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1.
Celebrating 50 years of the lithium power source for cardiac pacemakers.
Mond, HG, Villafaña, M
Heart rhythm. 2021;(3):491-492
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2.
The Cardiac Pacemaker Clinic: Memories From a Bygone Era.
Mond, HG, Sloman, JG
Heart, lung & circulation. 2021;(2):216-224
Abstract
In 1963, soon after the first ventricular pacemakers were implanted at the Royal Melbourne Hospital, attempts were made to identify impending pacing failure, thus preventing sudden death in these very vulnerable patients. By 1970, patient numbers had increased, a formal regular pacemaker clinic was established, and guidelines and protocols developed. The clinic was staffed by a physician, a biomedical engineer and cardiac technicians. The unipolar, asynchronous, non-programmable pulse generators were powered by mercuric oxide/zinc batteries and implanted in the abdomen, using either transvenous or epimyocardial leads. Although, pulse generators were electively replaced at 3 years, most had already been replaced because of power source depletion, electronic failure or lead issues. Testing in all patients involved an electrocardiographic rhythm strip and electronic analysis of the stimulus artefact using a calibrated high-speed storage oscilloscope. Results were compared to previous studies and significant changes were interpreted as impending power source depletion. As a result of this testing, 97% of cases of impending power source depletion were detected prior to failure. These findings allowed testing each 4 months and for pulse generator life to be extended beyond three years. With ventricular triggered pulse generators, new testing procedures were designed. With time, visiting regional centres and clinical evaluation of new products became important functions of the clinic.
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3.
Role of 18F-FDG PET/CT in the diagnosis of cardiovascular implantable electronic device infections: A meta-analysis.
Mahmood, M, Kendi, AT, Farid, S, Ajmal, S, Johnson, GB, Baddour, LM, Chareonthaitawee, P, Friedman, PA, Sohail, MR
Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology. 2019;(3):958-970
Abstract
OBJECTIVE We performed a meta-analysis evaluating the use of fluorine-18-fluorodeoxyglucose (18F-FDG) positron-emission tomography (PET)/computed tomography (CT) in the diagnosis of cardiovascular implantable electronic device (CIED) infections. BACKGROUND PET/CT may be helpful in the diagnosis of CIED infection, particularly in patients with the absence of localizing signs or definitive echocardiographic findings. METHODS PubMed, Embase, Cochrane library, CINAHL, Web of Knowledge, and www.clinicaltrials.gov from January 1990 to April 2017 were searched for studies evaluating the accuracy of PET/CT in the diagnosis of CIED infections. RESULTS Overall, 14 studies involving 492 patients were included in the meta-analysis. The pooled sensitivity of PET/CT for diagnosis of CIED infection was 83% (95% CI 78%-86%) and the pooled specificity was 89% (95% CI 84%-94%). PET/CT demonstrated a higher sensitivity of 96% (95% CI 86%-99%) and specificity of 97% (95% CI 86%-99%) for diagnosis of pocket infections. Diagnostic accuracy for lead infections or CIED-IE was lower with pooled sensitivity of 76% (95% CI 65%-85%) and specificity of 83% (95% CI 72%-90%). CONCLUSION Use of PET/CT in the evaluation of CIED infection has both a high sensitivity (83%) and specificity (89%) and deserves consideration in the management of selected patients with suspected CIED infections.
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4.
A double-blind, randomised, placebo-controlled, cross-over study assessing the use of XEN-D0103 in patients with paroxysmal atrial fibrillation and implanted pacemakers allowing continuous beat-to-beat monitoring of drug efficacy.
Shunmugam, SR, Sugihara, C, Freemantle, N, Round, P, Furniss, S, Sulke, N
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. 2018;(3):191-197
Abstract
PURPOSE The ultrarapid delayed rectifier current (IKur) carried by Kv1.5 channels, which are solely expressed in the atrium, is a potential target for safer treatment of paroxysmal atrial fibrillation (PAF). XEN-D0103 is a nanomolar ion channel blocker that selectively inhibits potassium ion flux through the Kv1.5 ion channel. The efficacy of XEN-D0103 in reducing AF burden was assessed in patients with DDDRp permanent pacemakers (PPMs) and PAF. METHODS A double-blind, placebo-controlled, cross-over study was performed in patients with PAF and DDDRp PPMs with advanced atrial and ventricular Holters allowing beat-to-beat arrhythmia follow-up. All anti-arrhythmic drugs were withdrawn before randomised treatment. After baseline assessment, patients were randomly assigned to two treatment periods of placebo then XEN-D0103 50 mg bd, or XEN-D0103 50 mg bd then placebo. RESULTS Fifty-four patients were screened and 21 patients were eligible and included in the randomised trial. All 21 patients completed both treatment periods. The primary endpoint was change in AF burden assessed by PPM. There was no significant difference in AF burden on treatment with XEN-D0103 versus placebo. There was a reduction in the mean frequency of AF episodes (relative reduction 0.72, 95% CI 0.66 to 0.77; p < 0.0001). XEN-D0103 was safe and well tolerated, and there were no serious adverse events. XEN-D0103 did not have any apparent effect on heart rate compared to placebo. CONCLUSIONS XEN-D0103 did not reduce AF burden in patients with PAF and dual chamber pacemakers providing beat-to-beat monitoring. XEN-D0103 was well tolerated and did not have any apparent effect on heart rate. Although single-ion channel blockade with XEN-D0103 did not affect AF in this study, there might be a potential for this agent to be used in combination with other atrially specific drugs in the treatment of AF. EUDRACT TRIAL REGISTRATION NUMBER 2013-004456-38.
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5.
Prevention of Cardiac Implantable Electronic Device Infections: Single Operator Technique with Use of Povidone-Iodine, Double Gloving, Meticulous Aseptic/Antiseptic Measures and Antibiotic Prophylaxis.
Manolis, AS, Melita, H
Pacing and clinical electrophysiology : PACE. 2017;(1):26-34
Abstract
BACKGROUND Cardiac implantable electronic device (CIED) implantation is complicated by infection still at a worrisome rate of 2-5%. Since early on during device implantation procedures, we have adopted an infection-preventive technique which has hitherto resulted in effective prevention of infections. Herein we present our results of applying this technique by a single operator in a prospective series of 762 consecutive patients undergoing device implantation. METHODS A meticulous search for and treatment of active, occult, or smoldering infection was undertaken preoperatively. An aseptic/antiseptic technique was used for implantation of each device. Skin preparation is thorough with initial cleansing performed with alcohol followed by povidone-iodine 10% solution, which is also used in the wound and inside the pocket. In addition, we routinely use double gloving, and IV antibiotic prophylaxis 1 hour before and for 48 hours afterwards followed by oral antibiotic for 2-3 days after discharge. The skin is closed with absorbable sutures. The study includes 382 patients having a new pacemaker (n = 333) or battery change, system upgrade or lead revision (n = 49), and 380 patients having a new implantable cardioverter-defibrillator (ICD) (n = 296) or device replacement/upgrade/lead revision (n = 84). RESULTS The pacemaker group, aged 70.2 ± 16.5 years, includes 18% VVI, 49% DDD, 29% VDD, and 4% cardiac resynchronization therapy (CRT) devices. The ICD group, aged 61.3 ± 13.0 years, with a mean ejection fraction of 36 ± 13%, includes 325 ICD and 55 CRT implants. Over 26.6 ± 33.4 months for the pacemaker group and 36.6 ± 38.3 months for the ICD group, infection occurred in one patient in each group (0.26%) having a device replacement. CONCLUSION A consistent and strict approach of aseptic/antiseptic technique with the use of double gloving and povidone-iodine solution within the pocket plus a 4-day regimen of antibiotic prophylaxis minimizes infections in CIED implants.
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6.
Early Right Ventricular Apical Pacing-Induced Gene Expression Alterations Are Associated with Deterioration of Left Ventricular Systolic Function.
Xu, H, Xie, X, Li, J, Zhang, Y, Xu, C, Yang, J
Disease markers. 2017;:8405196
Abstract
The chronic high-dose right ventricular apical (RVA) pacing may have deleterious effects on left ventricular (LV) systolic function. We hypothesized that the expression changes of genes regulating cardiomyocyte energy metabolism and contractility were associated with deterioration of LV function in patients who underwent chronic RVA pacing. Sixty patients with complete atrioventricular block and preserved ejection fraction (EF) who underwent pacemaker implantation were randomly assigned to either RVA pacing (n = 30) group or right ventricular outflow tract (RVOT) pacing (n = 30) group. The mRNA levels of OPA1 and SERCA2a were significantly lower in the RVA pacing group at 1 month's follow-up (both p < 0.001). Early changes in the expression of selected genes OPA1 and SERCA2a were associated with deterioration in global longitudinal strain (GLS) that became apparent months later (p = 0.002 and p = 0.026, resp.) The altered expressions of genes that regulate cardiomyocyte energy metabolism and contractility measured in the peripheral blood at one month following pacemaker implantation were associated with subsequent deterioration in LV dyssynchrony and function in patients with preserved LVEF, who underwent RVA pacing.
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7.
A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker.
Lakkireddy, D, Knops, R, Atwater, B, Neuzil, P, Ip, J, Gonzalez, E, Friedman, P, Defaye, P, Exner, D, Aonuma, K, et al
Heart rhythm. 2017;(12):1756-1763
Abstract
BACKGROUND The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. OBJECTIVE To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. METHODS The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. RESULTS Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported. CONCLUSION As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious.
