Transcatheter mitral valve (MV) replacement is an option in complex MV disease with potentially more predictable treatment outcomes and less invasiveness that increases the treatment spectrum to high-risk or non-surgical patients. We present an interesting case of failed MV bioprosthesis who presented with progressively worsening heart failure for heart transplant evaluation, but was successfully managed with transcatheter mitral valve-in-valve replacement (TMViVR). This case illustrates the pivotal role of TMViVR utilization in addressing complex cardiac scenarios, particularly when re-operative surgical MV replacement poses a high risk and also bridging the gap between the present and future heart transplantation preparations by paving the way for a well-prepared patient in the subsequent phase. The lifetime disease management and patient-centric approach with meticulous risk assessment reinforces the importance of shared decision-making in complex cases.

Hemostatic devices are critical for managing emergent severe bleeding. With the increased use of anticoagulant therapy, there is a need for next-generation hemostats. We rationalized that a hemostat with an architecture designed to increase contact with blood, and engineered from a material that activates a distinct and undrugged coagulation pathway can address the emerging need. Inspired by lung alveolar architecture, here, we describe the engineering of a next-generation single-phase chitosan hemostat with a tortuous spherical microporous design that enables rapid blood absorption and concentrated platelets and fibrin microthrombi in localized regions, a phenomenon less observed with other classical hemostats without structural optimization. The interaction between blood components and the porous hemostat was further amplified based on the charged surface of chitosan. Contrary to the dogma that chitosan does not directly affect physiological clotting mechanism, the hemostat induced coagulation via a direct activation of platelet Toll-like receptor 2. Our engineered porous hemostat effectively stopped the bleeding from murine liver wounds, swine liver and carotid artery injuries, and the human radial artery puncture site within a few minutes with significantly reduced blood loss, even under the anticoagulant treatment. The integration of engineering design principles with an understanding of the molecular mechanisms can lead to hemostats with improved functions to address emerging medical needs.

Lipid-lowering therapy plays a crucial role in reducing adverse cardiovascular (CV) events in patients with established atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia. Lifestyle interventions along with high-intensity statin therapy are the first-line management strategy followed by ezetimibe. Only about 20-30% of patients who are on maximally tolerated statins reach recommended low-density lipoprotein cholesterol (LDL-C) goals. Several factors contribute to the problem, including adherence issues, prescription of less than high-intensity statin therapy, and de-escalation of statin dosages, but in patients with very high baseline LDL-C levels, including those with familial hypercholesterolemia and those who are intolerant to statins, it is critical to expand our arsenal of LDL-C-lowering medications. Moreover, in the extreme risk group of patients with an LDL-C goal of ≤30 mg/dL according to the Lipid Association of India (LAI) risk stratification algorithm, there is a significant residual risk requiring the addition of non-statin drugs to achieve LAI recommended targets. This makes bempedoic acid a welcome addition to the existing non-statin therapies such as ezetimibe, bile acid sequestrants, and PCSK9 inhibitors. A low frequency of muscle-related side effects, minimal drug interactions, a significant reduction in high-sensitivity C-reactive protein (hsCRP), and a lower incidence of new-onset or worsening diabetes make it a useful adjunct for LDL-C lowering. However, the CV outcomes trial results are still pending. In this LAI consensus document, we discuss the pharmacology, indications, contraindications, advantages, and evidence-based recommendations for the use of bempedoic acid in clinical practice.

Background The coral reef aorta (CRA) is a rare disease of extreme calcification in the juxtarenal aorta. These heavily calcified exophytic plaques grow into the lumen and can cause significant stenoses, leading to visceral ischaemia, renovascular hypertension, and claudication. Surgery or percutaneous intervention with stenting carries a high risk of complications and mortality. Case summary A 67-year-old female had presented with severe hypertension and exercise limiting claudication for 18 months. On evaluation, she was found to have severe bilateral renal artery stenoses with juxtarenal CRA causing subtotal occlusion. Both renal arteries were stented. For CRA, we used intravascular lithotripsy (IVL) assisted plain balloon angioplasty to minimize possibilities of major dissection and perforation and avoided chimney stent-grafts required to protect visceral and renal arteries. We used a double-balloon technique using a 6 x 60 mm IVL Shockwave M5 catheter and a 9 x 30 mm simple peripheral balloon catheter, inflated simultaneously at the site of CRA as parallel, hugging balloons to have an effective delivery of IVL. Shockwaves were given in juxta/infrarenal aorta to have satisfactory dilatation without any complication. The gradient across aortic narrowing reduced from 80 to 4 mmHg. She had an uneventful recovery and has remained asymptomatic at 6-month follow-up. Discussion When CRA is juxtarenal with no safe landing zones for stent-grafts, IVL may be a safe, less complex and effective alternative to the use of juxtarenal aortic stent-graft with multiple chimney or snorkel stent-grafts. This is the first report of a novel use of IVL to treat CRA.

