Large Valve Research Articles

Un cas rare de fibroélastome papillaire révélé par un accident vasculaire cérébral ischémique (à propos d'un cas)

BackgroundPapillary fibroelastoma is a rare benign cardiac tumor, but capable of causing severe ischemic manifestations and exposing the patient to embolic complications and sudden death which requires urgent surgical resection. Case presentationWe report the case of a 34-year-old man presenting with ischemic stroke. Cardiac ultrasonography revealed a pedunculated tumor inserted on the basal interventricular septum, mobile in the LV hunting chamber in the vicinity of the large mitral valve. Surgical excision was performed without any operative or post-operative difficulties. Histological examination confirmed the diagnosis of papillary fibroelastoma. The clinical course was favorable, with no ischemic recurrence. ConclusionWe recall through this observation the high emboligenic potential of this tumor, whose surgical treatment prevents cerebral embolic recurrence.

Molecular phylogeny, morphology and distribution of Amphitetras antediluviana Ehrenberg from the Black Sea and the Sea of Azov

The intriguing large-celled species of Amphitetras antediluviana Ehrenberg was originally described as a fossil species (Ehrenberg, 1840), but later noted in a living state in various regions of the World ocean. Our recent studies revealed that the species has been found for the last decade in significant numbers in many habitats along the coast of the Azov-Black Sea basin. Two strains—the large valves from Laspi Bay, the Black Sea (BL-5_12092019) and the small valves from the Sea of Azov (AZ-12_24122019)—were isolated and analyzed using light and scanning electron microscopy along with molecular-genetic investigation. Specimens of the two populations differ in valve sizes and structure, however, their belonging to the same species was confirmed with the help of molecular analysis. Taxonomic positions of the strains of A. antediluviana isolated from two marine waterbodies were clarified. In addition, we provided a detailed morphological diagnosis of the species with a description of the valve ultrastructure and its elements, as well as geographical distribution and taxonomic history.

Abstract 4128606: Detailed Measurements of Surgical Mitral Valves: Implications for Transcatheter Mitral Valve-in-Valve Interventions

Background: With the increasing prevalence of transcatheter mitral valve-in-valve interventions (V-in-V), a detailed understanding of the surgical valves (SV) is of paramount importance. Left ventricular outflow tract obstruction (LVOTO) is a feared complication and is typically caused by the anterior displacement of the LVOT-facing surgical leaflet, which, along with the surgical post at that level, forms a fixed obstruction. Traditionally, the risk is estimated using computed tomography software by simulating a valve that extends to the surgical post height of the implanted SV. However, this does not account for the actual leaflet length and post width at the level of the leaflet tip, which could differ significantly from the surgical post height but accurately estimate LVOTO risk. Methods: We conducted detailed measurements of three different sizes of two commonly used surgical mitral valves: the Biocor EPIC ( Abbott ) in sizes 27 mm, 31 mm, and 33 mm, and the Mosaic ( Medtronic ) in sizes 25 mm, 31 mm, and 33 mm. Using a digital caliper and height gauge, we measured several key parameters for each valve, including leaflet height, post height, leaflet width, post width at the level of the leaflet tip, maximal post width, and valve inner diameter. Results: The results, presented in Table 1, show significant differences in leaflet height and post widths across manufacturers and sizes. Leaflet height was consistently shorter than post height in both Abbott and Medtronic valves, with this discrepancy more pronounced in larger valves and Medtronic valves. The post width at the leaflet tip also varied considerably. Conclusions: Given the substantial differences between leaflet and post heights—with the leaflet typically much shorter—an accurate assessment of LVOTO risk should account for both the leaflet height and the width of the post at that level to avoid overestimating the risk of LVOTO.

FSI investigation on the discharge valve lift in a R32 rotary compressor and its verification

R32 rotary compressor is commonly applied in the household air conditioner. The valve motion is significant to the performance and reliability of rotary compressor. Valve lift is an important factor which directly affects the valve motion. A suitable valve lift can both reduce power consumption and fracture risk of valve plate. Based on a compressor prototype, this paper developed a FSI model to simulate the working process of discharge valve. The simulation results show that a large valve lift means a large discharge effective flow area and a low indicated power. But both the velocity of valve plate impacting the retainer and the impact stress of valve plate are relatively large, which will lead to the fracture in the valve plate. The simulated initial impact location on the head of valve plate is near the oblique incision due to the uneven pressure distribution in the discharge port and the torsional movement of valve plate. The maximum impact stress distribution areas on the valve plate obtained from simulation results are matched with the fracture areas of two valve plate samples, which proves that the simulation results are accurate enough to guide the optimization design of discharge valve in the rotary compressor.

