Initial German Experience With Transapical Implantation of a Second-Generation Transcatheter Heart Valve for the Treatment of Aortic Regurgitation

ObjectivesThis analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.BackgroundExperience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.MethodsTransapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.ResultsImplantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.ConclusionsAortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.     

A New Transcatheter Aortic Valve Replacement System for Predominant Aortic Regurgitation Implantation of the J-Valve and Early Outcome

ObjectivesThis study introduces a newly designed transcatheter aortic valve system, the J-Valve system, and evaluates its application in patients with predominant aortic regurgitation without significant valve calcification. We also report the early results of one of the first series of transapical implantations of this device and aim to offer guidance on the technical aspects of the procedure.BackgroundTranscatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification.MethodsSix patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50 ± 8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co., Ltd., Suzhou, China), a self-expandable porcine valve, in the aortic position at our institution. All patients were considered to be prohibitive or high risk for surgical valve replacement (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.15% to 44.44%; mean, 29.32 ± 7.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed.ResultsImplantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00 ± 77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major post-operative complications or mortality during the follow-up.ConclusionsOur study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.     

Long-Term Outcomes of Percutaneous Paravalvular Regurgitation Closure After Transcatheter Aortic Valve Replacement: A Multicenter Experience

ObjectivesThis study sought to evaluate acute and long-term outcomes of percutaneous paravalvular regurgitation (PVR) closure after transcatheter aortic valve replacement (TAVR).BackgroundSevere symptomatic PVR is a predictor of all-cause mortality after TAVR. The current use of devices for transcatheter closure of PVR has been adapted from other indications without known long-term outcomes.MethodsThe study population consisted of a series of cases pooled together from an international multicenter experience. Patients underwent transcatheter implantation of a closure device for the treatment of clinically relevant PVR after TAVR with balloon-expandable or self-expandable prostheses. Procedural success was defined by successful deployment of a device with immediate reduction of PVR to a final grade ≤2 as assessed by echocardiography.ResultsTwenty-seven procedures were performed in 24 patients with clinically relevant PVR after the index TAVR procedure (54.2% Edwards Sapien [Edwards Lifesciences, Irvine, California], 45.8% CoreValve [Medtronic, Minneapolis, Minnesota]). The study population included 75% men with a mean age of 80.6 ± 7.1 years and mean Society of Thoracic Surgeon score of 6.6%. The most frequently used device was Amplatzer Vascular Plug (St. Jude Medical, St. Paul, Minnesota) in 80% of the cases. Overall, 88.9% (24 of 27) of the procedures were technically successful and the results assessed by echocardiography were durable. However, cumulative survival rates at 1, 6, and 12 months were 83.3%, 66.7%, and 61.5%. Most of the deaths (8 of 11) were due to noncardiac causes.ConclusionsTranscatheter closure of PVR after TAVR can be performed with a high procedural success rate; however, the long-term mortality remains high mainly due to noncardiac causes.     

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation

ObjectivesThis study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR).BackgroundThe treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak.MethodsThe study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria).ResultsEleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II.ConclusionsThis study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route.     

Long-Term Outcomes After Transcatheter Aortic Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: The U.K. Transcatheter Aortic Valve Implantation Registry

ObjectivesThe U.K. Transcatheter Aortic Valve Implantation Registry reported 30-day and 1-year mortality rates of 7.1% and 21.4%, respectively, for patients who underwent transcatheter aortic valve replacement (TAVR) in the United Kingdom between 2007 and 2009. The study aim was to report long-term outcomes in this same cohort of patients.BackgroundThere are few data on outcomes beyond 3 years after TAVR in any notable number of patients.MethodsData from all TAVR procedures performed in the United Kingdom between January 2007 and December 2009 were prospectively collected. All-cause mortality status was reported in March 2014. Mortality tracking was achieved in 97.7% patients.ResultsThe minimal time from replacement to census was 4.1 years, and the maximal time was 7.0 years. The 3- and 5-year survival rates were 61.2% and 45.5%, respectively. Independent predictors of 3-year mortality were renal dysfunction (hazard ratio [HR]: 1.65), atrial fibrillation (HR: 1.36), logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥18.5 (HR: 1.33), respiratory dysfunction (HR: 1.28), and ventricular dysfunction (left ventricular ejection fraction <30%) (HR: 1.53). Coronary artery disease (HR: 1.28) and age (HR: 1.03) were additional independent predictors of mortality at 5 years. Stroke within 30 days of TAVR was the only independent procedural predictor of mortality at 3 and 5 years (HR: 2.17 at 3 years). Device type, access route, and paravalvular leak did not independently predict long-term outcome.ConclusionsIn the large U.K. Transcatheter Aortic Valve Implantation Registry, long-term outcomes after TAVR are favorable with 3- and 5-year survival rates of 61.2% and 45.5%, respectively. Long-term survival after TAVR is largely determined by intrinsic patient factors. Other than stroke, procedural variables, including paravalvular aortic leak, did not appear to be independent predictors of long-term survival.     

