Original Article--Clinical and Procedural Characteristics of Successful Transcatheter Device Closure of Ostium Secundum Atrial Septal Defect in Symptomatic Children Weighing <15 kg: A Retrospective Study Spanning One Decade From South India.

Objectives: This retrospective study sought to determine the feasibility of transcatheter atrial septal defect device closure in patients less than 15 kg, as well as to assess complication rates and the reasons for unsuccessful device closure. Background: In general, the risks associated with transcatheter atrial septal defect device closure are believed and reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend atrial defect closure in device closure in children <15 kg, due to limited data available for feasibility and safety of device closure in this group of patients. Methods: Retrospective review of all patients who underwent elective transcatheter closure of ostium secundum atrial septal defect between September 2013 to February 2022. We excluded all children above 15 kg, as well as those with complex congenital heart defects. Major and minor complications were predefined and indications for referral were evaluated. Results: We identified 81 patients meeting criteria with a median procedural age of 3 years (1 year-8 years), and median weight of 12 kg (4-15 kg). Successful device closure was achieved in 95.1% (77/81) and in 4.9% (4/81), the procedure was aborted. There was 1 major (1.2%) and 1 minor (1.2%) complication, total complication rate (2.4%). 100% of the referrals had right heart enlargement and exertional dyspnoea, 18.5% had recurrent lower respiratory tract infection and 9.9% had failure to thrive. Rate of resolution of residual shunt was 95.1%. at post-procedure day 1 and 98.8% at post-procedure 3 and 6 months respectively. Conclusions: Percutaneous atrial septal defect closure can be done effectively and safely in symptomatic children weighing less than 15 kg in experienced centres. However, deferral for closure until the historically established timeline of around 4-5 years of age should be strongly considered in asymptomatic children.

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.

Smart Shelf System for Customer Behavior Tracking in Supermarkets.

Transactional data from point-of-sales systems may not consider customer behavior before purchasing decisions are finalized. A smart shelf system would be able to provide additional data for retail analytics. In previous works, the conventional approach has involved customers standing directly in front of products on a shelf. Data from instances where customers deviated from this convention, referred to as "cross-location", were typically omitted. However, recognizing instances of cross-location is crucial when contextualizing multi-person and multi-product tracking for real-world scenarios. The monitoring of product association with customer keypoints through RANSAC modeling and particle filtering (PACK-RMPF) is a system that addresses cross-location, consisting of twelve load cell pairs for product tracking and a single camera for customer tracking. In this study, the time series vision data underwent further processing with R-CNN and StrongSORT. An NTP server enabled the synchronization of timestamps between the weight and vision subsystems. Multiple particle filtering predicted the trajectory of each customer's centroid and wrist keypoints relative to the location of each product. RANSAC modeling was implemented on the particles to associate a customer with each event. Comparing system-generated customer-product interaction history with the shopping lists given to each participant, the system had a general average recall rate of 76.33% and 79% for cross-location instances over five runs.

Última generación de prótesis percutáneas expandibles con balón y autoexpandibles en la estenosis aórtica bicúspide: estudio TRITON / Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

Introducción y objetivos: La última generación de válvulas cardiacas expandibles con balón y autoexpandibles para implante percutáneo no se han comparado en valvulopatía aórtica bicúspide (VAB).Métodos: Registro multicéntrico de pacientes consecutivos con VAB y estenosis grave tratados con las válvulas cardiacas expandibles con balón (Myval y SAPIEN 3 Ultra [S3U]) o autoexpandible Evolut PRO+(EP+). Se realizó un análisis de tripletes mediante el software TriMatch para minimizar el impacto de las diferencias basales. El objetivo primario del estudio fue evaluar la tasa de éxito del dispositivo a 30 días y los objetivos secundarios, el objetivo combinado de seguridad y sus componentes individuales a 30 días.Resultados: Se incluyó a 360 pacientes (media de edad, 76,6±7,6 años; el 71,9% varones); 122 con Myval (33,9%), 129 con S3U (35,8%) y 109 con EP+(30,3%). La media de puntuación STS fue de 3,6±1,9%. No hubo ningún caso de oclusión coronaria, rotura de anillo, disección aórtica o mortalidad periprocedimiento. El evento primario de éxito del dispositivo a 30-días fue significativamente superior en el grupo que recibió Myval (Myval, 100%; S3U, 87,5%, y EP+, 81,3%), fundamentalmente a expensas de mayor gradiente residual con S3U y mayor tasa de insuficiencia aórtica al menos moderada con EP+. La tasa no ajustada de implante de marcapasos no presentó diferencias significativas.Conclusiones: En la VAB con estenosis grave y cirugía contraindicada, Myval, S3U y EP+tuvieron una seguridad comparable, aunque Myval presentó mejor gradiente residual que S3U y ambos dispositivos expandibles con balón resultaron en menos fuga perivalvular residual que EP+. Por lo tanto, ajustándose a los riesgos específicos de cada paciente, se puede seleccionar cualquiera de los 3 dispositivos con resultados óptimos.(AU)

