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Perineal skin tear repair following vaginal birth; skin adhesive versus conventional suture - a randomised controlled trial

Dasrilsyah RA, Kalok A, Ng BK, Ali A, Teik Chew K, Lim PS

J Obstet Gynaecol, 2021 Feb;41(2):242-247.
PMID: 32530340 DOI: 10.1080/01443615.2020.1740917

This was a prospective randomised controlled trial comparing the effects of first-degree perineal tear repair using adhesive glue versus conventional suturing in terms of pain score, wound complication and patient's satisfaction. One hundred and twenty one women were randomised. The skin adhesive group had a significantly lower pain score at rest as well as during sitting, walking and micturition during the first week of delivery compared to the suture group. The time taken to become pain free was significantly shorter in the tissue adhesive group (3.18 vs. 8.65 days, p < .001). Only two patients who had skin glue experienced wound gaping. No significant difference was observed in the level of satisfaction between the adhesive and suture groups. Tissue adhesive is better than subcuticular suture for repairing first-degree perineal tear as it causes less pain and has shorter recovery time.Impact statementWhat is already known on this subject. First- and second-degree tears following vaginal delivery are common and involved a third of women. Suturing of these tears is advocated to avoid wound gaping and poor healing.What the results of this study add. For first-degree tear repair, tissue adhesive is better than conventional suture in terms of pain reduction and recovery time.What the implications are of these findings for clinical practice and/or further research. Skin adhesive is an ideal method for first-degree perineal tear repair especially in out of hospital settings such as home birth or midwifery-led centre. A larger scale study is needed to establish its feasibility for second- and third-degree tears repair.

Matched MeSH terms: Natural Childbirth/methods; Pain Measurement/methods; Pain Management/methods
A rapid MCM-41 dispersive micro-solid phase extraction coupled with LC/MS/MS for quantification of ketoconazole and voriconazole in biological fluids

Yahaya N, Sanagi MM, Abd Aziz N, Wan Ibrahim WA, Nur H, Loh SH, et al.

Biomed Chromatogr, 2017 Feb;31(2).
PMID: 27474795 DOI: 10.1002/bmc.3803

A rapid dispersive micro-solid phase extraction (D-μ-SPE) combined with LC/MS/MS method was developed and validated for the determination of ketoconazole and voriconazole in human urine and plasma samples. Synthesized mesoporous silica MCM-41 was used as sorbent in d-μ-SPE of the azole compounds from biological fluids. Important D-μ-SPE parameters, namely type desorption solvent, extraction time, sample pH, salt addition, desorption time, amount of sorbent and sample volume were optimized. Liquid chromatographic separations were carried out on a Zorbax SB-C18 column (2.1 × 100 mm, 3.5 μm), using a mobile phase of acetonitrile-0.05% formic acid in 5 mm ammonium acetate buffer (70:30, v/v). A triple quadrupole mass spectrometer with positive ionization mode was used for the determination of target analytes. Under the optimized conditions, the calibration curves showed good linearity in the range of 0.1-10,000 μg/L with satisfactory limit of detection (≤0.06 μg/L) and limit of quantitation (≤0.3 μg/L). The proposed method also showed acceptable intra- and inter-day precisions for ketoconazole and voriconazole from urine and human plasma with RSD ≤16.5% and good relative recoveries in the range 84.3-114.8%. The MCM-41-D-μ-SPE method proved to be rapid and simple and requires a small volume of organic solvent (200 μL); thus it is advantageous for routine drug analysis.

Matched MeSH terms: Chromatography, High Pressure Liquid/methods; Solid Phase Microextraction/methods*; Tandem Mass Spectrometry/methods
Sonochemical and sustainable synthesis of graphene-gold (G-Au) nanocomposites for enzymeless and selective electrochemical detection of nitric oxide

Geetha Bai R, Muthoosamy K, Zhou M, Ashokkumar M, Huang NM, Manickam S

Biosens Bioelectron, 2017 Jan 15;87:622-629.
PMID: 27616288 DOI: 10.1016/j.bios.2016.09.003