3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm)

BackgroundA prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry–based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). ObjectivesThe aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. MethodsUsing the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. ResultsIn total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). ConclusionsPatients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.

Bird Nuisance at an Oil Gathering Station: A Landscape and Site Analysis

Abstract Barn swallow (Hirundo rustica) is a migratory bird. In Petapahan Gas Station (GS), Riau, this bird roost in a big number and create some nuisance due to their faeces. The objective of this paper was to analyse the possible causes of swallow’s roost behaviour at the landscape and site level, and formulate some recommendations. Migratory bird route was studied, the surrounding areas was analysed using, and characteristics of the GS was observed. Petapahan happened to be located at the known bird migratory route. The land-use of surrounded areas was a vast area of oil-palm plantation mixed with agricultural-area, open-area, and housing, create an excellent habitat for insects as the bird’s food. There was no other alternative for roost-site in the 5km radius. At the GS there are many large pipes, small pipes, handrails, I-beams, C-beams, valves, flares, big tanks, pits, office, and many other instruments that can function as the barn swallow’s roost site. Warm temperature, sufficient lighting, and safety from predator also provided good support. Basically, the GS has to accept the occurrence of the birds, while employing some management actions: (1) setting zonation for bird-free and bird-tolerance areas, and (2) put netting and other bird deterrent sensitive sites.

Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison.

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.

Gomphonema beaugerianum, a new Gomphonema species (Bacillariophyta) found in a historic William Smith sample from the Auvergne (France)

A large, unknown Gomphonema taxon belonging to the G. truncatum group was observed in a historic sample collected by William Smith during his 1854 excursion in the Auvergne (France). The unknown species presented sufficient differences with all known taxa in the truncatum-capitatum group to warrant further morphological investigations. Detailed light and scanning electron microscopy investigations in comparison with all published literature revealed that the unknown species had a unique combination of morphological (uniseriate striae, lack of well-develop headpole) and morphometric (large valve width) features. Therefore, the species is described as new: Gomphonema beaugerianum sp. nov. The new species was observed in Lac de Guéry, an oligotrophic, almost circumneutral lake in the Auvergne with a high ecological quality.

Current status of main distribution box for Korean heavy ion accelerator, RAON

A main distribution box is a large cryogenic valve box which connects two cryoplants with two superconducting linear accelerators (LINACs) of Korean heavy ion accelerator. A major role of the main distribution box is transferring cryogenic helium from the cryoplants to LINACs and controlling flow rate of the helium. It can take other several roles when it encounters special situations. It has total 44 cryogenic valves to manage the helium. DN10 to DN250 valves are applied according to sizes of the cryogenic lines in the main distribution box. Designed heat loads of the main distribution box are 440 W for thermal shield, 24 W for 4.5 K lines and 43 W for 2 K line. At present, the main distribution box keeps its cold status and is operated well although it needs some improvements. The improvements will be gradually carried out when our cryogenic system will be warmed up. Some occurred issues, our solutions and current status of the main distribution box are shared in this paper.

Alpha gal syndrome, a relative not absolute contraindication to the use of bovine pericardium to close an intracardiac septal defect: a case report

BackgroundAlpha-gal syndrome is an allergic condition in which individuals develop an immune-mediated hypersensitivity response when consuming red meat and its derived products. Its diagnosis is important in individuals undergoing cardiac surgery, as patients frequently require large doses of unfractionated heparin or the insertion of surgical implants, both of which are porcine or bovine in origin. There are currently no guidelines for heparin administration in alpha-gal patients, with even less knowledge regarding the long-term clinical implications of these patients after receiving bioprosthetic valve replacements or other prostheses.Case presentationWe present the case of a 31-year-old male who underwent cardiac surgery in the setting of alpha-gal syndrome for a large atrial septal defect (ASD) and mitral valve prolapse (MVP). The patient continues to do well one year after undergoing a mitral valve repair, tricuspid valve repair and an ASD closure using bovine pericardium. He sustained no adverse reaction to the use of heparin products or the presence of a bovine pericardial patch. This rare case was managed by a multidisciplinary team consisting of cardiothoracic surgery, cardiac anesthesiology, and allergy/immunology that led to an optimal outcome despite the patient’s pertinent allergic history.ConclusionsThis case highlights that the use of bovine pericardium and porcine heparin to close septal defects in patients with milder forms of alpha-gal allergy can be considered if other options are not available. Further studies are warranted to investigate the long-term outcomes of such potential alpha-gal containing prostheses and heparin exposure and establish the optimal decision making algorithm and prophylactic regimen.

