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. 2012 Dec 4;16(3):361–373. doi: 10.1093/icvts/ivs447

Table 1:

Best evidence papers

Author, date, journal and country
Study type
(level of evidence)		 Patient group Outcomes Key results Comments
Reichenspurner et al. (1995), Thorac Cardiovasc Surg, Germany [2]

Cohort studies
(level 2)		 Period: 1978–1990

476 porcine valves were implanted in 423 patients (313 aortic, 147 mitral, 16 tricuspid). Models [Carpentier-Edwards (CE) bioprostheses, CE supra-annular bioprostheses, Hancock bioprostheses 1st generation, Hancock bioprostheses 2nd generation]

647 bovine valves were implanted in 577 patients (438 aortic, 201 mitral, 8 tricuspid). Models (Hancock extracorporeal, Ionescu-Shiley, CE, Mitroflow)		 Incidence of thromboembolic (TE) complications






Incidence of infectious valve endocarditis (IE)







Incidence of primary tissue failure (PTF) based on degeneration tissue alterations










Long-term survival rates		 Incidence of TE
Porcine 1.8% vs bovine
0.9% per patient-year

Long-term TE freedom rate.
Bovine valve had significant lower long-term TE free rate at 5, 6, 7 years postop (P < 0.05)

Incidence of IE
Porcine 0.5% vs bovine 0.25% per patient-year (no statistic significance)

IE free rate (at 9 years) follow-up
Porcine 90.7% vs bovine 93.6%

Porcine global incidence rate
6 years: 6 ± 3.5%
8 years: 18 ± 7.1%
10 years: 60 ± 13.1%

Bovine
6 years 36 ± 6.5%
8 years 68 ± 10%
10 years: 86 ± 19.5%

PTF results were significant better in porcine at 7, 8, 9 years postop (P < 0.001)

At 10 years
Porcine (67.8%) vs bovine (61.0%)
From 3 to 8 years postop
Porcine long-term survival rate was higher (P < 0.05)
Long-term survival rate dependant on preop NYHA class		 Although the incidence of TE and IE is lower within bovine valve, long-term durability rates are significantly inferior when compared to porcine valve

In addition, porcine valve shows satisfying long-term results regarding TE and IE rates

In conclusion, older patients and patients with contraindication for anti-coagulative therapy would benefit from porcine valve
Gao et al. (2004),
J Am Coll Cardiol,
USA [3]

Cohort studies
(level 2)		 Period: 1974–1996

518 AVR porcine CE vs
1021 AVR CE bovine valve		 Bioprosthetic valve dysfunction















Thromboembolic events









Bioprosthetic valve endocarditis (IE)


Operative and long-term mortality		 At 10 years
Kaplan–Meier freedom from explantation for structural valve deterioration (SVD): Porcine 92 ± 2% vs bovine 98.5 ± 1%

Actual freedom
Porcine 96 ± 1% vs bovine 98.9 ± 1%

At 15 years
Kaplan-Meier and actual freedom
Porcine 87 ± 1%, 95 ± 1%, respectively

Prosthetic valve thrombosis
Porcine valve (0.03%/per patient-year) vs 0% bovine valve

Thromboembolic events
10-year freedom from thromboembolism
Porcine 80 ± 2% vs bovine 87 ± 2% (P = 0.24)

10-year freedom from IE
Porcine 98 ± 1% vs bovine 99 ± 1% (P = 0.3)

At 10 years
Kaplan-Meier freedom from explant
Porcine 90 2 vs bovine97 ± 1% (P = 0.04)

Operative
Porcine 7.7% vs bovine 4.2%

Long-term mortality
Porcine 34 ± 2% vs bovine 38 ± 6%, similar mortality (P = 0.29)		 10-year freedom from thromboembolism was similar in porcine and bovine valves

10-year freedom from IE was similar in porcine and bovine valves

Compared with CE porcine valve, CE bovine valve has superior durability. Its freedom from SVD and reoperation makes it the bioprosthesis of choice in this centre
Chambers et al. (2008), J Thorac Cardiovasc Surg, UK [4]

Randomized control trial
(level 1)		 100 patients were randomized to have single bioprosthetic aortic valve [Medtronic Mosaic porcine or Carpentier-Edwards Perimount bovine (CE-P)]. One patient received a mechanical valve due to aberrant coronary origin. Total subjects were 99 patients (51 with porcine and 48 with bovine valve) Haemodynamic function











































