Digital archive of theses discussed at the University of Pisa


Thesis etd-12172021-114924

Thesis type
Tesi di specializzazione (4 anni)
Thesis title
Transcatheter edge-to-edge mitral valve repair with PASCAL system: early results of a single-centre experience.
Course of study
relatore Prof. De Caterina, Raffaele
relatore Dott. Berti, Sergio
  • PASCAL mitral valve repair
  • mitral regurgitation
  • transcatheter edge-to-edge valve repair
Graduation session start date
Release date
Mitral regurgitation (MR) is the second most frequent heart valve disease in the general population. Data suggest that only a minority of affected patients undergoes surgical treatment. The most important patient characteristics associated with a decision to refuse the surgery are increased operative risk due to age, comorbidities and impaired left ventricular function. In the past two decades transcatheter mitral valve edge-to-edge repair (TEER) has become a valuable and established treatment option in this high-risk population. The MitraClip system is the most widely used technology for TEER. Nevertheless, percutaneous repair in more complex valve pathologies beyond anatomic criteria tested in clinical trials has resulted in a considerable number of patients who need re-intervention. Recently, the PASCAL Transcatheter Valve Repair System has been added to the armamentarium of TEER therapies and is expected to expand the treatable patient population by offering unique features.
Data on the real-world performance of the PASCAL system outside of clinical studies are limited. The aim of the present study is to characterize the real-world performance and clinical outcomes of TEER with the PASCAL System in a cohort of patients with functional and degenerative mitral regurgitations. A total of 45 consecutive patients with symptomatic moderate-to-severe and severe MR were treated in our Institute using the PASCAL device. Primary performance endpoint included procedural success and clinical success. The primary safety endpoint was the rate of MAEs at 30 days and 6 months. Between January 2020 and June 2021, 45 patients with symptomatic moderate-to-severe and severe MR were enrolled. The mean age was 79 years old. Patients were in New York Heart Association (NYHA) functional class III or IV, with 78% functional and 22% degenerative MR aetiology. At 30 days the MAE rate was 4%, 25 patients (56%) were in NYHA functional class I and 18 patients (40%) were in NYHA functional class II (p < 0.0001 vs baseline). The average six-minute walk distance (6MWD) increased 65 metres (p < 0.001 vs baseline). After six months of follow-up, the MAE rate was 5% with an all-cause mortality rate of 7% with no occurrence of stroke. The improvement of symptoms and functional capacity in the overall population and in both aetiologies, was maintained at 6 months with 40/42 (95%) patients in NYHA functional class I or II (p < 0.001 vs baseline) and by 80 metres (p < 0.0001) increase in mean 6-minute walking distance. The EQ-5D Health Questionnaire scores improved significantly from baseline to 6 months (p < 0.0001). In conclusion, in a real-world population, the treatment of severe MR can be successfully and safely treated with the PASCAL device regardless of aetiologies. This intervention resulted in a sustained MR reduction, improvement in exercise capacity and quality of life on a short-term follow-up.