ratio (RR): 0.71, 95% CI: 0.57 to 0.87; p = 0.001), lower risk of HFH (RR: 0.59, 95% CI: 0.50 to 0.71; p 0.00001) and more improvement in NYHA class (weighed mean difference (WMD): -0.36, 95% CI: -0.59 to -0.13; p 0.00001) compared with patients who received BVP-CRT. Compared with BVP-CRT, receipt of LBBAP-CRT in patients with HF is associated with a lower risk of mortality, and HFH and greater improvement in NHYA class.

Left bundle branch area pacing in patients with CRT indication: short-term results &amp; 1-year follow-up

Abstract Background Cardiac resynchronization therapy (CRT) using bi-ventricular pacing is class I recommendation for symptomatic patients with heart failure (LVEF ≤35%), QRS duration ≥150 msec and LBBB QRS morphology. Left bundle branch area pacing (LBBAP) has been reported as an alternative option for CRT. The aim of this study was to assess the feasibility and outcomes of LBBAP in patients eligible for CRT. Methods Patients with CRT indications were subjected to LBBAP. Peri-procedural outcomes &amp; QRS duration were recorded. Changes in New York Heart Association (NYHA) class, need for HF hospitalization, echocardiographic data, lead-device parameters were evaluated at follow-up. HF status was assessed by clinical (no HF hospitalization and improvement in NYHA class) and echocardiographic response (≥5% improvement in LVEF). Results LBBAP was attempted in 16 patients (mean age 59.3 ±7.04 years, 37.5% women, ischemic cardiomyopathy in 33.3%). All patients had baseline LBBB. Pacing threshold and R-wave amplitudes were 0.8 ± 0.3 V at 0.5 ms and 12.1 ± 3.5 mV at implantation and remained stable during mean follow-up of 11.25 ± 3.7 (Range 6-18) months. LBBAP resulted in significant QRS narrowing from 147.5 ± 9.7 to 116 ± 10.2 ms (p &amp;lt; 0.01). LVEF improved from 28.2 ± 2.8% to 38.9 ± 5.1% (p &amp;lt; 0.01). Clinical and echocardiographic improvement was observed in 77% and 74% of patients, respectively. Conclusions LBBAP is feasible, safe and effective. It provides an alternative option for CRT. LBBAP provides low and stable pacing thresholds and is associated with improved clinical and echocardiographic outcomes.

New York Heart Association Class and Kansas City Cardiomyopathy Questionnaire in Acute Heart Failure

Sparse data exist regarding how clinician-assigned New York Heart Association (NYHA) class compares with heart failure (HF)-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) in acute HF. To compare concordance between NYHA class and KCCQ overall summary score (KCCQ-OS) in acute HF and investigate associations of changes in NYHA class and KCCQ-OS with long-term outcomes. In this cohort study, patients with HF were enrolled from 52 hospitals in China between August 2016 and May 2018. Among patients with NYHA class and KCCQ-OS at admission and 1 month, levels of each scale were categorized into 4 groups from worst to best. Mild and moderate to severe discordance were defined as NYHA class and KCCQ-OS differing by 1 level or 2 or more levels, respectively. Multivariable models evaluated associations between improvements in the 2 measures and outcomes. Analysis was conducted from January to March 2023. Changes in NYHA class and KCCQ-OS from admission to 1 month. All-cause mortality, cardiovascular death, or first HF rehospitalization. A total of 2683 patients (1709 [63.7%] male; median [IQR] age, 66 [56-75] years) were included. NYHA class II, III, and IV were presented in 374 patients (13.9%), 1179 patients (44.0%), and 1130 patients (42.1%), respectively, and the median (IQR) KCCQ-OS was 44.4 (28.3-61.9). Concordance, mild discordance, and moderate to severe discordance between admission NYHA class and KCCQ-OS occurred in 954 patients (35.6%), 1203 patients (44.8%), and 526 patients (19.6%), respectively. For KCCQ-OS, kernel density overlaps were 73.6% between NYHA II and III, 63.8% between NYHA II and IV, and 88.3% between NYHA III and IV. Most patients experienced improvements in NYHA and KCCQ-OS from admission to 1 month. After adjustment, there was no significant association between improvements in NYHA class and 4-year all-cause mortality, whereas 5 or more point improvements in KCCQ-OS were independently associated with a lower risk of 4-year mortality (hazard ratio, 0.84; 95% CI, 0.74-0.96; P = .01). NYHA class and KCCQ-OS improvements were both associated with decreased risk of 1-year composite cardiovascular death or HF rehospitalization. In this cohort study of acute HF, discordance between NYHA class and KCCQ was common, and KCCQ was more relevant to subsequent mortality than NYHA class.