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.(AU)

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.

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.

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.

Reduction of permanent pacemaker implantation by using the cusp overlap technique in transcatheter aortic valve replacement: a meta-analysis.

BACKGROUND: The need for permanent pacemaker (PPM) implantation is a common complication after transcatheter aortic valve replacement (TAVR). Deep implantation position is a risk factor for PPM implantation. Thus, in the field of self-expandable (SE) transcatheter heart valves (THV) cusp overlap projection (COP) technique was implemented to reduce parallax, allowing a more precise guidance of implantation depth. AIMS: This meta-analysis aims to report the outcome of patients undergoing TAVR with SE THV using COP versus conventional implantation technique (CIT). METHODS: Systematical search in MEDLINE and EMBASE yielded five observational controlled studies comparing both implantation techniques for the SE Evolut prosthesis (Medtronic Intern. Ltd., CA, USA) and fulfilling the inclusion criteria for meta-analysis. RESULTS: Totally, 1227 patients were included, comprising 641 who underwent COP and 586 CIT TAVR. Incidence of post-procedural need for PPM implantation was significantly lower in COP group (9.8% vs 20.6%; OR = 0.43; p < 0.00001). This was accompanied by significantly higher implantation position in COP group (mean difference distance from distal end of the intraventricular portion of the THV to the non-coronary cusp (NCC): - 1.03 mm; p = 0.00001). Incidence of new-onset left bundle branch block did not differ. Regarding procedural and 30-day mortality, technical success, post-procedural aortic regurgitation, and rates of multiple device implantation, no difference between COP and CIT was found. CONCLUSION: COP is an effective and safe implantation technique to reduce the need for a permanent pacemaker implantation during TAVR with SE Evolut prosthesis.

Transcatheter valve-in-valve or valve-in-ring implantation with a novel balloon-expandable device in patients with bioprosthetic left side heart valves failure: 1-year follow-up from a multicenter experience.

BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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 closure of large ostium secundum atrial septal defects in symptomatic small children: A single-center retrospective study.

Background: In general, the risks associated with transcatheter atrial septal defect (ASD) device closure are reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend ASD device closure in children with defect sizes >20 mm due to limited data available in this group of patients. This retrospective study sought to determine the clinical and procedural characteristics of successful transcatheter ASD device closure in small children with large defects and assess the complication rates and reasons for unsuccessful device closure. Methods: We retrospectively reviewed the data of all patients who underwent elective transcatheter closure of ostium secundum ASD in our department between September 2013 and February 2022. All children weighing <20 kg, requiring a device of size 20 mm or greater, were included. Major and minor complications were predefined and indications for referral were evaluated. Echocardiogram reports were reviewed from the time of referral, postcatheterization day 1, and at 1-year follow-up. Results: We identified 40 patients meeting inclusion criteria with a median (interquartile range [IQR]) procedural age of 5 (4-7) years and median (IQR) weight of 14 (12-18) kg. Successful device closure was achieved in 39 patients with a success rate of 97.5%. The total complication rate was 2.5% (95% confidence interval: 0.44%- I2.8%) with only 1 major complication. All children had right heart enlargement and exertional dyspnea, 30% of patients had recurrent lower respiratory tract infections, and 10% had failure to thrive. At 1-year follow-up, a transthoracic echocardiogram showed a well-endothelialized device in a stable position in all the patients, and none of the patients had a residual shunt. Conclusion: In experienced centers, percutaneous ASD closure of large defects in symptomatic small children can be done effectively and safely with a great degree of predictability and a low complication rate.

