Medtronic CoreValve Revalving System Research Articles

Postoperative analysis of the mechanical interaction between stent and host tissue in patients after transcatheter aortic valve implantation

The analysis is based on a finite element procedure to extract the contact forces between an implanted Nitinol stent and the surrounding host tissue using postoperative CT images. The methodology was applied for patients (N=46) which have undergone a TAVI procedure with the Medtronic CoreValve Revalving System (MCRS) to obtain corresponding deformation and force maps. The postoperative CT data were recorded for each patient in both systolic and diastolic phase of the heart cycle. Scalar parameters were defined, which map deformed geometry and contact force field to mechanically relevant quantities: radial dilatation, radial shape distortion, non-convex points, mean force, a force deviation measure and a pressure equivalent. The latter demonstrates that in the area of the aortic root, the added circumferential loading is of the same order as the baseline average blood pressure, thus leading to a doubling of the local mechanical load. Generally the force distribution along the stent is non-homogeneous. A comparison of systolic and diastolic data revealed slightly higher contact forces during the diastole, indicating that the stent has to carry more load in this phase. The geometrical and mechanical parameters were compared for two types of clinical complication: para-valvular leakage (PVL) and permanent pacemaker requirement (PPM). It was found that an increase in mean force can be associated with both complications; significantly for PVL and as a trend for PPM.

Pacemaker implantation and need for ventricular pacing during follow-up after transcatheter aortic valve implantation.

To categorize indications of permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI), to determine predictors for conduction disturbances and to quantify the need for ventricular pacing during follow-up. We studied 97 patients (median age 83 years, 58% female) undergoing TAVI using the Medtronic CoreValve Revalving System (MCRS; Medtronic Inc., Minneapolis, MN, USA) or Edwards-Sapien Valve (Edwards Lifesciences, Irvine, CA, USA). During follow-up, no need for ventricular pacing was defined as <1% ventricular pacing and intrinsic 1:1 atrioventricular (AV) conduction. In the 35 patients (36.1%) undergoing PPM implantation three indication categories were identified: (1) high-grade AV block (Mobitz 2 or higher), (2) new-onset left bundle branch block (LBBB) with a prolonged PR interval, and (3) new-onset LBBB. The only independent predictors of high-grade AV block were the use of MCRS (odds ratio [OR] 79.25; 95% confidence interval [CI] 4.57-1373.31) and the presence of preprocedural right bundle branch block (OR 81.95; 95% 95% CI 8.72-770.46). Whereas high-grade AV block resolved only in 17% of cases, none of the patients receiving a PPM due to LBBB with or without PR prolongation required ventricular pacing during follow-up. Our findings justify early PPM implantation in patients with high-grade AV block and may suggest a more conservative approach to PPM implantation in patients with new-onset LBBB after TAVI.

Transcatheter aortic valve implantation using a direct aortic approach: a single-centre Heart Team experience.

The transaortic (TAo) approach has been introduced as an alternative to transapical and transaxillary aortic valve implantation for patients with symptomatic severe aortic stenosis in whom a transfemoral approach is not feasible. However, only very limited data from a minimal number of specialized centres are available on this approach. Therefore, the aim of this study was to evaluate the early postoperative 30-day outcomes of the direct aortic approach performed by a single-centre multidisciplinary Heart Team. Between May 2011 and July 2013, 159 patients underwent transcatheter aortic valve implantation (TAVI) at our institution; of which, 44 were believed to benefit most from the TAo as assessed by a multidisciplinary Heart Team. All patients underwent an upper 'J' median hemi-sternotomy through a 6-cm incision. The evaluation of early operative results was made according to the Valve Academic Research Consortium (VARC) consensus criteria. These include device success endpoints and combined safety endpoints at 30 days. The mean age of the patients was 78 years, the mean logistic EuroSCORE was 25.9 ± 14.4% and the mean Society of the Thoracic Surgeons score 5.8 ± 4.5%. Seventeen patients (39%) underwent redo operations; 4 (9%) received a transcatheter valve in a degenerated bioprosthesis. The procedure was performed using the Medtronic CoreValve Revalving system in 36 patients, with the Edwards SAPIEN XT in 7 cases and the St Jude Medical Portico valve in 1. Device success was achieved in 90.8% of the cases. Complications included; major stroke (n = 1), re-exploration for cardiac tamponade (n = 3), transient renal failure requiring temporary haemodialysis (n = 1) and permanent pacemaker implantation (n = 5). There were no myocardial infarctions. The total 30-day mortality rate was 6.8% (3 patients). Postoperative intensive care unit stay was 2.6 ± 3.6 days, and the mean hospitalization was 12 ± 9.6 days. The TAo TAVI approach is feasible and offers a safe alternative for patients in whom a transfemoral approach is not feasible or desirable.

