Conduction Disturbance After Transcatheter Aortic Valve Implantation With Self- or Balloon-Expandable Valve According to the Implantation Depth

Abstract

Membranous septum (MS) length, in conjunction with implantation depth (ID), is known as a determinant of conduction disturbance (CD) after transcatheter aortic valve implantation (TAVI). However, its impact might be dissimilar among valve types because each valve has a different platform. This study sought to investigate the different impacts of ID and MS length on the new-onset CD between ACURATE neo and SAPIEN 3. This study included patients without a previous permanent pacemaker implantation who underwent TAVI with ACURATE neo and SAPIEN 3 and divided them into 2 groups based on the ID according to MS length (deep and shallow implantation group). Deep implantation was defined as transcatheter heart valve implantation deeper than MS length. The primary endpoint was new-onset CD (new permanent pacemaker implantation or new-onset complete left bundle branch block). A total of 688 patients (deep implantation: n = 373, shallow implantation: n = 315) were identified as a study cohort. New-onset CD developed more frequently in the deep implantation group (16.6% vs 7.0%; p = 0.0001). Deep implantation was revealed as a predictor of new-onset CD. Moreover, deep implantation was significantly associated with new-onset CD after SAPIEN 3 implantation but not after ACURATE neo. Among patients with MS shorter than 2 mm, ACURATE neo was superior in terms of avoiding new-onset CD. In conclusion, the deep implantation was associated with new-onset CD after TAVI with SAPIEN 3 but not with ACURATE neo. These results may impact device selection in patients with a preexisting high risk of CD. Membranous septum (MS) length, in conjunction with implantation depth (ID), is known as a determinant of conduction disturbance (CD) after transcatheter aortic valve implantation (TAVI). However, its impact might be dissimilar among valve types because each valve has a different platform. This study sought to investigate the different impacts of ID and MS length on the new-onset CD between ACURATE neo and SAPIEN 3. This study included patients without a previous permanent pacemaker implantation who underwent TAVI with ACURATE neo and SAPIEN 3 and divided them into 2 groups based on the ID according to MS length (deep and shallow implantation group). Deep implantation was defined as transcatheter heart valve implantation deeper than MS length. The primary endpoint was new-onset CD (new permanent pacemaker implantation or new-onset complete left bundle branch block). A total of 688 patients (deep implantation: n = 373, shallow implantation: n = 315) were identified as a study cohort. New-onset CD developed more frequently in the deep implantation group (16.6% vs 7.0%; p = 0.0001). Deep implantation was revealed as a predictor of new-onset CD. Moreover, deep implantation was significantly associated with new-onset CD after SAPIEN 3 implantation but not after ACURATE neo. Among patients with MS shorter than 2 mm, ACURATE neo was superior in terms of avoiding new-onset CD. In conclusion, the deep implantation was associated with new-onset CD after TAVI with SAPIEN 3 but not with ACURATE neo. These results may impact device selection in patients with a preexisting high risk of CD. Transcatheter aortic valve implantation (TAVI) is increasingly used as a treatment of symptomatic aortic stenosis,1Smith CR Leon MB Mack MJ Miller DC Moses JW Svensson LG Tuzcu EM Webb JG Fontana GP Makkar RR Williams M Dewey T Kapadia S Babaliaros V Thourani VH Corso P Pichard AD Bavaria JE Herrmann HC Akin JJ Anderson WN Wang D Pocock SJ PARTNER Trial InvestigatorsTranscatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4939) Google Scholar,2Adams DH Popma JJ Reardon MJ Yakubov SJ Coselli JS Deeb GM Gleason TG Buchbinder M Hermiller Jr, J Kleiman NS Chetcuti S Heiser J Merhi W Zorn G Tadros P Robinson N Petrossian G Hughes GC Harrison JK Conte J Maini B Mumtaz M Chenoweth S Oh JK U.S. CoreValve Clinical InvestigatorsTranscatheter aortic-valve replacement with a self-expanding prosthesis.N Engl J Med. 2014; 370: 1790-1798Crossref PubMed Scopus (2111) Google Scholar and its benefit has been extended to low-surgical risk patients.3Mack MJ Leon MB Thourani VH Makkar R Kodali SK Russo M Kapadia SR Malaisrie SC Cohen DJ Pibarot P Leipsic J Hahn RT Blanke P Williams MR McCabe JM Brown DL Babaliaros V Goldman S Szeto WY Genereux P Pershad A Pocock SJ Alu MC Webb JG Smith CR PARTNER 3 InvestigatorsTranscatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380: 1695-1705Crossref PubMed Scopus (2682) Google