Mitral regurgitation. Timing of surgery or interventional treatment.

The treatment of mitral regurgitation has changed in recent years because of improvements in the surgical treatment, in particular valve repair, and the advent of interventional techniques, mainly percutaneous edge-to-edge repair. Regardless of the technique used, better results are obtained for interventions in primary mitral regurgitation than in secondary mitral regurgitation, which remains a challenge. Further developments are expected in the future thanks to a better understanding of the epidemiology and the mechanisms of secondary mitral regurgitation, the development of interventional techniques, and a careful evaluation.

[Percutaneous approaches to mitral valve disease]. / Approches percutanées des valvulopathies mitrales.

Percutaneous approaches to mitral valve disease consist in modifications of existing surgical techniques, aiming to replicate the favourable outcomes of surgery, with less procedure-related risk, due to their less invasive nature. While some of these techniques are clearly indicated for the management of certain valve diseases, other appear as possible alternatives to surgery among patients deemed at high-risk or considered inoperable, or are still under clinical investigation. Major development of these percutaneous approaches is expected within the future, thus hopefully allowing treatment of a larger proportion of patients with mitral valve disease.

An unusual cause of pacemaker-induced severe tricuspid regurgitation.

Pacemaker (PM) induced tricuspid regurgitation (TR) is a common echocardiographic finding. Although mild or moderate TR is frequently observed, severe TR is rare. We report the exceptional observation of a severe TR due to leaflet malcoaptation occurring late after PM implantation and in the following weeks after an aortic valve replacement. Our hypothesis is that the aortic valve surgery has been responsible for conformational changes between cardiac cavities, tricuspid valve and PM leads resulting in a severe TR.

Predictors of mitral annulus enlargement? A real-time three-dimensional transesophageal study.

BACKGROUND: Mitral annulus (MA) enlargement can be observed in various cardiac conditions but respective influence of left atrial (LA) and left ventricle (LV) size remained unclear. METHODS: In 120 patients who underwent a clinically indicated 3D-transesophageal-echocardiography, 30 atrial fibrillation (AF), 30 secondary mitral regurgitation (SMR), 30 primary myxomatous mitral regurgitation (PMR) and 30 mitral stenosis (MS), we evaluated the association between MA area (MA-area) and LA volume (LAvol) measured using the biplane area-length method, end-diastolic (LVEDV) and end-systolic (LVESV) volumes measured using the biplane Simpson method. MA-area was measured based on 3D datasets using QLab10. RESULTS: MA-area was correlated to LVEDV (r = 0.42, p < 0.0001), LVESV (r = 0.29, p = 0.001) but more markedly to LAvol (r = 0.62, p < 0.0001). Correlation between MA-area and LAvol was sustained in all subsets whereas MA-area was not correlated to LVEDV and LVESV in patients with SMR and with PMR (all p > 0.10). In multivariate analysis main predictors of MA-area were LAvol (p < 0.0001) and myxomatous etiology of MR (p = 0.0003) followed by LVEDV (p = 0.006) and LVESV (p = 0.02). CONCLUSION: In a population of patients with a wide range of LA/LV size related to various conditions, LA volume and myxomatous MR etiology appeared as main predictors of MA size whereas LV size had a more modest influence.

[Intracardiac echography]. / Echographie intracardiaque.

The role of echocardiography during non-coronary interventions is of increasing importance. They include percutaneous closure of atrial septal defects (ASD) or patent foramen ovale (PFO), percutaneous balloon mitral valvuloplasty (PMV), septal alcoholization, or interventional procedures managing arrhythmia. In all cases, echographic monitoring enables to guide the procedures, optimize and assess their results and avoid complications. This role could even increase with the development of other interventional techniques such as left auricle appendage exclusion or the percutaneous treatment of valvular diseases. This article reviews this new approach and its value in interventional cardiology.

