Transcatheter Aortic Valve Replacement Valve Research Articles

Surgical Technique And Clinical Implications Of Transcatheter Aortic Valve Bioprosthesis Explantation.

There has been a worldwide rapid adoption of transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. Currently, more TAVR explants with SAVRs are performed than TAVR-in TAV. TAVR explantation is a technically hazardous procedure mainly due to significant aortic neo-endothelialization which incorporates the TAVR valve. Surgical techniques for TAVR explantation are not well established and surgeon experience at present is limited. In this manuscript, we describe our technique for surgical explantation of transcatheter aortic bioprosthesis. Familiarity with the procedure and its clinical implications is essential for all cardiac surgeons.

Successful Implantation of Rapid Deployment Aortic Valve after TAVR Explantation.

Transcatheter aortic valve replacement (TAVR) has become widely used in recent years, However, there is also an increasing need for removal of TAVR valves due to prosthetic valve dysfunction (PVD) and the development of infective endocarditis. Surgical aortic valve replacement (AVR) for these patients is risky due to the original patient background and anatomic conditions. Intuity rapid deployment aortic valve (Edwards Lifesciences, Irvine, CA) replacement would be useful for such high risk patients to prevent longer cardiac arrest time and obtain good hemodynamic results. However, there are few reports which present Intuity valve replacement after TAVR explantation. Herein, We report two cases in which we have achieved good hemodynamics with shorter cardiac arrest times by using a rapid deployment valve after TAVR explantation. We present 2 cases of successful implantation of the Intuity rapid deployment valve after TAVR explantation. The 84- and 88-year-old female patients had previously received TAVR for severe aortic stenosis with SAPIEN XT (Edwards Lifesciences, Irvine, CA) and developed PVD during follow-up. The TAVR valve was removed carefully, then an Intuity valve was implanted with cardiac arrest times of 69 and 41min. Both patients had good echocardiographic results with effective orifice area of 2.0cm2 and 1.2cm2 and mean trans-aortic plessure gradient of 9 mmHg and 15 mmHg respectively without aortic regurgitation. They were discharged without major complications. Surgical AVR using a rapid deployment valve is a useful alternative to sutured AVR after TAVR valve explantation. It allows for shorter cardiac arrest times and better postoperative hemodynamics without major complication.

Outcomes of Valve-in-Valve Transcatheter Aortic Valve Replacement

Structural valve degeneration is increasingly seen given the higher rates of bioprosthetic heart valve use for surgical and transcatheter aortic valve replacement (TAVR). Valve-in-valve TAVR (VIV-TAVR) is an attractive alternate for patients who are otherwise at high risk for reoperative surgery. We compared patients who underwent VIV-TAVR and native valve TAVR through a retrospective analysis of our institutional transcatheter valve therapy from 2013 to 2022. Patients who underwent either a native valve TAVR or VIV-TAVR were included. VIV-TAVR was defined as TAVR in patients who underwent a previous surgical aortic valve replacement. The Kaplan-Meier survival analysis was used to obtain survival estimates. A Cox proportional hazards regression model was used for the multivariable analysis of mortality. A total of 3,532 patients underwent TAVR, of whom 198 (5.6%) underwent VIV-TAVR. Patients in the VIV-TAVR cohort were younger than patients who underwent native valve TAVR (79.5 vs 84years, p <0.001), with comparable number of women and a higher Society of Thoracic Surgeons risk score (6.28 vs 4.46, p <0.001). The VIV-TAVR cohort had a higher incidence of major vascular complications (2.5% vs 0.8%, p = 0.008) but lower incidence of permanent pacemaker placement (2.5% vs 8.1%, p = 0.004). The incidence of stroke was comparable between the groups (VIV-TAVR 2.5% vs native TAVR 2.4%, p = 0.911). The 30-day readmission rates (VIV-TAVR 7.1% vs native TAVR 9%, p = 0.348), in-hospital (VIV-TAVR 2% vs native TAVR 1.4%, p = 0.46), and overall (VIV-TAVR 26.3% vs native TAVR 30.8%, p = 0.18) mortality at a follow-up of 1.8years (0.83 to 3.5) were comparable between the groups. The survival estimates were comparable between the groups (log-rank p = 0.27). On the multivariable cox regression analysis, VIV-TAVR was associated with decreased hazards of death (hazard ratio 0.68 [0.5 to 0.9], p = 0.02). In conclusion, VIV-TAVR is a feasible and safe strategy for high-risk patients with bioprosthetic valve failure. There may be potentially higher short-term morbidity with VIV-TAVR, with no overt impact on survival.

