Vascular Surgery Expert Witness

Pradaxa (Dabigatran) may reduce risk of stroke with Atrial Fibrillation

Cerebrovascular stroke remains a significant and life changing complication of atrial fibrillation.  Early identification of atrial fibrillation, appropriate risk stratification with commencement of anticoagulation for carefully selected patients who have an appopriate risk-benefit profile is the standard of care for this disorder. Pradaxa Recently, a new agent Pradaxa (Dabigatran) stands to potentially be a game-changing entry into the market because of the potential to increase the mainenance of stable levels of the medication and eliminate the need to monitor blood levels as are currently required with warfarin-the current gold standard for oral anticoagulation.

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Warfarin, the current standard for oral anticoagulation is an inhibitor of the Vit K clotting cascade while Pradaxa is a direct thrombin inhibitor. Post release analysis will determine if bleeding rates are lower for treated patients. Preclinical trials suggested lower bleeding rates except in patients over 75 where there was a trend toward higher bleeding rates with Pradaxa.

Monitoring of warfarin presents a significant challenge for patients and clinicians and the maintenance of steady levels is sometimes difficults requiring a resource and patient committment to monitoring. Bleeding complications represent a source of medical liability as does afibrillation and stroke.

 

Medical malpractice tort reform potentially affects vascular surgery

Proposed Medical malpractice tort reform may have a significant impact on the practice of high risk specialists like vascular surgeons. Vascular surgery involves the diagnosis, management and treatment of blood vessel disorders. The patients who suffer with such disorders often times have comordities such as cardiovascular disease and diabetes increasing their risk for heart attack and stroke.

Medical malpractice tort reform, largely a partisan issue with Republican support, is an  issue that is followed closely by physician providers.

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Potential tort reform in state of Pennsylvania

The stat of Pennsylvania has tort reform legislation which has passed the House by a substantial margin. In a state which has a Republican majority in both the house and senate as well as in the governors office-tort reform has the greatest chance in some time.

Previous efforts had fallen short in the Democratic dominated state legislature. See the full article regarding tort reform.

Pennsylvania House Passes Tort Reform Bill

By Kenneth J. St. Onge | April 12, 2011

Pennsylvania House lawmakers have passed a major tort reform bill, an agent-supported move that sets up a vote in the Senate that could happen as early as this month.

The tort reform bill, also called the Fair Share Act, is an overhaul of civil liability rules in the Keystone State, where current law allows a single defendant to be held fully liable for the actions of other defendants. Reformers say that system is abused by plaintiff’s lawyer who go after defendants with deep pockets — like insurers. Proponents of the current system say it’s more favorable, since it forces defendants to sue each other to settle liability apportionments, while leaving plaintiffs indemnified more quickly.

 It’s a peculiar quirk sometimes called the “1 percent rule,” since it’s conceivable a defendant can be found 1 percent liable for causing an injury, but be forced to pay 100 percent of any damages.

Lawmakers, chiefly Republicans, have tried to pass tort reform for years in the state, which is home to what Americans for Tort Reform ranked as the number one “Judicial Hellhole” in the nation: Philadelphia, where the group says civil courts routinely hand out lopsided verdicts, encouraged by the state’s liability rules. But tort reform efforts have stalled in recent years thanks to ruling by the state’s top court in 2005 and a veto in 2006 by former Gov. Ed Rendell.

The house passed the bill by a vote of 112 to 88, with several democrats voting along with republicans. The measure heads now to the Senate, where the judiciary committee has already had a hearing and collected testimony on tort reforms, although it has not voted.

The bill would first need to pass the committee before heading to the full senate floor. That could happen as early as this month, although lawmakers in Harrisburg are still working on budget deals, which could back the timeline up a few weeks or months before a vote could happen.

