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).

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.

Radial Artery Occlusion - Incidence, Predictors and Long-term outcome after TRAnsradial Catheterization: clinico-Doppler ultrasound-based study (RAIL-TRAC study).

Background and aim The purpose of this study was to assess incidence, predictors and outcome of radial artery occlusion (RAO) after transradial catheterization (TRC) based on clinical and Doppler ultrasound study. Methods A total of 1,945 consecutive patients undergoing transradial catheterization for diagnostic evaluation or intervention were included. Radial artery examination was based on palpation and colour Doppler study on the day before, 1 day (D1), 1 month (D30) and 6 months (D180) following the procedure. RAO was defined as absence of pulse on palpation and forward flow on Doppler study. Predictors of RAO were found by logistic regression analysis. Results Baseline demographic and procedural data were recorded. The mean radial arterial diameter was 2.56 ± 0.29 mm. On D1, radial artery Doppler examination revealed RAO in 339 patients (17.4%) but pulse was still palpable in 115 (34%) of them. At D30, these were 221 (11.4%) and 114 (52%), respectively, as no new RAO were noted. Interestingly, 118 (34.8%) patients had spontaneous recanalization of their radial artery as shown by catch-up in patency rate. At D180, these were 99 (5.1%) and 68 (69%), respectively, meaning further new catch-up implying further recanalization. Patients with persistent RAO remained asymptomatic. On multivariate analysis, female sex, diabetes, lower BMI, radial artery diameter ≤2.2 mm and radial artery-to-sheath ratio (AS ratio) < 1 were predictors of RAO. Conclusion TRC for coronary angiography, ad hoc and staged angioplasty can be performed with similar efficacy and safety though RAO occurs more frequently in patients with prior radial artery cannulation and with larger sheath size. Persistent RAO remains asymptomatic.

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.

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.

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.

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.

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.

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.