Transcatheter aortic valve replacement: Past, present, and future.

Transcatheter aortic valve replacement (TAVR) has emerged as a ground-breaking, minimally invasive alternative to traditional open-heart surgery, primarily designed for elderly patients initially considered unsuitable for surgical intervention due to severe aortic stenosis. As a result of successful large-scale trials, TAVR is now being routinely applied to a broader spectrum of patients. In deciding between TAVR and surgical aortic valve replacement, clinicians evaluate various factors, including patient suitability and anatomy through preprocedural imaging, which guides prosthetic valve sizing and access site selection. Patient surgical risk is a pivotal consideration, with a multidisciplinary team making the ultimate decision in the patient's best interest. Periprocedural imaging aids real-time visualization but is influenced by anaesthesia choices. A comprehensive postprocedural assessment is critical due to potential TAVR-related complications. Numerous trials have demonstrated that TAVR matches or surpasses surgery for patients with diverse surgical risk profiles, ranging from extreme to low risk. However, long-term follow-up data, particularly in low-risk cases, remains limited, and the applicability of published results to younger patients is uncertain. This review delves into key TAVR studies, pinpointing areas for potential improvement while delving into the future of this innovative procedure. Furthermore, it explores the expanding role of TAVR technology in addressing other heart valve replacement procedures.

Hemostatic Profiles of Patients Who Underwent Transcatheter Versus Surgical Aortic Valve Replacement Versus Percutaneous Coronary Intervention

Guidelines for transcatheter aortic valve replacement (TAVR) antithrombotic prophylaxis are extrapolated predominantly from percutaneous coronary intervention (PCI) data. Here, we examined temporal coagulation changes occurring in the early perioperative period to determine the pathobiologic validity of this supposition. This was a prospective observational study of consecutive patients who underwent transfemoral TAVR (n=27), PCI (n=12), or surgical aortic valve replacement (SAVR) requiring cardiopulmonary bypass and cross-clamping (n=12). Blood samples were taken at 4 time points: T1 (baseline), after general anesthesia or sedation; T2, after heparin administration; T3, at the end of the procedure; and T4, 6 hours after the procedure. The samples were assessed concurrently using standard laboratory coagulation tests and viscoelastic tests of whole blood clotting, including the latest generation thromboelastometry (ROTEM sigma) and thromboelastometry (TEG 6s). Patients in the TAVR cohort were older and a had lower baseline hemoglobin level than patients in the PCI and SAVR cohorts. The baseline platelet function was similar between the TAVR and PCI cohorts and impaired in the SAVR cohort Figure S1. The baseline hemostatic measures were comparable among cohorts. Regarding the per-patient change from baseline, the TAVR cohort showed an overall more prothrombotic state than the other cohorts, with the most marked differences from the SAVR cohort after intraoperative heparin administration and from the PCI cohorts 6hours after the procedure. In addition, the ROTEM and TEG parameters were well correlated but not interchangeable. In conclusion, patients who underwent TAVR have a more prothrombotic hemostatic profile than PCI and SAVR patients. These findings question the current guidelines that extrapolate antithrombotic regimens from PCI to TAVR settings.

Secondary analysis of REPRISE III trial: The Lotus valve's persistence after withdrawal.

Aortic stenosis (AS) is the leading heart valve disease in developed countries, often caused by calcific degeneration. In low-and-middle-income countries, it's primarily due to RHD. Prevalence of AS increases with age and up to 22.8% of those affected over the age of 75. While surgical aortic valve replacement is standard treatment for AS, many older individuals are not ideal candidates. Transcatheter aortic valve replacement (TAVR) offers an alternative. The REPRISE III trial showed the Lotus valve outperformed the CoreValve/EvolutR TAVR valves in various metrics over 2 years. Despite its success and over 10,000 implantations, the Lotus valve was pulled from the market, highlighting the need to understand its long-term outcomes. Study and results: In the REPRISE III trial, the long-term outcomes of TAVR using the Lotus valve were compared to the CoreValve/EvolutR over 5 years across 55 global centers. Of the participants, 581 (95.7%) used the Lotus valve and 285 (93.4%) used CoreValve/EvolutR. Event rates for all-cause mortality were similar between the groups, but the Lotus valve group had lower rates of disabling stroke and pacemaker implantation. The Lotus valve showed a higher aortic gradient but lower effective orifice area. Additionally, the Lotus valve had reduced mild PVL, valve malpositioning, and the need for a second valve. Both groups showed comparable long-term improvements in heart and cardiomyopathy assessments. The REPRISE III analysis highlights the favourable long-term outcomes of the Lotus valve and CoreValve/EvolutR for high-risk surgical patients. These findings underscore the importance of ongoing management post-valve procedure and the potential advantages of the Lotus valve design. Further studies comparing these valves to surgery will inform aortic stenosis management and potentially expand TAVR indications. The future goal is to develop a tissue-engineered living heart valve to improve survival and quality of life.

