Indian heart journal最新文献

Background: Rotational atherectomy (RA) is advantageous in calcified coronary lesions to ablate calcified plaques and optimize stent expansion but associated with complications like coronary perforation, dissection, and slow/no-reflow.

Aim: To evaluate the safety and periprocedural outcomes of RA with a modified approach in a real-world Indian scenario.

Methods: This 6-year, retrospective, single-operator study at an Indian tertiary care institution included 320 patients, operated using a modified RA approach, which integrated slow burr speed (150,000-155,000 revolutions per minute), short runs and pretreatment adrenaline with aminophylline to avoid temporary pacemaker (TPM). Data on demographics, periprocedural characteristics, and complications were collected. The primary endpoint was angiographic and procedural success.

Results: The patient cohort comprised predominantly men (80.31%) with a mean age of 67.92±9.16 years. Common comorbidities included acute coronary syndrome (67.81%), diabetes mellitus (50.93%), and hypertension (67.81%). A total of 322 RA procedures (414 lesions) were performed. Of these 414 lesions, 7% were chronic total occlusions while 8.9% were in the left main coronary artery. TPM insertion was done in one (0.31%) patient who already had complete heart block. Imaging was performed in 35% of the procedures. Procedural success was achieved in 96.90% of the cases. Complications included slow flow/no-reflow in 4 cases (1.24%), dissection in 4 cases (1.24%), and burr entrapment in 2 cases (0.62%).

Conclusion: The use of TPM can be avoided during RA, and slow/no reflow incidence can be reduced with pretreatment aminophylline and adrenaline. Small burr sizes with a slow rotation speed and short runs are key for safe and effective calcium ablation with this debulking modality.

Aim: The Hydra THV incorporates an active release mechanism designed to facilitate the deployment of the supra-annular valve. The aim of the GENESIS-II study was to assess the safety and performance of Hydra THV at 6 months follow-up after treating severe aortic stenosis in patients at high surgical risk.

Methods: This prospective, multicenter, non-randomized, investigational study was conducted between November 2021 and November 2023. The study enrolled 40 patients with high surgical risk and symptomatic severe aortic stenosis from 19 sites across India. The primary safety endpoint of the study was cardiovascular mortality at 30 days, while the primary performance endpoint was device success, as defined by VARC-2.

Results: Among the 40 patients, the mean age was 74.4 ± 6.7 years, 65% were male, and the mean Society of Thoracic Surgeons (STS) risk score was 3.5 ± 1.6%. The device had a success rate of 95%. At 6 months, there was one cardiovascular death (2.5 %). All-cause death was observed in 5% patients. The incidence of new permanent pacemaker implantation was 7.9%. There was a progressive enhancement in effective orifice area, from 0.6 ± 0.2 cm² at baseline to 1.9 ± 0.4 cm² at 6 months (p < 0.001). Similarly, the mean aortic valve gradient significantly improved from 53.1 ± 12.5 mm Hg at baseline to 8.7 ± 3.3 mmHg at 6 months (p < 0.001) post-intervention.

Conclusion: The results of 6 months follow-up after implantation of the Hydra THV with an active release mechanism in the GENESIS-II study demonstrated a high device success rate with favorable safety and performance of the device.

Objective: The effect of aspirin and clopidogrel is not uniform in all patients due to drug resistance. The study was designed to evaluate the prevalence of aspirin and clopidogrel resistance and its association with various risk factors in stable CAD patients.

Methods: Total 151 clinically stable CAD patients taking either aspirin and/or clopidogrel were recruited in this prospective cohort study. Platelet function testing was performed using light transmittance platelet aggregometry. All the patients were prospectively followed up to detect any MACE (death, non-fatal MI, stroke, revascularization), worsening angina and bleeding from any site.

Results: Total 11(7.28%) patients showed complete resistance to aspirin, and an additional 35(23.18%) patients showed semi-resistance. For clopidogrel, 44(29.2%) and 11(7.6%) patients had complete and semi-resistance, respectively. The prevalence of dual antiplatelet resistance was 7.6%. In univariate regression analysis, diabetes mellitus [OR 2.2(95%CI 1.1-4.4);P=0.03] and clopidogrel resistance [OR 20.2(8-50.7);P<0.01] showed significant association with aspirin resistance. The parameters significantly associated with clopidogrel resistance were - hemoglobin level [OR 0.8(0.7-1);P=0.03], erythrocyte sedimentation rate [OR 1(1-1.1);P=0.04], family history of CAD [OR 5.1(1.5-17.1);P=0.01] and aspirin resistance [OR 20.2(8.0-50.7);P<0.01]. In multivariable analysis, apart from the significant association between aspirin and clopidogrel resistance, family history of CAD was the only independent predictor of clopidogrel resistance. The study was underpowered to detect any meaningful effect on MACE due to low event rate.