High-degree atrioventricular block in patients with preexisting bundle branch block or bundle branch block occurring during transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become the standard therapy for high-risk and non-operable patients with severe aortic stenosis. However, the procedure involves several adverse effects, such as rhythm and conduction disturbances. Patients with postprocedural left bundle branch block may have an increased mortality risk, whereas patients with preprocedural right bundle branch block display a higher rate of postinterventional bradyarrhythmias. The purpose of this study was to investigate the occurrence of high-degree atrioventricular block (AVB) in patients with preexisting bundle branch block (BBB) or BBB occurring during TAVI. In this prospective single-center study, 50 consecutive patients undergoing TAVI with the Medtronic CoreValve Revalving System were included. Of these patients, 17 with preexisting BBB or BBB occurring during TAVI received a primary prophylactic permanent DDD pacemaker, programmed to the SafeR-mode and featuring dual-channel event counters as well as stored intracardiac electrograms. Pacemaker readouts and intracardiac electrograms were analyzed for the occurrence of high-degree AVB. Ten of 17 patients (58.8%) with preexisting BBB or BBB occurring during TAVI developed episodes of high-degree AVB that were immediately terminated due to switch into DDD backup pacing. In 5 of the cases (29.4%), the first documented episode of high-degree AVB occurred after hospital discharge. Mean follow-up period was 578.1 ± 294.9 days. Development of high-degree AVB is a common complication in patients with preexisting BBB or BBB occurring during TAVI. Accordingly, intensified monitoring might be reasonable, especially in patients treated with the self-expandable Medtronic CoreValve Revalving System.

Predictors of Permanent Pacemaker Implantation in Patients With Severe Aortic Stenosis Undergoing TAVR: A Meta-Analysis

BackgroundAtrioventricular (AV) conduction disturbances requiring permanent pacemaker (PPM) implantation may complicate transcatheter aortic valve replacement (TAVR). Available evidence on predictors of PPM is sparse and derived from small studies. ObjectivesThe objective of this study was to provide summary effect estimates for clinically useful predictors of PPM implantation after TAVR. MethodsWe performed a systematic search for studies that reported the incidence of PPM implantation after TAVR and that provided raw data for the predictors of interest. Data on study, patient, and procedural characteristics were abstracted. Crude risk ratios (RRs) and 95% confidence intervals for each predictor were calculated by use of random effects models. Stratified analyses by type of implanted valve were performed. ResultsWe obtained data from 41 studies that included 11,210 TAVR patients, of whom 17% required PPM implantation after intervention. The rate of PPM ranged from 2% to 51% in individual studies (with a median of 28% for the Medtronic CoreValve Revalving System [MCRS] and 6% for the Edwards SAPIEN valve [ESV]). The summary estimates indicated increased risk of PPM after TAVR for men (RR: 1.23; p < 0.01); for patients with first-degree AV block (RR: 1.52; p < 0.01), left anterior hemiblock (RR: 1.62; p < 0.01), or right bundle branch block (RR: 2.89; p < 0.01) at baseline; and for patients with intraprocedural AV block (RR: 3.49; p < 0.01). These variables remained significant predictors when only patients treated with the MCRS bioprosthesis were considered. The data for ESV were limited. Unadjusted estimates indicated a 2.5-fold higher risk for PPM implantation for patients who received the MCRS than for those who received the ESV. ConclusionsMale sex, baseline conduction disturbances, and intraprocedural AV block emerged as predictors of PPM implantation after TAVR. This study provides useful tools to identify high-risk patients and to guide clinical decision making before and after intervention.

Comparison of Incidence and Predictors of Left Bundle Branch Block After Transcatheter Aortic Valve Implantation Using the CoreValve Versus the Edwards Valve

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.