CARD11: Polymeric Endoluminal Paving for Prevention of Paravalvular Leak in Transcatheter Aortic Valve Replacement

Background: Calcific aortic valve disease and associated aortic stenosis is increasingly common, with prevalence across the age spectrum. Transcatheter aortic valve replacement (TAVR) has emerged as a life-saving, non-surgical alternative for replacement of diseased aortic valves, restoring non-obstructive blood flow from the heart. While effective, current TAVR technology remains limited by adaptability to patient-specific anatomy, leading to incomplete deployment and non-conformal fit resulting in paravalvular leak. Polymeric endoluminal paving was previously developed as a methodology allowing deployment of polymeric materials on tissue surfaces, serving as structural materials and barriers. Here we adapt the paving methodology to fill gaps and defects resulting from incomplete TAVR valve deployment to limit paravalvular leak. Specifically, we assess the efficacy pf polymeric paving in vitro as a means of gap filling and leak reduction in valves deployed in 3-D physical models of severely stenosed aortic valves. We hypothesize that applied polymeric biomaterials will fill and conform to irregular aortic valve geometries acting as a sealant to reduce paravalvular leak. Methods: Polymeric hydrogels were prepared from ABA block copolymer macromers composed of diacrylate terminated by PLA-b-PEG-b-PLA. Hydrogel networks were prepared by swelling these macromers, following the addition of free radical initiators. Hollow tubular constructs were formed via melt-processing in PDMS molds to fit as a “sleeve” around deployed PolyV® nitinol stent (Fig 1A). The sealing efficacy of polymers was examined using a silicone replica of CAVD aortic root with deployed stent + polymer construct (Fig 1B). A rubber stopper was used to fully occlude aortic lumen and restrict flow to paravalvular areas for quantitative analysis. To test sealing against hydrostatic pressure, valve construct was connected to Tygon tubing and water was added at equivalent 10 mmHg increments at 5-minute intervals. Volume from paravalvular flow was measured at each step. Experiments were performed with N = 4 polymeric sleeves. Results: We found significant reduction in paravalvular leakage with polymer sleeves compared to no polymer at all pressures tested. Figure 1C shows the mean ± standard deviation volume of water leaked over 5 minutes of corresponding hydrostatic pressure. No leakage was detected up to 60mmHg for all polymer sleeves tested. At approximately 85-90 mmHg, the rubber stopper failed, however the polymer sleeve remained intact. Conclusions: Polymeric paving utilized with TAVR is a promising combinative therapy for preventing paravalvular leakage. Our results indicate that potential polymeric biomaterials are capable of conforming to non-physiologic aortic valve morphologies, filling and sealing paravalvular gaps, while withstanding physiologic trans-aortic pressures. With further translation, polymer paving can be useful in improving TAVR outcomes.

Treatment of pure aortic regurgitation using surgical or transcatheter aortic valve replacement between 2018 and 2020 in Germany.

In pure aortic regurgitation, transcatheter aortic valve replacement (TAVR) is not yet used on a regular base. Due to constant development of TAVR, it is necessary to analyze current data. By use of health records, we analyzed all isolated TAVR or surgical aortic valve replacements (SAVR) for pure aortic regurgitation between 2018 and 2020 in Germany. 4,861 procedures-4,025 SAVR and 836 TAVR-for aortic regurgitation were identified. Patients treated with TAVR were older, showed a higher logistic EuroSCORE, and had more pre-existing diseases. While results indicate a slightly higher unadjusted in-hospital mortality for transapical TAVR (6.00%) vs. SAVR (5.71%), transfemoral TAVR showed better outcomes, with self-expanding compared to balloon-expandable transfemoral TAVR having significantly lower in-hospital mortality (2.41% vs. 5.17%; p = 0.039). After risk adjustment, balloon-expandable as well as self-expanding transfemoral TAVR were associated with a significantly lower mortality vs. SAVR (balloon-expandable: risk adjusted OR = 0.50 [95% CI 0.27; 0.94], p = 0.031; self-expanding: OR = 0.20 [0.10; 0.41], p < 0.001). Furthermore, the observed in-hospital outcomes of stroke, major bleeding, delirium, and mechanical ventilation >48 h were significantly in favor of TAVR. In addition, TAVR showed a significantly shorter length of hospital stay compared to SAVR (transapical: risk adjusted Coefficient = -4.75d [-7.05d; -2.46d], p < 0.001; balloon-expandable: Coefficient = -6.88d [-9.06d; -4.69d], p < 0.001; self-expanding: Coefficient = -7.22 [-8.95; -5.49], p < 0.001). TAVR is a viable alternative to SAVR in the treatment of pure aortic regurgitation for selected patients, showing overall low in-hospital mortality and complication rates, especially with regard to self-expanding transfemoral TAVR.

