This is a typical cumulative adverse event-monitoring chart (figure) with the red circles indicate a higher than expected adverse event rate for the studied medical device as compared with prospectively identified, propensity-matched control, population who received an alternative device.

 

Recent DELTA implementation projects include active surveillance of several National Cardiovascular Data (NCD) Registries. A CathPCI DELTA pilot study used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the NCD Registry. The primary outcome was any vascular complication - a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. The study concluded that a strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. Following that, the team published the prospective, active safety surveillance of national clinical registries and concluded feasibility to provide near-real-time safety assessments of new medical devices.

 

The current DELTA implementation pilot project is studying Implantable Cardiac Defibrillator (ICD) with a goal to validate DELTA propensity matched survival methods applied to the four most commonly used ICD leads in a prospective study to monitor the failure rate of four contemporary ICD leads.

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Supported in part through MDEpiNet, FDA CDRH research grants, as well as private philanthropic foundation support, the DELTA projects are a part of the MDEpiNet Methodology Center of Harvard Medical School. The system has been validated in multiple medical device and medication safety surveillance domains and numerous data source environments from single hospital EHR systems, statewide clinical registries, national clinical registries, and distributed hospital networks. In conjunction with the American College of Cardiology, current DELTA implementation projects include active surveillance of several National Cardiovascular Data Registries. In addition, a fully open-source version of DELTA will be released for academic and public health applications in the coming year.

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Personnel

Frederic Resnic, MD MSc – Lahey Hospital and Medical Center

Susan L. Robbins, BS – Lahey Hospital and Medical Center

Michael Matheny, MD MSc MPH – Vanderbilt University,

Sharon-Lise Normand, PhD – Harvard Medical School

Lucila Ohno-Machado, MD PhD – UCSD

Richard Cope – Boston Applied Analytics, Inc.

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Sources of funding

NIH-NLM (R01 LM008142) “A System to Monitor Safety in Interventional Cardiology”

FDA–HHSF (223200830058C) “Automated Medical Device Safety Monitoring”

FDA–DHHS (U01 FD004963) “Active Surveillance of Cardiovascular Devices: The Multi-Registry DELTA Network” Enhancing Active Surveillance of High Risk Medical Devices

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Project Outputs

1. Registries/data sources – Collaborative projects with the ACC NCDR national registries.

2. Analytical systems
   DELTA3 Data Evaluation and Longitudinal Trend Analysis system version 3 as open-source tools to be distributed for use for academic and public health applications.

3. Validated methods
   From linked analytic engine OCEANS Observational Cohort Event and Analysis Notification System
   Risk Adjusted Logistic Regression
   Risk Adjusted Propensity Score Matching
   Risk Adjusted Sequential Probability Ratio Testing
   Propensity matched prospective survival analysis (in development)
   Automated variable selection within Multivariate Logistic Regression toolkit.

4. Open-source
   i. Actual programming code
   To be made available for academic and public health use through UCSD National Center for Biomedical Computing (NCBC) iDASH Program: Integrating Data for Analysis, Anonymization and Sharing

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Publications

 

1. Matheny ME, Arora N, Ohno-Machado L, Resnic FS. Rare adverse event monitoring of medical devices with the use of an automated surveillance tool. AMIA Annu Symp Proc. 2007 Oct 11:518-22.

2. Matheny ME, Ohno-Machado L, Resnic FS. Risk-adjusted sequential probability ratio test control chart methods for monitoring operator and institutional mortality rates in interventional cardiology. Am Heart J. 2008 Jan;155(1):114-20.

3. Matheny ME, Morrow DA, Ohno-Machado L, Cannon C, Sabatine MS, Resnic FS. Validation of an automated safety surveillance system with prospective randomized trial data. Med Decis Making 2008 Dec 2.

4. Resnic FS, Gross TP, Marinac-Dabic D, Loyos-Berrios N, Donnelly S, Normand ST, Matheny M. Automated surveillance to detect post-procedure safety signals of approved medical devices: A study from the Massachusetts Angioplasty Registry.   2010 Nov 10; 304(18): 2019-2028.

5. Vidi V, Matheny M, Donnelly S, Resnic FS. An Evaluation of a Distributed Medical Device Safety Surveillance System: The DELTA Network Study. Contemp Clin Trials. 2011 May; 32(3):309-17.

