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Valvular heart disease
Original research
Recovery rate from conduction disorders in patients with permanent pacemaker implantation after transcatheter aortic valve implantation
  1. Maria Yamamoto1,
  2. Arudo Hiraoka1,
  3. Toshinobu Yoshida2,
  4. Satoru Kishimoto1,
  5. Genta Chikazawa1 and
  6. Hidenori Yoshitaka1
  1. 1Department of Cardiovascular Surgery, The Sakakibara Heart Institute, Okayama, Japan
  2. 2Department of Cardiology, The Sakakibara Heart Institute, Okayama, Japan
  1. Correspondence to Dr Arudo Hiraoka; bassbord1028{at}yahoo.co.jp

Abstract

Backgrounds Permanent pacemaker implantation (PPMI) is one of the greatest disadvantages of transcatheter aortic valve implantation (TAVI). To seek the predictors and clinical impacts of PPMI and investigate the recovery rate from conduction disorders.

Methods We retrospectively analysed data from 745 consecutive patients who underwent TAVI for severe aortic stenosis from November 2013 to July 2022. The ventricular pacing (VP) rate was recorded at 1 and 6 months after PPMI and the recovery from conduction disorders was defined as the VP rate <1%.

Results Postoperative PPMI was performed in 7.1% (53/745) of patients. Balloon predilatation was significantly frequent in the PPMI (−) group (52.8% (28/53) vs 80.6% (558/692); p<0.001) and the oversizing ratio was significantly greater in the PPMI (+) group (11.8%±10.1% vs 9.1%±9.7%; p=0.035). Freedom from rehospitalisation due to heart failure rate was significantly higher in the PPMI (−) group (p=0.032). In patients with postoperative PPMI, recovery from conduction disorders was observed in 17.0% and 27.9% of patients at 1 and 6 months, respectively.

Conclusions Recovery from conduction disorders occurred frequently. Avoidance of oversizing and extension of observation time may reduce the need for PPMI after TAVI.

  • Aortic Valve Stenosis
  • Heart Valve Prosthesis Implantation
  • Pacemaker, Artificial

Data availability statement

Data are available on reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/openhrt-2024-002867

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    WHAT IS ALREADY KNOWN ON THIS TOPIC

    • Conduction disorders are one of the most frequent complications of transcatheter aortic valve implantation (TAVI). The permanent pacemaker implantation (PPMI) rate is higher compared with surgical aortic valve replacement and several predictors have been reported.

    WHAT THIS STUDY ADDS

    • The oversizing ratio was significantly greater in the PPMI (+) group. Freedom from rehospitalisation due to heart failure rate was significantly higher in the PPMI (−) group. However, in patients with PPMI after TAVI, recovery from conduction disorders was observed in 17.0% and 27.9% of patients at 1 and 6 months, respectively.

    HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

    • Recovery from conduction disorders occurred frequently. To reduce unnecessary PPMI after TAVI, observation time should be extended for conduction disorders and oversizing should be avoided.

    Introduction

    Recently, transcatheter aortic valve implantation (TAVI) has been accepted by the broad medical community and has become a less invasive routine procedure with extensive indications. However, despite the development of better devices with major refinements in technology, procedural techniques and biomedical engineering, postprocedural conduction disorders remain frequent and difficult to manage as reported in recent trials. Conduction disorders are one of the most frequent complications of TAVI. Permanent pacemaker implantation (PPMI) is sometimes required in patients with a high-degree atrioventricular block (HAVB) or complete heart block (CHB).1 The incidence rate of PPMI was reported to be 10.8%–17% overall.1–3 The breakdown was 10%–12% in balloon-expandable devices and 15% in self-expandable devices.4–6 Since the PPMI rate is higher compared with surgical aortic valve replacement (AVR) (3.0%–11.8%), this complication is one of the greatest disadvantages of TAVI.7 Though several adverse effects of PPMI are known, the predictors and clinical impacts are still controversial. PPMI is generally considered 1–2 weeks after surgical AVR to exclude unnecessary PPMI. In TAVI cases, hospitalisation stay is short and PPMI tends to be decided at a relatively early phase after surgery. Actually, conduction disorders sometimes recover by temporary pacing after TAVI. Therefore, reported cases with PPMI after TAVI may include patients whose PPMI could have been avoided.

