The Kansas City Cardiomyopathy Questionnaire in Relation to New York Heart Association Class.

BACKGROUND: In order to identify candidacy and treatment response for patients with obstructive hypertrophic cardiomyopathy (oHCM), clinicians need an accurate means of assessing symptoms, function, and quality of life. While the New York Heart Association (NYHA) Classification is most often used, the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) is more accurate and sensitive to change, although less familiar to practicing clinicians. To support interpreting the KCCQ, we describe cross-sectional and changes in KCCQ scores in the context of the NYHA. METHODS: Participants from the EXPLORER-HCM trial (NCT03470545) completed the KCCQ-23 and clinicians assigned NYHA classes at study visits. Participants were included if they had baseline and week 30 data for cross-sectional and longitudinal changes. Median KCCQ-23 scores were compared by NYHA class at baseline and week 30 and by change in NYHA class from baseline to week 30. RESULTS: Cross-sectionally, the KCCQ-23 Overall Summary Scores (KCCQ-23 OSS) and Clinical Summary Scores (KCCQ-23 CSS) had an inverse relationship with NYHA at baseline and 30 weeks, with marked variations in KCCQ-23 scores among patients assigned to the same NYHA class. When improving from NYHA class II to I, the median changes in KCCQ-23 OSS and KCCQ-23 CSS were 10 (IQR 4, 22) and 8 (IQR 2, 20), respectively. The changes were larger when improving from NYHA class III to II and from NYHA class III to I. CONCLUSION: KCCQ-23 scores are inversely related to NYHA classes, with significant variability within classes. Changes in scores are not linear, suggest greater differences when patients move between NYHA Class II and III than Class I and II. These insights may help clinicians better understand cross-sectional and changes in KCCQ scores.

Worsening effect of testosterone deficiency on males with heart failure with preserved ejection fraction.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF)is challenging. Patients usually have normal LV size and ejection fraction. This clinical syndrome develops from a complex interaction of several risk factors that cause organ dysfunction and clinical symptoms. There's evidence that testosterone deficiency is associated with a worse cardiometabolic profile and increased inflammatory markers. We thought that these changes might have an impact on heart failure pathogenesis. We aimed to study the relationship between testosterone level and symptoms in HFpEF. METHODS: We studied 120 male patients with HFpEF. According to New York Heart Association (NYHA), patients were classified into I, II and III classes; class IV patients were excluded. All patients were subjected to clinical and echocardiographic examinations. In addition, we measured serum testosterone, cardio-metabolic profile, intracellular adhesive molecule-1(ICAM-1), P-selectin and nitric oxide (NO) levels. RESULTS: Patients with testosterone deficiency had worse NYHA class and higher BNP P = (0.001). Additionally, they had a significantly worse metabolic profile; higher total cholesterol, triglycerides, LDL cholesterol, fasting insulin and HOMA-IR P = (0.005, 0.001, 0.001, 0.001), respectively. Also, they had higher inflammatory markers and worse endothelial functional parameters; (ICAM-1, NO and P- selectin) P = (0.001). Age, BNP and testosterone deficiency can be used as independent predictors of NYHA class III symptoms with a Testosterone cutoff value of 2.7 ng/ml. CONCLUSION: Testosterone deficiency could be used as an independent predictor of symptom severity in HFpEF, and it aggravates systemic inflammation and endothelial dysfunction in these patients.

LIPCAR Is Increased in Chronic Symptomatic HF Patients. A Sub-Study of the GISSI-HF Trial.

BACKGROUND: The long noncoding RNA LIPCAR (Long Intergenic noncoding RNA Predicting CARdiac remodeling) has emerged as a promising biomarker in cardiac disease and cardiac remodeling. To determine whether LIPCAR levels help for a molecular phenotyping of chronic heart failure (HF) patients, this study assessed the association of LIPCAR with severity of the disease and its progression, and with risk of death or hospitalization in HF patients. METHODS: LIPCAR was measured in plasma of 967 HF patients with symptomatic heart failure participating in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca - Heart Failure (GISSI-HF) biohumoral sub-study. RESULTS: Plasma levels of LIPCAR were significantly associated with functional impairment as assessed by the New York Heart Association (NYHA) class, kidney function as reflected by estimated glomerular filtration rate, and creatinine, hemoglobin and mitral insufficiency. In females, these associations were more marked as compared to males. LIPCAR plasma levels were significantly related to the two cardiac markers, N-terminal pro-B type natriuretic peptide and high-sensitivity cardiac troponin T, but not to inflammatory markers such as high sensitivity C-reactive protein and pentraxin-3, nor to patient reported outcomes such as depression and quality of life. HF patients with high LIPCAR levels univariately showed significantly higher incidence of cardiovascular hospitalizations but not of death; after adjusting for covariates, no significant effects of LIPCAR were found for cardiovascular hospitalizations. CONCLUSION: The circulating long noncoding RNA LIPCAR was increased in HF patients with higher NYHA class, impaired kidney function, and lower hemoglobin, which are indicators of patients' overall state.

