MedicalResearch.com Interview with:
Abdul Wase MD FACC FACP FHRS
Clinical Professor of Medicine &
Director, Cardiology Fellowship Program,
Wright State University Boonshoft School of Medicine,
Director, Electrophysiology Laboratories
Good Samaritan Hospital,
Dayton, OH
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Implantable cardiac defibrillators (ICD) patients are subject to electromagnetic interferences (EMI) from outside electrical sources.
TESLA electric vehicle has a large battery underneath the surface of vehicles, which may potentially interfere with the functioning of these devices. In the owner’s manual, TESLA warns that using mobile connector may impair the functioning of implantable pacemaker or a defibrillator.
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MedicalResearch.com Interview with:
Anne Elixhauser, Ph.D.
Senior Research Scientist
Agency for Healthcare Research and Quality
Rockville MD 20857
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Hospital inpatient data began using ICD-10-CM (I-10) codes on October 1, 2015. We have been doing analysis using the new codeset to determine to what extent we can follow trends crossing the ICD transition—do the trends look consistent when we switch from I-9 to I-10? Tracking the opioid epidemic is a high priority so we made this one of our first detailed analyses. We were surprised to find that hospital stays jumped 14% across the transition, compared to a 5% quarterly increase before the transition (under I-9) and a 3.5% quarterly increase after the transition (under I-10). The largest increase (63.2%) was for adverse effects in therapeutic use (side effects of legal drugs), whereas stays involving opioid abuse decreased 21% and opioid poisoning (overdose) decreased 12.4%.
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MedicalResearch.com Interview with:
Wayne C. Levy, MD
Division of Cardiology
University of Washington
Seattle, Washington
MedicalResearch.com: What is the background for this study?Response: There is uncertainty how effective ICDs are outside of clinical trials in real world patients who are often older with more comorbidities. The recent DANISH ICD only reiterates provider and patient concerns regarding the effectiveness of an ICD, that may be life saving, but does not improve heart failure symptoms or reduce hospitalizations. Many patients die without ever having an ICD shock, so the ICD was not necessary for the patient.
We postulated that the effectiveness of an ICD is not driven by the absolute risk of sudden death (event rate/year) but rather the proportion of all deaths that are due to sudden death vs non sudden death. If a patient has a 3% annual risk of sudden death and this is decreased to 1% with an ICD (a 67% reduction in sudden death), the patient benefit will be much greater if the non sudden death rate is 1%/year than if it is 12%/year. In the first scenario the absolute mortality is decreased from 4% to 2% (a 50% reduction) whereas in the second patient, the mortality would be decreased from 15% to 13% (a 13% benefit).
We developed the Seattle Proportional Risk Model (SPRM) using 10 clinical variables that had a differential impact on the mode of death, sudden vs. non sudden, in ~10,000 patients with ~2,500 deaths. Sudden death was more common in younger patients, male, without diabetes mellitus, NYHA 1 or 2 vs. 3 or 4, lower EF, SBP closer to 140, normal sodium and creatinine, higher BMI, and digoxin use.
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MedicalResearch.com Interview with:
Sean D. Pokorney, MD, MBA
Division of Cardiology, Duke University Medical Center
Duke Clinical Research Institute, Durham, North Carolina
Medical Research: What is the background for this study?
Dr. Pokorney: About 350,000 people die of sudden cardiac death in the US each year. Patients who have weakened heart function, particularly those with heart muscle damage as a result of a heart attack, are more likely to experience sudden cardiac death. Defibrillators have been around since the 1980s, and have prolonged countless lives. A previous study showed that 87% of patients who had a cardiac arrest were eligible for an implantable-cardioverter defibrillator (ICD) beforehand but did not get an ICD implanted prior to their arrest. The timing of ICD implantation is critical, as studies have not found a benefit to ICD implantation early after myocardial infarction (MI). Guidelines recommend primary prevention ICD implantation in patients with an EF ≤ 35% despite being treated with optimal medical therapy for at least 40 days after an MI. Given the need to wait for at least 40 days after an MI, ICD consideration is susceptible to errors of omission during the transition of post-MI care between inpatient and outpatient care teams. Also, the benefit of ICDs remains controversial among older patients, as these patients were underrepresented in clinical trials.
