https://doi.org/10.1007/s00392-024-02526-y
1Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; 2Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland
Background:
Cardiac implantable electronic devices (CIEDs) present challenges in managing lead-associated tricuspid regurgitation (LTR). Transcatheter tricuspid valve annuloplasty (TTVA) with Cardioband (Edwards Lifesciensce) offers a promising therapeutic approach to address TR also in this specific patient population, yet real-world evidence on TTVA in CIED patients is limited.
Objectives:
This study aims to assess the safety and efficacy of TTVA in CIED patients with symptomatic TR and examine postinterventional integrity and functionality of CIEDs.
Methods:
A multi-center retrospective, real-world analysis compared 41 CIED patients to 163 non-CIED candidates undergoing TTVA for TR with Cardioband between October 2018 and September 2023.
Results:
Among 204 TR patients undergoing TTVA, 41 (20.1%) were CIED carriers of whom 10 (24.4%) showed RV-lead impingement contributing to TR (LTR-A), while the other 75.6 % had mainly functional TR etiology (LTR-B). Pacemaker patients had a higher EuroSCORE II due to renal impairment. Despite greater NYHA-symptomatology in CIED patients (p=0.026), baseline TR severity was comparable. Both groups showed significant TR reduction post-TTVA, with similar efficacy and safety after comparable procedure duration and radiation dose. However, LTR-A patients showed significantly less TR reduction immediately after TTVA (p=0.022) (Table 1). In this small subgroup of patients (n=10), TTVA appeared less effective, with patients receiving higher diuretic doses and being more likely to be hospitalized for recurrent heart failure at follow up. CIED integrity and functionality remained unaffected, as confirmed by pre- and postprocedural interrogation (n=24).
Conclusions:
In this real-world study, TTVA was overall equally successful in patients with CIED compared to patients without CIED. In the small subgroup of patients with LTR-A, procedural and clinical success were limited. Post-interventional CIED interrogations showed no critical technical issues. These findings support the safety and efficacy of TTVA in patients with CIED, though with the increasing availability of interventional TR valve replacement, patients with strictly lead-related TR should be screened rigorously for replacement rather than repair.
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Table 1: CIED-related subgroup analysis | |||
|
|
LTR-A (n=10) |
LTR-B (n=31) |
|
|
TR severity at BL |
|
|
0.472 |
|
Severe |
40 % (4/10) |
22.58 % (7/31) |
|
|
Massive |
30 % (3/10) |
29.03 % (9/31) |
|
|
Torrential |
30 % (3/10) |
48.38 % (15/31) |
|
|
D TR severity discharge vs. BL (TTE) |
- 1.4 ± 0.7 |
- 2.03 ± 0.85 |
0.022* |
|
TR severity FU |
|
|
0.175 |
|
No/mild |
14.29 % (1/7) |
24 % (6/25) |
|
|
Moderate |
28.57 % (2/7) |
36 % (9/25) |
|
|
Severe |
28. 57 % (2/7) |
36 % (9/25) |
|
|
Massive |
0 % (0/7) |
4 % (1/25) |
|
|
Torrential |
28.57 % (2/7) |
0 % (0/25) |
|
|
D TR severity FU vs. discharge (TTE) |
0.57 ± 0.98 |
- 0.15 ± 0.83 |
0.075 |
|
NYHA functional class at FU |
|
|
0.058 |
|
I |
25 % (2/8) |
4.17 % (1/24( |
|
|
II |
25 % (2/8) |
62.5 % (15/24) |
|
|
III |
37.5 % (3/8) |
33.33 % (8/24( |
|
|
IV |
12.5 % (1/8) |
0 % (0/24) |
|
|
Need for heart failure hospitalization (n=35) |
33.33 % (3/9) |
3.85 % (1/26) |
0.044* |
|
Loop diuretics at FU (mg) |
98.75 ± 94.18 |
35.91 ± 31.42 |
0.047* |
|
eGFR (FAS) at FU ml/min |
36.13 ± 5.36 |
44.71 ± 17.4 |
0.186 |
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Values are presented in % or as mean/median* ± SD. Standard deviation; BL. Baseline. FU. Follow-up (mean 73 +/- 41 days); D. Delta (difference between two time points) | |||