Implications of concomitant obstructive or restrictive pulmonary diseases on functional and clinical results after MitraClip.

OBJECTIVES: We investigated the impact of underlying pulmonary limitations (PL) on symptoms and clinical outcomes after transcatheter mitral valve repair (TMVr). BACKGROUND: Patients with pulmonary disease and patients with symptomatic mitral regurgitation (MR) suffer common symptoms like dyspnea and reduced exercise capacity. METHODS: Datasets from the TMVr Ulm registry were retrospectively analyzed by a blinded specialist in pneumology. Patients were dichotomized according to an unambiguous manifestation of concomitant pulmonary disease in a PL-group and a non-PL-group and were analyzed regarding baseline characteristics and clinical follow-up. RESULTS: Overall, 483 patients were included in the study of which 32.3% (n = 156) showed an underlying pulmonary disease. Patients in the PL-group were similar to patients in the non-PL-group, including Euro SCORE II (8.2 vs. 8.4, p = 0.39), New York Heart Association (NYHA) classification (3.2 ± 0.7 in both groups, p = 0.65) and the incidence of moderate-to-severe or severe MR after TMVr (5.8 vs. 8.3%, p = 0.32). Equal and significant symptom relief after TMVr was experienced in both cohorts according to NYHA functional class (2.24 ± 0.84 vs. 2.24 ± 0.86, p = 0.93) and rate of hospitalization during 2 years of follow-up decreased comparably from 61.1 to 19.3%. However, all-cause mortality for 2 year follow-up was significantly higher in the PL-group compared to the non-PL-group (31.4 vs. 21.4%, p = 0.018). CONCLUSION: In patients with MR and concomitant pulmonary disorders, a significant increase of exercise capacity and a significant decrease of rehospitalization rate were observed after TMVr. Nevertheless, all-cause mortality remains significantly increased within a follow-up period of 2 years compared to patients without pulmonary disorders.

2D/3D Echocardiographic features of patients with reverse remodeling after cardiac resynchronization therapy.

PURPOSE: To describe clinical and echocardiographic characteristics associated with reverse left ventricular (LV) remodeling after 6 months of cardiac resynchronization therapy (CRT) in patients with nonischemic dilated cardiomyopathy. METHODS: Twenty-four consecutive patients underwent 2D and 3D echocardiography before and after 6 months of CRT implant. Several echocardiographic parameters including global longitudinal strain (GLS) and 3D mechanical dyssynchrony (MD) index were calculated. CRT response was defined as a decrease in LV end-systolic volume (LVESV) of at least 10% at follow-up. Patients were divided in two groups according to CRT response. RESULTS: Cardiac resynchronization therapy responder (CRTR+) rate was 50%. Nonresponder (CRTR-) patients showed a less significant improvement in NYHA class at follow-up. At baseline, CRTR- presented with higher LV end-diastolic volume (LVEDV) (P = 0.031), LVESV (P = 0.024), lower left ventricular ejection fraction (LVEF) (P = 0.002) and less negative GLS (P = 0.03), and with higher diastolic dysfunction, more impaired right ventricle (RV), and higher pulmonary artery systolic pressure (PASP) (P = 0.002). No significant differences in echocardiographic parameters of MD were found. Univariate determinants of CRTR+ were LVEF (OR = 1.59, CI 95% = 1.13-2.22, P = 0.007) and TAPSE (OR 1.21, CI 95% = 1.024-1.429, P = 0.025). A ROC curve analysis showed a cutoff value of LVEF of 22.15% significantly related to CRTR+ (SE 80%, SP 50%). CONCLUSIONS: Our findings suggest that end-stage HF patients, presenting before CRT with LVEF <22.15%, may not benefit from the procedure after 6 months. Mechanical dyssyncronicity did not provide additional information to improve candidate selection.

Prophylactic implantable cardioverter defibrillator in heart failure: the growing evidence for all or Primum non nocere for some?

