Brief Reports

Acute complications of permanent pacemaker implantation: their financial implication and relation to volume and operator experience

Cardiac implantable electronic devices (CIEDs), such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends.

We sought to describe trends in noninfectious CIED complications over the past 3 decades in Olmsted County.

The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966 to present. CIED implantations between 1988 and 2018 were determined. Trends in noninfectious complications within 30 days of implantation were analyzed.

A total of 157 (6.2%) of 2536 patients who received CIED experienced device complications. A total of 2.7% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.8%), followed by hematoma (1.7%). Complications went up from 1988 to 2005, and then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (P < .01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity index has trended up over the 30 years.

Our study describes a real-world trend of CIED complications over 3 decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management.

Axillary vein puncture is a popular puncture site for pacemaker implantation. However, due to the lacking of body surface markers, the current puncture method is too complicated and affect the popularization and application of axillary vein puncture. Here, we performed a new body surface landmark to make the blind axillary vein puncture simple and easy.

The study population included 30 patients referred for pacemaker implantation using axillary vein puncture. Digital subtraction angiography (DSA) was used to determine the direction and the surface landmarks of the axillary vein. Medial cusp of thoracic triangle and the coracoid process were directly touched with fingers. The puncture point was about 1 cm below the coracoid, and the needle tip pointed to the medial cusp of thoracic triangle with the angle of 30–60°.

There was little variation in distribution of axillary vein. The body surface landmark of the junction of the axillary vein and the subclavian vein is on the medial cusp of thoracic triangle. In these 30 patients, blind axillary vein puncture was successful obtained in all patients. There was no pneumothorax and inadvertent arterial puncture. The pacemaker lead wire was placed smoothly. Moreover, the pacemaker pocket was ideally positioned when cut along the puncture point.

Blind axillary vein access using the body surface landmark of the thoracic triangle is an effective method for pacemaker implantation and can obvious avoid the complications usually observed with the traditional subclavian vein approach.

Leadless pacemakers (LPs) have revolutionized the field of pacing by miniaturizing pacemakers and rendering them completelty intracardiac, hence reducing complications related to pacemaker pockets and transvenous leads. However, first generation LPs appear to be associated with a higher rate of myocardial perforation as compared to transvenous pacemakers (TV-PPM). Currently, LPs are predominantly designed to pace the right ventricle with no LPs that provide atrial or biventricular pacing. In this article, we review the available data on LPs while advocating for the need for a randomized controlled trial comparing LPs to TV-PPMs. In addition, we review the future directions of leadless devices.

Leadless cardiac pacemakers (LCPs) aim to mitigate lead- and pocket-related complications seen with transvenous pacemakers (TVPs).

The purpose of this study was to compare complications between the LCP cohort from the LEADLESS Pacemaker IDE Study (Leadless II) trial and a propensity score–matched real-world TVP cohort.

The multicenter LEADLESS II trial evaluated the safety and efficacy of the Nanostim LCP (Abbott, Abbott Park, IL) using structured follow-up, with serious adverse device effects independently adjudicated. TVP data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber TVPs between April 1, 2010 and March 31, 2014 and more than 1 year of preimplant enrollment data. Comorbidities and complications were identified via International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. Short-term (≤1 months) and mid-term (>1–18 months) complications were compared between the LCP cohort and a propensity score–matched subset of the TVP cohort.

Among 718 patients with LCPs (mean age 75.6 ± 11.9 years; 62% men) and 1436 patients with TVPs (mean age 76.1 ± 12.3 years; 63% men), patients with LCPs experienced fewer complications (hazard ratio 0.44; 95% confidence interval 0.32–0.60; P < .001), including short-term (5.8% vs 9.4%; P = .01) and mid-term (0.56% vs 4.9%; P < .001) events. In the short-term time frame, patients with LCPs had more pericardial effusions (1.53% vs 0.35%; P = .005); similar rates of vascular events (1.11% vs 0.42%; P = .085), dislodgments (0.97% vs 1.39%; P = .54), and generator complications (0.70% vs 0.28%; P = .17); and no thoracic trauma compared to patients with TVPs (rate of thoracic trauma 3.27%). In short- and mid-term time frames, TVP events absent from the LCP group included lead-related, pocket-related, and infectious complications.

Patients with LCPs experienced fewer overall short- and mid-term complications, including infectious and lead- and pocket-related events, but more pericardial effusions, which were uncommon but serious.