Improvement In NYHA Class Research Articles

Clinical Characteristics and Outcomes in Heart Failure Patients with Implantable Pulmonary Artery Pressure Monitors: A Single Centre Irish Experience

Background: Hospitalisation for acute decompensated heart failure (HF) portends a poor prognosis. Fluid retention manifesting in dyspnoea and oedema are important clinical features of decompensated heart failure and drive hospital admissions. Intracardiac and pulmonary artery pressure (PAP) monitoring can help predict heart failure decompensation, as changes in these haemodynamics occur before clinical congestion manifests. Methods: A retrospective single centre analysis of patients who underwent insertion of the Cordella™ PA Sensor System (Endotronix, Inc., Chicago, IL, USA) in University Hospital Galway, Ireland, as part of three separate clinical trials—SIRONA 1, SIRONA 2, PROACTIVE HF, was performed. The primary clinical outcome assessed was the difference between HF hospitalisation pre- and post-sensor implantation. Results: In total, there were 33 patients with symptomatic HF who underwent device insertion between 2018 and 2023. All patients had NYHA class 3 heart failure, and 48.5% (n = 16) of patients had HF with reduced ejection fraction. Only one device-related complication was noted, and no pressure sensor failures occurred. In total, there were 26 admissions for HF decompensation 1-year pre-device insertion and only three admissions post-insertion. The difference in the mean number of HF hospitalisations per patient pre- and post-device insertion was 0.70 (p < 0.0001). The difference in mean NYHA class score pre- and post-insertion was 1.0 (p < 0.001). Conclusions: Data from this single-centre cohort study have shown that the insertion of the Cordella™ PA Sensor System in symptomatic HF patients was safe and resulted in statistically significant improvements in HF hospitalisations and NYHA class.

ANTI-THROMBOTIC STRATEGY FOR THE MANAGEMENT OF NONOCCLUSIVE THROMBUS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION IN YOUNG PATIENTS - ANTARTICA STUDY.

Various cardiovascular thrombo-embolic clinical entities use combined ATS for prevention and treatment. After PCI, AF patients are typically prescribed DOAC, DAPT/SAPT, as component of ATS to minimize stroke risk and treat pulmonary embolism and venous thromboembolism. Some small observational studies have shown that a combined ATS can clear small thrombi in LV dysfunction and/or apical aneurysms. Therefore, we present a practical, cost-effective, and proof-of-concept ATS for non-occlusive significant coronary thrombus in young, clinically stable STEMI patients based on the aforementioned experiences. We retrospectively reviewed 145 stable STEMI cases with nonocclusive thrombus and thrombolysis in myocardial infarction flow 2/3 who received dabigatran and clopidogrel (ATS arm). They were compared to 147 comparable patients who received standard-of-care PCI (Control arm). At presentation and 6-months after ATS, NYHA functional class and LVEF were measured in all subjects. All the patients in the ATS arm underwent CT-CAG at 6-months. We examined significant safety outcomes like hemorrhage, reinfarction, and cardiac mortality. The primary angiographic outcome demonstrated complete resolution of the thrombus in all the cases of ATS arm. In the ATS arm, the clinical secondary outcome showed a greater improvement in NYHA class, from 3.53 to 1.07, compared to the control group's 3.6 to 1.49 (p=0.013). Also, the secondary echocardiographic outcome demonstrated a significant improvement in LVEF from a mean of 45.1% to 49.2% in the ATS arm vs. 44.0% to 44.9% in the control arm (p< 0.001). Clinical safety indicated TIMI bleeding and reinfarction reductions. There was no mortality in either arm. Delaying PCI and treating STEMI patients with antithrombotic drugs reduced no-reflow, distal embolization, and intraprocedural thrombotic events. The medical intervention improved myocardial preservation alone.

Association between age or duration of diagnosis in obstructive hypertrophic cardiomyopathy and response to mavacamten treatment: Exploratory analysis of the EXPLORER-HCM trial.

In patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM), it is unclear if response to cardiac myosin inhibition varies with older age or a longer duration of diagnosis. This study evaluated the response of these subgroups to mavacamten therapy for all primary, secondary, and exploratory endpoints in the EXPLORER-HCM trial (ClinicalTrials.gov: NCT03470545). Patients were stratified by age (≤60 vs. >60 years) and duration of HCM diagnosis (≤5 vs. >5 years). To estimate treatment differences and evaluate age and diagnosis duration by treatment interaction, analysis of covariance was used to model changes in continuous endpoints and a generalized linear model was used for binary endpoints. Older patients were more frequently female (53% vs. 29%), with a lower prevalence of pathogenic/likely pathogenic HCM gene variants (17% vs. 36%), lower mean peak oxygen consumption (pVO2) (17.6 vs. 21.1 ml/kg/min), and a higher mean NT-proBNP level (817 vs. 592 ng/L) but similar NYHA classes and quality of life scores. Patients with a longer vs. shorter diagnosis duration had similar mean ages (59.0±11.6 vs. 57.9±12.3 years) but more family history of HCM (38% vs. 16%) and a higher mean NT-pro BNP level (938±118 vs. 494±145 ng/ml). No differences were observed in improvement in peak oxygen consumption, NYHA class, or patient-reported outcomes among older patients and those with a longer duration of diagnosis. In EXPLORER-HCM, mavacamten treatment had a similar benefit for all primary, secondary, and exploratory endpoints in patients with symptomatic, obstructive HCM regardless of age or duration of diagnosis.

