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The atrial septal defect occluder system (ASDOS) (Osypka Corp., Grenzach-Wyhlen, Germany) has been used clinically for transcatheter closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO) after episodes of cerebral embolism over the last 10 years. In this article, the up-to-date experience with this system is reviewed.

Background: For transcatheter closure of atrial-septal defects, different occlusion systems are available. The purpose of this study was to examine the clinical feasibility of the ASD Occlusion System (ASDOS, Dr Osypka GmbH, Grenzach-Wyhlen, Germany) and to evaluate the short- and long-term results., Methods and Results: The study was composed of 20 consecutive patients with atrial-septal secundum defect (n = 13) or patent foramen ovale (n = 7). The device implantation was successful in all patients. For optimal closure of the defect, left atrial and right atrial umbrellas of different sizes were required in 10 of 20 patients. No major short- or long-term complications occurred. During the mean follow-up period of 13.9 +/- 5 months, 5 strut fractures without dislocation were observed, and in 8 (40%) of 20 patients transesophageal echocardiography revealed a small residual shunt., Conclusion: The ASDOS double umbrella system is suitable for transcatheter closure of interatrial defects in selected patients. This system showed a high procedural safety and has the unique advantage of individual adaptation of the occluding device on the defect anatomy that results in high closure effectiveness.

A clinical trial was conducted to assess the feasibility, safety, and efficacy of the atrial septal defect (ASD) occlusion system for transcatheter closure of secundum ASD and patent foramen ovale (PFO) after episodes of cerebral embolism. Occlusion was attempted in 200 patients aged 1 to 74 years (mean 32). The procedure failed in 26 patients (13%); the device was retrieved through a catheter in 20 and through surgery in 6 patients. Procedure-related complications necessitating surgical removal of the device included device embolization in 2, device entrapment within the Chiari network in 1, frame fracture in 1, and perforation of atrial wall in 2. All 6 patients experienced an uneventful postoperative course. An additional 11 patients (6%) underwent surgical removal of the device during follow-up. There were 163 patients (81%) with an implanted ASD occlusion system at follow-up of from 6 to 36 months (mean 17). Thrombus formation around the device was detected by transesophageal echocardiography in 9 patients 1 to 4 weeks after implantation. One of these patients (who had a coagulation factor XII deficiency) suffered a cerebral thromboembolism. Late atrial wall perforation (5, 6, and 8 months after implantation) occurred in 3 adult patients. Infectious endocarditis developed in 2 adult patients (1%). No late device embolization and no atrioventricular valve injury occurred. An asymptomatic device frame fracture was found in 14% and frame deformity in 4% of all patients during the follow-up period of >230 patient-years. Immediately after closure, a moderate/large residual shunt remained in 8% and a small shunt in 29% of patients. After 1 year, a moderate/large shunt was present in 2% and a small one in 26% of patients. During a total follow-up of 49 patient-years, only 1 of 46 patients with PFO had a transient neurologic event after the closure. The study indicates that patients with centrally situated secundum ASD and those with PFO after cerebral embolism can be treated with this system with a high success rate and an acceptable morbidity.

Transcatheter occlusion of cardiac defects has become an effective and less invasive alternative to open heart surgery. Thromboembolic complications are rare events, after both surgical and transcatheter closure of atrial septal defects [Galal et al.: Eur Heart J 15:1381-1384, 1994]. We report on a case of thrombus formation on the atrial septal defect occluder system (ASDOS) [Sievert et al.: Cathet Cardiovasc Diagn 36:232-240, 1995; Hausdorf et al.: Heart 75:83-88, 1996]. Two days after transcatheter occlusion, the patient suffered an acute stroke due to embolism despite anticoagulation with intravenous heparin. A coagulation disorder with reduced factor XII concentration was deduced as the likely cause. Repeated transesophageal echocardiographic (TEE) studies revealed an involution of the intracardial thrombus within weeks of subsequent anticoagulatory treatment. First off, this case shows that patients with factor XII deficiency are at risk for thromboembolism. Second, it again clarifies that even large amounts of intraartrial thrombotic material may not be seen by transthoracic echocardiography (TTE) and underscores the necessity of performing TEE. Screening patients for coagulation disorders (Quick's value (Q), partial thromboplastin time (PTT)) before they are selected for treatment with thrombogenic devices is indispensable. With regard to their personal history (earlier thromboembolism) and the result of this screening (e.g., prolongation of PTT), quantitative determination of coagulation factors is reasonable. If patients endangered by thromboembolic complications nevertheless undergo ASD occlusion procedures, anticoagulation monitoring requires exceptional attention. Furthermore, it is recommended that TEE should be carried out in these patients 2 days after treatment, since transthoracic echocardiography (TTE) might be unable to detect thrombus formation on the device.

