Transcatheter Aortic Valve Replacement Devices Research Articles

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.

The Effect of Aortic Angulation on Clinical Outcomes of Patients Undergoing Transcatheter Aortic Valve Replacement.

The aim of this study was to assess the impact of aortic angulation (AA) on periprocedural and in-hospital complications as well as mortality of patients undergoing Evolut™ R valve implantation. A retrospective study was conducted on 264 patients who underwent transfemoral-approach transcatheter aortic valve replacement with self-expandable valve at our hospital between August 2015 and August 2022. These patients underwent multislice computer tomography scans to evaluate AA. Transcatheter aortic valve replacement endpoints, device success, and clinical events were assessed according to the definitions provided by the Valve Academic Research Consortium-3. Cumulative events included paravalvular leak, permanent pacemaker implantation, new-onset stroke, and in-hospital mortality. Patients were divided into two groups, AA ≤ 48° and AA > 48°, based on the mean AA measurement (48.3±8.8) on multislice computer tomography. Multivariable logistic regression analysis was performed to identify predictors of cumulative events, utilizing variables with a P-value < 0.2 obtained from univariable logistic regression analysis, including AA, age, hypertension, chronic renal failure, and heart failure. AA (odds ratio [OR]: 1.73, 95% confidence interval [CI]: 0.89-3.38, P=0.104), age (OR: 1.04, 95% CI: 0.99-1.10, P=0.099), hypertension (OR: 1.66, 95% CI: 0.82-3.33, P=0.155), chronic renal failure (OR: 1.82, 95% CI: 0.92-3.61, P=0.084), and heart failure (OR: 0.57, 95% CI: 0.27-1.21, P=0.145) were not found to be significantly associated with cumulative events in the multivariable logistic regression analysis. This study demonstrated that increased AA does not have a significant impact on intraprocedural and periprocedural complications of patients with new generation self-expandable valves implanted.

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.

Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials

This report summarizes the current applicable regulatory framework and CDISC data standards for in vivo and in silico medical device randomized clinical trials, with an emphasis on transcatheter aortic valve replacement devices (TAVI). Trial Implementation issues and scenarios are discussed as well. This report has been prepared within the Horizon 2020 programme ‘In-Silico testing and validation of Cardiovascular IMplantable devices‘ (SIMCOR, GAID: 101017578) project and would be of relevance for clinical development, data management, and regulatory submission teams.

Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies

BackgroundThe postoperative outcomes of transcatheter aortic valve replacement (TAVR) with the new generation of self-expanding valves (SEV) and balloon-expandable valves (BEV) remain uncertain.MethodsWe conducted a meta-analysis based on randomized controlled trials (RCTs) and propensity score-matched (PSM) studies to evaluate the performance of the new generation TAVR devices, with a focus on Edwards SAPIEN 3/Ultra BEV, Medtronic Evolut R/PRO SEV, and Boston ACURATE neo SEV. Our primary endpoints were mortality and complications at both 30 days and one year post-operation.ResultsA total of 4 RCTs and 14 PSM studies were included. Our findings showed no significant difference between SEV and BEV regarding 30-day and 1-year mortality rates. ACURATE SEV required less permanent pacemaker implantation (PPI) at 30-day as compared to SAPIEN BEV, while Evolut SEV required a higher rate of PPI than SAPIEN BEV. The incidence of stroke, major or life-threatening bleeding (MLTB), major vascular complications (MVC), coronary artery obstruction (CAO) and acute kidney injury (AKI) did not differ significantly between the two groups. SEV had a larger effective orifice area (EOA) and lower mean transvalvular gradients (MPG) compared to BEV. However, there was an increased risk of paravalvular leakage (PVL) associated with SEV.ConclusionsIn terms of 30-day mortality, stroke, bleeding, MVC, AKI, CAO, and one-year mortality, there was comparability between the two valve types following TAVR. SEV was associated with better hemodynamic outcomes, except for a higher incidence of PVL. Compared to SAPIEN BEV, ACURATE SEV had a lower risk of PPI at 30 days, while Evolut SEV was associated with a higher risk of PPI. These findings underscore the importance of personalized valve selection.

