Non-Cardiac Surgery Too Soon After Cardiac Stenting Increases Risk of Complications

According to a recent study published in Circulation: Cardiovascular Interventions (an American Heart Association journal), patients should attempt to postpone having surgeries for at least six weeks after a coronary angioplasty procedure with stenting.  Researchers found that patients who wait at least six weeks before having another surgery are less likely to develop reduced blood flow to the heart (a.k.a. heart ischemia) and heart attacks.

The study data revealed that 42 % of patients who had other surgeries within the six-week period developed these complications. Only 13 % of patients who had surgeries beyond the six-week period developed the same complications. The study focused 1,953 patients with an average age of 64 who had cardiac angioplasty with stenting between 2003 and 2007.

According to the American Heart Association:

• Over 70 percent of coronary angioplasty procedures in the United States also include stenting.
• In 2006, approximately 65 percent of PCI procedures were performed on men, and approximately 50 percent were performed on people age 65 or older.
• In 2006, an estimated 1,313,000 PCI procedures were performed in the United States.
• In 2006, approximately 76% of stents implanted during PCI were drug-eluting, compared with 24 percent bare-metal stents.
• In 2006, there were 652,000 PCI procedures with stents — 425,000 in men, 227,000 in women.

If you recently had cardiac stenting and require another surgery, make sure to ask your doctor about waiting to have the next surgery. This is particularly true if your next surgery is an elective one. If your doctor or surgeon is not a cardiologist, you may want to consider asking your doctor for a referral to a cardiologist.  You may also want to make sure that your physician or surgeon obtains cardiac clearance before proceeding with another surgery.   Don’t assume that your doctor will do these things for you. Be proactive; ask questions.

For related blogs, please see:

• Drug- Eluting Stents Found Effective at Preventing Major Amputations
• Angina: The Efficacy of Percutaneous Coronary Intervention v. the Efficacy of Non-Surgical Treatment.
• The Efficacy of Drug-Eluting Stents and Bare Metal Stents in Heart Transplant Recipients with Coronary Artery Disease
• Study Finds Stents as Effective as Surgery to Prevent Strokes; European Study Finds Otherwise
• St. Joseph Medical Center Stent Patients Now Face Another Risk: The FDA Requires a Black-Box Warning on Anti-Clotting Drug Plavix
• St. Joseph Tells 169 More Patients They May Have Had Unneeded Surgery; Total Notified Now at 538
• Bill Clinton’s Stent Procedure – What It’s All About

Contributing author: Jon Stefanuca

Drug-Eluting Stents Found Effective at Preventing Major Amputations

It is generally accepted in the medical community that drug-eluting stents (DES) are helpful in restoring normal blood flow to the heart. In recent years, however, DES treatment has been applied with proven success in other contexts.

For example, consider a patient with peripheral vascular disease (PVD); an unfortunately common medical condition characterized by the occlusion of the arteries of the legs and arms. This disease is usually caused or exacerbated by other medical conditions such as diabetes, high cholesterol, high blood pressure, and kidney disease. People who smoke are at a much higher risk for developing PVD as well. It has been reported that as many as five million adults in the U.S. have PVD.

Patients with PVD tend to experience a gradual decrease in blood flow to their extremities. Over time, this can result in a complete interruption of blood and the development of necrotic tissue. In the past, once necrotic tissue was present, amputation was often the only available medical treatment.

Recent research suggests that DES treatment may be used effectively to prevent or reverse arterial occlusions in patients with PVD. According to an article published by Modern Medicine, researchers studied 106 patients who were treated with DES to restore blood flow in the lower extremities.

There were no procedural deaths, and 96 percent of the patients were discharged within 24 hours. The researchers found that the three-year cumulative incidence of amputation was 6 percent ± 2 percent, survival was 71 percent ± 5 percent, and amputation-free-survival was 68 percent ± 5 percent. Also, only 12 percent of patients who died had a previous major amputation. The target limb revascularization rate was 15 percent.

This study suggests that DES treatment can be effective at preventing major amputations. If you are facing the possibility of amputation as a result of PVD or another ischemic process, ask your doctor about angioplasty and DES treatment.

Contributing author: Jon Stefanuca

St Joseph Stent Cases and Dr. Midei Back in the News – More Cases Revealed

The Baltimore Business Journal just reported online that St. Joseph Medical Center has announced that it is now finished its review of the controversial stent procedures performed by Dr. Mark Midei between May 2007 and mid-2009.

