The effect of osteopathic manipulative treatment on quality of life in patients with cardiac implantable electronic devices.

CONTEXT: Osteopathic manipulative treatment (OMT) has been demonstrated to have an effect on the autonomic nervous system, which may have antiarrhythmic effects. The effects of OMT in patients with cardiac implantable electronic devices (CIEDs) have not previously been reported. This study investigated the impact of OMT on quality of life (QOL) in this patient population. OBJECTIVES: The purpose of this study is to investigate the effects of OMT on QOL in CIED patients. METHODS: Subjects with CIEDs were recruited into a double-blind randomized controlled institutional review board (IRB)-approved clinical trial (ClinicalTrials.gov ID: NCT04004741) and randomized to OMT or light touch (control) groups. Subjects received a one-time intervention, performed by board-certified neuromusculoskeletal medicine (NMM) and osteopathic manipulative medicine (OMM) physicians. The OMT protocol utilized techniques including myofascial release, rib raising, facilitated positional release (FPR), and osteopathic cranial manipulative medicine. Subjects' QOL was assessed immediately preceding intervention and one-month postintervention utilizing the Research ANd Development (RAND) 36-Item Short Form Health Survey (SF-36, eight parameters). Groups were compared utilizing unpaired t tests; α=0.05. RESULTS: Forty-two subjects were enrolled, with four lost to follow-up, which resulted in 19 OMT and 19 control subjects for analysis. Of the eight QOL parameters, two showed significant improvement with OMT: role limitations due to physical health (p=0.001) and pain (p=0.003). CONCLUSIONS: This study demonstrates the potential for QOL improvement in CIED patients. Specifically, subjects in the OMT group reported an improvement in activities of daily living as well as a decrease in overall pain, including pain interfering with work. Additional research is necessary to further understand the physiologic effects of OMT, including its effects on arrhythmias, in CIED patients.

MRI in Adult Patients with Active and Inactive Implanted MR-conditional, MR-nonconditional, and Other Devices.

Active implanted medical devices (AIMDs) enable therapy and patient monitoring by way of electrical activity and typically have a battery and electrical leads. The most common types of AIMDs include cardiac implantable electronic devices (CIEDs), spinal cord stimulators, deep brain stimulators, bone growth or fusion stimulators, other neurostimulators, and drug infusion pumps. As more patients with AIMDs undergo MRI, it is important to consider the safety of patients who have these implanted devices during MRI. The authors review the physics concepts related to MRI safety, such as peak spatial gradient magnetic field, specific absorption rate, root mean square value of the effective magnetic component of the transmitted RF pulse, and gradient slew rate, as well as the parameters necessary to remain within safety limits. The roles of MRI safety personnel, as set forth by the International Society of Magnetic Resonance in Medicine, are emphasized. In addition, the relevant information provided in vendor manuals is reviewed, with a focus on how to obtain relevant up-to-date information. The radiologist should be able to modify protocols to meet safety requirements, address possible alternatives to MRI, and weigh the potential benefits of MRI against the potential risks. A few more advanced topics, such as fractured or abandoned device leads and patients with multiple implanted medical devices, also are addressed. Recommended workflows for MRI in patients with implanted medical devices are outlined. It is important to implement an algorithmic MRI safety process, including a review of the MRI safety information; patient screening; optimal imaging; and monitoring patients before, during, and after the examination. ©RSNA, 2024 Test Your Knowledge questions for this article are available in the supplemental material. See the invited commentary by Shetty et al in this issue.

A self-assembled implantable microtubular pacemaker for wireless cardiac electrotherapy.

The current cardiac pacemakers are battery dependent, and the pacing leads are prone to introduce valve damage and infection, plus a complete pacemaker retrieval is needed for battery replacement. Despite the reported wireless bioelectronics to pace the epicardium, open-chest surgery (thoracotomy) is required to implant the device, and the procedure is invasive, requiring prolonged wound healing and health care burden. We hereby demonstrate a fully biocompatible wireless microelectronics with a self-assembled design that can be rolled into a lightweight microtubular pacemaker for intravascular implantation and pacing. The radio frequency was used to transfer energy to the microtubular pacemaker for electrical stimulation. We show that this pacemaker provides effective pacing to restore cardiac contraction from a nonbeating heart and have the capacity to perform overdrive pacing to augment blood circulation in an anesthetized pig model. Thus, this microtubular pacemaker paves the way for the minimally invasive implantation of leadless and battery-free microelectronics.

