News

Surgical Competence, a Crisis in US Health Care?

Posted on February 20, 2014 - 12:45pm

Surgical competence requires a complex set of interdependent roles and abilities that include psychomotor, cognitive, and interpersonal abilities.[i]

A shift in surgical procedures towards minimally invasive techniques has greatly complicated surgical education with a major potential impact on emergency patient care.

Introduction

This summer a former resident of mine – now an older surgeon himself – asked me whether I’d be interested in re-activating my surgical career (not a simple thing to do). As explanation, he mentioned a critical shortage of experienced surgeons in traditional surgical techniques, as present day’s education is now mainly focused on minimally invasive procedures. During the past ten years this has become a major issue, particularly in trauma and emergency surgery, where often “open” procedures are necessary.

Coronary Artery Bypass Grafting is Superior to Percutaneous Coronary Intervention in Diabetics with Coronary Artery Disease

Posted on November 6, 2012 - 2:29pm

A dramatic increase in percutaneous coronary intervention (PCI), coupled with a similar decrease in coronary artery bypass grafting (CABG) has characterized the treatment of coronary artery disease for the 20 years.

The just released FREEDOM trial results[1] have once again confirmed that diabetic patients with coronary artery disease have better outcomes with CABG than with PCI – even if contemporaneous techniques are used.

CABG Superior to PCI in long-term treatment of coronary artery disease

Posted on May 23, 2013 - 3:01pm

As shown in SYNTAX and other studies, CABG is associated with significantly lower rates of death, myocardial infarction (MI) and target vessel revascularization (TVR) vs. PCI.

Fatalities with Dabigatran and Warfarin Caused by Bleeding

Posted on March 18, 2013 - 10:36am

A FDA report presented at the 2013 American College of Cardiology (ACC) 2013 Scientific Sessions has suggested a much higher case fatality rate than that reported in other major clinical trials of the drug. For the study, reports of bleeding with dabigatran or warfarin submitted to the FDA between January 1, 2010, and June 30, 2012 were examined:

Adverse drug reactions relating to warfarin or dabigatran reported to FDA 

 

Interventions for Coronary Artery Disease

Posted on April 3, 2013 - 1:35pm

 

In determining a treatment strategy for a patient with CAD, there are a variety of considerations that need to be made when selecting the appropriate treatment:

Medical therapy often superior than stenting

Posted on November 10, 2011 - 6:29pm

There is more and more evidence of the superiority of medical therapy over stenting, not only with coronary artery disease, but also with stenotic arteries in your brain: The 30-day rate of stroke or death associated with stenting (14.7%) is nearly 2.5 times as high as the 6% rate associated with stenting in high-risk patients with a 70 - 90 % severe intracranial arterial stenosis.

An Approach to Hypertension Treatment In The Elderly

Question: 
Is there a diffence in the treatment of hypertension in the elderly?

In clinic today, I saw an 85 year old woman with Parkinson’s disease for follow-up of her high blood pressure. Her pressures have been difficult to control.

Today her BP is 170/80 with a heart rate of 62 bpm. She is taking an ACEi and a beta-blocker. Her daughter supervises the administration of her medications. She has no known history of heart disease or stroke, and mild renal disease which has been stable. Her EKG shows left ventricular hypertrophy.

Chronic anticoagulation in atrial fibrillation

Posted on March 20, 2013 - 12:13pm

A few days ago I published an article about fatalities involving the new drug Dabigatran. This has resulted almost immediately in a letter from the Media Group Director of the PR company that handles advertizing for the pharmaceutical firm involved. I am glad to post it here:

Comment:

"Just wanted to contact you with regard to your “Fatalities with Dabigatran and Warfarin Caused by Bleeding” article, and provide some further context about the analysis.

Cost-Effectiveness of PCI with Drug Eluting Stents versus CABG

Posted on November 29, 2012 - 7:09pm

Cost-Effectiveness of PCI with Drug Eluting Stents versus Bypass Surgery for Patients with Diabetes and Multi-vessel Coronary Artery Disease: Results from the FREEDOM Trial.

