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One-Year Follow-Up of Conduction Abnormalities After Transcatheter Aortic Valve Implantation With the SAPIEN 3 Valve

2019; Elsevier BV; Volume: 124; Issue: 8 Linguagem: Inglês

10.1016/j.amjcard.2019.07.035

1879-1913

Giulia Dolci, E. Mara Vollema, Frank van der Kley, Arend de Weger, Nina Ajmone Marsan, Victoria Delgado, Jeroen J. Bax,

Cardiac pacing and defibrillation studies

Long-term evolution of new-onset conduction abnormalities and need of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) have not been extensively evaluated. We describe the incidence and time course of new conduction abnormalities and the rate of PPI with the new-generation transcatheter aortic valve prosthesis Edwards SAPIEN 3 (S3). In total, 266 patients with severe aortic stenosis who underwent TAVI were retrospectively analyzed. Twelve-lead electrocardiograms at baseline, after TAVI, at discharge, at 1-, 6-, and 12-month follow-up were evaluated to identify conduction abnormalities and PPI requirements to investigate the correlates of PPI. After TAVI, a significant increase in PR interval duration and in QRS complex width was observed. New-onset left bundle branch block was observed in 65 patients (24%) after TAVI. The number of patients with left bundle branch block was maximum at hospital discharge and decreased at 12-month follow-up (39% and 32%, respectively). Thirty-five patients (13%) required PPI during the follow-up. However, paced rhythm was only observed in 7% of the patients with a complete 12-month follow-up. Patients who underwent PPI had a higher prevalence of first-degree atrioventricular block, complete right bundle branch block, and wider QRS complex at baseline. Baseline right bundle branch block and QRS width immediately after TAVI were the only variables independently associated with PPI. In conclusion, conduction disorders have a temporary nature after TAVI and showed a trend toward stabilization during the following months. With this new-generation device, the incidence of new conduction abnormalities requiring PPI is relatively low. Long-term evolution of new-onset conduction abnormalities and need of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) have not been extensively evaluated. We describe the incidence and time course of new conduction abnormalities and the rate of PPI with the new-generation transcatheter aortic valve prosthesis Edwards SAPIEN 3 (S3). In total, 266 patients with severe aortic stenosis who underwent TAVI were retrospectively analyzed. Twelve-lead electrocardiograms at baseline, after TAVI, at discharge, at 1-, 6-, and 12-month follow-up were evaluated to identify conduction abnormalities and PPI requirements to investigate the correlates of PPI. After TAVI, a significant increase in PR interval duration and in QRS complex width was observed. New-onset left bundle branch block was observed in 65 patients (24%) after TAVI. The number of patients with left bundle branch block was maximum at hospital discharge and decreased at 12-month follow-up (39% and 32%, respectively). Thirty-five patients (13%) required PPI during the follow-up. However, paced rhythm was only observed in 7% of the patients with a complete 12-month follow-up. Patients who underwent PPI had a higher prevalence of first-degree atrioventricular block, complete right bundle branch block, and wider QRS complex at baseline. Baseline right bundle branch block and QRS width immediately after TAVI were the only variables independently associated with PPI. In conclusion, conduction disorders have a temporary nature after TAVI and showed a trend toward stabilization during the following months. With this new-generation device, the incidence of new conduction abnormalities requiring PPI is relatively low. Transcatheter aortic valve implantation (TAVI) has become the treatment of choice in patients with symptomatic severe aortic stenosis (AS) and contraindications or high risk for surgical aortic valve replacement.1Baumgartner H Falk V Bax JJ De Bonis M Hamm C Holm PJ Iung B Lancellotti P Lansac E Rodriguez Munoz D Rosenhek R Sjogren J Tornos Mas P Vahanian A Walther T Wendler O Windecker S Zamorano JL Group ESCSD2017 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2017; 38: 2739-2791Crossref PubMed Scopus (2) Google Scholar Recently, this treatment has been extended to patients with intermediate operative risk.2Leon MB Smith CR Mack MJ Makkar RR Svensson LG Kodali SK Thourani VH Tuzcu EM Miller DC Herrmann HC Doshi D Cohen DJ Pichard AD Kapadia S Dewey T Babaliaros V Szeto WY Williams MR