The MyoPulser field stimulator, a do it yourself programmable electronic pacemaker for contracting cells and tissues.

After providing the free software MYOCYTER that analyzes a large amount of data from videos of contracting cells, tissues or organs, we now present an "Arduino"-based programmable, customizable and cost-effective electronic pacemaker ("MyoPulser") that triggers contraction by electric stimulation of the sample at arbitrary frequencies. In this work, construction, functions and application of the MyoPulser are explained in detail, the electronic pacemaker is also tested on isolated cardiomyocytes and HT22-cells to quantify biological effects of pacing. The device enables the user to select between different pulse types (monophasic, alternating, bi- and polyphasic) adjust the length of an applied pulse (1-200 ms), the gap between two consecutive pulses (20-2000 ms), application of irregular pulses with random length and gaps (simulation of arrhythmia) in a user-defined range, as well as manual pulsing, while extensive data are recorded for every single pulse during the experiment. Electrostimulation of isolated B6 cardiomyocytes showed very little deviation of the observed cellular contraction from the applied pulse settings of the device, while the carbon electrodes used proved to be biologically inert in long-term experiments. Due to the open source code and the expandable setup, the MyoPulser can be easily adapted to even highly specific requirements and together with the software MYOCYTER it represents a complete cardiomyophysiological measuring station.

Use of Spinal Cord Stimulators in Patients With Pacemakers or Implantable Cardiac Defibrillators: A Review of Documented Accounts of Interference.

OBJECTIVES: To assess the currently available evidence regarding associations between spinal cord stimulator (SCS) lead type, clinical indications for device placement, and interference between SCSs and cardiac pacemakers (CPMs)/implantable cardioverter-defibrillators (ICDs). STUDY DESIGN: Review of case reports and original research studies assessing the interference between SCS and CPM/ICD. MATERIALS AND METHODS: PubMed and Cochrane databases were searched for articles commenting on the interference between SCS and CPM/ICD. The search criteria which generated the greatest number of relevant studies was (spinal cord stimulator AND [pacemaker OR implantable cardioverter defibrillator]). Additional, empiric review was conducted using JSTOR, ScienceDirect, and EBSCOhost databases; however, no additional eligible studies were identified. Data were extracted, summarized into tables, and quantitatively analyzed using LibreTexts and MedCalc software. RESULTS: There was no statistically significant interference observed between SCS and CPM/ICD devices in patients regardless of indication for SCS placement and SCS lead polarity. LIMITATIONS: Limited by variability of patient cases and variability in maximum frequency and amplitude of SCS devices tried in individual cases. Also limited by small sample size and the absence of a standard definition for device interference across studies. CONCLUSIONS: Interference between cardiac devices and SCSs is a rare occurrence. As there are currently no published guidelines, devices should be interrogated on a case-by-case basis in the SCS trial period (if implanted after cardiac device), during permanent implantation, and during scheduled follow-up visits. Peri-operative testing should include increasing the SCS settings to maximally tolerated levels with cardiac device set at its maximum sensitivity.

The cost of CIED infectious complications treatment in Poland from the perspective of Polish hospitals.

INTRODUCTION: Cardiac implantable electronic devices (CIED) are a recognized form of therapy in cardiology. Apart from the benefits, the use of CIEDs is also associated with the risk of complications, and the most important ones influencing treatment results and prognosis are infectious complications. AIM: This study aimed to calculate the cost of treatment of CIED-related infections, including transvenous lead extraction and device reimplantation, from the perspective of a Polish hospital. METHODS: A retrospective analysis of hospitalization costs of patients referred to transvenous lead extraction (TLE) for CIED infection was performed. The study covers cases from three Polish reference centers specializing in the comprehensive treatment of cardiac electrotherapy complications. RESULTS: It was shown that the average cost of treating a CIED infection is 34 000 PLN (8010 EUR) and is the highest in the cardiac resynchronization therapy with defibrillator function (CRT-D) group, where it amounts to almost 50 000 PLN (11 440 EUR). Thus, treatment of CIED infections is associated with an average loss of 3000 PLN for the healthcare provider and the length of hospitalization has a major influence on final outcomes. CONCLUSIONS: The hospital cost of treatment of CIED-related infections was high and related mainly to the type of device and length of hospitalization. Despite the low utilization of costly extraction tools, the hospitalization was still likely to be unprofitable.

