Unplanned Percutaneous Coronary Revascularization After TAVR: A Multicenter International Registry

ObjectivesThis study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR).BackgroundCoronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated.MethodsPatients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry.ResultsBetween July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non–ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p = 0.150).ConclusionsUnplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indication to PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromes become prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparent differences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501)     

Coronary Access After TAVR

ObjectivesThe aim of this study was to assess the incidence of unfavorable coronary access after transcatheter aortic valve replacement (TAVR) using post-implantation computed tomography (CT).BackgroundReal-world data regarding coronary access after TAVR assessed using post-implantation CT are scarce.MethodsPost-TAVR CT of 66 patients treated with Evolut R or Evolut PRO valves and 345 patients treated with SAPIEN 3 valves were analyzed. The distance from inflow of the transcatheter heart valve (THV) to the coronary ostia and the overlap between THV commissures and the coronary ostia were assessed. Coronary access was defined as unfavorable if the coronary ostium was below the skirt or in front of the THV commissural posts above the skirt in each coronary artery.ResultsCT-identified features of unfavorable coronary access were observed in 34.8% (n = 23) for the left coronary artery and 25.8% (n = 17) for the right coronary artery in the Evolut R/Evolut PRO group, while those percentages were 15.7% (n = 54) for the left coronary artery and 8.1% (n = 28) for the right coronary artery in the SAPIEN 3 group. In the Evolut R/Evolut PRO group, 16 coronary engagements were performed after TAVR, while 64 coronary engagements were performed in the SAPIEN 3 group after TAVR. In an engagement-level analysis, the success rates of selective coronary engagement were significantly lower in patients with CT-identified features of unfavorable coronary access compared with those with favorable coronary access in both the Evolut R/Evolut PRO (0.0% vs. 77.8%; p = 0.003) and SAPIEN 3 (33.3% vs. 91.4%; p = 0.003) groups.ConclusionsCoronary access may be challenging in a significant proportion of patients after TAVR. THVs with low skirt or commissure height and large open cells that are designed to achieve commissure-to-commissure alignment with the native aortic valve may facilitate future coronary access. (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and Its Treatment With Anticoagulation [RESOLVE]; NCT02318342)     

The Effect of Coronary Lesion Complexity and Preprocedural Revascularization on 5-Year Outcomes After TAVR

BackgroundAortic stenosis and coronary artery disease (CAD) frequently coincide. However, the management of coexisting CAD in patients undergoing transcatheter aortic valve replacement (TAVR) remains controversial.ObjectivesThis study sought to determine whether the presence of CAD, its complexity, and angiography-guided percutaneous coronary intervention (PCI) are associated with outcomes after TAVR.MethodsAll patients undergoing TAVR at a tertiary referral center between 2008 and 2020 were included in a prospective observational study. Baseline SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score (SS) and, whenever applicable, a residual SS after PCI were calculated. A multivariate analysis was performed to determine the effect of CAD, stratified according to complexity, and PCI on 5-year outcomes.ResultsIn 604 patients, the presence of CAD and its complexity were significantly associated with worse 5-year survival (SS 0: 67.9% vs SS 1-22: 56.1% vs SS >22: 53.0%; log-rank P = 0.027) and increased cardiovascular mortality (SS 0: 15.1% vs SS 1-22: 24.0% vs SS >22: 27.8%; log-rank P = 0.024) after TAVR. Having noncomplex CAD (SS 1-22) was an independent predictor for increased all-cause mortality (HR: 1.43; P = 0.046), while complex CAD (SS >22) increased cardiovascular mortality significantly (HR: 1.84; P = 0.041). Angiography-guided PCI or completeness of revascularization was not associated with different outcomes.ConclusionsThe presence of CAD and its anatomical complexity in patients undergoing TAVR are associated with significantly worse 5-year outcomes. However, angiography-guided PCI did not improve outcomes, highlighting the need for further research into physiology-guided PCI.     

ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A Randomized Clinical Trial

ObjectivesThis study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm).BackgroundPCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice.MethodsPatients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population.ResultsAt 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021).ConclusionsObserved rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930)     

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Complex Coronary Artery Disease

ObjectivesThe aim of this study was to compare, in a cohort of patients with complex coronary artery disease (CAD) and severe aortic stenosis (AS), the clinical outcomes associated with transfemoral transcatheter aortic valve replacement (TAVR) (plus percutaneous coronary intervention [PCI]) versus surgical aortic valve replacement (SAVR) (plus coronary artery bypass grafting [CABG]).BackgroundPatients with complex CAD were excluded from the main randomized trials comparing TAVR with SAVR, and no data exist comparing TAVR + PCI vs SAVR + CABG in such patients.MethodsA multicenter study was conducted including consecutive patients with severe AS and complex CAD (SYNTAX [Synergy Between PCI with Taxus and Cardiac Surgery] score >22 or unprotected left main disease). A 1:1 propensity-matched analysis was performed to account for unbalanced covariates. The rates of major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, nonprocedural myocardial infarction, need for new coronary revascularization, and stroke, were evaluated.ResultsA total of 800 patients (598 undergoing SAVR + CABG and 202 undergoing transfemoral TAVR + PCI) were included, and after propensity matching, a total of 156 pairs of patients were generated. After a median follow-up period of 3 years (interquartile range: 1-6 years), there were no significant differences between groups for MACCE (HR for transfemoral TAVR vs SAVR: 1.33; 95% CI: 0.89-1.98), all-cause mortality (HR: 1.25; 95% CI: 0.81-1.94), myocardial infarction (HR: 1.16; 95% CI: 0.41-3.27), and stroke (HR: 0.42; 95% CI: 0.13-1.32), but there was a higher rate of new coronary revascularization in the TAVR + PCI group (HR: 5.38; 95% CI: 1.73-16.7).ConclusionsIn patients with severe AS and complex CAD, TAVR + PCI and SAVR + CABG were associated with similar rates of MACCE after a median follow-up period of 3 years, but TAVR + PCI recipients exhibited a higher risk for repeat coronary revascularization. Future trials are warranted.     

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry

ObjectivesThe aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).BackgroundCoronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.MethodsData were collected retrospectively from a multicenter international registry between April 2011 and February 2019.ResultsAmong 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in “valve-in-valve” procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).ConclusionsIn patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.     

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement

BackgroundAmong patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk.ObjectivesThe goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.MethodsThis was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.ResultsMedian door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.ConclusionsSTEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.     

Cusp Symmetry and Coronary Ostial Eccentricity and its Impact on Coronary Access Following TAVR

ObjectivesThe aim of this study was to assess cusp symmetry and coronary ostial eccentricity and its impact on coronary access following transcatheter aortic valve replacement (TAVR) using a patient-specific commissural alignment implantation technique.BackgroundTAVR implantation techniques to obtain neocommissural alignment have been introduced. The impact of cusp symmetry and coronary ostial eccentricity on coronary access after TAVR remains unknown.MethodsCardiac computed tomographic scans from 200 tricuspid aortic valves (TAVs) and 200 type 1 bicuspid aortic valves (BAVs) were studied. Cusp symmetry and coronary ostial eccentricity were assessed. In addition, the right coronary cusp/left coronary cusp and right coronary artery (RCA)/left coronary artery (LCA) ostia overlap views were calculated and compared.ResultsSevere cusp asymmetry (>135°) was more frequent in BAVs (52.5%) than in TAVs (2.5%) (P < 0.001), with the noncoronary cusp being the most common dominant cusp. The RCA ostium was found to be more often eccentric (>20°) than the LCA ostium (28% vs 6%, respectively; P < 0.001). Considering the right/left cusp overlap view, there was <20° deviation between the right coronary cusp–left coronary cusp centered line and the RCA-LCA centered line in 95% of all patients (TAV, 97%; BAV, 93%). The right/left cusp and coronary ostia overlap view differed by <10° and <20° fluoroscopic angulation in 75% and 98% of all cases, respectively.ConclusionsUsing the right/left cusp overlap view to obtain commissural alignment in TAVR is also an effective approach to implant one of the transcatheter heart valve commissures in the near center between both coronary ostia in most TAVs and type 1 BAVs. Preprocedural CT assessment remains crucial to assess cusp symmetry and coronary ostial eccentricity.     

