Interventional
Cardiology:
1990s
Kenneth M. Kent, MD
F
ifteen years ago,Andreas Gruentzig performedthe first coronary angioplasty procedure’ (PTCA) which changed not only therapeutic options for patients with obstructive coronary artery diseasebut our entire approach to such patients. Diagnostic tests have been improved and used more frequently to detect patients who are asymptomatic but have significant obstructive disease.Interventions, both nonoperative and operative, are used earlier. Patients with acute myocardial infarction are treated more aggressively. Studies are underway to test the effectivenessof these altered strategies; however, the availability of nonoperative revascularization procedures has definitely altered the management of patients with coronary artery disease. Gruentzig’s initial selection criteria was patients with l-vessel disease.Indeed, 74% of patients reported in the initial National Heart, Lung, and Blood Institute (NHLBI)-PTCA registry had l-vessel disease.2However, by 1985, the time of the second registry, half of the patients undergoing PTCA had multiple vesseldisease.3Over the past 5 years, non-balloon technologies have been introduced, atherectomy devices,laser angioplasty and stents have expandedthe selection criteria of patients for nonoperative revascularization procedures. Thus, in the United States, approximately half of the 650,000 revascularization performed annually are nonoperative. After revascularization, the prognosis of patients with coronary artery diseaseis so favorable, it is possible for patients to require both operative and nonoperative revascularization proceduresduring their We. Currently, 25% of patients in our practice of interventional cardiology have undergone previous operative revascularization procedures.Thus, Gruentzig’s initial concept of removing coronary obstructions in 1 artery with a balloon, has evolved into a discipline with many different tools in which more complex anatomy is treated. As coronary anatomy and pathophysiology of the patients and the devices increase in complexity, the partnership with cardiovascular surgeonsmust strengthen. The goal of the current approach is to provide the most effective means of revascularization by the most experiencedoperators using the most appropriate devices.If nonoperative revascularization is chosen and it fails, the patient will almost certainly get worse. If the device fails, the patient will certainly get worse. At that point, it is necessaryto abandon the initial choice and proceedimmediately to operative intervention. Elsewherein this issue, Klinke and Hui4 describetheir experienceover 11 years in 762 patients in whom PTCA was performed in a hospital without on-site surgical facilities. The overall reFrom the Washington Cardiology Center, Washington, D.C. Manuscript receivedAugust 7,1992, and acceptedAugust 9. Addressfor reprints: Kenneth M. Kent, MD, WashingtonCardiol;g$ltTter, 110 Irving Street, NW, Suite 4B18, Washington, DC.
sults seem reasonable; however, there are major concerns raised by this approach. During the first 9 years, 449 patients underwent PTCA, approximately 1 patient per week (Table I14). During that period, 31 patients with multiple vessel diseasewere treated, and 4 died (13%). Even though the investigators were careful in selecting low-risk lesions,8 1%had American Heart Association/American College of Cardiology type A and Bl lesions, and the overall complication rate, death, emergency operation and myocardial infarction was 4.6%. This complication rate is similar to that reported in the 1985-86 NHLBI-PTCA Registry5; however, the latter contained consecutive series of patients, half of whom had multiple vesseldiseasewith no intent to select only low-risk lesions.Although lesion classification is not available for that registry, it is unlikely that those centers,the most experiencedin North America, would have been as selective as the Klinke-Hui report. The experience in the current study has increased: 313 patients during the past 2 years, approximately 3 patients per week. Balloon angioplasty was used exclusively in this study. Other teclmologieshave extended our abilities to treat nonoperatively patients with obstructive disease.6It is unlikely that a laboratory staff or physician who performs 3 PTCA proceduresper week will be able to master the 3 available atherectomy devices,laser angioplasty and implantation of stents.The details of the 7 patients who died are given and appropriate management is detailed. Twenty-eight patients (3.7%), most of whom had low-risk lesions,underwent emergencyoperation or experienceda myocardial infarction. Management of the casesin this period, 1981 to 1991, will not be appropriate during the next decade.To perform balloon angioplasty on eventhe simplest, most discrete, stenosis of the proximal left anterior descendingcoronary artery and not be prepared to treat an occlusivedissection with directional atherectomy or implantation of a stent will no longer be appropriate management. If interventional cardiology is to provide the most effective nonoperative revascularization procedures, it must be performed in centers that maintain a high volume, with experiencedoperatorsand laboratory personnel who have sufficient experienceto chosethe devicein order to obtain the greatest successand effectively deal with complications. As new devicesare introduced, the volume of the operators and laboratories becomesincreasingly important, as does the close interaction with the cardiovascular surgeons.It is difficult to understand how the fragmented approach, described by Linke and Hui during 1981 to 1991 will serve a useful role in interventional cardiology of the 1990s. REFERENCES
1. Cmentzig AR, SenningA, SiegenthalerWE. Nonoperative dilation of core nary artery stenosis.Percutaneoustransluminal coronary angioplasty.N Engl J &ted 1979;301:61-68.