Study on the soft-landing of large inertia valve based on multi-objective optimization of annular gap

Variable valve mechanism and its technology are widely used in vehicle diesel engines. As a critical component, the performance of reciprocating actuator is the guarantee for the realization of electro-hydraulic variable valve. In order to solve the problem of high setting speed in electro-hydraulic camless variable valve system, a variable valve actuator based on annular gap buffer is proposed and optimized to realize quick closing and soft landing. The experimental results show that the actuator can achieve the purpose of setting buffer, and the setting speed is 0.5 m/s with 15 ms of closing time. AMESim is used to build the system simulation model and calibrated by experiments. The simulated lift curve is close to the experimental curve, and its Pearson coefficient is 0.9995. The influence of structural parameters on the system driving ability and buffering effect is studied through the model. According to the simulation results, the annular gap eccentricity will affect the buffering effect. When the eccentricity increases from 0.005 to 0.035 mm, the landing velocity increases by 0.1 m/s and the valve closing time decreases by 0.9 ms. NSGA-II method is used to optimize the structural parameters of the annular gap, and an obvious Pareto front is obtained and the optimal solution is applied in next experiments. The landing speed is reduced from 0.5 to 0.25 m/s, and the landing time is still less than 15 ms. This paper provides a simple cushioning scheme for electro-hydraulic camless variable valve soft landing which is independent of proportional valve.

Large Animal Translational Validation of 3 Mitral Valve Repair Operations for Mitral Regurgitation Using a Mitral Valve Prolapse Model: A Comprehensive In Vivo Biomechanical Engineering Analysis.

Various mitral repair techniques have been described. Though these repair techniques can be highly effective when performed correctly in suitable patients, limited quantitative biomechanical data are available. Validation and thorough biomechanical evaluation of these repair techniques from translational large animal in vivo studies in a standardized, translatable fashion are lacking. We sought to evaluate and validate biomechanical differences among different mitral repair techniques and further optimize repair operations using a large animal mitral valve prolapse model. Male Dorset sheep (n=20) had P2 chordae severed to create the mitral valve prolapse model. Fiber Bragg grating force sensors were implanted to measure chordal forces. Ten sheep underwent 3 randomized, paired mitral valve repair operations: neochord repair, nonresectional leaflet remodeling, and triangular resection. The other 10 sheep underwent neochord repair with 2, 4, and 6 neochordae. Data were collected at baseline, mitral valve prolapse, and after each repair. All mitral repair techniques successfully eliminated regurgitation. Compared with mitral valve prolapse (0.54±0.18 N), repair using neochord (0.37±0.20 N; P=0.02) and remodeling techniques (0.30±0.15 N; P=0.001) reduced secondary chordae peak force. Neochord repair further decreased primary chordae peak force (0.21±0.14 N) to baseline levels (0.20±0.17 N; P=0.83), and was associated with lower primary chordae peak force compared with the remodeling (0.34±0.18 N; P=0.02) and triangular resectional techniques (0.36±0.27 N; P=0.03). Specifically, repair using 2 neochordae resulted in higher peak primary chordal forces (0.28±0.21 N) compared with those using 4 (0.22±0.16 N; P=0.02) or 6 neochordae (0.19±0.16 N; P=0.002). No difference in peak primary chordal forces was observed between 4 and 6 neochordae (P=0.05). Peak forces on the neochordae were the lowest using 6 neochordae (0.09±0.11 N) compared with those of 4 neochordae (0.15±0.14 N; P=0.01) and 2 neochordae (0.29±0.18 N; P=0.001). Significant biomechanical differences were observed underlying different mitral repair techniques in a translational large animal model. Neochord repair was associated with the lowest primary chordae peak force compared to the remodeling and triangular resectional techniques. Additionally, neochord repair using at least 4 neochordae was associated with lower chordal forces on the primary chordae and the neochordae. This study provided key insights about mitral valve repair optimization and may further improve repair durability.