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Diabetic vascular complications including amputation increased in aged minorities

  

Medical research continues to document the relatively higher rates of vascular amputation in the aged and minorities as a rate of growing rates of diabetic complications.  New strategies to identify high risk patients for this complication are necessary is public policy is to change

 

Governor Corbett mentions tort reform as potential route to reduction in healthcare costs

Governor Corbett of Pennsylvania maintained his stance that mandates for insurance within the Affordable Care Act are unconstitutional, a position he took as Attorney General in The Commonwealth. Additionally, Governor Corbett, while discussion healthcare cost reduction, mentioned the absence of Tort Reform language within ACA

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Higher rate of amputations in African American Men in Philadelphia

Limb amputation occurs at a significantly rate in African American men in Philadelphia county compared to surrounding suburban counties. The study performed by Drs Ron Renzi of Abbington Hospital and Lee Kirksey Penn Presbyterian Medical Center and the Penn Wound Center. The results are a striking reminder that Health Disparities are a significant source of preventable patient illness. Over 80% of patients were diabetic and many underwent amputation without any attemptat at revascularization due to their severe advanced diseas

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Numerous factors are responsible for the disparity including disconnected care in a a lower socioeconomic patient population. Diabetic foot ulceration frequently preceeds amputation and thus diabetic foot programs may hold the best opportunities to reduce amputation.

The socioeconomic findings raises significant issues regarding the contribution of bias related to the choices that are offered to patients.

Arterial thromboses, diabetic foot ulcer may lead to limb loss without revascularization

We recently completed an analysis of limb amputation rates in the Southeaster Pennsylvania in the counties of Delaware, Philadelphia, Montgomery and Bucks county. The rate of limb amputation is 4-5 times higher for African American men in Philadelphia county. Most of the individuals were diabetic and over 20% did not undergo any attempt at revascularization prior to ampuation suggesting that limb salvage was not possible do to the advanced nature of the disease or not offered.

A previous study had similar findings in Chicago

African Americans Have Five Times Higher Amputation Rate

ScienceDaily (Apr. 29, 2008) — The overall amputation rate in northern Illinois is declining due to improved care for diabetes and peripheral vascular disease, new research shows. But not everyone is reaping the benefits.

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A new study from Northwestern University's Feinberg School of Medicine has found people in African American communities on Chicago's South and West Side have a five times higher rate of lower limb amputations than people in the predominantly white suburbs and exurbs.

"Amputations are the canary in the coal mine for quality of care," said Joe Feinglass, lead author and research professor of medicine at the Feinberg School. "Many amputations are preventable. This means the primary care for minority people may not be very good. "

Feinglass said the high rate of amputations means people are not being closely monitored. "They come in with gangrene or a skin ulcer that comes to the attention of a doctor really late and nothing can be done," he said. "They have to take their leg off."

This is the first longitudinal study -- nationally or locally -- to examine amputation trends over nearly 20 years. Most studies of amputation rates look at one point in time.

The study will be published in the May issue of the Journal of Vascular Surgery.

The high amputation rate for minorities in Chicago likely reflects other racial disparities in healthcare, Feinglass said. "Diabetes is a condition that is highly susceptible to quality of care. Amputation rates give you a basic idea of how the system is performing."

It was known in the late 1990's that African Americans were more likely to have an amputation than whites. But as the national trend of amputations declined in the early 2000's, Feinglass wanted to see if the gap closed or at least narrowed.

The study examined hospital discharge data from the Illinois Department of Public Health for nine counties in northern Illinois encompassing more than eight million people. Feinglass then broke the statistics into three rings of the metropolitan area based on their zip codes.

He found that amputations in the suburban and exurban areas with a primarily white population dropped to 12 per 100,000 in 2004 from 14 in 1987. The largely African American area on the South and West Side actually increased to 63 amputations from 60. The inner suburbs and other areas of Chicago, with between 10 and 50 percent African American population and a large Hispanic population, held fairly steady at 20 amputations per 100,000.

About half of the people who have amputations are diabetic patients with decreased circulation to the feet. Almost all who have amputations are smokers, a habit that can cause hardening of the arteries and clots in the legs.

