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.

Clinical evaluation of the Hydra self-expanding transcatheter aortic valve: 6 month results from the GENESIS trial.

OBJECTIVES: To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self-expanding system with supra-annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm. METHODS: The GENESIS trial was a prospective, multi-center, single-arm, 6 month follow-up study conducted in India. The primary performance endpoint was device success defined as per VARC-II criteria at 30 days. The primary safety endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: Forty high-risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p < .0001). Mean aortic valve gradient decreased from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < .0001). The rate of new permanent pacemaker implantation was 7.5% at 30 days, and no patient had more than mild paravalvular leak at 6 months. The 30 days and 6 month all-cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device-related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6 months. CONCLUSIONS: The GENESIS trial demonstrated high efficacy of the self-expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.

Clinical characteristics and outcomes after unplanned intraaortic balloon counterpulsation in the Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction trial.

BACKGROUND: Despite advances in primary percutaneous coronary intervention (pPCI) and regional systems of care, the development of cardiogenic shock is associated with poor clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). We sought to better characterize the baseline characteristics and clinical outcomes of patients who underwent crossover to intraaortic balloon counterpulsation (IABC) in the CRISP AMI trial. METHODS: Patients with anterior STEMI were randomized to IABC before pPCI or pPCI alone. Infarct size and 6-month clinical outcomes were evaluated in patients both in the pPCI-alone group who did undergo crossover to IABC and those who did not undergo crossover to IABC. RESULTS: Among 176 patients randomized to pPCI alone, 161 patients did not later receive IABC during the index hospitalization, and 15 patients (8.5%) underwent crossover and did receive unplanned IABC. Hypotension and/or cardiogenic shock precipitated crossover to IABC in 12 patients (80%). Patients who underwent crossover to IABC demonstrated lower systolic and diastolic blood pressures on admission. At 6 months, rates of death (26.7% vs 3.1%, P = .003), readmission for severe hypotension (53.3% vs 3.7%, P < .001), resuscitated cardiac arrest, and ventricular arrhythmia were higher in the group that did crossover to IABC. Crossover to IABC was not associated with increased infarct size. CONCLUSIONS: The most significant predictor of crossover to IABC in the setting of anterior STEMI was relative hypotension at the time of hospital admission, and crossover to IABC in CRISP AMI was associated with significantly worse clinical outcomes.

Nerve sparing clitoroplasty in a rare case of idiopathic clitoromegaly.

Clitoromegaly is an embarrassing condition causing psychological stress, requiring intervention. The goals of clitoroplasty are to achieve normal genital anatomy and to preserve tactile sensation with a satisfactory sexual response. We present a rare case of idiopathic clitoromegaly managed by reduction clitoroplasty, preserving the dorsal neurovascular bundle and extensive network of nerves around the corpora to the glans and the creation of labia minora.

Providing care for children with severe acute malnutrition in India: new evidence from Jharkhand.

OBJECTIVE: To assess the effectiveness of facility-based care for children with severe acute malnutrition (SAM) in malnutrition treatment centres (MTC). DESIGN: Early detection and treatment of SAM using locally adapted protocols; assessment of programme outcomes, including survival, default, discharge and recovery rates. SETTING: All forty-eight MTC in Jharkhand, India. SUBJECTS: Children (n 3595) with SAM admitted to MTC (1 July 2009-30 June 2011). RESULTS: Of children admitted, 55·0% were girls, 77·7% were 6-23 months old and 68·6% belonged to scheduled tribes or castes; 34·4% had oedema or medical complications. Of the 3418 programme exits, the proportion of children who died was 0·6% (n 20), the proportion of children who defaulted was 18·4% (n 628) and the proportion of children discharged was 81·0% (n 2770). Children's average weight gain was 9·6 (sd 8·4) g/kg body weight per d and their average length of stay was 16·0 (sd 5·7) d. Among the 2770 children who were discharged from the programme, 39·4% (n 1090) gained 15 % or more of their initial weight while 60·6% (n 1680) gained less than 15 % of their initial weight. CONCLUSIONS: MTC provide live-saving care for children with SAM as demonstrated by high survival rates. However, the protocols and therapeutic foods currently used need to improve to ensure the recovery of all discharged children. MTC should be reserved for children with complicated SAM; children with uncomplicated SAM should be admitted to a community-based programme for the management of SAM, at a lesser risk to children and a lesser cost to families and the health system.

