Self-expanding Device Research Articles

Procedure-related radiation and contrast use during TAVI procedures with balloon-expandable versus self-expanding devices

Abstract Background Transcatheter aortic valve implantation (TAVI) procedures show some fundamental differences, depending on the use of balloon-expandable (BEV) or self-expanding (SEV) devices. We aimed to assess, how it translates into contrast use and radiation exposure. Methods From five high volume European centers consecutive patients were included, who underwent transfemoral TAVI procedure. Patient- and procedural characteristics were recorded and compared in relation to the used TAVI device. Results In total 3131 patients were included. 53% were male and the mean age was 80±9 years. 1273 (41%) patients were treated with BEV, while 1858 (59%) with a SEV system. Patients, receiving SEV were older (81±9 vs 79±9 years, respectively; p<0.01) and were more often females (57% vs 33%, respectively; p<0.01). There was also a trend for less peripheral artery disease (14% vs 17%, respectively; p=0.06). Overall total radiation time was 15±9 min., that was markedly shorter for BEV than for SEV (13±8 vs. 17±10 min., respectively; p<0.01). On average 130±65 mL contrast media was used, that was less for BEV than for SEV (104±52 vs. 148±67 mL, respectively; p<0.01) In terms of contrast use, retrievable- and non-retrievable SEVs were comparable (148±71 vs. 146±63 mL, respectively; p=0.41), but both markedly higher, than for BEVs (p<0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p<0.01), but still markedly more than BEVs (p<0.01). Conclusion TAVI procedures with BEV require shorter radiation exposure for the team and markedly less contrast, than with SEV. This might be reasonable to consider during patient-tailored procedure planning.Radiation and contrast usage during TAVI

Safe transition home after transcatheter aortic valve implantation feasibility (START-F) study: Very early self-reported function and recovery status after early discharge

Abstract Background Despite significant excellent outcomes and significant improvements in rapid recovery protocols and early discharge, rates of 30-day readmission after transcatheter aortic valve implantation (TAVI) remain stubbornly high. There can be numerous drivers for readmission in older people with valvular heart disease; the time of transition home is the period of greatest risk when patients are most vulnerable to repeat hospitalization. We sought to assess patients’ early recovery (< post-procedure day 3) to inform the evaluation of a nurse-led telephone intervention to mitigate the risks of 30-day readmission after early (1 day) discharge TAVI. Methods We conducted a prospective observational cohort feasibility study in five Canadian TAVI programs to ascertain acceptability, compliance, delivery of the intervention, recruitment and retention. In this preliminary report, we assessed key indicators of patients’ status at the time of discharge and functional status in their early recovery. Results We recruited 188 participants, mean age 81.6 years (SD=7.0), 41.5% women with baseline mean KKCQ 53.4 (SD=20.1). Patients were admitted on the day of the procedure, and underwent TAVI with a balloon-expandable (n=146, 77.6%) or self-expanding (n=30, 16.0%) device, with local anaesthesia +/- light sedation (n=171, 90.1%) or general anaesthesia (n=17, 9.0%). There was 1 in-hospital death (0.5%) and 182 (97.4%) were discharged home. At the time of the 3-day telephone follow-up, 168 (95.5%) reported that an individual had stayed with them during the first 24 hours [spouse: 85 (48.9%); friend: 77 (44.3%)], and 165 (93.3%; missing: 11) were able to complete all activities of daily living, including cooking their own meals (n=80, 45.5%). Self-reported energy was low/very low for 49 participants (26.1%), moderate for 93 (52.8%), and high/very high for 34 (18.1%), with 104 (55.3%) describing feeling somewhat or quite a bit better than before TAVI, and 24 (12.8%) somewhat or quite a bit worse. Bruising was present in 120 participants (68.6%) and 137 (78.8%) had removed their bandage as instructed. 18 participants were readmitted within 30 days, including 14 cardiac-related events. Conclusion This is one of the first reports of TAVI patients’ self-reported function following next-day discharge, providing novel evidence that most patients describe safe self-care and very early improved functional status. Research is needed to identify and support patients who are at higher risk of poorer trajectories of recovery and readmission, and report the feasibility of a nurse-led intervention to mitigate these risks.

