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Disappearance of septal q waves following percutaneous transluminal septal myocardial ablation for obstructive hypertrophic cardiomyopathy
TABLE 1 Reported Diabetics in the ESPRIT Study No. of Reported Diabetics
Study Labinaz et al The ESPRIT Investigators2 O’Shea et al3 Tcheng4 O’Shea et al5 1
466 419 419 419 467
tion the validity of the data from this study, and hence its conclusions. Jeffrey S. Riesmeyer ,
MD
Philip R. Reid,
MD
Debra L. Miller, RN Indianapolis, Indiana 17 September 2002 1. Labinaz M, Madan M, O’Shea JC, Kilaru R, Chin W, Pieper K, McGuire DK, Saucedo JF, Talley JD, Lui H, Kitt MM, Califf RM, Tcheng JE, for the ESPRIT Investigators. Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] trial). Am J Cardiol 2002; 90:585–590. 2. The ESPRIT Investigators. Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomized, placebo-controlled trial. Lancet 2000;356:2037–2044. 3. O’Shea JC, Hafley GE, Greenberg S, Hasselblad V, Lorenz TJ, Kitt MM, Strony J, Tcheng JE. Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention. The ESPRIT trial: a randomized controlled trial. JAMA 2001;285: 2468 –2473. 4. Tcheng JE. ESPRIT: interpretations and implications of the 6-month data. Available at: http://www. dev.cybersessions.com/conference. Accessed September 13, 2002. 5. O’Shea JC, Buller CE, Cantor WJ, Chandler AB, Cohen EA, Cohen DJ, Gilchrist IC, Kleiman NS, Labinaz M, Madan M, et al. Long-term efficacy of platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention. JAMA 2002;287:618 –621.
doi:10.1016/S0002-9149(02)03291-5
Reply: We appreciate the interest of Dr. Riesmeyer and his colleagues in our article that examined 1-year outcomes of patients with diabetes mellitus enrolled in the ESPRIT trial (Am J Cardiol 2002; 90:585–590). We are pleased to provide an explanation for the discrepancies in the number of reported patients with diabetes. In publications that focused on shortterm outcomes (references 2– 4) diabetic status was determined by data provided on the ESPRIT trial
case report form. By definition, treatment with either an oral hypoglycemic agent or insulin was required to qualify a patient as having diabetes. Using this definition, 419 patients with medically treated diabetes were identified in the primary analyses of the ESPRIT trial. The numbers presented in these 3 publications have been checked and are valid. When performing the 1-year diabetes follow-up study, we took the opportunity to obtain greater detail on diabetic types. If the ESPRIT database indicated that a patient did not have diabetes, the site was then asked to specify if this was “no” diabetes or “diet-controlled” diabetes. If the ESPRIT database indicated that a patient had diabetes, the site was then asked to specify whether the patient was being treated with insulin. Discrepancies between the follow-up survey and the initial case report form data were found in 13 patients from the total study. In all 13 cases, the site was contacted to confirm the correct diagnosis. Five patients with insulin-dependent-diabetics had been misclassified as nondiabetic patients. Four nondiabetic patients had been misclassified as being patients with medically treated diabetes. Four patients with diet-controlled diabetes had been classified as being medically treated. In addition, the diabetes type was not available for 1 patient who had been classified as medically treated. The main difference was in the additional 47 patients who were diet-controlled. These patients were not included on the original form because they were not being medically treated during the initial survey; however, they have been included in the 1-year report after the reclassification. All analyses were then subsequently performed using these 466 patients, including a recalculation of the 30-day and 6-month outcomes. The difference between the 467 patients from reference 5 and 466 from reference 1 was the 1 patient described above for whom diabetes type was not available. We hope that we have adequately addressed the discrepancies raised by Riesmeyer and