Commissural Versus Coronary Optimized Alignment During Transcatheter Aortic Valve Replacement

ObjectivesThe aims of this study were to determine the rate of noncentered coronary ostia and their risk for coronary overlap (CO) and to develop an improved orientation strategy for transcatheter aortic valve replacement (TAVR) devices taking into account anatomical cues to identify patients at risk for CO regardless of commissural alignment and compute an alternative, CO-free TAVR rotation angle for those patients.BackgroundCommissural alignment during TAVR reduces CO risk. However, eccentricity of coronary ostia from the center of the sinus of Valsalva may result in CO even after perfect alignment of TAVR commissures.MethodsBaseline computed tomography from TAVR candidates helped identify distance from commissures to the right coronary artery (RCA) and the left coronary artery (LCA). Then, for each case, a virtual valve was simulated with ideal commissural or coronary alignment, and the degree of CO was determined. On the basis of the potential BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) efficacy, 3 groups were defined: no risk for CO (>35° from neocommissure to coronary ostia), moderate risk (20°-35°), and severe risk (≤20°).ResultsComputed tomographic studies from 107 patients were included. After excluding 7 patients (poor quality or bicuspid valve), 100 patients were analyzed. The RCA showed greater eccentricity compared with the LCA (18.5° [IQR: 3.3°-12.8°] vs 6.5° [IQR: 3.3°-12.8°]; P < 0.001). The mean intercoronary angle was 140.0° ± 18.7° (95% CI: 136.3°-143.7°). Thirty-two patients had moderate to severe risk for CO (≤35°) despite ideal commissural alignment. Greater coronary eccentricity (cutoff for RCA, 24.5°; cutoff for LCA, 19°) and intercoronary angle >147.5° or <103° were associated with greater risk for moderate to severe CO despite commissural alignment (area under the curve: 0.97; 95% CI: 0.91-0.99). If optimal coronary alignment was simulated, this prevented severe CO in all cases and reduced moderate CO from 27% to 5% (P < 0.001).ConclusionsOne third of patients would have CO during TAVR-in-TAVR despite commissural alignment; a 6-fold decrease in this risk was achieved with optimized coronary alignment. Coronary eccentricity and intercoronary angle were the main predictors.     

Alignment of Transcatheter Aortic-Valve Neo-Commissures (ALIGN TAVR): Impact on Final Valve Orientation and Coronary Artery Overlap

ObjectivesThe aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries.BackgroundCoronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated.MethodsPre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o’clock. The Evolut “Hat” marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation.ResultsInitial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut “Hat” at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut “Hat” at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases.ConclusionsThis is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.     

Procedural Characteristics and Late Outcomes of Percutaneous Coronary Intervention in the Workup Pre-TAVR

ObjectivesThis study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre–transcatheter aortic valve replacement (TAVR): 1) the clinical and peri-procedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features.BackgroundA PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown.MethodsMulticenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF).ResultsOne-half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population).ConclusionsPatients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR.     

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study

ObjectivesThe aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.BackgroundCertain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking.MethodsRE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.ResultsAmong 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV–sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01).ConclusionsUnsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV–sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204)     

Coronary Obstruction From TAVR in Native Aortic Stenosis: Development and Validation of Multivariate Prediction Model

BackgroundTranscatheter aortic valve replacement (TAVR)–related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies.ObjectivesThis study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis.MethodsPreprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort.ResultsSixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm³) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right.ConclusionsA novel computed tomography–based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis.     

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement

BackgroundCoronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal.ObjectivesThe 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.MethodsThe 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.ResultsFollowing 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%.ConclusionsEvaluation 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.     

