Original Article--Clinical and Procedural Characteristics of Successful Transcatheter Device Closure of Ostium Secundum Atrial Septal Defect in Symptomatic Children Weighing <15 kg: A Retrospective Study Spanning One Decade From South India.

Objectives: This retrospective study sought to determine the feasibility of transcatheter atrial septal defect device closure in patients less than 15 kg, as well as to assess complication rates and the reasons for unsuccessful device closure. Background: In general, the risks associated with transcatheter atrial septal defect device closure are believed and reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend atrial defect closure in device closure in children <15 kg, due to limited data available for feasibility and safety of device closure in this group of patients. Methods: Retrospective review of all patients who underwent elective transcatheter closure of ostium secundum atrial septal defect between September 2013 to February 2022. We excluded all children above 15 kg, as well as those with complex congenital heart defects. Major and minor complications were predefined and indications for referral were evaluated. Results: We identified 81 patients meeting criteria with a median procedural age of 3 years (1 year-8 years), and median weight of 12 kg (4-15 kg). Successful device closure was achieved in 95.1% (77/81) and in 4.9% (4/81), the procedure was aborted. There was 1 major (1.2%) and 1 minor (1.2%) complication, total complication rate (2.4%). 100% of the referrals had right heart enlargement and exertional dyspnoea, 18.5% had recurrent lower respiratory tract infection and 9.9% had failure to thrive. Rate of resolution of residual shunt was 95.1%. at post-procedure day 1 and 98.8% at post-procedure 3 and 6 months respectively. Conclusions: Percutaneous atrial septal defect closure can be done effectively and safely in symptomatic children weighing less than 15 kg in experienced centres. However, deferral for closure until the historically established timeline of around 4-5 years of age should be strongly considered in asymptomatic children.

Speckle tracking echocardiography-derived left ventricular global longitudinal strain in ex-thalassaemics.

AIMS: Long term survivors of haematopoietic stem cell transplantation (HSCT) for ß-thalassemia major are designated "ex-thalassaemics". Whether ex-thalassaemics continue to harbour residual myocardial dysfunction and thereby stand the risk of heart failure-related morbidity and mortality is unknown. The aim of this study was to assess the prevalence and predictors of subclinical left ventricular (LV) dysfunction in an apparently normal ex-thalassaemic population. METHODS: We conducted a single centre cross-sectional study among 62 ex-thalassaemic patients, who had undergone HSCT for ß-thalassaemia major at our centre. The primary outcome variable was LV systolic dysfunction, as assessed by 1) LV global longitudinal strain (GLS) derived by 2D speckle tracking echocardiography and 2) LV ejection fraction (EF) derived by 2D Simpsons Biplane method. RESULTS: Among the 62 patients included in the study, 7 [11.3%] were found to have LV systolic dysfunction, all of which were subclinical. Of these, 4 [6.5%] had abnormal GLS and LVEF, 2 [3.2%] had abnormal GLS with normal LVEF, and 1 [1.6%] had abnormal LVEF with low normal mean GLS. There were no statistically significant predictors of LV dysfunction in this cohort. CONCLUSION: There was a high prevalence of subclinical myocardial dysfunction in the ex-thalassaemic population reiterating the need for close follow up of these patients. 2D Speckle tracking echocardiography-derived LV global longitudinal strain is an effective tool in detecting subclinical myocardial dysfunction in this cohort.

Outcomes of Percutaneous Intervention in Patients With Takayasu Arteritis.

BACKGROUND: The status of vascular lesion treatment using percutaneous intervention (PI) in Takayasu arteritis (TAK) remains unresolved. OBJECTIVES: This study sought to develop PI strategies appropriate for TAK. METHODS: A prospectively maintained single-center database of TAK PI procedures from 1996 to 2022 was analyzed retrospectively. Obstructive lesions were treated by elective stenting (using bare or covered stents), balloon angioplasty (BA), or cutting-balloon angioplasty (CBA), with adjunctive stenting for suboptimal BA or CBA results. PIs were repeated in restenotic lesions until sustained success was obtained. Aortic or peripheral aneurysms and spontaneous aortic dissections were treated with covered stents or endografts. Immunosuppressive therapy, started before PI, was continued long term. RESULTS: A total of 942 patients underwent PI to treat 2,450 arterial lesions (2,365 stenoses or occlusions, 85 aneurysms or dissections) in 630 subclavian or axillary, 586 renal, 463 aortic, 333 carotid, 188 mesenteric, 116 iliac, 71 coronary, and 63 other arteries; 3,805 PIs were performed (1.55 PIs per lesion; range 1-7 PIs per lesion). Early success was obtained in 2,262 (92.3%), and late success in 1,460 (84.5%) of 1,727 lesions with a median of 39 months (IQR: 15-85 months) of follow-up. Repeated PIs increased late success in obstructive lesions from 48.6% to 83.3%. A total of 1,687 elective stenting lesions achieved 88% late success with 1.49 PIs per lesion; covered stents (1.18 PIs per lesion) restenosed less than bare stents (1.51 PIs per lesion; P < 0.001). A total of 183 (36%) of 513 BA-treated lesions had good outcomes without adjunctive stenting; 122 CBA-treated lesions had 19% dissections and 8% ruptures or pseudoaneurysm formations. Aneurysms or dissections had 91.3% late success after PI. A total of 472 complications occurred in 415 (17%) lesions; 375 (79%) were resolved. CONCLUSIONS: Most vascular lesions in TAK can be effectively, safely, and durably treated using predominantly stent-based PI strategies.

