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.     

Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing

ObjectivesThis study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).BackgroundTranscaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.MethodsPreclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration–approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.ResultsTranscaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.ConclusionsThe TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).     

Risk of Coronary Obstruction During Redo-TAVR in Patients With Bicuspid Versus Tricuspid Aortic Valve Stenosis

ObjectivesThe aim of this study was to investigate the risk of coronary obstruction during redo–transcatheter aortic valve replacement (TAVR) within a previously implanted self-expanding valve in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis.BackgroundThe prevalence of BAV in TAVR patients is expected to increase as the indication expands; however, no study has investigated the risk of coronary obstruction for future redo-TAVR in these patients.MethodsComputed tomography (CT) simulation analysis was performed in 86 type 0 BAV, 70 type 1 BAV, and 132 TAV patients who underwent TAVR with 1 VenusA-Valve (Venus Medtech) between January 2014 and December 2019.ResultsCT-identified risk of coronary obstruction during redo-TAVR was observed in 36.1% of patients for the left coronary ostium (LCO) and 27.8% of patients for the right coronary ostium (RCO); however, the incidences were significantly lower in the type 0 BAV group than in the type 1 BAV or TAV group (for LCO: OR: 1.00 [reference] vs OR: 2.49; 95% CI: 1.24-5.01 vs OR: 2.60; 95% CI: 1.40-4.81; for RCO: OR: 1.00 [reference] vs OR: 2.14; 95% CI: 1.02-4.48 vs OR: 1.97; 95% CI: 1.02-3.80). The leaflet laceration technique may be unfeasible to improve coronary flow in 61.5% of the threatened LCOs and 58.8% of the threatened RCOs during redo-TAVR. The percentages were significantly or numerically lower in the type 0 BAV group than other groups (for LCO: 26.3% vs 62.1% vs 73.2%; P overall = 0.001; for RCO: 43.8% vs 65.2% vs 61.0%; P overall = 0.374).ConclusionsDifferences in anatomical features may impact the feasibility of future redo-TAVR. Type 0 BAV anatomy was associated with the lower incidence of CT-identified risk of coronary obstruction during redo-TAVR, and the leaflet laceration technique may be more feasible to ensure coronary flow in this population.     

Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants

ObjectivesThis study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation.BackgroundA significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown.MethodsConsecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality.ResultsOf 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36).ConclusionsContinuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.     

Outcomes of Combined Transcatheter Aortic Valve Replacement and Peripheral Vascular Intervention in the United States

ObjectivesThe aim of this study was to compare the prevalence and real-world outcomes of patients who require peripheral vascular intervention during the same hospitalization as transcatheter aortic valve replacement (TAVR) compared with TAVR alone.BackgroundThere are limited data on the prevalence and outcomes of combined TAVR and percutaneous peripheral vascular intervention.MethodsAll patients who underwent TAVR in 2016 and 2017 were identified using the Nationwide Readmissions Database. Outcomes of patients undergoing TAVR alone were compared with those of patients undergoing combined TAVR and peripheral intervention, TAVR and peripheral intervention with and without a history of peripheral artery disease, and alternative-access TAVR with transfemoral TAVR in individuals undergoing peripheral intervention. The primary outcome was in-hospital mortality.ResultsA total of 99,654 hospitalizations were identified, among which 4,397 patients (4.42%) underwent peripheral intervention during the same admission as TAVR. Patients who required peripheral intervention had increased mortality (4.2% vs 1.5%; P < 0.001), stroke (3.5% vs 1.8%; P < 0.001), acute kidney injury (17.6% vs 10.8%; P < 0.001), blood transfusion (16.0% vs 11.3%; P < 0.001), 30-day readmission (16.3% vs 12.1%; P < 0.001), median length of stay (4 days [IQR: 2-8 days] vs 3 days [IQR: 2-5 days]; P < 0.001), and hospitalization charges. Compared with patients undergoing peripheral intervention to facilitate transfemoral TAVR, alternative-access TAVR was associated with increased mortality (4.6% vs 3.0%; P = 0.036), acute kidney injury (22.7% vs 14.3%; P < 0.001), median length of stay (5 days [IQR: 3-10 days] vs 4 days [IQR: 2-7 days]; P < 0.001), and 30-day readmission (18.1% vs 15.5%; P = 0.012).ConclusionsPeripheral vascular intervention may be used to facilitate transfemoral access or as a bailout for vascular complications during TAVR. Combined TAVR and peripheral intervention is associated with an increased risk for adverse events, though outcomes are better compared with alternative-access TAVR using a nonfemoral approach.     