Incidence and Outcomes of Acute Coronary Syndrome After Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to address a knowledge gap by examining the incidence, timing, and predictors of acute coronary syndrome (ACS) after transcatheter aortic valve replacement (TAVR) in Medicare beneficiaries.BackgroundEvidence about incidence and outcomes of ACS after TAVR is scarce.MethodsWe identified Medicare patients who underwent TAVR from 2012 to 2017 and were admitted with ACS during follow-up. We compared outcomes based on the type of ACS: ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina. In patients with non–ST-segment elevation ACS, we compared outcomes based on the treatment strategy (invasive vs. conservative) using inverse probability weighting analysis.ResultsOut of 142,845 patients with TAVR, 6,741 patients (4.7%) were admitted with ACS after a median time of 297 days (interquartile range: 85 to 662 days), with 48% of admissions occurring within 6 months. The most common presentation was NSTEMI. Predictors of ACS were history of coronary artery disease, prior revascularization, diabetes, valve-in-TAVR, and acute kidney injury. STEMI was associated with higher 30-day and 1-year mortality compared with NSTEMI (31.4% vs. 15.5% and 51.2% vs. 41.3%, respectively; p < 0.01). Overall, 30.3% of patients with non–ST-segment elevation ACS were treated with invasive approach. On inverse probability weighting analysis, invasive approach was associated with lower adjusted long-term mortality (adjusted hazard ratio: 0.69; 95% confidence interval: 0.66 to 0.73; p < 0.01) and higher risk of repeat revascularization (adjusted hazard ratio: 1.29; 95% confidence interval: 1.16 to 1.43; p < 0.001).ConclusionsAfter TAVR, ACS is infrequent (<5%), and the most common presentation is NSTEMI. Occurrence of STEMI after TAVR is associated with a high mortality with nearly one-third of patients dying within 30 days. Optimization of care is needed for post-TAVR ACS patients and if feasible, invasive approach should be considered in these high-risk patients.     

Feasibility of Coronary Access and Aortic Valve Reintervention in Low-Risk TAVR Patients

ObjectivesThe aim of this study was to evaluate the feasibility of coronary access and aortic valve reintervention in low-risk patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter heart valve (THV).BackgroundYounger, low-risk TAVR patients are more likely than older, higher risk patients to require coronary angiography, percutaneous coronary intervention, or aortic valve reintervention, but their THVs may impede coronary access and cause coronary obstruction during TAVR-in-TAVR.MethodsThe LRT (Low Risk TAVR) trial (NCT02628899) enrolled 200 subjects with symptomatic severe aortic stenosis to undergo TAVR using commercially available THVs. Subjects who received balloon-expandable THVs and who had 30-day cardiac computed tomographic scans were included in this study. In a subgroup, the feasibility of intentional THV crimping on the delivery catheter to pre-determine commissural alignment was tested.ResultsIn the LRT trial, 168 subjects received balloon-expandable THVs and had 30-day cardiac computed tomographic scans, of which 137 were of adequate image quality for analysis. The most challenging anatomy for coronary access (THV frame above and commissural suture post in front of a coronary ostium) was observed in 9% to 13% of subjects. Intentional THV crimping did not appear to meaningfully affect commissural alignment. The THV frame extended above the sinotubular junction in 21% of subjects, and in 13%, the distance between the THV and the sinotubular junction was <2 mm, signifying that TAVR-in-TAVR may not be feasible without causing coronary obstruction.ConclusionsTAVR may present challenges to future coronary access and aortic valve reintervention in a substantial number of low-risk patients.     

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography

ObjectivesThe aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)–in–TAVR using multidetector computed tomography.BackgroundExpanding 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.MethodsIn 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.ResultsAfter 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).ConclusionsCoronary 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.     

Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement

ObjectivesThe aim of this study was to evaluate the risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement (TAVR) using post-TAVR computed tomography (CT).BackgroundLittle information is available regarding the risk of coronary obstruction due to sinus sequestration in redo TAVR inside a previously implanted TAV.MethodsPost-TAVR CT of 66 patients who received an Evolut R or Evolut PRO and 345 patients who received a SAPIEN 3 were analyzed. Redo TAVR was considered at risk of coronary obstruction due to sinus sequestration if: 1) the prior TAV commissure level was above sinotubular junction (STJ); and 2) the distance between TAV and STJ was <2.0 mm in each coronary sinus.ResultsIn total, 45.5% in the Evolut R/Evolut PRO group and 2.0% in the SAPIEN 3 group had CT-identified risk of sinus sequestration at 1 or both coronary arteries (p < 0.001). CT-identified risk of sinus sequestration was observed in 39.4% for the left coronary artery and 24.2% for the right coronary artery in the Evolut R/Evolut PRO group, while those percentages were 2.0% for the left coronary artery and 0.6% for the right coronary artery in the SAPIEN 3 group. In a coronary-level analysis, overlaps between the first TAV commissural posts and coronary ostium were observed in 45.2% in the Evolut R/Evolut PRO group and 11.1% in in the SAPIEN 3 group among coronary arteries at CT-identified risk of sinus sequestration.ConclusionsThe risk of sinus sequestration in redo TAVR should be carefully screened by CT, especially in patients with low STJ height. TAV with low commissure height that was designed to achieve commissure-to-commissure alignment with the native aortic valves may be preferable to avoid the risk of coronary obstruction due to sinus sequestration and allow for a preventive leaflet laceration procedure in future redo TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation [RESOLVE]; NCT02318342)     

