PPM Implantation After TAVR

Sep 16, 2019   |  Fadi Sawaya, MD, FACC; Marwan Refaat, MD, FACC

Expert Analysis

Font Size
A
A
A

Transcatheter aortic valve replacement (TAVR) has been shown to be superior to medical therapy in inoperable patients with severe aortic valve stenosis and non-inferior to surgical aortic valve replacement in patients at high or intermediate risk for surgery.1-4 New studies showed that TAVR using a balloon-expandable prosthesis was associated with significantly lower composite rates of death, stroke, or re-hospitalization at 1 year,5 and a self-expanding prosthesis was found to be non-inferior to surgical aortic valve replacement with respect to the composite endpoint of death or disabling stroke at 24 months.6 Despite advances in TAVR outcomes with newer device iterations, permanent pacemaker (PPM) implantation remains a frequent barrier. Predictors of conduction disturbances are correlated to clinical, anatomic, and procedure-related factors. Clinical data regarding the impact of PPM requirement after TAVR have been controversial, with one study demonstrating reduced survival and increased hospitalization,7 and another study showed no difference in mortality or heart failure at 2-year follow-up.8 In addition, a new study of 212 patients showed that new left bundle branch block increased the risk of PPM implantation and negatively impacted left ventricular function over time. These results should inform future efforts for improving the management of patients with left bundle branch block post-TAVR as well.9 As TAVR is moving to younger and lower-risk patient populations, it is vital to understand the causality and consequences of post-TAVR PPM implantation. Figure 1 summarizes the main predictors of PPM implantation after TAVR.

Figure 1: Main Predictors of PPM Implantation After TAVR

Clinical Anatomic Procedure-Related
Male Membranous septum (MS) length Radial force of prosthesis
Age >75 years old The noncoronary cusp device landing zone calcium volume Depth of implantation
Right bundle branch block (RBBB) Variation in location of bundle branch location Valve index (>128) leading to oversizing/stretching of the aortic annulus/left ventricular outflow tract (LVOT)
Left anterior fascicular hemi block, first-degree atrioventricular block (AVB)   Implantation of a self-expandable Medtronic CoreValve (Medtronic, Inc.; Minneapolis, MN) system

Baseline Clinical Factors

The pre-procedural electrocardiogram contains vital information that may be predictive for post-TAVR PPM implantation. In analysis of 1,973 patients who underwent TAVR in the randomized PARTNER (Placement of Aortic Transcatheter Valves) trial, the strongest electrocardiographic predictors for post-TAVR PPM included preexisting RBBB and left anterior fascicular hemi block (p < 0.001).7 A meta-analysis including 11,210 TAVR patients who received either a balloon-expandable or self-expanding prosthesis showed a 17% post-TAVR PPM rate and an increased risk of PPM in men (risk ratio [RR] 1.23; p < 0.01), as well as those with baseline first-degree AVB (RR 1.52; p < 0.01) and RBBB (RR 2.89; p < 0.01).10 The development of intraprocedural AVB carried the highest risk (RR 3.49; p < 0.01). In another analysis of 9,785 patients from the Society of Thoracic Surgery and American College of Cardiology Transcatheter Valve Therapy Registry showed significant predictors of 30-day PPM implantation to be increasing age (odds ratio [OR] 1.07 per 5 years, p = 0.033), prior conduction defects (OR 1.93, p = 0.001), and male gender.11

Anatomic Factors

In recent years, the assessment of MS length on pre-TAVR computed tomography has been a gaining interest. MS length assesses the distance between the aortic valve annular plane and the bundle of His (Figure 2). In a study to assess MS length, for 73 patients who underwent TAVR with a self-expanding prosthesis, the reported post-TAVR PPM rate was 28%.12 Analysis of those 73 treated patients showed that MS length was the strongest pre-procedural predictor of high-degree AVB (OR 1.35; p = 0.01) and PPM implantation (OR 1.43; p = 0.002).15 Based on pre- and postprocedural parameters, the difference between MS length and valve implantation depth was shown to be an independent predictor of high-degree AVB and PPM (OR 1.4 and 1.39, respectively; p < 0.001).12 Thus, a shorter MS length was associated with increased PPM rates after TAVR.