A transient, closed-loop network of wireless, body-integrated devices for autonomous electrotherapy.

Temporary postoperative cardiac pacing requires devices with percutaneous leads and external wired power and control systems. This hardware introduces risks for infection, limitations on patient mobility, and requirements for surgical extraction procedures. Bioresorbable pacemakers mitigate some of these disadvantages, but they demand pairing with external, wired systems and secondary mechanisms for control. We present a transient closed-loop system that combines a time-synchronized, wireless network of skin-integrated devices with an advanced bioresorbable pacemaker to control cardiac rhythms, track cardiopulmonary status, provide multihaptic feedback, and enable transient operation with minimal patient burden. The result provides a range of autonomous, rate-adaptive cardiac pacing capabilities, as demonstrated in rat, canine, and human heart studies. This work establishes an engineering framework for closed-loop temporary electrotherapy using wirelessly linked, body-integrated bioelectronic devices.

Nursing the Patient With an Artificial Pacemaker.

Editor's note: From its first issue in 1900 through to the present day, AJN has unparalleled archives detailing nurses' work and lives over more than a century. These articles not only chronicle nursing's growth as a profession within the context of the events of the day, but also reveal prevailing societal attitudes about women, health care, and human rights. Today's nursing school curricula rarely include nursing's history, but it's a history worth knowing. To this end, From the AJN Archives highlights articles selected to fit today's topics and times. In this article from AJN's April 1964 issue, author Anne F. Heller discusses the science of "transistorized" artificial cardiac pacemakers and the care of patients who received these implants. Standard care included a pre-op soap-and-water enema and 10 days of post-op antibiotics. Readers were cautioned about the breakability of the large glass bottle attached to post-op chest tubes. The pacemaker itself cost $400. (To read the full article, go to https://links.lww.com/AJN/A229.) In this month's issue, Mary Ann Leavitt offers an update on the use of today's implantable cardioverter-defibrillators, cardiac resynchronization therapy, and ventricular assist devices. Newer "pacemakers" can now be used in primary prevention therapy for patients who are at greater risk for arrhythmias, and patient data can be transmitted wirelessly to the clinician's office. The latest devices can cost upward of $30,000.-Betsy Todd, MPH, RN.

A comparison of the effects of inspiratory muscle strength and endurance training on exercise capacity, respiratory muscle strength and endurance, and quality of life in pacemaker patients with heart failure: A randomized study.

BACKGROUND: Studies have widely investigated the effects of inspiratory muscle strength training in patients with heart failure (HF). The effects of inspiratory muscle strength or endurance training on outcomes in patients with pacemakers have not been adequately studied. OBJECTIVES: The aim was to compare the effects of inspiratory muscle strength and endurance training on exercise capacity, quality of life (QoL), peripheral and respiratory muscle strength, respiratory muscle endurance, pulmonary function, dyspnea, fatigue, and physical activity levels in pacemaker patients with HF. METHODS: A randomized, controlled, double-blind study was conducted. Fourteen pacemaker patients with HF received inspiratory muscle strength training (IMST) at 50% of maximal inspiratory pressure (MIP), and 18 patients received endurance training (IMET) at 30% of MIP 7 days/8 weeks. Exercise capacity [6 min. walking test (6MWT) and the Incremental Shuttle Walking Test (ISWT)], pulmonary function, respiratory muscle strength [MIP, maximal expiratory pressure (MEP)], endurance, peripheral muscle strength, dyspnea, fatigue, QoL, and physical activity level were evaluated before and after. RESULTS: Demographic characteristics were similar in IMST (3F/11M, 56.92 ± 7.61y, EF: 25%, ICD/CRT:11/3) and IMET (4F/14M, 56 ± 10.77y, EF: 30%, ICD/CRT:16/2) groups (p > 0.05). Significant improvements were present in MIP, MEP, respiratory muscle endurance, peripheral muscle strength, 6MWT and ISWT walking distances, dyspnea, QoL, physical activity level, fatigue scores within groups (p ≤ 0.05). However, there were no significant differences between the groups (p > 0.05). There were no significant improvements in FEV1%, FVC%, FEV1/FVC%, and FEF25-75 within and between the groups (p > 0.05). CONCLUSIONS: Inspiratory muscle strength and endurance training similarly improves respiratory and peripheral muscle strength, exercise capacity, QoL, physical activity level, and decreases dyspnea and fatigue and are safe and effective in pacemaker patients with HF. TRIAL REGISTRATION: www. CLINICALTRIALS: gov; study number: NCT03501355.

