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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]

Our objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials. Surgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm2/m2) or severe (indexed effective orifice area ≤0.65 cm2/m2). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years. By the predicted PPM method (PPM P), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPM M), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPM P (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P =.03) or severe PPM P (38.8%, P =.02). Using the PPM M method, there was no difference between the no (17.7%) and moderate PPM M groups (21.1%) in the primary outcome (P =.16). However, those with no PPM M or moderate PPM M were improved compared with severe PPM M (27.4%, P <.001 and P =.02, respectively). Severe PPM analyzed by PPM P was only 2.1% for surgical aortic valve replacement patients. The PPM M method overestimated the incidence of severe PPM relative to PPM P , but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical. [ABSTRACT FROM AUTHOR]

With growing adoption of coronary computed tomographic angiography (CTA), there is increasing evidence for and interest in the prognostic importance of atherosclerotic plaque volume. Manual tools for plaque segmentation are cumbersome, and their routine implementation in clinical practice is limited. The aim of this study was to develop nomographic quantitative plaque values from a large consecutive multicenter cohort using coronary CTA. Quantitative assessment of total atherosclerotic plaque and plaque subtype volumes was performed in patients undergoing clinically indicated coronary CTA, using an Artificial Intelligence–Enabled Quantitative Coronary Plaque Analysis tool. A total of 11,808 patients were included in the analysis; their mean age was 62.7 ± 12.2 years, and 5,423 (45.9%) were women. The median total plaque volume was 223 mm3 (IQR: 29-614 mm3) and was significantly higher in male participants (360 mm3; IQR: 78-805 mm3) compared with female participants (108 mm3; IQR: 10-388 mm3) (P < 0.0001). Total plaque increased with age in both male and female patients. Younger patients exhibited a higher prevalence of noncalcified plaque. The distribution of total plaque volume and its components was reported in every decile by age group and sex. The authors developed pragmatic age- and sex-stratified percentile nomograms for atherosclerotic plaque measures using findings from coronary CTA. The impact of age and sex on total plaque and its components should be considered in the risk-benefit analysis when treating patients. Artificial Intelligence–Enabled Quantitative Coronary Plaque Analysis work flows could provide context to better interpret coronary computed tomographic angiographic measures and could be integrated into clinical decision making. [Display omitted] [ABSTRACT FROM AUTHOR]

Mitral annular calcium (MAC) with severe mitral valvular dysfunction presents a complex problem, as valve replacement, either surgical or transcatheter, is challenging because of anatomy, technical considerations, concomitant comorbidities, and advanced age. The authors review the clinical and anatomical features of MAC that are favorable (green light), challenging (yellow light), or prohibitive (red light) for surgical or transcatheter mitral valve interventions. Under the auspices of the Heart Valve Collaboratory, an expert working group of cardiac surgeons, interventional cardiologists, and interventional imaging cardiologists was formed to develop recommendations regarding treatment options for patients with MAC as well as a proposed grading and staging system using both anatomical and clinical features. [Display omitted] • TMVR is emerging as an alternative for high-risk patients with MAC. • Surgical risk and anatomical features are important considerations in device choice. • MAC classification can improve patient selection and procedural outcomes. [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]

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]

With growing adoption of coronary computed tomographic angiography (CTA), there is increasing evidence for and interest in the prognostic importance of atherosclerotic plaque volume. Manual tools for plaque segmentation are cumbersome, and their routine implementation in clinical practice is limited. The aim of this study was to develop nomographic quantitative plaque values from a large consecutive multicenter cohort using coronary CTA. Quantitative assessment of total atherosclerotic plaque and plaque subtype volumes was performed in patients undergoing clinically indicated coronary CTA, using an Artificial Intelligence-Enabled Quantitative Coronary Plaque Analysis tool. A total of 11,808 patients were included in the analysis; their mean age was 62.7±12.2 years, and 5,423 (45.9%) were women. The median total plaque volume was 223 mm3 (IQR: 29-614 mm3) and was significantly higher in male participants (360 mm3; IQR: 78-805 mm3) compared with female participants (108 mm3; IQR: 10-388 mm3)(P < 0.0001). Total plaque increased with age in both male and female patients. Younger patients exhibited a higher prevalence of noncalcified plaque. The distribution of total plaque volume and its components was reported in every decile by age group and sex. The authors developed pragmatic age- and sex-stratified percentile nomograms for atherosclerotic plaque measures using findings from coronary CTA. The impact of age and sex on total plaque and its components should be considered in the risk-benefit analysis when treating patients. Artificial Intelligence-Enabled Quantitative Coronary Plaque Analysis work flows could provide context to better interpret coronary computed tomographic angiographic measures and could be integrated into clinical decision making. [ABSTRACT FROM AUTHOR]

Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography–based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR. [Display omitted] [ABSTRACT FROM AUTHOR]

Current expected normal echocardiographic measures of transcatheter heart valve (THV) function were derived from pooled cohorts of the randomized trials; however, THV function by flow state before or following transcatheter aortic valve replacement (TAVR) has not been previously reported. This study sought to assess the expected normal echocardiographic hemodynamics for the balloon-expandable THV grouped by stroke volume index (SVI). Patients with severe aortic stenosis enrolled in PARTNER (Placement of Aortic Transcatheter Valves) 1 (high/extreme surgical risk), PARTNER 2 (intermediate surgical risk), or PARTNER 3 (low surgical risk) trials with complete core laboratory echocardiography were included. Patients were grouped by low-flow (SVI LOW <35 mL/m2) and normal-flow (SVI NORMAL ≥35 mL/m2). Mean gradient, effective orifice area (EOA), and Doppler velocity index (DVI) were collected at baseline and at 30 days post-TAVR. Prosthesis-patient mismatch (PPM) was both calculated and predicted from normative data, using defined criteria. In the entire population (N = 4,991), mean age was 81.8 years, 58% of patients were male, and 42% had low flow. Compared with patients with baseline SVI NORMAL , those with SVI LOW were more likely to be male; have more comorbidities; and lower left ventricular ejection fraction, mean gradient, and EOA. Post-TAVR, SVI LOW increased to SVI NORMAL in 17.3% and SVI NORMAL decreased to SVI LOW in 12.3% of patients. Using baseline SVI, follow-up EOA, mean gradient, and DVI for patients with SVI LOW tended to be lower than for patients with SVI NORMAL. Using the post-TAVR SVI, follow-up EOA, mean gradient, and DVI were significantly lower for patients with SVI LOW than for those with SVI NORMAL (P < 0.001 for all). The incidence of calculated, but not predicted, severe PPM was higher in patients with low flow than it was in patients with normal flow, suggesting pseudo-PPM in the presence of low flow. This study demonstrates that flow affects THV hemodynamics and both baseline and follow-up SVI should be considered when predicting THV hemodynamics prior to TAVR, as well as assessing valve function following valve implantation. [Display omitted] [ABSTRACT FROM AUTHOR]

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]

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]

Physiologic right ventricle–pulmonary artery (RV-PA) coupling may be impaired in patients with aortic stenosis (AS). This study aimed to assess the incidence and prognostic significance of impaired RV-PA coupling in low-risk patients with symptomatic severe AS undergoing transcatheter aortic valve replacement or surgical aortic valve replacement. RV-PA coupling was measured by transthoracic echocardiography as the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP) in patients in the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at the 2-year follow-up. Among 570 low-risk patients included in the analysis, RV-PA uncoupling was defined by a TAPSE/PASP ratio ≤ 0.55 mm/mm Hg. At baseline, 222 of 570 (38.9%) patients had RV-PA uncoupling. At 2 years, patients with baseline RV-PA uncoupling had an increased incidence of the primary endpoint (19.1% vs 9.9%, P = 0.002), all-cause mortality (5.9% vs 0.6%, P < 0.001), cardiovascular mortality (4.1% vs 0.6%, P = 0.003), and rehospitalization (13.5% vs 7.3%, P = 0.018). On multivariable analysis, baseline RV-PA uncoupling remained an independent predictor of the primary endpoint at 2 years (HR: 1.92; 95% CI: 1.04-3.57; P = 0.038). In patients with symptomatic severe AS at low surgical risk undergoing transcatheter aortic valve replacement or surgical aortic valve replacement, baseline RV-PA uncoupling defined by TAPSE/PASP ≤ 0.55 mm Hg was associated with adverse clinical outcomes at 2 years, including all-cause mortality, cardiovascular mortality, and rehospitalization. [Display omitted] [ABSTRACT FROM AUTHOR]