    Based on these backgrounds, the aim of this study is to seek the predictive factors and clinical impacts of PPMI and to investigate the recovery rate from conduction disorders in patients with PPMI after TAVI.

    Patients and methods

    Study population

    We retrospectively analysed data in consecutive patients (n=795) who underwent TAVI for severe aortic stenosis at the Sakakibara Heart Institute of Okayama, Japan, from November 2013 to July 2022. Of them, 50 patients with preoperative PPM were excluded. In the remaining 745 patients, the incidence and risk factors of postoperative PPMI were investigated. Baseline demographics, medical comorbidities, conduction abnormalities, echocardiographic parameters, prosthetic valve type and procedural data were collected via a standardised data extraction sheet.

    Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research.

    Indication of pacemaker implantation and definition of pacemaker utilisation rate

    Generally, TAVI was the first-line choice in aged patients >80 years and TAVI was sometimes selected for high-risk younger patients (<80 years) for surgical AVR. PPMI was planned in patients with lasting HAVB or CHB requiring backup of a transcutaneous pacemaker >48 hours after TAVI. The ventricular pacing (VP) rate was recorded at the 1-month and 6-month postoperative pacemaker follow-up after PPMI. The VP rate <1% was defined as the unused PPM and recovery from conduction disorders.

    Statistical analysis

    Continuous data are presented as mean±SD and were analysed using two-tailed t-tests or compared with a Mann-Whitney test for independent data, as appropriate. Categorical variables are given as a count and percentage of patients and were compared using the χ2 test. When any expected frequency was less than 1, or 20% of expected frequencies were less than or equal to 5, the Fisher’s exact test was used. Freedom from death and rehospitalisation due to heart failure after surgery was compared by the Kaplan-Meier model and the log-rank test. All data were analysed by using the Statistical Analysis Systems software JMP V.12.0 (SAS Institute).

    Results

    Patients’ characteristics and ECG data

    Of the total 745 patients who underwent TAVI in our institute after excluding patients with preoperative PPM, postoperative PPMI was performed in 53 patients (7.1%). There was no significant difference in patients’ age between the groups (86.1±4.8 years vs 85.2±4.9 years; p=0.17). Other data on patients’ characteristics were similar (table 1). Table 2 shows ECG data. The percentage of atrial fibrillation was equivalent (13/53 (27.3%) vs 129/692 (18.6%); p=0.28). There was no significant difference in the percentage of complete right bundle branch block (CRBBB) (4/53 (7.6%) vs 38/692 (5.5%); p=0.53). There were no significant differences in heart rate, R-R, P-R, QRS duration and QT time between the two groups.

    View this table:
    Table 1

    Patient demographics

    View this table:
    Table 2

    ECG data

    Preoperative echocardiographic and cardiac CT data

    In echocardiographic parameters, there were no significant differences in preoperative cardiac function between patients with and without PPMI (left ventricular ejection fraction (LVEF): 60.7%±11.3% vs 60.6%±12.2%; p=0.92, stroke volume index: 49.8±13.7 mL/m2 vs 48.4±13.6 mL/m2; p=0.48). The severity of aortic valve stenosis including pressure gradient, velocity and effective area was equivalent. There were no significant differences in CT data of the aortic annulus size (annulus diameter by area: 22.4±1.8 mm vs 22.6±1.7 mm; p=0.31) (table 3).

    View this table:
    Table 3

    Preoperative echocardiographic and CT data

    Procedural data

    There was no significant difference in the type of prosthetic valve (self-expandable type: 47.2% (25/53) vs 36.9% (225/692); p=0.14). Though the rate of balloon postdilatation was similar (34.0% (18/53) vs 28.9% (200/692); p=0.44), balloon predilatation was significantly frequent in the PPMI (−) group (52.8% (28/53) vs 80.6% (558/692); p<0.001). There was no significant difference in prosthetic valve size, but the oversizing ratio (the prosthesis size to annulus diameter calculated by area) was significantly greater in the PPMI (+) group (11.8%±10.1% vs 9.1%±9.7%; p=0.035) (table 4).