Mechanical Viability and Functionality Assessment of a New Sutureless Endoluminal Microvascular Device: A Preliminary In Vivo Rabbit Study.

Our group has developed a new nitinol endoluminal self-expandable device for microvascular anastomosis. It attaches to each vessel ending with opposite directed microspikes and reaches complete expansion at body temperature, using the nitinol shape memory capacity. The main purpose of this first in vivo trial is to evaluate the mechanical viability of the device and its immediate and early functionality. A recuperation study with seven New Zealand White rabbits was designed. A 1.96 mm outer diameter prototype of the new device was placed on the right femoral artery of each rabbit. Each anastomosis was reassessed on the seventh postoperative day to reevaluate the device function. The average anastomosis time with the new device was 18 min and 45 seg (±0.3 seg). It could be easily placed in all the cases with an average of 1.14 (1) complementary stitches needed to achieve a sealed anastomosis. Patency test was positive for all the cases on the immediate assessment. On the 1 week revision surgery, patency test was negative for the seven rabbits due to blood clot formation inside the device. The new device that we have developed is simple to use and shows correct immediate functionality. On the early assessment, the presence of a foreign body in the endoluminal space caused blood clot formation. We speculate that a heparin eluting version of the device could avoid thrombosis formation. We consider that the results obtained can be valuable for other endoluminal sutureless devices.

Assessing post-TAVR cardiac conduction abnormalities risk using an electromechanically coupled beating heart.

Transcatheter aortic valve replacement (TAVR) has rapidly displaced surgical aortic valve replacement (SAVR). However, certain post-TAVR complications persist, with cardiac conduction abnormalities (CCA) being one of the major ones. The elevated pressure exerted by the TAVR stent onto the conduction fibers situated between the aortic annulus and the His bundle, in proximity to the atrioventricular (AV) node, may disrupt the cardiac conduction leading to the emergence of CCA. In this study, an in silico framework was developed to assess the CCA risk, incorporating the effect of a dynamic beating heart and preprocedural parameters such as implantation depth and preexisting cardiac asynchrony in the new onset of post-TAVR CCA. A self-expandable TAVR device deployment was simulated inside an electromechanically coupled beating heart model in five patient scenarios, including three implantation depths and two preexisting cardiac asynchronies: (i) a right bundle branch block (RBBB) and (ii) a left bundle branch block (LBBB). Subsequently, several biomechanical parameters were analyzed to assess the post-TAVR CCA risk. The results manifested a lower cumulative contact pressure on the conduction fibers following TAVR for aortic deployment (0.018MPa) compared to nominal condition (0.29MPa) and ventricular deployment (0.52MPa). Notably, the preexisting RBBB demonstrated a higher cumulative contact pressure (0.34MPa) compared to the nominal condition and preexisting LBBB (0.25MPa). Deeper implantation and preexisting RBBB cause higher stresses and contact pressure on the conduction fibers leading to an increased risk of post-TAVR CCA. Conversely, implantation above the MS landmark and preexisting LBBB reduces the risk.

Complete atrioventricular block after atrial flow regulator implantation in a 5 kg infant.

The atrial flow regulator is a new self-expandable double-disc fenestrated device providing a calibrated inter-atrial communication. Paediatric reports are scarce. We herein describe a case of complete atrioventricular block complicating the exemption use of an atrial flow regulator in a 5-kg infant with transposition of the great arteries, ventricular septal defect, and right ventricular outflow tract obstruction.

TCT-913 Procedural Aspects of Transcatheter Aortic Valve Replacement: Comparison Between Balloon-Expandable and Self-Expanding Devices

TCT-913 Procedural Aspects of Transcatheter Aortic Valve Replacement: Comparison Between Balloon-Expandable and Self-Expanding Devices

Impact of commissural alignment on the hemodynamic performance of supra-annular self-expandable transcatheter aortic valves.