Clinical and Demographic Characteristics of Patients with Coexistent Hypertension, Type 2 Diabetes Mellitus, and Dyslipidemia: A Retrospective Study from India.

BACKGROUND: Coexisting hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia (triple disease) can lead to greater risk of cardiovascular morbidity and mortality. The present study sought to comprehend the prevalence, demographic traits, clinical traits, and treatment patterns in Indian patients with these coexisting conditions. METHODS: An electronic medical record (EMR)-based, retrospective, multicenter, cross-sectional study was conducted, and data were collected for patients who were diagnosed with coexistent hypertension, T2DM, and dyslipidemia. Baseline patient variables evaluated were the percentage of patients with triple comorbidity, demographic characteristics, diagnostic laboratory parameters, and treatment pattern details. RESULTS: Data from 4793 centers (clinics) were included, with a total of 6,722,173 patients. Of these, 427,835 (6.36%) patients were found to have coexistent hypertension, T2DM, and dyslipidemia. Most of the patients belonged to the 40-64 year age group (62.10%) and were males (57.00%), while 27.40% patients had a body mass index (BMI) within normal limits, 43.30% patients were pre-obese, and 20.90% patients were class 1 obese. Further, 3402 patients (0.80%) had a recorded history of smoking. Mean glycated hemoglobin (HbA1c) for the patients included in the study was 8.35 ± 1.96 g%. Mean systolic blood pressure (SBP) was 138.81 ± 19.59 mm Hg, while mean diastolic blood pressure (DBP) was 82.17 ± 10.35 mm Hg; 27.60% cases had SBP < 130 mm Hg, while 28.37% cases had DBP < 80 mm Hg. The mean low-density lipoprotein (LDL), total cholesterol, and high-density lipoprotein (HDL) in mg/dl were 98.38 ± 40.39, 174.75 ± 46.73, and 44.5 ± 10.05, respectively. Of the enrolled cases, 55.64% had serum LDL below 100 mg/dl, 72.03% cases had serum cholesterol below 200 mg/dl, and 44.15% males and 71.77% females had serum HDL below the normal prescribed range. The most common monotherapy used for managing hypertension was angiotensin receptor blockers (ARB) (24.80%), followed by beta-blockers (24.30%). The most common combinations administered for management of hypertension were antihypertensives with diuretics (14.30%), followed by ARB plus calcium channel blockers (CCB) (13.30%). For dyslipidemia, the majority of patients (56.60%) received lipid-lowering medication in combination with drugs for other comorbidities. The most common antidiabetic agents prescribed were biguanides (74.60%). CONCLUSIONS: Coexistence of triple disease is not uncommon in the Indian population, with middle-aged patients diagnosed as pre-obese and obese being affected more commonly and receiving treatment for the same. The present study highlights that, though there are medications against the three chronic conditions, the rate of uncontrolled cases of hypertension, T2DM, and dyslipidemia remains high. Coexistence of triple disease increases the risk of cardiovascular and renal complications, which need to be closely monitored and effectively treated.

Safety and effectiveness of the novel Myval Octacor transcatheter heart valve in severe, symptomatic aortic valve stenosis - A real-world Indian experience (The OCTACOR India Study).

PURPOSE: To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor - Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). METHODS: This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. RESULTS: Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). CONCLUSIONS: Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS.

Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial.

OBJECTIVE: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) for the treatment of de novo calcified coronary lesions. BACKGROUND: Severely calcified coronary arteries pose an ongoing treatment challenge. Stent placement in calcified lesions can result in stent under expansion, malapposition, and procedural complications. OAS treatment may change calcified lesion compliance to reduce procedural complications and facilitate stent placement. METHODS: The ORBIT I trial, a prospective, nonrandomized study, was conducted in two centers in India. Fifty patients with de novo calcified coronary lesions were enrolled. Patients were treated with the OAS followed by stent placement. RESULTS: The average age of the patients was 57.4 years and 90% were male. Mean lesion length was 13.4 mm. The average number of OAS devices used per patient was 1.3. Device success was 98%, and procedural success was 94%. The cumulative major adverse cardiac event rate was 4% in-hospital (two non-Q-wave myocardial infarctions), 6% at 30 days (one additional non-Q-wave myocardial infarction leading to target lesion revascularization), and 8% at 6 months (one additional event of cardiac death). Angiographic complications were observed in seven patients (six dissections and one perforation). CONCLUSION: The ORBIT I trial suggests that the OAS may offer an effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult to treat patients. A larger trial is required to establish safety and overall effectiveness of the OAS in treating calcified coronary lesions.