Functional mitral regurgitation (FMR) occurs in patients with annular dilation (atrial, aFMR) or patients with left ventricular (LV) disease (ventricular, vFMR). Meticulous understanding of the mechanisms underpinning regurgitation is crucial to optimize therapeutic strategies. Patients with moderate-severe FMR were identified from a registry of patients referred for transcatheter mitral valve intervention. In addition, controls without cardiovascular disease were identified. Differences in the geometry of the LV and mitral valve apparatus (including leaflet and tenting geometry, papillary muscle displacement and movement, annular dimensions, and dynamism) between atrial and ventricular FMR, and control subjects, were assessed using multiphasic cardiac CT. Of 183 FMR patients, 18 patients (10%) were found to have aFMR. The remaining patients had either ischemic or non-ischemic ventricular FMR. In aFMR, both increasing LV end-systolic volume (rho 0.701, p ​< ​0.01) and left atrial volume (rho 0.909, p ​< ​0.01) were associated with larger annular area. By contrast, in vFMR larger annular area was most strongly associated with larger left atrial volume (rho 0.63, p ​< ​0.01). In controls, increased annular area was associated with larger LVEDV (rho 0.78, p ​< ​0.01) and LVESV (rho 0.824, p ​< ​0.01), but not left atrial size (rho 0.16, p ​= ​0.45). Ventricular FMR comprised apicolaterally displaced, akinetic posteromedial papillary muscles, resulting in pronounced leaflet tethering, leaflet elongation compared to controls, and only modest relative LA dilatation. Compared to vFMR, aFMR was characterised by marked relative annular dilation, smaller but discernible mitral valve tenting, shorter leaflet lengths when related to annular size, but normal papillary geometry. FMR is characterised by multiple changes within the mitral valve complex. Atrial and ventricular FMR differ significantly in terms of the drivers of annular size, and geometry and function of the subvalvular apparatus. This highlights the need to consider these as separate disease entities. [ABSTRACT FROM AUTHOR]

To investigate potential differences in plaque progression (PP) between in East Asians and Caucasians as well as to determine clinical predictors of PP in East Asians. Studies have demonstrated differences in cardiovascular risk factors as well as plaque burden and progression across different ethnic groups. The study comprised 955 East Asians (age 60.4 ​± ​9.3 years, 50.9% males) and 279 Caucasians (age 60.4 ​± ​8.6 years, 74.5% males) who underwent two serial coronary computed tomography angiography (CCTA) studies over a period of at least 24 months. Patients were enrolled and analyzed from the PARADIGM (P rogression of A the R osclerotic Pl A que D eterm I ned by Computed Tomo G raphic Angiography I M aging) registry. After propensity-score matching, plaque composition and progression were compared between East Asian and Caucasian patients. Within East Asians, the plaque progression group (defined as plaque volume at follow-up CCTA minus plaque volume at baseline CCTA> 0) was compared to the no PP group to determine clinical predictors for PP in East Asians. In the matched cohort, baseline volumes of total plaque as well as all plaque subtypes were comparable. There was a trend towards increased annualized plaque progression among East Asians compared to Caucasians (18.3 ​± ​24.7 ​mm3/year vs 16.6 ​mm3/year, p ​= ​0.054). Among East Asians, 736 (77%) had PP. East Asians with PP had more clinical risk factors and higher plaque burden at baseline (normalized total plaque volume of144.9 ​± ​233.3 ​mm3 vs 36.6 ​± ​84.2 ​mm3 for PP and no PP, respectively, p ​< ​0.001). Multivariate logistic regression analysis showed that baseline normalized plaque volume (OR: 1.10, CI: 1.10–1.30, p ​< ​0.001), age (OR: 1.02, CI: 1.00–1.04, p ​= ​0.023) and body mass index (OR: 2.24, CI: 1.01–1.13, p ​= ​0.024) were all predictors of PP in East Asians. Clinical events, driven mainly by percutaneous coronary intervention, were higher among the PP group with a total of 124 (16.8%) events compared to 22 (10.0%) in the no PP group (p ​= ​0.014). East Asians and Caucasians had comparable plaque composition and progression. Among East Asians, the PP group had a higher baseline plaque burden which was associated with greater PP and increased clinical events. [ABSTRACT FROM AUTHOR]