Kereiakes D Zajarias A Greason KL Whisenant BK Hodson RW Moses JW Trento A Brown DL Fearon WF Pibarot P Hahn RT Jaber WA Anderson WN Alu MC Webb JG Investigators PTranscatheter or surgical aortic-valve replacement in intermediate-risk patients.New Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (2595) Google Scholar The increased life expectancy of the population together with the current expansion of the indications for TAVI toward younger and lower surgical risk patients call for efforts to obtain similar (if not better) results than surgical aortic valve replacement which is currently the preferred treatment in these subpopulations.3Webb J Gerosa G Lefevre T Leipsic J Spence M Thomas M Thielmann M Treede H Wendler O Walther T Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.J Am Coll Cardiol. 2014; 64: 2235-2243Crossref PubMed Scopus (243) Google Scholar The development of conduction abnormalities and the need for permanent pacemaker implantation (PPI) is a common complication of TAVI. Using the new-generation transcatheter aortic valves, the incidence of PPI ranges 2.3% to 36.1%.4van Rosendael PJ Delgado V Bax JJ Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.Eur Heart J. 2018; 39: 2003-2013Crossref PubMed Scopus (117) Google Scholar This broad range of PPI incidence relies on the inclusion of patients with pre-existent conduction abnormalities, anatomical factors such as calcification of the left ventricular (LV) outflow tract, and procedural factors such as the design and depth of implantation of the transcatheter aortic valve prosthesis. Interestingly, the time course of TAVI-induced conduction abnormalities has not been fully elucidated and high-degree atrioventricular (AV) block may occur late (after 1 week) in a significant proportion of patients.5Toggweiler S Stortecky S Holy E Zuk K Cuculi F Nietlispach F Sabti Z Suciu R Maier W Jamshidi P Maisano F Windecker S Kobza R Wenaweser P Luscher TF Binder RK The electrocardiogram after transcatheter aortic valve replacement determines the risk for post-procedural high-degree AV block and the need for telemetry monitoring.JACC Cardiovasc Intervent. 2016; 9: 1269-1276Crossref PubMed Scopus (73) Google Scholar The present study describes the incidence of new conduction abnormalities after TAVI and their time course during 1-year follow-up using the Edwards SAPIEN S3 prosthesis (Edwards Lifesciences, Irvine, CA). Moreover, the need for PPI and factors associated with this complication are investigated. Patients with severe AS or degenerated aortic surgical bioprosthesis who underwent TAVI with the balloon-expandable Edwards SAPIEN S3 valve between February 2014 and February 2018 at the Leiden University Medical Center (The Netherlands) were analyzed (n = 327). Patients with a permanent pacemaker at baseline were excluded (n = 61). The remaining 266 patients were included in this single-center retrospective analysis. The indication for TAVI was established by the multidisciplinary heart team. Demographic and clinical characteristics were prospectively collected in the departmental Cardiology Information System (EPD-Vision; Leiden University Medical Center, Leiden, the Netherlands) and retrospectively analyzed. Twelve-lead electrocardiogram (ECG) acquired at baseline, immediately after the procedure, at hospital discharge, and at 1-, 6-, and 12-month follow-up, was evaluated. The occurrence of new cardiac conduction abnormalities after TAVI was recorded. These included any degree of new-onset AV block, left or right bundle branch block (LBBB and RBBB, respectively), unspecific ventricular conduction delay, atrial fibrillation (AF), and need for PPI. The changes over time in frequency of conduction abnormalities were analyzed during the follow-up. Among various clinical, electrocardiographic, and procedural variables, the associates of new PPI were investigated. The institutional review board approved this retrospective analysis of clinically acquired data and waived the need for patient-written informed consent. Standard 12-lead ECGs were obtained at baseline and immediately after the procedure, at hospital discharge, and at 1-, 6-, and 12-month follow-up. Calibration of the ECG was set at 0.1 mV/mm and the paper speed was 25 mm/s. Heart rhythm, PR interval duration, QRS width, the presence of AV block, LBBB, RBBB, or unspecific ventricular conduction delay were assessed. A first-degree AV block was defined as a PR interval ≥200 milliseconds. RBBB was defined as a QRS width >120 milliseconds in the presence of typical RBBB morphology (rR' in V1). LBBB was defined as QRS