perceval clinical evidence - livanova · 2020-02-11 · spanish experience with the perceval s...

Perceval Clinical Evidence

Key Published Experience by TopicUp to December 2018

PERCEVAL® PLATFORM

INDEX

GENERAL OVERVIEW

HEMODYNAMIC BEHAVIOUR

DURABILITY

PERMANENT PACEMAKER IMPLANTATION (PPI) FOLLOWING AVR

COMBINED PROCEDURES

SPECIAL CASES

MICS

VALVE-IN-VALVE

PERCEVAL VS. TRADITIONAL STENTED VALVES

PERCEVAL VS. TAVI

HEALTH ECONOMICS

TIME SAVING

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Perceval Clinical EvidencePERCEVAL® PLATFORM

2

1. Suri RM. et al. - Prospective US Investigational Device Exemption Trial of a Sutureless Aortic Bioprosthesis: One-Year Outcomes - J Thorac Cardiovasc Surg. 2018 Oct 23; PMID: 30553598

2. Chauvette V. et al. - Ten-year experience with the Perceval S sutureless prosthesis: lessons learned and future perspectives - J Vis Surg. 2018 May 3; PMID: 29963376

3. Berastegui Garcia E. et al. - Perceval Less Invasive Aortic Replacement Register: multicentric Spanish experience with the Perceval S bioprosthesis in moderate-high-risk aortic surgery - Interact Cardiovasc Thorac Surg. 2018 Apr 1; PMID: 29237015

4. Powell R. et al. - The Perceval Sutureless Aortic Valve: Review of Outcomes, Complications, and Future Direction - Innovations (Phila). 2017 May/Jun; PMID: 28570342

5. Glauber M. et al. - International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches - Innovations (Phila). 2016 May-Jun;11(3):165-73; PMID: 27540996

6. Muneretto C. et al. - A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in “real-world” patients with aortic stenosis and intermediate- to high-risk profile - J Thorac Cardiovasc Surg. 2015 Dec; PMID: 26384753

7. Shrestha M. et al. - European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients - Eur J Cardiothorac Surg. 2015 Mar 6; PMID: 25750010

8. Phan K. et al. - Sutureless aortic valve replacement: a systematic review and meta-analysis - Ann Cardiothorac Surg. 2015 Mar; PMID: 25870805

9. Gersak B. et al. - Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel - Eur J Cardiothorac Surg. 2015; PMID: 26516193

PERCEVAL® PLATFORM - Clinical evidence

GENERAL OVERVIEW

3


HEMODYNAMIC BEHAVIOUR

1. Suri RM. et al. - Prospective US Investigational Device Exemption Trial of a Sutureless Aortic Bioprosthesis: One-Year Outcomes - J Thorac Cardiovasc Surg. 2018 Oct 23; PMID: 30553598

2. Dalia AA. et al. - Transesophageal Echocardiographic Assessment of the Sutureless Perceval Aortic Valve - J Cardiothorac Vasc Anesth. 2018 Apr 26; PMID: 29804686

3. Rubino AS. et al. - Hemodynamic assessment of Perceval sutureless bioprosthesis by dobutamine stress echocardiography - Echocardiography. 2018 Jan; PMID: 29071795

4. Concistrè G. - Aortic Valve Replacement With Perceval Bioprosthesis: Single-Center Experience With 617 Implants - Ann Thorac Surg. 2018 Jan; PMID: 28964415

5. Belluschi I. et al. - Can Perceval sutureless valve reduce the rate of patient-prosthesis mismatch? - Eur J Cardiothorac Surg. 2017 Jun 1; PMID: 28329177

6. Tasca G. et al. - Comparison of the Performance of a Sutureless Bioprosthesis With Two Pericardial Stented Valves on Small Annuli: An In Vitro Study - Ann Thorac Surg. 2017 Jan; PMID: 27544288

7. Shrestha M. et al. - European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients - Eur J Cardiothorac Surg. 2015 Mar 6; PMID: 25750010

8. Santarpino G. et al. - Left ventricular mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis: preliminary results - Interact Cardiovasc Thorac Surg. 2014 Jan; PMID: 24105865

9. Shrestha M. et al. - Aortic valve replacement in geriatric patients with small aortic roots: are sutureless valves the future? - Interact Cardiovasc Thorac Surg. 2013 Nov; PMID: 23851988

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DURABILITY

1. Meuris B. - The Sutureless AVR Experience in a Single Center: 11 Years of Use in 468 Patients - Oral presentation AATS 2019

2. Meuris B. et al. - A novel tissue treatment to reduce mineralization of bovine pericardial heart valves - HYPERLINK \l “”J Thorac Cardiovasc Surg. 2018 Jul; PMID: 29572021

