Daniel B. Kramer M.D.

Contact Information

Institute for Aging Research
1200 Centre Street
Boston, MA 02131

Phone: 617-971-5328
email: danielkramer@hsl.harvard.edu

Education

Training

 Research Interests

Dr. Kramer's research focuses on ethics, outcomes, and policy questions surrounding the use of medical devices.  His work has included qualitative studies evaluating stakeholder knowledge and perspectives regarding deactivation of cardiac devices; risk stratification for recipients of implantable cardioverter-defibrillators; clinical outcomes for defibrillator leads; and unique aspects of device-based therapy for older patients.  Dr. Kramer's health policy research has focused on the regulatory assessment of medical devices, including the strength of pre-market clinical evaluation for novel technology and comparative approaches to device regulation worldwide.

 Keywords: Palliative care, caregiver stress, dementia, depression, end-of-life

Selected Publications

1. Tedrow UB, Kramer DB, Stevenson LW, Stevenson WG, Baughman KL, Epstein LM, Lewis EF.  Relation of right ventricular peak systolic pressure to major adverse events in patients undergoing cardiac resynchronization therapy. Am J Cardiol 2006; (97):1737-1740
2. Field ME, Solomon SD, Lewis EF, Kramer DB, Baughman KL, Stevenson LW, Tedrow UB. Right ventricular dysfunction and adverse outcome in patients with advanced heart failure.  J Card Fail 2006; 12(8):616-20.
3. Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, and Maisel WH.  Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther. 2010 Jan-Feb;17(1):2-7.
4. Kramer DB, Maisel WH.  An unusual cause of abnormal intrathoracic impedance in a patient with arrhythmogenic right ventricular cardiomyopathy.  Pacing Clin Electrophysiol. 2011 Jul;34(7):e60-3. doi: 10.1111/j.1540-8159.2010.02774.x. Epub 2010 Apr 26.
5. Konstantino Y, Hsing J, Zimetbaum PJ, Kramer DB, Chang JD.  Cardiac resynchronization in a patient with low-flow, low-gradient aortic stenosis and interventricular dyssynchrony.  Eur J Heart Fail. 2010 Aug;12(8):889-92.
6. Kramer DB, Kesselheim AS, Brock DW, and Maisel WH.  The ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices:  a quantitative assessment.  Heart Rhythm 2010 Nov;7(11):1537-42. Epub 2010 Jul 19
7. Kramer DB, Kesselheim AS, Salberg L, Brock DW, and Maisel WH.  Ethical and Legal Views Regarding Deactivation of Cardiac Implantable Electrical Devices in Patients with Hypertrophic Cardiomyopathy.  Am J Cardiol. 2011 Apr 1;107(7):1071-1075.e5. Epub 2011 Feb 4.
8. Miller AL, Kramer DB, Lewis EF, Koplan B, Epstein LM, Tedrow UB. Event-free survival following CRT with surgically implanted LV leads versus standard transvenous approach.  Pacing Clin Electrophysiol. 2011 Apr;34(4):490-500.
9. Kramer DB, Ottenberg AL, Gerhardson S, Mueller LA, Kaufman SR, Koenig BA, and Mueller PS. “Just because we can doesn't mean we should” -- Views of Nurses on Deactivation of Pacemakers and Implantable Cardioverter-Defibrillators.  J Interv Card Electrophysiol. 2011 Dec;32(3):243-52. Epub 2011 Jul 30.
10. Kramer DB, Reynolds MR, Friedman PA, Kallinen LM, Borrison TB, Crusan DJ, Hodge DO, and Hauser RG.  Development and Validation of a Risk Score to Predict Early Mortality in Recipients of Implantable Cardioverter-Defibrillators.  Heart Rhythm. 2012 Jan;9(1):42-6. Epub 2011 Sep 3.
11. Hauser RG, Mugglin AS, Friedman PA, Kramer DB, Kallinen LM, Hayes DL. Early Detection of Postmarket ICD Lead Failure Using an Automated Safety Surveillance Tool.  Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):189-96. Epub 2012 Mar 6.
12. Kramer DB, Baker M, Ransford B, Molina-Markham A, Stewart Q, Fu K, and Reynolds MR.  Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance.  PLoS One. 2012;7(7):e40200. Epub 2012 Jul 19.
13. Kramer DB, Xu S, Kesselheim AS.  How Does Medical Device Regulation Perform in the US and EU?: A Systematic Review.  PLoS Med. 2012 Jul;9(7):e1001276. Epub 2012 Jul 31.
14. Abdelhadi R, Saba S, Dimarco J, Gura M, Kramer DB, Ellis C, Bazaz R, Mason P, Coronado M, Hayes D, Friedman P, and Hauser R.  Independent Multicenter Study of Riata and Riata ST ICD Leads.  Heart Rhythm 2012 (in press).