Hemodynamic impact of commissural alignment (CA) with self-expandable transcatheter aortic valves (TAVR) has not been investigated yet. To determine hemodynamic impact of CA with self-expandable TAVR. Multicentric ambispective study comparing patients who underwent self-expandable TAVR in seven centers with the Evolut Pro/Pro+ (EP) (Medtronic) and Acurate neo2 (AN2) (Boston Scientific) with and without CA strategies. The degree of commissural misalignment (CMA) was assessed by computed tomography/angiography and 1-year transvalvular gradients/regurgitation evaluated by echocardiography. A matched comparison according to annular dimensions/eccentricity, prosthesis size/type, and baseline left ventricular function and gradients was performed. A total of 557 patients, mean age 80.7 ± 6.6 years, 61.4% men, and STS score of 4.3 ± 3.1% were analyzed. A CA technique was attempted in 215 patients (38.6%), including 113 patients with AN2 and 102 patients with EP. None/mild CMA was found in 158 (73.5% vs. 43.6% if no CA attempted, p < 0.001) with no differences between devices (AN2:75.2%; EP:71.6%, p = 0.545). Patients with moderate/severe CMA had a greater aortic peak gradient (22.3 ± 8.7 vs. 19.7 ± 8.5, p = 0.001), significantly greater progression of both peak (p = 0.002) and mean gradients (p = 0.001) after matching, and higher rate of central aortic regurgitation (1.2% vs. 0.4%, p = 0.005) at 1-year, but not a greater proportion of patients with mean gradient ≥ 10 mmHg. The use of CA strategies significantly reduced the rate of CMA for the self-expandable TAVR devices ACN2 and EP which was associated to lower transvalvular gradients and intra-prosthetic regurgitation progression at 1-year although no criteria of structural deterioration were met at this follow up. org: NCT05097183.

Extravascular protrusion of the Alterra adaptive prestent identified on surveillance computed tomography imaging.

The Alterra adaptive prestent is a novel self-expanding device designed to provide a landing zone for the 29 mm SAPIEN 3 valve to treat pulmonary regurgitation in patients with a right ventricular outflow tract that is too large for a balloon expandable valve alone. The mechanism of fixation for the Alterra prestent is radial force from the self-expanding stent frame, combined with a unique set of flared "tines" that protrude from both ends of the stent. In this report, we describe 6patients who underwent uncomplicated transcatheter pulmonary valve replacement with an Alterra adaptive prestent and SAPIEN 3 valve and had surveillance chest computed tomography (CT) scans performed 1 day to 21 months after implant. In each patient, the CT scan demonstrated extravascular extension of a portion of the Alterra prestent, without clinical sequelae, but with extension into the ascending aorta in 1 patient and contact with the ascending aorta, left pulmonary vein, or left atrial appendagein 3 others. Surveillance CT imaging shows that the Alterra prestent can perforate the pulmonary artery and/or right ventricle. Although no sequelae were seen in these patients, prestent perforation has the potential to be clinically important. Implanters should be aware of this finding and its potential implications. As experience with the Alterra prestent grows, it will be important to further define the risk factors, incidence, and implications of this phenomenon.

Clinical impact of multiple resheathing during transcatheter aortic valve implantation with Evolut self-expanding valves

