SUPPLEMENTARY MATERIAL

Supplemental Table 1. Factors Associated with an Increased Risk of Conduction Disturbances (New-Onset LBBB and PPM) post-TAVR

Multivariable Odds Ratio* References New-onset LBBB

Procedural characteristics

Implantation of a Medtronic Corevalve (vs Edwards Sapien valves)

2.5-8.5 1-4

Depth of implantation, per 1 mm

1.15-1.4 5-9

Overexpansion of native annulus, per 1% oversizing

1.8; 5.3 if > 15% 7, 10

Medtronic CoreValve 26 vs 23 mm

4.1 9

Edwards SAPIEN valves: 29 vs 20-23mm

3.1 11

Permanent Pacemaker Implantation

Baseline characteristics

Baseline right bundle-branch block

2.8-46.7 3, 8, 9, 12-42

Age 1.01-17 43-45

First-degree atrioventricular block 4.0-11.4 14, 15, 39, 46

Procedural characteristics

Implantation of a Medtronic Corevalve (vs Edwards Sapien valves)

2.6-25.7 3, 27, 28, 30, 31, 40, 42-44, 47, 48

Depth of implantation 1.1-1.5 7, 15, 17-19, 21, 24-26, 34, 37, 49, 50, 51

Oversizing/stretching of the aortic annulus/left ventricular outflow tract, per 1% oversizing

1.02-1.5 7, 16, 23, 26, 32, 39, 44, 45, 51, 52

* Ranges of odds ratio are from published studies with a multivariable analysis

Supplemental Table 2. Current available systems for outpatient ECG monitoring

DEVICE NAME MANUFACTURER

Holter

Holter Performer Model 2010 Applied Cariac Systems

Biomedical System BMS 300 Holter Monitor Biomedical Systems Corporation

Biomedical System BMS 1200 Holter Monitor Biomedical Systems Corporation

Braemar Cardiokey Holter Recorder Braemar Manufacturing LLC

DL900 Series Holter Recorder Braemar, INC.

IQMark Holter Midmark Medical

Datrix XR-300 Datrix

Dms 300-2w Holter ECG Recorder Diagnostic Monitoring Software

SE-2003/SE-2012 Edan Insruments, Inc.

Synescope Ela Medical Inc

FM-180 Fukuda Denshi USA, Inc

GBI-3SM Digital 3-Channel Holter Recorder Galix Biomedical Instrumentation

SEER Light Extend Compact Digital Holter System GE Healthcare

Matrix Holter System, Model M12 Global Instrumentation, LLC

Intricon Datrix Sirona Event/Holter Recorder Intricon Datrix Corporation

Cardiospy ECG Holter Systems Labtech Kft.

Model 950-3CH Holter Recorder Memtec Corp.

H3+ Holter Recorder Mortara Instrument, Inc

DL900 Holter Recorder Norav Medical Ltd.

Cardioline Click Holter Cardoline

RZ-153 Rozinn, Inc

DigiTrak Philips 

Chroma2 Holter ScottCare

Performer Plus Applied Cardiac Systems (ACS)

Decipher Medicomp

IQ Holter Midmark

Evo Spacelabs

HR300 Welch Allyn

Ambulatory ECG System/Holter Recorder BIOX Instruments Co. Ltd.

CardioMem CM 4000 Getemed

Spiderview Holter MicroPort/Sorin

CardioMera Meditech Ltd.

AR12 Plus Schiller AG

Trillium 5000 Forest Medical

External event recorder/Smartphone based recorder

KardiaMobile AliveCor

Zenicor-ECG Zenicor Medical Systems

Miniscope Shiller

Omron Heartscan HCG-801 Omron

E100 Reka Health

MiCor A100 MiTAC

Micro Ambulatory ECG Recorder Dimetek Digital Medical Technologies

V-Trust Model TD-2202 TaiDoc Technology Corporation

HeartCheck SMART Monitoring CardioComm Solutions Inc.