An atrial septum defect was closed with an ASDOS (Babic) occluder in 13 patients aged from 22 to 67 years. The diameters of the ASD ranged from 12 to 36 mm, the left to right shunt from 35% to 70%. With one exception, the occluder could be implanted in all patients. Two patients with an oversized ASD (diameter 31 and 36 mm respectively) had to be operated after 8 h and 2 weeks, respectively. In one patient, a small asymptomatic hemopericardium was detected after 24 h by routine echocardiogram and in another patient a single umbrella arm fracture was noticed by routine x-ray 4 months after the implantation. No further complications occurred. Follow-up is now 3 months to 1 year. With one exception, there was no residual shunt as measured by oximetry.

An improved 10 Fr version of the atrial septal defect (ASD) occlusion system consisting of two umbrellas for transvenous introduction over the long veno-arterial guide-wire was used to attempt closure in five adult patients with large defects (26-35 mm). The umbrellas are made of nitinol wire frame and a thin membrane of microporous polyurethane. Supported by the metal cannula and guided by selective left atriography, the umbrellas of 45-60 mm were placed individually into the atria and screwed together at the septum level by means of a torquer catheter. Positioning and screwing on, unscrewing, separating, and repositioning the umbrellas up to 17 times were needed to anchor the prosthesis correctly in a patient. The prosthesis could be implanted primarily in all patients (in one at second session). Dislodgement of a 60 mm prosthesis and left atrial perforation with a 55 mm prosthesis required surgery in two patients 8 hours and 2 weeks post procedure, respectively. A single umbrella-arm fracture was noticed in one patient 4 months after the implantation. All five patients were free of symptoms at follow-up after 7-10 months. Transcatheter closure of large ASDs is technically feasible with this system. The morbidity is mainly associated with the implantation of very large umbrellas.

Objective: To examine the value of transarterial balloon dilatation of the mitral valve for treatment of patients with mitral stenosis over a period of five years., Design: Analysis of patients' functional state, and haemodynamic and echocardiographic variables, before and immediately after the procedure and during a follow up of up to five years., Setting: A cardiovascular centre in Belgrade, Yugoslavia., Patients: Two hundred and ninety four patients who underwent percutaneous transarterial dilatation of the mitral valve between February 1985 and February 1990., Results: Mean mitral valve area was enlarged by 109%. Complications included death (0.7%), severe mitral insufficiency (2.3%), mild mitral insufficiency (9.9%), cerebral embolism (2%), and injury to the femoral artery (2%). Two more patients died at two and 11 months after the procedure. Late cardiac surgery was needed in eight patients (mitral insufficiency in three, restenosis in three, thrombus in one, and endocarditis in one. Restenosis occurred in seven patients. Four of these underwent repeat dilatation and three had surgery. Improvement of symptoms was seen in 94% of patients during the follow up., Conclusion: Transarterial balloon dilatation of the mitral valve gave good results with acceptable morbidity and mortality and had some advantages over the anterograde approach.

Coronary angiographic findings indicative for left atrial thrombi (neovascularization in the region of the left atrium) were compared with echocardiographic ones. Of 214 patients who had mitral surgery, the authors had all the available data for 161 (31 of whom had left atrial thrombi). The presence of a neovascularization had a sensitivity of 61%, a specificity of 100%, predictive accuracy of 100%, and predictive value of 92%, while echocardiography had a sensitivity of 52%, specificity of 96%, predictive accuracy of 76%, and predictive value of 89%. There was no difference in the sensitivity of both methods for the detection of thrombi located in the left atrium as a whole cavity (p less than 0.05). However, coronary angiography was superior to echocardiography in the diagnosis of thrombi located in the left atrial appendage (p less than 0.05). The diagnosis of left thrombi could be improved by using both methods (specificity 77%, predictive value 95%). Thus, selective coronary angiography is a useful diagnostic method, in addition to echocardiography, in the diagnosis of left atrial thrombi.

