Transcatheter Aortic Valve Implantation in Patients With Right Bundle-Branch Block: Should Prophylactic Pacing Be Undertaken?

Abstract

Introduction. Right bundle-branch block (RBBB) is a strong predictor of the development of high-grade AV block (AVB) after TAVI. Aims. To assess mortality, length-of-hospital stay, and cost in patients with RBBB undergoing TAVI according to whether or not they had preprocedural permanent pacemaker (PPM) implantation. Methods and Results. A total of 121 patients with RBBB who underwent TAVI between 2009-2021 were included. A total of 41 patients (33.9%) received a prophylactic PPM by clinical preference and 45/80 patients (56%) received PPM after TAVI. Baseline characteristics were balanced. Mortality was similar at 5 years, with death in 17 patients (41.4%) in the prophylactic PPM group vs 27 (33.8%) in the no prophylactic PPM group (adjusted hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.69-2.33; P=.44). Median survival for the prophylactic PPM (4.2 years), post TAVI PPM (4.5 years) and no pacemaker (4.7 years) groups was similar. Sixteen deaths (35.6%) occurred in those receiving PPM after TAVI and 11 deaths (31.4%) occurred in those not receiving PPM (HR, 0.95; 95% CI, 0.43-2.09; P=.90). Thirty-day all-cause mortality was similar. Compared with post-TAVI PPM, prophylactic PPM reduced hospital length of stay (4.3 ± 4.5 days vs 2.5 ± 1.6 days, respectively; P=.02). For the highest and lowest complication and comorbidity scores, prophylactic PPM resulted in cost savings of £297.32 (-2.9%) and excess cost of £423.89 (+5.6%), respectively. There were no major pacing-related complications. Conclusions. More than half of patients with RBBB undergoing TAVI require PPM shortly after their valve implant. A prophylactic pacing strategy is safe, reduces length of hospital stay, and is cost effective in the United Kingdom.

Keywords: conduction disease, pacemaker, prophylactic pacing, right bundle-branch block, transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) for the treatment of severe aortic stenosis has become an established treatment modality across all surgical risk groups.^1-3 The predicted number of TAVI procedures performed annually worldwide is expected to rise due partly to increasing average life expectancy, but also due to recent guidelines extending TAVI as a suitable treatment option to all patients over 75 years of age if technically feasible.^4,5

Compared with surgical aortic valve replacement (SAVR), TAVI reduces all-cause mortality, stroke, and new atrial fibrillation at the expense of an increased risk of major vascular complications and permanent pacemaker (PPM) implantation.⁶ Consequently, attention has focused on reducing new high-grade atrioventricular conduction block (HAVB) after TAVI to mitigate new PPM implantation.⁷ Depending on the study cohort and therefore the valve platform used, overall rates of PPM implantation after TAVI are in the order of 10% to 30%.^8,9 Several clinical, electrocardiographic (ECG), imaging, and procedural predictors for HAVB have been identified. Some of these are modifiable, such as depth of valve implantation and delivery method (self expanding vs balloon expandable), and others are fixed.

One such predictor is the presence of right bundle-branch block (RBBB) at baseline, which is seen in approximately 10% of ^­patients ­undergoing TAVI,¹⁰ and has remained a risk factor across subsequent analyses with consistently higher rates of HAVB and PPM implantation rates as high as 65%.^10-14 Some studies have also demonstrated an increased cardiovascular mortality in patients with RBBB discharged after TAVI with no pacemaker,¹⁰ raising the possibility of delayed HAVB after discharge leading to sudden cardiac death. Discharging patients with extended cardiac monitoring for up to 4 weeks has been proposed,¹⁵ though this strategy doesn’t mitigate the risk of sudden cardiac death occurring due to life-threatening bradyarrhythmia. Furthermore, the onus on streamlining TAVI pathways with the resultant trend toward shorter median length of stay (LOS) makes prolonged inpatient monitoring in this high-risk cohort less feasible.

One recent study evaluated implantation of a prophylactic PPM in patients with baseline RBBB undergoing TAVI and showed no difference in all-cause or cardiovascular mortality at 48 months,¹⁶ although PPM-associated morbidity and costs associated with this strategy were not reported. Furthermore, only 44% of the prophylactic group received PPM implant prior to TAVI. Our study aims are to extend these results by reporting on outcomes at 30 days and 5 years, PPM-associated complications, and cost analysis of a prophylactic pacing strategy in this high-risk cohort.

