Perceval

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The biological valve of choice in AVR

  • The truly sutureless solution in AVR:

    Perceval helps reducing complexity even in challenging and time consuming procedures1,2
     
  • With a reproducible surgical technique:

    Perceval allows precise positioning both in MICS and traditional surgery2,3
     
  • At your side in every day practice:

    Perceval is a valuable option to reduce post-operative complications1,2
     

REFERENCES

  1. Santarpino G, Pfeiffer S, Concistrè G et al. The Perceval S aortic valve has the potential of shortening surgical time: does it also result in improved outcome? Ann Thorac Surg. 2013;96:77-81

  2. Santarpino G, Pfeiffer S, Schmidt J et al. Sutureless aortic valve replacement: first-year single-center experience. Ann Thorac Surg. 2012;94:504-8

  3. Gilmanov D, et al. Sutureless implantation of the perceval s aortic valve prosthesis through right anterior minithoracotomy. Ann Thorac Surg. 2013;96:2101-8

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Features

Reduced trauma of operation 

  • Increased visualization:

    The reduced collapsed profile prevents trauma to the aortic wall enabling a full and direct view.
     
  • Precise positioning:

    The temporary guiding sutures the valve by guiding it along the annulus axis even in narrow spaces.
     
  • Ease of implant:

    Traditional valves require from 15 to 18 permanent sutures. Perceval is a truly sutureless valve.

“Atraumatic insertion of the device with self-anchoring of the prosthetic valve into its final position, minimizing the risk for iatrogenic aortic dissection or thromboembolic stroke”1


  • Time saving

 

 

 

 

 

 

 


Find out more:

  1. Santarpino G, Pfeiffer S, Concistré G et al. The Perceval S aortic valve has the potential of shortening surgical time: does it also result in improved outcome? Ann Thorac Surg. 2013;96:77-81

  2. Phan K, Croce B, Yan TD. Minimally invasive atrial fibrillation surgery. Ann Cardiothorac Surg. 2014 Jan;3(1):130. doi: 10.3978/j.issn.2225-319X.2014.01.02.

  3. Martens S, Ploss A, Sirat S et al. Sutureless aortic valve replacement with the 3f Enable aortic bioprosthesis. Ann Thorac Surg. 2009;87:1914-7. 

  4. Kocher AA, Laufer G, Haverich A et al. One-year outcomes of the surgical treatment of aortic stenosis with a next generation surgical aortic valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system. J Thorac Cardiovasc Surg. 2013;145:110-5; 

  5. Folliguet TA, Laborde F, Zannis K et al. Sutureless perceval aortic valve replacement: results of two European centers. Ann Thorac Surg. 2012;93:1483-8

 

Better patient outcome

  • ICU stay reduction1

 


  • Ventilation time reduction1

 

 

 

 


  • Less blood transfusion1

 

 

 


Find out more:

  1. Santarpino G, Pfeiffer S, Concistrè G et al. The Perceval S aortic valve has the potential of shortening surgical time: does it also result in improved outcome? Ann Thorac Surg. 2013;96:77-81

 

Perceval – Innovation starts at its core 

A distinctive design built around a super elastic stent with unique features and mechanical behavior.

  • Following heart movement:

       The Perceval stent is able to adapt to the movements of the aorta during the cardiac cycle.

  • Optimized blood flow:

       Thanks to the absence of a suturing ring, the geometric orifice area is maximized, providing excellent hemodynamics with stable results over time1,2

 

 


Find out more:

  1. Shrestha M, Maeding I, Höffler K et al. Aortic valve replacement in geriatric patients with small aortic roots: are sutureless valves the future? Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):778-82  

  2. Folliguet TA, Laborde F, Zannis K et al. Sutureless perceval aortic valve replacement: results of two European centers. Ann Thorac Surg. 2012;93:1483-8

 Stent elasticity

  • Optimal stress absorption
    • The elastic structure aims at reproducing the stress absorption properties of the native tissue at the valve commissures level
    • The Perceval valve passed a test 3 times harder than what is required by the I.S.O. and F.D.A. guidance (no failure after 600 million cycles)

 

  • This Perceval valve showed no failure after 2 Billion cycles, equivalent to 50-year heart cycles in-vivo.