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.

A comprehensive evaluation of available evidence of mavacamten in obstructive HCM: a meta-analysis of randomised controlled trials

Abstract Introduction Obstructive hypertrophic cardiomyopathy (HCM) poses a significant clinical challenge, characterized by left ventricular hypertrophy and impaired cardiac function. mavacamten, a novel medication targeting the sarcomere protein myosin, has emerged as a promising therapeutic option for patients with symptomatic obstructive HCM. Despite its potential efficacy, the comparative effectiveness and safety of Mavacamten remain uncertain, necessitating a comprehensive evaluation of available evidence. Purpose We aimed to give a comprehensive appraisal on mavacamten as a treatment option for patients with obstructive HCM informing clinical decision-making. Methods We systematically searched PubMed, Web of Science, Scopus, and Cochrane Central, and EMBASE from inception until February 2024. We included randomised controlled trials (RCTs) comparing mavacamten versus placebo in patients with obstructive HCM. The primary outcomes were improvement in NYHA class, Change from baseline in KCCQ-CSS, and the incidence of atrial fibrillation. All data were pooled as either Mean difference in the random effect model with the corresponding SD or pooled as RR and 95% CI for dichotomous data. Results Four randomised controlled trials involving 503 patients were included in the final analysis. the overall odds ratio demonstrated a substantial preference for Mavacamten in achieving more than a one-level improvement in NYHA functional class from baseline (OR: 3.83 (95% CI [2.54 to 5.77], P=0.0001). However, there was no significant difference in terms of KCCQ-CSS (MD= 1.06, 95% CI [ -0.03 to 2.15], P=0.06) or the incidence of atrial fibrillation (OR=1.27, 95% CI [0.51 to 3.14], P=0.60). Conclusion Mavacamten showed a significant improvement on NYHA functional class, with no observed significance in terms of reducing the incidence of AF, or improving the KCCQ-CSS score.KCCQ-CSSNYHA

Real-world experience with mavacamten in obstructive hypertrophic cardiomyopathy: observations from a tertiary care center

Abstract Background In symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients, mavacamten is commercially approved to help improve left ventricular (LV) outflow tract (LVOT) gradients, symptoms, and reduce eligibility for septal reduction therapy (SRT) under the risk evaluation and mitigation strategy (REMS) program. We sought to prospectively report the initial real-world clinical experience with the use of commercially available mavacamten in a multi-hospital tertiary healthcare system. Methods We studied the first 150 consecutive oHCM patients (mean age 65 years, 53% women, 83% on betablockers and 61% in New York Heart Association [NYHA] class III) who were initiated on 5 mg of mavacamten with dose titrations using symptom assessment and echocardiographic measurements of LVOT gradient and LV ejection fraction (LVEF) measurements. We measured changes in NYHA class, LVEF, LVOT gradients (resting and Valsalva) at baseline, 4, 8 and 12 weeks. Results At 261±143 days (range of 31-571 days), 69 (46%) patients had ≥1 NYHA class, 27 (18%) additional patients had ≥2 NYHA class improvement and 40 (27%) reported a no change in symptoms. The mean LVOT gradient at rest decreased from 41±33 mmHg at baseline to 16±17 mmHg at 4 weeks, 16±16 mmHg at 8 weeks and 15±16 mmHg at 12 weeks. The mean drop in resting LVOT gradient from baseline to last follow-up was 26±3 mmHg (p&amp;lt;0.0001). The mean Valsalva LVOT gradient decreased from 72±43 mmHg at baseline to 29±31 mmHg at 4 weeks, 29±28 mmHg at 8 weeks and 30±29 mmHg at 12 weeks (p&amp;lt;0.001). The mean reduction in post Valsalva LVOT gradient from baseline to last follow-up was 43±4 mmHg (p&amp;lt;0.0001). At baseline, 100% patients had Valsalva LVOT gradients ≥ 30 mm Hg and 142 (95%) had ≥ 50 mm Hg. After initiation of mavacamten therapy, Valsalva LVOT gradient ≥ 30 mm Hg was observed in 44/150 (29%) at 4 weeks, 40/141 (28%) at 8 weeks and 41/136 (30%) at 12 weeks. In 40 patients who reported no symptomatic improvement, the mean Valsalva LVOT gradient decreased from 73±39 mmHg at baseline to 34± 27 mmHg at 4 weeks, 35±28 mmHg at 8 weeks and 30±24 mmHg at 12 weeks (P&amp;lt;0.001). The mean LVEF at baseline was 66±6% and changed to 64±5% at 4 weeks, 63±5% at 8 weeks and 62±7% at 12 weeks (p&amp;lt;0.0001). No patient underwent SRT, developed LVEF ≤30% or developed heart failure requiring admission. Three (2%) patients needed temporary interruption of mavacamten due to LVEF&amp;lt;50. During follow up, dose reduction or discontinuation of background HCM therapy (betablockers, calcium channel blockers and disopyramide) occurred in 33 (22%) patients. The breakdown of various drug doses of mavacamten, at last follow-up, is as follows: 2.5 mg (n=29, 19%), 5 mg (n=80, 53%), 10 mg (n=37, 25%) and 15 mg (n=3, 2%). Conclusions In a real-world study in symptomatic oHCM patients at a multi-hospital tertiary care referral center, we demonstrate the efficacy and safety of prescribing mavacamten under the REMS program.

