EHRA expert statement on pacemakers and intracardial devices: “watch out for the little old lady”

Implantation of pacemakers and intracardial devices lead to a high complication rate. The recently published 2021 EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators provides guidance on the management of the most important complications, such as lead perforation, pericardial effusion, pocket haematoma, and infection [1,2].

Prof. Thomas Starck (German Heart Centre Berlin, Germany) provided recommendations on the prevention and management of complications in patients who received a pacemaker or intracardial devices, based on the 2021 EHRA expert consensus paper [1]. The rate of complications lies between 5 and 10%. Complications with the highest incidences are pocket haematoma (≤16.0%), pericardial effusion (10.2%), infection (≤3.4%), lead dislodgment (≤3.3%), and pneumothorax (≤2.8%). However, procedure-related mortality is low [2].

Different factors were identified for lead perforation, including old age, female sex, BMI <20, steroid use, and antiplatelet agent therapy. Prof. Starck said to “watch out for the little old lady.” Procedure-related risks include temporary pacing, small diameter intracardial devices leads, longer fluoroscopy time, and several lead locations. Lead revision is indicated in cases of perforation, especially those with additional risk factors, as conservatively treated patients showed a higher risk of tamponade and recurrent symptoms (6 and 1/22 vs 0 and 0/26) [3].

Lead perforation is often associated with pericardial effusion as shown in a prospective evaluation of 968 consecutive patients using a pre-operative and post-operative (within 24h) echocardiography [4]. The incidence of small-to-moderate pericardial effusion was 8.7%, with 94% of the patients being asymptomatic. The incidence of large pericardial effusion with tamponade (>20 mm) was 1.5%. Pericardiocentesis is recommended for large effusions or effusions causing haemodynamic compromise [2]. Pericardiocentesis can be considered in moderate effusions that do not regress quickly, especially if the patient requires anticoagulation. Patients with mild effusions should be monitored closely.

Development of pneumothorax is highly dependent on venous access, and risk factors again include ‘the little old lady,’ chronic obstructive pulmonary disease, and subclavian vein puncture [5]. Pneumothorax should be drained with a chest tube. The implantation technique of choice is axillary vein puncture or cephalic venous cutdown. Use of intrathoracic subclavian puncture is not advised.

Pocket haematoma is the most common complication after implantation procedures. Heparin-bridging significantly increases risk (P<0.001) and should be avoided, while continued treatment with warfarin or direct oral anticoagulant is recommended [6,7]. Haematoma should be conservatively treated unless there are further complications that require immediate surgical revision. Needle aspiration should not be performed due to a high risk of infection [8].

Further, device infection significantly reduces survival rates in implanted patients (P<0.001) and should be prevented at all costs [9,10]. Risk management includes treatment of modifiable risk factors and adjust medical procedures accordingly.

Prof. Starck emphasised the importance of proper training and implantation technique to avoid or minimise complications and the familiarity of physicians with the management of complications whenever encountered. The presented EHRA consensus statement provides good guidance herein.

1. 
   
   1. Starck CT. Prevention and management of complications. EHRA 2021 Congress, 23-25 April.
   2. Burri H, et al. EP Europace 2021:euaa367.
   3. Rav Acha M, et al. Europace 2019:21(6):937-943.
   4. Ohlow MA, et al. Circ J 2013:77(4):975-981.
   5. Kirkfeldt RE, et al. Europace 2012:14:1132-1138.
   6. Birnie DH, et al. N Engl J Med 2013:368:2084-2093.
   7. Vannasche T. Focus on special situations: NOACs in pre-operative and bleeding patients. EHRA 2021 Congress, 23-25 April.
   8. Essebag V, et al. J Am Coll Card 2016:67(11):1300-1308.
   9. Sohail MR, et al. PACE. 2015:38(2):231-239.
   10. Blomström-Lundqvist C, et al. Europace 2020:22(4):515-549.

 

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Posted on 16 June 202124 June 2021