Energy Efficient Biomedical Signal Processing in Implantable Devices

Many patients undergoing cardiac device implantation are taking direct oral anticoagulation (DOAC). Continuing DOAC during device implantation may increase periprocedural bleeding risk; however, interrupting DOACs may increase thromboembolic risk. To compare the incidence of clinically significant pocket hematoma and thromboembolism in patients who have their DOAC continued or interrupted for cardiac device implantation. We searched MEDLINE, EMBASE, and randomized controlled trial (CENTRAL) until December 2019 and included randomized controlled trials (RCTs) and observational studies that compared outcomes after continuing or interrupting DOAC during cardiac device implantation. Independently and in duplicate, reviewers screened titles, abstracts, and full text of potentially eligible studies. They then evaluated risk of bias and abstracted data. RCT data were pooled using a fixed-effect model. Quality of evidence was assessed using grading of recommendations assessment, development and evaluation (GRADE). Two RCTs, representing 763 patients, and three observational studies met eligibility criteria. In RCTs, continuing DOAC for device implantation compared to interrupting DOAC resulted in no significant difference in clinically significant pocket hematoma (2.1% vs 1.8%; RR 1.15; 95% CI 0.44-3.05) or thromboembolism (0.03% vs 0.03%; RR 1.02; 95% CI 0.06-16.21). Quality of evidence for both outcomes was moderate due to imprecision. Observational studies showed similar results. Continuing DOACs for device implantation results in little to no difference in the incidence of clinically significant pocket hematoma or thromboembolism. Given the ease of stopping and restarting DOACs, interrupting DOACs may be the preferred strategy for most patients. However, whenever continuous therapeutic anticoagulation is desired, DOAC continuation should be preferred over bridging with parenteral anticoagulation.

BackgroundInfection of implantable cardiac electrical devices (ICEDs) is associated with increased morbidity and mortality. The rates are higher with devices’ replacement than with primary device implantation.Aims and objectivesThe aim of...

Sex dependent mechanical properties of the human mandibular condyle

Chronic pain, especially low back pain and hip pain, has been a growing public health concern that affects over 100 million Americans annually. Radiofrequency ablation (RFA) has distinct advantages over other chronic pain management modalities and its use has been increasing over the past decade. Among the growing population with comorbid conduction disorders and persistent pain, RFA and its potential interference with implantable cardiac devices is of concern.RFA is becoming a foundational element of persistent pain management and has been shown to be effective in a multitude of chronic pain syndromes. Cardiac implantable electronic devices (CIED), such as cardiac pacemakers or implantable cardioverter defibrillators, have been used in the treatment of cardiac conduction diseases for a number of decades. With our aging population, these diseases have increased in both incidence and prevalence. Chronic pain and cardiac conduction diseases are both common in our increasingly aging population. This study aims to determine if the literature supports the hypothesis that patients with CIEDs can safely use RFA with minimal to no interaction. Systematic assessment of literature with a modified approach with bipolar RFA. A narrative review with systematic assessment of the literature was carried out. In this review, we included randomized controlled trials (RCTs), open non-randomized control studies, prospective studies, retrospective studies, case series, and case reports. All types of radiofrequency utilized for pain management including pulsed and conventional were included. Outcome measures included interactions between the cardiovascular implantable electronic device (CIED) and radiofrequency ablation (RFA), adverse events, RFA efficacy in treating the pain using pain scores, and other complications. Our search criteria yielded 4 studies for inclusion, with inclusion of 33 patients and 71 bipolar radiofrequency for treatments. No adverse events or interactions occurred between the bipolar radiofrequency device and the implanted cardiac devices in any of these patients. Bipolar radiofrequency was utilized in all patients (n = 33). Overall there were no complications or malfunctions. Small sample size, narrative review. This study provides evidence that bipolar RFA can be safely used in patients with CIEDs for chronic pain provided that proper precautions are employed. Considerations for safe use are provided.

