Therapeutic management in ambulatory elderly patients with atrial fibrillation: the S.AGES cohort.

UNLABELLED: Few epidemiologic studies have specifically focused on very old community dwelling population with atrial fibrillation (AF). The objectives of the AF-S.AGES cohort were to describe real-life therapeutic management of non-institutionalized elderly patients with AF according to age groups, i.e., 65-79 and ≥ 80 and to determine the main factors associated with anticoagulant treatment in both groups. METHODS: Observational study (N=1072) aged ≥ 65 years old, recruited by general practitioners. Characteristics of the sample were first evaluated in the overall sample and according to age (< 80 or ≥ 80 years) and to use of anticoagulant treatment at inclusion. Logistic models were used to analyze the determinants of anticoagulant prescription among age groups. RESULTS: Mean age was 78.0 (SD=6.5) years and 42% were ≥ 80 years. Nineteen percent had paroxysmal AF, 15% persistent, 56% permanent and 10% unknown type, 77% were treated with vitamin K antagonists (VKA), 17% with antiplatelet therapy with no differences between age groups. Rate-control drugs were more frequently used than rhythm-control drugs (55% vs. 37%, p < 0.001). VKA use was associated with permanent AF, younger age and cancer in patients ≥ 80 years old and with permanent AF and preserved functional autonomy in patients < 80 years old. Hemorrhagic scores were independently associated with non-use of VKA whereas thromboembolic scores were not associated with VKA use. CONCLUSIONS: In this elderly AF outpatient population, use of anticoagulant therapy was higher even after 80 years than in previous studies suggesting that recent international guidelines are better implemented in the elderly population.

The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES Cohort. Baseline data.

OBJECTIVE: The main objective of the S.AGES (Elderly Subjects) cohort study is to describe the current therapeutic strategy for chronic pain in non-institutionalised elderly patients in France. METHODS: In this prospective cohort study, non-institutionalised patients aged 65 years and over with chronic pain were recruited by general practitioners (GP) across France. All medicinal and non- medicinal prescriptions were recorded at inclusion and will be followed up over 3 years via an eCRF. Data recorded at baseline are presented in this paper. RESULTS: Two hundred and sixty GPs enrolled 1379 evaluable patients between June 3rd, 2009 and June 3rd, 2011. Pain was mainly of a mechanical nature, due to osteoarthritis or common back pain. 80% of the patients had moderate or severe pain. More than a third of patients were treated with a step 1 analgesic (mainly paracetamol), and approximately 30% received a step 2 analgesic (23% dextropropoxyphene and 40.3% tramadol/paracetamol combination). Only 3% received step 3 analgesics; this rate remained low even in patients with severe pain. The proportion of patients treated with an antiepileptic was higher in case of neuropathic pain. More than 25% of patients did not receive any analgesic medication. CONCLUSION: The baseline S.AGES study results exhibit a well-balanced therapeutic management of chronic pain by GPs for ambulatory elderly patients. Clinicaltrials.org NCT01065909.

[Fabry disease among hypertrophic cardiomyopathy of genetic origin]. / Place de la maladie de Fabry au sein des cardiomyopathies hypertrophiques d'origine génétique.

Primary hypertrophic cardiomyopathy is a relatively frequent disease (1/500) which results from a mutation in a gene encoding a sarcomeric protein. In a series of 184 cases, nearly half (46 %) were secondary to a mutation in one of the 4 following genes : MYBPC3, MYH7, TNNI3, TNNT2. In Fabry disease, an exclusive or nearly exclusive cardiac expression is possible and referred to as "cardiac variant". The hypertrophic cardiomyopathy of Fabry disease is usually unspecific. Two series reported a prevalence of Fabry disease of about 6% among male cases. An Italian series of 34 female cases with hypertrophic cardiomyopathy demonstrated that it was feasible to diagnose Fabry disease in females by screening for specific lesions in myocardial biopsies. We detected a patient who initially presented with a common hypertrophic cardiomyopathy except that his ECG showed depression of ST segment and inversion of T wave in leads D1, VL and in precordial leads. The family history revealed several affected relatives and female carriers. In conclusion, an isolated common hypertrophic cardiomyopathy may be secondary to Fabry disease. Male patients should be screened systemically for enzyme defect except in cases of father-to-son transmission. In females, an affected male relative should be searched for screening or the GLA gene should be sequenced. It is important to think about a putative Fabry disease in cases with hypertrophic cardiomyopathy not associated with any obvious cause.