Background: Transcatheter heart valve (THV) dysfunction with an elevated gradient or paravalvular leak (PVL) may be documented late after THV implantation. Medical management, paravalvular plugs, redo THV replacement, or surgical valve replacement may be considered. However, late balloon dilatation is rarely utilized because of concerns about safety or lack of efficacy.Objectives: We aimed to evaluate the safety and efficacy of late dilatation in the management of THV dysfunction.Methods: All patients who underwent late dilatation for symptomatic THV dysfunction at 2 institutions between 2016 and 2021 were identified. Baseline, procedural characteristics, and clinical and echocardiographic outcomes were documented. THV frame expansion was assessed by multislice computed tomography before and after late dilatation.Results: Late dilatation was performed in 30 patients a median of 4.6 months (IQR: 2.3-11.0 months) after THV implantation in the aortic (n = 25; 83.3%), mitral (n = 2; 6.7%), tricuspid (n = 2; 6.7%) and pulmonary (n = 1; 3.3%) position. THV underexpansion was documented at baseline, and frame expansion substantially improved after late dilatation. The mean transvalvular gradient fell in all patients. For aortic THVs specifically, mean transaortic gradient fell from 25.4 ± 13.9 mm Hg to 10.8 ± 4.1 mm Hg; P < 0.001. PVL was reduced to ≤mild in all 11 patients with a previous >mild PVL. Embolic events, stroke, annular injury, and bioprosthetic leaflet injury were not observed. Symptomatic benefit was durable at 19.6 months (IQR: 14.8-36.1 months) follow-up.Conclusions: Balloon dilatation late after THV implantation appears feasible and safe in appropriately selected patients and may result in THV frame expansion resulting in improvements in hemodynamic performance and PVL. [ABSTRACT FROM AUTHOR]

The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years. TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown. The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients. In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years. At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

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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 investigate the impact of computed tomography (CT)–based area and perimeter oversizing on the incidence of paravalvular regurgitation (PVR) and valve hemodynamics in patients treated with the SAPIEN 3 transcatheter heart valve (THV). The incremental value of considering annular perimeter or left ventricular outflow tract measurements and the impact of THV oversizing on valve hemodynamics are not well defined. The PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial included 495 low-surgical-risk patients with severe aortic stenosis who underwent THV implantation. THV sizing was based on annular area assessed by CT. Area- and perimeter-based oversizing was determined using systolic annular CT dimensions and nominal dimensions of the implanted THV. PVR, effective orifice area, and mean gradient were assessed on 30-day transthoracic echocardiography. Of 485 patients with available CT and echocardiography data, mean oversizing was 7.9 ± 8.7% for the annulus area and 2.1 ± 4.1% for the perimeter. A very low incidence of ≥moderate PVR (0.6%) was observed, including patients with minimal annular oversizing. Incidence of ≥mild PVR and need for procedural post-dilatation were inversely related to the degree of oversizing. For patients with annular dimensions suitable for 2 THV sizes, the larger THV with both area and perimeter oversizing was associated with the lowest incidence of ≥mild PVR (12.0% vs 43.4%; P < 0.0001). Left ventricular outflow tract area oversizing was not associated with PVR. THV prosthesis size, rather than degree of oversizing, had greatest impact on effective orifice area and mean gradient. In low-surgical-risk patients, a low incidence of ≥moderate PVR was observed, including patients with minimal THV oversizing. The degree of prosthesis oversizing had the greatest impact on reducing mild PVR and incidence of post-dilatation, without impacting valve hemodynamics. In selected patients with annular dimensions in between 2 valve sizes, the larger THV device oversized to both the annular area and perimeter reduced PVR and optimized THV hemodynamics. [Display omitted] [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the association between Doppler velocity index (DVI) and 2-year outcomes for balloon-expandable SAPIEN 3 transcatheter aortic valve replacement (TAVR) and for surgical aortic valve replacement (SAVR). DVI >0.35 is normal for a prosthetic valve, but recent studies suggest that DVI <0.50 is associated with poor outcomes following TAVR. Patients with severe aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valve) 2 (intermediate surgical risk) or PARTNER 3 (low surgical risk) trial undergoing TAVR (n = 1,450) or SAVR (n = 1,303) were included. Patients were divided into 3 DVI groups on the basis of core laboratory–assessed discharge or 30-day echocardiograms: DVI LOW (≤0.35), DVI INTERMEDIATE (>0.35 to ≤0.50), and DVI HIGH (>0.50). Two-year outcomes were assessed. Following TAVR, there were no differences among the 3 DVI groups in composite outcomes of death, stroke, or rehospitalization or in any individual components of 2-year outcomes (P > 0.70 for all). Following SAVR, there was no difference among DVI groups in the composite outcome (P = 0.27), but there was a significant association with rehospitalization (P = 0.02). Restricted cubic-spline analysis for combined outcomes showed an increased risk with post-SAVR DVI ≤0.35 but no relationship post-TAVR. DVI ≤0.35 was associated with increased 2-year composite outcome for SAVR (HR: 1.81; 95% CI: 1.29–2.54; P < 0.001), with no adverse outcomes for TAVR (P = 0.86). In intermediate- and low-risk cohorts of the PARTNER trials, DVI ≤0.35 predicted worse 2-year outcomes following SAVR, driven primarily by rehospitalization, with no adverse outcomes associated with DVI following TAVR with the balloon-expandable SAPIEN 3 valve. [Display omitted] [ABSTRACT FROM AUTHOR]

