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.

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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.

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