EDITORIALS
1607
2. Kent KM, Bentivoglio LG, Block PC, Cowley MJ, Dorros G, GosselinAJ, Gruentzig A, Myler RK, Simpson J, Stertzer SH, Williams DO, Fisher L, Gillespie MJ, Mullin SM, Mock MB. Percutaneoustransluminal coronary angioplasty report from the NHLBI Registry. Am J Cardiol 1981;47:201l-2020. 3. Detre K, Holubkov MS, Kelsey S, Cowley M, Kent K, Williams D, Myler R, Faxon D, Holmes D, BourassaM, Block P, GosselinA, Bentivoglio L, Leatherman L, Dorms G, King S, Galichia J, Al-Bassam M, Leon M, Robertson T, PassamaniE, and the Co-investigatorsof the National Heart, Lung, and Blood Institute’s PercutaneousTransluminal Coronary Angioplasty Registry. Percutaneoustransluminal coronary angioplasty in 1985-1986and 1977-1981National Heart, Lung, and Blood Institute Registry. N Engl J Med 1988;3l&265-270.
“Beauty
4. Klinke WP, Hui W. Coronary angioplasty without on-site surgical facilities. Am J Cardiol 1992;70:1520-1525. 5. Detre KM, Holmes DR, Holubkov R, Cowley MJ, BourassaMG, Faxon DP, Dorros GR, BentivoglioLG, Kent KM, Myler RK, and the Co-investigatorsof the National Heart, Lung, and Blood Institute’s PercutaneousTransluminal Coronary Angioplasty Registry. Incidenceand consequences of periproceduralocclusion: the 1985-86 National Heart, Lung, and Blood Institute’s Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1990;82:739-750. 6. Leon M, Kent K, Satler L, PopmaJ, Cooke R, Stark K, Donovan K, Witt J, Shotts P, Pichard A. A Multi-device lesion-specificapproach for unfavorable coronary anatomy (abstr). J Am Coil Cardiol 1992;19:93A\.
is in the Eye
n
n
?
Floyd D. Loop, MD, and Patrick L. Whitlow, MD
I
n this issueof The American Journal of Cardiology, Klinke and Hu? report their results of percutaneous transluminal coronary angioplasty (PTCA) performed from 1981 to 1991 in a center without on-site surgery facilities. Ninety-five percent of their 762 patients underwent l-vessel dilatation, and the PTCA successrate was 76%. Surgery was possibleonly by transfer to a regional center located 6 kilometers away; 12 patients (1.6%) were successfully transferred there for “emergency surgery.” Seven patients (0.9%) died during or within 24 hours after PTCA; none of these were successfullytransported to the operating room for emergency bypass grafting. Major complications affected 5 patients (4.6%), including 2.1% with myocardial infarction. At first glance, these results appear acceptablewhen compared with those from centers with on-site surgical facilities, and the low emergency surgery rate of 1.6% for procedures performed from 1981 to 1991 even appears commendable compared with other large series (National Heart, Lung, and Blood Institute Registry, 1985-1986, 3.5%2;Emory University, 4.8%3;and Cleveland Clinic, 2.9%4).However, closer scrutiny of the series produces several points of concern. Of critical importance when considering the results of PTCA without on-site surgical backup is whether patients have timely accessto surgical support. Although there are no controlled data to prove that emergency surgery after unsuccessful PTCA improves survival, prevents myocardial infarction, salvagesischemic myocardium or improves functional capacity over medical therapy, good early and long-term results obtained with emergency bypass surgery have been well-documented.s.5Randomized studies have not been initiated becausethe consensusof clinical opinion is that emergency surgery is effective for ischemia after unsuccessful PTCA. This view is substantiated by the Subcommittee on Coronary Angioplasty of the American College of Cardiology/American Heart Association (ACC/ From the Department of Thoracic and Cardiovascular Surgery, and the Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio. Manuscript received August 7, 1992, and accepted August 8. Address for reprints: Floyd D. Loop, MD, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195.
