Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease-2.

BACKGROUND: The role of percutaneous coronary interventions (PCI) in patients with diabetes mellitus and multi-vessel disease has been questioned by the results of the FREEDOM trial, which showed superiority of coronary artery bypass graft(CABG) over first generation drug-eluting stents (DES) including a reduction in mortality. In the light of safer and more efficacious stents and significantly better medical management, those results that date back to 2012 need to be revisited. TUXEDO-2 is a study designed to compare two contemporary stents in Indian diabetic patients with multi-vessel disease. AIMS: The primary objective of the TUXEDO-2 study is to compare the clinical outcomes of PCI with ultra-thin Supraflex Cruz vs Xience when combined with contemporary optimal medical therapy (OMT) in diabetic patients with multi-vessel disease. The secondary objective is to compare clinical outcomes between a pooled cohort from both arms of the study (Supraflex Cruz + Xience; PCI arm) vs CABG based on a performance goal derived from the CABG arm of the FREEDOM trial (historical cohort). The tertiary objective is a randomized comparison of ticagrelor vs prasugrel in addition to aspirin for the composite of ischemic and bleeding events. METHODS: In this prospective, open-label, multi-centre, 2 × 2 factorial, randomized, controlled study, 1,800 patients with diabetes mellitus and multi-vessel disease (inclusion criteria similar to FREEDOM trial) with indication for coronary revascularization will be randomly assigned to Supraflex Cruz or Xience stents and also to ticagrelor- or prasugrel- based antiplatelet strategies. All patients will receive guideline directed OMT and optimal PCI including image- and physiology-guided complete revascularization where feasible. The patients will be followed through five years to assess their clinical status and major clinical events. The primary endpoint is a non-inferiority comparison of target lesion failure at one-year for Supraflex Cruz vs Xience (primary objective) with an expected event rate of 11% and a non-inferiority margin of 4.5%. For PCI vs CABG (secondary objective), the primary endpoint is major adverse cardiac events (MACE), defined as a composite of all cause death, nonfatal myocardial infarction, or stroke at one-year and yearly up to five years, with a performance goal of 21.6%. For ticagrelor vs prasugrel (tertiary objective), the primary endpoint is composite of death, myocardial infarction, stroke, and major bleeding as per the Bleeding Academic Research Consortium (BARC) at one-year with expected event rate of 15% and a non-inferiority margin of 5%. CONCLUSIONS: The TUXEDO-2 study is a contemporary study involving state-of-the-art PCI combined with guideline directed OMT in a complex subset of patients with diabetes mellitus and multi-vessel disease. The trial will answer the question as to whether a biodegradable polymer coated ultra-thin Supraflex Cruz stent is an attractive option for PCI in diabetic patients with multi-vessel disease. It will also help address the question whether the results of FREEDOM trial would have been different in the current era of safer and more efficacious stents and modern medical therapy. In addition, the comparative efficacy and safety of ticagrelor vs prasugrel in addition to aspirin will be evaluated. (CTRI/2019/11/022088).

Post market surveillance registry (PIONEER) of the Yukon Choice PC-Elite Coronary Stent System for percutaneous coronary intervention in Indian acute coronary syndrome population.

AIM: The aim of this study was to assess the safety and efficacy profile of a newer generation biodegradable DES, the Yukon Choice PC Elite with a temperature controlling mechanism, in patients with acute coronary syndrome (ACS). METHODS: This prospective multi-center study (PIONEER Registry) was conducted in an Indian ACS population, therefore providing data in real world clinical practice. Patients with ACS underwent DES implantation in de novo native-vessel coronary lesions with the Yukon Choice PC Elite biodegradable polymer DES and were followed up for a year. RESULTS: A total 999 patients were evaluated. The majority of patients were male (79.2%). A total of 6.7% of the patients had a history of prior myocardial infarction (MI) and 2.7% of patients had a history of previous coronary artery bypass graft. The clinical presentations of the patients included: unstable angina pectoris (UA) (46.4%), ST-segment elevation MI (STEMI) (38.1%), and Non-ST-segment elevation MI (NSTEMI) (15.4%). Implantation of the device was successful in 99.9% of cases. The median stent length and stent size were 21.0 mm (Range: 8.0-40.0 mm) and 2.8 mm (Range 2.0-4.0 mm), respectively. Through to one-year clinical follow-up after percutaneous coronary intervention, all-cause death occurred in 4 of 999 patients (Crude Percentage: 0.4%). Cardiac death, MI, TLR, and stent thrombosis were occurred in 1 (0.1%), 8 (0.8%), 12 (1.2%) and 1 (0.1%) patients, respectively. CONCLUSION: The results of this post marketing surveillance registry suggest favorable safety and efficacy outcomes associated with the Yukon Choice PC Elite biodegradable DES in a real world Indian ACS population.

