Vol 24, No 3 (2017)
Original articles — Interventional cardiology
Published online: 2017-02-15

open access

Page views 2161
Article views/downloads 1369
Get Citation

Connect on Social Media

Connect on Social Media

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol

Florian Krackhardt1, Behrouz Kherad1, Maximilian Krisper1, Burkert Pieske123, Michael Laule4, Carsten Tschöpe135
Pubmed: 28248410
Cardiol J 2017;24(3):250-258.


Background: Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria.

Methods: A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19–27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation.

Results: The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days.

Conclusions: The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

Article available in PDF format

View PDF Download PDF file


  1. Smith CR, Leon MB, Mack MJ, et al. PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23): 2187–2198.
  2. Makkar RR, Fontana GP, Jilaihawi H, et al. PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012; 366(18): 1696–1704.
  3. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002; 106(24): 3006–3008.
  4. Osnabrugge RLJ, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013; 62(11): 1002–1012.
  5. Binder RK, Schäfer U, Kuck KH, et al. Transcatheter aortic valve replacement with a new self-expanding transcatheter heart valve and motorized delivery system. JACC Cardiovasc Interv. 2013; 6(3): 301–307.
  6. Freeman M, Rodés-Cabau J, Urena M, et al. First-in-man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT valve. Catheter Cardiovasc Interv. 2013; 82(4): 664–670.
  7. Gooley R, Lockwood S, Antonis P, et al. The SADRA Lotus Valve System: a fully repositionable, retrievable prosthesis. Minerva Cardioangiol. 2013; 61(1): 45–52.
  8. Meredith IT, Hood KL, Haratani N et al. Boston Scientific Lotus valve. EuroIntervention. 2012 Sep;8 Suppl Q:Q70-4. doi: 10.4244/EIJV8SQA12.
  9. Meredith IT, Worthley SG, Whitbourn RJ, et al. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention. 2014; 9(11): 1264–1270.
  10. Meredith IT, Worthley SG, Whitbourn RJ, et al. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention. 2014; 9(11): 1264–1270.
  11. 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(5): 747–754.
  12. Zahn R, Gerckens U, Grube E, et al. German Transcatheter Aortic Valve Interventions-Registry Investigators. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011; 32(2): 198–204.
  13. Lefèvre T, Kappetein AP, Wolner E, et al. PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011; 32(2): 148–157.
  14. Godin M, Eltchaninoff H, Furuta A, et al. Frequency of conduction disturbances after transcatheter implantation of an Edwards Sapien aortic valve prosthesis. Am J Cardiol. 2010; 106(5): 707–712.
  15. Boughaleb D, Mansourati J, Genet L, et al. [Permanent cardiac stimulation after aortic valve replacement: incidence, predictive factors and long-term prognosis]. Arch Mal Coeur Vaiss. 1994; 87(7): 925–930.
  16. Bagur R, Manazzoni JM, Dumont É, et al. Permanent pacemaker implantation following isolated aortic valve replacement in a large cohort of elderly patients with severe aortic stenosis. Heart. 2011; 97(20): 1687–1694.
  17. Baumgartner H, Hung J, Bermejo J, et al. EAE/ASE. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. Eur J Echocardiogr. 2009; 10(1): 1–25.
  18. Genereux P, Kodali S, Leon MB, et al. Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. JACC Cardiovasc Interv. 2011; 4(8): 861–867.
  19. Linke A, Wenaweser P, Gerckens U, et al. ADVANCE study Investigators. Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study. Eur Heart J. 2014; 35(38): 2672–2684.
  20. Kappetein AP, Head SJ, Généreux P, et al. Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013; 145(1): 6–23.
  21. Tchetche D, Dumonteil N, Sauguet A, et al. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention. 2010; 5(6): 659–665.
  22. Van Mieghem NM, Nuis RJ, Piazza N, et al. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. EuroIntervention. 2010; 5(6): 673–679.
  23. van der Boon RM, Nuis RJ, Van Mieghem NM, et al. New conduction abnormalities after TAVI-frequency and causes. Nat Rev Cardiol. 2012; 9(8): 454–463.
  24. Sherif MA, Abdel-Wahab M, Stöcker B, et al. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010; 56(20): 1623–1629.
  25. Nuis RJ, Van Mieghem NM, Schultz CJ, et al. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012; 109(11): 1637–1643.
  26. Eggebrecht H, Schmermund A, Voigtländer T, et al. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012; 8(1): 129–138.
  27. Siontis GCM, Jüni P, Pilgrim T, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol. 2014; 64(2): 129–140.
  28. Binder RK, Webb JG, Toggweiler S, et al. Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation. JACC Cardiovasc Interv. 2013; 6(5): 462–468.
  29. Ferreira ND, Caeiro D, Adão L, et al. Incidence and predictors of permanent pacemaker requirement after transcatheter aortic valve implantation with a self-expanding bioprosthesis. Pacing Clin Electrophysiol. 2010; 33(11): 1364–1372.
  30. Gooley RP, Talman AH, Cameron JD, et al. Comparison of self-expanding and mechanically expanded transcatheter aortic valve prostheses. JACC Cardiovasc Interv. 2015; 8(7): 962–971.
  31. Houthuizen P, van der Boon RMA, Urena M, et al. Occurrence, fate and consequences of ventricular conduction abnormalities after transcatheter aortic valve implantation. EuroIntervention. 2014; 9(10): 1142–1150.
  32. 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(11): 1600–1605.
  33. Roten L, Wenaweser P, Delacrétaz E, et al. Incidence and predictors of atrioventricular conduction impairment after transcatheter aortic valve implantation. Am J Cardiol. 2010; 106(10): 1473–1480.
  34. Bleiziffer S, Ruge H, Hörer J, et al. Predictors for new-onset complete heart block after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2010; 3(5): 524–530.
  35. Schroeter T, Linke A, Haensig M, et al. Predictors of permanent pacemaker implantation after Medtronic CoreValve bioprosthesis implantation. Europace. 2012; 14(12): 1759–1763.
  36. Piazza N, Onuma Y, Jesserun E, et al. Early and persistent intraventricular conduction abnormalities and requirements for pacemaking after percutaneous replacement of the aortic valve. JACC Cardiovasc Interv. 2008; 1(3): 310–316.
  37. Holmes D, Mack M, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. The Journal of Thoracic and Cardiovascular Surgery. 2012; 144(3): e29–e84.
  38. Masson JB, Kovac J, Schuler G, et al. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009; 2(9): 811–820.
  39. Ribeiro HB, Nombela-Franco L, Urena M, et al. Coronary obstruction following transcatheter aortic valve implantation: a systematic review. JACC Cardiovasc Interv. 2013; 6(5): 452–461.