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THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 70
AHA), which concluded that an on-site cardiovascular surgical team should be a prerequisite for coronary angioplasty.6 Since several new technologies to treat abrupt closure with PTCA becameavailable (coronary stents,7directional coronary atherectomy,8 laser balloon angioplasty9 and perfusion balloonslo), emergency surgery rates of
Cardiology:
1990s
Kenneth M. Kent, MD
F
ifteen years ago,Andreas Gruentzig performedthe first coronary angioplasty procedure’ (PTCA) which changed not only therapeutic options for patients with obstructive coronary artery diseasebut our entire approach to such patients. Diagnostic tests have been improved and used more frequently to detect patients who are asymptomatic but have significant obstructive disease.Interventions, both nonoperative and operative, are used earlier. Patients with acute myocardial infarction are treated more aggressively. Studies are underway to test the effectivenessof these altered strategies; however, the availability of nonoperative revascularization procedures has definitely altered the management of patients with coronary artery disease. Gruentzig’s initial selection criteria was patients with l-vessel disease.Indeed, 74% of patients reported in the initial National Heart, Lung, and Blood Institute (NHLBI)-PTCA registry had l-vessel disease.2However, by 1985, the time of the second registry, half of the patients undergoing PTCA had multiple vesseldisease.3Over the past 5 years, non-balloon technologies have been introduced, atherectomy devices,laser angioplasty and stents have expandedthe selection criteria of patients for nonoperative revascularization procedures. Thus, in the United States, approximately half of the 650,000 revascularization performed annually are nonoperative. After revascularization, the prognosis of patients with coronary artery diseaseis so favorable, it is possible for patients to require both operative and nonoperative revascularization proceduresduring their We. Currently, 25% of patients in our practice of interventional cardiology have undergone previous operative revascularization procedures.Thus, Gruentzig’s initial concept of removing coronary obstructions in 1 artery with a balloon, has evolved into a discipline with many different tools in which more complex anatomy is treated. As coronary anatomy and pathophysiology of the patients and the devices increase in complexity, the partnership with cardiovascular surgeonsmust strengthen. The goal of the current approach is to provide the most effective means of revascularization by the most experiencedoperators using the most appropriate devices.If nonoperative revascularization is chosen and it fails, the patient will almost certainly get worse. If the device fails, the patient will certainly get worse. At that point, it is necessaryto abandon the initial choice and proceedimmediately to operative intervention. Elsewherein this issue, Klinke and Hui4 describetheir experienceover 11 years in 762 patients in whom PTCA was performed in a hospital without on-site surgical facilities. The overall reFrom the Washington Cardiology Center, Washington, D.C. Manuscript receivedAugust 7,1992, and acceptedAugust 9. Addressfor reprints: Kenneth M. Kent, MD, WashingtonCardiol;g$ltTter, 110 Irving Street, NW, Suite 4B18, Washington, DC.
sults seem reasonable; however, there are major concerns raised by this approach. During the first 9 years, 449 patients underwent PTCA, approximately 1 patient per week (Table I14). During that period, 31 patients with multiple vessel diseasewere treated, and 4 died (13%). Even though the investigators were careful in selecting low-risk lesions,8 1%had American Heart Association/American College of Cardiology type A and Bl lesions, and the overall complication rate, death, emergency operation and myocardial infarction was 4.6%. This complication rate is similar to that reported in the 1985-86 NHLBI-PTCA Registry5; however, the latter contained consecutive series of patients, half of whom had multiple vesseldiseasewith no intent to select only low-risk lesions.Although lesion classification is not available for that registry, it is unlikely that those centers,the most experiencedin North America, would have been as selective as the Klinke-Hui report. The experience in the current study has increased: 313 patients during the past 2 years, approximately 3 patients per week. Balloon angioplasty was used exclusively in this study. Other teclmologieshave extended our abilities to treat nonoperatively patients with obstructive disease.6It is unlikely that a laboratory staff or physician who performs 3 PTCA proceduresper week will be able to master the 3 available atherectomy devices,laser angioplasty and implantation of stents.The details of the 7 patients who died are given and appropriate management is detailed. Twenty-eight patients (3.7%), most of whom had low-risk lesions,underwent emergencyoperation or experienceda myocardial infarction. Management of the casesin this period, 1981 to 1991, will not be appropriate during the next decade.To perform balloon angioplasty on eventhe simplest, most discrete, stenosis of the proximal left anterior descendingcoronary artery and not be prepared to treat an occlusivedissection with directional atherectomy or implantation of a stent will no longer be appropriate management. If interventional cardiology is to provide the most effective nonoperative revascularization procedures, it must be performed in centers that maintain a high volume, with experiencedoperatorsand laboratory personnel who have sufficient experienceto chosethe devicein order to obtain the greatest successand effectively deal with complications. As new devicesare introduced, the volume of the operators and laboratories becomesincreasingly important, as does the close interaction with the cardiovascular surgeons.It is difficult to understand how the fragmented approach, described by Linke and Hui during 1981 to 1991 will serve a useful role in interventional cardiology of the 1990s. REFERENCES
1. Cmentzig AR, SenningA, SiegenthalerWE. Nonoperative dilation of core nary artery stenosis.Percutaneoustransluminal coronary angioplasty.N Engl J &ted 1979;301:61-68.