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8.
Preoperative skin antiseptics for prevention of cardiac implantable electronic device infections: a historical-controlled interventional trial comparing aqueous against alcoholic povidone-iodine solutions.
Da Costa, A, Tulane, C, Dauphinot, V, Terreaux, J, Romeyer-Bouchard, C, Gate-Martinet, A, Levallois, M, Isaaz, K
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2015;(7):1092-8
Abstract
AIMS: Local skin antiseptic prevention against cardiac implantable electronic device (CIED) infections is not yet fully understood. This monocentre historical-controlled study sought to (i) conduct a prospective observational analysis comparing two antiseptic skin preparations over two similar consecutive periods of time, one conducted over a 1-year period using an aqueous povidone-iodine solution (Group I) and the other over the following with an alcoholic povidone-iodine solution (Group II); (ii) determine the predictive factors of CIED infection. METHODS AND RESULTS Cardiac implantable electronic device implantation was performed in 1326 patients (pts). A total of 32 pts (2.4%) developed a CIED infection. Long-term follow-up (26 ± 3 months) revealed no significant difference between the groups: infections were observed in 14 of the 648 pts (2.2%) in Group I vs. 18 of the 678 pts (2.7%) in Group II (P = 0.9). Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. The occurrence of infection was positively correlated with re-intervention (aOR, 7.16; 95% CI, 2.56-19.99; P < 0.0001), number of generator replacements, mean (aOR, 3.47; 95% CI, 2.22-5.44; P < 0.001), and haematoma (aOR, 48.4; 95% CI, 13.45-174.25; P < 0.0001). CONCLUSION This study found that aqueous and alcoholic povidone-iodine solutions displayed similar antiseptic effects regarding CIED infection prevention. Independent predictive factors of CIED infection were re-intervention, haematoma, and number of generator replacements.
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9.
Cardiovascular implantable electronic device infections: associated risk factors and prevention.
Rohacek, M, Baddour, LM
Swiss medical weekly. 2015;:w14157
Abstract
Infections of cardiovascular implantable electric devices (CIED) are a burden on patients and healthcare systems and should be prevented. The most frequent pathogens are coagulase-negative staphylococci and Staphylococcus aureus. The most important risk factors for CIED infections are diabetes mellitus, renal and heart failure, corticosteroid use, oral anticoagulation, fever within 24 hours before the procedure and leucocytosis, implantable cardioverter defibrillator compared with pacemaker, especially in the case of Staphylococcus aureus bacteraemia, lack of antibiotic prophylaxis, and postoperative haematoma and other wound complications. Other important risk factors are history of prior procedures and previous CIED infections, number of leads, use of povidone-iodine compared with chlorhexidine-alcohol, and centres and operators with a low volume of implants. To prevent CIED infections, patients undergoing CIED procedures and appropriate devices should be carefully selected, and interventions should be performed by trained operators. Antibiotic prophylaxis should be administered, and skin antisepsis should be done with chlorhexidine-alcohol. Oral anticoagulation should be continued during CIED procedures in high-risk patients for thromboembolism, instead of bridging with heparin. Early reintervention in cases of haematoma or lead dislodgement should be avoided. The implementation of infection prevention programmes reduces infection rates. More randomised controlled studies are needed to evaluate prevention strategies, especially skin preparation and antibiotic prophylaxis with glycopeptides.
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10.
The potential of FDG PET/CT for early diagnosis of cardiac device and prosthetic valve infection before morphologic damages ensue.
Chen, W, Kim, J, Molchanova-Cook, OP, Dilsizian, V
Current cardiology reports. 2014;(3):459
Abstract
Diagnosis of cardiac mechanical device or prosthesis valve infection, and more importantly accurate localization of the infection site, such as defibrillator pocket, pacemaker lead, annular or peri-annular valve ring abscesses remain clinically challenging. Inconclusive diagnosis can lead to delayed antibiotic therapy, device extraction or surgical intervention, which may have dire consequences to the patient. Among patients with suspected cardiac mechanical device or prosthetic valve infection, recent publications advocate the use of (18)F-fluoro-2-deoxyglucose positron emission tomography computed tomography (FDG PET/CT), particularly when anatomy based imaging studies, such as echocardiography or CT, are uncertain or negative. A potential advantage of FDG PET/CT is in its detection of inflammatory cells early in the infection process, before morphologic damages ensue. However, there are many unanswered questions in the literature. There is a need for standardization amongst the various imaging studies, such as dietary preparation, duration and timing of image acquisition, image processing with and without CT attenuation correction, and more importantly image interpretation criteria. The answer for these issues awaits well designed, prospective studies.