The Cardiovascular TransRadialAccess Platform (Cardio-TRAP®) is a radiation protection technology to absorb incident radiation during right transradial percutaneous coronary intervention (PCI). Randomized, prospective, observational single center comparative study was conducted. Radiation doses at

AbstractObjectiveWith COVID-19 pandemic severely affecting India and Ahmedabad city being one accounting for half COVID cases, objective was to determine disease course and severity of in patients at a COVID care hospital.DesignA Clinical trial registry of India registered observational study (CTRI/2020/05/025247).SettingCertified COVID hospital located in Ahmedabad, Gujarat, India.Participants549 COVID positive patients hospitalized between 15 th May to 10 th August, 2020 and treated in ICU and non ICU settings.Main Outcome MeasureComparative analysis of demographic, clinical characteristics, investigations, treatment, complications and outcome of COVID patients in ICU and non ICU settings.ResultsOf the 549 hospitalized COVID positive patients, 159 were admitted in ICU during disease course while 390 had ward admissions. Overall median age was 52 (1-86) years. The ICU group was older (>65years), with associated comorbidities like hypertension and diabetes (p<0.001); higher proportion of males (79.25%); with dyspnea as a major clinical characteristic and consolidation in lungs as a major radiological finding as compared to ward patients. C - reactive protein, D-Dimer and Ferritin were higher in ICU patients. Overall 50% females depicted elevated Ferritin levels. Steriods(92.45%)and tocilizumab (69.18%) were more frequently used for ICU patients. Remdesivir was prescribed to both ICU and non ICU patients. Favirapir was also a line of treatment for 25% of ICU patients. Convalescent plasma therapy was given to 7 ICU patients. Complications like acute kidney injury (13.84%), shock (10.69 %), sepsis and encephalopathy were observed in ICU patients. Overall mortality rate was 5.47 % with higher mortality among males in comparison to females (p<0.0001).ConclusionAbout 29% of overall patients required ICU admission that was commonly elderly males. Chances of ICU admission were higher with baselines comorbidities (1.5 times) and dyspnea (3.4 times) respectively. A multi-specialty COVID care team and updated treatment protocols improves outcomes.

Drug coated balloon has emerged as a new therapeutic option to treat obstructive coronary artery disease(CAD) in percutaneous coronary intervention (PCI). In past Paclitaxel coated balloons have been used in coronary artery stenosis. This study sought to define the impact of Magictouch “Sirolimus

Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting stent placement is a well-established treatment modality for coronary stenotic lesions. Although infection involving implanted stent is rare, it can occur at any point of time, leading to high morbidity and mortality. We describe a rare case of infected coronary stents complicated with recurrent stent thrombosis, sepsis, and myocardial abscess formation after 2 years of percutaneous cornary intervention (PCI). Using multi-modality imaging final diagnoses to evaluate the precise location, extent and morphology of myocardial abscess (MA) was done. "On pump" coronary artery bypass graft (CABG) was performed, left anterior descending (LAD) artery intramyocardially was opened up, about 7-10 ml of pus was evacuated, and two drug-eluting stents (DES) were removed. The isolated identified organism was Pseudomonas aeruginosa which had remained dormant and restricted to the stent area for almost 2 years thinning the myocardium; an unusual trait of a very virulent bacterium which otherwise spreads fast to cause septicemia. The present case exemplifies the high index of clinical sensitivity with early multi-modality diagnosis, aggressive medical therapy, multidisciplinary care, and timely surgical intervention saving the patient's life in otherwise fatal condition.

Indian government agency regulating prices, imposed highest price cap of INR 30000 ($464) in February 2017 on all drug eluting stents (DES) creating a stir in the global device industry. The impact of stent price reduction on selection for stent type and its associated outcomes was studied.

These Lipid Association of India (LAI) recommendations refer to specific patient populations. They follow the previously published LAI part 1 recommendations. These part 2 LAI recommendations focus...

