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Prevention of Recurrent Pulmonary Embolism
En~d J Med 1986; 314:285-90 2 Kahn KL, Kosecoff J, Chassin MR, Solomon DR, Brook RH. The use and misuse of upper ~astrointestinal endosl'opy. Ann Intern Med 1988; 109:644-70 3 E~dahl RH, Taft C. Financial inl-entives to physicians. N En~1 J Med 1986; 315;59-61 4 Sl'overn H. Hired help. A physician's experiences in a for-profit staff-model HMO. N En~1 J Med 1988; 319:787-90 5 Reiman AS. Salaried physicians and e(.'()nomk· ineentives. N En~1 J Med 1988; 319:784 6 Sowell T. A (.'()nfliet of vision, ideological origins of political stnlmes. New York: Quill William Morrow, 1987:19-23 7 Reiman AS. Dealin~ with l'()nflicts of interest. N En~1 J Med 1985; 313:749-51
Legal Issues in Cardiopulmonary Medicine To the Editor: Practicin~ cadiopulmonary physicians have numerous (.'()nl-erns. One major issue that has not been addressed by the ACCP is le~aI questions and l'()nCerns involvin~ professional liability. Alth()u~ there seems to be a widespread fee)jn~ amon~ our membership that somethin~ should be done about the medical malpractice dilemma, there are no data on which to make intelli~ent observations or sound re<..'()mmendations. For most doctors, the (.'()ncern seems to be a spiralling malpractice premium that increases almost yearly. Yet another concern is the expandin~ interpretation of tort liability by the courts of this nation. For example, a Ne\\r York court re<..-ently found a psychiatrist liable for having had sex with a fonner patient. I A very recent survey by the American College of Obstetricians and Gynecologists found that more than 70 percent ofall responding OB-GYN specialists had at least one lawsuit filed against them in their professional careers. Twenty-five percent had been sued three or more times.! Fifty-two percent involved obstetrics; 48 percent of the claims involved gyne<.'()logy with an average payout of $64,000. Many of these claims involved the failure to dia~ose simple early breast cancer. It is this author:4i impression that the majority of claims in cardiopulmonary medicineJsur~ery would arise from the f()nowin~: 1) interventional prol-edures that can only be described as ··Ie~ally risky behavior";3 2) ~isdia~nosed and mismanaf!;ed pulmonary emboli; 3) major cardiothoracic injuries during surgery; or 4) issues in lun~ cancer. But only reliable data could confirm or ne~ate this impression. It would also be useful to assess hy questionnaire the extent of the malpractice problem that affects cardiopulmonary physicians, and if in the area of o(.'Cupational lung disease there is equal compensation for equal disability, or whether the present tedious, time-<..'Onsuming, expensive, and unjust litif!;ation for occupational lunf!; disease should (,·ontinue. 4 A recent New York TImes article indicated that medical malpra<..'tice has be<..'()me a $4 billion industry and can have severe psycho-
New York Doctor, April, 1989 2 American College of Obstetricians and Gynecologists. Professionalliability and its affects: report of a 1987 survey of ACOG's membership. Washington, DC: ACOG, 1988 3 Robin ED. Medical care can he dangerous to your health: a guide to risks and benefits. New York: Harper and Row, 1986 4 Morgan WKC. In: Vevaina J, Bone R, Kassoff E, eds. Legal aspects of medicine. New York: Springe~ Verlag, 1989
Prevention of Recurrent Pulmonary Embolism To the Editor: In a recent paper we reported our experience with heparin therapy in patients with venous thromboembolism. I In our series, early recurrences were seen in seven of 38 patients (18.4 percent) with an original diagnosis of pulmonary embolism (PE), and in five of 83 patients (6 percent) with deep venous thrombosis (DVT) of lower limbs. Theoretically, higher doses of heparin would have decreased this recurrence rate, but also the risk ofbleedinR strongly correlates with the mean total daily dose of heparin. Several years a~o, Sullivan et all demonstrated that adding dipyridamole to warfarin in patients with mechanical valve prostheses may confer additional benefit without a higher bleeding rate. Since then, several authors recommend the combination of anticoa~lants and dipyridamole in preventing arterial thromboembolism.~s In order to investigate whether combined dipyridamole heparin therapy would be safe and effective, we perfonned a prospective, double-blind randomized study in patients with venous thromboembolism. The main objective was to detennine whether the risk of recurrence of PE associated with heparin therapy could be reduced, but without a ~eater risk of bleeding. Since January, 1988, 93 patients were diagnosed with acute venous thromboembolism in our hospital. Only those patients having an adequate course of heparin therapy were included; therefore 11 ofthese patients were not included (because ofclinically massive PE in three; recent intervention in three; thrombocytopenia in two; previous bleeding in two; hematoma in one patient). Additionally, another seven patients were excluded after randomization: four patients with PE because they refused venography, three because of technical reasons. A total of 75 patients entered into the study: 37 men and 38 women, aged 21 to 84 years, mean 63 y. A total of 14 patients had clinically apparent pulmonary embolism, and 61 patients had deep venous thrombosis on lower limbs. As in the previous study, all patients had objective tests to confinn the diagnosis (conventional ven~aphy and ventilation-perfusion lung scan, both baseline and ei~t days after therapy). In addition to heparin (also in the same
Table-Baeline Claaracteriaticl, and Baula ofdle Double-blind 1WtJl
lowe affects on the physician.