Methods

Study population. Consecutive patients undergoing TAVI for severe aortic stenosis following multidisciplinary team (MDT) review were prospectively enrolled in this single-center study. Patient records were analyzed between July 2009 and December 2021 and baseline ECGs were screened for RBBB. If present, those patients formed the study population and were separated into 2 cohorts: those receiving a prophylactic PPM prior to TAVI by clinical preference following MDT review, and those who underwent TAVI without a prophylactic PPM. Patients were excluded from the analysis if they had received a PPM prior to TAVI for a symptomatic bradyarrhythmia.

Data collection and endpoints. Baseline patient demographic, 12-lead ECG, and procedural data were prospectively collected in a standardized web-based database (Intellect) maintained by the University Hospitals Sussex NHS Foundation Trust Clinical Research Facility. This registry forms part of the United Kingdom (UK) TAVI data set and is quality controlled by the National Institute of Cardiovascular Outcomes Research (NICOR). All patients provided written informed consent for their procedures. NICOR has support under section 251 of the National Health Service Act of 2006. Formal ethics approval was not required for this study, which was conducted in compliance with the Declaration of Helsinki. ECG conduction disturbances were defined in accordance with international recommendations,¹⁷ and ECGs were performed at baseline, immediately following TAVI implant, and at discharge. Follow-up data and life status were obtained from electronic patient healthcare records and confirmed using the central UK National Health Service (NHS) database to maximize data capture. The prespecified endpoints were mortality at 30 days and 5 years, in-hospital LOS, and cost analysis of a prophylactic pacing strategy.

Pacemaker implantation. The decision to implant a PPM following TAVI was made at the discretion of the structural heart team in collaboration with an electrophysiologist in the presence of conduction disease not expected to resolve. The conduction abnormality leading to PPM implant was retrospectively collected from post-TAVI ECGs and electronic patient records and coded as: (1) HAVB, third-degree block; (2) HAVB, second-degree type II; (3) increase in PR interval in the presence of sinus rhythm or QRS duration >20 ms from baseline ECG; or (4) symptomatic sinus node dysfunction or atrial fibrillation with a slow ventricular response. The maximum device capability of the PPM was at the discretion of the implanting cardiologist. Immediate complications related to PPM implantation were collected from electronic patient records and by reviewing postimplant chest radiographs for the presence of hemo- or pneumothorax.    

Cost analysis. Costs were evaluated from the perspective of the English NHS. Unit costs for procedures (TAVI and pacemaker implant) were based on 2019/2020 NHS reference costs¹⁸ and vary according to complication and comorbidity (CC) score, and whether they occur electively or as an inpatient. Total costs for each cohort are presented in 3 groups: the lowest possible total procedure cost (sum of lowest CC score groups); highest possible total procedure costs (sum of highest CC score groups); and the sum of the mean procedure cost across all CC scores. It was anticipated that the hospital LOS for patients requiring a PPM after TAVI would be longer. The associated excess bed-day costs were estimated using a previously published value in the cardiovascular literature of £385 per day¹⁹ as these data have not been collected by the NHS since 2018/2019.

Statistical analysis. Categorical data are expressed as count (%) and compared using either the Chi-square test, or Fisher’s exact test if the cell count was expected to be less than 5. Histograms and prior clinical knowledge were used to determine if continuous variables followed a normal distribution and are expressed as mean ± 1 standard deviation; otherwise, median (interquartile range [IQR]). The independent student’s t test was used to compare the means of 2 independent, normally distributed data sets. Otherwise, the Mann-Whitney U test was used. For survival analysis, Kaplan-Meier curves were constructed with t0 defined as the TAVI procedure date and death from any cause as the event. Patients were right censored at 5 years to allow meaningful comparison between both cohorts. Since this study was not designed as a randomized controlled trial, differences in baseline ­characteristics were expected between the 2 cohorts. The primary statistical plan was to use a Cox regression model to estimate the hazard ratio (HR) which was adjusted if there were significant between- group differences in baseline variables felt to affect survival, with testing of the proportional hazard assumption using log-log plots and examining for crossed Kaplan-Meier curves. If this assumption was violated, then treatment allocation group was included as a time-varying covariate. All statistical analysis was carried out using Stata, version 13 (Stata Corp). A 2-tailed P≤.05 was considered statistically significant.

Results

Population characteristics. Out of 1684 patients who underwent TAVI at our institution between July 2008 and December 2021, a total of 122 (7.2%) had RBBB at baseline.  One patient was excluded from the analysis since a PPM had been implanted to treat a bradyarrhythmia historically (therapeutic indication), leaving 121 patients in the study cohort. The median age was 83 years (IQR, 79-87) and 32% were female. Forty-one out of 121 patients (33.9%) had a PPM fitted prophylactically prior to the TAVI procedure, leaving 80 patients (66.1%) who underwent TAVI with underlying RBBB and no PPM. Baseline demographic and procedural characteristics were similar between those who received a prophylactic PPM and those who did not (Table 1 and Table 2), although there was a trend toward a greater proportion of patients in the prophylactic PPM group having a history of stroke or transient ischemic attack (10 [26%] vs 9[11%], respectively; P=.06). Furthermore, more patients in the prophylactic PPM group had a history of chronic obstructive pulmonary disease (10 [24%] vs 7 [9%], respectively; P=.02). In-hospital complication rates were also similar.

Pacing characteristics. Complete ECG data from before and after TAVI were available for 105 patients (87%). The proportion of patients with an atrial arrhythmia (atrial fibrillation, tachycardia, or flutter) was similar between groups (8 [20%] in the PPM group vs 16 [20%] in the no-PPM group; P=.95). In those patients in sinus rhythm who had a prophylactic PPM implant prior to TAVI, the PR interval was longer than in those who did not receive a prophylactic pacemaker (200 ms [IQR, 170-228] vs 175 ms [IQR, 158-196]; P=.05). Similarly, the QRS duration was longer (140 ms [IQR, 126-156] vs 131 ms [IQR, 120-142]; P=.01) and there was numerically but not statistically more left anterior hemiblock (24 [62%] vs 29 [45%]; P=.10). With regard to PPM-related complications, 2 patients in the prophylactic pacing group developed a pocket hematoma and were managed non-operatively. There were no complications identified in the post-TAVI PPM group.

Forty-five patients (56%) who underwent TAVI without prophylactic PPM implantation required a PPM during their index admission, the majority of whom (37/45 [82%]) developed persistent 3rd-degree atrioventricular block. The remaining indications for PPM implant after TAVI were alternating bundle-branch block in 2 (4%), sinus bradycardia with attributable symptoms in 2 (4%), and persistent type II 2nd-degree atrioventricular block in 1 patient (2%). Three patients (7%) had missing data. Among patients discharged after TAVI without a PPM, 1 patient (2.9%) was readmitted within 90 days of TAVI for PPM implantation for advanced conduction disease and no patients received PPM within 30 days.

Across all baseline demographics, patients receiving PPM after TAVI had a trend toward lower baseline creatinine (96.5 µmol/L [IQR, 81-120] vs 110 µmol/L [IQR, 89-125]; P=.08) and had a larger TAVI implanted (27 mm [IQR, 26-29] vs 27 mm [IQR, 25-27], respectively; P=.05). The presence of previous surgical AVR appeared protective against new conduction disease, with fewer patients requiring post-TAVI PPM implant (1/45 [2.2%] vs 6/35 [17.1%]; odds ratio, 0.11; 95% confidence interval [CI], 0.01-0.96; P=.05). More patients receiving a mechanically expandable Lotus valve (Boston Scientific) required post-TAVI PPM (20 [44%] vs 8 [24%]; OR, 2.6; 95% CI, 0.97-6.7; P=.06), and conversely implantation of an Edwards Sapien valve (Edwards Lifesciences) had the lowest risk of PPM implant (8 [18%] vs 13 [38%]; OR, 0.35; 95% CI, 0.12-0.97; P=.04). There was no difference with the CoreValve platform (Medtronic) (16 [36%] vs 12 [35%]).

Thirty-day outcomes. Thirty-day all-cause mortality was similar with 2 deaths (5.3%) occurring 7 and 14 days after TAVI in the prophylactic group vs 5 deaths (6%) in those without a prophylactic PPM. Of these 5 deaths, 2 (4.4%) occurred in those receiving PPM after TAVI at days 1 and 12, and 3 (8.6%) occurred in those receiving no PPM after TAVI at days 1, 7, and 8. Thirty-day all-cause mortality was not compared using statistical methods due to the small numbers involved.

