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2019| October-December | Volume 8 | Issue 4
Online since
January 6, 2020
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ORIGINAL ARTICLES
Wellysis S-PAtch Cardio versus Conventional Holter Ambulatory Electrocardiographic Monitoring (The PACER Trial): Preliminary Results
Satyanarayana Upadhyayula, Ravi R Kasliwal
October-December 2019, 8(4):173-182
DOI
:10.4103/JCPC.JCPC_43_19
Aims and Objectives:
The Wellysis S-PAtch Cardio versus Conventional Holter Ambulatory Electrocardiographic Monitoring (PACER) trial consists of multiple arms. First arm is a prospective, interventional, nonrandomized, single group assignment, diagnostic substudy with intention to treat. This head-to-head trial aims to compare the diagnostic yield, or ability to detect arrhythmias – especially paroxysmal atrial fibrillation (PAF) – of the conventional Ambulatory Holter monitoring device with the Wellysis S-Patch Cardio, a novel, low-profile device consisting of a single positive bipolar lead corresponding to the standard limb lead II (
n
= 10). Second arm is a validation substudy of the Wellysis S-Patch Cardio device in terms of overall performance (
n
= 86).
Background:
It is widely recognized that technology can improve the health of populations in countries around the world. Smartphone technology is at the forefront of innovation in low-, middle-, and high-income countries. The smartphone technology has already improved the doctor–patient interaction, reducing costs and improving care for patients.
Methodology:
In the comparator arm, patients who satisfied the eligibility criteria as well as referred for ambulatory ECG monitoring were consented and enrolled prospectively to have the Holter monitor and the Wellysis S-Patch Cardio device placed simultaneously (
n
= 10) for 24–48 h and the incidence of clinically significant arrhythmias were compared. A feedback questionnaire was given to patients/paramedics and clinicians after completion of the study. The overall performance (patient, paramedic and clinician feedback and questionnaire derived subjective composite index of comfort, usability, interference with daily activities, adverse events, adaptability, robustness, repeatability, durability, clinical analysis, clarity of recorded signals, efficiency, accuracy, and cost-effectiveness) of Wellysis S-Patch Cardio device was compared with multi lead Holter Monitor in this head to head trial (
n
= 10). In the validation arm patients who satisfied the eligibility were consented and enrolled prospectively to have the Wellysis S-Patch Cardio device placed (
n
= 86) for 24–48 h and the incidence of clinically significant arrhythmias noted.
Results:
Preliminary results from the comparator arm (
n
= 10), Mc Nemars analysis, revealed odds ratio 1.000, 95% confidence interval 0.072–13.796, χ
2
= 0.250, DF = 1,
P
< 0.6171; supporting the null hypothesis-Wellysis S-Patch Cardio is comparable to Holter in terms of Overall Performance (comfort, usability, interference with daily activities, adverse events, adaptability, robustness, repeatability, durability, clinical analysis, clarity of recorded signals, efficiency, accuracy, and cost-effectiveness).
Conclusion:
Multi lead ambulatory Holter monitoring remains the gold standard for arrhythmia detection. However, Wellysis S-Patch Cardio device has a definite complementary role in the detection of PAF in cryptogenic stroke patients.
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Impact of comorbidities in heart failure – prevalence, effect on functional status, and outcome in indian population: A single-center experience
Saurabh Mehrotra, Tejinder M Sharma, Ajay Bahl
October-December 2019, 8(4):166-172
DOI
:10.4103/JCPC.JCPC_27_19
Background:
We sought to estimate the prevalence of comorbidities in heart failure (HF) patients and their impact on functional status and clinical outcomes in Indian population.
Patients and Methods:
This prospective study was carried out at a tertiary care institute in North India. Patients were followed up prospectively for readmission and mortality for a median of 18 months.
Results:
A total of 113 HF patients were included in the study – 59 being HF with preserved ejection fraction (HFpEF) and 54 being HF with reduced ejection fraction (HFrEF). Patients with HFpEF were older (
P
= 0.03) with an equal proportion of males and females. Patients with HFpEF were less intensively treated with HF medications, particularly, spironolactone and other diuretics (
P
= 0.001). A total of 17 comorbidities were identified, and patients with HFpEF exhibited a higher burden of total and noncardiac comorbidities. After 18 months of follow-up, the all-cause readmissions and all-cause mortality were higher (
P
= 0.01) in patients with HFrEF as compared to HFpEF. The high New York Heart Association (NYHA) class, low ejection fraction, and high proBNP were associated with an increased risk of all-cause mortality. The mean Geriatric Nutritional Risk Index (GNRI) was significantly low in the HFrEF group (96.4 ± 10.8 vs. 102.3 ± 12.9,
P
= 0.009). Quality of life was poor in patients with HFrEF as compared with the HFpEF group, and 36-item Short-Form Health Survey score decreased proportionately with a decrease in EF. Multivariate analysis showed EF, GNRI, albumin (mg/dl), urea (mg/dl), sodium, and all-cause mortality to be associated with HF-related readmissions. Furthermore, NYHA class, urea (mg/dl), all-cause readmission, and HF-related readmission were seen to be associated with HF-related mortality.