Transcatheter closure of large ostium secundum atrial septal defects in symptomatic small children: A single-center retrospective study.

Background: In general, the risks associated with transcatheter atrial septal defect (ASD) device closure are reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend ASD device closure in children with defect sizes >20 mm due to limited data available in this group of patients. This retrospective study sought to determine the clinical and procedural characteristics of successful transcatheter ASD device closure in small children with large defects and assess the complication rates and reasons for unsuccessful device closure. Methods: We retrospectively reviewed the data of all patients who underwent elective transcatheter closure of ostium secundum ASD in our department between September 2013 and February 2022. All children weighing <20 kg, requiring a device of size 20 mm or greater, were included. Major and minor complications were predefined and indications for referral were evaluated. Echocardiogram reports were reviewed from the time of referral, postcatheterization day 1, and at 1-year follow-up. Results: We identified 40 patients meeting inclusion criteria with a median (interquartile range [IQR]) procedural age of 5 (4-7) years and median (IQR) weight of 14 (12-18) kg. Successful device closure was achieved in 39 patients with a success rate of 97.5%. The total complication rate was 2.5% (95% confidence interval: 0.44%- I2.8%) with only 1 major complication. All children had right heart enlargement and exertional dyspnea, 30% of patients had recurrent lower respiratory tract infections, and 10% had failure to thrive. At 1-year follow-up, a transthoracic echocardiogram showed a well-endothelialized device in a stable position in all the patients, and none of the patients had a residual shunt. Conclusion: In experienced centers, percutaneous ASD closure of large defects in symptomatic small children can be done effectively and safely with a great degree of predictability and a low complication rate.

Transcatheter aortic valve implantation with a novel pre-packaged self-expandable dry-tissue transcatheter aortic valve: a case report.

BACKGROUND: Current commercially available transcatheter aortic valves are stored separately in a glutaraldehyde solution and mounted onto the delivery system by a technical expert during the transcatheter aortic valve implantation (TAVI) procedure. A pre-mounted dry-tissue valve that is crimped on a ready-to-use delivery system could simplify the procedure. The Vienna self-expanding transcatheter valve (P&F, GmbH, Wessling, Germany) is a novel ready-to-use pre-mounted dry-tissue transcatheter aortic valve. There are no prior reports on the efficacy of this valve system. CASE SUMMARY: Here, we report our experience of an implantation of a novel ready-to-use dry-tissue Vienna transcatheter aortic valve in a 72-year-old male with symptomatic severe aortic stenosis and severe left ventricular systolic dysfunction. He had presented with heart failure [N-terminal pro-brain natriuretic peptide (NT-proBNP) level at the admission of 10 600 pg/mL], New York Heart Association Class-3, and recurrent syncope. A 26 mm Vienna valve was successfully implanted via the transfemoral route under conscious sedation. There were no complications. The patient was discharged in a stable condition on the third post-procedure day. At 1-year follow-up, the valve is functioning well with no evidence of structural degeneration (mean gradient 9 mmHg, no valvular regurgitation). Currently, he is asymptomatic with normal left ventricular systolic function on echocardiography (NT-proBNP 57 pg/mL). DISCUSSION: To our knowledge, this is the first case of TAVI performed with the dry-tissue pre-mounted VIENNA valve. Our case highlights the feasibility and short-term efficacy of the VIENNA valve. Further safety and durability need to be addressed by a multicentre trial.

Coronary artery disease management and cost implications with fractional flow reserve guided coronary intervention in Indian patients with stable ischemic coronary artery disease.

