Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve.

AIM: Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Sciences, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. METHODS: Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. RESULTS: Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. CONCLUSION: TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

Continuing Burden of Rheumatic Heart Disease in India.

Rheumatic heart disease (RHD) disables millions in Asia and Africa. Epidemiological data and clinical studies in India have reported a significant decline in its prevalence in last century. Global Burden of Disease (GBD) study estimated that RHD in India led to 395/100000 disability adjusted life years (DALYs) and 9.2/100000 deaths in 1990. This declined to 270/100000 and 7.9/100000, respectively, in 2017. School-based epidemiological studies in India have reported decline in clinically diagnosed RHD. On the other hand, GBD study has reported that in terms of absolute numbers, India contributes to one-third of global RHD burden. RHD in 1990 led to 3.44 million DALYs and 80,470 deaths which has increased to 3.73 million DALYs and 108,460 deaths in 2017. India Disease Burden Initiative has reported high RHD burden in many less developed states of the country, e.g., Bihar, Odisha, Assam, Chhattisgarh, Uttar Pradesh, etc. Echocardiographic epidemiology studies have reported high burden of subclinical RHD. Significant proportions of patients in hospital-based echocardiographic clinics have RHD and it contributes to 25-45% of cardiac surgeries in government hospitals. The continuing burden of RHD needs proper public health and clinical response.

No reflow leading to catastrophic hemodynamic collapse in a patient with severe aortic stenosis and its management.

We report a case of an 87-year-old female who underwent percutaneous coronary intervention (PCI) for non-ST elevation myocardial infarction while she was being worked up for transcatheter aortic valve procedure. Hemodynamic compromise occurred during the PCI, which could only be mitigated by doing a balloon aortic valvuloplasty and Impella™ insertion. This case report will help in preparedness for any untoward events in patients with aortic stenosis and undergoing percutaneous coronary intervention.

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.

Concomitant transcatheter transfemoral double native valve replacement for severe aortic stenosis and severe mitral stenosis with mitral annular calcification.

Concomitant mitral and aortic valve stenosis in a patient with mitral annular calcification and porcelain aorta poses a unique problem to the surgical team. Transcatheter aortic and mitral valve replacements in native valves offer a viable option for such selected group of patients. We present the case of a 54-year-old male who presented with severe aortic stenosis (AS) and severe mitral stenosis (MS) but was deemed high risk for surgery owing to intense calcification of the aorta and mitral annular calcification, and successfully underwent transcatheter double native valve replacement.

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.

Sildenafil improves six-minute walk distance in chronic obstructive pulmonary disease: a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Sildenafil has been found to improve exercise capacity and haemodynamic parameters in patients with various pulmonary disorders. This study was undertaken to evaluate its efficacy in severe chronic obstructive pulmonary disease (COPD). METHODS: In this double-blind, randomised, placebo-controlled study, 37 patients with severe COPD received either sildenafil or placebo for 12 weeks. Distance covered in six-minute walk test (6MWD) was taken as primary end-point. Pulmonary artery pressure (PAP) was measured as secondary end point. RESULTS: Thirty-three patients (15 in sildenafil arm and 18 in placebo arm) completed the study. Non-parametric tests were used for comparison. There was significant increase in 6MWD from baseline after three months of follow-up in sildenafil users (median change in distance covered in six-minute walk test (delta6MWD) = 190m) as compared to placebo users (delta6MWD = 0m, p < 0.05). The PAP decreased significantly (chi2 = 14.94, p < 0.05) in sildenafil group after three months, while it did not change significantly among placebo group (chi2 = 3.84, p > 0.05). CONCLUSION: Sildenafil improved 6MWD and PAP in patients with severe COPD.

Percutaneous closure of native anterior mitral leaflet perforation under three-dimensional transesophageal echocardiography guidance.

We are presenting a unique case of native anterior mitral leaflet (AML) perforation with severe mitral regurgitation leading to progressive dyspnea. Using real time three-dimensional transesophageal echocardiography, this case was accurately diagnosed and percutaneous closure has been done successfully with the device. Review of the literature showed successful transcatheter closure of AML perforation of only four cases, all post-operative status. So, it seems to be the first case of native AML perforation closure till date.

Myval transcatheter heart valve system in the treatment of severe symptomatic aortic stenosis.

The transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS) at prohibitive risk for surgery. It is an alternative treatment to surgical aortic valve replacement in patients with AS at intermediate- and high-surgical risk. Although regulatory authorities extend the indications of TAVR to treat patients at low-surgical risk, the limitations of earlier-generation transcatheter heart valve (THV) systems accelerate the development of improved newer generation of THV systems. Myval™ THV (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) is a newer-generation, balloon-expandable TAVR system with features that facilitate accurate positioning of the bioprosthetic valve and favorable procedural and clinical outcomes. This review summarizes existing preclinical and clinical data on Myval THV for the intervention of symptomatic native AS and lays out the plan for future research program.