    View this table:
    Table 4

    Procedural data

    VP rate and follow-up data

    Of the 53 patients who underwent PPMI after TAVI, PPM was not used in 17.0% of patients (9 patients with VP rate <1%) at 1 month after TAVI. The number of patients with a VP rate ≥99%, 80%–98%, 10%–79%, 1%–10%, <1% was 31, 7, 5 1 and 9, respectively. The VP rate was followed up at 6 months. PPM was not used (VP rate <1%) in an additional three patients whose VP rate was >90% at 1 month (figure 1). As a result, the rate of recovery from conduction disorders was 5.9% (44/745) and 5.5% (41/745) at 1 and 6 months after TAVI. Risk factors were compared between patients with and without recovery from conduction disorders (n=12 and 41). Though there were no significant differences in CRBBB, type of prosthesis, preballoon aortic valvuloplasty and oversizing ratio, there was no patient with CRBBB (0% (0/12) vs 9.8% (4/41); p=0.56), and the oversizing ratio was insignificantly lower (9.9%±8.1% vs 13.3%±8.9%; p=0.25) in the VP <1% group (table 5).

    Figure 1
    Figure 1

    Change of ventricular pacing (VP) rate from 1 to 6 months after transcatheter aortic valve implantation.

    View this table:
    Table 5

    Comparison of risk factors between patients with and without VP <1%

    The overall 5-year survival and freedom from rehospitalisation due to heart failure rates were 58.1% and 73.7%, respectively (figure 2A,B). Though there was no significant difference in follow-up survival (p=0.39), freedom from rehospitalisation due to heart failure rate was significantly higher in the PPMI (−) group (p=0.032) (figure 2C,D). There was no significant difference in the rates of freedom from rehospitalisation between patients with and without recovery from conduction disorders (p=0.65) (figure 3).

    Figure 2
    Figure 2

    The Kaplan-Meier curve of overall 5-year survival (A) and freedom from rehospitalisation due to heart failure (B). Comparison of follow-up survival (C) and freedom from rehospitalisation due to heart failure (D) between patients the PPMI (−) (red line) and PPMI (+) (blue line) groups. PPMI, permanent pacemaker implantation.

    Figure 3
    Figure 3

    The Kaplan-Meier curve of freedom from rehospitalisation due to heart failure between patients with (red line) and without (blue line) recovery from conduction disorders.

    Discussion

    The major findings of this study are as follows: (1) postoperative PPMI was performed in 7.1% of patients, (2) preoperative echocardiographic and ECG data including CRBBB were not associated with PPMI, (3) the rates of unused balloon predilatation and oversizing ratio were significantly greater in patients with PPMI, (4) the rate of rehospitalisation due to heart failure was significantly higher in the PPMI (+) group and (5) in patients with postoperative PPMI, recovery from conduction disorders was observed in 17.0% and 27.9% of patients at 1 and 6 months, respectively. Significant predictors of recovery from conduction disorders were not detected and the rate of rehospitalisation due to heart failure was similar between patients with and without recovery from conduction disorders.

