CoreValve Prosthesis Research Articles

Direct Aortic Access for Transcatheter Aortic Valve Replacement Using a Self-Expanding Device

Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option. The current analysis compared outcomes inpatients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access. Patients treated in the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study were included. Propensity score matching was used to account for differences in baseline characteristics between groups. Clinical outcomes were compared at 30 days and 1 year. We identified 394 matched pairs of IF and DA patients. The all-cause mortality rate was significantly higher in the DA group than in the IF group at 30 days (10.9% vs 4.1%, p < 0.001), but this difference was reduced at 1 year (28.1% vs 23.2%, p= 0.063). All-cause mortality or major stroke was significantly higher for DA vs IF access at 30 days (13.5% vs 5.3%, p < 0.001) and at 1 year (30.4% vs 24.2%, p= 0.025). Major/life-threatening bleeding and acute kidney injury were significantly greater in the DA group at 30 days (66.7% vs 35.4% and 19.7% vs 10.0%, respectively, both p < 0.001). When femoral access is not feasible, DA access allows effective delivery of the valve but incurs an increased risk of death and adverse events, potentially the result of procedural differences.

Impact of Coronary Artery Disease on 30-Day and 1-Year Mortality inPatients Undergoing Transcatheter Aortic Valve Replacement: AMeta-Analysis.

BackgroundThe impact of coronary artery disease (CAD) on outcomes after transcatheter aortic valve replacement (TAVR) is understudied. Literature on the prognostic role of CAD in the survival of patients undergoing TAVR shows conflicting results. This meta‐analysis aims to investigate how CAD impacts patient survival following TAVR.Methods and ResultsWe completed a comprehensive literature search of Embase, MEDLINE, and the Cochrane Library, and included studies reporting outcome of TAVR based on CAD status of patients for the analysis. From the initial 1631 citations, 15 studies reporting on 8013 patients were analyzed using a random‐effects model. Of the 8013 patients undergoing TAVR, with a median age of 81.3 years (79–85.1 years), 46.6% (40–55.7) were men and 3899 (48.7%) had CAD (ranging from 30.8% to 78.2% in various studies). Overall, 3121 SAPIEN/SAPIEN XT/SAPIEN 3 (39.6%) and 4763 CoreValve (60.4%) prostheses were implanted, with transfemoral access being the most frequently used approach for the implantation (76.1%). Our analysis showed no significant difference between patients with and without CAD for all‐cause mortality at 30 days post TAVR, with a cumulative odds ratio of 1.07 (95% confidence interval, 0.82–1.40; P=0.62). However, there was a significant increase in all‐cause mortality at 1 year in the CAD group compared with patients without CAD, with a cumulative odds ratio of 1.21 (95% confidence interval, 1.07–1.36; P=0.002).ConclusionsEven though coexisting CAD does not impact 30‐day mortality, it does have an impact on 1‐year mortality in patients undergoing TAVR. Our results highlight a need to revisit the revascularization strategies for concomitant CAD in patients with TAVR.

Pacemaker implantation after TAVI: predictors of AV block persistence.

