NYHA Functional Class Research Articles

The Clinical Trajectory of NYHA Functional Class I Patients With Obstructive Hypertrophic Cardiomyopathy

The Clinical Trajectory of NYHA Functional Class I Patients With Obstructive Hypertrophic Cardiomyopathy

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

Torsemide versus furosemide in patients with heart failure: a systematic review and meta-analysis

Abstract Introduction Loop diuretics are essential agents in the management of fluid overload conditions, heart failure and renal dysfunction. Despite their widespread use, there is ongoing debate regarding the relative efficacy, safety, and clinical outcomes associated with furosemide and torsemide. By systematically analyzing existing literature, this study seeks to provide a comprehensive evaluation of the comparative effectiveness and safety profiles of these two medications , Helping to inform clinical decision-making and contribute to the optimization of diuretic therapy in patients with heart and kidney diseases. Methods We searched PubMed, Scopus, WOS, and Cochrane until February 2024 for relevant studies comparing the torsemide and furosemide in Heart failure patients. Outcomes of interest were all-cause mortality, cardiovascular mortality, all-cause hospitalization, hospitalization for HF, and improvement of ≥ 1 in NYHA functional class. Results 16 studies were included in this meta-analysis with a total of 12545 patients, There were no significant results between the two drugs in all-cause mortality, cardiovascular mortality or all-cause hospitalization, torsemide showed a reduction in hospitalization from heart failure (RR 0.85, 95% CI [0.71 to 1.02]), torsemide showed a significant improvement of ≥ 1 in NYHA functional class (OR 1.60, 95% CI [1.18, 2.17]). Conclusion There was no difference between torsemide and furosemide when it comes to all-cause and cardiovascular mortality, but torsemide showed better results in reducing hospitalization rates and and improving quality of life.Hospitalization from heart failureImprovement ≥ 1 in NYHA class

Functional capacity by cardiopulmonary exercise testing is not related to health status in obstructive hypertrophic cardiomyopathy

Abstract Background In obstructive hypertrophic cardiomyopathy (HCM), the primary goal of therapy is to improve patient quality of life by decreasing symptom burden. Increasingly, cardiopulmonary exercise testing (CPET), with peak oxygen consumption (pVO2) and ventilator efficacy (VE/VCO2), is used to assess efficacy of novel therapies in clinical studies and selectively in clinical practice to determine treatments. However, the relationship of CPET variables to symptom burden in HCM is not well established. Therefore, we examined the relationship between CPET variables and health status measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and NYHA functional classification in a cohort of obstructive HCM patients. Methods Consecutive patients with HCM and resting left ventricular outflow tract (LVOT) obstruction (≥50 mmHg) underwent CPET between October 2022 to January 2024. Patients with a peak RER <1.0 were excluded (n=4). To investigate distribution of patient reported health status (KCCQ) and NYHA functional classification, patients were stratified into groups for pVO2 (<14, 14-20, and >20 mL/kg/min) to reflect moderate to severe, mild to moderate, and little to no functional limitation, respectively. Results Of 58 patients, clinical evaluation was at 59 ± 13 years of age, 55% male, with LVOT gradient of 83 ± 28 mmHg at rest with 84% NYHA class II or III and 76% with KCCQ overall summary (OS) <75. Both pVO2 and VE/VCO2 had significant but weak correlation with NYHA class and KCCQ scores (Table 1), with the strongest correlation observed with pVO2 and KCCQ-OS (R2= 0.13, p=0.004). In contrast, % predicted pVO2 was not significantly correlated with NYHA or KCCQ. Notably, despite 14 patients being classified as having little to no limitations by pVO2, 29% of these patients had mild to moderate disability and 29% had moderate to severe disability by KCCQ-OS (Figure 1). Conclusion In patients with symptomatic obstructive HCM, objective measures of exercise performance, including pVO2 and VE/VCO2, correlate poorly with measurements of health status. These data suggest that CPET results should not be considered a surrogate marker of heart failure symptom burden in obstructive HCM.

Efficacy of specific drug class therapy in pulmonary arterial hypertension associated with HIV, portal hypertension or both: a single Center experience

Abstract Background Pulmonary arterial hypertension (PAH) is a rare complication of both HIV infection (HIV-PAH) and portal hypertension (Po-PAH); it can occur in patients with both diseases (HIV/Po-PAH). The use of the PAH-specific drug classes (prostanoids, endothelin-1 receptor antagonists [ERA] and phosphodiesterase-5 inhibitors [PDE5-i]) is largely justified by retrospective and observational case reports since, to date, there are no randomized clinical trials except for the PORTICO trial which demonstrated the efficacy of macitentan in Po-PAH. Purpose the aim of the study was to evaluate the efficacy of PAH-specific drugs, both monotherapy and dual oral upfront therapy (ERA + PDE5i started within 1 month apart), in patients with Po-PAH, HIV/Po-PAH and HIV-PAH. Methods Between 1998 and 2023 we enrolled patients with Po-PAH, HIV-PAH and HIV/Po-PAH referred to our Center and undergoing monotherapy with prostanoid, ERA and PDE5-I or dual upfront oral therapy. The efficacy of the drugs was assessed by comparing clinical parameters (NYHA functional class), exercise capacity (six-minute walking test) and hemodynamic parameters at baseline and after a treatment period of 3-6 months. The data are expressed as mean and standard deviation and were compared with Student's t-test for paired data. Results 128 patients were enrolled (83 Po-PAH, 23 HIV/Po-PAH and 22 HIV-PAH). 20 were treated with ERA monotherapy, 90 with PDE5-I, 13 with prostanoids and 5 treated with dual oral upfront therapy. Conclusions Prostanoids, ERAs and PDE5-Is, both in monotherapy and as dual upfront oral therapy, are associated with a significant improvement in functional class, exercise capacity and hemodynamic parameters. The effect of such drugs is similar to patients suffering from other forms of PAH.