BackgroundThe possibility to resheath some transcatheter heart valves (THV) facilitates the optimization of self-expandable devices implantation. However, resheating manoeuvres (expecially when repeated) increase the interaction between the transcatheter prosthesis and the patient's tissues potentially causing side-effects. AimsTo assess the clinical outcomes of resheathing at midterm follow-up with a focus on the safety of multiple resheathing. MethodsThis retrospective observational study included all consecutive patients who underwent TAVI with a self-expandable supra-annular THV between December 2018 and December 2022. Primary endpoint was a composite of cardiovascular (CV) mortality, neurological events, non-fatal acute myocardial infarction and CV rehospitalizations. All clinical endpoints were assessed according to VARC-3 criteria. Results469 TAVI procedures with self-expandable supra-annular THV were included in the study. The attempt to resheath and the resheath manoeuvres number was prospectively recorded into an electronic database. Resheating was attempted in 253 (53.9%) cases; 1, 2 and ≥ 3 resheathing were performed in respectively 122 (26.0%), 63 (13.4%) and 68 (14.5%) procedures. At a median follow-up of 640 days (interquartile range 340–1033 days), the incidence of the primary endpoint did not differ between 0 vs. ≥1 (22.7 vs. 26.1%, LogRank p = 0.584) and < 3 vs. ≥3 resheathing groups (24.2 vs. 26.5% LogRank p = 0.963). Furthermore, no significant differences in the primary endpoint were observed between 0, 1–2 and ≥ 3 resheathing (p = 0.84). ConclusionsOur study found that resheathing of self-expandable THVs during TAVI did not result in worse clinical outcomes compared with no resheathing at mid-term follow-up. These results are independent from the number of resheathing, underling the safety of multiple resheathing in terms of peri-procedural and mid-term outcome. Condensed abstractIn this retrospective observational study of 469 patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe aortic stenosis with self-expanding valves, we investigated the influence of resheathing on mid-term clinical outcomes. Specifically, we focused on the safety of multiple resheathing procedures. Our findings revealed no significant impact of resheathing on medium-term outcomes. The primary endpoint, a composite of cardiovascular mortality, neurological events, non-fatal acute myocardial infarction, and cardiovascular rehospitalizations, did not show statistically significant differences between no resheathing, single resheathing and multiple resheathing groups. Our study suggests that resheathing, even when performed multiple times, does not appear to significantly affect clinical outcomes at mid-term follow-up.

Ten-year Durability, Hemodynamic Performance, and Clinical Outcomes after Transcatheter Aortic Valve Implantation Using a Self-expanding Device.

The expansion of transcatheter aortic valve implantation (TAVI) to low-risk and younger patients has increased the relevance of the long-term durability of transcatheter heart valves (THV). The present study aims to assess the 10-year durability, hemodynamic performance, and clinical outcomes after TAVI using the CoreValve system. An analysis from a prospective registry with predefined clinical and echocardiographic follow-up included 302 patients who underwent TAVI with the CoreValve system between 2007 and 2015. Bioprosthetic valve failure (BVF) was defined as any bioprosthetic valve dysfunction-related death, re-intervention, or severe hemodynamic valve deterioration. At the time of TAVI, the mean age was 80.41 ± 7.01years, and the Society of Thoracic Surgeons (STS) score was 6.13 ± 5.23%. At latest follow-up (median [IQR]: 5 [2-7] years), cumulative all-cause mortality ratesat 3, 5, 7, and 10years was 23.7%, 40%, 65.8%, and 89.8%, respectively. Mean aortic valve area and transvalvular gradient post-TAVI and at 5, 7, and 10years were 1.94, 1.87, 1.69, and 1.98 cm2 (p = 0.236) and 8.3, 9.0, 8.2, and 10.1mmHg (p = 0.796), respectively. Overall, 11 patients had BVF, of whom six had structural valve deterioration (SVD). The 10-year actual and actuarial freedom from BVF was 96.1% and 78.8%, and from SVD was 97.9% and 80.9%, respectively. Three patients developed significant non-SVD due to severe paravalvular leakage, and two patients were diagnosed with infective endocarditis. Using an early-generation self-expanding bioprosthesis, we documented durable hemodynamic performance and low rates of BVF and SVD up to 10 years after TAVI.