Coding-Complete Genome Sequence of an African Swine Fever Virus from an Outbreak in 2021 among Domestic Pigs in Pangasinan, Philippines.

We report a coding-complete genome sequence of an African swine fever virus from an outbreak in 2021 among domestic pigs in Pangasinan, Philippines using Oxford Nanopore Technologies minION. The linear genome assembly is a single contig with 192,377 bp.

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.

Case report of a rare purine synthesis disorder due to 5-aminoimidazole-4-carboxamide ribonucleotide formyltransferase (AICAR) deficiency.

BACKGROUND: AICA (5-aminoimidazole-4-carboxamide) ribosiduria is an inborn error in purine biosynthesis caused due to biallelic pathogenic variants in the 5-aminoimidazole-4-carboxamide ribonucleotide-formyltransferase/imp cyclohydrolase (ATIC) gene located on chromosome 2q35. ATIC codes for a bifunctional enzyme, AICAR transformylase and inosine monophosphate (IMP) cyclohydrolase, which catalyse the last two steps of de novo purine synthesis. This disorder has been previously reported in only 4 cases worldwide, and herein, we report the first from India. CASE REPORT: The proband presented with global developmental delay, developmental hip dysplasia (DDH), acyanotic heart disease and nystagmoid eye movements. Whole exome sequencing (WES) identified compound heterozygous pathogenic variants in the ATIC. A novel splice site variant; c.1321-2A > G and a previously reported missense variant; c.1277A > G (p.Lys426Arg) were identified. Segregation analysis of parents showed the father to be a heterozygous carrier for the splice site variant and the mother, a heterozygous carrier for the missense variant. CONCLUSION: This case of a rare genetic disorder of purine biosynthesis of ATIC deficiency is the first case reported from India. Early diagnosis lead to early interventional therapy and genetic counselling.

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.

A System for Accurate Deployment of Unconstrained Triple-Fenestrated Aortic Arch Endografts.

PURPOSE: To achieve accurate rotational orientation and the axial position of unconstrained triple-fenestrated physician-modified endografts upon deployment in the aortic arch during total arch thoracic endovascular aortic repair (TA-TEVAR). MATERIALS AND METHODS: Following a detailed study of reconstructed computerized tomography angiography images of patients' arch anatomy, customized, sealable fenestrations with radio-opaque margins are created onsite on Valiant Captivia (Medtronic) endografts, transposing the arch branch ostial anatomic interrelationship onto the endograft precisely. Radio-opaque figure-of-8 markers, indicating the 12 o'clock (superior) position, are attached to the endograft on the surface and brought up to the surface under the endograft cover during resheathing. Resheathing without any twist in the endograft is achieved by lining up the welds in each endograft stent segment in a straight line. The fluoroscopic working view for arch endograft delivery and deployment is the left anterior oblique view that is orthogonal to the plane of the arch, which, in turn, is the right anterior oblique view in which parts of a stiff indwelling guidewire in the ascending and descending aorta precisely overlap. During introduction in the working view, the endograft delivery system is rotated in the descending thoracic aorta so that the 12 o'clock figure-of-8 markers are viewed on the edge and situated at the outer aortic curvature; continued advancement into the arch without any further rotation will ensure superior orientation of the figure-of-8 markers and, consequently, correct endograft rotational orientation. Proper axial endograft positioning requires locating the left common carotid artery (LCCA) fenestration just proximal to a taut externalized LCCA-femoral guidewire loop marking the posterior limit of the LCCA ostium. After endograft deployment during rapid cardiac pacing, the target arch branches are cannulated through their respective fenestrations using hydrophilic 0.035-inch guidewires that are externalized via distal sheaths to create femoral-arch branch (through-and-through) loops over which covered fenestrated stents are introduced and deployed. RESULTS: This technique was used successfully in 31 consecutive patients undergoing TA-TEVAR; systemic blood pressure was obtained in all arch branches immediately after endograft deployment, indicating adequate blood flow. All arch branches were successfully cannulated and stented. CONCLUSION: This system enables accurate deployment of unconstrained triple-fenestrated arch endografts simply and reliably during TA-TEVAR.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.

OBJECTIVES: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).