Early clinical experience with the E-vita thoracic stent-graft system: a single center study.
OBJECTIVE
The aim of this study was to evaluate the safety and efficacy of a new endovascular thoracic stent-graft, which was designed to overcome the restrictions of previously used stent-grafts.


METHODS
Between May 2004 and March 2008 a prospective evaluation was conducted in 126 consecutive patients (71% men; age 64 [19-86] years). A total of 138 implantations were performed. E-vita stent-grafts were implanted for type-B dissection (N.=56), degenerative aneurysm (N.=25), penetrating aortic ulcer (N.=17), blunt traumatic lesions (N.=10), mobile atheroma (N.=1), suture aneurysms (N.=7) and revisionary surgery following previous endograft implantation (N.=22). All patients eligible for stent-grafting were treated with this system regardless of their clinical status and aortic pathology. The percentage of emergency procedures was 52% (N.=72). Per implantation a mean of 1.3 segments was implanted with an effective total covered length of the aorta of mean 204 mm, median 230 mm (0-450 mm). In 32 of 39 cases with more than one segment, the entire descending aorta was included in the procedure.


RESULTS
The 30-day mortality rate was 12.3% (17 patients). All deaths but one were in the group of emergency surgery patients. This results in mortality of 1.5% in the elective and 22% in the emergency procedures. Reversible procedure-induced spinal cord ischemia was observed in 2 cases. Stroke occurred in 2.8% (4 patients). Primary technical success was rated at 77 % (106 procedures) and secondary success at 89 % (124 procedures).


CONCLUSIONS
All forms of thoracic aortic disease can be treated with this new stent-graft. It has proved particularly valuable in cases of difficult conditions in the aortic arch and extended aneurysms. In particular, it is possible to cover the entire thoracic aorta with two or three stent-graft segments, thus considerably reducing the number of connections.
Zipfel
B
B
Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany. zipfel@dhzb.de
Buz
S
S
Hammerschmidt
R
R
Krabatsch
T
T
Duesterhoeft
V
V
Hetzer
R
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001013:Aorta, Thoracic / Q000000981:diagnostic imaging / Q000601:surgery*; D001018:Aortic Diseases / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005858:Germany; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D020760:Spinal Cord Ischemia / Q000209:etiology; D015607:Stents; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome