Accura balloon dilatation catheter for percutaneous balloon pulmonary valvuloplasty among adult patients-its protean use.

BACKGROUND: Percutaneous balloon pulmonary valvuloplasty (PBPV) is the treatment of choice for hemodynamically significant pulmonary stenosis (PS). Currently, the Tyshak balloon is preferred but requires multiple dilatations because of its instability across the valve leading to a watermelon seeding effect. Accura balloon (Vascular Concept, UK) offers an advantage in its self-positioning configuration, variable diameter, and rapid inflation-deflation sequence which shortens the procedural time and valve injury. METHOD: 43 patients with severe pulmonary valve stenosis underwent PBPV using an Accura balloon at LPS Institute of Cardiology, GSVM Medical College, Kanpur, UP, India from March 2018 to February 2022. The procedure was carried out using the standard technique but the metallic straightener was removed when the catheter reached the right atrium to facilitate its delivery across the pulmonary valve. Patients were followed up by 2D echo at 24 hours and 6 months. RESULT: Successful BPV was done in all 43 patients [with mean age 21.9 (range 18-41); 31 males and 12 females] among which 5 patients had dysplastic valves. The mean diameter of the annulus was 18.5 (range 15-21) mm. Immediate hemodynamic improvement was observed in 38 patients (88%) as peak systolic gradient reduced from 84±13 to 22±12 mmHg (P<0.005) while 5 patients (12%) had <50% reduction of resting gradient, though it came down significantly at 6 months. Fluoroscopy and procedural time were 5.2±1.9 min and 22.6±3.4 min respectively. Major complications (death, cardiac perforation, tamponade, tricuspid regurgitation, requirement of blood transfusion) were none. Minor complications (transient hypotension, ventricular premature contraction, transient bradycardia) were reported in all patients. Accura balloon being bulky were delivered over left atrial and super stiff Amplatz wire in 36 and 7 patients respectively. CONCLUSION: PBPV using Accura balloon is safe and effective for both stenosed and dysplastic valves. In a few patients, maximal effect will be observed over a period of 6 months.

Twelve-month clinical outcomes of "nano-crush technique" for the treatment of bifurcation lesions using ultra-thin (60 µm) sirolimus-eluting coronary stents.

BACKGROUND: Provisional stenting is preferred for bifurcation lesion; however, certain anatomical substrate does require two stents as a part of dedicated stent technique. Here, the present study evaluated outcomes of ultra-thin (60 µm) Supra family sirolimus-eluting stent (SES) (Sahajanand Medical Technologies Limited, Surat, India) for dedicated bifurcation lesions using nano-crush technique at 12 months angiographic follow-up. METHODS: This was prospective, single-center observational study which enrolled patients with de novo bifurcation lesion and underwent angioplasty with Supra family SES using nano-crush technique at a tertiary care center in India, between March-2017 and February-2019. Primary endpoint at 12 months was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included patient-oriented composite endpoint (POCE), all-cause death, any revascularization, clinically driven target vessel revascularization, stent thrombosis, periprocedural and spontaneous MI, and device failure. RESULTS: The study enrolled total 63 patients with a mean age of 62.5±4.9 years and had male dominance (89%). Left main (LM) bifurcation and non-LM bifurcation were observed in 21 (33%) and 42 (67%) patients, respectively. Total 50 (80%) patients had Medina class- 1,1,1. At 12 months, TLF occurred in 4 (6%) patients which included one cardiac death (1.5%), two (3.0%) TV-MI, and one CD-TLR (1.5%). POCE was observed in 6 (9.6%) patients. Stent failure was seen in 2 (3.1%) patient and one patient (1.5%) developed late stent thrombosis. Twelve months angiographic follow-up indicated intact stent patency in all other patients. On multivariate analysis, LM bifurcation, renal dysfunction, LM bifurcation with renal dysfunction, ejection fraction (<35%) and calcified lesion were found as predictors of TLF. CONCLUSIONS: Dedicated stenting with ultra-thin Supra family SES for complex bifurcation lesion using nano-crush technique reported acceptable clinical outcomes among real-world patients and can be performed safely with ease without any procedural complications.

OpExHAN: opinion extraction using hierarchical attention network from unstructured reviews.