 


Innovation and Heritage

The Perceval tissue component is based on a double sheet design introduced by Sorin in 1985.

It has shown excellent results in terms of durability1,2


Collapsing, not crimping

Examination of the results after collapsing and deployment revealed optimal cusp coaptation and absence of tears, perforation or folding3

  • Collapsing:
    • Increases the visibility
    • Allows for easier procedure
    • Preserves the integrity of the leaflets

 

 

 

 

 

Source right image: Della Barbera M. SHVD 2011 poster presentation

 


Find out more:

  1. Folliguet TA, Le Bret E, Bachet J et al. Pericarbon pericardial bioprosthesis: an experience based on the lessons of the past. Ann Thorac Surg. 2001;71(5 Suppl):289-92.

  2. D’Onofrio A, Auriemma S, Magagna P et al. Aortic valve replacement with the Sorin Pericarbon Freedom stentless prosthesis: 7 years' experience in 130 patients. J Thorac Cardiovasc Surg. 2007;134:491-5

  3. Della Barbera M, Basso C, Valente M et al. Pre-implantation collapse in the Sorin Perceval S sutureless prosthesis does not affect pericardial graft structure. Cardiovascular pathology May-June 2013; Vol. 22, Issue 3, e43

 

INNOVATION AND SUSTAINABILITY

PERCEVAL HEALTH ECONOMICS

Perceval cost reduction in practice – 1

Better short-term outcome by using sutureless valves: a propensity-matched score analysis1

Methods:

From March 2010 to April 2013, 566 patients underwent aortic valve replacement with bioprostheses; A propensity-score analysis was used to create two groups (sutureless and stented) with 82 matched pairs with comparable preoperative characteristics. Hospital outcome, follow-up, and health care resource consumption were compared.

Conclusion:

Combining the advantage of shorter procedural times with a subsequent better outcome and reduced health care costs, sutureless AVR might become the first-line surgical treatment for patients with severe aortic valve stenosis.


Perceval cost reduction in practice – 2 

Perceval S sutureless valve versus conventional bioprosthesis: a matched case-control study2

Methods:

Clinical outcome and hemodynamic data of 53 patients with Perceval implantation (with or without concomitant CABG) were compared with an age-, gender- and operation type (AVR or AVR+CABG) matched patient cohort receiving an Edwards Perimount valve (n=53). Studied parameters included mortality, CPB and ACC times, transfusion requirements, duration of intubation and length of stay on intensive care and on the regular ward.

Conclusion:

In a population of elderly intermediate-risk patients, the shortened cross-clamp times and CPB-times, as obtained with the sutureless Perceval bioprosthesis, result in a favorable effect on the postoperative recovery and use of resources when compared to a conventional bioprosthesis.

 


Perceval cost reduction in practice – 3

Sutureless valves compared to traditional valves reduce hospital costs3

Methods:

A retrospective comparative study has been implemented with 65 patients implanted with traditional aortic valves (T) and 65 patients treated with the sutureless aortic prosthesis Sorin Group Perceval (P). Cost data were drawn from the proprietary cost accounting system of the hospital, excluding acquisition costs of the devices.

Conclusion:

Sutureless aortic valves present shorter procedural times and lower hospital costs compared with traditional valves, with higher cost savings at increased age and risk. Sutureless aortic valves are an excellent choice for patients undergoing AVR.


