Multicentre registry on robotically assisted percutaneous coronary interventions ? TESLA registry
Published in Congress: EUROPCR 2024

Dr. Ahmet Anıl Başkurt

Introduction
Robotic-assisted percutaneous coronary interventions (R-PCI) are an improving technology in the treatment of coronary artery disease. TESLA study was performed to evaluate the safety and efficacy of these interventions using Corindus CorPath GRX system (Siemens Healthineers).

Objective:
The aim of the study was to evaluate the safety and efficacy of R-PCI. In this context, clinical success rates and complications of R-PCI procedures performed using the Corindus CorPath GRX system were analysed.

Method:
The study was a retrospective, multi-centre and multi-operator registry study. A total of 534 patients from Spain, Poland, Germany, Belgium, Belgium and Japan were included in the study. The primary endpoints were clinical success, angiographic success (less than 30% residual stenosis and TIMI 3 flow after stenting) and the absence of major adverse cardiovascular events (MACE) in hospital, while the secondary endpoints were ischaemia-induced target lesion revascularisation (TLR), target lesion failure (TLF), target vessel failure (TVF), procedure time, contrast volume and patient radiation exposure.

Results:
The mean age was 69 ± 11 years and mean body mass index was 27.1 ± 4.7. Hypertension was seen in 74%, dyslipidaemia in 74% and diabetes in 37%. While 80% of the patients had chronic coronary syndrome, 20% had acute coronary syndrome.  Mean contrast dose was 179 ± 146 ml, total procedure time was 67.6 ± 39 minutes and fluoroscopy time was 21.8 ± 37.5 minutes. Catheter size was mostly 6 Fr (95.3%). Access sites were mostly right radial (74%) and left radial (10%). Procedures planned to be completely robotic were 74%, those requiring temporary manual assistance were 15%, and those requiring permanent manual conversion were 9%. Reasons for manual assistance included hybrid approach (58%), reduction of procedure time (0.6%), and operator decision (17.2%). The clinical success rate was 93.5%. There were no in-hospital deaths, target vessel MI or stent thrombosis. Bleeding events were reported at a rate of 2.5%. In terms of MACE, death at 1 year was 4.4% and cardiac death was 1.1%.  TLF was 2.9% at 1 year and TVF was 3.5%.

Conclusion:
This is the first large-scale R-PCI registry study using a second-generation robotic arm in Europe and Asia. R-PCI procedures could be performed safely in intermediate and complex lesions. High clinical success rates were achieved at in-hospital, 30-day and 1-year follow-up. 74% of the procedures were performed fully robotic, 15% with temporary manual assistance and only 9% with permanent manual conversion.

Comment:
The TESLA study demonstrated that R-PCI are safe and effective. The high clinical success rates and low complication rates showed that this technology can be used in the treatment of coronary artery diseases.  Future prospective and randomised studies are needed to confirm these findings. Legal grounds and responsibility in robotic-assisted medical interventions are another matter of curiosity.