Choice of echocardiography method for postoperative evaluation of mitral valve replacement with a mechanical prosthesis.

OBJECT: The French Cardiology Society (SFC) systematically recommends (Class I) transesophageal echocardiography (TEE) after any mitral valve replacement with a mechanical prosthesis (MMVR). Taking into account the increasing workload of echocardiography laboratories, our attitude was to propose that only post-operative transthoracic echocardiography (TTE) is performed. The purpose of this study was to evaluate the possible risks of this simplified procedure. METHODS: We performed a precise analysis of one full year of practice of MMVR with exhaustive follow-up for the first 2 years concentrating on thromboembolic complications. RESULTS: From January to December 2003, 84 MMVRs (46 after rheumatic fever, 22 degenerative disease, 11 infective endocarditis (IE) and 5 ischemia) were conducted in 45 women and 39 men of average age 61 years. Early mortality (<30 days) concerned 5 patients (5.9%). A control TTE to determine normal prosthetic function was performed 7+/-2 days after surgery and this revealed 2 cases of nonobstructive thrombosis which were treated medically, 3 cases of paraprosthetic regurgitation, and 1 vegetation due to underlying IE. Actuarial survival was 90.5% at 1 year and 83.3% at 2 years. After a mean follow-up of 179.3 patient-years, 5 patients were reoperated (5.9%): 1 for IE, 1 for paravalvular regurgitation, 1 for mitral valve insufficiency with haemolysis, and 2 for obstructive prosthetic valve thromboses. In addition there were 2 cases of prosthetic valve thrombosis, 8 ischemic strokes (2 ministrokes, 6 sequelar strokes), and 1 peripheral embolism. The global thromboembolic complication rate was therefore 6.1 per 100 patient-years (n=11). There were 4 hemorrhagic events, i.e. a rate of 2.2 events per 100 patient-years. 63% of the 1193 INR conducted were within the target range (3-4.5), 26% were below 3 and 11% were greater than 4.5. 35% of patients with thromboembolic complications had an INR<3. CONCLUSION: Morbidity and mortality during the first 2 years after MMVR were relatively high but equivalent to the values of comparable series in the literature. These complications would not have been reduced by a more precise screening based on early TEE. Despite the increasingly litigious nature of the doctor-patient relationship, it would probably be excessive to oppose that this guideline was not followed in a dispute; in particular as it is difficult to apply this measure as echocardiography departments are overworked.

Preoperative tissue Doppler imaging differentiates beneficial from detrimental left ventricular hypertrophy in patients with surgical aortic stenosis. A postoperative morbidity study.

BACKGROUND: In a pressure overloaded left ventricle, regional systolic function has often deteriorated despite normal ejection fraction. OBJECTIVE: To correlate regional systolic function obtained by tissue Doppler imaging (TDI) with improvement in functional status after aortic valve replacement in patients with aortic stenosis (AS). METHODS AND RESULTS: 24 hours before aortic valve replacement, 32 patients with severe AS underwent conventional and TDI echocardiography for systolic peak velocity, peak strain and peak strain rate measurement in the short-axis posterior wall. At follow-up, a composite end point of cardiovascular death, worsening of heart failure and limited exercise capacity was recorded. Before surgery, mean (SD) aortic valve area and pressure gradient were 0.69 (0.22) cm(2) and 50 (14) mm Hg, respectively. Ejection fraction was 61 (10)% and septal thickness was 15 (3) mm. Fourteen events were recorded but no cardiac death. By using the multivariate regression analysis, systolic peak strain rate (p = 0.003) was the strongest predictor of limited recovery after aortic valve replacement. The peak strain rate cut-off point was 2/s by receiver operating characteristic analysis. CONCLUSION: Irrespective of ejection fraction and thickness, strain rate is a determinant which predicts recovery after aortic valve replacement in patients with severe AS.

Percutaneous mechanical mitral commissurotomy with a newly designed metallic valvulotome: immediate results of the initial experience in 153 patients.