Not only did patients with diabetes and multi-vessel CAD experience significantly better clinical outcomes after revascularization with CABG than PCI with a drug-eluting stent, according to results of the FREEDOM trial, based on lifetime projections, CABG was found to be more cost‐effective compared to DES‐PCI.

Left-main PCI is only appropriate for a minority of patients

Posted on November 8, 2011 - 12:09pm

An atricle published in Cardiovascular Business on November 8, 2011 is very much in-line with our previous publications on this website about optimal treatment of Coronary Artery Disease that includes a Left Main Stenosis and/or three vessel disease:

Dick Cheney and modern heart failure treatment

Posted on April 4, 2012 - 3:34pm

Former Vice President Dick Cheney was released from the hospital on April 3rd, 2012, 10 days after getting a heart transplant. Cheney waited nearly two years for the transplant. During his life he sustained five heart attacks, the first at age 37 and the most recent one in 2010.

Five Things Physicians and Patients Should Question

Posted on February 21, 2013 - 6:46pm

Five Things Physicians and Patients Should Question:

Don’t perform stress cardiac imaging or advanced non-invasive imaging in the initial evaluation of patients without cardiac symptoms unless high-risk markers are present.

Asymptomatic, low-risk patients account for up to 45 percent of unnecessary “screening.” Testing should be performed only when the following findings are present: diabetes in patients older than 40-years-old; peripheral arterial disease; or greater than 2 percent yearly risk for coronary heart disease events.

Don’t perform annual stress cardiac imaging or advanced non-invasive imaging as part of routine follow-up in asymptomatic patients.

Heart health Risks of US Young People

Posted on April 10, 2013 - 9:58am

A new study by the American Heart Association has shown that although the majority of clinical CardioVascular Disease (specifically Coronary Artery Disease and Stroke) events occur at middle and older ages, atherosclerosis begins in childhood and cardiovascular health among adolescents aged 12 to 19 years  is alarmingly poor. 

Cardiovascular health in adolescent males by race/ethnicity (aged 12–19 years):

Stenting for stable coronary artery disease is wrong!

Posted on January 9, 2012 - 9:44am

In  a January 4th, 2012 JAMA editorial, the authors describe that patients were not being helped by a variety of well-established procedures including stenting for stable coronary artery disease:

Weight gains after dieting

Posted on November 1, 2011 - 3:21pm

As is well known, although restriction of diet often results in initial weight loss, more than 80 per cent of obese dieters fail to maintain their reduced weight.

A new study from Australia involved 50 overweight or obese patients without diabetes in a 10-week weight-loss program using a very-low-energy diet. Levels of appetite-regulating hormones were measured at baseline, at the end of the program and one year after initial weight loss.

A Mediterranean diet is Heart Healthy


 

Among persons at risk for cardiovascular disease, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduces the incidence of major cardiovascular events (Results from The PREDIMED Trial ).

Comments

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graft Surgery in Left Main Coronary Artery Disease

Posted on September 26, 2011 - 11:15am

In this study, the authors analyzed the combined results of four different randomized clinical trials, comparing PCI with CABG in the treatment of Left Main CAD.

Comparing MACCE (major adverse cardiac or cerebrovascular events) they found “nonsignificantly different 1-year rates of MACCE” between the two treatment modalities after 12 months (14.5% vs. 11.8%, P value 0.11).

The studies included were:

Many patients with coronary artery disease are not treated optimally

Posted on September 16, 2011 - 2:56pm

As we have reported repeatedly in previews of the SYNTAX trial, the rate of CABG surgeries declined by approximately one-third and that of PCI procedures fell by 4% between 2001 and 2008, according to another study published in JAMA in May, 2011.

