Consensus Statement from India on the Renal Benefits of ARNi, SGLT-2i, and Bisoprolol in Chronic Kidney Disease.

Chronic kidney disease (CKD) is a major contributor to morbidity and mortality in India. CKD often coexists with heart failure (HF), diabetes, and hypertension. All these comorbidities are risk factors for renal impairment. HF and CKD are pathophysiologically intertwined, and the deterioration of one can worsen the prognosis of the other. There is a need for safe renal pharmacological therapies that target both CKD and HF and are also useful in hypertension and diabetes. Neurohormonal activation achieved through the activation of the sympathetic nervous system (SNS), the renin-angiotensin-aldosterone system (RAAS), and the natriuretic peptide system (NPS) is fundamental in the pathogenesis and progression of CKD and HF. Angiotensin receptor neprilysin inhibitor (ARNi), sodium-glucose cotransporter 2 inhibitors (SGLT-2i), and selective ß1-blocker (B1B) bisoprolol suppress this neurohormonal activation. They also have many other cardiorenal benefits across a wide range of CKD patients with or without concomitant HF, diabetes, or hypertension. This consensus statement from India explores the place of ARNi, SGLT-2i, and bisoprolol in the management of CKD patients with or without HF and other comorbidities.

Current Place of SGLT2i in the Management of Heart Failure: An Expert Opinion from India.

Heart failure (HF) is a global health concern that is prevalent in India as well. HF is reported at a younger age in Indian patients with comorbidity of type 2 diabetes (T2DM) in approximately 50% of patients. Sodium-glucose cotransporter-2 inhibitors (SGLT2i), originally approved for T2DM, are new guideline-recommended and approved treatment strategies for HF. Extensive evidence highlights that SGLT2i exhibits profound cardiovascular (CV) benefits beyond glycemic control. SGLT2i, in conjunction with other guideline-directed medical therapies (GMDT), has additive effects in improving heart function and reducing adverse HF outcomes. The benefits of SGLT2i are across a spectrum of patients, with and without diabetes, suggesting their potential place in broader HF populations irrespective of ejection fraction (EF). This consensus builds on the updated evidence of the efficacy and safety of SGLT2i in HF and recommends its place in therapy with a focus on Indian patients with HF.

Role of Bisoprolol in Heart Failure Management: A Consensus Statement from India.

In India, heart failure (HF) is an important health concern affecting younger age groups than the western population. A limited number of Indian patients receive guideline-directed medical therapy (GDMT). Selective ß-1 blockers (BB) are one of the GDMTs in HF and play an important role by decreasing the sympathetic overdrive. The BB reduces heart rate (HR) reverse the adverse cardiac (both ventricular and atrial), vascular, and renovascular remodeling seen in HF. Bisoprolol, a ß-1 blocker, has several advantages and can be used across a wide spectrum of HF presentations and in patients with HF and comorbid conditions such as coronary artery disease (CAD), atrial fibrillation (AF), post-myocardial infarction (MI), uncontrolled diabetes, uncontrolled hypertension, and renal impairment. Despite its advantages, bisoprolol is not optimally utilized for managing HF in India. This consensus builds on updated evidence on the efficacy and safety of bisoprolol in HF and recommends its place in therapy with a focus on Indian patients with HF.

Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study.