Approximately every fifth patient undergoing transcatheter aortic valve implantation (TAVI) requires a permanent pacemaker (PPM) after the procedure. The aim of this study was to analyse predictors of atrioventricular block III° (AVBIII) persistence with concurrent PPM dependency after TAVI. Between 2010 and 2015 a total of 1198 patients underwent TAVI at the Kerckhoff Heart and Thorax Center, Germany. After exclusion of patients with prior PPM (n = 173) 14.7% (n = 176) of the patients underwent PPM implantation after the procedure. Independent predictors of PPM implantation were pre-existing right bundle branch block (RBBB, p < 0.001) and implantation of a CoreValve prosthesis (p < 0.001). A subgroup of patients with a newly implanted PPM (n = 102) were followed-up for a median of 73 (IQR 62-85) days. The leading indication for PPM implantation was AVBIII in 74.5% (76/102). Of these patients only 22.4% (17/76) had persistent AVBIII at follow-up. Predictors of AVBIII persistence were prior RBBB (p = 0.04), postdilatation (p = 0.006) and higher mean aortic valve gradient prior to implantation (p = 0.013). PPMs were implanted earlier in patients with persisting AVBIII [1day (IQR0-2.5) vs. 4days (IQR2-7); p < 0.001]. Early PPM implantation after TAVI was the only independent predictor of persistent AVBIII [OR 1.36 (95% 1.05-1.75); p = 0.02]. The long-term persistence of AVBIII is generally low after TAVI. Therefore, it may be wise to postpone the indication for PPM implantation for a couple of days. The only predictors of a lack of recovery of the AVB are prior RBBB, higher mean aortic valve gradients and postdilatation of the prosthesis.

65Effect of atrial fibrillation in the long-term follow-up of patients with severe aortic stenosis treated with the CoreValve prosthesis

65Effect of atrial fibrillation in the long-term follow-up of patients with severe aortic stenosis treated with the CoreValve prosthesis

Transcatheter aortic valve replacement with new-generation devices: A systematic review and meta-analysis

ObjectiveThe aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. MethodsA comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. ResultsA total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). ConclusionsSecond-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.

Clinical utility of a predictive model for paravalvular aortic regurgitation after transcatheter aortic valve implantation with a self-expandable prosthesis.

BackgroundA predictive model for Paravalvular aortic regurgitation (PAR) integrating the left ventricular outflow tract-to-ascending aorta angle (LVOT-AO) and depth to the non-coronary cusp (NCC) after TAVI with CoreValve prosthesis (MCP) was retrospectively identified (2 × ∠LVOT-AO + [depth to NCC-10]2; cutoff = 50). However, the validity and clinical utility of this model remain unknown.MethodsA total of 100 patients (79.6 ± 7 years, mean EuroScore 24.9 ± 16.3%, 41 males) constituted a validation cohort for the predictive model. Both angle (LVOT-AO) and depth to NCC were considered during patient selection and device implantation.ResultsSignificant AR occurred in 16% (group A) vs. 84% (group B). Angle ∠LVOT-AO and depth to NCC were larger in group A compared to group B (16.4 ± 7.2 vs. 11.8 ± 4.1, p < 0.001, and 9.1 ± 4.8 mm vs. 6.6 ± 2.7 mm, p = 0.004). The model showed a sensitivity of 68.7% and a specificity of 88.1% in prediction of PAR. Comparing the derivation cohort (initial experience, n = 50) and validation cohort (later experience, n = 100) it is showed that the ∠LVOT-AO, valve depth and PAR were significantly lower (12.5 ± 4.9 and 6.9 ± 3.2 mm vs. 19.7 ± 7.9 and 10.4 ± 3.7 mm, 40% vs. 16% respectively, all p < 0.001) in the validation cohort.ConclusionThe predictive model for significant PAR after TAVI using MCP is valid with a reassuring specificity and an acceptable sensitivity. A strategy incorporating these anatomical and procedural variables improves PAR after TAVI.

Erratum to: Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study.

Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting. To report clinical and echocardiographic 3-year results from the ADVANCE study. ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years. Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration. Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality. ClinicalTrials.gov, NCT01074658.