Conclusion: In our study high prevalence of aspirin and clopidogrel resistance was detected. Although aspirin and clopidogrel resistance showed significant association with clinical risk factors, their association with MACE was inconclusive.

Objective: To assess influence of echocardiographic left ventricular ejection fraction(LVEF) on outcomes following percutaneous coronary intervention(PCI) in ST-elevation myocardial infarction(STEMI) and other acute coronary syndromes(oACS).

Methods: Successive patients with ACS who underwent PCI from April'2019 to March'2022 were enrolled, while those who did not undergo PCI were excluded. In all patients, LVEF was obtained at hospital admission and classified into <30.0%,30.0-39.9%,40.0-49.9% and ≥50.0%. Details of risk factors, coronary angiography, interventions, management, and in-hospital and 3-year outcomes were obtained. Multivariate Cox-proportionate hazard ratios(HR) and 95% confidence intervals(CI), adjusted for age, sex, risk factors, presentation, angiography, interventions, management, and hospitalisation, for major adverse cardiovascular events(MACE) and deaths were calculated.

Results: Data of 3789 patients (men 3011, women 778) with ACS (STEMI = 1601; oACS = 2188) were available at baseline and 3.0yr (IQR 2.1-4.0) median follow-up. STEMI patients were younger, with more men, smoking, hypercholesterolemia, impaired LVEF, vasopressor support, hospitalisation duration, and in-hospital deaths vs oACS (p < 0.01). Important determinants of reduced LVEF were smoking, 3-vessel, left-main or left anterior descending CAD (p < 0.01). In both groups, patients with lower LVEF(<30.0%,30.0-39.9%) had more in-hospital deaths (p < 0.05). At 3-year follow-up, compared to LVEF >50.0%, multivariate-adjusted HR(95%CI) in LVEF<30.0% for MACE [STEMI 8.55(3.04-24.03); oACS 2.71(1.39-5.29)] as well as CV deaths [STEMI 16.50(3.64-74.71); oACS 3.72(1.40-9.85)] were significant (p < 0.001). For LVEF 30.0-39.9% group, HRs were of borderline significance [STEMI 2.26(0.86-5.89);oACS 1.34(0.76-2.36)] and not significant for LVEF 40.0-49.9% group. Outcomes were not significantly different in men and women.

Conclusions: STEMI and other ACS patients undergoing PCI with LVEF<30% have significantly higher in-hospital and 3-year major adverse cardiovascular events and deaths.

Background: Primary aldosteronism (PA) is the most prevalent cause of secondary hypertension and is associated with adverse cardiovascular outcomes. While its prevalence is well established among patients with resistant hypertension and hypokalemia, evidence regarding its occurrence in premature coronary artery disease (CAD) remains limited, particularly in South Asian populations with a high burden of early cardiovascular disease.

Objective: To determine the prevalence of PA in patients with premature CAD (≤45 years) and to describe their clinical and biochemical characteristics.

Methods: In this prospective observational study, 64 patients with premature CAD and 60 age-matched controls with CAD onset after 45 years were evaluated. Patients with a positive screening result-defined as plasma direct renin concentration (DRC) < 12 μIU/mL together with plasma aldosterone concentration (PAC) > 10 ng/dL-underwent a recumbent saline infusion test (SIT). A post-infusion PAC >5 ng/dL was considered confirmatory for the diagnosis of primary aldosteronism. Clinical, biochemical and cardiovascular parameters were systematically assessed.

Results: Among 64 patients with premature CAD, 2 (3.1%) were diagnosed with PA, whereas no cases were identified in the control group. PA-positive patients exhibited significantly higher systolic (161 ± 15.6 mmHg) and diastolic (94.0 ± 5.7 mmHg) blood pressures, longer hypertension duration, and echocardiographic evidence of left ventricular hypertrophy compared with PA-negative patients.

Conclusion: PA may represent an underrecognized contributor to premature CAD in young adults. Larger multicenter studies are needed to validate these observations. Routine PA screening in young CAD patients could enable earlier diagnosis and targeted management, potentially reducing long-term cardiovascular morbidity.

SARS-COV-2 virus affects the cardiovascular system by various pathophysiological mechanisms. The incidence of Acute coronary syndrome (ACS) seems to be on rise in the peri-covid era. The proinflammatory and prothrombotic milieu is primarily responsible. Traditional atherosclerotic risk factors do not seem to be responsible for this increased incidence of ACS. We chose to test this hypothesis on young Indian population lacking the traditional atherosclerotic risk factors. If established, Covid 19 infection will at least be considered a risk modifier in causing ACS in future. Subsequently, we went on to study the differences in presentation, diagnostic implications, revascularization and management strategies and finally outcomes in ACS patients in the Peri-covid compared to the pre-covid era. To the best of our knowledge, this seems to be the first of its kind study from eastern India.