"These people get sores on their feet that don't heal," Feinglass said. "They develop an ulcer that can often turn into something worse if it's not treated right away."

The high amputation rate is linked to lack of access to primary care and specialty care for diabetic patients and patients with vascular disease. In addition, patients without diabetes may not get a screening for peripheral arterial disease, an inexpensive test to indicate risk factors for circulation problems.

To address these problems, Feinglass said communities need diabetes management programs with nurses to help people control their blood sugar.

"Those are the kinds of programs we know would pay off in the inner city. When blood sugar is lower, there is a lower amputation rate," Feinglass said. Vascular surgeons and podiatrists are also needed in these areas.

"An amputation is a horrible thing to have anybody go through," Feinglass said. "We have to do better at preventing these."

Allegation of unnecessary coronary stent placement is not new

Recent allegations about the unnecessary placement of coronary stents at hospitals in baltimore and texas is not a new concept. In the early part of the decade, Redding a Tenet hospital was the center of an investigation of similar nature.

The Redding affidavit: FBI report alleges unnecessary procedures while hospital stayed mum

Fri, 15 Nov 2002 16:00:00 | Shelley Wood

Redding, CA - The alleged frauds are legion: healthy arteries subjected to catheterization and bypass surgery, cardiac valves needlessly replaced, IVUS images intentionally misinterpreted to convince patients they needed urgent life-or-death procedures, hospital CEOs turning a blind eye to the activities of 2 cardiologists bringing megabucks into the institution. All in all, the affidavit filed by FBI agent Michael A Skeen and acquired by heartwire reads more like a medico-murder mystery than real-life testimonies of patients and health professionals.

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Drs Chae Moon and Fidel Realyvasquez of Redding Medical Center (RMC), California, are under investigation for allegedly being involved in conspiracy to commit healthcare fraud, providing false statements relating to healthcare matters, and healthcare fraud, as reported by heartwire and mainstream media across the US.

Skeen's affidavit states, "This investigation shows that there is reason to believe that many known and unknown patients have been victims of a scheme to cause patients to undergo unnecessary invasive coronary procedures...specifically heart catheterizations, including angiogram and intravascular ultrasound (IVUS), stent placement, and angioplasty performed by Moon for profit. Further, this scheme includes unnecessary invasive coronary procedures, specifically CABG and heart valve replacement surgery, performed by Realyvasquez for money."

Witnesses allege "unnecessary" procedures performed

The affidavit itself is a compelling compilation of witness accounts, including 2 patients of Moon's, 2 Redding cardiologists, and an internist not affiliated with RMC, an RMC employee, and several cardiologists practicing outside of Redding. Between the summers of 2001 and 2002, Skeen reports, Realyvasquez billed Medicare a full US $3570825 and Moon US $3964744.31. As many as 50% of the procedures conducted by Moon and Realyvasquez to bring in these royal sums were, according to 2 independent Redding doctors (1 a cardiologist), "unnecessary by commonly held medial standards," the affidavit alleges.

Evidence from 1 cardiologist who saw patients after they'd been to Moon claimed that in many instances Moon's first interaction with the patient was to perform a heart catheterization procedure, the affidavit alleges. Two of Moon's patients interviewed by Skeen stated that Moon had conducted "urgent" angiography and concurrent IVUS on them, in 1 case in the absence of any symptoms and a normal treadmill test, in the other as the first line of investigation. Routine use of IVUS as a diagnostic adjunct to coronary angiography is not recommended in any current guidelines.