Balloon Aortic Valvuloplasty as a Bridge to Aortic Valve Replacement: A Contemporary Nationwide Perspective

ObjectivesThis study sought to use a national representative database to assess the incidence, predictors, and outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in contemporary practice.BackgroundNationwide data on the use and outcomes of BAV as a bridge to TAVR are limited.MethodsPatients who underwent BAV between January and June in 2015 and 2016 were identified in the National Readmission Database. We assessed rate of subsequent TAVR following BAV, and predictors and timing of subsequent TAVR. We then identified a group of patients who had direct TAVR (without prior BAV) in the original 2015 to 2016 National Readmission Database dataset. We compared in-hospital outcomes following TAVR between patients with prior bridging BAV and those undergoing direct TAVR.ResultsAmong the 3,691 included patients 1,426 (38.6%) had subsequent TAVR. Timing of TAVR was pre-discharge in 7.4%, within 30 days in 35%, between 31 and 90 days in 47%, between 91 and 180 days in 14%, and >180 days in 4%. Negative predictors of subsequent TAVR included prior defibrillator (odds ratio [OR]: 0.56; 95% confidence interval [CI]: 0.36 to 0.85), dementia (OR: 0.60; 95% CI: 0.46 to 0.79), malnutrition (OR: 0.64; 95% CI: 0.45 to 0.90), and malignancy (OR: 0.62; 95% CI: 0.47 to 0.82). In propensity-score matched cohorts of patients who underwent direct TAVR versus those with prior BAV, in-hospital mortality during TAVR admission was similar (3.7% vs. 3.5%; p = 0.91). Major complications, length of stay, and discharge disposition were also comparable. However, cost of the hospitalization was higher in the direct TAVR group.ConclusionsAbout 40% of BAV patients undergo subsequent TAVR mostly within 90 days. In-hospital outcomes of TAVR in these patients were comparable with propensity-score matched patients who underwent TAVR without prior BAV. Further investigations are needed to define the role of BAV in contemporary practice.     

Outcomes After Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Anatomy: A Systematic Review and Meta-Analysis

ObjectivesThe aim of this study was to compare the feasibility, safety, and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis.BackgroundAt present, limited observational data exist supporting TAVR in the context of bicuspid anatomy.MethodsPrimary endpoints were 1-year survival and device success. Secondary endpoints included moderate to severe paravalvular leak (PVL) and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually.ResultsIn the main analysis, 17 studies and 181,433 patients undergoing TAVR were included, of whom 6,669 (0.27%) had BAV. A secondary analysis of 7,071 matched subjects with similar baseline characteristics was also performed. Device success and 1-year survival rates were similar between subjects with BAV and those with TAV (97% vs 94% [P = 0.55] and 91.3% vs 90.8% [P = 0.22], respectively). In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in our main analysis (risk ratio [RR]: 1.12; 95% CI: 0.99-1.27; P = 0.07) but not in the matched population secondary analysis (RR: 1.00; 95% CI: 0.81-1.24; P = 0.99). The risk for moderate to severe PVL was higher in subjects with BAV (RR: 1.42; 95% CI: 1.29-1.58; P < 0.0001) as well as the incidence of cerebral ischemic events (2.4% vs 1.6%; P = 0.015) and of annular rupture (0.3% vs 0.02%; P = 0.014) in matched subjects.ConclusionsTAVR is a feasible option among selected patients with BAV anatomy, but the higher rates of moderate to severe PVL, annular rupture, and cerebral ischemic events observed in the BAV group warrant caution and further evidence.     

