Question

• Permanent pacemakers and/or ICD complications

Answer 1

Permanent pacemakers are used to control long-term heart rhythm problems. This article mainly discusses permanent pacemakers, unless stated otherwise. Doctors also treat arrhythmias with another device called an implantable cardioverter defibrillator (ICD). An ICD is similar to a pacemaker.
Infection where the pacemaker was implanted.
Allergic reaction to the dye or anesthesia used during your procedure.
Swelling, bruising or bleedingat the generator site, especially if you take blood thinners.
Damage to your blood vessels or nerves near the pacemaker.
Collapsed lung.
The most common complication is lead dislodgement (higher rate atrial dislodgment than ventricular dislodgment), followed bypneumothorax, infection,bleeding/pocket hematoma, and heart perforation, not necessarily in that order, depending on the study.There was a relevant rate of complications related to a permanent pacemaker implant. Thesecomplications occurred in the initial phase after the implant and decreased during the follow-up, the most frequent ones being pneumothorax, lead dislodgement, peripheral phlebitis, uncomplicated hematomas, and painful shoulders.Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates.We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively.Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems.The need for a pacemaker increases as patients age, and ICD implantation has expanded as a result of the publication of recent clinical trials.In the years after initial implantation, device replacement may become necessary for battery depletion or for upgrades to more complex multilead pacemakers or ICDs. The increase in generator or lead advisories and recalls contributes further to those patients considered for replacement.The determination of procedural adverse events is complex, related to the specific type of procedure and patient comorbidities such as congestive heart failure.Longer-term patient outcomes may also be affected by the procedure; thus, reporting of complications should include both short- and long-term results.
Although retrospective series have examined complications with generator replacements, prospective data are unavailable.Furthermore, risks related to generator replacements with lead additions are not well understood, particularly upgrades to cardiac resynchronization therapy (CRT).To answer these questions, we prospectively collected 6-month complication rates in patients undergoing pacemaker or ICD generator replacement, including CRT-pacemakers and CRT-ICDs.