Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial.

BACKGROUND: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. METHODS: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. RESULTS: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. CONCLUSIONS: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04198701.

Thinking in Stories: Narrative Reasoning of an Occupational Therapist Supporting People with Profound Intellectual Disabilities' Engagement in Occupation.

This article illustrates narrative reasoning using the findings from research into an occupational therapy intervention promoting changes in the ways a staff team facilitated meaningful engagement in occupation. Qualitative critical ethnographic case study research explored a single case over one year of an occupational therapist working with five people with profound intellectual disabilities and their support network. Data were collected using participant observation, interviews and document analysis. Illustrated by an ethnodramatic vignette, the findings demonstrate how the occupational therapist reasoned narratively by eliciting, telling and creating stories and how this supported individualization of her intervention to the specific context. Creation of a prospective story that the support network were invited to share, guided and propelled the intervention toward its hoped-for ending. Narrative reasoning was particularly apparent in opportunities to reflect aloud, supporting occupational therapists' need of opportunities for reflection through story-sharing and story-making. Case study and ethnographic research methodologies may be useful in further clinical reasoning research to better understand narrative reasoning.

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.

Protocol driven periprocedural anticoagulation for left atrial ablation.

INTRODUCTION: A weight-based heparin dosing policy adjusted for preprocedural oral anticoagulation was implemented to reduce the likelihood of subtherapeutic dosing during left atrial catheter ablation procedures. We hypothesized that initiation of the protocol would result in a greater prevalence of therapeutic activated clotting time (ACT) values and decreased time to therapeutic ACT during left atrial ablation procedures. METHODS: A departmental protocol was initiated for which subjects received intravenous unfractionated heparin (UFH) to achieve and maintain a goal of ACT >300 s. Initial bolus dose was adjusted for pre-procedure oral anticoagulation and weight as follows: 50 units/kg for those receiving warfarin, 75 units/kg for those not anticoagulated, and 120 units/kg for those on direct oral anticoagulants (DOACs). A UFH infusion was initiated at 10% of the bolus per hour. One hundred consecutive left atrial ablation procedures treated with Protocol Guided heparin dosing were compared with a retrospective consecutive cohort of Usual Care heparin dosing. RESULTS: When the Usual Care and Protocol Guided cohorts were compared, significant findings were limited to those on pre-procedure DOAC. The initial UFH bolus increased from 99.3 ± 24.8 to 118.2 ± 22.8 units/kg (p < .001), the proportion of therapeutic ACT on the first draw after heparin administration increased from 57.7% to 76.6% (p = .010), and the time to therapeutic ACT after UFH administration decreased from 37.8 ± 19.8 to 30.2 ± 16.4 min (p = .032). CONCLUSION: A weight-based protocol for periprocedural UFH administration resulted in a higher proportion of therapeutic ACT values and decreased the time to therapeutic ACT for those on pre-procedure DOAC.

Navigating inferior vena cava filters in invasive cardiology procedures: A systematic review.

BACKGROUND: Transfemoral venous access (TFV) is the cornerstone of minimally invasive cardiac procedures. Although the presence of inferior vena cava filters (IVCFs) was considered a relative contraindication to TFV procedures, small experiences have suggested safety. We conducted a systematic review of the available literature on cardiac procedural success of TFV with IVCF in-situ. METHODS: Two independent reviewers searched PubMed, EMBASE, SCOPUS, and Google Scholar from inception to October 2020 for studies that reported outcomes in patients with IVCFs undergoing TFV for invasive cardiac procedures. We investigated a primary outcome of acute procedural success and reviewed the pooled data for patient demographics, procedural complications, types of IVCF, IVCF dwell time, and procedural specifics. RESULTS: Out of the 120 studies initially screened, 8 studies were used in the final analysis with a total of 100 patients who underwent 110 procedures. The most common IVCF was the Greenfield Filter (36%), 60% of patients were males and the mean age was 67.8 years. The overall pooled incidence of acute procedural success was 95.45% (95% confidence interval = 89.54-98.1) with no heterogeneity (I2 = 0%, p = 1) and there were no reported filter-related complications. CONCLUSION: This systematic review is the largest study of its kind to demonstrate the safety and feasibility of TFV access in a variety of cardiac procedures in the presence of IVCF.

Safety and chronic lesion characterization of pulsed field ablation in a Porcine model.

