title: Hybrid procedures: adverse events and procedural characteristics--results of a multi-institutional registry.
abstract: BACKGROUND
  Procedural cooperation between cardiac surgeon and interventional cardiologist to facilitate interventions such as device delivery or angioplasty (hybrid procedure) has become increasingly common in the management of patients with congenital heart disease.
  
  
  METHODS
  Data were prospectively collected using a multicenter registry (C3PO). Between February 2007 and December 2008, seven institutions submitted data regarding 7019 cardiac catheterization procedures. Procedural data and adverse events (AEs) of 128 hybrid procedures were evaluated.
  
  
  RESULTS
  There was significant variability in the number of hybrid procedures per center, ranging from one to 89 with a median of eight. A total of 60% of interventional (vs. strictly diagnostic) hybrid procedures were performed by one center. The median weight was 3.7 kg (0.7-86 kg). Single-ventricle circulation was present in 60% of the procedures. Hybrid procedures included: patent ductus arteriosus (PDA) stent placement (n = 55), vascular rehabilitation (n = 25), ventricular septal defect (VSD) device closure (n = 7), valvotomy (n = 3), and diagnostic hybrid procedures (n = 38). Sixteen AEs occurred in 15/128 (12%) procedures. These included minor or trivial AEs (n = 9), moderate AEs (n = 5), major AEs (n = 1), and catastrophic AEs (n = 1). The type of AE documented included arrhythmias (n = 6), hypoxia or hypotension (n = 3), vessel or cardiac trauma (n = 2), and other events (n = 5). Of documented AEs, 9/16 (56%) were classified as not preventable, 6/16 (38%) as possibly preventable, and 1/16 (6%) as preventable. The incidence of AE related to PDA stent placement with surgical exposure (5/50, 10%) was significantly lower when compared with PDA stent placement performed percutaneously (4/5, 80%, P= .002).
  
  
  CONCLUSIONS
  Hybrid procedures appear to have a low incidence of associated major AEs. PDA stent placement performed as a palliation of hypoplastic left heart syndrome (HLHS) or complex single/two ventricle patients may have a lower incidence of AEs if performed using a direct approach with surgical exposure rather than a percutaneous approach. Accurate definitions of these innovative procedures are required to facilitate prospective data collection.
authors.affiliation: Department of Cardiology, Nationwide Children's Hospital, Columbus, Ohio 43205, USA. ralf.holzer@nationwidechildrens.org
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.forename: Audrey
authors.initials: A
authors.lastname: Marshall
authors.forename: Jackie
authors.initials: J
authors.lastname: Kreutzer
authors.forename: Russel
authors.initials: R
authors.lastname: Hirsch
authors.forename: Joanne
authors.initials: J
authors.lastname: Chisolm
authors.forename: Sharon
authors.initials: S
authors.lastname: Hill
authors.forename: Mark
authors.initials: M
authors.lastname: Galantowicz
authors.forename: Alistair
authors.initials: A
authors.lastname: Phillips
authors.forename: John
authors.initials: J
authors.lastname: Cheatham
authors.forename: Lisa
authors.initials: L
authors.lastname: Bergerson
mesh_terms: D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation / Q000706:statistics & numerical data; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000295:instrumentation / Q000706:statistics & numerical data; D002648:Child; D002675:Child, Preschool; D003299:Cooperative Behavior; D006330:Heart Defects, Congenital / Q000175:diagnosis* / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010166:Palliative Care; D010348:Patient Care Team; D018579:Patient Selection; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome; D014481:United States