What the patients allege One patient describes seeing Moon concerned about his family history of heart disease. The patient told Skeen that Moon recommended he undergo a calcium scan despite a normal treadmill test. Following the calcium scan, the patient was referred for an urgent angiogram and concurrent IVUS. "Immediately following the catheterization procedure, Moon stood over [the patient] and gravely announced, 'There is nothing I can do for you. You need immediate open-heart surgery," Skeen's report states. The patient decided to seek a second and third opinion from cardiologists in Las Vegas, who told him not only that his calcium score had been unremarkable for a man his age, but also that his coronary arteries were normal. One of the Las Vegas cardiologists "seemed disgusted and used the terms 'serious' and 'gross malpractice' to describe Moon's diagnosis," the affidavit reads. A second patient describes actually requesting a catheterization by Moon after an anxiety attack in which he says his heart skipped a beat. He, too, was catheterized for both an angiogram and IVUS, and then told he needed quadruple bypass surgery because of a "widow-maker" flap in his right coronary artery. While awaiting bypass surgery, the patient sought a second opinion from another Redding cardiologist. This outside cardiologist, from Mercy Hospital, said that the catheterizations had been unwarranted and that the patient had better-than-normal arteries with no evidence of any acute problems on either the angiogram or IVUS stills. On finding out that the patient had sought a second opinion, Moon was "very upset" and stated angrily, "Those boys at Mercy don't even know what [IVUS] is," the patient alleges in the affidavit. Moon then said that he had studied IVUS under Dr Yak at Stanford who had invented IVUS. A call to Stanford revealed that no one there had ever heard of a Dr Yak. The patient then called in a second outside cardiologist, who told him, "You don't need bypass surgery. You need to go home. There is nothing wrong with you...This place is a monstrosity. This is wrong. This should be stopped," the affidavit alleges. -SW

 

 

 

Maryland lawmakers seek greater oversight of physicians

TOWSON, Md. (WJZ)– Maryland lawmakers want to make sure someone’s keeping a close eye on doctors performing cardiac stent procedures in the wake of a scandal involving one of the area’s top cardiologists.

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Derek Valcourt reports there’s a state investigation into the matter and some new legislation in the works.

Stents are tiny devices designed to open up clogged arteries.Whether or not hundreds of patients who got them really needed them is the question at the center of a contentious legal battle between those patients, their cardiologist Dr. Mark Midei and his former employer St. Joseph Medical Center in Towson.

The controversy spurred a U.S. Senate investigation into the matter and a statewide review of other hospitals performing stent procedures.

“So we will be aggressive in checking and only then if we find a problem will we be acting on it,” said Joshua Sharfstein, Maryland Health Secretary.

Sharfstein was part of a panel briefing lawmakers in Annapolis on Wednesday on the status of their still ongoing investigation.

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Alleged placement of unnecessary coronary stents in Baltimore

Hundreds of Patients Affected in MD Hospital Malpractice Case

A hospital in Maryland is currently notifying patients of the possibility of mass medical malpractice after it was discovered that as many as 369 patients may have received unnecessary arterial stent implants.

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Cardiac catheterization with the use of coronary stents is commonly done in an attempt to open up clogged arteries.  According to reports, the patients affected had only minor blockages in their arteries that did not warrant the use of coronary stents.  As a result these patients were exposed to unnecessary risk. 

Coronary stents are typically implanted via the bloodstream and through the leg.  The risks associated with cardiac catheterization include:

• Bleeding
• Infection
• Allergic reaction
• Damage to blood vessels
• Blood clots
• Low blood pressure
• Kidney damage
• Arrhythmias
• Heart Attack
• Stroke

It is believed that a possible underlying reason for the unnecessary procedures is health care fraud, for which the hospital is currently under investigation.  These procedures are quite costly and most insurance providers, including Medicare, require that a patient’s artery be at least 70% blocked before they will approve the use of a stent.  It is reported that the hospital told the affected patients that they had frighteningly large blockages, some up to 95%, when in reality most of the blockages were less than 10%.

Being forced to undergo any unnecessary procedure can be physically and emotionally taxing on anyone.  The fact that the patients involved in this case underwent such a dangerous one only makes the situation that much more upsetting.  We will most likely see an influx of medical malpractice cases as a result.