Incidence, Predictors and Consequences of Permanent Pacemakers after TAVR Theodoros Apostolopoulos

Incidence, Predictors and Consequences of Permanent Pacemakers after TAVR Theodoros Apostolopoulos Electrophysiology Dept, HYGEIA Hospital

Conduction Abnormalities after TAVR The most common complication due to: Direct trauma Inflammation + edema Ischemia leading to Permanent Pacemaker Implantation (PPI)

Incidence of PPI after TAVR

Incidence of PPI: transcatheter (TAVR) vs surgical (SAVR) Smith CR, et al. N Eng J Med 2011 Bates MG, et al. Interact Cardiovasc Thorac Surg 2011.

Incidence of PPI after TAVR: causes of variability 1. Percentage of PPI pre-tavr (screening of preexisting conduction abnormalities leading to PPI)

Incidence of PPI after TAVR: causes of variability 1. Percentage of PPI pre-tavr (screening of preexisting conduction abnormalities leading to PPI) 2. Choice of prosthesis

Incidence of PPI after TAVR relative to type of prosthesis (30d post -TAVR) N. Piazza, TVT 2015

Hygeia experience (THV dept): PPI after TAVR (2011-17) Total TAVR= 491 No PPI pre-tavr= 435 PPI pre-tavr= 56 No PPI post-tavr= 354 PPI post-tavr= 81 (18,6%)

Hygeia experience (THV dept): Incidence of PPI after TAVR relative to type of prosthesis (n=81)

Incidence of PPI after TAVR: causes of variability 1. Percentage of PPI pre-tavr (screening of preexisting conduction abnormalities leading to PPI) 2. Choice of prosthesis 3. Implantation technique / experience

New Permanent Pacemaker after TAVR Single-Center Retrospective Studies Medtronic CoreValve

Team experience C Marzahn et al. J Cardiology: 71(2018) 101-108

Hygeia experience: Post TAVR PPI (2011-17) 20,9 % 16,9 17,4 14,2 16,8 17,3 10,7 8 2011 2012 2013 2014 2015 2016 2017 2018

Hygeia experience: Post TAVR PPI (2011-17)

Incidence of PPI after TAVR: causes of variability 1. Percentage of PPI pre-tavr (screening of preexisting conduction abnormalities leading to PPI) 2. Choice of prosthesis 3. Procedure technique / experience 4. Observation time before PPI

Need for Permanent Pacemaker as a Complication of TAVI and SAVR (similar ECG findings). Time to PM implantation Bagur R et al, JACC cardiocasc Intervent, 2012

Reevaluation of the Indications for Permanent Pacemaker Implantation After TAVI 261 pts 64 PM(27.4%) Absolute indications 3 rd degree AV block 2 nd degree AV block type II Relative indications 2 nd degree AV block type I 1rst degree AV block+ LBBB 53 TAVI related (83%) 11 non TAVI related (17%) Follow up 371±272 days 46 absolute (87%) Time to 5 days 7 relative (13%) Time to 8 days 86% no longer indication 84.6% no longer indication Vs>99.5% J Thygesen, et al. J INVASIVE CARDIOL 2014

Reversibility of the HB in patients that required PM implantation after TAVI 53% 47% PTS IMPLANTED WITH PM AFTER TAVI PM FOLLOW-UP 60% 40% Hygeia THV Dept, 2015

Could the PPI have been avoided? Hygeia THV Dept, 2015

Incidence of PPI after TAVR: causes of variability 1. Percentage of PPI pre-tavr (screening of preexisting conduction abnormalities leading to PPI) 2. Choice of prosthesis 3. Procedure technique / experience 4. Observation time before PPI 5. Individual clinical course and ECG criteria for PPI

ECG criteria for PPI after TAVR 13% 79% PARTNER Trial T Nazif et al, JACC 2015

Predictors of PPI after TAVR

Siontis et al, JACC 2014

Predictors of PPI after TAVR: Preexisting Conduction Abnormalities RBBB LAH 1 st degree AVB EPS: HV > 52ms Siontis G et al. JACC 2014 Nazif T et al. JACC 2015 Kostopoulou A et al. Europace 2016

Predictors of PPI after TAVR: Patient (anatomical) factors Smaller LVOT diameter Higher ratio annulus to LVOT Higher calcium volume below LCC or RCC Non CC device landing zone calcium volume Short membranous septum length High mean transaortic gradient Nazif T et al. JACC 2015 R van der Boon et al. Int J Cardiol, 2012

