Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve.

AIM: Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Sciences, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. METHODS: Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. RESULTS: Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. CONCLUSION: TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

Acute ST-Elevation Myocardial Infarction in the Young Compared With Older Patients in the Tamil Nadu STEMI Program.

OBJECTIVE: To compare the clinical presentation, risk factors and outcomes of young patients (≤45 years) presenting with ST segment-elevation myocardial infarction (STEMI) with older STEMI patients in the Tamil Nadu STEMI program (TN-STEMI). METHODS: A total of 2,420 patients were enrolled in the TN-STEMI program, which is a pre-implementation and post-implementation quality of care study. The cohort of patients was divided into young STEMI patients (≤45 years) and compared with those aged >45 years. RESULTS: A total of 591(24.4%) patients in this cohort were aged ≤45 years; 92.5% of the young STEMI were males. Smoking was the most common risk factor and its use was significantly more in younger myocardial infarction (MI) patients than in older patients (57% vs 31%; p<0.001). Compared with their older counterparts, younger patients had a lower prevalence of hypertension (14.2% vs 28.3%; p<0.001) and diabetes mellitus (13.2% vs 29.7%; p<0.001). Total ischaemic time was shorter for younger patients (235 vs 255 mins; p=0.03). Young STEMI patients more frequently presented with single vessel disease and the left anterior descending coronary artery was the most common infarct-related artery; they also had a higher thrombus load. Young MI patients had reduced mortality, both in-hospital (3.4% vs 6.4%; p=0.005) and at one year (7.6% vs 17.6%; p<0.001). Younger male STEMI patients also showed lower mortality than younger female patients. CONCLUSIONS: Young STEMI patients compared with older STEMI patients had lower prevalence of traditional risk factors, shorter ischaemic time and reduced mortality. Young female STEMI patients had higher mortality than young male STEMI patients.

Factors Contributing to Acute Kidney Injury and the Impact on Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) patients are at a high risk of acute kidney injury (AKI). This study aimed to investigate AKI and the relationship with iodinated contrast media (ICM), whether there are significant pre- or peri- procedural variables predicting AKI, and whether AKI impacts on hospital length of stay and mortality. METHODS: Serum creatinine (SC) levels pre- and post- (peak) TAVR were recorded in 209 consecutive TAVR patients. AKI was defined by the Valve Academic Research Consortium 2 (VARC2) criteria. Baseline characteristics, procedural variables, hospital length of stay (LOS) and mortality at 72hours, 30 days and one year were analysed. RESULTS: Eighty-two of 209 (39%) patients suffered AKI. Mean ICM volume was 228cc, with no difference between patients with AKI and those with no AKI (227cc (213-240(95%CI)) vs 231cc (212-250) p=0.700)). Univariate and multivariate analysis demonstrated that chronic kidney disease, respiratory failure, previous stroke, the need for blood transfusion and valve repositioning were all predictors of AKI. Acute kidney injury increased LOS (5.6 days (3.8 - 7.5) vs 3.2 days (2.6 - 3.9) no AKI (P=0.004)) but was not linked to increased mortality. Mortality rates did increase with AKI severity. CONCLUSION: Acute kidney injury is a common complication of TAVR. The severity of AKI is important in determining mortality. Acute kidney injury appears to be independent of ICM use but pre-existing renal impairment and respiratory failure were predictors for AKI. Transcatheter aortic valve replacement device repositioning or retrieval was identified as a new risk factor impacting on AKI.

A rare mechanism of very late bare metal stent thrombosis--role of optical coherence imaging in its evaluation and management.

Very late stent thrombosis is an uncommon event following implantation with bare metal stents (BMS) in coronary arteries. Long term follow up studies have shown that a small number of BMS develop very late thrombosis following years of stability. Atherosclerotic transformation of neointimal tissue is increasingly being recognised as the cause of these adverse events. A 49 year-old male presented with acute inferior wall myocardial infarction resulting from thrombosis of the BMS implanted in his right coronary artery five years earlier. He was successfully thrombolysed and his coronary angiogram showed mild diffuse instent restenosis. The intravascular optical coherence tomography revealed instent neoatherosclerotic plaque rupture without any flow limiting stenosis as the likely culprit event.

Primary percutaneous thrombus aspiration alone as definitive intervention for left main coronary artery occlusion presenting as acute anterior wall ST elevation myocardial infarction.