SmartHeart SHL Telemedicine

Patch ECG recorders

EZecg Patch Hemodynamics

Zio XT patch iRhythm

CardioSTAT Icentia

TelePatch Medicomp

LP1100 Life Signal Patch LifeSignals

CAM BardyDx

Cardea Solo Cardiac Insight

VitalPatch VitalConnect

myPatch DMS Service

TAGecg sensor Welch Allyn

RootiRx Rooti Medical

Body Guardian Heart Preventice Solutions

Body Guardian Mini Preventice Solutions

ePatch BioTelemetry

Novi+ ScottCare

External Loop Recorders

Q200/HE QRS/VectraCor

Vitaphone Tele ECG Loop Recorder Vitasystems

PER900 Braemar Manufacturing, LLC

GemsTrak AF Monitor CardioComm Solutions, Inc.

Cardioblue Recorder Meditech Ltd

CardioCall VS20 Spacelabs Healthcare Ltd.

LifeWatch Explorer LifeWatch Tecnologies

King of Hearts Express Card Guard Scientific Survival, Ltd.

CardioCall VS20 Cardiac Event Monitor Spacelabs Inc.

ACS Performer Plus ACS

Looping Event Recorder CardioNet Inc.

CardioPAL SAVI Event Monitor Medicomp

wEvent BioTelemetry

Mobile Cardiac Telemetry

CORE MCT Monitor ACS Diagnostics

Fusion MCT Braemar Inc.

CardioNet MCOT Monitor CardioNet

LifeStar ACT Monitor LifeWatch

SAVI MCT Monitor Medicomp

ECAT MCT Monitor Mednet

Body Guardian Heart Preventice Solutions

Body Guardian Verite Preventice Solutions

TeleSense MCT ScottCare

DR300 Holter Monitor North East Monitoring

DR400 NorthEast Monitoring, Inc

MoMe Kardia InfoBionic

TruVue Wireless Telemetry Device Biomedical Systems

Nuvant MCT System Corventis, Inc

MCOT Patch BioTelemetry

MCT 3 Lead BioTelemetry

m-CARDS M-Health Solutions Inc.

HeartView Aerotel Medical Systems (1998) Ltd

PocketECG CRS MEDICALgorithmics

Insertable Cardiac Monitor

Reveal Linq Medtronic Inc.

Confirm Rx Insertable Cardiac Monitor Abbott / St Jude Medical

Biomonitor3 Biotronik

Source: FDA and MDALL.

Supplemental Figure 1 A-B

Incidence of conduction disturbances post-TAVR according to valve type (studies with n ≥ 100; newer generation transcatheter valve systems).

1A. Incidence of PPM.

1B. Incidence of new-onset LBBB.

1. Bernardi FLM, Ribeiro HB, Carvalho LA, et al. Direct Transcatheter Heart Valve

Implantation Versus Implantation With Balloon Predilatation: Insights From the

Brazilian Transcatheter Aortic Valve Replacement Registry. Circ Cardiovasc Interv

2016;9.

2. Franzoni I, Latib A, Maisano F, et al. Comparison of incidence and predictors of left

bundle branch block after transcatheter aortic valve implantation using the CoreValve

versus the Edwards valve. Am J Cardiol 2013;112:554–559.

3. Schymik G, Tzamalis P, Bramlage P, et al. Clinical impact of a new left bundle

branch block following TAVI implantation: 1-year results of the TAVIK cohort. Clin

Res Cardiol 2015;104:351–362.

4. Houthuizen P, Van Garsse LA, Poels TT, et al. Left bundle branch block induced by

transcatheter aortic valve implantation increases risk of death. Circulation

2012;126:720–728.

5. Urena M, Mok M, Serra V, et al. Predictive factors and long-term clinical

consequences of persistent left bundle branch block following transcatheter aortic valve

implantation with a balloon-expandable valve. J Am Coll Cardiol 2012;60:1743–1752.

6.Aktug Ö, Dohmen G, Brehmer K, et al. Incidence and predictors of left bundle branch

block after transcatheter aortic valve implantation. Int J Cardiol 2012;160:26–30.

7. Katsanos S, van Rosendael P, Kamperidis V, et al. Insights into new-onset rhythm

conduction disorders detected by multi-detector row computed tomography after

transcatheter aortic valve implantation. Am J Cardiol 2014;114:1556–1561.

8.van der Boon RMA, Houthuizen P, Urena M, et al. Trends in the occurrence of new

conduction abnormalities after transcatheter aortic valve implantation. Catheter

Cardiovasc Interv 2015;85:E144–E152.

9. Boerlage-Van Dijk K, Kooiman KM, Yong ZY, et al. Predictors and permanency of

cardiac conduction disorders and necessity of pacing after transcatheter aortic valve

implantation. Pacing Clin Electrophysiol 2014;37:1520–1529.

