Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design.

Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients.

Tricuspid valve regurgitation following temporary or permanent endocardial lead insertion, and the impact of cardiac resynchronization therapy.

BACKGROUND: While some studies indicate that permanent pacemaker implantation is associated with development of tricuspid regurgitation (TR), other studies indicate no association.Little is known about the impact of temporary lead insertion during ablation procedures, or whether therapy (CRT) prevents TR post-device implantation. HYPOTHESIS: We hypothesized that permanent, but nottemporary endocardial leads, are associated with development of TR, and that CRT would prevent (physiologic) TR. METHODS: We performed a retrospective study of consecutive patients who underwent first device or radiofrequency catheter ablation over a 12-month period at a single, tertiary academic center who underwent pre- and post-procedure echocardiography. RESULTS: In the 89 patients in the device group, the degree of TR significantly increased ≥ 1 grade post-permanent lead implantation: 9 had less TR, 46 were unchanged, and 34 had more TR(p=0.005). TR increased in the 62 patients who underwent device implantation without CRT (p=0.005), but did not increase in the 27 patients with CRT (p=0.47). In the 66 patients in the ablation group, there was no significant change in TR post-ablation: 8 had less TR, 48 were unchanged, and 10 had more TR (p=0.31). CONCLUSION: Permanent endocardial lead implantation was associated with an increase in TR; however, patients who underwent device implantation with CRT did not have an increase in TR.Temporary lead insertion during ablation was not associated with changes in the degree of TR. A large, prospective study is needed to accurately define the incidence and exact mechanisms of permanent endocardial lead-related TR.