Objectives: During transradial percutaneous intervention (PCI), sharp edge of guide catheter tip may produce "razor blade effect" leading to radial vascular injury. Pigtail assisted tracking (PAT) technique has been described to overcome it, but has not been systematically evaluated. We prospectively evaluated the safety and efficacy of PAT technique in transradial PCI.

Methods: Consecutive patients undergoing transradial-PCI were randomized into two groups (Group 1: transradial navigation using PAT technique, Group 2: transradial navigation without PAT technique). Patients were observed for forearm complications and radial artery patency was determined by vascular Doppler at 48 h. Primary end point was the composite incidence of radial artery spasm, angiographic radial artery injury, forearm hematoma and radial artery occlusion (RAO). Secondary end points were incidence of each of these individual variables. Predictors of forearm complications were determined by multivariate analysis.

Result: Total 260 patients were finally included (130 patients in each group). Baseline and procedural characteristics were comparable in both groups. Majority [158 (60.8%) patients] had acute coronary syndrome. Primary outcome was significantly reduced by the PAT technique [15 (11.5%) vs. 33 (25.4%) patients; p = 0.004]. Individual outcomes were also significantly less in Group 1 [radial artery spasm 12 (9.2%) vs. 28 (21.5%), p = 0.006; angiographic radial artery injury 4 (3.1%) vs. 12 (9.2%), p = 0.04; forearm hematoma 6 (4.6%) vs. 17 (13.1%), p = 0.01; RAO 4 (3.1%) vs. 13 (10.0%), p = 0.02]. PCI without PAT technique and low body weight emerged as independent predictor for forearm complications.

Conclusion: PAT technique is safe and significantly reduces the forearm complications.

Objective: Vagal manoeuvres, particularly the Valsalva manoeuvre (VM), are recommended as first-line therapy for paroxysmal supraventricular tachycardia (PSVT). We aimed to compare the efficacy and safety of a modified Valsalva manoeuvre with the standard technique in terminating PSVT in the emergency department.

Methods: This prospective, randomised, parallel-group trial was conducted in the emergency department of a tertiary care hospital. Adults with stable PSVT were randomised (1:1) to receive either a modified or standard Valsalva manoeuvre. The modified manoeuvre involved a 40-mmHg strain for 15 s in a semi-recumbent position followed by immediate supine repositioning with passive leg elevation, while the standard manoeuvre comprised a 40-mmHg strain for 15 s in the semi-recumbent position alone. The primary outcome was return to sinus rhythm at 1 min, confirmed by electrocardiography.

Results: A total of 75 participants were enrolled (37 in the standard group and 38 in the modified group) on an intention-to-treat basis. Sinus rhythm was restored in 10 of 38 patients (26.3%) in the modified Valsalva group compared with 6 of 37 patients (16.2%) in the standard group (odds ratio 0.54; 95% CI 0.17-1.68; p > 0.05). No serious adverse events were observed in either group.

Conclusions: The modified Valsalva manoeuvre demonstrated a higher, though not statistically significant, cardioversion rate compared with the standard technique. Both manoeuvres were safe and well tolerated. Larger adequately powered studies are required to establish definitive efficacy.

Background: Sotatercept, a first-in-class activin signaling inhibitor, represents a paradigm shift in pulmonary arterial hypertension (PAH) by directly targeting pulmonary vascular remodeling. We conducted a meta-analysis of randomized controlled trials (RCTs) to quantify its efficacy and safety.

Methods: We systematically searched PubMed, Embase, and Cochrane Central from inception to October 2025 for RCTs comparing sotatercept with placebo in PAH. The primary outcome was trial-defined clinical worsening (CW). Secondary outcomes included all-cause mortality, multicomponent improvement (MCI), attainment of low-risk status, serious adverse events (SAEs), and bleeding. Data were pooled using a Mantel-Haenszel random-effects model. Risk of bias was assessed with RoB 2.0, certainty of evidence using GRADE, and trial sequential analysis (TSA) was performed to assess conclusiveness.

Results: Four RCTs comprising 921 patients (sotatercept n = 483; placebo n = 438) were included. Sotatercept significantly reduced clinical worsening (OR 0.18, 95 % CI 0.12-0.27) with minimal heterogeneity and TSA-confirmed conclusiveness. All-cause mortality showed a favorable but non-significant trend (OR 0.63, 95 % CI 0.33-1.20). Sotatercept significantly increased MCI (OR 4.68, 95 % CI 1.94-11.31) and attainment of low-risk status (OR 2.77, 95 % CI 1.49-5.17), with moderate heterogeneity. SAEs were reduced (OR 0.72, 95 % CI 0.53-0.99), while bleeding risk was increased, predominantly minor mucocutaneous events (OR 2.84, 95 % CI 1.94-4.15).

Conclusion: Sotatercept markedly reduces clinical worsening and improves multidimensional outcomes in PAH with an acceptable safety profile, supporting its role as a disease-modifying therapy.