Natasha Loghmanpour1, Gail Siewiorek1, Kelly Wanamaker2, Mark Wholey3, Rabih Chaer3, Satish Muluk2, Ender A. Finol4
1Carnegie Mellon University, Pittsburgh, PA; 2West Penn Allegheny Health System, Pittsburgh, PA; 3The University of Pittsburgh Medical Center, Pittsburgh, PA; 4The University of Texas at San Antonio, San Antonio, TX.
OBJECTIVES: To review retrospectively records of patients treated with carotid artery stenting (CAS) to investigate correlations between clinical variables, distal protection filter (DPF) characteristics, and 30-day peri-/post-procedural outcomes.
METHODS: This is a multicenter, single-arm study of DPF-protected CAS in the Pittsburgh region between 2000 and 2011. Analysis of peri/post-procedure complications included myocardial infarction (MI), transient ischemic attacks (TIA), stroke, death, and a composite of all adverse events (AE). Characteristics for the DPFs were previously determined in vitro and were used to find correlations with CAS outcomes. Univariate, multivariate, and goodness-of-fit analyses were performed.
RESULTS: 731 CAS procedures employing six different DPF were analyzed. Peri/post-procedural AE included 19 TIAs (2.6%), 38 strokes (5.2%), 1 MI (.1%), 19 deaths (3.6%) and a total of 61 patients with complications (8.3%). Univariate analysis for filter design characteristics showed that the composite of AE was negatively associated with both vascular resistance (p=.01) and eccentricity (p=.02), and positively associated with porosity (p=.0007), number of pores (p=.005), and pore density (p=.001). Multivariate analysis and the goodness-of-fit test revealed that history of congestive heart failure (CHF), stroke, and TIA (each with OR>1) led to a good-fit model p-value of .72 for peri/post-procedural AE. Multivariate analysis was inconclusive for all filter design characteristics.
CONCLUSIONS: The following filter design characteristics are independently significant for lower peri/post-procedural AEs: higher vascular resistance, concentric in shape, greater capture efficiency, lower porosity, lower number of pores and lower pore density. This information can be used when considering the desirable design characteristics of future DPFs, but our data also demonstrate that the patient's clinical features have overriding importance as predictors of AEs.
AUTHOR DISCLOSURES: R. Chaer, Nothing to disclose; E. A. Finol, Nothing to disclose; N. Loghmanpour, Nothing to disclose; S. Muluk, Nothing to disclose; G. Siewiorek, Nothing to disclose; K. Wanamaker, Nothing to disclose; M. Wholey, Cordis, Consulting fees or other remuneration (payment), Abbott, Consulting fees or other remuneration (payment), Boston Scientific, Consulting fees or other remuneration (payment).
Posted April 2012