Drug-coated balloons to treat fem-pop disease

April 27, 2014- Interviewed by Steven E. Greer, MD

At the Charing Cross symposium in London, Medtronic reported results of the IN-PACT trial of their paclitaxel balloon. 12-month patency rates were 82%, compared to Read more »

Is cath lab fluoroscopy radiation exposure dangerous?

Interviewed by Steven E. Greer, MD

With former President George W. Bush receiving a coronary stent and cardiac chest CT-scan, the topic of cath lab radiation, and whether it is dangerous, has been discussed within small circles, but not not widely in the mainstream press. Coincidentally, Emory cardiologist Reza Fazel published the first analysis of cath lab fluoroscopy time distributions from a  database of more than 1,000 hospitals. We interviewed Dr. Fazel to learn the factors associated with unnecessarily long fluoroscopy times, and the associated dangers.

Comparing radiation leaks from major nuclear events

Second-gen Sapien TAVI valve does not reduce stroke problem

March 10, 2013 By Steven E. Greer, MD  The Healthcare Channel

The main reason that Medicare has limited coverage for the Edwards Lifesciences (EW) Sapien percutaneous aortic valve is the high perioperative complication rate of ischemic strokes, in excess of 9%, as well as femoral artery complications. The newer second generation Sapien XT, with a smaller diameter “French” profile, was hoped to reduce the complications and make the TAVR procedure safer. The newest data on the second-gen Sapien do not seem to support the claims from Marty Leon, financial backer of the valve, that the new valve is safer.

The PARTNER II study was presented at the ACC meeting in San Francisco. Read more »

How many stent cases does it take to bill Medicare for $18 Million?

April 9, 2014- By Steven E. Greer, MD

The release of data by Medicare showing what each doctor earns from billing CMS is making news for the outlier doctors who billed for millions. One Miami ophthalmologist, for example, billed for $21 Million in 2012 alone. Also catching our eye was another Florida interventional cardiologist who billed for $18.1 Million.

Just how many stent cases per day would he have had to have performed to bill for $18.1 Million? We asked Dr. William O’Neill of Henry Ford Hospital. Read more »

Occluding the left atrial appendage to prevent stroke in A-fib

Thromboembolic stroke caused by atrial fibrillation is the primary reason patients are placed on anticoagulation. However, those blood thinners also carry significant bleeding risks. As a result, various mechanical surgical approaches have been tried to prevent stroke, and obviate the blood thinners.

The newly approved Boston Scientific Watchman left atrial appendage occlusion device aims to prevent clots from forming and migrating to the brain. We interviewed Dr. William O’Neill of Henry Ford Hospital, a leading interventional cardiologist, about the Watchman, and whether it will truly allow patients with A-fib to stop warfarin or other blood thinners.

TAVI: Comparing CoreValve to Sapien

Interviewed by Steven E. Greer, MD

William O’Neill, MD of Henry Ford discusses the recent pivotal data for the Medtronic CoreValve device, soon to be approved, and how this new device will compete in the clinical arena with the Edwards Lifesciences Sapien valve.

Renal denervation devices to treat hypertension

William O’Neill, MD of Henry Ford Hospital discusses renal denervation devices used to treat refractory hypertension. He is involved with the Medtronic device trials.

The FDA discusses Brilinta

February 4, 2014- The WSJ is reporting today on a Johns Hopkins doctor who filed a federal court complaint, using the Federal False Claims Act. The WSJ reports, “In July 2011, the Food and Drug Administration approved AstraZeneca PLC’s anticlotting drug Brilinta for patients with certain severe coronary conditions. A study had shown the pill saved lives and reduced heart attacks—a real eye-opener in medicine.

But behind the scenes, a drama is unfolding over whether the drug should have been approved. In a sealed complaint filed in U.S. district court in the District of Columbia, Victor Serebruany, an adjunct medical professor at Johns Hopkins Hospital who specializes in such drugs, contends the study numbers may have been manipulated.

Dr. Serebruany has told federal investigators that the number of deaths in the study’s control group—those taking a competing drug—was unusually high compared with earlier trials. He also has questioned the tabulation of heart attacks in the study, alleging it was skewed in Brilinta’s favor, according to people familiar with the matter and documents reviewed by The Wall Street Journal. The study measured cardiovascular deaths, heart attacks and strokes.

Dr. Serebruany filed his complaint under the federal False Claims Act. Under that law, the U.S. government has the option of joining the lawsuit to recover money.”

July 20, 2011-In a somewhat surprising move, the FDA approved AstraZeneca’s anticoagulation drug branded as Brilinta (ticagrelor). This drug had the PDUFA date delayed as the FDA wrangled with the messy clinical data that failed to show any benefit in the North American cohorts. It had become a case study in the bigger problem of Big Pharma relying on CRO’s to conduct their clinical trials.  Steven Greer, MD spoke with Janet Woodcock, Director of the FDA’s CDER, about the label. In addition, Pradaxa and Xarelto, two other new anticoagulation drugs, were discussed.

Matthews Chacko, MD: Renal denervation to treat HTN

December 29, 2010

Many medical devices cause a far greater clinical impact than pharmaceutical therapies such as statins and chemotherapies. For example, ICDs have a dramatic life-saving capability, but for only a small portion of the patients receiving an ICD. Likewise, coronary stents improvement survival in patients with acute MI, but merely alleviate angina in most other patients.

A new device, unknown to most doctors, currently being investigated in Australia, Europe, and South America, could confer the most dramatic clinical benefit to the largest group of patients in the history of medical devices. That device is the Ardian renal artery/nerve ablation catheter to treat essential hypertension, recently acquired by Medtronic.

Medications to treat high blood pressure deliver tens of billions in revenue to the pharmaceutical companies, yet the magnitude of effect is just a few millimeters of mercury reduction in hypertension. In a small, but well designed, trial of the Ardian device, improvements in blood pressure of the magnitude of 30 mmHg were seen in almost all patients. If these data hold up, and safety concerns do not arise, this device would turn the hypertension market upside down, to the dismay of Big Pharma. Total medical costs could be reduced as well if damage to the kidneys, eyes, and hearts of millions of patients are avoided.

Matthews Chacko, MD, Director of Peripheral Vascular Intervention at Johns Hopkins, discusses this device, the data in The Lancet, and his thoughts on safety and efficacy.

The finances of TAVI: do prices have to come down?

Interviewed by Steven E. Greer, MD

William O’Neill, MD of Henry Ford discusses the finances of transapical aortic valve implantation (TAVI) and why the $30,000 pricetag for the devices should be closer to $5,000. He also discusses the overall market size for TAVI.