10. Hein-Rothweiler R, Jochheim D, Rizas K, et al. Aortic annulus to left coronary

distance as a predictor for persistent left bundle branch block after TAVI. Catheter

Cardiovasc Interv 2017;89:E162-E168.

11. Urena M, Webb JG, Cheema A, et al. Impact of new-onset persistent left bundle

branch block on late clinical outcomes in patients undergoing transcatheter aortic valve

implantation with a balloon-expandable valve. JACC Cardiovasc Interv 2014;7:128–

136.

12. Bagur R, Rodes-Cabau J, Gurvitch R, et al. Need for permanent pacemaker as a

complication of transcatheter aortic valve implantation and surgical aortic valve

replacement in elderly patients with severe aortic stenosis and similar baseline

electrocardiographic findings. J Am Coll Cardiol Intv 2012;5:540-551.

13. Maeno Y, Abramowitz Y, Kawamori H, et al. A highly predictive risk model for

new permanent pacemaker implantation after SAPIEN 3 transcatheter aortic valve

replacement. J Am Coll Cardiol Img 2017;10:1139-1147.

14. Gonska 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;106:590-597.

15. De Carlo M, Giannini C, Bedogni F, et al. Safety of a conservative strategy of

permanent pacemaker implantation after transcatheter aortic CoreValve implantation.

Am Heart J 2012;163:492-499.

16. Nazif TM, Dizon JM, Hahn RT, et al. Predictors and clinical outcomes of permanent

pacemaker implantation after transcatheter aortic valve replacement: The PARTNER

(Placement of AoRtic TraNscathetER Valves) trial and registry. J Am Coll Cardiol Intv

2015;8:60-69.

17. Mauri V, Reimann A, Stern D, et al. Predictors of permanent pacemaker

implantation after transcatheter aortic valve replacement with the SAPIEN 3. J Am Coll

Cardiol Intv 2016;9:2200–2209.

18. Husser O, Pellegrini C, Kessler T, et al. Predictors of permanent pacemaker

implantations and new-onset conduction abnormalities with the Sapien 3 balloon-

expandable transcatheter heart valve. J Am Coll Cardiol Intv 2016;9:244-254.

19. López-Aguilera J, Segura Saint-Gerons JM, Mazuelos Bellido F, et al.

Atrioventricular Conduction Changes After CoreValve Transcatheter Aortic Valve

Implantation. Rev Esp Cardiol (Engl Ed) 2016;69:28–36.

20.Calvi V, Conti S, Pruiti GP, et al. Incidence rate and predictors of permanent

pacemaker implantation after transcatheter aortic valve implantation with self-

expanding CoreValve prosthesis. J Interv Card Electrophysiol 2012;34:189-195.

21.Zaman S, McCormick L, Gooley R, et al. Incidence and predictors of permanent

pacemaker implantation following treatment with the repositionable LotusTM

transcatheter aortic valve. Catheter Cardiovasc Interv 2017;90:147–154.

22. Lange P, Greif M, Vogel A, et al. Reduction of pacemaker implantation rates after

CoreValve® implantation by moderate predilatation. EuroIntervention 2014;9:1151–

1157.

23. Van Mieghem N, Van Gils L, Wöhrle J, et al. Tct-733 predictors of

Permanent Pacemaker Implantation in Patients Treated in Routine Clinical Practice with

the Repositionable and Fully Retrievable Lotus Valve. J Am Coll Cardiol

2016;68:B296-B296.

24. Guetta V, Goldenberg G, Segev A, et al. Predictors and course of high-degree

atrioventricular block after transcatheter aortic valve implantation using the CoreValve

Revalving system. Am J Cardiol 2011;108:1600-1605.

25. Fraccaro C, Buja G, Tarantini G, et al. Incidence, predictors, and outcome of

conduction disorders after transcatheter self-expandable aortic valve implantation. Am J

Cardiol 2011;107:747-754.

26. Rodríguez-Olivares R, van Gils L, El Faquir N, et al. Importance of the left

ventricular outflow tract in the need for pacemaker implantation after transcatheter

aortic valve replacement. Int J Cardiol 2016;216:9-15.