In this study, a sonochemical approach was utilised for the development of graphene-gold (G-Au) nanocomposite. Through the sonochemical method, simultaneous exfoliation of graphite and the reduction of gold chloride occurs to produce highly crystalline G-Au nanocomposite. The in situ growth of gold nanoparticles (AuNPs) took place on the surface of exfoliated few-layer graphene sheets. The G-Au nanocomposite was characterised by UV-vis, XRD, FTIR, TEM, XPS and Raman spectroscopy techniques. This G-Au nanocomposite was used to modify glassy carbon electrode (GCE) to fabricate an electrochemical sensor for the selective detection of nitric oxide (NO), a critical cancer biomarker. G-Au modified GCE exhibited an enhanced electrocatalytic response towards the oxidation of NO as compared to other control electrodes. The electrochemical detection of NO was investigated by linear sweep voltammetry analysis, utilising the G-Au modified GCE in a linear range of 10-5000μM which exhibited a limit of detection of 0.04μM (S/N=3). Furthermore, this enzyme-free G-Au/GCE exhibited an excellent selectivity towards NO in the presence of interferences. The synergistic effect of graphene and AuNPs, which facilitated exceptional electron-transfer processes between the electrolyte and the GCE thereby improving the sensing performance of the fabricated G-Au modified electrode with stable and reproducible responses. This G-Au nanocomposite introduces a new electrode material in the sensitive and selective detection of NO, a prominent biomarker of cancer.

Matched MeSH terms: Sonication/methods; Nanotechnology/methods; Electrochemical Techniques/methods*
Automated diagnosis of congestive heart failure using dual tree complex wavelet transform and statistical features extracted from 2s of ECG signals

Sudarshan VK, Acharya UR, Oh SL, Adam M, Tan JH, Chua CK, et al.

Comput Biol Med, 2017 04 01;83:48-58.
PMID: 28231511 DOI: 10.1016/j.compbiomed.2017.01.019

Identification of alarming features in the electrocardiogram (ECG) signal is extremely significant for the prediction of congestive heart failure (CHF). ECG signal analysis carried out using computer-aided techniques can speed up the diagnosis process and aid in the proper management of CHF patients. Therefore, in this work, dual tree complex wavelets transform (DTCWT)-based methodology is proposed for an automated identification of ECG signals exhibiting CHF from normal. In the experiment, we have performed a DTCWT on ECG segments of 2s duration up to six levels to obtain the coefficients. From these DTCWT coefficients, statistical features are extracted and ranked using Bhattacharyya, entropy, minimum redundancy maximum relevance (mRMR), receiver-operating characteristics (ROC), Wilcoxon, t-test and reliefF methods. Ranked features are subjected to k-nearest neighbor (KNN) and decision tree (DT) classifiers for automated differentiation of CHF and normal ECG signals. We have achieved 99.86% accuracy, 99.78% sensitivity and 99.94% specificity in the identification of CHF affected ECG signals using 45 features. The proposed method is able to detect CHF patients accurately using only 2s of ECG signal length and hence providing sufficient time for the clinicians to further investigate on the severity of CHF and treatments.

Matched MeSH terms: Diagnosis, Computer-Assisted/methods*; Electrocardiography/methods*; Pattern Recognition, Automated/methods
Fulltext Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia

Bazazi AR, Wickersham JA, Wegman MP, Culbert GJ, Pillai V, Shrestha R, et al.

Contemp Clin Trials, 2017 08;59:1-12.
PMID: 28479216 DOI: 10.1016/j.cct.2017.05.006

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed.

Matched MeSH terms: Behavior Therapy/methods*; Substance Abuse Treatment Centers/methods; Opiate Substitution Treatment/methods*
The o-toluidine method for blood glucose determination

Buttery JE, de Witt GF, Omar Ahmad U

Med J Malaya, 1968 Sep;23(1):54-7.
PMID: 4237558
Matched MeSH terms: Methods
Effect of heat on cholera vibrio: its implication for vaccine manufacture

Ghosh HK

Med J Malaya, 1969 Mar;23(3):179-80.
PMID: 4240070
Matched MeSH terms: Methods
Clinical application of ascending urethrography in males

Ng King Kwi, Yong SL

Med J Malaysia, 1973 Jun;27(4):258-61.
PMID: 4270782
Matched MeSH terms: Methods
A thermoprecipitin test for rapid diagnosis of cholera

Ghosh HK

Med J Malaya, 1970 Jun;24(4):300-1.
PMID: 4248352
Matched MeSH terms: Methods
Fulltext Persistent left superior vena cava and absence of innominate vein during coronary artery bypass surgery

Tan JH, Ng ZQ, Vendargon S

BMJ Case Rep, 2018 Apr 17;2018.
PMID: 29666108 DOI: 10.1136/bcr-2018-225271
Matched MeSH terms: Coronary Artery Bypass/methods*; Intraoperative Care/methods; Echocardiography, Transesophageal/methods
Inclusion of dosimetric data as covariates in toxicity-related radiogenomic studies : A systematic review