 Reviews

1. Kramer D, Raji A, Plutzky J.   Pre-Diabetes and its links to atherosclerosis.  Current Diabetes Reports 2003;3(1): 11-18.
2. Lubitz SL, Leong-Sit P, Fine N, Kramer DB, Singh JP, Ellinor PT.  Effectiveness of cardiac resynchronization therapy in mild congestive heart failure: systematic review and meta-analysis of randomized trials.  Eur J H Fail 2010; 12:360-366.
3. Kramer DB, Ottenberg A, and Mueller PS.  Management of cardiac electrical implantable devices in patients nearing the end-of-life or requesting withdrawal of therapy:  Review of Heart Rhythm Society 2010 consensus statement.  Polish Archives of Internal Medicine 2010.  Pol Arch Med Wewn. 2010 Dec;120(12):497-502.
4. Kramer DB, Zimetbaum PJ. Long QT Syndrome.  Cardiol Rev. 2011 September/October;19(5):217-225).
5. Kramer DB, Xu S, Kesselheim AS.  Regulation of Medical Devices in the United States and European Union.  N Engl J Med. 2012 Mar 1;366(9):848-55. Epub 2012 Feb 14.
6. Kramer DB, Mitchell SL, Brock DW.  Deactivation of Pacemakers and Implantable Cardioverter-Defibrillators.  Prog Cardiovasc Dis 2012 (in press)

Commentary/Editorials/Perspectives

1. Maisel WH, Kramer DB.  ICD Lead Performance.  Circulation 2008; 117: 2721-2723.
2. Maisel WH, Kramer DB.  Extracting sense from clinical data.  J Am Coll Cardiol 2010 Jun 17.
3. Kramer DB, Josephson ME.  Three Questions for Evidence-based Electrophysiology. Circ Cardiovasc Qual Outcomes. 2010 Nov 1;3(6):704-9.
4. Kramer DB, Brock DW, Tedrow UB.  Informed Consent in Cardiac Resynchronization Therapy:  What Should be Said?  Circ Cardiovasc Qual Outcomes 2011 Sep 1;4(5):573-7.
5. Kramer DB, Josephson ME.  Expanding the Use of Cardiac Resynchronization Therapy:  Words of Caution.  Cardiac Electrophysiology Clinics December 2011.
6. Kramer DB, Buxton AE, Zimetbaum PJ.  Time for a change--a new approach to ICD replacement.  N Engl J Med 2012 Jan 26;366(4):291-3.
7. Kramer DB, Kesselheim AS.  User fees and beyond:  The Food and Drug Administration Safety and Innovation Act of 2012.  N Engl J Med 2012 Oct 4;367(14):1277-9.

 Guidelines

1. Lampert R, Hayes D, Annas GJ, Farley MA, Goldstein NE, Hamilton R, Kay GN, Kramer DB, Mueller PS, Padeletti L, Pozuelo L, Schoenfeld MH, Vardas PE, Wiegand D, Zellner R.  HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy.  Heart Rhythm. 2010 Jul;7(7):1008-26. Epub 2010 May 14.