Development of a multicenter peripheral arterial interventional database: the PVD-QI2.
BACKGROUND
The number of peripheral vascular intervention (PVI) procedures performed is steadily increasing in the United States. PVD-QI 2 is a prospective, multicenter observational study designed to improve the quality of care for patients undergoing PVI and to better understand the effectiveness and appropriateness of PVI in improving outcomes of peripheral arterial disease. The registry aims to elucidate which comorbid conditions and procedure-related variables are associated with beneficial or adverse outcomes after vascular interventions.


METHODS
Five centers are currently prospectively collecting data on consecutive PVIs performed at their institutions and will include patients with both claudication and critical limb ischemia. A common data collection form and a standard set of definitions were developed during several planning meetings. Information on patient demographics, clinical history, comorbid conditions, treatment approaches, and in hospital outcomes are being collected. Patients will be followed up at 30 days, 6 months, and 1 year after each procedure to identify recurrent vascular events, medication use, lifestyle modifications (regular exercise, dietary modification), self-reported walking scores, and mortality. Data validity will be assured through review of data form accuracy by a trained nurse, by automatic database diagnostic routines, and by site visits that include review of angiography suite logs and randomly selected charts.


CONCLUSIONS
The development of a quality-controlled PVI registry requires the commitment and collaboration of clinician-investigators and hospital systems devoted to understanding factors that contribute to quality outcomes. Central to achievement of this goal is the creation of a careful diagnostic and data quality assessment system. This registry will provide important clinical insights into patient demographic and clinical characteristics, procedural characteristics, and current practice patterns that foster or impede achievement of long-term quality-based clinical outcomes for patients with peripheral arterial disease.
Mukherjee
Debabrata
D
Gill Heart Institute, Division of Cardiovascular Medicine, Lexington, KY 40436-0200, USA.
Munir
Khan
K
Hirsch
Alan T
AT
Chetcuti
Stanley
S
Grossman
Paul M
PM
Rajagopalan
Sanjay
S
Nallamothu
Brahmajee K
BK
Moscucci
Mauro
M
Henke
Peter
P
Kassab
Elias
E
Sohal
Chaman
C
Riba
Arthur
A
Person
Donna
D
Luciano
Ann E
AE
DeGregorio
Michele
M
Patel
Kiritkumar
K
Rutkowski
Karen C
KC
Eagle
Kim A
KA
D016208:Databases, Factual; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy*; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D012042:Registries; D012107:Research Design