It is my opinion that a questionnaire on the leJtal aspects of medical practice would he most useful.
}ames R. \i?vaina, M.D., F.C.C.~, Division of Pulmonary and Critical Care Medicine, long Island Jewish-Hillside Medical Center, Albert Einstein College of Medicine, New Hyde Park, New York
REFERENCES 1 Judge finds psychiatrist liable for sex with a f()rmer patient. The
Heparin +
Heparin +
40
35
dipyridamole Baseline characteristics Patients, number with venous thrombosis with pulmonary embolism Age, years (mean ± SD) Results of the trial Recurrences of PE Bleeding complications
placebo
p value·
34 6
63±13
27 8 64±17
N.S.
4 (10%) 7 (17,5%)
2 (5,7~) 2 (5,7%)
N.S. N.S.
*Chi-squared test was used CHEST I 98 I 3 I SEPTEMBER, 1990
781
dosage), patients were assi~ed, according to a prescribed random.. ized arrangement, to treatment with either dipyridamole (100 mg PO with meals) or placebo. Patients, nurses., and attending physi· clans were all unaware of the treatment regimen for a particular patient. Patients were allocated by numbers from a randomized list. To each one corresponded a numbered box containing prophylaxis material for eight days. A sealed envelope system guaranteed that, in case of emergency, the type of prophylaxis could be checked without breaking the code for other patients. The study was approved by the Ethics Committee, and the patients were infonned and gave their oral consent to participate in the study. Bleeding complications during these eight days of treatment were recorded. Major bleedinK was de6ned as any unexplained decrease in hematocrit of more than 4 points, or bleeding that caused substantial morbidity or risk to life. Minor bleeding was defined as bleeding that did not require transfusion or other specific therapy and did not endanger life. Initially, the protocol was designed to study 150 consecutive patients, but given the high bleeding rate, we decided to open the randomization list after patient 75. Recurrences were seen in fOur of 40 patients (10 percent) taking dipyridamole plus heparin, in two of whom recurrent PE was accompanied by clinical symptoms (acute dyspnea and chest pain). The other two patients remained without symptoms, but new perfusion defects were seen on repeat lung scan. Similarly, new perfusion defects were seen in two of 35 patients (5.7 percent) taking heparin and placebo. As seen in the Table, differences between groups were not statistically significant. Acute bleeding developed during the study in seven patients (17.5 percent) taking heparin and dipyridamole, and in two of 35 patients (5.7 percent) taking only heparin. The site of bleeding was the gastroduodenal tract in four patients, genitourinary tract in four, and a gross hematoma in one. Blood loss was considered major bleeding in two patients taking dipyridamole and heparin, and in one patient on heparin and placebo. In our experience, not only was the recurrence rate increased, but also the number of bleeding complications was higher. Diff'er· ences are not statistically significant because of the small number of patients, but in view of these 6ndings we decided do not continue the study.