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Severely Reduced Left Ventricular Systolic Function in the Low Systolic Function and Transcatheter Aortic Valve Implantation (LOSTAVI) International Registry

Transcatheter aortic valve replacement (TAVR) is an established therapy for severe, symptomatic aortic valve stenosis even in patients with impaired left ventricular systolic function. However, there is uncertainty on the clinical effectiveness of the currently available TAVR devices in patients with reduced left ventricular ejection fraction (LVEF). The LOSTAVI (Low Systolic function and Transcatheter Aortic Valve Implantation) registry is a retrospective observational study using baseline, procedural, discharge, and long-term follow-up details. A total of 3 groups of interest were distinguished: extremely reduced LVEF (<25%), severely reduced LVEF (25% to 30%), and reduced LVEF (31% to 35%). Unadjusted and adjusted analyses were carried out for in-hospital and follow-up outcomes. A total of 923 patients were included from 12 centers, with 146 patients (16%) with LVEF <25%, 425 (46%) with LVEF 25% to 30%, and 352 (38%) with LVEF 31% to 35%. Several baseline and procedural features were different across groups, including age, risk, functional class, and prevalence of bicuspid disease (all p <0.05). In-hospital mortality was similar in the 3 groups (7 [4.8%], 18 [4.2%], and 7 [2.0%], respectively, p=0.661), but major adverse events were more common in those with extremely reduced and severely reduced LVEF (19 [13%], 53 [13%], and 25 [7.1%], respectively, p=0.024). The 12-month follow-up confirmed the significant detrimental impact of reduced LVEF on both death (21 [14%], 49 [12%], and 25 [7.1%], respectively, p=0.024) and major adverse events (37 [25%], 89 [21%], and 53 [15%], respectively, p=0.016). The adjusted analysis confirmed the significant prognostic role of LVEF on both outcomes, whereas TAVR device type was not associated with death or major adverse events (all p >0.05). In conclusion, TAVR yields favorable early and 1-year results in patients with reduced LVEF, including those with extremely depressed systolic dysfunction. However, reduced LVEF still represents a major adverse prognostic factor for both short- and mid-term outcomes.

BIO3: Advancement of a Novel Polymeric Transcatheter Aortic Valve as an Alternative to Tissue-based Valves

Background: Transcatheter aortic valve replacement (TAVR) is a minimally invasive alternative to surgical valve replacement, originally targeted to elderly patients with aortic stenosis (AS), now increasingly utilized in younger lower risk AS patients. With growth of TAVR the shortcomings of current tissue-based valves are becoming prevalent, namely limited durability and thromboembolic risk. To address these, a polymeric TAV named PolyV-2 (27 mm, PolyNova Cardiovascular Inc, Stony Brook, NY) was designed, optimized, and further tested. Methods: The design of the PolyV-2 (Figure A) was achieved with a battery of in silico simulations including the use of finite element analysis (FEA, Abaqus 2020, Dassault Systems, Providence, RI) to optimize the radial force of the stent frame and minimize leaflet stresses during the cardiac cycle. The PolyV-2 employs a sutureless design via coating the stent with polymer, bypassing problematic hand suturing manufacture of tissue valves. The PolyV-2 utilizes a thermoplastic elastomer polymeric material which was tested in vitro with accelerated wear durability testing according to ISO 5840-3 (2015) with periodic performance testing, evaluated against tissue-based surgical and TAV devices for platelet activation rate (PAR) in a pulsatile flow loop, and evaluated for calcification risk with similar wear testing in a pro-calcific medium. To assess the deposition of calcifications in the valves, both µCT and ICP spectroscopy were used. Results: The optimization process of the PolyV-2 leaflets (Figure B) was able to greatly lower the peak and mean stresses throughout over the cardiac cycle by employing a variable thickness across the entire leaflet. With success of this in silico optimization process, the leaflets were then tested in vitro (Figure C) in accelerated wear testing, performing 1Billion cycles w/o failure – correlating to 25 years of efficacy in vivo, exceeding the 250 million minimum required by the FDA. The material also demonstrated favorable hemocompatiblity as to PAR (Figure D) with activation significantly lower than a commercial tissue TAVR device, more comparable to a surgical device. The pro-calcific wear testing demonstrated no deposition of calcific salts within the polymer leaflet (µCT image, Figure E) compared to the tissue valve and minimal calcium detected with ICP spectroscopy. Conclusion: To mitigate the persistent complications of tissue-based TAV devices, the polymeric PolyV-2 valve was optimized through a battery of in silico and in vitro trials to offer superior hemodynamics, performance, and durability. Proper design and material considerations are essential to ensure successful translation, demonstration of enhanced bio/hemocompatibility and advance of the PolyV-2 through in vivo animal trials.