This study aimed to compare incidence and impact of measured prosthesis-patient mismatch (PPM M) versus predicted PPM (PPM P) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). TAVR studies have used measured effective orifice area indexed (EOAi) to body surface area (BSA) to define PPM, but most SAVR series have used predicted EOAi. This difference may contribute to discrepancies in incidence and outcomes of PPM between series. The study analyzed SAVR patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and TAVR patients from the PARTNER 2 SAPIEN 3 Intermediate Risk registry. PPM was classified as moderate if EOAi ≤0.85 cm2/m2 (≤0.70 if obese: body mass index ≥30 kg/m2) and severe if EOAi ≤0.65 cm2/m2 (≤0.55 if obese). PPM M was determined by the core lab–measured EOAi on 30-day echocardiogram. PPM P was determined by 2 methods: 1) using normal EOA reference values previously reported for each valve model and size (PPM P1 ; n = 929 SAVR, 1,069 TAVR) indexed to BSA; and 2) using normal reference EOA predicted from aortic annulus size measured by computed tomography (PPM P2 ; n = 864 TAVR only) indexed to BSA. Primary endpoint was the composite of 5-year all-cause death and rehospitalization. The incidence of moderate and severe PPM P was much lower than PPM M in both SAVR (PPM P1 : 28.4% and 1.2% vs. PPM M : 31.0% and 23.6%) and TAVR (PPM P1 : 21.0% and 0.1% and PPM P2 : 17.0% and 0% vs. PPM M : 27.9% and 5.7%). The incidence of severe PPM M and severe PPM P1 was lower in TAVR versus SAVR (P < 0.001). The presence of PPM by any method was associated with higher transprosthetic gradient. Severe PPM P1 was independently associated with events in SAVR after adjustment for sex and Society of Thoracic Surgeons score (hazard ratio: 3.18;95% CI: 1.69-5.96; P < 0.001), whereas no association was observed between PPM by any method and outcomes in TAVR. EOAi measured by echocardiography results in a higher incidence of PPM following SAVR or TAVR than PPM based on predicted EOAi. Severe PPM P is rare (<1.5%), but is associated with increased all-cause death and rehospitalization after SAVR, whereas it is absent following TAVR. [Display omitted] [ABSTRACT FROM AUTHOR]

With the advent of transcatheter mitral valve replacement (TMVR), the concept of the neo–left ventricular outflow tract (LVOT) was introduced and remains an essential component of treatment planning. This paper describes the LVOT anatomy and provides a step-by-step computed tomography methodology to segment and measure the neo-LVOT while discussing the current evidence and outstanding challenges. It also discusses the technical and hemodynamic factors that play a major role in assessing the neo-LVOT. A summary of expert-based recommendations about the overall risk of LVOT obstruction in different scenarios is presented along with the currently available methods to reduce the risk of LVOT obstruction and other post-procedural complications. [Display omitted] • TMVR is increasingly becoming more common. • Neo-LVOT is a concept that was introduced to describe the residual LVOT area created after the implanted transcatheter mitral valve prosthesis. • Measurement of the neo-LVOT is explained and step-by-step process is proposed. • Multiple factors affect the hemodynamic and sizing of the measured neo-LVOT. • A summary of recommendations with regard to the risk of LVOTO and methods to reduce the risk of LVOTO are reviewed. [ABSTRACT FROM AUTHOR]