In recent decades, sellers and merchants have asked their customers to share their opinion on the products at online marketplace. Analysis of the massive amounts of reviews for a potential customer is an immense challenge, to decide whether to purchase a product or not. In this paper, a hierarchical attention network-based framework is presented to resolve this challenge. In this proposed framework, the Amazon's Smartphone review dataset is preprocessed using NLP approaches and then applied Glove embedding to extract word vector representation of reviews which identifies contextual information of words. These word vectors are fed into the hierarchical attention network, which produces vectors at the word and sentence levels. Bi-GRU model encodes the words and sentences into hidden vectors. Finally, reviews are classified into five opinion classes like extremely positive, positive, extremely negative, negative and neutral. Furthermore, to perform the experiments with the proposed method, the dataset is divided into three parts such as 80% train, 10% validation and 10% test. Experiments reveal that the proposed framework outperforms baseline methods in terms of accuracy, precision and recall. The OpExHAN model achieved admirable results like 94.6% accuracy, 91% both precision and recall after a lot of hyper-parameter experimentation.

Transcatheter closure of secundum atrial septal defect using Cocoon septal occluder: immediate and long-term results.

BACKGROUND: Atrial septal defect (ASD) is one of the common congenital heart defects. Its management has transformed dramatically in the last 4 decades with the transition from surgical to percutaneous transcatheter closure for most secundum-type ASDs. Various devices are available for transcatheter closure of ASD with Amplatzer atrial septal occluder being most commonly used worldwide. Cocoon septal occlude has a nanocoating of platinum using nano-fusion technology over nitinol framework that imparts better radiopacity and excellent biocompatibility and prevents leaching of nickel into circulation, and by smoothening nitinol wire makes this device very soft and smooth. The aim of this study was to evaluate feasibility, effectiveness, safety, and long-term outcome of transcatheter closure of ASD using Cocoon septal occluder (Vascular Innovation, Thailand). RESULTS: All patients undergoing transcatheter closure of hemodynamically significant ASD between September 2012 and July 2019 in our institute were included into this single-center, prospective study. Exclusion criteria were defect > 40 mm, unsuitable anatomy, Eisenmenger syndrome, and anomalous pulmonary venous return. Three hundred and twenty patients underwent device closure, of which 238 (74%) were female. The mean age was 14.6 years (range 6-29), and the median weight was 30.2 kg (range 10-53 kg). Procedure was performed under fluoroscopy using transthoracic and transesophageal echocardiography in 298 (93.1%) and 22(6.9%) patients, respectively. Balloon-assisted technique was used, when septal defect was ≥ 34 mm, in 9 (2.8%) patients. The mean diameter of defect and device was 21.4 mm (range 12-36 mm) and 26.9 mm (range 14-40 mm), respectively. Aortic rim was absent in 11 (3.4%) patients. Primary success was achieved in 312 (97.5%) patients. Early embolization to right ventricle was noted in 2 (0.6%) patients. In both cases, 40-mm device was attempted for defect of 36 mm with inadequate aortic rim using balloon-assisted technique. One (0.3%) patient developed perforation of right atrium. All were surgically repaired. Three (0.9%) patients developed complete heart block following device deployment requiring device retrieval. Two patients had had moderate residual shunt at 6 months of follow-up. After mean follow-up of 50.92 months (range 12.5-89 months), no erosion, allergic reactions to nickel, or other major complications were reported. CONCLUSIONS: Percutaneous transcatheter closure of ASD by Cocoon septal occluder (up to 36 mm) is safe and feasible with high success rate and without any significant device-related major complications over long-term follow-up. With unique device design and excellent long-term safety, it could be preferred dual-disk occluder for transcatheter closure of atrial septal defect. In most of the patients, ASD device can be safely deployed under transthoracic echocardiographic guidance.

Multifaceted potential applicability of hydrotalcite-type anionic clays from green chemistry to environmental sustainability.

Hydrotalcite-like anionic clays (HTs) also known as Layered double hydroxides (LDHs) have been developed as multifunctional materials in numerous applications related to catalysis, adsorption, and ion-exchange processes. These materials constitute an important class of ionic lamellar solid clays of Brucite-like structure which comprise of consecutive layers of divalent and trivalent metal cations with charge balancing anions and water molecules in interlayer space. These materials have received increasing attention in research due to their interesting properties namely layered structure, ease of preparation, flexible tunability, ability to intercalate different types of anions, electronic properties, high thermal stability, high biocompatibility, and easy biodegradation. Moreover, HTs/LDHs have unique tailorable and tuneable characteristics such as both acidic and basic sites, anion exchange capability, surface area, basal spacing, memory effect, and also exhibit high exchange capacities, which makes them versatile materials for a wide range of applications and extended their horizons to diverse areas of science and technology. This study enlightens the various rational researches related to the synthetic methods and features focusing on synthesis and/or fabrication with other hybrids and their applications. The diverse applications (namely catalyst, adsorbent to toxic chemicals, agrochemicals management, non-toxic flame retardants, and recycling of plastics) of these multifunctional materials related to a clean and sustainable environment were also summarized.