Impact of dapagliflozin on cardiometabolic outcomes after myocardial infarction according to baseline left ventricular ejection fraction: a DAPA-MI substudy

Abstract Background Dapagliflozin improved cardiometabolic outcomes compared with placebo following acute myocardial infarction (MI) in participants without prior diabetes mellitus (DM) or chronic heart failure (HF) in the DAPA-MI trial. Purpose Cardiometabolic outcomes were assessed in the DAPA-MI trial according to left ventricular ejection fraction (EF) at randomisation. Methods Participants were categorised according to whether baseline EF was ≥50 or <50%. Those without a baseline EF result and those who did not receive a dose of study drug were excluded. The primary objective was to determine the clinical effect of dapagliflozin 10 mg versus placebo assessed using a hierarchical composite outcome and analysed by the win ratio method. The primary outcome was the hierarchical composite, by order of perceived clinical importance, of death, hospitalization for HF (HHF), nonfatal MI, atrial fibrillation/flutter event, new diagnosis of type 2 DM, NYHA functional class at the last trial visit, and body weight decrease of ≥5% from baseline to the last trial visit. Time to first event of NYHA class II-IV or HHF and time to first event of NYHA class III-IV or HHF were assessed as endpoints of special interest. Hazard ratios (HR) with 95% confidence intervals (CI) were determined using Cox proportional hazards models. The main subgroup variable (baseline EF ≥50 or <50) and its interaction with treatment (P int) were included. Results 838 participants had EF≥50 and 2913 had EF<50 at baseline. The primary hierarchical composite outcome resulted in a win ratio for those with EF≥50 of 1.32 (CI 1.00-1.73) and 1.38 for those with EF<50 (CI 1.21-1.57; P int 0.8) (Figures). There were no significant interactions by EF for any of the secondary outcomes. In those with EF<50, a first event of NYHA class II-IV or HHF occurred in 435 (29.4%) participants in the dapagliflozin group and 485 (33.8%) in the placebo group (absolute risk difference [ARD] 4.4%; HR 0.83, CI 0.73-0.94, P<0.01). In those with EF≥50, this occurred in 81 (19.7%) and 93 (21.8%), respectively (ARD 2.1%; HR 0.96, CI 0.65-1.41, P=0.7; P int 0.47). In those with EF<50, a first event of NYHA class III-IV or HHF occurred in 77 (5.2%) in the dapagliflozin and 115 (8.0%) in the placebo groups (ARD 2.2%; HR 0.64, CI 0.48-0.85, P<0.01). In those with EF≥50, this occurred in 14 (3.4%) and 19 (4.4%), respectively (ARD 1.0%; HR 0.80, CI 0.40-1.60, P=0.5; P int 0.55). There was no significant effect of dapagliflozin on death/MI/stroke in either subgroup (EF<50: HR 0.96, CI 0.65-1.41; EF≥50: HR 0.83, CI 0.38-1.84; P int 0.75). Dapagliflozin increased the incidence of 5% weight loss in both of the EF subgroups with no significant interaction. Conclusions Dapagliflozin resulted in significant benefit in cardiometabolic outcomes compared with placebo regardless of baseline EF. The absolute reduction in HF symptoms or HHF with dapagliflozin, compared with placebo, was greatest in those with baseline EF<50.Figures

Valve unit instead of intensive care unit admission after transcatheter edge-to-edge tricuspid valve repair

Abstract Background Standardization of periprocedural pathways reduces the length of hospital stay and thus healthcare costs and increases patient safety. Post-procedure admission to the intensive care unit (ICU) after transcatheter edge-to-edge tricuspid valve repair (T-TEER) has been the standard of care. Due to the COVID-19 pandemic related decline in high-care hospital beds, our center established primary admission to a dedicated general cardiologic care ward, the valve unit (VU). Aim To assess benefits and risks of admission to the VU instead of ICU after T-TEER. Methods This retrospective observational study included 270 consecutive patients who underwent T-TEER between March 2017 and June 2023 at our university hospital. Patients were admitted to the ICU post-procedure up to April 9th 2020 as standard (ICU-group, n = 53). Subsequent patients were planned for admission to a dedicated VU (VU-group, n = 217). We compared the groups and assessed length of hospital stay and in-hospital complications. In the VU-group, we examined unplanned transfer to the ICU (cross-over) and its predictors. Results Monitoring at the VU included continuous telemetric ECG-recording, oxygen saturation assessment, periodical blood pressure measurements and 24-hours physician presence. In contrast to the ICU, only non-invasive blood pressure measurements, less frequent laboratory controls and less intense fluid monitoring took place. The postinterventional hospital stay of patients with planned VU admission was significantly shorter compared to patients with planned ICU admission (median 4 (interquartile range (IQR) 3 - 5) vs. 4 (IQR 4 - 5) days, p = 0.030). Remarkably, overall complication rates were low and cardiogenic shock, infections, bleeding, vascular complications, delirium and acute kidney injury requiring dialysis were similar in both groups. 37 patients that were planned for VU had to cross over to unplanned ICU admission (17.1 %). Patients that had crossed over to unplanned ICU treatment had significantly higher risk for acute kidney injury (20.0 vs. 10.0%, p = 0.039) and in-hospital mortality (5.6 vs. 0%, p = 0.045). Higher systolic pulmonary artery pressure (sPAP) (OR 1.048, 95 %-CI 1.015 – 1.082, p = 0.003), NYHA functional class >= III (OR 9.176, 95 % CI 1.141 – 74.396, p = 0.037), and pre-interventional tricuspid regurgitation (TR) grade V (OR 2.941, 95 % CI 1.089 – 7.970, p = 0.033) were found to independently predict cross-over to unplanned ICU treatment. Conclusion Postinterventional admission to the VU instead of ICU after T-TEER shortens postprocedural hospital stay. A small proportion of had an unplanned transfer to ICU, which was accompanied by slightly higher complication rates. This cross-over affects patients with more advanced disease indicated by high pulmonary pressures, NYHA class and TR grade. Thus, admission to a valve unit is favorable for most patients after T-TEER, but those with advanced disease should be monitored more closely.