Heart failure (HF) is a common health problem and has reached epidemic in many western countries. Despite the current era of HF treatment, the risk of sudden cardiac death (SCD) in HF remains significant. Implantable cardioverter defibrillator (ICD) support has been shown to reduce the risk of SCD in patients with HF and impaired left ventricular function. Prophylactic ICD implantation in HF patients seems a logical step to reduce mortality through a reduction in SCD. However, ICD implantation is an invasive procedure, and both short- and long-term complications can occur. This needs to be carefully considered when evaluating the risk-benefit ratio of ICD implantation for individual patients. As the severity of HF increases, the proportion of SCD compared with HF-related deaths decreases. The challenge lies in identifying patients with HF who are at significant risk of SCD and who would most benefit from an ICD in addition to other anti-arrhythmic strategies. This review offers insight on the applicability and practicability of ICD for this growing population.

In search of an efficient strategy to monitor disease status of chronic heart failure outpatients: added value of blood biomarkers to clinical assessment.

INTRODUCTION: Blood biomarkers have the potential to monitor the severity of chronic heart failure (CHF). Studies correlating repeated measurements of blood biomarkers with repeatedly assessed New York Heart Association (NYHA) class over a prolonged follow-up period, and concomitantly investigating their associations with clinical endpoints, have not yet been performed. METHODS: Between 2011-2013, 263 CHF patients were included. At inclusion and subsequently every 3 months, we measured N­terminal pro-B-type natriuretic (NT-proBNP), high-sensitivity troponin T (Hs-TnT) and C­reactive protein (CRP), and assessed NYHA class. The primary endpoint comprised heart failure hospitalisation, cardiovascular mortality, cardiac transplantation or left ventricular assist device implantation. Time-dependent Cox models were used. RESULTS: Mean age was 67 ± 13 years, 72% were men and 27% were in NYHA class III-IV. We obtained 886 repeated measures (median 3 [IQR 2-5] per patient). The primary endpoint was reached in 41 patients during a median follow-up of 1.0 [0.6-1.4] year. Repeatedly measured NT-proBNP and Hs-TnT were significantly associated with repeatedly assessed NYHA class, whereas CRP was not (NT-proBNP: ß [95% CI]: 1.56 [1.17-2.06]ln(ng/l) increase per point increase in NYHA class, p = 0.002; HsTNT: ß [95% CI]: 1.58 [1.21-2.07]). Serially measured NT-proBNP (HR [95% CI]:2.86 [1.73-4.73]), CRP (1.69 [1.21-2.34]) and NYHA class (2.33 [1.51-3.62]) were positively and independently associated with the primary endpoint, whereas Hs-TnT lost statistical significance after multivariable adjustment. A model containing serially measured NYHA class and NT-proBNP displayed a C-index of 0.84, while serially measured NYHA class and CRP showed a C-index of 0.82. CONCLUSION: Temporal NT-proBNP, CRP and NYHA class patterns are independently associated with adverse clinical outcome. Serially measured NT-proBNP and NYHA class are best suited for monitoring CHF outpatients.

Costs and benefits in patients with NYHA class III heart failure treated with CardioMEMS in Italy.

Background: CardioMEMS is a device suitable for telemedicine that is currently being evaluated by the Regional Health Technology Assessment (HTA) Committee of Tuscany. Two detailed HTA reports are available in the specialized literature, the results of which need to be transferred to our regional setting. These decisions in Tuscany are made by the so-called Centro Operativo HTA. Aim: To validate, with local cost-effectiveness data, the decision on CardioMEMS that will be made in the Tuscany region. Methods: Two detailed international HTA reports were rearranged and adapted to our regional setting to generate a simplified analysis that could form the basis of our decision. Two willingness-to-pay (WTP) thresholds of €20,000/quality-adjusted life year (QALY) and €50,000/QALY were considered. Results: Based on epidemiological and regulatory information, the target population in Tuscany for this device is 166 cases. The value-based price of CardioMEMS is estimated to be €4,332 and €16,662 at WTP thresholds of 20,000/QALY and 50,000/QALY, respectively. Its current price in Italy is €12,000. Conclusion: In our region, the introduction of CardioMEMS is likely to be gradual, around 50 patients/year (or €0.60 million/year at current price). This example highlights the need to adapt the information published in the international literature to the local context in which the approval decision is made. In this context, simplified analyses are easier to apply than complex Markov models.

Safety and efficacy of aficamten in patients with non-obstructive hypertrophic cardiomyopathy: A 36-week analysis from FOREST-HCM.

