Abstract
Objective
The objective of this study was to report midterm clinical outcomes with a self-expandable
sutureless aortic valve.
Methods
Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval
sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years;
late cumulative follow-up was 2325.2 patient-years.
Results
The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years
of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score
was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients.
Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic
cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7%
(23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6%
at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained
stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively,
at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210)
were in New York Heart Association functional class I or II versus 93.1% (n = 242)
at 5 years.
Conclusions
This series, representing, to our knowledge, the longest follow-up with sutureless
technology in a prospective, multicenter study, shows that aortic replacement using
sutureless valves is associated with low mortality and morbidity and good hemodynamic
performance.
Graphical abstract
Graphical Abstract
Key Words
Abbreviations and Acronyms:
AVR (aortic valve replacement), CAVALIER (Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark), CEC (Clinical Event Committee), CI (confidence interval), NYHA (New York Heart Association), PARTNER (Placement of Aortic Transcatheter Valve Trial), STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to The Journal of Thoracic and Cardiovascular SurgeryAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607
- Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198
- Surgical or transcatheter aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2017; 376: 1321-1331
- Five-year outcomes of transcatheter or surgical aortic-valve replacement.N Engl J Med. 2020; 382: 799-809
- 2017 ESC/EACTS guidelines for the management of valvular heart disease.Eur J Cardiothorac Surg. 2017; 52: 616-664
- Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier trial).Eur J Cardiothorac Surg. 2016; 49: 978-986
- The sutureless aortic valve at 1 year: a large multicenter cohort study.J Thorac Cardiovasc Surg. 2016; 151: 1617-1626.e4
- Early outcomes after isolated aortic valve replacement with rapid deployment aortic valve.J Thorac Cardiovasc Surg. 2016; 151: 1639-1647
- 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
- Minimally invasive aortic valve replacement with sutureless and rapid deployment valves: a report from an international registry (sutureless and rapid deployment international registry).Eur J Cardiothorac Surg. 2019; 56: 793-799
- Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials.Ann Thorac Surg. 2014; 98: 1294-1300
- Five-year results of the pilot trial of a sutureless valve.J Thorac Cardiovasc Surg. 2015; 150: 84-88
- 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; 49: 234-241
- Sutureless perceval aortic valve replacement: results of two European centers.Ann Thorac Surg. 2012; 93: 1483-1488
- Effect of sutureless implantation of the Perceval S aortic valve bioprosthesis on intraoperative and early postoperative outcomes.J Thorac Cardiovasc Surg. 2011; 142: 1453-1457
- Guidelines for reporting mortality and morbidity after cardiac valve interventions.J Thorac Cardiovasc Surg. 2008; 135: 732-738
- Guidelines of the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).(Available at:)
- Long-term outcomes of a rapid deployment aortic valve: data up to 5 years.Eur J Cardiothorac Surg. 2017; 52: 281-287
- Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve.J Thorac Cardiovasc Surg. 2017; 153: 561-569.e2
- Transcatheter aortic valve-in-valve implantation in degenerative rapid deployment bioprostheses.EuroIntervention. 2019; 15: 37-43
- Rapid deployment versus conventional bioprosthetic valve replacement for aortic stenosis.J Am Coll Cardiol. 2018; 71: 1417-1428
- Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A).J Am Coll Cardiol. 2012; 60: 548-558
- The German aortic valve registry: 1-year results from 13,680 patients with aortic valve disease.Eur J Cardiothorac Surg. 2014; 46: 808-816
- Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.Eur Heart J. 2011; 32: 198-204
- Minimally invasive aortic valve replacement with sutureless valves: results from an international prospective registry.Innovations (Phila). 2020; 15: 120-130
- 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: 561-567
Article info
Publication history
Published online: January 13, 2021
Accepted:
December 3,
2020
Received in revised form:
November 27,
2020
Received:
May 26,
2020
Footnotes
This work was supported by LivaNova. LivaNova funded all trial-related activities and participated in site selection, data monitoring, trial management, and statistical analysis.
Identification
Copyright
© 2021 by The American Association for Thoracic Surgery
ScienceDirect
Access this article on ScienceDirectLinked Article
- Commentary: How long it takes is not as important as how long it lastsThe Journal of Thoracic and Cardiovascular SurgeryVol. 164Issue 6
- PreviewTranscatheter aortic valve replacement (TAVR) has been approved for patients with severe aortic stenosis at all levels of risk, and is now performed in more than 700 centers. In fact, annual TAVR volume, for the first time in 2019, exceeded the total number of surgical AVR procedures.1-4 At least in part to make the surgical approach more palatable to patient preference compared with TAVR, access through smaller, less invasive hemisternotomy or right thoracotomy incisions has increased, with excellent outcomes.
- Full-Text
- Preview
- Commentary: The truth is out thereThe Journal of Thoracic and Cardiovascular SurgeryVol. 164Issue 6
- PreviewWe are focusing on the new, we are distracting from the old. The rapid development of transcatheter devices and the subsequent flourishing of randomized clinical trials and large registries have shown not only the feasibility and good results of new technologies but have also brought to light that something is missing, rigorous data on surgical aortic valve replacement (SAVR).1,2 A critical appraisal of recent randomized clinical trials can suggest that incidence of end points in the SAVR arm are abnormally high compared with the real world; nonetheless, looking for high-quality data supporting this hypothesis, we stay with a fistful of flies in hand as there are no strong updated mid- and long-term outcomes confirming surgery as the gold standard for the treatment of aortic valve disease, until proven otherwise.
- Full-Text
- Preview