One-year outcomes of transcatheter mitral valve replacement in patients with severe mitral regurgitation

Abstract Background Mitral valve regurgitation (MR) is a prevalent valvular heart disease, and a subset of patients face challenges in undergoing surgical treatment. Transcatheter mitral valve replacement (TMVR) has emerged as a viable option for selected patients with severe MR deemed unsuitable for traditional valve surgery. Purpose This study aims to evaluate the feasibility, safety, durability, and clinical outcomes of a novel transapical mitral valve system (MitraFix valve) in treating moderate to severe MR patients. Methods The early feasibility study of the MitraFix TMVR transapical system is a multicenter, prospective, nonrandomized study. All patients underwent evaluation by a multidisciplinary heart team and were deemed suitable for mitral valve intervention. Clinical events were adjudicated by an independent clinical events committee. Results From June 2021 to July 2022, 10 patients (mean age: 71.2 ± 7.4 years, 40% male) were enrolled. The mean Society of Thoracic Surgeons(STS) predicted risk of mortality was 7.5 ± 2.7%. All implants were successful, with a mean operational time of 45.2 ± 25.9 min. One patient was converted to open cardiac surgery after successfully implanting the valve due to persistent apical bleeding. At 1-year follow-up, all-cause mortality was 20%, with a cardiovascular mortality at 10.0%. Among survival patients, 87.5% of surviving patients had MR ≤1+ and 75% patients were in NYHA functional class I or II at 1 year. The overall KCCQ score significantly increased from 55.8 (42.9, 72.9) points at baseline to 77.5 (73.7, 88.6) points at 1-year follow up (P = 0.012). Left ventricular ejection fraction showed no significant change from basline (51.5%) to 1 year (50.0%) (P=0.799). No evidence of mitral stenosis or left ventricular outflow tract (LVOT) obstruction was observed. Conclusions The MitraFix TMVR transapical system demonstrated excellent valve function, low mortality, sustained MR elimination and clinical improvement up to one year in this study. Further studies, encompassing a larger cohort of patients and an extended follow-up duration, are needed to confirm these findings.Change in MR and NYHA functional classChange in Quality-of-Life Assessment

Tafamidis for the treatment of transthyretin cardiac amyloidosis (ATTR-CM) - Real-world data from a tertiary center

Abstract Introduction Tafamidis 61mg was shown to be the first treatment to reduce cardiovascular hospitalizations and to improve survival in patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Real-world data on the efficacy of transthyretin (TTR) stabilizers in patients with Heart Failure (HF) due to ATTR-CM is scarce. Purpose We aimed to assess the use of tafamidis in our center, that features a dedicated Cardiomyopathy Clinic. Methods We conducted an all-comers single-centre prospective study of consecutive patients with symptomatic HF due to ATTR-CM followed up to November 2023. As per site protocol, the diagnosis was established according to the ESC algorithm and all patients were assessed at least twice yearly. Disease management plans include HF treatment tailored to ATTR-CM (CHAD-STOP) and treatment with disease-modifying tafamidis 61mg. The latter is considered in patients who meet the local protocol criteria, including key inclusion criteria - NYHA class I-II - and none of the exclusion criteria - e.g. estimated glomerular filtration rate (GFR) <25mL/min. The primary endpoint was time to cardiovascular hospitalization or all-cause death. Results A total 226 ATTR-CM patients were identified, of whom 181 had a follow-up of at least 6 months and were included in the analysis (mean age 84 ± 7 years; 81% males, 16% hATTR-CM). Overall, there were 84 patients treated with tafamidis. Compared to non-treated patients, those receiving tafamidis were younger (mean age 83 vs. 86 years, p=0.007), more often with a lower NYHA functional class (e.g., NYHA I-II: 92 vs. 62%; p<0.001), scored higher on performance scales (e.g., Karnovsky >70: 67 vs 33%; p<0.001), and had less comorbidities (e.g., GFR: 40 vs. 30mL/min; p<0.001). Over a median follow-up of 16 months, 68 (37.6%) patients met the primary endpoint (49.5% vs. 22.6%, respectively; p<0.001). In multivariate analysis, treatment with tafamidis was an independent predictor of the primary endpoint (HR 0.24; 95%CI 0.13-0.43; p<0.001), adjusted for NYHA functional class (HR for NYHA I-II vs. III-IV: 0.54; 95%CI 0.32-0.92; p=0.023), NT-proBNP (HR 1.83; 95%CI 1.09-3.08; p=0.023) and high-sensitivity Troponin T (HR per 10 units: 1.01; 95%CI 1.01-1.02; p=0.024). These findings were consistent in multivariate analysis with any combination of the prior variables with either creatinine, GFR, albumin, or TTR type (wild-type vs. mutated). These results were primarily driven due to association of tafamidis treatment with increased survival. Conclusion The use of tafamidis in a cohort of patients with symptomatic HF and ATTR-CM was shown to be independently associated with reduced cardiovascular hospitalization or all-cause death. The effect had a similar magnitude of effect to that of the ATTR-ACT trial, suggesting that our local protocol based on the key criteria from this trial may allow for appropriate patient selection.

