Balloon-expandable Transcatheter Aortic Valve Replacement Research Articles

LB-9 | Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial

LB-9 | Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Cusp-overlap view reduces conduction disturbances and permanent pacemaker implantation after transcatheter aortic valve replacement even with balloon-expandable and mechanically-expandable heart valves.

Conduction disturbances demanding permanent pacemaker implantation (PPI) remain a common complication after transcatheter aortic valve replacement (TAVR). Optimization of the implantation depth (ID) by introducing the cusp-overlap projection (COP) technique led to a reduced rate of PPI when self-expanding valves were used. The aim of the present study was to determine if using the novel COP view is applicable for all types of TAVR prosthesis and results in a higher ID and reduced incidence of new conduction disturbances and PPI. In this prospective case-control study 586 consecutive patients undergoing TAVR with either balloon-expandable Edwards SAPIEN S3 (n = 280; 47.8%), or mechanically expandable Boston LOTUS Edge heart valve prostheses (n = 306; 52.2%) were included. ID as well as rates of periprocedural PPI and left bundle branch block (LBBB) were compared between the conventional three-cusp coplanar (TCC) projection and the COP view for implantation. Of 586 patients, 282 (48.1%) underwent TAVR using COP, whereas in 304 patients (51.9%) the TCC view was applied. Using COP a significantly higher ID was achieved in Edwards SAPIEN S3 TAVR procedures (ID mean difference -1.0 mm, 95%-CI -1.9 to -0.1 mm; P = 0.029), whereas the final platform position did not differ significantly between both techniques when a Boston LOTUS Edge valve was used (ID mean difference -0.1 mm, 95%-CI -1.1 to +0.9 mm; P = 0.890). In Edwards SAPIEN S3 valves, higher ID was associated with a numerically lower post-procedural PPI incidence (4.9% vs. 7.3%; P = 0.464). Moreover, ID was significantly deeper in patients requiring PPI post TAVR compared to those without PPI [8.7 mm (6.8-10.6 mm) vs. 6.5 mm (6.1-7.0 mm); P = 0.005]. In Boston LOTUS Edge devices, COP view significantly decreased the incidence of LBBB post procedure (28.1% vs. 47.9%; P < 0.001), while PPI rates were similar in both groups (21.6% vs. 25.7%; P = 0.396). The present study demonstrates the safety, efficacy and reproducibility of the cusp-overlap view even in balloon-expandable and mechanically-expandable TAVR procedures. Application of COP leads to significantly less LBBB in repositionable Boston LOTUS Edge valves and a numerically lower PPI rate in Edwards SAPIEN S3 valves post TAVR compared to the standard TCC projection. The results should encourage to apply the COP view more widely in clinical practice.

Self-expanding or balloon-expandable transcatheter aortic valve replacement in a German comparison

Abstract Background Studies demonstrated that results for self-expanding vs balloon-expandable transcatheter aortic valve replacement (TAVR) are similar, with larger subgroup analyzes missing. Methods We identified 46,243 self-expanding (SE) and balloon-expandable (BE) transfemoral TAVR for aortic stenosis in German hospitals in 2019 or 2020. Both in-hospital outcomes as well as subgroups for in-hospital mortality were analyzed. Results Regarding baseline characteristics, the logistic EuroSCORE was higher in SE (SE 13.6% - BE 12.7%; p&amp;lt;0.001), which also applied to age (SE 81.6a - BE 80.0a; p&amp;lt;0.001). There was a comparable in-hospital mortality rate in both groups (BE 2.37% - SE 2.35%; p=0.916). Risk adjusted in-hospital mortality was also not significantly different (OR=0.98, p=0.799). The SE group presented a significantly lower risk of major bleeding events (OR=0.83, p=0.006), however, there was a significantly higher risk of stroke (OR=1.38, p&amp;lt;0.001), risk of delirium (OR=1.15, p=0.001) as well as risk of permanent pacemaker implantation (OR=1.29, p&amp;lt;0.001). No difference has been found for acute kidney injury, mechanical ventilation &amp;gt;48h, length of hospital stay, and reimbursement. In addition, the subgroups showed no significant differences for in-hospital mortality regarding age, logistic EuroSCORE, gender, heart failure NYHA III/IV, previous coronary artery bypass graft, peripheral vascular disease, chronic obstructive pulmonary disease, pulmonary hypertension, renal disease GFR &amp;lt;30ml/min or diabetes mellitus. Conclusion Self-expanding or balloon-expandable TAVR did not show significant differences for in-hospital mortality in a subgroup analysis in Germany.

