Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
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Kunadian et al, 2007 USA | Ten studies were identified that included 919 patients in which the Freedom (Sorin Biomedica Cardio, Via Crescentino, Italy), Freestyle (Medtronic, Minneapolis, MN), Prima Plus (Edwards Life Sciences, Irvine, CA) and the Toronto and Biocor (St Jude Medical, St. Paul, MN) valves were used | Meta analysis (level 1a) | Peak gradient postoperatively | Stentless valve mean difference 5.80mmHg (4.69 to 6.90) better than stented valves | This meta-analysis showed that stentless aortic valves provide an improved level of left ventricular mass regression at 6 months, reduced aortic gradients, and an improved effective orifice area index, at the expense of times that were 23 minutes longer for cross clamp and a 29 minutes longer for bypass. this improvement disappeared after 12 months |
Left ventricular mass Index | At 6 months Weighted mean difference; 6.42, [95% CI 1.21 to 11.63] in favour of stentless valve 12 months WMD, 1.19; [95% CI, - 4.15 to 6.53], no significant difference | ||||
Cross clamp time | Cross clamp time 23 min longer | ||||
Bypass time | Bypass time 29 mins longer | ||||
Ali et al, 2006 UK | Patients with severe aortic valve stenosis (n=161) undergoing aortic valve replacement (AVR) were randomised Intraoperatively to receive either the C-E Perimount stented bioprosthesis (n=81) or the Prima Plus stentless bioprosthesis (n =80). | PRCT (level 2b) | Left ventricular mass regression Transvalvular gradients were measured postoperatively | . Haemodynamic performance of the 2 valves was similar with no difference in mean and peak systolic transvalvular gradients 1 year after surgery. In patients with reduced ventricular function (left ventricular ejection fraction [LVEF] <60%), there was a significantly greater improvement in LVEF from baseline to 1 year in stentless valve recipient | There was no difference between groups with regard to age, symptom status, need for concomitant coronary artery bypass surgery, or baseline LVM regression in both groups but with no significant difference between groups at 1 year |
Perez de Arenaza et al, 2005 UK | Patients undergoing AVR with an aortic annulus < or =25 mm in diameter were randomly allocated to a stentless (n=93) or a stented supra-annular (n=97) valve | PRCT (level 2b) | change in left ventricular mass (LVMI) measured Measurements were taken before valve replacement and at 6 and 12 month | -LVMI between the stentless versus stented groups at baseline (176+/-62 and 182+/-63 g/m2, respectively) or at 6 months (142+/-49 and 131+/-45 g/m2 respectively . Changes in -reduction in peak aortic velocity (P<0.001) and a greater increase in indexed effective orifice area. (P<0.001) in the stentless group than in the stented group. | Despite significant differences in indexed effective orifice area and peak flow velocity in favour of the stentless valve, there were similar reductions in left ventricular mass at 6 months with both stented and stentless valves, which persisted at 12 months |
Bakhtiary et al, 2006 UK | A total of 24 patients (73 +/- 6 years) referred for treatment of aortic stenosis were randomised to aortic valve replacement with stented (Medtronic Mosaic; (Medtronic Inc, Minneapolis, Minn) or stentless (Medtronic Freestyle; Medtronic Inc) | PRCT (level 2b) | Coronary flow was measured preoperatively, 5 days after the operation and 6 months quantify transvalvular gradients left ventricular mass regression | flow increased in both groups significantly (P < .001). This increase was higher in the stentless group compared with that seen in the stented group (343 +/- 137 vs 221 +/- 66 mL/min) Also, coronary flow reserve was higher for stentless valves (3.4 +/- 0.3 for stentless valves and 2.3 +/- 0.1 for stented valves) Mean pressure gradients for Freestyle valves were lower (10 +/- 4 and 8 +/- 3 mm Hg, respectively,vs 19 +/- 6 postoperatively and 15+/- 4 mm Hg at follow-up for Mosaic valves, P < .05). | Normalisation of coronary artery flow after aortic valve replacement for aortic stenosis was more pronounced for stentless valves. This increase was higher in the stentless group compared with that seen in the stented group Left ventricular mass regression was similar in both groups |
