Expanding a single­lead mobile electrocardiographic device to multiple­lead recordings improves diagnostic accuracy and confidence.

BACKGROUND: Mobile electrocardiographic (mECG) devices that record ECG lead I have been used to detect atrial fibrillation. Other arrhythmias may not be readily diagnosed with one lead. Obtaining multi­lead tracings from an mECG (MLmECG) to simulate a 12­lead ECG may lead to more accurate diagnoses. METHODS: We developed a method to generate multi­lead ECGs using a mECG device by attaching it with alligator clips connected to an insulated copper wire to adhesive electrodes on the patient's limbs and torso according to standard lead configurations. Different rhythm and conduction abnormalities from a sample of inpatients were collected. Arrhythmias were recorded in three ways (single lead, MLmECG, and standard 12­lead) and grouped by category. Recordings were sent to cardiology fellows in the form of a multiple choice survey. Participants were asked for their diagnosis and confidence in their decision. RESULTS: Survey response rate was 100%. Single­lead, MLmECG, and 12­lead yielded 48.2%, 81.6%, and 88.6% of agreement with the correct diagnosis, respectively (single­lead vs. MLmECG or 12­lead; p < 0.01). Overall mean confidence scores were 3.34, 4.35, and 4.53 out of 5, for single­lead, MLmECG, and 12­lead ECG, respectively (single­lead vs. MLmECG or 12­lead; p < 0.01, MLmECG vs. 12­lead; p = 0.09). CONCLUSION: The diagnostic accuracy of MLmECGs were similar to that of a standard 12­lead ECG. Fellows' confidence in their diagnosis were similar between MLmECG or 12­lead ECG, and higher with both modalities compared to a single­lead tracing. The ability to recreate, as fully as possible, a standard 12­lead ECG is a reasonable goal for mobile technology.

Testing the feasibility of operationalizing a prospective, randomized trial with remote cardiac safety EKG monitoring during a pandemic.

BACKGROUND: The coronavirus SARS-CoV-2 is highly contagious. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2. The FDA authorized emergency use of HCQ against COVID-19. HCQ may have dose-related cardiotoxicity. This clinical trial received ethical approval on May 15, 2020, operationalized in June to evaluate a low prophylaxis dose of HCQ (200mg BID) in household contacts of COVID-19-positive patients without physical contact between investigators and participants. It represents the first report of the FDA approved 6-lead EKGs with a smartphone KardiaMobile® 6L application. METHODS: To reach a sample size of 170, household members were contacted by telephone, emailed consent forms with electronic signature capability, and randomized 2:1 to HCQ or observation for 10 days with follow-up of 14 days. Home saliva PCR tests recorded COVID status on days 1 and 14. Symptoms and 6-lead EKGs were obtained daily. RESULTS: Fifty-one participants were randomized with 42 evaluable at day 14. Remote monitoring of 407 EKGs revealed no QTc prolongation or other ECG changes in either group. At time of consent, no participants were symptomatic or COVID+. On days 1 and 14, COVID tests were positive in 4 and 2 in the HCQ group and 4 and 0 in the observation group. No tests converted to positive. There were no deaths or hospitalizations. CONCLUSIONS: A clinical trial without personal contact, rapidly initiated and operationalized to exclude cardiac toxicity using daily remote 6-lead EKG monitoring, is feasible. Of 407 EKGs from 42 participants, there was no evidence of cardiac toxicity. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov : NCT04652648 registration date: December 3, 2020.

A review of upper extremity deep vein thrombosis.

This review aims to describe the epidemiology, pathophysiology, risk factors, presentation, complications, evaluation/diagnosis, and treatment of upper extremity deep vein thrombosis (UEDVT). Upper extremity deep vein thrombosis (UEDVT) accounts for 6% of cases of deep vein thrombosis (DVT). It can lead to swelling and discomfort in that extremity and can be complicated by pulmonary embolism, post-thrombotic syndrome, and recurrence of DVT. Evaluation can begin with a dichotomized Constans score and fibrin degradation product testing. Diagnosis is typically made with compression ultrasound. Anticoagulation is the mainstay of therapy. Primary UEDVT is known as Paget Schroetter Syndrome (PSS) which occurs due to venous thoracic outlet syndrome (vTOS). Anticoagulation, thrombolysis, and decompression of the venous thoracic outlet are used for treatment but the optimal strategy remains to be elucidated. Secondary UEDVT are most commonly caused by indwelling catheters and malignancy. There is an ongoing realization that UEDVT are more than simply 'leg clots in the arm.' Given the increasing incidence, research needs to be done to further our understanding of this disease state, its evaluation, and its treatment.

The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic.

BACKGROUND: The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare systems. Clinical research trials were hindered by infection control measures discouraging physical contact and diversion of resources to meet emergent requirements. The need for effective treatment and prevention of COVID-19 prompted an untested investigational response. Trial groups adapted approaches using remote enrolment and consenting, newly developed diagnostic tests, delivery of study medications and devices to participants' homes, and remote monitoring to ensure investigator/enrollee safety while preserving ethical integrity, confidentiality, and data accuracy. METHODS: Clinical researchers at our community health system in the USA undertook an outpatient randomized open-label study of hydroxychloroquine (HCQ) prophylaxis versus observation of SARS-CoV-2 infection in household COVID-19 contacts. Designed in March 2020, challenges included COVID-19 infection in the research group, HCQ shortage, and lack of well-established home SARS-CoV-2 tests and remote ECG monitoring protocols in populations naive to these procedures. The study was written, funded, and received ethical committee approval in 4 months and was completed by September 2020 during a period of fluctuating infection rates and conflicting political opinions on HCQ use; results have been published. Singular methodology included the use of a new RNA PCR saliva SARS-CoV-2 home diagnostic test and a remote smartphone-based 6-lead ECG recording system. RESULTS: Of 483 households contacted regarding trial participation, 209 (43.3%) did not respond to telephone calls/e-mails and 90 (18.6%) declined; others were not eligible by inclusion or exclusion criteria. Ultimately, 54 individuals were enrolled and 42 completed the study. Numbers were too small to determine the efficacy of HCQ prophylaxis. No serious treatment-related adverse events were encountered. CONCLUSIONS: Flexibility in design, a multidisciplinary research team, prompt cooperation among research, funding, ethics review groups, and finding innovative study approaches enabled this work. Concerns were balancing study recruitment against unduly influencing individuals anxious for protection from the pandemic and exclusion of groups based on lack of Internet access and technology. An issue to address going forward is establishing research cooperation across community health systems before emergencies develop. TRIAL REGISTRATION: ClinicalTrials.gov NCT04652648 . Registered on December 3, 2020.

Pseudomonas MitraClip® endocarditis: A case report and review of literature.

Endocarditis from Pseudomonas aeruginosa is a rare cause of endocarditis with most of those cases in patients with intravenous drug abuse. The MitraClip® is a relatively new device with few incidences of endocarditis in the literature. Here we present the first reported case of pseudomonal endocarditis of a MitraClip® in a non-IV drug user.