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.

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience.

BACKGROUND: Bicuspid aortic valve (BAV) affects approximately 1.5% of the general population and is seen in nearly 50% of candidates for aortic valve replacement (AVR). Despite increasingly utilised transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) patients, its use among patients with severe bicuspid AS is limited as BAV is a heterogeneous disease associated with multiple and complex anatomical challenges. AIM: To investigate the one-year outcomes of TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., Vapi, India) in patients with severe bicuspid AS. METHODS AND RESULTS: We collected data from consecutive patients with bicuspid AS who underwent TAVI with the Myval THV and had at least one-year follow-up. Baseline characteristics, procedural, and 30-day echocardiographic and clinical outcomes were collected. Sixty-two patients were included in the study. The median age was 72 [66.3, 77.0] years, 45 (72.6%) were males, and the mean STS PROM score was 3.2 ± 2.2%. All TAVI procedures were performed via the transfemoral route. The median follow-up duration was 13.5 [12.2, 18.3] months; all-cause mortality was reported in 7 (11.3%) patients and cardiovascular hospitalisation in 6 (10.6%) patients. All-stroke was reported in 2 (3.2%), permanent pacemaker implantation 5 (8.3%), and myocardial infarction 1 (1.6%) patients. The echocardiographic assessment revealed a mean pressure gradient of 10 [8, 16.5] mmHg, effective orifice area 1.7 [1.4, 1.9] cm2, moderate AR in 1 (2%), mild AR in 14 (27%), and none/trace AR in 37 (71%). In total, 1 patient was diagnosed with valve thrombosis (2.1%), Stage II (moderate) haemodynamic deterioration was seen in 3 (6.4%), and stage III (severe) haemodynamic deterioration in 1 (2.1%) patient. CONCLUSIONS: TAVI with the Myval THV in selected BAV anatomy is associated with favourable one-year hemodynamic and clinical outcomes.

Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial.

BACKGROUND: Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown. OBJECTIVES: The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial. METHODS: The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding. RESULTS: At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI. CONCLUSIONS: At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication.

BACKGROUND: The balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. OBJECTIVES: The focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. METHODOLOGY: We report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). RESULTS: Final aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. CONCLUSION: The initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities.

Choosing an appropriate size valve for transcatheter pulmonary valve implantation in a native right ventricle outflow tract.

Introduction: Transcatheter pulmonary valve implantation has been an effective treatment for dysfuntional right ventricular tract outflow tract (RVOT). Defining a landing zone before the intervention is crucial in patients with native RVOT. Improper sizing and undefined landing zone will lead to embolization. Methods: It is a retrospective observational study from August 2020 to December 2020 in native RVOT. Three patients who had significant Right ventricle dilatation were analyzed. The multi-slice computed tomography (MSCT) with magnetic resonance imaging and angiography data of all patients before the procedure were analyzed. All patients underwent an angiogram in the same sitting, before the procedure to assess the landing zone, valve diameter as well as the risk for coronary compression. We chose a valve based on valve area 23%-25% more than the area at the waist during balloon sizing. Results: All three patients underwent successful valve implantation. Valve sizes used were 27.5 mm in one and 32 mm in the other two. The mean RVOT gradient postprocedure was 11.5 mm Hg and pre procedure was 43 mmHg. There were no complications during the procedure or at a mean follow-up of 3.6 months. Conclusion: The balloon sizing gives the true narrowest diameter in comparison with MSCT, and increasing this area by 23%-25% will give the appropriate valve size for successful implantation.

Coronary thrombo-embolic events after Covid-19 vaccination- a single centre study.