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.

Outcome of submitral aneurysm.

INTRODUCTION: Submitral aneurysm is a rare cardiac entity with outpouching in relation to the posterior annulus of the mitral valve. Multiple etiology have been described with the role of infection and inflammation with varied clinical presentation in different case reports. However, the literature on clinical outcome and follow-up is lacking. MATERIAL AND METHOD: This retrospective, observational study included all the adult patients (>18 years) who were diagnosed with a submitral aneurysm. Epidemiological, demographic, laboratory, clinical management, and outcome data were extracted and followed for the endpoints of cardiac death, noncardiac death, recurrent hospitalization (due to heart failure, rupture, arrhythmic events, embolic events), surgical repair, and echocardiography parameters for mitral regurgitation or change in the size of the left ventricle for 1-year postdischarge from the index hospitalization. RESULTS: A total of 10 patients were enrolled in the study with a mean age of 31.2 ± 11.1 years. Possible etiology could be established in only five (50%) patients (two patients had tuberculosis and three patients had acute coronary syndrome). At index hospitalization, nine (90%) patients had heart failure, two (20%) patients had rupture of a submitral aneurysm, four patients underwent surgery, and one patient expired. On follow-up of 1 year, one more patient underwent surgical repair while three patients expired. CONCLUSION: A submitral aneurysm is a rare cardiac entity with poor outcomes. Surgical repair with or without mitral valve replacement plays a definitive role in management.

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.

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.

Hematinic deficiency in patients with heart failure with reduced ejection fraction (HFrEF).

BACKGROUND AND OBJECTIVES: Hematinic deficiency irrespective of anemia is not uncommon in patients with heart failure. We studied the prevalence, distribution, and etiology of anemia in patients with heart failure with reduced ejection fraction (HFrEF) and compared it with non-anemic patients. METHODS: Congestive heart failure (CHF) was diagnosed by modified Framingham criteria and ejection fraction (EF) <40%. Iron deficiency (ID) anemia was defined as serum ferritin level <100 ng/ml (absolute) or 100-300 ng/ml with transferrin saturation <20% (functional). Vitamin B12 and folate deficiency were defined as <200pg/ml and <4ng/ml respectively. RESULT: 688 patients with HFrEF were studied with an overall mean age of 57.2±13.8 years, and males outnumbering females (62.3% vs. 37.7%). Coronary artery disease (44.2%), dilated cardiomyopathy (46.8%), and valvular heart disease (6.7%) were major causes of CHF.Anemia was found in 63.9% of patients. Vit B12 deficiency, and folate deficiency were found in 107 (15.55%), and 54 (7.85%) subjects, respectively. Absolute ID was detected in 186 (42.27%) patients with anemia and 84 (33.87%) patients without anemia, while functional ID was present in 80 (18.18%) patients with anemia and 29 (11.69%) patients without anemia. Vitamin B12 deficiency was noted in 70 (15.9%) patients with anemia and 37 (14.9%) patients without anemia, while folate deficiency was noted in 31 (7.04%) patients with anemia and 23 (9.2%) patients without anemia. Hematinic deficiency among the study population was distributed equally among patients irrespective of EF, NYHA class, socioeconomic class diet pattern. CONCLUSION: The study shows that hematinic deficiency was seen even in non-anemic patients irrespective of diet pattern. Supplementation could be a strong strategy to improve outcomes in these patients of heart failure irrespective of anemia and should be evaluated in prospective studies.

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.

Percutaneous endovascular exclusion of radial artery pseudoaneurysm.

BACKGROUND: Coronary angiography and intervention through transradial approach is becoming default approach because of infrequent local site complications. Although pseudoaneurysm is a well described complication for femoral access, it is extremely rare in transradial access. CASE REPORT: Our patient was 68-year old female who had presented with pulsatile, painful, and gradually increasing swelling over lower part of right forearm near wrist joint for past 8-weeks following coronary angiography through right radial route. Swelling did not resolve following manual compression. It was diagnosed as pseudoaneurysm arising from right radial artery by duplex ultrasound. It was successfully excluded by deploying 3.5x18mm Graftmaster covered stent (Abott Vascular, USA) through right transbrachial route. Ultrasonography next day revealed partially thrombosed and completely excluded pseudoaneurysm with swelling completely disappearing at 6 weeks with patency maintained at one year. CONCLUSION: With increasing use of transradial access, more cases of radial pseudoaneurysm are likely to surface which can be prevented following a proper haemostatic protocol. To best of our knowledge, it is first ever report of percutaneous endovascular exclusion using covered stent of radial pseudoaneurysm through transbrachial approach.