3. Shrestha M. et al. - European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients - Eur J Cardiothorac Surg. 2016 Jan; PMID: 25750010

4. Meuris B. et al. - Five-year results of the pilot trial of a sutureless valve - J Thorac Cardiovasc Surg. 2015 Jul; PMID: 25940415

5. Della Barbera M. et al. - Pre-implantation collapse in the Sorin Perceval S Sutureless prosthesis does not affect pericardial graft structure - Cardiovascular Pathology 22 (2013); http://dx.doi.org/10.1016/j.carpath.2013.01.052

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PERMANENT PACEMAKER IMPLANTATION(PPI) FOLLOWING AVR

1. Di Eusanio M. et al. - Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR): early results from 3343 patients - Eur J Cardiothorac Surg. 2018 Oct 1; PMID: 29617925

2. Minami T. et al. - Hospital cost savings and other advantages of sutureless vs stented aortic valves for intermediate-risk elderly patients - Surg Today. 2017 Oct; PMID: 28386747

3. Laborde F. et al. - Sutureless Valves Reduce Hospital Costs Compared to Traditional Valves - J Heart Valve Dis. 2017 Jan; PMID: 28544824

4. Toledano B. et al. - Incidence and predictors of new-onset atrioventricular block requiring pacemaker implantation after sutureless aortic valve replacement - Interact Cardiovasc Thorac Surg. 2016 Dec; PMID: 27572616

5. Fischlein T. et al. - How to prevent a pacemaker implantation after sutureless bioprosthesis - J Thorac Cardiovasc Surg. 2016 Aug; PMID: 27423841

6. Yanagawa B. et al. - A simple modification to lower incidence of heart block with sutureless valve implantation - J Thorac Cardiovasc Surg. 2016 Aug; PMID: 26971380

7. Vogt F. et al. - Sutureless aortic valve replacement with Perceval bioprosthesis: are there predicting factors for postoperative pacemaker implantation? - Interact Cardiovasc Thorac Surg. 2016 Mar; PMID: 26614526

8. Phan K. et al. - Sutureless aortic valve replacement: a systematic review and meta-analysis - Ann Cardiothorac Surg. 2015 Mar; PMID: 25870805

9. Gilmanov D. et al. - Aortic valve replacement through right anterior minithoracotomy: can sutureless technology improve clinical outcomes? - Ann Thorac Surg. 2014 Nov; PMID: 25200732

10. Pollari F. et al. - Better short-term outcome by using sutureless valves: a propensity-matched score analysis - Ann Thorac Surg. 2014 Aug; PMID: 24928678


COMBINED PROCEDURES

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1. Baran C. et al. - Sutureless aortic valve replacement with concomitant valvular surgery - J Thorac Cardiovasc Surg. 2018 Jun; PMID: 29551538

2. Akca F. et al. - Sutureless aortic valve replacement in a calcified homograft combined with mitral valve replacement - J Cardiothorac Surg. 2017 Sep 7; PMID: 28882144

3. Lio A. et al. - Minimally invasive approach for aortic and mitral valve surgery - Eur J Cardiothorac Surg. 2016 Dec; PMID: 27301388

4. Lio A. et al. - Valve Replacement with a Sutureless Aortic Prosthesis in a Patient with Concomitant Mitral Valve Disease and Severe Aortic Root Calcification - THI J. 2016 Apr 1; PMID: 27127442

5. Mazine A. et al. - Sutureless Aortic Valve Replacement in the Setting of Triple-Valve Surgery - Innovations (Phila) - 2015 Jul-Aug; PMID: 26368034

6. Shrestha M. et al. - Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials - Ann Thorac Surg. 2014 Oct; PMID: 25106682

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SPECIAL CASES

1. Gangahanamaiah S. et al. - Rapid deployment of an aortic valve prosthesis during ventricular assist device implantation - J Heart Lung Transplant. 2018 Oct 2; PMID: 30391200

2. Freystaetter K. et al. - Replacement of a Stenotic Quadricuspid Aortic Valve With a Sutureless Prosthesis - Ann Thorac Surg. 2018 Jun; PMID: 29374512

3. Stoker T. et al. - Novel Treatment of a Degenerated Bioroot With the Use of the Sutureless Valve Technique - Ann Thorac Surg. 2018 May; PMID: 29288660

4. Boultadakis V. et al. - Sutureless aortic valve implantation in patient with porcelain aorta via unclamped aorta and deep hypothermic circulatory arrest - Ann Card Anaesth. 2017 Oct-Dec; PMID: 28994683

5. Baikoussis NG. et al. - The Perceval S aortic valve implantation in patients with porcelain aorta; is this ideal option? - Ann Card Anaesth, 2017 Jan; PMID: 28074827

