Overall, complications occur in 1% to 6% of all pacemaker implantation procedures.
Complications can range from superficial bleeding to fatal infections or cardiac arrest.
Common complications associated with permanent pacemaker implantation using a transvenous lead system are hematoma, lead dislodgement, infection, lead perforation, and dysrhythmias.
Generator pocket hematoma is the most common complication accounting for over 3% of pacemaker complications.
Hematoma treatment includes surgical evacuation, interruption of previously anticoagulants, extended peeiod for monitoring, and possible transfusion.
In a retrospective study of over 78,000 patients, 2.1% develop a postprocedural hematoma after primary pacemaker implantation.
The likelihood of developing a hematoma increases in patients over age 75 and in patients with comorbid heart failure, coagulopathy, or renal failure.
Patients who received heparin bridging are over four times more likely (16%) to develop a hematoma than patients who remained on warfarin (3.5%).
In the patients undergoing generator replacement alone, 0.7% experienced hematoma requiring intervention.
Lead dislodgement is a common cause of failure to capture and failure to sense.
Lead dislodgement requiring replacement of one or more lead wires is the most common complication of pacemaker generator or lead upgrade.
Lead dislodgement typically occurs within the first 3 months after implantation.
Patients over age 75 were twice as likely to develop lead dislodgement than their younger counterparts.
Lead dislodgement May bevdue to loosely tied sutures, allowing the lead wire to move freely,
Twiddler’s syndrome another cause of lead dislodgement, results from twisting or rotating the generator within the subcutaneous pocket.
Pacemaker infections can occur in the generator pocket, along the lead wires, the heart valves, and the endocardium.
The incidence of infection can be as high as 5% of patients receiving a permanent pacemaker or generator replacement.
Three-quarters of infections occur within the first year after implantation.
Increased infection risk after pacemaker placement is associated with comorbidities such as diabetes, end-stage renal disease, heart failure, steroid use, lack of antibiotic prophylaxis, chronic obstructive pulmonary disease, history of device infection, hematoma at the insertion site, use of temporary cardiac pacing, intervention for lead dislodgement, and device replacement.
Generator pocket infection signs and symptoms include erythema, pain, edema, warmth, purulent drainage, or nonhealing incision.
A common pocket infection is caused by contamination with Staphylococcus aureus and coagulase-negative staphylococci.
An infected pocket can also lead to the generator eroding through the skin.
10 to 14 days of appropriate antibiotic therapy and device removal for pocket infections with negative blood cultures is recommended.
Infection along the lead wires or endocarditis, may be characterized by fever, chills, and pain at the site.
Vegetations or other signs of endocarditis or myocardial abscess can be identified by transesophageal echocardiography.
As with pocket infections, deep infections require device removal and antibiotic therapy for as long as 6 weeks.
Current guidelines recommend waiting 14 days after negative blood culture following device removal for valve vegetation, and 72 hours after negative blood culture following device removal for lead vegetation.
Lead perforation is relatively uncommon.
Lead perforation accounts for up to 0.8% of pacemaker complications.
Lead perforation can lead to pericardial effusion, pneumothorax, hemothorax, or even death.
Lead perforation risk factors:
female gender, steroid administration, and advanced age.
Signs and symptoms of lead perforation include:
chest pain, fatigue, fever, pleural effusion, and cardiac tamponade.
Acute lead perforations occur less than 1 month after implantation, and can be fatal in up to 1% of patients.
Diagnosis-computed tomography showing the lead malposition.
Treatment involves:
repositioning or replacement of the lead wire
treatment of pleural effusion and other complications if necessary.
Hemothorax or pneumothorax may require chest tube placement.
Ventricular dysrhythmias can occur when the pacemaker doesn’t sense an intrinsic QRS complex,
including premature ventricular contractions, as it may deliver an impulse inappropriately, which can induce ventricular tachycardia or ventricular fibrillation.
Undersensing can be corrected by adjusting the sensitivity or automatic capture feature of the pacemaker.
Additional complications with permanent pacemaker implantation. include increased scar formation at the generator pocket site, chronic pain, thromboembolism, and stroke.