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Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV). The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV. The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR. Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02). PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth. [Display omitted] [ABSTRACT FROM AUTHOR]

The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms. The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology. TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs. A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm3; 58.8-603.0 mm3), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14). TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification. [Display omitted] [ABSTRACT FROM AUTHOR]

Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P =.1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P =.07). In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (−52%; P = 0.001), Central-South America (−33%; P < 0.001), and Asia (−29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises. [Display omitted] [ABSTRACT FROM AUTHOR]

Preprocedural computed tomography (CT) workup with assessment of virtual transcatheter heart valve-to-coronary ostia (VTC) distance and transcatheter heart valve-to-sinus (VTS) distances is recommended to assess the risk of coronary obstruction following valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). The authors sought to investigate the agreement of predicted VTC and VTS distances and observed post-TAVR anatomy on CT and their relationship with transcatheter heart valve (THV) expansion and deployment conditions. Fifty-one patients who underwent a balloon-expandable ViV procedure were included in this study. The expansion of the THV stent frame was evaluated at 4 levels: THV inflow, surgical heart valve (SHV) sewing ring, SHV outflow, and THV outflow. Assessment of the VTC/VTS distances was performed on the pre-TAVR CT, and THV-to-coronary ostia and THV-to-sinus distances were assessed on the post-TAVR CT. Following the ViV procedure, the THV stent frame flared toward the outflow but was generally underexpanded at all levels, particularly at the SHV sewing ring level. Postdilatation impacted the extent of THV expansion, resulting in greater expansion than nominal balloon filling at all 4 THV levels (P < 0.001). Observed THV-to-coronary ostia distances were systematically larger than predicted by the VTC distance (mean difference 1.25 ±1.28 mm) in patients with nominal balloon filling but systematically smaller in case of postdilatation (mean difference −0.45 ± 0.52 mm). A similar relationship was observed between VTS and THV-to-sinus distance measurements. With nominal balloon filling, VTC and VTS distances underestimate postprocedural distances due to THV frame underexpansion. However, postdilatation may lead to distances smaller than predicted due to THV overexpansion at the outflow level. [Display omitted] [ABSTRACT FROM AUTHOR]

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There are limited data on the effect of bioprosthetic valve remodeling (BVR) on transcatheter heart valve (THV) expansion and function following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in a nonfracturable surgical heart valve (SHV). This study sought to assess the impact of BVR of nonfracturable SHVs on THVs after VIV implantation. VIV TAVR was performed using 23-mm SAPIEN3 (S3, Edwards Lifesciences) or 23/26-mm Evolut Pro (Medtronic) THVs implanted in 21/23-mm Trifecta (Abbott Structural Heart) and 21/23-mm Hancock (Medtronic) SHVs with BVR performed with a noncompliant TRUE balloon (Bard Peripheral Vascular Inc). Hydrodynamic assessment was performed, and multimodality imaging including micro–computed tomography was performed before and after BVR to assess THV and SHV expansion. BVR resulted in limited improvement of THV expansion. The largest gain in expansion was observed for the S3 in the 21-mm Trifecta with up to a 12.7% increase in expansion at the outflow of the valve. Minimal change was observed at the level of the sewing ring. The Hancock was less amenable to BVR with lower final expansion dimensions than the Trifecta. BVR also resulted in notable surgical post flaring of up to 17.6°, which was generally more marked with the S3 than with the Evolut Pro. Finally, BVR resulted in very limited improvement in hydrodynamic function. Severe pinwheeling was observed with the S3, which improved slightly but persisted despite BVR. When performing VIV TAVR inside a Trifecta and Hancock SHV, BVR had a limited impact on THV expansion and resulted in SHV post flaring with unknown consequences on coronary obstruction risk and long-term THV function. [Display omitted] [ABSTRACT FROM AUTHOR]

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The cusp-overlap (CO) technique has recently been advocated and is being increasingly adopted for self-expandable transcatheter heart valve (THV) implantation. The aim of this study was to evaluate the feasibility, implantation depth, and outcomes of the CO technique for the balloon-expandable SAPIEN 3 THV. The CO technique was used in consecutive patients undergoing balloon-expandable THV implantation at one center between April 2021 and March 2022. Optimal fluoroscopic angles were determined from preprocedural computed tomography and confirmed on predeployment angiography. The THV radiolucent line was positioned 2 to 4 mm below the noncoronary cusp in the CO view, and positioning was confirmed in the 3-cusp view. Postdeployment THV implantation depth was assessed in both views. One-month outcomes were assessed using Valve Academic Research Consortium 3 criteria. Among 137 patients eligible for the CO technique, the CO view was not used because of unfavorable ergonomics in 27 patients (26.5%) and hemodynamic instability in 8 patients (7.8%). Among 102 patients, the mean age was 81.1 ± 6.6 years, the mean Society of Thoracic Surgeons score was 3.3% ± 2.2%, and 64.7% were men. The mean measured THV implantation depth was 3.0 ± 1.4 mm in the CO view and 2.5 ± 1.4 mm in the 3-cusp view. At 1-month follow-up, 1 patient (1.0%) had died, 1 (1.0%) had had a stroke, and 7 (6.8%) had undergone permanent pacemaker implantation. The CO technique is feasible and safe and may facilitate more accurate balloon-expandable THV positioning, especially when deep implantation needs to be avoided. Further studies are required to explore potential reduction in atrioventricular conduction block, pacemakers, or paravalvular regurgitation. [Display omitted] [ABSTRACT FROM AUTHOR]