Manuel Monreal, M.D.; lUlU. 11..1%, M.D.; jordi Roig, M.D.;
Elena LAfoz, M.D.; Luillnaraja, M.D., Hospital de Badalona Germans '&itu i Pujol Barcelona, Spain
Pleural, Alveolar and Blood T-Iymphocyte Subsets In Pleuropulmonary sarcoidosis 7b the FAitor: In two patients with pleuropulmonary sarcoidosis, T·lymphocyte subsets have been evaluated in peripheral blood, bronchoalveolar lavage and pleural fluids. A non...smolcing man, 34 years of age, with no previous medical history, was referred to our hospital for right paratracheal and bilateral hilar lymph node enlargement and a right pleural effusion detected by routine chest roentgenogram. Usual biologic test results were normal. Serum angiotensin-converting enzyme activity was 135 fJ.mollminlml (n
Table 1- T - ~ Subteta* in Peripheral Blood, BAL Gnd Pleural Fluidt
REFERENCES 1 Monreal M, Ruiz J, Salvador R, Morera J, Arias A. Recurrent pulmonary embolism. A prospective study. Chest 1989; 95:97679 2 Sullivan JM, Harken DE, Corlin R. Pharmacologic control of thromboembolic complications of cardiac-valve replacement. N Eng) J Med 1971; 284:1391-94 3 Chesebro JU, Fuster ~ Elveback LR, Mc Goon DC, Pluth JR. Trial of combined warfarin plus dipyridamole or aspirin therapy in prosthetic heart valve replacement: danger ofaspirin compared with dipyridamole. Am J Cardioll983; 51:1537-41 4 Miller A, Lees RS. Simultaneous therapy with antiplatelet and anticoagulant drugs in symptomatic cardiovascular disease. Stroke 1985; 16:fi68...75 5 American College of Chest Physicians and the National Heart, Lung, and Blood Institute National Conference on Antithrombotic Therapy. Arch Intern Med 1986; 146:462-72
782
Peripheral blood
BAL8uid
Case 1 Case 2 Case 1 Case 2 Total cells (lmm3 ) Lymphocytes OKT4 0KT8 CD4:CD8 ratio
144
770 188 ~
0.9
1,067 181 427 0.4
65% 76% 12% 6
185
54% 78% 16% 4.9
Pleural 8uid Case 1 Case 2
I ,BOO 73% 61.5% 12.5% 5
330 72% 62% 18% 3.4
·SUrface phenotyping ofT·lymphocytes was determined by indirect immunoOuorescence microscopy usin~ CD4 and COB monoclonal antibodies (OKT4 plus OKT4 A and OKT8; Ortho DiaJ(llostics, Raritan, NJ). t Expressed in absolute numbers in peripheral blood and in per(:enta~e of lymphocytes in BAL and pleural fluid.
Legal Issues in Cardiopulmonary Medicine To the Editor: Practicin~ cadiopulmonary physicians have numerous (.'()nl-erns. One major issue that has not been addressed by the ACCP is le~aI questions and l'()nCerns involvin~ professional liability. Alth()u~ there seems to be a widespread fee)jn~ amon~ our membership that somethin~ should be done about the medical malpractice dilemma, there are no data on which to make intelli~ent observations or sound re<..'()mmendations. For most doctors, the (.'()ncern seems to be a spiralling malpractice premium that increases almost yearly. Yet another concern is the expandin~ interpretation of tort liability by the courts of this nation. For example, a Ne\\r York court re<..-ently found a psychiatrist liable for having had sex with a fonner patient. I A very recent survey by the American College of Obstetricians and Gynecologists found that more than 70 percent ofall responding OB-GYN specialists had at least one lawsuit filed against them in their professional careers. Twenty-five percent had been sued three or more times.! Fifty-two percent involved obstetrics; 48 percent of the claims involved gyne<.'()logy with an average payout of $64,000. Many of these claims involved the failure to dia~ose simple early breast cancer. It is this author:4i impression that the majority of claims in cardiopulmonary medicineJsur~ery would arise from the f()nowin~: 1) interventional prol-edures that can only be described as ··Ie~ally risky behavior";3 2) ~isdia~nosed and mismanaf!;ed pulmonary emboli; 3) major cardiothoracic injuries during surgery; or 4) issues in lun~ cancer. But only reliable data could confirm or ne~ate this impression. It would also be useful to assess hy questionnaire the extent of the malpractice problem that affects cardiopulmonary physicians, and if in the area of o(.'Cupational lung disease there is equal compensation for equal disability, or whether the present tedious, time-<..'Onsuming, expensive, and unjust litif!;ation for occupational lunf!; disease should (,·ontinue. 4 A recent New York TImes article indicated that medical malpra<..'tice has be<..'()me a $4 billion industry and can have severe psycho-