Chinese guideline for the clincal application of transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR), as an important procedure for aortic valve diseases worldwide, features with a late start and rapid development in China. In the process of clinical application, the lack of standard guidelines and training system has brought challenges to the widespread use of this technique. In order to standardize the application of TAVR technique and improve the quality of medical care, the National Center for Cardiovascular Diseases and the National Center for Quality Control of Structural Heart Disease Intervention, together with the Chinese Society of Cardiology and the Chinese Society for Thoracic and Cardiovascular Surgery, jointly established an expert group on the guidelines for TAVR, combined with the recommendations of international guidelines and the current clinical practice in China, integrated the latest evidence in China and worldwide to develop the clinical guideline of TAVR with extensive consultation (Chinese Expert Consensus). The guideline mainly included 11 parts: methods, epidemiological feature, TAVR devices, requirements of cardiac teams, recommendations for TAVR indications, perioperative multimodality imaging evaluation, surgical procedures, anti-thrombotic strategies after TAVR, prevention and treatment of complications, postoperative rehabilitation and follow-up, limitations and prospects, aiming to provide reasonable recommendations for all-level clinicians in China.

Fusion Imaging–Guided BASILICA of a Stentless Bioprosthesis for Valve-in-Valve Transcatheter Aortic Valve Replacement

Fusion Imaging–Guided BASILICA of a Stentless Bioprosthesis for Valve-in-Valve Transcatheter Aortic Valve Replacement

Can Measuring the 'Dual Anchors of Aorta' Enhance the Success Rate of TAVR?-A Single-Center Experience.

Chronic severe aortic regurgitation (AR) has a poor long-term prognosis, especially among old-age patients. Considering their advancing age, the surgical approach of aortic valve replacement may not always be the best alternative modality of treatment in such patients. Therefore, this study's primary goal was to provide an initial summary of the medium- and short-term clinical effectiveness of transcatheter aortic valve replacement (TAVR) guided by accurate multi-detector computed tomography (MDCT) measurements in patients with severe and chronic AR, especially in elderly patients. The study enrolled retrospectively and prospectively patients diagnosed with severe AR who eventually underwent TAVR procedure from January 2019 to September 2022 at Fuwai cardiovascular Hospital, Beijing. Baseline information, MDCT measurements, anatomical classification, perioperative, and 1-year follow-up outcomes were collected and analyzed. Based on a novel anatomical categorization and dual anchoring theory, patients were divided into four categories according to the level of anchoring area. Type 1, 2, and 3 patients (with at least two anchoring regions) will receive TAVR with a transcatheter heart valve (THV), but Type 4 patients (with zero or one anchoring location) will be deemed unsuitable for TAVR and will instead receive medical care (retrospectively enrolled patients who already underwent TAVR are an exception). The mean age of the 37 patients with severe chronic AR was 73.1 ± 8.7 years, and 23 patients (62.2%) were male. The American Association of Thoracic Surgeons' score was 8.6 ± 2.1%. The MDCT anatomical classification included 17 cases of type 1 (45.9%), 3 cases of type 2 (8.1%), 13 cases of type 3 (35.1%), and 4 cases of Type 4 (10.8%). The VitaFlow valve (MicroPort, Shanghai, China) was implanted in 19 patients (51.3%), while the Venus A valve (Venus MedTech, Hangzhou, China) was implanted in 18 patients (48.6%). Immediate TAVR procedural and device success rates were 86.5% and 67.6%, respectively, while eight cases (21.6%) required THV-in-THV implantation, and nine cases (24.3%) required permanent pacemaker implantation. Univariate regression analysis revealed that the major factors affecting TAVR device failure were sinotubular junction diameter, THV type, and MDCT anatomical classification (p < 0.05). Compared with the baseline, the left ventricular ejection fraction gradually increased, while the left ventricular end-diastolic diameter remained small, and the N-terminal-pro hormone B-type natriuretic peptide level significantly decreased within one year. According to the results of our study, TAVR with a self-expanding THV is safe and feasible for patients with chronic severe AR, particularly for those who meet the criteria for the appropriate MDCT anatomical classification with intact dual aortic anchors, and it has a significant clinical effect for at least a year.