BACKGROUND: Percutaneous balloon valvotomy has become a common treatment of mitral stenosis, but the cost of the procedure remains a limitation in countries with restricted financial resources, leading to a frequent reuse of the disposable catheters. To overcome this limitation, a reusable metallic valvotomy device has been developed with the goals of both improving the mitral valvotomy results and decreasing the cost of the procedure. METHODS AND RESULTS: The device consists of a detachable metallic cylinder with 2 articulated bars screwed onto the distal end of a disposable catheter whose proximal end is connected to an activating pliers. By the transseptal route, the device is advanced across the valve over a traction guidewire. Squeezing the pliers opens the bars up to a maximum extent of 40 mm. The clinical experience consisted of 153 patients with a broad spectrum of mitral valve deformities. The procedure was successful in 92% of cases and resulted in a significant increase in mitral valve area, from 0.95+/-0.2 to 2. 16+/-0.4 cm2. No increase in mitral regurgitation was noted in 80% of cases. Bilateral splitting of the commissures was observed in 87%. Complications were 2 cases of severe mitral regurgitation (1 requiring surgery), 1 pericardial tamponade, and 1 transient cerebrovascular embolic event. In this series, the maximum number of consecutive patients treated with the same device was 35. CONCLUSIONS: The results obtained with this new device are encouraging and at least comparable to those of current balloon techniques. Multiple uses after sterilization should markedly decrease the procedural cost, a major advantage in countries with limited resources and high incidence of mitral stenosis.

[Detection of acute rejection of heart transplantation by Doppler color imaging]. / Détection du rejet aigu myocardique après transplantation cardiaque par Doppler couleur tissulaire.

Doppler tissue imaging is a new technique of measuring the velocities of myocardial wall motion. In order to assess its value in the diagnosis of acute rejection, the velocities of the interventricular septum and left ventricular posterior wall were measured in systole and early diastole in 34 cardiac transplant patients at the time of their endomyocardial biopsy, using an M mode left parasternal short axis view. During 40 episodes of acute rejection (26 mild and/or moderate, 10 sub-severe and 4 severe), the wall velocities decreased significantly (p < 0.001) both in the interventricular septum and endocardium of the posterior wall. Myocardial velocities were significantly slower in sub-severe or severe rejection than in mild or moderate rejection. The most sensitive criterion was the measurement of posterior wall endocardial velocity in early diastole, a decrease of 10% having a sensitivity of 92% whereas the sensitivity of usual Doppler echocardiographic parameters is only 73%. Acute rejection, even mild cases, can be diagnosed with excellent sensitivity by measuring myocardial velocities by Doppler tissue imaging. This technique has the advantage of being non-invasive, reproducible and reliable in the follow-up of cardiac transplant patients.

[Blood flow in the isovolumetric relaxation phase in heart transplant patients. Its use in the noninvasive diagnosis of acute rejection]. / Flux en phase de relaxation isovolumétrique chez le transplanté cardiaque. Apport dans le diagnostic non invasif de rejet aigu.

The aim of this study was to assess a Doppler-echocardiographic parameter which has not been previously reported for the diagnosis of acute cardiac rejection. The parameter was left ventricular isovolumic relaxation blood flow. Eighty patients who had undergone orthoptic cardiac transplantation were followed up regularly with echocardiography for a period of 2 years. In all, 495 echocardiographic studies were performed and the results compared with those of endomyocardial biopsy performed on the same day (11.4 echocardiographic studies per patient). In the absence of cardiac rejection, isovolumic relaxation Doppler signal was recorded in all patients (364/387 echo studies). This was a positive signal directed towards the apex detected by continuous mode Doppler in the apical position, arising along the interventricular septum in the mid part of the left ventricle (82% of cases) or from the basal region of the septum (18% of cases) and lasting throughout the phase of isovolumic relaxation. The maximal velocity was 0.53 +/- 0.08 m/s (range 0.32 to 0.73 m/s) : the velocity-time integral was 34 +/- 33 cm. This signal was associated with medioventricular endosystolic acceleration of blood flow in 75% of cases. The incidence of the isovolumic relaxation flow signal decreased in cardiac rejection with no significant changes in the other usual Doppler-echocardiographic parameters except for a significant decrease in the ejection fraction in the group with severe rejection. In the group with mild rejection (n = 89) an isovolumic relaxation flow signal was only observed in 52 cases (including 29 in whom immunosuppressive treatment was not increased). In patients with moderate rejection (n = 12) there were only 5 cases in which a isovolumic relaxation flow signal was recorded, and in the group with severe rejection (n = 7), the signal could only be recorded in 1 case. The authors conclude that the absence of an isovolumic relaxation blood flow signal in a cardiac transplant patient is a reliable sign of cardiac rejection with an excellent specificity (94%). The absence of this signal is a sensitive indicator of severe rejection (86%) but less so for moderate (58%) or mild rejection (42%).