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

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

5-Year Outcomes With Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients With Small Annuli

BackgroundSelf-expanding transcatheter heart valves (THVs) are associated with better echocardiographic hemodynamic performance than balloon-expandable THVs and are considered preferable in patients with small annuli. ObjectivesThis study sought to compare 5-year outcomes between self-expanding vs balloon-expandable THVs in severe aortic stenosis (AS) patients with small annuli. MethodsConsecutive severe AS patients with an aortic valve annulus area <430 mm2 who underwent transcatheter aortic valve replacement (TAVR) with either the CoreValve Evolut (Medtronic) or SAPIEN (Edwards Lifesciences) THV between 2012 and 2021 were enrolled from the Bern TAVI registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups. ResultsA total of 723 patients were included, and propensity score matching resulted in 171 pairs. Technical success was achieved in over 85% of both groups with no significant difference. Self-expanding THVs were associated with a lower transvalvular gradient (8.0 ± 4.8 mm Hg vs 12.5 ± 4.5 mm Hg; P < 0.001), a larger effective orifice area (1.81 ± 0.46 cm2 vs 1.49 ± 0.42 cm2; P < 0.001), and a lower incidence of prosthesis-patient mismatch (19.7% vs 51.8%; P < 0.001) than balloon-expandable THVs. At 5 years, there were no significant differences in mortality (50.4% vs 39.6%; P = 0.269) between groups. Disabling stroke occurred more frequently in patients with a self-expanding THV than those with a balloon-expandable THV (6.6% vs 0.6%; P = 0.030). Similar results were obtained using inverse probability of treatment weighting in the Bern TAVI registry and the nationwide Swiss TAVI registry. ConclusionsThe echocardiographic hemodynamic advantage of self-expanding THVs was not associated with better clinical outcomes compared with balloon-expandable THVs up to 5 years in patients with small annuli. (Swiss TAVI Registry; NCT01368250)

Abstract 15768: Relative Longitudinal Strain Apical Sparing Pattern as a Detrimental Factor of Cardiovascular Outcome After Transcatheter Aortic Valve Replacement

Introduction: Several risk scores have been developed for outcome after heart surgery. However, risk factors associated with clinical outcome in patients undergoing transcatheter aortic valve replacement (TAVR) are still not well defined. This study aimed to determine laboratory and echocardiography determinants of short- and long-term outcome after TAVR. Methods: This retrospective study comprised 598 consecutive patients with sole aortic stenoseis (AS) who received balloon-expandable TAVR in our hospital (mean age 81.7±5.7 years, 48.7% male, median EuroSCORE II 5.0%). Pre-operative laboratory and imaging data including speckle-tracking echocardiography were analyzed. Clinical outcomes included cardiovascular (CV) death, CV hospitalization, and procedure related complications at 30 days, 1 year, and at 2 years after TAVR. Results: Semi-quantitative assessment defined as ≥3 LV wall segments with the apico-basal LS ratio &gt;3.0 was used to define relative apical sparing pattern (RASP). The prevalence of RASP was 19.2%. RASP patients had higher prevalence of acute kidney injury (AKI, 10.4% vs. 3.3%, P=0.001) and new-onset left bundle branch block (LBBB) after TAVR (17.4% vs. 6.8%, P&lt;0.001). CV mortality at 30 days (7.0% vs. 3.1%, P=0.062), 1 year (15.7% vs. 7.9%, P=0.010), and 2 years (22.6% vs. 9.9%, P&lt;0.001) was also higher after TAVR. RASP remained the strongest determinant for AKI (OR=3.11, P=0.007), new-onset LBBB (OR=2.89, P&lt;0.001), increased 30-day CV related hospitalization or death risk (OR=2.20, P=0.033). Lower albumin level and RASP were identified as independent determinants of increased 1-year and 2-year CV mortality risk (RASP: HR=1.83 and 2.18, P=0.039 and 0.002; albumin&lt;4.0g/dl: HR=3.18 and 2.55, both P&lt;0.001), regardless of TAVR approach and EuroSCORE II. After adjustment, the addition of RASP significantly improved prognostic power of a model including clinical variables and low albumin level for predicting CV death at 2-year follow-up ( χ 2 from 28.18 to 40.70, P=0.001). Conclusions: RASP represents a novel clinically relevant determinant of outcome after TAVR. Low albumin and RASP were identified as the strongest laboratory and echocardiography determinants for increased short- and long-term outcome after TAVR.