Unguided temporary pacing via jugular/subclavian vein in an emergency department of a high-volume tertiary care hospital of India: its safety, efficacy, and practicability.

BACKGROUND: Temporary pacing is usually performed by cardiologists under fluoroscopic, echocardiographic, or ECG guidance. However, in the developing world, there are inadequate number of cardiologists, and C-arm, catheterization laboratories, or echocardiography are not available at primary or secondary healthcare facilities. In addition, in emergencies option of fluoroscopy and echocardiography is limited. So these patients are transferred to a facility where cardiologists and these facilities are available. Crucial time is lost in transit, which leads to increased mortality. In this study, we aimed to evaluate the safety, efficacy, and practicability of unguided temporary pacemaker insertion. RESULTS: A total of 1093 patients were enrolled in this study. After cannulating the internal jugular vein or subclavian vein, the pacing lead attached to the pulse generator was advanced blindly till ventricular pacing was achieved. Procedural success was taken as the primary endpoint. Secondary endpoints included the number of attempts taken for successful central venous puncture and procedural time. Complications and mortality were assessed for safety outcomes. Finally, the position of the pacing lead was assessed after the procedure on X-ray or fluoroscopy. The procedure was successful in all but one patient in whom a femoral vein approach was required because of brachiocephalic vein obstruction. Right internal jugular access was achieved in 981 (89.75%) patients. The mean number of attempts taken for achieving successful venous accesses was 1.54 ± 0.85; however, in 726 (66.42%) patients it was achieved in the first attempt. The mean procedural time was 11.5 ± 2.1 min. Overall, 117 (10.70%) patients developed complications; however, most of them were minor. Pneumothorax developed in 12 (1.1%) patients, of whom 2 needed an intercostal tube. Pericardial effusion was seen in 21 (1.92%) patients. Pacing lead tip was located in the right ventricular cavity abutting interventricular septum or free wall in 843 (77.20%) patients. No mortality attributable to procedure occurred. CONCLUSIONS: Unguided temporary pacing via jugular or subclavian venous approach in an emergency setting is possible with high success and a low complication rate. Thus, it is a safe and effective procedure, and clinicians working at primary and secondary healthcare levels should be encouraged to perform this procedure. Trial registration UMIN Clinical Trials Registry, UMIN000046771. Registered 28 January 2022-Retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053348.

Assessment of the Left Atrial Reservoir Function and Left Atrial Volume After Percutaneous Balloon Mitral Valvuloplasty Using Peak Atrial Longitudinal Strain.

Objective To evaluate the impact of successful percutaneous balloon mitral valvuloplasty (BMV) on left atrial (LA) reservoir function and LA volume in patients with severe mitral stenosis (MS) using peak atrial longitudinal strain (PALS). Method This was a prospective, non-randomized observational study conducted at the Laxmipat Singhania (LPS) Institute of Cardiology, Kanpur from August 2018 to February 2020 among patients with severe rheumatic MS undergoing BMV to assess LA reservoir function and its volume after BMV using PALS. Inclusion criteria were symptomatic severe rheumatic MS (NYHA ≥II), normal ventricular systolic function, and suitable valve morphology. Exclusion criteria were the coexistence of aortic valve involvement, left atrial appendage clot, mitral leak more than mild, pregnancy, hypertension, diabetes, and coronary artery disease. To assess LA reservoir function and its volume after BMV, PALS was used. LA was divided into six regions of interest and longitudinal strain curves of individual segments together with global strain were recorded. PALS was calculated at baseline 24 hours following the intervention, and at three months of follow-up. Result Successful BMV was performed in 260 patients (109 or 41.9% males and 151 or 58.1% females), resulting in significant improvement in mitral valve area (MVA) (0.89±0.11 cm2 vs. 1.83±0.3 cm2; p<0.001). The mean age of patients was 26.7±4.7 years; 214 (82.3%) patients were in normal sinus rhythm (NSR) while 46 (17.7%) had atrial fibrillation (AF). Significant improvement in PALS was noted immediately following the procedure (6.5±11.6% vs. 7.7±10.5%; p< 0.001) and it continued to improve at three months of follow-up (6.5±11.6% vs. 11.3±12.5%; p<0.001), which was 24% and 74% improvement from baseline respectively. Significant reduction in indexed left atrial (LA) volume was observed immediately following the procedure (56.8±14.3 ml/m2 vs 48.4±12.5 ml/m2; p=0.003), and at three months of follow-up (56.8±14.3 ml/m2 vs. 45.4±13.3 ml/m2; p=0.002). Those with AF had lesser improvement in PALS in comparison to those with NSR (60% vs. 84%; p=0.044) at three months of follow-up. At three months, the increase in PALS was also lower in patients with a history of stroke as compared to those without it (55% vs 80%; p=0.039). Both LA volume and indexed LA volume reduced significantly immediately at 24 hours and during follow-up. Conclusion LA reservoir function, as assessed by PALS, is reduced in patients with severe MS. It improved significantly within 24 hours following BMV and continued to improve at three months of follow-up. It is an underutilized modality among patients of MS for decision-making prior to intervention and to assess the effect of the intervention.