Totaro et al, 2005 UK | Sixty-three patients (>70 years old) were enrolled. Randomized to the Carpentier-Edwards PERIMOUNT-Edwards Prima Plus Furthermore the best size suitable of the Carpentier-Edwards PERIMOUNT -Magna and the Carpentier- Edwards PERIMOUNT | PRCT (level 2b) | Early postoperative haemodynamic performance | Magna, , was superior to those of both the Edwards Prima Plus and the Carpentier-Edwards PERIMOUNT in both effective orifice area index (1.07 +/- 0.4 cm2/m2, 0.87 +/- 0.3 cm2/m2, and 0.80 +/- 0.2 cm2/m2, respectively) and mean peak gradient (20 +/- 6 mm Hg, 27 +/- 8 mm Hg, and 28 +/- 12 mm Hg, respectively) The best size suitable of Edwards Prima Plus (24.3 +/- 1.7 mm) was significantly superior to those of both the Carpentier-Edwards PERIMOUNT Magna (23.4 +/- 2.1mm) and Carpentier-Edwards PERIMOUNT (22.4 +/- 1.8 mm). | The third-generation stented bioprosthesis Carpentier- Edwards PERIMOUNT Magna had similar function to the stentless valve |
Doss et al, 2003 Canada | Forty patients with aortic stenoses, over the age of 75 years, were randomised to receive either the stented Perimount (n=20) or the stentless Prima Plus (n=20) bioprosthesis | PRCT (level 2b) | Left ventricular mass regression, effective orifice area, ejection fraction and mean gradients were evaluated at discharge, 6 months and 1 year after surgery | A significant decrease in left ventricular mass was found 1 year postoperatively However, there was no significant difference in the rate of left ventricular mass regression between the groups | 1 year postoperatively, the haemodynamic performance of the valves and the change in the ejection fraction did not differ between the groups |
Cohen et al, 2002 Germany | Fifty-three patients were randomised to receive the stented C-E pericardial valve (CE) and 46 patients the Toronto Stentless Porcine valve (SPV). Annuli were sized for the optimal insertion of both valve types, such that surgeons were required to commit to specific valve sizes before randomisation. Echocardiographic measurements and functional status (Duke Activity Status Index) were assessed at 3 and 12 months postoperatively. | PRCT (level 2b) | cardiopulmonary-aortic cross-clamp times perioperative morbidity and mortality implantation effective orifice area - transvalvular gradients regression of left ventricular mass Duke Activity Status Index scores of functional status | Cardiopulmonary bypass times (CE: 118.6+/-36.3 minutes; SPV: 148.5+/-30.9 minutes; p = 0.0001) and aortic cross-clamp times (CE: 95.4+/-28.6 minutes; SPV:123.6+/-24.1 minutes; p = 0.0001). ventricular outflow tract diameter after valvular implantation: SPV: 3.4+/-1.11 mm versus CE: 3.7+/-1.33 mm; p = 0.25). -the actual mean valve size based on internal valvular diameter was no different between groups (CE: 21.9+/-2.0 mm; SPV: 22.3+/-2.0 mm; p = 0.286). | Although offering excellent outcomes, stentless valves did not demonstrate superior haemodynamic indices in comparison to stented valves up to 12 months after. Neither valve offered a superior internal diameter for any given annular diameter |
Maselli et al, 1999 Italy | Four groups of 10 patients each were randomly assigned to receive: (1) aortic homograft preserved in antibiotic solution at 4 degrees C, (2) Toronto stentless porcine valve, (3) Medtronic Freestyle stentless valve, or (4) Medtronic Intact aortic valve | PRCT (level 2b) | The left ventricular mass index, effective orifice area index, and peak and mean transaortic gradients were measured by doppler echocardiography before the operation and 8 months postoperatively | The haemodynamic performance indices were much better for the homograft and stentless valves than for the stented one. The absolute left ventricular mass index reduction was greater in the homograft group compared with the Intact (p = 0.0004) and Toronto (p = 0.007) groups. The extent of left ventricular mass index reduction was greater only in the homograft group versus Intact group (p = 0.005). | Multivariate analysis showed that the only predictors of left ventricular mass index reduction were the homograft type, a higher valve size index, and a higher preoperative left ventricular mass index |