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System

ObjectivesThe purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis.BackgroundAlthough outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges.MethodsSuitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure.ResultsPatients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients.ConclusionsThe repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420)     

Quantity and Location of Aortic Valve Complex Calcification Predicts Severity and Location of Paravalvular Regurgitation and Frequency of Post-Dilation After Balloon-Expandable Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR).BackgroundThe impact of AVC in different locations within the aortic valve complex is incompletely understood.MethodsThis study analyzed 150 patients with severe, symptomatic aortic stenosis who underwent TAVR. Total AVC volume scores were calculated from contrast-enhanced multidetector row computed tomography imaging. AVC was divided by leaflet sector and region (Leaflet, Annulus, left ventricular outflow tract [LVOT]), and a combination of LVOT and Annulus (AnnulusLVOT). Asymmetry was assessed. Receiver-operating characteristic analysis was performed with greater than or equal to mild PVR and PD as classification variables. Logistic regression was performed.ResultsQuantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index.ConclusionsQuantity and asymmetry of AVC in all regions of the aortic valve complex predict greater than or equal to mild PVR and performance of PD, with the exception of Leaflet asymmetry. Quantity of AnnulusLVOT and Leaflet calcification independently predict PVR and PD when taking into account multidetector row computed tomography area cover index.     

Thrombus Formation Following Transcatheter Aortic Valve Replacement

ObjectivesThis paper reviews the published data and reports 3 cases of thrombosis involving CoreValve (Medtronic, Minneapolis, Minnesota) and 1 involving Edward Sapien (Edwards Lifesciences, Irvine, California) devices. Three of these cases had pathological findings at autopsy.BackgroundOnly a limited number of cases of valve dysfunction with rapid increase of transvalvular aortic gradients or aortic insufficiency post-transcatheter aortic valve replacement (TAVR) have been described. This nonstructural valvular dysfunction has been presumed to be because of early pannus formation or thrombosis.MethodsThrough reviews of the published reports and 4 clinical cases, pathological and clinical findings of early valve thrombosis are examined to elucidate methods for recognition and identifying potential causes and treatments.ResultsThis paper presents 4 cases, 2 of which had increasing gradients post-TAVR. All 3 pathology cases showed presence of a valve thrombosis in at least 2 TAV leaflets on autopsy, but were not visualized by transthoracic echocardiogram or transesophageal echocardiogram. One case was medically treated with oral anti coagulation with normalization of gradients. The consequence of valve thrombosis in all 3 pathology patients either directly or indirectly played a role in their early demise. At least 18 case reports of early valve thrombosis have been published. In 12 of these cases, the early treatment with anticoagulation therapy resolved the thrombus formation and normalized aortic pressures gradients successfully.ConclusionsThese 4 cases elucidate the occurrence of valve thrombosis post-TAVR. Consideration should be given to treatment with dual antiplatelet therapy and oral anticoagulation in patients post-TAVR with increasing mean pressure gradients and maximum aortic valve velocity. Further research should be conducted to create guidelines for antithrombotic therapy following TAVR procedure.     

Comparison of Self-Expanding and Mechanically Expanded Transcatheter Aortic Valve Prostheses

