19. Serruys PW, Guilliere Y, Bertrand M. Additional improvementof stenosis geometry in human coronary arteries by stenting after balloon dilatation. Afi J Cardiol 1988;61:7-16. 20. S&wart V, Kaufmann J, Goy JJ, KappenbergerL. Suppressionof residual transtenotic pressure gradient after PTCA by implantation of self-expanding stents. Circulation 1987;76:IV-186. 21. Fishell TA, Derby G, Tse TM, Stadius ML. Coronary artery vasoconstriction routinely occurs after PTCA: a quantitative arteriographic analysis. Circulation 1988;78:1323-1334. 22. Sigwart V, Urban P, Golf S, Kaufmann U, Imbert C, Fischer A, Kappenberger L. Emergencystentingfor acuteocclusionafter balloon angioplasty.Circulation 1988;78:1121-1127. 23. Roubin GS, King SB III, DouglasJS. Intracoronary stentingdaring percutaneous transluminal coronary angioplasty. Circulation 1990;81:IV-92-IV-100. 24. Vetter JW, SimpsonYB, RobertsonGC, SelmonMR, Rowe MH, Bartzokis TC, Braden LJ, Hinohara T. Review directional coronary atherectomy for failed
balloon angioplasty (abstr). J Am CONCardiol 1991;17:384A. 25. Muller DWM, Ellis SG, Dehowe DL, Topol GJ. Quantitative angiographic compensationof the immediatesuccessof coronary angioplasty,coronary atherectomy and endoluminal stenting. Am J Cardiol 1990;66:938-942. 26. Rowe MH, Hinohara T, White NW, RobertsonGC, Selmon MR, Simpson JB. Comparisonof dissectionnotesand angiographicresultsfollowing directional coronary atherectomy and coronary angioplasty. Am J Cardiol 1990;66:49-53. 27. Teirstein PS. Stent and restenosis:do coronary stentspresent restenosis?J Itwas Cardiol 1991;3:67B-71B. 28. Hirshfeld JW, Schwartz JS, Jugo R, MacDonald RG, Goldberg S, Savage MP, BassTA, Vetrovec G, Cowley M, TaussigAS, Whitworth HB, Margolis JR, Hill JA, PepineCJ, Hill JA. Restenosisafter coronary angioplasty:a multivariety statistical model to relate lesion and procedure variables with restenosis.J .4m Coil Cardiol 1991;18:647-656. 29. Macander PJ, Agrawa SK, Roubm GS. The Gianturco-Roubin balloonexpandableintracoronary flexible coil stent. J has Cardiol 1991;3:85-94.
Inappropriate Terminology in Publications Concerning Aortic Balloon Valvuloplasty Francis Robicsek, MD risks (see “contraindicated”). Frequently, the reader turns a few pages,examinesthe tables and charts carefully, and finds to his/her consternation that “non-surgical” simply implies that the patients (for various reasons) have not undergone surgery! These reasonsmay include not only true contraindications, but also higher than usual (but certainly not prohibitive) operative risks and patients who are not high surgical risks at all, but do not undergo surgery for other reasonssuch as mental debilitation and refusal for religious or personalreasons. In some cases,such as the Harvard experience of 1’70 patients with aortic balloon valvuloplasty,’ the share of patients included in the “non-surgical” group for the sole reason of refusal was >32%! To label such a group “non-surgical” is misleading. In the protocol of the recent Mansfield Scientific Balloon Valvuloplasty Registry (Mansfield Scientific Incorporated, Mansfield, Massachusetts), the term “non-surgical” was defined as: “Patients with high risk for valve replacementor patients who have refused surgery.” Reading this, one may expect that the processIof determining who is “high risk” for valve replacement and should therefore not undergo surgery is a complex one in which the surgeon did indeed participate. However, in the Mansfield study, only “thirty-one percent of the total group had been formally denied surgical valve replacementas documentedin writing by the consulting cardiovascular surgeon.“2 In other words, in the lion’s share of cases,declaring the patient unfit for surgery was done without surgical consultation. Also, regarding patients who would have been candidates for surgery but refused, one would expect that a surgeon had been given the chance to discussthe matter with the patient, but again, this did not materialize in most cases. The controversial expression“high risk” for surgery, From the Heineman Medical ResearchLaboratory and the Carolinas per se, is not very informative. In the complex setting of Heart Institute at the Carolinas Medical Center, Charlotte, North clinical medicine one needs to know not only that the Carolina. Manuscript received July 16, 1991; revised manuscript rerisk of a procedure is “high,” but also how ‘this risk ceived and acceptedNovember 7,199l. Address for reprints: Francis Robicsek, MD, Heineman Medical compareswith the natural course of the disease,as well ResearchCenter, P.O. Box 35457,Charlotte, North Carolina 28235. as the alternative treatment modalities. Currently, in an
I