Edge-to-edge repair for tricuspid valve regurgitation: 1-year follow up and clinical implications from the TR- Interventional Study (TRIS)

Abstract Background Tricuspid regurgitation (TR) affects 7% of the population, contributing significantly to heart failure-related hospitalizations. Traditional treatments have several limitations, prompting the exploration of innovative interventions. Purpose The present study aims to investigate the efficacy of tricuspid valve transcatheter edge-to-edge repair (T-TEER) in real-world patients with severe and symptomatic TR deemed at high surgical risk. Primary objectives focus on assessing T-TEER-induced TR reduction and reverse structural remodeling of the RV. Secondary objectives include assessment of functional status, quality of life, and residual regurgitation during the 12-month follow-up period. Methods The TR-Interventional study (TRIS) is a prospective, single-arm study. From January 2021 to December 2023, we enrolled 44 symptomatic patients with at least severe TR referred for TEER. Outcomes included safety and effectiveness along with assessment of clinical status. Results The study cohort had a mean age of 78.3±7 years, with 77.3% women and a mean TRISCORE of 5.1±1.9. Seventeen patients (38.6%) had massive, 7 (15.9%) had torrential, and 20 (45.5%) patients had severe TR. Etiologies included functional (40.9%), degenerative (13.64%), lead-induced (15.9%), and mixed (29.54%) origin. The primary efficacy endpoint, which assesses the successful implantation and performance of the device at the 30-day mark, was attained in 82.9% of patients. The secondary efficacy endpoint, assessing the stability of TR reduction at the 12-month, was achieved in 82,3% of patients. Post-procedural TR reduction of at least 2 degrees was achieved in 84% of patients. Echocardiographic assessments indicate ongoing beneficial remodeling over the one-year follow-up (Figure 1). Effects on RV remodeling also became apparent at the one-year follow-up, including reductions in the RV end-diastolic basal (p<0.01) and medium (p= 0.04) diameters of the TA septal-lateral diameter (p< 0.01). Significant reduction in vena contracta width (9 mm to 3 mm; p=<0.01), regurgitant volume (58 ml to 30 ml; p<0.01), and effective regurgitant orifice area (EROA) (0.6 cm2 to 0.3 cm2; p<0.01), occurred between baseline and one-year follow-up (Figure 2). The NYHA Functional Class and KCCQ scores were improved from 30 days to 1 year (Figure 2). Conclusion TRIS suggests that T-TEER is a durable, effective, and safe therapeutic option for high-risk patients with severe TR. The enduring nature of TR reduction at one year correlates with sustained clinical benefits and reverse structural remodeling of the right ventricle.TR reductionNYHA and functional status

Trans catheter edge to edge repair for mitral regurgitation and left ventricular outflow obstruction in hypertrophic cardiomyopathy

Abstract Background Based on previous reports, mitral valve transcatheter edge to edge repair (TEER) may be considered in patients with severe mitral regurgitation (MR) and left ventricular obstruction in patients with hypertrophic obstructive cardiomyopathy (HOCM) that are high risk for surgery. Objective We aimed to evaluate the feasibility, and immediate and short-term outcomes of mitral TEER in symptomatic patients with severe MR and HOCM. Methods Five patients (age 75±6, 3 men) with severe MR and HOCM with high surgical risk, and anatomy not suitable for septal ethanol ablation, who remained symptomatic despite maximally tolerated drug therapy were selected for TEER using the MitrClip system. Result The procedure was performed successfully on all 5 patients. Devices were deployed at the A2-P2 scallops of the mitral valve. MR severity declined from severe to mild in all patients, left ventricular outflow (LVOT) maximal gradient decreased from 140±46 to 8±5 mmHg after TEER, and was 41±32 mmHg at 4±2 month follow- up, Clinically, all patients reported improvement of their symptoms to Class I-II NYHA functional Class. Conclusion TEER may be a beneficial procedure for severely symptomatic patients with severe MR and obstructive HOCM on maximal tolerated medical therapy, who are not amenable to surgery because of excessive risk, old age, and frailty.Pre and Post procedure EchoPre and Post Cath

Predictors of Ischemic Stroke in a cohort of patients with Chagas Cardiomyopathy: the CLOT-Chagas study