Coronary access may be challenging following transcatheter aortic valve replacement (TAVR) in the setting of transcatheter heart valve (THV) commissural misalignment. The authors aimed to quantify the degree of commissural alignment following balloon-expandable THV implantation using a fluoroscopy-based trigonometric approach and assess its correlation with post-TAVR computed tomography (CT). Twenty patients who had undergone both TAVR with the balloon-expandable SAPIEN 3 THV and post-TAVR CT were included in the analysis. Optimized, predeployment 3-cusp angiographic view and postdeployment angiographic view using identical fluoroscopic projections were required. The distance between the most central posterior commissural strut and the THV centerline was assessed. Commissural alignment was calculated by means of a trigonometrical approach using an arcsine function, assuming circular deployment of the THV. Commissural alignment was stratified using a 4-tier scale: aligned (0° to 15°); mildly misaligned (15° to 30°); moderately misaligned (30° to 45°), and severely misaligned (45° to 60°). Seven patients (35.0%) were misclassified by 1 tier, and no patient was misclassified by 2 or more tiers, with strong agreement between CT and fluoroscopy (weighted Cohen's kappa coefficient = 0.724). Correlation of the commissural offset angle determined from fluoroscopy and CT was excellent (r = 0.986; 95% CI: 0.965 to 0.995). Bland-Altman analysis demonstrated a strong agreement between both modalities with a mean difference of 0.5° (95% limits of agreement: −12.7° to 13.7°). The degree of commissural alignment of the balloon-expandable THV can be reliably assessed and quantified on postdeployment fluoroscopy using a standardized 3-cusp view and trigonometry-based analysis. [Display omitted] [ABSTRACT FROM AUTHOR]

Surgical aortic valve replacement can be performed through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI vs FS for isolated surgery among patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 3 low-risk trial. Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment. The primary outcome was the composite end point of death, stroke, or rehospitalization (valve-, procedure-, or heart failure-related) at 1 year. Secondary outcomes included the individual components of the primary end point as well as patient-reported health status at 30 days and 1 year. In the PARTNER 3 study, 358 patients underwent isolated valve replacement at 68 centers through an MI (n = 107) or FS (n = 251) approach (8 patients were converted from MI to FS). Mean age and Society of Thoracic Surgeons score were similar between groups. The Kaplan-Meier estimate of the primary outcome was similar in the MI vs FS groups (16.9% vs 14.9%; hazard ratio, 1.15; 95% CI, 0.66-2.03; P =.618). There were no significant differences in the 1-year rates of all-cause death (2.8% vs 2.8%), all stroke (1.9% vs 3.6%), or rehospitalization (13.3% vs 10.6%, P >.05 for all). Quality of life, as assessed by the Kansas City Cardiomyopathy Questionnaire score at 30 days or 1 year, was comparable in both groups. For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes. [ABSTRACT FROM AUTHOR]

Selection of the transcatheter heart valve size for a mitral valve-in-valve procedure is based on the type and manufacturer's labelled size. However, accurate information of surgical heart valve (SHV) size may not be available in the patient's medical record. The purpose of this study is to establish reference data for computed tomography (CT) dimensions of commonly used mitral SHV in order to determine the manufacturer's labelled size from a cardiac CT data set. CT datasets of 105 patients with surgical mitral bioprosthesis and available manufacturer labeled datasets were included in the analysis. CT derived valve dimensions were assessed by two observers using multiplanar reformats aligned with the basal sewing ring. A circular region of interest was used in a standardized fashion to minimize influence of image acquisition and reconstruction parameters. Interobserver variability was assessed by Bland-Altman analysis. The CT-derived dimensions were stratified by valve size and type, and SHV properties were demonstrated for 5 common valve types. Variability of measurements was small and inter-observer limits of agreement were narrow. Stratified by SHV type, no overlap was noted for CT-derived dimensions among different SHV sizes. A reference table of CT characteristics of surgical mitral bioprosthesis types was created. The study provides reference CT data for determining the manufacturers' labeled SHV size across a range of commonly used mitral SHVs. The findings will be important to help identify types of surgical mitral bioprosthesis utilizing CT characteristics for patients without SHV size documentation. Table of Contents Summary: With an increasing adoption of mitral vavle-in-valve procedures for patients with failed surgical mitral bioprosthetic valves, CT may be used for measurement of the surgical heart valve size if this data is not available from the patient's medical records. The aim of this study was to establish reference data for CT dimensions across commonly used mitral stented surgical heart valve types and sizes in order to determine the manufacturer's labelled size from cardiac CT data set. [ABSTRACT FROM AUTHOR]