Find Out More

  1. Pollari F, Santarpino G, Dell’Aquila AM et al. Better short-term outcome by using sutureless valves: a propensity-matched score analysis. Ann Thorac Surg. 2014;98:611-6 
  2.  B. Meuris, S. Sainte, H. De Praetere; HVSA congress, 2014
  3. F. Laborde, T. Folliguet, G. Ghorayeb, K. Zannis; SFCTCV Congress, 2014

Evidence

CLINICAL RESULTS OF THREE PROSPECTIVE MULTICENTRIC STUDIES

  • Pooled analysis of 3 prospective multicentric studies
    • 765 patients
    • 5 years follow-up
    • 3 consecutive trials in 26 Centers in 8 European Countries
    • Surgical access: median and mini-sternotomy
    • Age: ≥ 65 years
    • Mean Euro score: 11.04%
    • Available sizes: S, M, L, (XL*)
  • 26 Investigational Sites in Europe
    • Austria (2 centers)
    • Belgium (2 centers)
    • France (4 centers)
    • Germany (12 centers)
    • Netherlands (3 centers)
    • Poland (1 center)
    • Switzerland (1 center)
    • UK (1 center)

Sorin clinical report perceval clinical experience: Pooled analysis of pilot (V10601), pivotal (V10801), and Cavalier (TPS001) trials - CLNR-00011 A.

*XL size included in clinical trial although not reported in the results of the present pooled analysis.


INCLUSION CRITERIA AND PATIENTS’ DEMOGRAPHIC DATA 

  • Major inclusion criteria
    • Adult patients (≥75 years; ≥65 years from 2010)
    • Stenosis or steno-insufficiency
    • Aortic annulus in the range 19 - 25 mm

 

  • Major exclusion criteria
    • Pure aortic regurgitation
    • Congenital bicuspid aortic valve
    • Subjects with aortic root enlargement

 

DEMOGRAFIC DELTA

Implant period April 2007-September 2012
Mean age 78.9 ± 5.4
Gender (female) 68.1%
EuroScore(Mean) 11.04%
STS score (Mean) 8.59%

 

SURGICAL APPROACH AND PROCEDURE

  • AV pathology


  • Surgical approach


  • Concomitant procedures

 

 

 

 

 

 


HEMODYNAMICS

  • Pressure gradients

 

 

 

 

 

 

 

 

 


  • EOA and EOAi

 

 

 

 

 

 

 

 

 

 


CLINICAL OUTCOMES

  • No thrombosis
  • No post-operative migrations
  • No structural valve deterioration
  • Early cardiac mortality 1.9% (late 1.4%)
  • Survival @ 5 years 74.7%
  • Early AV Block III leading to PM implantation 6% (late 1.4%)
  • Early major stroke 1.6% (late 0.8%)
  • Early major paravalvular leak 1.4% (late 1%)