Effect of Mavacamten on Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Mavacamten has shown clinical benefits in global studies for patients with obstructive hypertrophic cardiomyopathy (oHCM), but evidence in the Asian population is lacking. To evaluate the safety and efficacy of mavacamten compared with placebo for Chinese patients with symptomatic oHCM. This phase 3, randomized, double-blind, placebo-controlled clinical trial was conducted at 12 hospitals in China. Between January 4 and August 5, 2022, patients with oHCM and a left ventricular outflow tract (LVOT) gradient of 50 mm Hg or more and New York Heart Association (NYHA) class II or III symptoms were enrolled and received treatment for 30 weeks. Patients were randomized 2:1 to receive mavacamten (starting at 2.5 mg once daily) or placebo for 30 weeks. The primary end point was change in Valsalva LVOT peak gradient from baseline to week 30. Left ventricular outflow tract gradients and left ventricular ejection fraction (LVEF) were assessed by echocardiography, while left ventricular mass index (LVMI) was determined by cardiac magnetic resonance imaging. Analysis was performed on an intention-to-treat basis. A total of 81 patients (mean [SD] age, 51.9 [11.9] years; 58 men [71.6%]) were randomized. Mavacamten demonstrated a significant improvement in the primary end point compared with placebo (least-squares mean [LSM] difference, -70.3 mm Hg; 95% CI, -89.6 to -50.9 mm Hg; 1-sided P < .001). Similar trends were demonstrated for resting LVOT peak gradient (LSM difference, -55.0 mm Hg; 95% CI, -69.1 to -40.9 mm Hg). At week 30, more patients receiving mavacamten than placebo achieved a Valsalva LVOT peak gradient less than 30 mm Hg (48.1% [26 of 54] vs 3.7% [1 of 27]), less than 50 mm Hg (59.3% [32 of 54] vs 7.4% [2 of 27]), and NYHA class improvement (59.3% [32 of 54] vs 14.8% [4 of 27]). Greater improvements were also observed with mavacamten regarding the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (LSM difference, 10.2; 95% CI, 4.4-16.1), N-terminal pro-B-type natriuretic peptide level (proportion of geometric mean ratio, 0.18; 95% CI, 0.13-0.24), high-sensitivity cardiac troponin I level (proportion of geometric mean ratio, 0.34; 95% CI, 0.27-0.42), and LVMI (mean difference, -30.8 g/m2; 95% CI, -41.6 to -20.1 g/m2). Safety and tolerability were similar between mavacamten and placebo. No patients experienced LVEF less than 50%. Mavacamten significantly improved Valsalva LVOT gradient vs placebo for Chinese patients. All secondary efficacy end points were also improved. Mavacamten was well tolerated with no new safety signals. This study supports the efficacy and safety of mavacamten in diverse populations, including Chinese patients. ClinicalTrials.gov Identifier: NCT05174416.

Cell sheet transplantation for ischemic heart disease: a systematic review.

Cell sheet transplantation is emerging as an appealing alternative for ischemic heart disease patients as it potentially can increase stem cell viability and retention. But the outcomes and safety of this treatment are still limited in literature and the result varies widely. We conduct a systematic review to look at the efficacy and safety of this promising transplantation method. A systematic review was performed according to PRISMA guidelines. A comprehensive literature search was undertaken using the PubMed, Scopus, and Embase databases. Articles were thoroughly evaluated and analyzed. Seven publications about cell sheet transplantation for ischemic heart disease patients were included. The primary outcomes measured were left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) class. Safety measurement was depicted by cardiac-related readmission and deaths. The follow-up time ranged from 3 to 36months for clinical outcomes and 8.5years for safety outcomes. Cell sheet transplantation showed improvement in LVEF and NYHA class in most studies. Cardiac-related readmission and adverse events of cell sheet transplantation range from 0 to 30.4%, all were nonfatal as no cardiac-related death was reported. Patient preoperative status seems can affect the patient's response to cell sheet therapy. Cell sheet transplantation can safely improve LVEF and NYHA class in ischemic heart disease patients, even in very low ejection fraction patients with unsuccessful standard therapy before. Further studies with better patient inclusion, larger population, and long-term follow-up required to confirm these results.