duration >120 milliseconds and QRS complex negative in V1 with small R or no R. When the patient presented with paced rhythm, the duration of the QRS was not measured. Preoperative transthoracic echocardiography was performed using commercially available ultrasound systems (Vivid 7, Vivid E9 and E95; General Electric Healthcare, Horten, Norway) equipped with 3.5 MHz or M5S-D transducers. Parasternal, apical, subcostal, and suprasternal views were obtained according to current recommendations.6Lang RM Badano LP Mor-Avi V Afilalo J Armstrong A Ernande L Flachskampf FA Foster E Goldstein SA Kuznetsova T Lancellotti P Muraru D Picard MH Rietzschel ER Rudski L Spencer KT Tsang W Voigt JU Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.J Am Soc Echocardiogr. 2015; 28 (e14): 1-39Abstract Full Text Full Text PDF PubMed Scopus (5121) Google Scholar The echocardiographic data were digitally stored in cine-loop format and data were retrospectively analyzed using commercially available software (EchoPac 112.0.1; GE Medical Systems, Horten, Norway). LV dimensions and ejection fraction (LVEF) were assessed as recommended.6Lang RM Badano LP Mor-Avi V Afilalo J Armstrong A Ernande L Flachskampf FA Foster E Goldstein SA Kuznetsova T Lancellotti P Muraru D Picard MH Rietzschel ER Rudski L Spencer KT Tsang W Voigt JU Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.J Am Soc Echocardiogr. 2015; 28 (e14): 1-39Abstract Full Text Full Text PDF PubMed Scopus (5121) Google Scholar Preoperative aortic valve function was evaluated using color, continuous and pulsed wave Doppler according to current recommendations.6Lang RM Badano LP Mor-Avi V Afilalo J Armstrong A Ernande L Flachskampf FA Foster E Goldstein SA Kuznetsova T Lancellotti P Muraru D Picard MH Rietzschel ER Rudski L Spencer KT Tsang W Voigt JU Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.J Am Soc Echocardiogr. 2015; 28 (e14): 1-39Abstract Full Text Full Text PDF PubMed Scopus (5121) Google Scholar Aortic valve area was calculated by the continuity equation and indexed for body surface area.1Baumgartner H Falk V Bax JJ De Bonis M Hamm C Holm PJ Iung B Lancellotti P Lansac E Rodriguez Munoz D Rosenhek R Sjogren J Tornos Mas P Vahanian A Walther T Wendler O Windecker S Zamorano JL Group ESCSD2017 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2017; 38: 2739-2791Crossref PubMed Scopus (2) Google Scholar In addition, preoperative multidetector computed tomographic data were acquired to assess the aortic annulus dimensions, aortic valve calcification grade, and the feasibility of transfemoral access. Edwards SAPIEN S3 transcatheter heart valves were used for all the patients. Selection of the device size was based on measurements of the aortic annulus obtained with multidetector row computed tomography. TAVI was performed via transfemoral access, if adequate iliofemoral arterial anatomy was present, or via transapical access otherwise. Balloon dilation was performed before implantation of the transcatheter valve in patients with severe native AS. Positioning and deployment of the device was achieved using fluoroscopic guidance. A temporary pacemaker was used for rapid right ventricular pacing during balloon predilatation as well as during implantation of the prosthesis. Patients were followed up at the outpatient clinic at 1, 6, and 12 months. An ECG was performed at each outpatient visit. The decision to implant a permanent pacemaker was left at the discretion of the treating physician according to the current guidelines,7Brignole M Auricchio A Baron-Esquivias G Bordachar P Boriani G Breithardt OA Cleland J Deharo JC Delgado V Elliott PM Gorenek B Israel CW Leclercq C Linde C Mont L Padeletti L Sutton R Vardas PE Zamorano JL Achenbach S Baumgartner H Bax JJ Bueno H Dean V Deaton C Erol C Fagard R Ferrari R Hasdai D Hoes AW Kirchhof P Knuuti J Kolh P Lancellotti P Linhart A Nihoyannopoulos P Piepoli MF Ponikowski P Sirnes PA Tamargo JL Tendera M Torbicki A Wijns W Windecker S Document R Kirchhof P Blomstrom-Lundqvist C Badano LP Aliyev F Bansch D Baumgartner H Bsata W Buser P Charron P Daubert JC Dobreanu D Faerestrand S Hasdai D Hoes AW Le Heuzey JY Mavrakis H McDonagh T Merino JL Nawar MM Nielsen JC Pieske B Poposka L Ruschitzka F Tendera M Van Gelder IC Wilson CM Guidelines ESCCfP2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA).Eur Heart J. 2013; 34: 2281-2329Crossref PubMed Scopus (1438) Google Scholar8Epstein AE DiMarco JP Ellenbogen KA Estes 3rd, NA Freedman RA Gettes LS Gillinov AM Gregoratos G Hammill SC Hayes DL Hlatky MA Newby LK Page RL Schoenfeld MH Silka MJ Stevenson LW Sweeney MO Tracy CM Epstein AE Darbar D DiMarco JP Dunbar SB Estes 3rd, NA Ferguson Jr., TB Hammill SC Karasik PE Link MS Marine JE Schoenfeld MH Shanker AJ Silka MJ Stevenson LW Stevenson WG Varosy PD American College of Cardiology F, American Heart Association Task Force on Practice G, Heart Rhythm S2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society.J Am Coll Cardiol. 