Perceval publications 

2014

  • König KC, Wahlers T, Scherner M et al. Sutureless perceval aortic valve in comparison with the stented Carpentier-Edwards Perimount aortic valve. J Heart Valve Dis. 2014 Mar;23(2):253-8
  • Michelena HI, Michler RE, Enriquez-Sarano M et al. An alternative for surgical management of calcific aortic valve stenosis: sutureless valve implants. J Card Surg. 2014;29(4):490-3.  
  • Miceli A, Santarpino G, Pfeiffer S et al. Minimally invasive aortic valve replacement with Perceval S sutureless valve: early outcomes and one-year survival from two European centers. J Thorac Cardiovasc Surg. 2014 Mar 4. pii: S0022-5223(14)00293-1. doi: 10.1016/j.jtcvs.2014.02.085. [Epub ahead of print]  
  • Minh TH, Mazine A, Bouhout I et al. Expanding the indication for sutureless aortic valve replacement to patients with mitral diseaseJ Thorac Cardiovasc Surg. 2014 Oct;148(4):1354-9.  
  • Ouazzani M, Frapier JM, Rouvière P et al. Première étude comparative entre les trois prothèses valvulaires aortiques sutureless disponibles. Journal de Chirurgie Thoracique et Cardio-Vasculaire 2014;18(2) 89-95
  • Phan K, Tsai YC, Niranjan N et al. Sutureless aortic valve replacement: a systematic review and meta-analysis. Ann Cardiothorac Surg. Accepted for publication Apr 27, 2014. doi: 10.3978/j.issn.2225-319X.2014.06.01
  • Pollari F, Santarpino G, Pfeiffer S et al. Doppia sostituzione mitro-aortica in paziente ad alto rischio: the sutureless way. [Double mitro-aortic valve replacement in a high-risk patient: the sutureless way] G Ital Cardiol 2014;15(2): 128-9 [Article in Italian].  
  • Pollari F, Santarpino G, Dell’Aquila AM et al. Better short-term outcome by using sutureless valves: a propensity-matched score analysis. Ann Thorac Surg. 2014;98(2):611-6
  • Rubino AS, Santarpino G, De Praetere H et al. Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: results of a multicenter study. J Thorac Cardiovasc Surg. 2014;148(3):865-71  
  • Santarpino G, Pollari F, Fischlein T. Sutureless versus transcatheter aortic valve implantation: an unresolved dilemma. J Thorac Cardiovasc Surg. 2014 Jul;148(1):364-5.  
  • Santarpino G, Pfeiffer S, Jessl J et al. Sutureless replacement versus transcatheter valve implantation in aortic valve stenosis: a propensity-matched analysis of 2 strategies in high-risk patients. J Thorac  Cardiovasc Surg. 2014;147(2):561–7.
  • Santarpino G, Fischlein T: Aortenklappenersatz mit nahtfreien Herzklappenprothesen - aktueller Stand und Stellenwert in der Zukunft. [Use of Sutureless Valves for Aortic Valve Replacement in Clinical Practice: State of the Art] Aktuel Kardiol 2014; 3(2): 105-112
  • Santarpino G, Fischlein T. Use of sutureless prosthetic aortic valves in cardiac surgery. Ital Cardiol (Rome) 2014;15(3):170-6 [Article in Italian].  
  • Shrestha M. Folliguet TA, Pfeiffer S et al. Aortic Valve Replacement and Concomitant Procedures With the Perceval Valve: Results of European Trials. Ann Thorac Surg. 2014;98(4):1294-300
  • Tavlasoglu M, Guler A, Yesil FG et al. Should sutureless aortic valve replacement be preferred only for decreasing aortic crossclamp time? J Thorac Cardiovasc Surg. 2014 May;147(5):1726-7 