OBJECTIVE: Evaluate the effects of a novel autonomic regulation therapy (ART) via vagus nerve stimulation (VNS) in patients with chronic heart failure (HF) and reduced left ventricular ejection fraction during a 12-month follow-up period. METHODS: The Autonomic Regulation Therapy for the Improvement of Left Ventricular Function and Heart Failure Symptoms (ANTHEM-HF) study enrolled 60 subjects with New York Heart Association class II-III HF and low left ventricular ejection fraction (≤40%), who received open-loop ART using VNS randomized to left or right cervical vagus nerve placement and followed for 6 months after titration to a therapeutic output current (2.0 ± 0.6 mA). Patients received chronic stimulation at a frequency of 10 Hz and pulse duration of 250 µsec. Forty-nine subjects consented to participate in an extended follow-up study for an additional 6 months (12 months total posttitration) to determine whether the effects of therapy were maintained. RESULTS: During the 6-month extended follow-up period, there were no device malfunctions or device-related serious adverse effects. There were 7 serious adverse effects unrelated to the device, including 3 deaths (2 sudden cardiac deaths, 1 worsening HF death). There were 5 nonserious adverse events that were adjudicated to be device-related. Safety and tolerability were similar, and there were no significant differences in efficacy between left- and right-sided ART. Overall, mean efficacy measure values at 12 months were not significantly different from mean values at 6 months. CONCLUSIONS: Chronic open-loop ART via left- or right-sided VNS continued to be feasible and well-tolerated in patients with HF with reduced EF. Improvements in cardiac function and HF symptoms seen after 6 months of ART were maintained at 12 months.

Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial.

OBJECTIVE: ANTHEM-HF evaluated a novel autonomic regulation therapy (ART) via either left or right vagus nerve stimulation (VNS) in patients with heart failure (HF) and reduced ejection fraction (HFrEF). METHODS AND RESULTS: Sixty subjects (New York Heart Association [NYHA] functional class II-III, left ventricular ejection fraction (LVEF) ≤ 40%, left ventricular end-diastolic diameter ≥ 50 mm to < 80 mm) receiving optimal pharmacologic therapy were randomized at 10 sites. VNS systems were randomly implanted on the left (n = 31) or right (n = 29) side. All patients were successfully implanted and 59 were titrated over 10 weeks to a well tolerated stimulation intensity. One patient died 3 days after an embolic stroke that occurred during implantation. Common device-related adverse events after VNS titration were transient mild dysphonia, cough, and oropharyngeal pain, which were similar for left- and right-side VNS. After 6 months of ART, the adjusted left-right differences in LVEF, left ventricular end-systolic volume (LVESV), and left ventricular end-systolic diameter (LVESD) were 0.2% (95% CI -4.4 to 4.7), 3.7 mL (95% CI -7.0 to 14.4), and 1.3 mm (95% CI -0.9 to 3.6), respectively. In the combined population, absolute LVEF improved by 4.5% (95% CI 2.4-6.6), LVESV improved by -4.1 mL (95% CI -9.0 to 0.8), and LVESD improved by -1.7 mm (95% CI -2.8 to -0.7). Heart rate variability improved by 17 ms (95% CI 6.5-28) with minimal left-right difference. Six-minute walk distance improved an average of 56 m (95% CI 37-75); however, improvement was greater for right-side ART (77 m [95% CI 49-105]). NYHA functional class improved in 77% of patients (baseline to 6 months). CONCLUSIONS: Chronic open-loop ART via left- or right-side VNS is feasible and well tolerated in HFrEF patients. Safety and efficacy measures are encouraging and warrant further study.

Approaches in Managing Resistant Hypertension: A Review.

In India, around 234 million adults (one in three) suffer from hypertension (HTN). An average of 10% of these cases are likely to be resistant hypertension (RH). This load of 23 million patients is expected to expand further with revisions in diagnostic criteria. The treatment and control rates of hypertension in India average around 30% and 15%, respectively. Pharmacological management involves a stepwise approach starting with optimizing the A-C-D (angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), and thiazide-like diuretics) triple-drug combination, followed by substitution with a thiazide-like diuretic and use of spironolactone as a next step (fourth drug). The subsequent steps are suggestions based on expert input and must be individualized. These include using a ß-blocker as the fifth drug and an α1-blocker or a peripheral vasodilator as a final option when target blood pressure (BP) values are not achieved. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are likely to be helpful in managing RH due to their renal and cardiovascular protection as well as mortality benefits. SGLT2i lowers BP independent of the dosage and concomitant anti-hypertensive medications. Patient education and tools to monitor BP and treatment compliance will improve outcomes with these medications. In addition to therapeutic intervention, a preventive approach for RH mandates a need to identify patients at risk and use appropriate preventive and optimal therapy to prevent uncontrolled hypertension in patients with cardiovascular disorders.

