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.

The Promise of Cilnidipine in Hypertension with Comorbidities: National Consensus Statement: National Consensus Group Comprises Cardiologists, Nephrologists, and Diabetologists from India in a National Meet at New Delhi held on 22nd May 2022.

The rapidly increasing burden of hypertension is responsible for premature deaths from cardiovascular disease (CVD), renal disease, and stroke, with a tremendous public health and financial burden. Hypertension detection, treatment, and control vary worldwide; it is still low, particularly in low- and middle-income countries (LMICs). High blood pressure (BP) and CVD risk have a strong, linear, and independent association. They contribute to alarming numbers of all-cause and CVD deaths. A major culprit for increased hypertension is sympathetic activity, and further complications of hypertension are heart failure, ischemic heart disease (IHD), stroke, and renal failure. Now, antihypertensive interventions have emerged as a global public health priority to reduce BP-related morbidity and mortality. Calcium channel blockers (CCB) are highly effective vasodilators. and the most common drugs used for managing hypertension and CVD. Cilnidipine, with both L- and N-type calcium channel blocking activity, is a promising 4th generation CCB. It causes vasodilation via L-type calcium channel blockade and inhibits the sympathetic nervous system (SNS) via N-type calcium channel blockade. Cilnidipine, which acts as a dual L/N-type CCB, is linked to a reduced occurrence of pedal edema compared to amlodipine, which solely blocks L-type calcium channels. The antihypertensive properties of cilnidipine are very substantial, with low BP variability and long-acting properties. It is beneficial for hypertensive patients to deal with morning hypertension and for patients with abnormal nocturnal BP due to exaggerated sympathetic nerve activation. Besides its BP-lowering effect, it also exhibits organ protection via sympathetic nerve inhibition and renin-angiotensin-aldosterone system inhibition; it controls heart rate and proteinuria. Reno-protective, neuroprotective, and cardioprotective effects of cilnidipine have been well-documented and demonstrated.

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.

Role of Iron Therapy in Heart Failure: A Consensus Statement from India.

Iron deficiency (ID) with or without anemia is frequently observed in patients with heart failure (HF). Uncorrected ID is associated with higher hospitalization and mortality in patients with acute HF (AHF) and chronic HF (CHF). Hence, in addition to chronic renal insufficiency, anemia, and diabetes, ID appears as a novel comorbidity and a treatment target of CHF. Intravenous (IV) ferric carboxymaltose (FCM) reduces the hospitalization risk due to HF worsening and improves functional capacity and quality of life (QOL) in HF patients. The current consensus document provides criteria, an expert opinion on the diagnosis of ID in HF, patient profiles for IV FCM, and correct administration and monitoring of such patients.

Angiotensin Receptor-Neprilysin Inhibitor Therapy and Cardiac Remodeling in Heart Failure: Consensus Statement from India.

Adverse cardiac remodeling refers to progressive structural and functional modifications in the heart because of increased wall stress in the myocardium, loss of viable myocardium, and neurohormonal stimulation. The guideline-directed medical therapy for Heart failure (HF) includes Angiotensin receptor-neprilysin inhibitor (ARNI) (sacubitril/valsartan), ß-blockers, sodium-glucose co-transporter 2 (SGLT2) inhibitors, and mineralocorticoid receptor antagonists (MRA). ARNI is under-prescribed in India despite its attractive safety and efficacy profile. Therefore, the consensus discusses objectives and topics related to ARNI in the management of cardiac remodeling, and experts shared their views on the early timely intervention of effective dosage of ARNI to improve the diagnosis and enhance mortality and morbidity benefits in cardiac reverse remodeling (CRR).

The Power and Promise of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Heart Failure Management: National Consensus Statement.

;Heart failure (HF) is a huge global public health task due to morbidity, mortality, disturbed quality of life, and major economic burden. It is an area of active research and newer treatment strategies are evolving. Recently angiotensin receptor-neprilysin inhibitor (ARNI), a class of drugs (the first agent in this class, Sacubitril-Valsartan), reduces cardiovascular mortality and morbidity in chronic HF patients with reduced left ventricular ejection fraction (LVEF). Positive therapeutic effects have led to a decrease in cardiovascular mortality and HF hospitalizations (HFH), with a favorable safety profile, and have been documented in several clinical studies with an unquestionable survival benefit with ARNI, Sacubitril-Valsartan. This consensus statement of the Indian group of experts in cardiology, nephrology, and diabetes provides a comprehensive review of the power and promise of ARNI in HF management and an evidence-based appraisal of the use of ARNI as an essential treatment strategy for HF patients in clinical practice. Consensus in this review favors an early utility of Sacubitril-Valsartan in patients with HF with reduced EF (HFrEF), regardless of the previous therapy being given. A lower rate of hospitalizations for HF with Sacubitril-Valsartan in HF patients with preserved EF who are phenotypically heterogeneous suggests possible benefits of ARNI in patients having 40-50% of LVEF, frequent subtle systolic dysfunction, and higher hospitalization risk.