Évaluation préliminaire de l'intérêt d'une cellule d'optimisation thérapeutique sur la titration des traitements de l'insuffisance cardiaque à fraction d’éjection ventriculaire gauche réduite et la qualité de vie des patients

IntroductionA multidisciplinary therapeutic optimization unit (COT) was created in January 2023 at Versailles Hospital, aimed at therapeutic optimisation of patients with chronic heart failure with reduced left ventricular ejection fraction. The objective of the study was to assess the impact of the first year of COT activity on the sequential implementation and titration of heart failure treatments, the clinical evolution, and improvement of patients’ quality of life. MethodsThis prospective study included consecutive patients treated by the COT after hospitalisation for acute heart failure, from January to December 2023. Clinical, biological, titration, and tolerance data were analysed. Quality of life was assessed at baseline and at the end of the follow-up by COT, using standardized SF-12 and EQ-5D questionnaires. ResultsWe included 90 patients (men 73%, mean age 67 years). The mean left ventricular ejection fraction was 34 ± 10 %. At final visit (median number of visits 4 ; median follow-up duration 156 days), 76.7% of patients achieved optimisation with respect to maximum individually tolerated doses, but only 13.3% with respect to theoretical maximum doses for the four therapeutic classes. At 1-year follow up, total mortality was 4.4% (4/90), and 9 patients (10%) were rehospitalised unplanned for acute heart failure. COT monitoring was associated with significant improvement in NYHA class, left ventricular ejection fraction, and SF-12 and EQ-5D-5L quality of life scores. ConclusionAlthough titration of heart failure treatments remained suboptimal, significant improvement was observed for NYHA class, left ventricular ejection fraction, and patient quality of life parameters.

Mid-term clinical outcomes and cardiac function in patients receiving cardiac contractility modulation.

To describe the mid-term clinical and functional cardiac contractility modulation therapy (CCM) recipients in an urban population with heart failure. CCM is a non-excitatory electrical therapy for patients with systolic heart failure with NYHA class III symptoms and ejection fraction (EF) 25-45%. How CCM affects a broad range of clinical measures, including diastolic dysfunction (DD) and weight change, is unexplored. We reviewed 31 consecutive patients at our center who underwent CCM implant. NYHA class, hospitalizations, ejection fraction (EF), diastolic function, and weight were compared pre- and post-CCM implant. Mean age and follow-up time was 63 ± 10years and 1.4 ± 0.8years, respectively. Mean NYHA class improved by 0.97 functional classes (p < 0.001), and improvement occurred in 68% of patients. Mean annualized hospitalizations improved (0.8 ± 0.8 vs. 0.4 ± 1.0 hospitalizations/year, p = 0.048), and after exclusion of a single outlier, change in annualized days hospitalized also improved (total cohort 3.8 ± 4.7 vs. 3.7 ± 14.8days/year; p = 0.96; after exclusion, 3.8 ± 4.7 vs. 1.1 ± 1.9days/year, p < 0.001). Mean EF improved by 8% (p = 0.002), and among those with DD pre-CCM, mean DD improvement was 0.8 "grades" (p < 0.001). Mean weight change was 8.5 pounds lost, amounting to 4% of body weight (p = 0.002, p = 0.002, respectively), with 77% of patients having lost weight after CCM. Five patients (16%) experienced procedural complications; incidence skewed toward early implants. In an observational cohort, CCM therapy resulted in improvement in NYHA class, hospitalizations, systolic and diastolic function, and weight.

Percutaneous versus surgical closure of paravalvular leaks in prosthetic valves: A cross-sectional comparison of clinical outcomes.