The aim of the current study was to explore the impact of plaque calcification in terms of absolute calcified plaque volume (CPV) and in the context of its percentage of the total plaque volume at a lesion and patient level on the progression of coronary artery disease. Coronary artery calcification is an established marker of risk of future cardiovascular events. Despite this, plaque calcification is also considered a marker of plaque stability, and it increases in response to medical therapy. This analysis included 925 patients with 2,568 lesions from the PARADIGM (Progression of Atherosclerotic Plaque Determined by Computed Tomographic Angiography Imaging) registry, in which patients underwent clinically indicated serial coronary computed tomography angiography. Plaque calcification was examined by using CPV and percent CPV (PCPV), calculated as (CPV/plaque volume) × 100 at a per-plaque and per-patient level (summation of all individual plaques). CPV was strongly correlated with plaque volume (r = 0.780; p < 0.001) at baseline and with plaque progression (r = 0.297; p < 0.001); however, this association was reversed after accounting for plaque volume at baseline (r = –0.146; p < 0.001). In contrast, PCPV was an independent predictor of a reduction in plaque volume (r = –0.11; p < 0.001) in univariable and multivariable linear regression analyses. Patient-level analysis showed that high CPV was associated with incident major adverse cardiac events (hazard ratio: 3.01: 95% confidence interval: 1.58 to 5.72), whereas high PCPV was inversely associated with major adverse cardiac events (hazard ratio: 0.529; 95% confidence interval: 0.229 to 0.968) in multivariable analysis. Calcified plaque is a marker for risk of adverse events and disease progression due to its strong association with the total plaque burden. When considered as a percentage of the total plaque volume, increasing PCPV is a marker of plaque stability and reduced risk at both a lesion and patient level. (Progression of Atherosclerotic Plaque Determined by Computed Tomographic Angiography Imaging [PARADIGM]; NCT02803411) [ABSTRACT FROM AUTHOR]

Catheter-based interventions to improve mitral valve function are dependent on anatomic and functional information provided by noninvasive imaging to plan, perform, and evaluate each intervention. In this review we highlight the importance of imaging guidance for catheter-based interventions on prosthetic mitral valves, surgical rings, and native valve annular calcification. Both repair and replacement procedures are discussed. We review the general features common to this collection of procedures and discuss specific imaging issues and concerns for each procedure. Figures and intraprocedural videos emphasize central messages using case examples. • Computed tomography is an essential imaging modality for patient selection and procedural planning of catheter-based mitral valve interventions on a prosthetic valve or calcified native annulus. • Echocardiography and limited fluoroscopy are principal imaging tools for intraprocedural guidance. Echocardiography is well suited for acute postprocedure functional evaluation. • Accurate prediction of left ventricular outflow tract patency is a specific imaging challenge for these interventions. • Functional evaluation of residual mitral regurgitation and paravalvular regurgitation post procedure are important tasks for the echocardiographer. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has affected patient care deliver throughout the world, resulting in a greater emphasis on efficiently and safety. In this article, we discuss the experiences of several North American centers in utilizing cardiac CT during the pandemic. We also provide a case-based overview which highlights the advantages of cardiac CT in evaluating the following scenarios: (1) patients with possible myocardial injury versus myocardial infarction; (2) patients with acute chest pain; (3) patients with stable chest pain; (4) patients with possible intracardiac thrombus; (5) patients with valvular heart disease. For each scenario, we also provide an overview of various societies recommendations which have highlighted the use of cardiac CT during different phases of the COVID-19 pandemic. We hope that the advantages of cardiac CT that have been realized during the pandemic can help promote wider adoption of this technique and improved coverage and payment by payors. [ABSTRACT FROM AUTHOR]

The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR). Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV. Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular–to–pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported. Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported. This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed. [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]

Background: Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction.Objectives: The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes.Methods: The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory.Results: The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04).Conclusions: Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment. [ABSTRACT FROM AUTHOR]

Background: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.Objectives: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.Methods: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.Results: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.Conclusions: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283). [ABSTRACT FROM AUTHOR]

The aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction. Coronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction. A 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance. Within both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001). ViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR. [ABSTRACT FROM AUTHOR]