Tiger Stripes in Carditis of Rheumatic Origin.

"Tiger stripes" or "Zebra stripes" are multiple band-like signals noted on Doppler spectral recordings and have been associated with intracardiac oscillating structures. They have been attributed to flail prosthetic valve leaflet, native valve regurgitation without flail leaflet, papillary muscle rupture in acute coronary syndrome, and possibly Lambl's excrescences. To our knowledge, there is only one case report in the English literature that had identified this sign in rheumatic carditis. We present the case of a 14-year-old boy, who was known to have rheumatic heart disease and presented with worsening dyspnea of recent onset. His antistreptolysin O, C-reactive protein, and erythrocyte sedimentation rate titer were raised. Echocardiography revealed severe eccentric mitral regurgitation with multiple high-intensity signals (tiger stripes) on continuous wave (CW) Doppler. The patient was managed as rheumatic carditis with steroids. Repeat echocardiography after 1 month showed the resolution of tiger stripes. Upon tapering, steroids patient's symptoms worsened and echocardiography revealed the reappearance of tiger stripes. We propose that these high-intensity signals in spectral Doppler reflect valvulitis and are the echocardiographic counterpart of musical overtones. We suggest that these signals on CW Doppler in a patient with established rheumatic heart disease be taken as a marker of carditis and the patient should be managed accordingly. We refer to this sign as a "Fingerprint sign" due to its resemblance to it and to differentiate it from Tiger strips because of its dynamic nature. This sign can be used to identify and follow carditis in a rheumatic scenario.

Perforated balloon technique mediated intracoronary delivery of nicorandil to treat coronary no-reflow phenomenon: a novel pharmacological solution to precarious situation.

BACKGROUND: Coronary no-reflow (NRF) following percutaneous coronary intervention (PCI) is infrequent but one of the most dreaded complication which results from impaired flow of microvascular bed. It is associated with adverse outcome if flow is not restored. Objective of this study was to find safety, effectiveness and outcome of intracoronary nikorandil (IC) administered using perforated balloon technique (PBT) to reverse NRF. METHOD: 2-4 mg of nicorandil was diluted with 5 ml of normal saline and administered using PBT over 5-minute. Its effectiveness was evaluated after 10 minute qualitatively using TIMI flow and quantitatively corrected TIMI frame count (cTFC) method. RESULT: Study comprised of 84 patients (out of 1789 patients undergoing PCI between January 2019 and February 2020). Their mean age was 57.8±17.9 years. Following PBT, TIMI III flow was successfully normalized in 71 subjects (84.5%), ten (12%) patients had TIMI II flow and it was not successful in three (3.5%) patients. TIMI flow grade got bettered from 1.03 to 2.58 and cTIMI frame count regressed from 52.9±11 to 16.5±5 (P < 0.001). PBT was well tolerated except short lived drop in blood pressure (n=10; 11.9%). CONCLUSION: This study, for the first time to the best our knowledge, demonstrated that PBT mediated intracoronary administration of nikorandil distally was rapid, safe, and efficacious method to deal with NRF.

An echocardiographic evaluation to determine the immediate and short-term changes in biventricular systolic and diastolic functions after PDA device closure-an observational analytical prospective study (echo- PDA study).

OBJECTIVES: -This prospective study with a sizable cohort was undertaken to assess changes in left and right ventricle systolic and diastolic functions after percutaneous patent ductus arteriosus device closure with appropriate follow up evaluation. METHODS: - It is an observational analytical prospective study. Ninety-eight patients were recruited out of which sixty-eight patients underwent percutaneous PDA device closure and were taken for final analysis. The primary objective was to study the left and right ventricular systolic and diastolic functions pre- and post-procedure at 48 h with follow up analysis at six months. RESULTS: - The mean age of the patients was 7.88 ± 5.05 years with the female to male ratio was 3.85:1. Thirty-three (48.52%) of the patients had immediate post PDA device closure LV systolic dysfunction. It was more common in those having pre-procedure mean low LVEF and those having a significant reduction in mitral A velocity. It became normal at six months follow up. The study reported immediate decrease in mea/n LVEF from 63.55 ± 8.11% to 48.19 ± 7.9%. The changes in LVEDD, LVEF, LVFS and LVEDV were statistically significant (p < 0.0001). In diastolic functions, there were significant reductions in peak early and late diastolic velocities. There was no statistically significant difference in right chamber functional assessment. CONCLUSION: Asymptomatic LV systolic and diastolic dysfunction in immediate post PDA closure period is a common complication and reported in around 48.5% cases. It was more common in those having pre-procedure mean low LVEF and those having a significant reduction in mitral A velocity.