Scholar,4Popma JJ Deeb GM Yakubov SJ Mumtaz M Gada H O'Hair D Bajwa T Heiser JC Merhi W Kleiman NS Askew J Sorajja P Rovin J Chetcuti SJ Adams DH Teirstein PS Zorn 3rd, GL Forrest JK Tchétché D Resar J Walton A Piazza N Ramlawi B Robinson N Petrossian G Gleason TG Oh JK Boulware MJ Qiao H Mugglin AS Reardon MJ Evolut Low Risk Trial InvestigatorsTranscatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380: 1706-1715Crossref PubMed Scopus (2054) Google Scholar Conduction disturbance (CD), including new permanent pacemaker implantation (PPI) and complete left bundle branch block (cLBBB), have been reported as significant complications after TAVI, and they are also related to the risk of increased mortality and readmission.5Nazif TM Dizon JM Hahn RT Xu K Babaliaros V Douglas PS El-Chami MF Herrmann HC Mack M Makkar RR Miller DC Pichard A Tuzcu EM Szeto WY Webb JG Moses JW Smith CR Williams MR Leon MB Kodali SK PARTNER Publications OfficePredictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry.JACC Cardiovasc Interv. 2015; 8: 60-69Crossref PubMed Scopus (407) Google Scholar, 6Nazif TM Chen S George I Dizon JM Hahn RT Crowley A Alu MC Babaliaros V Thourani VH Herrmann HC Smalling RW Brown DL Mack MJ Kapadia S Makkar R Webb JG Leon MB Kodali SK New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial.Eur Heart J. 2019; 40: 2218-2227Crossref PubMed Scopus (84) Google Scholar, 7Regueiro A Abdul-Jawad Altisent O Del Trigo M Campelo-Parada F Puri R Urena M Philippon F Rodés-Cabau J Impact of new-onset left bundle branch block and periprocedural permanent pacemaker implantation on clinical outcomes in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis.Circ Cardiovasc Interv. 2016; 9e003635Crossref PubMed Scopus (205) Google Scholar Despite the development of TAVI technology, the incidence of CD after TAVI is still more frequent than that after surgical aortic valve replacement.6Nazif TM Chen S George I Dizon JM Hahn RT Crowley A Alu MC Babaliaros V Thourani VH Herrmann HC Smalling RW Brown DL Mack MJ Kapadia S Makkar R Webb JG Leon MB Kodali SK New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial.Eur Heart J. 2019; 40: 2218-2227Crossref PubMed Scopus (84) Google Scholar,7Regueiro A Abdul-Jawad Altisent O Del Trigo M Campelo-Parada F Puri R Urena M Philippon F Rodés-Cabau J Impact of new-onset left bundle branch block and periprocedural permanent pacemaker implantation on clinical outcomes in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis.Circ Cardiovasc Interv. 2016; 9e003635Crossref PubMed Scopus (205) Google Scholar Several factors have been associated with significant risks of CD after TAVI.8Siontis GC Jüni P Pilgrim T Stortecky S Büllesfeld L Meier B Wenaweser P Windecker S Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis.J Am Coll Cardiol. 2014; 64: 129-140Crossref PubMed Scopus (459) Google Scholar Recently, membranous septum (MS) length was reported as 1 of the anatomic determinants of CD,9Kim WK Möllmann H Walther T Hamm CW Predictors of permanent pacemaker implantation after ACURATE neo transcatheter heart valve implantation.Pacing Clin Electrophysiol. 2021; 44: 410-415Crossref PubMed Scopus (8) Google Scholar,10Mauri V Reimann A Stern D Scherner M Kuhn E Rudolph V Rosenkranz S Eghbalzadeh K Friedrichs K Wahlers T Baldus S Madershahian N Rudolph TK Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3.JACC Cardiovasc Interv. 2016; 9: 2200-2209Crossref PubMed Scopus (150) Google Scholar in conjunction with transcatheter heart valve (THV) implantation depth (ID).11Jilaihawi H Zhao Z Du R Staniloae C Saric M Neuburger PJ Querijero M Vainrib A Hisamoto K Ibrahim H Collins T Clark E Pushkar I Bamira D Benenstein R Tariq A Williams M Minimizing permanent pacemaker following repositionable self-expanding transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 1796-1807Crossref PubMed Scopus (166) Google Scholar Deep implantation is considered to have a higher risk for new-onset CD than shallow implantation.12Miyashita H Moriyama N Yamanaka F Saito S Lehtola H Piuhola J Niemelä M Laine M Predictors of conduction disturbances after transcatheter aortic valve implantation with balloon-expandable valve for bicuspid aortic valve stenosis.J Cardiovasc Electrophysiol. 2022; 33: 1576-1586Crossref PubMed Scopus (1) Google Scholar,13Breitbart P Minners J Hein M Schröfel H Neumann FJ Ruile P Implantation depth and its influence on complications after TAVI with self-expanding valves.Int J Cardiovasc Imaging. 