AIMS: The aim of this study was to report safety and efficacy of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM) over 36 weeks in the ongoing FOREST-HCM trial. METHODS AND RESULTS: Patients were started on aficamten 5 mg daily, with doses adjusted in 5-mg increments (5-20 mg) at ≥2-week intervals according to site-read left ventricular ejection fraction (LVEF). Aficamten dose was increased if LVEF ≥55%, maintained if LVEF 50-54%, decreased if LVEF 40-<50%, and temporarily interrupted if LVEF <40%. Safety and efficacy were assessed over 36 weeks. Overall, 34 patients were enrolled (mean age 57.2 ± 15.3 years, 62% female, 41% in New York Heart Association [NYHA] class III). Over 36 weeks, 82.3% achieved 15-20 mg daily dose and there was a modest reduction in LVEF by -4.3% ± 5.2 from 70% ± 6.1 (p < 0.0001). At Week 36, NYHA class improved by ≥1 class in 27 (79.4%) patients. Mean Kansas City Cardiomyopathy Questionnaire clinical summary score improved by 13.8 ± 12.5 points relative to baseline. Median (interquartile range) levels of N-terminal pro-B-type natriuretic peptide were significantly improved from baseline (-665.5 pg/ml [-1244.0, -232.0]; p < 0.0001), while high-sensitivity cardiac troponin I was unchanged (-2.7 ng/L [-11.3, 1.6]; p = 0.25). There were no drug discontinuations due to adverse events. LVEF <50% occurred in 2 (5.9%) patients, one following pulmonary vein isolation and one associated with atrial fibrillation. CONCLUSIONS: Over 36 weeks, aficamten appeared safe and effective in the studied patients with nHCM.

Relationship between New York functional class and duke activity status index with the severity of mitral valve stenosis and echocardiographic parameters: is left atrial strain a better predictor?

Purpose This study aimed to investigate the relationship between symptoms of patients with severe mitral stenosis (MS), evaluated by the New York Heart Association (NYHA) functional class and Duke Activity Status Index (DASI) score, and echocardiographic parameters. We evaluated patients with severe rheumatic MS diagnosed as mitral valve area (MVA) less than 1.5 cm2. All patients underwent transthoracic echocardiography and the left atrium (LA) reservoir auto-strain (LASr) analysis. In addition, DASI and NYHA scores were determined to evaluate the functional capacity and symptoms of MS patients. We evaluated 60 patients with MS with a mean age of 50.13 ± 10.28 and a median DASI score of 26.95 (26.38). There were 6 (10%) and 28 (46.7%) patients with NYHA class I and II, and 25 (40.0%) and 2 (3.3%) patients with NYHA class III and IV, respectively. NYHA class was positively correlated with LA area (LAA, r = 0.638), LA volume (LAV, r = 0.652), LAV index (LAVI, r = 0.62), E (r = 0.45), A (r = 0.25), and pulmonary artery pressure (PAP, r = 0.34), while negatively correlated with LASr (r = - 0.73) and MVA (r = - 0.417). Furthermore, the DASI score was positively associated with LASr (r = 0.81) and MVA (r = 0.52) while negatively correlated with LAA (r = - 0.62), LAV (r = - 0.65), LAVI (r = - 0.56), E (r = - 0.46), A (r = - 0.3), and PAP (r = - 0.32). Our findings indicate that LAA, LAV, LAVI, E, A, PAP, MVA, and LASr are associated with NYHA and DASI scores in MS patients. Additionally, the LASr had the strongest correlation between all measured parameters in severe MS patients.

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

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

Clinical course of patients with hypertrophic cardiomyopathy away from tertiary referral care.

AIMS: Data on the clinical course of hypertrophic cardiomyopathy (HCM) are mainly derived from tertiary HCM centre studies, and knowledge of clinical outcomes of patients leaving specialty care and returning to local physicians is limited due to gaps between clinical encounters or complete loss of follow-up. This survey aims to describe the clinical course of HCM in patients following their evaluation at a tertiary referral centre. METHODS AND RESULTS: A comprehensive outcomes survey was developed and sent to 4495 eligible patients with HCM previously evaluated at Mayo Clinic. Questions assessed general well-being, New York Heart Association class, procedures performed, and probable HCM-triggered ventricular arrhythmic events (VAEs) since last visit. In total, 2058 patients (mean age 63 ± 15 years; 42% female) responded to the survey covering a total of 10 510 patient-years with an average of 5.4 ± 6.4 years of follow-up since their last on-campus/virtual visit to Mayo Clinic. During their time away from specialty care, 20% of patients reported having cardiac-related hospitalizations and 25% reported having cardiac-related procedures. Similar to high-risk referral cohorts, 5% of patients reported VAEs with an event rate of 0.98 events/100 patient-years. The prevalence of atrial fibrillation, syncope, pre-syncope, cardiac-related hospitalizations, and VAEs during time away from specialty care increased significantly with increasing New York Heart Association class (P < 0.001). CONCLUSIONS: Acknowledging ascertainment bias, the clinical course of patients away from tertiary care may be more severe than previously anticipated. Among those with exertional symptoms, HCM-related morbidity increased substantially. Higher risk HCM patients should remain in contact with HCM specialty care.