Predictors of PPI after TAVR: Procedural factors Type of valve (SEV vs BEV) Depth of prosthesis in LVOT Prosthesis diameter / LVOT diameter Preditation Intraoperative CHB Siontis G et al. JACC 2014 Nazif T et al. JACC 2015

Predictors of PPI after TAVR: Metanalysis of 41 studies, 11210 pts Siontis G et al, JACC 2014

Consequences of PPI after TAVR

Consequences of PPI after TAVR Complications of PPI: relative rare, but not negligible Kirkfeldt R et al, EHJ 2014 Chronic RV pacing results in LV dyssynchrony and adverse remodelling Sweeny M et al Circulation 2003

Consequences of PPI after TAVR: conflicting results

Consequences of PPI after TAVR: conflicting results No difference in mortality or heart failure (PPI vs no PPI) 8 centers, 1556 pt, 22mo FU Urena M et al. Circulation 2014;129:1233-1243

Consequences of PPI after TAVR: conflicting results No difference in mortality or heart failure (PPI vs no PPI) Protective effect of PPI: decrease of sudden - unexpected deaths (perhaps due to prevention of very late bradyarrhythmias) 8 centers, 1556 pt, 22mo FU Urena M et al. Circulation 2014;129:1233-1243

Consequences of PPI after TAVR: conflicting results PPI: mild LVEF deterioration with no clinical impact due to positive hemodynamic effect of TAVR 8 centers, 1556 pt, 22mo FU Urena M et al. Circulation 2014;129:1233-1243

Consequences of PPI after TAVR: conflicting results PPI: higher incidence of repeat hospitalization (p=0.045) and death (p=0.08) PPI: longer post TAVR hospitalization with no difference in LVEF (1y FU) PARTNER trial, 1973 pt, 1y FU T Nazif et al, JACC 2015

Consequences of PPI after TAVR: conflicting results PPI: Higher mortality and a composite of mortality or heart failure admission (1y FU) PPI: longer median hospital and ICU stay 229 centers, 9785 pt, 1y FU O Fadahunsi et al, JACC 2016

Predictors of LVEF deterioration after TAVR: Role of dyssynchrony in redused baseline LVEF C Monteiro et al, Arc Bras Cardiol, 2017

Hygeia experience: Post TAVR CRT (2011-17) 4 patients (0,05%) 1 emergency CRTP implantation 3 CRTP implantation 2-6 mo after TAVR (100% RV pacing and deterioration of functional status and LVEF)

Acute MR after TAVR, CHB and temporary PM Stunning of left ventricle due to period of low flow Dysynchrony due to pacemaker rhythm No evident interference between CoreValve and mitral valve

Acute MR after TAVR, CHB and temporary PM: Emergency CRTP implantation

Acute MR after TAVR, CHB and temporary PM: Emergency CRTP implantation CRT OFF CRT OΝ

Sudden Death... PM diagnostics: Ventricular arrhythmias Upgrade to ICD (2 patients)

Conclusions (1) 5-20% pt undergoing TAVR need PPI TAVR using SEV needs threefold PPI than BEV Baseline RBBB and intraoperative CHB are the main ECG predictors of PPI Most of the conduction distarbunces after TAVI are reversible, so a period of clinical observation up to 7d is indicated before PM implantation (with exceptions).

Conclusions (2) Studies on consequences of PPI after TAVR present conflicting results In general, PPI after TAVR does not have significant effect in mortality or morbidity In individual patients (baseline low LVEF) PPI may have detrimental effect due to dyssynchrony Use of algorithms that reduce unnecessary RV pacing is recommended Biventricular Pacing (CRT) may be useful as early procedure in acute MR after CHB due to TAVR, or later as upgrade in low EF, CHF that do not improve significantly after TAVR.

Thank You

Ν= 996 New Pacemaker implantation= 26.3 %

Deterioration of mitral regurgitation due to LV dyssynchrony after CHB

Pacemaker CRT Implantation CRT OFF CRT ON

TAVI and need for new Pacemaker: CRT

Preexisting Conduction Abnormalities and need for PM implantation The UK CoreValve Collaborative, Circulation 2011

Preexisting Conduction Abnormalities and need for PM implantation D Erkapic, Europace 2010

Implication of reversibility of the HB in patients that required PM implantation after TAVI Reprogramming of the PM algorithms to reduce unnecessary RV pacing (MVP on, search AV on)

Paroxysmal complete HB 3rd day posttavi!