27. Al-Azzam F, Greason KL, Krittanawong C, et al. The influence of native aortic

valve calcium and transcatheter valve oversize on the need for pacemaker implantation

after transcatheter aortic valve insertion. J Thorac Cardiovasc Surg 2017;153:1056-

1062.e1.

28. Erkapic D, Kim WK, Weber M, et al. Electrocardiographic and further predictors

for permanent pacemaker requirement after transcatheter aortic valve implantation.

Europace 2010;12:1188-1190.

29. Fujita B, Kutting M, Seiffert M, et al. Calcium distribution patterns of the aortic

valve as a risk factor for the need of permanent pacemaker implantation after

transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging 2016;17:1385-

1393.

30. Gensas CS, Caixeta A, Siqueira D, et al. Predictors of permanent pacemaker

requirement after transcatheter aortic valve implantation: Insights from a Brazilian

registry. Int J Cardiol 2014;175:248-252.

31. Koos R, Mahnken AH, Aktug O, et al. Electrocardiographic and imaging predictors

for permanent pacemaker requirement after transcatheter aortic valve implantation. J

Heart Valve Dis 2011;20:83-90.

32. Maan A, Refaat MM, Heist EK, et al. Incidence and Predictors of Pacemaker

Implantation in Patients Undergoing Transcatheter Aortic Valve Replacement. Pacing

Clin Electrophysiol 2015;38:878-886.

33. Mouillet G, Lellouche N, Yamamoto M, et al. Outcomes following pacemaker

implantation after transcatheter aortic valve implantation with CoreValve(®) devices:

Results from the FRANCE 2 Registry. Catheter Cardiovasc Interv 2015;86:E158-E166.

34. Muñoz-Garcia AJ, Hernandez-Garcia JM, Jimenez-Navarro MF, et al. Factors

predicting and having an impact on the need for a permanent pacemaker after

CoreValve prosthesis implantation using the new Accutrak delivery catheter system.

J Am Coll Cardiol Intv 2012;5:533-539.

35. Roten L, Wenaweser P, Delacretaz E, et al. Incidence and predictors of

atrioventricular conduction impairment after transcatheter aortic valve implantation. Am

J Cardiol 2010;106:1473-1480.

36. Sawaya FJ, Spaziano M, Lefèvre T, et al. Comparison between the SAPIEN S3 and

the SAPIEN XT transcatheter heart valves: A single-center experience. World J

Cardiol 2016;8:735-745.

37. Gomes B, Geis NA, Chorianopoulos E, et al. Improvements of Procedural Results

With a New-Generation Self-Expanding Transfemoral Aortic Valve Prosthesis in

Comparison to the Old-Generation Device. J Interv Cardiol 2017;30:72-78.

38. Walther T, Manoharan G, Linke A, et al. Incidence of new-onset left bundle branch

block and predictors of new permanent pacemakerfollowing transcatheter aortic valve

replacement with the Portico™ valve. Eur J Cardiothorac Surg 2018;54:467-474.

39. Dumonteil N, Meredith IT, Blackman DJ, et al. Insights into the need for

permanent pacemaker following implantation of the repositionable LOTUS valve for

transcatheter aortic valve replacement in 250 patients: results from the REPRISE II trial

with extended cohort. EuroIntervention 2017;13:796-803.

40. Monteiro C; Ferrari ADL, Caramori PRA, et al. Permanent Pacing After

Transcatheter Aortic Valve Implantation: Incidence, Predictors and Evolution of Left

Ventricular Function. Arq Bras Cardiol 2017 Dec; 109(6): 550–559.

41. Schaefer A, Neumann N, Linder M, et al. Outcomes with a latest generation self-

expandable, intra-annular, re-sheathable transcatheter heart valve system: analysis of

patients with impaired left ventricular function and determinants for pacemaker

implantation. Clin Res Cardiol 2018;107:914–923.

42. Abramowitz Y, Kazuno Y, Chakravarty T, et al. Concomitant mitral annular

calcification and severe aortic stenosis: prevalence, characteristics and outcome

following transcatheter aortic valve replacement. Eur. Heart J. 2017;38:1194–1203.

43. Fadahunsi OO, Olowoyeye A, Ukaigwe A, et al. Incidence, Predictors, and

Outcomes of Permanent Pacemaker Implantation FollowingTranscatheter Aortic

Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American

College of Cardiology TVT Registry. J Am Coll Cardiol Intv 2016;9:2189-2199.