[A pitfall of transseptal catheterisation for percutaneous mitral commissurotomy: interruption of the inferior vena cava with azygos continuation]. / Piège du cathétérisme transseptal pour commissurotomie mitrale percutanée: l'interruption de la veine cave inférieure avec continuation azygos. A propos d'un cas et revue de la littérature.

Transseptal catheterisation is a widely used technique in interventional cardiology. The authors report the case of a 37 year old woman admitted for percutaneous mitral commissurotomy of a symptomatic rheumatic mitral stenosis in whom transseptal catheterisation was impossible because of a rare congenital anomaly: interruption of the inferior vena cava with azygos vein continuation.

[Echocardiography in the catheterization unit]. / L'échocardiographie en salle de cathétérisme.

Non-coronary interventional cardiology has for about ten years been undergoing significant development, with the arrival of new percutaneous procedures in various domains. Some of them have already been well validated, notably percutaneous mitral comissurotomy, percutaneous closure of inter-atrial (IA) communications and patent foramen ovale, trans-septal catheterisation, and alcohol septal ablation of hypertrophic obstructive cardiomyopathy. Other interventional techniques are still in the validation phase, such as the techniques for percutaneous occlusion of the left atrium, percutaneous implantation of valvular prostheses, or the new approaches to percutaneous treatment of mitral valvulopathy. The rapid development of these techniques has benefited widely from the use of echocardiography in the catheter suite, providing a very precise clarification of the anatomy and continuous guidance during procedures. This echocardiographic guidance provides optimal results for the interventional procedure and reduces the incidence of complications.

[Patent foramen ovale percutaneous closure: indications, techniques and results]. / Fermeture percutanée des foramens ovales perméables: indications, techniques et résultats.

A patent foramen ovale is almost physiological (15% of the population) but can be associated with some pathological situations in which its closure can be considered. The only medical indication currently accepted is a right-left shunt without elevation of the right pulmonary pressure, whose most famous pattern is the rare platypnea-orthodeoxie syndrome. PFO may be responsible for diving decompression accidents. Before taking the decision of closing a PFO, each situation must be discussed on a case to case basis. In spite of the possible link between some kinds of migraine and PFO, according to current knowledge, there is no evidence of the efficiency of PFO closure in this situation. The secondary prevention of a cryptogenic ischaemic cerebrovascular attack on a young person with a PFO associated to a membranous septum aneurysm, is the most commonly considered indication, but we lack valid data for this indication. The PFO closing procedure is well codified and its success rate is close to 100%, with rare major complications. Residual permeability within the prosthesis ensuring the closure of the PFO decreases gradually to get under 15% after six months. The clinical result is often dramatic when treating right-left shunts. As far as the secondary prevention of cryptogenic ischaemic cerebro vascular attacks in young people is concerned, there might be some clinical benefit, but we are waiting for the results of ongoing randomized and scheduled studies.

Identifying the needs for competency-based education in Europe: a needs assessment of cardiologists across 52 countries.

Objective: This international needs assessment was mandated by the European Society of Cardiology (ESC) to obtain an in-depth understanding of the current gaps and challenges of European cardiology professionals, with the aim to provide evidence for the development of needs-driven educational and professional development activities. Methods: This ethics-approved needs assessment was conducted among cardiologists from all sub-specialties across 56 countries of Europe and the Mediterranean basin. A mixed-methods research approach was used, combining qualitative in-depth interviews and focus groups with a quantitative survey. Results: Seventy-four (74) cardiologists participated in the qualitative phase and 866 completed the survey. Respondents represented 52 of the 56 targeted countries. Three themes were identified: 1) Challenges in the clinical decision-making process, 2) Challenges in establishing the patient-physician relationship, and 3) Sub-optimal team communication and collaboration. Specific gaps and causalities related to each challenge were found. Although most of the gaps were common across countries and sub-specialties, some significant differences were noted. Conclusion: The findings of this needs assessment indicate gaps and challenges in clinical practice across countries and across sub-specialities. Taking cardiology as an example, this study identifies clear areas of focus, especially around issues of collaboration and communication, for targeted competency-based education in Europe.