t has been customary to refer to patients in need of surgical treatment, but in whom the extent of disease or associatedconditions, or both, would have made operative intervention futile or risky beyond expected benefits as “inoperable.” Inoperable (literally translated as “non-operable”) is an inappropriate term. Anybody can be operated on, even those who should not be. Although it is still usedin everyday medical jargon, in professional writing it has been largely replaced by more proper terms such as “contraindicated” (i.e., although technically feasible, by someprofessionalcriteria it should not be performed) or “relatively contraindicated,” which implies the presence of factors constituting either an unreasonablehazard to health or life, or a situation that would make intervention unlikely to succeed.The term “absolute contraindication” is usually applied to a scenario in which these factors reach prohibitive severity. “Non-indicated” simply implies that the patient may be managed more effciently by other than surgical means. In recent times, a new term becamecommonplacein professionalwriting: “non-surgical.” This word has been used repeatedly to describecohorts of patients who have undergone balloon valvuloplasty for calcified aortic stenosis. Surgeons seldom use the word “non-surgical,” and it seemsthat only “non-surgeons” appreciate what is “non-surgical” and use the term in such a way that its meaning seemsto change from study to study, even if the term comes from the pen of the same author. An average reader of medical publications is likely to interpret the term “non-surgical” (sometimesalso referred to as “non-operative”) as a category of patients who after careful evaluation were found to be unsuitable for surgical intervention owing to prohibitively high
EDITORIALS
689
average cardiac surgical establishment, the in-hospital mortality rate for aortic valve replacement is approximately 4 to 5%. The rate in octogenariansmay increase to 8 to 15%.In the latter group, those with very significant additional risk factors may have rates as high as 20 to 25%. However, if thesepatients survive surgery, there is an 89% five-year survival rate among them, and they can expect to have good hemodynamic and clinical re suits. Thus, the operative risk may be judged “high,” but it also seemsto be “reasonable.” The procedural risk of aortic balloon valvuloplasty in this group may be lower than that of surgery, but it will yield unacceptably poor late results. Thus, it would be more appropriate to categorize the patient as to whether the risk is “unreasonably high,” instead of just saying “high risk.” It is also difficult to understand the processby which this risk is being determined. Naturally, in extreme caseseveryonecan agreethat the risk may be unreasonably high. However, in the greyer areas, a single cardiologist’sjudgment may not necessarilybe enough. Especially in scientific trials (where merits of surgical and nonsurgical methods are compared), the input of an experienced cardiac surgeonwould be most appropriate to avoid the appearanceof professional bias. To illustrate how offhand such a judgment can be, one should read the 2 interesting consecutivepapers of the Harvard group. In the pages of the New England Journal of Medicine (July 21, 1988), case histories were reported of 170 patients in whom balloon valvuloplasty was attempted. “115 patients (68%) were considered poor candidates for cardiac surgery with an estimated perioperative mortality risk of more than 15%.” “ 55 patients (32%), including 26 patients over the age of 80, refused surgery.” Of the 170 patients, 6 died in the hospital and 25 died within 6 months. The “event-free” survival (no death, repeat valvuloplasty or surgery) at 1 year was only 50%.’ The same patient pool was presented a year and a half later, with the cardiac surgeon as the primary author. Forty-five of 179 (25%) postpercutaneousaortic valvuloplasty patients (presumably the most serious cases) subsequently underwent aortic valve replacement. Of these 45 patients, 15 initially had balloon valvuloplasty as a preference,and 30 did not undergo surgery, becauseof “estimated excessiveoperative mortality.” In spite of the estimated “high-risk” status of these patients, valve replacement yielded only 4 surgical deaths. Three additional patients died within a year after surgery,3 results not different from what one may expect in a regular cohort of elderly patients undergoing aortic valve replacement. In our institution, 3 patients previously judged unsuitable -for surgery underwent emergencyor urgent valve replacementafter unsuccessful aortic balloon valvuloplasty. There was no mortality, and all 3 patients are doing well 1, 1.5 and 2 years, respectively, after aortic valve replacement. Similar experiences have been reported by other investigators. Reference to this has also been made by McKay4 reporting on the recent Mansfield Scientific Aortic Valvuloplasty trial: “Left ventricular perforation, acute valvular insufficiency and severe vascular trauma are all complications that may respond successfullyto surgical 690
THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 69
intervention, even in extremely high risk patients.” I guessthat is 1 way to make “non-surgical” patients suddenly “surgical.” This situation also brings up a poignant question. Is the clinician obliged to perform a second-rate, often worthless but high-risk procedure if the patient refuses an optimal treatment modality? Or should he evenoffer a definitely inferior treatment as an “alternative” for the patient who is expectedto fare much better with a different approach? Recommendations: (1) The word “non-surgical” should not be usedin scientific publications, but according to the situation, should be replaced by terms such as “nonoperated” (those who did not undergo surgery for various reasons), “refused surgery” (those who were surgical candidates, but preferred other forms of treatment), and “surgery thought to be contraindicated” (the physician in charge of the case did not recommend surgery, because the risk of the operation was thought to be prohibitively high, or the expectedbenefit prohibitively low). To the aforementioned I add my own personal plea-the ridiculous term “non-survivor” should be replaced by a very good Anglo-Saxon word: “dead” (see Webster Unabridged Dictionary, New York: World Publishing Company, 1964). (2) In scientific publications, the reason a patient was regarded as “high risk” should be explained in detail. Was there an estimatedunacceptably high percentage of mortality or morbidity (how high?), and what was the projected risk of (a) not doing anything or (b) using an alternative therapy such as conservativemedical treatment or surgery? (3) The “processof refusal” by the patient should be formalized, and when it refers to a surgical procedure that is judged to be the optimal treatment for that particular case, this fact should be emphasizedto the patient in a very explicit way. The patient who refusesthe preferred surgical treatment modality should be counselled by both a cardiologist and a cardiac surgeon.Unusually high numbers of refusalsin the sameinstitutional setting should be explained. As to aortic balloon valvuloplasty, there is now ample evidence that indicates low yield and poor late results. This procedureshould not be offered as an acceptable treatment modality, but should be reserved for a small group of severely symptomatic patients in whom the carefully consideredsurgical risk is not only high or even very high, but is judged totally unacceptableby a careful multidisciplinary evaluation.
REFERENCES
1. Safian RD, Berman AD, Diver DJ, McKay L, Come PC, Riley MF, Warren SE, Cunningham MJ, Wyman RM, Weinstein JS. Balloon valvuloplasty in 170 consecutive patients. N Engl J Med 1988;319:125-130. 2. O’Neill WW, for the Mansfield Scientific Aortic Valvuloplasty Registry Investigators. Predictors of long-term survival after percutaneous aortic valvuloplasty. Report of the Mansfield Scientific Balloon Valvuloplasty Registry. J Am CON Cardiol 1991;17:193-198. 3. Johnson RG, Dhillon JS, Thurer RL, Safian RD, Weintraub RM. Aortic valve operation following percutaneous balloon aortic valvuloplasty. Ann Thorac Surg 1990;49:740-743. 4. McKay RG, for the Mansfield Scientific Aortic Valvuloplasty Registry Investigators. Overview of acute hemodynamic results and procedural complications. J Am CON Cardiol 1991;17:485-491.
MARCH 1, 1992
balloon angioplasty (abstr). J Am CONCardiol 1991;17:384A. 25. Muller DWM, Ellis SG, Dehowe DL, Topol GJ. Quantitative angiographic compensationof the immediatesuccessof coronary angioplasty,coronary atherectomy and endoluminal stenting. Am J Cardiol 1990;66:938-942. 26. Rowe MH, Hinohara T, White NW, RobertsonGC, Selmon MR, Simpson JB. Comparisonof dissectionnotesand angiographicresultsfollowing directional coronary atherectomy and coronary angioplasty. Am J Cardiol 1990;66:49-53. 27. Teirstein PS. Stent and restenosis:do coronary stentspresent restenosis?J Itwas Cardiol 1991;3:67B-71B. 28. Hirshfeld JW, Schwartz JS, Jugo R, MacDonald RG, Goldberg S, Savage MP, BassTA, Vetrovec G, Cowley M, TaussigAS, Whitworth HB, Margolis JR, Hill JA, PepineCJ, Hill JA. Restenosisafter coronary angioplasty:a multivariety statistical model to relate lesion and procedure variables with restenosis.J .4m Coil Cardiol 1991;18:647-656. 29. Macander PJ, Agrawa SK, Roubm GS. The Gianturco-Roubin balloonexpandableintracoronary flexible coil stent. J has Cardiol 1991;3:85-94.