Yahya N, Chua XJ, Manan HA, Ismail F

Strahlenther Onkol, 2018 08;194(8):780-786.
PMID: 29774397 DOI: 10.1007/s00066-018-1303-5

PURPOSE: This systematic review evaluates the completeness of dosimetric features and their inclusion as covariates in genetic-toxicity association studies.
MATERIALS AND METHODS: Original research studies associating genetic features and normal tissue complications following radiotherapy were identified from PubMed. The use of dosimetric data was determined by mining the statement of prescription dose, dose fractionation, target volume selection or arrangement and dose distribution. The consideration of the dosimetric data as covariates was based on the statement mentioned in the statistical analysis section. The significance of these covariates was extracted from the results section. Descriptive analyses were performed to determine their completeness and inclusion as covariates.
RESULTS: A total of 174 studies were found to satisfy the inclusion criteria. Studies published ≥2010 showed increased use of dose distribution information (p = 0.07). 33% of studies did not include any dose features in the analysis of gene-toxicity associations. Only 29% included dose distribution features as covariates and reported the results. 59% of studies which included dose distribution features found significant associations to toxicity.
CONCLUSION: A large proportion of studies on the correlation of genetic markers with radiotherapy-related side effects considered no dosimetric parameters. Significance of dose distribution features was found in more than half of the studies including these features, emphasizing their importance. Completeness of radiation-specific clinical data may have increased in recent years which may improve gene-toxicity association studies.

Matched MeSH terms: Data Collection/methods*; Radiation Genetics/methods*; Radiometry/methods*
Monitoring of tobramycin in human plasma via mixed matrix membrane extraction prior to capillary electrophoresis with contactless conductivity detection

Mukhtar NH, Mamat NA, See HH

J Pharm Biomed Anal, 2018 Sep 05;158:184-188.
PMID: 29883881 DOI: 10.1016/j.jpba.2018.05.044

A sample pre-treatment method based on a dynamic mixed matrix membrane tip extraction followed by capillary electrophoresis with contactless conductivity detection (CE-C4D) was evaluated for the determination of tobramycin in human plasma. The extraction tip device consisted of a cellulose triacetate membrane tip wall immobilised with 15% (w/w) of hydrophilic lipophilic balance (HLB) nanoparticles as adsorbent. The extraction was performed dynamically by withdrawing/dispensing the plasma sample through the tip device followed by desorption into 20 μL of acidified aqueous solution at pH 3 prior to the CE-C4D analysis. Under the optimum conditions, the detection limit of the method for tobramycin was 10 ng/mL, with intraday and interday repeatability RSDs of 3.5% and 4.5%, respectively. Relative recoveries in spiked human plasma were 99.6%-99.9%. The developed approach was successfully demonstrated for the quantification of tobramycin in human plasma samples.

Matched MeSH terms: Chemical Fractionation/methods*; Drug Monitoring/methods*; Electrophoresis, Capillary/methods
Development and validation of a comprehensive solid-phase extraction method followed by LC-TOF/MS for the analysis of eighteen pharmaceuticals in influent and effluent of sewage treatment plants

Al-Qaim FF, Mussa ZH, Yuzir A

Anal Bioanal Chem, 2018 Aug;410(20):4829-4846.
PMID: 29806068 DOI: 10.1007/s00216-018-1120-9

The scarcity of data about the occurrence of pharmaceuticals in water bodies in Malaysia prompted us to develop a suitable analytical method to address this issue. We therefore developed a method based on solid-phase extraction combined with liquid chromatography-time of flight/mass spectrometry (SPE-LC-TOF/MS) for the analysis of sixteen prescribed and two nonprescribed pharmaceuticals that are potentially present in water samples. The levels of these pharmaceuticals, which were among the top 50 pharmaceuticals consumed in Malaysia during the period 2011-2014, in influent and effluent of five sewage treatment plants (STPs) in Bangi, Malaysia, were then analyzed using the developed method. All of the pharmaceuticals were separated chromatographically using a 5 μm, 2.1 mm × 250 mm C18 column at a flow rate of 0.3 mL/min. Limits of quantification (LOQs) were 0.3-8.2 ng/L, 6.5-89 ng/L, and 11.1-93.8 ng/L in deionized water (DIW), STP effluent, and STP influent, respectively, for most of the pharmaceuticals. Recoveries were 51-108%, 52-118%, and 80-107% from the STP influent, STP effluent, and DIW, respectively, for most of the pharmaceuticals. The matrix effect was also evaluated. The signals from carbamazepine, diclofenac sodium, and mefenamic acid were found to be completely suppressed in the STP influent. The signals from other compounds were found to be influenced by matrix effects more strongly in STP influent (enhancement or suppression of signal ≤180%) than in effluent (≤94%). The signal from prednisolone was greatly enhanced in the STP influent, indicating a matrix effect of -134%. Twelve pharmaceuticals were frequently detected in all five STPs, and caffeine, prazosin, and theophylline presented the highest concentrations among all the pharmaceuticals monitored: up to 7611, 550, and 319 ng/L in the STP influent, respectively. To the best of our knowledge, this is the first time that prazosin has been detected in a water matrix in Malaysia. Graphical abstract ᅟ.

