Contemporary Transcatheter Aortic Valve Replacement Research Articles

Incidencia, predictores e impacto pronóstico de una clase funcional disminuida inmediatamente después de un implante percutáneo de válvula aórtica

Introduction and objectivesThere are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR. MethodsThis multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis. ResultsThe mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up. ConclusionsUp to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed.

Impact of sex on Transcatheter aortic valve replacement outcomes: Results of a single-center study

BackgroundEarly studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known. MethodsRetrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences. Results927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20–26 mm: 78.0% vs 32.9%; 29–34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality. ConclusionOur data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities.

Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors

BackgroundBleeding is one of the most frequent complications in patients undergoing transcatheter aortic valve replacement (TAVR). Importantly, major bleeding is associated with poor clinical outcomes after TAVR. However, large studies on bleeding complications in the contemporary TAVR population are limited. ObjectivesThe aim of this study was to assess the incidence, temporal trends, clinical outcomes, and predictors of bleeding in patients undergoing transfemoral TAVR. MethodsThe CENTER2 study is a pooled patient-level database from 10 clinical studies including patients who underwent TAVR between 2007 and 2022. ResultsA total of 23,562 patients underwent transfemoral TAVR. The mean age was 81.5 ± 6.7 years, and 56% were women. Major bleeding within the first 30 days was observed in 1,545 patients (6.6%). Minor bleeding was reported in 1,143 patients (4.7%). Rates of major bleeding decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022 (Ptrend < 0.001). Dual antiplatelet therapy was associated with higher major bleeding rates compared with single antiplatelet therapy (12.2% vs 9.1%; OR: 1.40; 95% CI: 1.13-1.72; P = 0.002). Patients with major bleeding had increased mortality risk during the first 30 days (14.1% vs 4.3%; OR: 3.66; 95% CI: 3.11-4.31; P < 0.001) and during 1-year follow-up (27.8% vs 14.5%; HR: 1.50; 95% CI: 1.41-1.59; P < 0.001). Minor bleeding did not affect 1-year mortality risk (16.7% vs 14.5%; HR: 1.11; 95% CI: 0.93-1.32; P = 0.27). Predictors of major bleeding were female sex and peripheral vascular disease. ConclusionsBleeding complications remain frequent and important in patients undergoing transfemoral TAVR. Increased mortality risk in major bleeding persists after the initial 30 days. (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves [CENTER]; NCT03588247)

Incidence, predictors, and prognostic significance of impaired functional status early after transcatheter aortic valve replacement

Introduction and objectivesThere are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR. MethodsThis multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis. ResultsThe mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up. ConclusionsUp to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed.

Prevalence of ATTR-CA and high-risk features to guide testing in patients referred for TAVR.

Transthyretin cardiac amyloidosis (ATTR-CA) is thought to be prevalent in patients with severe aortic stenosis (AS) who are referred for transcatheter aortic valve replacement (TAVR). However, prior studies were published when TAVR was only offered to elderly, inoperable, and high-risk patients. The aim of this study was to reevaluate the prevalence of ATTR-CA in a contemporary TAVR population and identify high-risk features to guide referral for technetium-99 pyrophosphate scan (99mTc-PyP scan) screening. Patients seen in a multidisciplinary TAVR clinic for severe AS 70years and older were referred for a 99mTc-PyP scan to evaluate for ATTR-CA. The primary outcome was the percent with a positive scan. The discriminatory ability of high-risk features was assessed to develop a more judicious screening system. Over the study period, 380 patients underwent screening, and 20 patients (5.3%) had a positive scan, with 17 patients having confirmed ATTR-CA, 1 patient deferring confirmatory testing (combined 4.7%), 1 having light chain amyloidosis, and 1 negative on biopsy. Compared to other patient and echocardiographic measures, elevated NT-pro BNP (> 1000ng/L) was the best discriminator on who should be referred for 99mTc-PyP scan screening, with a sensitivity of 90% and a negative predictive value of 99%. The prevalence of ATTR-CA may be lower in a contemporary TAVR population due to its expanded indication for low-risk patients. NT-pro BNP is a simple test that can improve screening yield and more judiciously guide screening for ATTR-CA in this at-risk population. Comparison of the original versus the proposed algorithm.