Bleiziffer et al, 2005 Germany | Twenty patients underwent AVR for aortic stenosis with the St. Jude Medical (SJM) Toronto Root stentless porcine bioprosthesis, using a subcoronary implantation technique. Through the authors' institutional database, 20 additional patients were identified who had undergone AVR with the Medtronic Mosaic stented completely supra-annular porcine bioprosthesis. The patient groups were not matched for labeled valve size, but for annulus diameter measured intraoperatively using Hegar's dilators | PRCT (level 2b) | Hemodynamic performance | Transvalvular mean pressure gradients (MPG) at rest were significantly lower in the stentless group, but cardiac output was similar in both groups. Stress echocardiography also revealed significantly lower gradients at 25 W and 50 W exercise in the stentless group. The EOA index (EOAI), grouped by annulus diameter, tended to be larger in the stentless group and showed no severe patient-prosthesis mismatch (PPM; EOAI <0.65 cm2/m2) which, in contrast, occurred in three patients (15%) in the stented group (p = 0.072). | In summary, the SJM Toronto Root porcine stentless bioprosthesis in the subcoronary position showed lower MPGs and larger EOAs at rest and during exercise compared to the Medtronic Mosaic porcine stented bioprosthesis. Therefore, physically active patients in particular may benefit from use of the stentless valve. Because of its larger EOA, a stentless valve should be implanted if severe PPM is expected. |
Borger et al, 2005 Canada | (n = 737). Patients were divided into two groups according to type of bioprosthetic implanted: stentless patients (total n = 310) (Toronto SPV [St Jude Medical, St Paul, MN], n = 146 and Freestyle [Medtronic, Minneapolis, MN], n = 164) and stented patients (total n = 427) (Perimount [Edwards Life Sciences Inc, Irvine, CA], n = 291 and Mosaic [Medtronic], n = 136) | Retrospective study (level 2b) | Midterm LVM regression, | Stentless patients had significantly lower LVM index during follow-up (100 +/- 32 vs 107 +/- 32 g/m2, p = 0.005) and stentless valves were an independent predictor of LVM regression Furthermore, a higher proportion of stented patients had residual LV hypertrophy during follow-up (28% vs 18%, p = 0.001). | Stentless valves were associated with improved midterm survival by univariate analysis, but not by multivariable analysis |
Hemodynamic data, | Predischarge echos revealed that stentless patients had significantly lower mean transvalvular gradients (11 +/- 5 vs 15 +/- 6 mm Hg, p < 0.001) and larger effective orifice areas (1.32 +/- 0.52 vs 1.22 +/- 0.48 cm2, p = 0.01). | ||||
Survival | Follow-up echocardiograms were obtained in 99% of surviving patients 28 +/- 22 (range, 0-79) months postoperatively | ||||
160 consecutive patients on 1 surgeon's list randomized to receive either a Toronto stentless porcine valve (St Jude Medical, Inc, St Paul, Minn) or a Perimount stented bovine pericardial valve (Edwards Lifesciences, Irvine, Calif). Echocardiography was performed at discharge, between 3 and 6 months, and at 1 year after surgery. implanted. stentless biological valves chosen for comparison in the early postoperative period or in preliminary follow-up. | Randomised study (level 2b) | Effective orifice area | At 3 to 6 months for the Toronto versus the Perimount valve, the effectiveorifice area was 1.58 versus 1.66 cm2, | There were no significant differences in hemodynamic function or clinical events between the stented and stentless up to 5 years | |
The mean pressure difference | - the mean pressure difference was 7.54 versus 7.42 mm Hg, and the peak velocity was 2.07 versus 2.0.1 m/s | ||||
regression of left ventricular hypertrophy | There was no difference in regression of left ventricular hypertrophy | ||||
Mortality and complications | There was no difference in mortality, or complications other than paraprosthetic regurgitation at 12 months or on follow-up for a proportion of the sample to 8 years | ||||
Regurgitation through the valves | The incidence of regurgitation through the valves was similar for Toronto (10%) and Perimount (13.8%) at 1 year, but mild paraprosthetic regurgitation was found in 5 patients with the Perimount valve and none with Toronto valves | ||||
Walther et al, 1999 Germany | 180 patients were prospectively selected; 106 patients received a stentless aortic valve (SAV), and 74 received a conventional stented bioprosthesis (CSB). Of these patients, 95% and 96%, respectively, had aortic stenosis. Their mean age was 72.3 and 74.8 years, | PRCT (level 2b) | All patients were in NYHA class 1 or 2 Baseline enddiastolic Left ventricular posterior wall Left ventricular mass index | At follow-up, all patients were in class 1 or 2.Baseline enddiastolic left ventricular posterior wall thickness was 15.6 (SAV) and 14.8(CSB) mm (P=NS) and decreased to 11.8 (SAV) and 13.2 (CSB) mm (P<0.05) at 6 months. Left ventricular mass index was 213 and 202 g/m2 at baseline (P=NS), whereas after 6 months, it was 141 (SAV) and 170 (CSB) g/m2 (P<0.05) | Aortic annulus diameter indexes were comparable at 13.46 (SAV) versus 13.55 (CSB) mm (P=NS). Larger SAVs were implanted because of the oversizing technique. Inhospital mortality (n=3 and 1 for SAV and CSB) was not valve related |