Simultaneous transcatheter dual valve replacement (mitral and tricuspid valves): a case report.

Background: Structural valve dysfunction in bioprosthetic heart valves necessitates redo replacement procedure that are associated with high mortality and morbidity. The transcatheter valve-in-valve (VIV) approach has emerged as a preferred option for patients requiring redo procedures due to structural valve degeneration. We report from India the first case of the simultaneous transcatheter dual VIV implantation (mitral valve and tricuspid valves) in a high-surgical-risk patient. Case summary: A 57-year-old female was presented with a history of rheumatic heart disease, post-mitral valve as well as tricuspid valve replacement (perimount 33 mm) 11 years back. Bioprosthetic heart valve was chosen probably due to limited life expectancy and compliance issues with monitoring of international normalised ratio (INR). She now presented with progressive dyspnoea, oedema, and palpitations (New York Heart Association Class III) for the last 6 months. The patient was scheduled for transcatheter dual valve replacement simultaneously. The procedure was successful with a favourable outcome, short hospital stays, and early recovery. Discussion: This is the first case of simultaneous transcatheter dual valve replacement reported from India, which is fluoroscopically guided and supported by TEE. It is a valuable and considerable option for patients with failing bioprosthesis valves who are at increased peri-operative risk.

Practical Recommendations for the Use of Angiotensin Receptor-Neprilysin Inhibitors (ARNI) in Heart Failure: Insights from Indian Cardiologists.

Heart failure is a significant public health concern characterized by notable rates of morbidity and mortality. Despite the presence of guideline-directed medical therapy (GDMT), its utilization remains inadequate. This practical recommendation paper focuses on the utilization of angiotensin receptor-neprilysin inhibitor (ARNI) as a pivotal treatment for heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF), and heart failure with improved ejection fraction (HFimpEF). The recommendations presented in this paper have been developed by a group of cardiologists in India who convened six advisory board meetings to discuss the utilization of ARNI in the management of heart failure. The paper emphasizes the importance of accurate biomarkers for diagnosing heart failure, particularly N-terminal pro-B-type natriuretic peptide (NT-proBNP) and B-type natriuretic peptide (BNP), which are commonly used. Additionally, the paper advocates the use of imaging, specifically echocardiography, in diagnosing and monitoring heart failure patients. Moreover, the paper highlights the role of ARNI in heart failure management, with numerous clinical trials that have demonstrated its effectiveness in reducing cardiovascular death or heart failure hospitalization, enhancing quality of life, and diminishing the risk of ventricular arrhythmias. This practical recommendation paper offers valuable insights into the utilization of ARNI in the management of heart failure, aiming to enhance the implementation of GDMT and ultimately alleviate the burden of heart failure on society.

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry.

BACKGROUND: Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. METHODS: This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm2 MSA for non-left main and 3.5 mm2 for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. RESULTS: Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm2) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm2). The average MSA (with expansion ≥80% cutoff) was 6.63 mm2 and 4.74 mm2 with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm2 and 3.95 mm2, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. CONCLUSION: PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication.

BACKGROUND: The balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. OBJECTIVES: The focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. METHODOLOGY: We report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). RESULTS: Final aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. CONCLUSION: The initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities.

A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients.

INTRODUCTION: Despite considerable benefits associated with current drug-eluting stents, continued attention to the safety, efficacy, and deliverability of available drug-eluting stent has led to the development of newer stent. METHODS: This study was a single-centre, prospective, non-randomized, first-in-man study which included clinical follow-up data was collected at 1, 8 and 12 months after the procedure. The study included 105 patients with de novo native coronary artery lesions including multi-vessel disease treated with Supralimus-Core® stent. Repeat angiography was performed 8 months post-stent implantation. RESULTS: At quantitative coronary angiography 8-month luminal late loss was 0.39 ± 0.33 mm in-stent and 0.33 ± 0.35 mm in-segment. The incidence of any major adverse cardiac event at 30 days, 8 months and 12 months was 1 (1%), 6 (6%) and 7 (7%) respectively. CONCLUSION: This study demonstrates that the Supralimus-Core® SES is a safe and effective treatment for patients with obstructive coronary artery disease. ClinicalTrials.gov ID: NCT00811616.

Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions.

BACKGROUND: Non stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. METHODS: This was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. RESULTS: A total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. CONCLUSION: The novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.