Clinical event rates















Exercise capacity





Overall health 1 year after operation		 At 1 year
Peak transvalve pressure difference
Porcine 28 ± 13 vs bovine19 ± 9 mmHg (P < 0.0001)

Mean pressure
Porcine 17 ± 7 vs bovine11 ± 5 mmHg (P < 0.0001)

At 1 year: Effective orifice
Porcine 1.28 ± 0.46 vs bovine 1.47 ± 0.45 cm2 (P =0.05)

At 1 year (no differences in pre- and postop LV dimensions (LVDD), LV mass index (LVMI), fractional shortening (FS) and LV outflow velocity (LVOT VTI)

LVDD
Pre: porcine 5.1 ± 0.86 vs bovine 4.9 ± 1.1 cm (P = NS)
Post: porcine 4.5 ± 0.8 vs bovine 4.6 ± 0.9 cm

LVMI
Pre: porcine 233 ± 123 vs bovine 211 ± 77 g/m2 (P = NS)
Post: porcine 152 ± 50 vs bovine 160 ± 62 (P = NS)

FS
Pre: porcine 35 ± 9 vs bovine 32 ± 11% (P = NS)
Post: porcine 36 ± 8 vs bovine 34 ± 10 (P = NS)

LVOT VTI
Pre: porcine 21 ± 5 vs bovine 20 ± 5 (P = NS)
Post: porcine 22 ± 5 vs bovine 20 ± 5 (P = NS)
Early death (30 days)
Porcine 1 vs bovine 1 patient

Late death (1–12 months)
Porcine 3 vs bovine 5

Perioperative strokes
Porcine 3 vs bovine 2 patients

Early TE
Porcine 2 patients vs bovine 1 patient

Late TE
Porcine 2 vs bovine 1 patient

6-min walk distance (m)
Porcine: preop: 255, postop: 366 (P < 0.0001)
Bovine: preop: 223, postop: 334, (P = 0.002)

Anxiety score (1 year)
Porcine: preop 7.2 ± 3.7, postop 5.0 ± 3.0 (P = 0.001)
Bovine: preop 7.6 ± 4.4, postop 4.2 ± 3.7 (P < 0.0001)

Depression score (1 year)
Porcine: preop 5.9 ± 3.5, postop 4.4 ± 2.8 (P = 0.003)
Bovine: preop 6.1 ± 4.1 postop 4.4 ± 3.7 (P = 0.32)

Physical composite score (1 year)
Porcine: preop 28.1 ± 11.8, postop 38.3 ± 11.7 (P < 0.0001)
Bovine preop 26.0 ± 9.9 postop 38.3 ± 12.03 (P < 0.0001)
Men

Mental composite score (1 year)
Porcine: preop 47.6 ± 10.8 post 51.1 ± 8.6 (P = 0.005)
Bovine: preop 45.2 ± 11.8 post 49.9 ± 12.6 (P = 0.009)		 Better haemodynamic function in a bovine compared with a porcine stented valve

Non statistic significant trend to a larger effective orifice in bovine valve

No difference in exercise ability between two valve types

Both groups showed large improvement in anxiety, depression, mental and physical health. No difference in two valve types

Conclusion: minor differences in haemodynamic function in favour of the bovine valve. Both valves had similar and significant improvements in life quality, exercise ability and regression of LV mass
Jamieson et al. (2006), Asian Cardiovasc Thorac Ann, Canada [5]

Cohort studies
(level 2)		 Period: 1981–1999
Aortic valve replacement: Carpentier-Edwards supra-annular porcine valve was implanted in 1825 patients in Vancouver, Canada
vs
Period: 1984–2001
CE-P was implanted in 1430 patients 1984–2001 in Tours, France		 Mortality




















Valve-related mortality













Valve-related reoperation











SVD		 Early mortality
Porcine 5.0% vs bovine 2.8%per patient-year (P < 0.001)

Late mortality
Porcine 6.48% vs bovine 4.76% per patient-year

Survival at 15 years (all age group)
Porcine 29.3 ± 1.5 vs bovine 35.2 ± 3.1% (P = 0.0009)

Survival (patients <65 years old) Porcine 51.0 ± 2.9% vs bovine 61.2 ± 4.7% (P = 0.0165)
Survival (patients ≥65 years old)
Porcine 19.6 ± 1.6% vs bovine 17.6 ± 4.2% (P = 0.0104)