2021; 37: 3081-3092Crossref PubMed Scopus (5) Google Scholar However, it is unclear how the valve type (self- or balloon-expandable THV) affects the incidence of CD in relation to ID. Therefore, this study investigated the interaction between the combination of ID and MS length and THV types concerning their impact on CD after TAVI. A total of 887 consecutive patients who underwent TAVI with ACURATE neo and SAPIEN 3 (or SAPIEN 3 Ultra) from January 2016 to October 2020 at Helsinki University Central Hospital were retrospectively reviewed (Figure 1). From this cohort, cases with implantation failure (n = 5), valve-in-valve (n = 61), nontransfemoral approach (n = 52), previous PPI (n = 68), and poor multidetector computed tomography (MDCT) quality (n = 13) were excluded. This study compared the clinical outcomes after TAVI between a deep implantation group (ID > MS length) and a shallow implantation group (ID ≤ MS length). A total of 688 patients (deep implantation: n = 373 and shallow implantation: n = 315) were identified as a study cohort. Preoperative examinations, including MDCT and coronary angiography, were performed before TAVI hospitalization. We selected the THV size based on the integration of preprocedural MDCT assessment. The selection of THV was based on a discussion in our multidisciplinary heart team. MDCT was evaluated by 3mensio Workstation (3mensio Structural Heart 9.1, Pie Medical Imaging BV, Maastricht, The Netherlands). The MS was defined as the thinnest part of the interventricular septum on the perpendicular annular plane image. MS length was measured as the distance from the annular plane to the vertex of the muscular septum in a stretched vessel image.11Jilaihawi H Zhao Z Du R Staniloae C Saric M Neuburger PJ Querijero M Vainrib A Hisamoto K Ibrahim H Collins T Clark E Pushkar I Bamira D Benenstein R Tariq A Williams M Minimizing permanent pacemaker following repositionable self-expanding transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 1796-1807Crossref PubMed Scopus (166) Google Scholar Short MS is defined as an MS length shorter than 2 mm based on a previous report.11Jilaihawi H Zhao Z Du R Staniloae C Saric M Neuburger PJ Querijero M Vainrib A Hisamoto K Ibrahim H Collins T Clark E Pushkar I Bamira D Benenstein R Tariq A Williams M Minimizing permanent pacemaker following repositionable self-expanding transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 1796-1807Crossref PubMed Scopus (166) Google Scholar Left ventricular outflow tract (LVOT) calcification severity was semiquantitatively measured, as previously defined.14Barbanti M Yang TH Rodès Cabau J Tamburino C Wood DA Jilaihawi H Blanke P Makkar RR Latib A Colombo A Tarantini G Raju R Binder RK Nguyen G Freeman M Ribeiro HB Kapadia S Min J Feuchtner G Gurtvich R Alqoofi F Pelletier M Ussia GP Napodano M de Brito Jr, FS Kodali S Norgaard BL Hansson NC Pache G Canovas SJ Zhang H Leon MB Webb JG Leipsic J Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement.Circulation. 2013; 128: 244-253Crossref PubMed Scopus (414) Google Scholar Leaflet calcification was scored with the threshold of 850 HU, as previously described.15Jilaihawi H Makkar RR Kashif M Okuyama K Chakravarty T Shiota T Friede G Nakamura M Doctor N Rafique A Shibayama K Mihara H Trento A Cheng W Friedman J Berman D Fontana GP A revised methodology for aortic-valvar complex calcium quantification for transcatheter aortic valve implantation.Eur Heart J Cardiovasc Imaging. 2014; 15: 1324-1332Crossref PubMed Scopus (131) Google Scholar The ID was defined as the distance between the bottom of the noncoronary cusp to the ventricular end of the valve stent frame in the final angiogram after the valve deployment and measured using institutional imaging software Syngo.share webview diagnostic (Siemens Healthineers, Erlangen, Germany). The angle of the image was normally a perpendicular deployment view, but the attending physician could adjust it. MS length and ID were retrospectively measured by HM, MJ, and YS. The interobserver reliability for measuring MS length and ID was analyzed on 60 randomly selected cases (30 patients from each group) using the Bland Altman 1). The were for ID and for MS length. were treatment in patients with the The study to the of Helsinki and by the Helsinki University the CD after TAVI, a of new PPI and new-onset PPI after TAVI was considered the developed block type and with significant impacts on was defined as in the from the Heart in B R JJ A M P P JW P O G H Heart and on Clinical of Heart for the and of the part conduction a from the Heart and on Clinical the of and the Heart by the for Am Coll Cardiol. PubMed Scopus Google Scholar THV and clinical outcomes evaluated as or aortic aortic and a of mortality and were defined as the the clinical outcomes according to the SJ P Piazza N TG Cohen DJ Hahn RT Kodali S Mack MJ R Rodés-Cabau J P Webb JG Windecker S Leon MB endpoint for transcatheter aortic valve implantation: the Am Coll Cardiol. PubMed Scopus Google Scholar at was in the or the by The risk was evaluated by the of risk of mortality are as and were compared using the or are as the and were compared using or the based on their the of the end a analysis including the and procedural was used to the and for the development of the end were included for the according to the previous GC Jüni P Pilgrim T Stortecky S Büllesfeld L Meier B Wenaweser P Windecker S Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis.J Am Coll Cardiol. 