Angulation and curvature of aortic landing zone affect implantation depth in transcatheter aortic valve implantation

In transcatheter aortic valve implantation (TAVI), final device position may be affected by device interaction with the whole aortic landing zone (LZ) extending to ascending aorta. We investigated the impact of aortic LZ curvature and angulation on TAVI implantation depth, comparing short-frame balloon-expanding (BE) and long-frame self-expanding (SE) devices. Patients (n = 202) treated with BE or SE devices were matched based on one-to-one propensity score. Primary endpoint was the mismatch between the intended (HPre) and the final (HPost) implantation depth. LZ curvature and angulation were calculated based on the aortic centerline trajectory available from pre-TAVI computed tomography. Total LZ curvature (kLZ,tot\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${k}_{LZ,tot}$$\\end{document}) and LZ angulation distal to aortic annulus (αLZ,Distal\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\\alpha }_{LZ,Distal}$$\\end{document}) were greater in the SE compared to the BE group (P < 0.001 for both). In the BE group, HPost was significantly higher than HPre at both cusps (P < 0.001). In the SE group, HPost was significantly deeper than HPre only at the left coronary cusp (P = 0.013). At multivariate analysis, αLZ,Distal\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\\alpha }_{LZ,Distal}$$\\end{document} was the only independent predictor (OR = 1.11, P = 0.002) of deeper final implantation depth with a cut-off value of 17.8°. Aortic LZ curvature and angulation significantly affected final TAVI implantation depth, especially in high stent-frame SE devices reporting, upon complete release, deeper implantation depth with respect to the intended one.

Prosthesis Infolding Incidence and Short-Term Outcomes in Transcatheter Aortic Valve Implantation Using Evolut Self-Expandable Device: A Multicenter Study

Transcatheter aortic valve implantation (TAVI) is an established treatment strategy in aortic valve disease. Infolding, as a nonuniform expansion of the prosthesis leading to introflection of part of the device circumference, is a complication specific to self-expandable prostheses. The aim of the study is to determine incidence, predictors, treatment strategy, and outcomes of infolding during Medtronic Evolut TAVI (Minneapolis, MN, US). Between January 2018 and March 2022, all patients treated with Evolut TAVI were included in a multicenter observational retrospective study. According to the occurrence of infolding, the enrolled cohort was divided into 2 groups; periprocedural characteristics and 30-day outcomes were compared. A total of 1,470 patients were included; 23 infolding cases (1.6%) were detected. Preprocedural imaging showed larger aortic anatomy and greater calcium burden in the infolding group. Infolding occurred mostly with Evolut Pro+ and size 34 mm and was diagnosed before full prosthesis release in 78.3%. The rate of moderate-to-severe paravalvular regurgitation was higher in the infolding group (21.7% vs 1.9%, p <0.001). Short-term follow-up showed greater all-cause and cardiovascular mortality (respectively, 4.3% vs 0.7% and 4.3% vs 0.6%, p <0.05) and higher rate of pacemaker implantation (33.3% vs 15.7%, p = 0.042) in case of infolding. High right cusp calcium score and resheathing maneuvers were independent predictors of infolding. In conclusion, prosthesis infolding is a TAVI complication burdened by worse cardiovascular outcomes. Prompt intraprocedural infolding diagnosis is pivotal, especially in case of great native valve calcium burden and resheathing maneuvers, to safely overcome this complication by prosthesis recapture or postdilation.

Fish swim bladders as valve leaflets enhance the durability of transcatheter aortic valve replacement devices

Transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for inoperable patients with severe aortic stenosis (AS). However, calcification-induced limited durability restricts its application. Fish swim bladders (FSB), which are resistant to calcific degeneration, offer a viable solution to this challenge. In this study, we developed a new TAVR device using FSB as the valve leaflet. Furthermore, the in vitro durability, in vivo performance, and size selection of this TAVR device were assessed by an experimental study and finite element analysis. A self-expandable TAVR device was fabricated by suturing the FSB films into a 23 mm nitinol alloy frame. Further, hemodynamic performance, such as effective orifice area, transvalvular pressure difference and regurgitant fraction, the durability was tested by the pulsatile flow test and accelerated fatigue test, according to the ISO 5840-3. The effect of release size on hydrodynamic performance was also investigated. Finally, the in vivo performance of the TAVR device were examined using a porcine implantation model. The results showed that the strength of the FSB films satisfied the requirements for valve leaflets. The hemodynamic performance of the FSB TAVR device met the requirements of ISO 5840-3 standards. After 400 million cycles, the FSB showed no fiber loss, torn, perforation, or other valve failure phenomena. In porcine models, the devices were well-positioned, functioned well with no stenosis immediately after the operation. Collectively, we successfully developed a TAVR device with FSB as valve leaflets that exhibited good fatigue resistance. Statement of significanceThe source of material for the leaflets of commercialized biological heart valves (BHVs) is mainly bovine pericardium, but this material suffers the following problems: large and uneven thickness of the material, the presence of α-Gal and Neu5Gc antigens, and the susceptibility to structural valve degradation (SVD). New material for BHVs leaflets is rarely reported. In this study, we prepared a transcatheter aortic valve (TAV) and performed long-term in vitro and short-term in vivo studies using fish swim bladder (FSB) as the leaflets. The study confirmed that FSB TAV device can complete 400 million fatigue tests and maintain the good morphology of the leaflets, and that it still maintains good functionality after a certain amount of compression, indicating that FSB is a promising material for leaflets.

Coronary Cannulation Following TAVR Using Self-Expanding Devices With Commissural Alignment: The RE-ACCESS 2 Study

BackgroundCoronary re-engagement after transcatheter aortic valve replacement (TAVR) using self-expanding transcatheter heart valves (THVs) systematically implanted using commissural alignment (CA) techniques has been poorly investigated. ObjectivesThe aim of this study was to evaluate unsuccessful coronary cannulation, and its predictors, after TAVR using self-expanding devices implanted using CA techniques. MethodsRE-ACCESS 2 (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent 2) was an investigator-driven, single-center, prospective study that enrolled consecutive TAVR patients receiving Evolut and ACURATE THVs implanted using CA techniques. The primary endpoint was unsuccessful coronary cannulation after TAVR. The secondary endpoint was the identification of postprocedural predictors of unfeasible, selective coronary ostia re-engagement on computed tomographic angiography performed after TAVR. ResultsAmong 127 patients enrolled from September 2021 to December 2022, 7 (5.5%) had unsuccessful coronary cannulation after TAVR, and 6 of them received Evolut THVs (7.5% vs 2.3%; P = 0.26). Failure of left coronary artery cannulation was similar between Evolut and ACURATE THVs (2.5% vs 2.1%; P = 1.00), whereas that of right coronary artery cannulation was prevalent in the Evolut group (6.3% vs 0.0%; P = 0.16). Coronary overlap was associated with the inability to selectively cannulate the right coronary artery (OR: 5.6; 95% CI: 1.2-25.8; P = 0.03), but not in ACURATE recipients (P = 0.39). Severe misalignment of Evolut THVs was associated with the inability to selectively cannulate both coronary arteries (OR: 24.7; 95% CI: 1.9-312.9; P = 0.01). ConclusionsUnsuccessful coronary cannulation after TAVR using self-expanding THVs implanted using CA techniques was reported in 5.5% of cases, with the majority involving the Evolut THV. Commissural misalignment affected coronary cannulation after TAVR mostly in Evolut recipients.

Concept for intrathecal delivery of brain recording and stimulation device.

Neurological disorders are common, yet many neurological diseases don't have efficacious treatments. The protected nature of the brain both anatomically and physiologically through the blood brain barrier (BBB) make it exceptionally hard to access. Recent advancements in interventional approaches, like the Stentrode™, have opened the possibility of using the cerebral vasculature as a highway for minimally invasive therapeutic delivery to the brain. Despite the immense success that the Stentrode™ has faced recently, it is limited to major cerebral vasculature and exists outside the BBB, making drug eluting configurations largely ineffective. The present study seeks to identify a separate anatomical pathway for therapeutic delivery to the deep brain using the ventricular system. The intrathecal route, in which drug pumps and spinal cord stimulators are delivered through a lumbar puncture, is a well-established route for delivering therapies to the spinal cord as high as C1. The present study identifies an extension of this anatomical pathway through the foramen of Magendie and into the brains ventricular system. To test this pathway, a narrow self-expanding electrical recording device was manufactured and its potential to navigate the ventricular system was assessed on human anatomical brain samples. While the results of this paper are largely preliminary and a substantial amount of safety and efficacy data is needed, this paper identifies an important anatomical pathway for delivery of therapeutic and diagnostics tools to the brain that is minimally invasive, can access limbic structures, and is within the BBB.