The ABCS of Preventing Heart Attacks and Strokes

Posted on September 13, 2011 - 2:51pm

Each year, more than 2 million Americans have a heart attack or stroke, of whom more than 800,000 of them die; cardiovascular disease is the leading cause of death in the United States and the largest cause of lower life expectancy among blacks.

Diastolic Dysfunction and Risk of Heart Failure

Posted on September 10, 2011 - 1:11pm

Left ventricular diastolic dysfunction is highly prevalent, tends to worsen over time, and is associated with advancing age. Worsening diastolic function can be detected even in apparently healthy persons, the conclusion by the authors of a recent article published in JAMA.

Statin usage in low-risk patients

Posted on May 17, 2011 - 3:44pm

Cardiovascular disease (CVD) is ranked as the number one cause of mortality and is a major cause of morbidity world-wide. Reducing high blood cholesterol, a risk factor for cardiovascular disease (CVD) events in people with and without a past history of coronary heart disease (CHD) is an important goal of pharmacotherapy. Statins are the first-choice agents. Previous reviews of the effects of statins have highlighted their benefits in people with coronary artery disease. The case for primary prevention, however, is less clear.

Trans catheter aortic valve implantation (TAVI)

Posted on April 19, 2011 - 4:41pm

There are many patients with severe aortic stenosis and coexisting conditions who are not candidates for surgical replacement of the aortic valve. For those patients trans-catheter aortic-valve implantation (TAVI) may be an option.

Treatment of Ischemic Heart Failure

Posted on April 6, 2011 - 6:22pm

Patients with heart failure caused by blocked coronary arteries, who are treated with bypass surgery  reduce their risk of dying from heart disease, and also the risk of death from any cause or hospitalization from heart disease, compared with medication alone.

Cardiac Surgery Risk Analysis

Posted on March 2, 2011 - 10:20pm

Since its first publication, our cardiac surgery risk calculator has proven very popular, with over 1000 completed questionnaires since August, 2010. Although the validity of the analysis is somewhat questionable, it has nonetheless shown some interesting results and showcases how this type of data can be utilized, especially if coupled with outcome analysis.

SYNTAX and CABG after two years

Posted on December 23, 2010 - 12:14am

A new study, published in the Januari, 2011 issue of the Journal of Thoracic and Cardiovascular Surgery, reviewed 2-year follow-up outcome data of  1468 CABG patients from the SYNTAX trial.

Low HDL and Cardiovascular Risk

Posted on December 21, 2010 - 9:33pm

Current national guidelines for CVD risk reduction are primarily focused on strategies to reduce levels of low-density lipoprotein cholesterol (LDL-C), with the most recent focus being on “lower is better” rather than an effort to increase high-density lipoprotein cholesterol (HDL-C). A careful examination of randomized, controlled trials (RCTs) using statins demonstrates that even with intensive statin therapy and intensive LDL-C lowering, many cardiovascular events are not prevented.

VT-111 results

Posted on December 16, 2010 - 5:49pm

Viron phase 2a data, published in leading cardiovascular journal, circulation: cardiovascular interventions. VT-111 results demonstrate statistically significant reduction in two key biomarkers of cardiac damage.

Improper Cardiac Stent Implantations

Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Chuck Grassley (R-Iowa) today released a Finance Committee report detailing the case of a doctor who reportedly implanted nearly 600 potentially medically unnecessary stents from 2007 through mid-2009 at St. Joseph Medical Center in Towson, Maryland, and his relationship with the manufacturer of the stents, Abbott Labs.  The Senators’ report found that the questionable stent implantations cost the Medicare program $3.8 million during that period.

Small vessels are a predictor of restenosis after percutaneous coronary intervention (PCI)

In an article[1] published on October 9,2010 in Vascular Health and Risk Management, a British journal, the outcome of PCI in small coronary arteries was studied. Small coronary arteries (with a diameter of <3 mm) account for about 40%–50% of all coronary stenoses.

Is HbA1c the gold standard for diagnosis of Diabetes?

HbA1c is not a sure-fire tool for Diabetes diagnosis.