Williams et al, 1999 UK | Forty patients were randomised after the annular and sinotubular diameters had been measured St Jude Toronto valve, versus Carpentier-Edwards Perimount valve. | PRCT (level 2b) | Early haemodynamic measurements were made with a thermo dilution cardiac output catheter, and echocardiography was used thereafter Regression of left ventricular mass assessed using magnetic resonance imaging (MRI) at 1 week, 6 months, and 32 months. | Echocardiography showed superior transvalvular gradients in the stentless group at 1 week (mean 5.5+/-3.1 mm Hg cf. 8.9+/-2.5 mm Hg), and this difference was maintained at a mean follow-up time of 32 months (3.5+/-0.6 mm Hg cf. 6.3+/-0.6 mm Hg). Similar regression of left ventricular mass was seen in both groups at 6 months, but at 32 months, measurement in diastole showed a reduction of 38% (P<.01) in the stentless group compared with 20% (P = ns) in the stented group, and measurements in systole showed a 23% (P<.01) and 13% (P = ns) reduction, respectively | The mean annular size was 25.3+/-2.2 mm (CE) and 25.5+/-1.5 mm (Toronto), although it was possible to implant valves with a mean diameter 3 mm larger in the stentless group (26.0+/-1.7 mm cf. 23.0+/-1.7 mm). Haemodynamic performance in the first 24 hours showed no significant difference |
Santini et al, 1998 Italy | 77 patients (28 men) were prospectively randomised to undergo aortic valve replacement using the Hancock valves (group A: 40 patients, 16 men; age, 77+/-3 years; body surface area, 1.7+/-0.17 m2) or a stentless bioprosthesis (group B: 37 patients, 12 men; age, 76+/-2 years; body surface area, 1.7+/-0.15 m2; Biocor, 17; Toronto SPV, 20 ) | PRCT (level 2b) | Bypass time and aortic cross-clamp time Valve size normalised to body surface concomitant myocardial revascularisation neurologic event Actuarial survival at 12 and 24 months peak transaortic gradient regression of left ventricular mass | Bypass time was 123+/-46 versus 133+/-51 minutes, and aortic crossclamp time was 83+/-26 versus 95+/-24 minutes for group A and group B, respectively (not significant) body surface area was 13.7+/-1.5 versus 14.1+/-1.6 mm/m2 for group A and group B Overall perioperative mortality was 5% ingroup A (low patients), and 8% in group B (low cardiac output in 1; major neurologic event in 2 cardiac output in 2) | Actuarial survival at 12 and 24 months is 92% versus 91% and 92% versus 81% for group A and group B, respectively. At 6 months, patients in group A showed a peak transaortic gradient of 25+/-7 versus 20+/-9 mm Hg in group B. Progressive regression of left ventricular mass expressed as a percentage of preoperative value was 10.5% and 19% for group A and group B at 1 year postoperatively (not significant) |
Bove et al, 2006 Belgium | 145 patients with a Toronto stentless prosthesis are compared with 110 patients with a stented Carpentier-Edwards valve | Retrospective study (level 2b) | The 5- to 10-year clinical outcome transprosthetic gradients - early and late (LVM) regression | survival at 5 years is 82% after stentless AVR versus 68% after stented AVR (p < 0.001) in elderly patients. However, there was no difference in survival at 8 years, being 55.9% and 59.5%, respectively. Stented and stentless xenografts were equally effective in terms of transprosthetic gradients and LVMI regression. mass regression. However, late LV remodeling was predominantly affected by systemic hypertension and severe preoperative LV hypertrophy, resulting in the incomplete LVMI resolution in 61.3% and 66.7% of these patients, respectively | In elderly patients, aortic valve replacement appears to be equally effective with a stentless or stented bioprosthesis |
Tsialtas et al, 2007 Italy | The effects of the bioprotheses were studied by echocardiography in 68 patients (age, 74 +/- 7 years) | PRCT (level 2b) | Left ventricular mass | A progressive and similar decrease in left ventricular mass of 30% was observed in both stented and stentless bioprostheses at 12 months | Advantages consisting of a progressive increase in transprosthetic effective orifice area and a decrease of the transprosthetic pressure gradient were observed in the Toronto group in comparison to the CEP and Shelhigh groups the early- and mid-term (12 months) periods after surgery with all 3 types of bioprostheses |
Transprosthetic effective orifice area | A progressive increase in transprosthetic effective orifice area and a decrease in transprothetic pressure gradient were observed at 3, 6, and 12 months in the Toronto group, but these variables showed improvement only at 3 months in the CEP and Shelhigh |