6. Gatti G. et al. - Aortic valve replacement within an unexpected porcelain aorta: the sutureless valve option - Interact Cardiovasc Thorac Surg. 2014 Mar; PMID: 24287953

7. Santarpino G. et al. - Perceval sutureless approach in a patient with porcelain aorta unsuitable for transcatheter aortic valve implantation - Int J Cardiol. 2012 Feb 23; PMID: 21958752

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MICS

1. Bouchot O. et al. - Technical points for aortic valve replacement through right anterior minithoracotomy - Eur J Cardiothorac Surg. 2018 May 1; PMID: 29718234

2. Gilmanov D. et al. - Alternative incision sutureless aortic valve replacement: propensity matched comparison between partial sternotomy and right anterior minithoracotomy - Minerva Cardioangiol. 2018 Apr; PMID: 29125270

3. Bonaros N. et al. - Minimally invasive redo-aortic valve replacement - Multimed Man Cardiothorac Surg. 2018 Jan 30; PMID: 29485772

4. Dalen M. et al. - Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis - Eur J Cardiothorac Surg. 2016 Jan; PMID: 25653252

5. Fischlein T. et al. - Sutureless Valve Implantation via Mini J-Sternotomy: A Single Center Experience with 2 Years Mean Follow-up - Thorac Cardiovasc Surg. 2015 Sep; PMID: 26177222

6. Dalen M. et al. - Ministernotomy versus full sternotomy aortic valve replacement with a sutureless bioprosthesis: a multicenter study - Ann Thorac Surg. 2015 Feb; PMID: 25483001

7. Miceli A. 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 Dec; 2 PMID: 4698558

8. Gilmanov D. et al. - Aortic valve replacement through right anterior minithoracotomy: can sutureless technology improve clinical outcomes? - Ann Thorac Surg. 2014 Nov; PMID: 25200732

9. Shrestha M. et al. - Minimally invasive aortic valve replacement with self-anchoring Perceval valve - J Heart Valve Dis. 2013 Mar; PMID: 23798213

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VALVE-IN-VALVE

1. Landes U. et al. - Transcatheter Aortic Valve-in-Valve Implantation in Degenerative Rapid Deployment Surgical Bioprosthesis. - Catheter Cardiovasc Interv. 2018 Apr 1; PMID: 27696650

2. Sun X. et al. - Transcatheter aortic valve-in-valve implantation for early failure of sutureless aortic bioprosthesis - J Card Surg. 2018 Apr; PMID: 29611217

3. Mangner N. et al. - Treatment of a degenerated sutureless Sorin Perceval® valve using an Edwards SAPIEN 3 - Interact Cardiovasc Thorac Surg. 2018 Feb 1; PMID: 29049819

4. Amabile N. et al. - Early outcome of degenerated self-expandable sutureless aortic prostheses treated with transcatheter valve implantation: A pilot series - J Thorac Cardiovasc Surg. 2016 Dec; PMID: 27663520

5. Durand E. et al. - Emergency Transcatheter Aortic Valve Implantation for Acute and Early Failure of Sutureless Perceval Aortic Valve - Can J Cardiol. 2015 Sep; PMID: 26095935

6. Di Eusanio M. et al. - In the era of the valve-in-valve: is transcatheter aortic valve implantation (TAVI) in sutureless valves feasible? - Ann Cardiothorac Surg. 2015 Mar; PMID: 25870827

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PERCEVAL VS. TRADITIONAL STENTED VALVES

1. Meco M. et al. - Sutureless Perceval Aortic Valve Versus Conventional Stented Bioprostheses: Meta-Analysis of Postoperative and Midterm Results in Isolated Aortic Valve Replacement - J Am Heart Assoc. 2018 Feb 16; PMID: 29453309

2. Belluschi I. et al. - Can Perceval sutureless valve reduce the rate of patient-prosthesis mismatch? - Eur J Cardiothorac Surg. 2017 Jun 1; PMID: 28329177


4. Tasca G. et al. - Comparison of the Performance of a Sutureless Bioprosthesis With Two Pericardial Stented Valves on Small Annuli: An In Vitro Study - Ann Thorac Surg. 2017 Jan; PMID: 27544288

5. Muneretto C. et al. - A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in “real-world” patients with aortic stenosis and intermediate - to high-risk profile - J Thorac Cardiovasc Surg. 2015 Dec; PMID: 26384753


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PERCEVAL VS. TAVI

1. Shinn SH. et al. - A Systemic Review and Meta-Analysis of Sutureless Aortic Valve Replacement Versus Transcatheter Aortic Valve Implantation - Ann Thorac Surg. 2018 Sep; PMID: 29709503

