Tighter rules for ad hoc PCI

The increased frequency in recent years of what has been termed "ad hoc" percutaneous coronary intervention is of concern to both interventional cardiologists and third-party payers.

The definition of ad hoc PCI that accompanied recent guidelines on that subject in a statement by the Society of Cardiovascular Angiography and Interventions (SCAI) is a "diagnostic catheterization followed in the same session or same sitting by PCI." Much of this increase has occurred in patients without symptoms and with minimal if any evidence of ischemia. Convenience and economics also play a role. As a result, cardiologists presume that they can do no harm without asking the question of whether they are doing any good.

A recent report on 144,737 nonacute PCIs using the National Cardiovascular Data Registry indicated that almost 30,000 PCIs (24.4%) were performed in patients without symptoms or class I angina and 30% were at low risk by noninvasive testing. In these nonacute patients, 67% were considered either inappropriate or uncertain (JAMA 2011;306:53-61). The rate of performing inappropriate PCI in hospitals varied between 6% and 16%. A number of hospitals had inappropriate rates exceeding 25%, and some had rates as high as 48%. The registry does not provide the number of ad hoc procedures performed, but one might presume that many of these patients would have fit the criteria for entry into the COURAGE trial (N. Engl. J. Med. 2007;356:1503-16), in which patients with stable coronary disease, 43% of whom had either no angina or class I angina, did as well with medical treatment as with PCI.

Angiographers have admitted having difficulty assessing the severity of stenosis, and therefore often proceeding to ad hoc PCI. The recent FAME study suggests that the measure of fractional flow reserve (FFR) is able to define coronary lesions that are clinically significant (N. Engl. J. Med. 2009;360;213-24). However, the conclusions of FAME have been challenged in regard to the clinical importance of FFR measurement.

Included in the recent SCAI guidelines is the requirement that before ad hoc PCI is performed, patients should be given information about the appropriateness, relative risk, and benefit of the procedure as well as therapeutic alternatives to PCI. For patients with ongoing symptoms and positive diagnostic tests for ischemia, this is easily obtained prior to intervention. But patients without symptoms and without evidence by stress testing may not be given the real story before the procedure. For these patients, SCAI advises that "time-out" be called and that they be given time to consider the alternatives for treatment of their disease (Catheter. Cardiovasc. Interv. 2012 Nov. 29 [doi: 10.1002/ccd.24701]).

Unfortunately for all of us, the federal government is also concerned about the issue of appropriateness. A recent whistleblower lawsuit in Ohio was resolved with a payment of fines of $3 million by the hospital and more than $500,000 by the physician group involved in the lawsuit. According to press reports, the physicians defended their "high rates as a result of their aggressive style of medicine." The physicians defended the medical care that they provided although they "might not have met the government’s guidelines of reimbursement" (New York Times, Jan. 5, 2013, sec. B1).

Unless we adhere to good practice guidelines, the federal government will force our adherence, whether we like it or not.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies. This column, "Heart of the Matter," appears regularly in Cardiology News.

The increased frequency in recent years of what has been termed "ad hoc" percutaneous coronary intervention is of concern to both interventional cardiologists and third-party payers.

The definition of ad hoc PCI that accompanied recent guidelines on that subject in a statement by the Society of Cardiovascular Angiography and Interventions (SCAI) is a "diagnostic catheterization followed in the same session or same sitting by PCI." Much of this increase has occurred in patients without symptoms and with minimal if any evidence of ischemia. Convenience and economics also play a role. As a result, cardiologists presume that they can do no harm without asking the question of whether they are doing any good.

A recent report on 144,737 nonacute PCIs using the National Cardiovascular Data Registry indicated that almost 30,000 PCIs (24.4%) were performed in patients without symptoms or class I angina and 30% were at low risk by noninvasive testing. In these nonacute patients, 67% were considered either inappropriate or uncertain (JAMA 2011;306:53-61). The rate of performing inappropriate PCI in hospitals varied between 6% and 16%. A number of hospitals had inappropriate rates exceeding 25%, and some had rates as high as 48%. The registry does not provide the number of ad hoc procedures performed, but one might presume that many of these patients would have fit the criteria for entry into the COURAGE trial (N. Engl. J. Med. 2007;356:1503-16), in which patients with stable coronary disease, 43% of whom had either no angina or class I angina, did as well with medical treatment as with PCI.