Paravalvular leak (PVL) is a serious complication of prosthetic valve replacement. Both surgical and percutaneous closure techniques are used for PVL closure, but optimal strategies and comparative outcomes are uncertain. This study aimed to compare the efficacy and safety of percutaneous versus surgical PVL closure by analyzing changes in leak severity, functional status, echocardiographic parameters, and clinical outcomes. A total of 72 patients were included in this retrospective cross-sectional single-center study comparing percutaneous (n = 25) and surgical (n = 47) PVL closure from 2015 to 2022. Demographics, medical history, echocardiograms, laboratory data, complications, and mortality data were extracted from the records. Changes in leak severity, NYHA class, echocardiographic parameters, and clinical outcomes were compared between the percutaneous and surgical groups. Both percutaneous and surgical PVL closure significantly reduced leak severity and improved NYHA class (both p < 0.01), with no difference between the quantity of changes in each group. The 30-day mortality was 4% after percutaneous and 6.4% after surgical closure (p = 0.65). At 90 days, mortality was 24% percutaneous versus 17% surgical (p = 0.48). The length of stay in the hospital and post-procedural decrease in hemoglobin were considerably lower in the percutaneous group. The rate of complication rates was similar between the groups. Echocardiographic changes were also comparable. Percutaneous and surgical PVL closure had similar efficacy in reducing leaks and improving symptoms, with no significant difference in early outcomes. Both options should be considered viable for PVL repair after heart team evaluation.

Assessing the Efficacy and Safety of Ivabradine as Adjunctive Therapy in Acute Heart Failure: A Prospective Clinical Trial

Objective: To compare the clinical outcome in terms of efficacy and safety of Ivabradine as adjunctive therapy in patients with acute heart failure. Methods: A prospective clinical trial was conducted involving patients admitted with acute heart failure, who were randomized to receive either standard care alone or standard care with adjunctive Ivabradine therapy. Efficacy endpoints included improvement in symptoms, left ventricular ejection fraction (LVEF), and reduction in heart rate. Safety endpoints encompassed adverse events, including bradycardia and hypotension. Data were collected at baseline, during treatment, and at follow-up visits. Results: The mean age (67.5 vs. 68.2 years), Gender distribution, mean ejection fraction (35.7 ± 5.2 vs 36.1 ± 4.8), NYHA class, and prevalent comorbidities were comparable between both groups. The mortality rate (10% vs. 15%), and hospital readmissions (20% vs. 30%, p=0.12) showed no significant difference between both groups. The improvement in NYHA class (65% vs. 50%, p=0.04) was significantly (P-value &gt; 0.05) higher in the treatment group. Treatment group demonstrated a significantly greater increase in ejection fraction (mean change 4.8% vs. 2.3%, p&lt;0.001). Clinical outcomes, heart rate reduction, 6-minute walk distance, reduction in NT-proBNP, all-cause mortality and rate of heart failure hospitalizations were found significantly (p-value &lt; 0.05) better in treatment group. Conclusion: This prospective clinical trial suggests that Ivabradine as adjunctive therapy in acute heart failure is efficacious in improving symptoms and reducing heart rate, with a favorable safety profile. These findings support the consideration of Ivabradine as an adjunctive treatment option in acute heart failure management. Keywords: Ivabradine, acute heart failure, adjunctive therapy, clinical trial, efficacy, safety.

Role of Strauss ECG criteria as predictor of response in patients undergoing cardiac resynchronization therapy

Abstract Background Cardiac resynchronization therapy( CRT) is a standard treatment in patients with heart failure, however, approximately 20–40% of recipients of (CRT) do not respond to it based on the current patients’ election criteria. The purpose of this study was to identify the baseline parameters that predict the CRT response and how the ECG morphology can affect the outcome. Objective To evaluate the Strauss ECG criteria as predictor of response in patients undergoing Cardiac resynchronization therapy. Material and Methods From March 2020 to March 2022, 70 patients underwent CRT or CRT-D insertion with LBBB morphology in Ain Shams university hospitals, Cardiology department were enrolled in the study. All patients subjected to history, clinical examination, Electrocardiogram and echocardiography before CRT insertion and after 6 months. We analyzed the QRS morphology of the patients with LBBB-like pattern as we classified patients in two groups, Strauss LBBB criteria (SLBBB) which was (a QRS duration of &amp;lt; 140 ms for men and &amp;lt;130 ms for women, along with mid-QRS notching or slurring in at least 2 of the leads V1, V2, V5, V6, I, or aVL and also rS or QS morphology in lead V1 patients) and the other group that was not meeting the previous criteria as non-strauss LBBB (non-SLBBB), also all patients subjected to echocardiography ( conventional 2D and speckle tracking “global longitudinal strain and global circumferential strain), Ejection fraction was assessed together with LV volumes and speckle tracking to assess response to CRT. Results Out of 70 patients, 3 patients missed the 6 months follow up after CRT implantation, so the study enrolled 67 patients that have been classified according to ECG morphology of LBBB to 37 patients with non-Strauss ECG criteria- one of whom died after 4 months- and 30 patients with Strauss ECG criteria. The number of responders in the study was 50 patients with percentage 75.8%, 52% of CRT responder (26 patients) had non Strauss ECG criteria while 48% of CRT responders (24 patients) had Strauss ECG criteria with P value=0.463. While there was no statistical significance of overall CRT response nor 6 months hospitalization and mortality between patients of Strauss and non-Strauss ECG criteria, there was a significant improvement in NYHA class, EF assessed by biplane Simpson’s, End- systolic volume, Global longitudinal strain and Global circumferential strain by speckle tracking echocardiography in patients with Strauss ECG criteria of LBBB. Conclusion There is no statistical significance in overall CRT response nor the 6 months hospitalization and mortality after 6 months of follow up between patients with Strauss and non-Strauss ECG criteria of LBBB, however, patients with Strauss ECG criteria have better improvement in NYHA class, echocardiographic parameters such as EF and ESV and speckle tracking parameters (GLS and GCS).