New York Doctor, April, 1989 2 American College of Obstetricians and Gynecologists. Professionalliability and its affects: report of a 1987 survey of ACOG's membership. Washington, DC: ACOG, 1988 3 Robin ED. Medical care can he dangerous to your health: a guide to risks and benefits. New York: Harper and Row, 1986 4 Morgan WKC. In: Vevaina J, Bone R, Kassoff E, eds. Legal aspects of medicine. New York: Springe~ Verlag, 1989
Prevention of Recurrent Pulmonary Embolism To the Editor: In a recent paper we reported our experience with heparin therapy in patients with venous thromboembolism. I In our series, early recurrences were seen in seven of 38 patients (18.4 percent) with an original diagnosis of pulmonary embolism (PE), and in five of 83 patients (6 percent) with deep venous thrombosis (DVT) of lower limbs. Theoretically, higher doses of heparin would have decreased this recurrence rate, but also the risk ofbleedinR strongly correlates with the mean total daily dose of heparin. Several years a~o, Sullivan et all demonstrated that adding dipyridamole to warfarin in patients with mechanical valve prostheses may confer additional benefit without a higher bleeding rate. Since then, several authors recommend the combination of anticoa~lants and dipyridamole in preventing arterial thromboembolism.~s In order to investigate whether combined dipyridamole heparin therapy would be safe and effective, we perfonned a prospective, double-blind randomized study in patients with venous thromboembolism. The main objective was to detennine whether the risk of recurrence of PE associated with heparin therapy could be reduced, but without a ~eater risk of bleeding. Since January, 1988, 93 patients were diagnosed with acute venous thromboembolism in our hospital. Only those patients having an adequate course of heparin therapy were included; therefore 11 ofthese patients were not included (because ofclinically massive PE in three; recent intervention in three; thrombocytopenia in two; previous bleeding in two; hematoma in one patient). Additionally, another seven patients were excluded after randomization: four patients with PE because they refused venography, three because of technical reasons. A total of 75 patients entered into the study: 37 men and 38 women, aged 21 to 84 years, mean 63 y. A total of 14 patients had clinically apparent pulmonary embolism, and 61 patients had deep venous thrombosis on lower limbs. As in the previous study, all patients had objective tests to confinn the diagnosis (conventional ven~aphy and ventilation-perfusion lung scan, both baseline and ei~t days after therapy). In addition to heparin (also in the same
Table-Baeline Claaracteriaticl, and Baula ofdle Double-blind 1WtJl
lowe affects on the physician.
It is my opinion that a questionnaire on the leJtal aspects of medical practice would he most useful.
}ames R. \i?vaina, M.D., F.C.C.~, Division of Pulmonary and Critical Care Medicine, long Island Jewish-Hillside Medical Center, Albert Einstein College of Medicine, New Hyde Park, New York
REFERENCES 1 Judge finds psychiatrist liable for sex with a f()rmer patient. The
Heparin +
Heparin +
40
35
dipyridamole Baseline characteristics Patients, number with venous thrombosis with pulmonary embolism Age, years (mean ± SD) Results of the trial Recurrences of PE Bleeding complications
placebo
p value·
34 6
63±13
27 8 64±17
N.S.
4 (10%) 7 (17,5%)
2 (5,7~) 2 (5,7%)
N.S. N.S.