OBJECTIVES: To study the safety of stent avoidance, frequency of change in management decisions, and its cost implications while using a fractional flow reserve (FFR)-guided treatment strategy for intermediate-grade coronary artery stenosis. BACKGROUND: The impact of FFR in guiding management decisions and its cost implications has not been studied after imposition of a ceiling on stent prices by the Government of India. METHODS: In 400 patients with 477 intermediate-grade coronary lesions for whom coronary intervention was planned, functional assessment using FFR was done. Incidence of the primary composite endpoint (major adverse cardiac event [MACE], cardiac death, myocardial infarction, objective evidence of ischemia, and target vessel revascularization) in the stent avoided subset was compared with the stented group at follow-up. Micro-costing analysis was done using a computed model with current stent and FFR wire prices. RESULTS: The overall incidence of MACE was 4.9%, 0.9% in the stent-avoided subset and 6.9% in stented group (p = 0.04, comparing the latter two) at a median follow-up of 21 months (interquartile range 12-31 months). Serious adverse events occurred only in 1% of patients receiving adenosine. The average cost saving was Indian rupees (INR) 51,847 [United States Dollar (USD) 746] per patient, resulting in total savings of INR 15,813,379 (USD 227,530). Cost savings persisted but were lower by 36% (INR 18,613/USD 268 per patient) after the ceiling of stent prices. CONCLUSION: FFR-guided percutaneous coronary intervention (PCI) strategy is safe and cost-effective in countries where majority of patients self-finance their health care, resulting in stent and PCI avoidance in approximately one in three patients referred for coronary angioplasty.

Estimating the prevalence of elevated plasma neutrophil gelatinase associated lipocalin level in patients with acute coronary syndromes and its association with outcomes.

OBJECTIVES: The principal objective of this study was to estimate the plasma levels of neutrophil gelatinase associated lipocalin (NGAL) in a cohort of patients with acute coronary syndromes (ACS) across their entire spectrum, and to correlate them with outcomes. METHODS: 87 patients with acute coronary syndromes were included in the study. Apart from the routine work up and management, all patients underwent determination of plasma NGAL and serum high sensitivity C reactive protein (HSCRP) levels at admission. The patients were followed up through the hospital stay as well as for one month after discharge for clinical outcomes, and echocardiographic parameters of left ventricular function. Plasma NGAL was studied for its predictive power for various defined outcomes. RESULTS: Plasma NGAL levels were detectably elevated in 67% of patients with ACS without any significant proportion with renal dysfunction, sepsis or overt infection. Plasma NGAL was the strongest independent predictor of all cause hospital mortality in Cox regression multivariate analysis with an odds ratio of 8.353, p=0.0237. Plasma NGAL did not correlate with HSCRP, or severity of coronary artery disease (CAD). CONCLUSION: This is a small study that shows that plasma NGAL in patients admitted with ACS can predict hospital mortality and forms the basis for consideration of this molecule as a possible new risk marker in ACS meriting further and more extensive investigation.

Criss-cross heart: Transthoracic echocardiographic features.

OBJECTIVE: To study the echocardiographic features of criss-cross heart (CCH), a congenital cardiac anomaly characterized by crossed ventricular inflow streams, in Indian patients. METHODS: In this retrospective observational study, all pediatric echocardiograms performed in a single tertiary care institution in South India over a three-year period were scrutinized for a diagnosis of CCH. Demographic, clinical and echocardiographic data were collected from patients' medical records and echocardiographic database. Crossed ventricular inflow streams was identified when there was inability to visualize both atrio-ventricular valves in a single imaging plane in cardiac four chamber view. RESULTS: CCH was diagnosed in five patients from 10,500 pediatric echocardiographic studies. The age at diagnosis ranged from one month to 8 years. Cyanosis was present in all but one of the five cases. Crossed ventricular inflow streams was present by definition in all cases, whereas superior-inferior ventricular relationship was present in only three cases. All cases were associated with ventricular septal defects. Atrio-ventricular discordance was seen in three cases and concordance in two. Ventriculo-arterial discordance was seen in three cases, concordance in one and double outlet right ventricle in one. Three cases had pulmonary stenosis and the other two had pulmonary arterial hypertension. Straddling of AV valve was observed in four cases and hypoplastic aortic arch in one case. CONCLUSION: CCH is an extremely rare congenital cardiac anomaly. Superior-inferior ventricular relationship often co-exists with CCH, but is not necessarily present in all cases. CCH requires early diagnosis because of its common association with diverse cardiac anomalies.

Radiation dose from percutaneous transluminal coronary angioplasty procedure performed using a flat detector for different clinical angiographic projections.

