Indian heart journal最新文献

{"title":"Beyond the STEMI paradigm: Prevalence, predictors, and angiographic signatures of Wellens, de Winter, and Aslanger patterns in acute coronary syndromes.","authors":"Qayoom Yousuf, Aamir Rashid, Sameer Purra, Imran Hafeez, Hilal Ahmad Rather, Bilal Syed","doi":"10.1016/j.ihj.2026.04.008","DOIUrl":"https://doi.org/10.1016/j.ihj.2026.04.008","url":null,"abstract":"<p><strong>Objective: </strong>Several high-risk electrocardiographic (ECG) phenotypes in acute coronary syndrome (ACS)-Wellens, de Winter, and Aslanger-signal critical ischemia or occlusion despite absent diagnostic ST-segment elevation myocardial infarction (STEMI) and would benefit from expedited reperfusion. Data on their joint estimates are scarce. The objectives were: (1) to quantify their prevalence; and (2) to compare their baseline characteristics and angiographic vessel-burden.</p><p><strong>Methods: </strong>In this prospective single centre observational study, 1223 consecutive ACS patients undergoing invasive coronary angiography were included with their ECGs reviewed against prespecified criteria for Wellens (Types A/B), de Winter, and Aslanger pattern. Their prevalence, baseline and angiographic features were analysed.</p><p><strong>Results: </strong>High-risk ECG phenotypes occurred in 71/1223 (5.8%): Wellens 48 (3.9%), Aslanger 15 (1.2%), and de Winter 8 (0.7%). Wellens presented as non-STEMI (NSTEMI) 36/48 (75%) or unstable angina (UA) 12/48 (25%), representing 10.4% (48/463) of combined NSTEMI plus UA presentations. de Winter constituted 2.3% of anterior STEMI (8/351). Aslanger accounted for 3.6% of NSTEMI (15/415). Compared to other ACS, Aslanger patients were older (69.3 ± 9.3 years) with marked metabolic clustering (diabetes 73.3%, dyslipidaemia 73.3%). Wellens (54.5 ± 11.4 years) and de Winter (54.2 ± 7.9 years) were younger and smoking-predominant (60.4% and 62.5%, respectively). Angiographically, Wellens was single-vessel disease (SVD) predominant (56.2%); de Winter localized to the left anterior descending artery (100%) and Aslanger exhibited a multivessel signature.</p><p><strong>Conclusions: </strong>About 1 in 17 (∼6%) ACS presentations exhibits a high-risk ECG phenotype not captured by STEMI criteria and each with a distinct clinico-angiographic profile. Recognizing these patterns supports an occlusion myocardial infarction (OMI) focused approach and expedited invasive management.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147716621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation of right ventricular volumes and ejection fraction by 3D echo and cardiac MRI in postoperative tetralogy of Fallot patients with free pulmonary valve regurgitation.","authors":"Touseef Ul Ayoub, Athar Un Nisa Quraishi, Anuradha Agarwal, Ashutosh Marwah, Neeraj Awasthy","doi":"10.1016/j.ihj.2026.04.007","DOIUrl":"10.1016/j.ihj.2026.04.007","url":null,"abstract":"<p><strong>Background: </strong>The aim of this study was to compare and correlate the right ventricular volumes and ejection fraction by 3D echo and cardiac MRI in postoperative tetralogy of Fallot patients with free pulmonary valve regurgitation.</p><p><strong>Methods: </strong>Twenty-six patients with severe PR secondary to either pulmonary valvotomy or tetralogy of Fallot repair were evaluated using 3D echo and MRI.</p><p><strong>Results: </strong>The mean end-diastolic volumes (ml/m²) were 161.61 ± 29.31 and 170.16 ± 30.79 (p = 0.03) and the mean end-systolic volumes(ml/m²) 83.74 ± 24.16 and 94.18 ± 24.13 (p = 0.12) on 3D echo and MRI, respectively. The mean RV ejection fractions were 47.90 ± 7.81% on 3D echo and 44.83 ± 8.29% on MRI (r = 0.89, P < .001). Similarly, there were strong correlations of both end-diastolic volume and end-systolic volume on 3D echo and MRI (r = 0.94 and r = 0.74, respectively).</p><p><strong>Conclusions: </strong>Three-dimensional echo was comparable with MRI in determining RV volume and ejection fraction in post operative TOF patients with free pulmonary regurgitation. It will be important to study 3D echo in a larger population of patients with TOF, which will be possible only through multi-centre collaboration.