Conduction Disturbances with TAVR Current Status Future Directions
Conduction Disturbances with TAVR Current Status/ Future Directions Steven J Yakubov, MD FACC FSCAI John H. Mc. Connell Chair of Advanced Structural Heart Disease System Chief, Ohio. Health Structural Heart Disease Medical Director, Ohio. Health Research Institute Riverside Methodist Hospital, Ohio. Health Columbus, Ohio
Permanent Pacemakers Why Do Conduction Disturbances Happen? • Conduction disturbances can arise when there is compression or inflammation to conductive tissue. • The bundle of His and left bundle branch are located close to the “interleaflet triangle” between right and non-coronary cusps, so this area may be vulnerable to tissue damage during balloon valvuloplasty or TAV deployment. 1 1 Mangieri, et al. Front Cardiovasc Med. 2018; 5: 85.
Time from TAVR to PPI Chekrallah Chamandi et al. JCIN 2018; 11: 301 -310
Pacemaker Dependency Variable dependency at 30 days • The extent of pacemaker dependency in the TAVI population requires further investigation • Approximately ⅓ of patients with a Core. Valve prosthesis were dependent on their new pacemaker at 30 days, according to one study 1 Kereiakes, presented at ACC 2018
Left Bundle Branch Block Clinical Impact ADVANCE found that new LBBB was associated with mortality 100% Freedom from All-cause Mortality (%) 100% 91. 6% 90 P-value (log rank) =0. 0542 84. 6% 87. 4% 80 No New LBBB at 30 Days 70 76. 8% 76. 1% New LBBB at 30 Days 65. 7% 60 50 Number at risk: 72 72 205 0 63 185 6 12 53 168 18 24 Months Post-Procedure Excludes patients with pacemakers and / or LBBB at baseline. New LBBB is defined as a LBBB present at day 30. 32 109 30 36 Gerckens U, et al. Eur Heart J 2017; 38: 2729 -38
Permanent Pacemakers Clinical Impact Looking more closely at the Core. Valve ADVANCE study, data out to five years has found no difference in mortality in patients with existing pacemaker, no pacemaker, or a new pacemaker. Gerckens U, et al. Eur Heart J 2017; 38: 2729 -38
Long-Term Outcomes in Patients With New Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement Chamandi, et al. Multicenter study: 1, 629 patients without prior PPI undergoing TAVR (median f/u 4 yrs. ) PPI post-TAVR was associated with: • • Increased risk of heart failure Increased risk of rehospitalization and Lack of LVEF improvement, No mortality difference. Chekrallah Chamandi et al. JCIN 2018; 11: 301 -310
Long Term Clinical Outcomes (increase in re-hosp) Cumulative incidence curves for (A) long-term (4 -year) all-cause mortality, (B) cardiovascular death, (C) heart failure admission, and (D) composite of mortality and heart failure admission. Chekrallah Chamandi et al. JCIN 2018; 11: 301 -310
Permanent Pacemakers at 30 Days Contemporary TAVI Devices New Pacemaker at 30 days (%)* While some first generation TAVI devices were associated with a rate of PPI of ~20% or greater, rates fall around 10 -15% with current commercially available TAVI devices 35. 5% 25. 6% 19. 8% 16. 1% 8. 5% 16. 4% 13. 5% 11. 7% 10. 1% 8. 9% 4. 9% SAPIEN XT Core. Valve SURTAVI Evolut R Lotus Portico TF Evolut PROSapien 3 P 2 ACURATE Centera P 2 A HR Pivotal N=864 CAS N=275 US Study REPRISE III EU Study N=60 S 3 IR Neo CE Trial N=203 N=1, 011 N=390 N=241 N=607 N=222 N=1, 078 Study N=89 Early generation valves Current valve iterations *Not appropriate for cross-trial comparisons 1 Leon, et al. , N Engl J Med 2016; 374: 1609 -20; 2 Adams, et al. , N Engl J Med 2014; 370: 1790 -8; 3 Reardon et al. , N Engl J Med. 2017 Apr 6; 376(14): 1321 -1331; 4 Van Mieghem et al. , presented at TCT 2017; 5 Popma et al. JACC Cardiovasc Intv 2017; 10: 268 -75; 6 Feldman, et. al. presented at Euro. PCR 2017 7 Mollmann, et al. , Euro. Intervention 2017; 10: 1538– 47; 8 Forrest, et al. , presented at ACC 2017; 9 Kodali, et al. , Eur Heart J 2016; 37: 2252 -62 10 Mollman et al. Euro. Intervention 2017; 13: e 1040 -e 1046; 11 Tchetche, et al. , presented at Euro. PCR 2017.
stabilizers orientation marker soft tip
Hospital Policy: Patients are not allowed to receive PT/OT if TVP in place.
2. 5 Days 2. 8 Days 3. 1 Days 30 -day hospital readmission 4% 1. 7 Days
Issues with TAVR: Pacemakers • Temporary pacemakers for high risk patients • His Bundle Pacing
Clinical Outcomes of His-Bundle Pacing in Patients with New Heart Block or Ventricular Conduction Disease following Transcatheter Aortic Valve Replacement Anish Amin, et al
Trial Goals: Anish Amin, et al
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