Replacement of the proximal aorta and aortic valve using a composite bileaflet prosthesis and gelatin-impregnated polyester graft (Carbo-Seal): early results in 143 patients.
OBJECTIVE
We report the combined early results from two centers in the United Kingdom using a composite conduit consisting of a bileaflet mechanical valve incorporated into a gelatin-impregnated, ultra-low porosity, woven polyester graft (Carbo-Seal; Sulzer Carbomedics, Inc, Austin, Tex).


METHODS
Between August 1992 and March 1997, 143 patients underwent aortic root replacement with the Carbo-Seal composite prosthesis. The indication for surgery was acute type A dissection in 31 (22%), chronic type A dissection in 9 (6%), ascending aortic aneurysm without dissection in 100 (70%), and false aneurysm of the ascending aorta in 3 (2%). Twenty-seven patients (19%) had undergone previous sternotomy, and 40 (28%) were seen as emergencies. Concomitant procedures were performed in 38 (27%), including 18 aortic arch or hemiarch replacements. Total follow-up is 270 patient-years. Follow-up is 100% complete.


RESULTS
The early (30-day) mortality was 7% (10 patients). Permanent neurologic events occurred in 2%. At a mean follow-up of 23 months, 94% of survivors were in New York Heart Association functional class I. Freedom from reoperation was 97.2% +/- 1.6% (1 standard error [1 SE]) at 12 months and 95.7% +/- 2.2% at 48 months. Including early mortality, survival was 90.1% +/- 2.6% at 12 months and 83.1% +/- 3. 5% at 48 months.


CONCLUSIONS
Aortic root replacement with use of the Carbo-Seal prosthesis can be undertaken with a relatively low early mortality and morbidity. A low reoperation rate and high intermediate-term survival can be expected, but continued follow-up is needed to determine the long-term efficacy of this prosthesis.
Langley
S M
SM
Wessex Cardiothoracic Centre, Southampton General Hospital, Southampton, United Kingdom. StephenLangley@dial.pipex.com
Rooney
S J
SJ
Dalrymple-Hay
M J
MJ
Spencer
J M
JM
Lewis
M E
ME
Pagano
D
D
Asif
M
M
Goddard
J R
JR
Tsang
V T
VT
Lamb
R K
RK
Monro
J L
JL
Livesey
S A
SA
Bonser
R S
RS
D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000601:surgery; D017541:Aneurysm, False / Q000601:surgery; D001011:Aorta / Q000601:surgery*; D001013:Aorta, Thoracic / Q000601:surgery; D001014:Aortic Aneurysm / Q000601:surgery; D001021:Aortic Valve / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation; D005260:Female; D005500:Follow-Up Studies; D005780:Gelatin; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination; D011091:Polyesters; D016062:Porosity; D011474:Prosthesis Design; D012086:Reoperation; D013249:Sternum / Q000601:surgery; D013499:Surface Properties; D015996:Survival Rate; D016896:Treatment Outcome
D011091:Polyesters; D005780:Gelatin