Stent Implantation Across the Atrial Flow Regulator Device.

The Atrial Flow Regulator (AFR) is a self-expandable double-disc device with a central fenestration, intended to maintain a calibrated communication across the interatrial septum. We reported for the first time a stent implantation across an AFR device in an adolescent born with complex congenital heart disease with duct-dependent systemic circulation and severe combined pulmonary hypertension.

Implantation of atrial flow regulator devices in patients with congenital heart disease and children with severe pulmonary hypertension or cardiomyopathy-an international multicenter case series.

The Occlutech Atrial Flow Regulator (AFR) is a self-expandable double-disc nitinol device with a central fenestration. Its use has been approved in the adult population with heart failure and described for pulmonary hypertension (PH). Only case reports and small series have been published about its use in the paediatric population and for congenital heart disease (CHD). The authors sought to investigate the feasibility, safety, and short-term follow-up of AFR implantation in patients with CHD or children with PH or cardiomyopathy. This is a multicenter retrospective study involving 10 centers worldwide. Patients of any age with CHD or patients aged < 18 years with PH or cardiomyopathy needing AFR implantation were included. A total of 40 patients underwent AFR implantation. The median age of the population at the time of the procedure was 58.5 months (IQR: 31.5-142.5) and the median weight was 17 kg (IQR: 10-46). A total of 26 (65.0%) patients had CHD, nine (22.5%) children, a cardiomyopathy, and five (12.5%), a structurally normal heart. The implantation success rate was 100%. There were two early and one late device thrombosis. Two patients (5.0%) with dilated cardiomyopathy on extracorporeal membrane oxygenator (ECMO) died during the hospital stay. At a median follow-up of 330 days (IQR: 125-593), 37 (92.5%) patients were alive. At follow-up, 20 patients improved their New York Heart Association (NYHA) class, 12 patients did not change their NYHA class, and one patient with idiopathic PH worsened. AFR implantation in patients with CHD and children with severe PH or cardiomyopathy is promising and seems to have beneficial effects at short-term follow-up.

Transcatheter “Sandwich” Valve-in-Valve Implantation Technique for Pure Aortic Regurgitation: Operation Skills and Early Experience

No commercial “on-label” transfemoral transcatheter aortic valve replacement (TAVR) device for aortic regurgitation (AR) is available in most countries. TAVR for AR with an “off-label” self-expanding device has shown acceptable procedural success but it elevated rates of early mortality and other complications. Valve disposition or displacement frequently occurs during transfemoral TAVR (TF-TAVR) for AR with a self-expanding valve, because of weak anchoring force. To overcome this problem, we propose a transcatheter “sandwich” valve-in-valve implantation (SVIV) technique, which has achieved good results. Our initial results and experience in a case series comprising seven patients suggest that the SVIV technique using commercially available self-expanding valves may be an option for treating selected patients with AR with high risk for surgical valve replacement. Compared with the traditional method, this technique can decrease the incidence of complications, particularly conduction block, but several technical details require the operator’s attention. Additional research is required to confirm the superiority of this technology.

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

First-in-human trial of a self-expandable, temporary dilation system for intracranial atherosclerotic disease in patients presenting with acute ischemic stroke

BackgroundIntracranial atherosclerotic disease (ICAD) significantly contributes to ischemic stroke, especially among Asian populations. Large vessel occlusion (LVO) due to underlying ICAD accounts for 15–35% of acute ischemic stroke cases requiring...