Limited evidence is available regarding valve-in-valve (VIV) intervention with the ACURATE neo transcatheter heart valve (THV). Low implantation has demonstrated leaflet interaction between the surgical bioprosthesis and the THV, leading to impaired hydrodynamic performance. It is unknown if commissural alignment (CA) can affect this phenomenon. Novel techniques have now been developed to achieve CA with the ACURATE neo THV. The aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model. VIV intervention was performed with the ACURATE neo (a self-expanding THV with supra-annular leaflet position) implanted deep in the surgical bioprosthetic aortic valve (Mitroflow). Hydrodynamic function at CA (0°) and 3 different degrees of CMA (30°, 60°, and 90°) was tested. As per the International Organization for Standardization, a regurgitant fraction <20% is considered optimal. Following VIV, the central THV regurgitant fraction at 0°, 30°, 60°, and 90° of CMA was 8.6% ± 2.0%, 30.3% ± 12.0%, 42.6% ± 11.9%, and 66.7% ± 25.4% (P < 0.0001), respectively. On high-speed video there was no evidence of leaflet interaction at CA, whereas at 30°, 60°, and 90° of CMA there was clear evidence of THV leaflet interaction with those of the surgical valve, leading to impaired leaflet closure and to severe central THV regurgitation. In VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA. [Display omitted] [ABSTRACT FROM AUTHOR]

The implications and potential challenges of coronary access after redo transcatheter aortic valve replacement (TAVR) are unknown. The authors sought to evaluate the impact of different transcatheter heart valve (THV) designs, neoskirt height, implant technique, and cell misalignment on coronary access after redo TAVR. Different THV designs (Sapien 3 [Edwards Lifesciences LLC], Evolut Pro [Medtronic], ACURATE neo [Boston Scientific Corporation], and Portico [Abbott Structural Heart]) and sizes were implanted inside Sapien XT (Edwards Lifesciences LLC) and Evolut R (Medtronic) THVs, which were modeled as the "failed" THVs, at different implant depths. Valve combinations underwent micro–computed tomography to determine the neoskirt height and dimensions of the lowest accessible cell for potential coronary access. This was compared with dimensions of 6-F/7-F/8-F coronary guiding catheters. Redo TAVR combinations resulted in a wide range of neoskirt heights (15.4-31.6 mm) and a variable diameter of the lowest accessible cell (1.9-21.8 mm). An ACURATE neo implanted in a Sapien XT resulted in the largest accessible cells, whereas a Portico implanted in a Sapien XT resulted in the lowest neoskirt heights. The smallest accessible cell was observed in the Evolut Pro–in–Evolut R configuration with higher neoskirt heights. Redo TAVR in a tall frame valve with supra-annular leaflets caused a taller neoskirt height. In Evolut-in-Evolut combinations, misalignment of the cells of the 2 THVs reduced the cell area by 30% to 50% compared with an aligned configuration. This study demonstrates that different redo TAVR combinations are not equivalent in terms of future coronary access. Redo TAVR using a tall frame valve in a failed tall frame valve and misaligned cells may lead to potentially challenging coronary access. [Display omitted] [ABSTRACT FROM AUTHOR]

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The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR). Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population. Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events. At baseline, all patients (age: 77 ± 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% ± 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation. In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy. [Display omitted] [ABSTRACT FROM AUTHOR]

The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis. [Display omitted] [ABSTRACT FROM AUTHOR]

This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV. Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs. An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard. The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm. Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement. [Display omitted] [ABSTRACT FROM AUTHOR]

The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses. [Display omitted] [ABSTRACT FROM AUTHOR]

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is approved by the FDA in patients at high surgical risk and increasingly utilized by heart teams as an alternative to reoperation for failing surgical tissue valves. Optimizing transcatheter heart valve (THV) expansion and decreasing the risk of patient-prosthesis mismatch are important concerns when performing VIV TAVR, particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) are techniques to facilitate VIV TAVR in which a high-pressure inflation with a non-compliant balloon is performed to either fracture or stretch the surgical valve ring allowing for a more optimal expansion of the THV and reducing the potential for high residual transvalvular gradients. This article, along with the supplemental video, will provide a practical guide to performing BVF and BVR. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR. In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter. Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality. In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality. [Display omitted] [ABSTRACT FROM AUTHOR]