Analysis of surgical bailout after transcatheter aortic valve replacement in Germany

Abstract Background Severe complications during transcatheter aortic valve replacement (TAVR) may require a surgical bailout. However, little is known about the outcomes after bailout in Germany. Methods All TAVR between 2007 and 2020 were identified using German national electronic health records, with focus on 2018 to 2020. Additionally, those procedures requiring surgical bailout were selected. Results A total of 159,643 patients received TAVR. Overall rate of surgical bailout was 2.30% and overall in-hospital mortality 3.85%. In-hospital mortality after surgical bailout was 16.51%. While the annual number of procedures in all TAVR rose steeply (202 to 22,972), the rate of surgical bailout dropped from 27.23 to 0.61% and that of overall mortality from 11.39 to 2.29%. However, mortality in case of surgical bailout remained high with 28.37% in 2020. After risk adjustment, in 2018 to 2020, standardized rates of overall in-hospital mortality and surgical bailout for both balloon-expandable and self-expanding transfemoral TAVR were significantly lower than for transapical TAVR (transapical vs transfemoral balloon-expandable vs self-expanding TAVR: in-hospital mortality: 5.66% [95% CI 4.81%; 6.52%] vs 2.30% [2.03%; 2.57%] vs 2.32% [2.07%; 2.57%]; surgical bailout: 2.33% [1.68%; 2.97%] vs 0.79% [0.60%; 0.98%] vs 0.42% [0.31%; 0.53%]). Main risk factors for surgical bailout were coronary artery disease (risk adjusted OR=1.50 [1.21; 1.85], p&amp;lt;0.001), atrial fibrillation (OR=1.29 [1.07; 1.57], p=0.009), and higher grade heart failure NYHA III/IV (OR=1.26 [1.01; 1.57], p=0.037). Conclusion Rates of surgical bailout as well as overall in-hospital mortality after TAVR decrease substantially over the years. However, in the case of surgical bailout, outcomes remain poor with a constantly high in-hospital mortality. Funding Acknowledgement Type of funding sources: None.

Long-term outcomes of balloon-expandable transcatheter aortic valve replacement in Japanese patients

BackgroundData on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. MethodsBetween June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. ResultsThe rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %. ConclusionsThe 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.

Coronary Obstruction After Transcatheter Aortic Valve Replacement: From Risk Prediction to Prevention

Coronary Obstruction After Transcatheter Aortic Valve Replacement: From Risk Prediction to Prevention

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity‐matched analysis

In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated. We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively). In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.

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

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

A computational framework for post-TAVR cardiac conduction abnormality (CCA) risk assessment in patient-specific anatomy.