Linearized rate
Porcine 1.14% vs bovine 1.28% per patient-year (P = 0.3572)

Overall actuarial freedomat 15 years
Porcine 82.0 ± 1.6% vs bovine 79.3 ± 2.8% (not significant difference)

Actual freedom at 15 years
Porcine 88.5 ± 0.9% vs bovine 84.9 ± 1.7%

Linearized occurrence rate
Porcine 1.09% per patient-year vs bovine 0.63% (P = 0.0005)

Actuarial freedom at 15 years
Porcine 73.7 ± 2.3% vs bovine 81.9 ± 3.8% (not significantly different)

Actual freedom at 15 years
Porcine 87.8 ± 1.0% vs bovine 90.2 ± 1.7%

Actual freedom (>70 years) at 15 years
Porcine 98.2 ± 0.6% vs bovine 99.6 ± 0.4%

Actual freedom (61–70 years) at 15 years
Porcine 93.0 ± 1.5% vs bovine 92.7 ± 2.5%

Actual freedom (51–60 years) at 15 years
Porcine 75.4 ± 3.6% vs bovine 84.8 ± 5.6%

Actual freedom (41–50 years) at 15 years
Porcine 63.1 ± 6.4% vs bovine 85.8 ± 6.6%

Actual freedom (≤40 years) at 15 years
Porcine 48.4 ± 7.5% vs bovine 72.6 ± 14.6%		 Early and late mortality and overall survival differentiate the populations in this study and favour bovine over porcine valve. This is related to the preponderance of concomitant CABG in the porcine valve population

Actual freedom from SVD did not differentiate the populations, but in the age groups ≤60 years, the bovine was superior to the porcine


Concomitant CABG likely decreased the incidence of SVD in porcine valve because of the reduced survival

Conclusion: both valves have excellent and comparable durability at 15 years. Both bioprostheses provide excellent clinical performance for AVR, especially in patients >60 years old
Chaudhry et al. (2000), J Heart Valve Dis, UK [6]




Prospective randomized trial
(level 1)		 Period: Feb 1987–Mar 1990
170 patients undergoing aortic valve replacement (AVR) or mitral valve replacement (MVR) or both


Assigned randomly to receive either Bioflo bovine valve (85 patients) or Carpentier-Edwards (CE) supra-annular porcine valve (85 patients)		 Mortality rate
Operative mortality (≤30 days or before discharge)



Valve-related mortality



Valve-related mortality and morbidity










Survival rate



Reoperation







Complications































Functional status		 Operative mortality
Porcine (5 patients) vs bovine
(2 patients)

AVR operative mortality
Porcine (2 patients) vs bovine
(1 patient)
MVR operative mortality
Porcine (2 patients) vs bovine
(1 patient)

Freedom from valve-related mortality at 11 years
Porcine 91.0 ± 3.5% vs bovine 89.5 ± 3.9% (P = 0.4)

Freedom from all valve-related morbidity and mortality at 11 years

Porcine 64.9 ± 6.3% vs bovine 58.3 ± 6.7% (P = 0.4)

At 11 years
Porcine 55.3 ± 6.8% vs bovine 41.4 ± 6.8% (P = 0.15)

Porcine 8 patients vs bovine
5 patients

Freedom from reoperation
at 11 years
Porcine 86.88 ± 4.2% vs bovine 84.8 ± 5.9% (P = 0.8)

SVD
Porcine 11 patients vs bovine
10 patients

Freedom from SVD at 11 years
Porcine 87.5 ± 4.2% vs bovine 83.9 ± 5.4% (P = 0.9)

Non-structural valve dysfunction
Only 1 porcine patient in MVR

Thromboembolism
Porcine 12 patients vs bovine 12 patients

Freedom from thrombo-embolism at 11 years
Porcine 83.5 ± 5.3% vs bovine 82.6 ± 5.7% (P = 0.9)

Freedom from Anticoagulant-related haemorrhage at 11 years
Porcine 85.5 ± 5.0% vs bovine 85.9 ± 4.5% (P = 0.9)

Freedom from endocarditis at 11 years
Porcine 96.3 ± 2.1 vs bovine91.2 ± 3.2% (P = 0.4)