Biomimetic polymeric transcatheter heart valve leaflets with low calcification and good regenerative ability.

Transcatheter aortic valve replacement (TAVR) technology is quickly advancing in clinic, however, as it expands to low-risk populations and younger patients (age <65 years), device durability is becoming a major challenge. Tissue-engineered heart valves (TEHVs) are a potential alternative. In this study, a bionic tri-layer tissue-engineered heart valve was constructed using poly (L-lactate-co-ε-caprolactone) (PLCL), gelatin (GEL), hyaluronic acid (HA) and silk fibroin (SF), to simulate the fibrosa, spongiosa and ventricular layer of natural heart valves. To obtain a scaffold with sufficient strength and regenerative capacity, we optimized the ratio of components of each layer. The physical and mechanical properties were tested, and the cytocompatibility, calcification deposition and regeneration potential were tested in a rat model of subcutaneous implantation. Finally, the hydrodynamic function of the new TAVR device was verified. The results demonstrated that the strength of the tri-layer valve could reach up to 10 MPa, significantly higher than that of the PLCL and mono-layer groups. Most importantly, calcification related gene expression was down-regulated in the TEHV groups compared to valvular interstitial cells (VICs) treated with calcification induced medium, and calcification levels of TEHVs in in vivo assay were below 0.5 μg mg-1. Besides, we found HA in the middle layer was very conducive to rapid cell infiltration and good angiogenesis, which ultimately promoted host tissue regeneration at 8 weeks after implantation. Collectively, we provide a bionic tri-layer electrospun leaflet with appropriate mechanical strength, low calcification and good regenerative capacity, which has great potential as a TEHV leaflet.

909 TIMING AND DETERMINANTS OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: IS THE NEW GENERATION BETTER?

Abstract Background conduction disturbances requiring permanent pacemaker (PPM) implantation are among the most common adverse events in patients undergoing transcatheter aortic valve replacement (TAVR). The introduction in clinical practice of a new generation of TAVR devices has contributed to a significant reduction in procedural complications. However, limited data is available regarding the usual timing of PPM implantation after TAVR with the latest available valves. Therefore, in this analysis, we aimed to investigate the incidence, risk factors, and timing of new permanent pacemakers after TAVR, with respect to the type of valve implanted. Methods Patients who underwent TAVR at our Institution from September 2008 to June 2022 were included in this analysis. Patients with previous PPM/ICD implantation or receiving only balloon angioplasty were excluded, as well as cases with procedural unsuccess. The independent association between baseline clinical and procedural variables and the occurrence of PPM implantation was investigated with cross-sectional logistic regression analysis. Results A total of 497 patients were included in the study, with a mean age of 80.4±5.6 years old; 59% were females, 37.2% of patients had diabetes, 60.2% had dyslipidemia, and 25.8% had chronic kidney disease. The mean left ventricular ejection fraction (LVEF) was 52.1%, and the mean Euroscore II was 7.7±5.1. The new generation of self-expandable valves was used in 280 (56.3%) patients, while the new generation of balloon-expandable devices was implanted in 118 (23.7%). After TAVR, 109 (21.3%) patients underwent PPM/ICD implantation after a mean time of 4.1±3.1 days. After adjustment, self-expandable devices, larger valve sizes (29 or 34 mm), and diabetes were significantly associated with PPM/ICD implantation. Of note, the new generation of valve devices was associated with a lower risk of PPM/ICD implantation. Conclusion The necessity for a permanent pacemaker is a well-known possible adverse effect after TAVR. In this analysis, we confirm the previous evidence of an increasing risk of PPM implantation with self-expandable compared to balloon-expandable devices. Interestingly, the new valve generation was associated with a lower risk of conduction disturbances requiring PPM implantation. Further analyses and investigations will be needed to assess the impact of developing interventional techniques and advanced technologies on the occurrence of conduction disturbances.