Angiographers have admitted having difficulty assessing the severity of stenosis, and therefore often proceeding to ad hoc PCI. The recent FAME study suggests that the measure of fractional flow reserve (FFR) is able to define coronary lesions that are clinically significant (N. Engl. J. Med. 2009;360;213-24). However, the conclusions of FAME have been challenged in regard to the clinical importance of FFR measurement.

Included in the recent SCAI guidelines is the requirement that before ad hoc PCI is performed, patients should be given information about the appropriateness, relative risk, and benefit of the procedure as well as therapeutic alternatives to PCI. For patients with ongoing symptoms and positive diagnostic tests for ischemia, this is easily obtained prior to intervention. But patients without symptoms and without evidence by stress testing may not be given the real story before the procedure. For these patients, SCAI advises that "time-out" be called and that they be given time to consider the alternatives for treatment of their disease (Catheter. Cardiovasc. Interv. 2012 Nov. 29 [doi: 10.1002/ccd.24701]).

Unfortunately for all of us, the federal government is also concerned about the issue of appropriateness. A recent whistleblower lawsuit in Ohio was resolved with a payment of fines of $3 million by the hospital and more than $500,000 by the physician group involved in the lawsuit. According to press reports, the physicians defended their "high rates as a result of their aggressive style of medicine." The physicians defended the medical care that they provided although they "might not have met the government’s guidelines of reimbursement" (New York Times, Jan. 5, 2013, sec. B1).

Unless we adhere to good practice guidelines, the federal government will force our adherence, whether we like it or not.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies. This column, "Heart of the Matter," appears regularly in Cardiology News.

The increased frequency in recent years of what has been termed "ad hoc" percutaneous coronary intervention is of concern to both interventional cardiologists and third-party payers.

The definition of ad hoc PCI that accompanied recent guidelines on that subject in a statement by the Society of Cardiovascular Angiography and Interventions (SCAI) is a "diagnostic catheterization followed in the same session or same sitting by PCI." Much of this increase has occurred in patients without symptoms and with minimal if any evidence of ischemia. Convenience and economics also play a role. As a result, cardiologists presume that they can do no harm without asking the question of whether they are doing any good.

A recent report on 144,737 nonacute PCIs using the National Cardiovascular Data Registry indicated that almost 30,000 PCIs (24.4%) were performed in patients without symptoms or class I angina and 30% were at low risk by noninvasive testing. In these nonacute patients, 67% were considered either inappropriate or uncertain (JAMA 2011;306:53-61). The rate of performing inappropriate PCI in hospitals varied between 6% and 16%. A number of hospitals had inappropriate rates exceeding 25%, and some had rates as high as 48%. The registry does not provide the number of ad hoc procedures performed, but one might presume that many of these patients would have fit the criteria for entry into the COURAGE trial (N. Engl. J. Med. 2007;356:1503-16), in which patients with stable coronary disease, 43% of whom had either no angina or class I angina, did as well with medical treatment as with PCI.

Angiographers have admitted having difficulty assessing the severity of stenosis, and therefore often proceeding to ad hoc PCI. The recent FAME study suggests that the measure of fractional flow reserve (FFR) is able to define coronary lesions that are clinically significant (N. Engl. J. Med. 2009;360;213-24). However, the conclusions of FAME have been challenged in regard to the clinical importance of FFR measurement.

Included in the recent SCAI guidelines is the requirement that before ad hoc PCI is performed, patients should be given information about the appropriateness, relative risk, and benefit of the procedure as well as therapeutic alternatives to PCI. For patients with ongoing symptoms and positive diagnostic tests for ischemia, this is easily obtained prior to intervention. But patients without symptoms and without evidence by stress testing may not be given the real story before the procedure. For these patients, SCAI advises that "time-out" be called and that they be given time to consider the alternatives for treatment of their disease (Catheter. Cardiovasc. Interv. 2012 Nov. 29 [doi: 10.1002/ccd.24701]).

Unfortunately for all of us, the federal government is also concerned about the issue of appropriateness. A recent whistleblower lawsuit in Ohio was resolved with a payment of fines of $3 million by the hospital and more than $500,000 by the physician group involved in the lawsuit. According to press reports, the physicians defended their "high rates as a result of their aggressive style of medicine." The physicians defended the medical care that they provided although they "might not have met the government’s guidelines of reimbursement" (New York Times, Jan. 5, 2013, sec. B1).

Unless we adhere to good practice guidelines, the federal government will force our adherence, whether we like it or not.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies. This column, "Heart of the Matter," appears regularly in Cardiology News.