    The specific complications of PPMI including pacemaker pocket haematomas and infections are known and the incidence is as high as 12%.8 Additionally, increased mortality and greater heart failure hospitalisation rates have been reported in patients with new PPM implantation after TAVI.9–12 PPMI after TAVI was associated with reduced LVEF and impaired LV unloading. The negative effect on LVEF recovery driven by TAVI draws many concerns about long-term impact of pacing in TAVI patients.12–15 The postulated mechanism of pacemaker-induced cardiomyopathy is the electrical and mechanical dyssynchrony from right ventricular apical pacing resulting in less effective ventricular contractions and changes in coronary blood flow. Therefore, a preventive method of PPMI should be emphasised to improve long-term outcomes of TAVI. Several risk factors of PPMI have been reported. In a recent systematic review, Ullah et al reported that male patients and those with baseline conduction abnormalities (Mobitz type 1 block, bifascicular block, left anterior hemiblock and right bundle branch block), and those receiving mechanical or self-expanding larger-sized prostheses were at an increased risk of PPMI.16–18 In the present study, only procedural factors (non-use of balloon predilatation and oversizing of prosthesis) were detected as related factors of PPMI. Balloon predilatation may result in a more accurate positioning of the prosthetic valve. Nevertheless, the selection of an oversized prosthesis should be avoided to prevent PPMI. On the other hand, electrophysiological testing is recommended in the latest European Society of Cardiology guidelines to identify left bundle branch block patients after TAVI. While infrahisian conduction delay is generally defined by a His-ventricular (HV) interval of >55 ms, a cut-off of ≥70 ms to trigger PPMI has been proposed. However, the optimal cut-off value of HV interval is still undetermined and further studies will be required.19 Since several risk factors have been reported in previous papers, different strategy is selected for high-risk patients in our institute. For example, balloon expanding valve, higher level implantation and underfilling tend to be selected for high-risk patients to avoid PPMI. The different strategy of procedure may reduce the risk of PPMI in high-risk patients.

    On the other hand, the present study suggests a new aspect of PPMI after TAVI from different points of view. To the best of our knowledge, our study is the first to investigate the VP ratio after PPMI following TAVI. In this cohort, new PPMI was performed in 7.1% of patients for conduction disorders after TAVI. The majority of our patients were considered to be at intermediate surgical risk by the Society of Thoracic Surgeons model.20 However, PPM was actually used in 5.9% and 5.5% of patients at 1 month and 6 months after TAVI. PPMI was planned within 48 hours after TAVI with an intended short hospital stay. These results show the possibility of reducing the PPMI rate after TAVI. Considering there was no significant difference in the rates of freedom from rehospitalisation between patients with and without recovery from conduction disorders, reduction of PPMI can lead to better long-term outcomes. Though significant predictors of recovery from conduction disorders were not detected, there was no patient with CRBBB and the oversizing ratio was insignificantly lower in the conduction disorders recovery group. To reduce unnecessary PPMI after TAVI, observation time should be extended for conduction disorders in patients without CRBBB prosthesis and oversizing should be avoided. However, a temporary modality of pacing may increase the risk of infection. Therefore, further study is needed to seek more accurate indicators of required PPMI to prevent unnecessary PPMI after TAVI.

    Study limitations

    This study had several limitations. First, the study was a retrospective analysis. Therefore, it is difficult to standardise the indication of PPMI. Second, it is unknown whether it is appropriate to define recovery from conduction disorders as the VP rate <1% at 6 months. Additionally, VP less than 1% may also not be benign. However, we cannot get accurate data for VP less than 1%, therefore, VP <1% was used as an endpoint. Finally, the sample size was relatively small to detect the risk of PPMI after TAVI and identify predictors of recovery from conduction disorders. Additionally, several factors (LVOT calcium/short membranous septum) were not assessed in this study.

    Conclusions

    Postoperative PPMI was performed in 7.1% of patients and the rate of rehospitalisation due to heart failure was significantly higher in the PPMI (+) group. However, recovery from conduction disorders was frequently observed at 1 and 6 months. Avoidance of oversizing and extension of observation time for conduction disorders may reduce unnecessary PPMI after TAVI.

    Data availability statement

    Data are available on reasonable request.

    Ethics statements

    Patient consent for publication

    Ethics approval

    This study involves human participants and was approved by the ethics committee of the Sakakibara Heart Institute of Okayama (Approval No: R202208-04, Date: 25 August 2022). Participants gave informed consent to participate in the study before taking part.

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    Footnotes

    • Contributors Conception and design: AH and MY. Analysis and interpretation: MY and AH. Data collection: MY, TY and SK. Writing the article: MY and AH. Critical revision: GC and HY. Statistical analysis: MY and AH. Final approval: AH.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.