Objectives: The aim of this study was to investigate the effectiveness and safety of transseptal endocardial left ventricular lead implantation (TELVLI) in heart failure patients, and evaluate the long-term follow-ups of the patients.
Methods: TELVLI was performed in 53 patients (44 men, 69±7 years, NYHA III-IV stage) between 2007 and 2018. Intracardiac ultrasound was used to guide the transseptal puncture (TP) in 27 pts. In 35 cases, the TP was performed via the femoral vein, and in the other 18 cases, the TP and also the LV lead placement were both performed via the subclavian vein. The site of the puncture was dilated with a 6mm (the first 3 pts), later with an 8 mm balloon (50 pts). After the puncture of the left subclavian vein, an electrophysiological (EP) deflectable CS catheter or ablation catheter was introduced into the CS sheath. The CS catheter was used to reach the left atrium and after it the left ventricle through the dilated TP hole. The site of the latest activation was mapped with the deflectable EP catheter. At the latest LV activation site 65 cm active fixation bipolar lead was screwed into the LV wall, at the site of the latest activation.
Results: The lead was fixed in the left ventricle in all cases with good pacing threshold (0,82±0,5 V;0,4 ms). Puncture complication, pericardial effusion was not observed. Because of intraoperatively started anticoagulation, pocket hematoma was observed in three (5%) and needed evacuation in one case (2%). Follow-up (FU) was longer than one month in 53 patients [median 29 (IQR 9-40) months]. Significant improvement of NYHA was observed in all but one case (98%), the 6-month control LV EF was 30% (IQR 27-33%) vs. 36% (IQR 32-41 %). Early lead dislocation was noticed in three cases (5%), reposition was performed using the original puncture site in all cases. Explantation of the system was necessary because of pocket infection in four cases (8%), in three of these cases, TELVLI was carried out successfully 3 months later, in one patient 22 months later. All patients were maintained on anticoagulation therapy with INR between 2.5-3. Three thromboembolic complications (2 non-disabling stroke – 4%, 1 TIA – 2%) were noticed during the FU. 28 patients died during the FU in average 15 months after the implantation. Conclusion: TELVLI approach seems to be a very promising alternative technique when transvenous implantation could not be applied. Long-term follow-ups proved a long-term positive effect on LV EF. The stroke rate is similar to the CHF patient’s historical data (3,5-5% during 5 years), however further investigations could clarify the potential role of NOAC treatment in the life-long anticoagulation therapy of these patients.