Patient reported outcomes in obstructive hypertrophic cardiomyopathy undergoing myectomy: Results from SPIRIT-HCM study

BackgroundPatient reported outcomes (PRO) can assess quality of life (QOL) in obstructive hypertrophic cardiomyopathy (oHCM). In symptomatic oHCM patients, we sought to study the correlation between various PROs, their association with physician reported New York Heart Association (NYHA) class and changes after surgical myectomy. MethodsWe prospectively studied 173 symptomatic oHCM patients undergoing myectomy (age 51 years, 62% men) between 3/17–6/20. PROs, including a) Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score b) Patient-Reported Outcomes Measurement Information System [PROMIS] c) Duke Activity Status Index [DASI] & d) European QOL score [EQ-5D], along with NYHA class, 6-min walk test (6MWT) distance and peak left ventricular outflow tract gradient (PLVOTG) were recorded at baseline and 12 month follow-up. ResultsThe median baseline PRO scores (KCCQ summary, PROMIS physical, PROMIS mental, DASI, EQ-5D) were 50, 67, 63, 25, 50, 37, 44, 25 and 0.61, respectively; 6MWT distance was 366 m. There were significant correlations between various PROs (r-values between 0.66 and 0.92, p < 0.001), but only modest correlations with 6MWT and provokable LVOTG (r-values between 0.2 and 0.5, p < 0.01). At baseline, 35–49% patients in NYHA class II had PROs worse than median, while 30–39% patients in NYHA Class III/IV had PROs better than median. At follow-up, a 20 point improvement in KCCQ summary score was observed in 80%, 4 point improvement in DASI score in 83%, 4 point improvement in PROMIS physical score 86% and a 0.04 point improvement in EQ-5D in 85%); along with improvements in NYHA class (67% in Class I) and peak LVOTG (median 13 mmHg) and 6MWT (median distance 438 m). ConclusionsIn a prospective study of symptomatic oHCM patients, surgical myectomy significantly improved PROs, LVOT obstruction, and functional capacity, with a high correlation between various PROs. However, there was high rate of discordance between PROs and NYHA class. Study registrationClinicalTrials.gov: NCT03092843.

PO-05-055 A META-ANALYTIC COMPARISON OF OUTCOMES OF LEFT BUNDLE BRANCH AREA PACING (LBBP) VERSUS BI-VENTRICULAR PACING FOR CARDIAC RESYNCHRONIZATION THERAPY

Left bundle branch area pacing (LBBP), has emerged as a novel method to deliver cardiac resynchronization therapy (CRT), as an alternative to biventricular pacing (BVP). We aimed to evaluate the outcomes of LBBP as an alternative to BVP as a method of CRT. We aimed to evaluate the outcomes of LBBP as an alternative to BVP as a method of CRT. A systematic literature-based search was performed on various electronic databases, i.e., PubMed, Embase, Scopus, and Cochrane libraries, for studies that compared LBBP with BVP. The primary outcomes that were studied were changes in left ventricular end-diastolic diameter (LVEDD), New York Heart Association (NYHA) classification, left ventricular ejection fraction (LVEF) and paced QRS duration post CRT device implantation. Six articles (1 randomized trial and five observational studies) with a total of 399 patients (42% with LBBP as CRT) were included in the final analysis. A pooled random-effects analysis of the primary outcomes revealed that patients who underwent LBBP had a significantly greater reduction in left ventricular end-diastolic diameter [Mean Difference (MD) 0.40 (95% Confidence Interval (CI), 0.17-0.63); p < 0.001] and paced QRS duration [MD 1.03 (95% CI, 0.63-1.43); p < 0.001] as compared to the BVP group. There was also a significantly greater improvement in NYHA class [MD 0.64 (95% CI, 0.33-0.96); p < 0.001] and the LVEF [MD 0.83 (95% CI, 0.33-1.33); p < 0.001] in the LBBP group. (Figure 1 with the forest plots) LBBP has the potential to improve clinical outcomes over conventional BVP in patients undergoing CRT. This finding should be further confirmed by randomized trials with a larger sample size and well-defined outcome measures and feasibility indicators. Although limited by the observational nature of the included studies, our meta-analysis sets the stage towards the consideration of LBBP in patients who meet the indications for CRT.

Effectiveness and safety of transcatheter aortic valve replacement in elderly people with severe aortic stenosis with different types of heart failure

BackgroundImpaired left ventricular function is an independent predictor of adverse clinical outcomes in patients with aortic stenosis. The aim of this study is to evaluate the short-term changes of echocardiographic parameters, New York Heart Association (NYHA) class and B-type natriuretic peptide (BNP) level and adverse events amongst patients with heart failure (HF) after transcatheter aortic valve replacement (TAVR) procedure.MethodsThis was a retrospective cohort study conducted at affiliated Yantai Yuhuangding Hospital of Qingdao University between September 2017 and September 2022. TAVR cases were stratified into three groups [heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), heart failure with preserved ejection fraction (HFpEF)] by left ventricular ejection fraction (LVEF). Baseline characteristics, changes in echocardiographic parameters (1 week and 1 month), BNP (1 month), and NYHA class (6 months) post-TAVR were compared across the three groups. Meanwhile, we observed the adverse events of the patients after TAVR.ResultsA total of 96 patients were included, of whom 15 (15.6%) had HFrEF, 15 (15.6%) had HFmrEF, and 66 (68.8%) had HFpEF. Compared to the HFpEF subgroup, patients in the HFrEF subgroup were younger (p < 0.05), and with a higher BNP (p < 0.05). The left ventricular end-diastolic dimension (LVEDD) in HFrEF group decreased significantly after TAVR. HFmrEF and HFrEF patients showed significant improvements in LVEF after TAVR. The pulmonary artery systolic pressure (PASP), aortic valve peak gradient (AVPG) and aortic valve peak gradient (Vmax) decreased significantly 1 month after TAVR in all three groups compared to the baseline (all p < 0.05). BNP significantly reduced in HFrEF group compared to HFpEF patients after TAVR (p < 0.05). The majority of patients experienced an improvement at least one NYHA class in all three groups 6 months post-TAVR. There is no significant increase in the risk of adverse events in the HFrEF group.ConclusionsPatients who underwent TAVR achieved significant improvements in BNP, NYHA class, LVEDD, LVEF, and PASP across the three HF classes, with a more rapid and pronounced improvement in the HFrEF and HFmrEF groups. Complication rates were low in the different HF groups. There is no significant increase in the risk of periprocedural complications in the HFrEF and HFmrEF groups.