Primary angioplasty and stenting remains the standard of care for patients presenting with acute ST-segment elevation myocardial infarction. Recently, thrombus aspiration has been shown to improve the myocardial perfusion and outcomes in STEMI. In a subset of patients thrombus aspiration may result in optimal perfusion and minimal residual stenosis. These patients may be managed without additional stenting. Three patients with anterior wall STEMI were successfully managed with thrombus aspiration alone without additional stenting. All three are doing well at 30 day follow up with significant improvement in left ventricular ejection fraction.

Outcomes of mitral transcatheter edge to edge repair with MitraClip™ - An Indian single center experience.

OBJECTIVE: To evaluate the outcomes of transcatheter edge-to-edge repair (TEER) with MitraClip™ (Abbott Vascular) in symptomatic high surgical risk Indian patients with significant mitral regurgitation (MR). METHODS: Patients with moderately severe or severe primary or secondary MR and deemed high surgical risk were treated with MitraClip™. The data were collected retrospectively from medical records. The primary outcome was technical success, and secondary outcomes were ≤2+ MR reduction and improvement in functional capacity at 30 days. RESULTS: Between November 2018 and August 2023, 64 patients were treated with MitraClipTM. The mean age was 70.0 ± 12.1 years and 64 % were males. The mean EuroScore II and STS score predicted mortality for mitral valve repair were 5.8 ± 4.5 % and 4.0 ± 3.8 % respectively. MR etiology was primary in 56.3 %, secondary in 40.6 % and mixed in 3.1 %. The device was implanted successfully in all but one patient with technical success rate of 98.4 %. The average number of clips per patient was 1.5 ± 0.6 and 42.2 % patients received more than one clip. The mean mitral valve gradient was 3.5 ± 1.6 mmHg. The MR severity of ≤2+ was achieved in 91.8 % of the subjects and similar proportion were in New York Heart Association Functional Class I or II at 30 days. CONCLUSION: In high-risk Indian patients with symptomatic significant MR, TEER with MitraClip™ was achieved with a high technical success rate. It was associated with significant reduction in MR severity and improvement in functional capacity in >90 % of the subjects.

Safety and effectiveness of the novel Myval Octacor transcatheter heart valve in severe, symptomatic aortic valve stenosis - A real-world Indian experience (The OCTACOR India Study).

PURPOSE: To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor - Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). METHODS: This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. RESULTS: Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). CONCLUSIONS: Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS.

Impact of real-time optical coherence tomography and angiographic coregistration on the percutaneous coronary intervention strategy.

Background: The use of optical coherence tomography (OCT) with angiographic coregistration (ACR) during percutaneous coronary intervention (PCI) for procedural decision-making is evolving; however, large-scale data in real-world practice are lacking. Aims: Our study aims to evaluate the real-time impact of OCT-ACR on clinician decision-making during PCI. Methods: Patients with angiographic diameter stenosis >70% in at least one native coronary artery were enrolled in the study. The pre- and post-PCI procedural strategies were prospectively assessed after angiography, OCT, and ACR. Results: A total of 500 patients were enrolled in the study between November 2018 and March 2020. Among these, data related to 472 patients with 483 lesions were considered for analysis. Preprocedural OCT resulted in a change in PCI strategy in 80% of lesions: lesion preparation (25%), stent length (53%), stent diameter (36%), and device landing zone (61%). ACR additionally impacted the treatment strategy in 34% of lesions. Postprocedural OCT demonstrated underexpansion (15%), malapposition (14%), and tissue/thrombus prolapse (7%), thereby requiring further interventions in 30% of lesions. No further change in strategy was observed with subsequent postprocedural ACR. Angiographic and procedural success was achieved in 100% of patients, and the overall incidence of major adverse cardiovascular events at 1 year was 0.85%. Conclusions: The outcomes reflect the real-time impact of OCT-ACR on the overall procedural strategy in patients undergoing PCI. ACR had a significant impact on the treatment strategy and was associated with better clinical outcomes at 1 year after index PCI. OCT-ACR has become a practical tool for improving outcomes in patients with complex lesions.

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry.

BACKGROUND: Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. METHODS: This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm2 MSA for non-left main and 3.5 mm2 for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. RESULTS: Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm2) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm2). The average MSA (with expansion ≥80% cutoff) was 6.63 mm2 and 4.74 mm2 with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm2 and 3.95 mm2, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. CONCLUSION: PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

The role of the sewing ring in tissue healing: a pathologic study of explanted mechanical heart valves.

