Clinical trial of the week: Study of patients scheduled to undergo TAVR

By Donna Loyle, communications specialist, LIMR

 

Researchers seek to determine if use of the FDA-approved Sentinel® Cerebral Protection System significantly reduces the risk of stroke in patients undergoing a transcatheter aortic valve replacement (TAVR). The Sentinel System captures and removes embolic material during a TAVR and is meant to reduce ischemic injury to the brain.

 

Eligible participants in the post-market, multicenter Protected TAVR clinical study are those with aortic valve stenosis and in need of a TAVR. Subjects to be treated via a transfemoral approach will be randomized 1:1 into either the Test cohort (TAVR using the Sentinel) or the Control cohort (TAVR without using the Sentinel).

 

The study is approved for Lankenau Medical Center. The principal investigator is Roberto Rodriguez, MD. For more, visit www.mainlinehealth.org/research/clinical-trials/protected-tavr

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Prior Authorization for Certain Hospital Outpatient Department (OPD) Services-July 1st Launch

CMS believes prior authorization for certain hospital out-patient services will ensure that Medicare beneficiaries continue to receive medically necessary care – while protecting the Medicare Trust Fund from improper payments and, at the same time, keeping the medical necessity documentation requirements unchanged for providers.

The following hospital OPD services will require prior authorization when provided on or after July 1, 2020:

  1. Blepharoplasty
  2. Botulinum toxin injections
  3. Panniculectomy
  4. Rhinoplasty
  5. Vein ablation

The full list of HCPCS codes requiring prior authorization is available here:  https://www.cms.gov/files/document/cpi-opps-pa-list-services.pdf

Additional information from CMS: https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services

Main Line Health Pre-Encounter Department is available for questions at 484-337-1970 option 3.

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LIMR researchers awarded NIH grant for their proposal to advance breakthroughs for life-threatening heart conditions

Investigators at the Lankenau Institute for Medical Research (LIMR), the research division of Main Line Health, were awarded a $2.5 million, four-year grant from the National Institutes of Health (NIH) for their proposal to develop a whole heart model of the J wave syndromes and novel therapeutic approaches for the cardiac arrhythmias caused by the disorders.

Early repolarization syndrome (ERS) and Brugada syndrome (BS), two manifestations of the J wave syndromes, are associated with vulnerability to development of polymorphic ventricular tachycardia and ventricular fibrillation leading to sudden cardiac death in young adults —especially young men — who have no apparent structural heart disease. These cardiac conditions also can lead to sudden infant death syndrome.

The LIMR investigators awarded the grant from the NIH are Charles Antzelevitch, PhD, professor and executive director of cardiovascular research at LIMR and director of research at Lankenau Heart Institute; and Jose Di Diego, MD, research associate professor in Dr. Antzelevitch’s laboratory.

“Our principal aim for this research is to develop a whole heart model of BrS and ERS to

advance our understanding of the pathophysiology of these syndromes,” said Dr. Antzelevitch. “We will also follow up on earlier research that pointed to potential pharmacologic approaches to these life-threatening disorders for which treatment options currently are very limited.”

For this research, NIH has awarded LIMR $2.5 million, which will cover 70% of the project’s estimated cost. Non-governmental sources will fund approximately $1 million, or 30%, of the project.

This has been a milestone year for Dr. Antzelevitch. Earlier this year he received the prestigious Lifetime Achievement Award from the American College of Cardiology, a non-profit medical association, for his groundbreaking research into arrhythmias.

He also was ranked by Expertscape in the top 0.1 percent of scholars writing about electrocardiography and 13th out of about 72,000 scientists and physicians worldwide in the field of electrocardiography and cardiac electrophysiology. And he was ranked second in the state of Pennsylvania.

Dr. Antzelevitch has a long history of pioneering biomedical advancements regarding the J wave syndromes. In 2015, he and fellow LIMR researcher Gan-Xin Yan, MD, PhD, convened a consensus conference to update the global scientific and clinical communities on the mechanisms, diagnosis, prognosis, risk stratification, and treatment of J wave syndromes. And in 2016, the report of the J-Wave Expert Consensus Conference was published simultaneously in three biomedical journals, a highly unusual occurrence that speaks to the importance of their work.