In a statement released to the Baltimore Business Journal, hospital officials had to correct an earlier estimate provided by the hospital’s CEO, Jeff Norman, this past April 19th, when he indicated that the number of unnecessary stent implantations totaled 538. The so-called ‘final’ number, according to the report, is now 47 more than the last figure or a total of 585 patients, who have now been notified that “their blockage may not have been so severe to warrant a stent implanted by Dr. Midei.”    

We have been covering this St. Joe’s stent fiasco since February 20th, when we reported that the US Senate was launching an investigation into this matter.  The news of the congressional investigation followed lawsuits by former patients and a class action filing against the hospital.  On March 10th, we posted a story about a news release of that day in which the hospital reported an additional 169 more patients had received similar notification of unnecessary stenting by Dr. Midei, bringing the number at that time to 538.  Today’s release by the Baltimore Business Journal, as noted, adds a new 47 patients to this list.  Will more ‘review’ yield even more patients, who were, by the hospital’s own admission, subjected to implantations for blockages that “may have not been so severe to warrant a stent…”?  (What lawyer wrote that language for the hospital’s news release?).

To explain the seemingly ever-growing list of patients, the hospital stated “that an initial count of the total number of flagged stent procedures performed by Dr. Midei was “incomplete but has been corrected.

Guess it’s good that they now have the number of  patients corrected.  It would have been a lot better had they gotten the situation corrected before all these patients were submitted to unnecessary treatment with its life-long consequences.

Angina : The Efficacy of Percutaneous Coronary Intervention vs. the Efficacy of Non-Surgical Treatment

Angina is characterized by chest pain resulting from insufficient blood flow to the heart. In this context, abnormal blood flow is caused by the build up of plaque in the coronary arteries or as a result of coronary artery stenosis. Consequently, angina symptoms are usually indicative of heart disease. It is estimated that nearly seven million people in the United States have angina and that nearly 400, 000 patients present with new cases of angina each year.

A recent study published by Annals of Internal Medicine compared the efficacy of percutaneous coronary intervention vs. the efficacy of non-surgical medical care in treating angina in patients with stable coronary artery disease. Percutanious coronary intervention refers to coronary angioplasty. The study in question involved cardiac angioplasties with and without cardiac stents. Non-surgical treatment refers to drug treatment of angina symptoms.

Researchers performed a comprehensive review of 14 previous trials, which compared the efficacy of coronary angioplasty (with and without stents) vs. non-surgical medical care. In total, the 14 trials involved 7818 patients. Researchers concluded that older trials suggest that percutaneous coronary intervention was only marginally more effective in the treatment of angina. This, however, did not appear to be true in more recent trials. The study suggests that coronary angioplasty may not be necessary or recommended to treat angina in patients with stable coronary artery disease if proper evidence-based medications are employed.

Contributing author: Jon Stefanuca

The Efficacy of Drug-Eluting Stents and Bare Metal Stents in Heart Transplant Recipients with Coronary Artery Disease

A recent study published in Kardiologia Polska (Poland) compared the long-term results of drug-eluting stents and bare metal stents in heart transplant patients. Various stents are routinely used in patients post heart transplant surgery to correct blood flow abnormalities caused by coronary artery disease. Coronary artery disease is generally defined as the build-up of plaque on the interior wall of coronary arteries causing decreased or obstructed blood flow to the heart.  Despite the routine use of stents in heart transplant recipients, there is very little scientific research tracking the efficacy of drug-eluting stents vs. bare metal stents in this population.

The study in question retrospectively evaluated the long-term impact of all available coronary stents used to correct transplanted heart coronary artery disease. Researchers focused on 23 patients. The goal of the study was to identify the mortality rate and the rate of restenosis in this population of patients. Researchers found that 7% patients with drug-eluting stents had restenosis vs 61% of restenosis in patients with bare metal stents. Researchers also found that there was an 18% mortality rate in patients with drug-eluting stents vs. a 31% mortality rate in patients with bare metal stents.

Contributing author: Jon Stefanuca

St. Joseph Medical Center Stent Patients Now Face Another Risk: The FDA Requires a Black-Box Warning on Anti-Clotting Drug Plavix

For those of you who have been following the St. Joseph Medical Center stent fiasco, a story in the Los Angeles Times regarding the anti-clotting drug Plavix brings home a new concern for the patients who received this drug as part of the post-procedure therapy. Plavix is used “to prevent clotting of blood in patients who have stents or other prostheses or conditions that predispose them to clotting, and thus strokes and heart attacks.”

The Food and Drug Administration said Friday that it will require a new black-box warning on the label of   the popular anti-clotting drug Plavix to indicate that some patients do not metabolize the drug properly and may receive little benefit from it. The warning indicates that the drug is dangerous only in the sense that it doesn’t work in those patients and thus may leave them unprotected against heart attacks and strokes.