Inappropriate Terminology in Publications Concerning Aortic Balloon Valvuloplasty Francis Robicsek, MD risks (see “contraindicated”). Frequently, the reader turns a few pages,examinesthe tables and charts carefully, and finds to his/her consternation that “non-surgical” simply implies that the patients (for various reasons) have not undergone surgery! These reasonsmay include not only true contraindications, but also higher than usual (but certainly not prohibitive) operative risks and patients who are not high surgical risks at all, but do not undergo surgery for other reasonssuch as mental debilitation and refusal for religious or personalreasons. In some cases,such as the Harvard experience of 1’70 patients with aortic balloon valvuloplasty,’ the share of patients included in the “non-surgical” group for the sole reason of refusal was >32%! To label such a group “non-surgical” is misleading. In the protocol of the recent Mansfield Scientific Balloon Valvuloplasty Registry (Mansfield Scientific Incorporated, Mansfield, Massachusetts), the term “non-surgical” was defined as: “Patients with high risk for valve replacementor patients who have refused surgery.” Reading this, one may expect that the processIof determining who is “high risk” for valve replacement and should therefore not undergo surgery is a complex one in which the surgeon did indeed participate. However, in the Mansfield study, only “thirty-one percent of the total group had been formally denied surgical valve replacementas documentedin writing by the consulting cardiovascular surgeon.“2 In other words, in the lion’s share of cases,declaring the patient unfit for surgery was done without surgical consultation. Also, regarding patients who would have been candidates for surgery but refused, one would expect that a surgeon had been given the chance to discussthe matter with the patient, but again, this did not materialize in most cases. The controversial expression“high risk” for surgery, From the Heineman Medical ResearchLaboratory and the Carolinas per se, is not very informative. In the complex setting of Heart Institute at the Carolinas Medical Center, Charlotte, North clinical medicine one needs to know not only that the Carolina. Manuscript received July 16, 1991; revised manuscript rerisk of a procedure is “high,” but also how ‘this risk ceived and acceptedNovember 7,199l. Address for reprints: Francis Robicsek, MD, Heineman Medical compareswith the natural course of the disease,as well ResearchCenter, P.O. Box 35457,Charlotte, North Carolina 28235. as the alternative treatment modalities. Currently, in an
I
t has been customary to refer to patients in need of surgical treatment, but in whom the extent of disease or associatedconditions, or both, would have made operative intervention futile or risky beyond expected benefits as “inoperable.” Inoperable (literally translated as “non-operable”) is an inappropriate term. Anybody can be operated on, even those who should not be. Although it is still usedin everyday medical jargon, in professional writing it has been largely replaced by more proper terms such as “contraindicated” (i.e., although technically feasible, by someprofessionalcriteria it should not be performed) or “relatively contraindicated,” which implies the presence of factors constituting either an unreasonablehazard to health or life, or a situation that would make intervention unlikely to succeed.The term “absolute contraindication” is usually applied to a scenario in which these factors reach prohibitive severity. “Non-indicated” simply implies that the patient may be managed more effciently by other than surgical means. In recent times, a new term becamecommonplacein professionalwriting: “non-surgical.” This word has been used repeatedly to describecohorts of patients who have undergone balloon valvuloplasty for calcified aortic stenosis. Surgeons seldom use the word “non-surgical,” and it seemsthat only “non-surgeons” appreciate what is “non-surgical” and use the term in such a way that its meaning seemsto change from study to study, even if the term comes from the pen of the same author. An average reader of medical publications is likely to interpret the term “non-surgical” (sometimesalso referred to as “non-operative”) as a category of patients who after careful evaluation were found to be unsuitable for surgical intervention owing to prohibitively high
EDITORIALS
689
average cardiac surgical establishment, the in-hospital mortality rate for aortic valve replacement is approximately 4 to 5%. The rate in octogenariansmay increase to 8 to 15%.In the latter group, those with very significant additional risk factors may have rates as high as 20 to 25%. However, if thesepatients survive surgery, there is an 89% five-year survival rate among them, and they can expect to have good hemodynamic and clinical re suits. Thus, the operative risk may be judged “high,” but it also seemsto be “reasonable.” The procedural risk of aortic balloon valvuloplasty in this group may be lower than that of surgery, but it will yield unacceptably poor late results. Thus, it would be more appropriate to categorize the patient as to whether the risk is “unreasonably high,” instead of just saying “high risk.” It is also difficult to understand the processby which this risk is being determined. Naturally, in extreme caseseveryonecan agreethat the risk may be unreasonably high. However, in the greyer areas, a single cardiologist’sjudgment may not necessarilybe enough. Especially in scientific trials (where