*Chi-squared test was used CHEST I 98 I 3 I SEPTEMBER, 1990
781
dosage), patients were assi~ed, according to a prescribed random.. ized arrangement, to treatment with either dipyridamole (100 mg PO with meals) or placebo. Patients, nurses., and attending physi· clans were all unaware of the treatment regimen for a particular patient. Patients were allocated by numbers from a randomized list. To each one corresponded a numbered box containing prophylaxis material for eight days. A sealed envelope system guaranteed that, in case of emergency, the type of prophylaxis could be checked without breaking the code for other patients. The study was approved by the Ethics Committee, and the patients were infonned and gave their oral consent to participate in the study. Bleeding complications during these eight days of treatment were recorded. Major bleedinK was de6ned as any unexplained decrease in hematocrit of more than 4 points, or bleeding that caused substantial morbidity or risk to life. Minor bleeding was defined as bleeding that did not require transfusion or other specific therapy and did not endanger life. Initially, the protocol was designed to study 150 consecutive patients, but given the high bleeding rate, we decided to open the randomization list after patient 75. Recurrences were seen in fOur of 40 patients (10 percent) taking dipyridamole plus heparin, in two of whom recurrent PE was accompanied by clinical symptoms (acute dyspnea and chest pain). The other two patients remained without symptoms, but new perfusion defects were seen on repeat lung scan. Similarly, new perfusion defects were seen in two of 35 patients (5.7 percent) taking heparin and placebo. As seen in the Table, differences between groups were not statistically significant. Acute bleeding developed during the study in seven patients (17.5 percent) taking heparin and dipyridamole, and in two of 35 patients (5.7 percent) taking only heparin. The site of bleeding was the gastroduodenal tract in four patients, genitourinary tract in four, and a gross hematoma in one. Blood loss was considered major bleeding in two patients taking dipyridamole and heparin, and in one patient on heparin and placebo. In our experience, not only was the recurrence rate increased, but also the number of bleeding complications was higher. Diff'er· ences are not statistically significant because of the small number of patients, but in view of these 6ndings we decided do not continue the study.
Manuel Monreal, M.D.; lUlU. 11..1%, M.D.; jordi Roig, M.D.;
Elena LAfoz, M.D.; Luillnaraja, M.D., Hospital de Badalona Germans '&itu i Pujol Barcelona, Spain
Pleural, Alveolar and Blood T-Iymphocyte Subsets In Pleuropulmonary sarcoidosis 7b the FAitor: In two patients with pleuropulmonary sarcoidosis, T·lymphocyte subsets have been evaluated in peripheral blood, bronchoalveolar lavage and pleural fluids. A non...smolcing man, 34 years of age, with no previous medical history, was referred to our hospital for right paratracheal and bilateral hilar lymph node enlargement and a right pleural effusion detected by routine chest roentgenogram. Usual biologic test results were normal. Serum angiotensin-converting enzyme activity was 135 fJ.mollminlml (n
Table 1- T - ~ Subteta* in Peripheral Blood, BAL Gnd Pleural Fluidt
REFERENCES 1 Monreal M, Ruiz J, Salvador R, Morera J, Arias A. Recurrent pulmonary embolism. A prospective study. Chest 1989; 95:97679 2 Sullivan JM, Harken DE, Corlin R. Pharmacologic control of thromboembolic complications of cardiac-valve replacement. N Eng) J Med 1971; 284:1391-94 3 Chesebro JU, Fuster ~ Elveback LR, Mc Goon DC, Pluth JR. Trial of combined warfarin plus dipyridamole or aspirin therapy in prosthetic heart valve replacement: danger ofaspirin compared with dipyridamole. Am J Cardioll983; 51:1537-41 4 Miller A, Lees RS. Simultaneous therapy with antiplatelet and anticoagulant drugs in symptomatic cardiovascular disease. Stroke 1985; 16:fi68...75 5 American College of Chest Physicians and the National Heart, Lung, and Blood Institute National Conference on Antithrombotic Therapy. Arch Intern Med 1986; 146:462-72
782
Peripheral blood
BAL8uid
Case 1 Case 2 Case 1 Case 2 Total cells (lmm3 ) Lymphocytes OKT4 0KT8 CD4:CD8 ratio
144
770 188 ~
0.9
1,067 181 427 0.4
65% 76% 12% 6
185
54% 78% 16% 4.9
Pleural 8uid Case 1 Case 2
I ,BOO 73% 61.5% 12.5% 5
330 72% 62% 18% 3.4
·SUrface phenotyping ofT·lymphocytes was determined by indirect immunoOuorescence microscopy usin~ CD4 and COB monoclonal antibodies (OKT4 plus OKT4 A and OKT8; Ortho DiaJ(llostics, Raritan, NJ). t Expressed in absolute numbers in peripheral blood and in per(:enta~e of lymphocytes in BAL and pleural fluid.