Efficacy and Safety of Direct Annuloplasty in CIED Patients with Tricuspid Regurgitation: real-world insights

J. Wrobel (Köln)¹, T. Gietzen (Köln)¹, J. L. Althoff (Köln)², C. Hasse (Köln)¹, J. von Stein (Köln)³, P. von Stein (Köln)¹, C. Iliadis (Köln)¹, S. Baldus (Köln)³, R. Pfister (Köln)¹, M. I. Körber (Köln)^1
1Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ²Universitätsklinikum Köln Klinik III für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; ³Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland

Background: Cardiac implantable electronic devices (CIEDs) present a challenge in managing patients with tricuspid regurgitation (TR). Direct transcatheter tricuspid valve annuloplasty (TTVA) with the Cardioband® has emerged as a promising therapeutic approach to address TR in this specific patient population, yet evidence on the efficacy and safety of TTVA in CIED patients is lacking.
Objectives: This study aimed to evaluate the safety and efficacy of TTVA in CIED patients with secondary TR in terms of reducing TR severity, improving functional status and to investigate the impact of TTVA on the integrity and functionality of CIEDs.
Methods: A retrospective, single-center analysis was conducted to compare patients with CIEDs to non-CIED patients who underwent TTVA using the Edwards Cardioband®. Data were collected from the electronic health records of the University Hospital Cologne from October 2018 to September 2023.
Results: Out of a total of 104 TR patients treated with TTVA, 29 (27,9%) were identified as CIED carriers. There were no significant intergroup differences in baseline (BL) patient characteristics, TR severity and New York Heart Association functional (NYHA) class. Both cohorts exhibited considerable TR reduction, with comparable procedural success, minimal device-related and periprocedural complications. NTproBNP levels were higher at baseline and follow-up in the CIED cohort. The integrity and functionality of CIEDs remained unaffected, considering pre- and postprocedural CIED interrogation (n=18). Echocardiographic follow-up at 30 days (d) yielded similar TR reduction in CIED and non-CIED patients, translating into comparable symptomatic improvements according to the NYHA class and NTproBNP reduction in both groups. One-year survival was nonsignificantly different between cohorts. (Table 1)
Conclusions: TTVA using the Edwards Cardioband® proved equally effective and safe in CIED patients and holds promise as a viable strategy for managing TR in this high-risk group, without impairing post-interventional CIED performance.

Table 1:
Efficacy and Safety	TTVA + CIED (n = 29)	TTVA only (n = 75)	p-value
TR severity (BL)	4,13 (±0,86)	4(±0,88)	0,512
-EROA cm2	0,81(±0,41)	0,81(±0,78)	0,542
-TR VC mm	14,74(±5,05)	13,33(±4,28)	0,156
TR severity (discharge)	2,62(±0,94)	2,28(±1,01)	0,091
TR severity (30 d)	2,54(±1,1)	2,34(±1,0)	0,441
-EROA cm2	0,36(±0,24)	0,36(±0,49)	0,26
-TR VC mm	7,48(±3,96)	7,12(±4,04)	0,425
NYHA class (BL)	3,07(±0,45)	2,95(±0,49)	0,228
NYHA class (30 d)	2,33(±0,76)	2,15(±0,62)	0,229
NYHA class (BL vs. 30 d)	-1(±1,09)	-1,2(±1,09)	0,357
NTproBNP (BL) (pg/ml)	5082(±5033)	2384(±1994)	< 0,0001
NTproBNP (30 days) (pg/ml)	3371(±2345)	1806(±1166)	0,001
NTproBNP (BL vs. 30 d) (pg/ml)	-63,35(±1653)	-77,81(±1231)	0,981
1-year survival (%)	78,23	85,28	0,3269
RCA perforation/penetration	8/28	9/75	0,07
RCA Stent implantation	0/29	4/75	0,574
Emergency cardiac surgery	0/29	1/75	>0,999
New arrhythmias	4/29	5/75	0,261
Device detachment	1/29	2/75	>0,999
Femoral bleeding	8/29	13/75	0,28
Stroke	1/29	1/75	0,482
CIED Interrogation	Pre TTVA (n = 18)	Post TTVA (n = 18)	p-value
Battery life (months)	67,29(±45,07)	58,09(±38,14)	0,199
RA and RV sensing (%)	11,05(±9,71)	10,51(±9,4)	0,534
RV capture threshold (V)	0,92(±0,2)	0,91(±0,25)	0,696
RV impedance (Ohm)	477,4(±124,5)	495,8(±129,6)	0,371
RV output (V)	1,97(±0,36)	1,97(±0,49)	0,758
RA impedance (Ohm)	480,2(±128,8)	406(±90,2)	0,048
RV stimulation (%)	76,06(±35,52)	74,84(±39,18)	0,695