merits of surgical and nonsurgical methods are compared), the input of an experienced cardiac surgeonwould be most appropriate to avoid the appearanceof professional bias. To illustrate how offhand such a judgment can be, one should read the 2 interesting consecutivepapers of the Harvard group. In the pages of the New England Journal of Medicine (July 21, 1988), case histories were reported of 170 patients in whom balloon valvuloplasty was attempted. “115 patients (68%) were considered poor candidates for cardiac surgery with an estimated perioperative mortality risk of more than 15%.” “ 55 patients (32%), including 26 patients over the age of 80, refused surgery.” Of the 170 patients, 6 died in the hospital and 25 died within 6 months. The “event-free” survival (no death, repeat valvuloplasty or surgery) at 1 year was only 50%.’ The same patient pool was presented a year and a half later, with the cardiac surgeon as the primary author. Forty-five of 179 (25%) postpercutaneousaortic valvuloplasty patients (presumably the most serious cases) subsequently underwent aortic valve replacement. Of these 45 patients, 15 initially had balloon valvuloplasty as a preference,and 30 did not undergo surgery, becauseof “estimated excessiveoperative mortality.” In spite of the estimated “high-risk” status of these patients, valve replacement yielded only 4 surgical deaths. Three additional patients died within a year after surgery,3 results not different from what one may expect in a regular cohort of elderly patients undergoing aortic valve replacement. In our institution, 3 patients previously judged unsuitable -for surgery underwent emergencyor urgent valve replacementafter unsuccessful aortic balloon valvuloplasty. There was no mortality, and all 3 patients are doing well 1, 1.5 and 2 years, respectively, after aortic valve replacement. Similar experiences have been reported by other investigators. Reference to this has also been made by McKay4 reporting on the recent Mansfield Scientific Aortic Valvuloplasty trial: “Left ventricular perforation, acute valvular insufficiency and severe vascular trauma are all complications that may respond successfullyto surgical 690
THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 69
intervention, even in extremely high risk patients.” I guessthat is 1 way to make “non-surgical” patients suddenly “surgical.” This situation also brings up a poignant question. Is the clinician obliged to perform a second-rate, often worthless but high-risk procedure if the patient refuses an optimal treatment modality? Or should he evenoffer a definitely inferior treatment as an “alternative” for the patient who is expectedto fare much better with a different approach? Recommendations: (1) The word “non-surgical” should not be usedin scientific publications, but according to the situation, should be replaced by terms such as “nonoperated” (those who did not undergo surgery for various reasons), “refused surgery” (those who were surgical candidates, but preferred other forms of treatment), and “surgery thought to be contraindicated” (the physician in charge of the case did not recommend surgery, because the risk of the operation was thought to be prohibitively high, or the expectedbenefit prohibitively low). To the aforementioned I add my own personal plea-the ridiculous term “non-survivor” should be replaced by a very good Anglo-Saxon word: “dead” (see Webster Unabridged Dictionary, New York: World Publishing Company, 1964). (2) In scientific publications, the reason a patient was regarded as “high risk” should be explained in detail. Was there an estimatedunacceptably high percentage of mortality or morbidity (how high?), and what was the projected risk of (a) not doing anything or (b) using an alternative therapy such as conservativemedical treatment or surgery? (3) The “processof refusal” by the patient should be formalized, and when it refers to a surgical procedure that is judged to be the optimal treatment for that particular case, this fact should be emphasizedto the patient in a very explicit way. The patient who refusesthe preferred surgical treatment modality should be counselled by both a cardiologist and a cardiac surgeon.Unusually high numbers of refusalsin the sameinstitutional setting should be explained. As to aortic balloon valvuloplasty, there is now ample evidence that indicates low yield and poor late results. This procedureshould not be offered as an acceptable treatment modality, but should be reserved for a small group of severely symptomatic patients in whom the carefully consideredsurgical risk is not only high or even very high, but is judged totally unacceptableby a careful multidisciplinary evaluation.
REFERENCES
1. Safian RD, Berman AD, Diver DJ, McKay L, Come PC, Riley MF, Warren SE, Cunningham MJ, Wyman RM, Weinstein JS. Balloon valvuloplasty in 170 consecutive patients. N Engl J Med 1988;319:125-130. 2. O’Neill WW, for the Mansfield Scientific Aortic Valvuloplasty Registry Investigators. Predictors of long-term survival after percutaneous aortic valvuloplasty. Report of the Mansfield Scientific Balloon Valvuloplasty Registry. J Am CON Cardiol 1991;17:193-198. 3. Johnson RG, Dhillon JS, Thurer RL, Safian RD, Weintraub RM. Aortic valve operation following percutaneous balloon aortic valvuloplasty. Ann Thorac Surg 1990;49:740-743. 4. McKay RG, for the Mansfield Scientific Aortic Valvuloplasty Registry Investigators. Overview of acute hemodynamic results and procedural complications. J Am CON Cardiol 1991;17:485-491.
MARCH 1, 1992
