nitinol and Drug-Hypersensitivity

There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity. Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure.

Topics: Adult; Alloys; Cardiac Catheterization; Drug Hypersensitivity; Female; Fluoroscopy; Foramen Ovale, Patent; Humans; Male; Middle Aged; Nickel; Prosthesis Design; Septal Occluder Device; Treatment Outcome; Young Adult

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