A “modified crossover technique” for vascular access management in high‐risk patients undergoing transfemoral transcatheter aortic valve implantation

To describe results from our "modified crossover technique" for vascular access management during transcatheter aortic valve implantation (TAVI). Vascular access management remains a major cause of complications following TAVI due to the large bore sheaths required. All suitable patients undergoing TAVI in our center, between June and August 2011, underwent our "modified crossover technique," which enables the passage of a balloon through left radial access and inflation in the proximal iliac to allow percutaneous closure in a clean field. In total, 15 patients were included: the logistic EuroSCORE was 19.7 ± 12.1% and STS score 5.7 ± 5.6%. The mean therapeutic femoral access site diameter was 8.1 ± 1.0 mm. Ten (66.7%) patients received Edwards SAPIEN™ XT (two using the new E-sheath) and five (33.3%) patients a Medtronic CoreValve ReValving System® device. The "modified crossover technique" was used successfully in all patients. There were three vascular complications occurring at the therapeutic access site: one rupture of the external iliac artery, one Prostar failure, and one pseudoaneurysm of the right common femoral artery. All complications were successfully treated percutaneously with covered stent implantation via access from the contralateral femoral artery. In view of the balloon inflation from the left radial artery, the complications could be treated in a clean field with minimal blood loss. Our "modified crossover technique" using the left radial artery as the diagnostic site for balloon inflation appears a helpful adjunct in managing TAVI vascular access sites.

TCT-843 Transcatheter Aortic Valve Implantation with Edwards SAPIEN XT™ versus Medtronic CoreValve Revalving System® with AccuTrak™: The SAPERE Pilot Study

Background: To our knowledge no data exists comparing new generation commercially available devices for transfemoral (TF) transcatheter aortic valve implantation (TAVI). Methods: All consecutive patients from our single-center prospective registry with AS treated with TAVI with from Edwards SAPIEN XTTM (SXT) vs. Medtronic CoreValve® with AccuTrakTM delivery sy stem (MCVAT) when the devices became commercially available were included. The study endpoints were according to the Valve Academic Research Consortium (VARC) definitions. Results: In total, 235 patients treated in our center by TF TAVI for severe AS were included: 142 (60.4%) underwent SXT vs. 93 (39.6%) MCVAT. More females (60.6% vs. 43.0%; p 0.008) and smaller annulus size (23.2 1.9 vs. 24.3 2.0; p 0.001) were present in the SXT group. There were no differences between valves in 30-day combined safety endpoint (SXT 26.1% vs. MCVAT 29.7%; p 0.558), all-cause mortality (3.1% vs. 6.5%; p 0.218), cardiovascular mortality (2.3% vs. 5.4%; p 0.214), myocardial infarction (1.4% vs. 2.2%; p 0.683) or stroke (0.7% vs. 1.1%; p 0.774). Additionally, no differences were observed in life-threatening bleeding (12.4% vs. 20.4%; p 0.100) or major vascular complications (12.0% vs. 9.7%; p 0.583). Conversely, with SXT there was a lower occurrence of conduction disturbances/arrhythmia (16.5% vs. 36.6%; p 0.001) and pacemaker implantation (5.8% vs. 33.3%; p 0.001). Of note, a higher device success (96.5% vs. 88.2%; p 0.013) was observed with SXT. At median follow-up of 328 (IQR 83-401) days, there was no difference in combined efficacy endpoint (14.8% vs. 9.8%; p 0.265) or mortality (8.0% vs. 6.5%; p 0.654). Conclusions: In our single center experience, there was a lower incidence of arrhythmia and pacemaker, with higher device success with SXT. Differences in the characteristics of the patients treated with each valve may explain some of these findings.

040 Outcomes following transcatheter aortic valve implantation comparing Edwards SAPIEN with Medtronic CoreValve ReValving system devices: results from the Milan registry

BackgroundTo assess clinical outcomes of transcatheter aortic valve implantation comparing Medtronic CoreValve ReValving System® with Edwards SAPIEN XT.MethodsAll consecutive patients in our center with aortic stenosis treated with transfemoral Medtronic...

Transcatheter aortic valve implantation with a self‐expanding nitinol bioprosthesis

To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self-expanding aortic bioprosthesis. TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post-procedural conduction abnormalities and frequent need for PPM. Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12-lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. Patients exhibited high-risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32-0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03-1.83). Conduction abnormalities are frequently observed after TAVI with self-expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness.

