The subcutaneous ICD

The concept of applying high voltage to shock a heart out of Read more »

FDA official, William Maisel, pleads guilty to crime, keeps job

April 24, 2013 By Steven E. Greer, MD

In July of 2012, the New York Times reported on an FDA scandal of the agency spying on internal whistleblowers, by hacking into their work and personal emails. The FDA employees who were the victims filed lawsuits, and The Healthcare Channel interviewed the plaintiff’s lawyer, Stephen Kohn.

One month later, a senior FDA official who was named as a defendant in the lawsuit above, William Maisel, MD, PhD (a former Harvard cardiologist), was a arrested in a Maryland suburb on five counts relating to soliciting a prostitute. The story was not reported well in the national press and the fate of Dr. Maisel at the FDA had been unknown. Read more »

William Maisel, MD, MPH: Reforms for the medical device 510K and PMA process

Update: January 19, 2011

Dr. Maisel is now a Deputy Director within the medical device division of the FDA, CDRH.

June 26, 2009

Dr. William Maisel of the Harvard system has chaired several FDA advisory committees for the approval of medical devices and runs the Medical Device Safety Institute. He recently testified before congress about reforms needed in the way medical devices are approved under the PMA process, and even less rigorous 510K process. Dr. Maisel discusses these topics.

Mark Josephson, MD: ICD risks versus benefits

Mark Josephson, MD, Chief of Cardiology at Beth Israel Deaconess Medical Center in Boston, discusses ICDs and their risks.

Joshua Hare, MD: Stem cells to repair myocardial infarcts

August 12, 2010

Interviewed by Steven Greer, MD

Dr. Joshua Hare, Director of the Interdisciplinary Stem Cell Institute, University of Miami Health System, discusses a recent study published testing stem cells to repair myocardial infarcts. They used a porcine infarct model to follow mesenchymal stem cells injected into MI’s. The infarct areas diminished and heart function improved. Moreover, the stem cells seemed to be the cause for the recovery rather than nonspecific inflammation.

Dr. Brett Faulknier: Medtronic ICD fractures rates

Dr. Brett Faulknier, an electrophysiologist who trained at Rochester, recently published a paper of their retrospective study looking at the fracture rates over time of the Medtronic Fidelis ICD leads.

Is the problem worse than Medtronic estimates and is it growing with time?

Are younger healthier patients more at risk?

William Maisel, MD: discusses the Medical Device Safety Institute

The medical device industry has been replete with safety recalls and scandals at the CDRH device section of the FDA. Cardiologists have had to deal with most of the highest profile problems ranging from ICDs to drug eluting stents. As a result, cardiologist William Maisel of the Beth Israel Deaconess Medical Center founded the Medical Device Safety Institute.

Great PR on pacemakers from President Obama

June 25, 2009

The ABC televised “town hall” meeting at The White House on healthcare reform featured a very positive discussion about how a pacemaker extended life and saved cost. A 99 year-old woman was bouncing back into the hospital dozens of times due to dysrhythmias. She received a pacemaker and is now 105 years old and apparently free of the dysrhythmia. The talk mentions the $30,000 cost of the procedure and how it saved much more than that.

MADIT-CRT results disappoint

September 1

The full results of the MADIT-CRT were presented in Barcelona and are now published in the NEJM. As suspected, there was no improvement in mortality, and the combined endpoint significance was driven by the “nonfatal heart failure” component, which is a subjective measure. The decision to admit a patient and administer diuretics, etc is based on clinical judgment and the doctors were not blinded in the trial.

The goal of MADIT-CRT was to show that the less sick patients would benefit from earlier placement of CRT devices. When the data were analyzed further, it was only the group with wide QRS (>150 msec) on their ECG’s, indicating expanded hearts and significant heart failure, that benefited. Moreover, many of the enrolled patients had recently been sick Class III or IV patients just 30 days prior, so they really do not represent “early stage” heart failure patients that can be prevented from deteriorating further.

The accompanying editorial in the NEJM by Mariell Jessup, MD is quite critical of MADIT-CRT and warns of “indication creep” if the labels are expanded to the MADIT-CRT indications. Dr. Jessup also warns of the cost associated with ICDs and the few lives saved. Bruce Nudell of UBS and Dr. Jessup also point out that many patients in the MADIT-CRT trial currently qualify for CRT devices based on other studies, so the incremental impact to the market will be minimal. The negative details described above explain why the data were not presented on Sunday when most doctors are in attendance on the ESC.

The street consensus was that MADIT-CRT would be a positive for the market. Therefore, the full data today represent an incremental negative.

William Maisel, MD MPH: The MADIT CRT trial

Dr. William Maisel of Beth Israel discuss the design of the MADIT CRT trial and what the data will mean to the ICD CRT market. The study looked at less sick NYHA Class 1 and Class 2 heart failure patients with wide QRS and low EF. The outcome measure was a combined endpoint of heart failure hospitalizations and death.

Dr. Maisel is enthused by the data and discusses the cost associated with heart failure admissions. If CRT devices cut back on readmissions then they will be financially beneficial.

Of note, the study was not blinded to the cardiologists which is important since the decision to admit a patient for heart failure is subjective and impacted by whether a CRT was implanted versus an ICD. When the full data are presented, it will be crucial to look at the mortality data to determine whether they show a statistically significant benefit. If the combined endpoint was driven to significance by the hospitalization parameter, then the data are suspect.