Matched MeSH terms: Chromatography, Liquid/methods*; Spectrometry, Mass, Electrospray Ionization/methods*; Solid Phase Extraction/methods*
School refusal in adolescents with systemic lupus erythematosus (SLE): A case series

Lee KKS, Chong JQ, Abu Bakar AK

Asian J Psychiatr, 2018 Apr;34:59-60.
PMID: 29653342 DOI: 10.1016/j.ajp.2018.04.021
Matched MeSH terms: Desensitization, Psychologic/methods; Patient Education as Topic/methods; Psychotherapy/methods
The potential for evaluating the effects of intensified antithrombotic therapy using retinal optical coherence tomography angiography

Aik Kah T

Med Hypotheses, 2018 Jun;115:54-57.
PMID: 29685198 DOI: 10.1016/j.mehy.2018.03.022

Oral anticoagulants are widely used in the treatment and prevention of both venous and arterial thromboembolism. They are classified into vitamin K anticoagulants (VKAs) and non-vitamin K antagonist oral anticoagulants (NOACs). The main advantage of NOACs over VKAs is the absence of the need for continuous monitoring. However, there are concerns about their effectiveness and safety in certain clinical situations. In this manuscript, I discussed the possibility of using optical coherence tomography angiography [OCTA] in the monitoring of the activity of NOACs. The rapid development of OCTA technology is very promising. Further research and development will extend its use beyond the realm of ophthalmology.

Matched MeSH terms: Angiography/methods*; Drug Monitoring/methods; Tomography, Optical Coherence/methods*
Fulltext Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: A randomized clinical trial

Abdulrahman SA, Rampal L, Ibrahim F, Radhakrishnan AP, Kadir Shahar H, Othman N

PLoS One, 2017;12(5):e0177698.
PMID: 28520768 DOI: 10.1371/journal.pone.0177698

BACKGROUND: Adherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART).
OBJECTIVE(S): Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia.
METHODS: A single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation), in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention.
RESULTS: The response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39-96.97) as compared to the control group (87.5; 95% CI: 86.14-88.81). The proportion of respondents who had Good (>95%) adherence was significantly higher in the intervention group (92.2%) compared to the control group (54.6%). A significantly lower frequency in missed appointments (14.0% vs 35.5%) (p = 0.001), lower viral load (p = 0.001), higher rise in CD4 count (p = 0.017), lower incidence of tuberculosis (p = 0.001) and OIs (p = 0.001) at 6 months follow up, was observed among patients in the intervention group.
CONCLUSION: Mobile phone reminders (SMS and telephone call reminders) and peer counseling are effective in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. These findings may be of potential benefit for collaborative adherence planning between patients and health care providers at ART commencement.

Matched MeSH terms: Distance Counseling/methods*; Telemedicine/methods; Antiretroviral Therapy, Highly Active/methods*
An improved SPE-LC-MS/MS method for multiclass endocrine disrupting compound determination in tropical estuarine sediments

Omar TFT, Aris AZ, Yusoff FM, Mustafa S

Talanta, 2017 Oct 01;173:51-59.
PMID: 28602191 DOI: 10.1016/j.talanta.2017.05.064

Estuary sediments are one of the important components of coastal ecosystems and have been regarded as a sink for various types of organic pollutants. Organic pollutants such as endocrine disrupting compounds (EDCs) which have been associated with various environmental and human health effects were detected in the estuary sediment at trace level. Considering various interferences that may exist in the estuarine sediment, a sensitive and selective method, capable of detecting multiclass EDC pollutants at the trace levels, needs to be developed and optimized to be applied for environmental analysis. A combination of Soxhlet extraction followed by offline solid phase extraction (SPE) cleaned up with detection based on LC triple quadrupole MS was optimized and validated in this study. The targeted compounds consisted of ten multiclass EDCs, namely, diclofenac, primidone, bisphenol A, estrone (E1), 17β-estradiol (E2), 17α-ethynylestradiol (EE2), 4-octylphenol (4-OP), 4-nonylphenol (4-NP), progesterone, and testosterone. The method showed high extraction efficiency with percentage of recovery from 78% to 108% and excellent sensitivity with detection limit between 0.02ngg-1 and 0.81ngg-1. Excellent linearity from 0.991 to 0.999 was achieved for the developed compounds and the relative standard deviation was less than 18%, an indication of good precision analysis. Evaluation of the matrix effects showed ionization suppression for all the developed compounds. Verification of the method was carried out by analyzing the estuarine sediment collected from Langat River. The analyzed estuarine sediments showed a trace concentration of diclofenac, bisphenol A, progesterone, testosterone, primidone, and E1. However, E2, EE2, 4-OP, and 4-NP were below the method's detection limit. Diclofenac exhibited the highest concentration at 2.67ngg-1 followed by bisphenol A (1.78ngg-1) while E1 showed the lowest concentration at 0.07ngg-1.

