Leadless pacemakers reduce risk of device-related infection: Review of the potential mechanisms.

Pacemaker-related infections remain a constant concern due to increased risk of patient morbidity and mortality. Although transvenous pacemakers are expected to have an infection rate ranging from 0.77% to 2.08%, no cases of leadless pacemaker infection have been reported in clinical trials enrolling more than 3000 patients. Many potential reasons why leadless pacemakers may be resistant to infection include the absence of a subcutaneous pocket and leads, reduced skin and glove contact, size, location, and device material. This review summarizes the current state of evidence regarding the apparent infection resistance of leadless pacemakers.

Reduced bacterial adhesion with parylene coating: Potential implications for Micra transcatheter pacemakers.

INTRODUCTION: Infections of cardiac implantable electronic devices remain a prevalent health concern necessitating the advent of novel preventative strategies. Based on the observation that bacterial infections of the Micra transcatheter pacemaker device are extremely rare, we examine the effect of parylene coating on bacterial adhesion and growth. METHODS: Bacterial growth was compared on polyurethane coated, bare, or parylene coated titanium surfaces. Eight test samples per bacterial species and material combination were incubated with Staphylococcus Aureus or Pseudomonas aeruginosa for 24 hours and then assayed for bacterial growth. The surface contact angle was also characterized by measuring the angle between the tangent to the surface of a liquid droplet made with the surface of the solid sample. RESULTS: The mean bacterial colony counts were significantly reduced for both parylene coated titanium versus bare samples (3.69 ± 0.27 and 4.80 ± 0.48 log[CFU/mL] respectively for S. aureus [P < .001] and 5.51 ± 0.27 and 6.08 ± 0.11 log[CFU/mL] respectively for P. aeruginosa [P < .001]), and for parylene coated titanium versus polyurethane samples (4.27 ± 0.42 and 5.40 ± 0.49 log[CFU/mL] respectively for S. aureus [P < .001] and 4.23 ± 0.42 and 4.84 ± 0.32 log[CFU/mL] respectively for P. aeruginosa [P = .006]). Parylene coated titanium samples had a higher contact angle compared with bare titanium, but lower compared with polyurethane (mean contact angle 87.5 ± 3.1 degrees parylene, 73.3 ± 3.7 degrees titanium [P < .001 vs parylene], and 94.8 ± 3.7 degrees polyurethane [P = .002 vs parylene]). CONCLUSIONS: Parylene coating significantly reduced the ability of bacteria to grow in colony count assays suggesting that this could contribute to the reduction of bacterial infections of Micra transcatheter pacemakers.

Distal right ventricular coil position reduces defibrillation thresholds.

UNLABELLED: Distal RV Coil Position Reduces DFTs. INTRODUCTION: Understanding the factors that affect defibrillation thresholds (DFTs) has important implications both for optimization of defibrillation efficacy and for the design of new transvenous leads. The aim of this prospective study was to test the hypothesis that defibrillation efficacy is improved with the right ventricular (RV) coil in a distal position compared with a more proximal RV coil position. METHODS AND RESULTS: A novel defibrillation lead with three adjacent RV defibrillation coils (distal 0.8 cm, middle 3.7 cm, proximal 0.8 cm) was used for this study to permit comparison of DFTs with the proximal and distal RV coil positions without lead repositioning. In the distal RV configuration, the distal and middle RV coils were connected electrically as the anode for defibrillation. In the proximal RV configuration, the middle and proximal coils were the anode. A superior vena cava (SVC) coil and active can were connected electrically as the cathode (reversed polarity, RV-->Can+SVC). In each patient, the DFT was measured twice using a binary search protocol with the distal RV and proximal RV configurations, with the order of testing randomized. The study cohort consisted of 31 subjects (mean age 65 +/- 12 years, mean left ventricular ejection fraction 30% +/- 16%, 81% male predominance). The mean delivered energy (8.2 +/- 5.3 J vs 11.2 +/- 6.1 J), leading-edge voltage (335 +/- 109 V vs 393 +/- 118 V), and peak current (11.6 +/- 5.2 A vs 14.9 +/- 7.3 A) at DFT all were significantly lower with the distal RV configuration compared to the proximal RV configuration (P < 0.01 for all comparisons). CONCLUSION: DFTs are significantly reduced with the distal RV configuration compared to the proximal RV configuration. Defibrillation leads should be designed with the shortest tip to coil distance that can be achieved without compromising ventricular fibrillation sensing.