SYNTAX three year results

Posted on September 15, 2010 - 4:39pm

The latest SYNTAX results extend CABG's superiority over PCI.

PCI for STEMI should be limited to infarct related coronary arteries

NEW YORK (From Reuters Health) - Performing percutaneous coronary interventions (PCI) in non-infarct-related coronary vessels along with primary PCI for ST-segment elevation myocardial infarction (STEMI) appears to jeopardize patient survival, Canadian researchers reported online June 8 in the European Heart Journal.

Treatment of Chronic Kidney Disease (CKD) and multivessel CAD

CABG is associated with better survival than PCI with DES in patients with non Hemodialysis Dependent (HD) Chronic Kidney Disease (CKD) and multivessel CAD, but CABG patients have a greater short-term risk of needing permanent  hemodialysis.

Patients with 3-vessel disease should be operated!

Posted on July 13, 2010 - 9:30pm

Point-Counter point 1

Best way to revascularize patients with main stem and three-vessel lesions. Patients should be operated!

Patients with three vessel disease should undergo PCI!

Point-Counter point 2

Best way to revascularize patients with main stem and three-vessel lesions: Patients should undergo PCI![i]

Computed Tomography Coronary Angiography (CTCA) screening for Coronary Artery Disease

The major risk factors of inappropriate diet, physical inactivity, high cholestreol (> 250 mg%), high BMI (>26) and hypertension (>155 mmHg) and smoking, explain at least 75% of new cases of Coronary Artery Disease (CAD). In the absence of these risk factors, CAD is a rare cause of death.

Courage Under Fire - On the Management of Stable Coronary Disease

George A. Diamond, and Sanjay Kaul, J. Am. Coll. Cardiol. 2007;50;1604-1609

While the actual numbers are open to debate, the simple fact is that many patients with stable angina (and an additional number of asymptomatic patients) are undergoing PCI without having received sufficient medical therapy.

 

 

The Syntax Trial

Although coronary-artery bypass grafting (CABG) has been the standard of care for patients with left-main or three-vessel coronary disease who require revascularization, percutaneous coronary intervention (PCI) with stenting is also an option in such cases. These two interventions were compared in the SYNTAX trial, which was sponsored by the manufacturer of the Taxus drug-eluting stent.

Occluded Artery Trial

The Coronary Intervention for Persistent Occlusion after Myocardial Infarction (Occluded Artery Trial, (OAT) study evaluated treatment of 2166 high-risk, but otherwise stable survivors of a myocardial infarction and persistent total occlusion of the infarct-related coronary artery.

High risk criteria included an ejection fraction of <50% or proximal occlusion (TIMI flow =0-1). Treatment was randomized to either routine PCI or stenting with Optimal Medical Therapy (OMT) (1082 patients), or OMT alone (1084).

For Profit Research

“For Profit Research” with investigators receiving consulting fees from the sponsor (not much progress since 2001):

Medical Journal Editors Demand Accountability from Study Authors, Sponsors, AJHP, 11/1/2001: "clinical studies are increasingly conducted with the goal of marketing products ”

 

Niacin vs. Ezitimibe, Niacin Therapy

Posted on December 9, 2009 - 12:38am

Extended-Release Niacin or Ezetimibe and Carotid Intima–Media Thickness (The ARBITER 6–HALTS trial, Taylor et al., NEJM, 11/15/2009): In a recent study, the effect of  extended-release niacin (Niaspan, target dose, 2000 mg per day) was compared with ezetimibe (Zetia, 10 mg per day) in a small group of 208 patients with established Coronary Artery Disease (CAD). All these patients had been on long-term Statin therapy.

CABG – Stroke and Surgery

Combining Cardiac Surgery and surgery for carotid stenosis is not effective in the prevention of Stroke.

Elective cardiac catherization

Low Diagnostic Yield of Elective Coronary Angiography (From: Manesh R. Patel, M.D.,et al.,N Engl J Med 362;10, 886-895)

PCI equals OMT

Improved medical therapy equals Percutaneous Coronary Intervention (PCI) for angina relief in patients with stable Coronary Artery Disease.