Eclipsed mitral regurgitation: an unusual cause of acute heart failure.

AIMS: So far, a total of five patients with eclipsed mitral regurgitation (MR) have been reported in the literature by three different teams. The aim of this article was to detail clinical and echocardiographic characteristics, and outcome of patients presenting eclipsed MR. METHODS AND RESULTS: We defined eclipsed MR as spontaneous appearance, at rest, from 1 min to the next of an acute restriction in the motion of mitral leaflets preventing coaptation and leading to massive MR in patients with normal left ventricular end-diastolic diameter, left ventricular ejection fraction >45%, and baseline MR ≤2. Spontaneous regression occurred within 30 min, and no obvious trigger such as acute hypertension, new-onset arrhythmia, or myocardial ischaemia is present. Clinical data, ECG, echocardiographic data, surgery report, and follow-up status of six patients with eclipsed MR are reported: all were post-menopausal women with median age of 74 [57-80] years presenting hypertension (4/6), chronic kidney disease (5/6), or chronic anaemia (4/6). Five out of six patients experienced acute pulmonary oedema requiring hospitalization and underwent mitral valve replacement because of heart failure recurrence. Two patients died in the first days after surgery while the three others are free of symptoms at, respectively, 56, 18, and 10 months follow-up. CONCLUSION: Eclipsed MR is a clinical and echocardiographic syndrome responsible for heart failure with preserved EF. It is presently underdiagnosed and should be evoked in cases of recurrent acute pulmonary oedema without obvious trigger, in particular in patients presenting discordant evaluation of MR severity over time.

[Feasibility of percutaneous exclusion of the left atrial appendage: results of 11 cases]. / Faisabilité de l'exclusion percutanée de l'auricule gauche. A propos de 11 cas.

Atrial fibrillation is associated with a risk of cerebral embolism, the only proven effective prevention of which is anticoagulant therapy. There is no known alternative in cases with contra-indications to this treatment. Percutaneous exclusion of the left atrial appendage by the implantation of a prosthesis (PLAATO System, ev3 Inc., Plymouth, Minnesota) is a new approach to the prevention of these complications. The authors report the results observed in a series of 11 consecutive patients (7 men, mean age 72 +/- 9 years) in whom this procedure was proposed. All patients had atrial fibrillation for over 3 months, were at high risk and had contra-indications to oral anticoagulants. The implantation of the prosthesis was performed after treatment with aspirin and clopidogrel, under general anaesthesia radioscopy and transoesophageal echocardiographic guidance with success in 9 cases (1 implantation refused in the catheter laboratory and 1 failure). The only complication observed was transient ST elevation treated by emergency angioplasty. The echographic and angiographic criteria of success of left atrial appendage exclusion were fulfilled in all implanted patients. The hospital course was uncomplicated. One recurrence of stroke was observed at the second month: transoesophageal echocardiography confirmed the absence of thrombosis, of migration of the prosthesis and its impermeability in all the patients. After 7 +/- 5 months' follow-up, no other adverse event was observed. This new procedure is technically feasible. Despite encouraging results, its long-term efficacy in the prevention of thromboembolic complications of atrial fibrillation remains to be demonstrated.

Late results of percutaneous mitral commissurotomy in a series of 1024 patients. Analysis of late clinical deterioration: frequency, anatomic findings, and predictive factors.