Quantitative Prediction of Paravalvular Leak in Transcatheter Aortic Valve Replacement Based on Tissue-Mimicking 3D Printing

ObjectivesThis study aimed to develop a procedure simulation platform for in vitro transcatheter aortic valve replacement (TAVR) using patient-specific 3-dimensional (3D) printed tissue-mimicking phantoms. We investigated the feasibility of using these 3D printed phantoms to quantitatively predict the occurrence, severity, and location of any degree of post-TAVR paravalvular leaks (PVL). BackgroundWe have previously shown that metamaterial 3D printing technique can be used to create patient-specific phantoms that mimic the mechanical properties of biological tissue. This may have applications in procedural planning for cardiovascular interventions. MethodsThis retrospective study looked at 18 patients who underwent TAVR. Patient-specific aortic root phantoms were created using the tissue-mimicking 3D printing technique using pre-TAVR computed tomography. The CoreValve (self-expanding valve) prostheses were deployed in the phantoms to simulate the TAVR procedure, from which post-TAVR aortic root strain was quantified in vitro. A novel index, the annular bulge index, was measured to assess the post-TAVR annular strain unevenness in the phantoms. We tested the comparative predictive value of the bulge index and other known predictors of post-TAVR PVL. ResultsThe maximum annular bulge index was significantly different among patient subgroups that had no PVL, trace-to-mild PVL, and moderate-to-severe PVL (p = 0.001). Compared with other known PVL predictors, bulge index was the only significant predictor of moderate-severe PVL (area under the curve = 95%; p < 0.0001). Also, in 12 patients with post-TAVR PVL, the annular bulge index predicted the major PVL location in 9 patients (accuracy = 75%). ConclusionsIn this proof-of-concept study, we have demonstrated the feasibility of using 3D printed tissue-mimicking phantoms to quantitatively assess the post-TAVR aortic root strain in vitro. A novel indicator of the post-TAVR annular strain unevenness, the annular bulge index, outperformed the other established variables and achieved a high level of accuracy in predicting post-TAVR PVL, in terms of its occurrence, severity, and location.

Incidence, indications and predicting factors of permanent pacemaker implantation after transcatheter aortic valve implantation: A retrospective study

As the number of transcatheter aortic valve implantation (TAVI) procedures is constantly increasing, it is important to consider common complications, such as pacemaker (PM) implantation, and their specific risk factors. Echocardiographic, computed tomography and electrocardiographic data were analysed to determine the predicting factors, if any, associated with PM implantation. This retrospective study included patients referred to Nancy University Hospital for a TAVI procedure from January 2013 to December 2015. Both Medtronic CoreValve and Edwards SAPIEN valves were implanted. Patients with preprocedurally implanted PMs and/or referred from another institution were excluded. Of 208 TAVI patients, 23 had a pre-existing PM and were excluded. A new PM was required in 38 patients (20.5%). Pre-existing right bundle branch block (RBBB), the use of the Medtronic CoreValve and large prostheses were identified as predictors of PM implantation (P=0.0361, P=0.0004 and P=0.0019, respectively). Using logistic regression, predictors of PM implantation included first-degree atrioventricular block (odds ratio 3.7, 95% confidence interval 1.5-9.1; P=0.0054) and large aortic annulus diameter in echocardiography (odds ratio 1.2, 95% confidence interval 1-1.4; P=0.0447), with a threshold of 24.1mm. For the combination of preTAVI PR duration >220ms and QRS duration >120ms, the positive predictive value for PM implantation reached 80%. Use of the Medtronic CoreValve, RBBB and first-degree atrioventricular block are major risk factors for post-TAVI PM implantation. In addition, large aortic annulus and large valvular prosthesis are independent risk factors for PM implantation. The combination of preTAVI prolonged PR interval and increased QRS duration could be used as a marker for periprocedural PM implantation.

How to Perform a Late Surgical Explantation of a CoreValve Aortic Bioprothesis

As transcatheter techniques expand to younger patients, cardiac surgeons need to know a safe surgical technique to extract these kinds of prostheses. We describe here anadequate surgical strategy for the explantation of a CoreValve prosthesis that was implanted more than 5 years previously.

Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study

Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting. To report clinical and echocardiographic 3-year results from the ADVANCE study. ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3years. Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7cm2 from discharge to 3years, and average mean aortic valve gradient remained ≤10mmHg. At 3years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration. Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality. ClinicalTrials.gov, NCT01074658.