ObjectivesThe aim of this study was to determine whether transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus valve (Boston Scientific, Natick Massachusetts) offers potential benefits over treatment with the self-expanding CoreValve (Medtronic, Minneapolis, Minnesota).BackgroundNew-generation transcatheter aortic valve systems are emerging in clinical trials and practice with design features aimed at improving safety and efficacy. To date, these devices have not been compared systematically with current-generation devices.MethodsA total of 100 patients (83.4 ± 4.8 years of age, 44% male, Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 2.4) were assessed. Fifty consecutive patients undergoing a Lotus transcatheter aortic valve replacement were enrolled and compared with 50 matched patients treated with a CoreValve. An independent core laboratory reviewed all echocardiographic data, and an independent clinical events committee adjudicated all events.ResultsValve Academic Research Consortium 2–defined device success was 84% and 64% in the Lotus and CoreValve cohorts, respectively (p = 0.02). This difference was driven by lower rates of moderate or greater aortic regurgitation (4% vs. 16.7%, respectively; p = 0.04) and higher rates of successfully implanting a single device in the correct anatomic position (100% vs. 86%, respectively; p = 0.06). Cardiovascular mortality rate (0% vs. 4%, respectively; p = 0.32), major stroke rate (4% vs. 2%, respectively; p = 0.56), and permanent pacemaker insertion rate (28% vs. 18%, respectively; p = 0.23) were not different at 30 days in the Lotus and CoreValve cohorts.ConclusionsIn this matched comparison of high surgical risk patients undergoing transcatheter aortic valve replacement, the use of the Lotus device was associated with higher rates of Valve Academic Research Consortium 2–defined device success compared with the CoreValve. This was driven by higher rates of correct anatomic positioning and lower incidences of moderate paraprosthetic regurgitation. The clinical significance of these differences needs to be tested in a large randomized, controlled trial.     

Clinical and Functional Outcomes Associated With Myocardial Injury After Transfemoral and Transapical Transcatheter Aortic Valve Replacement: A Subanalysis From the PARTNER Trial (Placement of Aortic Transcatheter Valves)

ObjectivesThis study sought to clarify the clinical and echocardiographic prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR).BackgroundThe clinical significance of cardiac biomarker elevation after TAVR remains unclear.MethodsPatients treated with TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial were divided into tertiles (T1, T2, T3) based on the difference between the values on post-procedure day 1 and the baseline values of 2 cardiac biomarkers: cardiac troponin I (ΔcTnI); and creatine kinase-myocardial band (ΔCK-MB) fraction. Patients were stratified according to their access route: transfemoral (TF) (n = 1,840) or transapical (TA) (n = 1,173).ResultsAt 30 days after TF-TAVR, patients in the highest tertile (T3) of cardiac biomarker elevation had a higher rate of all-cause mortality (ΔcTnI: T3: 5.4% vs. T1: 0.5%, p = 0.006; ΔCK-MB: T3: 5.7% vs. T1: 0.9%, p = 0.006) and cardiovascular mortality (ΔcTnI: T3: 4.9% vs. T1: 0.5%, p = 0.01; ΔCK-MB: T3: 3.9% vs. T1: 0.5%, p = 0.02). At 1 year, only patients in the highest CK-MB tertile had higher rates of all-cause (25.4% vs. 16.8%, p = 0.02) and cardiovascular (10.3% vs. 5.0%) mortality. Multivariable analysis demonstrated that greater release of cardiac biomarkers was independently associated with increased mortality in the TF population. After TA-TAVR, being in the highest tertile of cardiac biomarker elevation had no influence on clinical and echocardiographic outcomes at 30 days and 1 year.ConclusionsAfter TF-TAVR, a greater degree of myocardial injury was associated with higher rates of 30-day all-cause and cardiovascular mortality. At 1 year, being in the highest tertile of ΔCK-MB was correlated with a higher rate of all-cause and cardiac mortality. Finally, the level of myocardial injury after TA-TAVR had no impact on clinical and echocardiographic outcomes.     

Regional Systems of Care to Optimize Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to describe the development of a multicenter, transcatheter aortic valve replacement program and regional systems of care intended to optimize coordinated, efficient, and appropriate delivery of this new therapy.BackgroundTranscatheter aortic valve replacement (TAVR) has become an accepted treatment option for patients with severe aortic stenosis who are at high surgical risk. Regional systems of care have led to improvements in outcomes for patients undergoing intervention for myocardial infarction, cardiac arrest, and stroke. We implemented a regional system of care for patients undergoing TAVR in British Columbia, Canada.MethodsWe describe a prospective observational cohort of 583 patients who underwent TAVR in British Columbia between 2012 and 2014. Regionalization of TAVR care in British Columbia refers to a centrally coordinated, funded, and evaluated program led by a medical director and a multidisciplinary advisory group that oversees planning, access to care, and quality of outcomes at the 4 provincial sites. Risk-stratified case selection for transfemoral TAVR is performed by heart teams at each site on the basis of consensus provincial indications. Referrals for lower volume and more complicated TAVR, including nontransfemoral access and valve-in-valve procedures, are concentrated at a single site. In-hospital and 30-day outcomes are reported.ResultsThe median age was 83 years (interquartile range [IQR]: 78 to 87 years) and median STS score was 6% (IQR: 4% to 8%). Transfemoral access was performed in 499 (85.6%) cases and nontransfemoral in 84 (14.4%). Transcatheter valve-in-valve procedures in for failed bioprosthetic valves were performed in 43 patients (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All-cause 30-day mortality was 3.5%. All-cause in-hospital mortality and disabling stroke occurred in 3.1% and 1.9%, respectively. Median length of stay was 3 days (IQR: 3 to 6 days), with 92.8% of patients discharged directly home.ConclusionsThis experience demonstrates the potential benefits of a regional system of care for TAVR. Excellent outcomes were demonstrated: most patients had short in-hospital stays and were discharged directly home.     

