Frequency of Conduction Disturbances After Edwards SAPIEN Percutaneous Valve Implantation

doi:10.1016/j.amjcard.2012.05.057

The American Journal of Cardiology

Volume 110, Issue 8, 15 October 2012, Pages 1164-1168

https://doi.org/10.1016/j.amjcard.2012.05.057 Get rights and content

Disturbances in atrioventricular conduction and the additional need for a permanent pacemaker are recognized complications after transcatheter aortic valve replacement (TAVR). We analyzed the incidence of postprocedural conduction disorders and the need for permanent pacemaker implantation in patients undergoing TAVR with the Edwards SAPIEN valve. In 125 consecutive patients with symptomatic, severe aortic stenosis undergoing TAVR, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. The cohort was divided into 2 groups with regard to the post-TAVR appearance of conduction disturbances, defined as left bundle branch block, right bundle branch block, fascicular hemiblock, atrioventricular block, and the need for a permanent pacemaker. The patients with and without conduction disturbances were compared. After TAVR, 19 patients (15.2%) met the study definition of a “new conduction defect” and 5 patients (4%) required a permanent pacemaker because of an advanced atrioventricular block. New left bundle branch block appeared in 5 patients (4%) and left anterior hemiblock in 9 (7.2%). No new right bundle branch block or left posterior hemiblock was observed. Although most baseline, echocardiographic, and procedural characteristics were equally distributed, the patients with new conduction disturbances more often had diabetes mellitus and peripheral vascular disease. Also, they more often were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and the procedure was performed more often with apical access (12 [63.2%] vs 7 with femoral access [36.8%], p = 0.002). In conclusion, although the incidence of conduction disturbances was high after TAVR using the Edwards SAPIEN valve, with a significant increase in the rate of left bundle branch block and left anterior hemiblock, the need for permanent pacemaker implantation after TAVR with this valve remained low.

Section snippets

Methods

The study population consisted of 159 consecutive patients with severe symptomatic aortic stenosis who underwent percutaneous implantation of an Edwards SAPIEN aortic valve. All were participants in the PARTNER trial. Of those, 34 were excluded from the present analysis, because a permanent pacemaker was in place before TAVR in 31 and 3 died during the procedure. The remaining 125 patients formed the population for the present analysis (91 [72.8%] in cohort A and 34 [27.2%] in cohort B).

The

Results

The baseline clinical characteristics are summarized in Table 1. The advanced age (mean 84.2 years) of all 125 patients was noteworthy. Of those 125 patients, 19 (15.4%) developed conduction disturbances and 106 (84.6%) did not. The clinical characteristics were similar in both groups, except for greater rates of diabetes mellitus (p = 0.05) and peripheral vascular disease (p = 0.03) and a greater frequency of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker use (p =

Discussion

Our data have indicated that the rate of identifiable damage to the left ventricle conduction system follows TAVR in 15% of patients and that damage severe enough to necessitate placement of a permanent pacemaker occurs in 4%. Penetration by valvular calcification has been presumed to account for the bundle branch block and atrioventricular block encountered in the natural history of calcific aortic stenosis.⁴

The size of the predilation balloon or the implanted prosthesis could be important in

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Cited by (41)