Effect of Percutaneous Coronary Intervention on Diastolic Function in Coronary Artery Disease.

BACKGROUND: Left ventricle (LV) diastolic dysfunction is often present in patients with significant coronary artery disease (CAD), even in the absence of regional or global LV systolic dysfunction. It has been suggested that abnormalities in LV diastolic function may actually precede LV systolic dysfunction, and therefore, serve as an early and sensitive marker of ischemia. This study aims to find improvement of diastolic function after percutaneous coronary intervention (PCI) in patients with stable or unstable angina. METHODS: In this single-center hospital-based study, we enrolled 309 patients with either stable or unstable CAD and with normal systolic function who underwent successful PCI. Two-dimensional transthoracic echocardiography was performed at baseline (before PCI) and repeated 48 h after PCI. LV diastolic parameters were compared before and after PCI using paired samples t-test results. RESULTS: Mean age of study population was 56.65 ± 9.65 years. Majority of patients were male (63%). There was significant increase in mitral E-wave velocity (68.39 ± 17.52 cm/s vs. 71.64 ± 18.23 cm/s), E/A ratio (0.85 ± 0.29 vs. 0.89 ± 0.32), and early diastolic mitral annular motion (e') (7.02 ± 0.89 cm/s vs. 8.45 ± 0.86 cm/s) following PCI (P < 0.0001). Left atrial volume index (22.53 ± 4.43 vs. 20.81 ± 4.14), tricuspid jet velocity (0.91 ± 0.57 m/s vs. 0.76 ± 0.67 m/s), and E/e' ratio (10.03 ± 3.5 vs. 8.62 ± 2.61) decreased significantly following PCI (P < 0.001). CONCLUSION: This study suggests that LV diastolic filling pattern is modified significantly as early as 48 h after successful PCI. Improvement in impaired relaxation appears to be most likely explanation for these changes. PCI may be potential therapeutic target to improve diastolic function in patients with CAD.

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.

Comparison of original and modified Q risk 2 risk score with Framingham risk score - An Indian perspective.

OBJECTIVE: No study among Indian population has proposed modification of existing cardiovascular disease (CVD) risk scores or novel risk scores as risk estimation using conventional risk calculators can't be generalized because of epidemiological differences. MATERIAL AND METHODS: A single center observational study was performed at a tertiary care center among participants having no evidence of CVD. Prevalence of various cardiac risk factors were analysed and 10-year risk was estimated using Framingham risk score (FRS), Q risk 2 score calculator (QRISK2) and Modified Q risk 2 (mQRISK2) which included smokeless tobacco consumption. QRISK2 and mQRISK2 were compared with FRS and participant's eligibility for statin therapy as primary preventive measure was assessed. RESULTS: Total of 4045 participants were enrolled from August 2016 to July 2019. 3520(87%) had no history of smoking in their lifetime while smokeless tobacco consumption was seen in 1153(28.5%), diabetes in 422(10.4%), hypertension in 1096(27.1%), obesity in 2035(50.3%), and family history of CVD in 353(8.7%) participants. High risk participants were found to be 826(20.4%), 627(15.5%), and 509(12.6%) by using FRS, mQRISK2 and QRISK2, whereas those eligible for statin therapy were maximum by mQRISK2 among 1323(32.7%) participants compared to QRISK2 (n = 1191; 29.4%) and FRS (n = 826; 20.4%) model. Krippendorff's alpha for mQRISK2 was in better agreement with body mass index (BMI) and lipid FRS CVD scoring system as compared to QRISK2 risk model. CONCLUSION: CVD risk stratification based on smokeless tobacco use is first of its kind from this part of world and should be part of CV risk assessment.

Adverse effects and short-term developmental outcomes of infants exposed to atypical antipsychotics during breastfeeding.