Effect of Sacubitril / Valsartan Combination on Abnormal ECG Findings in Patients with Heart Failure with Reduced Ejection Fraction

Abstract Background The mortality rate of patients suffering from choronic heart failure is still high despite advantages in diagnosis and treatment. A new therapeutic class of agents acting on the renin angiotensin aldosterone system (RAAS) and neutral endopeptidase system has been developed, known as angiotensin receptor neprilysin inhibitors (ARNI). Recently, promising data from its administration have demonstrated a decrease in the mortality rate as compared to angiotensin receptor blocker alone. Aim of the Work The aim of this study is to asses effect of Sacubitril/Valsartan combination on abnormal ECG and ECHO parameters in patients with heart failure with reduced ejection fraction as a marker of reverse cardiac remodeling. Patients and Methods Our study was conducted at Ain Shams university hospitals and our target population was heart failure patients with reduced ejection fraction planned to initiate Sacubitril \ Valsartan combination therapy. 100 patients were collected from February 2022 to August 2022. It was an interventional study to follow up the effects of the drug on ECG parameters besides ECHO parameters 6 months after drug initiation. Results We found that in Sacubitril/Valsartan combination therapy there was significant decrease in HR, QRS width and QTc values which reflects the role of this combination to reduce ventricular arrhythmias and preventing SCD. There was significant increase in the EF which was correlated to the significant decrease in QRS width. There was significant improvement in diastolic dysfunction. There was significant decrease in the LA and LV dimensions giving an explanation of the role of the drug in reverse cardiac remodeling. There was significant improvement in NYHA class reflecting the role of the drug in improving quality of life. Conclusion HR, QRS width and QTc were significantly decreased with Sacubitril/Valsartan combination therapy through the follow up period reflecting the effect of the drug on ECG. EF, LA dimension and LVID were improving with Sacubitril/Valsartan combination therapy through the follow up period which give an explanation of the combination therapy for its role in reverse cardiac remodeling. NYHA class of our patients was improving through follow up period which means this drug improves quality of life and reduces hospitalization.

Single-center experience of efficacy and safety of atrioventricular node ablation after left bundle branch area pacing for the management of atrial fibrillation.

Atrioventricular node ablation (AVNA) with permanent pacing is an effective treatment of symptomatic atrial fibrillation (AF). Left bundle branch area pacing (LBBAP) prevents cardiac dyssynchrony associated with right ventricular pacing and could prevent worsening of heart failure (HF). In this retrospective monocentric study, all patients who received AVNA procedure with LBBAP were consecutively included. AVNA procedure data, electrical and echocardiographic parameters at 6 months, and clinical outcomes at 1 year were studied and compared to a matched cohort of patients who received AVNA procedure with conventional pacing between 2010 and 2023. Seventy-five AVNA procedures associated with LBBAP were studied. AVNA in this context was feasible, with a success rate of 98.7% at first ablation, and safe without any complications. There was no threshold rise at follow-up. At 1 year, 6 (8%) patients were hospitalized for HF and 2 (2.7%) were deceased. Patients had a significant improvement in NYHA class and left ventricular ejection fraction (LVEF) (P ≤ 0.0001). When compared to a matched cohort of patients with AVNA and conventional pacing, AVNA data and pacing complications rates were similar. Patients with LBBAP had a better improvement of LVEF (+5.27 ± 9.62% vs. -0.48 ± 14%, P = 0.01), and a lower 1-year rate of composite outcome of hospitalization for HF or death (HR 0.39, 95% CI: 0.16-0.95, P = 0.037), significant on survival analysis (log-rank P-value = 0.03). AVNA with LBBAP in patients with symptomatic AF is feasible, safe, and efficient. Hospitalization for HF or death rate was significantly lower and LVEF improvement was greater.