TCT-120: Mid-Term Outcomes Following Transcatheter Aortic Valve Replacement with Both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® Devices According to VARC Definitions: the Milan Experience

TCT-120: Mid-Term Outcomes Following Transcatheter Aortic Valve Replacement with Both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® Devices According to VARC Definitions: the Milan Experience

TCT-124: Transfemoral Treatment of Bioprosthetic Aortic Valve Failure–Suitability of the Medtronic CoreValve ReValving System

TCT-124: Transfemoral Treatment of Bioprosthetic Aortic Valve Failure–Suitability of the Medtronic CoreValve ReValving System

The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® devices: the Milan registry

To assess outcomes after transcatheter aortic valve implantation (TAVI) according to sex, with the two available valves and four recognised delivery approaches. VARC outcomes are reported according to sex for 305 high-risk patients consecutively treated in our centre, via available access routes utilising the Edwards SAPIEN™/SAPIEN™ XT or the Medtronic CoreValve ReValving System® devices. Three hundred and five patients underwent TAVI: 52.1% male and 47.9% female. Females had a smaller body surface area (1.84±0.16 m² vs. 1.70±0.16 m²; p<0.001) and aortic annulus (24.4±1.6 mm vs. 22.6±1.7 mm; p<0.001) with increased symptoms (NYHA Class III/IV 61.6% vs. 73.6%; p=0.026). Conversely, men had more comorbidities: diabetes mellitus (35.2% vs. 21.9%; p=0.010), chronic kidney disease (41.8% vs. 23.3%; p=0.001), chronic obstructive pulmonary disease (45.3% vs. 30.1%; p=0.006) and previous myocardial infarction (28.3% vs. 14.4%; p=0.003). Thirty-day mortality was 4.7% with no difference between groups. There was a trend for females to develop more major vascular complications (11.9% vs. 19.9%; p=0.058). Notably, females required more blood transfusion (38.4% vs. 50.0%; p=0.041). No differences were observed in device success (92.5%; p=0.667), combined safety endpoint (61.8%; p=0.211) or combined efficacy endpoint (72.0%; p=0.889). Female sex was a predictor of major vascular complications with females requiring more transfusion. No differences were noted amongst patients undergoing TAVI in composite safety and efficacy endpoints according to sex.

Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes

Transcatheter aortic valve implantation (TAVI) is a treatment option for high-risk patients with severe aortic stenosis. Previous reports focused on a single device or access site, whereas little is known of the combined use of different devices and access sites as selected by the heart team. The purpose of this study is to investigate clinical outcomes of TAVI using different devices and access sites. A consecutive cohort of 200 patients underwent TAVI with the Medtronic CoreValve Revalving system (Medtronic Core Valve LLC, Irvine, CA; n = 130) or the Edwards SAPIEN valve (Edwards Lifesciences LLC, Irvine, CA; n = 70) implanted by either the transfemoral or transapical access route. Device success and procedure success were 99% and 95%, respectively, without differences between devices and access site. All-cause mortality was 7.5% at 30 days, with no differences between valve types or access sites. Using multivariable analysis, low body mass index (<20 kg/m(2)) (odds ratio [OR] 6.6, 95% CI 1.5-29.5) and previous stroke (OR 4.4, 95% CI 1.2-16.8) were independent risk factors for short-term mortality. The VARC-defined combined safety end point occurred in 18% of patients and was driven by major access site complications (8.0%), life-threatening bleeding (8.5%) or severe renal failure (4.5%). Transapical access emerged as independent predictor of adverse outcome for the Valve Academic Research Consortium-combined safety end point (OR 3.3, 95% CI 1.5-7.1). A heart team-based selection of devices and access site among patients undergoing TAVI resulted in high device and procedural success. Low body mass index and history of previous stroke were independent predictors of mortality. Transapical access emerged as a risk factor for the Valve Academic Research Consortium-combined safety end point.

P180 Nursing care after Transcatheter Aortic Valve Implantation with the Medtronic CoreValve Revalving system

P180 Nursing care after Transcatheter Aortic Valve Implantation with the Medtronic CoreValve Revalving system

Frequency, determinants, and prognostic effects of acute kidney injury and red blood cell transfusion in patients undergoing transcatheter aortic valve implantation

To determine the frequency and independent predictors of acute kidney injury (AKI) in addition to the prognostic implications of both AKI and periprocedural red blood cell (RBC) transfusions on 30 day and cumulative late mortality in patients undergoing transcatheter aortic valve implantation (TAVI). RBC transfusions have been reported to predict AKI following TAVI. Data on the prognostic implications of both factors, however, are lacking. 126 consecutive patients underwent TAVI with the Medtronic CoreValve Revalving System. AKI was defined according to the valve academic research consortium definitions as an absolute increase in serum creatinine ≥0.3 mg dL⁻¹ (≥26.4 μmol L⁻¹) or a percentage increase ≥ 50% within 72 hr following TAVI. Five patients on chronic haemodialysis and three intraprocedural deaths were excluded, leading to a final study population of 118 patients. AKI occurred in 19% of the patients necessitating temporary haemodialysis in 2%. Independent predictors of AKI included: previous myocardial infarction (OR: 5.72; 95% CI: 1.64-19.94), periprocedural (<24 hr) RBC transfusions (OR: 1.29; 95% CI: 1.01-1.70), postprocedural (<72 hr) leucocyte count (OR: 1.18; 95% CI: 1.02-1.37), and logistic EuroSCORE (OR: 1.08; 95% CI: 1.01-1.14). In patients with AKI, 30-day mortality was 23% and cumulative late mortality (median: 13 months) was 55%. AKI (OR: 5.47; 95% CI: 1.23-24.21) and postprocedural leucocyte count (OR: 1.20; 95% CI: 1.03-1.38) were independent predictors of 30-day mortality while AKI (HR: 2.79; 95% CI: 1.36-5.71) was the only independent predictor of late mortality. AKI following TAVI occurred in 19% of the patients. RBC transfusion was found to be an independent predictor of AKI, which in turn predicted both 30-day and cumulative late mortality.