Single-center experience of 105-minimalistc transfemoral transcatheter aortic valve replacement and its outcome.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) increases worldwide, and indications expand from high-risk aortic stenosis patients to low-risk aortic stenosis. Studies have shown that minimalistic TAVR done under conscious sedation is safe and effective. We report single-operator, the single-center outcome of 105 minimalist transfemoral, conscious sedation TAVR patients, analyzed retrospectively. METHODS: All patients underwent TAVR in cardiac catheterization lab via percutaneous transfemoral, conscious sedation approach. A dedicated cardiac anesthetist team delivered the conscious sedation with a standard protocol described in the main text. The outcomes were analyzed as per VARC-2 criteria and compared with the latest low-risk TAVR trials. RESULTS: A total of 105 patients underwent transcatheter aortic valve replacement between July 2016 to February 2020. The mean age of the population was 73 years, and the mean STS score was 3.99 ± 2.59. All patients underwent a percutaneous transfemoral approach. Self-expanding valve was used in 40% of cases and balloon-expandable valve in 60% (Sapien3™ in 31% and MyVal™ in 29%) of cases. One patient required conversion to surgical aortic valve replacement. The success rate was 99 percent. The outcomes were: all-cause mortality: 0.9%, stroke rate 1.9%, New pacemaker rate 5.7%, 87.6% had no paravalvular leak. The mild and moderate paravalvular leak was seen in 2.8% and 1.9%, respectively. The mean gradient decreased from 47.5 mmHg to 9 mmHg. The average ICU stay was 26.4 h, and the average hospital stay was 5.4 days. Our outcomes are comparable with the latest published low-risk trial. CONCLUSION: Minimalist, conscious sedation, transfemoral transcatheter aortic valve replacement when done following a standard protocol is safe and effective.

Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available.

BACKGROUND: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. METHODS: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. RESULTS: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. CONCLUSIONS: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs.

First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study.

AIMS: The aim of this study was to demonstrate the safety and efficacy of the next-generation balloon-expandable Myval transcatheter heart valve (THV) in an intermediate- or high-risk patient population with severe symptomatic native aortic stenosis. METHODS AND RESULTS: MyVal-1 was a first-in-human, prospective, multicentre, single-arm, open-label study. Between June 2017 and February 2018, a total of 30 patients were enrolled at 14 sites across India. Mean age was 75.5±6.7 years; 43.3% had coronary artery disease. The mean Society of Thoracic Surgeons score was 6.4±1.8% and 100% of the patients were in New York Heart Association (NYHA) functional Class II/III/IV pre-procedure. The six-minute walk test and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were recorded. After successful implantation of the Myval THV, 96.6% and 100% were in NYHA functional Class I/II at 30-day and 12-month follow-up, respectively. Outcomes of the six-minute walk test (148.0±87.4 vs 336.0±202.9 m) and KCCQ score (36.6±11.0 vs 65.9±11.4) improved from baseline to 12-month follow-up. The effective orifice area (0.6±0.2 vs 1.8±0.3 cm2, p<0.0001), mean aortic valve gradient (47.4±8.8 vs 12.0±3.3 mmHg, p<0.0001), peak aortic valve gradient (71.7±13.0 vs 20.3±5.9 mmHg, p<0.0001) and transaortic velocity (4.5±0.4 vs 2.2±0.4 m/s, p<0.0001) improved substantially from baseline to 12 months post procedure. Four all-cause mortality cases were reported up to 12 months. Moreover, there was no other moderate/severe paravalvular leak, aortic regurgitation or need for new permanent pacemaker (PPM) up to 12-month follow-up. CONCLUSIONS: The MyVal-1 study demonstrated the primary safety and efficacy of the Myval THV with no new PPM requirement up to 12-month follow-up. However, future trials with a larger number of patients and long-term follow-up are warranted to establish the safety and efficacy of the device.

Recent trends in epidemiology of dyslipidemias in India.