His bundle pacing versus left bundle branch area pacing in patients undergoing atrioventricular node ablation: A prospective and comparative study

BackgroundPacemaker implantation combined with atrioventricular node ablation (AVNA) is a well-established strategy for uncontrolled atrial arrhythmias. Limited data are available regarding His bundle pacing (HBP) and left bundle branch area pacing (LBBAP) in this setting. AimTo compare the outcomes of HBP and LBBAP in patients undergoing pacemaker implantation combined with AVN in routine clinical practice. MethodsWe prospectively included all patients who underwent AVNA after successful conduction system pacing (CSP) in two hospitals between September 2017 and May 2023. The primary outcome was the 1-year composite of first episode of heart failure hospitalization, symptomatic atrioventricular node reconduction requiring a second AVNA procedure, lead revision or death from any cause. ResultsA total of 164 patients underwent AVNA following successful CSP (68 HBP and 96 LBBAP). Mean pacemaker implantation and AVNA procedure times were shorter in the LBBAP group than the HBP group (46±18 vs 59±23min; P<0.001 and 31±12 vs 43±22min, respectively; P<0.001). Complete atrioventricular block was more frequently obtained in the LBBAP group (88/96 patients [92%] vs 54/68 patients [79%]; P=0.04). One-year freedom from the composite outcome was more frequent in the LBBAP group (89.7% vs 72.9%; hazard ratio 0.32, 95% confidence interval 0.14−0.72; P=0.01). The strategy was similarly effective in both groups with a significant improvement in NYHA class and left ventricular ejection fraction. A secondary pacing threshold elevation >1V occurred only in the HBP group (11%). ConclusionIn this prospective, comparative study, LBBAP provided better 1-year outcomes than HBP.

Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study

BackgroundThe aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve.MethodsMANTRA is an ongoing “umbrella” prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days.ResultsA total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients.The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported.ConclusionsPreliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS.Trial RegistrationThe MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).

Two-Year Clinical Outcomes of Staged Transcatheter Mitral Edge-to-Edge Repair After Transcatheter Aortic Valve Replacement

Residual significant mitral regurgitation (MR) can increase the risk of adverse events following transcatheter aortic valve replacement (TAVR). The clinical benefits of staged transcatheter edge-to-edge repair (TEER) post-TAVR remain underexplored. This study aimed to investigate the clinical outcomes of staged TEER for residual significant MR post-TAVR. This observational study included 314 consecutive patients with chronic residual grade 3+ or 4+ MR at 30 days follow-up post-TAVR, with 104 (33.1%) treated with staged TEER (TEER group) and 210 (66.9%) with medical therapy alone (MT group). The primary composite outcomes were all-cause mortality and heart failure (HF) hospitalization at 2 years. Additional analysis, including changes in MR grade and the New York Association (NYHA) functional classification, and subgroup outcome comparisons based on MR etiology were also conducted. In our study, the rate of primary composite outcome was lower in the TEER group than in the MT group (33.7% vs. 48.1%, p = 0.015). Significant improvement in MR grade and NYHA class was observed in the TEER group after 2 years. Subgroup analysis demonstrated that, among patients with degenerative MR, a lower incidence of composite outcome and HF hospitalization was observed in the TEER group (hazard ratio: 0.35; 95% confidence interval: 0.23–0.53, p < 0.001).In conclusion, staged TEER post-TAVR was associated with reduced MR and improved clinical outcomes. The clinical significance of MR post-TAVR should be carefully evaluated, and TEER should be considered for patients with significant residual MR, particularly those with degenerative MR.