Infective Endocarditis After Transcatheter Aortic Valve Replacement

BackgroundInfective endocarditis may affect patients after transcatheter aortic valve replacement (TAVR).ObjectivesThe purpose of this study was to provide detailed information on incidence rates, types of microorganisms, and outcomes of infective endocarditis after TAVR.MethodsBetween February 2011 and July 2018, consecutive patients from the SwissTAVI Registry were eligible. Infective endocarditis was classified into early (peri-procedural [<100 days] and delayed-early [100 days to 1 year]) and late (>1 year) endocarditis. Clinical events were adjudicated according to the Valve Academic Research Consortium-2 endpoint definitions.ResultsDuring the observational period, 7,203 patients underwent TAVR at 15 hospitals in Switzerland. During follow-up of 14,832 patient-years, endocarditis occurred in 149 patients. The incidence for peri-procedural, delayed-early, and late endocarditis after TAVR was 2.59, 0.71, and 0.40 events per 100 person-years, respectively. Among patients with early endocarditis, Enterococcus species were the most frequently isolated microorganisms (30.1%). Among those with peri-procedural endocarditis, 47.9% of patients had a pathogen that was not susceptible to the peri-procedural antibiotic prophylaxis. Younger age (subhazard ratio [SHR]: 0.969; 95% confidence interval [CI]: 0.944 to 0.994), male sex (SHR: 1.989; 95% CI: 1.403 to 2.818), lack of pre-dilatation (SHR: 1.485; 95% CI: 1.065 to 2.069), and treatment in a catheterization laboratory as opposed to hybrid operating room (SHR: 1.648; 95% CI: 1.187 to 2.287) were independently associated with endocarditis. In a case-control matched analysis, patients with endocarditis were at increased risk of mortality (hazard ratio: 6.55; 95% CI: 4.44 to 9.67) and stroke (hazard ratio: 4.03; 95% CI: 1.54 to 10.52).ConclusionsInfective endocarditis after TAVR most frequently occurs during the early period, is commonly caused by Enterococcus species, and results in considerable risks of mortality and stroke. (NCT01368250)     

Incidence,Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States

ObjectivesThis study sought to evaluate the incidence and outcomes of endocarditis after transcatheter aortic valve replacement (TAVR).BackgroundData about endocarditis after TAVR are limited.MethodsThe study investigated Medicare patients who underwent TAVR from 2012 to 2017 and identified patients admitted with endocarditis during follow-up using a validated algorithm. The main study outcome was all-cause mortality.ResultsOf 134,717 patients who underwent TAVR, 1868 patients developed endocarditis during follow-up (incidence 0.87%/year), with majority of infections (65.0%) occurring within 1 year. Incidence of endocarditis declined in recent years. The most common organisms were Staphylococcus (22.0%), Streptococcus (20.0%), and Enterococcus (15.5%). Important predictors for endocarditis were younger age at TAVR, male sex, prior endocarditis, end-stage renal disease, repeat TAVR procedures, liver and lung disease, and post-TAVR acute kidney injury. Thirty-day and 1-year mortality were 18.5% and 45.6%, respectively. After adjusting for comorbidities and procedural complications, endocarditis after TAVR was associated with 3-fold higher risk of mortality (44.9 vs. 16.2 deaths per 100 person-years; adjusted hazard ratio [aHR]: 2.94; 95% confidence interval [CI]: 2.77 to 3.12; p < 0.0001). End-stage renal disease (aHR: 2.12; 95% CI: 1.72 to 2.60), endocarditis complicated by cardiogenic shock (aHR: 2.50, 95% CI: 1.56 to 4.02), ischemic stroke (aHR: 1.56; 95% CI: 1.07 to 2.28), intracerebral hemorrhage (aHR: 1.67; 95% CI: 1.01 to 2.76), acute kidney injury (aHR: 1.44; 95% CI: 1.27 to 1.63), blood transfusion (aHR: 1.28; 95% CI: 1.09 to 1.50), staphylococcal (aHR: 1.71; 95% CI: 1.49 to 1.97), and fungal endocarditis (aHR: 1.72; 95% CI: 1.23 to 2.39) (p < 0.05 for all) portended higher mortality following endocarditis.ConclusionsThe incidence of endocarditis after TAVR is low and declining. However, it is associated with poor prognosis with one-half the patients dying within 1 year.     