The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets.

Leaflet durability and costs restrict contemporary trans-catheter aortic valve replacement (TAVR) largely to elderly patients in affluent countries. TAVR that are easily deployable, avoid secondary procedures and are also suitable for younger patients and non-calcific aortic regurgitation (AR) would significantly expand their global reach. Recognizing the reduced need for post-implantation pacemakers in balloon-expandable (BE) TAVR and the recent advances with potentially superior leaflet materials, a trans-catheter BE-system was developed that allows tactile, non-occlusive deployment without rapid pacing, direct attachment of both bioprosthetic and polymer leaflets onto a shape-stabilized scallop and anchorage achieved by plastic deformation even in the absence of calcification. Three sizes were developed from nickel-cobalt-chromium MP35N alloy tubes: Small/23 mm, Medium/26 mm and Large/29 mm. Crimp-diameters of valves with both bioprosthetic (sandwich-crosslinked decellularized pericardium) and polymer leaflets (triblock polyurethane combining siloxane and carbonate segments) match those of modern clinically used BE TAVR. Balloon expansion favors the wing-structures of the stent thereby creating supra-annular anchors whose diameter exceeds the outer diameter at the waist level by a quarter. In the pulse duplicator, polymer and bioprosthetic TAVR showed equivalent fluid dynamics with excellent EOA, pressure gradients and regurgitation volumes. Post-deployment fatigue resistance surpassed ISO requirements. The radial force of the helical deployment balloon at different filling pressures resulted in a fully developed anchorage profile of the valves from two thirds of their maximum deployment diameter onwards. By combining a unique balloon-expandable TAVR system that also caters for non-calcific AR with polymer leaflets, a powerful, potentially disruptive technology for heart valve disease has been incorporated into a TAVR that addresses global needs. While fulfilling key prerequisites for expanding the scope of TAVR to the vast number of patients of low- to middle income countries living with rheumatic heart disease the system may eventually also bring hope to patients of high-income countries presently excluded from TAVR for being too young.

Baseline mean platelet volume is a strong predictor of major and life-threatening bleedings after transcatheter aortic valve replacement

Bleeding following transcatheter aortic valve replacement (TAVR) has important prognostic implications. This study sought to evaluate the impact of baseline mean platelet volume (MPV), a routinely used marker of platelet reactivity, on bleeding events in a contemporary real-world TAVR cohort. Patients undergoing TAVR between February 2010 and May 2019 with available preprocedural MPV were included. Low MPV (L-MPV) was defined as MPV ≤ 10 fL and high MPV (H-MPV) as MPV > 10 fL. The primary endpoint was the occurrence of major/life-threatening bleeding complications (MLBCs) at one year follow-up. Among 1,111 patients, 398 (35.8%) had L-MPV and 713 (64.2%) had H-MPV. The rate of MLBCs at 1 year was higher in L-MPV patients compared with H-MPV patients (22.9% vs. 17.7% respectively, P = 0.034). L-MPV was associated with vascular access-site complications (36.2% vs. 28.9%, P = 0.012), early (< 30 days) major bleeding (15.6% vs. 9.4%, P < 0.01) and red blood cell transfusion > 2 units (23.9% vs. 17.5%, P = 0.01). No impact of baseline MPV on overall death, cardiovascular death and ischemic events (myocardial infarction and stroke) was evidenced. Multivariate analysis using Fine and Gray model identified preprocedural hemoglobin (sHR 0.84, CI95% [0.75–0.93], P = 0.001), preprocedural L-MPV (sHR 1.64, CI95% [1.16–2.32], P = 0.005) and CT-ADP post-TAVR (sHR 2.71, CI95% [1.87–3.94], P < 0.001) as predictors of MLBCs (Fig. 1, Table 1). Preprocedural MPV was identified as an independent predictor of MLBCs one year after TAVR, regardless of the extent of platelet inhibition and primary hemostasis disorders. MPV should be regarded as a simple, common and valuable biomarker of bleeding prediction after TAVR.