2013; 61: e6-75PubMed Google Scholar and the indication was reported for every patient. Continuous variables are expressed as mean ± standard deviation or as the median (interquartile range [IQR]) and were compared using the unpaired Student t test or Mann-Whitney U test as appropriate. Categorical variables are presented as numbers and percentages and were compared with the chi-square test or Fisher's exact test as appropriate. The Wilcoxon signed-rank test (for continuous variables) and the McNemar test (for binomial variables) were used to perform paired comparisons between 2 time-points. Univariable and multivariable logistic regression analyses were performed to identify independent clinical and ECG correlates of PPI. All variables with a p value <0.10 on univariable logistic regression analysis were included in the multivariable model. The odds ratio (OR) and 95% confidence interval (CI) were calculated and reported. All analyses were performed with the SPSS for Windows, version 23.0 (SPSS, Armonk, NY). All statistical tests were two-sided. A p value <0.05 was considered statistically significant. A total of 266 patients (mean age 80 ± 7, 52% male) were included in the present analysis. Baseline clinical, imaging, and procedural characteristics of the overall population are shown in Table 1.Table 1Baseline clinical, echocardiographic, and procedural characteristicsVariableOverall population (n = 266)Age (y)80 ± 7Men139 (52%)Body mass index (kg/m2)26 ± 5NYHA functional class III or IV164 (62%)Hypertension187 (70%)Dyslipidemia148 (56%)Diabetes mellitus75 (28%)Peripheral artery disease58 (22%)Past smoker46 (17%)Prior myocardial infarction59 (22%)Chronic obstructive pulmonary disease40 (15%)Creatinine level (mmol/L)94 [74-118]Prior myocardial revascularization (PCI or CABG)137 (52%)Logistic EuroSCORE (%)14.7±8.7Medical treatment Beta-blocker146 (55%) Calcium antagonist53 (20%)Echocardiographic variables Left ventricular ejection fraction (%)53 ± 15 Aortic valve area (cm2)0.7 ± 0.2 Mean transvalvular gradient (mmHg)43 ± 17 Peak transvalvular gradient (mmHg)69 ± 24Computed tomography variables Aortic annulus area (mm2)475.7 ± 97.0 Aortic valve calcification (Hounsfield units)3364.7 ± 1681.6 Eccentricity index0.21 ± 0.07Procedural variables Transfemoral access223 (84%) Transapical access43 (16%)Valve-in-valve procedure4 (2%)Prosthesis size (mm) 2384 (32%) 26100 (38%) 2982 (30%)Need of balloon postdilation34 (13%)Grade of oversizing prosthesis (%)13.2±11.4Data are presented as mean value ± standard deviation or as frequencies and percentages. Open table in a new tab Data are presented as mean value ± standard deviation or as frequencies and percentages. The time course of cardiac conduction abnormalities after S3 valve implantation is presented in Table 2. Most patients were in sinus rhythm (SR) at baseline and the majority remained in SR during follow-up (Table 2). The mean changes in PR interval duration and in QRS complex width throughout the entire study period are shown in Figure 1. After TAVI, there was an increase in the PR interval duration and a significant increase in the QRS complex width compared with baseline. The PR interval duration showed its maximum values at hospital discharge (183 ± 32 milliseconds before treatment vs 195 ± 43 milliseconds at hospital discharge, p <0.001) and significantly decreased at follow-up (195 ± 43 milliseconds at hospital discharge vs 188 ± 40 milliseconds at 6-month follow-up, p = 0.039). At 12-month follow-up, the PR duration was slightly increased compared with 6 months (188 ± 40 milliseconds vs 192 ± 40 milliseconds, p = 0.045). Similarly, the QRS width was largest at discharge (111 ± 25 milliseconds at baseline vs 128 ± 30 milliseconds at discharge, p <0.001) and significantly decreased at follow-up (128 ± 30 milliseconds at discharge vs 121 ± 28 milliseconds at 1 month, p <0.001). Subsequently, the QRS width remained stable (Figure 1). The percentage of patients with first-degree AV block was significantly higher at discharge compared with baseline (18% at baseline vs 25% at hospital discharge, p = 0.002; Table 2). Of note, at 12-month follow-up, the number of patients with first-degree AV block increased (Table 