Expert recommendations for the management of iron deficiency in patients with heart failure in Asia.

BACKGROUND: Iron deficiency is a common comorbidity in heart failure (HF) and is independently associated with a worse quality-of-life and exercise capacity, as well as increased risk of hospitalization, regardless of anemia status. Although international guidelines have provided recommendations for the management of iron deficiency in patients with HF, guidelines in Asia are less established, and practical use of guidelines for management of iron deficiency is limited in the region. METHODS: A panel comprising cardiologists from China, Hong Kong, India, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, and Thailand convened to share insights and provide guidance for the optimal management of iron deficiency in patients with HF, tailored for the Asian community. RESULTS: Expert opinions were provided for the screening, diagnosis, treatment and monitoring of iron deficiency in patients with HF. It was recommended that all patients with HF with reduced ejection fraction should be screened for iron deficiency, and iron-deficient patients should be treated with intravenous iron. Monitoring of iron levels in patients with HF should be carried out once or twice yearly. Barriers to the management of iron deficiency in patients with HF in the region include low awareness of iron deficiency amongst general physicians, lack of reimbursement for screening and treatment, and lack of proper facilities for administration of intravenous iron. CONCLUSIONS: These recommendations provide a structured approach to the management of iron deficiency in patients with HF in Asia.

Autonomic regulation therapy in chronic heart failure with preserved/mildly reduced ejection fraction: ANTHEM-HFpEF study results.

BACKGROUND: Autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) appeared to be safe and to improve autonomic tone, symptoms, and cardiac mechanical function in patients with symptomatic heart failure and reduced ejection fraction in the ANTHEM-HF Study. The ANTHEM-HFpEF Study is the first investigation to evaluate the safety and feasibility of ART in patients with symptomatic heart failure and preserved or mildly reduced ejection fraction (HFpEF, HFmrEF). METHODS: This open-label interventional study enrolled 52 patients with HFpEF or HFmrEF, NYHA Class II-III, and LVEF ≥40%, who received stable guideline-directed medical therapy. All patients were successfully implanted with LivaNova VNS Therapy® system with an electrical lead surrounding the right cervical vagus nerve. RESULTS: Adverse event incidence was low. At 12 months, NYHA class (p <0.0001), 6-min walk distance (p <0.05), and quality of life (p <0.0001) were improved. Cardiac mechanical function measures were normal at baseline, except for left ventricular mass index in women and E/e' ratio in all patients, which were elevated at baseline, and were unchanged by ART. Autonomic tone and reflexes improved, indicated by 29% decrease in low-frequency/high-frequency heart rate variability to normal levels (p = 0.028) and by increased heart rate turbulence slope (p = 0.047). T-wave alternans (p = 0.001) and T-wave heterogeneity (p = 0.001) were reduced from abnormal to normal ranges. Nonsustained ventricular tachycardia incidence decreased (p = 0.027). CONCLUSIONS: ART appeared well-tolerated and safe in patients with HFpEF or HFmrEF. Chronic ART did not alter mechanical function measures but was associated with improved heart failure symptoms, exercise tolerance, autonomic tone, and cardiac electrical stability. CLINICAL TRIAL REGISTRY: Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure with Preserved Ejection Fraction [ClinicalTrials.gov #NCT03163030, registered 05/22/2017].

Development of Consensus Recommendations on the Management of Vitiligo and the Role of Decapeptide in Vitiligo by the Delphi Method.