EDITORIALS
1607
2. Kent KM, Bentivoglio LG, Block PC, Cowley MJ, Dorros G, GosselinAJ, Gruentzig A, Myler RK, Simpson J, Stertzer SH, Williams DO, Fisher L, Gillespie MJ, Mullin SM, Mock MB. Percutaneoustransluminal coronary angioplasty report from the NHLBI Registry. Am J Cardiol 1981;47:201l-2020. 3. Detre K, Holubkov MS, Kelsey S, Cowley M, Kent K, Williams D, Myler R, Faxon D, Holmes D, BourassaM, Block P, GosselinA, Bentivoglio L, Leatherman L, Dorms G, King S, Galichia J, Al-Bassam M, Leon M, Robertson T, PassamaniE, and the Co-investigatorsof the National Heart, Lung, and Blood Institute’s PercutaneousTransluminal Coronary Angioplasty Registry. Percutaneoustransluminal coronary angioplasty in 1985-1986and 1977-1981National Heart, Lung, and Blood Institute Registry. N Engl J Med 1988;3l&265-270.
“Beauty
4. Klinke WP, Hui W. Coronary angioplasty without on-site surgical facilities. Am J Cardiol 1992;70:1520-1525. 5. Detre KM, Holmes DR, Holubkov R, Cowley MJ, BourassaMG, Faxon DP, Dorros GR, BentivoglioLG, Kent KM, Myler RK, and the Co-investigatorsof the National Heart, Lung, and Blood Institute’s PercutaneousTransluminal Coronary Angioplasty Registry. Incidenceand consequences of periproceduralocclusion: the 1985-86 National Heart, Lung, and Blood Institute’s Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1990;82:739-750. 6. Leon M, Kent K, Satler L, PopmaJ, Cooke R, Stark K, Donovan K, Witt J, Shotts P, Pichard A. A Multi-device lesion-specificapproach for unfavorable coronary anatomy (abstr). J Am Coil Cardiol 1992;19:93A\.
is in the Eye
n
n
?
Floyd D. Loop, MD, and Patrick L. Whitlow, MD
I
n this issueof The American Journal of Cardiology, Klinke and Hu? report their results of percutaneous transluminal coronary angioplasty (PTCA) performed from 1981 to 1991 in a center without on-site surgery facilities. Ninety-five percent of their 762 patients underwent l-vessel dilatation, and the PTCA successrate was 76%. Surgery was possibleonly by transfer to a regional center located 6 kilometers away; 12 patients (1.6%) were successfully transferred there for “emergency surgery.” Seven patients (0.9%) died during or within 24 hours after PTCA; none of these were successfullytransported to the operating room for emergency bypass grafting. Major complications affected 5 patients (4.6%), including 2.1% with myocardial infarction. At first glance, these results appear acceptablewhen compared with those from centers with on-site surgical facilities, and the low emergency surgery rate of 1.6% for procedures performed from 1981 to 1991 even appears commendable compared with other large series (National Heart, Lung, and Blood Institute Registry, 1985-1986, 3.5%2;Emory University, 4.8%3;and Cleveland Clinic, 2.9%4).However, closer scrutiny of the series produces several points of concern. Of critical importance when considering the results of PTCA without on-site surgical backup is whether patients have timely accessto surgical support. Although there are no controlled data to prove that emergency surgery after unsuccessful PTCA improves survival, prevents myocardial infarction, salvagesischemic myocardium or improves functional capacity over medical therapy, good early and long-term results obtained with emergency bypass surgery have been well-documented.s.5Randomized studies have not been initiated becausethe consensusof clinical opinion is that emergency surgery is effective for ischemia after unsuccessful PTCA. This view is substantiated by the Subcommittee on Coronary Angioplasty of the American College of Cardiology/American Heart Association (ACC/ From the Department of Thoracic and Cardiovascular Surgery, and the Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio. Manuscript received August 7, 1992, and accepted August 8. Address for reprints: Floyd D. Loop, MD, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195.
1606
THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 70
AHA), which concluded that an on-site cardiovascular surgical team should be a prerequisite for coronary angioplasty.6 Since several new technologies to treat abrupt closure with PTCA becameavailable (coronary stents,7directional coronary atherectomy,8 laser balloon angioplasty9 and perfusion balloonslo), emergency surgery rates of
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