The radiation dose from complex cardiac procedures is of concern due to the lengthy fluoroscopic screening time and vessel complexities. This study intends to assess radiation dose based on angiographic projection and vessel complexities for clinical protocols used in the performance of percutaneous transluminal coronary angioplasty (PTCA). Dose-area product (DAP), reference air kerma (K a,r) and real-time monitoring of tube potentials and tube current for each angiographic projection and dose setting were evaluated for 66 patients who underwent PTCA using a flat detector system. The mean DAP and cumulative K a,r were 32.71 Gy cm2 (0.57 Gy), 51.24 Gy cm2 (0.9 Gy) and 102.03 Gy cm2 (1.77 Gy) for single-, double- and triple-vessel PTCA, respectively. Among commonly used angiographic projections, left anterior oblique 45°-caudal 35° reached 2 Gy in 55 min using a low-dose fluoroscopy setting and 21 min for a medium-dose setting. Use of a low-dose setting for fluoroscopic screening showed a radiation dose reduction of 39% compared with a medium-dose setting.

Left ventricular global longitudinal strain following revascularization in acute ST elevation myocardial infarction - A comparison of primary angioplasty and Streptokinase-based pharmacoinvasive strategy.

OBJECTIVE: Tenecteplase-based pharmacoinvasive percutaneous coronary intervention (PCI) has been shown to yield outcomes comparable to primary PCI in the setting of acute ST elevation myocardial infarction (STEMI). This study was designed to compare the efficacy of pharmacoinvasive PCI following successful thrombolysis with Streptokinase versus primary PCI in patients with STEMI. METHODOLOGY: We conducted a prospective single center observational study in 120 patients with STEMI who underwent primary PCI (n=60) and Streptokinase-based pharmacoinvasive PCI (n=60). Patients with Killips class 3 or 4 at presentation, and those with evidence of failed fibrinolysis were excluded. The primary outcome was LV systolic function after angioplasty, as assessed by 2D global longitudinal strain (GLS) using speckle tracking echocardiography (STE), as well as 2D LVEF using Simpson's biplane method. RESULTS: LV systolic function after PCI was significantly lower in the pharmacoinvasive arm as compared to the primary PCI arm, both by 2D STE (GLS: -9% vs -11%; p=0.03) and 2D Simpson's biplane method (LVEF: 40.7% vs 45.1%; p=0.02). TIMI flow in the culprit vessel prior to angioplasty was better in the pharmacoinvasive arm indicating successful thrombolysis, whereas post angioplasty flow was not different. There was no in-hospital mortality in either group. There was a trend toward increased incidence of acute kidney injury in the pharmacoinvasive arm. CONCLUSION: LV systolic function is significantly better after primary angioplasty as compared to pharmacoinvasive PCI following successful thrombolysis with Streptokinase.

Radiation dose and risk in children undergoing cardiac interventions performed using flat detector angiography systems.

The purpose of the study was to measure radiation doses and estimate risk from various beam projections in children undergoing cardiac interventions. The dose area product (DAP) was measured for eleven patent ductus arteriosus device closures (PDA), four atrial septal defect device closures (ASD), and three balloon pulmonary valvuloplasty (BPV) interventions performed using a flat detector system. The total mean DAPs for PDA, ASD and BPV were 1.9 Gycm2, 9.8 Gycm2 and 6.2 Gycm2 respectively. The fluoroscopic kerma dose rates increased by 10%, 33% and 92% when changing the projection from posterior-anterior to lateral projection for PDA interventions among infants, <5 yrs and >5 yrs respectively. The effective dose (ED) and organ doses were estimated from DAP using Monte Carlo software. Lungs received the highest organ dose of 7.4 mGy (PDA), 20.7 mGy (ASD) and 17.3 mGy (BPV) compared to other organs. The mean EDs from PDA, ASD and BPV were 2.5 mSv, 6.1 mSv and 4.9 mSv respectively. PDA intervention performed in infants had a radiation risk 66% higher than children aged between 3-10 years. Their lifetime attributable risk as per BEIR VII for cancer incidence was 1 in 907 males and 1 in 1047 females.

'Chamber within a chamber': a rare cardiac anomaly.

Double-chambered left ventricle is a rare cardiac anomaly. We report a case of double-chambered left ventricle in a one-and-half-year-old asymptomatic boy. We depict the use of three-dimensional echocardiography in the demonstration and diagnosis of the condition.

Radiation doses and estimated risk from angiographic projections during coronary angiography performed using novel flat detector.

