Acquired cardiovascular disease
Are stentless valves hemodynamically superior to stented valves? Long-term follow-up of a randomized trial comparing Carpentier–Edwards pericardial valve with the Toronto Stentless Porcine Valve

Read at the Eighty-eighth Annual Meeting of The American Association for Thoracic Surgery, San Diego, Calif, May 10–14, 2008.
https://doi.org/10.1016/j.jtcvs.2009.04.067Get rights and content
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Objective

The benefit of stentless valves remains in question. In 1999, a randomized trial comparing stentless and stented valves was unable to demonstrate any hemodynamic or clinical benefits at 1 year after implantation. This study reviews long-term outcomes of patients randomized in the aforementioned trial.

Methods

Between 1996 and 1999, 99 patients undergoing aortic valve replacement were randomized to receive either a stented Carpentier–Edwards pericardial valve (CE) (Edwards Lifesciences, Irvine, Calif) or a Toronto Stentless Porcine Valve (SPV) (St Jude Medical, Minneapolis, Minn). Among these, 38 patients were available for late echocardiographic follow-up (CE, n = 17; SPV, n = 21). Echocardiographic analysis was undertaken both at rest and with dobutamine stress, and functional status (Duke Activity Status Index) was compared at a mean of 9.3 years postoperatively (range, 7.5–11.1 years). Clinical follow-up was 82% complete at a mean of 10.3 years postoperatively (range, 7.5–12.2 years).

Results

Preoperative characteristics were similar between groups. Effective orifice areas increased in both groups over time. Although there were no differences in effective orifice areas at 1 year, at 9 years, effective orifice areas were significantly greater in the SPV group (CE, 1.49 ± 0.59 cm2; SPV, 2.00 ± 0.53 cm2; P = .011). Similarly, mean and peak gradients decreased in both groups over time; however, at 9 years, gradients were lower in the SPV group (mean: CE, 10.8 ± 3.8 mm Hg; SPV, 7.8 ± 4.8 mm Hg; P = .011; peak: CE, 20.4 ± 6.5 mm Hg; SPV, 14.6 ± 7.1 mm Hg; P = .022). Such differences were magnified with dobutamine stress (mean: CE, 22.7 ± 6.1 mm Hg; SPV, 15.3 ± 8.4 mm Hg; P = .008; peak: CE, 48.1 ± 11.8 mm Hg; SPV, 30.8 ± 17.7 mm Hg; P = .001). Ventricular mass regression occurred in both groups; however, no differences were demonstrated between groups either on echocardiographic, magnetic resonance imaging, or biochemical (plasma B-type [brain] natriuretic peptide) assessment (P = .74). Similarly, Duke Activity Status Index scores of functional status improved in both groups over time; however, no differences were noted between groups (CE, 27.5 ± 19.1; SPV, 19.9 ± 12.0; P = .69). Freedom from reoperation at 12 years was 92% ± 5% in patients with CEs and 75% ± 5% in patients with SPVs (P = .65). Freedom from valve-related morbidity at 12 years was 82% ± 7% in patients with CEs and 55% ± 7% in patients with SPVs (P = .05). Finally, 12-year actuarial survival was 35% ± 7% in patients with CEs and 52% ± 7% in patients with SPVs (P = .37).

Conclusion

Although offering improved hemodynamic outcomes, the SPV did not afford superior mass regression or improved clinical outcomes up to 12 years after implantation.

CTSNet classification

35

Abbreviations and Acronyms

AI
aortic insufficiency
AVR
aortic valve replacement
BNP
B-type (brain) natriuretic peptide
CE
Carpentier–Edwards (stented) Perimount valve
CW
continuous wave
DASI
Duke Activity Status Index
EOA
effective orifice area
LV
left ventricular
LVMI
left ventricular mass index
LVOT
left ventricular outflow tract
MRI
magnetic resonance imaging
NYHA
New York Heart Association
PW
pulsed wave
SPV
Toronto Stentless Porcine Valve
2D
2-dimensional

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Disclosures: None.

Supported by the Heart and Stroke Foundation of Canada.