BACKGROUND: The optimal use of percutaneous mitral commissurotomy (PMC) in a wide range of patients requires accurate evaluation of late results and identification of their predictors. METHODS AND RESULTS: Late results of PMC were assessed in 1024 patients whose mean age was 49+/-14 years. Echocardiography showed that 141 patients (14%) had pliable valves and mild subvalvular disease, 569 (55%) had extensive subvalvular disease, and 314 (31%) had calcified valves. A single balloon was used in 26 patients, a double balloon in 390, and the Inoue Balloon in 608. Good immediate results were defined as valve area >/=1.5 cm2 without regurgitation >2/4 (Sellers' grade) and were obtained in 912 patients. Median duration of follow-up was 49 months. The 10-year actuarial rate of good functional results (survival with no cardiovascular death and no need for surgery or repeat dilatation and in New York Heart Association [NYHA] class I or II) was 56+/-4% in the entire population. Follow-up echocardiography was available in 90% of the patients who experienced poor functional results after good immediate results and showed restenosis in 97% of these. In multivariate analysis, the predictors of poor functional results were old age (P=0.0008), unfavorable valve anatomy (P=0.003), high NYHA class (P<0.0001), atrial fibrillation (P<0.0001), low valve area after PMC (P=0.001), high gradient after PMC (P<0.0001), and grade 2 mitral regurgitation after PMC (P=0.04). CONCLUSIONS: PMC can be performed with good late results in a variety of patient subsets. Prediction of late events is multifactorial. Knowledge of these predictors can improve patient selection and follow-up.

Cardiogenic shock in patients with acute ischemic syndromes with and without ST-segment elevation.

BACKGROUND: Cardiogenic shock is usually considered a sequela of ST-segment elevation myocardial infarction. There are limited prospective data on the incidence and significance of shock in non-ST-segment elevation patients. This study assessed the incidence and outcomes of cardiogenic shock developing after enrollment among patients with and without ST-segment elevation in the Global Use of Strategies To Open Occluded Coronary Arteries (GUSTO)-IIb trial. METHODS AND RESULTS: Among 12,084 patients in GUSTO-IIb who did not present with cardiogenic shock, 4092 (34%) had and 7991 (66%) did not have ST-segment elevation on the enrollment ECG. Cardiogenic shock developed in 4.2% of ST-segment elevation patients compared with 2.5% of patients without ST-segment elevation (odds ratio, 0. 581; 95% CI, 0.472 to 0.715; P<0.001). Shock developed significantly later among patients without ST-segment elevation. There were significant differences in baseline characteristics between shock patients with and without ST-segment elevation: Patients without ST-segment elevation were older, more frequently had diabetes mellitus and 3-vessel disease, but had less TIMI grade 0 flow at angiography. Regardless of the initial ECG, mortality was high: 63% among patients with ST-segment elevation and 73% in those without ST-segment elevation. CONCLUSIONS: Cardiogenic shock occurs in the setting of acute ischemic syndromes regardless of whether ST-segment elevation is present. The incidence, patient characteristics, timing, clinical course, and angiographic findings differ between the 2 groups. Mortality from cardiogenic shock is similarly high among patients with and without ST-segment elevation.

Early reinfarction after fibrinolysis: experience from the global utilization of streptokinase and tissue plasminogen activator (alteplase) for occluded coronary arteries (GUSTO I) and global use of strategies to open occluded coronary arteries (GUSTO III) trials.