Medical Research: What are the main findings?Dr. Pokorney: We looked at Medicare patients discharged from US hospitals after a heart attack between 2007 and 2010. We focused on those patients who had weak heart function, and this left us with a little over 10,300 patients from 441 hospitals for our study. This was an older patient population with a median age of 78 years. We looked to see how many of these patients got an ICD within the first year after MI, and how many patients survived to 2 years after their heart attack. Only 8% of patients received an ICD within 1 year of their heart attack. ICD implantation was associated with a third lower risk of death within 2 years after a heart attack, and this was consistent with the benefit that were seen in the randomized clinical trials. Importantly, 44% of the patients in our study were over 80 years old, and we found that the relationship between ICD use and mortality was the same for patients over and under age 80 years. Increased patient contact with the health care system through early cardiology follow-up or re-hospitalization for heart failure or MI was associated with higher likelihood of ICD implantation. Rates of ICD implantation remained around 1 in 10 patients within 1 year of MI even among patients with the largest heart attacks and the weakest hearts (lowest ejection fractions), who were least likely to have improvement in their heart function over time. Similarly, even after excluding patients at highest risk for non-arrhythmic death (prior cancer, prior stroke, and end stage renal disease), ICD implantation rates remained around 1 in 10 patients.
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MedicalResearch.com Interview with: Gregg C. Fonarow, MD, FACC, FAHA
Eliot Corday Professor of Cardiovascular Medicine and Science
Director, Ahmanson-UCLA Cardiomyopathy Center
Co-Chief of Clinical Cardiology, UCLA Division of Cardiology
Co-Director, UCLA Preventative Cardiology Program
David Geffen School of Medicine at UCLA
Los Angeles, CA, 90095-1679
Medical Research: What are the main findings of the study?Dr. Fonarow: Drawing on data from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF), 15,177 heart failure patients were followed over two years to measure the benefits of implantable device therapy on survival in community practice settings. The study demonstrated that ICD device therapy reduced the likelihood of death during the two-year period by 36 percent, with no significant differences by race or ethnicity. The study also demonstrated a 45 percent reduction in mortality during the two-year period with CRT therapy, again without any significant differences device benefit by race or ethnicity.
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MedicalResearch.com Interview with: Ryan T. Borne MD
University of Colorado Anschutz Medical Campus
Division of Cardiology
Aurora, CO 80045
Medical Research: What are the main findings of the study?Dr. Borne: Using the NCDR ICD Registry, we identified Medicare beneficiaries aged 65 years and older with low left ventricular ejection fraction (≤ 35%) who underwent primary prevention implantable cardioverter defibrillator implantation, including those receiving cardiac resynchronization therapy with defibrillator, between 2006 and 2010 who could be matched to Medicare claims. We found that while there were modest changes in the patient characteristics undergoing ICD implantation, there were significant improvements over time in mid-term outcomes including 6-month mortality, re-hospitalization, and device-related complications.
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MedicalResearch.com Interview with: Jonathan Hsu, MD, MAS
Cardiac Electrophysiology, Division of Cardiology
University of California, San Diego (UCSD)
MedicalResearch.com: What are the main findings of the study?Dr. Hsu: We found that the prevalence of cardiac perforation during modern day ICD implantation is 0.14%.
We also found that specific patient and implanter characteristics predict cardiac perforation risk: older age, female sex, left bundle branch block, worsened heart failure class, higher left ventricular ejection fraction, and non-single chamber ICD implant are associated with a greater odds of perforation, whereas atrial fibrillation, diabetes, previous cardiac bypass surgery, and higher implanter procedural volume are associated with a lower odds of perforation.
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