Cardiac conduction abnormality (CCA)- one of the major persistent complications associated with transcatheter aortic valve replacement (TAVR) may lead to permanent pacemaker implantation. Localized stresses exerted by the device frame on the membranous septum (MS) which lies between the aortic annulus and the bundle of His, may disturb the cardiac conduction and cause the resultant CCA. We hypothesize that the area-weighted average maximum principal logarithmic strain (AMPLS) in the MS region can predict the risk of CCA following TAVR. Rigorous finite element-based analysis was conducted in two patients (Balloon expandable TAVR recipients) to assess post-TAVR CCA risk. Following the procedure one of the patients required permanent pacemaker (PPM) implantation while the other did not (control case). Patient-specific aortic root was modeled, MS was identified from the CT image, and the TAVR deployment was simulated. Mechanical factors in the MS region such as logarithmic strain, contact force, contact pressure, contact pressure index (CPI) and their time history during the TAVR deployment; and anatomical factors such as MS length, implantation depth, were analyzed. Maximum AMPLS (0.47 and 0.37, respectively), contact force (0.92N and 0.72N, respectively), and CPI (3.99 and 2.86, respectively) in the MS region were significantly elevated in the PPM patient as compared to control patient. Elevated stresses generated by TAVR devices during deployment appear to correlate with CCA risk, with AMPLS in the MS region emerging as a strong predictor that could be used for preprocedural planning in order to minimize CCA risk.

The Transaxillary Approach via Prosthetic Conduit for Transcatheter Aortic Valve Replacement With the New-Generation Balloon-Expandable Valves in Patients With Severe Peripheral Artery Disease.

Background: The left subclavian artery (LSA) is an infrequently used alternative access route for patients with severe peripheral artery disease (PAD) in patients who underwent transcatheter aortic valve replacement (TAVR). We report a new endovascular approach for TAVR combining an axillary prosthetic conduit-based access technique with new-generation balloon-expandable TAVR prostheses.Methods and Results: Between January 2020 and December 2020, 251 patients underwent TAVR at the West German Heart and Vascular Center. Of these, 10 patients (3.9%) were deemed to be treated optimally by direct surgical exposure of the left or right axillary artery via a surgically adapted prosthetic conduit. All procedures were performed under general anesthesia. One procedural stroke occurred due to severe calcification of the aortic arch. No specific complications of the subclavian access site (vessel rupture, vertebral, or internal mammary ischemia) were reported. Two minor bleedings from the access site could be treated conservatively. No surgical revision was necessary.Conclusion: The axillary prosthetic conduit-based access technique using new-generation balloon-expandable valves allows safe and successful TAVR in a subgroup of patients with a high risk of procedural complications due to severe peripheral vascular disease. Considering the increasing number of patients referred for TAVR, this approach could represent an alternative for patients with limited access sites.

Anatomical Features of Native Aortic Valves Associated with Coronary Obstruction during Balloon-expandable Transcatheter Aortic Valve Replacement

Anatomical Features of Native Aortic Valves Associated with Coronary Obstruction during Balloon-expandable Transcatheter Aortic Valve Replacement

Neosinus and Sinus Flow After Self-Expanding and Balloon-Expandable Transcatheter Aortic Valve Replacement.

The aim of this study was to evaluate flow dynamics in the aortic sinus and the neosinus (NS) after transcatheter heart valve (THV) implantation in valve-in-valve (ViV). Leaflet thrombosis may occur on THVs and affect performance and durability. Differences in flow dynamics may affect the risk for leaflet thrombosis. Hemodynamic assessment following THV implantation in a surgical aortic valve was performed in a left heart simulator under pulsatile physiological conditions. Assessment was performed using a 23-mm polymeric surgical aortic valve (not diseased) and multiple THV platforms, including self-expanding devices (26-mm Evolut, 23-mm Allegra, small ACURATE neo) and a balloon-expandable device (23-mm SAPIEN 3). Particle image velocimetry was performed to assess flow in the sinus and NS. Sinus and NS washout, shear stress, and velocity were calculated. Sinus and NS washout was fastest and approximately 1 cardiac cycle for each with the Evolut, ACURATE neo, and Allegra compared with the SAPIEN 3, with washout in 2 and 3 cardiac cycles, respectively. The Allegra showed the largest shear stress distribution in the sinus, followed by the SAPIEN 3. In the NS, all 4 valves showed equal likelihoods of occurrence of shear stress<1 Pa, but the Allegra showed the highest likelihoods of occurrence for shear stress >1 Pa. The velocities in the sinus and NS were 0.05, 0.078, 0.080, and 0.075m/s for Evolut, SAPIEN 3, ACURATE neo, and Allegra ViV, respectively. Sinus and NS flow dynamics differ substantially among THVs after ViV. Self-expanding supra-annular valves seem to have faster washouts compared with an equivalent-size balloon-expandable THV.