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)     

Routine Ultrasound or Fluoroscopy Use and Risk of Vascular/Bleeding Complications After Transfemoral TAVR

ObjectivesThis study aimed to examine the benefits of routine use of 2D-US in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR).BackgroundTwo-dimensional ultrasound (2D-US) reduces access-related vascular complications (VCs) and bleeding in patients undergoing percutaneous coronary intervention via transfemoral approach. Potential similar benefits in patients undergoing transfemoral TAVR have not been systemically investigated.MethodsRates of access-related VCs or bleeding were compared using 5-year retrospective observational data from 2 neighboring high-volume UK TAVR centers systemically using 2 different techniques (center 1: fluoroscopy and contralateral angiography [FCA], center 2: 2D-US) for femoral puncture at the time of transfemoral TAVR.ResultsOverall, 1,171 patients were included in the study (FCA, n = 624; 2D-US, n = 529). Baseline clinical and procedural characteristics were similar between the 2 groups. There was no difference in the risk of VCs, bleeding, or their composite according to femoral puncture technique (FCA vs. 2D-US: 6.7% [95% confidence interval (CI): 4.9% to 8.9%] vs. 6.8% [95% CI: 4.8% to 9.3%]; p = 0.63; 6.1% [95% CI: 4.4% to 8.2%] vs. 6.4% [95% CI: 4.8% to 9.3%]; p = 0.70; and 9.8% [95% CI: 7.6% to 12.4%] vs. 9.8% [95% CI: 7.4% to 12.7%]; p = 0.76, respectively) and no difference when analysis was restricted to a composite of major VCs or major and life-threatening bleeding.ConclusionsVascular and bleeding complications can be achieved using either FCA or 2D-US guidance. Further studies are required to identify and assess alternative strategies to reduce periprocedural VCs and bleeding in this patient population.     

Delayed Total Atrioventricular Block After Transcatheter Aortic Valve Replacement Assessed by Implantable Loop Recorders

ObjectivesThe aims of this study were to evaluate the rate and time course of delayed total atrioventricular block (DT-AVB) after transcatheter aortic valve replacement (TAVR) using continuous electrocardiographic monitoring by implantable loop recorders and to identify potential predictors.BackgroundDT-AVB has been defined as onset more than 2 days after TAVR or after hospital discharge and is reported in 10% to 15% of patients at 30-day follow-up. To date, there is no standardized diagnostic and therapeutic algorithm to manage TAVR patients at risk for DT-AVB.MethodsConsecutive patients undergoing TAVR and simultaneous electrophysiologic testing without persistent or recurrent total atrioventricular block within 48 hours after the procedure underwent loop recorder implantation for full disclosure of atrioventricular conduction during 12-month follow-up.ResultsDT-AVB occurred in 7 of 59 patients (11.9%), with onset between 2 days and 3 months after the procedure. Both prolongation of the PQ interval between baseline and day 2 after TAVR (OR: 1.04; 95% CI: 1.01-1.09); P = 0.032) and prolongation of the HV interval during the procedure (OR: 1.07; 95% CI: 1.02-1.14; P = 0.015) significantly predicted the onset of DT-AVB.ConclusionsTAVR was associated with a considerable rate of DT-AVB of nearly 12% in this series. Prolongation of the PQ interval between baseline and day 2 and intraprocedural prolongation of the HV interval were significant predictors of DT-AVB.     