Predicting permanent pacemaker implantation following transcatheter aortic valve replacement: A contemporary meta-analysis of 981,168 patients
2022, Heart Rhythm O2
Citation Excerpt :
Despite the continuous improvement in TAVR technology and procedural techniques, postprocedural conduction disturbances remain frequent. The reported rate of conduction disturbances requiring permanent pacemaker (PPM) varies widely between 5% and 33%.3–8 Because of the financial and clinical implications of a PPM, numerous studies have attempted to discern modifiable predictors of PPM after TAVR.
Heart block requiring permanent pacemaker (PPM) implantation is a relatively frequent complication of transcatheter aortic valve replacement (TAVR).
The purpose of this study was to perform a contemporary meta-analysis to provide an updated assessment of clinically useful predictors of PPM implantation post-TAVR.
Medline and EMBASE searches were performed to include all studies reporting PPM post-TAVR between 2015 and 2020. Pertinent data were extracted from the studies for further analysis. RevMan was used to create forest plots and calculate risk ratios (RRs).
We evaluated 41 variables from 239 studies with a total of 981,168 patients. From this cohort, 17.4% received a PPM following TAVR. Strong predictors for PPM implant were right bundle branch block (RBBB) (RR 3.12; P <.001) and bifascicular block (RR 2.40; P = .002). Intermediate factors were chronic kidney disease (CKD) (RR 1.53; P <.0001) and first-degree atrioventricular block (FDAVB) (RR 1.44; P <.001). Weak factors (RR 1–1.50; P <.05) were male gender, age ≥80 years, body mass index ≥25, diabetes mellitus (DM), atrial fibrillation (AF), and left anterior fascicular block (LAFB). These factors along with increased left ventricular outflow tract (LVOT) area (>435 mm²) and/or aortic annulus diameter (>24.4 mm) were incorporated to propose a new scoring system to stratify patients into high- and low-risk groups.
Male gender, age ≥80 years, FDAVB, RBBB, AF, DM, CKD, Medtronic CoreValve, transfemoral TAVR, increased LVOT, and aortic annulus diameter were significant predictors of post-TAVR PPM implantation. Preprocedural assessment should consider these factors to guide clinical decision-making before TAVR. Validation of our scoring system is warranted.
2020 ACC Expert Consensus Decision Pathway on Management of Conduction Disturbances in Patients Undergoing Transcatheter Aortic Valve Replacement: A Report of the American College of Cardiology Solution Set Oversight Committee
2020, Journal of the American College of Cardiology
Consensus regarding a reasonable strategy to manage cardiac conduction disturbances after transcatheter aortic valve replacement (TAVR) has been elusive. This is due to the absence of adequately powered, randomized controlled trials; the often transient nature of the conduction disturbances; evolving technologies; and the interplay of cardiology subspecialties involved. In the absence of high-quality trials, numerous practice styles have been developed, and prolonged observation, electrophysiological testing, and pre-emptive pacemaker implantation have been described. Although the 2013 European Society of Cardiology guidelines address pacing post-TAVR, they do not provide in-depth discussion of this topic. Furthermore, a summary and proposed strategy for this problem have not been published by cardiovascular societies in the United States, despite an interest in establishing best practices in TAVR, valvular heart disease, and cardiovascular implantable electrical devices.
This document reviews existing data and experience regarding the management of conduction disturbances after TAVR and proposes an evidence-based expert consensus decision pathway for their management. Where evidence is lacking or insufficient, the recommendations herein are based on expert opinion.
Outcomes of Acute Conduction Abnormalities Following Transcatheter Aortic Valve Implantation With a Balloon Expandable Valve and Predictors of Delayed Conduction System Abnormalities in Follow-up
2019, American Journal of Cardiology
Citation Excerpt :
Based on our single-center retrospective study, the development of new conduction abnormalities following TAVI remains a common occurrence. Overall, the rates of PPI and new LBBB at 30-day follow-up in our study were similar to previous investigations.3-10 The majority of new conduction abnormalities occurred in the perioperative period which is similar to what has been previously demonstrated.17
Transcatheter aortic valve implantation (TAVI) is an acceptable treatment for severe aortic stenosis in high or intermediate risk patients. Conduction abnormalities are a known complication of TAVI. Most abnormalities occur perioperatively but can develop later. The predictors of delayed conduction abnormalities are unknown. Patients who underwent TAVI at our institution were reviewed. Patients with a pre-existing pacemaker were excluded. Baseline, in-hospital, and 30-day follow-up ECGs were reviewed. Patient and procedural characteristics were analyzed to look for predictors of acute and delayed abnormalities. Ninety-eight patients were included. All valves implanted were balloon expandable, most commonly SAPIEN S3 (78%). Thirty-seven (37.7%) patients developed abnormalities before discharge. Of these patients, 20 (57.1%) had complete resolution at 30-day follow-up. No patients with new conduction abnormalities during hospitalization had additional abnormalities at 30-day follow-up. Five (5.1%) patients developed new conduction abnormalities following discharge. Overall, 22 (22.4%) patients had conduction abnormalities at 30-day follow-up which were not present at baseline. Predilatation (p = 0.003), higher ratios of balloon (p = 0.03) or valve (p = 0.05) size to left ventricular outflow tract, and previous myocardial infarction (p = 0.034) were predictive of acute conduction abnormalities. Baseline right bundle branch block (p = 0.002), longer baseline (p <0.001) and discharge (p = 0.004) QRS duration, moderate, or severe aortic insufficiency (p = 0.002) and atrial fibrillation (p = 0.031) were predictors of new conduction abnormalities after discharge. In conclusion, most new in-hospital conduction abnormalities resolve by 30-day follow-up. In-hospital conduction abnormalities are related to technical aspects of TAVI while delayed conduction abnormalities are related to baseline conduction system disease.
Delayed pacemaker requirement after transcatheter aortic valve implantation with a new-generation balloon expandable valve: Should we monitor longer?