PO-04-061 A RARE CASE OF FOCAL LEFT VENTRICULAR OUTFLOW TRACT VENTRICULAR TACHYCARDIA LATE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT

Transcatheter aortic valve replacement (TAVR) is commonly used to treat severe aortic stenosis (AS). To date there is only one reported case of post-TAVR, new onset, left ventricular outflow tract (LVOT) ventricular tachycardia (VT) which was ablated above the TAVR valve. We report a case of late presenting symptomatic LVOT VT, which was successfully ablated via a trans-septal approach, without fluoroscopy, using intracardiac echocardiography (ICE) and electroanatomic mapping (EAM), thereby, avoiding catheter manipulation in the aorta above the valve. N/A A 68-year-old man underwent TAVR for severe AS with Sapien 3 valve (Edwards Lifescience). Nine months later, the patient developed worsening dyspnea. Echocardiogram showed well seated TAVR valve, and exercise nuclear stress revealed no ischemia. During the stress test, he had slow monomorphic VT at rest, during exercise, and recovery (100-120 bpm). A 24-hour Holter monitor revealed a ventricular arrhythmia burden of 55% with rates between 85 and 112 bpm. The 12-lead ECG of VT had an initial positive deflection in lead I, QS in V1 and V2, and an initial R wave in V3 taller than the sinus QRS, suggesting a septal right ventricular outflow tract (RVOT) vs. LVOT origin. There was no improvement with beta-blocker therapy. An electrophysiology study was performed using ICE and CARTO (Biosense Webster, Diamond Bar, CA). Activation mapping in the septal RVOT revealed a 20ms presystolic electrogram (far field) and an 80% pace map, despite the unipolar signal with QS complex. Radiofrequency ablation performed at this site only mildly suppressed the arrhythmia. The decision was made to map from the LVOT via transseptal access using EAM and real-time markers from Cartosound real time images to accurately visualize the ablation catheter below the TAVR. Earliest activation was beneath the left coronary cusp directly across the RVOT lesions with a sharp 22ms pre-systolic electrogram, unipolar QS, and 90% pace map match. Ablation performed here successfully eliminated the VT even after isoproterenol infusion and programmed stimulation. The patient’s symptoms have resolved, and he remains arrhythmia free. LVOT VA’s may rarely occur post TAVR, although a direct cause cannot be ascertained. This is the first report of successfully ablating the arrhythmia in a TAVR patient using a transeptal, subvalvular approach without fluoroscopy, and avoiding any risks associated with the aortic approach.

Reoperation following transcatheter aortic valve replacement: Insights from 10 years' experience

ObjectiveUse of transcatheter aortic valve replacement (TAVR) has demonstrated dramatic growth in the past decade. This study aims to investigate implications of post-TAVR reoperation from our 10-year experience. MethodsBetween 2011 and 2022, 66 post-TAVR patients underwent a reoperation, consisting of 42 (63.6%) patients with native TAVR and 24 (36.4%) patients with valve-in-valve TAVR (VIV-TAVR) after surgical aortic valve replacement. ResultsThe aggregate proportion of patients belonging to the low-/intermediate-risk group at the time of TAVR exceeded that of the high-/extreme-risk cohort in 2021. The native TAVR group received a larger TAVR valve, whereas more frequent low-risk status at the time of TAVR than the VIV-TAVR group. Concurrent procedures were highly common during reoperation and isolated surgical aortic valve replacement represented only 18.2% of the entire cohort. The native TAVR group demonstrated significantly higher TAVR explant difficulty index score (2.0 vs 1.0 points; P < .001) and operative mortality (14.2% vs 0%; P = .079) compared with the VIV-TAVR group. The 8-year cumulative incidence of reoperation was 1.9% and 14.1% (subdistribution hazard ratio, 8.0; 95% CI, 4.1-15.9; P < .001) in the native and VIV-TAVR group, respectively. Furthermore, cumulative incidence of valve reintervention, combining reoperations and redo TAVRs, was 3.3% and 19.0% (subdistribution hazard ratio, 6.2; 95% CI, 3.6-10.9; P < .001). ConclusionsLow-/intermediate-risk patients are emerging as the predominant group necessitating reoperations. Native TAVR was associated with lower postimplant reintervention rates, albeit with higher reoperative technical difficulty and mortality. Conversely, VIV-TAVR was associated with higher reintervention, but demonstrated lower technical difficulty and mortality for reoperation.

