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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). 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. 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 %). Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS. • Transcatheter aortic valve implantation (TAVI) has become an established intervention for treating severe aortic stenosis. • Cardiac complications can occur after TAVI due to improper size or fit of the valve. • The commonest complications are left bundle branch block and paravalvular leak. • The design of the new Myval Octacor transcatheter heart valve (THV) aims at minimizing these complications. • In this study, the rate of these complications after Myval Octacor THV implantation was low. [ABSTRACT FROM AUTHOR]

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. 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. 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%). 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. 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. • The new BE Myval Octacor THV shows changes in cell design to minimise over-shortening of the device. • The improved internal and external skirt design shows improvement in the incidence of residual AR. • In comparison to the First Myval iteration, Myval Octacor shows a significant reduction of moderate or more AR. • A reduction of mild AR with a shift to none/trace AR was observed when AR was assessed using quantitative technology. [ABSTRACT FROM AUTHOR]

Transcatheter aortic and mitral valve-in-valve (ViV) or valve-in-ring (ViR) implantation into failed bioprosthetic heart valves (BHVs) or rings represents an appealing, less invasive, treatment option for patients at high surgical risk. Nowadays, few data have been reported on the use of balloon-expandable Myval (Meril Life Science, Vapi, India) transcatheter heart valve (THV) for the treatment of degenerated BHVs or rings. We aimed at evaluating the early and mid-term clinical outcomes of patients with left side heart bioprosthesis deterioration treated with transcatheter ViV/ViR implantation using Myval THV. 97 consecutive patients with symptomatic, severe aortic(n=33) and mitral(n=64) BHVs/ring dysfunction underwent transcatheter aortic ViV and mitral ViV/ViR implantation with Myval THV. Technical success was achieved in 95 (98%) of the patients. Two cases of acute structural trans-catheter mitral ViV/ViR dysfunction requiring a second THV implantation were reported. At 30-day, a significant reduction in prosthetic trans-valvular pressure gradients and increase in valve areas were seen following both aortic and mitral ViV/ViR implantation. Overall survival at 15 months (IQR 8-21) was 92%. Patients undergoing mitral ViV/ViR had a relatively worse survival compared with those undergoing aortic ViV implantation (89% vs. 97% respectively; HR:2.7,CI:0.33-22.7;p=0.34). At longest follow-up available a significant improvement in NYHA functional class I and II was observed in patients with aortic and mitral ViV/ViR implantation(93.8% and 92.1%). Despite high surgical risk, transcatheter ViV/ViR implantation for failed left side heart bioprosthesis can be performed safely using Myval THV with a high success rate and low early and mid-term mortality and morbidity. • Transcatheter aortic and mitral ViV implantation is an appealing treatment option for patients with failed BHVs. • We evaluated mid-term outcomes of patients with aortic or mitral BHV deterioration treated with Myval THV. • Technical success was achieved in 95 (98%) of the patient. • Patients undergoing mitral ViV/ViR had a relatively worse survival compared with those undergoing aortic ViV implantation. • Myval THV for failed BHVs can be performed safely with a high success rate and low mid-term mortality and morbidity. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

• We report the step by step approach for JenaValve TAVR and early use of non-dedicated THV devices for severe pure native AR • This is the first report on videodensitometry quantification of AR before and after JenaValve TAVR for severe pure native AR. • Videodensitometry shows decrease of AR regurgitation fraction from 55% to 0% after JenaValve TAVR. [ABSTRACT FROM AUTHOR]

Background: The vast majority of transcatheter valve-in-valve (ViV) mitral procedures have been reported with the SAPIEN family. We aimed to report the preliminary experience with the Myval balloon-expandable device in this setting. Methods: Multicenter retrospective study of high-risk surgical patients with mitral bioprosthesis degeneration undergoing transcatheter ViV implantation with Myval device. Results: A total of 11 patients from five institutions were gathered between 2019 and 2022 (age 68 ± 7.8, 63% women). The peak and mean transvalvular gradients were 27 ± 5 mmHg and 14.7 ± 2.3 mmHg, respectively, and the predicted neo-left ventricular outflow tract (neo-LVOT) area was 183.4 ± 56 mm2 (range: 171 to 221 mm2). The procedures were performed via transfemoral access in all cases (through echocardiography-guided transeptal puncture (81.8% transesophageal, 11.2% intracardiac)). Technical success was achieved in all cases, with no significant residual mitral stenosis in any of them (peak 7.2 ± 2.7 and mean gradient 3.4 ± 1.7 mmHg) and no complications during the procedure. There were no data of LVOT obstruction, migration, or paravalvular leak in any case. Mean hospital stay was 3 days, with one major vascular complication and no stroke. At 6-month follow-up, there was one case with suboptimal anticoagulation presenting an increase in the transmitral gradients (mean 15 mmHg) that normalized after optimization of the anticoagulation, but no other relevant events. Conclusions: Transseptal ViV mitral implantation with the balloon-expandable Myval device was feasible and safe avoiding redo surgery in high-risk patients with bioprosthesis degeneration. [ABSTRACT FROM AUTHOR]