Coronary angiography (CA) procedure uses various angiographic projections to elicit detailed information of the coronary arteries with some steep projections involving high radiation dose to patients. This study intends to evaluate radiation doses and estimated risk from angiographic projections during CA procedure performed using novel flat detector (FD) system with improved image processing and noise reduction techniques. Real-time monitoring of radiation doses using kerma-area product (KAP) meter was performed for 140 patients using Philips Clarity FD system. The CA procedure involved seven standard projections, of which five were extensively selected by interventionalists. Mean fluoroscopic time (FT), KAP, and reference air kerma (Ka,r) for CA procedure were 3.24 min (0.5-10.51), 13.99Gycm2 (4.02-37.6), and 231.43 mGy (73.8-622.15), respectively. Effective dose calculated using Monte Carlo-based PCXMC software was found to be 4.9mSv. Left anterior oblique (LAO) 45° projection contributed the highest radiation dose (28%) of the overall KAP. Radiation-induced risk was found to be higher in females compared to males with increased risk of lung cancer. An increase of 10%-15% in radiation dose was observed when one or more additional projections were adopted along with the seven standard projections. A 14% reduction of radiation dose was achieved from novel FD system when low-dose protocol during fluoroscopy and medium-dose protocol during cine acquisitions were adopted, compared to medium-dose protocol.

Testosterone as a marker of coronary artery disease severity in middle aged males.

Historically, higher levels of serum testosterone were presumed deleterious to the cardiovascular system. In the last two decades, studies have suggested that low testosterone levels are associated with increased prevalence of risk factors for cardiovascular disease (CVD), including dyslipidemia and diabetes. This is a cross sectional study. The aim of our study was to determine the relationship between serum testosterone levels and angiographic severity of coronary artery disease (CAD). Serum testosterone levels were also correlated with flow mediated dilation of brachial artery (BAFMD) - an indicator of endothelial function. Consecutive male patients, aged 40-60 years, admitted for coronary angiography (CAG) with symptoms suggestive of CAD, were included in the study. Out of the 92 patients included in the study, 32 patients had normal coronaries and 60 had CAD on coronary angiography. Severity of CAD was determined by Gensini coronary score. The group with CAD had significantly lower levels of total serum testosterone (363±147.1 vs 532.09±150.5ng/dl, p<0.001), free testosterone (7.1215±3.012 vs 10.4419±2.75ng/dl, p<0.001) and bioavailable testosterone (166.17±64.810 vs 247.94±62.504ng/dl, p<0.001) when compared to controls. Adjusting for the traditional risk factors for CAD, a multiple linear regression analysis showed that low testosterone was an independent predictor of severity of CAD (ß=-0.007, p<0.001). This study also showed that levels of total, free and bioavailable testosterone correlated positively with BAFMD %.

Efficacy of stem cell in improvement of left ventricular function in acute myocardial infarction--MI3 Trial.

BACKGROUND & OBJECTIVES: Acute myocardial infarction (AMI) is characterized by irreparable and irreversible loss of cardiac myocytes. Despite major advances in the management of AMI, a large number of patients are left with reduced left ventricular ejection fraction (LVEF), which is a major determinant of short and long term morbidity and mortality. A review of 33 randomized control trials has shown varying improvement in left ventricular (LV) function in patients receiving stem cells compared to standard medical therapy. Most trials had small sample size and were underpowered. This phase III prospective, open labelled, randomized multicenteric trial was undertaken to evaluate the efficacy in improving the LVEF over a period of six months, after injecting a predefined dose of 5-10 × 10 [8] autologous mononuclear cells (MNC) by intra-coronary route, in patients, one to three weeks post ST elevation AMI, in addition to the standard medical therapy. METHODS: In this phase III prospective, multicentric trial 250 patients with AMI were included and randomized into stem cell therapy (SCT) and non SCT groups. All patients were followed up for six months. Patients with AMI having left ventricular ejection fraction (LVEF) of 20-50 per cent were included and were randomized to receive intracoronary stem cell infusion after successfully completing percutaneous coronary intervention (PCI). RESULTS: On intention-to-treat analysis the infusion of MNCs had no positive impact on LVEF improvement of ≥ 5 per cent. The improvement in LVEF after six months was 5.17 ± 8.90 per cent in non SCT group and 4.82 ± 10.32 per cent in SCT group. The adverse effects were comparable in both the groups. On post hoc analysis it was noted that the cell dose had a positive impact when infused in the dose of ≥ 5 X 10 [8] (n=71). This benefit was noted upto three weeks post AMI. There were 38 trial deviates in the SCT group which was a limitation of the study. INTERPRETATION & CONCLUSIONS: Infusion of stem cells was found to have no benefit in ST elevation AMI. However, the procedure was safe. A possible benefit was seen when the predefined cell dose was administered which was noted upto three weeks post AMI, but this was not significant and needs confirmation by larger trials.