“The new warning appears on the label of the drug in a black box — hence the name — which is considered the most severe form of warning.”  A black box warning is the strongest warning required by the FDA.  The intent of requiring such a warning is to alert physicians and help them treat their patients correctly. “The FDA says between 2% and 14% of Plavix users don’t respond well to the drug and might benefit from alternative treatment.”

According to the FDA press release:

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

A Wall Street Journal Blog suggests that this situation may actually make the physicians’ job more difficult.

Genetic testing could identify the poor responders. But most doctors aren’t well equipped to do genetic testing. They don’t have quick access to the tests. Even if they did, they might not have time in the cases of many patients to wait for results to come back.

Only one genetic test has been approved by the FDA,  Roche’s AmpliChip, “to look for the variation, but not specifically for determining treatment with Plavix. Many laboratories offer other tests, whose quality the FDA says doctors will have to assess before using. Doctors should make sure the tests are at least 98% accurate, FDA officials told reporters.”

According to Christopher Cannon, a Harvard Medical School associate professor and editor-in-chief of Cardiosource, associations involved with the cardiac-related specialties and sub-specialties “will need to develop protocols for testing and treatment. The alternatives include increasing the dose of Plavix or switching to bloodthinner Prasugrel from Lilly and Daiichi Sankyo, but Cannon says neither has been tested for that purpose.”

“Thus a real conundrum” for patients and their physicians, Cannon said. “I expect mass confusion in response to this FDA warning,” he added.

As we reported in “Eye Opener” on March 13, 2010, St. Joseph Medical Center this past week added another 169 patients to the list of those notified by letter that they had received unnecessary, expensive and potentially dangerous stent procedures.  This brought the number notified to a whopping 538 patients – at least to date.

One has to wonder in all of this, was there a single moment of thought given to the potential risks to the patients at St. Joseph Medical Center when these unnecessary stents were put in hundreds of patients?  Maybe those involved in this tragic story of despicable care were not fully versed in the genetic complication of Plavix (or maybe they were); however, they were most assuredly aware that they were exposing these unwitting patients to a risk of hemorrhage, not to mention the risks associated with having a foreign body unnecessarily placed in their coronary vessels.

St. Joseph tells 169 more patients they may have had unneeded surgery; total notified at now at 538

The Baltimore Sun reports today that another 169 patients have been notified by St. Joseph Medical Center in Towson, Maryland, that the coronary stent implants they received may well have been (read – were) unnecessary.  The total number of patients so far notified by the hospital has now reached 538.

Stents, mesh tubes that are threaded into damaged arteries to prop them open, are generally considered appropriate when vessels have at least a 70 percent blockage. But hospital officials say their review uncovered stents implanted by Midei in patients with insignificant blockage. And attorneys representing some patients say the amount of blockage was often overstated in their medical records.

Dr. Mark Midei, a cardiologist at the center of this storm, was terminated by St. Joseph Medical Center after the hospital came under investigation by federal authorities last year.  He at one time was an employee of one of the leading cardiology group practices in the area, MidAtlantic Cardiovascular Associates, but left that group when he was recruited by St. Joseph Medical Center to head its cardiovascular laboratory in 2008.  His departure from his group was apparently not peaceful.

[Dr. Midei’s] departure helped scuttle a deal MidAtlantic had to merge with St. Joseph rival Medstar Health, and prompted the practice’s chief executive to tell Midei: “I will spend the rest of my life trying to destroy you personally and professionally,” according to court records.  

A class action lawsuit has been filed by the the Murphy Firm in Baltimore, Maryland, working in conjunction with another Baltimore legal powerhouse, The Law Offices of Peter Angelos. These firms have been involved in many class action lawsuits across the country.  The current lawsuit has been filed in Circuit Court for Baltimore City, Maryland.  On January 28, 2010, the Murphy firm posted an announcement regarding this class action.  A similar press release detailing some of the relief being sought in the class action is posted on Peter Angelos’ firm’s website.

In February of this year, according to the Sun’s report today, “two senior members of the U.S. Senate Finance Committee called on St. Joseph to turn over records of its financial relationships with stent manufacturers, including records of how the $10,000 procedures were billed to federal and private insurers.”

“In addition to putting patients’ lives at risk, unnecessary medical procedures amount to wasteful spending of precious federal health care dollars,” they wrote in a letter to the hospital.

As for Dr. Midei’s comments or reaction to today’s article, the Sun reports:

A spokesman for Midei declined to comment. He reiterated a statement the doctor issued in January, which read: “I am confident that I have always acted in the best interest of my patients, and when all the facts are presented, I will continue providing quality medical care to my patients.”