Abstract 13118: Sex Disparities in Hemodynamics and Outcomes Among Women Undergoing Contemporary Transcatheter Aortic Valve Replacement

Introduction: Several studies have demonstrated worse outcomes following transcatheter aortic valve replacement (TAVR) in women compared to men using early transcatheter heart valves (THV). Different THV designs impact hemodynamics in patients with small annuli and women constitute the majority of these patients. Hypothesis: We hypothesized that women represent the majority of patients with small annuli resulting in worse hemodynamics. Methods: We examined patients with symptomatic severe aortic stenosis who underwent TAVR using contemporary THVs across all surgical risk categories. We compared baseline characteristics, procedural details, in-hospital outcomes, and hemodynamics (30-day) according to sex. We then performed a secondary analysis focusing on the female patients, dichotomizing them based on aortic annular area above or below 430mm 2 . Results: Included were a total of 869 patients who underwent TAVR using a contemporary THV. The majority of patients with an annular area &lt;430mm 2 were female (82.5%) and most with an annular area &gt;430mm 2 were male (76.8%). Females saw a trend towards higher 30-day (1.5% vs. 0.6%; p=0.313) and 1-year (4.1% vs. 2.7%; p=0.265) mortality. Females with an annular area &lt;430mm 2 who received an self-expanding THV saw lower mean gradients at 30 days compared to those who received a balloon-expandable THV (8.0mmHg vs. 13.8mmHg; p&lt;0.001) which resulted in lower rates of moderate patient prosthesis mismatch (PPM) (21.2% vs. 73.6%; p&lt;0.001). A similar trend was seen in females with an annular area &gt;430mm 2 who received a self-expanding THV (9.3mmHg vs. 11.5mmHg; p&lt;0.001) which resulted in lower rates of moderate PPM as well (24.5% vs. 59.2%; p&lt;0.001). Conversely, female patients who received a self-expanding THV saw higher rates of permanent pacemaker implantation regardless of annular size. Conclusions: Female patients undergoing contemporary TAVR saw numerically higher short-term mortality which could be, a result of higher rates of PPM. These findings were more pronounced in the subset of females with small aortic annuli, where those who received a self-expanding THV demonstrated superior hemodynamics but at the cost of increased rates of permanent pacemaker implantation.

Abstract 13120: Short-Term Outcomes of Transcatheter Aortic Valve Replacement in Very Low Gradient Severe Aortic Stenosis

Introduction: Hemodynamic improvements following transcatheter aortic valve replacement (TAVR) have been show to correlate with outcomes. TAVR in patients with severe aortic stenosis (AS) and low mean gradients (MG) (&lt;40mmHg) have demonstrated significant improvements in their MG post-TAVR. However, data on low, intermediate and high-risk patients with severe AS and very low MGs (&lt;20mmHg) are lacking. Hypothesis: We hypothesized that patients with very low gradient severe AS see smaller improvements in MG but similar outcomes following TAVR using contemporary transcatheter heart valves (THV). Methods: This was a retrospective, observational study of 1114 low-, intermediate- or high-risk patients who underwent TAVR at our institution between 2015-2020. We trichotomized our population based on their pre-TAVR MG (cohort 1 (n=71): &lt;20mmHg, cohort 2 (n=506): 20-39mmHg, cohort 3 (n=537): &gt;40mmHg). We examined pre-TAVR and post-TAVR echocardiographic data. We examined in-hospital, 30-day and 1-year outcomes. Statistical analysis of outcomes was performed using two-sided t-test and one-way ANOVA. Results: Among the 1114 who underwent TAVR, 776 utilized the SAPIEN 3 or SAPIEN 3 Ultra THV and 338 utilized the CoreValve Evolut PRO THV. The patients had a mean age of 80.9 years with a mean Society of Thoracic Surgeons score of 6.4%. Patients in cohort 1 (15.4mmHg to 8.4mmHg, p&lt;0.0001), cohort 2 (30.3mmHg to 9.6mmHg, p&lt;0.0001) and cohort 3 (53.4mmHg to 11.6mmHg, p&lt;0.0001) all saw significant improvement in their MG post-TAVR. Patients saw similar rates of death and stroke out to 1 year (Table 1). Conclusions: Our study of 1114 low-, intermediate- and high-risk patients who underwent contemporary TAVR demonstrated significant improvements in post-TAVR MGs across all variants of severe AS which translated to excellent short-term outcomes.