Redo Surgical Aortic Valve Replacement After Prior Transcatheter Versus Surgical Aortic Valve Replacement

BackgroundAortic stenosis treatment should consider risks and benefits for lifetime management. Although the feasibility of redo transcatheter aortic valve replacement (TAVR) remains unclear, concerns are emerging regarding reoperation after TAVR. ObjectivesThe authors sought to define comparative risk of surgical aortic valve replacement (SAVR) after prior TAVR or SAVR. MethodsData on patients undergoing bioprosthetic SAVR after TAVR and/or SAVR were extracted from the Society of Thoracic Surgeons Database (2011-2021). Overall and isolated SAVR cohorts were analyzed. The primary outcome was operative mortality. Risk adjustment using hierarchical logistic regression as well as propensity score matching for isolated SAVR cases were performed. ResultsOf 31,106 SAVR patients, 1,126 had prior TAVR (TAVR-SAVR), 674 had prior SAVR and TAVR (SAVR-TAVR-SAVR), and 29,306 had prior SAVR (SAVR-SAVR). Yearly rates of TAVR-SAVR and SAVR-TAVR-SAVR increased over time, whereas SAVR-SAVR was stable. The TAVR-SAVR patients were older, with higher acuity, and with greater comorbidities than other cohorts. The unadjusted operative mortality was highest in the TAVR-SAVR group (17% vs 12% vs 9%, respectively; P < 0.001). Compared with SAVR-SAVR, risk-adjusted operative mortality was significantly higher for TAVR-SAVR (OR: 1.53; P = 0.004), but not SAVR-TAVR-SAVR (OR: 1.02; P = 0.927). After propensity score matching, operative mortality of isolated SAVR was 1.74 times higher for TAVR-SAVR than SAVR-SAVR patients (P = 0.020). ConclusionsThe number of post-TAVR reoperations is increasing and represent a high-risk population. Yet even in isolated SAVR cases, SAVR after TAVR is independently associated with increased risk of mortality. Patients with life expectancy beyond a TAVR valve and unsuitable anatomy for redo-TAVR should consider a SAVR-first approach.

Energy loss index as a predictor of all-cause mortality after transcatheter aortic valve replacement: A long-term follow-up.

As transcatheter aortic valve replacement (TAVR) procedures become more widely available, there is a growing need to monitor and evaluate postoperative outcomes accurately. The energy loss index (ELI) of the ascending aorta has been commonly used to examine the agreement between the echocardiographic and Gorlin measurement of the aortic valve area. This project aims to demonstrate a link between ELI values and mortality following implanted TAVR valves and determine an ELI cutoff value associated with post-TAVR events. We retrospectively reviewed patients undergoing TAVR from 2012 to 2017. We calculated ELI values for patients immediately postoperative after a TAVR procedure. Using Receiver-Operator Characteristic and Cox Regression analyses, we identified a cutoff value to distinguish between "High ELI"(≥1.34) and "Low ELI"(<1.34) patients. This study showed low ELI (hazard ratio, 2.30; 95% confidence interval 1.57-3.36, p<.001) as representative of patients with a high risk of mortality post-TAVR. Additionally, post-TAVR, ejection fraction increased by 3.6% (p<.001), and the aortic valve effective orifice area increased by 1.41cm squared (p<.001) while the mean transvalvular gradient decreased by 32.8mmHg (p<.001) and the peak transvalvular gradient decreased by 49.0mmHg (p<.001). ELI is an additional prognostic factor that should be considered during risk assessment before TAVR. This study shows that patients with Low ELI had decreased cumulative survival post-TAVR. These patients almost had a fivefold increased risk of death following TAVR.

Commissural Alignment With ACURATE neo2 Valve in an Unselected Population.