Yoga as an adjuvant therapy in heart failure patients on optimal medical management analysed using echocardiographic parameters.

BACKGROUND: Heart failure (HF) is a chronic complex disease that prevails as a prime cause of concern for healthcare sectors worldwide, with a concordant objective to improve the long-term prognosis. Analysis of the available literature is evidence that yoga therapy and basic lifestyle modifications have considerably augmented heart failure patients' quality of life and enhanced left ventricular ejection fraction and NYHA functional class. AIM: Our study aims to establish the long-term outcomes of yoga therapy to validate the addition of yoga therapy as a complementary treatment in managing HF. METHODS: A prospective non-randomized study was conducted at a tertiary care center including seventy-five HF patients with NYHA class III or less who underwent coronary intervention, revascularization, or device therapy within the past six months to one year and continuing guideline-directed optimal medical therapy (GDMT). Thirty-five participants were part of the Interventional Group (IG), and forty were in the Non-Interventional Group (Non-IG). The IG received yoga therapy and GDMT, while the non-IG were only under standard GDMT. Echocardiographic parameters were compared at various follow-ups up to one year to see the impact of Yoga therapy on HF patients. RESULTS: A total of 75 heart failure patients, including 61 males and 14 females. The IG and non-IG had 35 subjects (31 males and 4 females) and 40 subjects (30 males and 10 females), respectively. Echocardiographic parameters were observed to compare the IG and Non-IG groups, and those did not demonstrate any significant difference between the two groups (p-value > 0.05). But, the echocardiographic parameters of the IG and non-IG from baseline to six months and one year showed a significant improvement (p-value of <0.05). The functional outcome (NYHA classes) was assessed after follow-up, and a p-value <0.05 showed a substantial improvement in the IG. CONCLUSION: Yoga therapy results in better prognosis, functional outcome, and left ventricular performance in HF patients with NYHA III or less. Hence this investigation has attempted to justify its importance as adjuvant/complimentary treatment for HF patients.

Late gadolinium enhancement and the risk of ventricular arrhythmias and sudden death in NYHA class I patients with non-ischaemic cardiomyopathy.

AIM: To compare the risk of ventricular arrhythmias (VA) and sudden death (SD) between New York Heart Association (NYHA) class I and NYHA class II-III patients with non-ischaemic cardiomyopathy (NICM). METHODS AND RESULTS: Observational retrospective cohort study including patients with NICM who underwent cardiac magnetic resonance at two hospitals. The primary endpoint included appropriate implantable cardioverter defibrillator (ICD) therapies, sustained ventricular tachycardia, resuscitated cardiac arrest and SD. The secondary endpoint included heart failure (HF) hospitalizations, heart transplant, left ventricular assist device implant or HF death. Overall, 698 patients were included, 33% in NYHA class I. During a median follow-up of 31 months, the primary endpoint occurred in 57 patients (8%), with no differences between NYHA class I and NYHA class II-III cases (7% vs. 9%, p = 0.62). Late gadolinium enhancement (LGE) was the only independent predictor of the primary outcome both in NYHA class I and NYHA class II-III patients. LGE+ NYHA class I patients had a similar cumulative incidence of the primary endpoint as compared to LGE+ NYHA class II-III (p = 0.92) and a significantly higher risk as compared to LGE- NYHA class II-III cases (p < 0.001). The risk of the secondary endpoint was significantly higher in patients in NYHA class II-III as compared to those in NYHA class I (hazard ratio 3.2, p = 0.001). CONCLUSIONS: Patients with NICM in NYHA class I are not necessarily at low risk of VA and SD. Actually, LGE+ NYHA class I patients have a high risk. NYHA class I patients with high-risk factors, such as LGE, could benefit from primary prevention ICD at least as much as those in NYHA class II-III with the same risk factors.