To determine the correlation between echocardiographic diastolic parameters and invasively measured left ventricular end diastolic pressure in patients with heart failure with preserved ejection fraction- an observational, descriptive study. (CEAL-HFpEF study).

OBJECTIVES: Though invasive monitoring is the most accurate to estimate diastolic dysfunction but it has its own risk. The purpose of this study was to find out any standardized correlation between invasive and non -invasive parameters. METHODS: It is an observational, descriptive study comprising of a total of 500 patients. The primary objective of the study was to determine the correlation between echocardiographic diastolic parameters and invasively measured left ventricular end diastolic pressure (LVEDP). RESULTS: On studying correlation of different invasive and non-invasive data it was reported that there was a weak correlation between peak E velocity (r = 0.14, p = 0.631), Peak A velocity (r = 0.67, p = 0.59), IVRT (r = -0.35, p = 0.178), Mitral deceleration time (DT) (r = -0.06, p = 0.842), pulmonary venous peak systolic (r = -0.02, p = 0.966) and diastolic flows (r = 0.47, p = 0.201) to LVEDP. There was a good positive correlation between elevated LVEDP and difference in duration of pulmonary venous and mitral flow at atrial contraction (A-Ard) and E/Ea at all four longitudinal segments of the left ventricle. The sensitivity and specificity for detecting an elevated LVEDP of more than 12 mm Hg, using a cut off value of E/Ea< 8, were 89% and 90%.Lateral E/Ea ≥ 12, LAVI ≥34 mL/m2, and Ard-Ad > 30 msec have the greatest diagnostic value for diagnosing diastolic dysfunction in HFpEF patients. CONCLUSION: Lateral E/Ea ≥ 12, LAVI ≥34 mL/m2, and Ard-Ad > 30 msec have the greatest diagnostic value for diagnosing diastolic dysfunction in HFpEF patients and have good correlation with invasively measured LVEDP.

Balloon Deflection Technique to Facilitate Stent Delivery in Impassable Situations During Percutaneous Coronary Intervention.

BACKGROUND: Long and multiple lesions especially in the background of tortuous coronary artery often require multiple stents. The entry and passage of another stent through an already deployed stent becomes challenging because of poorly expanded stent struts, calcified tissue, underlying tortuosity, highly angulated takeoff of the vessel, and lack of coaxiality. It can be facilitated by balloon deflection technique (BDT) where balloon at proximal edge of main vessel stent over a buddy wire helps to deflect second stent either distally or into side branch by blocking potential dead. METHODS: The present retrospective, single-center study included 16,189 consecutive patients who underwent percutaneous coronary intervention (PCI) either through transfemoral or transradial route from January 2014 to August December 2019 at LPS Institute of Cardiology, GSVM Medical College, Kanpur, UP, India where BDT was used in situation of impassable stent among 37 patients. RESULTS: The mean age of patients was 75.4 ± 6.5 years. The commonest clinical presentation was chronic coronary syndrome (n = 19; 51.3%) followed by non-ST-segment elevation myocardial infarction (NSTEMI) (n = 9; 24.4%), ST-segment elevation myocardial infarction (STEMI) (n = 5; 13.5%), and unstable angina (UA) (n = 10; 10.8%). Type B2 lesion was commonest (45.9%) followed by type C (35.2%) and B1 (18.9%). The commonest indication for BDT was angulation (n = 10; 27.1%) followed by tortuosity (n = 9; 24.3%), chronic total occlusion (n = 8; 17.9%), calcification (n = 7; 18.9%), and distally located lesion (n = 3; 8.1%). The left circumflex artery (LCX) was the most commonly intervened artery (n = 16; 43.2%) followed by left anterior descending (n = 11; 29.7%) and right coronary artery (n = 10; 27.1%). Mean diameter and mean length of stents were 3.3 ± 0.9 mm and 18 ± 6 mm respectively. The mean diameter and mean length of deflection balloon were 3 ± 0.5 mm and 20 ± 5 mm respectively. Lesions were modified using aggressive pre-dilatation in all cases while 19.4% of lesion required cutting balloon for additional modification. Additional wire as buddy wire was used in 54% of cases while wire in main vessel acted as buddy wire in dedicated bifurcation stenting. Stent implantation was successful in 36 cases with success rate of 97.3%; while in one case, stent could not be delivered using BDT. Stent was finally delivered using GuideZilla mother-in-child catheter. Overall failure rate was 2.7% which was contributed by extreme tortuosity, angulation, and severe calcification. CONCLUSIONS: In selected cases of impassable lesions; the deflection balloon technique may provide a simple, convenient, and inexpensive solution without further need of additional hardwares except a buddy wire and a balloon.