Commissural alignment has become an important topic in transcatheter aortic valve replacement (TAVR) because it may improve coronary access, facilitate future valve procedures, and possibly improve valve durability. The efficacy of commissural alignment with ACURATE neo2 has not yet been shown in a large population. The authors sought to determine the feasibility and success of attempting commissural alignment in an unselected TAVR population treated with the ACURATE neo2 prosthetic heart valve. A total of 170 consecutive patients underwent TAVR with a dedicated implantation technique to align the TAVR valve to the native valve. Using right-left overlap and 3-cusp views, valve orientation was adjusted by rotation of the unexpanded valve at the level of the aortic root. Effectiveness was assessed postprocedure as the degree of misalignment determined by analyzing fluoroscopic valve orientation to corresponding cusp orientation on preprocedural computed tomography. Safety endpoints included mortality, stroke/transient ischemic attack, and additional complications through 30days. Of 170 patients, 167 (98.2%) could be analyzed for alignment, and all 170, for safety outcomes. Most patients (97%) had successful alignment (≤ mild misalignment), with 80% with commissural alignment, while the degrees of misalignment were 17% mild, 1.2% moderate, 1.8% severe. In this large evaluation of a commissural alignment technique, alignment was achieved in nearly all patients without safety concerns or impact to procedure duration. Commissural alignment appears effective and safe across all patients with this novel technique.

Cost Utility of Transcatheter Aortic Valve Replacement: Sapien 3 Versus CoreValve Evolut R.

Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for severe aortic stenosis. Previous studies compare clinical outcomes of leading TAVR valves, but there is no evidence of cost-utility comparison, leaving a clinical information gap when selecting valves. Here we share a cost-utility analysis comparing the Sapien 3 (S3) (Edwards Lifesciences, Irvine, CA) and CoreValve Evolut R (ER) (Medtronic, Dublin, IR) across five clinical endpoints. Utility scores from patient surveys and clinical outcomes from the literature were used to estimate quality-adjusted life years (QALYs) associated with successful procedure and postoperative complications for S3 and ER. A decision tree was constructed with rollback analysis to highlight the more cost-effective strategy. An incremental cost-utility ratio (ICUR) analysis was performed with a willingness to pay at $50,000. Deterministic and probabilistic sensitivity analyses were performed to validate robustness of results and account for uncertainty. S3 was found to be more costly ($68,377 vs. $66,072), but more effective (1.87 vs . 1.66) compared with ER. An ICUR of 11,288.12 favored S3, making it the more cost-effective option with a moderate confidence of 73.68% in Monte Carlo analysis. Cost-utility analysis can be used to aid in healthcare economics decision-making when selecting between comparable technologies used for TAVR procedures.

Abstract 14282: Outcomes Following Aortic Valve Replacement Among Kidney Transplant Recipients. A Systematic Review and Meta-Analysis

Introduction: While kidney transplant recipients (KTR) are high risk candidates for valve replacements, the safety of transcatheter aortic valve replacement (TAVR) is limited among this population as they are excluded from major trials. We aimed to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) among KTR by a systematic review and meta-analysis. Methods: We comprehensively searched PubMed, Embase, and Cochrane Library from its inception until April 20, 2022 for relevant studies. Outcomes were pooled using the DerSimonian and Laird random-effects model and reported as odd ratios (OR) or standardized mean difference (SMD) and 95% confidence intervals (CI). Results: 6 studies involving 5,452 patients (1,956 TAVR, 3,496 SAVR) were included in the analysis. TAVR patients were older (69.4 years vs 62.8 years), were less likely to be male (66.7% vs 67.9%) and had a higher prevalence of most comorbidities including coronary artery diseases (78% vs 58%), heart failure (71% vs 42%) and diabetes mellitus (52% vs 45%). Compared with SAVR, KTR undergoing TAVR had significantly lower risk of in-hospital all-cause mortality (OR 0.51, 95% CI: 0.39 to 0.67, p&lt;0.001), acute kidney injury (RR 0.49, 95% CI: 0.34 to 0.71, p&lt;0.001), blood transfusion (OR 0.29, 95% CI: 0.19 to 0.55, p&lt;0.001) and a shorter length of hospital stay (SMD -0.67, 95% CI: -1.10 to -0.24, p=0.002). In contrast, there was a higher need for permanent pacemaker implantation among the TAVR cohort compared to SAVR cohort (OR 3.44, 95% CI: 2.67-4.43, p&lt;0.001). Conclusions: TAVR appeared to be a safe alternative compared to SAVR in KTR, with a lower rate of short-term mortality, AKI and length of hospitalization but a higher rate of permanent pacemaker implantation. Further studies are encouraged to study the long-term outcomes among these patients.