P180 Poster Nursing care after Transcatheter Aortic Valve Implantation with the Medtronic CoreValve Revalving system

P180 Poster Nursing care after Transcatheter Aortic Valve Implantation with the Medtronic CoreValve Revalving system

Incidence and Predictors of Atrioventricular Conduction Impairment After Transcatheter Aortic Valve Implantation

Atrioventricular (AV) conduction impairment is well described after surgical aortic valve replacement, but little is known in patients undergoing transcatheter aortic valve implantation (TAVI). We assessed AV conduction and need for a permanent pacemaker in patients undergoing TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards Sapien Valve (ESV). Sixty-seven patients without pre-existing permanent pacemaker were included in the study. Forty-one patients (61%) and 26 patients (39%) underwent successful TAVI with the MCRS and ESV, respectively. Complete AV block occurred in 15 patients (22%), second-degree AV block in 4 (6%), and new left bundle branch block in 15 (22%), respectively. A permanent pacemaker was implanted in 23 patients (34%). Overall PR interval and QRS width increased significantly after the procedure (p <0.001 for the 2 comparisons). Implantation of the MCRS compared to the ESV resulted in a trend toward a higher rate of new left bundle branch block and complete AV block (29% vs 12%, p = 0.09 for the 2 comparisons). During follow-up, complete AV block resolved in 64% of patients. In multivariable regression analysis pre-existing right bundle branch block was the only independent predictor of complete AV block after TAVI (relative risk 7.3, 95% confidence interval 2.4 to 22.2). In conclusion, TAVI is associated with impairment of AV conduction in a considerable portion of patients, patients with pre-existing right bundle branch block are at increased risk of complete AV block, and complete AV block resolves over time in most patients.

Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation

Early conduction abnormalities and need for pacemaking after transcatheter aortic valve implantation (TAVI) is well recognised. It is still unknown, however, if these conduction abnormalities are persistent, and what is the need for permanent pacemaking after 1-month follow-up. In this prospective study, we examined the incidence of post-procedural and 6-month conduction abnormalities and need for permanent pacemaking after TAVI. We examined the 12-lead electrocardiogram (ECG) of 91 consecutive patients in whom a Medtronic CoreValve ReValving System was implanted between November 2005 and April 2009. We evaluated the ECGs before treatment, after treatment, at 1-month and 6-month follow-up. The requirement and timing of permanent pacemaking was documented. The mean age of patients was 81±7 years and the mean logistic EuroSCORE was 16±9%. Median duration of follow-up was 213 days (IQR 64, 519). There was a 39% increase in the frequency of LBBB after TAVI (15% before treatment vs. 54% after treatment, p<0.001). Importantly, there was no significant change in the frequency of LBBB from after treatment to 1- or 6-month follow-up (54% after treatment vs. 42% at 1-month follow-up, p=0.45, and 54% after treatment vs. 45% at 6-month follow-up, p=0.39). Permanent pacemaking was required in 17/91 (19%) of patients. A permanent pacemaker was implanted in 8/17 patients (47%) within seven days of TAVI, in 6/17 (35%) at 7-30 days, and in 3/17 (18%) after 30 days. Male gender, previous myocardial infarction, pre-existing right bundle branch block, actual diameter (mm) of the inflow portion of the CoreValve frame post-implantation and depth of implantation were predictors for new LBBB; pre-treatment QRS duration (msec) and septal wall thickness were predictors for permanent pacemaking. These results suggest that early conduction abnormalities occurring after TAVI persist at 6-months follow-up. Patient-related, anatomical-related, and procedure-related factors need to be considered in the pathogenesis of conduction abnormalities after TAVI.