Evaluation of a novel mechanical compression device for hematoma prevention and wound cosmesis after CIED implantation.

BACKGROUND: An important complication of cardiac implantable electronic devices (CIED) implantation is the development of hematoma and device infection. OBJECTIVE: We aimed to evaluate a novel mechanical compression device for hematoma prevention and cosmetic outcomes following CIED implantation. METHODS: An open, prospective, randomized, single-center clinical trial was performed in patients undergoing CIED implantation. Patients were randomized to receive a novel mechanical compression device (PressRite, PR) or to receive the standard of care post device implantation. Skin pliability was measured with a calibrated durometer; the surgical site was evaluated using the Manchester Scar Scale (MSS) by a blinded plastic surgeon and the Patient and Observer Scar Scale (POSAS). Performance of PR was assessed through pressure measurements, standardized scar scales and tolerability. RESULTS: From the total of 114 patients evaluated for enrollment, 105 patients were eligible for analysis. Fifty-one patients were randomized to management group (PR) and 54 to the control group. No patients required early removal or experienced adverse effects from PR application. There were 11 hematomas (14.8% vs. 5.9% in the control and PR group respectively, p = NS). The control group had higher post procedure durometer readings in the surgical site when compared with the PR group (7.50 ± 3.45 vs. 5.37 ± 2.78; p = < .01). There were lower MSS scores in the PR group after 2 weeks (p = .03). CONCLUSION: We have demonstrated the safety of PR application and removal. In addition, PR appears to improve postoperative skin pliability, which could facilitate wound healing.

Baseline incision characteristics and early scar maturation indices following cardiac device implantation.

AIMS: Dermatologic evaluation for cardiac implantable electronic devices (CIEDs) has not been established. We sought to ascertain baseline wound scar features using quantifiable surgical tools and scar scales on post-CIED patients. METHODS: A single-center, prospective observational case-control study was performed where 92 study subjects (40 healthy volunteers and 52 post-CIED patients) completed the study. Durometer was used to quantify skin pliability before CIED placement, postprocedure, and 2 weeks postprocedure. Higher durometer readings signified reduced skin pliability. Durometer readings were compared to the patients' contralateral pectoral skin and to a healthy volunteer's cohort skin within the prepectoral region. Patient wounds were observed and graded using the Patient Observer Scar Assessment Scale (POSAS) and Manchester Scar Scale (MSS). RESULTS: Baseline pectoral skin pliability readings were similar in healthy volunteers and CIED patient population. In comparison to preprocedural measurements, surgical site skin pliability decreased in postprocedural and 2 weeks follow-up time points (P-value .004 and <.001, respectively). The increases in durometer readings were higher in the older population (age >75 over time, P = .008). POSAS evaluations showed on average a thin painless hypopigmented scar with moderate stiffness. MSS scar evaluation showed a palpable scar with slight contour differences and color mismatch and appeared to be slightly better in the African American population. There was no difference in scar characteristics with preprocedural use of antiplatelet or anticoagulation or staple closure or gender. CONCLUSIONS: Serial measurements could be of value for development of new strategies for cosmesis and improved wound healing.

Impact of Variableorientation and Flow Rates on Radiofrequency Ablation Lesions Created by Externally Irrigated Catheters: An Ex-Vivo Study.

The impact of variability in irrigation rates and catheter orientation on radiofrequency ablation (RF) lesion creation has not been studied systematically for the uniformly irrigated 56-pore (56P) catheter. This study aimed to analyze the impact of irrigation flow rates (IFRs) and catheter orientation (CO) settings on RF lesions sizes produced by a 56P irrigation catheter in a power-controlled mode using an ex-vivo model. RF lesions were created in strips of chicken muscle in a saline bath heated to 37°C with 56P and 6P catheters using low flow rate (LFR) at 2 cc/min and standard flow (SFR) irrigation rates at 8 cc/min for 56P and 17 cc/min for 6P with horizontal (HO) and vertical (VO) catheter orientations. Ablation power of 20W was delivered for 30 seconds with a mean contact force of 10 g. Sixty RF lesions were analyzed. For the 56P catheter, in contrast to the 6P catheter lesion geometry was independent of CO and IFR in our model. Although 6P catheter had slightly deeper lesions, the overall lesion volumes were similar for 6P and 56P catheters. CO and IFR appeared to have minimal impact on lesion volume creation with 56P catheter. In head-to-head comparison the 6P and 56P irrigated catheters performed similarly.