Abstract 12859: Transcatheter Aortic Valve Implants Using Virtual Reality May Predict Paravalvular Leak in Bicuspid Severe Aortic Valve Stenosis

Introduction: Preoperative 3-dimensional (3D) planning in transcatheter aortic valve replacement (TAVR) has improved outcomes and reduced adverse events. Moderate and even mild paravalvular leak (PVL) is an important predictor of adverse events. PVL remains a challenge for TAVR in bicuspid severe aortic valve stenosis (AS). Here, we investigate virtual reality (VR) simulated TAVR implants in bicuspid severe AS to predict PVL. Hypothesis: VR TAVR simulation may predict PVL in bicuspid severe AS and allow for improved valve selection before TAVR procedures. Methods: Patients with bicuspid severe AS treated with TAVR between 2014 and 2018 were included. The aortic root, ascending aorta, and left ventricular outflow tract were reconstructed based on pre-operative computed tomography. A 3D TAVR valve was then inserted into the reconstructed root in VR. The primary endpoint was the percent circumference of valve malapposition in VR (Elucis, Realize Medical) as compared to the severity of PVL on postprocedure echocardiography. Results: 12 patients were included in this study. The mean age was 69.2 years ± 17 and 41.7% were female. 75% received a 26mm Sapien 3 valve (Edwards Lifesciences) and 25% had a 29 mm Evolut R CoreValve (Medtronic) implanted. Among patients who had no or trivial PVL (n=9), 7 patients had no malapposition on VR and 2 patients had less than 5% malapposition. Both patients with mild PVL had 10% malapposition. The only patient with moderate PVL had 25% malapposition (table 1, figure 1). There was 100% agreement between the VR simulated implants and post-procedure PVL measured by echocardiography. Conclusion: TAVR implantation in VR may predict PVL in bicuspid severe AS.

Trends in invasive treatment of patients hospitalized with aortic stenosis complicated by cardiogenic shock.

Before the development of transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV) was the only potential nonsurgical intervention for patients with aortic stenosis complicated by cardiogenic shock. Emergent TAVR is now an option and has shown acceptable outcomes compared with elective TAVR. We explored how treatment patterns for aortic stenosis and cardiogenic shock among patients received invasive intervention have shifted since TAVR was introduced. We used the Nationwide In patients Sample to identify nonelective hospitalizations for patient with aortic stenosis complicated by cardiogenic shock who received invasive treatment (TAVR, BAV, or surgical aortic valve replacement [SAVR]). We explored the proportion treated with each treatment modality over time, the patient characteristics and in-hospital mortality associated with each treatment, and used multivariable logistic regression to examine whether changes in in-hospital mortality over time differed by treatment. Between 2010 and 2019, we identified 9899 hospitalizations for decompensated aortic stenosis with cardiogenic shock during which patients received invasive treatment (TAVR 17.7%, BAV 20.2%, SAVR 62.1%). Use of both TAVR and BAV has increased over time compared with SAVR (TAVR 6.6% ≥ 33.8%, BAV 8.4% ≥ 23.2%, SAVR 91.6% ≥ 43.0%; p < 0.001 for trend). The overall in-hospital mortality rate was 21.0%, which decreased over time for all treatments (TAVR 20.0% ≥ 18.8%, BAV 66.0% ≥ 25.5%, SAVR 17.7% ≥ 11.8%; linear trend p < 0.001 for each), with lower mortality for TAVR versus BAV at all time points. Patients treated with TAVR (vs. BAV) were less likely to require mechanical ventilation (36.8% vs. 46.3%, p < 0.001) or mechanical circulatory support (22.5% vs. 29.9%, p < 0.001). In the multivariable analysis, the interaction between treatment and time was not significant (p = 0.245), indicating the reduction in in-hospital mortality over time did not differ among the treatments. Since the introduction of TAVR, there has been a shift toward increased use of nonsurgical invasive treatments (both BAV and TAVR) for aortic stenosis and cardiogenic shock. Although in-hospital mortality has declined, it remains high in all groups, but particularly among patients treated with BAV, where the severity of cardiogenic shock appears to be higher than in those treated with other modalities.

