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.
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).
Background: Graduated elastic compression stockings are a frequently prescribed therapy for cardiovascular conditions with established benefit. However patient compliance remains low owing to significant difficulty donning the device, discomfort and poor fit. Based on end-user feedback, a novel compression device (CompressRite CR) to facilitate one handed application with minimal use of upper extremity strength was compared to Jobst stocking (Control). Methods: An open, prospective, single-center study was done in in volunteers and in-patients. Study subject’s lower extremities were clinically classified by a blinded vascular specialist. Pressure readings were obtained using a pressure sensor in standing position every 5 minutes during two 30-minute sessions using CR and Control. Results: Ninety study subjects (82 healthy volunteers, 8 in-patients, 34% males, 66% females, 70% White, 22% African American, %7 Asian, 1% Hispanic) completed the study. Clinical vascular classification revealed 31% C0, 18% C3, 16% C1, 7% C2, 4% C4 and 22% unclassified. CR performed similar to Control in terms of pressure delivery. Calf circumference was not impacted by pressure sessions in both groups. Application time of CR was higher but removal times were similar. Qualitative feedback collected showed that CR was superior to conventional garment. Conclusion: CR appeared to be equally effective to Control graduated elastic stockings with a longer application time on first attempt but consistently higher scores for satisfaction. This may represent an attractive alternative with higher patient compliance rates.
Background Ablation lesions represent a complex interaction between the ablation catheter configuration and tissue anatomy. An understanding of each variable can assist in determination of the optimal lesion set. One such variable is the catheter orientation. With an irrigated radiofrequency ablation catheter with 6 pores (6P) near the distal tip, lesion surface area and volumes are smaller in the horizontal catheter orientation compared to the vertical catheter orientation. This finding is explained by the 6P irrigation catheter design, where irrigation fluid is discharged from six ports around the circumference of the electrode. Introduced in 2015, the ThermoCool SmartTouch® SF catheter has a 56-pore (56P) distribution to provide high density low volume irrigation settings. Irrigation catheters create smaller lesions in horizontal orientation compared to vertical orientation, however this has not been studied for the 56P irrigated catheter. Purpose Evaluate the impact of catheter orientation with sequential application of 56P catheter. Methods Ablation lesions were created on additive-free chicken model in a saline bath heated to 37°C using the 56P catheter under standard flow rate (8cc/min) conditions. Ablation energy of 20W and 30W was delivered twice for 30 seconds with 3 minutes interval between applications. Contact force (CF) of 5, 10, 15, and 20g was applied with the following conditions: horizontal catheter orientation followed by horizontal (HH), vertical by vertical (VV), horizontal by vertical (HV), and vertical by horizontal catheter orientation (VH). Measurements were obtained by lesion dissection through the midpoint by 3 independent operators. Kruskal-Wallis test was used for comparison of lesion depth, surface area and volume. Results Ninety-six lesions were analyzed. No coagulum or steam pops were included in the analysis. The minimum and maximum lesion depth, surface area and volume were 1.5 & 6.0 mm, 14.1 & 117.7mm2, 47.1 & 471.0 mm3 respectively. There was no significant difference in the lesion depth, surface area or volume in HH, VV, HV or VH orientation at different CF with 20W and 30W. (Fig 1) Figure 1 Conclusion Unlike other irrigated catheters, catheter orientation with sequential application with different CF and power did not impact lesion depth, surface area and volume with 56P catheter. This finding could be considered useful in situations where the catheter orientation could be challenging owing to tissue anatomy to achieve adequate lesion size. Acknowledgement/Funding UVA Health System
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