44. Giustino G, Van der Boon RM, Molina-Martin de Nicolas J, et al. Impact of

permanent pacemaker on mortality after transcatheter aortic valve implantation: The

PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration) Pacemaker

substudy. EuroIntervention 2016;12:1185-1193.

45. Schroeter T, Linke A, Haensig M, et al. Predictors of permanent pacemaker

implantation after Medtronic CoreValve bioprosthesis implantation. Europace

2012;14:1759-1763.

46. Akin I, Kische S, Paranskaya L, et al. Predictive factors for pacemaker requirement

after transcatheter aortic valve implantation. BMC Cardiovasc Disord 2012;12:87.

47. Ledwoch J, Franke J, Gerckens U, et al. Incidence and predictors of permanent

pacemaker implantation following transcatheter aortic valve implantation: Analysis

from the German transcatheter aortic valve interventions registry. Catheter Cardiovasc

Interv 2013;82:E569-577.

48. Ramazzina C, Knecht S, Jeger R, et al. Pacemaker implantation and need for

ventricular pacing during follow-up after transcatheter aortic valve implantation. Pacing

Clin Electrophysiol 2014;37:1592-1601.

49. Saia F, Lemos PA, Bordoni B, et al. Transcatheter aortic valve implantation with a

self-expanding nitinol bioprosthesis: Prediction of the need for permanent pacemaker

using simple baseline and procedural characteristics. Catheter Cardiovasc Interv

2012;79:712-719.

50. Toutouzas K, Synetos A, Tousoulis D, et al. Predictors for permanent pacemaker

implantation after core valve implantation in patients without preexisting ecg

conduction disturbances: The role of a new echocardiographic index. Int J Cardiol

2014;172:601-603.

51. Kim WJ, Ko YG, Han S, et al. Predictors of Permanent Pacemaker Insertion

Following Transcatheter Aortic Valve Replacement With the CoreValve Revalving

System Based on Computed Tomography Analysis: An Asian Multicenter Registry

Study. J Invasive Cardiol 2015;27:334-340.

52. Nishiyama T, Tanosaki S, Tanaka M, et al. Predictive factor and clinical

consequence of left bundle-branch block after a transcatheter aortic valve implantation.

Int J Cardiol 2017;227:25-29.

53. Vahanian A, Urena M, Walther T, et al. Thirty-day outcomes in patients at

intermediate risk for surgery from the SAPIEN 3 European approval trial.

EuroIntervention 2016;12:e235–e243.

54. Rogers T, Steinvil A, Buchanan K, et al. Contemporary transcatheter aortic valve

replacement with third-generation balloon-expandable versus self-expanding devices. J

Interv Cardiol 2017;30:356–361.

55. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement

with a Balloon-Expandable Valve in Low-Risk Patients. New England Journal of

Medicine 2019 [E-pub ahead of print]; http://dx.doi: 10.1056/NEJMoa1814052.

56. Vendrik J, Van Kesteren F, Van Mourik MS, et al. Procedural Outcome and

Midterm Survival of Lower Risk Transfemoral Transcatheter Aortic Valve Implantation

Patients Treated With the SAPIEN XT or SAPIEN 3 Device. Am J Cardiol

20181;121:856-861.

57. Meyer A, Unbehaun A, Hamandi M, et al. Comparison of 1-Year Survival and

Frequency of Paravalvular Leakage Using the Sapien 3 Versus the Sapien XT for

Transcatheter Aortic Valve Implantation for Aortic Stenosis. Am J Cardiol

2017;120:2247-2255.

58. Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic

outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-

risk and intermediate-risk patients with aortic stenosis. Eur Heart J 2016;37:2252–2262.

59. Wendler O, Schymik G, Treede H, et al. 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;135:1123–1132.

60. Jochheim D, Zadrozny M, Theiss H, et al. Aortic regurgitation with second versus

third-generation balloon-expandable prostheses in patients undergoing transcatheter

aortic valve implantation. EuroIntervention 2015;11:214–220.

61. Ramirez Del Val F, Hirji SA, Carreras ET, et al. Clinical Significance of Greater

Implantation Height with SAPIEN 3 Transcatheter Heart Valve. J. Heart Valve Dis.

2018;27:9–16.