Figure 2: Anatomical Relationships Within the Aortic Root and the LVOT

Figure 2
This image of the aortic root opened from the left ventricle shows the right coronary leaflet (R), non-coronary leaflet (N), the left coronary leaflet (L), the two interleaflet triangles, the MS, the right and left fibrous trigones separating the aortomitral fibrous continuity, and the left bundle branch of the His bundle exiting below the base of the interleaflet triangle separating the noncoronary and the right coronary leaflets and splitting in three fascicles: left anterior fascicle, left septal fascicle, and left posterior fascicle. Reproduced with permission from Professor Andrew Cook, UCL Institute of Child Health, London, who retains copyright for the original image.

A retrospective analysis of 240 patients who received the Edwards SAPIEN (Edwards Lifesciences; Irvine, CA) transcatheter heart valve demonstrated that patients who required a new PPM after TAVR tended to have shorter MS length (6.4 ± 1.7 mm vs. 7.7 ± 1.9 mm; p < 0.001) and a greater valve implantation depth (0.60 ± 2.9 mm vs. 2.5 ± 2.4 mm; p < 0.001).13 Additionally, in the lower regions of the aortic valve leaflets, the noncoronary cusp device landing zone calcium volume (measured in mm3 on the pre-TAVR multidetector computed tomography scan) is an independent predictor of new PPM requirement.13 In fact, multivariate analysis from this study showed that the combination of baseline RBBB, a low or negative valve implantation depth, and significant noncoronary cusp device landing zone calcium volume is highly predictive of post-TAVR PPM.

In a multivariable analysis of 244 patients treated with SAPIEN S3 (Edwards Lifesciences; Irvine, CA), independent predictors of PPM were previous RBBB (OR 11.965; 95% confidence interval [CI], 3.406-42.026]; p < 0.001) and implantation depth at the nonseptal side (OR 1.066; 95% CI, 1.066-1.127; p = 0.022, per % of frame below annulus) but not prosthesis oversizing (OR 0.217; 95% CI, 0.026-1.780]; p = 0.155).14 In another study, oversizing did not affect new PPM rates; however, the ratio of the valve diameter to LVOT diameter has a trend toward statistical significance, with every 0.1 increment conferring a 1.29 odds increase in the likelihood of needing a new PPM (p = .07).16 In a report on 867 patients treated with the SAPIEN transcatheter heart valve, valve implantation depth >6 mm was associated with a significant increase in new PPM (OR 2.03; p = 0.0092).15

Device Factors

Although old data showed higher risk of PPM with self-expanding or mechanically expanding devices over balloon-expandable devices,16,17 new data showed that pacemaker rates with newer generation valves are comparable.18,19 Furthermore, data from 137 consecutive patients who underwent TAVR (Edwards SAPIEN valve) between June 2008 and October 2012 at Massachusetts General Hospital were reviewed.20 The role of various predictors for pacemaker implantation after TAVR, including the valve index (calculated as [valve size/LVOT diameter] × 100), was investigated. A total of 31/110 (28.2%) patients required implantation of a PPM after TAVR. The median time to implantation of a PPM was 5 days after the procedure. On multivariate analysis, the presence of preexisting RBBB was found to be a strong predictor of PPM implantation after TAVR (adjusted OR 4.87; 95% CI, 1.29-18.46; p = 0.020). Using the receiver operator curve analysis, a cut-off value of valve index = 128 was found to be a strong predictor for PPM implantation with a sensitivity of 73% and specificity of 61% (c statistic = 0.68). A larger implanted valve size relative to LVOT diameter leads to a greater compression of the intrinsic conduction system, increasing the need for pacemaker placement.