Trends in the use of mechanical and bioprosthetic aortic valve replacement in the era of transcatheter aortic valve replacement

Abstract Background The choice between a mechanical versus a bioprosthetic valve in aortic valve replacement (AVR) is based on life expectancy, bleeding risk and co-morbidities, since bioprosthetic AVR (bAVR) as compared to mechanical AVR (mAVR), are associated with a more rapid structural deterioration. However, refinements in bioprosthetic valves and the introduction of transcatheter aortic valve replacement (TAVR) (potential for valve-in-valve procedures), will most likely influence valve selection in the future. The impact of widespread transcatheter valve replacements, on the decision to use bAVR versus mAVR, in the contemporary era and subsequent outcomes remain to be determined. Purpose The goal of our study was to assess trends in utilization of bAVR and mAVR in the United States while, assessing in-hospital mortality over time. Methods The National Inpatient database (2009–18) was used to study trends in admissions for bAVR and mAVR and in-hospital mortality over time. Survey estimation commands were used to determine weighted national estimates. Results There were 700,896 inpatient visits for AVR with 70.1% (95% CI 69.2%-71.1%) and 29.9% (95% CI 28.9%-30.8%) visits for bAVR and mAVR, respectively. Those undergoing bAVR were significantly older, [bAVR (69.8 years) vs mAVR (62.7 years) p&amp;lt;0.001]. Heart failure, cardiac arrhythmias, hypertension, diabetes with complications and renal failure were more common in those undergoing a bAVR. Through the course of the study period, the rates of mAVR decreased across all age groups (p trend &amp;lt;0.001), including patients younger than 50 years (p trend &amp;lt;0.001). Both crude (OR = 1.20 95% CI 1.13–1.27) and adjusted (OR = 1.34 95% CI 1.25–1.44) inpatient mortality was higher amongst mAVR recipients. Conclusions In the contemporary TAVR era, the utilization of mAVR has decreased across all age groups, including those younger than 50 years old. Although mAVR recipients were healthier with significantly less co-morbidities, inpatient mortality was higher after mAVR compared to bAVR. In addition to understanding the causes accounting for the higher mortality after mAVR, future research should focus on developing TAVR friendly bAVR; possibly enhancing our ability to perform percutaneous valve-in-valve procedures in the future. Funding Acknowledgement Type of funding sources: None.

Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial)

The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.

Optimal Valve Selection in Contemporary Transcatheter Aortic Valve Replacement for Women with Small Aortic Annuli