The Use and Outcomes of Cerebral Protection Devices for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Clinical Practice

ObjectivesThis study hypothesized that cerebral protection prevents strokes in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in clinical practice.BackgroundPreventing strokes is an important aim in TAVR procedures. Embolic protection devices may protect against cardiac embolism during TAVR, but their use and outcomes in clinical practice remain controversial.MethodsIsolated transfemoral TAVR procedures performed in Germany with or without cerebral protection devices were extracted from a comprehensive nationwide billing dataset.ResultsA total of 41,654 TAVR procedures performed between 2015 and 2017 were analyzed. The overall share of procedures incorporating cerebral protection devices was 3.8%. Patients receiving cerebral protection devices were at increased operative risk (European System for Cardiac Operative Risk Evaluation score 13.8 vs. 14.7; p < 0.001) but of lower age (81.1 vs. 80.6 years; p = 0.001). To compare outcomes that may be related to the use of cerebral protection devices, a propensity score comparison was performed. The use of a cerebral protection device did not reduce the risk for stroke (adjusted risk difference [aRD]: +0.88%; 95% confidence interval [CI]: ?0.07% to 1.83%; p = 0.069) or the risk for developing delirium (aRD: +1.31%; 95% CI: ?0.28% to 2.89%; p = 0.106) as a sign of acute brain failure. Although brain damage could not be prevented, in-hospital mortality was lower in the group receiving a cerebral protection device (aRD: ?0.76%; 95% CI: ?1.46% to ?0.06%; p = 0.034).ConclusionsIn this large national database, cerebral embolic protection devices were infrequently used during TAVR procedures. Device use was associated with lower mortality but not a reduction in stroke or delirium. Future studies are needed to confirm these findings.     

Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement: An Updated Meta-Analysis

ObjectivesThe aim of this study was to evaluate early results of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) for structural valve degeneration (SVD).BackgroundViV TAVR has been increasingly used for SVD, but it remains unknown whether it produces better or at least comparable results as redo SAVR.MethodsObservational studies comparing ViV TAVR and redo SAVR were identified in a systematic search of published research. Random-effects meta-analysis was performed, comparing clinical outcomes between the 2 groups.ResultsTwelve publications including a total of 16,207 patients (ViV TAVR, n = 8,048; redo SAVR, n = 8,159) were included from studies published from 2015 to 2020. In the pooled analysis, ViV TAVR was associated with lower rates of 30-day mortality overall (odds ratio [OR]: 0.52; 95% confidence interval [CI]: 0.39 to 0.68; p < 0.001) and for matched populations (OR: 0.419; 95% CI: 0.278 to 0.632; p = 0.003), major bleeding (OR 0.48; 95% CI: 0.28 to 0.80; p = 0.013), as well as with shorter hospital stay (OR: ?3.30; 95% CI: ?4.52 to ?2.08; p < 0.001). In contrast, ViV TAVR was associated with higher rates of severe patient-prosthesis mismatch (OR: 4.63; 95% CI: 3.05 to 7.03; p < 0.001). The search revealed an important lack of comparative studies with long-term results.ConclusionsViV TAVR is a valuable option in the treatment of patients with SVD because of its lower incidence of post-operative complications and better early survival compared with redo SAVR. However, ViV TAVR is associated with higher rates of myocardial infarction and severe patient-prosthesis mismatch.     

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.     

Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services

ObjectivesThe aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database.BackgroundRepeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited.MethodsAll Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis.ResultsOf 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154 days (interquartile range: 58-537 days). Mortality at 30 days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30 days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P = 0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P = 0.05), although 1-year mortality was similar (21.0% vs 20.8%; P = 1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95% CI: 1.88-4.99; P ≤ 0.001).ConclusionsRepeat TAVR was performed with acceptable 30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR.     