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.

BioResorbable scaffolds: Out of sight but not out of mind.

The article highlights the results of a new novel BioResorbable Scaffold in "real world" practice Based on this, further design iterations could be reviewed for next generation BRS Larger and longer-term trials would be needed to define the safety and effectiveness of new BRS in daily clinical practice.

Protein-C deficiency presenting as pulmonary embolism and myocardial infarction in the same patient.

Plasma protein-C exerts anticoagulatory effects by inactivating factors V and VIII. Hereditary protein C deficiency is transmitted as an autosomal dominant disorder. Homozygous individuals usually develop purpura fulminans as newborns; heterozygous protein C-deficient individuals are at increased risk for venous thrombosis and pulmonary embolism. However, arterial thrombosis occurring as a result of congenital protein-C deficiency is still controversial. We describe a young patient with heterozygous protein-C deficiency who experienced both pulmonary embolism as well as myocardial infarction due to thrombotic occlusion without underlying major risk factors. Acute myocardial infarction in young without underlying major risk factors may be evaluated for protein c deficiency.

Transcatheter aortic valve implantation with Core Valve: first Indian experience of three high surgical risk patients with severe aortic stenosis.

The prevalence of aortic stenosis is increasing with aging population. However with multiple co-morbidities and prior procedures in this aging population, more and more patients are being declared unfit for the 'Gold Standard' treatment i.e. surgical aortic valve replacement (AVR). Among the patients who are unfit or high risk for aortic valve replacement (AVR) by open heart surgery, transcatheter aortic valve implantation (TAVI) has been proven to be a valuable alternative improving survival and quality of life. We report first Indian experience of Core Valve (Medtronic Inc.) implantation in three high surgical risk patients performed on 22nd and 23rd February 2012.

Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.

Transcatheter aortic valve implantation (TAVI) performed using femoral arterial access is now a guideline recommended treatment for severe calcific aortic stenosis (AS) in elderly patients. Technological advancements and procedural refinements have focused on making TAVI simpler, safer, more effective and durable. Myval (Meril Lifesciences) is a new generation balloon-expandable transcatheter heart valve (THV) developed in India that possesses novel features to improve deliverability and aid precise deployment. Following the first-in-human study, Myval was approved in India for commercial implantation in October 2018 and was subsequently given a CE mark in April 2019. This article reviews the science, technology and up-to-date clinical evidence for the Myval THV.

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis - 2 Years Follow up Experience From India.