Abstract Introduction a high risk of embolic events characterizes Chronic Chagas Cardiomyopathy (CCC) due to the presence of structural alterations of the left ventricle, the high incidence of arrhythmias, and intrinsic coagulation disorders. Despite its relevance, there is limited information on factors associated with this type of embolic event in patients with CCC, with most studies designed as case-control studies. This study aimed to prospectively analyze independently associated factors with this population's Ischemic Stroke (IS). Materials and Methods A prospective study was conducted between 2019 and 2023 at a cardiovascular center's Heart Failure and Heart Transplant Clinic. Adult patients diagnosed with CCC were included, recording sociodemographic, clinical, and echocardiographic variables as potential predictors of IS. Patients were followed up for 18 months via telephone for outcome assessment. Multivariate logistic regression models were used to identify factors potentially associated with IS during follow-up. Results A total of 232 patients diagnosed with CCC were included (males: 54.9%; median age: 67 years), the majority of whom were receiving anticoagulant therapy (n=144; 62.1%), with DOACs being the most frequently prescribed type of anticoagulants (51%). During follow-up, 16 patients (6.9%) developed an IS. There was a trend towards a lower incidence of IS in patients treated with direct oral anticoagulants (6.8%) compared to those receiving Warfarin (11.5%); however, this difference was not statistically significant (p=0.584). In the multivariate regression analysis including all potential predictors of IS, only the presence of a ventricular aneurysm (RR 5.64; 95% CI 1.61-19.70, p=0.007) and the score obtained when applying the Pfeiffer cognitive impairment questionnaire (RR 0.56; 95% CI 0.42-0.75, p<0.001) were significantly associated with the outcome of IS, even after adjusting for age, sex, NYHA functional class, ejection fraction, and anticoagulant therapy. The model composed of ventricular aneurysms and the Pfeiffer questionnaire score showed adequate performance in predicting IS during follow-up (AUC 0.79). Conclusions and Discussion: The incidence of IS in this population was higher than reported in the literature for both CCC patients and those with heart failure from other etiologies. The finding of an association between the presence of ventricular aneurysms and IS has been previously reported; however, the association between the Pfeiffer cognitive test and the development of IS represents a novel observation that deserves validation in future studies for its applicability in the clinical setting.

Factors influencing hospital stay duration in an elective cardiac surgery cohort

Abstract Cardiac surgery has become more complex in recent years, with increases in patient age, complexity, and associated costs. The use of a multidisciplinary strategy to analyze and standardize patient management offers significant benefits. The development of Enhanced Recovery After Surgery (ERAS) programs has proven useful in various types of surgery, recently including cardiac surgery, yielding good results. One of the primary objectives of ERAS programs is the reduction of the Inpatients' length of stay (LOS), with the subsequent improvement in the patient experience and a reduction in costs. The aim of this study is to analyze preoperative and postoperative factors related to the LOS reduction in a cohort of elective cardiac surgery patients included in the Cardiac ERAS program at our hospital. All patients included in the ERAS program, corresponding to elective cardiac surgery, were included in the analysis. 138 patients were divided into four quartiles based on the inpatient’s LOS. An extensive search was conducted in our quality control database, which contains 470 variables on the factors more strongly associated with LOS. The results were analyzed using Chi-Square test for categorical and the Kruskal-Wallis test for continuous variables, generally of non-normal distribution. The results are summarized in the table. Age, poor mobility, surgery other than coronary bypass, and reoperation were the non-modifiable factors most associated with a prolonged LOS. Lower preoperative hemoglobin and albumin levels were associated with an increase in LOS. A class 3 or 4 NYHA functional class, chronic pulmonary disease, and anticoagulation use were associated with higher LOS. Classic cardiovascular risk factors, such as dyslipidemia, hypertension, and tobacco use, were not associated with differences in hospitalization duration. Postoperative and intraoperative factors associated with higher LOS included extubation in the operating room or within six hours, ICU stay duration, mobilization on postoperative days one and two, time to oral food tolerance and gut motility recovery, hyperglycemia on postoperative day one, the duration of arterial, venous, and urinary catheters, the amount of fluids on postoperative day one and the opioid use in POD 2. The complications most associated with a prolonged duration were any infectious complication, any respiratory complication, reoperation, readmission to intensive care, transfusion after 12 hours or at any time during hospitalization, prolonged postoperative sedation, and any rhythmic complication. Conclusion In our cohort of elective patients for cardiac surgery, factors traditionally addressed by ERAS programs were identified as being associated with a longer inpatient’s length of stay. Pre-operative nutritional and anemia optimization, early extubation and mobilization, and the prevention of respiratory and infectious complications should be targeted to improve hospital stay duration.

Circulating secretoneurin concentrations predict cardiovascular death in ambulatory patients with heart failure