BACKGROUND: Pulsed field ablation (PFA) has been identified as an alternative to thermal-based ablation systems for treatment of atrial fibrillation patients. The objective of this Good Laboratory Practice (GLP) study was to characterize the chronic effects and safety of overlapping lesions created by a PFA system at intracardiac locations in a porcine model. METHODS: A circular catheter with nine gold electrodes was used for overlapping low- or high-dose PFA deliveries in the superior vena cava (SVC), right atrial appendage (RAA), and right superior pulmonary vein (RSPV) in six pigs. Electrical isolation was evaluated acutely and chronic lesions were assessed via necropsy and histopathology after 4-week survival. Acute and chronic safety data were recorded peri- and post-procedurally. RESULTS: No animal experienced ventricular arrhythmia during PFA delivery, and there was no evidence of periprocedural PFA-related adverse events. Lesions created in all anatomies resulted in electrical isolation postprocedure. Lesions were circumferential, contiguous, and transmural, with all converting into consistent lines of chronic replacement fibrosis, regardless of trabeculated or smooth endocardial surface structure. Ablations were non-thermally generated with only minimal post-delivery temperature rises recorded at the electrodes. There was no evidence of extracardiac damage, stenosis, aneurysms, endocardial disruption, or thrombus. CONCLUSION: PFA deliveries to the SVC, RAA, and RSPV resulted in complete circumferential replacement fibrosis at 4-week postablation with an excellent chronic myocardial and collateral tissue safety profile. This GLP study evaluated the safety and efficacy of a dosage range in preparation for a clinical trial and characterized the non-thermal nature of PFA.

Pulsed field ablation for pulmonary vein isolation in the treatment of atrial fibrillation.

Pulsed-field ablation (PFA) is a promising new ablation modality for the treatment of atrial fibrillation. This energy form employs a train of microsecond duration high amplitude electrical pulses that ablate myocardium by electroporation of the sarcolemmal membrane without measurable tissue heating. The ablation pulse waveform has multiple variable components that can affect ablation efficacy, thus each proprietary system has unique properties that cannot be generalized to other systems. Success with PFA depends upon the proximity of the electrode to the target tissue, but not necessarily upon contact. A unique feature of PFA is tissue specificity. Myocardium is very susceptible to irreversible injury whereas the esophagus, phrenic nerves, pulmonary veins, and coronary arteries are relatively resistant to injury. The tissue specificity of PFA may result in a wide therapeutic range and improved safety profile during atrial fibrillation ablation. Vein isolation can be achieved very rapidly (seconds) promising that PFA may reduce procedure time to 1 hour or less. This attractive new technology promises to be a major advance in the field of atrial fibrillation ablation.

Physicians' perceptions of shared decision-making for implantable cardioverter-defibrillators: Results of a physician survey.

BACKGROUND: Centers for Medicare and Medicaid Services has mandated the use of shared decision-making (SDM) for implantable cardioverter-defibrillator (ICD) implantation. SDM tools help facilitate quality SDM by presenting patients with balanced evidence-based facts related to risk and benefits. Perceptions of ICD implantation may differ based on patients' sex and race. OBJECTIVE: To determine if and how physicians are incorporating SDM in counseling patients about ICD and if they are aware of sex- and race-based differences in patients' perception of ICDs. METHODS: This was a pilot study involving an online survey targeting attending physicians who implant ICDs. Physicians were randomly selected by a computer-based program; 350 surveys were sent. RESULTS: Of the 124 (35%) respondents to the survey, 102 (84%) met the inclusion criteria, and of those, 99 (97%) were adult electrophysiologists. Most physicians (90, 88%) stated they engaged in SDM during the general consent process. Sixty-three (62%) physicians discuss end of life issues while obtaining general consent. Forty-four (43%) physicians said they use an existing SDM tool with the Colorado SDM tool being the most common (39, 89%). The majority of physicians were unaware of sex- and race-based differences in perceptions related to ICD implantation (sex 64, 63% and race 63, 62%). CONCLUSION: A vast majority of physicians are engaging in SDM; however less than half are using a formal SDM tool, and a minority of physicians were aware of sex- and race-based differences in patients' perception of ICD implantation. Sex- and race-based tools might help address this gap.

Occupational health hazards in the interventional laboratory: Time for a safer environment.