BACKGROUND: Trials report a 2% to 6% incidence of reinfarction after fibrinolysis for acute myocardial infarction (MI). We combined the Global Utilization of Streptokinase and Tissue plasminogen activator (alteplase) for Occluded coronary arteries (GUSTO I) and Global Use of Strategies To Open occluded coronary arteries (GUSTO III) populations to better define frequency, timing, and clinical predictors of in-hospital reinfarction. METHODS AND RESULTS: In 55 911 patients with ST-segment elevation myocardial infarction (MI) who were receiving fibrinolysis, we compared baseline characteristics and mortality rate by reinfarction incidence and developed multivariable logistic regression models to predict in-hospital reinfarction and composite of death or reinfarction. Reinfarction occurred in 2258 patients (4.3%) a median of 3.8 days after fibrinolysis; rates did not differ between GUSTO I (4.0%) and GUSTO III (4.2%) or by fibrinolytic assignment (streptokinase, 4.1%; alteplase, 4.3%; reteplase, 4.5%; combined streptokinase and alteplase, 4.4%; P=0.55). Advanced age, shorter time to fibrinolysis, non-US enrollment, nonsmoking status, prior MI or angina, female sex, anterior MI, and lower systolic blood pressure were associated significantly with reinfarction. Patients with reinfarction had higher mortality at 30 days (11.3% versus 3.5% without reinfarction; odds ratio, 3.5; P<0.001) and from 30 days to 1 year (4.7% versus 3.2%; hazard ratio, 1.5; P<0.001). Significant multivariate predictors of in-hospital death or reinfarction included age, Killip class, systolic and diastolic blood pressures, heart rate, anterior MI, smoking status, prior MI, sex, and country of enrollment (all P<0.001). CONCLUSIONS: Reinfarction occurs infrequently after fibrinolysis but confers increased risk of 30-day and 1-year mortality. Some predictors of reinfarction differ from known predictors of death after MI. Improved treatment and prevention strategies for reinfarction deserve study.

Clinical and therapeutic profile of patients presenting with acute coronary syndromes who do not have significant coronary artery disease.The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) Trial Investigators.

BACKGROUND: A proportion of patients who present with suspected acute coronary syndrome (ACS) are found to have insignificant coronary artery disease (CAD) during coronary angiography, but these patients have not been well characterized. METHODS AND RESULTS: Of the 5767 patients with non-ST-segment elevation ACS who were enrolled in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy (PURSUIT) trial and who underwent in-hospital angiography, 88% had significant CAD (any stenosis >50%), 6% had mild CAD (any stenosis >0% to

Survival outcomes 1 year after reperfusion therapy with either alteplase or reteplase for acute myocardial infarction: results from the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) III Trial.

BACKGROUND: New recombinant plasminogen activators have been developed to simulate the fibrinolytic action of the physiological serine protease tissue plasminogen activator (alteplase, t-PA), and have prolonged half-life features permitting bolus administration. One such activator, reteplase (r-PA), was compared with t-PA in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO)-III Trial. METHODS AND RESULTS: At 1-year follow-up, survival status was ascertained in 97.4% of the 15 059 patients enrolled in the GUSTO-III trial. At 1 year, the mortality rate for the t-PA-assigned group was 11.06%, and for r-PA it was 11.20% (P:=0. 77). The absolute mortality difference of 0.14% has 95% CIs of -1. 21% to 0.93%. There were no significant differences in outcome by intention-to-treat for the 2 different plasminogen activators in the prespecified groups (age, infarct location, time-to-treatment). The absolute difference in mortality rates between t-PA and r-PA progressively narrowed over the predetermined observation times after random assignment; it was 0.31% at 24 hours, 0.26% at 7 days, 0.23% at 30 days, and 0.14% at 1 year. Of note, mortality rate in the trial between 30 days and 1 year in 13 883 patients was 4.02% and did not differ between the treatment groups. However, this mortality rate was substantially greater than in GUSTO-I, in which mortality rate for t-PA versus streptokinase between 30 days and 1-year was 2.97% (heart rate 1.36, 95% CI 1.23, 1.50, P:<0.001). CONCLUSIONS: The r-PA and t-PA strategies yielded similar survival outcomes after 30 days in this trial. The increase in mortality rate during extended follow-up compared with previous trials may reflect higher-risk patients and highlights the need for improved secondary prevention strategies.

Abciximab facilitates the rate and extent of thrombolysis: results of the thrombolysis in myocardial infarction (TIMI) 14 trial. The TIMI 14 Investigators.