2014; 64: 129-140Crossref PubMed Scopus (459) Google Scholar, WK Möllmann H Walther T Hamm CW Predictors of permanent pacemaker implantation after ACURATE neo transcatheter heart valve implantation.Pacing Clin Electrophysiol. 2021; 44: 410-415Crossref PubMed Scopus (8) Google Scholar, V Reimann A Stern D Scherner M Kuhn E Rudolph V Rosenkranz S Eghbalzadeh K Friedrichs K Wahlers T Baldus S Madershahian N Rudolph TK Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3.JACC Cardiovasc Interv. 2016; 9: 2200-2209Crossref PubMed Scopus (150) Google H S N G Okuyama K Kashif M Chakravarty T Nakamura M Cheng W Friedman J Berman D Makkar RR Jilaihawi H A risk for pacemaker implantation after Cardiovasc Imaging. PubMed Scopus Google Scholar were A p was considered were performed using The patients without a previous PPI who underwent TAVI with SAPIEN 3 or ACURATE neo were divided into 2 groups (deep implantation n = 373 and shallow implantation: n = 315) and analyzed for the outcomes (Figure 1). 1 that the between the groups were for in the deep implantation group and in the shallow implantation p = and and p = were significant in the of complete bundle branch and In terms of MDCT the bicuspid valve was more frequent and p and MS length was shorter in the deep implantation group and mm, p 1). The procedural significant in the and and p = and and p The ACURATE neo was more frequently in the deep implantation group and p = A significant was in the ID between the groups and mm, p 1). in the deep implantation group a significantly increased of new PPI and p = and the of new PPI or (16.6% and 7.0%; p The from TAVI and PPI is in A total of of were performed on the or the after the TAVI. The deep implantation group in the after TAVI than the shallow implantation group and p = were significant in device and or results significant in severity and aortic shallow implantation in a significantly higher aortic and p = features and procedural implantation (n = implantation (n = mm aortic Leaflet calcification annular MS length, THV ACURATE SAPIEN 3 Implantation MS = = aortic valve = aortic valve = = coronary = = complete left bundle branch = complete bundle branch = = = left = left outflow MDCT = multidetector computed = Heart = = coronary PPI = permanent pacemaker = of risk of in a new implantation (n = implantation (n = outcomes new PPI or new-onset Hospital after TAVI, clinical outcomes results = aortic valve = aortic valve = complete left bundle branch PPI = permanent pacemaker = TAVI = transcatheter aortic valve in a new = = aortic valve = aortic valve = = coronary = = complete left bundle branch = complete bundle branch = = = left = left outflow MDCT = multidetector computed = Heart = = coronary PPI = permanent pacemaker = of risk of = aortic valve = aortic valve = complete left bundle branch PPI = permanent pacemaker = TAVI = transcatheter aortic valve The analysis revealed that of ACURATE neo was significantly associated with new-onset CD to calcification to and ID MS to were significantly associated with new-onset of preexisting conduction for of permanent pacemaker implantation or new-onset left bundle branch type aortic > MS (deep = = complete bundle branch = left ventricular outflow = MS = membranous THV = transcatheter heart in a new = = complete bundle branch = left ventricular outflow = MS = membranous THV = transcatheter heart The analysis that was significant interaction between the of ID MS and THV type = significant interaction between the of ID MS and severe calcification was = (Figure 3 the between deep and shallow implantation and the of deep were with the of severe calcification in each The of deep implantation for new-onset CD were to with SAPIEN 3 and to with ACURATE between shallow and deep implantation in each THV were with the of severe left ventricular outflow tract = complete left bundle branch = MS = membranous = PPI = permanent pacemaker image 3 the based on ID in the MS length in the and new-onset CD. The are patients who developed new-onset and are who A the