2013

  • Carrel T, Englberger L, Stalder M. Recent developments for surgical aortic valve replacement: the concept of sutureless valve technology. Open Journal of Cardiology 2013; 4-1 [Review Article]
  • Concistrè G, Santarpino G, Pfeiffer S et al. Two alternative sutureless strategies for aortic valve replacement: a two-center experience. Innovations (Phila) 2013 Jul-Aug;8(4):253-7.  
  • Della Barbera M, Basso C, Valente M et al. Pre-Implantation collapse in the Sorin sutureless prosthesis does not affect Pericardial Graft Structure. Cardiovascular Pathology 2013;28(2):158-63
  • D’Onofrio A, Rizzoli G, Messina A et al. Conventional surgery, sutureless valves, and transapical aortic valve replacement: what is the best option for patients with aortic valve stenosis? A multicenter, propensity-matched analysis. J Thorac Cardiovasc Surg. 2013;146(5):1065-70  
  • Folliguet TA and Laborde F. Sutureless Perceval Aortic Valve Replacement in Aortic Homograft. Ann Thorac Surg. 2013;96(5):1866-8
  • Gatti G, Benussi B, Camerini F et al. Aortic valve replacement within an unexpected porcelain aorta: the sutureless valve option. Interact Cardiovasc Thorac Surg. 2014;18(3):396-8  
  • Gilmanov D, Miceli A, Bevilacqua S et al. Sutureless implantation of the Perceval S aortic valve prosthesis through right anterior minithoracotomy. Ann Thorac Surg. 2013;96(6):2101-8.
  • Lorusso R, Gelsomino S, Renzulli A. Sutureless aortic valve replacement: an alternative to transcatheter aortic valve implantation? Curr Opin Cardiol. 2013;28(2):158-63  
  • Mazine A, Minh TH, Bouchard D et al. Sutureless aortic valve replacement in the presence of a mechanical mitral prosthesis. J Thorac Cardiovasc Surg. 2013;146(4):e27-8.  
  • Mokráček A, Čanádyová J, Kurfirst V et al. Sutureless Aortic Bioprotheses - Initial experience with Sorin Perceval S Prosthesis. Interv Akut Kardiol 2013; 12(3): 121–123
  • Raja S. Sutureless aortic valve replacement using perceval s valve. Recent Pat Cardiovasc Drug Discov. 2013;8(2):75-80.
  • Santarpino G, Pfeiffer S, Sirch J et al. Minimally invasive aortic valve replacement with Perceval valves: first clinical experience. J Cardiovasc Med (Hagerstown) 2014;15(3):230-4  
  • Santarpino G, Pfeiffer S, Pollari F et al. Left ventricular mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis: preliminary results. Interact Cardiovasc Thorac Surg. 2014;18(1):38-42.  
  • Santarpino G, Pfeiffer S, Vogt F et al. Advanced age per se should not be an exclusion criterion for minimally invasive aortic valve replacement. J Heart Valve Dis. 2013;22(4):455-9.  
  • Santarpino G, Pfeiffer S, Concistrè G et al. The Perceval S aortic valve has the potential of shortening surgical time: does it also result in improved outcome? Ann Thorac Surg. 2013;96(1):77-81
  • Santarpino G, Pfeiffer S, Concistrè G et al. REDO aortic valve replacement: the sutureless approach. J Heart Valve Dis. 2013;22(5):615-20.
  • Shrestha M, Maeding I, Höffler K et al. Aortic valve replacement in geriatric patients with small aortic roots: are sutureless valves the future? Interact Cardiovasc Thorac Surg. 2013;17(5):778-82  
  • Shrestha M, Timm R, Höffler K et al. Minimally invasive aortic valve replacement with self-anchoring Perceval Valve. J Heart Valve Dis. 2013;22(2):230-5.  
  • Varela-Lema L, De La Fuente Cid R, López Garcia, ML. Recambio valvular aórtico mediante prótesis sin sutura en pacientes con estenosis aórtica grave y alto riesgo quirúrgico: revisión sistemática - Medicina Clinica Vol 140, Issue 3:119–127 [Article in Spanish].  
  • Villa E, Messina A, Cirillo M et al. Perceval sutureless valve in freestyle root: new surgical valve-in-valve therapy. Ann Thorac Surg. 2013;96(6):e155-7  

2012

  • D’Onofrio A, Messina A, Lorusso R et al. Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone” between transcatheter aortic valve implantation and conventional surgery: a propensity-matched, multicenter analysis. J Thorac Cardiovasc Surg. 2012;144(5):1010-6.   

  • Folliguet TA, Laborde F, Zannis K et al. Sutureless Perceval aortic valve replacement: results of two European centers. Ann Thorac Surg. 2012;93(5):1483-8   

  • Manasse E. Sutureless aortic heart valve technology - present and future perspectives. In: Percutaneous Valve Technology: Present and Future. Nova Publishers, Chapter 13: 293-306 

  • Najm HK and Ahmad M. Suture-less aortic valve replacementJ Saudi Heart Assoc. 2012;24(1):55-6.

  • Niklewski T. et al. Aortic valve replacement with a new sutureless aortic valve Perceval S prosthesis: 12 months of Polish experience. Kardiochirurgia i Torakochirurgia Polska; 2012;2:165–169.