Comparing New York Heart Association Class and Patient-Reported Outcomes Among Patients Hospitalized for Heart Failure.

BACKGROUND: Alignment between clinician-reported New York Heart Association (NYHA) class compared and patient-reported outcomes among patients hospitalized for heart failure is unclear. METHODS: ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) was a global randomized trial comparing nesiritide versus placebo among patients hospitalized for heart failure, irrespective of ejection fraction. Among patients with complete baseline data for NYHA class and the patient-reported EuroQOL-5 dimensions ([EQ-5D], both utility index and visual analog scale), levels of each scale were mapped across 4 prespecified categories "best" to "worst." Minor and moderate-severe discordance were defined as NYHA class and EQ-5D differing by 1 level and ≥2 levels, respectively. Multivariable models assessed factors independently associated with moderate-severe discordance, and associations between discordance and clinical outcomes. RESULTS: Among 5741 patients, concordance, minor discordance, and moderate-severe discordance between NYHA class and EQ-5D utility index occurred in 22%, 40%, and 38% of patients, respectively. For NYHA class and EQ-5D visual analog scale, this categorization occurred in 29%, 48%, and 23%. Discordance was more often due to disproportionately higher EQ-5D score (78% of discordance cases with utility index, and 70% with visual analog scale). NYHA class IV, higher EQ-5D scores, race, and geographic region were among patient factors independently associated with moderate-severe discordance. Magnitude of discordance was not associated with clinical outcomes; however, EQ-5D utility index disproportionately worse than NYHA class was associated with increased 180-day mortality (adjusted hazard ratio 1.27 [95% CI, 1.01-1.60]; P=0.04). CONCLUSIONS: In a global trial cohort of patients hospitalized for heart failure, the majority of patients exhibited discordance between clinician-reported NYHA class and patient-reported health status. Multiple patient factors were independently associated with moderate-severe discordance, and patients who perceived their health status as worse than the clinician's perception had higher mortality. Registration: URL: http://www. CLINICALTRIALS: gov; Unique identifier: NCT00475852.

Effect of low-level laser physiotherapy on left ventricular function among patients with chronic systolic heart failure.

BACKGROUND: Low-level laser therapy (LLLT) is a promising noninvasive physiotherapeutic approach that has been demonstrated to improve cardiac performance. This study aimed to assess the impact of low-level laser therapy on cardiac functions and clinical status in patients with chronic left ventricular systolic heart failure who were not candidates for cardiac revascularization or resynchronization. A case series of 27 patients received a course of low-level laser physiotherapy, the clinical outcomes, echocardiographic parameters, and serum nitric oxide levels were evaluated before and after LLLT. RESULTS: Of the total patients enrolled in the study, 21 (or 77.8%) were male, with a mean age of 57.7 ± 6.89 years. NYHA classification significantly improved after low-level laser therapy, 15 patients were in class III,12 were in class IV, and no one was in class II before laser therapy while after laser therapy; 25 patients shifted to class II, two patients were in class III with P < 0.001, Six-minute walk distance test was performed, and the results showed that the mean of 6MWT was less than 200 m (148.556 ± 39.092) before the study but increased to more than 300 after laser therapy (385.074 ± 61.740), left ventricular ejection fraction before laser therapy was 26 ± 7.5 while after laser therapy it became 30 ± 8.6 but diastolic function did not change after low-level laser therapy, the mean peak TR pressure was 40.0 ± 9.0 mmHg and 33.0 ± 7.0 before and after laser therapy respectively P < 0.001. A significant change was observed in NO level from 4.1 ± 1.4 IU/ml before laser therapy to 5.2 ± 1.7 IU/ml after laser therapy P < 0.001. CONCLUSIONS: Low-level laser therapy may add benefits to improve symptoms, clinical condition, and quality of life in patients with left ventricular systolic dysfunction, further studies are necessary to evaluate the changes in cardiac functions at a longer follow-up duration.

Cardiovascular outcomes by time-varying New York Heart Association class among patients with obstructive hypertrophic cardiomyopathy: a retrospective cohort study.