Characteristics and Outcomes of Patients With History of CABG Undergoing Cardiac Catheterization Via the Radial Versus Femoral Approach

ObjectivesThe aims of this study were to examine rates of radial artery access in post–coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach.BackgroundThere are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI.MethodsUsing the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access.ResultsThe rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG.ConclusionsThe rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG.     

New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

ObjectivesThe authors aimed to identify risk factors and outcomes associated with new-onset atrial fibrillation (NOAF) after transcatheter aortic valve replacement (TAVR).BackgroundNOAF is a common complication after TAVR, although estimates of the precise occurrence are variable. This study sought to quantify the occurrence of NOAF after TAVR and to explore the outcomes and predictors associated with this complication.MethodsWe searched Medline, EMBASE, and the Cochrane database from 2016 to 2020 for articles that reported NOAF after TAVR. We extracted data for studies published before 2016 from a previous systematic review. We pooled data using a random effects model.ResultsWe identified 179 studies with 241,712 total participants (55,271 participants with pre-existing atrial fibrillation (AF) were excluded) that reported NOAF from 2008 to 2020. The pooled occurrence of NOAF after TAVR was 9.9% (95% CI: 8.1%-12%). NOAF after TAVR was associated with a longer index hospitalization (mean difference = 2.66 days; 95% CI: 1.05-4.27), a higher risk of stroke in the first 30 days (risk ratio [RR]: 2.35; 95% CI: 2.12-2.61), 30-day mortality (RR: 1.76; 95% CI: 1.12-2.76), major or life-threatening bleeding (RR: 1.60; 95% CI: 1.39-1.84), and permanent pacemaker implantation (RR: 1.12; 95% CI: 1.05-1.18). Risk factors for the development of NOAF after TAVR included higher Society of Thoracic Surgeons score, transapical access, pulmonary hypertension, chronic kidney disease, peripheral vascular disease, and severe mitral regurgitation, suggesting that the risk for NOAF is highest in more comorbid TAVR patients.ConclusionsNOAF is common after TAVR. Whether AF after TAVR is a causal factor or a marker of sicker patients remains unclear.     

Validation of the VARC-3 Technical Success Definition in Patients Undergoing TAVR

ObjectivesThe authors aimed to investigate the rates, predictors, and prognostic impact of technical success in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundThe Valve Academic Research Consortium-3 (VARC-3) has introduced a composite endpoint to assess the immediate technical success of TAVR.MethodsIn the prospective Bern TAVR registry, patients were stratified according to VARC-3 technical success. Technical failure differentiated between vascular and cardiac complications.ResultsIn a total of 1,624 patients undergoing TAVR between March 2012 and December 2019, 1,435 (88.4%) patients had technical success. Among 189 patients with technical failure, 140 (8.6%) had vascular and 49 (3.0%) had cardiac technical failure. Female, larger device landing zone calcium volume, and the early term of the study period were associated with an increased risk for cardiac technical failure, whereas higher body mass index and the use of the Prostar (Abbott Vascular Inc) MANTA (Teleflex) (compared with the ProGlide [Abbott Vascular Inc]) were predictors of vascular technical failure. In multivariable analysis, technical failure conferred an increased risk for cardiovascular death or stroke (HR: 2.01; 95% CI: 1.37-2.95). The adverse effect remained when stratified to cardiac (HR: 2.62; 95% CI: 1.38-4.97) or vascular technical failure (HR: 1.95; 95% CI: 1.28-2.95) and limited to the periprocedural period (0-30 days: HR: 3.42 [95% CI: 2.05-5.69]; 30-360 days: HR: 1.36 [95% CI: 0.79-2.35]; P for interaction = 0.002).ConclusionsTechnical failure according to VARC-3 was observed in 1 of 10 patients undergoing TAVR and was associated with a 2-fold increased risk of the composite outcome at 1 year after TAVR. (Swiss TAVI Registry; NCT01368250)     

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy

BackgroundSubclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.ObjectivesThe aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.MethodsThe randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.ResultsSeven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (P_interaction = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).ConclusionsApixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649)