Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.

Transcatheter Mitral Valve-in-Valve Implantation with the Balloon-Expandable Myval Device.

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.

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis - 2 Years Follow up Experience From India.

Background: Transcatheter aortic valve implantation (TAVI) is challenging in bicuspid aortic valve (BAV) anatomy. The patients are young, morphological phenotypes are many, calcium burden is high and there are technical challenges for best outcomes. Observational studies and registries are available with favorable data and experiences from around the world sharing methodologies and algorithms for sizing and implantation. We, therefore, analysed our data of procedural and in-hospital outcomes of TAVI in Bicuspid Aortic Valve cases performed at two high volume centres in India and their follow up for two years. Methods and Results: The data were collated and analysed from two centres (Fortis Escorts Heart Institute, New Delhi and Apollo Hospitals, Chennai) in India for patients who underwent TAVI in a BAV anatomy. It included a total of 70 cases from 2 centres. All symptomatic severe AS patients more than and equal to 65 years having bicuspid anatomy were included in the study irrespective of their STS score. Patients under 65 years of age were advised TAVI only if they were at high risk for open heart surgery. These patients were followed for a period of 2 years and the data were analysed. Pre TAVI imaging tools utilised were 2D echo, transthoracic echocardiography (TTE), trans oesophageal echocardiography (TEE), and ECG gated multi slice CT (MSCT) scan imaging. MSCT was utilised for confirmation of the anatomy and classifying the morphological type of valve, measuring, and evaluating all anatomic determinants of aortic root complex for planning the procedure and choice of the valve and its size. Sizing in balloon expanding valve (BEV) and self-expanding valve sizing (SEV) were based primarily on annulus area and perimeter, respectively. The SEV used in our study were the Core Valve and Evolut R (Medtronic, United States) and the BEVs included Sapien3 (Edwards Lifesciences, United States) and Myval (Meril Lifesciences, India). The BAV cohort constituted 24.4% of the total 287 TAVI cases, followed up for 2 years. The mean age of these patients was 72 years. The incidence of male patients was 68.57% and female patients was 31.4%. The Sievers type 1 included 78.5%, type 0 were 21.4% of the cases and there was no case of type 2 in the study. The procedural success was to the tune of 98%. Patients with normal left ventricular ejection fraction (LVEF) improved their symptoms class after TAVI and remained so at 2 years follow up. The poor LVEF subset of patients did not have heart failure admissions and also had improvement in their symptom status. The peak-to-peak aortic valve gradient decreased to 0 mmHg at the end of the procedure in most of the cases. The mean pressure gradient (PG) across the new valve ranged between 0 and 15 mmHg and the aortic valve area (AVA) was close to 2 cm2. These numbers were consistent at 2 years follow up. Significant paravalvular leak (PVL) 24.28% was seen immediately after deployment of the valve in heavily calcified anatomy but it reduced to mild or trivial PVL after post-dilation and one patient needed a second valve to treat PVL. No patient had more than mild PVL with either type of valve at the end of the procedure. Permanent pacemaker implantation (PPI) was required in 11.4% of the patients within 24 h to 7 days of the procedure. No one needed a PPI in the 2 year follow up. Coronary occlusion did not happen to any patient. No patient had a disabling stroke. Non-disabling stroke was seen in 10% of cases and mostly in the first week or 30 days of the procedure and the incidence was more with BEV (14%) as compared to SEV (8%). There was one case of valve embolisation after 24 h of the procedure, which needed a surgical valve replacement. There was no case of annular injury or injury to other parts of the aortic root complex. Two cases had access vessel (femoral artery) thrombosis at end of the procedure and a third patient had proglide related residual stenosis. Two cases had acute kidney injury and needed dialysis. There was no major bleeding complication in any patient. Peri procedural mortality occurred in two patients. Valve thrombosis was seen in one patient after 3 months, which was treated with oral anticoagulation. Valve degeneration and failure or infective endocarditis were not seen in any patient. Conclusion: The patients with BAV stenosis who underwent TAVI in this study had good procedural success rates and clinical outcomes. The haemodynamics achieved with both SEV and BEV were good at 2 years. The rates of PVL, PPI, and stroke are similar to that of many other studies and registries. PPI rate and non-disabling stroke incidence appear to be higher similar to many studies done. There was no case of coronary occlusion in the study. Meticulous CT analysis of the aortic root complex, selection of appropriate type and size of the valve, and best implantation practices along with cerebral protection will probably be the key to safer and more successful TAVI in this population.

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.

Saline as an Alternative to Radio-Contrast for Optical Coherence Tomography-Guided Percutaneous Coronary Intervention: A Prospective Comparison.

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.

Impact of renal function in high bleeding risk patients undergoing percutaneous coronary intervention: a patient-level stratified analysis from four post-approval studies.