Conclusion:
Despite differential prevalence, comorbidities exert substantial impact on the functional status in HFrEF as well as HFpEF patients. An individualized treatment approach based on comorbidities could provide a way forward, especially in low-resource countries.
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A study of cardiac dysfunction in human immunodeficiency virus-infected patients and its correlation with cd4 count
Vinay Tuteja, CL Nawal, CB Meena, Aradhana Singh, RS Chejara, Rajbeer Singh, Pradeep Kumar Bansal
October-December 2019, 8(4):156-160
DOI
:10.4103/JCPC.JCPC_20_19
Introduction:
Human immunodeficiency virus (HIV) is an infectious disease, leading to rapid failure of the immune system. Since the introduction of combination antiretroviral therapy (ART), it has led to a substantial decrease in the incidence of AIDS-related conditions and all-cause mortality over time. However, clinical chronic nonAIDS conditions including cardiovascular disease are on a rise with the prolonged life expectancy of HIV-infected patients.
Study Design:
The study design involves hospital-based observational comparative analysis.
Materials and Methods:
A total of 200 individuals, including 100 infected with HIV and 100 controls, were taken after ruling out the various exclusion factors. Cases were further scrutinized on the basis of CD4 count and duration of highly active ART. Every patient underwent a battery of tests, and also various echocardiography parameters were recorded and analyzed carefully.
Results
: Male:female ratio in cases and controls was 3.3:1. Cases were divided according to CD4 count, as patients having CD4 <200/200–350/>350. The mean CD4 count was 108.47 ± 36.51/277.85 ± 46.73/576.63 ± 195, respectively. Forty-one percent of individuals had abnormal electrocardiography findings, pulmonary hypertension (PH) was found in 10% of patients, and also three patients (30%) had a moderate grade of PH. Twenty-seven percent had minimal pericardial effusion. Among cases, the mean ejection fraction observed was 54.68% ± 6.82% which was significantly lower than controls (60.72% ± 1.47%). Left ventricular diastolic dysfunction was seen in 46% of cases as compared to 3% controls.
Conclusions:
This study indicates that cardiovascular abnormalities are more common in HIV-infected patients than the normal population. Even asymptomatic patients had abnormal echocardiographic findings. Echocardiography is a useful noninvasive technique for the early recognition of cardiac dysfunction in such patients.
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Can Shorter Fluoroscopic Time Obviates the Need of Routine Heparin Use in Coronary Angiography via Femoral Route? A Prospective Study
Om Murti Anil, Nabin Chaudhary, Arun Sayami, Saheb Kumar Jayswal, Naresh Maharjan, Bhawani Manandhar, Paras Koirala, Ujit Kumar Karmacharya
October-December 2019, 8(4):161-165
DOI
:10.4103/JCPC.JCPC_28_19
Background:
The use of heparin in coronary angiography (CAG) through radial route is a well-known practice. However, the prophylactic use of heparin following the femoral arterial sheath insertion is still controversial, so we aimed to assess the safety of CAG without the use of heparin through femoral approach by minimizing fluoroscopy time.
Methods:
All patients undergoing diagnostic CAG through femoral approach were enrolled in our study. Heparin was not given after femoral sheath insertion contrary to the usual practice. Depending on the fluoroscopy time, patients were divided into three groups: (a) group with fluoroscopy time <2 min, (b) group with fluoroscopy time 2–5 min, and (c) group with fluoroscopy time 5–10 min. The study patients were prospectively assessed for any thrombus formation or embolic event. Femoral puncture site and other complications were also studied simultaneously. Patients with primary/elective angioplasty and longer fluoroscopy time (>10 min) were excluded from the study as well as those who received heparin.
Results:
Altogether, 1550 patients were enrolled in the study over a period of 3 years. The mean age of the study population was 57.0 ± 12.5 years; 71% of the patients were male. Fluoroscopy time was <2 min in 63% of the patients, 2–5 min in 33% of the patients, and 4% of the patients had fluoroscopy time of 5–10 min. No thromboembolic clinical events were recorded in the entire population during the study. Femoral sheath thrombus was seen in only 2.9% of the patients, and all of these cases had a fluoroscopy time of min.
Conclusion:
CAG can be safely performed through femoral route without the use of heparin and without any associated thromboembolic complications if fluoroscopy time is <10 min.
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CASE REPORT
Two T waves following one QRS complex – Unusual treadmill test tracings due to printer malfunction
Sita Ram Mittal
October-December 2019, 8(4):183-185
DOI
:10.4103/JCPC.JCPC_39_19
We observed two T waves following one QRS complex during treadmill stress testing of three patients evaluated on the same machine. Careful analysis revealed that this happened due to transient stopping of the printer of the machine.
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EDITOR’S PAGE
Editor's Page October 2019
Ravi R Kasliwal
October-December 2019, 8(4):155-155
DOI
:10.4103/2250-3528.275399
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IMAGE IN CARDIOLOGY
Self-Assessment Quiz
Vishnu Sharma Moleyar
October-December 2019, 8(4):186-187
DOI
:10.4103/JCPC.JCPC_26_19
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1,703
178
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© Journal of Clinical and Preventive Cardiology | Published by Wolters Kluwer -
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