PS-C17-4: ASSOCIATION BETWEEN SERUM INSULIN LEVELS AND HEART FAILURE-RELATED PARAMETERS IN PATIENTS WITH TYPE 2 DIABETES AND HEART FAILURE

Background: Insulin resistance and hyperinsulinemia in patients with type 2 diabetes (T2D) are adversely associated with the development and worsening of heart failure (HF). Herein, we sought to investigate the effect of canagliflozin on insulin concentrations and the associations of changes in insulin concentrations with HF-related clinical parameters in patients with T2D and HF. Methods: This was a post hoc analysis of the investigator-initiated, multicenter, open-label, randomized, controlled CANDLE trial for patients with T2D and chronic HF (UMIN000017669). The endpoints were the effects of 24 weeks of canagliflozin treatment, relative to glimepiride treatment, on insulin concentrations and the relationship between changes in insulin concentrations and clinical parameters of interest, including New York Heart Association (NYHA) classification. The effects of canagliflozin on those parameters were also analyzed by baseline insulin level. Results: Among the participants in the CANDLE trial, a total of 129 patients (canagliflozin, n = 64; glimepiride, n = 65) who were non-insulin users with available serum insulin data both at baseline and week 24 were included in this analysis. Overall, the mean age was 69.0 ± 9.4 years; 75% were male; the mean HbA1c was 6.8 ± 0.7%; and the mean left ventricular ejection fraction was 59.0 ± 14.1%, with parameters roughly balanced between treatment groups. Canagliflozin treatment significantly reduced insulin concentrations at week 24 (p &lt; 0.001), and the between-group difference (canagliflozin minus glimepiride) in those changes was -3.52 mU/L (95% confidence interval, -4.85 to -2.19; p &lt; 0.001). Decreases in insulin concentrations, irrespective of baseline insulin level, were significantly associated with improvement in NYHA class in patients treated with canagliflozin. Conclusion: Our findings suggest that canagliflozin treatment in patients with T2D and HF ameliorated excess insulin overload, contributing to the improvement of clinical HF status.

Trends and predictors of functional class after high-risk left ventricular assist device implantation at a destination therapy center.

Although left ventricular assist device (LVAD) implantation is associated with improved survival, long-term impact on functional class is less well understood in high-risk implants. We undertook this study to better understand how destination therapy (DT) LVAD implantation affects patient functional status and predictors of functional improvement. We conducted a single-center, retrospective review of all primary LVAD implantations. Primary outcome was New York Heart Association (NYHA) functional class. An improved sustainable functional improvement was defined as being alive at 1-year with NYHA class I or II symptoms. Multivariable logistic regression was performed to identify predictors of sustainable functional improvement. From 2017 to 2023, 151 primary LVAD implantations were performed. Operative mortality was 7.95% (n=12). At 6-month follow-up, 113 (92.62%) of patients had experienced an improvement in functional class with 35 (28.69%) class I, 53 (43.44%) class II, 29 (23.77%) class III, and 5 (4.10%) class IV. At 12 months, 86 (91.49%) patients had sustained improvement in NYHA class with 32 (34.04%) class I, 40 (42.55%) class II, 19 (20.21%) class III, and 3 (3.19%) class IV. At 2 years, 57 (91.94%) patients still experienced improved symptoms. On multivariable logistic regression analysis, an ischemic etiology of heart failure (HF) was associated with a sustainable functional improvement [odds ratio: 5.53 (95% confidence interval: 1.06-28.89), P=0.04]. LVAD implantation is associated with significant functional improvement as measured by NYHA class. The high-risk cohort showed similar improvement in functional status. In our series, the best predictor of a sustainable improvement in functional status is an ischemic etiology of HF.