We describe a case of percutaneous balloon valvoplasty of a stenotic Ionescu-Shiley mitral bioprosthesis with the help of an original emboli-protecting device. The procedure reduced diastolic gradient from 29 to 9 mmHg. The calculated area of the orifice increased from 0.7 to 1.7 cm2. At 10 months follow-up examination there was no change of hemodynamic parameters.

A new device for transcatheter closure of heart defects was constructed and used to close a patent ductus arteriosus (PDA) in seven adult patients and an atrial septal defect (ASD) in six adult patients. The device consisted of two self-opening umbrellas and a piece of Ivalon. A Dacron patch was sewn on the "male" umbrella for the ASD closure. The device required a 9 Fr introducing venous sheath for PDA and a 14 Fr sheath for the ASD. The venoarterial (right femoral vein-PDA or ASD-left femoral artery) long wire track was arranged. The "male" umbrella and the Ivalon were inserted transvenously one after another, advanced over the long wire across the PDA or ASD and extruded into the aorta or left atrium, respectively. The "female" umbrella was advanced transvenously over the long wire into the pulmonary artery (for PDA) or into the right atrium (for ASD). The metal conus on the long wire was used to pull the "male" umbrella while a special stiff pusher was used to bring the "female" umbrella to the "male" umbrella along the long wire. By these means the umbrellas interlocked at the defect level and closed it. The long wire was then removed through the left femoral artery. Protrusion of the interlocked device through the PDA occurred in one patient and through the ASD in two patients. In all three patients the device was kept on the wire until surgery and an early postrelease device embolization was avoided. In all other patients the defects were successfully closed. The follow-up of 3-27 months was uneventful in all patients. These results indicate that the described procedure is effective and safe, and warrants further clinical trial.

We measured pulmonary and systemic flows in 22 patients with mitral stenosis and in 7 controls. In patients with mitral stenosis, pulmonary flow index averaged 2.33 +/- 0.41 l/min/m2 and systemic flow index averaged 2.15 +/- 0.60 l/min/m2, p = 0.045. There was a strong correlation between the difference in pulmonary and systemic flow indexes and the difference in mean left and right atrial pressure (r = 0.749, p = 0.00008). After a successful dilatation in 17 patients, there was a significant drop in the difference between pulmonary and systemic flow indexes (0.26 +/- 0.41 vs. 0.07 +/- 0.37 l/min/m2, p = 0.048). We conclude that chronic elevation of left atrial pressure leads to a left to right shunt probably through bronchial veins.

Between February 1985 and May 1987, 72 patients with mitral stenosis (MS) underwent percutaneous transluminal mitral valvuloplasty (PTMV). The retrograde transarterial double-balloon technique was used on 54/72 patients (75%); 16 males, 38 females; mean age: 39 +/- 11 years. Transseptal catheterization was used to place two 0.035", 350-cm exchange wires into the ascending aorta in order to be snared, retrieved, and exteriorized, each through a femoral artery. Over these wires, the balloon dilation catheters were advanced through the femoral artery, retrogradely, across the mitral valve, for PTMV. The transmitral mean gradient fell [18 +/- 4 to 9 +/- 5 mmHg (P less than 0.001)]; the cardiac output increased [5.1 +/- 0.8 6.1 +/- 0.8 L/min (P less than 0.001)]; the hemodynamically calculated valve area increased [1.2 +/- 0.2 to 2.3 +/- 0.6 cm2 (P less than 0.001)]; and the short axis two-dimensional echocardiographic valve area increased [1.1 +/- 0.3 to 2.2 +/- 0.7 (P less than 0.001)]. PTMV was unsuccessful in two patients (4%), due to the inability to maintain the inflated balloons in the mitral position. Significant complications were encountered in two patients: two strokes (3.7%) and one mortality from the stroke (1.4%). Significant mitral regurgitation occurred in two patients (3.7%); no post-PTMV hemodynamically significant atrial septal defects were detected. Follow-up (mean time: 11 +/- 6 months) of 43 patients showed a persistent improvement in echocardiographic findings in 27 (63%) and hemodynamically measured mitral valve area in the 16 patients in which cardiac catheterization was repeated. The retrograde, transarterial double-balloon technique can successfully accomplish PTMV with good results and an acceptable low morbidity and mortality.