BACKGROUND: The TIMI 14 trial tested the hypothesis that abciximab, the Fab fragment of a monoclonal antibody directed to the platelet glycoprotein (GP) IIb/IIIa receptor, is a potent and safe addition to reduced-dose thrombolytic regimens for ST-segment elevation MI. METHODS AND RESULTS: Patients (n=888) with ST-elevation MI presenting <12 hours from onset of symptoms were treated with aspirin and randomized initially to either 100 mg of accelerated-dose alteplase (control) or abciximab (bolus 0.25 mg/kg and 12-hour infusion of 0.125 microg. kg-1. min-1) alone or in combination with reduced doses of alteplase (20 to 65 mg) or streptokinase (500 000 U to 1.5 MU). Control patients received standard weight-adjusted heparin (70-U/kg bolus; infusion of 15 U. kg-1. h-1), whereas those treated with a regimen including abciximab received low-dose heparin (60-U/kg bolus; infusion of 7 U. kg-1. h-1). The rate of TIMI 3 flow at 90 minutes for patients treated with accelerated alteplase alone was 57% compared with 32% for abciximab alone and 34% to 46% for doses of streptokinase between 500 000 U and 1.25 MU with abciximab. Higher rates of TIMI 3 flow at both 60 and 90 minutes were observed with increasing duration of administration of alteplase, progressing from a bolus alone to a bolus followed by either a 30- or 60-minute infusion (P<0.02). The most promising regimen was 50 mg of alteplase (15-mg bolus; infusion of 35 mg over 60 minutes), which produced a 76% rate of TIMI 3 flow at 90 minutes and was tested subsequently in conjunction with either low-dose or very-low-dose (30-U/kg bolus; infusion of 4 U. kg-1. h-1) heparin. TIMI 3 flow rates were significantly higher in the 50-mg alteplase plus abciximab group versus the alteplase-only group at both 60 minutes (72% versus 43%; P=0.0009) and 90 minutes (77% versus 62%; P=0.02). The rates of major hemorrhage were 6% in patients receiving alteplase alone (n=235), 3% with abciximab alone (n=32), 10% with streptokinase plus abciximab (n=143), 7% with 50 mg of alteplase plus abciximab and low-dose heparin (n=103), and 1% with 50 mg of alteplase plus abciximab with very-low-dose heparin (n=70). CONCLUSIONS: Abciximab facilitates the rate and extent of thrombolysis, producing early, marked increases in TIMI 3 flow when combined with half the usual dose of alteplase. This improvement in reperfusion with alteplase occurred without an increase in the risk of major bleeding. Substantial reductions in heparin dosing may reduce the risk of bleeding even further. Modest improvements in TIMI 3 flow were seen when abciximab was combined with streptokinase, but there was an increased risk of bleeding.

Functional results 5 years after successful percutaneous mitral commissurotomy in a series of 528 patients and analysis of predictive factors.

OBJECTIVES: This study sought to assess late functional results after successful percutaneous mitral commissurotomy and to determine their predictors. BACKGROUND: Few studies have reported late results of percutaneous mitral commissurotomy or have analyzed their late results regardless of immediate results, despite the fact that late deterioration may well be related either to a decrease in valve area or to poor initial results. METHODS: Between 1986 and 1992, 528 patients underwent successful percutaneous mitral commissurotomy (mean [+/- SD] age 46 +/- 18 years; mean follow-up 32 +/- 18 months). A successful procedure was defined by a mitral valve area > or = 1.5 cm2 and no regurgitation > 2/4. Dilation was performed using a single balloon in 13 patients, a double balloon in 349 and the Inoue balloon in 166. Multivariate analysis was performed with a Cox model. RESULTS: The survival rate for patients in New York Heart Association functional class I or II, with no cardiac-related deaths or need for mitral surgery or repeat dilation, was 76 +/- 6% at 5 years. By multivariate analysis, the independent predictors of good functional results were echocardiographic group (p = 0.01), functional class (p = 0.02) and cardiothoracic index (p = 0.005) before the procedure and valve area after the procedure (p = 0.007). The predictive model derived allowed estimation of the probability of good functional results according to the value of these four predictors for any given patient. CONCLUSIONS: Good functional results were observed 5 years after successful percutaneous mitral commissurotomy in a large series of varied patients. The analysis of predictive factors may provide useful indications for follow-up results in patients undergoing this technique.