2018, International Journal of Cardiology
Citation Excerpt :
Transcatheter aortic valve implantation (TAVI) has become an accepted treatment alternative for severe aortic stenosis in elderly patients with increased surgical risk [1,2] Development of conduction abnormalities (CAs) remains one of the most frequent complications after TAVI [3–5], and is associated with a significant rate of permanent pacemaker (PM) implantations [6,7].
To analyze the timing of appearance of conduction abnormalities (CAs) after transcatheter aortic valve implantation (TAVI), to identify predictors of delayed CAs requiring pacemaker (PM) implantation and to provide guidance regarding the duration of telemetry monitoring.
How long patients remain at risk of development of CAs requiring PM implantation after TAVI and for how long they should be monitored remains unclear but is crucial when considering early discharge.
Development of CAs was studied in 701 consecutive patients treated with Edwards Sapien 3 valves and monitored with telemetry for 7 days in a single center. After excluding valve-in-valve procedures and patients with previous PM, 606 patients remained for analysis. Predictors of CAs requiring PM and the time of onset of CAs were analyzed.
Of 606 patients 76 (12.5%) required a PM after TAVI. CAs requiring PM implantation occurred after 48 h in 22.4% (17 patients) and in 10.5% (8 patients) even after 5 days. Of the patients who developed high grade CAs requiring PM after 48 h, 47.1% had no CAs prior to TAVI, and 23.5% had neither pre-existing CAs nor new-developed CAs within the first 48 h after TAVI.
After TAVI using a new-generation balloon-expandable valve, delayed development of CAs requiring PM implantation is not uncommon, even after 5 days. More importantly, 23.5% of patients eventually requiring a delayed PM implantation had still no CAs at 48 h after TAVI in this study. These results question the safety of early discharge and support ECG monitoring for a longer time period. The most optimal way to monitor these patients is yet to be determined.
Predictors of permanent pacemaker implantation after transfemoral aortic valve implantation with the Lotus valve
2017, American Heart Journal
Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation is of high clinical relevance, but PPMI rates differ widely between valve types. Although the Lotus valve can be repositioned, reported rates for PPMI are high. The predictors of PPMI after Lotus valve implantation have not been defined yet.
We analyzed the impact of preexisting conduction disturbances, depth of implantation, oversizing, and amount of calcification on PPMI in 216 patients with severe symptomatic aortic stenosis underdoing Lotus valve implantation.
PPMI was required in 39.8% of patients. Patients with need for PPMI compared with patients without need for PPMI had more often the following criteria: male gender (P = .035); preprocedural right bundle-branch block (RBBB) (16.3% vs 0, P < .001); atrioventricular (AV) block first degree (26.7% vs 10.1%, P = .004); higher calcium volume of the left coronary cusp (63.1 ± 87.5 mm³ vs 42.8 ± 49.3 mm³, P = .05); and deeper valve implantation at right coronary (P = .011), noncoronary (P = .026), and left coronary (P = .012) position. Oversizing in relation to annulus and left ventricular outflow tract did not have an impact on need for PPMI. By multiple regression analysis, preprocedural AV block first degree (P = .005), RBBB (P < .001), and depth of implantation (P = .006) were independent risk factors for need of PPMI.
In patients with severe aortic stenosis receiving transfemoral Lotus valve, preexisting AV block first degree, RBBB, and implantation depth are independent predictors of PPMI, highlighting the importance of careful valve positioning.
A Prospective Analysis of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation
2016, American Journal of Cardiology
Citation Excerpt :
Of 153 transfemoral TAVIs performed during the study period, 23 patients were excluded from analysis; this is thus a selected and relatively “uncomplicated” study population. It involves balloon-expandable valves, and we cannot extend our findings to self-expanding valves such as CoreValve, which may require longer surveillance due to increased risk of delayed conduction disturbance.16–18 Our data include Edwards SAPIEN-XT and SAPIEN-3 valves but are underpowered to detect differences in outcomes relative to the specific valve model.
As transcatheter aortic valve implantation (TAVI) becomes more routinely used, the recommended duration of monitoring after uncomplicated TAVI remains indeterminate. Retrospective analysis suggests that discharge within 72 hours is safe, but prospective data are largely lacking. We therefore prospectively assess the feasibility and safety of early discharge (within 72 hours) after transfemoral TAVI using Edwards SAPIEN-XT and SAPIEN-3 prostheses. Patients undergoing elective transfemoral TAVI were assessed prospectively for early discharge home. Feasibility and safety (death or repeat hospitalization within 30 days of discharge) of early discharge were assessed. Causes for failure of early discharge were assessed by prospective data collection and multivariate analysis. Of 130 patients, 76 (59%) were discharged early. Death or repeat hospitalization within 30 days occurred only in 4 cases (5%) among patients who discharged early: repeat hospitalization within 30 days was required in 3 early-discharge patients (4%), and there was a single death at 30 days. By multivariate analysis, factors associated with delayed discharge were blood transfusion (hazard ratio 13.85, 95% CI 1.61 to 119.40, p = 0.017) and pacemaker implantation (hazard ratio 4.47, 95% CI 1.34 to 14.26, p = 0.012). In conclusion, early discharge after elective transfemoral TAVI with SAPIEN-XT/SAPIEN-3 prostheses is safe and attainable in a large proportion of patients, with no evident compromise in safety. Factors associated with failure of early discharge are postprocedural blood transfusion and permanent pacemaker implantation.

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Valvular heart diseaseFrequency of Conduction Disturbances After Edwards SAPIEN Percutaneous Valve Implantation

Section snippets

Methods

Results

Discussion

Am Heart J

Am J Cardiol

JACC Cardiovasc Interv

Am Heart J

JACC Cardiovasc Interv

JACC Cardiovasc Intv

Rev Esp Cardiol

Valvular heart disease
Frequency of Conduction Disturbances After Edwards SAPIEN Percutaneous Valve Implantation