2). New-onset complete LBBB was observed in 65 patients (24%) after TAVI. The number of patients with LBBB was maximum at hospital discharge and decreased at 12-month follow-up (from 39% to 32%, respectively). The percentage of patients who remained free of any type of bundle branch block decreased from 74% at baseline to 47% at discharge.Table 2Electrocardiographic changes during 12-month follow-upVariablesPre-TAVI (n = 266)Post-TAVI (n = 265)Predischarge (n = 259)1 month (n = 216)6 months (n = 171)12 months (n = 142)RhythmSinus rhythm192 (72%)191 (72%)170 (66%)155 (72%)123 (72%)99 (70%)Atrial fibrillation74 (28%)64 (24%)69 (27%)47 (22%)33 (19%)33 (23%)Idioventricular001 (0.4%)000Ventricular paced010 (4%)19 (7%)14 (7%)15 (9%)10 (7%)Atrioventricular blockFirst degree49 (18%)52 (20%)64 (25%)56 (26%)39 (23%)40 (28%)Bundle branch blockRight31 (12%)25 (9%)17 (7%)13 (6%)11 (6%)13 (9%)Left37 (14%)102 (38%)100 (39%)69 (32%)51 (30%)45 (32%)None198 (74%)128 (48%)123 (47%)120 (55%)94 (55%)74 (52%)Cumulative percentage of PPI implanted for each time interval01 (0.4%)29 (11%)30 (11%)35 (13%)35 (13%)New PPI for each time interval01 (0.4%)28 (11%)1 (0.5%)5 (3%)0Data are presented as frequencies and percentages. PPI = permanent pacemaker implantation; TAVI = transcatheter aortic valve implantation. Open table in a new tab Data are presented as frequencies and percentages. PPI = permanent pacemaker implantation; TAVI = transcatheter aortic valve implantation. After TAVI, 35 patients (13%) required PPI during a 12-month follow-up period. The median time from TAVI to PPI was 4 days (IQR: 3 to 25 days). The majority of the subjects were implanted before hospital discharge. Indications for PPI are shown in Table 3 and the precise timing of implantation is displayed in Figure 2. Importantly, paced rhythm was present in only 7% of the patients of the total population at hospital discharge. This proportion of patients remained unchanged during the entire follow-up period (9% at 6 months and 7% at 12 months, p = 1.000). There were no significant differences in clinical, imaging, and procedural characteristics between patients who underwent PPI versus patients who did not (Table 4). Patients who underwent PPI had a higher prevalence of first-degree AV block, complete RBBB and wider QRS complex at baseline compared with their counterparts (Table 5). Table 6 demonstrates the univariable and multivariable logistic regression analyses to identify correlates of PPI during 12-month follow-up after TAVI. The presence of RBBB, first-degree AV block, and a wider QRS complex at baseline together with a wider QRS complex at the ECG performed immediately after TAVI were included in the final multivariable model. Baseline RBBB and QRS width immediately after TAVI were the only variables independently associated with PPI.Table 3Indications for permanent pacemaker implantationIndicationN (%)Atrioventricular block grade III26 (74%)Bradyarrhythmia with left bundle branch block3 (8%)Cardiac resynchronization therapia and His ablation2 (6%)Implantable cardioverter defibrillator1 (3%)Bradyarrhythmia1 (3%)Atrioventricular block grade II (Mobitz 2)2 (6)Data are presented as frequencies and percentages. Open table in a new tab Table 4Clinical, procedural, and echocardiographic parameters in patient receiving permanent pacemaker versus patients withoutVariablePermanent pacemaker implantationp ValueYes (n = 35)No (n = 231)Age (y)79 ± 880 ± 70.586Men19 (54%)120 (52%)0.796Body mass index (kg/m2)26 ± 526 ± 50.477New York Heart Association functional class III or IV11 (31%)62 (27%)0.772Hypertension25 (71%)162 (70%)0.904Dyslipidemia19 (54%)129 (56%)0.842Diabetes mellitus8 (23%)67 (29%)0.443Peripheral artery disease6 (17%)52 (23%)0.466History of smoking7 (20%)39 (17%)0.658Prior myocardial infarction8 (23%)51 (22%)0.928Chronic obstructive pulmonary disease4 (11%)36 (16%)0.421Creatinine level (mmol/L)127 ± 125108 ± 660.156Prior myocardial revascularization (percutaneous coronary intervention or coronary artery by-pass graft)19 (54%)118 (52%)0.688Logistic EuroSCORE (%)13 ± 815 ± 90.214Echocardiographic variablesLeft ventricular ejection fraction (%)52 ± 1553 ± 150.770Aortic valve area (cm2)0.72 ± 0.200.75 ± 0.190.325Mean gradient (mm Hg)44 ± 1443 ± 160.628Peak gradient (mm Hg)70 ± 2068 ± 250.700Computed tomography variablesAortic annulus area (mm2)468.1 ± 91.2476.8 ± 97.90.648Aortic valve calcification (Hounsfield units)3234.4 ± 1696.33381.7 ± 1685.50.739Eccentricity index0.21 ± 0.080.20 ± 0.070.454Procedural variablesTransfemoral access31 (89%)192 (83%)0.622Transapical access4 (11%)39 (17%)0.622Prosthesis size (mm) 239 (26%)75 (32%)0.423 2613 (37%)87 (38%)0.953 2913 (37%)69 (30%)0.385Grade of oversizing prosthesis (%)16.3 ± 13.412.8 ± 11.00.119Need of postballoon dilation5 (14%)29 (13%)0.775Data are reported as mean and standard deviation or as frequencies and percentages as appropriate. Open table in a new tab Table 5Electrocardiographic characteristics between patients with and without permanent pacemaker implantationPPI (n = 35)No PPI (n = 231)p ValueRhythmSinus rhythm26 (74%)166 (72%)0.766Atrial fibrillation9 (26%)65 (28%)0.766PR duration (ms)196 ± 37182 ± 320.078QRS width (ms)125 ± 30110 ± 240.005Atrioventricular block1st degree11 (31%)38 (16%)0.0322nd degree1 (3%)1 (0.4%)0.127Bundle branch blockRight12 (34%)17 (7%)<0.001Left3 (9%)38 (16%)0.229Data are presented as frequencies and percentages. Open table in a new tab Table 6Determinants of PPI during 12-month follow-up after TAVIVariablesUnivariate analysisMultivariate analysisOdds ratio95% Confidence intervalp ValueOdds ratio95% Confidence intervalp ValueAge (y)0.9860.939-1.0360.585Pre-TAVI sinus rhythm1.1310.503-2.5440.766Pre-TAVI atrial fibrillation0.8840.393-1.9880.766Pre-TAVI right bundle branch block6.5682.793-15.444<0.0015.0291.163-21.7500.031Pre-TAVI left bundle branch block0.4760.774-3.2320.238Pre-TAVI first-degree atrioventricular block2.5090.139-1.6350.0362.2090.833-5.8620.111Pre-TAVI QRS width1.0211.008-1.0340.0010.9750.947-1.0050.099Post-TAVI left bundle branch block1.5810.774-3.2320.209New-onset post TAVI left bundle branch block2.0340.959-4.3150.0640.8970.271-2.9740.859Post-TAVI QRS width1.0411.024-1.057<0.0011.0421.016-1.0680.001TAVI = transcatheter aortic valve implantation. Open table in a new tab Data are presented as frequencies and percentages. Data are reported as mean and standard deviation or as frequencies and percentages as appropriate. Data are presented as frequencies and percentages. TAVI = transcatheter aortic valve implantation. Cardiac conduction abnormalities are relatively frequent in patients with severe AS, as the aortic valve is in close anatomical proximity with the AV node and the origin of the left bundle branch, which can be affected by the degeneration and calcification processes that cause aortic valve stenosis.9Friedman HS Zaman Q Haft JI Melendez S Assessment of atrioventricular conduction in aortic valve disease.Br Heart J. 1978; 40: 911-917Crossref PubMed Scopus (25) Google Scholar In addition, both surgical aortic valve replacement and TAVI can induce conduction abnormalities.10Karyofillis P Kostopoulou A Thomopoulou S Habibi M Livanis E Karavolias G Voudris V Conduction abnormalities after transcatheter aortic valve implantation.J Geriatr Cardiol. 2018; 15: 105-112PubMed Google Scholar In TAVI, direct trauma or compression of the AV node and left bundle branch can occur during balloon dilatation of the native valve and transcatheter valve deployment, leading to AV block and LBBB. Periprocedural edema of the left ventricular outflow tract is the most frequent cause of these conduction abnormalities.4van Rosendael PJ Delgado V Bax JJ Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.Eur Heart J. 2018; 39: 2003-2013Crossref PubMed Scopus (117) Google Scholar Importantly, edema of the AV node and left bundle branch area is transient and conduction abnormalities may resolve over time. The design of the S3 prosthesis is characterized by a stent 3 to 4 mm longer than that of the earlier SAPIEN XT and an adaptive external tissue seal aiming at reducing paravalvular leak.3Webb J Gerosa G Lefevre T Leipsic J Spence M Thomas M Thielmann M Treede H Wendler O Walther T Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.J Am Coll Cardiol. 2014; 64: 2235-2243Crossref PubMed Scopus (243) Google Scholar The greater length of S3 valve potentially extends the area of contact with the septum, potentially increasing the probability of AV block and other conduction disorders.11Binder RK Rodes-Cabau J Wood DA Mok M Leipsic J De Larochelliere R Toggweiler S Dumont E Freeman M Willson AB Webb JG Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.JACC Cardiovasc Intervent. 2013; 6: 293-300Crossref PubMed Scopus (174) Google Scholar However, during the valve deployment, the stent shortens from the ventricular end, resulting in higher position and less damage of the AV node and low incidence of PPI.12Vahanian A Urena M Walther T Treede H Wendler O Lefevre T Spence MS Redwood S Kahlert P Rodes-Cabau J Leipsic J Webb J Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial.EuroIntervention. 