Atribuições do enfermeiro no manejo do marcapasso transcutâneo em pacientes idosos: Uma revisão integrativa / Asignaciones del enfermero em el manejo del marcapasos transcutáneo en anciano: Una revisión integrativa / Nurse attributions in the handling of transcutaneous pacemaker in elderly patients: Integrative review

Objetivo: investigar a produção científica nacional e internacional sobre as ações e cuidados do enfermeiro no manejo do marca-passo transcutâneo em idosos. Método: revisão integrativa, realizada nas bases de dados "Scopus", "Web of Science", "EMBASE", "PUBMED", "MEDLINE", no período de 2012 a 2022. Resultados: foram selecionados oito artigos, todos internacionais, somente um conduzido por enfermeiros. Categorizados por: (1) Possibilidades e limitações no uso do marca-passo trânscutâneo na prática clínica; (2) Cuidados de enfermagem na utilização do marca-passo transcutâneo em idosos e (3) Sistematização da Assistência de Enfermagem e a abordagem ao paciente em uso de marca-passo transcutâneo. Conclusão: os principais cuidados de enfermagem ao idoso que utiliza o marca-passo transcutâneo são: prevenção de queimaduras cutâneas; administração de medicamentos; manejo da dor; monitoramento dos dados vitais; avaliação da captura mecânica; investigação do histórico familiar; medicações em uso; realização do exame físico e acesso venoso periférico.(AU)

Objective: : to investigate the national and international scientific production regarding the actions and handling of the transcutaneous pacemaker in elderly. Method: integrative review, made in the databases Scopus", "Web of Science", "EMBASE", "PUBMED", and "MEDLINE", for the period 2012 to 2022. Findings: there were selected eight articles, all international, and only one conducted by nurses. Categorized into: (1) Possibilities and limitations of the use from the transcutaneous pacemaker in clinical practice; (2) Nursing care when utilizing transcutaneous pacemaker in elderly and (3) Systematization of Nursing Care and approach to patients using transcutaneous pacemaker. Conclusion: the main Nursing Care approaches to elderly who use transcutaneous pacemaker are prevent skin burn; drug administration; pain management; monitoring vital signs; evaluation of heart activity; investigating family history and drugs in use; performing physical examination and peripheral venous access.(AU)

Objetivo: investigar cual és lá produccion científica nacional e internacional sobre Las acciones y cuidados del enfermero en el manejo del marca-pado intracutaneo en ancianos. Método: Revision Integrativa realizada en Las bases de datos "Scopus" web of Science", EMBASE", "PUBMED", "MEDLINE", durante el período 2012 a 2022. Resultados: fueron Seleccionados ocho articulos todos internacionales, solanemente uno fue llevado a cabo por enfermeros. Categorizado por (1) posibilidades y limitaciones en El uso del marca-paso intracutaneo en lá práctica clínica; (2) cuidados de enfermeria en lá utilização del marca-paso intracutaneo y (3) sistematizacion de la assistencia de enfermeria y el abordaje del paciente que usa marca-paso intracutaneo. Conclusion: Los principales cuidados de enfermeria Al anciano que utiliza marca-paso intracutaneo son: prevencion de quemaduras cutaneas; administracion de medicamentos, manejo del dolor, monitorizacion de datos vitales, evaluacion de lá captura mecanica, investigação del histórico famíliar, medicaciones en uso, realizacion de examen fisico y acceso venoso periférico.(AU)

Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study.