BACKGROUND AND AIM OF THE STUDY: Serious complications may occur after heart valve replacement, and many such patients will require reoperation. The study aim was to identify the pattern of tissue response around the sewing ring of those valves that have been explanted as a result of various valve-associated complications. METHODS: A total of 51 mechanical heart valves (MHVs) was explanted from 45 patients who had undergone reoperation for valve-related complications. The examination of the valves included an analysis of the operative findings, macroscopic findings, histopathology, and dissection of the sewing ring. RESULTS: The extent of tissue hyperplasia was variable around the sewing rings of valves explanted for various pathologies. In pannus, the hyperplastic tissue extended into the valve orifice and produced an obstruction to flow, whereas in thrombosed valves the thrombus was attached to the tissue at the annulus. In non-infective pathologies, the histology revealed cellular infiltration that was limited to the peripheral fabric layers of the sewing ring, though the extent of infiltration was not increased with the duration of implantation. In prosthetic valve endocarditis (PVE), the surrounding hyperplastic tissue was granulomatous, but cellular infiltration into the sewing ring was absent. The dissection of various models of explanted valves revealed that different types of filler and fixing mechanisms had increased the bulk of the sewing ring. CONCLUSION: Tissue hyperplasia of varying extent occurs around the sewing ring after MHV implantation. The cellular elements grow into the peripheral layers, but not the deeper layers, of the sewing ring. In PVE, there was an absence of cellular infiltration into the sewing ring.

Posterior mitral leaflet aneurysm - a rare cause of mitral regurgitation.

Posterior mitral leaflet aneurysm is a very rare complication of infective endocarditis. A 28-year-old athlete got admitted with fever, congestive heart failure and multi-organ dysfunction syndrome. The echocardiogram showed large aneurysm of the posterior mitral leaflet with severe mitral regurgitation. Patient succumbed to refractory heart failure.

Longitudinal deformation - price we pay for better deliverability of coronary stent platforms.

Coronary stents, especially drug eluting stents (DES), have revolutionized the practice of interventional cardiology. Newer stents are manufactured by altering basic design characteristics to tackle complex coronary morphologies more effectively. Alteration in one particular attribute might affect other attributes adversely. Even though, reduction in the number and alteration of the orientation of the connectors improves the stent flexibility and deliverability, it adversely decreases the axial strength of the stent with resulting longitudinal stent deformation. A 67 year old female underwent percutaneous coronary intervention for a mid left anterior descending artery stenosis with a 2.75 × 16 mm Promus Element stent (Boston Scientific, Natick, Massachusetts). The stent got longitudinally distorted during post-stent balloon dilatation which was effectively managed with further dilatation with non-compliant balloon.

Apical ballooning syndrome in first degree relatives.

Apical ballooning syndrome (Takotsubo cardiomyopathy) is an unusual stress-related reversible cardiomyopathy occurring commonly in postmenopausal females. Genetic etiology of this condition is uncertain. A 68-year-old female and her daughter aged 43 got admitted to our institute simultaneously with acute chest pain following demise of one of their close relative. Both had features typical of Takotsubo cardiomyopathy and recovered completely. This reports point to the possible genetic predisposition to this abnormality.

Percutaneous coronary intervention in cardiogenic shock complicating acute ST-elevation myocardial infarction-a single centre experience.

BACKGROUND: Mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) approaches 70 - 80%, regardless of the type of pharmacological treatment. Early revascularisation improves survival in AMI with CS. Our aim is to assess the predictors of mid-term outcome after percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) and CS. METHODS: Forty-one patients who underwent primary or rescue PCI for CS were analysed comparing their baseline, angiographic, PCI data, 30-day and 1-year survival. RESULTS: There were no significant differences between survivors and non-survivors in baseline characters, except for more number of transfer admissions (P= 0.0005), and cardiopulmonary resuscitations (P= 0.015) in the later group. The mean time between myocardial infarction (MI) onset to shock and MI onset to revascularisation were 12.8 ± 12.9 hours and 17.0 ± 16.8 hours, respectively. Patients with better pre-procedure thrombolysis in myocardial infarction (TIMI) flow in the infarct-related artery (IRA) had better survival (P= 0.0005). Successful PCI was achieved in 48.8% of patients. The 30-day mortality was 56.1% and all were prior to hospital discharge. Patients with successful PCI had better short-term survival in comparison with patients with failed PCI (80% vs 9.6%). Eighteen patients who survived at 30 days were followed up for 12-72 months (mean 28.5 ± 5.4 months). Fifteen patients survived at 1 year after PCI and all were in good functional status. CONCLUSION: Mortality remains high even with PCI. Achieving IRA patency with TIMI 3 flow is the main determinant of survival. Survival and functional status are good in patients who are discharged from hospital.