Percutaneous mitral commissurotomy for restenosis after surgical commissurotomy: late efficacy and implications for patient selection.

OBJECTIVES: The results of percutaneous mitral commissurotomy were assessed in patients with restenosis after surgical commissurotomy. BACKGROUND: Balloon dilation is feasible in patients with restenosis after surgical commissurotomy, but little is known about its late efficacy. METHODS: We studied 232 patients who had undergone percutaneous mitral commissurotomy a mean of 16 +/- 8 years after surgical commissurotomy. Mean age was 47 +/- 14 years; 81 patients (35%) had valve calcification. All patients had restenosis with bilateral commissural fusion as assessed by echocardiography. Technical failure occurred in 9 patients and the procedure used a single balloon in 7 patients, a double balloon in 95, and the Inoue balloon in 121. RESULTS: Complications were death in 1 patient (0.4%) and mitral regurgitation >2/4 in 10 (4%); 191 patients (82%) had good immediate results (valve area > or =1.5 cm2 without regurgitation >2/4). Predictors of poor immediate results in multivariate analysis were older age (p < 0.001), lower initial valve area (p = 0.01) and the use of the double-balloon technique (p = 0.015). In the 175 patients who underwent follow-up, 8-year survival without operation and in New York Heart Association class I or II was 48 +/- 5%, and 58 +/- 6% after good immediate results. In this latter group, poor late functional results were predicted by higher cardiothoracic index (p < 0.0001), previous open-heart commissurotomy (p = 0.05) and lower final valve area (p < 0.0001) in a multivariate Cox model. CONCLUSIONS: Percutaneous mitral commissurotomy is safe and provides good immediate results in selected patients with restenosis after surgical commissurotomy. After good immediate results, the conditions of more than half of the patients remained improved at 8 years, enabling reoperation to be deferred.

Diabetic retinopathy should not be a contraindication to thrombolytic therapy for acute myocardial infarction: review of ocular hemorrhage incidence and location in the GUSTO-I trial. Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries.

OBJECTIVES: This study sought to evaluate the incidence of ocular hemorrhage in patients with and without diabetes after thrombolytic therapy for acute myocardial infarction. BACKGROUND: Ocular hemorrhage after thrombolysis has been reported rarely. However, there is concern that the risk is increased in patients with diabetes. In fact, diabetic hemorrhagic retinopathy has been identified as a contraindication to thrombolytic therapy without clear evidence that these patients have an increased risk for ocular hemorrhage. METHODS: We identified all suspected ocular hemorrhages from bleeding complications reported in patients enrolled in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO)-I trial. Additional information was collected on a one-page data form. We compared the incidence and location of ocular hemorrhages in patients with and without diabetes. RESULTS: There were 40,899 patients (99.7%) with information about diabetic history and ocular bleeding. Twelve patients (0.03%) had an ocular hemorrhage. Intraocular hemorrhage was confirmed in only one patient. There were 6,011 patients (15%) with diabetes, of whom only 1 had an ocular hemorrhage (eyelid hematoma after a documented fall). The upper 95% confidence intervals for the incidence of intraocular hemorrhage in patients with and without diabetes were 0.05% and 0.006%, respectively. CONCLUSIONS: Ocular hemorrhage and, more important, intraocular hemorrhage after thrombolytic therapy for acute myocardial infarction is extremely uncommon. The calculated upper 95% confidence interval for the incidence of intraocular hemorrhage in patients with diabetes was only 0.05%. We conclude that diabetic retinopathy should not be considered a contraindication to thrombolysis in patients with an acute myocardial infarction.