62. Webb J, Gerosa G, Lefevre T, et al. Multicenter evaluation of a next-generation

balloon-expandable transcatheter aortic valve. J Am Coll Cardiol 2014;64: 2235–2243.

63. Pilgrim T, Stortecky S, Nietlispach F, et al. Repositionable versus balloon-

expandable devices for transcatheter aortic valve implantation in patients with aortic

stenosis. J Am Heart Assoc 2016;5.

64. Abramowitz Y, Jilaihawi H, Chakravarty T, et al. Sapien 3 Transcatheter Aortic

Valve Implantation With Moderate or Without Predilation. J Invasive Cardiol

2016;28:421–426.

65. Finkelstein A, Steinvil A, Rozenbaum Z, et al. Efficacy and safety of new-

generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve

replacement registry. Clin Res Cardiol 2018 Sep 20 [Epub ahead of print]; doi:

10.1007/s00392-018-1372-6.

66. Seeger J, Gonska B, Rottbauer W, Wöhrle J. Outcome With the Repositionable and

Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable

Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve

Replacement. Circ Cardiovasc Interv 2017;10

67. De Torres-Alba F, Kaleschke G, Diller GP, et al. Changes in the Pacemaker Rate

After Transition From Edwards SAPIEN XT to SAPIEN 3 Transcatheter Aortic Valve

Implantation: The Critical Role of Valve Implantation Height. J Am Coll Cardiol Intv

2016;9:805–813

68. Schwerg M, Fulde F, Dreger H, Poller WC, Stangl K, Laule M. Optimized

Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker

Implantation After TAVI. J Interv Cardiol 2016;29:370-4.

69. Ben-Shoshan J, Konigstein M, Zahler D, et al. Comparison of the Edwards SAPIEN

S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation.

Am. J. Cardiol. 2017;119:302–307.

70. Schulz E, Jabs A, Tamm A, et al. Comparison of transcatheter aortic valve

implantation with the newest-generation Sapien 3 vs. Direct Flow Medical valve in a

single center cohort. Int J Cardiol 2017;232:186–191.

71. Hellhammer K, Piayda K, Afzal S, et al. The Latest Evolution of the

Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement:

Matched Comparison of the Evolut PRO and Evolut R. JACC Cardiovasc Interv

2018;11:2314–2322.

72. Kalra SS, Firoozi S, Yeh J et al. Initial Experience of a Second-Generation Self-

Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters'

Registry. J Am Coll Cardiol Interv 2017;10:276–282.

73. Popma JJ, Reardon MJ, Khabbaz K, et al. Early Clinical Outcomes After

Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding

Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery:

Results of the Evolut R U.S. Study. J Am Coll Cardiol Interv 2017;10:268–275.

74. Sorajja P, Kodali S, Reardon MJ, et al. Outcomes for the commercial use of

selfexpanding prostheses in transcatheter aortic valve replacement: a report from the

STS/ACC TVT registry. J Am Coll Cardiol Interv 2017;10:2090–2098.

75. Grube E, Van Mieghem NM, Bleiziffer S, et al. Clinical outcomes with a

repositionable self-expanding transcatheter aortic valve prosthesis: the International

FORWARD Study. J Am Coll Cardiol 2017;70: 845–853.

76. Noble S, Stortecky S, Heg D, et al. Comparison of procedural and clinical outcomes

with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis.

EuroIntervention 2017;12:e2170–e2176.

77. Giannini C, De Carlo M, Tamburino C, et al. Transcathether aortic valve

implantation with the new repositionable self-expandable Evolut R versus CoreValve

system: A case-matched comparison. Int J Cardiol 2017 Sep 15;243:126-131.

78. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-

valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321–1331.

79. De Backer O, Gotberg M, Ihlberg L, et al. Efficacy and safety of the Lotus Valve

System for treatment of patients with severe aortic valve stenosis and intermediate

surgical risk: results from the Nordic Lotus-TAVR registry. Int J Cardiol 2016;219:92–

97.

80. Rampat R, Khawaja MZ, Byrne J, et al. Transcatheter aortic valve replacement

using the repositionable LOTUS Valve: United Kingdom experience. J Am Coll Cardiol

Interv 2016;9:367–372.

81. Montone RA, Testa L, Fraccaro C, et al. Procedural and 30-day clinical outcomes

following transcatheter aortic valve replacement with lotus valve: Results of the

RELEVANT study. Catheter Cardiovasc Interv 2017;90:1206–1211.

82. Meredith Am IT, Walters DL, Dumonteil N, et al. Transcatheter aortic valve

replacement for severe symptomatic aortic stenosis using a repositionable valve system:

30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol

2014;64:1339–1348.

83. Falk V, Wohrle J, Hildick-Smith D, et al. Safety and efficacy of a repositionable and

fully retrievable aortic valve used in routine clinical practice: the RESPOND Study. Eur

Heart J 2017;38:3359–3366.

84. Keßler M, Gonska B, Seeger J, Rottbauer W, Wöhrle J. Predictors of permanent

pacemaker implantation after transfemoral aortic valve implantation with

the Lotus valve. Am Heart J 2017 Oct;192:57-63.

85. Manoharan G, Linke A, Moellmann H, et al. Multicentre clinical study evaluating a

novel resheathable annular functioning self-expanding transcatheter aortic valve system:

safety and performance results at 30 days with the Portico system. EuroIntervention

2016;12:768–774.

86. Möllmann H, Linke A, Holzhey DM, et al. Implantation and 30-day Follow-Up on

All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family J Am

Coll Cardiol Interv 2017;10:1538–1547.

87. Linke A, Holzhey D, Möllmann H, et al. Treatment of Aortic Stenosis With a Self-

Expanding, Resheathable Transcatheter Valve: One-Year Results of the International

Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ

Cardiovasc Interv 2018;11:e005206.

88. Millan-Iturbe O, De Backer O, Bieliauskas G, et al. Transcatheter aortic valve

implantation with the self-expanding Portico valve system in an all-comers population:

procedural and clinical outcomes. EuroIntervention 2018;14:621–628.

89. Søndergaard L, Rodés-Cabau J, Hans-Peter Linke A, et al. Transcatheter Aortic

Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I

Trial 1-Year Outcomes. J Am Coll Cardiol 2018;72:2859–2867.

90. Mas-Peiro S, Vasa-Nicotera M, Weiler H, et al. Thirty-Day Outcomes in 100

Consecutive Patients Undergoing Transfemoral Aortic Valve Replacement With the

Portico Valve on an All-Comer Basis. J Invasive Cardiol 2017;29:431–436.

91. Toggweiler S, Nissen H, Mogensen B, et al. Very low pacemaker rate following

ACURATE neo transcatheter heart valve implantation. EuroIntervention 2017;13:1273–

1280.

92. Mauri V, Deuschl F, Frohn T, et al. Predictors of paravalvular regurgitation and

permanent pacemaker implantation after TAVR with a next-generation self-expanding

device. Clin Res Cardiol 2018;107:688-697.

93. Kim W-K, Hengstenberg C, Hilker M, et al. The SAVI-TF Registry: 1-Year

Outcomes of the European Post-Market Registry Using the ACURATE neo

Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients. J Am Coll

Cardiol 2018;11:1368–1374.

94. Börgermann J, Holzhey DM, Thielmann M, et al. Transcatheter aortic valve

implantation using the ACURATE TA system: 1-year outcomes and comparison of 500

patients from the SAVI registries. Eur J Cardiothorac Surg 2017;51:936–942.

95. Kim WK, Möllmann H, Liebetrau C, et al. The ACURATE neo

Transcatheter Heart Valve: A Comprehensive Analysis of Predictors of Procedural

Outcome. J Am Coll Cardiol. 2018;11:1721-1729.

96. Hamm K, Reents W, Zacher M, Kerber S, Diegeler A, Schieffer B, Barth S.

Transcatheter aortic valve implantation using the ACURATE TA and ACURATE neo

valves: a 4-year single-center experience. EuroIntervention 2017;13:53–59.

97. Reichenspurner H, Schaefer A, Schäfer U, et al. Self-Expanding Transcatheter

Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis.

JACC 2017.

98. Kim U, Blanke P, Windecker S, et al. Computed tomography-based oversizing and

incidence of paravalvular aortic regurgitation and permanent pacemaker implantation

with a new-generation self-expanding transcatheter heart valve.

EuroIntervention 2018;14:e511-e518.

99. Rodés-Cabau J, Urena M, Nombela-Franco L, et al. Arrhythmic Burden as

Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-

Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic

Valve Replacement: The MARE Study. J Am Coll Cardiol Interv 2018;11:1495-1505.