Conventional and total orthotopic cardiac transplantation: a comparative clinical and echocardiographical study.

OBJECTIVE: Clinical interest has recently emerged in a new technique of heart transplantation with bicaval and pulmonary venous anastomosis. This technique is thought to improve left heart function and reduce thromboembolism. We have used this technique systematically since 1993. We compared the patients transplanted before September 1993 with the standard technique and the patients transplanted with the new technique. METHODS: A total of 135 patients were transplanted at our institution from 1987 to 1995, 100 with the standard technique and 35 with the new technique. of these, 95 survivors were studied by transthoracic and transesophageal echocardiography; 65 were transplanted with the standard technique ('standard' group) and 30 with the new technique ('total heart' group). All patients were free from rejection and in sinus rhythm when studied. RESULTS: Boths groups were similar in pretransplant characteristics. Operative data were similar with a limited increase in the ischemic time with the total heart technique (210 +/- 73 min for 'total heart' vs. 196 +/- 84 min for 'standard'). Right heart catheterization showed comparable cardiac output and pulmonary pressures. Peripheral embolic events occured in 9 patients in the 'standard' group and none in the 'total heart' group. The left atrium was larger in the 'standard' group (58 +/- 6 vs. 42 +/- 4 mm, P = 0.0006). Left atrial spontaneous echo contrast was present in 32 patients in group 'standard' and none in 'total heart' group (P < 0.0001), and left atrial thrombi were detected in 17 patients in group 'standard' vs. none in group 'total heart' (P = 0.01). All patients with a history of embolism had left atrial thrombus and spontaneous echo contrast. CONCLUSION: This study showed a high incidence of left atrial spontaneous echo contrast and thrombi when using the standard technique, which was absent when using the total heart technique. Total heart transplantation with bicaval and pulmonary venous anastomosis should be preferred for heart transplantation.

[Cerebrovascular complication in non-bacterial thrombotic endocarditis. Value of cardiac transesophageal ultrasonography]. / Accident vasculaire cérébral compliquant une endocardite thrombotique non bactérienne. Intérêt de l'échographie cardiaque transoesophagienne.

BACKGROUND: Non-bacterial thrombotic endocarditis in patients with cancer can lead to ischemic stroke. Endocardial vegetations are usually small and may be missed at transthoracic echocardiography. CASE REPORT: Disseminated intravascular coagulation developed in a woman with ischemic stroke. Transthoracic echocardiography was normal. Four days later, transesophageal echocardiography revealed a large mitral vegetation suggesting non-bacterial thrombotic endocarditis. The diagnosis was confirmed at pathology which reported carcinoma of the colon. DISCUSSION: Transthoracic echocardiography is rarely contributed to the diagnosis of thrombotic endocarditis. In our patient transesophageal echocardiography grave the diagnosis before death instead of retrospectively at autopsy as usually occurs, demonstrating the value of transesophageal echocardiography for cancer patients who develop ischemic stroke.

[Primary treatment of left coronary artery diseases by percutaneous implantation of stents]. / Traitement en première intention des lésions du tronc commun de la coronaire gauche par implantation percutanée d'une endoprothèse.

Left main coronary artery (LM) stenting has only been reported in bail-out situations or absolute contraindications so surgery. The authors report the immediate and midterm results of primary Palmaz-Schatz stent implantation in two young patients without contraindication to surgery. The first patient, 58 year-old, was admitted for unstable angina in October 1994. Coronary angiography showed an isolated severe ostial lesion of the LM. After conferring with the surgical team which remained on stand-by, angioplasty and stent implantation were performed with excellent results, no complications and no restenosis on angiographic controls at 3 and 12 months. The patient remained asymptomatic 24 months later. The second patient, 38 year-old, was admitted in June 1995 for unstable angina, and coronary angiography showed a severe isolated stenosis in the middle of a long and wide LM. Primary coronary stenting was also performed with excellent results, no complication and no restenosis on angiographic controls at 4 and 8 months. This patient was still asymptomatic 16 months after stenting. These excellent immediate and medium-term results are encouraging and suggest that this form of treatment might be extended to patients with an isolated whether primary LM stent implantation could become a suitable alternative to surgery in the future.

Aortic valve replacement after aortic valvuloplasty for calcified aortic stenosis.