colleagues, and we believe that our conclusions remain valid. Marino Labinaz,
MD
James E. Tcheng,
MD
Karen Pieper,
MSc
Gail Hafley,
MSc
Conor O’Shea, MD Ottawa, Ontario, Canada and Durham, North Carolina 11 October 2002 doi:10.1016/S0002-9149(02)03292-7
Disappearance of Septal Q Waves Following Percutaneous Transluminal Septal Myocardial Ablation for Obstructive Hypertrophic Cardiomyopathy
I read with great interest the recent report on electrocardiographic (ECG) findings after percutaneous transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive cardiomyopathy.1 The observation that there was a significant number of patients (15 of 53) who lost their baseline Q waves after PTSMA was of particular interest to me. This was the first report, to my knowledge, of such an ECG finding in association with PTSMA. Pure septal infarction due to natural isolated occlusion of the septal branch of the left anterior descending coronary artery is extremely rare.2 Theoretically, the characteristic ECG feature of a pure septal infarct should be the disappearance of a normal septal Q wave.3,4 PTSMA provides an ideal situation in which this hypothesis can be tested. The fact that this has never been reported in any of the published series (of which there have been many) until this article suggests that in most patients, PTSMA does not result in a myocardial infarct that involves only the interventricular septum. In contrast, new Q waves were observed after PTSMA in all the reported series, indicating that the iatrogenic myocardial infarct after PTSMA was more extensive than a pure septal infarct. Tsung O. Cheng, MD Washington, DC 20 November 2002 1. Runquist LH, Nielsen CD, Killip D, Gazes P,
READERS’ COMMENTS
515
Spencer WH III. Electrocardiographic findings after alcohol septal ablation therapy for obstructive hypertrophic cardiomyopathy. Am J Cardiol 2002; 90:1020 –1022. 2. Nagano S, Miyahara K, Sohara H, Tanaka Y,
Arima T. Angina pectoris or myocardial infarction? J Cardiol 2002;39:277–280. 3. Levy L II, Hyman AL. Difficulties in the electrocardiographic diagnosis of myocardial infarction. Am Heart J 1950;39:243–262.
516 THE AMERICAN JOURNAL OF CARDIOLOGY姞
VOL. 91
FEBRUARY 15, 2003
4. Cheng TO. Diagnostic, prognostic and therapeutic significance of disappearance of Q waves in the electrocardiogram. J Cardiol 2002;20:83.
doi:10.1016/S0002-9149(02)03293-9
Study Labinaz et al The ESPRIT Investigators2 O’Shea et al3 Tcheng4 O’Shea et al5 1
466 419 419 419 467
tion the validity of the data from this study, and hence its conclusions. Jeffrey S. Riesmeyer ,
MD
Philip R. Reid,
MD
Debra L. Miller, RN Indianapolis, Indiana 17 September 2002 1. Labinaz M, Madan M, O’Shea JC, Kilaru R, Chin W, Pieper K, McGuire DK, Saucedo JF, Talley JD, Lui H, Kitt MM, Califf RM, Tcheng JE, for the ESPRIT Investigators. Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] trial). Am J Cardiol 2002; 90:585–590. 2. The ESPRIT Investigators. Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomized, placebo-controlled trial. Lancet 2000;356:2037–2044. 3. O’Shea JC, Hafley GE, Greenberg S, Hasselblad V, Lorenz TJ, Kitt MM, Strony J, Tcheng JE. Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention. The ESPRIT trial: a randomized controlled trial. JAMA 2001;285: 2468 –2473. 4. Tcheng JE. ESPRIT: interpretations and implications of the 6-month data. Available at: http://www. dev.cybersessions.com/conference. Accessed September 13, 2002. 5. O’Shea JC, Buller CE, Cantor WJ, Chandler AB, Cohen EA, Cohen DJ, Gilchrist IC, Kleiman NS, Labinaz M, Madan M, et al. Long-term efficacy of platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention. JAMA 2002;287:618 –621.