Telecardiology and its outcome among patients with implantable cardiac devices during COVID-19 pandemic.

BACKGROUND: During ongoing coronavirus disease 2019 (COVID-19) pandemic, social isolation and lockdown measures were implemented to prevent spread of virus which created enormous challenges to patient healthcare. In order to overcome these challenges, teleconsultation (telecardiology) was initiated. Objective of this study was to assess outcome of telecardiology using audio/visual/audio-visual consultation among patients with implantable cardiac devices. METHODS: Telecardiology was performed (either physician-initiated or patient-initiated) among 1200 patients over a five-month period (July 13 to December 13, 2020) to review health status of patients to decide further course of treatment and to access their satisfaction level with telecardiology. RESULTS: Teleconsultation was cardiologist- and patient-initiated in 1042 (86.8%) and 158 (13.2%) cases, respectively. 1117 (93.2%) patients were stable, while scheduled admission, urgent hospitalization, and death were noted in 20 (1.8%), 45 (3.9%), and 18 (1.5%) patients, respectively. Next visit was rescheduled in 986 (82.2%), while 127 (10.6%) were called earlier because of battery depletion. Majority (n = 1077, 89.8%) were satisfied. CONCLUSION: Telecardiolgy is an effective option during COVID-19 to minimize interpersonal contact, spread of disease, psychological stress, and burden on already stretched healthcare.

Study of Safety and Efficacy of Novel Sirolimus-Eluting Stent Incorporating Properties of Drug Coating Balloon Among Real World Patients Focusing Younger Population (<35 years).

OBJECTIVE: Aim of study was to evaluate safety and efficacy of abluminal Mitigator DES + Sirolimus Eluting Stent (Envision Scientific, Surat, India) incorporating novel technology of fusion coating of bioresorbable polymer on both abluminal surface of stent and exposed parts of balloon among real world patients specially focusing younger patients (<35 years). METHOD: 1293 patients received Mitigator DES + at LPS Institute of Cardiology, Kanpur, India. Primary outcome was target lesion failure (TLF)- composite of cardiovascular death, target vessel myocardial infarction (TVMI), and target lesion revascularization (TLR) and secondary end points including peri-procedural device failure (failure of stent delivery, change of stent, stent fracture), target vessel failure (TVF), and patient oriented composite end point (POCE)-composite of all deaths, MI, and revascularization and stent thrombosis (ST) at 1-year follow-up. RESULT: Younger population comprised of 374 (29%) patients. Various indications of interventions were STEMI (n = 614; 47.4%), NSTEMI (n = 416; 32.2%), UA (n = 161; 12.5%), and CCS (n = 102; 7.9%). TLF at 1 year in young and overall population were 3.4% and 3.5% respectively which was driven by TVMI and TLR in 1.3% and 1.1% patients respectively. POCE was observed in 9.5% in each group mainly contributed by any revascularization (3.9%). Device failure was significantly lower in young group than overall population (1.3% vs. 2.2%; p = 0.04) which was mainly driven by stent delivery (1.1%) and edge dissection (0.5%). Definite and probable ST was 1.3% and 1.7% respectively which was not significant. Young patients showed insignificantly lower TLF, TVF, ST and POCE and significantly lower device failure (1.3% vs. 2.6%; p = 0.04) when compared to patients >35 years. On multivariate regression analysis, complex lesion, in-stent restenosis, failure of stent delivery and edge dissection were independent predictors of events or device success rate. CONCLUSION: Mitigator DES+™ is safe among real world patients, including young population.

Clinical safety and efficacy of World's thinnest (50 µm), very long (>40 mm) Everolimus Eluting Stent (SES) among real world patients.