in the 2 (deep implantation and shallow the of the incidence of new-onset CD between SAPIEN 3 and ACURATE neo in MS and MS the new-onset CD was not different in the MS vs p = the SAPIEN 3 group developed a new-onset CD more frequently than ACURATE neo group in the MS vs p = This study the following (1) new-onset CD developed more frequently in the deep implantation deep implantation (ID MS severe and SAPIEN 3 were of new-onset in the deep implantation was significantly associated with new-onset CD after SAPIEN 3 implantation but not after ACURATE neo and in the MS cohort, the incidence of new-onset CD was in patients with ACURATE neo than in with SAPIEN 3. The ID conjunction with the MS is reported as 1 of the of CD after TAVI with the SAPIEN 3 and Evolut H Zhao Z Du R Staniloae C Saric M Neuburger PJ Querijero M Vainrib A Hisamoto K Ibrahim H Collins T Clark E Pushkar I Bamira D Benenstein R Tariq A Williams M Minimizing permanent pacemaker following repositionable self-expanding transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2019; 12: 1796-1807Crossref PubMed Scopus (166) Google Scholar, H Moriyama N Yamanaka F Saito S Lehtola H Piuhola J Niemelä M Laine M Predictors of conduction disturbances after transcatheter aortic valve implantation with balloon-expandable valve for bicuspid aortic valve stenosis.J Cardiovasc Electrophysiol. 2022; 33: 1576-1586Crossref PubMed Scopus (1) Google Scholar, P Minners J Hein M Schröfel H Neumann FJ Ruile P Implantation depth and its influence on complications after TAVI with self-expanding valves.Int J Cardiovasc Imaging. 2021; 37: 3081-3092Crossref PubMed Scopus (5) Google Scholar the ACURATE neo 1 study that the deeper ID was associated with new-onset WK Möllmann H Walther T Hamm CW Predictors of permanent pacemaker implantation after ACURATE neo transcatheter heart valve implantation.Pacing Clin Electrophysiol. 2021; 44: 410-415Crossref PubMed Scopus (8) Google Scholar The results of this study are with the previous the deep implantation was associated with new-onset CD among patients with SAPIEN 3 but not among with ACURATE neo. A for this is that the SAPIEN 3 has higher than the ACURATE neo S B L D T S an in transcatheter aortic valve replacement in analysis with J. 64: PubMed Scopus Google Scholar to the Therefore, the valve could the conduction with a high the implantation is deeper than the MS length. In the ACURATE neo may with the conduction because of the Among the patients with a the ACURATE neo group a significantly new-onset CD than the SAPIEN 3 group vs p = may ACURATE neo implantation for the patients with MS length to CD after TAVI. the could the ID with SAPIEN is to the MS length the MS length is In the ACURATE neo may CD it is deeper than the MS length. However, it is that patients with MS length still have a risk to new-onset CD in were by the of conduction by or THV of conduction or the of severe In our severe calcification was an predictor of new-onset CD and not have interaction with the of deep shallow implantation could the interaction between the conduction and the may new-onset CD. However, the of patients with severe calcification was of might not an with a of patients are at our study has of the study of the were factors were different between the the of ID and MS length are not In the were for ID and MS length, interobserver might not be the SAPIEN 3 group included SAPIEN 3 and SAPIEN 3 The of could influence the T C J J M E Transcatheter aortic valve replacement with balloon-expandable of SAPIEN 3 versus SAPIEN 3.JACC Cardiovasc Interv. PubMed Scopus Google Scholar and may have clinical the ACURATE neo has been with a to neo and our study not it. among is In conclusion, this study on the impact of the ID on the new-onset CD after TAVI between the ACURATE neo and SAPIEN 3. The deep implantation significantly the incidence of new-onset CD in the patients with the SAPIEN 3 but not in with the ACURATE neo. In among patients with a MS shorter than 2 mm, the ACURATE neo was superior in terms of new-onset CD. results may impact the THV selection in patients with a high risk of CD. The that the of this study are from the Moriyama is a clinical of and and from is a clinical of Laine from and The have of to with Bland Altman for of implantation depth and membranous septum the of and with The from TAVI to permanent pacemaker the from TAVI to permanent pacemaker = transcatheter aortic valve with 3. The of the implantation depth and membranous septum the based on ID MS length and new-onset CD or in ACURATE neo group and SAPIEN 3 group A the in the (ID > MS length or ID ≤ MS = conduction ID = implantation MS = membranous

Topics & Concepts