Quinolinic acid (QUIN) is a neuroactive metabolite of the kinurenine pathway, considered to be involved in aging and some neurodegenerative disorders, including Huntington׳s disease. In the present work we have studied the long-lasting effect of acute intrastriatal injection of QUIN (150 nmol/0.5 µL) in 30 day-old rats on the phosphorylating system associated with the astrocytic and neuronal intermediate filament (IF) proteins: glial fibrillary acidic protein (GFAP), and neurofilament (NF) subunits (NFL, NFM and NFH) respectively, until 21 days after injection. The acute administration of QUIN altered the homeostasis of IF phosphorylation in a selective manner, progressing from striatum to cerebral cortex and hippocampus. Twenty four hours after QUIN injection, the IFs were hyperphosphorylated in the striatum. This effect progressed to cerebral cortex causing hypophosphorylation at day 14 and appeared in the hippocampus as hyperphosphorylation at day 21 after QUIN infusion. PKA and PKCaMII have been activated in striatum and hippocampus, since Ser55 and Ser57 in NFL head domain were hyperphosphorylated. However, MAPKs (Erk1/2, JNK and p38MAPK) were hyperphosphorylated/activated only in the hippocampus, suggesting different signaling mechanisms in these two brain structures during the first weeks after QUIN infusion. Also, protein phosphatase 1 (PP1) and 2B (PP2B)-mediated hypophosphorylation of the IF proteins in the cerebral cortex 14 after QUIN injection reinforce the selective signaling mechanisms in different brain structures. Increased GFAP immunocontent in the striatum and cerebral cortex 24 h and 14 days after QUIN injection respectively, suggests reactive astrocytes in these brain regions. We propose that disruption of cytoskeletal homeostasis in neural cells takes part of the long-lasting molecular mechanisms of QUIN toxicity in adolescent rats, showing selective and progressive misregulation of the signaling mechanisms targeting the IF proteins in the striatum, cerebral cortex and hippocampus with important implications for brain function.

Aortic Angulation Does Not Influence Outcomes in Contemporary Transcatheter Aortic Valve Replacement

Aortic Angulation Does Not Influence Outcomes in Contemporary Transcatheter Aortic Valve Replacement

The Impact of Aortic Angulation on Contemporary Transcatheter Aortic Valve Replacement Outcomes.

The aim of this study was to investigate whether the degree of aortic angulation (AA) affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation transcatheter heart valves (THVs). AA≥48° has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with early generation self-expanding (SE) THVs. A retrospective observational study was conducted among 841 patients across all risk strata who underwent transfemoral TAVR using the balloon-expandable (BE) SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020. The previously published cutoff of 48° was used to analyze procedural success and in-hospital outcomes according to THV type. Receiver-operating characteristic analysis was performed to investigate the impact of AA on an in-hospital composite outcome (need for >1 THV, more than mild PVL, new permanent pacemaker implantation, stroke, and death). AA≥48° did not influence outcomes in patients with BE THVs. Additionally, AA≥48° did not influence procedural success (99.1% vs. 99.1%; p=0.980), number of THVs used (1.02 vs. 1.04; p=0.484), rates of more than mild PVL (0.4% vs. 0%; p=0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p=0.178), in-hospital stroke (3.9% vs. 1.8%; p=0.298), or in-hospital death (0.4% vs. 0.9%; p=0.980) in patients with SE THVs. Receiver-operating characteristic analysis demonstrated similar outcomes irrespective of AA, with areas under the curve of 0.5525 for SE THVs and 0.5115 for BE THVs. AA no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice. AA≥48° did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection.

Validation of the 2019 Expert Consensus Algorithm for the Management of Conduction Disturbances After TAVR.

The aim of this study was to validate the 2019 consensus algorithm in a large cohort of contemporary transcatheter aortic valve replacement (TAVR) patients. The optimal management of patients with atrioventricular conduction disturbances after TAVR is unknown. Guidance was consolidated in an expert consensus algorithm in2019. In a retrospective analysis of a prospective registry, patients were classified according to the 2019 consensus algorithm as eligible for early discharge (day 1 or 2 after TAVR), higher risk for high-degree atrioventricular block (HAVB) or complete heart block (CHB) or in need for a permanent pacemaker (PPM). The primary endpoint was the incidence of PPM implantation for HAVB or CHB within 30days after TAVR. Patients with prior PPM or implantable cardioverter-defibrillator implantation, valve-in-valve procedures, or incomplete electrocardiographic data were excluded. Among 1,439 patients undergoing TAVR between January 2014 and December 2019, the 2019 consensus algorithm classified 73% as eligible for early discharge, 21% as at higher risk for HAVB or CHB, and 6% as in need of PPM. PPM implantation for HAVB or CHB occurred in 234 patients (16%) within 30days after TAVR. The incidence of PPM implantation was 2.7% in the early discharge group, 41% in the group with higher risk for HAVB or CHB, and 100% in the PPM group. The 2019 consensus algorithm safely identifies patients with no need for PPM implantation. This strategy allows more uniform management of TAVR patients and facilitates early discharge of low-risk patients without prolonged monitoring in 3 of 4 patients. However, the algorithm is less precise in the identification of high-risk patients.