Diagnostic Performance of CCTA and CT-FFR for the Detection of CAD in TAVR Work-Up

BackgroundThe work-up for transcatheter aortic valve replacement (TAVR) currently uses computed tomography to evaluate the annulus diameter and peripheral vascular access plus invasive coronary angiography (ICA) to assess significant coronary artery disease (CAD). ICA might partially be redundant with the use of coronary computed tomography angiography (CCTA). Prior studies found an improvement of the diagnostic accuracy of CCTA with the use of computed tomography–derived fractional flow reserve (CT-FFR).ObjectivesThe aim of this study was to assess the diagnostic performance of CT-FFR for the diagnosis of CAD in the work-up for TAVR.MethodsConsecutive patients with severe symptomatic aortic valve stenosis who underwent TAVR work-up between 2015 and 2019 were included in this retrospective cross-sectional study. All patients underwent CCTA and ICA within 3 months, and the diagnostic performance of both CCTA and CT-FFR was assessed using ICA as the reference.ResultsSeventy-six of the 338 patients included in the analysis had ≥1 significant coronary stenosis on ICA. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy per patient were 76.9%, 64.5%, 34.0%, 92.1%, and 66.9% for CCTA and 84.6%, 88.3%, 63.2%, 96.0%, and 87.6% for CT-FFR. The area under the receiver-operating characteristic curve was significantly different between CCTA and CT-FFR (0.84 vs 0.90, P = 0.02). A CT-FFR–guided approach could avoid ICA in 57.1% versus 43.6% of patients using CCTA.ConclusionsCT-FFR significantly improves the diagnostic accuracy of CCTA without additional testing and increases the proportion of patients in whom ICA could have been safely avoided. It has the potential to be integrated in the current clinical work-up for TAVR for diagnosing stable CAD requiring treatment.     

Real-World Examination of Revascularization Strategies for Left Main Coronary Disease in Ontario,Canada

BackgroundRandomized trials have compared percutaneous coronary intervention and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease undergoing nonemergent revascularization. However, there is a paucity of real-world contemporary observational studies comparing percutaneous coronary intervention (PCI) and CABG.ObjectivesThe purpose of this study was to compare the long-term clinical outcomes of CABG versus PCI in patients with left main coronary disease.MethodsClinical and administrative databases for Ontario, Canada, were linked to obtain records of all patients with angiographic evidence of left main coronary artery disease (≥50% stenosis) treated with either isolated CABG or PCI from 2008 to 2020. Emergent, cardiogenic shock, and ST-segment elevation myocardial infarction patients were excluded. Baseline characteristics of patients were compared and 1:1 propensity score matching was performed. Late mortality and major adverse cardiac and cerebrovascular events were compared between the matched groups using a Cox proportional hazard model.ResultsAfter exclusions, 1,299 and 21,287 patients underwent PCI and CABG, respectively. Prior to matching, PCI patients were older (age 75.2 vs 68.0 years) and more likely to be women (34.6% vs 20.1%), although they had less CAD burden. Propensity score matching on 25 baseline covariates yielded 1,128 well-matched pairs. There was no difference in early mortality between PCI and CABG (5.5% vs 3.9%; P = 0.075). Over 7-year follow-up, all-cause mortality (53.6% vs 35.2%; HR: 1.63; 95% CI: 1.42-1.87; P < 0.001) and major adverse cardiac and cerebrovascular events (66.8% vs 48.6%; HR: 1.77; 95% CI: 1.57-2.00) were significantly higher with PCI than CABG.ConclusionsCABG was the most common revascularization strategy in this real-world registry. Patients undergoing PCI were much older and of higher risk at baseline. After matching, there was no difference in early mortality but improved late survival and freedom from major adverse cardiac and cerebrovascular events with CABG.