Concurrent endovascular repair of extensive thoracic aortic and infra-renal aorto-iliac aneurysms.

A 60 year-old woman presented with large extensive aneurysms in the thoracic aorta and infra-renal abdominal aorta with a normal segment of visceral aorta in between; the entire right common iliac artery was also aneurysmal. Concurrent endovascular repair of all aneurysmal regions was successfully performed using a left common iliac artery conduit to access the aorta, and multiple stent-grafts; a chimney graft preserved blood flow into the left subclavian artery. There were no features of spinal cord ischaemia despite coil embolisation of the right hypogastric artery. CT angiogram at six months showed patent stent-grafts with no endoleaks. The patient continued to do well at one-year clinical follow-up. Concurrent endovascular repair of thoracic and abdominal aortic aneurysms can be safely and successfully performed when anatomically feasible, and is an attractive alternative to staged or hybrid repair.

Hybrid trans-apical device closure of left ventricular pseudoaneurysm under trans-oesophageal echocardiographic guidance.

Left ventricular pseudo aneurysm (LVPA) results from contained left ventricular free wall rupture following either myocardial infarction or cardiac surgery. Untreated LVPA carries approximately 30-45% risk of rupture in the first year. Conventional treatment for LVPA is surgery which carries a mortality of about 20%. Interventional closure of LVPA has been reported from trans-arterial and trans-apical routes. Here we report successful hybrid closure of a LVPA under trans-oesophageal echocardiogram (TEE) guidance.

Left aortic sinus to right atrial fistula--percutaneous closure in a septuagenarian female.

A 71 year-old female presented with a large left aortic sinus to right atrial fistula causing severe congestive heart failure and atrial fibrillation. Successful percutaneous closure of the defect was achieved using a 20/18 duct occluder with dramatic improvement in symptoms.

Percutaneous edge-to-edge mitral valve repair for symptomatic high surgical risk patients with significant mitral regurgitation - Short term and one year follow up results from a single center in India.

This series reports the safety and feasibility of MitraClip (Abbott Vascular) in 7 high surgical risk Indian patients with symptomatic mitral regurgitation (MR). The clip was deployed successfully in all patients, and more than one clip was required in 5. All had reduction in MR to ≤2+. Mean mitral valve gradient was 3.0 ± 0.8 mmHg. At 12 months follow up, all were alive, and the MR grade was 1+ in 6 patients and 2+ in one. Mean MV gradient was 3.4 ± 1.0 mmHg. The modified Kansas City Quality of life (KCQ) analysis revealed significant improvement in their quality of life (p < 0.0001).

AngioNet: a convolutional neural network for vessel segmentation in X-ray angiography.

Coronary Artery Disease (CAD) is commonly diagnosed using X-ray angiography, in which images are taken as radio-opaque dye is flushed through the coronary vessels to visualize the severity of vessel narrowing, or stenosis. Cardiologists typically use visual estimation to approximate the percent diameter reduction of the stenosis, and this directs therapies like stent placement. A fully automatic method to segment the vessels would eliminate potential subjectivity and provide a quantitative and systematic measurement of diameter reduction. Here, we have designed a convolutional neural network, AngioNet, for vessel segmentation in X-ray angiography images. The main innovation in this network is the introduction of an Angiographic Processing Network (APN) which significantly improves segmentation performance on multiple network backbones, with the best performance using Deeplabv3+ (Dice score 0.864, pixel accuracy 0.983, sensitivity 0.918, specificity 0.987). The purpose of the APN is to create an end-to-end pipeline for image pre-processing and segmentation, learning the best possible pre-processing filters to improve segmentation. We have also demonstrated the interchangeability of our network in measuring vessel diameter with Quantitative Coronary Angiography. Our results indicate that AngioNet is a powerful tool for automatic angiographic vessel segmentation that could facilitate systematic anatomical assessment of coronary stenosis in the clinical workflow.

Guiding catheter tip avulsion--an unusual complication of renal artery stenting.

A 68-year-old hypertensive male underwent stenting for critical stenosis of the right renal artery through right femoral approach. The stent missed the ostium and repeated attempts at stenting the ostium did not succeed. Brachial approach was resorted to and ostium could be stented successfully. While deploying the stent the balloon was slightly inside the guiding catheter and the catheter tip got partially detached. The whole assembly was withdrawn to the brachial artery and the detached fragment was snared and removed.