Abstract 14021: A Meta Analysis for Clinical Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid versus Tricuspid Aortic Valves Using Balloon Expandable versus Self Expanding Valves

Introduction: Over the past decade, several next generation transcatheter aortic valve replacement (TAVR) devices have been developed with the aim of improving patients’ outcomes. Bicuspid aortic valves (BAVs) are an emerging issue in TAVR practice. The goal of this study was to compare clinical outcomes of TAVR using balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves in patients with BAV vs tricuspid aortic valve (TAV). Methods: We searched PubMed, Cochrane and Embase databases systematically for relevant studies from inception to March 2022. The primary focus was 1-year all-cause mortality. Additional outcomes included short term (30-days) all-cause mortality, cardiovascular mortality, stroke, major/life threatening bleeding, permanent pacemaker (PPM) implantation and major vascular complications. Results: There were 28 studies with a total 346,033 patients who underwent TAVR, 17,835 of which had BAV stenosis. In the BE group, there was a statistically lower risk of mortality of TAVR in the BAV when compared to the TAV (OR 0.69 [95% CI 0.49-0.97]; p=0.03). In terms of short-term outcomes of BE group, the risks of all-cause mortality, stroke, PPM implantation, major bleeding, and major vascular complications were all similar between the two arms. In the SE group, there were not statistically significant in the clinical outcomes between patients in BAV and TAV. Conclusions: The use of balloon-expandable valves in TAVR was associated with a lower risk of 1-year mortality in patients with BAV compared to patients with TAV. These data support the need for a randomized trial to compare the balloon-expandable valves in BAV patients.

Patient–Specific Immersed Finite Element–Difference Model of Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) first received FDA approval for high-risk surgical patients in 2011 and has been approved for low-risk surgical patients since 2019. It is now the most common type of aortic valve replacement, and its use continues to accelerate. Computer modeling and simulation (CM&S) is a tool to aid in TAVR device design, regulatory approval, and indication in patient-specific care. This study introduces a computational fluid-structure interaction (FSI) model of TAVR with Medtronic’s CoreValve Evolut R device using the immersed finite element-difference (IFED) method. We perform dynamic simulations of crimping and deployment of the Evolut R, as well as device behavior across the cardiac cycle in a patient-specific aortic root anatomy reconstructed from computed tomography (CT) image data. These IFED simulations, which incorporate biomechanics models fit to experimental tensile test data, automatically capture the contact within the device and between the self-expanding stent and native anatomy. Further, we apply realistic driving and loading conditions based on clinical measurements of human ventricular and aortic pressures and flow rates to demonstrate that our Evolut R model supports a physiological diastolic pressure load and provides informative clinical performance predictions.

Incidence, Outcomes and Predictors of Aortic Regurgitation After Transcatheter Aortic Valve Replacement in Al Azhar University Hospitals and National Heart Institute, Egypt

