nitinol and Heart-Defects--Congenital

A 25-year old woman with complicated cyanotic heart disease and a large persistent left superior vena cava (PLSVC) with dysplasia of the innominate vein draining into the left atrium underwent cardiac surgery. Six months later, the narrowed PLSVC was successfully occluded using a muscular ventricular septal occluder (nitinol wire mesh). No complications occurred during or immediately following the catheterization. This case report is the first to describe the utilization of a hybrid method to occlude a narrowed PLSVC after cardiac surgery.

Topics: Adult; Alloys; Cardiac Surgical Procedures; Catheterization; Female; Heart Defects, Congenital; Humans; Phlebography; Prosthesis Design; Septal Occluder Device; Treatment Outcome; Vascular Malformations; Vena Cava, Superior

Transcatheter closure has become the method of choice for treatment of many heart defects. Recently, Lifetech Scientific introduced the Cera occluder (CO), a self-expandable nitinol wire-mesh device covered with ceramic coating. We present our preliminary experience in transcatheter closure of atrial septal defect (ASD), patent foramen ovale (PFO), patent ductus arteriosus (PDA), and post-infarction ventricular septal defect (PIVSD) with the CO.. The study population consisted of 25 patients (17 female) ages 1.1-82 years (median age, 34.0 years) with either ASD (n = 7), PFO (n = 11), PDA (n = 6), or PIVSD (n = 1). All patients were treated percutaneously with appropriate CO devices, without any preliminary patient selection. The implantation technique applied in these procedures was the same as previously described for Amplatzer occluders.. All procedures were performed successfully. Complete shunt closure was achieved in all but 1 patient with PIVSD. No complications were observed during procedures or during follow-up of 0.5-4 months.. Our preliminary experience in the clinical application of COs for transcatheter closure of ASD, PFO, PDA, and PIVSD has confirmed their utility, feasibility, and safety, at least in the short-term follow-up.

Topics: Adult; Alloys; Cardiac Catheterization; Echocardiography, Transesophageal; Female; Heart Defects, Congenital; Heart Septal Defects, Ventricular; Humans; Male; Prosthesis Design; Prosthesis Implantation; Prosthesis Retention; Retrospective Studies; Septal Occluder Device; Treatment Outcome

Topics: Alloys; Animals; Aortic Valve; Aortic Valve Insufficiency; Bicuspid Aortic Valve Disease; Cardiac Catheterization; Femoral Artery; Heart Defects, Congenital; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Incidence; Models, Animal; Prosthesis Design; Stents; Treatment Outcome

Topics: Alloys; Aortic Valve; Bicuspid Aortic Valve Disease; Bioprosthesis; Cardiac Catheterization; Heart Defects, Congenital; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Polyesters; Prosthesis Design; Stents; Treatment Outcome

Nickel allergy (NA) occurring after implantation of a nitinol-containing device is rare and not well understood. This study aimed to evaluate the current practices and experience of interventional cardiologists with NA after closure of congenital heart defects (CHD) with nitinol-containing devices.. E-mail invitations were sent to the 96 members of the Congenital Cardiovascular Interventional Study Consortium (CCISC). The survey was Internet-based and mainly consisted of multiple-choice questions.. A total of 50 responses (52%) were returned and the median number of device closures was 300 for all responders. While 80% of responders believe that NA exists, only 44% routinely inquire about NA prior to device closure and no responders perform skin testing prior to device closure. Slightly more than half of responders (58%) utilize antiplatelet medications (97% aspirin) in the days prior to device closure. Of the 50 survey responders having a total experience of 16,075 implants, 7 operators reported 33 cases of NA among 1,600 implants. Atrial septal defect closure was associated with all well-described cases of NA. Reaction occurred anywhere from 2 days up to 1 month after implantation and manifested as headaches, rash/urticaria, difficulty breathing, fever or pericardial effusion. All patients responded to medical management and no longer require medication.. While a majority of interventional cardiologists believe that NA exists, it remains a rare and poorly defined phenomenon. Although CCISC survey responders indicate that their patients with NA responded to medical therapy, further investigation of risk factors and safety is warranted.

Topics: Alloys; Aspirin; Cardiac Catheterization; Data Collection; Drug Hypersensitivity; Female; Heart Defects, Congenital; Humans; Internet; Male; Nickel; Platelet Aggregation Inhibitors; Risk Factors

Control of distal pulmonary artery (PA) pressure and flow is a critical step in palliating infants with complex congential heart disease. Surgical procedures to protect or isolate the pulmonary circulation carry significant risk and can be unpredictable. Interventional control of pulmonary pressure/flow with an intravascular device (band) could reduce risk and improve regulation of pulmonary flow.. Internal pulmonary bands were created from woven nitinol to create an internal orifice estimated to reduce distal pulmonary arterial pressure by 50%. Two designs were tested, a single eccentric lumen and two symmetrical lumens. The devices were approximately 7-mm long and the external diameter varied to suit the pulmonary arterial lumen size. A total of 15 devices were implanted in seven lambs with a stented ductus arteriosus to create high pulmonary pressure/flow. Four lambs were followed with devices and stent in place for a mean of 37 +/- 13 days.. Fourteen of 15 devices were successfully implanted. One was acutely removed since the size was too large. Both device designs created greater than a 50% reduction in distal pulmonary pressure. Main PA pressure was 70/38, mean 50 +/- 13 mm Hg, and distal PA pressure 25/16, mean 20 +/- 7 mm Hg (P < 0.05). Angiography demonstrated protection of the internal banded pulmonary segments from overcirculation. Late follow-up showed that the device lumen(s) remained patent. Histology showed the vessel media to be intact but there was intimal proliferation where the device approximated the wall. There were no thrombotic emboli detected.. Percutaneous internal banding of the pulmonary arteries was feasible and successful in lambs with high pulmonary flow/pressure analogous to infants with complex congenital heart disease.

Topics: Alloys; Angiography; Animals; Animals, Newborn; Blood Pressure; Cardiac Catheterization; Disease Models, Animal; Ductus Arteriosus; Equipment Design; Feasibility Studies; Heart Defects, Congenital; Hypertension, Pulmonary; Pulmonary Artery; Pulmonary Circulation; Sheep; Stents; Time Factors; Vascular Patency; Vascular Surgical Procedures