The incidence and predictive factors of arrhythmias and/or conduction abnormalities (ACAs) requiring cardiac device (CD) implantation are poorly characterized in Fabry disease (FD). The aim of our retrospective study was to determine the prevalence, incidence, and factors associated with ACA requiring CD implantation in a monocentric cohort of patients with confirmed FD who were followed up in a department of internal medicine and reference center for FD.Forty-nine patients (20M, 29F) were included. Nine patients (4M, 5F; 18%) had at least one episode of ACA leading to device therapy. Six patients (4M/2F) required a pacemaker (PM) for sinus node dysfunction (n = 4) or atrioventricular disease (n = 2). One female patient required an internal cardioverter-defibrillator (ICD) to prevent sudden cardiac death because of nonsustained ventricular tachycardia (nSVT). One female patient required PM-ICD for sinus node dysfunction and nSVT. One patient underwent CD implantation before the diagnosis of FD. The annual rate of CD implantation was estimated at 1.90 per 100 person years. On univariate analysis at the end of the follow-up period, the factors associated with ACAs requiring CD implantation were as follows: delayed diagnosis of FD, delayed initiation of enzyme replacement therapy, age at the last follow-up visit, and severe multiorgan phenotype (hypertrophic cardiomyopathy, chronic kidney disease, and/or sensorineural hearing loss). On multivariate analysis, age at diagnosis of FD and age at the last follow-up visit were independently associated with an increased risk of ACAs requiring CD (P < 0.05).Considering the high frequency of ACAs requiring CD implantation and the risk of sudden death in patients with FD, regular monitoring is mandatory, especially in patients with a late diagnosis of FD and/or with a severe phenotype. Regular Holter ECGs, therapeutic education of patients, and deliverance of an emergency card including a phenotype summary are crucial in the care of FD patients.Available guidelines for device therapy and the efficacy of enzyme replacement therapy for arrhythmias or conduction abnormalities are discussed.

Introduction: Capsule endoscopy (CE) is widely used for the evaluation of small bowel pathology. Electromagnetic waves generated by CE may interfere with other electronic devices. For this reason, CE is contraindicated in patients with implantable cardiac devices. The primary aim of this study was to assess the safety of CE in patients with implantable cardiac devices. Methods: All patients who underwent CE and also had an implantable cardiac device such as pacemaker (PM), implantable cardiac defibrillators (ICD), and/or left ventricular assist device (LVAD) at an academic medical center from January 2007 to May 2014 were retrospectively reviewed. Age, gender, ethnicity, indication for CE, type of cardiac device(s) were evaluated. All patients underwent cardiac telemetry monitoring during CE. Pre and post procedure cardiac assessments were performed. Any cardiac events during CE and cardiac events within 30 days of study completion were reviewed. Results: Seventy-nine CE were performed on 70 patients who fulfilled inclusion criteria. The majority of patients were male (70.9%). Mean age was 67.9. Most patients were Caucasian (60.8%), followed by African American (25.3%), Hispanic (8.9%), Middle Eastern (3.8%), and Asian (1.3%). Patients most commonly had PM (46.8%), followed by PM + ICD (21.5%), ICD (13.9%), LVAD + ICD (12.7%), LVAD, ICD + PM (5.0%). Indications for CE included anemia (55.7%), GI bleed (26.6%), melena (8.8%), abdominal pain (6.3%) planned anticoagulation (1.3%), and Crohn’s disease (1.3%). During the study period of 8 hours, no cardiac events were noted on telemetry monitoring. No cardiac events occurred within 30 days of completion of CE. Recording of the CE images was not affected by the presence of cardiac devices. One patient experienced chest pain during the study, however, interrogation of the ICD revealed no cardiac event. Conclusion: Although CE is contraindicated in patients with implantable cardiac devices, our study demonstrates that CE may be safe in such patients. CE images were not compromised by the presence of cardiac devices.Table 1

ImportanceStaphylococcus aureus, a gram-positive bacterium, is the leading cause of death from bacteremia worldwide, with a case fatality rate of 15% to 30% and an estimated 300 000 deaths per year.ObservationsStaphylococcus aureus bacteremia causes metastatic infection in more than one-third of cases, including endocarditis (≈12%), septic arthritis (7%), vertebral osteomyelitis (≈4%), spinal epidural abscess, psoas abscess, splenic abscess, septic pulmonary emboli, and seeding of implantable medical devices. Patients with S aureus bacteremia commonly present with fever or symptoms from metastatic infection, such as pain in the back, joints, abdomen or extremities, and/or change in mental status. Risk factors include intravascular devices such as implantable cardiac devices and dialysis vascular catheters, recent surgical procedures, injection drug use, diabetes, and previous S aureus infection. Staphylococcus aureus bacteremia is detected with blood cultures. Prolonged S aureus bacteremia (≥48 hours) is associated with a 90-day mortality risk of 39%. All patients with S aureus bacteremia should undergo transthoracic echocardiography; transesophageal echocardiography should be performed in patients at high risk for endocarditis, such as those with persistent bacteremia, persistent fever, metastatic infection foci, or implantable cardiac devices. Other imaging modalities, such as computed tomography or magnetic resonance imaging, should be performed based on symptoms and localizing signs of metastatic infection. Staphylococcus aureus is categorized as methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) based on susceptibility to β-lactam antibiotics. Initial treatment for S aureus bacteremia typically includes antibiotics active against MRSA such as vancomycin or daptomycin. Once antibiotic susceptibility results are available, antibiotics should be adjusted. Cefazolin or antistaphylococcal penicillins should be used for MSSA and vancomycin, daptomycin, or ceftobiprole for MRSA. Phase 3 trials for S aureus bacteremia demonstrated noninferiority of daptomycin to standard of care (treatment success, 53/120 [44%] vs 48/115 [42%]) and noninferiority of ceftobiprole to daptomycin (treatment success, 132/189 [70%] vs 136/198 [69%]). Source control is a critical component of treating S aureus bacteremia and may include removal of infected intravascular or implanted devices, drainage of abscesses, and surgical debridement.Conclusions and relevanceStaphylococcus aureus bacteremia has a case fatality rate of 15% to 30% and causes 300 000 deaths per year worldwide. Empirical antibiotic treatment should include vancomycin or daptomycin, which are active against MRSA. Once S aureus susceptibilities are known, MSSA should be treated with cefazolin or an antistaphylococcal penicillin. Additional clinical management consists of identifying sites of metastatic infection and pursuing source control for identified foci of infection.

