Transcatheter closure of patent ductus arteriosus with the use of Rashkind occluders and/or Gianturco coils: long-term follow-up in 123 patients and special reference to comparison, residual shunts, complications, and technique.

BACKGROUND: This report describes the long-term follow-up of transcatheter closure of patent ductus arteriosus (PDA) with 2 different modalities in 123 patients of diverse ages. METHODS AND RESULTS: Between October 1990 and August 1997, 123 patients underwent transcatheter PDA (1.9 to 7.5 mm) closure at a mean age of 6.8 +/- 8.9 years (range 0.06 to 52) and mean weight of 20.9 +/- 17. 6 kg (range 2.7 to 83). In the initial procedure, the Rashkind device was used in 60, the Gianturco coil(s) in 60, and the Rashkind device with a coil in 3 patients. Six-month closure rate for the Rashkind group was 77% versus 90% for the coil group. The second procedure was carried out for residual shunt in 19 (14 in the Rashkind group and 5 in the coil group) and a third procedure in 1 patient from the Rashkind group. A balloon wedge catheter was used in 50 of 78 coil procedures to prevent coil embolization. One device and 11 coils (8 without balloon aid) embolized to the pulmonary arteries. The device and all coils except 2 were retrieved successfully. Overall, 122 (99%) patients showed complete PDA closure. The mean uneventful follow-up period was 44.11 +/- 23.77 months (range 8.7 to 90.28). CONCLUSIONS: Transcatheter closure of PDA is feasible in infants as well as in patients >50 years of age without significant complications. The coils are easy to implant, less expensive, and multiple coils may be used in moderately large (>3.5 mm) ducts more effectively than with the Rashkind device. The use of a balloon wedge catheter prevents immediate coil embolization. Multiple procedures are feasible and safe to achieve complete closure.

Relation between serum cardiac troponin I values and severity of clinical, electrocardiographic and quantitative angiographic features in unstable angina.

This study sought to find out a correlation, if any, between serum cardiac troponin I values and extent and severity of coronary artery disease in patients with unstable angina. Eighty patients with unstable angina and normal serum creatine kinase values were studied and a comparative evaluation of serum cardiac troponin I values with clinical findings, electrocardiography, quantitative coronary angiography and follow-up events was performed. Among 80 patients, 34 (43%) had cardiac troponin I values of 0.6 microgram/L or higher (group I) and 46 (57%), below 0.6 microgram/L (group II). The mean cardiac troponin I in group I was 2.6 +/- 1.7 micrograms/L and 0.2 +/- 0.1 microgram/L in group II. The patients in group I had more type C lesions, frequent triple vessel and left main coronary artery involvement, and higher mean percentage diameter stenosis in the coronary arteries than those in group II. Early follow-up showed that more patients in group I required procedures earlier (including PTCA and CABG) than those from group II. Mid-term follow-up (9.5 +/- 4 months) data also showed greater occurrence of cardiac events (i.e. myocardial infarction and the increased need of PTCA) in group I. Patients with elevated cardiac troponin I more often experienced Braunwald's class III (A and B) unstable angina associated with presence of marked ST-T changes on the electrocardiography than those from group II. Our study suggests elevated values of serum cardiac troponin I to be evenly associated with the severity and extent of coronary lesions, clinical severity of unstable angina and marked electrocardiographic changes. Follow-up results confirm the potential value of this marker in predicting the course of coronary artery disease.

Transcatheter closure of ventricular septal defects using the Rashkind device: initial experience.

We report our initial experience with transcatheter closure of ventricular septal defects (VSD) using the Rashkind device. Transcatheter closure of 25 VSDs was attempted in 16 patients with a median age of 2 (range 0.1-4) years and a median weight of 11 (range 4.1-19) kg. The location of the VSDs was apical in 14, midmuscular in 8, and anterior muscular in 3. Five patients had complex heart lesions, 10 patients had associated defects, including perimembranous VSD, atrial septal defect, patent ductus arteriosus, and coarctation of aorta. The remaining patient had isolated multiple muscular VSDs. The surgical repair of VSDs was a high-risk option in all the patients. Of the 25 attempted closures, 22 devices were placed successfully. Nine patients had a single device, four patients had two devices each and one patient had a total of five devices placed. In two patients attempts to close three VSDs were associated with major problems/death. Fourteen patients have been followed up for at least 1 year and all are doing well. Five patients, who otherwise remain asymptomatic, have a trace residual shunt. The fluoroscopy time ranged from 51 to 205 min (median 110) and the procedure time 120 to 300 min (median 200). The transcatheter closure of VSDs acts as a palliation as well as a definitive therapeutic modality in some patients with surgically inaccessible VSDs. Deployment of multiple devices in a patient is feasible. Increased experience may diminish the initial rate of complications.

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.

Primary stenting of de novo lesions in small coronary arteries: a prospective, pilot study.

Technical advancement and new anti-thrombotic regimens have recently shown so much improvement in the results of coronary stenting that the conventional contra-indication for stenting in small coronary arteries (<3 mm) needs to be revised. We undertook a prospective pilot study of elective Palmaz-Schatz stenting in de novo lesions located in coronary arteries of less than 3 mm diameter. Fifty consecutive patients (63 +/- 9 years) with stable (n = 38) and unstable angina (n = 12) were included. Philips-DCI quantitative coronary analysis was used to measure reference diameter, minimal lumen diameter and percent diameter stenosis before PTCA, after stenting and at 6-month angiographic follow-up study. All measurements were performed after intracoronary injection of nitroglycerin (300 microg). All patients received ticlopidine (250 mg/day) and aspirin (100 mg/day). The mean lesion length was 9 +/- 3 mm. The balloon size used for stent delivery was 2.75 mm in 30 patients and 2.5 mm in 20 patients and the mean balloon inflation pressure used for stent deployment was 12 +/- 2 atm. All stents were deployed successfully. In-hospital complications occurred in two patients, diagonal branch occlusion at day 2 requiring emergency PTCA in one and a hematoma at the femoral puncture site requiring surgery in the other. Major adverse cardiac event (MACE) rate remained 2% (nonfatal infarct in one). Follow-up angiography (n = 46, 92%) at 6 +/- 3 months showed a 30% restenosis rate. Target vessel revascularization (TVR) rate was 13%. We conclude that elective stenting in small coronary arteries is feasible and involves an acceptable risk of restenosis.