Background: Treatment of vitiligo is still a challenge in dermatology. Literature is sparse on the definitive clinical role of basic fibroblast growth factor (bFGF) in vitiligo patients. Aims: We decided to generate a consensus in an attempt to answer some critical questions related to the management of vitiligo and the role of bFGF. Materials and Methods: A Delphi method among 21 experts across India was conducted. A consensus (agreement was 75% or greater) was taken on 27 statements on the prevalence, epidemiology, and treatment of vitiligo and the role of bFGF in the management of vitiligo. The consensus process was completed after two rounds. Results: Topical corticosteroid therapy is the first-line therapy for vitiligo; however, its adverse effects are widely known, especially in sensitive areas. Topical calcineurin inhibitors are preferred in stable vitiligo of the face, neck, genitals, or intertriginous regions as an alternative to topical corticosteroids. Topical bFGF is a relatively newer therapy with a promising role in stable vitiligo. bFGF is safe and effective in inducing repigmentation of vitiligo lesions. Combination therapy of bFGF with other topical therapies, phototherapy, and surgical procedures can be beneficial in patients of vitiligo. Conclusion: This consensus would complement the currently available literature on bFGF and help the practitioner to recognize the unmet need in the treatment of vitiligo.

Persistent Autonomic Engagement and Cardiac Control After Four or More Years of Autonomic Regulation Therapy Using Vagus Nerve Stimulation.

Introduction: Although heart failure (HF) outcomes have improved dramatically with the use of guideline directed medical therapy and implantable devices, the overall prognosis of patients with HF and reduced ejection fraction (HFrEF) remains poor. Autonomic Regulation Therapy (ART) using chronic vagus nerve stimulation (VNS) has been evaluated in the ANTHEM-HF study, using changes in heart rate (HR) dynamics as a biomarker of autonomic nervous system engagement and cardiac control to guide VNS titration. ART was associated with sustained improvement in cardiac function and HF symptoms in patients with HFrEF and persistent HF symptoms despite guideline-directed medical therapy (GDMT). We sought to determine whether the responsiveness of the autonomic nervous system to ART, as reflected in HR response to vagus stimulation during the VNS duty cycle, is maintained after long-term chronic VNS administration. Methods: Fifteen patients with HFrEF and implanted with a VNS systems in the ANTHEM-HF study were evaluated after 4.7 ± 0.3 years (range: 4.0-5.0 years) of chronic ART. ECG electrodes were placed on each patient's wrists, and ECG rhythm strips were recorded. Instantaneous HR time series was computed at each patient's chronically programmed VNS intensity and during progressively increasing VNS intensity. HR during active stimulation (on-time) was compared to HR just prior to initiation of each stimulation cycle (off-time). Results: Persistent autonomic engagement was observed in a majority of patients (11 of 15, 73%) after chronic ART for four or more years. The average magnitude of HR reduction during ART on-time in all patients was 2.4 ± 3.2 bpm at the chronically programmed VNS pulse parameter settings. Conclusion: Autonomic responsiveness to VNS persists in patients with HFrEF who received chronic ART for up to 5 years as a supplement to GDMT. This suggests that the effects of ART on autonomic engagement and cardiac control remain durable over time. Clinical Trial Registration: [ClinicalTrials.gov], identifier [#NCT01823887, CTRI registration #CTRI/2012/05/002681].

Enhanced external counterpulsation and CVD protection: 3D echo validation: a promising approach.