Thrombo-embolic complications after Corona virus disease-19 (COVID-19) vaccination have been previously reported. We aimed to study the coronary thrombo-embolic complications (CTE) after COVID-19 vaccination in a single centre during the initial 3 months of vaccination drive in India. All patients admitted to our hospital between 1st March 2021 and 31st May 2021 with Acute coronary syndrome (ACS) were included. Of the 89 patients [Age 55 (47-64)y, 13f] with ACS and angiographic evidence of coronary thrombus, 37 (42%) had prior vaccination history. The timing from last vaccination dose to index event was <1, 1-2, 2-4 and >4 weeks in 9(24%), 4(11%), 15(41%) and 9 (24%) respectively. ChAdOx1 nCoV-19/AZD1222 (Covishield) was the most used vaccine- 28 (76%), while 9 (24%) had BBV152 (Covaxin). Baseline characteristics were similar in both vaccinated (VG) and non-vaccinated group (NVG), except for symptom to door time [8.5 (5.75-14) vs 14.5 (7.25-24) hrs, p = 0.003]. Thrombocytopenia was not noted in any of the VG patients, while 2 (3.8%) of NVG patient had thrombocytopenia (p = 0.51). The pre- Percutaneous Coronary Intervention (PCI) Thrombolysis in Myocardial Infarction (TIMI) flow was significantly lower [1 (0-3) vs2 (1-3), p = 0.03) and thrombus grade were significantly higher [4 (2.5-5) vs 2 (1-3), p = 0.0005] in VG. The in-hospital (2.7% vs 1.9%, p = 1.0) and 30-day mortality were also similar (5.4% vs 5.8%, p = 1.0). This is the first report of CTE after COVID-19 vaccination during the first 3 months of vaccination drive in India. We need further reports to identify the incidence of this rare but serious adverse events following COVID-19 vaccination.

Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience.

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI's procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits.

BACKGROUND: Transcatheter pulmonary valve implantation (TPVI) is a surgical alternative for correcting dysfunctional right ventricular outflow tract conduits in previously operated patients. MyVal transcatheter heart valve (THV) (Meril Life Sciences, India), a new transcatheter valve designed for aortic position has not been used for TPVI. METHODS: Patients with stenosed dysfunctional conduits from the right ventricle to pulmonary artery (RV-PA) were prestented after initial computed tomography and balloon interrogation before the implantation of MyVal. Size of MyVal was chosen based on the final diameter of the prestent. Procedural details and post-TPVI follow-up were analyzed. RESULTS: Seven patients aged 17-60 years (median 26 years) had stenosed RV-PA conduits implanted 5-17 years (median 9 years) ago for tetralogy of Fallot in three, following Ross procedure in two, repair of pulmonary stenosis, and following PA debanding in one patient each. Prestenting improved the conduit diameter from 9.3 ± 2.8 mm to 20.8 ± 1.1 mm and relieved the gradient from 87.3 ± 31.7 mmHg (50-137 mmHg) to 12.7 ± 6.4 mmHg (5-20 mmHg). A 23 mm MyVal was implanted in all the seven patients successfully; one patient needed an additional 24.5 mm MyVal valve in valve implantation for residual regurgitation. The mean fluoroscopic time and dose area product were 38.7 ± 25.3 min and 66.917 ± 39.211Gray. cm2, respectively. At a median follow-up duration of 16 months (10-22 months), all patients were asymptomatic receiving dual antiplatelet therapy with no PR and the gradient was 12.5 ± 5.8 mmHg on echocardiography. Although one patient needed an additional valve-in-valve implantation, there were no valve-related adverse events. CONCLUSIONS: Early experience of TPVI with MyVal THV in prestented conduits is encouraging with procedural success in all patients and acceptable mid-term outcomes.

Disseminated melioidosis with native valve endocarditis: a case report.

BACKGROUND: Burkholderia pseudomallei is a Gram negative, soil-water saprophytic bacterium endemic in South-East Asia and Northern Australia. Melioidosis is being increasingly diagnosed in other regions like India, China, and Sri Lanka during recent years. The clinical presentation of melioidosis is extremely variable. CASE SUMMARY: We present a case of melioidosis presenting as native valve infective endocarditis with concomitant hepatic and splenic abscesses. This is the second case of melioidosis with infective endocarditis reported from India. DISCUSSION: Melioidosis can present with pneumonia, pleural effusion, subcutaneous abscesses, visceral abscesses, osteomyelitis, and septicaemia, but cardiac involvement is rare. Endocarditis due to melioidosis is rare (∼1%) and is rarely reported in literature. This case highlights the unusual presentation of this emerging disease.

