Coronary Access After TAVR With a Self-Expanding Bioprosthesis: Insights From Computed Tomography

ObjectivesThe authors sought to estimate possible interference of the Medtronic Evolut R/Pro transcatheter heart valve (THV) frame with coronary access using multislice computed tomography (MSCT) data.BackgroundLower-risk patients undergoing transcatheter aortic valve replacement (TAVR) endure a high cumulative risk of coronary events, but coronary access can be challenging.MethodsIn 101 patients who received an Evolut R/Pro THV, post-TAVR MSCT (performed at a median of 30 days after TAVR) was used to assess possible interference of the elements of the THV frame with coronary access.ResultsThe closest cell of the THV frame vertically aligned with the coronary ostium was located opposite the ostium in 58% and 63%, below the ostium in 22% and 30%, or above the ostium in 20% and 7% of left and right coronary arteries, respectively. The free sinus of Valsalva space between the THV frame and the coronary ostium was 0.45 ± 0.17 cm and 0.44 ± 0.17 cm for the left and right coronary arteries, respectively, and showed a stepwise decrease with decreasing THV size (p < 0.001). Bioprosthetic valve commissures were antianatomic (i.e., not aligned with native commissures) in 45 patients (47%), and the commissural post was overlapping a coronary ostium in 15 patients (16%). Two patients (2.0%) had a possible interference of the paravalvular sealing skirt with coronary access.ConclusionsUsing post-TAVR MSCT data, the main mechanism of potential interference of Evolut R/Pro frame with coronary access was an antianatomic commissural post overlapping the coronary ostium.     

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)     

Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR

ObjectivesThe aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR).BackgroundImpaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences.MethodsIn this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included.ResultsSuccess rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement.ConclusionsCA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.     

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.     

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.     

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.     

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.     

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.     

Coronary Access Following Redo TAVR: Impact of THV Design,Implant Technique,and Cell Misalignment

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

Delirium After TAVR: Crosspassing the Limit of Resilience

Patients who undergo transcatheter aortic valve replacement often are frail and elderly. Delirium is a frequently observed complication, associated with impaired recovery, prolonged hospital stay, and mortality. In different hospital settings, interventions that reduced the incidence of delirium resulted in improved clinical outcome and reduced costs. In that context, prevention, early recognition, and timely interventions could be the next step toward better outcomes of transcatheter aortic valve replacement. This review is focused on awareness and recognition of delirium, including predisposing “vulnerability” factors (such as cognitive impairment and carotid artery disease) and “trigger” factors (such as anesthesia, hemodynamic imbalance, and complications). For prevention and treatment, clinicians should focus on sleep hygiene, orientation, pain management, and early mobilization. In case of delirium, a thorough search and treatment of trigger factors is warranted. Future studies should focus on risk assessment, preventive and therapeutic interventions, and their potential benefit in terms of costs and clinical outcomes.     

Chimney Stenting for Coronary Occlusion During TAVR: Insights From the Chimney Registry

ObjectivesThe aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO).BackgroundCAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication.MethodsIn the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR.ResultsTo date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days.ConclusionsChimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.     

Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli

ObjectivesThe aim of this study was to define predictors of prosthesis-patient mismatch (PPM) and its impact on mortality after transcatheter aortic valve replacement (TAVR) with self-expandable valves (SEVs) in patients with small annuli.BackgroundTAVR seems to reduce the risk for PPM compared with surgical aortic valve replacement, especially in patients with small aortic annuli. Nevertheless, predictors and impact of PPM in this population have not been clarified yet.MethodsPredictors of PPM and all-cause mortality were investigated using multivariable logistic regression analysis from the cohort of the TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm² on computed tomography) treated with transcatheter SEVs: 445 patients with (n = 129) and without (n = 316) PPM were enrolled.ResultsIntra-annular valves conferred increased risk for PPM (odds ratio [OR]: 2.36; 95% confidence interval [CI]: 1.16 to 4.81), while post-dilation (OR: 0.46; 95% CI: 0.25–0.84) and valve oversizing (OR: 0.53; 95% CI: 0.28–1.00) seemed to protect against PPM occurrence. At a median follow-up of 354 days, patients with severe PPM, but not those with moderate PPM, had a higher all-cause mortality rate compared with those without PPM (log-rank p = 0.008). Multivariable Cox regression confirmed severe PPM as an independent predictor of all-cause mortality (hazard ratio: 4.27; 95% CI: 1.34 to 13.6).ConclusionsAmong patients with aortic stenosis and small aortic annuli undergoing transcatheter SEV implantation, use of intra-annular valves yielded higher risk for PPM; conversely, post-dilation and valve oversizing protected against PPM occurrence. Severe PPM was independently associated with all-cause mortality.     

Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry

ObjectivesThe aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation.BackgroundSurgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking.MethodsData from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year.ResultsFrom November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively.ConclusionsThe EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.     

Validation of the 2019 Expert Consensus Algorithm for the Management of Conduction Disturbances After TAVR

ObjectivesThe aim of this study was to validate the 2019 consensus algorithm in a large cohort of contemporary transcatheter aortic valve replacement (TAVR) patients.BackgroundThe optimal management of patients with atrioventricular conduction disturbances after TAVR is unknown. Guidance was consolidated in an expert consensus algorithm in 2019.MethodsIn a retrospective analysis of a prospective registry, patients were classified according to the 2019 consensus algorithm as eligible for early discharge (day 1 or 2 after TAVR), higher risk for high-degree atrioventricular block (HAVB) or complete heart block (CHB) or in need for a permanent pacemaker (PPM). The primary endpoint was the incidence of PPM implantation for HAVB or CHB within 30 days after TAVR. Patients with prior PPM or implantable cardioverter-defibrillator implantation, valve-in-valve procedures, or incomplete electrocardiographic data were excluded.ResultsAmong 1,439 patients undergoing TAVR between January 2014 and December 2019, the 2019 consensus algorithm classified 73% as eligible for early discharge, 21% as at higher risk for HAVB or CHB, and 6% as in need of PPM. PPM implantation for HAVB or CHB occurred in 234 patients (16%) within 30 days after TAVR. The incidence of PPM implantation was 2.7% in the early discharge group, 41% in the group with higher risk for HAVB or CHB, and 100% in the PPM group.ConclusionsThe 2019 consensus algorithm safely identifies patients with no need for PPM implantation. This strategy allows more uniform management of TAVR patients and facilitates early discharge of low-risk patients without prolonged monitoring in 3 of 4 patients. However, the algorithm is less precise in the identification of high-risk patients.     

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.     

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)     

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry

BackgroundThe optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined.ObjectivesThis study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD.MethodsPatients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score).ResultsAmong the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (P_interaction = 0.049).ConclusionsAmong patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.     

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.     

Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR

ObjectivesNo standardized algorithm exists to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR). The aim of this study was to generate and validate a useful predictive model.BackgroundBleeding events after TAVR influence prognosis and quality of life and may be preventable.MethodsUsing machine learning and multivariate regression, more than 100 clinical variables from 5,185 consecutive patients undergoing TAVR in the prospective multicenter RISPEVA (Registro Italiano GISE sull’Impianto di Valvola Aortica Percutanea; NCT02713932) registry were analyzed in relation to Valve Academic Research Consortium-2 bleeding episodes at 1 month. The model’s performance was externally validated in 5,043 TAVR patients from the prospective multicenter POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) database.ResultsDerivation analyses generated a 6-item score (PREDICT-TAVR) comprising blood hemoglobin and serum iron concentrations, oral anticoagulation and dual antiplatelet therapy, common femoral artery diameter, and creatinine clearance. The 30-day area under the receiver-operating characteristic curve (AUC) was 0.80 (95% confidence interval [CI]: 0.75–0.83). Internal validation by optimism bootstrap-corrected AUC was 0.79 (95% CI: 0.75–0.83). Score quartiles were in graded relation to 30-day events (0.8%, 1.1%, 2.5%, and 8.5%; overall p <0.001). External validation produced a 30-day AUC of 0.78 (95% CI: 0.72–0.82). A simple nomogram and a web-based calculator were developed to predict individual patient probabilities. Landmark cumulative event analysis showed greatest bleeding risk differences for top versus lower score quartiles in the first 30 days, when most events occurred. Predictivity was maintained when omitting serum iron values.ConclusionsPREDICT-TAVR is a practical, validated, 6-item tool to identify patients at risk of bleeding post-TAVR that can assist in decision making and event prevention.