Paroxysmal complete HB

13,5%

D. Percentage of reversibility of the HB in patients that required PM implantation after TAVI 1. 2% 2. 5-10% 3. 10-20% 4. 30-40% 5. >40%

A. Most common new conduction disorder post TAVI 1. LBBB 2. RBBB 3. LAH 4. 1 st degree AV block 5. Advanced AV block 6. Intraventricular conduction delay (IVCD)

B. New onset LBBB post TAVI: should be implanted PM? 1. YES 2. NO

C. Most common pretavi conduction abnormality, leading to PM implantation after TAVI 1. LBBB 2. RBBB 3. LAH 4. 1 st degree AV block 5. Intraventricular conduction delay (IVCD)

E. Observation time after HB for PM implantation: patient with intraop AV block that restores conduction after 1h 1. PM implantation 2. Observation for 4 days 3. Observation for 7 days 4. EPS 5. None

F. Percentage of PM implantation post TAVI (mean) 1. 3-5% 2. 10-12% 3. 18-22% 4. 30-35% 5. 40-45%

% of different types of Valve related with Post TAVR need for P/m Implantation

Hygeia experience 2010-12: 16% 2013: 19% 7.6% 41.1% 2014: 18% 11% 21%

The pathophysiological pathway causing conduction abnormalities after TAVI (Managing Complications in Transcatheter Aortic Valve Implantation Manolis Vavuranakis et al. 2015) (i) the mechanical stress applied to the subvalvular region (which houses critical parts of the conduction System); (ii) the induced local inflammation and associated oedema caused by pre- or post- TAVI balloon dilatation or directly by the bioprosthesis frame; (iii) subclinical microembolisms of the coronary arteries during TAVI; (iv) a combination of the above. Still, it should be highlighted that the validity of the above mechanisms is

HJC: 2013, 54 (1): 18-24

New Permanent Pacemaker after TAVR Single-Center Retrospective Studies Medtronic CoreValve CoreValve ADVANCE (Ν= 996) New Pacemaker implantation= 26.3 % Sapien PARTNER (N=1151) New Pacemaker implantation= 3.4 % Surgical Aortic Valve Replacement (SAVR)= 3.2 7.1%

Προβλεπτικοί παράγοντες Παράγοντες σχετιζόμενοι με την επέμβαση Μέγεθος μπαλονιού - προδιάταση CAVB αμέσως, κατά τη διάρκεια της επέμβασης Επιλογή βαλβίδας (CoreValve) Βάθος εμφύτευσης (CoreValve + Sapien) Προϋπάρχουσες διαταραχές αγωγιμότητας ΗΚΓ: RBBB ΗΦΜ: παράταση HV> 55 msec

Προβλεπτικοί παράγοντες Μεταανάλυση: 41 μελέτες, 11210 ασθενείς G. Siontis et al JACC 2014

Προβλεπτικοί παράγοντες Ανατομικοί παράγοντες Πάχος μεσοκοιλιακού διαφράγματος Πάχος μη στεφανιαίας πτυχής Μικρή LVOT διάμετρος Μικρό μήκος (και ασβέστωση) μεμβρανώδους ΜΚΔ

HV > 52 ms

Σημασία των προβλεπτικών παραγόντων - ενδείξεων βηματοδότησης Η παρατεταμένη παρακολούθηση διαταραχών αγωγής και αντίστοιχη καθυστέρηση στην τοποθέτηση μόνιμου βηματοδότη, συνεπάγεται: Παράταση νοσηλείας (ΜΕΘ, διαφλέβιος προσωρινός βηματοδότης) Καθυστέρηση κινητοποίησης αποκατάστασης Κοινωνικοοικονομική επιβάρυνση Αντίθετα, η πρώιμη τοποθέτηση μόνιμου βηματοδότη με «χαλαρά» κριτήρια, συνεπάγεται: Αύξηση μη αναγκαίων επεμβάσεων βηματοδότησης (αύξηση επιπλοκών) Ενδεχόμενη «καταπίεση» αυτόχθονα ρυθμού Δυσυγχρονισμός λόγω μη αναγκαίας συνεχούς βηματοδότησης RV