BACKGROUND: The optimal right ventricular pacing site for patients requiring pacemaker implantation for permanent atrioventricular block is a matter of debate. Long-term right ventricular apical pacing has been associated with left ventricular ejection fraction impairment and heart failure. Right ventricular septal pacing has been proposed as an alternative. AIM: The aim of this randomized prospective multicentre trial was to compare left ventricular remodelling and outcomes between right ventricular apical and septal pacing after mid-term follow-up. METHODS: Patients requiring pacemaker implantation for high-degree atrioventricular block were enrolled and randomized in a 1:1 fashion to receive a right ventricular apical or septal lead. RESULTS: A total of 141 patients were included, 69 in the septal group and 72 in the apical group. Both groups exhibited similar left ventricular ejection fractions after 18 months of follow-up (septal 57.1±11.9% vs. apical 57.4±13.4%), and left ventricular ejection fraction variation was similar in the two groups at the end of follow-up (septal -1.5±13.2% vs. apical 0.3±13.3%). Additionally, left ventricular volume, quality of life and 6-minute walk distance were similar in the two groups. However, patients in the septal group were more likely to be asymptomatic, with a significantly lower concentration of N-terminal prohormone of brain natriuretic peptide. Lastly, lead position did not impact 18-month survival. CONCLUSION: Pacing from the right ventricular apex does not have any detrimental effect on left ventricular systolic function compared with septal pacing over an 18-month period.

Regional variation in cardiac implantable electronic device implants trends in New Zealand over the past decade (ANZACS-QI 54).

BACKGROUND: Permanent pacemaker (PPM) and implantable cardioverter defibrillator (ICD) implant rates have increased in New Zealand over the past decade. AIMS: To provide a contemporary analysis of regional variation in implant rates. METHODS: New PPM and ICD implants in patients aged ≥15 years were identified for 10 years (2009-2018) using procedure coding in the National Minimum Datasets, which collects all New Zealand public hospital admissions. Age-standardised new implant rates per million adult population were calculated for each of the four regions (Northern, Midland, Central and Southern) and the 20 district health boards (DHB) across those regions. Trend analysis was performed using joinpoint regression. RESULTS: New PPM implant rates increased nationally by 3.4%/year (P < 0.001). The Northern region had the highest new PPM implant rate, increasing by 4.5%/year (P < 0.001). Excluding DHB with <50 000 people, the new PPM implant rate for 2017/2018 was highest in Counties Manukau DHB (854.3/million; 95% confidence interval (CI): 774.9-933.6/million) and lowest in Canterbury DHB (488.6/million; 95% CI: 438.1-539.0/million). New ICD implant rates increased nationally by 3.0%/year (P = 0.002). The Midland region had the highest new ICD implant rate, increasing by 3.8%/year (P = 0.013). Excluding DHB with <50 000 people, the new ICD implant rate for 2017-2018 was highest in the Bay of Plenty DHB (228.5/million; 95% CI: 180.4-276.6/million) and lowest in Canterbury DHB (90.2/million; 95% CI: 69.9-110.4/million). CONCLUSION: There was significant variation in PPM and ICD implant rates across regions and DHB, suggesting potential inequity in patient access across New Zealand.

Ten-year trends in cardiac implantable electronic devices in New Zealand: a national data linkage study (ANZACS-QI 51).

BACKGROUND: Implant rates for cardiac implantable electronic devices (CIED), including permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD), have increased globally in recent decades. AIMS: This is the first national study providing a contemporary analysis of national CIED implant trends by sex-specific age groups over an extended period. METHODS: Patient characteristics and device type were identified for 10 years (2009-2018) using procedure coding in the National Minimum Datasets, which collects all New Zealand (NZ) public hospital admissions. CIED implant rates represent implants/million population. RESULTS: New PPM implant rates increased by 4.6%/year (P < 0.001), increasing in all age groups except patients <40 years. Males received 60.1% of new PPM implants, with higher implant rates across all age groups compared with females. The annual increase in age-standardised implant rates was similar for males and females (3.4% vs 3.0%; P = 0.4). By 2018 the overall PPM implant rate was 538/million. New ICD implant rates increased by 4.2%/year (P < 0.001), increasing in all age groups except patients <40 and ≥ 80 years. Males received 78.1% of new ICD implants, with higher implant rates across all age groups compared to females. The annual increase in age-standardised implant rates was higher in males compared with females (3.5% vs 0.7%; P < 0.001). By 2018 the overall ICD implant rate was 144/million. CONCLUSION: CIED implant rates have increased steadily in NZ over the past decade but remain low compared with international benchmarks. Males had substantially higher CIED implant rates compared with females, with a growing gender disparity in ICD implant rates.