Matched MeSH terms: Chromatography, Liquid/methods*; Solid Phase Extraction/methods*; Tandem Mass Spectrometry/methods*
Fulltext Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial

Oei JL, Saugstad OD, Lui K, Wright IM, Smyth JP, Craven P, et al.

Pediatrics, 2017 01;139(1).
PMID: 28034908 DOI: 10.1542/peds.2016-1452

BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation.
METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.
RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13).
CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.

Matched MeSH terms: Oximetry/methods; Oxygen Inhalation Therapy/methods*; Resuscitation/methods*
Analysis of Terpenoid Indole Alkaloids, Carotenoids, Phytosterols, and NMR-Based Metabolomics for Catharanthus roseus Cell Suspension Cultures

Saiman MZ, Mustafa NR, Verpoorte R

Methods Mol Biol, 2018;1815:437-455.
PMID: 29981141 DOI: 10.1007/978-1-4939-8594-4_31

The plant Catharanthus roseus is a rich source of terpenoid indole alkaloids (TIA). Some of the TIA are important as antihypertensive (ajmalicine) and anticancer (vinblastine and vincristine) drugs. However, production of the latter is very low in the plant. Therefore, in vitro plant cell cultures have been considered as a potential supply of these chemicals or their precursors. Some monomeric alkaloids can be produced by plant cell cultures, but not on a level feasible for commercialization, despite extensive studies on this plant that deepened the understanding of the TIA biosynthesis and its regulation. In order to analyze the metabolites in C. roseus cell cultures, this chapter presents the method of TIA, carotenoids, and phytosterols analyses. Furthermore, an NMR-based metabolomics approach to study C. roseus cell culture is described.

Matched MeSH terms: Magnetic Resonance Spectroscopy/methods*; Cell Culture Techniques/methods*; Metabolomics/methods*
Rate adaptive pacing in an intracardiac pacemaker

Lloyd M, Reynolds D, Sheldon T, Stromberg K, Hudnall JH, Demmer WM, et al.

Heart Rhythm, 2017 02;14(2):200-205.
PMID: 27871854 DOI: 10.1016/j.hrthm.2016.11.016

BACKGROUND: The Micra transcatheter pacemaker was designed to have similar functionality to conventional transvenous VVIR pacing systems. It provides rate adaptive pacing using a programmable 3-axis accelerometer designed to detect patient activity in the presence of cardiac motion.
OBJECTIVE: The purpose of this study was to evaluate the system's performance during treadmill tests to maximum exertion in a subset of patients within the Micra Transcatheter Pacing Study.
METHODS: Patients underwent treadmill testing at 3 or 6 months postimplant with algorithm programming at physician discretion. Normalized sensor rate (SenR) relative to the programmed upper sensor rate was modeled as a function of normalized workload in metabolic equivalents (METS) relative to maximum METS achieved during the test. A normalized METS and SenR were determined at the end of each 1-minute treadmill stage. The proportionality of SenR to workload was evaluated by comparing the slope from this relationship to the prospectively defined tolerance margin (0.65-1.35).
RESULTS: A total of 69 treadmill tests were attempted by 42 patients at 3 and 6 months postimplant. Thirty tests from 20 patients who completed ≥4 stages with an average slope of 0.86 (90% confidence interval 0.77-0.96) confirmed proportionality to workload. On an individual test basis, 25 of 30 point estimates (83.3%) had a normalized slope within the defined tolerance range (range 0.46-1.08).
CONCLUSION: Accelerometer-based rate adaptive pacing was proportional to workload, thus confirming rate adaptive pacing commensurate to workload is achievable with an entirely intracardiac pacing system.

Matched MeSH terms: Cardiac Pacing, Artificial/methods*; Exercise Test/methods*; Materials Testing/methods

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