Dyslipidemia is the most important atherosclerotic risk factor. Review of population based studies in India shows increasing mean total cholesterol levels. Recent studies have reported that high cholesterol is present in 25-30% of urban and 15-20% rural subjects. This prevalence is lower than high-income countries. The most common dyslipidemia in India are borderline high LDL cholesterol, low HDL cholesterol and high triglycerides. Studies have reported that over a 20-year period total cholesterol, LDL cholesterol and triglyceride levels have increased among urban populations. Case-control studies have reported that there is significant association of coronary events with raised apolipoproteinB, total cholesterol, LDL cholesterol and non-HDL cholesterol and inverse association with high apolipoproteinA and HDL cholesterol. Prevalence of suspected familial hypercholesterolemia in urban subjects varies from 1:125 to 1:450. Only limited studies exist regarding lipid abnormalities in children. There is low awareness, treatment and control of hypercholesterolemia in India.

Learning Alternative Access Approaches for Transcatheter Aortic Valve Replacement: Implications for New Transcatheter Aortic Valve Replacement Centers.

BACKGROUND: Smaller transcatheter aortic valve replacement (TAVR) delivery systems have increased the number of patients eligible for transfemoral procedures while decreasing the need for transaortic (TAo) or transapical (TA) access. As a result, newer TAVR centers are likely to have less exposure to these alternative access techniques, making it harder to achieve proficiency. The purpose of this study was to evaluate the learning curve for TAVR approaches and compare perioperative outcomes. METHODS: From January 2008 to December 2014, 400 patients underwent TAVR (transfemoral, n = 179; TA, n = 120; and TAo, n = 101)). Learning curves were constructed using metrics of contrast utilization, procedural, and fluoroscopy times. Outcomes during the learning curve were compared with after proficiency was achieved. RESULTS: Depending on the metric, learning curves for all three routes differed slightly but all demonstrated proficiency by the 50th case. There were no significant differences in procedural times whereas improvements in contrast use were most notable for TA (69 ± 40 mL versus 50 ± 23 mL, p = 0.002). For both TA and TAo, fewer patients received transfusions once proficiency was reached (62% versus 34%, p = 0.003, and 42% versus 14%, p = 0.002, respectively). No differences in 30-day or 1-year mortality were seen before or after proficiency was reached for any approach. CONCLUSIONS: The learning curves for TA and TAo are distinct but technical proficiency begins to develop by 25 cases and becomes complete by 50 cases for both approaches. Given the relatively low volume of alternative access, achieving technical proficiency may take significant time. However, technical proficiency had no effect on 30-day or 1-year mortality for any access approach.

Delirium after surgical and transcatheter aortic valve replacement is associated with increased mortality.

OBJECTIVE: The purpose of this study was to determine the incidence and clinical significance of postoperative delirium (PD) in patients with aortic stenosis undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHOD: Between 2010 and 2013, 427 patients underwent TAVR (n = 168) or SAVR (n = 259) and were screened for PD using the Confusion Assessment Method for the Intensive Care Unit. The incidence of PD in both treatment groups was determined and its association with morbidity and mortality was retrospectively compared. RESULTS: PD occurred in 135 patients (32%) with a similar incidence between SAVR (33% [86 out of 259]) and TAVR (29% [49 out of 168]) (P = .40). TAVR by transfemoral approach had the lowest incidence of PD compared with SAVR (18% vs 33%; P = .025) or TAVR when performed by alternative access techniques (18% vs 35%; P = .02). Delirium was associated with longer initial intensive care unit stay (70 vs 27 hours), intensive care unit readmission (10% [14 out of 135] vs 2% [6 out of 292]), and longer hospital stay (8 vs 6 days) (P < .001 for all). PD was associated with increased mortality at 30 days (7% vs 1%; P < .001) and 1 year (21% vs 8%; P < .001). After multivariable adjustment, PD remained associated with increased 1-year mortality (hazard ratio, 3.02; 95% confidence interval, 1.75-5.23; P < .001). There was no interaction between PD and aortic valve replacement approach with respect to 1-year mortality (P = .12). Among propensity-matched patients (n = 170), SAVR-treated patients had a higher incidence of PD than TAVR-treated patients (51% vs 29%; P = .004). CONCLUSIONS: PD occurs commonly after SAVR and TAVR and is associated with increased morbidity and mortality. Given the high incidence of PD and its associated adverse outcomes, further studies are needed to minimize PD and potentially improve patient outcomes.

Esophageal-left atrial fistula: an unsual cause.

A 55-year-old male presented with progressive dyspnea, swelling of legs and abdominal distension for past one week. Routine investigation showed presence of large pericardial effusion. Pericardiocentesis tapped a yellow colored sterile fluid with predominant polymorphs. However sequence of events following pericardiocentesis were unusual as patient developed stroke. MRI brain and CECT thorax were done. MRI brain showed small infarct and CECT showed presence of open safety pin eroding through esophagus and communicating with left atrium with thrombus and an air pocket within. Patient developed progressive encephalopathy and CT brain revealed multiple infarcts with pneumocephalus.