6. Matheny M, Resnic FS, etal. Evaluation of an Automated Safety Surveillance System using Risk Adjusted Sequential Probability Ratio Testing. BMC Med Inform Decis Mak. 2011 Dec 14;11:75.

7. Kumar A, Matheny ME, Ho KK, Yeh RW, Piemonte TC, Waldman H, Shah PB, Cope R, Normand SL, Donnelly S, Robbins S, Resnic FS.   The Data Extraction and Longitudinal Trend Analysis Network Study of Distributed Automated Postmarket Cardiovascular Device Safety Surveillance. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1)38-46.

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Presentations

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“Automated Safety Surveillance and the MA Interventional Cardiology Pilot Study”/ Invited Lecturer, Medical Device Epidemiology Network Conference 2010.
Food and Drug Administration – Center for Device and Radiologic Health (CDRH), Silver Spring, MD

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Automated Safety Surveillance and the MA Interventional Cardiology Pilot Study/ Featured Presenter, Medical Product Safety Roundtable Program (Webinar) 2010
Brookings Institute, Washington, D.C.

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Automated Post-Market Safety Surveillance – The DELTA Surveillance Project/ Featured Presenter and Panel Member, Workshop on Public Health Effectiveness of the FDA 510(k) Clearance Process 2010
Institute of Medicine, Washington, D.C.

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Improving the Post-Market Safety of Medical Devices in the United States/ Invited Witness and Panel Member 2011

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United States Senate Special Committee on Aging, Hearing on Medical Device Approval Process and Safety Surveillance, Washington, D.C.

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Automated Safety Surveillance and DELTA Program/ Invited Speaker and Panel Member, Medical Device Epidemiology Network Conference 2011
Food and Drug Administration – Center for Device and Radiologic Health (CDRH), Silver Spring, MD

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Medical Device Safety Surveillance – Lessons from the DELTA Program/ Research Grand Rounds 2011
Duke Clinical Research Institute, Durham, North Carolina

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Current Landscape of Post-Market Safety Surveillance for Medications and Devices in the United States/ Invited Speaker 2011
American Heart Association, Annual Scientific Meeting, Orlando, Florida

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Automated Surveillance – Is it Feasible?
Invited Speaker and Panel Participant 2011
American College of Cardiology, Annual Scientific Sessions, Chicago, IL

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Medical Device Safety – The MDEpiNet Program
Invited Speaker 2012
Brookings Institute, Washington D.C. (webinar)

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Registries and Prospective Device Safety Surveillance
MDEpiNet Conference
Food and Drug Administration
Invited Speaker and Panel Participant 2012

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Automated Safety Surveillance
Post-Market International Registries Workshop
Food and Drug Administration
Invited Speaker and Panel Participant 2012

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Medical Device Post-Market Safety Surveillance in the United States
Medical Grand Rounds
Lahey Clinic Medical Center
Tufts University School of Medicine 2012

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Active Surveillance – Update on the DELTA Project
Post Market Safety Monitoring Symposium
American College of Cardiology Annual Scientific Sessions
Invited Speaker 2013
San Francisco, CA

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Medical Device Post-Market Safety Surveillance in the United States
Cardiovascular Grand Rounds
Tufts University School of Medicine 2013

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Evolution of Continuous Safety Surveillance for Medical Devices
Medical Informatics Research Conference
Tennessee Valley VA Healthcare System and Vanderbilt University Medical Center
Nashville, TN   1/27/14
10 attendees

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Active Surveillance of Medical Device Safety: The DELTA Project
Epidemiology Grand Rounds
Center for Devices and Radiologic Health
Food and Drug Administration
White Oak, MD   6/11/14
40 attendees: PhD, MD, FDA scientists.

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Post-Market Safety Surveillance for Medical Devices: Current Status and Future Opportunities.
CUTEHeart Symposium – Sponsored by the Portuguese Ministry of Health
Faculty of Medicine, University of Lisbon
Lisbon, Portugal   12/11/14
60 attendees: MD, MPH, PhD international health services researchers

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Active Surveillance and National Clinical Registries
S.M.A.R.T. Informatics Workshop
AHRQ Forum on Medical Device Safety
Rockville, MD 2/24/15
200 attendees; MD, PhD, MPH and Federal public health officials