Five-year outcomes. All-cause mortality was similar between groups, with deaths in 17 patients (41.4%) in the prophylactic PPM group vs 27 (33.8%) in the no prophylactic PPM group (adjusted HR, 1.27; 95% CI, 0.69-2.33; P=.44) (Figure 1). In the no prophylactic PPM group, 16 deaths (35.6%) occurred in those receiving PPM after TAVI and 11 deaths (31.4%) occurred in those not receiving PPM (HR, 0.95; 95% CI, 0.43-2.09; P=.90) (Figure 2). Median survival times for the prophylactic PPM (4.2 years), post-TAVI PPM (4.5 years), and no pacemaker groups (4.7 years) were similar.

Length of stay. Out of 121 patients, 116 were included in the analysis as 5 patients (4%) died in hospital before discharge. There was a trend to a reduced hospital LOS in those receiving prophylactic PPM compared with those who either received a post-TAVI PPM or were discharged without PPM implant (2.5 ± 1.6 days vs 4.0 ± 4.8 days, respectively; P=.08). When comparing the prophylactic PPM group with those who required a post-TAVI PPM only, there was a statistically significant reduction in LOS (2.5 ± 1.6 days vs 4.3 ± 4.5 days, respectively; P=.02) (Figure 3).

Cost analysis. The results of the cost analysis are shown in Table 3. For the purposes of calculating costs, all patients in the prophylactic PPM group received both a TAVI and a PPM (assumed dual-chamber system as the prevalence of atrial arrhythmia was the same in both groups), while for the no prophylactic PPM group, the PPM cost was reduced to 56% of the cost (the proportion receiving PPM after TAVI) in addition to 56% of the cost of 2 extra-high-dependency unit bed-days (£385 per day). Using the total cost of the no prophylactic PPM group as the reference, costs were very similar across the CC scores. For the least comorbid patients, a prophylactic pacing strategy was £423.89 (+5.6%) more expensive, while it led to a cost saving of £297.32 (-2.9%) for patients with the highest CC scores. Across all CC risk groups, the mean difference in cost was £134.58 (+1.5%).

Discussion

In this study, we show that a prophylactic pacing strategy in patients undergoing TAVI with RBBB at baseline is safe, is not associated with altered mortality at 5 years, and reduces hospital LOS. There was a negligible increase in associated cost.

The overall prevalence of RBBB in our cohort of 7.2% is broadly similar to previously published estimates, which range from 10.1% to 13.6%.^12,20 The prognostic impact of RBBB in healthy people has been debated. Data from the Women’s Health Initiative demonstrated an increased risk of cardiovascular death among women with RBBB and cardiovascular risk factors, but not among those without.²¹ This contrasts with the findings of the Copenhagen City Heart study showing that RBBB was a predictor of both all-cause and cardiovascular mortality among 18,411 patients followed up over several decades.²² In patients undergoing TAVI, several studies have established RBBB as a risk factor for all-cause mortality and cardiovascular death,^23,24 with higher rates of immediate and delayed PPM implantation. Results from a subgroup analysis of the OCEAN TAVI registry, which enrolled 102 patients with RBBB at baseline who received a balloon-expandable Sapien XT prosthesis, revealed worse short-term cardiovascular outcomes for those not receiving PPM after TAVI.²⁰ In a separate study of 362 patients with RBBB undergoing TAVI with both balloon-expandable and self-expanding platforms, cardiovascular risk was higher at 2 years in those not receiving a PPM post TAVI.¹⁰ Taken together, these data suggest that patients with pre-existing RBBB undergoing TAVI not receiving PPM are particularly at risk of developing delayed atrioventricular block and sudden cardiac death, and prophylactic pacing may mitigate that risk.

From a mechanistic perspective, it is felt that trauma to the infra-Hisian conduction system, particularly the left bundle due to its proximity to the aortic valve apparatus as it passes through the membranous septum, results in complete atrioventricular block in patients with RBBB, which explains the high rates of PPM implantation in this cohort. Particularly with self-expanding TAVI platforms, this may be delayed after patient discharge,²⁵ which may explain a signal from some studies of an increased risk of sudden cardiac death. While recent guidelines advocate maintaining transvenous pacing capability for 24 hours after valve implant in this cohort with continuous cardiac monitoring, this strategy does not mitigate against the development of delayed high-grade atrioventricular block and increases hospital LOS at a time where there has been a shift toward streamlining pathways toward earlier patient discharge. Lastly, transvenous pacing systems are not without risk — these risks including infection, vascular complications, and cardiac tamponade.