APEX-AMI trial Analysis

Posted on August 16, 2010 - 6:18pm

Although 40-65% of patients admitted for treatment of an acute heart attack with percutaneous coronary intervention (PCI) have multiple blockages, current guidelines strongly suggest to limit the procedure to the blocked artery (the culprit vessel).

PCI in “Non-culprit coronary arteries” is associated with a significantly increased risk of dying, as Armstrong and colleagues of the APEX-AMI trial recently published in the European Heart Journal of June, 2010.

CAS vs CEA (the CREST study)

Posted on July 12, 2010 - 2:18am

“Primary composite outcomes” (lumping complications together into one composite complication), allows shading of negative results that only become visible with careful study of a publication. In the CREST study described below, the authors combined procedural death, stroke and myocardial infarction together into a composite complication. In doing so they found no outcome difference between Carotid artery stenting (CAS) and Endarterectomy (CEA).

I strongly disagree with the conclusion as well as this kind of data manipulation, and will address the issue in my analysis of this paper:

Statins may improve your cholesterol but not your cardiac risks

Question: 
Do Statins really improve the risk of coronary artery disease?

A paper published in this issue of the Annals of Internal Medicine, reviewed the association of statin therapy and cardiovascular outcomes, but found little difference between treated and untreated patients. As the current focus of statin therapy is to reduce low-density lipoprotein cholesterol (LDL-C), rather than increase high-density lipoprotein cholesterol (HDL-C), the conclusion was that persistent low levels of HDL-C may be responsible for ongoing risks of cardiovascular events such as myocardial infarction (MI) and cardiac death.

The ARBITER 6 trial that compared Niacin with Ezitimibe came to the same conclusion in 2009.

Treatment of 3VD with/without Diabetes in Washington State

A paper from Washington State examines the treatment of patients with multi-vessel coronary artery disease. A second paper, like the BARI-2D study and a much earlier published paper, focuses on patients with diabetes and 3VD. The short as well as long term benefits of CABG for these type of patients have been described in the SYNTAX trial as well as other publications but have rejected in daily clinical practice with a call for new studies as the most positive answer.

Comments on the niacin ezitimibe study

In November 2009 a study compared adjunct therapy (niacin vs. ezitimibe) for patients with known coronary artery disease (CAD) and hypercholesterolemia. The results indicated that patients would be better of with niacin (results published elsewhere on this website).

The NYTimes commented on the study outcomes: Study Raises Questions About Cholesterol Drug’s Benefit on November 15, 2009: “For patients taking a statin to control high cholesterol, adding an old standby drug, niacin, was superior in reducing buildup in the carotid artery to adding Zetia, a newer drug that reduces bad cholesterol, according to a new study.”  The next day, in a follow-up report …”Merck investors viewed the results with relief, analysts said, because there was no sign that Zetia made the arterial condition worse.

Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease

Posted on November 13, 2015 - 1:02pm

During an extended-follow-up of up to 15 years, VA patients had similar survival rates between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease. In an article, published in the NEJM of 11/12/2015, 

In the COURAGE trial, the authors compared an initial management strategy of optimal medical therapy alone with optimal medical therapy plus PCI among patients with stable ischemic heart disease and found no significant difference between the treatment groups with respect to the composite primary end point of death from any cause or nonfatal myocardial infarction or with respect to any of the other cardiac end points (including death from any cause or hospitalization for acute coronary syndrome) during a median follow-up period of 4.6 years.

Medical therapy for stable coronary artery disease

Yet another article compares Medical therapy with PCI (Stenting) in patients with stable Coronary Artery Disease. This time the focus was on control of angina symptoms, rather than survival. However, its conclusions were similar in that in this group of stable patients, medical therapy alone has become just as effective as PCI (75% vs. 77% control of symptoms).