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Published on: February 28, 2012
Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless
François Diederik Regoli1,2, Ardan M Saguner3, Angelo Auricchio2
1Service of Cardiology, Hospital of San Giovanni, Cardiocentro Ticino Institute, 6500 Bellinzona, Switzerland.
Introduction:
Data on peri-operative management of direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations remain limited. This study aimed to evaluate a standardized DOAC management regime consisting of interruption of a single dose prior to implantation and reinitiation within 6-24 h; also, patient clinical characteristics associated with this approach were identified.
Method:
Consecutive patients undergoing standard TPS implantation procedures from two Swiss tertiary centers were included. DOAC peri-operative management included the standardized approach (Group 1A) or other approaches (Group 1B).
Results:
Three hundred and ninety-two pts (mean age 81.4 ± 7.3 years, 66.3% male, left ventricular ejection fraction 55.5 ± 9.6%) underwent TPS implantation. Two hundred and eighty-two pts (71.9%) were under anticoagulation therapy; 192 pts were treated with DOAC; 90 pts were under vitamin-K antagonist. Patients treated with DOAC less often had structural heart disease, diabetes mellitus, and advanced renal failure. The rate of major peri-procedural complications did not differ between groups 1A (n = 115) and 1B (n = 77) (2.6% and 3.8%, p = 0.685). Compared to 1B, 1A patients were implanted with TPS for slow ventricular rate atrial fibrillation (AF) (p = 0.002), in a better overall clinical status, and implanted electively (<0.001).
Conclusions:
Standardized peri-procedural DOAC management was more often implemented for elective TPS procedures and did not seem to increase bleeding or thromboembolic adverse events.
Insights
A standardized approach to managing direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations is safe. This DOAC management strategy did not increase bleeding or thromboembolic events.
Area of Science:
- Cardiology
- Medical Devices
- Pharmacology
Background:
- Limited data exists on managing direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations.
- Peri-operative management of DOACs requires careful consideration to balance bleeding and thromboembolic risks.
- Evaluating standardized DOAC management protocols is crucial for patient safety and procedural success.
Purpose of the Study:
- To assess a standardized DOAC management regimen for TPS implantation.
- To identify patient clinical characteristics associated with the standardized DOAC approach.
- To evaluate the safety and efficacy of peri-operative DOAC management during TPS procedures.
Main Methods:
- A retrospective study included consecutive patients undergoing TPS implantation at two Swiss tertiary centers.
- DOAC peri-operative management was categorized into a standardized approach (Group 1A) and other approaches (Group 1B).
- Standardized approach involved single-dose interruption before implantation and reinitiation within 6-24 hours.
Main Results:
- 392 patients underwent TPS implantation; 192 were on DOACs.
- The rate of major peri-procedural complications was similar between the standardized (2.6%) and other (3.8%) DOAC management groups (p=0.685).
- The standardized DOAC approach was more frequently used for elective TPS procedures in patients with better clinical status.
Conclusions:
- Standardized peri-operative DOAC management for TPS implantation is feasible and safe.
- This protocol did not appear to increase the risk of bleeding or thromboembolic adverse events.
- The standardized approach was associated with elective procedures and patients in better overall clinical condition.
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