Abstract Background Secretoneurin (SN) is a novel biomarker, which predicts cardiovascular (CV)-related mortality in patients with acute dyspnea and sepsis. Higher SN concentrations have also been found associated with all-cause death in outpatients with heart failure (HF), but whether SN primarily reflects cardiovascular (CV)-related mortality in HF outpatients is not known. Objectives To evaluate the relation between SN concentrations and CV- & non-CV death in ambulatory patients with HF. Methods We studied 184 consecutive patients who attended our HF clinic for routine follow up and had stored blood samples available for SN analysis. SN concentrations were measured with a CE-marked SN ELISA assay. We assessed the associations between SN concentrations and CV & non-CV death. Mortality was ascertained using medical records, autopsy reports and death certificates, and CV deaths included sudden cardiac deaths or mortality due to myocardial infarction, HF or stroke. We assessed association with CV & non-CV death by Kaplan-Meier curves and by Cox proportional hazard regression analysis. Results Median age was 76 years (range: 38-94 years) and two thirds were male. Sixty-three percent had HF with reduced ejection fraction, 22% had NYHA III/IV symptoms and median NT-proBNP was 1079 (interquartile range: 462-2347) ng/L. Median SN level was 60 (range: 21-134) pmol/L. In multivariable linear regression analysis, impaired renal function and lower body-mass index were significantly associated with increasing (log)SN concentration. During median follow up of 540 days, there were 18 CV deaths, including 15 HF deaths, and 7 non-CV deaths. A higher SN concentration was associated with higher risk of CV death, while we did not find statistically significant association between SN concentrations and non-CV deaths (Figure). Patients with SN concentration in the top tertile had 15-fold increased risk of CV death compared to patients with SN concentration in the lowest tertile. In multivariable Cox regression analysis that adjusted for age, NYHA functional class, frailty status, increasing SN concentrations were independently associated with CV death: hazard ratio per logSN (95% CI): 3.01 (1.02-8.90), p=0.04. Conclusion In ambulatory patients with HF, circulating SN concentrations were predictive of CV death. Higher SN concentrations in ambulatory HF patients seemed to be linked to impaired renal function and lower body-mass index. Figure: Kaplan Meier curves illustrating the relation between SN tertiles and (A) CV mortality (B) Non-CV mortality.

Outcome of pregnancy in women with unrepaired atrial septal defect - study of a single tertiary centre

Abstract Background Patients with unrepaired atrial septal defect (ASD) are prone to develop arrhythmia, right heart failure and to suffer paradoxical embolism. The risk might be even bigger during pregnancy due to the hemodynamic changes combined with the hypercoagulable state. Purpose To evaluate maternal, foetal, and neonatal outcome of pregnancy in women with unrepaired ASD. Methods A retrospective study of 43 pregnancies in 24 women with unrepaired ASD was performed in our tertiary centre from 2004. Previous maternal cardiovascular events and events during pregnancy (maternal, neonatal, and obstetric) were documented. Results 24 women with unrepaired ASD (median age: 27.5 ± 6.2) had 43 pregnancies resulting in one termination, 4 miscarriages and 38 live births. 55% were primigravida and 2 twin pregnancies were documented. At baseline 2 women (10.5%) were in NYHA functional class II and signs of right ventricle (RV) volume overload were detected on echocardiography in 18 cases (47%). 2 women had a history of supraventricular tachycardia. Median gestation at delivery was 39 ± 2.6 weeks. No thromboembolic events, pulmonary hypertension, or desaturation occurred during pregnancy. However maternal cardiovascular complications all affected women with RV volume overload: 2 cases (5.2%) of supraventricular tachycardia, 2 (5.2%) cases with NYHA functional class deterioration and 1 case (2.6%) of syncope were documented. Only one obstetric event; preeclampsia occured. Neonatal complications were as follows: premature delivery in 3 cases (7.9%) and recurrence of congenital heart disease (CHD) in 4 pregnancies (10.5%). After the pregnancy device or surgical closure of the ASD was indicated for 11 women (45.8%). Since then, five already underwent device closure, one had surgical repair, while five women are still waiting for intervention. Conclusions Our results align with the mWHO classification. Pregnancy with an unrepaired ASD is well tolerated and has a low risk of neonatal and maternal cardiovascular events. However, women with right ventricle volume overload are prone to develop arrhythmia or right heart failure during pregnancy. Therefore, cardiology follow-up during pregnancy should be decided on an individual basis. In our cohort no thromboembolic events were documented during pregnancy, however the prevalence of congenital heart disease in the foetus was higher compared to the literature.

Differences in myocardial work across functional class strata in a severe aortic stenosis AHA D1 population. A cross-sectional study

Abstract Background Aortic stenosis is the most prevalent degenerative valvopathy. [1,2] The contractile state of the left ventricle has prognostic value in these patients. Global longitudinal strain (GLS) is the most accurate method for the estimation of myocardial performance. However, its value depends on the left ventricular afterload, [3,4] making GLS values challenging to interpret for decision-making purposes. The global myocardial work index (GWI) is an innovative echocardiographic technique for assessing myocardial function.[5] From these values, other indices representing constructive work, wasted work, and myocardial efficiency can be calculated.[6] Purpose The objective of our study was to measure the GWI and its derivatives using transthoracic echocardiography and relate them to the patient's functional class. Methods We conducted an observational, cross-sectional, and analytical study, including patients with severe aortic stenosis AHA D1, aged over 45 years, hypertensive, without coronary lesions. We exclude patients with other associated valvulopathies and rhythm disorders. All patients underwent transthoracic echocardiography, with measurements of GLS and GWI. Systolic blood pressure was added to the mean gradient of the aortic valve obtained by continuous Doppler. The population was divided into those with NYHA functional classes I/II and those with NYHA III/IV. Results Between May 2022 and August 2023, we included 152 patients, average age was 68 +/- 9 years. Of these, 54% were male, 38% had type 2 diabetes, 36% had dyslipidemia, and 30% had a history of smoking. Regarding functional class, 21% were in NYHA class I, 37% in NYHA II, 32% in NYHA III, and 9% in NYHA IV. The mean LVEF of 60 +/- 5%, GLS strain of -15.1 +/- 3.1; mean GWI was 2251 +/- 595 mmHg%, while the global constructive work index was 2526 +/- 596 mmHg%. The median wasted work index was 198.2 (196-204.2) mmHg%, and the mean myocardial efficiency was 89.9 +/- 4.7%. The global myocardial work index was 2455 +/- 582 in patients with NYHA I/II vs 1978 +/- 527 mmHg% in patients with NYHA III/IV (p<0.001) (Table 1). For the global constructive work, patients in NYHA I/II had a mean of 2708 +/- 590 mmHg, while those in NYHA III/IV had 2281 +/- 542 mmHg% (p<0.001). There were no significant differences in wasted work (190 +/- 11 mmHg%, NYHA I/II vs 210 +/- 113 mmHg%, NYHA III/IV, p=0.27). Marginally statistically significant difference was observed for myocardial efficiency (91 +/- 4.8%, NYHA I/II vs 89 +/- 4.5%, NYHA III/IV, p=0.49). Conclusions Patients with severe aortic stenosis have supranormal myocardial work indices.[7] However, as the disease progresses and patients experience greater clinical deterioration, these indices decrease, showing a significant difference between functional classes I/II and III/IV. Further studies are needed to determine the utility of these indices as prognostic indicators in this patient group.Table 1.Differences in myocardial workBulley