  • Pradelli L and Zaniolo O. Perceval sutureless valves in isolated and concomitant AVR procedures: an economic model shows overall decrease of costs for isolated or combined operations. Farmaeconomia. Health economics and therapeutic pathways 2012;13(4):159-174.

  • Ranucci M, Frigiola A, Menicanti L et al. Aortic cross-clamp time, new prostheses, and outcome in aortic valve replacement. J Heart Valve Dis. 2012;21(6):732-9.  

  • Santarpino G, Pfeiffer S, Concistrè G et al. A supra-annular malposition of the Perceval S sutureless aortic valve: the ‘X-movement’ removal technique and subsequent reimplantation. Interact Cardiovasc Thorac Surg. 2012;15(2):280-1

  • Santarpino G, Pfeiffer S, Concistrè G et al. Perceval S aortic valve implantation in mini-invasive surgery: the simple sutureless solution. Interact Cardiovasc Thorac Surg. 2012;15(3):357-60

  • Santarpino G, Pfeiffer S, Schmidt J et al. Sutureless aortic valve replacement: first-year single-center experience. Ann Thorac Surg. 2012;94(2):504-8

  • Santarpino G, Pfeiffer S, Fischlein T. Sutureless aortic valve replacement to prevent PPM in the era of valve in valve implantation. J Thorac Cardiovasc Surg. 2012;144(1):279-80.

  • Santarpino G, Pfeiffer S, Fischlein T. Sutureless valve implantation in a patient with bicuspid aortic valve. Int J Cardiol. 2012 May 31;157(2):e21-2.  

  • Santarpino G, Pfeiffer S, Fischlein T. Perceval sutureless approach in a patient with porcelain aorta unsuitable for transcatheter aortic valve implantation. Int J Cardiol. 2012 Feb 23;155(1):168-70   

  • Sepehripour AH, Harling L and Athanasiou T. What are the current results of sutureless valves in high-risk aortic valve disease patients? Interact Cardiovasc Thorac Surg. 2012;14(5):615-21.  

  • Zannis K, Folliguet T, Laborde F. New sutureless aortic valve prosthesis: another tool in less invasive aortic valve replacement. Curr Opin Cardiol. 2012;27(2):125-9.  

2011

  • Al-Attar N. Next generation surgical aortic biological prostheses: “sutureless valves”. ESC Council for Cardiology Practice; Vol. 10 No. 14.
  • Flameng W, Herregods MC, Hermans H et al. Effect of sutureless implantation of the Perceval S aortic valve bioprosthesis on intraoperative and early postoperative outcomes. J Thorac Cardiovasc Surg. 2011;142(6):1453-7.  
  • Santarpino G, Pfeiffer S, Concistrè G. Perceval sutureless aortic valve prosthesis: easy, fast, and safe. Innovations (Phila). 2011; 6: 378–381  

2010

  • Stalder M, Suri RM, Kraehenbuehl ES et al. Transapical Implantation of a Novel Self-Expanding Sutureless Aortic Valve Prosthesis. J Heart Valve Dis. 2010;19(2):182-7   
  • Suri M, Burkhart et al. Robot-assisted aortic valve replacement using a novel sutureless bovine pericardial prosthesis: proof of concept as an alternative to percutaneous implantation. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery 5(6): 419-423

2009

  • Folliguet T, Dibie A, Laborde F. Future of cardiac surgery: minimally invasive techniques in sutureless valve resection. Future Cardiol. 2009;5(5):443-52.  
  • Shrestha M, Folliguet T, Meuris B et al. - Sutureless Perceval S aortic valve replacement: a multicenter, prospective pilot trial. J Heart Valve Dis. 2009;18(6):698-702

2008

  • Shrestha M, Khaladj N, Bara C et al. A staged approach towards interventional aortic valve implantation with a sutureless valve: initial human implants. Thorac Cardiovasc Surg. 2008;56(7):398-400

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