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147689813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of a multicomponent digital health and telemonitoring intervention on hypertension and diabetes control in cardiac patients: A randomized controlled trial.","authors":"Arvind Kumar, Tania Bansal, Salil Jaura","doi":"10.1016/j.ihj.2026.04.005","DOIUrl":"https://doi.org/10.1016/j.ihj.2026.04.005","url":null,"abstract":"<p><strong>Background: </strong>Digital health technologies are promising tools to improve cardiovascular risk factors. We evaluated the impact of a multicomponent digital health program-including a mobile app, home blood pressure (BP) monitor, wearable activity tracker, and telecoaching-on hypertension and diabetes control in cardiac outpatients.</p><p><strong>Methods: </strong>In this pragmatic randomized controlled trial, 240 adults with cardiovascular disease and hypertension and/or type 2 diabetes were assigned to receive either the digital health program plus usual care or usual care alone for 6 months. Co-primary outcomes were change in systolic BP and hemoglobin A1c (HbA1c). Secondary outcomes included risk factor target achievement, medication adherence, and quality of life.</p><p><strong>Results: </strong>A total of 228 patients (mean age 57 ± 12 years; 38% women) completed follow-up. At 6 months, the intervention group showed a greater reduction in systolic BP compared with controls (-11.2 ± 12.6 vs -5.1 ± 11.8 mmHg; adjusted mean difference -6.1 mmHg, 95% CI -9.3 to -2.9; p < 0.001). Among participants with diabetes (n = 142), HbA1c decreased by -0.7 ± 1.1% versus -0.3 ± 1.0% (adjusted mean difference -0.4%, 95% CI -0.7 to -0.1; p = 0.008). More intervention patients achieved BP < 130/80 mmHg (52% vs 34%, p = 0.01) and HbA1c <7% (48% vs 32%, p = 0.04). Physical activity improved significantly, with increased step counts. More benefit observed in patients with poorly controlled baseline risk factors. Medication adherence and quality-of-life scores improved significantly.</p><p><strong>Conclusions: </strong>A multicomponent digital health intervention significantly improved BP and glycemic control in cardiac outpatients, supporting integration of digital strategies into secondary cardiovascular prevention.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes of off-pump coronary artery bypass surgery in the elderly: A propensity-matched analysis.","authors":"Keshav Bansal, Varshini Subash, Neethu Krishna, Sheejamol V Sukumaran, Rohik Micka, Rajesh Jose, Praveen Kerala Varma, Kirun Gopal","doi":"10.1016/j.ihj.2026.04.004","DOIUrl":"https://doi.org/10.1016/j.ihj.2026.04.004","url":null,"abstract":"<p><strong>Objective: </strong>Coronary artery bypass surgery (CABG) in the elderly is associated with increased mortality. Comorbidities are also more common in the elderly. The objective of this study was to ascertain the impact of comorbidities on mortality in elderly patients undergoing CABG.</p><p><strong>Methods: </strong>All patients undergoing isolated off-pump CABG at a single-center from October 2014 to December 2021 were included. Patients were divided into two groups - <75 years and ≥75 years. Cox-regression analysis was done to assess for factors associated with mortality. Kaplan-Meier survival curves were used to assess survival. Due to unequal distribution of comorbidities between the two groups, 1:1 propensity score matching was done to assess the impact of age on outcomes.</p><p><strong>Results: </strong>A total of 2200 patients who underwent off-pump CABG were included of which 139 were ≥75 years. Both operative mortality and intermediate-term mortality (mean 4.7 years) was higher in patients ≥75 years (6.5% vs 1.5% and 20.1% vs 8.9% p value < 0.001). Multivariate Cox-regression analysis showed re-exploration, high EuroSCORE II and the presence of chronic obstructive pulmonary disease to be associated with intermediate-term mortality. Overall survival was worse for patients ≥75 years (6-year survival 68.9% vs 89.6% p value < 0.001). However, on propensity matching these differences between the two groups disappeared.</p><p><strong>Conclusion: </strong>Factors other than age also contribute to mortality in elderly patients who undergo CABG. Comorbidity assessment should be an important focus of attention when evaluating risks for surgery in elderly patients.