Mortality and safety. To propose a prophylactic pacing strategy, it is important to show that a PPM implant has no impact on all-cause mortality. There are concerns that PPM implantation post TAVI can lead to excess heart failure hospitalization, worsening left ventricular ejection fraction, and increased rate of all-cause mortality,²⁶ in part driven by pacing-induced heart failure. The data remain conflicting, however, as a meta-analysis of 23 studies including over 20,000 patients revealed no impact on PPM implant after TAVI on all-cause and cardiovascular mortality at 30 days and 1 year.²⁷ Differences in statistical analysis and the inclusion of retrospective studies evaluating the effect of late PPM implant on mortality may in part explain the conflicting results.

Our study demonstrates that a prophylactic PPM strategy is not associated with excess 5-year all-cause mortality, which supports a recent study of 260 patients with RBBB undergoing TAVI, of which 90 patients received prophylactic PPM on a selective basis with no excess mortality seen at 2 years.¹⁶ In the present study, this can be partly explained as both cohorts were well balanced at baseline and only a proportion of patients in the prophylactic group would receive persistent right ventricular pacing. Pacemaker implantation is a low-risk procedure and across all patients receiving PPM we identified 2 pocket hematomas, which were managed non-operatively. Longer-term morbidity and mortality from cardiac implantable electronic device (CIED)-related infection is an important consideration that was not captured in this study though it is rare, occurring in an estimated 0.8% to 1% of patients at 1 year in large randomized trials.²⁸ Since the median age in our cohort was 83 years with a median survival of just over 4 years, we believe that the benefits of prophylactic PPM implant outweigh the potential risk of CIED infection. In the future, as TAVI is utilized in younger patients, this risk balance may change.

Our observed post-TAVI PPM implant rate of 56% is slightly higher than the 20%-40% reported in older studies, but similar to a recent paper reporting on a selective prophylactic pacing strategy where 50% of patients received PPM post TAVI.¹⁶ Importantly, we observed no difference in all-cause mortality between those receiving PPM after TAVI and those discharged without a device, which contrasts with data from 2 studies showing both worse²⁰ and better¹⁰ mid-term outcomes for patients with RBBB and PPM implant after TAVI. These differences may be explained by the high overall PPM implant rate in our study as the entire prophylactic group and 56% of the no prophylactic group received a device, leaving only a small proportion with the lowest risk of conduction disease discharged from hospital with no PPM. It is noteworthy that we also reaffirm published findings suggesting a higher rate of post-TAVI PPM implant in patients receiving a mechanically expandable Lotus valve²⁹ and that prior surgical AVR is associated with a lower rate of post-TAVI PPM implant.³⁰

Length of stay and cost. Median length of hospital stay for patients having TAVI has gradually decreased over the last decade from 6 nights in 2012 to 1 night in the current era, with an inverse relationship with the number of PPM implants occurring after discharge during a subsequent hospitalization.³¹ Whether a PPM is implanted during the index admission or subsequently, the total length of time in hospital is increased, which impacts catheterization laboratory logistics and increases cost. Using our preventative strategy with prophylactic PPM implant, we show a reduction in LOS of 1.8 days, corroborating the only other study evaluating a prophylactic PPM strategy, which demonstrated a reduction in the proportion of patients staying in hospital longer than 5 days from 40% to 15%.¹⁶ To the best of our knowledge, we report for the first time the cost implications of a prophylactic pacing strategy, showing a small mean increase in cost of £134.58 (1.5%). Since 2018/2019, the NHS has not published the daily cost of a hospital bed due to the way in which the tariff system changed, but we applied a conservative estimate of £385 per day previously used in the cardiovascular literature. Since TAVI is a fixed cost and a high proportion of patients require a PPM after TAVI, a prophylactic pacing strategy is likely to become more cost effective in healthcare systems where the cost of a bed day is higher, such as in the United States, where it is estimated to be $2873.³²

Study limitations. This was a single-center observational cohort study and due to the non-randomized nature of the study design, unmeasured confounders may have influenced the primary endpoints. However, we used statistical methods to correct for any differences in measured baseline variables that were felt to influence survival. The findings presented should be confirmed with a randomized controlled trial. We were unable to report on cardiovascular-specific outcomes, including CIED-related infection, as the UK-TAVI database does not capture this information. Lastly, the cost estimates are based on the UK-NHS national tariff system and the conclusions may differ according to each nation’s healthcare system. Future studies should focus on determining costs associated with prophylactic PPM implantation in different healthcare settings, such as the United States, where cost of PPM implantation may be greater than extra days in hospital.