Long-term clinical impact of permanent cardiac pacing after transcatheter aortic valve implantation with the CoreValve prosthesis: a single center experience.

To determine the impact of permanent cardiac pacing after transcatheter aortic valve implantation (TAVI) with the CoreValveTM prosthesis in terms of all-cause mortality and morbidity [rehospitalizations for heart failure (HF) or stroke] at the long-term follow-up. The prospective analysis comprised 259 patients (138 women, 53.3%, age 78 ± 6 years) treated by a CoreValveTM prosthesis from April 2008 to December 2015. Forty-two patients were excluded for analysis: 9 with pre-existing permanent pacemaker (PPM) implantation, 19 who required a PPM during the follow-up and 14 patients because of hospital mortality during or after the CoreValveTM prosthesis implantation procedure. The remaining 217 patients were divided in two groups: Group-1 included those patients who required a PPM immediately after TAVI, and Group-2 included those patients who did not require permanent cardiac pacing at the long-term follow-up. Patients received follow-up at 1-month, 6-months, 12-months, and yearly thereafter. A total of 39 patients required a PPM immediately after TAVI (15.0%), but 178 patients (68.7%) did not. The mean follow-up was 37 ± 27 months (range 3-99 months) in both groups. There was no difference between the two groups in terms of all-cause mortality (52.6% vs. 56.8%, P = 0.125; HR 1.22 [0.87-1.77, 95% CI]), or stroke (13.3% vs. 15.1% P = 0.842; HR 1.12 [0.37-3.32, 95% CI]). However, patients who underwent PPM implantation developed an increase in readmissions for HF (21.1% vs. 31.9%, P = 0.015; HR 1.82 [1.23-3.92, 95% CI]). Patients requiring a PPM after TAVI did not have an increase in mortality, or an increase in the likelihood of developing a stroke at a long-term follow-up. However, this subgroup of patients showed an increase in rehospitalization due to HF at medium- and long-term follow-up.

Practical determination of aortic valve calcium volume score on contrast-enhanced computed tomography prior to transcatheter aortic valve replacement and impact on paravalvular regurgitation: Elucidating optimal threshold cutoffs

BackgroundThe threshold for the optimal computed tomography (CT) number in Hounsfield Units (HU) to quantify aortic valvular calcium on contrast-enhanced scans has not been standardized. Our aim was to find the most accurate threshold to predict paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). Methods104 patients who underwent TAVR with the CoreValve prosthesis were studied retrospectively. Luminal attenuation (LA) in HU was measured at the level of the aortic annulus. Calcium volume score for the aortic valvular complex was measured using 6 threshold cutoffs (650 HU, 850 HU, LA × 1.25, LA × 1.5, LA+50, LA+100). Receiver-operating characteristic (ROC) analysis was performed to assess the predictive value for > mild PVR (n = 16). Multivariable analysis was performed to determine the accuracy to predict > mild PVR after adjustment for depth and perimeter oversizing. ResultsROC analysis showed lower area under the curve (AUC) values for fixed threshold cutoffs (650 or 850 HU) compared to thresholds relative to LA. The LA+100 threshold had the highest AUC (0.81), and AUC was higher than all studied protocols, other than the LA x 1.25 and LA + 50 protocols, where the difference approached statistical significance (p = 0.05, and 0.068, respectively). Multivariable analysis showed calcium volume determined by the LAx1.25, LAx1.5, LA+50, and LA+ 100 HU protocols to independently predict PVR. ConclusionsCalcium volume scoring thresholds which are relative to LA are more predictive of PVR post-TAVR than those which use fixed cutoffs. A threshold of LA+100 HU had the highest predictive value.

Relation between calcium burden, echocardiographic stent frame eccentricity and paravalvular leakage after corevalve transcatheter aortic valve implantation.

Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before. Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve System© and who had available pre-discharge transthoracic echocardiography were studied. Echocardiographic stent inflow frame eccentricity was defined as major-minor diameter in a short-axis view >2 mm. PVL was scored according to the updated Valve Academic Research Consortium (VARC-2) recommendations. In a subgroup of 162 (73%) patients, the calcium Agatston score was available. Stent frame eccentricity was seen in 77 (35%) of patients. The correlation between the Agatston score and stent frame eccentricity was significant (ρ = 0.241, P = 0.003). Paravalvular leakage was absent in 91 cases (41%), mild in 67 (30%), moderate in 51 (23%), and severe in 14 (6%) cases. The correlation between stent frame eccentricity and PVL severity was significant (ρ = 0.525, P < 0.0001). There was a relation between particular eccentric stent frame shapes and the site of PVL. Calcification of the aortic annulus is associated with a subsequent eccentric shape of the CoreValve prosthesis. This eccentric shape results in more PVL, with the localization of PVL related to the shape of stent frame eccentricity.

IMPACT OF BALLOON PRE-DILATATION ON HEMODYNAMICS AND CLINICAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE SELF-EXPANDING COREVALVE PROSTHESIS

Background: The Pivotal trials of transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve (CV) prosthesis mandated balloon pre-dilatation (BPD) for every patient. Since then, use of BPD has steadily fallen. However, the impact of BPD on prosthesis hemodynamics and clinical

Haemodynamic Evaluation of Long-term TAVR Durability: A Single Centre Experience

Background: Transcatheter aortic valve replacement (TAVR) is now an acceptable treatment for patients at high surgical risk. Recent limited data raise some concerns on valve durability long-term. We aim to determine structural valve deterioration (SVD) in TAVR over 5-year implant durations. Methods: Patients undergoing TAVR with Edwards SAPIEN/SAPIEN XT or Medtronic CoreValve prostheses at The Prince Charles Hospital between August 2008 and November 2011 with echocardiographic follow-up of a minimum of 5 years were included. Exclusion criteria included cases with aortic endocarditis, index valve-in-valve cases, and patients lost to follow-up. Valve performance was assessed using VARC-2 criteria for SVD and analysed using JMP 13 statistical software. Results: 28 patients (average age 82.14 ± 8.68 years) met selection criteria, who underwent TAVR with either Edwards (n = 12) or Medtronic (n = 16) valves. Average STS score was 6.43 ± 2.88 and average EuroSCORE was 18.74 ± 8.53. Comparison of 30-day (30D) post-implant data with 5 year (5Y) follow up data showed a slight increase in mean aortic gradient (30D: 10.46 ± 2.92 mmHg; 5Y:12.52 ± 15.26 mmHg; p = NS). Only one patient demonstrated a mean gradient increase of over 20 mmHg. This patient required a TAVR-in-TAVR 8 years post-initial TAVR. Aortic valve area showed a slight decrease (30D: 2.03 ± 0.37 cm2; 5Y: 1.83 ± 0.54 cm2; p = NS). 2 (7.1%) patients showed moderately severe/severe valvular or circumferential aortic regurgitation (grade ≥ 3) 5 years post-implant. Conclusion: In this small observational cohort, TAVR SVD requiring reintervention was infrequently observed. Defining SVD for TAVR and longer-term follow-up will be essential for the future.

Improvements of Procedural Results With a New-Generation Self-Expanding Transfemoral Aortic Valve Prosthesis in Comparison to the Old-Generation Device.

