Study cz-050120151400
Study Name
Nurse-performed sheath removal after heparin reversal with protamine in patients undergoing radiofrequency catheter ablation for atrial fibrillation – a randomized study
Clinical Trial Registry Identifier
cz-050120151400
Study First Received
05.01.2015 10:40
Sponsor
Faculty of Health and Social Sciences, South Bohemia University in Ceske Budejovice, Ceske Budejovice, Czech Republic, grant BOV2012_001
Principal Investigator
Lucie Rolantova, Alan Bulava, Martin Eisenberger
Information provided by
Lucie Rolantova
Purpose
Atrial fibrillation (AF) is the most common sustained arrhythmia, increases with age and manifests with a wide spectrum of symptoms and severity. AF affects approximately 1.0-1.5% of the general population and its incidence will markedly increase due to the advancing age. Catheter ablation has been shown to be a successful treatment for AF. During the procedure, multiple catheters are advanced to the heart via the femoral veins. Due to the increased risk of procedure-related thromboembolism, patients are anticoagulated with heparin during the procedure. Standard protocol requires several hours of leaving the sheaths in the groin after the procedure until the coagulation time returns to its normal range prior to the removal of the sheaths. This requires prolonged immobilization and patient may experience discomfort due to the sheaths placed in the femoral veins. An alternative method is to remove the femoral sheaths immediately after the procedure and apply manual compression. This requires using protamine-sulphate to neutralize the heparin and facilitate immediate removal of the sheaths. It is now increasingly common for the removal of the sheaths to be a nursing procedure9. In many institutions, however, femoral sheaths extraction is still performed solely by medical doctors.
Primary endpoints
To show that nurse-performed sheath removal after catheter ablation is feasible and safe.
Secondary endpoints
To compare standard approach of femoral sheath removal after spontaneous heparin cessation with approach using immediate heparin neutralization with protamine-sulphate to allow femoral sheath removal in the electrophysiology laboratory.
Eligibility
Patients of both genders with paroxysmal or persistent atrial fibrillation and cardiac condition requiring and enabling radiofrequency catheter ablation of the arrhythmia are eligible to enter the trial. The exclusion criteria comprise the presence of left atrial thrombus, elevated international normalized ratio (INR) on the day of the procedure, previous protamine intolerance, vascular complications that were noticed before the sheath removal, more than one inadvertent femoral artery puncture, previously known coagulopathy and patient age below 18.
Contacts and Locations
Lucie Rolantova, rolantova@zsf.jcu.cz, Faculty of Health and Social Sciences, South Bohemia University in Ceske Budejovice, Ceske Budejovice, Czech Republic
More Information
No publications provided
Keywords
femoral sheaths, staff nurses, protamine, catheter ablation, atrial fibrillation
Status
Enrolment completed
Protocol of the study published
Data being analyzed
Catheter ablation for atrial fibrillation
Patients with symptomatic paroxysmal or persistent AF were included in the study. All patients were pre-treated with oral anticoagulation therapy with Warfarin. This was discontinued 7 days before the procedure and substituted with low molecular heparin as soon as the international normalized ratio (INR) dropped below 2. Last heparin injection was administered 24 hours before the procedure. Chronic antiplatelet therapy with aspirin was continued. The operation was performed by one of the three cardiac electrophysiologists. Removal of the sheaths in the end of the procedure was performed by one of the staff nurses. All patients received conscious sedation in the beginning of the study. Both femoral veins were punctured by Seldinger technique and two 8.5Ftransseptal sheaths (Channel, Bard, Lowell, MA) were inserted to the right femoral vein and 7F and 11F sheaths (Fast Cath, St Jude Medical, USA) were positioned in the left femoral vein (for the intracardial echocardiography probe and for the decapolar catheter to the coronary sinus). If accidental puncture of the femoral artery occurred, a manual compression was applied for at least three minutes with visual confirmation of no further bleeding. If the artery was punctured for the second time, the patient was excluded from the study.