Over the past 30 years, the advent of fluoroscopically guided interventional procedures has resulted in dramatic increments in both X-ray exposure and physical demands that predispose interventionists to distinct occupational health hazards. The hazards of accumulated radiation exposure have been known for years, but until recently the other potential risks have been ill-defined and under-appreciated. The physical stresses inherent in this career choice appear to be associated with a predilection to orthopedic injuries, attributable in great part to the cumulative adverse effects of bearing the weight and design of personal protective apparel worn to reduce radiation risk and to the poor ergonomic design of interventional suites. These occupational health concerns pertain to cardiologists, radiologists and surgeons working with fluoroscopy, pain management specialists performing nonvascular fluoroscopic procedures, and the many support personnel working in these environments. This position paper is the work of representatives of the major societies of physicians who work in the interventional laboratory environment, and has been formally endorsed by all. In this paper, the available data delineating the prevalence of these occupational health risks is reviewed and ongoing epidemiological studies designed to further elucidate these risks are summarized. The main purpose is to publicly state speaking with a single voice that the interventional laboratory poses workplace hazards that must be acknowledged, better understood and mitigated to the greatest extent possible, and to advocate vigorously on behalf of efforts to reduce these hazards. Interventional physicians and their professional societies, working together with industry, should strive toward the ultimate zero radiation exposure work environment that would eliminate the need for personal protective apparel and prevent its orthopedic and ergonomic consequences. © 2008 Wiley-Liss, Inc.

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 2: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure to clinical personnel. While the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. ACC leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. "Optimal Use of Ionizing Radiation in Cardiovascular Imaging - Best Practices for Safety and Effectiveness" is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. "Part I: Radiation Physics and Radiation Biology" addresses radiation physics, dosimetry and detrimental biologic effects. "Part II: Radiologic Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection" covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy). For each modality, it includes the determinants of radiation exposure and techniques to minimize exposure to both patients and to medical personnel.

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 1: Radiation Physics and Radiation Biology: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways Developed in Collaboration With Mended Hearts.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure for clinical personnel. Although the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. The American College of Cardiology leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. Optimal Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and Effectiveness is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. Part I: Radiation Physics and Radiation Biology addresses the issue of medical radiation exposure, the basics of radiation physics and dosimetry, and the basics of radiation biology and radiation-induced adverse effects. Part II: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy) and will be published in the next issue of the Journal.

Health professionals working effectively with support workers to enhance the quality of support for adults with intellectual disabilities: A meta-ethnography.

BACKGROUND: Paid support workers are often central to the quality of life of adults with intellectual disabilities. Health and social care professionals increasingly carry out interventions indirectly through those support workers and therefore need to understand how best to collaborate. METHODS: This article synthesizes findings from the qualitative research of others investigating health professionals' work with support staff. From sixty-two articles retrieved from a database and journal search, seven met inclusion criteria and a meta-ethnographic synthesis allowed construction of an interpretive line-of-argument. RESULTS: Thirteen themes within the articles were synthesized into three over-archingconstructs, suggesting that professionals should collaborate by providing effective leadership, working in partnership with support workers and managers and recognizing the influence of organizational structures and context. CONCLUSIONS: As these constructs seem reflective of important components of teamwork, a "line-of-argument" is proposed that it could be helpful for professionals to view themselves as part of a "team" with support workers.

Autophagy: an adaptive physiological countermeasure to cellular senescence and ischaemia/reperfusion-associated cardiac arrhythmias.

Oxidative stress placed on tissues that involved in pathogenesis of a disease activates compensatory metabolic changes, such as DNA damage repair that in turn causes intracellular accumulation of detritus and 'proteotoxic stress', leading to emergence of 'senescent' cellular phenotypes, which express high levels of inflammatory mediators, resulting in degradation of tissue function. Proteotoxic stress resulting from hyperactive inflammation following reperfusion of ischaemic tissue causes accumulation of proteinaceous debris in cells of the heart in ways that cause potentially fatal arrhythmias, in particular ventricular fibrillation (VF). An adaptive response to VF is occurrence of autophagy, an intracellular bulk degradation of damaged macromolecules and organelles that may restore cellular and tissue homoeostasis, improving chances for recovery. Nevertheless, depending on the type and intensity of stressors and inflammatory responses, autophagy may become pathological, resulting in excessive cell death. The present review examines the multilayered defences that cells have evolved to reduce proteotoxic stress by degradation of potentially toxic material beginning with endoplasmic reticulum-associated degradation, and the unfolded protein response, which are mechanisms for removal from the endoplasmic reticulum of misfolded proteins, and then progressing through the stages of autophagy, including descriptions of autophagosomes and related vesicular structures which process material for degradation and autophagy-associated proteins including Beclin-1 and regulatory complexes. The physiological roles of each mode of proteotoxic defence will be examined along with consideration of how emerging understanding of autophagy, along with a newly discovered regulatory cell type called telocytes, may be used to augment existing strategies for the prevention and management of cardiovascular disease.

Atrioesophageal Fistula Following Radiofrequency Catheter Ablation of Atrial Fibrillation.

