Aneurysm Papers of the Month - April 1996

It was a quiet month.  I am putting up only one brief
abstract of a scientific paper and one short summary of
a letter to the editors of the JVS.

1. Moore WS, Rutherford RB, for the EVT Investigators. 
Transfemoral endovascular repair of AAA: Results of the
North American EVT phase 1 trial.  J Vasc Surg  1996; 23:
543-53.

Purpose: Describe results of a phase I trial of
endovascular repair of AAA, conducted under FDA protocal
in 13 US medical centers from Feb 93 to Dec 94.

Methods: Forty six patients, ages 54-84, were subjects of
the study.

Results: Thirty nine (85%) were successful; average
operating time a little over 3 hours.  The seven
unsuccessful attempts were converted to standard open
procedures without complication.  There were no 30-day
deaths.  Leakage outside the graft but within the AAA sac
was observed in 17 grafts, of which nine leaks resolved
spontaneously.  Of the eight persistent leaks, two have
been repaired (1 surgically and 1 by endovasc methods). 
The remaining six patients have had no evidence of AAA
enlargement.  Metallic fracture, a device-related
malfunction, was identified in nine implants, which led
to one removal.

Conclusions: EV repair appears to be safe and
efficacious.  Long-term results are as yet unknown, but
the long-term results of peri-graft leakage into the AAA
sac "are unknown but worrisome."

Comment by mdt:  These encouraging results are the
product of persistence and dedication on the part of many
cooperating institutions and persons.  The future for
this approach certainly seems good, but as the authors
caution, the long-term results are as yet unknown.  I tip
my hat to Harrison Lazarus, a friend and
surgeon/innovator, whose initial work led to the
development of this device.  As I have said before, the
use of this approach should still be limited to
investigational centers until it is shown to be as
effective and safe on a long-term basis as conventional
repair.


2. Sara J, Laara E, Juvonen T.  Intraluminal thrombus
predicts repture of an AAA.  J Vasc Surg  1996; 23: 737-
9.

I mention en passant this letter to the editors of the
JVS, which presents data that substantially confirm the
observations (previously presented in the papers of the
month) of my late friend, Gene Bernstein.  The authors
conclude that "the thickness of the endoluminal thrombus
is clearly associated with the risk of rupture...". 
Every investigator is thrilled by rapid confirmation of
a scientific claim, and I wish Gene were still alive to
enjoy this.