Incidence and Severity of Paravalvular Aortic Regurgitation With Multidetector Computed Tomography Nominal Area Oversizing or Undersizing After Transcatheter Heart Valve Replacement With the Sapien 3: A Comparison With the Sapien XT

ObjectivesThis study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform.BackgroundThe inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known.MethodsSixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography.ResultsMild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR.ConclusionsOur retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.     

Prosthetic Valve Endocarditis After Transcatheter Valve Replacement: A Systematic Review

ObjectivesThe aim of this review is to describe the incidence, features, predisposing factors, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter valve replacement (TVR).BackgroundVery few data exist on PVE after TVR.MethodsStudies published between 2000 and 2013 regarding PVE in patients with transcatheter aortic valve replacement (TAVR) or transcatheter pulmonary valve replacement (TPVR) were identified through a systematic electronic search.ResultsA total of 28 publications describing 60 patients (32 TAVRs, 28 TPVRs) were identified. Most TAVR patients (66% male, 80 ± 7 years of age) had a very high-risk profile (mean logistic EuroSCORE: 30.4 ± 14.0%). In TPVR patients (90% male, 19 ± 6 years of age), PVE was more frequent in the stenotic conduit/valve (61%). The median time between TVR and infective endocarditis was 5 months (interquartile range: 2 to 9 months). Typical microorganisms were mostly found with a higher incidence of enterococci after TAVR (34.4%), and Staphylococcus aureus after TPVR (29.4%). As many as 60% of the TAVR-PVE patients were managed medically despite related complications such as local extension, embolism, and heart failure in more than 50% of patients. The valve explantation rate was 57% and 23% in balloon- and self-expandable valves, respectively. In-hospital mortality for TAVR-PVE was 34.4%. Most TPVR-PVE patients (75%) were managed surgically, and in-hospital mortality was 7.1%.ConclusionsMost cases of PVE post-TVR involved male patients, with a very high-risk profile (TAVR) or underlying stenotic conduit/valve (TPVR). Typical, but different, microorganisms of PVE were involved in one-half of the TAVR and TPVR cases. Most TPVR-PVE patients were managed surgically as opposed to TAVR patients, and the mortality rate was high, especially in the TAVR cohort.     

Incidence and Predictors of Debris Embolizing to the Brain During Transcatheter Aortic Valve Implantation

ObjectivesThe aim of this study was to identify variables associated with tissue fragment embolization during transcatheter aortic valve replacement (TAVR).BackgroundBrain magnetic resonance imaging and transcranial Doppler studies have revealed that cerebrovascular embolization occurs frequently during TAVR. Embolized material may be r thrombotic, tissue derived, or catheter (foreign material) fragments.MethodsA total of 81 patients underwent TAVR with a dual filter–based embolic protection device (Montage Dual Filter System, Claret Medical, Inc., Santa Rosa, California) deployed in the brachiocephalic trunk and left common carotid artery. Both balloon-expandable and self-expanding transcatheter heart valves (THVs) were used. Filters were retrieved after TAVR and sent for histopathological analysis.ResultsOverall, debris was captured in 86% of patients. Captured material varied in size from 0.1 to 9.0 mm. Thrombotic material was found in 74% of patients and tissue-derived debris in 63%. Tissue fragments were found more often with balloon-expandable THVs (79% vs. 56%; p = 0.05). The embolized tissue originated from the native aortic valve leaflets, aortic wall, or left ventricular myocardium. On multivariable logistic regression analysis, balloon-expandable THVs (odds ratio: 7.315; 95% confidence interval: 1.398 to 38.289; p = 0.018) and cover index (odds ratio: 1.141; 95% confidence interval: 1.014 to 1.283; p = 0.028) were independent predictors of tissue embolization.ConclusionsDebris is captured with filter-based embolic protection in the vast majority of patients undergoing TAVR. Tissue-derived material is found in 63% of cases and is more frequent with the use of balloon-expandable systems and more oversizing.