All valves
Preop: 52% in NYHA class I or II
Postop: 91% in class I or II (Porcine 87% vs porcine 97%)

Mean peak aortic gradient
Porcine 30.6 ± 19.7 mmHg vs bovine 30.3 ± 15.9 mmHg, P = 0.9		 Operative mortality was not related to the prosthesis implanted

No difference in freedom from reoperation at 11 years

At 11 years, no significant difference was in the probability freedom from endocarditis

The quality of a bioprosthetic is directly related to its ability to resist SVD. However, no difference in freedom from SVD at 11 years in between two valves

No differences in SVD between different age groups

No difference was evident between two valves regarding thromboembolism risks

14% difference in overall survival rate at 11 years (higher in porcine group) but did not reach statistical significance

Conclusion: both porcine and bovine offered excellent long-term clinical results

This RCT showed no difference in clinical performance between a well-tested porcine valve and a representative of the 2nd generation of bovine valves, whether in aortic or mitral positions
Casabona et al. (1992),
Ann Thorac Surg, Italy and Brazil [7]

Cohort studies
(level 2)		 Study group: 27 patients undergoing isolated AVR received stentless porcine aortic valve vs 30 patients who received stentless bovine aortic valve

Control groups: two groups of 30 patients who had either tilting-disc mechanical valve (Omnicarbon) or stented porcine bioprosthesis (Biocor)

Follow-up
Stentless porcine 9 ± 4 months
Stentless bovine 14 ± 5 months
Stented porcine 17 ± 7 months
Mechanical 29 ± 12 months		 Aortic valve area
















Trivial central aortic regurgitation


Mortality







Maximum velocity across the valve (Vmax)		 Valve size 23
Stentless porcine 1.59 ± 0.3 vs stentless bovine 1.50 ± 0.06 cm2

Valve size 25
Stentless porcine 1.76 ± 0.3 vs stentless bovine 1.63 ± 0.1 cm2

Valve 27
Stentless porcine 1.76 ± 0.04 vs stentless bovine 1.77 ± 0.1 cm2

Valve size 29
Stentless porcine 2.20 ± 0.04 vs stentless bovine 1.99 ± 0.4 cm2

Stentless porcine (18.5%) vs stentless bovine (43.3%), (P = 0.04)

3 patients with stentless porcine died within 30 days of operation

1 patient with stentless bovine valve had a sudden death 6 months after operation

Valve size 23
Stentless porcine 2.22 ± 0.6 vs stentless bovine 1.93 ± 0.03 m/s

Valve size 25
Stentless porcine 2.72 ± 0.1 vs stentless bovine 1.91 ± 0.3 m/s

Valve 27
Stentless porcine 1.98 ± 0.4 vs stentless bovine 1.86 ± 0.5 m/s

Valve size 29
Stentless porcine 1.80 ± 0.1 vs stentless bovine 1.55 ± 0.5 m/s		 No significant differences were found within the two groups of stentless valves

Trivial central aortic regurgitation was more common in stentless bovine valve than stentless porcine valve. It could depend on a more difficult sizing and positioning of the pericardial valve and could therefore be related to the surgeon's experience

There are no clear differences, and therefore, no substantial advantages that may justify the use of one type of stentless valve over the other. Both are superior to stented bioprosthesis and become the first choice when a tissue valve is indicated and the patient has a small aortic annulus
Pelletier et al. (1989),
Ann Thorac Surg,
Canada [8]

Prospective cohort studies
(level 2)		 Period: 1976–1988

A total of 1593 patients underwent valve replacement (AVR, MVR, multiple valve replacement ± CABG) with Carpentier-Edwards porcine (878) or bovine bioprosthesis (715) (316 Ionescu-Shiley, 295 Carpentier-Edwards, and 178 Mitroflow valves)

Follow-up
Porcine (average 74 months) vs bovine (average 34 months)		 Survival





















Complications




















































Reoperation















Clinical improvement		 30-day mortality
Porcine (9.0%) vs bovine (5.2%) (P < 0.01)

Early mortality rate of AVR
Porcine (6.6%) vs bovine (3.8%) (P >0.05)

Early mortality rate of multiple valve replacement
Porcine (15.6%) vs bovine (10.5%) (P >0.05)

Late mortality rate (linearized)
Porcine 2.9% per patient-year bovine 3.5% per patient-year