A case of end-stage mitral stenosis is presented. Because of too high an operative risk surgical treatment was not advisable. Using an original technique, we performed the percutaneous transarterial balloon mitral valvotomy. The mitral diastolic pressure gradient was reduced after dilatation and there was no resultant mitral regurgitation.

A new technique was developed that allows mitral commissurotomy without surgery. A balloon catheter was inserted percutaneously from the left femoral artery over a long guidewire introduced into the right femoral vein and advanced transseptally through the Brockenbrough catheter to the left ventricle and drawn out of the body through the left femoral artery using an intravascular retriever set. This procedure was performed in 3 patients with moderate mitral stenosis. After the procedure, the mean diastolic pressure gradient across the mitral valve was reduced and left ventriculography revealed no resultant mitral regurgitation in any of the patients. The procedure was easy to perform and caused no complications.

Between February 1985 and November 1986, 36 patients, aged between 15 and 67 years (mean 39 years), with moderate (27 patients) and severe (9) mitral valvular stenosis (MS) underwent percutaneous transarterial balloon mitral valvuloplasty (PTBMV). Originally, a right femoral vein-LA-LV-aorta-left femoral artery track had been formed with a long guide wire, which had been advanced transseptally through the Brockenbrough catheter to the LV, where its distal end was caught by means of a retriever set and exteriorized through the femoral artery. Introduction of the transseptal sheath through the LA-LV to the aorta with the Swan-Ganz catheter as a guidance, made the formation of two long guide tracks much easier and enabled the application of the double balloon technique. PTBMV was performed in 15 patients using the single balloon technique with a balloon of 25 mm in diameter and in 19 patients using double-balloon technique (18 + 15 mm in one patient, 20 + 18 mm in two patients and 18 + 18 mm in 16 patients). The mitral valve gradient decreased from 18 +/- 4.3 to 8.4 +/- 4.4 mm Hg (p less than 0.001) and the mitral valve area (MVA) enlarged from 1.26 +/- 0.025 to 2.3 +/- 0.66 cm2 (p less than 0.001) (87%) immediately after valvuloplasty. PTBMV produced significant mitral regurgitation in two patients (grade IV and II). Enlargement of the MVA by 127% was achieved in patients with type A MS and only by 53% in patients with type B MS.(ABSTRACT TRUNCATED AT 250 WORDS)

Between February, 1985, and August, 1987, 76 patients with mitral stenosis underwent percutaneous transarterial mitral balloon valvuloplasty (MVP). There were 58 females and 18 males aged from 15 to 69 years (mean 39 +/- 11). In 31 patients the mitral valve was pliable (40%) and in 45 patients (60%) the valve was nonpliable. Calcified mitral stenosis was found in 24 patients (31%). Transseptal catheterization was used to place one or two 0.035" (350 cm long) exchange wires into the ascending aorta in order to be snared, retrieved and exteriorized, each one through a femoral artery. Over these wires, the balloon dilation catheters were advanced through the femoral artery, retrogradely, across the mitral valve, for mitral dilation. Single (25 mm in diameter, trefoil 3 x 12 mm, bifoil 2 x 19 mm) and double (18 and 15 mm, 18 and 18 mm, 18 and 20 mm) balloons were used in 24 and 52 patients respectively. Transarterial mitral valvuloplasty produced immediate improvement of mitral valve area (MVA = 1.1 +/- 0.3 to 2.4 +/- 0.4 cm2, p less than 0.001), mitral valve gradient (19 +/- 4 to 8 +/- 6 mmHg, p less than 0.001), echocardiographic left atrial diameter (LAD = 58 +/- 6 to 54 +/- 5 mm, p greater than 0.05) and echo-MVA (0.9 +/- 0.4 to 2.1 +/- 0.7, p less than 0.001). In three patients no MVA enlargement was achieved. A significant mitral regurgitation was produced in two patients. A stroke occurred in three patients (3.9%), one of these patients subsequently died (1.3%), one recovered and one remained hemiplegic. No atrial septal defect was found after valvuloplasty.(ABSTRACT TRUNCATED AT 250 WORDS)