Percutane hartklep implantatie bij congenitale en ... - KCE

30 Percutaneous Heart Valves KCE Reports 95
Mean age of patients was 82.4±4.6 (range:65-93) years. Logistic EuroSCORE was
27.6±12.2. A “technically possible implantation” was reported in all patients although in
their previous report, valve implantation reportedly was not successful in 1 of 30
patients. Moreover, in three patients early conversion to conventional sternotomy was
needed because of valve dislocation or coronary problems that had been induced by the
procedure. Based on this interpretation, we re-calculated an immediate success rate of
46/50 (92%). At 30 days postoperatively, four patients (8%) had died. Actuarial survival
at 1 month, 6 months and 1 year was 92±3.8%; 73.9±6.2% and 71.4±6.5% respectively.
At inception, patients were in NYHA functional class III or IV. No post-procedural data
related to quality of life or functional class were provided.
A multicentre report, initiated by the Leipzig group and incorporating experience from
Vienna, Frankfurt and Dallas, was reported shortly after publication of the first single
centre experience. 67 It covers a time window from February 2006 to October 2006.
Fifty-nine patients (81±6 years, 44 female) were operated at 4 centres. Average
EuroSCORE was 11.2±1.8. Transapical PAV valve positioning was performed
successfully in 55 patients (93%), and 4 required early conversion to sternotomy.
Thirty-one patients were operated without the use of ECC. Post procedural
echocardiography revealed paravalvular leakage in 26 patients (trace in 11, mild in 12,
and severe in 3). Eight patients died in-hospital (13.6%). Actuarial survival was 75.7±5.9%
at a follow-up interval of 110±77 days (range 1 to 255 days) (Table 3.3). The authors did
not provide data on post-procedural functional status or quality of life.
Very recently, Svensson et al. reported on a Food and Drug Administration (FDA)
approved feasibility study incorporating 40 patients treated between December 2006
and February 2008 with a transapical inserted Edwards equine or bovine PAV. 34 Patients
were required to be at least 70 years, to present with severe aortic stenosis (valve area
≤0.6 cm²) and considered inoperable or at very high risk for surgery. Their EuroSCORE
was 35.5±15.3% Mean age was 83.0±7.5 (range:69-93) years. A 33F sheath was used in
the first 20 patients and 26F in de second 20. Ten patients required ECC because of
intraoperative problems. Successful seating of the PAV was obtained in 35 patients,
while in 5, open AVR was needed because of migration of the PAV or because of severe
aortic regurgitation. There were 3 deaths at the day of operation. There were seven
30-day deaths (17.5%) and 9 (22.5%) in-hospital deaths (Table 3.3). From baseline to 30day
follow-up, mean effective aortic valve area increased from 0.62±0.12 to 1.61±0.37
cm². At 30 days, no perivalvular leakage was present in 19%, grade 1 in 46%, grade 2 in
31%, grade 3 in 4%, and grade 4 in none. One patient underwent delayed operative
aortic valve replacement for perivalvular leakage. On follow-up after discharge from
hospital, 6 additional patients died. The Kaplan-Meier curves showed 81.8% (1 month),
71.7% (3 months), and 58.7% (6 months) survival. Mean NYHA class at inception was
3.33; at 1 month it was 2.25, at 3 months 1.81 and at 6 months 2.08. Quality of life
scores improved from preoperatively (SF-12 Physical 28.7, SD 6.1; Mental 48.1, SD 11.5)
to postoperatively at 6 months (SF-12 Physical 35.2, SD 7.4; Mental 50.4, SD 11.7).
Interestingly, the authors also report the fate of patients that were referred to their
respective institutions for potential PAV insertion, but who ultimately were not treated
with a PAV. Of the 71 patients referred to Medical City Hospital, Dallas, 14.1% (n = 10)
received a conventional surgically inserted valve (no peri-operative deaths) and 21% (n
= 15) transapical or transfemoral PAV with 13.3% mortality. 46 patients (65%) were
further treated medically. For the 92 patients referred to the Cleveland Clinic, 20% (n =
19) had conventional open surgery with no operative deaths, 19.6% (n = 18) underwent
transapical or transfemoral PAV with 5% 30-day deaths, and 20% (n = 19) underwent
balloon valvuloplasty with 4% mortality. 36 patients (39%) were further treated
medically. The authors conclude that for patients referred for screening for PAV, open
conventional surgery is preferable if deemed feasible by experienced surgeons, with no
deaths in their series.