BACKGROUND: Safety and efficacy of newer-generation and World's thinnest everolimus eluting stent (Evermine 50) in patients with very long and multiple lesions. METHOD: Total of 711 patients received >40 mm long, World's thinnest (50 µm) Evermine 50 Everolimus eluting stent (Meril Life Sciences Pvt. Ltd., India) for various indications at LPS Institute of Cardiology, GSVM Medical College, Kanpur, UP, India between August 2017 and December 2018. Primary outcome as Device-oriented composite outcome (DOCO)- composite of cardiovascular death, target vessel myocardial infarction, and target lesion revascularization, secondary end points including peri-procedural device failure (failure of stent delivery, change of stent, edge dissection, stent fracture), target vessel failure (TVF), Global Cardiovascular End Points (GCEP)- composite of all-cause death, any MI, and any revascularization, and stent thrombosis (ST) were evaluated at 1-year follow-up. RESULT: Mean age was 52.7±15.9 years and majority (78.6%) were male. Indications for implantation were STEMI (n=284; 46.2%), NSTEMI (n=201; 32.8%), UA (n=78; 12.6%), and CCS (n=52; 8.4%). Total of 989 lesions were treated among 711 patients. Median length of stent per lesion was 54±14 mm. DOCO occurred in 47 (6.6%) which was contributed by target vessel MI and TLR in 23 (3.2%) and 15 (2.1%) patients respectively. GCEP was observed in 117 (16.4%) at 12-month follow-up mainly attributed by any revascularization 60 (8.4%). Stent failure was seen in 36 (5.1%) patients mainly as result of failure of assigned stent delivery (n=18; 2.5%), and edge dissection (n=15; 2.1%). Definite and probable ST were observed in 8 (1.1%) and 6 (0.8%) patients respectively. CONCLUSION: Evermine 50 Everolimus eluting stent is safe and effective to treat unduly long and multiple lesions.

A comparative assessment of Dorsal radial artery access versus classical radial artery access for percutaneous coronary angiography-a randomized control trial (DORA trial).

OBJECTIVES: This is an open-label randomized control trial with a parallel assignment with single masking comparing patients undergoing coronary angiography via dorsal radial and classical radial access. METHODS: Study done at three tertiary cardiac care centers for two years. A total of 970 patients were finally recruited for the study. Patients were randomly selected for dorsal radial artery access Group A (485 patients) and classical radial artery access Group B (485 patients) without any bias for age & sex. RESULTS: On comparative assessment both techniques are found to be equal in terms of procedural success rate. While dorsal access was superior in terms of fewer incidences of forearm radial artery occlusion, radial artery spasm, less post-procedure persistence of pain, and hand clumsiness. In comparison to this, the number of puncture attempts and time to achieve post-procedure hemostasis is less in classical radial access. CONCLUSION: So both techniques have pros and coins and it is the discretion of interventionists to adopt which technique.

Successful occlusion of a large pulmonary arterio-venous fistula with Amplatzer septal occluder in a 16-year-old cyanotic boy.

Pulmonary arterio-venous fistula is an uncommon cause of cyanosis and should be suspected when normal cardiac examination is associated without evidence of intra-cardiac shunt. Diagnosis of extra-cardiac shunt can be suspected by contrast echocardiography using agitated saline and confirmation of pulmonary arterio-venous fistula can be made by computed tomography pulmonary angiography with information regarding the size feeding vessels necessary for the planning of intervention. With the advancement of trans-catheter devices, fistula can be occluded successfully by embolotherapy. Coils, duct occluders, and vascular plugs are some of the commonly used trans-catheter devices among the armamentarium. Each device has its own inherent advantages and limitations. However, operators' familiarity and expertise is an important parameter to choose the device to be employed in closure of fistula. The experience of Amplatzer family of devices in closure of pulmonary arterio-venous fistula is limited in the literature. We report a case of large pulmonary arterio-venous fistula successfully closed with a 20 mm Amplatzer septal occluder device in a 16-year-old cyanotic boy. Post-procedure contrast echocardiography confirmed absence of right to left shunt and computed tomography pulmonary angiography confirmed the device in situ closing the feeding vessel. Over a follow-up of six months reversal of clubbing and cyanosis was noted. .

Feasibility Study of the Health Empowerment Intervention in Older Adults With Heart Failure.

BACKGROUND: Of almost 5.7 million Americans with heart failure, 80% are 65 years and older. Empowerment approaches facilitating recognition of personal and social contextual resources may improve well-being in this vulnerable population. OBJECTIVE: This research evaluated the feasibility of the Health Empowerment Intervention (HEI) in older adults with heart failure, including effects on health empowerment, purposeful participation, self-management, functional health, and well-being. METHODS: Twenty older adults with heart failure were randomly assigned to HEI or Attention Control conditions. The HEI consisted of 6 weekly sessions based on the Health Empowerment Theory. Outcomes were measured at baseline and at 6 weeks. RESULTS: Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.ConclusionsThis research supports the feasibility of the HEI and provides a basis for continued evaluation.

Non-pharmaco, non-invasive management of coronary no-reflow phenomenon.

INTRODUCTION: No-reflow is an infrequent but dreaded complication of percutaneous coronary intervention (PCI), where the culprit is obstruction of the downstream microvascular bed. The aim of this study was to evaluate the efficacy and safety of forceful injection of blood (autologous blood transfusion - ABT) in reversing no-reflow during PCI because data regarding its effectiveness is not available. MATERIAL AND METHODS: 100-120 ml of blood was withdrawn through guiding catheter over 3 to 5 min using a 10 ml syringe and re-infused by forceful injection over 3 min through it, and its efficacy was assessed at 10 min using TIMI flow grade and quantitative corrected TIMI frame count. RESULTS: In total 93 patients received ABT following no-reflow. Their clinical presentation was ST-elevation myocardial infarction (STEMI) (n = 61; 65.6%), non-ST-elevation myocardial infarction (NSTEMI) (n = 23; 24.7%), and unstable angina (n = 9; 9.6%). It was observed among patients undergoing primary PCI (n = 18; 19.3%), pharmaco-invasive PCI (n = 27; 29%), rescue PCI (n = 11; 11.8%), and PCI for cardiogenic shock (n = 5; 5.3%). A mean volume of 108 ±4 ml blood was transfused. Commonest culprit vessel was left anterior descending artery (n = 51; 54.8%) followed by right coronary (n = 29; 31.2%), left circumflex (n = 19; 10.8%), and saphenous vein grafts (n = 3; 3.2%). Following ABT, TIMI 3 flow was successfully restored in 77 (82.7%) patients. TIMI flow grade improved from 1.02 to 2.52 and cTIMI frame count decreased from 60.6 ±12 to 16.1 ±6 (p < 0.001). ABT was well tolerated except transient hypotension (n = 17; 18.3%). Overall mortality was reported in 10 (10.7%) patients at 1 year. CONCLUSIONS: In this largest and only study to date, ABT is a safe and highly effective approach to reverse no-reflow by raising driving pressure across the capillary bed.

The Safety and Efficacy of Guidezilla Catheter (Mother-in-Child Catheter) in Complex Coronary Interventions: An Observational Study.

BACKGROUND: Lesion characteristics (anatomy, calcification, tortuosity and angulation), vessel morphology, and lack of support add complexity of coronary intervention. Guidezilla catheter, acting as an extension of guide catheter system (mother-in-child catheter), helps to overcome these complexities by enhancing backup during complex intervention. METHODS: The present retrospective, single-center study included 13,157 consecutive patients who underwent percutaneous coronary intervention (PCI) through both transfemoral and transradial routes from January 2015 to July 2019 at LPS Institute of Cardiology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India among which Guidezilla™ catheter (Boston Scientific, Natick, MA, USA) was used in 156 patients. Study endpoints were target lesion crossing, procedural success, and complications. The clinical, angiographic and procedural data of all 156 patients were evaluated to assess safety and efficacy of Guidezilla extension catheter (GEC). RESULTS: The mean age of the enrolled patients was 61.2 ± 8.67 years. Type-C lesion was commonest (69.9%) followed by B2 (22.4%) and B1 (7.7%). The commonest indication for its use was tortuosity (30.1%) followed by calcification (21.1%), angulation (18.8%), chronic total occlusion (17.9%), distally located lesion (8.3%), and anomalous origin of vessel in 3.8%. The right coronary artery (39.2%) was most commonly intervened artery followed by left anterior descending (LAD) (30.8%), left circumflex (LCX) (19.9%), multivessels (7.6%), and saphenous vein graft in 2.5%. The mean depth of intubation was 4.2 ± 1.9 cm. Mean diameter of stents was 34.2 ± 14.4 mm while mean length of stents was 31.2 ± 10.2 mm. Lesions were modified using aggressive pre-dilatation in 87.8%, followed by cutting balloon in 10.9%. GEC was delivered across the lesion using buddy wire technique (9.6%), balloon-assisted tracking (BAT) in 30.1%, and balloon-assisted sliding and tracking (BLAST) in 4.5% of patients. Stent implantation was successful in 151 out of 156 patients with success rate of 96.7%. Overall failure rate was 3.3% which was contributed by extreme tortuosity, angulation, and severe calcification. Guidezilla-associated procedural complication (dissection, stent dislodgement, shaft breakage) were reported in three patients (1.9%) who were successfully managed. CONCLUSION: s Guidezilla system acting as mother-in-child extension catheter is a safe and effective tool which provides additional backup support and increases success rate of PCI for complex coronary lesions.