HF Etiology and cardiac contractility modulation therapy

ObjectivesOur study aimed to assess the safety and efficacy of cardiac contractility modulation (CCM) therapy in patients with heart failure with reduced ejection fraction (HFrEF) depending on HF etiology.MethodsWe enrolled 166 patients with optimal medical therapy-resistant HFrEF (median age 59 years, 83.7% males, median NYHA class − 2, median left ventricular ejection fraction (LVEF) − 29.0%) who underwent CCM therapy device implantation from 2013 to 2019 in four medical centers in Russia. The HF etiology was determined based on invasive coronary angiography or cardiac MRI data. Transthoracic echocardiography (TTE), 6-minute walking test (6MWT), and NTproBNP-tests were performed at a baseline and 12 months after the implantation.ResultsThe ischemic etiology of HF was revealed in 100 patients (61.5%) (ICM group); the non-ischemic group (NICM) evolved 66 patients (38.5%). Patients in the ICM group were significantly older (61[57–69] vs. 55 [42.8–61], p < 0.001), more frequently had hypertension (79% vs. 42.4%, p < 0.001) and chronic kidney disease (43% vs. 22.7%, p = 0.012). Patients in the NICM group had significantly more often atrial fibrillation (AF) (58% vs. 74%, p = 0.048), larger end-diastolic volume (EDV) (249 [208–309] vs. 220 [192–271], p = 0.019) and end-systolic volume (ESV) (183 [147–230] vs. 154 [128–199], p = 0.003). There were no significant differences in mortality between ICM and NICM groups (14.4 vs. 10.8%, p = 0.51). In 12 months, there was a significant increase in LVEF in the NICM group (+ 2.0 [2–6] vs. +7.7 [2–12], p < 0.001), while the improvement in the 6MWT (+ 75 [22–108] vs. +80 [10–160], p = 0.851) and NYHA class did not reach the level of significance. The subanalysis between patients with improved NYHA class and those without improvement revealed that patients without improvement more frequently had AF (56% vs. 89%; p < 0.01), chronic obstructive lung disease (18% vs. 35% p = 0.047), higher blood pressure (110 [105–120] vs. 120[110–129]; p = 0.032).ConclusionIn this multicenter retrospective study, patients with non-ischemic HFrEF showed a significantly higher improvement in LVEF and LV reverse remodeling following CCM therapy device implantation. There was no significant association between HF etiology and survival in drug-resistant HFrEF patients following CCM therapy.

Outcome after cryoballoon ablation of persistent atrial fibrillation in patients with heart failure with preserved ejection fraction versus tachycardiomyopathy: a propensity score-matched analysis

Abstract Introduction Atrial fibrillation (AF) often coexists with heart failure (HF). The aim of the study was to detect differences in outcome between patients with arrhythmia induced cardiomyopathy (AIC)/tachycardiomyopathy and HFpEF undergoing cryoballoon pulmonary vein isolation (cryo-PVI) using a propensity score-based model. Methods In this retrospective observational study, we analysed persistent AF patients with HFpEF and AIC undergoing cryoballoon ablation between 2014 and 2020. AIC was diagnosed ex juvantibus during the first year after ablation at the 3- and 12-month follow-up when LVEF recovered to &amp;gt; 50% and by more than 10% after ablation and a different aetiology for reduced LVEF was excluded. Propensity score matching was used to pair patients based on their age, sex, CHA2DS2-VASc score and left atrial (LA) area. The primary endpoint was the first documented &amp;gt; 30-s recurrence of atrial arrhythmia after a 3-month blanking period during the one-year follow-up. The secondary endpoints were improvements in NYHA class and reduction of LA area. For identification of independent predictors of atrial arrhythmia recurrence after ablation, univariate and multivariate Cox regression analyses were performed. Results Out of 1293 consecutive patients who underwent cryo-PVI, 148 persistent AF patients with HFpEF and 66 patients with AIC were identified. Propensity score matching yielded 46 patients in each group. HFpEF patients were more symptomatic than AIC patients (NYHA: 2.4 +/- 0.5 vs. 2.0 +/- 0,8; p = 0.002). Other baseline characteristics did not differ between the two groups, except LVEF (57 % [IQR: 52-62%] vs. 41% [QR: 35%-45%]; p= 0.002). Kaplan-Meier curves (Figure 1) demonstrated no difference in recurrence-free survival rate between the groups during the 12-month follow-up (71.7 % vs. 56.5%, log-rank P = 0.16). After the 12-month follow-up, the median LA area decreased significantly in the HFpEF group from 25.8 cm2 (IQR: 23.4-29.5 cm2) to 24.6cm2 (IQR: 22.0-29.6 cm2; p = 0.045) and in the AIC group from 26.6 cm2 (IQR: 22.9-31.1 cm2) to 23.0 cm2 (IQR: 18.3-25.2 cm2; p=0.024). At the 12-month follow-up the median LA-area was significantly higher in the HFpEF than in the AIC cohort (p= 0.007). NYHA class improved significantly in both groups from baseline. At the 1-year follow-up NYHA class was similar between both groups (1.6 +/- 0.8 vs. 1.4 +/- 0,6; p = 0.206). After univariate and multivariate analysis, the following predictors of atrial arrhythmia recurrence were identified: body-mass-index (BMI; HR = 1.082, p = 0.015) and LA area (HR = 1.079, p = 0.003). Conclusions Cryoballoon catheter ablation of persistent AF seems to have similar effectiveness on arrhythmia free survival in patients with HFpEF and AIC. NYHA class and LA enlargement improved after ablation in both groups although LA area in HFpEF was higher than in AIC patients at follow-up. BMI and LA area were identified as predictors of arrhythmia recurrence.

