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.

Meta-Analysis of New-Onset Atrial Fibrillation Versus No History of Atrial Fibrillation in Patients With Noncardiac Critical Care Illness.

The incidence of new-onset secondary atrial fibrillation (NOSAF) is as high as 44% in noncardiac critical illness. A systematic review and meta-analysis were performed to evaluate the impact of NOSAF, compared with history of prior atrial fibrillation (AF) and no history of AF in noncardiac critically ill patients. Patients undergoing cardiothoracic surgery were excluded. NOSAF incidence, intensive care unit (ICU)/hospital length of stay (LOS), and mortality outcomes were analyzed. Of 2,360 studies reviewed, 19 studies met inclusion criteria (n = 306,805 patients). NOSAF compared with no history of AF was associated with increased in-hospital mortality (risk ratio [RR] 2.06, 95% confidence interval [CI] 1.76 to 2.41, p <0.001), longer ICU LOS (standardized difference in means [SMD] 0.66, 95% CI 0.41 to 0.91, p <0.001), longer hospital LOS (SMD 0.31, 95% CI 0.07 to 0.56, p = 0.001) and increased risk of long-term (>1 year) mortality (RR 1.76, 95% CI 1.29 to 2.40, p <0.001). NOSAF compared with previous AF was also associated with higher in-hospital mortality (RR 1.29, 95% CI 1.12 to 1.49, p <0.001), longer ICU LOS (SMD 0.37, 95% CI 0.03 to 0.70, p = 0.03) but no difference in-hospital LOS (SMD -0.18, 95% CI -0.66 to 0.31, p = 0.47). In conclusion, NOSAF, in the setting of noncardiac critical illness is associated with increased in-hospital mortality compared with no history of AF and previous AF. NOSAF (vs no history of AF) is also associated with increased long-term mortality.

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.

Intracardiac echocardiography-guided, anatomically based radiofrequency ablation of focal atrial fibrillation originating from pulmonary veins.

OBJECTIVES: In patients with a pulmonary vein (PV) source for atrial fibrillation (AF), we sought the use of intracardiac echocardiography (ICE) to evaluate PV anatomy, guide radiofrequency (RF) ablation and monitor for acute stenosis during ablation. BACKGROUND: A focal source for AF may be found in the proximal component of the PVs and can be effectively treated by ablative techniques. However, the procedure may be challenging due to the complex anatomy of the left atrium and PVs, uncertain catheter positioning within the PVs and difficulties in mapping atrial extrasystoles, which may be rare or repeatedly induce AF and require cardioversion. METHODS: Sixty-four patients were referred for RF ablation of a focal source of AF, and 56 were identified as having AF triggers in > or =1 PV. Using ICE guidance, RF lesions were applied around the circumference of the vein near the os until there was electrical isolation. RESULTS: Lesions were placed in 82 veins (36 right superior PV, 33 left superior PV, 9 left inferior PV, 4 right inferior PV); 24 +/- 12 lesions per vein were necessary to create electrical isolation with a fluoroscopic time of 11 +/- 4 min and a mean of 22% reduction in luminal area. After a follow-up of 13 +/- 7 months, 66% of patients remained free of AF, and another 13% responded better to medications. CONCLUSIONS: We describe an anatomic approach to PV electrical isolation in which ICE is used to define the anatomy, guide RF ablation and monitor for acute PV changes.