UNLABELLED: AIMS & OBJECTIVE: To evaluate the impact of enhanced external counterpulsation (EECP) on various echo variables by 3D-Echocardiography. MATERIALS AND METHODS: 60 adult patients from indoor and outdoor patient department; consisting of 16 patients with heart failure (HF) with left ventricular systolic dysfunction, 20 patients with heart failure with normal ejection fraction (HFNEF), 4 patients with prior percutaneous coronary intervention (PCI), 3 patients with prior coronary artery bypass grafting (CABG) and 17 patients with syndrome X; were subjected to Echocardiographic evaluation. The various echo variables included were left ventricular myocardial performance index (LVMPI), left ventricular mass index (LVMi), left ventricular diastolic dysfunction (LVDD), left ventricular systolic function (LVEF) and left atrial volume index (LAVi). Once randomized, patients underwent 35 hrs EECP treatment sessions, each lasting 1 hour, could be given once or twice per day. RESULTS: There was a significant reduction in the overall prolonged mean LVMPI from baseline (0.54 +/- 0.2) to post ECP treatment (0.43 +/- 0.1) in the total study population (p < 0.001). EECP treatment significantly reduced baseline grade II or grade III diastolic dysfunction and E/E' ratio > 12, but not in patients with baseline E/E' < 12, baseline normal diastolic function or grade I diastolic dysfunction. Similiarly the mean LVEF in the subset of patients with HF treatment was 30.7 +/- 3.1; post ECP the mean LVEF was increased to 36.9 +/- 3.2 which was statistically significant (p < 0.001). In the remaining patients, who had mean LVEF within normal range, there was no significant difference pre and post EECP (p value- NS). Pre EECP the mean LAVi in the total population was increased up to 33.4 +/- 5.6 ml/m2. Post EECP the mean LAVi reduced to 24.8 +/- 4.2 ml/m2, which was also statistically significant (p < 0.001). Regarding mean LVMi as well as in the patterns of LVH, there were no significant changes seen as compared to baseline. CONCLUSION: Enhanced External counterpulsation is noninvasive, non-surgical method of choice for CVD & heart failure protection. It is very useful in Single vessel or multivessel disease, heart failure, HFNEF, Post PCI or post CABG and syndrome X. It reduces LVMPI and improves global cardiac function, increases LVEF in patients with ejection fraction of less than 50%, reduces grade II or grade III diastolic dysfunction and E/E' ratio more than 12, decreases LAVi by 25.7%; thereby reducing adverse clinical events in CAD and heart failure.

Therapeutic responsiveness to vagus nerve stimulation in patients receiving beta-blockade for heart failure with reduced ejection fraction.

BACKGROUND: The effect of beta-blockade (BB) on response to vagus nerve stimulation (VNS) has not been reported in patients with heart failure and reduced ejection fraction (HFrEF). In the ANTHEM-HF Study, 60 patients received chronic cervical VNS. Background pharmacological therapy remained unchanged during the study, and VNS intensity was stable once up-titrated. Significant improvement from baseline occurred in resting 24-hour heart rate (HR), 24-hour HR variability (SDNN), left ventricular EF (LVEF), 6-minute walk distance (6MWD), and quality of life (MLWHFS) at 6 months post-titration. We evaluated whether response to VNS was related to percentage of target BB dose (PTBBD) at baseline. METHODS: Patients were categorized by baseline PTBBD, then analyzed for changes from baseline in symptoms and function at 6 months after VNS titration. RESULTS: All patients received BB, either PTBBD ≥ 50 % (16 patients, 27 %; group 1) or PTBBD < 50 % (44 patients, 73 %; group 2). Heart rate, systolic blood pressure, LVEF, use of ACE/ARB, and use of MRA were similar between the two groups at baseline. Six months after up-titration, VNS reduced HR and significantly improved SDNN, LVEF, 6MWD, and MLWHFS equally in both groups. CONCLUSIONS: In the ANTHEM-HF study, VNS responsiveness appeared to be independent of the baseline BB dose administered.

Long-term Follow-Up of Patients with Heart Failure and Reduced Ejection Fraction Receiving Autonomic Regulation Therapy in the ANTHEM-HF Pilot Study.

BACKGROUND: The ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months. METHODS: Continuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months. RESULTS: Between 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months. CONCLUSIONS: In a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.

Effect of ferric-carboxy maltose on oxygen kinetics and functional status in heart failure patients with iron deficiency.

There is a very high prevalence of iron deficiency anemia in patients with systolic heart failure. The present study is a prospective, parallel, 1:1 randomized controlled trial of intravenous ferric-carboxy maltose compared with standard of care in patients with heart failure. A total of 70 patients who presented to us with symptomatic chronic heart failure were included and randomly assigned to either groups (35 per group). Post 12 weeks, there were improvements noticed in peak VO2, New York Heart Association functional classification, 6-min walk test distance covered and reduction in Minnesota Living with Heart Failure Questionnaire score in the ferric-carboxy maltose as compared with standard of care group. However, no improvement in ejection fraction was noticed.