2. Folliguet T. - Sutureless aortic valve and TAVI: pros and cons - Minerva Cardioangiol. 2018 Apr; PMID: 29160046

3. Repossini A. et al. - Stentless sutureless and transcatheter valves: a comparison of the hemodynamic performance of different prostheses concept - Minerva Cardioangiol. 2018 Apr; PMID: 29160045


5. Meco M. et al. - Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching - Interactive CardioVascular and Thoracic Surgery 2017; PMID: 29049787

6. Wang N. et al. - Transcatheter aortic valve implantation (TAVI) versus sutureless aortic valve replacement (SUAVR) for aortic stenosis: a systematic review and meta-analysis of matched studies - J Thorac Dis. 2016 Nov; PMID: 28066608

7. Miceli A. et al. - Minimally invasive aortic valve replacement with a sutureless valve through a right anterior mini-thoracotomy versus transcatheter aortic valve implantation in high-risk patients - Eur J Cardiothorac Surg. 2016 Mar; PMID: 26113005

8. Muneretto C. et al. - A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in “real-world” patients with aortic stenosis and intermediate- to high-risk profile - J Thorac Cardiovasc Surg. 2015 Dec; PMID: 26384753

9. Santarpino G. et al. - Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis - Am J Cardiol. 2015 Dec 1; PMID: 26433277

10. Muneretto C. et al. - Treating the patients in the ‘grey-zone’ with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement - Interact Cardiovasc Thorac Surg. 2015 Jan; PMID: 25320140

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HEALTH ECONOMICS

1. Povero M. et al. - Cost-utility of surgical sutureless bioprostheses vs TAVI in aortic valve replacement for patients at intermediate and high surgical risk - Clinico Economics and Outcomes Research 2018; PMID: 30510436

2. Villa E. et al. - Sutureless aortic valve replacement in high risk patients neutralizes expected worse hospital outcome: A clinical and economic analysis - Cardiol J. 2018 Sep 20; PMID: 30234906



5. Santarpino G. et al. - Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis - Am J Cardiol. 2015 Dec 1; PMID: 26433277


7. Pradelli L. et al. - Perceval Sutureless valves in isolated and concomitant AVR procedures: an economic model shows overall decrease of costs for isolated or combined operations - Farmeconomia. Health economics and therapeutic pathways 2012; 13(4): 159-174

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TIME SAVING




4. Glauber M. et al. - International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches - Innovations (Phila). 2016 May-Jun; PMID: 27540996

5. Shrestha M. et al. - European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients - Eur J Cardiothorac Surg. 2016 Jan; PMID: 25750010

6. Gersak B. et al. - Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel - Eur J Cardiothorac Surg. 2015; PMID: 26516193

7. Shrestha M. et al. - Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials - Ann Thorac Surg. 2014 Oct; PMID: 25106682


9. Shrestha M. et al. - Aortic valve replacement in geriatric patients with small aortic roots: are sutureless valves the future? - Interact Cardiovasc Thorac Surg. 2013 Nov; PMID: 23851988

INDICATIONSEUROPE: The Perceval prosthesis is indicated for the replacement of diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated for use in adult patients who are diagnosed to have aortic valve stenosis or steno-insufficiency.USA: The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.CANADA: The Perceval S bioprosthesis is intended for use in patients aged ≥ 65 years when the aortic valve pathology is in an advanced stage to require the replacement of the native or malfunctioning previously implanted prosthesis.AUSTRALIA: Perceval S prosthesis is indicated for the replacement of a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated in patients who meet the following criteria: 1) subjects of age ≥ 65 years 2) subjects with aortic valve stenosis or steno-insufficiency.

KEY CONTRAINDICATIONS: Aneurysmal dilation or dissection of the ascending aortic wall; Known hypersensitivity to nickel or cobalt alloys; STJ/annulus diameter ratio greater than 1.3.

KEY WARNINGS: It is strongly recommended that the Perceval valve not be used in children, adolescents, or young adults, in patients with increased risk of accelerated valve tissue calcification. Do not under or oversize the prosthesis. The guiding sutures must not be tied. The decision to make a transcatheter aortic valve implantation in Perceval compared to other options should be done by the Heart team based on individual assessment of the patient’s conditions. Valve-in-Valve procedures in a Perceval valve should be performed according to indications provided by the transcatheter valve manufacturer.

TOP POTENTIAL SIDE EFFECTS: central and paravalvular leak, cardiac disorders, structural valve deterioration, thromboembolism, reoperation.

MRI conditional.

For professional use. Please contact us through our website to receive instructions for use containing full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Not approved in all geographies. Consult your labeling.

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perceval clinical evidence - livanova · 2020-02-11 · spanish experience with the perceval s...

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