Conclusion

Over half of patients with RBBB undergoing TAVI require a pacemaker after their valve implant for high-grade atrioventricular block. A prophylactic pacing strategy in this high-risk cohort is safe, reduces hospital LOS, and is cost effective.

Impact on daily practice. We evaluated a prophylactic pacing strategy in patients with RBBB undergoing TAVI. We show this was not associated with excess mortality at 5 years, reduces hospital LOS compared with implanting a PPM after TAVI, and for the first time demonstrate prophylactic pacing is cost effective. Given the high rates of PPM implantation after TAVI in this high-risk cohort, we believe our findings will help inform decision making regarding the management of patients with RBBB undergoing TAVI.

Affiliations and Disclosures

From Sussex Cardiac Centre, Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, England, United Kingdom.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Hildick-Smith reports he is a proctor/advisory for Boston, Edwards Lifesciences, Medtronic, and Abbott. Dr Pavitt reports funding by an education research grant from Terumo Ltd, UK. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted September 15, 2022.

Address for correspondence: Dr Christopher Pavitt, Sussex Cardiac Centre, Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust, Eastern Road, Brighton, BN2 5BE, England, United Kingdom. Email: Christopher.pavitt@nhs.net

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(17):1597-1607. Epub 2010 Sep 22. doi:10.1056/NEJMoa1008232

2. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609-1620. Epub 2016 Apr 2. doi:10.1056/NEJMoa1514616

3. 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(18):1695-1705. Epub 2019 Mar 16. doi:10.1056/NEJMoa1814052

4. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: developed by the task force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2021;60(4):727-800. doi:10.1093/ejcts/ezab389

5. Durko AP, Osnabrugge RL, Van Mieghem NM, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J. 2018;39(28):2635-2642. doi:10.1093/eurheartj/ehy107

6. Siontis GCM, Overtchouk P, Cahill TJ, et al. Transcatheter aortic valve implantation vs surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. Eur Heart J. 2019;40(38):3143-3153. doi:10.1093/eurheartj/ehz275

7. Jilaihawi H, Zhao Z, Du R, et al. Minimizing permanent pacemaker following repositionable self-expanding transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2019;12(18):1796-1807. Epub 2019 Aug 28. doi:10.1016/j.jcin.2019.05.056

8. Lilly SM, Deshmukh AJ, Epstein AE, et al. 2020 ACC Expert consensus decision pathway on management of conduction disturbances in patients undergoing transcatheter aortic valve replacement. J Am Coll Cardiol. 2020;76(20):2391-2411. Epub 2020 Oct 21. doi:10.1016/j.jacc.2020.08.050

9. Huang HD, Mansour M. Pacemaker implantation after transcatheter aortic valve replacement: a necessary evil perhaps but are we making progress? J Am Heart Assoc. 2020;9(9):e016700. Epub 2020 May 2. doi:10.1161/JAHA.120.016700

10. Auffret V, Webb JG, Eltchaninoff H, et al. Clinical impact of baseline right bundle branch block in patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2017;10(15):1564-1574. Epub 2017 Jul 19. doi:10.1016/j.jcin.2017.05.030

11. Maeno Y, Abramowitz Y, Kawamori H, et al. A highly predictive risk model for pacemaker implantation after TAVR. JACC Cardiovasc Imaging. 2017;10(10 Pt A):1139-1147. Epub 2017 Apr 12. doi:10.1016/j.jcmg.2016.11.020

12. Weferling M, Liebetrau C, Renker M, et al. Right bundle branch block is not associated with worse short- and mid-term outcome after transcatheter aortic valve implantation. PLoS One. 2021;16(6):e0253332. eCollection 2021. doi:10.1371/journal.pone.0253332

13. 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(1 Pt A):600-609. doi:10.1016/j.jcin.2014.07.022

14. Khawaja MZ, Rajani R, Cook A, et al. Permanent pacemaker insertion after corevalve transcatheter aortic valve implantation. Circulation. 2011;123(9):951-960. Epub 2011 Feb 21. doi:10.1161/CIRCULATIONAHA.109.927152

15. Rodés-Cabau J, Ellenbogen KA, Krahn AD, et al. Management of conduction disturbances associated with transcatheter aortic valve replacement. J Am Coll Cardiol. 2019;74(8):1086-1106. doi:10.1016/j.jacc.2019.07.014