Baseline NT-proBNP and responsiveness to autonomic regulation therapy in patients with heart failure and reduced ejection fraction.

BACKGROUND: Recent heart failure studies have associated lower baseline natriuretic peptide levels with improved morbidity/mortality outcomes during pharmaceutical treatment, and better clinical outcomes during neuromodulation (NM) with carotid nerve plexus stimulation for HFrEF when NT-proBNP < 1600 pg/ml. Whether baseline NT-proBNP is associated with HFrEF responsiveness to NM using vagus nerve stimulation (VNS) has not been examined. Hence, we evaluated the interaction of baseline NT-proBNP with changes in symptoms and function that occurred during chronic VNS in the ANTHEM-HF study. METHODS: A repeated measures, generalized-estimating, equations model evaluated the relationship of baseline NT-proBNP values above and below 1600 pg/ml to symptomatic and functional responses in ANTHEM-HF. RESULTS: Median (interquartile range; maximum) NT-proBNP was 868 (322, 1875; 14,656) pg/ml (N = 58). Heart rate (HR), HR variability (SDNN), 6-minute walk distance, MLWHF mean score, and NYHA improved significantly, independent of baseline NT-proBNP. While there was a statistical interaction between baseline NT-proBNP and better LVEF improvement during VNS, LVEF improved overall in the study cohort (N = 60; 32 ± 7 to 37 ± 10%; p = 0.0042), and in those patients whose baseline NT-proBNP was below the median baseline NT-proBNP value (n = 29; 36 ± 6 to 42 ± 10%; p < 0.0025)] or above this value (n = 29; 29 ± 7 to 32 ± 9%; p < 0.05). CONCLUSIONS: In ANTHEM-HF, overall symptomatic and functional improvement during chronic VNS was independent of baseline NTproBNP. These are preliminary and hypothesis-generating findings, and the reason for a differing interaction between baseline NT-proBNP and response to CNPS and VNS remains unclear. It is anticipated that the ongoing ANTHEM-HFrEF Pivotal Study of VNS will provide additional insight.

Effects of increased dose of diuretics on symptoms, weight, 6-minute walk distance, and echocardiographic measurements of left ventricular systolic and diastolic function in 51 patients with symptomatic heart failure caused by reduced left ventricular ejection fraction treated with beta blockers and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.

We investigated in 51 consecutive outpatients with symptomatic congestive heart failure caused by abnormal left ventricular (LV) ejection fraction treated with furosemide or torsemide (10% also with metolazone), beta blockers, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, 55% with spironolactone, and 18% with digoxin, the effects of doubling the dose of furosemide, torsemide, and metolazone on symptoms, weight, 6-minute walk distance, and echocardiographic measurements of LV systolic and diastolic function at 24 ± 6 days follow-up. At follow-up, the weight decreased from 70 ± 6 kg to 65 ± 6 kg (P < 0.001), the New York Heart Association functional class decreased from 2.9 ± 0.4 to 2.1 ± 0.2 (P < 0.001), the Minnesota With Heart Failure Questionnaire score decreased from 43 ± 7 to 28 ± 8 (P < 0.001), the 6-minute walk distance increased from 270 ± 46 m to 318 ± 44 m (P < 0.001), and there was no significant change in LV ejection fraction, LV end-diastolic dimension, LV end-systolic dimension, left atrial dimension, pulmonary artery systolic pressure, peak mitral early/ atrial ratio, mitral deceleration time, and velocity time interval. In conclusion, doubling the dose of diuretics in outpatients with symptomatic congestive heart failure caused a significant loss of weight and a significant improvement in symptoms and 6-minute walk distance but did not change LV systolic and diastolic function.

Effect of enhanced external counterpulsation on clinical symptoms, quality of life, 6-minute walking distance, and echocardiographic measurements of left ventricular systolic and diastolic function after 35 days of treatment and at 1-year follow up in 47 patients with chronic refractory angina pectoris.