Intravascular ultrasound for valve frame expansion and orifice area measurement as well as paravalvular leak assessment during transcatheter aortic valve replacement

Abstract Introduction Valve frame expansion (measured outer valve frame area/nominal valve dimension), but not oversizing (nominal valve dimension/annulus area, %) determines pattern of restored blood flow after transcatheter aortic valve replacement (TAVR). There is no online measure of frame expansion, and error in current echocardiographic assessment of effective orifice area (EOA) and paravalvular leak (PVL) are common. Purpose To evaluate large imaging field intravascular ultrasound (IVUS) during TAVR for measuring valve geometry [frame expansion, minimal geometric orifice area (min GOA), and mechanism of PVL] with transthoracic echo and angio-CT serving for comparative measures, along with the nominal EOA as established by Hahn et al. Methods After successful TAVR either a 10MHz Vision PV 0.035" (60mm imaging field) or 20MHz Vision PV 0.018" (24mm imaging field plus Chr omaFlo) IVUS catheter (Philips) was slowly pulled from the left ventricle outflow (LVOT) to the aorta with continuous imaging of the aortic root. Results There were 16 pts (80.8±7.1 yrs, 8 female) treated for de novo aortic stenosis (n=15) or failed bioprosthesis (n=1), 7 of whom were treated with balloon-expandable TAVR. PV 0.35" catheters were used in 8 pts (including valve-in-valve) and allowed complete geometry assessment of 26.6±2.7mm nominal prosthesis Ø (Figure 1A) whereas PV 0.018" allowed complete geometry assessment in only 4 of 8 pts with nominal prosthesis Ø of 26.1±2.8mm (Figure 1B). Actual % valve inflow expansion (IVUS outer frame/valve nominal dimension) was significantly smaller than % valve oversizing (80%±19% vs 125±19%, p=0.005). Min GOA was substantially bigger than corresponding nominal EOA and EOA calculated using the post-procedural LVOT diameter (272±84mm2 vs 174±25mm2 vs 181±59mm2, p=0.001 correspondingly). However, min GOA was similar to EOA calculated using baseline LVOT area (272±84mm2 vs 230±90mm2; r=0.713, p=0.009). IVUS and angio-CT measurements of outer prosthesis frame area were similar for inflow, coaptation site, and outflow (460±143mm2 vs 454±134mm2 and 455±134mm2 vs 447±114mm2 and 722±174mm2 vs 725±180; p≤0.001 for all paired correlations). Inflow expansion (IVUS outer frame/baseline CT annulus area) tended to be smaller among valves with ≥mild vs no PVL (95±14% vs 107±11%, p=0.156), with clear ChromaFlo signal seen in the space between the aortic annulus wall and outer-valve frame surface (Figure 1C). Conclusions Large imaging field IVUS during TAVR allows for peri-procedural assessment of actual valve geometry that differs substantially from nominal. IVUS offers online tomographic perspective and highest accuracy in anatomy evaluation corresponding with valve function. Funding Acknowledgement Type of funding sources: None. Figure 1

Self-expanding and balloon-expandable transfemoral transcatheter aortic valve replacement: in-hospital outcomes in Germany

