Parkview Health Research Repository
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Synchronized Diaphragmatic Stimulation for the Treatment of Symptomatic Heart Failure: A Novel Implantable Therapy Concept
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Audicor Remote Patient Monitoring: FDA Breakthrough Device and Technology for Heart Failure Management
Get PDFResearch Letter: The impact of heart failure (HF) on patients, physicians, and hospital systems remains despite recent successes in pharmacologic and device-based treatments. Chronic HF represents one of the nation’s top health issues, leading to reduced patient quality of life, increased risks of hospitalization, increased health care utilization, and high incidence of patient morbidity and mortality. Titration of guideline directed medical therapy and prevention of HF hospitalizations have been identified as key targets in the management of HF. Remote monitoring provides the opportunity to address both issues and has gained significant momentum during the COVID-19 pandemic. Device-based solutions to manage HF remotely, such as CardioMEMS and Boston Scientific HeartLogic, have demonstrated promise for the prevention of HF hospitalizations but are invasive and expensive. A noninvasive system for remote HF monitoring for easy at-home use, Audicor RPM has recently received a FDA Breakthrough Device designation
Synchronized Diaphragmatic Stimulation for Heart Failure With a Reduced Left Ventricular Ejection Fraction Using the VisONE System: A First-in-Patient Study With Extended Population
Get PDFHighlights Synchronized diaphragmatic stimulation (SDS) is a new extra-cardiac HFrEF therapy SDS impacts intrathoracic pressure and pericardial restraint• SDS exhibits a favorable safety profile over 1 year of chronic use Exercise tolerance and QOL improved with SDS over 1 year Early results will soon be validated in a randomized control trial Abstract Background Synchronized diaphragmatic stimulation (SDS) produces localized contractions of the diaphragm gated to the cardiac cycle to transiently modulate intrathoracic pressures, thereby impacting cardiac function for heart failure patients with reduced ejection fraction (HFrEF). This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded first-in-patient cohort using multiple implant methods. Methods Symptomatic patients with HFrEF despite guideline-directed therapy were enrolled. Patients were evaluated at 3, 6 and 12 months for adverse events, quality of life (SF-36 QOL), echocardiography and 6-minute hall walk distance. The SDS system consists of 2 bipolar, active-fixation leads, and an implantable pulse generator. Results Nineteen men were enrolled (age 63 [57, 67] years, New York Heart Association class II [53%]/III [47%], N-terminal pro B-type natriuretic peptide 1779 [886, 2309] pg/mL, left ventricular ejection fraction 27 [23, 33] %). Three implant techniques (abdominal laparoscopy: sensing and stimulating leads on the inferior diaphragm (n = 15); subxiphoid access for an epicardial sensing lead and abdominal laparoscopy for stimulation on the inferior diaphragm (n = 2); thoracoscopy to place an epicardial sensing lead and a stimulating lead on the superior diaphragm (n = 2)) were employed with 100% success. Patients were unaware of diaphragmatic stimulation. From discharge to 12 months, 6-minute hall walk distance increased (315 [296, 332]m to 340 [319, 384]m; p = 0.002), left ventricular end-systolic volume decreased (135 [114, 140]mL to 99 [90, 105]mL; p = 0.04), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], p = 0.004; emotional scale 0 [0, 33] to 67 [33, 67], p = 0.001). N-terminal pro B-type natriuretic peptide was lower (1784 [944, 2659]pg/mL vs. 962 [671, 1960]pg/mL; p = ns) and left ventricular ejection fraction increased (28 [23, 38]% vs. 35 [31, 40]%; p = ns) although neither reached statistical significance. There were no procedure- or SDS-related adverse events. Conclusions These data demonstrate that SDS can be delivered using alternative implantation methods without raising safety concerns and suggest improved outcomes over 1 year of follow-up. Adequately powered randomized trials are now needed to confirm these findings
Impact of Pharmacist-Led Direct Oral Anticoagulant Monitoring on Appropriate Medication Use
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Background: Direct oral anticoagulants (DOACs) are the preferred treatment for patients with venous thromboembolism and atrial fibrillation and are an attractive alternative to vitamin K antagonists in multiple indications for long-term anticoagulation. Although DOACs require less frequent clinical monitoring than vitamin K antagonists and their standardized dosing is often more convenient for patients, these medications still require monitoring. Medication adherence, monitoring renal function, hepatic function and drug interactions are important safety concerns for managing patients on DOAC therapy. Previous studies have shown pharmacist can impact monitoring, dosing and adherence to DOACs. This study aims to evaluate the impact of pharmacist-led anticoagulation services on appropriate dosing and monitoring of DOAC agents compared to other providers in the healthcare system. At Parkview Health’s Anticoagulation Therapy Unit, patients on DOACs have an initial visit where dosing, renal function, liver function and drug interactions are monitored. Patients are also counseled on adherence, adverse drug reactions and signs or symptoms of adverse events like stroke, VTE or bleeds. Follow up visits take place at 4 weeks, 3 months, 6 months, then every 6-12 months based on patient specific factors. At these visits patients are assessed using a DOAC checklist.
Primary Endpoint: Adherence to recommended frequencies for blood work and dosing
Secondary Endpoint: Incidence of venous thromboembolism, cerebrovascular accident, or clinically relevant bleeding, rate of use of interacting or contraindicated medications at any point of DOAC therapy
Evaluation of Rituximab Use at Parkview Health
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Objective: Characterize the use of rituximab at Parkview Health by differentiating between inpatient and outpatient use as well as evaluate indications for use, incidence of documented infusion reactions, and biosimilar use
Continued Use of Proton Pump Inhibitors and Risk for Recurrence of Clostridium Difficile Infection-A Retrospective study
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Objective: To determine if the continued use of proton pump inhibitors leads to an increased risk of recurrent Clostridium difficile infections
Creating the Stroke Compliance Report for System Wide Use
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Purpose/Aim: The aim of this project was to create an all encompassing stroke core measure report in one easy to access location which would decrease time spent completing audits.
Problems: • Feedback regarding audit tool determined it to be cumbersome and tedious • Each audit required nurse leader to enter each patient record to search for the information • Completion of the audit took a considerable amount of time which removed the nurse leader from the bedside and patient care
Implementing Services for Pediatric Cystic Fibrosis Treatment in a Community Hospital
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Evaluation of a Pharmacy-Led Statin Medication Use Review and Outreach Initiative
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