Background: Transcatheter aortic valve implantation (TAVI) is challenging in bicuspid aortic valve (BAV) anatomy. The patients are young, morphological phenotypes are many, calcium burden is high and there are technical challenges for best outcomes. Observational studies and registries are available with favorable data and experiences from around the world sharing methodologies and algorithms for sizing and implantation. We, therefore, analysed our data of procedural and in-hospital outcomes of TAVI in Bicuspid Aortic Valve cases performed at two high volume centres in India and their follow up for two years. Methods and Results: The data were collated and analysed from two centres (Fortis Escorts Heart Institute, New Delhi and Apollo Hospitals, Chennai) in India for patients who underwent TAVI in a BAV anatomy. It included a total of 70 cases from 2 centres. All symptomatic severe AS patients more than and equal to 65 years having bicuspid anatomy were included in the study irrespective of their STS score. Patients under 65 years of age were advised TAVI only if they were at high risk for open heart surgery. These patients were followed for a period of 2 years and the data were analysed. Pre TAVI imaging tools utilised were 2D echo, transthoracic echocardiography (TTE), trans oesophageal echocardiography (TEE), and ECG gated multi slice CT (MSCT) scan imaging. MSCT was utilised for confirmation of the anatomy and classifying the morphological type of valve, measuring, and evaluating all anatomic determinants of aortic root complex for planning the procedure and choice of the valve and its size. Sizing in balloon expanding valve (BEV) and self-expanding valve sizing (SEV) were based primarily on annulus area and perimeter, respectively. The SEV used in our study were the Core Valve and Evolut R (Medtronic, United States) and the BEVs included Sapien3 (Edwards Lifesciences, United States) and Myval (Meril Lifesciences, India). The BAV cohort constituted 24.4% of the total 287 TAVI cases, followed up for 2 years. The mean age of these patients was 72 years. The incidence of male patients was 68.57% and female patients was 31.4%. The Sievers type 1 included 78.5%, type 0 were 21.4% of the cases and there was no case of type 2 in the study. The procedural success was to the tune of 98%. Patients with normal left ventricular ejection fraction (LVEF) improved their symptoms class after TAVI and remained so at 2 years follow up. The poor LVEF subset of patients did not have heart failure admissions and also had improvement in their symptom status. The peak-to-peak aortic valve gradient decreased to 0 mmHg at the end of the procedure in most of the cases. The mean pressure gradient (PG) across the new valve ranged between 0 and 15 mmHg and the aortic valve area (AVA) was close to 2 cm2. These numbers were consistent at 2 years follow up. Significant paravalvular leak (PVL) 24.28% was seen immediately after deployment of the valve in heavily calcified anatomy but it reduced to mild or trivial PVL after post-dilation and one patient needed a second valve to treat PVL. No patient had more than mild PVL with either type of valve at the end of the procedure. Permanent pacemaker implantation (PPI) was required in 11.4% of the patients within 24 h to 7 days of the procedure. No one needed a PPI in the 2 year follow up. Coronary occlusion did not happen to any patient. No patient had a disabling stroke. Non-disabling stroke was seen in 10% of cases and mostly in the first week or 30 days of the procedure and the incidence was more with BEV (14%) as compared to SEV (8%). There was one case of valve embolisation after 24 h of the procedure, which needed a surgical valve replacement. There was no case of annular injury or injury to other parts of the aortic root complex. Two cases had access vessel (femoral artery) thrombosis at end of the procedure and a third patient had proglide related residual stenosis. Two cases had acute kidney injury and needed dialysis. There was no major bleeding complication in any patient. Peri procedural mortality occurred in two patients. Valve thrombosis was seen in one patient after 3 months, which was treated with oral anticoagulation. Valve degeneration and failure or infective endocarditis were not seen in any patient. Conclusion: The patients with BAV stenosis who underwent TAVI in this study had good procedural success rates and clinical outcomes. The haemodynamics achieved with both SEV and BEV were good at 2 years. The rates of PVL, PPI, and stroke are similar to that of many other studies and registries. PPI rate and non-disabling stroke incidence appear to be higher similar to many studies done. There was no case of coronary occlusion in the study. Meticulous CT analysis of the aortic root complex, selection of appropriate type and size of the valve, and best implantation practices along with cerebral protection will probably be the key to safer and more successful TAVI in this population.

Clinical expert consensus document on the use of percutaneous left ventricular assist devices during complex high-risk PCI in India using a standardised algorithm.

Over the past decade, percutaneous left ventricular assist devices (pLVAD), such as the Impella microaxial flow pump (Abiomed), have been increasingly used to provide haemodynamic support during complex and high-risk revascularisation procedures to reduce the risk of intraprocedural haemodynamic compromise and to facilitate complete and optimal revascularisation. A global consensus on patient selection for the use of pLVADs, however, is currently lacking. Access to these devices is different across the world, thus, individual health care environments need to create and refine patient selection paradigms to optimise the use of these devices. The Impella pLVAD has recently been introduced in India and is being used in several centres in the management of high-risk percutaneous coronary intervention (PCI) and cardiogenic shock. With this increasing utilisation, there is a need for a standardised evaluation protocol to guide Impella use that factors in the unique economic and infrastructural characteristics of India's health care system to ensure that the needs of patients are optimally managed. In this consensus document, we present an algorithm to guide Impella use in Indian patients: to establish a standardised patient selection and usage paradigm that will allow both optimal patient outcomes and ongoing data collection.

Advanced heart failure beckons: where are the cardiologists?

Advanced Heart Failure is one of the leading causes of death and hospitalization worldwide. Its incidence is increasing steadily in India as well. Despite a huge need, not many cardiologists take heart failure as a career option. The present article seeks to explore the potential reasons for this lack of interest among cardiologists of the country. It also briefly attempts to suggest remedial actions.

Long-term follow-up of BVS from a prospective multicenter registry: Impact of a dedicated implantation technique on clinical outcomes.

OBJECTIVES: The aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. BACKGROUND: Bioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. METHODS: 573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. RESULTS: The registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ±â€¯27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ±â€¯3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802-1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. CONCLUSIONS: These long-term results from a complex "real-world" population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique.

Isolated thrombus producing tricuspid stenosis: an unusual presentation in primary antiphospholipid syndrome.