Background: Aortic regurgitation (AR), which has ill-defined predictors and an unknown long-term influence on outcomes, is a significant transcatheter aortic valve replacement (TAVR) constraint. Objective: this research aimed to assess the prevalence, identify predictors, and evaluate the outcomes of aortic regurgitation following trans catheter aortic valve implantation (TAVI). 1. To calculate the prevalence of aortic regurgitation in elderly patients receiving trans catheter aortic valve implantation who have severe symptomatic aortic stenosis. 2. To determine aortic regurgitation risk factors after trans catheter aortic valve implantation. Methods: From November 2017 to November 2020, this prospective observational study was done in the National Heart Institute on severe aortic valve stenosis patients above 65 years who were candidates for aortic valve replacement from the outpatient department. Results: LVEF significantly improved. Compared to before TAVI (55.08 ± 9.71), LVEF elevated to 58.9 ± 8.8 (P&lt;0.001). Twenty-five patients (83.3%) showed class III/IV, four patients (13.3%) showed class II, and one patient (3.3%) showed class I before TAVI. While after TAVI, three patients (10%) only showed NYHA class III/IV, six patients (20 %) in class II, and 21 patients (70%) improved to be in class I. The left ventricular mass index mean was 158 ±32.37 before TAVI and 133.50 ±21.96 after TAVI (p&lt;0.001). Compared to before TAVI (0.75 ± 0.2), mean aortic valve area was improved to 2.0 ± 0.2 following TAVI (P&lt;0.001). A significant reduction in the mean pressure gradient from 47 ± 11.08 mmHg across the native valve prior to TAVI to 10.28 ± 3.21 mmHg across the prosthetic valve following TAVI (P &lt;0.001). Expert commentary: The clinical and results of TAVR devices were clearly outlined in literature study. The study showed a high incidence of pacemaker implantation with Core valve and aortic regurgitation. This information strongly supports the need for a randomized trial with sufficient power to compare the most recent self-expandable valve generation to balloon expandable valves. In the 2019 PARTNER 3 prospective randomized trial, it was discovered that, when compared to surgical management, low-risk patients (defined as STS 4%) had a lower risk of the composite outcome of stroke, death, and rehospitalization at 1 year. Additionally, it was shown that TAVR had a lower risk of stroke and required less time in the hospital (3 days as opposed to 7, P0.001) than surgery [1]. In addition, despite an elevated permanent pacemaker implantation rate, the 2019 Medtronic Evolut Transcatheter Aortic Valve Replacement revealed no inferiority for composite all-cause stroke and death, as well as a statistically significant decrease in the rates of life-threatening bleeding, acute kidney injury and atrial fibrillation, compared with SAVR at 30 days following the procedure [2]. Conclusion: According to the study in high-risk patients with severe symptomatic aortic stenosis, TAVI is alternative, viable, safe, and successful therapy compared to traditional open-heart surgery.

Use of the SAPIEN 3 Transcatheter Heart Valve in High-Risk Scenarios.

The transcatheter aortic valve replacement procedure is used in patients with aortic stenosis. Transcatheter aortic valve replacement devices are quite versatile; thus, they are increasingly being used for nonaortic applications, such as tricuspid valve-in-valve implantation. This case series describes a transcatheter aortic valve replacement procedure in 4 patients with anatomic challenges (eg, aortic tortuosity, high valvular calcium burden, highly calcified bicuspid valve, low coronary artery takeoff, left main coronary artery occlusion, and large aortic annulus) and a fifth patient who had a failed tricuspid bioprosthesis and underwent a tricuspid valve-in-valve implantation with the Edwards SAPIEN 3 transcatheter heart valve (Edwards Lifesciences). All procedures required adjustments to the standard protocol, and each procedure was successful. The critical, technical adjustments in the deployment technique and preprocedural planning of the procedures are detailed to provide a road map for other cardiologists who encounter similar challenges.

A Comparison of Thirty-Day Clinical and Echocardiographic Outcomes of Patients Undergoing Transcatheter vs. Surgical Aortic Valve Replacement for Native Aortic Insufficiency

ObjectivesWe aim to compare in-hospital and 30-day outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) for native aortic insufficiency (AI). BackgroundTAVR is increasingly used off-label in patients with AI deemed high risk for SAVR. There is a paucity of data comparing TAVR and SAVR with current commercially available TAVR devices. MethodsA single-center, retrospective cohort study of patients undergoing TAVR or SAVR for native AI between 2014 and 2020 was performed. Data were obtained from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database, Transcatheter Valve Therapy (TVT) registry, and chart review. In-hospital and 30-day outcomes are reported. ResultsOf 125 total patients, 91 underwent SAVR and 34 underwent TAVR. The TAVR group had a higher STS predictive risk of mortality (PROM) (TAVR = 3.96 %, SAVR = 1.25 %, p < 0.0001). In the postoperative period, the SAVR group had higher rates of new-onset atrial fibrillation (20.9 % vs. 0 %, p < 0.001), while the TAVR group had higher rates of complete heart block requiring permanent pacemaker implantation (20.6 % vs. 2.2 %, p < 0.001). There was no difference in in-hospital or 30-day mortality, stroke, myocardial infarction, residual AI, or repeat valve intervention. ConclusionsDespite higher STS PROM and more comorbidities, patients who underwent TAVR for AI had similar in-hospital and 30-day outcomes as patients who underwent SAVR for AI. These results support TAVR in selected high-risk patients with AI, with the knowledge that pacemaker needs may be higher than patients undergoing SAVR.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance.