Experimental and numerical study of the hydraulic and vibrational behaviour of the submerged large diameter Howell Bunger valves

Experimental and numerical study of the hydraulic and vibrational behaviour of the submerged large diameter Howell Bunger valves

Optimization of process parameters for laser cladding Stellite6 cobalt-based alloy

As a new remanufacturing technology, laser cladding can repair damaged parts in large valves in nuclear power plants. The objective is to enhance the surface morphology quality of parts post-remodeling, the paper optimizes the key process parameters in the laser cladding process. Numerical simulation was used to analyze the influence of each process parameter ( laser power, scanning speed, powder feeding speed) on the morphology of the cladding layer. The laser power and powder feeding rate were positively correlated with the width of the cladding layer, and the scanning speed was negatively correlated with the width of the cladding layer. The orthogonal experiments are designed based on the Taguchi method, and the Stellite6 single cobalt-based alloy cladding layer was prepared on the WCB low-carbon steel substrate. Analysis of variance and RSM was used to analyze the experimental results. The influence order of process parameters on the morphology of the cladding layer was determined. The regression prediction model was established to analyze the relationship between the process parameters and the morphology quality (width and height) of the cladding layer. The errors of the model are 5% and 3.5%, respectively. The optimal combination of process parameters is determined as follows: P = 1700 W, Vs = 8 mm/s, Vf = 26 g/min. The cladding layer prepared by the optimal process parameters has fine structure and good bonding. The accuracy of the predictions was validated using this model, which offered valuable theoretical guidance for predicting and controlling the geometric characteristics of the laser cladding of Stellite6 alloy.

Tricuspid regurgitation burden following transcatheter aortic valve replacement requiring early pacemaker implantation

Background Conduction abnormality requiring the implantation of a permanent pacemaker (PPM) is a well-known and clinically important complication of transcatheter aortic valve replacement (TAVR). However, PPM implantation may result in lead-associated tricuspid valve regurgitation (TR). This study sought to determine the incidence and progression of TR following PPM implantation after TAVR. Methods This was a retrospective review of all echocardiograms of patients who underwent PPM following TAVR at the Baylor Scott & White hospitals from 2012 to 2021. The primary endpoint was TR progression at 30 days and 1 year. A subanalysis comparing the change in TR progression between small and large TAVR devices was also conducted. Secondary outcomes included all-cause death at 30 days and 1 year. Results Out of the 2744 patients who underwent TAVR between April 2012 and August 2021, 177 patients (6.5%) subsequently received a new PPM. There was a statistically significant progression of TR at 1-year follow-up (McNemar’s P value = 0.02). TR progression rates were comparable between the small and large valve groups at 1-year follow-up (4% vs 11%, P = 0.09, respectively). Conclusion In this single healthcare system study, we demonstrated a significant progression of TR in patients with PPM post TAVR at 1 year.

Implantation of a large self-expanding pulmonary valve using the jugular vein approach in a teenage patient.

Implantation of a large self-expanding pulmonary valve using the jugular vein approach in a teenage patient.

Abstract 17910: Is Implantation of a Larger Edwards Sapien Transcatheter Pulmonary Valve Associated With Early Valve Failure? A Different Type of Patient-Prosthesis Mismatch

Introduction: Transcatheter pulmonary valve replacement (TPVR) is an alternative option to address failing native and bioprosthetic pulmonary valves (BPV). TPVR has expanded to implantation in native right ventricular outflow tracts (nRVOT) and progressively smaller patients. We aim to define the relationship between valve-to-patient size ratio and early development of pulmonary insufficiency (PI). Methods: This single-center retrospective cohort study identified patients who underwent TPVR with a Sapien valve between 2014 and 2021. We collected demographic, anatomic, and pre- and post-TPVR echo data. Echo data were collected at four post-TPVR time points: prior to discharge, short-term (1-9 months), mid-term (9-18 months), and most recent study. The primary outcome was development of moderate or severe PI by mid-term follow-up. Valve size-to-body surface area (BSA) ratio was evaluated for correlation with the development of moderate or severe PI. Results: The cohort consisted of 187 patients; 79 (42.2%) underwent TPVR within the nRVOT (Table). Compared to patients with TPVR in a conduit or BPV, patients with a nRVOT were younger, had lower weight, and lower BSA. Moderate or severe PI post-TPVR was more common in patients in the nRVOT group (P-value &lt; 0.001), occurring in 9 (11.5%) by mid-term follow-up, compared to 2 (1.9%) in a conduit or BPV. In the subset of patients with TPVR within the nRVOT, the development of moderate or severe PI was associated with a larger valve size-BSA ratio (OR=1.13, 95% CI: 1.03, 1.26, P-value=0.012). Conclusions: Development of moderate or severe PI following TPVR with a Sapien valve was rare in this cohort. Patients receiving a Sapien TPVR within the nRVOT with a large valve size-to-BSA ratio were more likely to develop early PI. The increased risk of early valve failure in these patients should inform counseling regarding expected longevity of the valve and may guide valve choice as more transcatheter valve options become available.