Transradial access for coronary diagnostic and interventional procedures: Consensus statement and recommendations for India: Advancing Complex CoronariES Sciences through TransRADIAL intervention in India - ACCESS RADIAL™: Clinical consensus recommendations in collaboration with Cardiological Society of India (CSI).

Radial access for cardiac catheterization and intervention in India has been growing steadily over the last decade with favorable clinical outcomes. However, its usage by interventional cardiologists varies greatly among Indian operators and hospitals due to large geographic disparities in health care delivery systems and practice patterns. It also remains unclear whether the advantages, as well as limitations of transradial (TR) intervention (as reported in the western literature), are applicable to developing countries like India or not. An evidence-based review involving various facets of radial procedure for cardiac catheterization, including practical, patient-related and technical issues was conducted by an expert committee that formed a part of Advancing Complex CoronariES Sciences through TransRADIAL intervention (ACCESS RADIAL™) Advisory Board. Emerging challenges in redefining TR management based on evidence supporting practices were discussed to formulate these final recommendations through consensus.

Transcatheter aortic valve replacement in India-Early experience, challenges, and outcomes from a single center.

BACKGROUND: Despite the increasing popularity of transcatheter aortic valve replacement (TAVR), only about 10,000 TAVR cases have been performed in Asia to date. The procedure is still in a nascent stage in India with very few centers offering this state-of-art technique. Here, we present the early results of TAVR experience at our center. METHODS: Forty-nine patients with severe symptomatic aortic stenosis (AS) were referred to our center for TAVR from November 2015 to February 2018. Twenty-five patients underwent TAVR at our conventional cardiac catheterization laboratory under local or general anesthesia, with standby surgical team support. RESULTS: The mean age of the patients was 72.0 ± 8.1 years. The mean Society of Thoracic Surgeons score was 13.8 ± 10.2. Baseline mean ejection fraction was 50.3 ± 14.8%. Baseline mean aortic valve gradient was 55.8 ± 24.7 mmHg. There was one procedural-related death. Two of the patients required urgent surgery: one for contained annular rupture and one underwent vascular repair for femoral artery occlusion. Mild and moderate paravalvular leak was seen in 11 and 3 patients, respectively. Four patients (16%) required permanent pacemaker. Eighty percent were in New York Heart Association class I-II at discharge. One-year all-cause mortality was 8%, with no hospitalizations or major adverse cardiac event during the 1-year follow-up. CONCLUSION: Our early data clearly shows that in our country, TAVR is a good alternative for symptomatic severe AS for high surgical risk cases. Large-scale multicenter studies are required to study the real impact of TAVR in the Indian scenario. During initial years of implementation of a nationwide TAVR program, it may be prudent to focus on creating TAVR Centers of Excellence by developing an ideal hub and spokes model.

Percutaneous transluminal coronary angioplasty by right transradial approach in a patient with arteria lusoria.

Though the radial artery is an ideal site of access for coronary interventions, at times anatomical variations make this procedure complicated. We describe one such arterial aberrancy, the retroesophageal right subclavian artery or arteria lusoria, in which the right subclavian artery arises distal to the left subclavian artery. Therefore, approaching through the right radial artery, the catheter has to take a zigzag course through the right subclavian to the descending aorta, and then to the ascending aorta. This often makes it difficult to perform diagnostic angiography. Performing angioplasty by the right transradial approach also becomes a more difficult task and requires greater perseverance and skill. In the case described here, the patient with arteria lusoria had tandem 90% stenosis involving the proximal and mid left anterior descending artery. Percutaneous transluminal coronary angioplasty with stenting of the proximal and mid left anterior descending artery by the right transradial approach was performed, negotiating the loop with two paclitaxel-eluting stents.

Radial artery perforation and its management during PCI.

Radial artery perforation is a rare but important complication of the transradial approach. This report highlights two cases of radial artery perforation during percutaneous coronary intervention managed by simple strategies without resorting to an alternative route. The guiding catheter itself helps to seal the perforation, hence continuing to perform the procedure through the same route is an effective way to seal off the perforation.