After transseptal puncture, the ablation catheter (SmartTouch, Biosense-Webster, Diamond Bar, USA) and the Lasso catheter were placed in the left atrium and ablation procedure was performed according to the standard protocol – pulmonary vein isolation with or without linear ablation lines as per operator discretion. Heparin bolus of 100 units/kg was given immediately after the transseptal puncture and an infusion of 15 units/kg body weight was started. Additional heparin was given if necessary to achieve activated clotting time (ACT) 300 to 350 s throughout the procedure. The ACT was checked every 10 minutes until the target ACT was reached, after which time the ACT was measured every 20 minutes. The heparin was stopped at the end of the procedure as soon as all the catheters were pulled out from the left atrium.
Protamine group
The anticoagulation effect of heparin was reversed with protamine-sulphate. The total dose of protamine-sulphate given at the end of the procedure was derived from the total dose of unfractionated heparin during the procedure and from the last ACT value (Table 2). All sheaths were extracted and manual compression was applied to achieve haemostasis by one of the staff nurses. At least 10 minutes of manual pressure was applied for all punctures. Repeated doses of protamine and prolonged manual pressure were allowed if appropriate haemostasis was not achieved. Compression times and protamine doses were recorded. The punctures were dressed for 8 hours while the bed rest was maintained for 12 hours unless instructed otherwise by the staff. Low molecular weight heparin was administered immediately after returning to the ward and applied twice a day until therapeutic INR with Warfarin was achieved.
Control group
Patients in the control group had all their sheaths left in both groins and were transferred to the cardiology ward after the procedure. ACT was checked 6 hours after the procedure and every hour thereafter to make sure that the level has dropped below 1.5 times the maximum normal value. Once satisfactory ACT was achieved, all sheaths were extracted and manual compression for at least 10 min was applied by one of the cardiac nurses in the similar way as in the study group. Low molecular weight heparin was injected after the sheaths were extracted and both groins were compressed for 8 hours with bed rest for 12 hours. Oral anticoagulation therapy with Warfarin was resumed the next day after the procedure and the LMWH was given every 12 hours until the INR reached 2 or more.
Exclusion criteria
Exclusion criteria comprised the presence of left atrial thrombus, elevated international normalized ratio (INR) on the day of the procedure, previous protamine intolerance, vascular complications that were noticed before the sheath removal, more than one in advertent femoral artery puncture, previously known coagulopathy and patient age below 18.
Data collection and endpoints
All following data were entered prospectively into a computer database: total heparin and protamine-sulphate doses, procedure times (from the first femoral vein puncture attempt to the removal of all the catheters from the body), X-ray times, mean ACT, manual compression times, discomfort during manual compression (on a scale 1-10), total immobilization time(i.e. total time counted from the end of the ablation procedure to the moment when patient was allowed to leave the bed) and all adverse events. Any allergic or hypotensive events after protamine administration were recorded. The puncture site was evaluated by the staff nurse in the electrophysiology laboratory and on the cardiology ward the day of the procedure and the next day. It included a clinical examination, hematoma size measurement (maximum diameter) and also ultrasound duplex in indicated cases. All patients were followed up with a phone call 7 days after hospital discharge.
Puncture site complications were defined as groin hematoma (maximum diameter was recorded), excessive bleeding, bleeding requiring transfusion, infection, pseudoaneurysm, arterio-venous fistula, retroperitoneal bleeding and any other complication requiring vascular surgical intervention. Other serious adverse events documented included any thromboembolic complications, myocardial infarction, cerebrovascular event and death.
Statistical analysis
In normally distributed variables, mean ± standard deviation (SD) was used as a descriptive summary, and student t-test was used to compare groups. When the variables were not normally distributed, median was used to report the summaries, and the Mann-Whitney U test was used to compare groups. The results for categorical variables were summarized with percentages. Groups were compared on categorical variables using either Pearson’s Chi-square test or Fisher’s exact test. The statistical analysis was completed using SAS software, version 9.4 (SAS Institute Inc., Cary, North Carolina).
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