Background: The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.Methods: We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.Results: At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).Conclusions: In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830). [ABSTRACT FROM AUTHOR]

Introduction: Trans-radial approach (TRA) is recommended over trans-femoral approach (TFA) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We intended to study the effect of access on all-cause mortality. Methods and results: We searched PubMed and EMBASE for randomized studies on patients with ACS undergoing PCI. The primary outcome was all-cause mortality at 30-days. The secondary outcomes included in-hospital mortality, major adverse cardiac or cerebrovascular event (MACE) as defined by the study, net adverse clinical event (NACE), non-fatal myocardial infarction, non-fatal stroke, stent thrombosis, study-defined major bleeding, and minor bleeding, vascular complications, hematoma, pseudoaneurysm, non-access site bleeding, need for transfusion, access site cross-over, contrast volume, procedure duration, and hospital stay duration. We studied 20,122 ACS patients, including 10,037 and 10,085 patients undergoing trans-radial and trans-femoral approaches, respectively. We found mortality benefit in patients with ACS for the trans-radial approach [(1.7% vs. 2.3%; RR: 0.75; 95% CI: 0.62–0.91; P = 0.004; I2 = 0%). Out of 10,465 patients with STEMI, 5,189 patients had TRA and 5,276 had TFA procedures. A similar benefit was observed in patients with STEMI alone [(2.3% vs. 3.3%; RR: 0.71; 95% CI: 0.56–0.90; P = 0.004; I2 = 0%). We observed reduced MACE, NACE, major bleeding, vascular complications, and pseudoaneurysms. No difference in re-infarction, stroke, and serious bleeding requiring blood transfusions were noted. We noticed a small decrease in contrast volume(ml) {mean difference (95% CI): −4.6 [−8.5 to −0.7]}, small but significantly increase in procedural time {mean difference (95% CI) 1.2 [0.1 to 2.3]}and fluoroscopy time {mean difference (95% CI) 0.8 [0.3 to1.4] min} in the trans-radial group. Conclusion: TRA has significantly reduced 30-day all-cause mortality among patients undergoing PCI for ACS. TRA should be the preferred vascular access in patients with ACS. [ABSTRACT FROM AUTHOR]

Objectives: To do a quantitative comparison of saline and contrast Frequency domain optical coherence tomography (FD-OCT) during percutaneous coronary intervention (PCI) optimisation.Methods: 13 pairs of OCT runs were analysed, wherein each pair consisted of a contrast run and a heparinized saline run taken in the same coronary artery at the same position. Quantitative analysis was done comparing minimal lumen area (MLA), proximal reference diameter (PRD), distal reference diameter (DRD) and percentage area stenosis (AS) at the same anatomical location. Lesion morphologies, rendered stent view and 3D reconstruction were compared for image clarity.Result: The saline OCT runs resulted in comparable MLA (3.88 ± 2.59 mm2 with saline run vs 3.88 ± 2.71 mm2 with contrast run; p = 0.650), PRD (3.66 ± 0.52 mm with saline vs 3.65 ± 0.52 mm with contrast; p = 0.463), DRD (2.97 ± 0.22 mm with saline vs 2.99 ± 0.88 mm with contrast; p = 0.433), and AS (59.60 ± 18.62% with saline vs 59.18 ± 19.11% with contrast; p = 0.753) with respect to the contrast runs. The Bland Altman plots of the measured parameters indicate good agreement between saline and contrast OCT. Linear regression analysis indicated the absence of proportional bias All lesion morphologies (calcified, fibrotic, thin cap fibroatheroma, macrophages, cholesterol crystals and edge dissection), 3D reconstruction and rendered stent view were clearly demonstrable in the saline OCT runs.Conclusions: Using heparinized saline as flushing media in coronary FD-OCT may result in vessel dimensions that are comparable with contrast. Heparinized saline may be used as a contrast saving alternative for FD-OCT during PCI optimization. [ABSTRACT FROM AUTHOR]

Plasma protein-C exerts anticoagulatory effects by inactivating factors V and VIII. Hereditary protein C deficiency is transmitted as an autosomal dominant disorder. Homozygous individuals usually develop purpura fulminans as newborns; heterozygous protein C-deficient individuals are at increased risk for venous thrombosis and pulmonary embolism. However, arterial thrombosis occurring as a result of congenital protein-C deficiency is still controversial. We describe a young patient with heterozygous protein-C deficiency who experienced both pulmonary embolism as well as myocardial infarction due to thrombotic occlusion without underlying major risk factors. Acute myocardial infarction in young without underlying major risk factors may be evaluated for protein c deficiency. [ABSTRACT FROM AUTHOR]