We report the case of a female patient who presented with signs and symptoms of tricuspid stenosis. Echocardiography revealed a sessile mass on the tricuspid valve. A diagnosis of primary cardiac tumor was made but histopathologic examination revealed the mass to be an organized thrombus. Subsequent serological tests showed elevated titers of anticardiolipin antibodies in the absence of any associated disease. This case highlights an unusual presentation of the primary antiphospholipid syndrome.

Transcatheter aortic valve implantation under conscious sedation - the first Indian experience.

Transcatheter aortic valve implantation (TAVI) is maturing strongly as an alternative to surgical aortic valve replacement (SAVR) in patients who are inoperable/high risk for open heart surgery. General anesthesia (GA) is the usual mode of anesthesia in these patients, but local anesthesia with conscious sedation (LACS) has recently been described as a safe alternative with some added advantages. We report 2 cases who were unfit for GA and were done successfully under LACS.

Heart failure: preventing disease and death worldwide.

Heart failure is a life-threatening disease and addressing it should be considered a global health priority. At present, approximately 26 million people worldwide are living with heart failure. The outlook for such patients is poor, with survival rates worse than those for bowel, breast or prostate cancer. Furthermore, heart failure places great stresses on patients, caregivers and healthcare systems. Demands on healthcare services, in particular, are predicted to increase dramatically over the next decade as patient numbers rise owing to ageing populations, detrimental lifestyle changes and improved survival of those who go on to develop heart failure as the final stage of another disease. It is time to ease the strain on healthcare systems through clear policy initiatives that prioritize heart failure prevention and champion equity of care for all. Despite the burdens that heart failure imposes on society, awareness of the disease is poor. As a result, many premature deaths occur. This is in spite of the fact that most types of heart failure are preventable and that a healthy lifestyle can reduce risk. Even after heart failure has developed, premature deaths could be prevented if people were taught to recognize the symptoms and seek immediate medical attention. Public awareness campaigns focusing on these messages have great potential to improve outcomes for patients with heart failure and ultimately to save lives. Compliance with clinical practice guidelines is also associated with improved outcomes for patients with heart failure. However, in many countries, there is considerable variation in how closely physicians follow guideline recommendations. To promote equity of care, improvements should be encouraged through the use of hospital performance measures and incentives appropriate to the locality. To this end, policies should promote the research required to establish an evidence base for performance measures that reflect improved outcomes for patients. Continuing research is essential if we are to address unmet needs in caring for patients with heart failure. New therapies are required for patients with types of heart failure for which current treatments relieve symptoms but do not address the disease. More affordable therapies are desperately needed in the economically developing world. International collaborative research focusing on the causes and treatment of heart failure worldwide has the potential to benefit tens of millions of people. Change at the policy level has the power to drive improvements in prevention and care that will save lives. It is time to make a difference across the globe by confronting the problem of heart failure. A CALL TO ACTION: POLICY RECOMMENDATIONS: We urge policymakers at local, national and international levels to collaborate and act on the following recommendations. PROMOTE HEART FAILURE PREVENTION: Support the development and implementation of public awareness programmes about heart failure. These should define heart failure in simple and accessible language, explain how to recognize the symptoms and emphasize that most types of heart failure are preventable.Highlight the need for healthcare professionals across all clinical disciplines to identify patients with illnesses that increase the risk of heart failure and to prescribe preventive medications.Prioritize the elimination of infectious diseases in parts of the world where they still cause heart failure. IMPROVE HEART FAILURE AWARENESS AMONGST HEALTHCARE PROFESSIONALS: Encourage the development and use of heart failure education programmes for all appropriate healthcare professionals. These should aim to improve the prevention, diagnosis, treatment and long-term management of heart failure and raise awareness of clinical practice guidelines. ENSURE EQUITY OF CARE FOR ALL PATIENTS WITH HEART FAILURE: Provide a healthcare system that delivers timely access to diagnostic services and treatment of heart failure, as well as a seamless transition to long-term management.Ensure that the best available and most appropriate care is consistently provided to all patients with heart failure through efficient use of resources. SUPPORT AND EMPOWER PATIENTS AND THEIR CAREGIVERS: Provide resources for the education and practical support of patients with heart failure and their families or other caregivers, empowering them to engage proactively in long-term care. PROMOTE HEART FAILURE RESEARCH: Fund and encourage international collaborative research to improve understanding of the patterns, causes and effects of modern day heart failure and how the disease can be prevented across the globe.Fund and encourage research into new and more affordable therapies and medical devices for all types of heart failure.Fund and encourage research into evidence-based healthcare performance measures that reflect improved clinical outcomes for patients with heart failure.