In a prospective study, enhanced external counterpulsation (EECP) was performed for 1 hour each day for 35 days in 47 patients, mean age 61 +/- 8 years, with prior coronary revascularization who had chronic refractory angina pectoris despite antianginal drugs and who were not candidates for further coronary revascularization. Compared with baseline values, EECP significantly improved anginal symptoms, dyspnea on exertion, and quality of life after 35 days of treatment (P < 0.001) and at 1-year follow up (P < 0.001). Compared with the baseline value of 653 +/- 249 feet, EECP significantly improved the 6-minute walking distance to 1025 +/- 234 feet after 35 days of treatment (P < 0.001) and to 1040 +/- 221 feet at 1-year follow up (P < 0.001). However, EECP did not significantly affect left ventricular ejection fraction, left ventricular end-diastolic and end-systolic dimensions, left ventricular end-diastolic and end-systolic volumes, E/A ratio, isovolumic relaxation time, and deceleration time measured by two2-dimensional and Doppler echocardiography.

3D echocardiography: "The most powerful predictor of masked CVD in metabolic syndrome".

UNLABELLED: AIMS & OBJECTIVE: To evaluate the impact of the Metabolic Syndrome (MetS) on various echo variables by 3D Echocardiography. MATERIALS AND METHODS: 100 patients of MetS from indoor and outdoor patient departments were subjected to Echocardiographic and Carotid Doppler evaluation. They were divided into three groups: Group A, Group B and Group C on the basis of age <40 yrs, 40-60 yrs and >60 yrs respectively. The echo variables included left ventricular myocardial performance index (LVMPI), left ventricular mass index (LVMi), left ventricular diastolic dysfunction (LVDD), systolic function (LVEF), left atrial volume index (LAVi) and composite common carotid intima media thickness (CCIMT). RESULTS: The mean LVMPI was abnormal in all the groups and showed an increasing trend with prolonged LVMPI (> 0.4) in 74% of the total population. Prolonged LVMPI in Group A, Group B and Group C were 12.1%, 52.7% and 35.1% respectively. There was also a strong correlation between LVMPI & LVDD (p-value < 0.0001). Only 9% had systolic dysfunction (LVEF < 50%), but 68% of patients had abnormal diastolic function, of which 53% had grade I LVDD, 12% had grade II LVDD and 3% had grade III diastolic dysfunction. None of our patients had grade IV diastolic dysfunction. The mean LA Vi was normal in all the groups, but LAVi increased with worsening LVDD. The mean LVMi indexed to Body Surface Area (BSA) was normal in all the groups, but showed a statistically significant increasing trend from Group A to Group C (p-value < 0.05). Statistically significant higher LVMi values were observed for males as compared to females (p-value < 0.0001). On analysis of patients having left ventricular hypertrophy (LVH), 76% had concentric remodeling; only 11 % had concentric hypertrophy, but none had eccentric hypertrophy. Most of our patients in Group B & Group C had higher mean Composite CCIMT (0.73 +/- 0.33 & 0.84 +/- 0.42 respectively) which was statistically very significant (p-value < 0.001) CONCLUSION: Metabolic Syndrome is associated with masked cardiovascular disease (CVD) as evident by 3D Echo in this series of patients. LVMPI was an early indicator and the most robust marker of early LVDD. Impaired relaxation was highly prevalent; while LAVi was less robust predictor of LVDD in this series of patients. Concentric left ventricular remodeling was the most common pattern of LVH. Most of our series of patients had increased Composite CCIMT. Thus 3D Echocardiography has great potential and is very useful for early detection and timely therapeutic interventions in patients with subclinical CVD in MetS.

Clinical profile and one-year survival of patients with heart failure with reduced ejection fraction: The largest report from India.