BackgroundThe impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation.MethodsConsecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death.ResultsA total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10–22; SA 11%, 95%CI: 6–20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20–23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar.ConclusionIn this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Economic Evaluation of Transcatheter Aortic Valve Replacement Compared to Surgical Aortic Valve Replacement in Chinese Intermediate-Risk Patients.

BackgroundAortic stenosis (AS) is a severe disease that causes heart failure and sudden death. Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are both recommended for patients with intermediate surgical risk, but the cost-effectiveness of TAVR compared to SAVR in China has not been investigated.MethodsA combined decision tree and Markov model were conducted to compare the cost-effectiveness of TAVR versus SAVR with a 5-year simulation. The primary outcome was the incremental cost-effectiveness ratio (ICER), a ratio of incremental costs to incremental quality-adjusted life-year (QALY). One-way sensitive analysis and probabilistic sensitivity analysis (PSA) were conducted to test the robustness of the model.ResultsAfter a simulation of 5 years, the costs of TAVR and SAVR were 54,573 and 35,002 USD, respectively, and the corresponding effectiveness was 2.826 versus 2.712 QALY, respectively. The ICER for the TAVR versus SAVR comparison was 170,056 USD/QALY, which was three times higher than the per capita gross domestic product (GDP) in China. One-way sensitive analysis showed that the cost of the TAVR device impacted the ICER. The TAVR could be cost-effective only in the case where its cost is lowered to 29,766 USD.ConclusionTAVR is currently not cost-effective in China, but it could be cost-effective with a reduction of costs to 29,766 USD, which is approximately 65% of the current price.

P326 SURGICAL VERSUS TRANSCATHETER AORTIC VALVE REPLACEMENT WITH NEWER GENERATION DEVICES IN REAL–WORLD PRACTICE: ONE–YEAR OUTCOMES FROM THE ITALIAN OBSERVANT STUDIES

Abstract Objective To compare the early and 1–year outcomes after transcatheter aortic valve replacement (TAVR) with new–generation devices over surgical replacement (SAVR) among patients with severe aortic stenosis (AS). Background TAVR is gaining acceptance for the treatment of lower risk patients with AS after several randomized and observational studies confirmed comparable early results to SAVR. On the other hand, clinical studies have shown that SAVR is still widely used in intermediate and high risk patients. There is need of data from large clinical registries to demonstrate the efficacy and safety of TAVR in the real–world setting, particularly after the introduction of new TAVR technology. Methods A total of 5706 AS patients who underwent SAVR and 2989 AS patients who underwent TAVR enrolled in the national, prospective OBSERVANT and OBSERVANT II studies, respectively in 2010–2012 and 2016–2018, were analyzed. Outcomes were adjusted using the propensity score matching. The primary outcomes of interest were all–cause mortality, major adverse cardiac and cerebrovascular events (MACCEs) and hospital readmission due to heart failure at 1–year. Secondary outcomes were major adverse events occurring during the index hospitalization. Results Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30–day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), acute kidney injury (0.6 vs. 8.2%, p &amp;lt; 0.001), infectious complications (3.8 vs. 6.5%, p = 0.006) and cardiogenic shock (1.4 vs. 5.1%, p &amp;lt; 0.001) compared to SAVR. Moderate–to–severe paravalvular regurgitation (5.9 vs. 2.0%, p &amp;lt; 0.001), major vascular complications requiring invasive treatment (2.2 vs. 0.1%, p &amp;lt; 0.001) and permanent pacemaker implantation (during the index hospitalization, 13.8 vs. 3.3%, p &amp;lt; 0.001) were more frequent after TAVR. At 1–year, TAVR was associated with lower risk of all–cause death (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p &amp;lt; 0.001) and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. Conclusions In a real–world setting, patients with intermediate operative risk treated with newer generation TAVR devices had a low risk of major adverse events during the index–hospitalization and at 1–year follow–up. TAVR could become the treatment of choice for AS in the elderly provided that its durability is proved by long–term follow–up studies.