Background: Reduced risk of bleeding, reduced hospital stay, and increased comfort has increased the use of the transradial approach for percutaneous coronary procedures. However, risk of increased operator exposure to scatter radiation is a concern, for the transradial approach. The Cardiovascular

251. Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials. The Lancet

Background/Purpose: The ORBIT I trial, a first-in-man study, was conducted to evaluate the safety and performance of the orbital atherectomy system (OAS) in treating de novo calcified coronary lesions.Methods/Materials: Fifty patients were enrolled between May and July 2008 based on several criteria, and were treated with the OAS followed by stent placement. The safety and performance of the OAS were evaluated by procedural success, device success, and overall major adverse cardiovascular event (MACE) rates, including cardiac death, myocardial infarction (MI) and need for target lesion revascularization (TLR). Our institution enrolled and treated 33 of the 50 patients and continued follow-up for 5 years.Results: Average age was 54 years and 91% were males. Mean lesion length was 15.9 mm. Device success was 100%, and average number of orbital atherectomy devices (OAD) used per patient was 1.3. Stents were placed directly after OAS in 31/32 patients (96.9%). All stents (average stent per lesion 1.1) were successfully deployed with 0.3% residual stenosis. The overall cumulative MACE rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, 18.2% at 3 years and 21.2% at 5 years (4 total cardiac deaths). None of the patients had Q-wave MIs. Angiographic complications were observed in 5 patients. No flow/slow flow due to distal embolization was observed.Conclusions: The ORBIT I trial suggests that OAS treatment continues to offer a safe and effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult-to-treat patients. (C) 2015 Elsevier Inc.

DELIVER was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity™ zotarolimus-eluting stent (R-ZES). In-hospital clinical outcomes and resource utilization following radial and femoral access implantations are compared in a post-hoc analysis.

Background/Purpose: DELIVER (DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER stenting) was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity (TM) zotarolimus-eluting stent (R-ZES).Methods/Materials: Patients (n = 7740 patients, 10449 lesions) undergoing percutaneous coronary intervention and deemed suitable for R-ZES implantation were enrolled and treated according to standard practice of the participating centers in 30 countries. Outcomes included delivery success and in-hospital target lesion failure (TLF), major adverse cardiac event (MACE), and Academic Research Consortium definite/probable stent thrombosis. We performed a post hoc analysis comparing deliverability, in-hospital clinical outcomes and resource utilization with radial vs. femoral access.Results: A high proportion of the population had complex disease (71%): mean lesion length was 26.7 +/- 17.5 mm, 35% of lesions were moderately/severely calcified and 17% were bifurcated. Femoral and radial accesses were used in 53% and 46% of patients, respectively. Patients treated using femoral access had more complex coronary artery disease. Primary delivery success was 98.9% and did not differ by approach. Radial access was associated with lower stent and balloon utilization, but higher guide catheter utilization, lower procedure duration, and contrast administered compared with femoral access. In-hospital TLF and MACE occurred in 1.6% of patients; definite or probable stent thrombosis occurred in 0.2%. Clinical outcomes did not differ by vascular access.Conclusions: R-ZES was found to be highly deliverable in a complex, all-comers, international population, regardless of whether radial or femoral access was used. In-hospital outcomes were excellent with very low risk of complications. (C) 2014 Elsevier Inc. All rights reserved.

Background/Purpose: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Severely calcified coronary arteries pose ongoing treatment challenges. Stent placement in calcified lesions can result in stent under expansion, malapposition and procedural complications. OAS treatment may be recommended to facilitate coronary stent implantation in these difficult lesions.Materials/Methods: Fifty patients with de novo calcified coronary lesions were enrolled in the ORBIT I trial. Patients were treated with the OAS followed by stent placement. Our institution treated 33/50 patients and continued follow-up for 3 years.Results: Average age was 54.4 years and 90.9% were males. Mean lesion length was 15.9 mm. The average number of OAS devices used per patient was 1.3. Procedural success was achieved in 97% of patients. Angiographic complications were observed in five patients (two minor dissections, one major dissection and two perforations). The cumulative major adverse cardiac event (MACE) rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, and 18.2% at 3 years. The MACE rate included two in-hospital non Q-wave myocardial infarctions (MI), one additional non Q-wave MI at 30 days leading to target lesion revascularization (TLR), and three cardiac deaths.Conclusions: The ORBIT I trial suggests that OAS treatment may offer an effective method to modify calcified coronary lesion compliance to facilitate optimal stent placement in these difficult-to-treat patients with acceptable levels of safety up to 3 years post-index procedure. (C) 2014 The Authors. Published by Elsevier Inc.

Coronary Artery Disease continues to be a widespread and growing problem worldwide. Performing PCI on calcified lesions can lead to higher MACE rates and stent under expansion/malapposition. The Orbit I trial was conducted to evaluate the safety and performance of the Diamondback 360 Orbital