Data on ischemic and bleeding outcomes after percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with chronic kidney disease (CKD) are scarce. We aimed to evaluate the association between CKD and ischemic and bleeding outcomes in HBR patients who underwent PCI. Among 10,502 patients in the four post-approval registries evaluating patients undergoing PCI, 2,300 patients presented with at least one major or two minor ARC-HBR criteria. CKD was defined as eGFR < 60 mL/min/1.73 m2. These HBR patients were divided into 3 groups: eGFR < 30 mL/min/1.73 m2 defined as severe CKD (N = 221), eGFR 30- < 60 mL/min/1.73 m2 defined as moderate CKD (N = 970), eGFR ≥ 60 mL/min/1.73 m2 defined as no CKD (N = 1,109). The primary endpoint was the composite of cardiac death, myocardial infarction, or stent thrombosis, and the safety endpoint was major bleeding up to 4-year follow-up. HBR patients with CKD were more often female and had higher rates of comorbidities compared to those without CKD. Reduced renal function was associated with higher rates of the primary endpoint (severe CKD vs. moderate CKD vs. no CKD: 30.2% vs. 12.5% vs. 9.1%, P < 0.01) as well as major bleeding (10.3% vs. 8.9% vs. 6.4%, P = 0.03). After adjustment, severe CKD and moderate CKD in HBR patients remained independent predictors for the primary endpoint (HR [95%CI] 2.84 [1.94-4.16], P < 0.01, 1.48 [1.10-2.00], P < 0.01) compared to those with no CKD. However, decreased renal function was no longer significantly associated with major bleeding after adjustment. In conclusions, in HBR patients undergoing PCI, CKD has an important impact on major ischemic events after PCI.

Transcatheter aortic valve implantation during the COVID-19 pandemic: Clinical expert opinion and consensus statement for Asia.

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.

Long-Term Safety and Efficacy of Durable Polymer Cobalt-Chromium Everolimus-Eluting Stents in Patients at High Bleeding Risk: A Patient-Level Stratified Analysis From Four Postapproval Studies.

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.

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

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.

Comparison of anti-thrombotic strategies using Bivalirudin, Heparin plus Glycoprotein IIb/IIIa inhibitors and Unfractionated Heparin Monotherapy for patients undergoing percutaneous coronary intervention - A single centre observational study.

AIMS: The study was planned to compare Anti-thrombotic strategies for patients undergoing PCI in a real world population with an emphasis on occurrence of major bleeding, composite ischemic end points and economic outcomes. METHODS: The present study is a single center, prospective, observational study in consecutive patients undergoing PCI at Fortis Escorts Heart Institute (FEHI) and describes Authors' experience with three different Anti-Thrombotic Strategies in a real world population. Patients were consecutively enrolled in the study and the choice of Anti-thrombotic strategy was left to individual operator(s) based on their own clinical judgment and patient's affordability. No specific inclusion/exclusion criteria were specified on the choice of Anti-Thrombotic Strategy. RESULTS: A total 1453 patients were consecutively enrolled into the study and were followed telephonically after 30 days. 252 patients were treated with Bivalirudin (Angiomax) during PCI (17.3%), 430 (29.6%) patients were treated with Heparin plus GPI & remaining 771 (53.1%) were treated with Heparin monotherapy. Incidence of major bleeding was lowest in patients treated with Bivalirudin (1.59%) when compared to Heparin plus GPI (3.49%) and Heparin monotherapy (5.97%), p = 0.005 Bivalirudin vs. Heparin Monotherapy, and p = 0.145, Bivalirudin vs. Heparin + GPI. No bleeding was observed in STEMI patients treated with Bivalirudin compared to 7.4% in patients treated with GPI and 14.3% in patients treated with UFH. Similarly non-access site bleeding was lowest in patients treated with Bivalirudin. Only 4 patients (1.6%) treated with Bivalirudin required Blood transfusion compared to 25 in Heparin plus GPI (5.8%) and 38 (5%) in Heparin Monotherapy arm. In Composite Ischemic end-points, no "All-cause Mortality" was observed in Bivalirudin group compared to 2.8% in Heparin plus GPI. Early stent thrombosis was seen in 1 patient with Heparin plus GPI and none with Heparin monotherapy and Bivalirudin group. None of the patients underwent TLR (target lesion revascularization) and TVR (target vessel revascularization) within 30 days post procedure other than one early stent thrombosis reported with Heparin plus GPI. Cost of blood product transfusion was lower with Bivalirudin as compared to Heparin plus GP IIb/IIIa arm (p = 0.01) and with Heparin alone (p = 0.001). Due to lower complications including blood transfusions and reduced hospital stay in Bivalirudin group, these benefits outweigh the incremental cost due to higher acquisition cost of the drug. CONCLUSION: Bivalirudin use during PCI is associated with a distinct advantage of having lower access site and non-access site bleeding without compromising on the efficacy. We observed a reduction in blood transfusions, hospital stay and mortality for patients treated with Bivalirudin compared with Heparin plus GPI or Heparin Monotherapy. Bivalirudin can be safely adopted into our Institutional protocol for the treatment of high risk PCI such as STEMI, ACS, and Complex elective PCI.

