Long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure: a single-center experience (LAAC combined PFO/ASD closure)

Expert Rev Med Devices. 2019 May;16(5):429-435. doi: 10.1080/17434440.2019.1604216. Epub 2019 Apr 19.

Abstract

Objectives: To report long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure.

Methods: A retrospective study of 370 consecutive patients undergoing LAAC procedures using the Watchman (WM) device. Data were compared between 330 cases only with LAAC procedure (Group I) and 25/5 (PFO/ASD) cases with sequential procedures of LAAC and PFO/ASD closure (Group II).

Results: Compared to Group I, Group II had more males (86.7% vs. 65.8%, p < 0.05) and a higher rate of stroke (33.3% vs. 10.6%, p < 0.01), but there were no statistical differences in the remaining patient characteristics. During the follow-up period, there were no significant differences between the two groups in embolism events (6.1% vs. 0%, p = 0.39), device related thrombus (5.8% vs 3.3%, p = 1.0), major bleeding (9.4% vs. 6.7%, p = 1.0) and cardiac death (3.6% vs. 0%, p = 0.61). The observed rate of all thromboembolic events by Kaplan-Meier analysis was decreased by 39.9% and 100% and the observed annual rate of bleeding was reduced by 32.9% and 57.6% in Group I and Group II, respectively.

Conclusions: LAAC combined with PFO/ASD closure might be an ideal choice to prevent stroke and other thrombotic complications in patients with both NVAF and PFO/ASD.

Keywords: Atroke prevention; Watchman; left atrial appendage closure; patent foramen ovale closure.

MeSH terms

  • Aged
  • Cardiovascular Surgical Procedures*
  • Female
  • Follow-Up Studies
  • Foramen Ovale, Patent / complications
  • Foramen Ovale, Patent / surgery*
  • Heart Septal Defects, Atrial / complications
  • Heart Septal Defects, Atrial / surgery*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Retrospective Studies
  • Stroke / etiology
  • Time Factors
  • Treatment Outcome