Abstract 14878: Be Aware of False Negative Bubble Study in Diagnosis of Patent Foramen Ovale!

Introduction: Echocardiography plays an important role in diagnosis of Patent Foramen Ovale (PFO). However, there are some anatomic variations which may result in a false negative study. Case presentation: A 55-year-old male was hospitalized for acute right-hemiplegia. The EKG revealed normal sinus rhythm. Brain imaging revealed acute bilateral infarcts. The transthoracic echocardiogram (TTE) showed a normal ejection fraction without significant valve disease and a negative agitated saline Bubble study. A Trans-esophageal echocardiogram (TEE) revealed a negative Bubble study using intravenous access via the left arm. The TEE also revealed an atrial septal aneurysm and large eustachian valve (EV). The Bubble study was then repeated with agitated saline injected from lower extremity. This demonstrated a significant right to left shunt through a PFO. Discussion: EV is a remnant of the valve of the inferior vena cava that directs blood flow through the fossa ovalis during embryonic life. A large or prominent EV may be a risk factor for paradoxical embolism by preventing spontaneous foramen closure. Agitated saline originating from the superior vena cava (SVC) may result in a false-negative study due to the prominent EV preventing microbubbles from the SVC from crossing the interatrial septum. In this case, the patient’s age, clinical presentation and the finding of EV and atrial septal aneurysm raised the suspicion of PFO. Repeating the bubble study using a lower extremity peripheral access was positive. This step played a crucial role in the diagnosis of PFO in this patient and his subsequent management. Conclusion: Cardiologists should be aware that the presence of a prominent EV may result in a false negative bubble study result when the injection is performed via upper limb intravenous access.

Abstract 11698: Torsades de Aortique Pustule: A Case of Aortic Abscess Leading to 2:1 AV Block and Torsades de Pointes

Introduction: Endocarditis of the aortic valve has a propensity to create A-V conduction disturbances in up to 10% of cases. Torsades de pointes (TdP) is polymorphic ventricular tachycardia in the setting of prolonged QT interval and bradycardia that is typically preceded by a short-long-short sequence of ventricular activation. We present a case of infective endocarditis with aortic root abscess leading to acute 2:1 A-V conduction and culminating in TdP. Case Summary: A 30-year-old male with history of IV drug use and bioprosthetic aortic valve repair presented with pleuritic chest pain, nausea and vomiting. He was febrile and tachycardic with a systolic murmur at the right upper sternal border. Initial electrocardiogram showed sinus rhythm with no conduction abnormalities. A Transthoracic echocardiography showed a large aortic valve vegetation with an abscess cavity. E Blood cultures grew Streptococcus oralis. Two days later, he developed VT/VF arrest requiring external defibrillation. Preceding ECGs and telemetry showed sinus tachycardia with new left bundle branch block and prolonged QTc. B This progressed to 2:1 AV block C with abrupt transition to relative bradycardia and ventricular ectopy leading to short-long-short ventricular intervals and subsequent TdP. D A temporary pacemaker was placed, and he underwent an aortic root reconstruction with valve replacement. Discussion: While both the etiology of TdP and aortic root abscesses leading to conduction system disease are well described, this case exhibits the real time progression of aortic abscess involvement. The patient presented with a normal QRS morphology. During hospitalization, he developed new LBBB, and the appropriate sinus tachycardia then deteriorated into 2:1 AV conduction leading to relative bradycardia. This abrupt transition with QTc prolongation sets up the nidus for ventricular ectopy (due to early after depolarizations) with salvos of short-long-short sequences causing TdP.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

BackgroundThe CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. MethodsThis was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. ResultsWe enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). ConclusionsThe Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrials.gov IdentifierNCT03752866.