2016; 12: e235-e243Crossref PubMed Scopus (29) Google Scholar Several studies evaluated the ECG changes over time secondary to TAVI, demonstrating the transient nature of the new-onset conduction abnormalities.13van Gils L Baart S Kroon H Rahhab Z El Faquir N Rodriguez Olivares R Aga Y Maugenest AM Theuns DA Boersma E Szili Torok T De Jaegere PP Van Mieghem NM Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study.Europace. 2018; 20: 1981-1988Crossref PubMed Scopus (6) Google Scholar, 14Piazza N Nuis RJ Tzikas A Otten A Onuma Y Garcia-Garcia H Schultz C van Domburg R van Es GA van Geuns R de Jaegere P Serruys PW Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation.EuroIntervention. 2010; 6: 475-484Crossref PubMed Scopus (101) Google Scholar, 15Leire U Eulogio G Francisco Jose RR Francisco Javier PJ Juan MP Belen DA Miguel RDR Adolfo F Rodrigo T Belen RA Electrocardiographic changes and conduction disturbances after transfemoral aortic valve implantation with Edwards Sapien 3 prosthesis.J Electrocardiol. 2018; 51: 416-421Crossref PubMed Scopus (4) Google Scholar Van Gils et al13van Gils L Baart S Kroon H Rahhab Z El Faquir N Rodriguez Olivares R Aga Y Maugenest AM Theuns DA Boersma E Szili Torok T De Jaegere PP Van Mieghem NM Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study.Europace. 2018; 20: 1981-1988Crossref PubMed Scopus (6) Google Scholar demonstrated that in patients without conduction abnormalities before TAVI, a persistent QRS widening after procedure was able to identify patients at higher risk for PPI. However, the follow-up period was limited (14 days) and no distinction between different valve prosthesis implanted was performed. Piazza et al14Piazza N Nuis RJ Tzikas A Otten A Onuma Y Garcia-Garcia H Schultz C van Domburg R van Es GA van Geuns R de Jaegere P Serruys PW Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation.EuroIntervention. 2010; 6: 475-484Crossref PubMed Scopus (101) Google Scholar studied only patients treated with the self-expanding Medtronic CoreValve prosthesis and reported that patients who developed new-onset LBBB had persisting LBBB at 6 months of follow-up. Leire et al15Leire U Eulogio G Francisco Jose RR Francisco Javier PJ Juan MP Belen DA Miguel RDR Adolfo F Rodrigo T Belen RA Electrocardiographic changes and conduction disturbances after transfemoral aortic valve implantation with Edwards Sapien 3 prosthesis.J Electrocardiol. 2018; 51: 416-421Crossref PubMed Scopus (4) Google Scholar analyzed exclusively 59 patients who received the S3 valve and showed that advanced AV block requiring PPI occurred in 2 patients. Conversely, the incidence of minor conduction abnormalities was relatively high (39% of patients demonstrated new-onset LBBB). In half of these cases, the new conduction abnormality was transient, although the time course of conduction disorders was analyzed only until hospital discharge. This difference may be due to technical factors and design of the balloon-expandable valve compared with the self-expandable prosthesis. Of note, a recent work of De Torres Alba et al16De-Torres-Alba F Kaleschke G Vormbrock J Orwat S Radke R Feurle M Diller GP Reinecke H Baumgartner H Delayed pacemaker requirement after transcatheter aortic valve implantation with a new-generation balloon expandable valve: should we monitor longer.Int J Cardiol. 2018; 273: 56-62Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar analyzed 606 patients receiving the S3 valve and demonstrated that the risk of PPI remained high beyond 7 days after TAVI and that this risk cannot be accurately predicted based on clinical or electrocardiographic factors: 23.5% of the patients requiring PPI at a late stage did not show any previous conduction abnormalities. This suggests that the conduction abnormalities requiring PPI at a late stage after TAVI may be due to progression of degeneration of the conduction system rather than the effect of the procedure or of the presence of the prosthetic valve. Our study also demonstrated that in a small proportion of patients, the need for PPI may develop even months after TAVI. Therefore, repeat ECG at long-term follow-up is recommended. Initial experiences with the S3 device showed an increased risk of PPI compared with the previous iterations of Edwards SAPIEN balloon-expandable prostheses.3Webb J Gerosa G Lefevre T Leipsic J Spence M Thomas M Thielmann M Treede H Wendler O Walther T Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.J Am Coll Cardiol. 2014; 64: 2235-2243Crossref PubMed Scopus (243) Google Scholar In our study, the rate of PPI was 13%, which is in line with previously reported incidences.3Webb J Gerosa G Lefevre T Leipsic J Spence M Thomas M Thielmann M Treede H Wendler O Walther T Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.J Am Coll Cardiol. 