Cardiac Reoperations in Patients With Transcatheter Aortic Bioprosthesis

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), the frequency and clinical outcomes of reoperation after TAVR are not well-described. MethodsBetween 2011 and 2020, 1719 patients underwent a TAVR at our institution. Among these, 32 patients (2%) required a reoperation. Additionally, 16 patients who received a TAVR at another institution received a reoperation at our institution. We retrospectively reviewed these 48 patients. The median interval from TAVR to reoperation was 2.3 years. ResultsPrimary reoperations included 37 TAVR valve explants (TAVR-explant; 77%) with surgical aortic valve replacement (SAVR), 8 mitral repairs/replacements (17%), 2 coronary artery bypass grafting procedures (4%), and 1 tricuspid valve replacement (2%). Forty-nine percent of nonaortic valve cardiac lesions were present at the time of TAVR. Furthermore, 18 TAVR-explant patients (49%) were deemed anatomically unsuitable for repeat TAVR based on the index TAVR imaging. During TAVR-explant, 6 patients (13%) with native TAVR sustained various degrees of aortic trauma. Patients with unplanned aortic repair demonstrated a smaller sinotubular junction diameter than those without unplanned repair. In contrast, no unplanned aortic repair was needed in the 14 patients with previous SAVR or the latest 20 consecutive patients. The overall in-hospital mortality was 15%, with an observed-to-expected morality ratio of 1.8. ConclusionsThe clinical impact of post-TAVR reoperation remains substantial despite the lower frequency of unplanned aortic repair over time. The necessity of reoperations or unfavorable repeat TAVR anatomy appears predictable at the time of the index TAVR, and implanters must be mindful of “lifetime management” strategy during candidate selection.

Designing a Novel Asymmetric Transcatheter Aortic Valve for Stenotic Bicuspid Aortic Valves Using Patient-Specific Computational Modeling.

Bicuspid aortic valve (BAV), the most common congenital heart malformation, is characterized by the presence of only two valve leaflets with asymmetrical geometry, resulting in elliptical systolic opening. BAV often leads to early onset of calcific aortic stenosis (AS). Following the rapid expansion of transcatheter aortic valve replacement (TAVR), designed specifically for treating conventional tricuspid AS, BAV patients with AS were initially treated "off-label" with TAVR, which recently gained FDA and CE regulatory approval. Despite its increasing use in BAV, pathological BAV anatomy often leads to complications stemming from mismatched anatomical features. To mitigate these complications, a novel eccentric polymeric TAVR valve incorporating asymmetrical leaflets was designed specifically for BAV anatomies. Computational modeling was used to optimize its asymmetric leaflets for lower functional stresses and improved hemodynamic performance. Deployment and flow were simulated in patient-specific BAV models (n = 6) and compared to a current commercial TAVR valve (Evolut R 29mm), to assess deployment and flow parameters. The novel eccentric BAV-dedicated valve demonstrated significant improvements in peak systolic orifice area, along with lower jet velocity and wall shear stress (WSS). This feasibility study demonstrates the clinical potential of the first known BAV-dedicated TAVR design, which will foster advancement of patient-dedicated valvular devices.

Did ethno-racial disparities in access to transcatheter aortic valve replacement change over time?

ObjectiveIn this study we sought to evaluate whether disparate use of transcatheter aortic valve replacement (TAVR) among non-White patients has decreased over time, and if unequal access to TAVR is driven by unequal access to high-volume hospitals. MethodsFrom 2013 to 2017, we used the State Inpatient Database across 8 states (Ariz, Colo, Fla, Md, NC, NM, Nev, Wash) to identify 51,232 Medicare beneficiaries who underwent TAVR versus surgical aortic valve replacement. Hospitals were categorized as low- (<50 per year), medium- (50-100 per year), or high-volume (>100 per year) according to total valve procedures (TAVR + surgical aortic valve replacement). Multivariable logistic regression models with interactions were performed to determine the effect of race, time, and hospital volume on the utilization of TAVR. ResultsNon-White patients were less likely to receive TAVR than White patients (odds ratio [OR], 0.77; 95% CI, 0.71-0.83). However, utilization of TAVR increased over time (OR, 1.73; 95% CI, 1.73-1.80) for the total population, with non-White patients’ TAVR use growing faster than for White patients (OR, 1.06; 95% CI, 1.00-1.12), time × race interaction, P = .034. Further, an adjusted volume-stratified time trend analysis showed that utilization of TAVR at high volume hospitals increased faster for non-White patients versus White patients by 8.6% per year (OR, 1.09; 95% CI, 1.01-1.16) whereas use at low- and medium-volume hospitals did not contribute to any decreasing utilization gap. ConclusionsThis analysis shows initial low rates of TAVR utilization among non-White patients followed by accelerated use over time, relative to White patients. This narrowing gap was driven by increased TAVR utilization by non-White patients at high-volume hospitals.