For more on Dr. Antzelevitch’s research, visit: https://www.mainlinehealth.org/research/lankenau-institute-for-medical-research/researchers/our-faculty/charles-antzelevitch

 

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Updated MLH travel policy

Colleagues:

Due to increases in COVID-19 outbreaks in several States across the country, the Pennsylvania Department of Health has mandated a quarantine period for all travelers returning from specific States – currently 15 states are named on the PA state website: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Travelers.aspx.

Consistent with our adherence to the State guidelines, effective retroactively to July 3rd, 2020 at 7:00 am, Main Line Health will require a mandatory, 14-day quarantine for Employees, Medical Staff, Vendors and Students.  If a medical staff member has already returned to work after July 3rd, 2020, they will be required to stop rounding in the hospital and start the 14-day quarantine period away from the hospital from the date they left the restricted State.  We continue to follow the State recommendations as we know these decisions help keep our communities, patients, co-workers and ourselves protected and safe.

MLHC employed medical staff members will follow the same guidance as the employee policy and should work with their practice administrators.

Independent providers are encouraged to follow the state’s quarantine recommendations for their office practices but will be required to stay away from the hospital for the 14 days as described above.

The medical staff member and their department chair or campus chief will determine the return to the work/hospital date based on 14-days after the medical staff member leaves the restricted State –the medical staff member or the campus chief are not required to contact the Employee Exposure Line.

Please note, before returning to work in the hospital, the Medical Staff member should however call the Employee Exposure line at 484-580-4955 if:

Potential significant exposure has occurred

COVID + travel companion

COVID possible symptoms

Because of the seriousness of these recent COVID-19 outbreaks in other States, we rely on our medical staff members to provide their department chairs or chiefs with accurate and timely information regarding their travel plans to these DOH specified restricted states.

We appreciate your understanding of the need to make these changes, which will help us keep our patients, employees and medical staff safe as we continue to provide a superior experience to all.

Thank you,

Jim Gengaro, DO

Jon Stallkamp, MD

Andy Norton, MD

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Clinical Trial of the Week: Treatment trial for patients with advanced kidney cancer

By Donna Loyle, communications specialist, LIMR

PDIGREE is phase III clinical trial for patients with untreated metastatic kidney cancer. Researchers seek to determine if the addition of cabozantinib to the usual treatment — which is ipilimumab and nivolumab followed by nivolumab alone — is better at treating cancer than the usual treatment without it.

Inclusion criteria:

  • Must have renal cell carcinoma with clear cell component, including patients who have sarcomatoid features
  • Must have metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1
  • No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents, or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways
  • Must have no active autoimmune disease requiring ongoing therapy.

Other inclusion criteria apply.

All patients in this study receive nivolumab IV and ipilimumab IV on day 1. Treatment repeats every 21 days for up to 4 cycles.

  • Patients with PD receive cabozantinib PO daily on days 1-28.
  • Those with CR receive nivolumab IV on day 1; treatment repeats every 28 days.
  • Patients with non-CR/non-PD receive nivolumab IV on day 1, and one group (the experimental arm) also receives cabozantinib PO daily on days 1-28. Treatment repeats every 28 days

This study is approved for all Main Line Health acute care hospitals. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit https://www.mainlinehealth.org/research/clinical-trials/pdigree

 

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SmokeFREE Summer

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Clinical Trial of the Week: Device trial for patients diagnosed with coronary artery lesion

By Donna Loyle, communications specialist, LIMR

Researchers seek patients who are scheduled to undergo cardiac catheterization for diagnostic and/or treatment purposes for a single-arm, open-label clinical study of the Philips Angio-iFR medical software device. The software uses the geometry of the patient’s vessel (obtained from coronary angiography) together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.

ReVEAL iFR is a multicenter clinical study that is gathering data into a large database using lesion and blockage information obtained from the software. The study’s sponsors hope the software can provide future guidance to physicians on diagnostic decisions similar to that obtained through invasive measures.

Eligible participants must have at least one lesion in a major epicardial vessel of 40% to 90% angiographic stenosis with a reference vessel size ≥2.5mm in the diseased segment. They must not have acute coronary syndrome within four weeks prior to the scheduled index procedure. And they must not have cardiogenic shock, systolic blood pressure of <90 mmHg or cardiac arrhythmia.