Trans-femoral transcatheter intramyocardial septal radiofrequency ablation: a novel therapeutic approach for obstructive hypertrophic cardiomyopathy

Abstract Background Septal reduction techniques play a pivotal role in mitigating morbidity and mortality among patients with obstructive hypertrophic cardiomyopathy (oHCM). While trans-apical intramyocardial septal radiofrequency ablation (PIMSRA or LIWEN procedure) has shown promise in reducing left ventricular outflow tract (LVOT) gradients and improving symptoms in oHCM patients, it is associated with complications such as cardiac tamponade and atrioventricular block. Objective This study introduces a novel approach for transcatheter radiofrequency ablation of hypertrophic septum via femoral access, utilizing the DragonFire Transcatheter Myocardial Puncture and Radiofrequency Ablation System. We aim to evaluate its safety and medium-term outcomes in patients with oHCM. Methods A prospective, single-center, single-arm study of tf-PIMSRA was conducted in patients with drug-refractory oHCM. Ten patients were enrolled and underwent the procedure under the guidance of transesophageal echocardiography. The primary outcome was 30-day major adverse clinical events, with secondary outcomes including 90-day improvements in outflow obstruction and quality of life. Results All patients, with an average age of 57±10 years, including 4 males, underwent the procedure successfully without any complications, including major adverse clinical events or conduction abnormalities. The average duration of the procedure was 125.2±34.6 minutes, with an average ablation time of 38.69±18.29 minutes and ablation energy of 3.60±1.49KJ. At 90-day follow-up, significant reductions were observed in peak LVOT gradients (resting gradient: from 82.00 [56.00] mmHg to 14.00 [6.25] mmHg; p < 0.001; provoked gradient: from 102.00 [76.25] mmHg to 33.00 [16.50] mmHg; p = 0.002), and interventricular septum thickness (from 22.00 [19.00] mm to 17.00 [15.00] mm; p = 0.002). These improvements were associated with enhancements in NYHA functional classification (from 3.00 [2.75] to 1.00 [1.00]; p < 0.0001), Kansas City Cardiomyopathy Questionnaire scores (from 59.00 [44.50] to 80.00 [77.25]; p < 0.02), 6-minute walk distance (from 441 [400] m to 480 [465] m; p < 0.01), and pro B-type natriuretic peptide levels (from 1738.00 [1113.25] pg/ml to 252.00 [200.00] pg/ml; p = 0.002). All patients achieved New York Heart Association functional class I or II at follow-up. Conclusions Transfemoral PIMSRA appears to be a safe and effective procedure for relieving LVOT obstruction and symptoms in patients with drug-refractory oHCM. These findings support further investigation through randomized clinical trials comparing it with established septal reduction therapies.Patient-Level Outcomes for the trans-fem

Myocardial performance improvement after iron replacement in heart failure patients with LVEF <50% and TSAT <20%: The IRON-PATH II echo-substudy

Abstract Background Iron deficiency (ID) is a prevalent comorbidity in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) <50%. ID leads to impaired myocardial global function. Some echocardiographic parameters have demonstrated an additive value in advanced assessment of cardiac performance, like global longitudinal strain (GLS), myocardial work (MW) and its derivatives constructive work (CW), wasted work (WW) and work efficiency (WE). The usual definition of ID may have limitations in rightly identifying systemic iron status, especially those with isolated hypoferritinemia. However, the impact on cardiac function measured by echocardiography after intravenous iron replacement according to TSAT values has never been explored. Purpose Describe the myocardial performance associated with systemic ID defined as TSAT <20% in patients with HF compared to patients with HF without ID (TSAT ≥20%). Afterwards, we aimed to explore changes in myocardial function after iron replacement by echocardiography. Methods The IRON-PATH II was a multicenter, prospective, observational study. The total number of patients to be recruited was 210 in 7 centers across Spain and Portugal. Patients with HF and LVEF ≤50%, without signs of fluid overload or low cardiac output, and haemoglobin ≥11 g/dL were included. The IRON-PATH II echo-substudy included 100 patients who undergone a specific pilot evaluation of echocardiographic. All patients undergone an echocardiography at baseline, ID-patients received a second echocardiography three months after ID replenishment. Results The final study cohort included in the echo-substudy consisted of 98 patients, 41 (42%) were classified in the ID group (TSAT <20%). Regarding the usual definition of ID, 7 patients (15%) in the ID group had TSAT ≥20%, while 4 (7%) in the non-ID group showed TSAT <20%. Mean age was 72±10 years, 22 (22%) were women and most were in NYHA functional class II (71%). Ischemic was the main etiology of HF (50%). The ID group presented worse LV function expressed by LVEF (34% vs. 38%), WW (302[235.5-439,75] mmHg% vs. 209.5[136-297.25] mmHg%) and WE (74±10% vs. 80±10%) (Figure 1). Right ventricle function was also worse in the ID group when measured by fractional area change (FAC) (41.76[33.26-50.33] % vs 46.79[39.23 – 54.94] %) and RV coupling ratio (0.52±0.21 vs 0.64±0.24) but not by TAPSE. Strikingly, no differences were observed in any echocardiographic parameter of myocardial function between the non-ID patients compared with the ID-patients after iron replenishment (Table 1). Conclusions TSAT <20% identified ID status that causes impaired myocardial performance in HF patients. This can be reversed with intravenous iron repletion. This reversible damage to cardiac function can be detected by advanced echocardiographic parameters, both for LV (GLS, WE, MW, WW) and for RV (RVFW strain, RV coupling), but not by LVEF or TAPSE.Figure 1Table 1