Coronary artery calcification is a significant contributor to reduced accuracy of coronary computed tomographic angiography (CTA) in the assessment of coronary artery disease severity. The aim of the current study is to assess the impact of a prototype calcium deblooming algorithm on the diagnostic accuracy of CTA. 40 patients referred for invasive catheter angiography underwent CTA and invasive catheter angiography. The CTA were reconstructed using a standard soft tissue kernel (CTA STAND) and a deblooming algorithm (CTA DEBLOOM). CTA studies were read with and without the deblooming algorithm blinded to the invasive coronary angiogram findings. Sensitivity, specificity, accuracy, positive predictive value and negative predictive value for the detection of stenosis ≥50% or ≥70% were evaluated using quantitative coronary angiography as the reference standard. Image quality was assessed using a 5-point scale, and the presence of image artifact recorded. All studies were diagnostic with 548 segments available for evaluation. Image score was 3.64 ± 0.72 with CTA DEBLOOM , versus 3.56 ± 0.72 with CTA STAND (p = 0.38). CTA DEBLOOM had significantly less calcium blooming artifact than CTA STAND (12.5% vs. 47.5%, p = 0.001). Based on a 50% stenosis threshold for defining significant disease, the Sensitivity/Specificity/PPV/NPV/Accuracy were 65.9/84.9/27.6/96.6/83.4 for CTA DEBLOOM and 75.0/81.9/26.6/97.4/81.4 for CTA STAND using a ≥50% threshold. CTA DEBLOOM specificity was significantly higher than CTA STAND (84.9% vs. 81.5%, p = 0.03), with no difference between the algorithms in sensitivity (p = 0.22), or accuracy (p = 0.15). These results remained unchanged when a stenosis threshold of ≥70% was used. Interobserver agreement was fair with both techniques (CTA DEBLOOM k = 0.38, CTA STAND k = 0.37). In this proof of concept study, coronary calcification deblooming using a prototype post-processing algorithm is feasible and reduces calcium blooming with an improvement of the specificity of the CTA exam. Coronary calcification deblooming using a prototype post-processing algorithm is feasible and significantly reduces calcium blooming with an improvement of the specificity of the CTA exam. [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]

Abstract Objectives The purpose of this study is to report the 1-year results of the CENTERA-EU trial. Background The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve. Methods Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee. Results Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm2, and no incidences of severe or moderate aortic regurgitation. Conclusions The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560) Central Illustration [ABSTRACT FROM AUTHOR]

Abstract Objectives This study investigated processes causing leaflet thickening and structural valve degeneration (SVD). Background Although transcatheter aortic valve replacement (TAVR) has changed the treatment of aortic stenosis, concerns remain regarding SVD, potentially related to valve thrombosis and thickening, based on studies using computed tomography (CT). Detailed histological analyses are provided to help attain insights into these processes. Methods Explanted transcatheter heart valves (THVs) were evaluated for thrombosis, fibrosis, and calcification for quantification of leaflet thickness. Immunohistochemical and microscopy approaches were used to investigate SVD-associated mechanisms. Results THVs (n = 23) were obtained from 22 patients (median 81 years of age; 50% male) from 0 to 2,583 days post TAVR. Maximal leaflet thickness increased relative to implant duration (ρ = 0.427; p = 0.027). THVs explanted after >2 years were thicker than those explanted after <2 years (p = 0.007). All THVs had adherent thrombus on both aortic and ventricular sides, which beyond 60 days was seen in combination with fibrosis and beyond 4 years had calcification. Early thrombus formation (<60 days) occurred despite rapid endothelialization with an abnormal hyperplastic phenotype. Fibrosis was observed in 6 patients on both the aortic and the ventricular THV surfaces, remodeled over time, and was associated with matrix metalloproteinase-1 expression. Five THVs showed overt calcification associated with adherent thrombus and fibrosis. Conclusions There is a time-dependent degeneration of THVs consisting of thrombus formation, endothelial hyperplasia, fibrosis, tissue remodeling, proteinase expression, and calcification. Future investigation is needed to further understand these mechanisms contributing to leaflet thickening and SVD. Graphical abstract [ABSTRACT FROM AUTHOR]

Abstract Objectives This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves. Background Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function. Methods We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves. Results For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001). Conclusions Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed. Graphical abstract [ABSTRACT FROM AUTHOR]