BACKGROUND: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate- and low-surgical risk. METHODS: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. RESULTS: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P<0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P<0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. CONCLUSIONS: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. [ABSTRACT FROM AUTHOR]

Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction). Eccentricity of the coronary ostia in relation to coronary cusps of native and valve-in-valve transcatheter aortic valve replacement (TAVR) was not well described before. A total of 121 pre-TAVR patients' CT data (72 native valves TAVR and 49 bioprosthetic surgical valves TAVR) was included and coronary ostial eccentricity angles were measured and compared. Coronary ostial angles were measured between mid-cusp line to coronary ostium in CT perpendicular images. In the overall cohort, the right coronary artery (RCA) had an eccentric origin in the majority of cases, favoring the commissure between the right and the non coronary cusp (17.0°, IQR; 10–25). On the other hand, the left coronary artery (LCA) originated most commonly near center of the cusp position (0°, IQR; -8 -7.5) In comparison of native and bioprosthetic valves, RCA ostial angles were more eccentric in native valves (19.0°, IQR; 12–26) than in bioprosthetic valves (14.0°, IQR; 3–20) (p = 0.004). Whereas, LCA ostial angle has no significant differences between native valves (−2.0°, IQR;-7.75-5.75) and bioprosthetic valves (1°, IQR;-8-13), (p = 0.6). RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate near the center of the cusp. This finding may contribute to better performance of BASILICA procedures. Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA. This report highlights the distribution of eccentric coronary ostia which showed that RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate in the center of the cusp. This finding may contribute to better performance of BASILICA procedures. [ABSTRACT FROM AUTHOR]

CT measurement of supra-annular area (SA) has been proposed as an alternative to annular area (AA) for sizing of trancatheter valves in biscuspid aortic valves (BAV). This study examines the reproducibility of SA and AA measurements and their potential impact on downstream transcatheter heart valve sizing and clinical outcomes. 44 consecutive patients (mean age: 73 ± 15 years, 57% male) undergoing CTA with subsequent SAPIEN 3 valve insertion for severe bicuspid aortic stenosis (AS) were included. AA was measured at the basal ring. SA was measured by generating a circle defined by the intercommisural distance. AA and SA were measured by 2 independent observers. Baseline characteristics, TAVR procedural data, and discharge echocardiography data were collected. The SA was significantly larger than the AA (562 ± 146mm2 vs. 518 ± 112mm2,p = 0.013). Interobserver agreement was high using both techniques (ICC AA = 0.98,p < 0.001; SA = 0.80,p < 0.001), but with narrower limits of agreement with AA measurements (mean difference (limits of agreement): AA = −3mm2 (22; 19), SA = −16mm2 (−92; 76)). AA-based device sizing demonstrated substantial agreement with final valve inserted (κ = 0.72,p < 0.001), while SA demonstrated fair agreement (κ = 0.40,p < 0.001). There was no difference in post TAVR gradients, paravalvular leakage or valve success between patients with concordant sizing between AA and SA, and those in whom SA would have suggested an alternate valve size. Supra-annular sizing is less reproducible than annular sizing, with no difference in procedural complication rates in patients in whom supra-annular sizing would have altered the device size used. These results suggest no role for supra-annular sizing in current clinical practice. [ABSTRACT FROM AUTHOR]

Bicuspid aortic valve (BAV) is the most common congenital cardiac abnormality in adults, and symptoms typically develops in adulthood. In the majority of cases, BAV disease progresses with age and surgical aortic valve replacement (AVR) is performed with excellent operative outcomes. Based on a series of randomized trials, transcatheter AVR (TAVR) has evolved from a novel technology to an established therapy for patients with symptomatic severe aortic stenosis (AS) regardless of risk profile. Despite exclusion of bicuspid anatomy from the randomized trials, an increasing number of patients with BAV-AS have been treated with TAVR. Recent observational studies showed the comparable outcomes of TAVR between bicuspid and tricuspid AS. However, worse outcomes in patients with unfavorable bicuspid anatomy such as calcified raphe plus excessive leaflet calcification have raised concerns for TAVR in younger and lower risk population. For the further expansion of TAVR toward BAV-AS population, we need randomized trials of TAVR in this population. Until then, previous registry data combined with computed tomographic-based anatomical assessment may guide the optimal therapy in patients with bicuspid anatomy. [ABSTRACT FROM AUTHOR]

This study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. The long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance. SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. THV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. Nominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5 years wear. [ABSTRACT FROM AUTHOR]