Interview with Dr. Arjun Sharma on Clinical Trial Proves Effectiveness of Cardiac Resynchronization Therapy in Slowing Heart Failure
12 August 2009, 3:00 PM EDT
Read more about Dr. Arjun Sharma
Transcript
Cindy:
According to the American Heart Association, it appears that the field of cardiology will be negatively affected by potential Health Care Reforms. Will any of the reform measures in Congress affect the FDA’s approval of this study and its findings?
Dr. Arjun Sharma:
The proposed payment cuts in cardiology will affect health care providers such as cardiologists. The FDA should not take this into consideration as patient safety and effectiveness of therapy are the main concerns of the FDA.
Judita:
Can physicians already use these devices in the general public or are they only still being used in clinical trials?
Dr. Arjun Sharma:
The ICDs used in the MADIT-CRT trial are all market released devices approved for use in patients indicated for ICD therapy. The CRT-D devices used in the MADIT-CRT trial are FDA approved for use in patients who meet the current CRT-D indication, which means they fall into NYHA Class III/IV and therefore have advanced symptoms of heart failure. However, the MADIT-CRT trial looked at patients who have not reached the advanced symptoms of heart failure. Boston Scientific will likely be using the data from this trial to seek an “expanded indication” for all market-approved CRT-D devices to include the MADIT-CRT population.
Peggy:
Does this mean that patients with ICDs will need to get them replaced with CRT-Ds?
Dr. Arjun Sharma:
Even though the MADIT-CRT study results are positive new indications for CRT-Ds in patients in the NYHA Class I/II categories, this type of treatment has not yet been approved by the FDA for heart failure patients in Class I/II. The study will be published and examined by the FDA before a decision is available. In the future, if a person meets the criteria of the MADIT-CRT study then it is likely that those patients will be upgraded to a CRT-D device once FDA approval is received.
Tucker:
If CRT-Ds are different than regular ICDs, can I still exercise, swim, garden, and pretty much do the things I enjoy? Or are there unique limitations to the CRT-Ds?
Dr. Arjun Sharma:
CRT-Ds are different than regular ICDs. Specifically, CRT-Ds work with every beat of the heart to create a resynchronized contraction, which may increase exercise capacity AND provide the protection of an ICD. ICDs on the other hand, provide pacemaker support when called upon to do so and also provide protection from sudden cardiac arrest (SCA). Exercise has been shown in general to benefit patients with a variety of heart conditions. However, as every patient is unique, it is important to check with your physician about how much exercise is safe, and what types of exercise are appropriate.
Cynthia:
If this study has demonstrated a slowing of heart failure in Class I and Class II patients, what about those people in the Class III and Class IV categories? Does this type of treatment work in them as well?
Dr. Arjun Sharma:
Yes, CRT-D is beneficial for patients with a wide QRS (ECG), reduced heart function (ejection fraction less than 35 percent) and NYHA failure Class III and IV. These results have been demonstrated in a previous trial titled COMPANION and approved CRT-Ds have been approved by the FDA for usage in NYHA Class III/IV patients. The new finding is that preliminary results suggest that high-risk patients with mild heart failure (Class I/II) benefit from early intervention with cardiac resynchronization therapy.
Mark:
This study has proven to slow the progression of heart failure – what exactly does this mean? What is happening in the body to slow the progression? Are certain symptoms decreased, are patients not readmitted to hospital as often?
Dr. Arjun Sharma:
MADIT-CRT preliminary results indicate that CRT-D therapy is associated with a significant reduction in the risk of death or heart failure intervention when compared to ICD therapy. Additional information on the study results will be published in the future. We do know that heart failure is a progressive disease where over time a patient’s clinical status declines. An analysis provided by Dr. Parag Jain in the February 2003 supplement of American Heart Journal discusses the progression of heart failure with each acute event further impacting a patient’s clinical status. Therefore, reducing hospitalizations in heart failure patients greatly impacts patient outcomes.