Objective: Review the current literature in search of better knowledge about the use of implantable devices in patients who are investigating ischemic heart disease, and evaluate the possibility of its systematic use. Methods: Non-systematic literature review with exams and studies already published to date. Results: Risk stratification using implantable cardiac devices, associated with or as a substitute for the use of medication or physical stress, seems to be very safe, effective and highly reliable when compared to the methods traditionally established. Conclusion: Patients with implantable cardiac electronic devices constitute a specific challenging population, while research on ischemia is limited by secondary low/bay perfusion changes that result from the interaction of the device with the heart. These changes must be previously known, expected and interpreted with great care in order to reduce the number of false positives.

Cardiac implantable therapeutic medical devices

Transparent sharing of digital health data: A call to action

During a recent set of telemedicine consultations, Joaquin E. Cigarroa, MD, a cardiologist at Oregon Health & Science University in Portland, was able to establish relationships with 4 new patients and their families, conduct a physical examination using an electronic stethoscope, review the patients’ laboratory results, and develop a care plan. The best part was that the patients, who all live in coastal Lincoln City, Oregon, were able to skip the 3-hour drive to Portland through traffic and often fog. Figure 1. A mock telecardiology consult. Increasingly, cardiologists across the country are leveraging technology to provide remote care, whether through virtual visits and exams, consultations, or continuous monitoring using a growing array of implantable or wearable devices. “Patients love it,” said Cigarroa. They only need to make the trek to Portland when they need advanced diagnostics or procedures. For Cigarroa and his colleagues at Oregon Health & Science University, providing such off-site care is “critical to providing patient-centered care,” he said. He explained that ≈60% of the patients admitted to the cardiovascular service line at Oregon Health & Science University’s hospital are from outside of the Portland metro area, and many are from rural regions of the state. He and his colleagues have increasingly made use of Oregon Health & Science University’s telemedicine portals, which can even be used to perform echocardiograms, to care for patients closer to their homes. “It’s compassionate to the patient and their family to maintain them in their community and only transfer them if they need procedural or …

Axillary vein puncture (AVP) is an effective technique in cardiac implantable electronic device (CIED) implantation. This study evaluates the venous tenting (VnT) technique as a novel method and compares its effectiveness to contrast venography (CV) in reducing early and late complications. This retrospective multicenter study included 464 patients who underwent CIED implantation using VnT or CV techniques. Patients were matched 1:1 and divided into two groups: Group 1 (n = 232) included those who underwent VnT, and Group 2 (n = 232) included those who underwent CV. Early complications, including pneumothorax (PTX), pocket hematoma (PH), and pocket infection (PI), were collectively defined as total complications (TC). Late complications were defined as device lead integrity (DLI). Independent predictors of complications were identified using multivariate logistic regression analysis. The TC rate was 5.2%. VnT significantly reduced PH rates (0.9%vs. 4.3%, p = 0.019) and TC rates (2.2%vs. 8.19%, p = 0.003) compared to CV. No significant differences were observed between the groups in PTX, PI, or DLI rates. Multivariate logistic regression analysis identified VnT as an independent protective factor for both TC (p = 0.009) and PH (p = 0.022). During CIED implantation, the VnT technique was associated with lower TC and PH than the CV technique. This study highlights the potential of VnT to improve outcomes. Further prospective studies are recommended to confirm these findings.