Slide 21 of 29 Powe

ESC Guidelines 2013

Predictors of conduction disorders Anatomical features Septal wall thickness Non-coronary cusp thickness Decreased LVOT diameter (SAPIEN patient registry) Procedural features Valve choice (CoreValve) Timing of development of conduction disorder Balloon size Moderate predilatation Depth of implant

Conduction Abnormalities after TAVI Rutger-Jan Nuis et al EHJ 2011

Conduction Abnormalities after TAVI LBBB CHB CoreValve 35-65% 15-44% Sapien 3-30% 0-27% T Nazif et al, EHJ 2014 RJ Nuis et al, EHJ 2011

PARTNER Trial Edwards SAPIEN N=1151 T Nazif et al, EHJ 2014

Εμπειρία στο Νοσ. «Υγεία» 2010-2015 Ανάκτηση ΚΚ αγωγής μετά από CHB, 1 εβδομάδα posttavi

ECG before and after TAVI Overall (68) Pts without PM (57) Pts with PM (11) Before After Before After Before After SR 59 (86.7%) 58 (85.2%) 50 (87.7%) 49 (85.9%) 9 (82%) 9 (82%) 1 st AVB 10 (14.7%) 11 (16.1%) 8 (12%) 10 (17.5%) 2 (18%) 1 (9%) AF 9 (13.2%) 10(14.7%) 7 (12.2%) 8 (19.6%) 2 (18%) 2 (18%) IVCD 2 (2.9%) 1 (1.47%) 2 (3.5%) 1 (1.75%) 0 0 RBBB 7 (10.2%) 3 (4.4%) 3 (5.2%) 3 (5.2%) 4 (36.4%) 0 LBBB 5 (7.3%) 24 (35.2%) 4 (7%) 20 (35%) 1 (9%) 4 (36.4%) LAFH 13 (19.1%) 7 (10.2%) 10 (17.5%) 7 (12.3%) 3 (27%) 0 LPFH 1 (1.47%) 1 (1.47%) 1 (1.75%) 1 (1.75%) 0 0 3 rd AVB 0 5 (7.3%) 0 0 0 5 (45.5%) THV Dept

Implications of new onset LBBB after TAVI

Implications of new onset LBBB after TAVI

Implications of new onset LBBB after TAVI Ν= 996

PM and cardiovascular outcome... EuroIntervention 2016;12:1185-1193 (i) the presence of PPM at baseline was associated with a higher clinical risk profile and a higher risk of mortality at 30 days and two years of follow-up; (ii) several clinical and procedural factors independently predicted the need for PPM after TAVI, including anti-ppar strategies such as valvular post-dilation and device oversizing; (iii) in the overall population, new-ppm implantation had no effect on either longterm all-cause or cardiovascular mor tality after TAVI; however, it was associated with longer in-hospi tal stay; (iv) new PPM did not independently correlate with lower LVEFR, while old PPM did;

Hygeia Hospital 2010- May 2016

R Kalathiya et al, JACC 2016

Προβλεπτικοί παράγοντες Σημασία: η αναγνώριση των ασθενών υψηλού κινδύνου να αναπτύξουν σοβαρή διαταραχή κολποκοιλιακής αγωγής λόγω TAVI που να απαιτεί τοποθέτηση βηματοδότη, με σκοπό: 1. Τροποποίηση άλλων συμπαραγόντων κινδύνου 2. Μεγαλύτερη διάρκεια παρακολούθησης μετά TAVI 3. Αποφυγή φαρμάκων που επιδεινώνουν κκ αγωγή Ταξινόμηση: 1. Ανατομικοί παράγοντες 2. Παράγοντες σχετιζόμενοι με την επέμβαση 3. Προϋπάρχουσες διαταραχές αγωγιμότητας

Significance of predictors Prolonged observation period and PPI delay: Prolonged hospitalization (ΜΕΘ, διαφλέβιος προσωρινός βηματοδότης) Delayed mobilization - rehabilitation Socioeconomic burden Early PPI using relative criteria: Unnecessary PPIs (increased number of complications) Possible endogenous rhythm suppression Dysynchrony due to unnecessary continuous RV pacing

Managed Ventricular Pacing (MVP, Medtronic Adapta) AAI DDD