POST SCDHEFT ERA: SURVIVAL AFTER FIDELIS LEAD IMPLANT

1

POST SCD-HEFT ERA SURVIVAL AFTER FIDELIS LEAD
IMPLANT
Hans Moore, Wenjie Xu, Pamela Karasik, Ed
Keung, Richard Amdur, Steve Singh, Ross Fletcher
Veterans Affairs Medical Center and Department of
Medicine, Georgetown University, Washington,
DC National ICD Surveillance Center, San
Francisco
Georgetown University
Abstract
Objectives
(Q)?
Introduction We studied survival following
Medtronic Sprint lead implant, and found that
year-of-implant impacts survival. Sprint 6945 and
Quattro 6947 leads (Q) were released 7 and 3
years prior to SCD-HeFT. Fidelis leads (F) were
not released until after SCD-HeFT. We compared
post-implant veteran (V) survival for all F to a
year-of-implant matched cohort of (Q).
Methods Data from ICD implants between 6/1/04
and 9/1/06 reported to the Veterans
Administration National ICD Surveillance Center
were extracted, cross matched with Carelink
website, and retrospectively analyzed for
post-implant survival. Cox regression analysis
was used to control for age at implant (AGE),
time-at-risk, and biventricular lead (BIV)
implant. Results A total of 3262 V were implanted
with F (2664) or Q (598). The average age was 65
years. The average time at risk following F was
743 days, compared to 1034 days for Q. AGE
(pOnly AGE remained significant after covariate
analysis (pat implant increased the cumulative risk of death
during the study period by 5.1.
Conclusions Survival of V following F does not
differ from Q, implanted in the post SCD-HeFT
era. Our analysis minimized the effect of the
year-of-implant, which we found is related to
survival. Prophylactic removal of F does not
seem indicated. Continued F surveillance and Q
implant are appropriate. Age at implant has a
significant effect upon post-implant survival.
In prior analysis, we found that age at implant
and year of implant had significant effects upon
survival after ICD lead implant. It was proposed
that changes in patient selection driven by
randomized trials might influence survival
outcomes in quality assurance analysis. Therefore
to understand the difference in survival of
veterans implanted with Fidelis compared to
Sprint Quattro leads, we studied only implants
after SCD-HeFT was released. We compared
post-implant survival for veterans implanted with
Fidelis, to a year of implant matched cohort of
Sprint Quattro ICD leads.
(F)?
Methods

• Veterans were identified from the Veterans
  Administration National ICD Surveillance Center,
  a quality assurance effort tracking veterans
  following ICD implant from 118 Veterans Affairs
  Medical Centers.
• The Medtronic Carelink web based database also
  tracks patients implanted with leads or ICD of
  their make.
• Data of patients implanted with Medtronic Sprint
  6945 and Sprint Quattro 6947 leads, and Sprint
  Fidelis 6930, 6931, 6948, and 6949 leads between
  6/1/2004 and 9/1/2006 were extracted.
• The data from the two sources were cross-matched
  for accuracy.
• Death as of 10/23/07 was assessed through VA data
  sources and confirmed by the Social Security
  Death Index.
• Cox regression analysis (COX) was used to control
  for age at implant, biventricular lead presence,
  and time-at-risk.
• Veterans were assessed for survival in the first
  1000 days post implant to match recall data and
  implant duration for the Fidelis compared to the
  Sprint and Quattro leads.

• In Kaplan-Meier analysis, the effect of lead-type
  on survival time was not significant (chi square
  0.05, df1, p.82).
• Only age-at-implant made a significant
  contribution to the regression equation
  (pimplant increased the cumulative risk of death
  during the study period by 5.1.

Discussion
Introduction

• Changes in patient selection, which are largely
  driven by randomized controlled trials, may
  influence survival outcomes for standard
  therapies.
• Quality assurance analysis need to consider
  evolving selection criteria when retrospectively
  reviewing large uncontrolled datasets.
• Is the impact of age at implant on survival
  influenced by changes in patient selection from
  an aging population?

Medtronic recalled Sprint Fidelis leads Models
6930, 6931, 6948 6949 (F) on 10/20/08 due to a
failure rate of 2.3. Implant of larger diameter
Sprint 6945 and Sprint Quattro 6947 leads (Q),
with failure rate of 0.9, is advised. From the
Veterans Affairs National ICD Surveillance Center
database, Kaplan Meier survival analysis showed
significantly lower survival following implant of
the Fidelis compared to Sprint Quattro ICD
leads. Actual lead failure was rarely
identified.
Conclusions
Results

• A total of 3262 V were implanted with F (2664) or
  Q (598).
• The average age was 65 years.
• The average time at risk following Fidelis was
  743 days, compared to 1034 days for Quattro (6945
  6947).
• Only age at implant remained significant after
  covariate analysis (p
• Each additional year of age at implant increased
  the cumulative risk of death during the study
  period by 5.1.

• In the Post SCD-HeFT ERA, Survival of Veterans
  following Fidelis implant does not differ from
  survival following Sprint Quattro implant.
• Prophylactic removal of F does not seem
  indicated.
• Continued F surveillance is appropriate.
• Age at implant has a significant effect upon
  post-implant survival.

Presenter has no financial disclosures related to
this presentation.
PO2-87 Heart Rhythm Vol. 5, No. 5, May
Supplement 2008, S191.