AIMS: Assess the relationship between New York Heart Association (NYHA) functional class and cardiovascular (CV) outcomes in obstructive hypertrophic cardiomyopathy (HCM). MATERIALS AND METHODS: This retrospective cohort study used the Optum Market Clarity database with linked claims and electronic health records. Adults (aged ≥18 years) with obstructive HCM and ≥1 NYHA class assessment after first HCM diagnosis were eligible (selection period: 2007-2021). Thirteen outcomes were assessed following the index date (first documented NYHA class assessment after first HCM diagnosis in the study period): all-cause mortality; first occurrences of all-cause hospitalization; CV-related hospitalization; primary ischemic stroke or transient ischemic attack (TIA); myocardial infarction (MI); deep vein thrombosis (DVT) or pulmonary embolism (PE); and major adverse CV event (MACE); as well as first incident events of atrial fibrillation or flutter; primary ischemic stroke or TIA; heart failure; acute MI; DVT/PE; and a composite endpoint of pacemaker and cardiac resynchronization therapy. Their associations with the index NYHA class were described using the Kaplan-Meier method (mortality) or cumulative incidence functions (other outcomes). Hazard ratios between NYHA class over time and outcomes were evaluated using time-varying Cox models, adjusting for age at first observed HCM diagnosis, sex, and race. RESULTS: Among 4,631 eligible patients, the mean age was 59 years at the first observed HCM diagnosis (female, 47%; White, 77%). The risks of all outcomes increased with worse (higher) index NYHA class and worsening NYHA class over time. Deterioration in the NYHA class from the index date was associated with increased risks of outcomes. LIMITATIONS: The study population may not be representative of all patients with obstructive HCM in the real world. Documented NYHA classes may not fully reflect the longitudinal variation of NYHA class for each patient. CONCLUSIONS: Worsening NYHA class was associated with increased risks of all-cause mortality and CV outcomes in obstructive HCM.

The New York Heart Association (NYHA) class is a simple way for doctors to measure how bad a patient's heart failure is by how it affects a person's ability to do everyday activities. It is a 4-point scale from 1, indicating no limitations on activity and no shortness of breath, to 4, at which patients have symptoms even at rest and any activity leaves people struggling to catch their breath. NYHA class is also used to assess patients with obstructive hypertrophic cardiomyopathy (HCM), a disease that causes thickening of the heart muscle. While doctors know that as obstructive HCM becomes worse, patients are at greater risk of having to go to the hospital, getting other conditions (like atrial fibrillation or heart failure), having to have more treatments (like surgery), or even death, doctors and researchers do not know how much risk the patient has and how it changes as the disease changes over time. Although there have been some smaller studies that have estimated this risk, we studied a large, national database and found that patients with worse (higher) NYHA class over time had an increased risk of dying, having to go to the hospital for heart-related care, and developing other heart-related conditions. This finding suggests that it is important for doctors to follow up patients with obstructive HCM carefully and to adjust treatments in order to help patients to stay at lower NYHA classes to improve long-term outcomes.

Efficacy and safety of sacubitril/valsartan in an outpatient setting: A single-center real-world retrospective study in HFrEF patients with focus on possible predictors of clinical outcome.

BACKGROUND: Currently, data on sacubitril/valsartan therapy from the real-world settings are scarce and the predictors of a good clinical responsiveness to this drug are unknown. OBJECTIVES: To assess efficacy and safety profile of sacubitril/valsartan and to identify predictors for a better clinical outcome. MATERIAL AND METHODS: Clinical, laboratory and echocardiographic data of 95 chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) were retrospectively analyzed. A good efficacy of sacubitril/valsartan was defined as the fulfilment of at least 2 of the following criteria: improvement of left ventricular ejection fraction (LVEF) or functional status, and reduction of N-terminal pro-brain natriuretic peptide (NT-proBNP) levels or hospitalization rates. RESULTS: Under sacubitril/valsartan, major improvements were observed in LVEF, the New York Heart Association (NYHA) class, NT-proBNP levels, and hospitalization rates. Patients with a good efficacy of sacubitril/valsartan were characterized by initially worse LVEF (median (interquartile range (IQR)): 29.0% (23.0-33.0%) compared to 32.0% (28.5-38.0%) with more frequent nonischemic etiology (65.4% compared to 41.9%) and hospitalizations for CHF/month (0.016 (0.004-0.057) compared to 0.000 (0.000-0.012)), lower cholesterol (42.3% compared to 65.1%), higher C-reactive protein (CRP) levels at baseline (0.5 mg/L (0.5-1.0 mg/L) compared to 0.5 mg/L (0.5-0.5 mg/L)), and a shorter timespan between CHF diagnosis and the start of sacubitril/valsartan treatment (66.0 (11.0-127.0) compared to 111 (73.0-211.0) months) (p < 0.05 each). In a multivariate Cox analysis, only the last 2 parameters were shown to be independent predictors of good clinical responsiveness to sacubitril/valsartan (hazard ratio (HR) = 1.263, 95% confidence interval (95% CI) = [1.048; 1.521]; HR = 0.992, 95% CI = [0.987; 0.997], p < 0.05, respectively). CONCLUSIONS: Sacubitril/valsartan improved LVEF, NYHA class, NT-proBNP levels, and hospitalization rates, mostly without relevant side effects. The independent predictors of a good clinical efficacy were higher CRP levels at baseline and a shorter delay between CHF diagnosis and the initialization of sacubitril/valsartan therapy.