Short-Term Outcomes of Transcatheter Versus Isolated Surgical Aortic Valve Replacement for Mediastinal Radiation-Associated Severe Aortic Stenosis.

Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population. We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons' database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011-2014) versus contemporary (2015-2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared. In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR]TAVR/SAVR=0.60 [0.40-0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; ORTAVR/SAVR, 2.03 [1.09-3.77]) and pacemaker implantation (ORTAVR/SAVR, 1.62 [1.21-2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OREarly, 0.78 [0.48-1.28]; ORContemporary, 0.31 [0.14-0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OREarly, 1.60 [1.03-2.46]; ORContemporary, 1.64 [1.10-2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OREarly, 1.39 [0.58-3.36]; ORContemporary, 2.46 [0.99-6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (ORStroke/TIA, 1.57 [0.79-3.09]). TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.

Utility of Routine Invasive Coronary Angiography Prior to Transcatheter Aortic Valve Replacement

Background/purposeDespite the high prevalence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS), the optimal management of concomitant CAD, including revascularization before transcatheter aortic valve replacement (TAVR), remains controversial. Contemporary, real-world practice patterns have not yet been described. We aimed to characterize the burden of CAD in contemporary TAVR patients and evaluate revascularization practices at a high-volume center. Methods/materialsWe retrospectively analyzed all adult patients referred for TAVR at our center between January 2019 and January 2020. Presence of significant CAD and subsequent management were recorded. Presenting symptoms, use of non-invasive and invasive ischemia testing, and pre-TAVR computed tomography (CT) imaging were analyzed. ResultsA total of 394 patients with severe AS were referred for TAVR. Thirty-nine patients (9.9%) instead underwent surgery, of whom only 5 (1.3%) received coronary artery bypass grafting. Of the remaining 355 patients, 218 patients (61.4%) had insignificant CAD. Of the 137 patients (38.6%) with significant CAD, only 30 (8.5%) underwent percutaneous coronary intervention (PCI). Of these, less than half had anginal symptoms, a third had CAD in proximal segments, and a third underwent ischemia testing before PCI. Pre-TAVR CT accurately identified significant CAD in 28/30 patients (93.3%) who underwent PCI. ConclusionsOnly 1 in 25 contemporary TAVR patients had significant CAD and angina requiring intervention, calling into question the utility of routine invasive coronary angiography before TAVR. A Heart Team approach integrating anginal symptoms, ischemia testing and possibly pre-TAVR CT is needed to guide the need, timing, and strategy of revascularization.

Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial

The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.

Over 15 years: the advancement of transcatheter aortic valve replacement.

The management of aortic stenosis has been revolutionized by transcatheter aortic valve replacement (TAVR). Initially only undertaken in patients at prohibitive or high surgical risk, as the evidence base and indications have expanded, TAVR is now approved and undertaken in patients at all risk levels. Evolution of valve technology, delivery systems and pathways for patient work-up have been rapid, with associated reductions in the complication profile, particularly vascular complications. Challenges remain as TAVR continues to advance, however, specifically achieving further reduction in paravalvular regurgitation, the requirement for permanent pacemaker implantation, and balancing the risks of thrombosis and bleeding. In this review, we outline the historical advances leading to contemporary TAVR practice, and discuss the future trajectory.

The utility of the nationwide readmissions database in understanding contemporary transcatheter aortic valve replacement outcomes.

The utility of the nationwide readmissions database in understanding contemporary transcatheter aortic valve replacement outcomes.