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147645133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electrocardiographic Prediction of Multivessel Disease in ST-Elevation Myocardial Infarction: A Validation of Standard Criteria and Identification of Novel Patterns.","authors":"Saurabh V Limaye, Siddhant Yadav, Milind S Phadke, Pratap J Nathani, Yash Y Lokhandwala","doi":"10.1016/j.ihj.2026.04.003","DOIUrl":"https://doi.org/10.1016/j.ihj.2026.04.003","url":null,"abstract":"<p><strong>Objective: </strong>To assess the value of the admission electrocardiogram (ECG) in predicting multivessel coronary artery disease (MVD) in patients with ST-elevation myocardial infarction (STEMI) and to identify novel predictive patterns.</p><p><strong>Methods: </strong>This was a single-center, retrospective observational study of 169 STEMI patients who underwent coronary angiography. Two cardiologists, blinded to angiographic findings, reviewed admission ECGs to identify the culprit artery and predict MVD using pre-specified criteria. Diagnostic accuracy metrics were calculated, and associations between ECG findings and MVD were assessed.</p><p><strong>Results: </strong>MVD was present in 81 (48%) patients. While the ECG identified the culprit artery with 97% accuracy, its sensitivity for predicting MVD using standard criteria was low (21.0%), though specificity was high (94.3%). However, in inferior STEMI, ST depression in aVR was significantly associated with MVD (p=0.010; OR 4.2). In anterior STEMI, the absence of limb lead changes was a highly specific predictor of MVD (p=0.009; OR 13.3; Spec 98.4%).</p><p><strong>Conclusions: </strong>While the admission ECG is highly accurate for culprit artery localization, its sensitivity for MVD is low. ST depression in aVR in inferior STEMI and the absence of limb lead changes in anterior STEMI are novel, highly specific predictors of MVD that can enhance early risk stratification.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147622847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Upfront Aspirin-Free Antiplatelet Monotherapy After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Safety and Efficacy.","authors":"Kunal Mahajan, Deep Dutta, A B M Kamrul-Hasan, Akshyaya Pradhan, Shekhar Vohra, Nitin Mahajan","doi":"10.1016/j.ihj.2026.04.002","DOIUrl":"https://doi.org/10.1016/j.ihj.2026.04.002","url":null,"abstract":"<p><strong>Background: </strong>Evidence comparing non-aspirin single antiplatelet therapy (SAPT) with aspirin-containing dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is limited. We performed a systematic review and meta-analysis to evaluate the safety and efficacy of non-aspirin SAPT with a P2Y12​ inhibitor started at or within one week of PCI.</p><p><strong>Methods: </strong>Electronic databases were searched for studies evaluating non-aspirin SAPT after PCI. Primary outcomes were bleeding defined by Bleeding Academic Research Consortium (BARC) criteria [BARC 1-5 (any bleeding) and BARC 3-5 (major bleeding)], all-cause mortality (ACM), and cardiovascular mortality. Secondary outcomes were stroke, myocardial infarction (MI), need for revascularization, and stent thrombosis (STS).</p><p><strong>Results: </strong>Seven studies (2 randomized controlled trials and 5 observational studies) including 5468 patients on non-aspirin SAPT were analysed. In the single-arm meta-analysis of non-aspirin SAPT, pooled prevalence was 5% (95% CI 3-11;I²=92%) for any BARC 1-5 bleeding, 3% (95% CI 1-7;I²=92.5%) for major BARC 3-5 bleeding, 2% (95% CI 1-3;I²=65.4%) for ACM, 2% (95% CI 2-3;I²=31%) for cardiovascular mortality, 1% (95% CI 1-1;I²=0%) for STS, 1% (95% CI 0-1;I²=40.1%) for stroke, 2% (95% CI 1-3;I²=66.6%) for MI, and 2% (95% CI 1-4;I²=75.9%) for revascularization. In pairwise analyses of the two trials, non-aspirin SAPT versus aspirin-based DAPT showed similar risks of all-cause mortality, cardiovascular mortality, bleeding, and stroke but higher risks of MI (odds ratio [OR]1.41;95% CI 1.01-1.97; P=0.05; I²=0%) and revascularization (OR1.73; 95% CI 1.18-2.52;P=0.005;I²=0%).</p><p><strong>Conclusion: </strong>Upfront aspirin-free SAPT after PCI was associated with increased risks of MI and revascularization without a reduction in bleeding compared with aspirin-based DAPT.