We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter aortic valve (S3).
Of 249 patients who had undergone S3 implantation, we studied ...156 consecutive patients (85 women, median age 82.2 ± 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after a median of 5 days post-transcatheter aortic valve implantation. The prosthesis was assessed for HALT. Apart from heparin, peri-interventional antithrombotic therapy consisted of single- (aspirin 29%) or dual- (aspirin plus clopidogrel 71%) antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients 10.3% (95% confidence interval (CI) 5.5-15.0%) of the patients. None of the baseline and procedural variables were significantly associated with HALT, nor did we find a significant association with the antithrombotic regimen, either peri-interventionally or at the time of CTA. Hypo-attenuated leaflet thickening was found in 6 of 45 patients with peri-interventional single-antiplatelet therapy and in 10 of 111 patients with dual-antiplatelet therapy at the time of intervention 13.3% (95% CI 3.4-23.3%) vs. 9% (95% CI 3.7-14.3%), P = 0.42. Hypo-attenuated leaflet thickening was not associated with clinical symptoms, but a small, albeit significant difference in mean pressure gradient at the time of CTA (11.6 ± 3.4 vs. 14.9 ± 5.3 mmHg, P = 0.026). Full anticoagulation led to almost complete resolution of HALT in 13 patients with follow-up CTA.
Irrespective of the antiplatelet regimen, early HALT occurred in 10% of our patients undergoing transcatheter aortic S3 implantation. Early HALT is clinically inapparent and reversible by full anticoagulation.
Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).
This study sought to compare the procedural and clinical outcomes ...in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry.
Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria.
Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28).
Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.
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Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR ...may play a key strategy in treating patients in whom THVs fail.
The authors sought to examine outcomes following redo-TAVR.
The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.
Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke 1.4%, 7 valve malposition 3.3%, 2 coronary obstruction 0.9%, 20 new permanent pacemaker 9.6%, no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.
Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
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The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT).
The clinical significance of early LT after transcatheter aortic valve replacement, diagnosed ...by computed tomography angiography in approximately 10% of patients, is uncertain.
In this observational study, computed tomographic angiography was performed a median of 5 days after transcatheter aortic valve replacement and assessed for evidence of LT. Follow-up consisted of clinical visits, telephone contact, or questionnaire.
LT was diagnosed in 120 of 754 patients (15.9%). Patients with LT were less likely male (36.7% vs. 47.0%, p = 0.045), with a lower rate of atrial fibrillation (28.3% vs. 41.5%, p = 0.008). Peri- and post-procedural characteristics were comparable between groups (e.g., valve implantation technique; p = 0.116). During a median follow-up period of 406 days, there were no significant differences in the primary endpoint of all-cause mortality and the secondary combined endpoint of stroke and transient ischemic attack between patients with LT and those without LT (18-month Kaplan-Meier estimate for mortality 86.6% vs. 85.4%, p = 0.912; for stroke- or transient ischemic attack–free survival 98.5% vs. 96.8%, p = 0.331). In univariate and multivariate analyses, LT was not predictive of either endpoint, whereas male sex (p = 0.03), atrial fibrillation (p = 0.002), and more than mild paravalvular leak (p = 0.015) were associated with all-cause mortality.
In this prospective observational cohort undergoing post–transcatheter aortic valve replacement computed tomographic angiography, LT was not associated with increased mortality or rates of stroke over a follow-up period of 406 days.
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Abstract Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data ...exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT Edwards Lifesciences Corporation, Irvine, California: n = 87; CoreValve Medtronic, Minneapolis, Minnesota: n = 112) and 102 with new-generation devices (Sapien 3 Edwards Lifesciences Corporation: n = 91; Lotus Boston Scientific Corporation, Marlborough, Massachusetts: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry Bicuspid TAVR; NCT02394184 )
Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The ...choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.
The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).
Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.
For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm
vs. 1.37 ± 0.5 cm
; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).
In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography.
Expanding TAVR to patients with longer ...life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.
In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.
After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).
Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.
Prior studies in patients with transcatheter aortic valve implantation (TAVI) demonstrated an influence of transcatheter heart valve (THV) position on the occurrence of new conductions disturbances ...(CD) and paravalvular leakage (PVL) post TAVI in balloon-expandable valves (BEV). Purpose of this study was to investigate the THV implantation depth and its influence on the occurrence of CD and PVL in self-expanding valves (SEV). We performed fusion imaging of pre- and post-procedural computed tomography angiography in 104 TAVI-patients (all with Evolut R) to receive a 3-D reconstruction of the THV within the native annulus region. The THV length below the native annulus was measured for assessment of implantation depth. Electrocardiograms pre-discharge were assessed for conduction disturbances (CD), PVL was determined in transthoracic echocardiography. The mean implantation depth of the THV in the whole cohort was 4.3 ± 3.0 mm. Using the best cut-off of ≥ 4 mm in receiver operating characteristic curve analysis (sensitivity 83.3%, specificity 60.0%) patients with lower THV position developed more new CD after TAVI (68.2 vs. 23.7%, P < 0.001). A deep THV position was identified as the only predictor for new CD after TAVI (odds ratio CI 1.3121.119–1.539, P = 0.001). The implantation depth showed no influence on the grade of PVL (r = 0.052, P = 0.598). In patients with TAVI using the Evolut R SEV, a lower THV positioning (≥ 4 mm length below annulus) was a predictor for new conduction disturbances. In contrast, implantation depth was not associated with the extent of PVL.
Graphic abstract
Prostheses positions of self-expanding valves and their influence on the occurrence of new conduction disturbances and the grade of paravalvular leakage after TAVI.
The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
MR is common in patients ...undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited.
The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared.
In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio HR: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score–matched cohort (91 patients’ pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097).
Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter AMTRAC Valve Registry AMTRAC; NCT04031274).
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Background
Low prosthesis position after transcatheter aortic valve implantation (TAVI) is associated with higher rates of new onset conduction disturbances and permanent pacemaker implantations. ...Purpose of this study was to investigate possible predictors of a low prosthesis position of the SAPIEN 3 (Edwards Lifesciences, Irvine, California, USA) valve type using fusion imaging of pre- and post-procedural computed tomography angiography (CTA).
Methods
CTA fusion imaging was performed in 120 TAVI-patients with 3D-reconstruction of the transcatheter heart valve (THV) position within the device landing zone. A low implantation position was defined according to the manufacturer’s recommendations as > 30% of the prosthesis below the native annulus plane.
Results
A low THV position was found in 17 patients (14%). Patients with low THV position had less calcification of the annulus region and a smaller annulus size compared to patients with a normal or high THV position (
P
= 0.003 and 0.041, respectively). The only independent predictor of a low THV position in multivariate logistic regression analysis was the extent of calcification of the cusp region (odds ratio CI 0.842 0.727–0.976,
P
= 0.022).
Conclusions
Fusion imaging of pre-and post-procedural CTA identified reduced calcification of the cusp region as an independent predictor of a low THV position of the SAPIEN 3. This should be considered when planning the TAVI procedure.
Graphic abstract
Correlation of cusp region calcification and prosthesis position after TAVI
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