doi:10.1016/S0002-9149(02)03291-5
Reply: We appreciate the interest of Dr. Riesmeyer and his colleagues in our article that examined 1-year outcomes of patients with diabetes mellitus enrolled in the ESPRIT trial (Am J Cardiol 2002; 90:585–590). We are pleased to provide an explanation for the discrepancies in the number of reported patients with diabetes. In publications that focused on shortterm outcomes (references 2– 4) diabetic status was determined by data provided on the ESPRIT trial
case report form. By definition, treatment with either an oral hypoglycemic agent or insulin was required to qualify a patient as having diabetes. Using this definition, 419 patients with medically treated diabetes were identified in the primary analyses of the ESPRIT trial. The numbers presented in these 3 publications have been checked and are valid. When performing the 1-year diabetes follow-up study, we took the opportunity to obtain greater detail on diabetic types. If the ESPRIT database indicated that a patient did not have diabetes, the site was then asked to specify if this was “no” diabetes or “diet-controlled” diabetes. If the ESPRIT database indicated that a patient had diabetes, the site was then asked to specify whether the patient was being treated with insulin. Discrepancies between the follow-up survey and the initial case report form data were found in 13 patients from the total study. In all 13 cases, the site was contacted to confirm the correct diagnosis. Five patients with insulin-dependent-diabetics had been misclassified as nondiabetic patients. Four nondiabetic patients had been misclassified as being patients with medically treated diabetes. Four patients with diet-controlled diabetes had been classified as being medically treated. In addition, the diabetes type was not available for 1 patient who had been classified as medically treated. The main difference was in the additional 47 patients who were diet-controlled. These patients were not included on the original form because they were not being medically treated during the initial survey; however, they have been included in the 1-year report after the reclassification. All analyses were then subsequently performed using these 466 patients, including a recalculation of the 30-day and 6-month outcomes. The difference between the 467 patients from reference 5 and 466 from reference 1 was the 1 patient described above for whom diabetes type was not available. We hope that we have adequately addressed the discrepancies raised by Riesmeyer and
colleagues, and we believe that our conclusions remain valid. Marino Labinaz,
MD
James E. Tcheng,
MD
Karen Pieper,
MSc
Gail Hafley,
MSc
Conor O’Shea, MD Ottawa, Ontario, Canada and Durham, North Carolina 11 October 2002 doi:10.1016/S0002-9149(02)03292-7
Disappearance of Septal Q Waves Following Percutaneous Transluminal Septal Myocardial Ablation for Obstructive Hypertrophic Cardiomyopathy
I read with great interest the recent report on electrocardiographic (ECG) findings after percutaneous transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive cardiomyopathy.1 The observation that there was a significant number of patients (15 of 53) who lost their baseline Q waves after PTSMA was of particular interest to me. This was the first report, to my knowledge, of such an ECG finding in association with PTSMA. Pure septal infarction due to natural isolated occlusion of the septal branch of the left anterior descending coronary artery is extremely rare.2 Theoretically, the characteristic ECG feature of a pure septal infarct should be the disappearance of a normal septal Q wave.3,4 PTSMA provides an ideal situation in which this hypothesis can be tested. The fact that this has never been reported in any of the published series (of which there have been many) until this article suggests that in most patients, PTSMA does not result in a myocardial infarct that involves only the interventricular septum. In contrast, new Q waves were observed after PTSMA in all the reported series, indicating that the iatrogenic myocardial infarct after PTSMA was more extensive than a pure septal infarct. Tsung O. Cheng, MD Washington, DC 20 November 2002 1. Runquist LH, Nielsen CD, Killip D, Gazes P,
READERS’ COMMENTS
515
Spencer WH III. Electrocardiographic findings after alcohol septal ablation therapy for obstructive hypertrophic cardiomyopathy. Am J Cardiol 2002; 90:1020 –1022. 2. Nagano S, Miyahara K, Sohara H, Tanaka Y,
Arima T. Angina pectoris or myocardial infarction? J Cardiol 2002;39:277–280. 3. Levy L II, Hyman AL. Difficulties in the electrocardiographic diagnosis of myocardial infarction. Am Heart J 1950;39:243–262.
516 THE AMERICAN JOURNAL OF CARDIOLOGY姞
VOL. 91
FEBRUARY 15, 2003
4. Cheng TO. Diagnostic, prognostic and therapeutic significance of disappearance of Q waves in the electrocardiogram. J Cardiol 2002;20:83.
doi:10.1016/S0002-9149(02)03293-9