BACKGROUND: India has one of the largest population of heart failure (HF) patients in the world; yet only limited information is available about HF in India. METHODS: This observational study was performed at Medanta- The Medicity, a large, tertiary-care institute in the National Capital Region of India. Records of HF patients with reduced left ventricular ejection fraction (LVEF) registered at Medanta HF clinic during the period early 2014 to mid-2017 were reviewed. Disease characteristics and one-year mortality details were collected. RESULTS: Mean age of the subjects (n = 5590) was 59.1 ± 11.8 years with 83.0% males. Mean LVEF was 30.0 ± 6.6%. Coronary artery disease (CAD) was the dominant cause of HF, accounting for 77.8% of the total population. Most patients received guideline-directed medical therapy with a beta blocker being prescribed to 81.8% subjects. The one-year all-cause mortality was 17.6%. On multivariate analysis, age, usage of loop diuretics and ivabradine, and serum creatinine were independently associated with one-year mortality, whereas rheumatic etiology had an inverse association. CONCLUSIONS: This represents the largest single-center data of HF patients reported so far and the largest study describing clinical outcomes from HF patients in India. Our patients were younger, had high proportion of CAD, and there was higher usage of beta-blockers. Despite this, the one-year mortality was substantial. Given the enormous magnitude of HF burden in India and the paucity of information on this subject, these findings should be of help in identifying key problem areas and potential solutions for management of HF in India.

Background pharmacological therapy in the ANTHEM-HF: comparison to contemporary trials of novel heart failure therapies.

AIMS: Clinical trials of new heart failure (HF) therapies administer guideline-directed medical therapy (GDMT) as background pharmacologic treatment (BPT). In the ANTHEM-HF Pilot Study, addition of autonomic regulation therapy to GDMT significantly improved left ventricular function, New York Heart Association (NYHA) class, 6 min walk distance, and quality of life in patients with HF with reduced ejection fraction (HFrEF). A post hoc analysis was performed to compare BPT in ANTHEM-HF with two other trials of novel HF therapies: the PARADIGM-HF study of sacubitril-valsartan and the SHIFT study of ivadrabine. All three studies evaluated patients with HFrEF, and the recommendations for use of GDMT were similar. A left ventricular ejection fraction ≤40% was required for entry into ANTHEM-HF and PARADIGM-HF and ≤35% for SHIFT. NYHA 2 or 3 symptoms were required for entry into ANTHEM-HF, and patients with predominantly NYHA 2 or 3 symptoms were enrolled in PARADIGM-HF and SHIFT. METHODS AND RESULTS: Data on BPT were obtained from peer-reviewed publications and the public domain. Pearson's χ2 test was used to evaluate differences in proportions, and Student's unpaired t-test was used to evaluate differences in mean values. The minimum period of stable GDMT required before randomization was longer in ANTHEM-HF: 3 months vs. 1 month in PARADIGM-HF and SHIFT, respectively. When compared with PARADIGM-HF and SHIFT, more patients in ANTHEM-HF received beta-blockers (100% vs. 93% and 89%, P < 0.04 and P < 0.007) and mineralocorticoid receptor antagonists (75% vs. 55% and 61%, P < 0.002 and P < 0.03). More patients in PARADIGM-HF received an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker than in ANTHEM-HF or SHIFT (100% vs. 85%, P < 0.0001, and 100% vs. 91%, P < 0.001), which was related to PARADIGM's design. When beta-blocker doses in ANTHEM-HF and SHIFT were compared, significantly fewer patients in ANTHEM-HF received doses ≥100% of target (10% vs. 23%, P < 0.02), and fewer patients tended to receive doses ≥50% of target (17% vs. 26%, P = 0.11). When ANTHEM-HF and PARADIGM-HF were compared, more patients in ANTHEM-HF tended to receive doses ≥100% of target (10% vs. 7%, P = 0.36), and fewer patients tended to receive doses ≥50% of target (17% vs. 20%, P = 0.56). CONCLUSIONS: Background treatment with GDMT in ANTHEM-HF compared favourably with that in two other contemporary trials of new HF therapies. The minimum period of stable GDMT required before randomization was longer, and GDMT remained unchanged for the study's duration. These findings serve to further support the potential role of autonomic regulation therapy as an adjunct to GDMT for patients with HFrEF.