Atrioesophageal fistula (AEF) is a rare but catastrophic complication of catheter ablation of atrial fibrillation (AF), with an incidence of 0.03% to 1.5% per year. We report two cases and review the epidemiology, clinical features, pathogenesis, and management of AEF after AF ablation. The principal clinical features of AEF include fever, hematemesis, and neurologic deficits within 2 months after ablation. The close proximity of the esophagus to the posterior left atrial wall is considered responsible for esophageal injury during ablation and the eventual development of AEF. Prophylactic proton pump inhibitors, esophageal temperature monitoring, visualization of the esophagus during catheter ablation, esophageal protection devices, esophageal cooling, and avoidance of energy delivery in close proximity to the esophagus are some techniques to prevent esophageal injury. Eliminating esophageal injury during AF ablation is of utmost importance in preventing AEF. A high index of suspicion and early intervention are necessary to prevent fatal outcomes. Early surgical repair is the mainstay of treatment.

Alpha-Melanocyte-stimulating Hormone Induces Vasodilation and Exerts Cardioprotection Through the Heme-Oxygenase Pathway in Rat Hearts.

Alpha-melanocyte-stimulating hormone (α-MSH) is a protein with known capacity for protection against cardiovascular ischemia-reperfusion (I/R) injury. This investigation evaluates the capacity of α-MSH to mitigate I/R effects in an isolated working rat heart model and determine the dependency of these alterations on the activity of heme oxygenase-1 (HO-1, hsp-32), a heat shock protein that functions as a major antioxidant defense molecule. Healthy male Sprague Dawley rats were used for all experiments. After treatment with selected doses of α-MSH, echocardiographic examinations were performed on live, anesthetized animals. Hearts were harvested from anesthetized rats pretreated with α-MSH and/or the HO-1 inhibitor SnPP, followed by cardiac function assessment on isolated working hearts, which were prepared using the Langendorff protocol. Induction of global ischemia was performed, followed by during reperfusion assessment of cardiac functions. Determination of incidence of cardiac arrhythmias was made by electrocardiogram. Major outcomes include echocardiographic data, suggesting that α-MSH has mild effects on systolic parameters, along with potent antiarrhythmic effects. Of particular significance was the specificity of dilatative effects on coronary vasculature, and similar outcomes of aortic ring experiments, which potentially allow different doses of the compound to be used to selectively target various portions of the vasculature for dilation.

Effects of Momordica charantia (Bitter Melon) on Ischemic Diabetic Myocardium.

Objective: A rat model is here used to test a hypothesis that Momordica charantia (Bitter melon (BM)) extract favorably alters processes in cardiovascular tissue and is systemically relevant to the pathophysiology of type 2 diabetes (T2DM) and related cardiovascular disease. Methods: Male Lean and Zucker Obese (ZO) rats were gavage-treated for six weeks with 400 mg/kg body weight bitter melon (BM) extract suspended in mucin-water vehicle, or with vehicle (Control). Animals were segregated into four treatment groups, 10 animals in each group, according to strain (Lean or ZO) and treatment (Control or BM). Following six-week treatment periods, peripheral blood was collected from selected animals, followed by sacrifice, thoracotomy and mounting of isolated working heart setup. Results: Body mass of both Lean and ZO rats was unaffected by treatment, likewise, peripheral blood fasting glucose levels showed no significant treatment-related effects. However, some BM treatment-related improvement was noted in postischemic cardiac functions when Lean, BM-treated animals were compared to vehicle treated Lean control rats. Treatment of Lean, but not ZO, rats significantly reduced the magnitude of infarcted zone in isolated hearts subjected to 30 min of ischemia followed by 2 h of working mode reperfusion. Immunohistochemical demonstration of caspase-3 expression by isolated heart tissues subjected to 30 min of ischemia followed by 2 h of reperfusion, revealed significant correlation between BM treatment and reduced expression of this enzyme in hearts obtained from both Lean and ZO animals. The hierarchy and order of caspase-3 expression from highest to lowest was as follows: ZO rats receiving vehicle > ZO rats receiving BM extract > Lean rats treated receiving vehicle > Lean rats administered BM extract. Outcomes of analyses of peripheral blood content of cardiac-related analytics: with particular relevance to clinical application was a significant elevation in blood of ZO and ZO BM-treated, versus Lean rats of total cholesterol (high density lipoprotein HDL-c + low density lipoprotein LDL-c), with an inferred increase in HDL-c/LDL-c ratio-an outcome associated with decreased risk of atherosclerotic disease. Conclusions: BM extract failed to positively affect T2DM- and cardiovascular-related outcomes at a level suggesting use as a standalone treatment. Nevertheless, the encouraging effects of BM in enhancement of cardiac function, suppression of post-ischemic/reperfused infarct size extent and capacity to modulate serum cholesterol, will likely make it useful as an adjuvant therapy for the management of T2DM and related cardiovascular diseases.