OBJECTIVE: This study concerns patients who underwent one or several aortic balloon valvuloplasties at our institution and subsequently required cardiac surgery, either on an emergency basis after aortic valvuloplasty or due to the development of aortic stenosis. METHODS: Between February 1987 and December 1993, 137 patients (73 male, 64 female, mean age 72 +/- 9 years) underwent aortic valve replacement for calcified aortic stenosis after several percutaneous balloon aortic valvuloplasties. Thirty-one patients were in NYHA stage II, 70 in stage III and 36 in stage IV. Seventy patients had angina (23 stage I or II, 47 stage III or IV) and 24 patients presented syncope or lipothymia. Twenty-three percent had at least two of these three symptoms. The indications for balloon dilatation were non-definitive surgical contraindication or high surgical risk (73), personal choice (49), refusal of surgery (9) and emergency (5:2 massive aortic regurgitation, 1 left ventricle perforation, 1 cardiogenic shock, 1 endocarditis in cardiogenic shock). Seven patients received preoperative aortic valvuloplasty due to a very high operative risk. The average time between dilatation and surgery was 472 days and there was clinical improvement for an average period of 261 days. The aortic valve replacements consisted of 58 mechanical prostheses and 79 xenografts with 22 concomitant procedures. RESULTS: Operative mortality was eight patients (5.8%). During the follow-up (17.4 +/- 9.2 months), four patients died (3.6%), 91.2% of the patients were in class I and II and 95% were without angina. The actuarial survival rate was 90.5 +/- 6.6% including hospital mortality. CONCLUSIONS: Both our experience and the literature show that balloon aortic valvuloplasty is followed by an immediate improvement in hemodynamic status with a decrease in valve gradient and an increase in valve area. However, the hemodynamic benefit is typically short-lived with a very high restenosis rate. Balloon aortic valvuloplasty is not an alternative to aortic valve replacement, which remains the best treatment for calcified aortic stenosis; the benefits and long-term results of aortic valve replacement are well established, even in the elderly.

High incidence of left atrial thrombus detected by transoesophageal echocardiography in heart transplant recipients.

The aim of the study was the detection of spontaneous echo contrast (SEC) and left atrial thrombus by transoesophageal echocardiography (TEE) in patients who had undergone orthotopic heart transplantation. TEE was prospectively performed in 64 heart transplant recipients (53 males, 11 females, mean age 51 years). Since surgery (mean time: 31 months), all heart transplant recipients had received either aspirin (39), or dipyridamole (22), or both (3). Despite the antiplatelet treatment, an acute arterial embolism (two strokes, one popliteal and one mesenteric ischaemia) occurred in four patients who subsequently received an oral anticoagulant therapy. TEE was performed with a biplane high-frequency transducer after lidocaine pharyngeal anaesthesia, midazolam intravenous injection and antibiotic prophylaxis. Mean ejection fraction was 63 +/- 10%. None had evidence of rejection at endomyocardial biopsy performed on the same day as TEE and analysed in a blinded fashion. All were in sinus rhythm. Left atrial SEC was found in 35 patients (55%) and was associated with left atrial thrombus in 18 patients (28%). These thrombi were localized in the donor left atrial appendage in 10 cases, on the posterior wall of the left atrium in six cases, on the donor part of inter-atrial septum in one case and on the suture line in one case. They were not detected by transthoracic echocardiography (TTE). When compared with patients without thrombus, no difference was found concerning left atrial size, left ventricular ejection fraction, pulmonary artery pressure and number of previous episodes of rejection. However, cardiac index was significantly lower in patients with left atrial thrombus.(ABSTRACT TRUNCATED AT 250 WORDS)

[Prevalence of intra-auricular thrombi detected by transesophageal echocardiography in patients with cardiac transplants]. / Fréquence des thrombus intra-auriculaires détectés par l'échocardiographie transoesophagienne chez les transplantés cardiaques.