2014; 64: 2235-2243Crossref PubMed Scopus (243) Google Scholar17Wendler O Schymik G Treede H Baumgartner H Dumonteil N Ihlberg L Neumann FJ Tarantini G Zamarano JL Vahanian A SOURCE 3 registry: Design and 30-day results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 transcatheter heart valve.Circulation. 2017; 135: 1123-1132Crossref PubMed Scopus (127) Google Scholar Vahanian et al recently reported an incidence of PPI of 4.3% in 101 patients treated with the S3 prosthesis.12Vahanian A Urena M Walther T Treede H Wendler O Lefevre T Spence MS Redwood S Kahlert P Rodes-Cabau J Leipsic J Webb J Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial.EuroIntervention. 2016; 12: e235-e243Crossref PubMed Scopus (29) Google Scholar The lower incidence of PPI reported in this study was achieved through a careful positioning of the S3 prosthesis, high in the left ventricular outflow tract, following current recommendations for implantation to minimize the damage to the AV node and left bundle branch.18Tarantini G Mojoli M Purita P Napodano M D'Onofrio A Frigo A Covolo E Facchin M Isabella G Gerosa G Iliceto S Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.EuroIntervention. 2015; 11: 343-350Crossref PubMed Scopus (70) Google Scholar Nevertheless, the present study also shows that the need for pacemaker implantation may decrease over time as a significant proportion of patients receiving a pacemaker before hospital discharge did not show paced rhythm during follow-up. This emphasizes the need for frequent surveillance of these patients as they may not need PPI, and the settings of the pacemaker can be adjusted to allow intrinsic rhythm. The predictors of PPI after S3 implantation have been previously investigated.19Gonska B Seeger J Kessler M von Keil A Rottbauer W Wohrle J Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards SAPIEN 3 valve.Clin Res Cardiol. 2017; 106: 590-597Crossref PubMed Scopus (35) Google Scholar20Husser O Pellegrini C Kessler T Burgdorf C Thaller H Mayr NP Kasel AM Kastrati A Schunkert H Hengstenberg C Predictors of permanent pacemaker implantations and new-onset conduction abnormalities with the SAPIEN 3 balloon-expandable transcatheter heart valve.JACC Cardiovasc Intervent. 2016; 9: 244-254Crossref PubMed Scopus (98) Google Scholar In the present study, wider QRS, presence of RBBB, and first-degree AV block at baseline were associated with an increased risk for PPI after TAVI. These findings are corroborated by previous studies evaluating the association between the S3 prosthesis and the need for PPI.19Gonska B Seeger J Kessler M von Keil A Rottbauer W Wohrle J Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards SAPIEN 3 valve.Clin Res Cardiol. 2017; 106: 590-597Crossref PubMed Scopus (35) Google Scholar20Husser O Pellegrini C Kessler T Burgdorf C Thaller H Mayr NP Kasel AM Kastrati A Schunkert H Hengstenberg C Predictors of permanent pacemaker implantations and new-onset conduction abnormalities with the SAPIEN 3 balloon-expandable transcatheter heart valve.JACC Cardiovasc Intervent. 2016; 9: 244-254Crossref PubMed Scopus (98) Google Scholar Alternatively, in the present study, new-onset LBBB was not associated with the requirement for PPI. This finding is similar to the study by Gonska et al,19Gonska B Seeger J Kessler M von Keil A Rottbauer W Wohrle J Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards SAPIEN 3 valve.Clin Res Cardiol. 2017; 106: 590-597Crossref PubMed Scopus (35) Google Scholar who showed that only first-degree AV block and RBBB before procedure were independently associated with PPI. Some limitations have to be acknowledged. First, this is a single-center retrospective study. Second, we also included patients who underwent a valve-in-valve procedure. As an advantage, this reflects a real-life population in clinical practice. In conclusion, in a large population of patients treated with the S3 valve, new-onset conduction abnormalities exhibit a temporary nature after TAVI and showed a trend toward stabilization during 1-year follow-up. The presence of baseline RBBB and the QRS width after TAVI were significantly associated with the need for PPI. The Department of Cardiology of the Leiden University Medical Center receives unrestricted research grants from Biotronik, Boston Scientific, Edwards Lifesciences, GE Healthcare, and Medtronic. Victoria Delgado, Nina Ajmone Marsan and Jeroen J Bax received speaker fees from Abbott Vascular.