Clinical impact of cardiovascular magnetic resonance with optimized myocardial scar detection in patients with cardiac implantable devices

Objective: Since patients with implantable cardiac devices tend to develop chronotropic incompetence (CI) associated with the effect of the device itself or the pharmacological effect of the underlying disease, CI could act as a limiting factor in improving exercise tolerance in patients undergoing cardiac rehabilitation program, since an increase in HR is a crucial part in improving cardiac output as a central component of oxygen consumption (VO2). However, it has been observed that there could be other factors contributing to the improvement in exercise tolerance in these patients regardless of the presence of CI. The aim of this research is to clarify the effect of chronotropic incompetence on the improvement in exercise capacity in patients with implantable cardiac devices after a phase II cardiac rehabilitation program (CRP). Methods: Quasi-experimental study applied to patients with implantable cardiac devices (ICDs, CRT, pacemakers) undergoing a supervised concurrent CRP, lasting 4-6 weeks, at an intensity between 65-80% of heart rate reserve (HRR), associated with kinesiotherapy sessions (with strength and endurance training and other biomotor qualities) and interdisciplinary intervention, education, and counseling. CI was calculated using the chronotropic response index, and METs-load measurement was performed at the beginning and at the end of the intervention. Results: Forty patients with a mean age of 61.4 years were included, mostly male (29) 72.5%, (23) 57.5% diagnosed with heart failure, and regarding the type of device, pacemakers (20) 50%, implantable cardioverter-defibrillator (ICD) (12) 30%, and cardiac resynchronization therapy with defibrillator (CRT-D) (20) 8%, of the total patients (35) 87.5% presented chronotropic incompetence and only (5) 12.5% with normal chronotropic response at the end of the intervention. A significant decrease in the chronotropic response index from 0.70 to 0.47 (p &lt;0.001) and a significant increase in METs-load from 5.47 to 9.35 (p &lt;0.001) were found. The value of the differential between initial and final METs (delta-METs) was obtained for both groups, observing a significant increase between initial and final METs in favor of patients with CI (3.8 Vs 3.5, p&lt;0.012) at the end of the intervention. A significant moderate negative correlation (r=-0.395, Spearman, p&lt;0.012) was determined between the degree of CI and final METs-load. Conclusions: It was observed that patients with implantable cardiac devices undergoing a CRP show an increase in exercise tolerance measured in METs, with an inversely proportional correlation to chronotropic incompetence.

Introduction Sodium-glucose cotransporter-2 (SLGT2) inhibitors have demonstrated benefits on survival and hospital admissions in patients with heart failure and reduced ejection fraction. However, their impact on the burden of ventricular (VA) and atrial arrhythmias (AA) is unknown. Methods Retrospective multicentric study of heart failure patients with implantable cardiac defibrillator device (ICD) from 2015 to 2020 with or without cardiac resynchronization therapy (CRT) receiving SGLT2 inhibitors. Device-registered arrhythmic events were analyzed and compared during one year following SLGT2 inhibitor initiation and during one year before initiation. Relevant VA were defined as the occurrence of any sustained VT (SVT) (&amp;gt;30 seconds), ventricular fibrillation (VF), or appropriate therapy (antytachycardia pacing or shock). All VA included all the relevant VA and the occurrence of non-sustained ventricular tachycardia (NSVT). AA included atrial fibrillation (AF) burden, and episodes of more than 24 hour of AF. Results 147 patients (67 ± 10 years, 82.3% males, LVEF 30.3 ± 11%, CRT 39.3%), were included in the study. 77.6% had complete remote tele-monitoring during the entire follow up and there was no difference in the antiarrhythmic therapy between the two periods. Following SGLT2 inhibitor initiation, there was a significant reduction in the percentage of patients with relevant VA (19.7% pre vs 10.9% post; p=0.019) and all VA (47.6% pre vs 30.6% post; p&amp;lt;0.001) (Figure 1 and 2). There was a reduction in the prevalence of NSVT (40.1% pre vs. 27.2% post; p&amp;lt;0.001), of SVT (17.7% vs 8.8%; p&amp;lt;0.001), of VF (4.1% vs 2%; p=NS) and appropriate therapies (14.3% vs 9.5%; p=NS). Among patients with any VA, there was a significant reduction in the incidence of NSVT (p&amp;lt;0.001), but not in the incidence of SVT or appropriate therapies (p=NS). There was no impact on atrial fibrillation burden or in the number of AF episodes lasting more than 24 hours (p=NS). Conclusions In our study, initiation of a SGLT2 inhibitor in patients with heart failure, was associated with a reduction in the prevalence of relevant VA and any VA, with a significant reduction in the number of NSVT per patient. There was no impact on AF burden or the number of AF episodes lasting more than 24 hours. Prospective studies should be performed to sustain these conclusions.Relevant ventricular arrhythmiasAny ventricular arrhythmia