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147622854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcatheter device closure of post-myocardial infarction ventricular septal rupture: A single-centre experience.","authors":"Praveen Chandra, Nagendra Singh Chouhan, Seenu Prasanth Adimoulame, Siddarth Varshney, Deepti Yadav, Anushree Kumbhalkar","doi":"10.1016/j.ihj.2026.04.001","DOIUrl":"https://doi.org/10.1016/j.ihj.2026.04.001","url":null,"abstract":"<p><p>Post-myocardial infarction ventricular septal rupture is a rare but fatal mechanical complication, frequently complicated by cardiogenic shock. We conducted a single-centre retrospective cohort study of seventeen surgically declined patients who underwent transcatheter device closure between 2014 and 2025. Cardiogenic shock was present in 15 of 17 patients (88.2%). Device implantation achieved high technical success; however, early mortality remained substantial, with only six patients (35.3%) surviving beyond 30 days. Deaths were mainly due to refractory shock and multiorgan failure. Survival was associated with lower SCAI shock stage, preserved lactate clearance, and higher arterial pH, underscoring the importance of physiological status.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147618653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revisiting non-HACEK gram-negative endocarditis: Emerging clinical and microbiological trends from a prospective cohort.","authors":"Durga Shankar Meena, Deepak Kumar, Bhuvanesh Kumar, Gopal Krishana Bohra, Naresh Midha, Rahul Choudhary, Surender Deora, Vibhor Tak, Alok Kumar Sharma, Mahesh Devnani","doi":"10.1016/j.ihj.2026.03.007","DOIUrl":"10.1016/j.ihj.2026.03.007","url":null,"abstract":"<p><strong>Background: </strong>Non-HACEK gram-negative pathogens are an emerging cause of infective endocarditis (IE) with limited data from lower-middle-income countries. This study aimed to evaluate the clinical characteristics, treatment, and outcomes of non-HACEK gram-negative IE in an Indian cohort.</p><p><strong>Methods: </strong>This prospective observational study was conducted in a tertiary care center in western India. Clinical presentation, microbiology, echocardiographic findings, and treatment outcomes of non-HACEK gram-negative IE were analyzed and compared with patients who had IE due to other etiology.</p><p><strong>Results: </strong>Among 121 patients with IE, 30 cases (24.8%) were due to non-HACEK gram-negative pathogens (median age: 48 years; 73.3% male). In this group, predisposing cardiac conditions were present in 56%, including prosthetic valves/devices in 26.6%. Pseudomonas aeruginosa was the most common etiology (n = 14, 46.6%), followed by E. coli (n = 6, 20%). The median vegetation size was 12 mm. Common complications included heart failure (56.7%), peripheral septic emboli (40%), and stroke (33.3%). Surgical intervention was performed in 23.3% of cases. The 60-day and 1-year mortality rates were 36% and 43.3%, respectively; relapse occurred in 11.8% of 1-year survivors. Compared to other etiology (n = 91), non-HACEK gram-negative IE had a significantly higher Charlson Comorbidity Index (2 vs 1, p = 0.035), persistent bacteremia (30% vs 12%, p = 0.02), and 60-day mortality (36.6% vs 17.6%, p = 0.032).</p><p><strong>Conclusions: </strong>Non-HACEK gram-negative IE predominantly caused by Pseudomonas aeruginosa, is increasingly recognized. Compared to other etiology, Non-HACEK gram-negative IE was linked to higher comorbidity scores, frequent persistent bacteremia, and greater early mortality, highlighting its aggressive clinical course.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147520845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety, efficacy, and outcomes of the modified rotational atherectomy approach: A real-world single-center experience.","authors":"Ravinder Singh Rao, Kailash Chandra, Govind Narayan Sharma, Prashant Sk Varshney, Piyush Joshi, Somyata Somendra, Sanjeev Kumar, Nagendra Boopathy Senguttuvan","doi":"10.1016/j.ihj.2026.03.005","DOIUrl":"10.1016/j.ihj.2026.03.005","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aim: </strong>To evaluate the safety and periprocedural outcomes of RA with a modified approach in a real-world Indian scenario.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147503919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and performance of the Hydra self-expanding THV: 6 months outcomes from the GENESIS-II study.","authors":"Anmol Sonawane, Praveen Chandra, John Jose, Sandeep Bansal, Rahul Gupta, Krishnankutty Sudhir, Nagendra Boopathy Senguttuvan","doi":"10.1016/j.ihj.2026.03.004","DOIUrl":"10.1016/j.ihj.2026.03.004","url":null,"abstract":"<p><strong>Aim: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}