Abstract Background The impact of valve type used in transfemoral transcatheter aortic valve replacement (TF-TAVR) on outcomes is currently under discussion. Purpose We examine the in-hospital outcomes of balloon-expandable (BE) and self-expanding (SE) valves in a complete national cohort in Germany in 2018. Methods All 17,295 patients receiving TF-TAVR with BE (N=9,882) or SE (N=7,413) valves in Germany in 2018 were identified. Outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, mechanical ventilation &amp;gt;48h, length of hospital stay, and reimbursement. Since there was no randomization of patients to the two treatment options, logistic or linear regression models were carried out using 22 baseline patient characteristics and center-specific variables as potential confounders. Propensity score methods served as sensitivity analysis. Results Both valve types differed significantly in baseline characteristics with higher EuroSCORE (p&amp;lt;0.001), age (p&amp;lt;0.001) and rate of female sex (p&amp;lt;0.001) in patients treated with SE valves. After risk adjustment, there were no marked differences in outcomes for in-hospital mortality (risk adjusted odds ratio (aOR) for SE instead of BE: 0.94 [95% CI 0.76; 1.17], p=0.617), major bleeding (aOR 0.91 [0.73; 1.14], p=0.400), stroke (aOR 1.13 [0.88; 1.46], p=0.347), acute kidney injury (aOR 0.97 [0.85; 1.10], p=0.621), postoperative delirium (aOR 1.09 [0.96; 1.24], p=0.184), mechanical ventilation &amp;gt;48h (aOR 0.98 [0.77; 1.25], p=0.893), length of hospital stay (risk adjusted difference in days of hospitalization: −0.05 [−0.34; 0.25], p=0.762) and reimbursement (−€72 [−€291; €147], p=0.519). Similar results were found using propensity score methods. Conclusion Outcomes in contemporary TF-TAVR procedures are broadly equivalent regardless of the valve type used. Major complications rarely occur in both types of valve. Funding Acknowledgement Type of funding sources: None. Self- vs balloon-expanding TF-TAVR

Late-Phase Delayed Coronary Obstruction Caused by Protruding Calcified Aortic Valve Leaflet After Balloon-Expandable Transcatheter Aortic Valve Replacement

Late-Phase Delayed Coronary Obstruction Caused by Protruding Calcified Aortic Valve Leaflet After Balloon-Expandable Transcatheter Aortic Valve Replacement

Evaluating the Validity of Risk Scoring in Predicting Pacemaker Rates following Transcatheter Aortic Valve Replacement.

Introduction Requirement of permanent pacemaker (PPM) implantation is a known and common postoperative consequence of transcatheter aortic valve replacement (TAVR). The Emory risk score has been recently developed to help risk stratify the need for PPM insertion in patients undergoing TAVR with SAPIEN 3 valves. Our aim was to assess the validity of this risk score in our patient population, as well as its applicability to patients receiving self-expanding valves. Methods We conducted a retrospective review of 479 TAVR patients without preoperative pacemakers from November 2016 through December 2018. Preoperative risk factors included in the Emory risk score were collected for each patient: preoperative QRS, preoperative right bundle branch block (RBBB), preoperative syncope, and degree of valve oversizing. Multivariable analysis of the individual variables within the scoring system to identify predictors of PPM placement was performed. The predictive discrimination of the risk score for the risk of PPM placement after TAVR was assessed with the area under the receiver operating characteristic curve (AUC). Results Our results demonstrated that, of the 479 patients analyzed, 236 (49.3%) received balloon-expandable valves and 243 (50.7%) received self-expanding valves. Pacemaker rates were higher in patients receiving self-expanding valves than those receiving balloon-expandable valves (25.1% versus 16.1%, p=0.018). The Emory risk score showed a moderate correlation with pacemaker requirement in patients receiving each valve type, with AUC for balloon-expandable and self-expanding valves of 0.657 and 0.645, respectively. Of the four risk score components, preoperative RBBB was the only predictor of pacemaker requirement with an AUC of 0.615 for both balloon-expandable and self-expanding valves. Conclusion. In our cohort, the Emory risk score had modest predictive utility for PPM insertion after balloon-expandable and self-expanding TAVR. The risk score did not offer better discriminatory utility than that of preoperative RBBB alone. Understanding the determinants of PPM insertion after TAVR can better guide patient education and postoperative management.