McLeod, Christopher J.

AbstractWearable electronic devices are a convenient solution to pain intensity assessment as they can provide continuous monitoring for more precise medication adjustments. However, there is little evidence regarding the use of wearable electronic devices for chronic pain intensity assessment. Our primary objective was to examine the physiologic parameters used by wearable electronic devices for chronic pain intensity assessment. We initially inquired PubMed, CINAHL, and Embase for studies evaluating the use of wearable electronic devices for chronic pain intensity assessment. We updated our inquiry by searching on PubMed, Embase, Scopus, and Google Scholar. English peer‐reviewed studies were included, with no exclusions based on time frame or publication status. Of 348 articles that were identified on the first inquiry, 8 fulfilled the eligibility criteria. Of 179 articles that were identified on the last inquiry, only 1 fulfilled the eligibility criteria. We found articles evaluating wristbands, smartwatches, and belts. Parameters evaluated were psychomotor and sleep patterns, space and time mobility, heart rate variability, and skeletal muscle electrical activity. Most of the studies found significant positive associations between physiological parameters measured by wearable electronic devices and self‐reporting pain scales. Wearable electronic devices reliably reflect physiologic or biometric parameters, providing a physiological correlation for pain. Early stage investigation suggests that the degree of pain intensity can be discerned, which ideally will reduce the bias inherent to existing numeric/verbal scales. Further research on the use of these devices is vital.

Background Wearable devices and sensor technology provide objective, unbiased range of motion measurements that help health care professionals overcome the hindrances of protractor-based goniometry. This review aims to analyze the accuracy of existing wearable sensor technologies for hand range of motion measurement and identify the most accurate one. Methods We performed a systematic review by searching PubMed, CINAHL, and Embase for studies evaluating wearable sensor technology in hand range of motion assessment. Keywords used for the inquiry were related to wearable devices and hand goniometry. Results Of the 71 studies, 11 met the inclusion criteria. Ten studies evaluated gloves and 1 evaluated a wristband. The most common types of sensors used were bend sensors, followed by inertial sensors, Hall effect sensors, and magnetometers. Most studies compared wearable devices with manual goniometry, achieving optimal accuracy. Although most of the devices reached adequate levels of measurement error, accuracy evaluation in the reviewed studies might be subject to bias owing to the use of poorly reliable measurement techniques for comparison of the devices. Conclusion Gloves using inertial sensors were the most accurate. Future studies should use different comparison techniques, such as infrared camera–based goniometry or virtual motion tracking, to evaluate the performance of wearable devices.

AbstractBackgroundThe subcutaneous implantable cardioverter‐defibrillator (S‐ICD) has a larger generator and its implantation involves more dissection and tunneling compared to traditional transvenous defibrillator system. Liposomal bupivacaine, an extended‐release bupivacaine with 72 h of duration has been used for postoperative pain management in patients undergoing S‐ICD implantation. Our aim was to compare postoperative pain and opioid prescription patterns among patients undergoing S‐ICD implantation who received intraprocedural liposomal bupivacaine and those who did not.MethodsWe performed a retrospective analysis of all patients who underwent subcutaneous ICD implantation from January 1, 2013 to March 30, 2018 at the Mayo Clinic in Rochester, Minnesota. Patients were categorized into those who received liposomal bupivacaine and those who did not. Data on inpatient pain score, outpatient opioid prescription rates at discharge, and doses based on oral morphine equivalents (OME) were collected.ResultsA total of 104 patients underwent S‐ICD implantation. Intraprocedural liposomal bupivacaine was used in 69% of patients. Patients who received intraprocedural liposomal bupivacaine had similar mean inpatient pain scores (2.9 vs. 2.9, p = .786). There was also no difference in the rate of inpatient opioid administration (79.2% vs. 87.5%, p = .4139), outpatient opioid prescription (23.6% vs. 12.5%, p = .29), or mean OME (41.7‐mg vs. 16.6‐mg, p = .188) when comparing patients those who received intraprocedural liposomal bupivacaine and those who did not.ConclusionIntraprocedural liposomal bupivacaine administration was not associated with any significant impact on postoperative pain scores, inpatient opioid administration, and outpatient opioid prescription rates or OME amounts at discharge.