Global actuarial survival at 5 years
Porcine 80 ± 1% vs bovine 79 ± 2%

Thromboembolism
Porcine 1.08% vs bovine 2.01% per patient-year

Freedom from thromboembolism
AVR (P = NS)
Porcine at 10 years 96 ± 1 vs bovine at 6 years 94 ± 2%
Multiple valve replacement
(P = NS)
Porcine at 10 years 86 ± 5 vs bovine at 6 years 88 ± 4%

Endocarditis
Porcine 0.47% vs bovine 1.39% per patient-year
AVR (P = NS)
Porcine at 10 years 95 ± 2 vs bovine at 6 years 942 ± 4%
Multiple valve replacement (P = 0.05)
Porcine at 10 years 96 ± 3 vs bovine at 6 years 88 ± 5%

Haemorrhage
Porcine 0.35% vs bovine 0.41% per patient-year

Haemolysis
No significant haemolysis detected in both valves

PTF
Porcine 2.0% vs bovine 20.98% per patient-year (P < 0.01)

Actuarial freedom
AVR at 6 years
Porcine 98 ± 1 vs bovine at 94 ± 4% (P >0.05)

Freedom from all valve-related complications at 6 years
AVR
Porcine 90 ± 2 vs bovine at 79 ± 5% (P = 0.05)

Valve survival at 6 years
AVR
Porcine 89 ± 2 vs bovine at 82 ± 4% (P = NS)

Porcine 2.14% vs bovine 2.07% per patient-year

Freedom from reoperation
at 6 years
Porcine 96 ± 1 vs bovine 91 ± 4% (P >0.05)
Indication for reoperation
PTF
Porcine 88% vs bovine 48% (P < 0.0001)

Prosthesis valve endocarditis
Porcine 3.8% vs bovine 30% (P < 0.0001)

Among patients who survived without reoperation
Porcine (94%) vs bovine 98% remained NYHA class I or II after average of 79 months and 36 months follow-up respectively		 Overall patient late survival was similar in two groups

Among late survivors, excellent clinical improvement was obtained after valve replacement with either type

The higher rate of reoperation because of endocarditis among bovine valve was probably due to aggressive attitude toward early surgical treatment at that time

Although there is a tendency for survival of porcine valves to be better than that of bovine valves in all positions, it reaches significance only with mitral position

However, if freedom from all valve-related complications is considered, results are significant better with porcine valve in all positions

In conclusion, the Carpentier-Edwards porcine bioprosthesis appears to perform better than pericardial valves after three or four years
Eichinger et al. (2005),
J Thorac Cardiovasc Surg, Germany [9]

Prospective randomized study
(level 1)		 Period: August 2000–September 2002

Aortic valve replacement: 66 patients with Medtronic Mosaic porcine vs 70 patients CE-P

Follow-up 10 months postoperation by echocardiography at rest and at stress		 Mean pressure gradient


















Mean stroke volume



Patient–prosthesis mismatch

Effective orifice area index (EOAI)
EOAI >0.85 cm2/m2 = mismatch not present
EOAI ≤0.85 cm2/m2 = moderate mismatch
EOAI ≤0.65 cm2/m2 = severe mismatch

Left ventricular mass regression		 At rest

Valve size 21 and 23
Bovine better than porcine, (P = 0.001)

Valve size 25
No difference in porcine and bovine (P = 0.139)

During exercise

Valve size 21 and 23
Bovine has lower pressure than porcine (P < 0.05)

Valve size 19 and 25
No difference in porcine and bovine (P >0.05)

Valve size 21 and 23
No difference in porcine and bovine

Severe mismatch

Size 19
Procine 100% vs bovine 100%

Size 21
Porcine 46.2% vs bovine 40%

Size 23
Porcine 22.7% vs 13%

Size 25
Porcine 10% vs 20%

All patients showed regression in LV mass and mass index

Absolute amount of LV mass regression
No difference between porcine and bovine valves		 Both porcine and bovine show satisfactory haemodynamic results at rest and at stress

Bovine valve was superior in terms of mean pressure gradient in small size valve (21 and 23)

Patient–prosthesis mismatch is common in AVR with small valve size. No difference between both valves
Walther et al. (2004),
Circulation, Germany [10]

Prospective randomized study
(level 1)		 Period: March 2000–April 2003

AVR: 100 patients were randomized to receive Medtronic Mosaic porcine or Perimount bovine valves		 Circulatory function