A systemic review of endocardial left ventricular pacing.

BACKGROUND: Endocardial left ventricular pacing is an alternative technique used in cardiac resynchronization therapy (CRT), when placement of a left ventricular lead is not possible via the coronary sinus or in non-responders to conventional CRT. OBJECTIVES: To review the evidence regarding the efficacy and safety of endocardial left ventricular pacing. METHODS: Systematic research on Medline (PubMed), ClinicalTrials.gov and Embase with the terms "endocardial left ventricular pacing", "biventricular pacing" or "endocardial left pacing" was performed with the identification of 1038 results. Eleven studies with endocardial left ventricular pacing patients were included, independent of the technique being applied to naïve CRT patients or con non-responders to conventional CRT. The end-point of this analysis was the impact of endocardial left ventricular pacing techniques regarding New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF) and QRS width, and the occurrence of complications Mean differences (MD) and confidence interval (CI) was used as a measurement of treatment. RESULTS: A total of 560 patients were included, with different techniques used (trans-atrial septal technique, trans-ventricular septal technique and transapical technique). Significant improvement was registered in NYHA class (MD 0.73, CI 0.48-0.98, p<0.00001, I2 = 87%), LVEF (MD -7.63, CI -9.93 - -5.33, p<0.00001, I2 = 69%) and QRS width (MD 29.25, CI 9.99-48.50, p<0.00001, I2 = 91%). Several complications were reported after the procedure, 11 pocket infections, 22 transient ischemic attacks, 18 ischemic strokes, 41 thromboembolic events, among other complications. The mortality rate during the follow-up was 20.54%. CONCLUSION: Left ventricular endocardial pacing is a feasible alternative to conventional CRT, with clinical, electrocardiographic and echocardiogrphic improvement. However, first data regarding this procedure was associated with significant complications rates.

An Alternative Prediction Equation for Evaluation of Six-Minute Walk Distance in Stable Coronary Artery Disease Patients.

Background: As cardio-vascular diseases are the leading cause of death worldwide, establishing measures to improve cardiovascular health is of crucial importance. Exercise plays an essential role in cardiac rehabilitation of patients with coronary artery disease (CAD), in whom an evaluation of the cardiorespiratory fitness (CRF) is necessary. CRF of CAD patients could be assessed using 6-min walk test (6MWT), and the results interpreted by using Enright-Sherill prediction equation which has mainly been designed and evaluated for a healthy population. Hypothesizing that the Enright-Sherill prediction equation might not be best suited for CAD patients, our aim was to reevaluate this equation in CAD patients, and potentially establish a more accurate 6MWD prediction equation to be applied in these patients. Methods: 6MWD was measured in a cross-sectional study in 67 CAD patients (44 women) who were members of the Coronary club Ljubljana, Slovenia. In addition, the predicted 6MWD was calculated for men and women using Enright-Sherill gender specific regression equation. Multivariate regression analysis was used to obtain a new prediction equation, and the agreement between the measured and the predicted 6MWD analyzed using the repeated measures ANOVA. Results: Men achieved 451 ± 122 m and women 485 ± 69 m without significant differences between sexes (F = 0.022, p = 0.882) when adjusted for age, height, body mass, and waist circumference. When comparing the measured (473 ± 91 m) and the predicted (422 ± 57 m) values of 6MWD in CAD patients we found that the Enright-Sherill prediction equation significantly (F = 27.734, p < 0.001) underestimated the 6MWD by 52 ± 81 m. A significant regression equation was established [F (3,63) = 44.663, p < 0.001], with a R 2 of 0.680 where 6MWD equals 1,057 m-4.966 x age (years)-0.614 x WC (cm)-68.629 x NYHA class. Conclusion: The results of this study stress the importance of regular and actual walking ability testing in patients with stable CAD to obtain their CRF, rather than simply predicting it from regression equations obtained from non-representative or non-comparable samples. Our developed prediction equation warrants additional validation and may represent a good substitute for currently used predictions obtained from a healthy population.