Antioxidant Properties and Oxidative Transformation of Different Chromone Derivatives.

Nowadays, there is an increase in the application of natural products for the prevention of different disorders or adjuvant substances next to pharmacological treatment. Phytochemicals include different chromone derivatives, which possess a wide spectrum of biological activity. The aim of the present study was the investigation of the antioxidant activity, cytotoxicity and oxidative transformation of nine chromone derivatives. First, we investigated the radical scavenging activity (ABTS), the oxygen radical absorption capacity (ORAC) and the ferric reducing antioxidant power (FRAP) of the investigated molecules. The cytotoxic effects of the compounds were tested on H9c2 cell cultures by the MTT assay. Each compound showed a significant ORAC value compared to the reference. However, the compound 865 possess significantly higher FRAP and ABTS activity in comparison with the reference and other tested molecules, respectively. Based on these assays, the compound 865 was selected for further analysis. In these experiments, we investigated the oxidative metabolism of the compound in vitro. The molecule was oxidized by the Fenton reaction, artificial porphyrin and electrochemistry; then, the formed products were identified by mass spectrometry. Four possible metabolites were detected. The results revealed the compound 865 to possess good antioxidant properties and to be stable metabolically; hence, it is worth investigating its effects in vivo.

Figure-of-eight suture for venous hemostasis in fully anticoagulated patients after atrial fibrillation catheter ablation.

INTRODUCTION: Limited data exists for types of venous closure and its associated complications in patients after atrial fibrillation (AF) catheter ablation. We evaluated the subcutaneous figure-of-eight closure (FO8) for achieving venous hemostasis after AF catheter ablation compared to manual pressure. METHODS: 284 consecutive patients that underwent AF catheter ablation by two operators were included. All patients received continuous therapeutic warfarin or interrupted novel oral anticoagulants (NOAC) and heparin (ACT300-400 s) without reversal. Patients were divided into two groups: 1) sheaths were left in place and pulled once ACT < 180 s, with hemostasis being achieved with manual pressure (MP); and 2) a subcutaneous FO8 suture closed the venous access site immediately after the ablation on each groin site and sheaths were removed immediately after the ablation despite full anticoagulation with heparin and warfarin or interrupted NOAC. Sutures were removed after four hours, and the patients laid flat for an additional two hours. RESULTS: The MP group (n = 105) was similar to the FO8 group (n = 179). Time in bed was 573 ± 80 min for MP group vs. 373 ± 49 min for FO8 group (p < 0.0001). Eleven hematomas were seen in the MP group compared to seven in the FO8 group (P = 0.041). CONCLUSIONS: In fully anticoagulated patients undergoing AF catheter ablation, excellent hemostasis was achieved with figure-of-eight sutures, with no major vascular complications, a lower hematoma rate, and a significantly shorter flat-time-in-bed compared to manual pressure.

Incidence of Pocket Infection Postcardiac Device Implantation Using Antibiotic versus Saline Solution for Pocket Irrigation.

BACKGROUND: Preprocedure systemic antibiotic prophylaxis reduces infections in patients undergoing cardiac implantable electronic devices (CIEDs) implantations. Whether pocket irrigation with antibiotic solution offers any advantage over saline solution in CIED implantation is unknown. METHODS: Records from 327 consecutive patients who underwent CIED implantation by three operators from February 2011 to January 2014 were reviewed. From February 2011 to January 2012, the antibiotic solution was used for pocket irrigation; from February 2012 to January 2014, saline solution was used. All patients received preprocedural IV antibiotics. Baseline demographics, comorbidities, lab data, and occurrence of any pocket infection postimplant were collected. RESULTS: There were 118 and 209 patients in the antibiotic solution and saline solution group, respectively. A total of four (1.2%) patients had CIED infection: two in the antibiotic solution group and two in the saline solution group. Median time to infection from implant date was 81.5 ± 35 days. Two patients (50%) had infection after first device implantation. Of the four patients, one had positive blood culture, three had positive pocket cultures, one had lead vegetation, one underwent pocket exploration, and all of them had devices/leads extracted, with reimplantation on the contralateral side. No mortality was observed due to infectious complications. CONCLUSION: When compared to pocket irrigation in the antibiotic solution group, the saline solution group was not associated with increased incidence of infectious complications after CIED implantation. The use of saline solution pocket irrigation alone may be used in CIED pocket irrigation periprocedurally.  Further evaluation in larger randomized trials is needed.