In this study, we compare procedural results of our first Evolut R (Medtronic, Minneapolis, MN, USA) implantations with the last CoreValve implantations. Main endpoints include paravalvular regurgitation, major vascular complications, stroke, and pacemaker implantation. The evolution of transcatheter aortic valve replacement (TAVR) was possible due to various technical improvements, leading to better periprocedural and long-term outcome. The newly designed Evolut R valve has the potential to further improve TAVR's performance. We retrospectively analyzed our first 100 consecutive patients who received the Evolut R valve with the last 100 consecutive patients who received the CoreValve prosthesis between July 2013 and February 2016. Only patients treated with a 26 mm or 29 mm bioprosthesis were included. No significant differences in patient characteristics were noticed. Both angiography and echocardiography after TAVR showed significantly higher rates of "none or trace" regurgitation in the Evolut R group (angiography: 67% Evolut R vs. 29.3% CoreValve; P < 0.001; echocardiography: 68% Evolut R vs. 46.5% CoreValve; P < 0.05). No significant differences were seen in 30-day mortality (7% CoreValve vs. 1% Evolut R), stroke rates (3% CoreValve vs. 2% Evolut R), pacemaker implantation rates (24% CoreValve vs. 23% Evolut R), and major vascular complications (6% CoreValve vs. 1% Evolut R). Implantations were significantly higher with the Evolut R prosthesis. TAVR with the new Evolut R resulted in significantly lower paravalvular regurgitation. This may be due to redesigned cell geometry and higher precision during implantations, as well as the ability to resheath a malpositioned valve.

Long-term Follow-up of Patients With Severe Aortic Stenosis Treated With a Self-expanding Prosthesis

Introduction and objectivesTranscatheter aortic valve implantation (TAVI) is a safe and effective alternative to surgical treatment in patients with severe aortic stenosis (AS) and those who are inoperable or at high surgical risk. The primary objective of this study was to evaluate the long-term survival of consecutive patients with severe AS treated with TAVI. MethodsObservational, multicenter, prospective, follow-up study of consecutive patients with severe symptomatic AS treated by TAVI in 3 high-volume hospitals in Spain. ResultsWe recruited 108 patients, treated with a self-expanding CoreValve prosthesis. The mean age at implantation was 78.6 ± 6.7 years, 49 (45.4%) were male and the mean logistic EuroSCORE was 16% ± 13.9%. The median follow-up was 6.1 years (2232 days). Survival rates at the end of years 1, 2, 3, 4, 5, and 6 were 84.3% (92.6% after hospitalization), 77.8%, 72.2%, 66.7%, 58.3%, and 52.8%. During follow-up, 71 patients (65.7%) died, 18 (25.3%) due to cardiac causes. Most (82.5%) survivors were in New York Heart Association class I or II. Six patients (5.5%) developed prosthetic valve dysfunction. ConclusionsLong-term survival in AS patients after TAVI is acceptable. The main causes of death are cardiovascular in the first year and noncardiac causes in subsequent years. Valve function is maintained over time.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Steroid therapy and conduction disturbances after transcatheter aortic valve implantation.

Direct mechanical compression of the frame struts on the adjacent bundle branch with local inflammatory reaction might cause conduction system disturbances and need for pacemaker implantation following transcatheter aortic valve implantation (TAVI). We assessed the impact of preprocedural anti-inflammatory steroid therapy on the occurrence of conduction disturbances following TAVI. From a cohort of 324 patients who underwent transfemoral TAVI, 39 (12%) were pretreated with steroids because of iodine allergy (n=29) or active obstructive pulmonary disease (n=10). We compared the rate of occurrence of new conduction disturbances and pacemaker implantation between TAVI patients with (n=39) and without (n=285) steroid treatment, using Cox logistic regression estimates and proportional hazards models. The overall occurrence of new conduction defects and the need for new pacemaker implantation were similar among steroid and non-steroid-treated patients (38.4% vs 37.5% and 25.6% vs 25.3%, respectively). New conduction disturbances were more prevalent in patients treated with CoreValve prosthesis, low implantation, and smaller aortic annulus diameter (P<.001, P<.001, and P=.006, respectively). Thirty-day mortality and complication rates were similar between the groups. Although safe, steroid treatment prior to TAVI failed to reduce the incidence of new conduction defects and the need for pacemaker implantation.