Objectives: The impact of the COVID-19 pandemic on the treatment of patient with aortic valve stenosis is unknown and there is uncertainty on the optimal strategies in managing these patients.Methods: This study is supported and endorsed by the Asia Pacific Society of Interventional Cardiology. Due to the inability to have face to face discussions during the pandemic, an online survey was performed by inviting key opinion leaders (cardiac surgeon/interventional cardiologist/echocardiologist) in the field of transcatheter aortic valve implantation (TAVI) in Asia to participate. The answers to a series of questions pertaining to the impact of COVID-19 on TAVI were collected and analyzed. These led subsequently to an expert consensus recommendation on the conduct of TAVI during the pandemic.Results: The COVID-19 pandemic had resulted in a 25% (10-80) reduction of case volume and 53% of operators required triaging to manage their patients with severe aortic stenosis. The two most important parameters used to triage were symptoms and valve area. Periprocedural changes included the introduction of teleconsultation, preprocedure COVID-19 testing, optimization of protests, and catheterization laboratory set up. In addition, length of stay was reduced from a mean of 4.4 to 4 days.Conclusion: The COVID-19 pandemic has impacted on the delivery of TAVI services to patients in Asia. This expert recommendation on best practices may be a useful guide to help TAVI teams during this period until a COVID-19 vaccine becomes widely available. [ABSTRACT FROM AUTHOR]

Background: Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent implantation.Methods: We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates.Results: Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76-5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93-6.41]), as well as after MB (HR 4.92 [95% CI, 3.82-6.35]). Of note, this effect was consistent across the spectrum of bleeding risk (P-interaction test 0.97 and 0.06, respectively).Conclusions: Compared with the non-HBR population, HBR patients experienced worse 4-year outcomes after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk. [ABSTRACT FROM AUTHOR]

Abstract Objectives The aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. Background Bioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. Methods 573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. Results The registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ± 27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ± 3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802–1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. Conclusions These long-term results from a complex “real-world” population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique. Highlights • Recent studies showed higher than expected incidence of scaffold thrombosis. • Large registries highlighted the importance of a dedicated implant technique. • The performance of this dedicated technique was tested in this large registry. • The incidence of scaffold thrombosis was reassuringly low (0.7% at 4 years). • Dedicated technique has a key-role in bioresorbable scaffolds implantation. [ABSTRACT FROM AUTHOR]

Background: Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes.Objectives: This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters).Methods: TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and post-dilation). Multivariable analysis was used to adjust for differences in up to 18 patient and lesion characteristics.Results: Optimal pre-dilation (balloon to core laboratory-derived reference vessel diameter ratio ≥1:1), vessel size selection (reference vessel diameter ≥2.25 mm and ≤3.75 mm), and post-dilation (with a noncompliant balloon at ≥18 atm and larger than the nominal scaffold diameter, but not by >0.5 mm larger) in all BVS-treated lesions were performed in 59.2%, 81.6%, and 12.4% of patients, respectively. BVS implantation in properly sized vessels was an independent predictor of freedom from TLF through 1 year (hazard ratio [HR]: 0.67; p = 0.01) and through 3 years (HR: 0.72; p = 0.01), and of freedom from ScT through 1 year (HR: 0.36; p = 0.004). Aggressive pre-dilation was an independent predictor of freedom from ScT between 1 and 3 years (HR: 0.44; p = 0.03), and optimal post-dilation was an independent predictor of freedom from TLF between 1 and 3 years (HR: 0.55; p = 0.05).Conclusions: In the present large-scale analysis from the major ABSORB studies, after multivariable adjustment for baseline patient and lesion characteristics, vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281; ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906; A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT] [ABSORB CHINA]; NCT01923740; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND]; NCT01023789; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284). [ABSTRACT FROM AUTHOR]

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients. [ABSTRACT FROM AUTHOR]

The article discusses an evaluation of the three-dimensional echocardiographic evaluation of an aspergilloma which complicates the right ventricular permanent pacemaker implant on a 65-year-old man. Based on the imaging technologies used, the mass revealed characteristic of hyphae and culture the electrode tip grew Aspergillus fumigatus. It has been proven that three-dimensional echocardiography can help in early diagnosis as well as surgical planning.

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. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background: Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods: Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results: All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p < 0.0001). Stress-induced ST-segment depression was reduced in 6 of 9 patients and was eliminated in 2 of these 6 (p = 0.047). The extent and severity of myocardial ischemia by dobutamine echocardiography and by thallium single-photon emission computed tomography was reduced (p = 0.004 [n = 13] and p = 0.042 [n = 10], respectively). Conclusions: Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization. [Copyright &y& Elsevier]