A recent study by Ream et al. showed the utility of 30-day ambulatory event monitoring in identifying post-TAVR delayed high-grade AVB (≥2 days post-TAVR).21 In this single-center study, ambulatory event monitoring was helpful in the identification and treatment of 10% of post-TAVR outpatients who had delayed high-grade AVB. Unexplained post-TAVR 30-day mortality is significant, with syncope and sudden cardiac death post-TAVR possibly related to undiagnosed incident delayed high-grade AVB occurring after hospital discharge. Ambulatory event monitoring may become part of the routine post-TAVR follow-up.

Conclusion

Tailored assessment of the risk of new PPM requirement should include all the aforementioned variables to anticipate the risk and fully inform the patient. There are several studies demonstrating that nearly 50% of patients who receive a post-TAVR PPM are no longer pacemaker-dependent at 1 year.22 This suggests that certain patients may experience recovery of their atrioventricular nodal function after the initial mechanical or ischemic conduction system injury immediately after TAVR. Regarding health care costs, receiving a new PPM after TAVR has been reported to significantly increase per-patient costs and hospital length of stay. Special attention must be taken to minimize the need for post-TAVR PPM in cases when it can be prevented.

References

  1. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607.
  2. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-98.
  3. Leon MB, Smith CR. Transcatheter Aortic-Valve Replacement. N Engl J Med 2016;375:700-1.
  4. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2017;376:1321-31.
  5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380:1695-1705.
  6. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med 2019;380:1706-15.
  7. 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. JACC Cardiovasc Interv 2015;8:60-9.
  8. Urena M, Webb JG, Tamburino C, et al. Permanent pacemaker implantation after transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function. Circulation 2014;129:1233-43.
  9. Chamandi C, Barbanti M, Munoz-Garcia A, et al. Long-Term Outcomes in Patients With New-Onset Persistent Left Bundle Branch Block Following TAVR. JACC Cardiovasc Interv 2019;12:1175-84.
  10. Siontis GC, 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;64:129-40.
  11. Fadahunsi OO, Olowoyeye A, Ukaigwe A, et al. Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv 2016;9:2189-99.
  12. Hamdan A, Guetta V, Klempfner R, et al. Inverse Relationship Between Membranous Septal Length and the Risk of Atrioventricular Block in Patients Undergoing Transcatheter Aortic Valve Implantation. JACC Cardiovasc Interv 2015;8:1218-28.
  13. Maeno Y, Abramowitz Y, Kawamori H, et al. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging 2017;10:1139-47.
  14. 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. JACC Cardiovasc Interv 2016;9:244-54.
  15. Tarantini G, Mojoli M, Purita P, et al. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention 2015;11:343-50.
  16. Siontis GC, Praz F, Pilgrim T, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials. Eur Heart J 2016;37:3503-12.
  17. Van Mieghem NM, Wöhrle J, Hildick-Smith D, et al. Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort. JACC Cardiovasc Interv 2019;12:38-49.
  18. 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;37:2252-62.
  19. Manoharan G, Walton AS, Brecker SJ, et al. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv 2015;8:1359-67.
  20. 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;38:878-86.
  21. Ream K, Sandhu A, Valle J, et al. Ambulatory Rhythm Monitoring to Detect Late High-Grade Atrioventricular Block Following Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2019;73:2538-47.
  22. Regueiro A, Abdul-Jawad Altisent O, Del Trigo M, et al. 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;9:e003635.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Nuclear Imaging

Keywords: Arrhythmias, Cardiac, Transcatheter Aortic Valve Replacement, Aortic Valve, Bundle-Branch Block, Multidetector Computed Tomography, Ventricular Function, Left, Thoracic Surgery, Retrospective Studies, Hospitals, General, Multivariate Analysis, Outpatients, Factor XI, Follow-Up Studies, Bundle of His, Aortic Valve Stenosis, Heart Valve Prosthesis, Electrocardiography, Heart Conduction System, Syncope, Death, Sudden, Cardiac, Registries, Heart Failure, Hospitalization, Stroke, Pacemaker, Artificial


< Back to Listings