The trial is approved for Bryn Mawr Hospital and Lankenau Medical Center. The principal investigator is Antonis Pratsos, MD. For more on the ReVEAL iFR clinical trial, visit www.mainlinehealth.org/research/clinical-trials/reveal-ifr.

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Interested in Main Line Health’s research initiatives?

The research findings from MLH clinicians continues to grow in scope and breadth. Following are just a few recent noteworthy examples:

  • MLH’s John Marks and LMC colleagues published a new study describing their use of the da Vinci Single-Port robot, a platform designed to facilitate single-incision robotic surgery.
  • MLH’s William Gray coauthored a new report of the first-in-human novel approach for left-sided transcatheter cardiac interventions. Percutaneous atriotomy enabled placement of an LA-to-CS shunt for LA decompression.
  • Signs and care of post-cesarean peptic ulcer perforations were outlined by an MLH surgical resident and colleagues.
  • Lynch Syndrome was explored in a new book chapter by MLH authors.
  • Metapneumovirus was characterized and compared to other viruses.
  • Metacarpal fractures: radiographic analysis of optimal screw choice was coauthored by an MLH orthopedic surgeon.
  • The announcement that MLH is participating in Expanded Access programs for ruxolitinib and convalescent plasma for COVID-19 treatment.
  • Charles Antzelevitch, PhD, coauthored a new study that characterized and quantified the contribution of common genetic variations leading to susceptibility to Long QT syndrome.

To get frequent updates on research findings from MLH, follow the “MLH Research Reports” module on the MLHToGo mobile app.

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COVID-19 Medical Staff Update

Colleagues

We hope this COVID-19 update finds you and your family healthy and doing well.

The next Medical Staff town hall will be next Wednesday June 24 at 5 PM.  Please mark your calendars.  A WebEx invite will come that day.

Operational and Recovery Planning update

Fortunately, we’ve seen an ongoing reduction in the number of COVID-19 admissions to Main Line Health hospitals. As a result, our inpatient COVID-19 census is now the lowest it’s been since March. As of June 18th, we had 38 COVID19 inpatients; 15 patients in the ICU and 11 on ventilators. We have discharged 1,234 COVID19 patients from our MLH hospitals. We continue to grieve for and be impacted by the 429 COVID19 related inpatient deaths.

Our rolling three-day average of admissions is now less than 5 admissions per day.

Non COVID-19 related clinical activity continues to increase across the system. On average we are running at about 75% of our pre-COVID-19 activity in most of our major clinical services. We have seen Emergency Department activity increase but to a lesser degree. It still appears that patients are reluctant to return for clinical services. On a weekly basis we assess our readiness to further expand clinical services across the Main Line Health environment. In addition, we are using multiple communication channels to reach out to the patients in our community with a message of reassurance about safety of the environment and our accessibility and capacity to meet their clinical needs.

Rapid COVID-19 testing supplies continue to be very limited creating operational complexities for all of you. Our expected delivery of the new testing platform this week did not materialize but we are hopeful to receive it next week. We hope to soon resume the ability to rapidly test all admissions to the hospital as well as any untested add-on surgery and procedure. We need to continue the pre-procedural testing of scheduled surgery and procedures for the foreseeable future.

On June 10, Dr. Rachel Levine, Pennsylvania Secretary of Health directed specific orders to health systems in the Commonwealth. We are now required to assure that all employees and medical staff are aware of the following:

  • That they will be notified within 24 hours if exposed to a patient with COVID-19 or suspected of it when not in protective PPE
  • That COVID-19 testing will be provided if exposed
  • N95 respirators are now required when caring for any patient with COVID-19 or suspected of it
  • Universal masking for all employees, patients and visitors is now required

By June 23 we must have documentation that all employees and medical staff have received this information. For the medical staff that will be done via email using Microsoft Forms. The first email will have the relevant policies and instructions. The second email will have a link to the required attestation. This completed attestation will be required for all members of the medical staff with clinical privileges as ordered by the Secretary.