Echocardiographic and clinical features of patients developing prosthesis-patient mismatch after TAVI: insights from an international multicenter registry

Abstract Background The impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) is controversial. Purpose Our study aims to evaluate the impact of PPM on mortality and clinical-echocardiographic progression of cardiac damage in a "real world" cohort of patients at intermediate and low surgical risk and to characterize its main predictors. Methods 963 patients who underwent TAVI procedure between 2017 and 2021, from an international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations (VARC-3 criteria). Results 18% of patients developed post-TAVI PPM, (7.7% of the whole cohort severe). At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, p=0.33), aged 82y (interquartile range (IQR) 79-85y) vs 82y (IQR 78-86y; p=0.46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, p=0.04); they had smaller left ventricular outflow tract (LVOT) diameter (20mm, IQR 19-21 vs 20mm, IQR 20-22, p=0.02), reduced Stroke Volume index (SVi) (34.2 vs 38 ml/m2, p<0.01) and transaortic flow rate (190.6 vs 211 ml/s, p<0.01). At pre-discharge FU patients with PPM had more paravalvular aortic regurgitation (AR) (moderate/severe AR 15.8% vs 9.2%, p<0.01). At a median FU of 1.46 years (IQR 1-4), there was no evidence of a significant impact of PPM on overall mortality (15.3% vs 13.1%, p=0.46) nor on rehospitalization rate for heart failure (4.3% vs 8.0%, p=0.10). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in endsystolic diameter (ESD) (33 vs 28mm, p=0.03) and a statistically non-significant increase in LV mass index (121 vs 106g/m2, p=0.07). Interestingly, trajectory parameters of patients with PPM from baseline to 1-year FU showed a reduced cardiac remodeling compared to patients without PPM, including no LVEF improvement (p=0.88), absent reduction of LV end-diastolic volume (p=0.70), indexed LV mass (p=0.31), ESD (p=0.48) and pulmonary artery systolic pressure (p=0.82), and an increase of basal RV diameter (p<0.001). Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, p=0.03). Independent predictor of PPM at multivariable logistic regression was male gender (OR=1.93, p=0.04); while SVi (OR=0.86, p<0.001), prosthetic size >23mm (OR=0.62, p=0.03) and LVOT diameter (OR=0.79, p=0.02) had protective effect. Conclusions There was no evidence of a short- or medium-term impact of PPM on mortality. However, clinical-echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations associated with a significant deterioration in NYHA class at 1 year.

Exercise oscillatory ventilation as a predictor of mortality in patients with amyloid cardiomyopathy

Abstract Background Exercise oscillatory ventilation (EOV) signals multiple abnormalities in hemodynamics and ventilatory control which may predict poor outcome in patients with cardiac diseases. Purpose To assess whether EOV (+) patients with amyloid cardiomyopathy show higher mortality rates compared to their counterparts without EOV. Methods We analyzed cardiopulmonary exercise testing results for EOV defined by continuous (>60% of exercise duration) oscillations in minute ventilation (VE), cycling with a frequency of one minute and an amplitude above 15% of resting VE, in patients with amyloid cardiomyopathy. Results 156 patients with amyloid cardiomyopathy, aged 78 (±7) years, 87% male with a NYHA functional class of II (49.4%) and median B-type natriuretic peptide levels of 2548 (1374-4703) ng/L. Comorbidities include hypertension (73.1%), polyneuropathy (45.5%), coronary heart disease (41.0%), diabetes mellitus (17.3%) and chronic obstructive pulmonary disease (10.9%). Patients had a mean peak oxygen consumption of 14.8 (±4.42) ml/kg·min and a VE to carbon dioxide production (VCO2) slope ≥ 40 in 67.9% of cases. EOV was seen in 38 (24.4%), clearly absent in 92 (59.0%) and not clearly differentiable in 26 (16.7%) patients. 33 (21.2%) had a HF-related hospitalization and 31 (19.9%) died. EOV shows a hazard ratio of 2.35 (CI 1.088 – 5.075, p-value <0.05) for all-cause mortality. In fact, the log-rank test showed a difference in survival time between patients with and without EOV (p=0.03) with a median survival time of 46 months. Conclusion EOV may improve the prognostic yield of incremental CPET in patients with amyloid cardiomyopathy.Kaplan-Meier Curve for EOV