Introduction: Patients with D-TGA palliated with atrial switch operations have the morphologic right ventricle in the systemic position. There is increased risk of atrial arrhythmias and systemic right ventricle (SRV) failure. We sought to analyze the long term outcomes of these patients. Methods: All patients with D-TGA and SRV followed in the Adult Congenital Heart Disease Clinic of a large tertiary care institution were reviewed. A comprehensive retrospective analysis of the medical record was performed, including consult notes, ECGs, echocardiograms and electrophysiology reports. Results: A total of 154 patients (63% male) aged 29±11 years were followed for a mean of 10±9 years (range 0-51). During follow-up, 3 patients underwent cardiac transplantation and 15 died; 5 had sudden death, 2 had cardiogenic shock, 5 had non-cardiac death (i.e., infective endocarditis, sepsis) and 3 had unknown causes of death. Heart failure symptoms were present in 53(34%) patients. Severe SRV systolic dysfunction occurred in 37(24%) patients, with a mean EF of 23±5.5%; moderate SRV dysfunction occurred in 67(44%) patients, mean EF 35±4%. Sinus node dysfunction was present in 75(49%) patients, complete AV block in 9(5%) patients, and a pacemaker placed in 60(39%) patients, with cardiac resynchronization therapy in 5. Atrial arrhythmias occurred in 94(61%) patients and ablations were performed in 47(31%) patients. An ICD was implanted in 37 patients; 5 patients had appropriate shocks, but 7 had inappropriate shocks due to atrial arrhythmias. Age (HR 1.07, p=001), heart failure symptoms (HR 4.9, p= 0.007), severe SRV enlargement (HR 3.7, p=0.03), severe systolic dysfunction (HR 5.4, p=0.003), severe systemic AV valve regurgitation (HR 5.2, p=0.002) and a QRS duration> 122ms (HR 3.7, p=0.02) were significant predictors of mortality. The 15 year probability of sudden death was 3.2%(95% CI 0-6.9%). Conclusions: Atrial arrhythmias are common after atrial switch operations secondary to atriotomy scars. Further studies will need to determine whether restoration of sinus rhythm or cardiac synchrony may prevent further deterioration of the systemic right ventricle. Severe SRV dysfunction and prolonged QRS duration >122ms were significantly correlated with mortality.

AbstractIntroductionTherapies for substrate‐related arrhythmias include ablation or drugs targeted at altering conductive properties or disruption of slow zones in heterogeneous myocardium. Conductive compounds such as carbon nanotubes may provide a novel personalizable therapy for arrhythmia treatment by allowing tissue homogenization.MethodsA nanocellulose carbon nanotube‐conductive hydrogel was developed to have conduction properties similar to normal myocardium. Ex vivo perfused canine hearts were studied. Electroanatomic activation mapping of the epicardial surface was performed at baseline, after radiofrequency ablation, and after uniform needle injections of the conductive hydrogel through the injured tissue. Gross histology was used to assess distribution of conductive hydrogel in the tissue.ResultsThe conductive hydrogel viscosity was optimized to decrease with increasing shear rate to allow expression through a syringe. The direct current conductivity under aqueous conduction was 4.3 × 10−1 S/cm. In four canine hearts, when compared with the homogeneous baseline conduction, isochronal maps demonstrated sequential myocardial activation with a shift in direction of activation to surround the edges of the ablated region. After injection of the conductive hydrogel, isochrones demonstrated conduction through the ablated tissue with activation restored through the ablated tissue. Gross specimen examination demonstrated retention of the hydrogel within the tissue.ConclusionsThis proof‐of‐concept study demonstrates that conductive hydrogel can be injected into acutely disrupted myocardium to restore conduction. Future experiments should focus on evaluating long‐term retention and biocompatibility of the hydrogel through in vivo experimentation.

AbstractObjectiveThis study sought to determine if single‐chamber operation and/or loss of rate response (RR) during elective replacement indicator (ERI) in patients with dual‐chamber pacemakers lead to increased symptom burden, healthcare utilization, and atrial fibrillation (AF).BackgroundDual‐chamber pacemakers often change from dual‐ to single‐chamber pacing mode and/or lose RR functionality at ERI to preserve battery. Single‐chamber pacing increases the incidence of heart failure, AF, and pacemaker syndrome suggesting these changes may be deleterious.MethodsA retrospective analysis of 700 patients was completed. Three comparisons were analyzed: Comparison 1: mode change and RR loss versus no change; Comparison 2: RR loss only versus no change; Comparison 3: mode change only versus no change (in patients with no RR programmed at baseline).ResultsIn Comparison 1, 121 (46%) patients with setting changes experienced symptoms (most often dyspnea and fatigue/exercise intolerance) versus 3 (4%) without setting changes (p < .0001). Similar results were noted in Comparisons 2 and 3 (p = .0016 and p = .0001, respectively). In Comparison 1, patients with setting change sought provider contact more than patients without setting changes (p = .0001). A significant difference was not noted in Comparison 2 or 3. Overall 14 (2%) patients were hospitalized, all of whom had setting changes.ConclusionsSetting changes at ERI including a change from dual‐ to single‐chamber pacing and/or loss of RR results in a significantly increased symptom burden and increased healthcare utilization.

