Echocardiography-guided CIED implantation to reduce tricuspid regurgitation – preliminary data of a prospective RCT

Background: Endocardial leads of CIEDs across the tricuspid valve (TV) can lead to tricuspid regurgitation (TR) or can worsen existing TR with subsequent severe morbidity and mortality. Suggested mechanisms are mechanical and functional. 3D transthoracic echocardiography (3DTTE) had shown association between lead position and TR, however, the role of intraprocedural 2DTTE was not evaluated. We aimed to evaluate prospectively the efficacy of intraprocedural 2DTTE in reducing/preventing lead-associated TR.

Methods: A randomized controlled study comparing echocardiographic results in patients undergoing device implantation with intraprocedural echo-guided RV lead placement (group 1) versus non-echo guided implantation (group 2). Lead position with least grade of TR was chosen as final in group 1. All cohort patients underwent 2DTTE at baseline, 3 and 6 months after implantation. Excluded were patients with baseline TR > moderate; CRT patients; baseline moderate/severe RV dysfunction; a non-de-novo implantation; and patients with inadequate baseline image quality.

Results: 85 patients were enrolled (75±11y, 56% male,16% ICD, 42% active leads, 3.5% SR devices, 33% advanced AV block, 85% normal EF, 13% > mild TR). 51 and 34 patients had 3- and 6-months echo, respectively. Among the 46 patients in group 1, two patients (4%) needed intraprocedural RV electrode repositioning due to lead-associated worsening TR and none had worsening TR during follow-up. Among the 39 patients in group 2, one patient (sick sinus syndrome, DR-pacemaker, passive lead, moderate AR) had worsening TR from mild to severe within 3 months, with significant morbidity and a need for TV surgery. Among the 34 patients with 6 months follow-up, 5 patients (one from group 1 without changing RV lead position and 4 from group 2) had worsening EF due to CAVB and pacing, with no change in TR.

Conclusions: The rate of mechanically induced lead-associated TR is low, however, intra-procedural 2DTTE probably has significant role in reducing/preventing it.