The aim of this study was to determine the prevalence of intra-atrial thrombi or spontaneous contrast by transoesophageal echocardiography in patients who underwent cardiac transplantation by Lower and Shumway's technique. Transoesophageal echocardiography was performed in 52 transplant patients (43 men, 9 women: average age 51 years) with a high frequency biplane transducer. After surgery, all patients received platelet antiaggregant therapy. Despite this treatment, 4 patients had a sudden systemic embolic episode and were then placed on oral anticoagulants. All patients were in sinus rhythm at the time of the examination and some had signs of acute rejection on endomyocardial biopsy performed the same day. Spontaneous contrast was observed in 27 patients (52%) and was associated with thrombosis in 15 patients (29%). These thrombi were located in the left atrial appendage in 8 cases, on the left atrial posterior wall in 5 cases and on the left atrial sutures in 2 cases. None of these thrombi had been detected by transthoracic echocardiography. No significant difference was observed between those with and those without thrombosis with respect to left atrial dimensions, left ventricular ejection fraction, cardiac index, pulmonary pressures and the number of episodes of acute rejection. The 4 patients with a history of arterial embolism all had an intra-atrial thrombus. This study demonstrates a high incidence of spontaneous contrast and intracardiac thrombi in the dilated left atrium of patients transplanted by Lower and Shumway's technique. It also underlines the value of transoesophageal echocardiography in the follow-up of transplant patients.(ABSTRACT TRUNCATED AT 250 WORDS)

[Current status of aortic valvuloplasty in patients aged 80 and over. Apropos of a recent series of 70 patients (1989-90)]. / Etat actuel de la valvuloplastie aortique chez l'octogénaire. A propos d'une série récente (1989-1990) de 70 patients.

In contrast with aortic valve replacement, the treatment of choice for severe aortic stenosis because of the better long-term results, percutaneous aortic valvuloplasty, has only limited indications, mainly because of the high rate of restenosis. However, in very elderly patients, the surgical risk is high, sometimes prohibitive. For this reason, the authors report their latest results with this technique in a series of octogenarians. Between January 1989 and December 1990, 70 aortic valvuloplasties were performed in octogenarians (average age 85 +/- 3 years). The indications were advanced age > or = 85 years (46%), poor left ventricular ejection fraction < 40% (20%), secere associated coronary artery disease (3%), associated extracardiac pathology (11%), poor general condition (11%) or refusal of surgery (4%). The great majority of these patients (83%) were very symptomatic: 70.5% had Grade III-IV dyspnoea, 20% had Grade III-IV angina and 20% had syncopal attacks. Valvuloplasty reduced the mean transvalvular pressure gradients from 61 +/- 23 to 30 +/- 11 mmHg (p < 0.01) and increased aortic valve surface area from 0.53 +/- 0.19 to 0.94 +/- 0.12 cm2 (p < 0.001). There were two deaths (2.9%) in the catheterization laboratory and 4 (5.7%) complications during the hospital period (myocardial infarction: 1, cerebrovascular accident: 1, severe aortic regurgitation: 1 and complete atrio-ventricular block: 1). There were no serious vascular complications. The average duration of the hospital period was 6 +/- 5 days. Clinical follow-up of 17 +/- 7 months was obtained in 97% of patients.(ABSTRACT TRUNCATED AT 250 WORDS)

[Extensive isolated aneurysm of the right coronary vessel developing within 4 years]. / Volumineux anévrisme isolé de la coronaire droite apparu en 4 ans.

The authors report the case of a 64 year old man on chronic haemodialysis therapy in whom coronary angiography showed a right coronary artery aneurysm. This patient had undergone coronary angiography 4 years previously and no aneurysm had been found on that occasion. The aneurysm occurred in the context of coronary atherosclerosis, coronary angiography showing typical appearances of double vessel disease. There were several special features of this aneurysm which contribute to the originality of the case: its rapid development within 4 years, its large size and the fact that it was an isolated finding on the right coronary artery. Several aetiologies are discussed but none can be formally confirmed.

Evaluation of restenosis after balloon dilatation in adult aortic stenosis by repeat catheterization.

To evaluate the restenosis rate after successful balloon aortic valvuloplasty, clinical evaluation and repeat catheterization were performed in 96 patients who had undergone balloon dilatation 7 +/- 5 months earlier. Restenosis, defined as a loss of greater than 50% of the benefit in aortic valve area obtained after balloon valvuloplasty, was observed in 48% of the patients. Actuarial analysis showed that the restenosis rate was time dependent and was 80% at 15 months. However, functional improvement was observed in most of the patients with or without restenosis. The restenosis rate was not correlated with the degree of enlargement of the aortic orifice produced by the valvuloplasty procedure. Because of the high incidence of restenosis, balloon aortic valvuloplasty should be limited to patients who have a contraindication to surgery or are at high risk for surgery, or as a bridge to surgery.