Abstract Introduction: Therapies for substrate-related arrhythmias include ablation or drugs targeted at altering conductive properties or disruption of slow zones in heterogeneous myocardium. Conductive compounds such as carbon nanotubes may provide a novel personalizable therapy for arrhythmia treatment by allowing tissue homogenization. Methods: A nanocellulose-carbon nanotube conductive hydrogel was developed to have conduction properties similar to normal myocardium. Ex vivo perfused canine hearts were studied. Electroanatomic activation mapping of the epicardial surface was performed at baseline, after radiofrequency ablation, and after uniform needle injections of the conductive hydrogel through the injured tissue. Gross histology was used to assess distribution of conductive hydrogel in the tissue. Results: The conductive hydrogel viscosity was optimized to decrease with increasing shear rate to allow expression through a syringe. The DC conductivity under aqueous conduction was 4.3·10-1 S/cm. In 4 canine hearts, when compared to the homogeneous baseline conduction, isochronal maps demonstrated sequential myocardial activation with a shift in direction of activation to surround the edges of the ablated region. After injection of conductive hydrogel, isochrones demonstrated conduction through the ablated tissue with activation similar to baseline in all 4 hearts. Gross specimen examination demonstrated retention of the hydrogel within the tissue. Conclusions: This proof-of-concept study demonstrates that conductive hydrogel can be injected into acutely disrupted myocardium to restore conduction. Future experiments should focus on evaluating long-term retention and biocompatibility of the hydrogel through in vivo experimentation.

Background Patients with Eisenmenger syndrome are known to have a high incidence of sudden cardiac death ( SCD ), yet the underlying causes are not well understood. We sought to define the predictors of SCD in this population. Methods and Results A retrospective analysis of all patients with Eisenmenger syndrome from 2 large tertiary referral centers was performed. ECGs, prolonged ambulatory recordings, echocardiograms, and clinical histories were reviewed; and the cause of death was identified. A total of 246 patients (85 [34.6%] men) with a mean age of 37.3 (±14.2) years were followed up for a median of 7 years. Over the study period, 136 patients died, with 40 experiencing SCD and 74 experiencing cardiac death (sudden and nonsudden). Age, atrial fibrillation, prolonged QRS duration, complete heart block, right atrial enlargement, right bundle branch block, increased right atrial pressure, impaired biventricular function, and the presence of a pacemaker were associated with increased risk of SCD , whereas advanced pulmonary hypertension therapies were protective. Atrial fibrillation (11.45‐fold increased risk; P <0.001) and QRS duration ≥120 ms (2.06‐fold increased risk; P =0.034) remained significant predictors of SCD in the multivariate analysis, whereas advanced pulmonary hypertension therapies were strongly protective against SCD ( P <0.001). Conclusions Atrial arrhythmias, impaired ventricular function, and conduction system disease were associated with increased risk of SCD in this cohort of patients with Eisenmenger syndrome, providing an opportunity for early risk stratification and potential intervention. Clinical heart failure symptoms (New York Heart Association class ≥ II ) were predictive of increased mortality but not of SCD , suggesting a potential arrhythmic cause behind SCD .

Background: Mechanical injury in the conduction system requiring permanent pacemaker (PPM) associated with transcatheter aortic valve replacement (TAVR) procedure is a common complication. The objective of this study was to use ambulatory monitor BodyGuardian to assess late occurrence of atrioventricular block (AVB) after TAVR. Methods: This prospective study evaluated 365 patients who underwent TAVR at Mayo Clinic, Rochester, Minnesota between June 2016 and August 2017. Patients who received PPM for bradycardia after TAVR before discharge were considered as the PPM group. Those not requiring PPM received a BodyGuardian system (BodyGuardian group) for 30 days of continuous monitoring. Primary end point was Mobitz II or third-degree atrioventricular block (II/III AVB) at 30-day follow-up. Results: Of 365 patients, 74 who had a PPM or an implantable cardioverter-defibrillator before TAVR and 94 who were enrolled in other studies were excluded. Of 197 patients enrolled in the study, 70 (35.5%) received PPM and 127 had BodyGuardian before the hospital dismissal. Eleven of 127 (8.6%) BodyGuardian group required PPM within 30 days after TAVR for late occurrence of symptomatic bradycardia. In total, 33 of 197 (16.7%) patients developed II/III AVB (24 before and 9 after discharge). Thirty-four patients had preexisting right bundle branch block. Of them, 16 (47%) developed II/III AVB. Of 53 patients who developed new left bundle branch block after TAVR, 14% progressed to II/III AVB within 30 days. Conclusions: In patients without a standard post-TAVR pacing indication, yet a potential risk to develop AVB, a strategy of 30-day monitoring identifies additional patients who require permanent pacing.

Abstract Aims As health systems around the world increasingly look to measure and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. To support the shift towards value-based health care in atrial fibrillation (AF), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international Working Group (WG) of 30 volunteers, including health professionals and patient representatives to develop a standardized minimum set of outcomes for benchmarking care delivery in clinical settings. Methods and results Using an online-modified Delphi process, outcomes important to patients and health professionals were selected and categorized into (i) long-term consequences of disease outcomes, (ii) complications of treatment outcomes, and (iii) patient-reported outcomes. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, comorbidities, cognitive function, date of diagnosis, disease duration, medications prescribed and AF procedures, as well as smoking, body mass index (BMI), alcohol intake, and physical activity. Where appropriate, and for ease of implementation, standardization of outcomes and case-mix variables was achieved using ICD codes. The standard set underwent an open review process in which over 80% of patients surveyed agreed with the outcomes captured by the standard set. Conclusion Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of chronic AF care. Their consistent definition and collection, using ICD codes where applicable, could also broaden the implementation of more patient-centric clinical outcomes research in AF.