The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled.

AIMS: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system (Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A and cohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a global continued access study (outside of the USA) to expand experience with the Absorb BVS system to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population. METHODS AND RESULTS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study which will enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of two de novo native coronary artery lesions is permitted when each lesion is located in a different epicardial vessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemia-driven target vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite and probable scaffold thrombosis for this population was 0.8% at one year. CONCLUSIONS: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffold thrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Three-year data from the XIENCE V INDIA study: safety and efficacy of XIENCE V in 1000 real world Indian patients.

BACKGROUND: Cardiovascular disease in Asia has reached epidemic proportions in recent years. Use of drug eluting stents in Asians has rapidly expanded with varying penetration rates across different countries. The XIENCE V INDIA Study included 'real world' patients who underwent XIENCE V stent implantation to assess short and intermediate term outcomes in Indian patients with diverse risk factors. OBJECTIVE: To evaluate 3-year clinical outcomes in a cohort of 'real world' Indian patients with CAD being treated with XIENCE V Everolimus Eluting Coronary Stent System. METHODS: 1000 patients were enrolled from 18 sites in India between June 2008 and March 2009. Patients were included if their index procedures were completed using only XIENCE V. There were no clinical or angiographic exclusions. An independent Clinical Events Committee adjudicated all endpoint-related events. The primary endpoint was stent thrombosis rate annually through to 3 years as defined by the Academic Research Consortium criteria. The co-primary endpoint was the composite rate of cardiac death and myocardial infarction at 1 year. RESULTS: At 1-year the primary endpoint of definite/probable stent thrombosis rate was 0.51%. No additional very late stent thrombosis was reported through a 3-year follow up. The composite endpoint of cardiac death and any myocardial infarction was 1.9%, 2.7% and 3.1% at 1, 2 and 3 years respectively. CONCLUSION: Despite the high risk population of coronary artery disease, the use of XIENCE V in 'real world' Indian patients was associated with very low clinical event rates upto three years of follow up.

Transcatheter aortic valve implantation under conscious sedation - the first Indian experience.

Transcatheter aortic valve implantation (TAVI) is maturing strongly as an alternative to surgical aortic valve replacement (SAVR) in patients who are inoperable/high risk for open heart surgery. General anesthesia (GA) is the usual mode of anesthesia in these patients, but local anesthesia with conscious sedation (LACS) has recently been described as a safe alternative with some added advantages. We report 2 cases who were unfit for GA and were done successfully under LACS.

Transcatheter aortic valve implantation with Core Valve: first Indian experience of three high surgical risk patients with severe aortic stenosis.

The prevalence of aortic stenosis is increasing with aging population. However with multiple co-morbidities and prior procedures in this aging population, more and more patients are being declared unfit for the 'Gold Standard' treatment i.e. surgical aortic valve replacement (AVR). Among the patients who are unfit or high risk for aortic valve replacement (AVR) by open heart surgery, transcatheter aortic valve implantation (TAVI) has been proven to be a valuable alternative improving survival and quality of life. We report first Indian experience of Core Valve (Medtronic Inc.) implantation in three high surgical risk patients performed on 22nd and 23rd February 2012.

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study.

BACKGROUND: Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions. METHODS: The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed. RESULTS: The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). CONCLUSIONS: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Systemic exposure of everolimus after stent implantation: a pharmacokinetic study.

OBJECTIVES: We evaluated the pharmacokinetics of the eluted everolimus by assessing systemic drug release and distribution of everolimus-eluting stents. BACKGROUND: Drugs eluted by a coronary stent might cause adverse events such as tumors, infections, or noncardiac death. The systemic exposure of the drugs is unknown because there are only limited data about pharmacokinetics of drug-eluting stents in humans. METHODS: Venous blood samples in a subset of 39 patients were drawn just before implantation of the first stent (baseline, 0-minute time point) and at 10 and 30 minutes and 1, 2, 4, 6, 12, 24, 36, 48, 72, 168, and 720 hours (30 days) after completion of implantation of the last stent. Whole blood concentrations of everolimus were determined using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method. RESULTS: The total dose of everolimus received by the patients ranged from 53 to 588 microg. The last time point up to which whole blood concentrations could be quantified ranged per patient from 4 to 720 hours after implantation of the last stent. Across all dose levels, individual T(max) values ranged from 0.13 and 2.17 hours; individual C(max) ranged from 0.14 to 2.79 ng/mL. CONCLUSION: This study confirms the limited exposure to the systemic circulation of the eluted drug with the use of the XIENCE V Everolimus-Eluting Coronary Stent System (Abbott Vascular, Santa Clara, CA). Therefore, a systemic cause of adverse events is unlikely.