16. Fukutomi M, Hokken T, Wong I, et al. Prophylactic permanent pacemaker strategy in patients with right bundle branch block undergoing transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2021;98(7):E1017-E1025. Epub 2021 Aug 14. doi:10.1002/ccd.29914

17. Surawicz B, Childers R, Deal BJ, et al. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III: intraventricular conduction disturbances: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009;53(11):976-981. doi:10.1016/j.jacc.2008.12.013

18. NHS England. 2019/20 National Cost Collection Data Publication. Accessed November 22, 2022. https://www.england.nhs.uk/publication/2019-20-national-cost-collection-data-publication/

19. Little M, Gray A, Altman D, et al. Five-year costs from a randomised comparison of bilateral and single internal thoracic artery grafts. Heart. 2019;105(16):1237-1243. Epub 2019 Apr 4. doi:10.1136/heartjnl-2018-313932

20. Watanabe Y, Kozuma K, Hioki H, et al. Pre-existing right bundle branch block increases risk for death after transcatheter aortic valve replacement with a balloon-expandable valve. JACC Cardiovasc Interv. 2016;9(21):2210-2216. doi:10.1016/j.jcin.2016.08.035

21. Zhang ZM, Rautaharju PM, Soliman EZ, et al. Mortality risk associated with bundle branch blocks and related repolarization abnormalities (from the Women’s Health Initiative [WHI]). Am J Cardiol. 2012;110(10):1489-1495. Epub 2012 Aug 2. doi:10.1016/j.amjcard.2012.06.060

22. Bussink BE, Holst AG, Jespersen L, Deckers JW, Jensen GB, Prescott E. Right bundle branch block: prevalence, risk factors, and outcome in the general population: results from the Copenhagen City Heart Study. Eur Heart J. 2013;34(2):138-146. Epub 2012 Sep 4. doi:10.1093/eurheartj/ehs291

23. Myat A, Mouy F, Buckner L, et al. Survival relative to pacemaker status after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2021;98(3):E444-E452. Epub 2021 Jan 27. doi:10.1002/ccd.29498

24. Mangieri A, Montalto C, Pagnesi M, et al. TAVI and post procedural cardiac conduction abnormalities. Front Cardiovasc Med. 2018;5:85. eCollection 2018. doi:10.3389/fcvm.2018.00085

25. Kooistra NHM, van Mourik MS, Rodríguez-Olivares R, et al. Late onset of new conduction disturbances requiring permanent pacemaker implantation following TAVI. Heart Br Card Soc. 2020;106(16):1244-1251. Epub 2020 Jan 31. doi:10.1136/heartjnl-2019-315967

26. Faroux L, Chen S, Muntané-Carol G, et al. Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis. Eur Heart J. 2020;41(29):2771-2781. doi:10.1093/eurheartj/ehz924

27. Mohananey D, Jobanputra Y, Kumar A, et al. Clinical and echocardiographic outcomes following permanent pacemaker implantation after transcatheter aortic valve replacement: meta-analysis and meta-regression. Circ Cardiovasc Interv. 2017;10(11):e005972. doi:10.1161/CIRCINTERVENTIONS.117.005972

28. Krahn AD, Longtin Y, Philippon F, et al. Prevention of arrhythmia device infection trial: the PADIT trial. J Am Coll Cardiol. 2018;72(24):3098-3109. doi:10.1016/j.jacc.2018.09.068

29. Solomonica A, Choudhury T, Bagur R. The mechanically expandable Lotus valve and Lotus Edge transcatheter aortic valve systems. Expert Rev Med Devices. 2018;15(11):763-769. Epub 2018 Oct 22. doi:10.1080/17434440.2018.1536543

30. Alperi A, Rodés-Cabau J, Simonato M, et al. Permanent pacemaker implantation following valve-in-valve transcatheter aortic valve replacement: VIVID registry. J Am Coll Cardiol. 2021;77(18):2263-2273. doi:10.1016/j.jacc.2021.03.228

31. Mazzella AJ, Hendrickson MJ, Arora S, et al. Shifting trends in timing of pacemaker implantation after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2021;14(2):232-234. Epub 2020 Nov 9. doi:10.1016/j.jcin.2020.09.034

32. Kaiser Family Foundation. Hospital Adjusted Expenses per Inpatient Day. 2022.  Accessed November 22, 2022. https://www.kff.org/health-costs/state-indicator/expenses-per-inpatient-day/