BACKGROUND: Postpartum period in women is vulnerable to the occurrence and exacerbation of psychiatric disorders. Mothers with postpartum psychosis or bipolar disorder need treatment with psychotropic medications, especially atypical antipsychotics. However, many mothers and families will have reservations about the use of psychotropics during the perinatal period, particularly during breastfeeding because of its presumed side effects and adverse developmental outcomes of the child. Since there are limited data in this area, the present study aimed to examine the adverse effects, if any, and the short-term developmental outcome of infants exposed to atypical antipsychotics during breastfeeding. METHODS: The study involved infants of postpartum women (n = 28) who were admitted in the mother and baby inpatient psychiatry unit of a tertiary care center in India. The medication side effects were checked every alternate day for 1-2 weeks using a checklist based on common side effects that infants may experience due to lactation exposure of atypical antipsychotics. Developmental assessments of the infants were done using the Developmental Assessment Scales for Indian Infants and through anthropometric measurements such as weight, length, head circumference, and chest circumference in follow-up when they came as an outpatient after 1-3 month interval. RESULTS: The occurrence of adverse side effects was quite low (17.85%). The main side effects directly attributable to atypical antipsychotics were constipation and sedation. Of the 17 infants who attended follow-up, 52.9% (n = 9) showed some form of developmental delay at the time of the first follow-up. However, low birth weight, higher maternal age (>35 years), and exposure to medications (quetiapine and phenytoin) during pregnancy may be confounding risk factors. CONCLUSIONS: The acute adverse effects of atypical antipsychotics such as sedation and constipation in the infant through breast milk were seen in less than a fourth of the sample. Developmental delay was noted in a proportion of infants; however, this may be due to other risk factors.

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.

Ultrathin (60 µm), ultralong (≥40 mm) sirolimus-eluting stent: study of clinical and safety profiles among real-world patients.

OBJECTIVE: Although thin-strut drug-eluting stents (DES) with a more flexible design are easily obtainable, data regarding using ultralong DES (≥40 mm) for long coronary lesions are limited in the literature. Therefore, the current study assessed the safety and efficacy of an ultralong (≥40 mm) and ultrathin (60 µm) biodegradable polymer-coated sirolimus-eluting stent (SES), Supralimus Grace, with a unique Long Dual Z-link (LDZ-link) design (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world patients with long coronary lesions. METHODS: The assigned stents were implanted in 684 patients. The primary endpoint was target lesion failure (TLF), which is a composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), whereas periprocedural secondary endpoints included device failure (failure of stent delivery, change of stent, and stent fracture) and patient-oriented composite endpoint (POCE), which is a composite of all deaths, any MI, and any revascularization, and stent thrombosis (ST). These outcomes were analyzed at one-year follow-up and during the procedure. RESULTS: The patients' mean age was 52.7±15.9 years; 537 (78.5%) were males. 626 (91.5%) patients suffered from acute coronary syndrome and 58 (8.5%) patients from chronic coronary syndrome (CSS). 989 lesions were removed. The mean numbers of lesions and stents implanted per patient were 1.3±0.2 mm and 1.4±0.3 mm, respectively. TLF occurred in 42 (6.1%) as a result of cardiac death, target vessel MI, and TLR in 9 (1.3%), 20 (2.9%), and 13 (1.9%) patients, respectively. POCE was observed in 131 patients (19.1%) at one-year follow-up, mainly in 63 (9.2%) patients because of any revascularization. Stent failure was seen in 21 patients (3.1%) as a result of delivery failure (2.2%), edge dissection (0.8%), and fracture (0.1%). Definite and probable ST were observed in 8 (1.1%) and 9 (1.3%) patients, respectively. CONCLUSION: Ultralong (≥40 mm), ultrathin (60 µm) Supralimus Grace stent can be safely implanted in vessels having long and multiple lesions.

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.

Isolated pneumopericardium; An extremely rare complication following active resuscitation in a term neonate.

BACKGROUND: Pneumopericardium, presence of air in pericardial cavity, is rare entity with potentially severe complications and mortality. In the neonatal period, it is associated with prematurity, low birth weight, and assisted ventilation, but in full term neonates its occurrence after resuscitation is exceedingly rare. CASE REPORT: Our patient was a 2-day old full term neonate who developed respiratory distress following active resuscitation which was carried out at the time of birth in lieu of perinatal asphyxia. He was immediately put on mechanical ventilatory support. Chest x-ray showed a "halo sign"- rim of air completely surrounding the heart, and echocardiography confirmed pneumopericardium with cardiac tamponade. Pericardiocentesis was performed as a life saving measure. CONCLUSION: He was successfully discharged on the tenth day following sheath removal, and is doing fine on follow up.

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.