Maximum trans-valvular blood flow velocity (m/s)





Transvalvular mean pressure gradient (mmHg)





Left ventricular regression		 Comparable between groups

Baseline function (size 25)
Porcine 2.54 ± 0.5 vs bovine 2.05 ± 0.4 (P < 0.05)

Follow-up
Porcine 2.45 ± 0.6 vs bovine 2.18 ± 0.3 (P < 0.05)

Baseline function (size 25)
Porcine 14.9 ± 7.1 vs bovine 11.3 ± 3.7 (P < 0.05)

Follow-up
Porcine 14.3 ± 6.7 vs bovine 11.2 ± 3.9 (P >0.06)

Left ventricular mass index (baseline, size 23)
Porcine 204 ± 89 vs bovine 156 ± 52		 Bovine valve has haemodynamic advantage compared to porcine valve

More pronounced left ventricular mass regression in bovine valve



In summary, both valves provide acceptable haemodynamic function with significant left ventricular mass regression in all patients. However, haemodynamic profile was better in bovine valve
Czer et al. (1987),
Chest, USA [11]

Cohort study
(level 2)		 Period: January 1976–March 1984

656 patients underwent isolated aortic, isolated mitral or double aortic MVR
Porcine (Hancock standard, Carpentier-Edwards) vs bovine (St Jude Medical bileaflet)		 Mortality, late survival and valve-related death










Valve-related complication





















Reoperation


Functional status of survivors		 Early mortality
Porcine 7.5% vs bovine 10.2% (P = NS)

Survival
Porcine 72 ± 3% vs bovine 71 ± 3% (P = NS)

Freedom from valve-related death
Porcine 93 ± 2% vs bovine 94 ± 2% (P = NS)

Structural failure

1–4 years
Porcine <1% per patient-year vs bovine 0%

After 4 years
Porcine 3–4.5% vs bovine 0%
P < 0.05

Embolism rate (5 years)
Porcine 92% vs bovine 92%(P = NS)

Freedom from haemorrhage at 5 years
Porcine 93 ± 3% vs bovine 91 ± 2%. No difference

Bacterial endocarditis
Porcine 1.0 per patient-year vs bovine 0.5% per patient-year

Porcine 1.4% per patient-year vs 0.46% per patient-year (P < 0.05)

Larger proportion of bovine valve in NYHA class 1 and smaller proportion in class 3 and 4 (P < 0.001)		 No early mortality difference between two valves

Porcine valve has higher structural failure rate

No significant difference in freedom from complication rates between two valves

Porcine valve has higher reoperation rate

Conclusion: both valves achieved a comparable operative and late survival, total complication rates, freedom from valve-related morbidity and mortality after 5 years

Limited durability, susceptibility to infection and inferior haemodynamic function remains major drawback in porcine valve
Dalmau et al. (2007), Interact CardioVasc Thorac Surg,
Spain [12]

Prospective randomized study
(level 1)		 AVR: 43 patients with Medtronic Mosaic porcine bioprosthesis vs 43 patients with Edward Perimount Magna bovine valve

Follow-up: 1 year		 Mean pressure gradient






Indexed mean effective orifice area (EOA)

Patient–prosthesis mismatch (IEOA ≤ 0.85 cm2/m2)

LV mass regression		 Porcine gradient is higher than bovine in size 19, 21, 23, 25, 26 mm

Size 21 mm (P < 0.001)
Size >23 mm (P = 0.01)
Size 25 mm (P = 0.016)

Porcine 0.97 ± 0.22 cm2/m2 vs bovine 1.12 ± 0.21 cm2/m2 (P < 0.001)

Prevalence
Porcine 26.8% vs bovine 6.9% (P < 0.01)

Absolute amount of LV mass regression
Porcine −72.5 ± 54.4 vs bovine −70.7 ± 50.5 (no significant difference)		 Conclusion: haemodynamic outcomes of bovine valves were better than porcine
Borger et al. (2007),
Ann Thorac Surg, Canada [13]

Cohort study
(level 2)		 Period: 2004–2005

AVR ± concomitant procedures: 57 patients with Medtronic Hancock II porcine valve vs 57 patients with Carpentier-Edwards Perimount Magna bovine valve		 Mortality



Transvalvular gradient








Patient–prosthesis mismatch

EOA		 Early postoperative morality
Porcine 4% vs bovine 2% (P = 0.5)