Long-Term, Single-Centre Observation of Patients with Cardiac Implantable Electronic Devices.

Background and Objectives: Electrotherapy is a valuable treatment method for patients with heart rhythm disturbances. There are very few observations of long-term patients treated with these techniques. There is a particular lack of this type of study conducted in Eastern European countries. The aim of this single-centre analysis was to evaluate the long-term survival (from 2010 to 2018) of patients treated with electrotherapy devices, taking into account clinical factors facilitating the prognosis of these patients. Materials and Methods: The patients (N = 2071) subsequently included in the study were subjected to the implementation or replacement of cardiac pacemakers. The medical records of all the patients were analysed. Data concerning death, made available by the State Systems Department of the Ministry of Administration and Digitization, were used. Results: The patients with VVI pacemakers had the worst prognosis after the replacement of the devices. Male patients had a worse prognosis, regardless of the kind of device implanted. Advanced atrioventricular conduction disturbances, chronic kidney disease, and hypothyroidism with reduced left ventricular ejection fraction were among the most significant coexisting diseases. Conclusions: The long-term prognosis of patients under different forms of electrotherapy remains poor. Despite the more straightforward technique, a single-chamber device (VVI/AAI) or generator replacement leads to the worst prognosis. The complexity of the clinical picture that stems from coexisting diseases and advanced age is of the utmost importance.

Effectiveness of Saireito, a Traditional Japanese Kampo Herbal Medication, on Pacemaker-Related Pleural Effusion: A Case Report.

BACKGROUND Post-cardiac injury syndrome, including pleural effusion as a delayed complication of permanent pacemaker implantation, has rarely been reported. To resolve pleural effusion, prolonged chest tube placement is often required. Anti-inflammatory agents combined with diuretics are also often prescribed. Saireito, a Japanese herbal medication, which is a combination of Goreisan and Shousaikoto, has both anti-inflammatory and water-modulation properties and has been used for edema (lymph edema, cerebral edema) and inflammation (chronic nephritis). CASE REPORT We describe a 71-year-old woman with a history of syncope and bradycardia who underwent dual permanent pacemaker implantation (placed in the right chest because of a persistent left superior vena cava) without complications. Two months later, she came to the hospital as an outpatient with a dry cough, and was diagnosed with right-sided pleural effusion. A pleural fluid analysis revealed exudative effusion, according to Light's criteria. The fluid was negative for infectious etiology. Chest X-ray, computed tomography, and echocardiography revealed no signs of pericardial effusion or perforation of the pacemaker lead to outside the heart. The pleural effusion persisted despite use of anti-inflammatory medication for several weeks and diuretics for a short period. Saireito was administered with good response; the pleural effusion resolved completely and there was no deterioration of renal function. CONCLUSIONS The present case highlights the clinical significance of Saireito as an effective therapeutic agent for late-onset pacemaker-related pleural effusion, without adverse effects such as renal dysfunction.

Adverse device-device interaction between pacemaker and subcutaneous implantable cardiac defibrillator.

A 26-year-old patient with prior surgery for Ebstein's anomaly and a pacemaker (placed for post-surgical heart block and poor underlying rhythm) underwent SICD was placement. During defibrillation testing, device-device interaction led to undersensing of ventricular fibrillation with failure to shock. Increasing the pacemaker sensitivity resolved the problem but post shock pacing was unable to capture the heart after both shocks. The patient underwent removal of both the pacemaker and the SICD and placement of a transvenous ICD. Complex device-device interactions can occur in patients who are pacemaker dependent and undergo placement of a SICD.