Please do not work if you are ill. Take your temperature daily and monitor for any symptoms. If symptomatic, contact your primary care physician or the MLH employee exposure hotline (484-580-4955) and you will be directed to MLH Occupational Health resources for advice regarding testing and return to work options. We are aware of the personal toll this situation can cause and want to remind you to take advantage of our employee assistance program First Call as a resource to our medical staff by calling 1-800-382-2377.

Daily COVID updates are emailed to employees and the medical staff.  For detailed information go to the MLH Intranet COVID site on a regular basis at https://mlhs365.sharepoint.com/sites/wellspring/Pages/Coronavirus.aspx . Reach out to your Chairs, Chiefs, Main Line HealthCare leadership and/or campus interim VPMAs for information or with your questions. Questions and input can also be sent to COVID19command@MLHS.org.

We again thank you for your hard work, adaptability and resilience during this 4-month COVID-19 situation. As summer officially begins this week, we hope that you’re planning for some downtime to enjoy time with family and friends.

Please be safe and stay well

Andy Norton, MLH CMO   NortonAJ@mlhs.org

Jim Gengaro, Regional VPMA     GengaroJ@mlhs.org

Jon Stallkamp, Regional VPMA     StallkampJ@mlhs.org

 

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Action Required: COVID-19 Policy Review & Attestation

Dear Colleagues,

Earlier this week, the PA Secretary of Health, Dr. Rachel Levine, put an order in place that requires select hospital-based medical staff and employees who may have exposure to COVID-19 patients to confirm that they have received and reviewed their hospital’s COVID-19 policies.

Since the arrival of COVID-19 in our region and at our hospitals in early March, our Main Line Health team has worked together to institute several policies and guidelines to govern employee safety and patient care in the midst of this pandemic. These have been communicated in daily and weekly communications, including our COVID-19 page on Wellspring, MLH To Go, daily email updates, and town halls with employees and medical staff.

All medical staff receiving this notification should review the attached COVID-19 policies and guidelines and must complete the attestation form by June 23, 2020 for MLH to comply with the Secretary’s order.

There are four key elements that are required in the Secretary’s order that the provider must acknowledge understanding of:

  1. Exposure notification process (that we will notify you within 24 hours of a confirmed exposure to a COVID-19 patient).
  1. That MLH will arrange for testing for symptomatic and asymptomatic hospital staff members who have received notification of an exposure to a COVID-19 case to request to undergo testing for COVID-19.
  • Attached policies and guidelines for elements 1&2: MLH COVID Policy, Employee Exposure Process Grid, IP Job Aide- Post Exposure Management Notification Process
  1. That you understand that you have access to necessary PPE through the MLH procurement and distribution of NIOSH or FDA approved Personal Protective Equipment (PPE) to hospital staff and the requirement to wear an N95 mask during direct patient contact on a COVID unit.
  1. That universal staff, patient, and visitor masking is in place.
  • Attached policies and guidelines for elements 3&4: Conservation Plan for PPE and other Isolation, COVID-19 Pandemic Respiratory Protection Policy for Main Line Health Employees and Medical Staff How to access the Attestation SiteWithin the hour, you will receive another email message with the subject “[PARTNER] Physician Attestation – Review of Main Line Health COVID-19 Policies” that includes a custom link for you to record your attestation. Please use the link provided in that message and follow the instructions below if you are prompted to authenticate. If you have a mlhs.org email address, use the email address and the password you use to access Epic.  If you do not have a mlhs.org email address, use your six-letter Epic sign-on name and ‘mlhs.org’ as the email address. (For example: If your Epic sign on is “klindo” – you would use klindo@mlhs.org as the email address.)  You will receive a text message with a 6-digit code. Enter this code to access the site. You will be taken immediately to the attestation form.  If you have difficulty accessing the attestation form, please contact the Main Line Health Service Desk at 494-596-4357.  As we learn more about COVID-19, we will continue to make changes and updates to our guidelines, policies and procedures based on the latest recommendations from the Department of Health and Centers for Disease Control and Prevention. These updates will continue to be shared with you and your colleagues on a regular basis, and we appreciate your cooperation. Thank you for your continued support of Main Line Health, our patients, and each other.

Sincerely,   Jon Stallkamp, MD, Regional VPMA, Main Line Health

Jim Gengaro, DO, Regional VPMA, Main Line Health

Andy Norton, MD, CMO, Main Line Health

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