Peak transvalvular gradient (mmHg)
Porcine 32.3 ± 7.4 vs bovine 22.1 ± 7.4 (P < 0.001)

Mean gradient
Porcine 18.5 ± 15.5 vs bovine 10.4 ± 4.0 (P < 0.001)

Porcine 52% vs bovine 30% (P = 0.02)

EOA (cm2)
Porcine 1.29 ± 0.34 vs bovine 1.40 ± 0.24 (P = 0.07)		 Bovine valves showed significant lower mean and peak gradient

Patient–prosthesis mismatch was significantly higher in porcine

Bovine valves had better haemodynamic results
Wagner et al. (2007),
J Thorac Cardiovasc Surg, Germany [14]

Cohort study
(level 2)		 Period: 2000–2004

AVR: 50 patients received CE Perimount bovine valve, 70 patients received Perimount Magna bovine valve, 44 patients received Mosaic porcine valve, and 28 patients received Soprano bovine valve

Follow-up: 6 months		 Mean systolic pressure gradients


Effective orifice fraction (EOF)




Patient–prosthesis mismatch



EOAI (cm2/m2)		 Porcine valve has higher gradient compared to bovine valves (P < 0.05)

Porcine valve has lower EOF compared to the bovine valves (35.2%) vs Perimount (41.9%), Magna (45.1%), Soprano (45.8%)

Porcine has more patient-prosthesis mismatch (69%) vs bovine valves, lowest in Soprano valve (32%)

Porcine (0.75 ± 0.24) vs Perimount (0.90 ± 0.25), Magna (0.93 ± 0.22), Soprano (0.92 ± 0.15) (P < 0.05)		 Satisfactory haemodynamic results in patients with a small aortic annulus

The pericardial, completely supra-annular Magna bioprosthesis with a reduced sewing ring indicated the lowest pressure gradients seems to deal best with the challenge of achieving good haemodynamic in patients with a small aortic annulus
Suri et al. (2009),
Ann Thorac Surg, USA [15]

Prospective randomized study
(level 1)		 Period 2004–2006

AVR: Edwards Perimount bovine (n = 76) vs Medtronic Mosaic porcine valve (n = 76)



Follow-up: 1 year		 Mean aortic valve gradient (mmHg)

Mean indexed aortic valve area (cm2/m2)







Regression in LVMI
(g/m2)

Early deaths		 Porcine 20.4 vs 13.4 (P < 0.001)


At dismissal
Porcine 0.9 vs bovine 1.1 (P < 0.01)


At 1 year
Porcine 0.9 vs bovine 1.1 (P < 0.001)

Porcine −32.4 vs bovine −27.0 (P = 0.40)

None in both types of valve		 Both valves had similar regression in LV mass, despite small differences in prosthetic haemodynamics 1 year after surgery
Dalmau et al. (2011),
Eur J Cardiothoracic Surg, Spain [16]

Prospective randomized study
(level 1)		 Period: 2004–2006

AVR: Edwards Perimount Magna bovine (54) vs Medtronic Mosaic porcine valve (54)

Follow-up: 1 and 5 years		 Mean transvalvular gradients (mmHg)






IEOAs cm2 m−2







Absolute left ventricular mass index







Overall survival at 5 years		 At 1 year
Porcine 16.3 ± 7.6 vs bovine 10.3 ± 3.4 (P < 0.0001)

At 5 year
Porcine 16.8 ± 8.7 vs bovine 9.6 ± 3.5 (P < 0.0001)

At 1 year
Porcine 0.96 ± 0.22 vs bovine 1.10 ± 0.22

At 5 year
Porcine 0.76 ± 0.19 vs
Bovine 1.02 ± 0.25

At 1 year
Porcine −26.3 ± 43.8 vs bovine −30 ± 36.2
(no significant difference)

At 5 year
Porcine −4.3 ± 36.1 vs bovine −47.4 ± 35.1 (P < 0.0001)

Porcine 79.6 ± 4.1% vs bovine 94.4 ± 2.2% (P = 0.039)		 The study clearly demonstrates a favourable haemodynamic function of the bovine valve up to 5 years after implantation. With long-term follow-up, Magna valves were found to haemodynamically outperform the porcine valve and such improvements positively affected LV hypertrophy regression

NS: not significant.