Single center experience of efficacy and safety of atrioventricular node ablation after left bundle branch area pacing for the management of atrial fibrillation

Abstract Introduction Atrioventricular node ablation (AVNA) with permanent pacing is an effective treatment of symptomatic atrial fibrillation (AF). Permanent right ventricular pacing is associated with cardiac dyssynchrony, which can worsen heart failure (HF) symptoms. Left bundle branch area pacing (LBBAP) is a recent pacing technique, more physiologic and less associated with cardiac dyssynchrony. Purpose To evaluate feasibility, safety and outcomes at 6 months of AVNA associated with LBBAP in patients with symptomatic AF. Methods In this retrospective monocentric study, we included all consecutive patients treated with AVNA procedure and LBBAP. Procedures characteristics, clinical follow-up, electrical and echographic data at baseline and 6 months were studied and compared to the data of a matched cohort (1:1) of patients who received an AVNA procedure with conventional pacing between March 2010 and February 2023. Results 75 AVNA procedures and LBBAP were studied. The success rate of AVNA was 98.7% at first ablation without any complications, especially no lead dislodgement or threshold rise. Pacing electrical parameters at implant were good, and stable at 6 months follow-up, with no threshold rise. At 6 months, 4 (5%) patients were hospitalized for heart failure and 1 (1.3%) was deceased. Patients had a significative improvement in NYHA class, palpitations symptoms, and left ventricular ejection fraction (LVEF) (p ≤ 0.0001 for all). After matching with a cohort of patients with AVNA and conventional pacing (n=68), patients with LBBAP had a significantly better improvement of LVEF (+5.27±9.62% versus -0.48±14%; p = 0.01), and a lower rate of a composite endpoint (all cause death and hospitalization for HF) (HR 0.34, 95%CI: 0.1-1.06; p = 0.064). Conclusions AVNA with LBBAP in patients with symptomatic AF was feasible and safe. Complication rate and adverse outcomes at 6 months were similar to AVNA with conventional pacing, and LVEF improvement was significantly greater.Matched populationsOutcomes at 6 months

SGLT2i IN THE REAL WORLD: DATA FROM THE PONTE (bridge) HF PROJECT (PDTA FOR INTEGRATED TERRITORY HOSPITAL FOLLOW-UP OF PATIENTS WITH HEART FAILURE)

Abstract Background Over the last few years, treatment with sodium glucose cotransporter 2 inhibitors (SGLT2i) dapaglifozin and empaglifozin was shown to reduce the combined risk of cardiovascular death and/or hospitalization for heart failure (HF) among patients with heart failure with reduced ejection fraction. Subsequent RCTs have demonstrated similar reduction in the combined endpoint also in patients with left ventricular ejection fraction (LVEF) &amp;gt;40%. Nevertheless, real world data on the current state of implementation of SGLT2i therapy in HF clinical practice are scarce. The aim of the study was therefore to evaluate the impact of SGLT2i treatment in a real world population of HF patients. Methods 527 consecutive patients with HF, treated with SGLT2i and with 6 months of follow-up already enrolled in the PONTE (PDTA FOR THE INTEGRATED FOLLOW-UP IN THE HOSPITAL TERRITORY OF THE PATIENT WITH HEART FAILURE) HF project, a care model implemented in Puglia region (Italy) based on hospital-territory integration aimed at the optimized management of patient with HF after hospitalization, were considered for the study. Demographic, clinical, laboratory and instrumental characteristics, changes in NYHA class, creatinine, NT-proBNP, medications, LVEF after initiation of therapy with SGLT2i were evaluated. Results The 527 enrolled patients (mean age of 67,40 years, 75% hypertensive, 39% diabetic, 51% ischemic heart disease, 52% with ICD, 35% with atrial fibrillation) were in NYHA class I in 3,2% of cases, class II in 56,6%, class III in 38,5%, class IV in 1,7%. Mean LVEF was 34,20% (63% of patients had LVEF &amp;lt;35%), NT-proBNP 2606,86 pg/ml, creatinine 1,19 mg/dl. 95,1% of patients was on treatment with beta-blockers, 52,7% with ACE inhibitors, 55,1% with ARNI. After a follow-up of 6 months, a reduction of patients in NYHA classes III+IV from 40,2 to 19,0% as well as an increase in patients in classes I+II from 59,8 to 81,0% (NYHA I increasing from 3,2 to 14,6%) were observed. Furthermore, mean LVEF increased from 34,20 to 37,68% and patients taking loop diuretics reduced from 83,9 to 77,4%. Creatinine remained stable (1,19 vs 1,21 mg/dl), while NT-proBNP lowered from 2606,86 to 1603,32 pg/ml. Conclusions Our real world data on SGLT2i in HF patients seem to confirm the efficacy of this class of drugs in a short term follow-up, with a positive effect on symptoms (improvement in NYHA class and fewer patients taking loop diuretics), NT-proBNP and LVEF.