Abstract
OBJECTIVES
Patients with failed stentless aortic prostheses are a challenging population to treat, as reoperative procedures may be complex and catheter-based treatments are associated with a high rate of procedural events. Reoperative surgery using sutureless valves may be an alternative.
METHODS
In this multicentre experience, we assess outcomes of 17 patients who underwent reoperative surgery using the Perceval valve (Corcym UK Limited, London, UK) inside Freestyle prosthesis (Medtronic Inc., Dublin, Ireland) or bioroots from 2018 to 2023.
RESULTS
Mean age was 71.1 ± standard deviation 15.1 years and mean EuroSCORE II was 13.5 ± 15.8%, Society of Thoracic Surgeons Score was 5.9 ± 11.7%. Mean transvalvular gradient at baseline was 25.3 ± 19.9 mmHg and left ventricular ejection fraction was 53.5 ± standard deviation 8.5%. In 70.6% (12/17), moderate or severe aortic regurgitation was present. Implant success was 100%. Aortic cross-clamp time was 44.5 ± standard deviation 23.6 min. No patient needed a pacemaker and no mild paravalvular regurgitation occurred. Mean gradient was 12.5 ± 4.7 mmHg; 30-day mortality was 5.9% (1/17).
CONCLUSIONS
Rate of mortality was lower than predicted by EuroSCORE II in these high-risk patients and haemodynamic outcomes were favourable. Heart teams should consider this treatment concept when discussing patients with failed stentless valves or bioroots.
Keywords: Aortic valve, Stentless valves, Sutureless valves, Valve deterioration, Failed valves, Valve-in-valve
Among patients undergoing biological aortic valve replacement, stentless valves were once favoured in younger patients and in endocarditis, since they were believed to provide superior haemodynamics and lower rate of re-infection [1].
Graphical Abstract
INTRODUCTION
Among patients undergoing biological aortic valve replacement, stentless valves were once favoured in younger patients and in endocarditis, since they were believed to provide superior haemodynamics and lower rate of re-infection [1].
However, in stentless aortic valves and in ‘bioroots’, reoperative procedures may be complex [2, 3]. Catheter-based valve-in-valve (ViV) treatments in stentless valves are associated with increased peri-interventional risks compared to ViV inside stented prostheses [4]. Complications result from a lack of fluoroscopic markers and a shallow aortic sinus and the mode of failure often being regurgitation. Redo aortic valve replacement using sutureless prostheses may be an alternative.
PATIENTS AND METHODS
Ethical statement
IRB approval number is S64845 for Leuven, Belgium. In Germany, data collection and follow-up were covered as part of the German Aortic Valve Registry.
Study design
This is a retrospective, multicentre (3 centres), observational study. Patients with failed stentless valves or bioroots undergoing redo surgery with use of a sutureless prosthesis were included.
From 2018 to 2023, 17 patients received a Perceval sutureless valve (Corcym UK Limited, London, UK) inside either a degenerated Freestyle prosthesis (Medtronic Inc., Dublin, Ireland) in 15 Patients, inside a failed Bioroot (25 mm Perimount) and a failed Ross procedure in 1 patient, respectively. Procedural steps have been described [5]. In addition to clinical data, we assessed the combined end-point ‘device success’ by the Valve Academic Research Consortium (VARC-3) [6].
Statistical analysis
Data are presented as absolute numbers and percentages for categorical variables. Continuous variables are given as mean values and standard deviation. There was no imputation for missing values, denominators are provided. Kaplan–Meier estimation was used for survival analyses. We used GraphPad Prism 5.0 (GraphPad Software Inc., La Jolla, CA, USA) and MedCalc (MedCalc Software Ltd, Ostend, Belgium).
RESULTS
Baseline characteristics
Mean age was 71.1 ± 15.1 years and mean EuroSCORE II was 13.5 ± 15.8%. Society of Thoracic Surgeons Scores was 5.9 ± 11.7% (see Table 1). Time since previous surgery was 11.1 years and mode of valve failure was regurgitation in the majority. The indication for the sutureless prosthesis in the failed Bioroot’s case was actually a formerly failed David’s case who was then reoperated with a Bioroot (25 mm Perimount); therefore, 3rd operation for this patient, which was performed as a combined procedure with mitral repair. The prosthesis was excised and the root left intact.
Table 1:
Baseline, operative and postoperative results
| Baseline characteristics | N = 17 |
|---|---|
| Age (years), mean ± SD | 71.1 ± 15.1 |
| Median (IQR) | 76.0 (71.5–79) |
| EuroSCORE II (%), mean ± SD | 13.5 ± 15.8 |
| Median (IQR) | 10.0 (6–39) |
| STS (%), mean ± SD | 5.9 ± 11.7 |
| Female gender, n (%) | 5 (29.4) |
| BMI, mean ± SD | 28.2 ± 5.8 |
| Diabetes mellitus, n (%) | 3 (17.7) |
| Endocarditis, n (%) | 2 (11.8) |
| Mean gradient (mmHg), mean ± SD | 25.3 ± 19.9 |
| Moderate/severe aortic regurgitation, n (%) | 12 (70.6) |
| Left ventricular ejection fraction (LVEF in %), mean ± SD | 53.5 ± 8.5 |
| Time since last surgery (years), mean ± SD | 11.1 ± 3.9 |
| Median years (IQR) | 10.8 (8.9–12.6) |
| Type of previous surgery, n (%) | |
|
15 (88.2) |
|
1 (5.9) |
|
1 (5.9) |
| Third redo procedure, n (%) | 3 (17.7) |
| CABG during prior surgery, n (%) | 4 (23.5) |
| Permanent pacemaker present, n (%) | 2 (11.8) |
| Chronic kidney disease (GFR ≤90 ml/min), n (%) | 6 (35.3) |
| Size of previously implanted Freestyle/Bioroot (mm), n (%) | |
| 21 | 3 (17.7) |
| 23 | 6 (35.2) |
| 25 | 4 (23.5) |
| 27 | 2 (11.8) |
| 29 | 2 (11.8) |
|
| |
| Procedural data | |
|
| |
| Surgical access | |
| Re-sternotomy, n (%) | 16 (94.1) |
| Right anterior minithoracotomy, n (%) | 1 (5.9) |
| Arterial cannulation, n (%) | |
| Femoral | 9 (52.9) |
| Central | 5 (29.4) |
| Axillary | 3 (17.7) |
| Concomitant procedures, n (%) | |
| Coronary artery bypass grafting | 2 (11.8) |
| Myectomy (Morrow) | 2 (11.8) |
| Mitral valve procedure | 3 (17.7) |
| Tricuspid valve procedure | 2 (11.8) |
| Transcatheter valve removalb | 1 (5.9) |
| Perceval size implanted, n (%) | |
| S | 4 (23.5) |
| M | 5 (29.4) |
| L | 5 (29.4) |
| XL | 3 (17.7) |
| Implant success, n (%) | 17 (100) |
| Cardiopulmonary bypass time (min), mean ± SD | 85.2 ± 41.8 |
| Aortic cross clamp time (min), mean ± SD | 44.5 ± 23.6 |
| Procedural time (min), mean ± SD | 181.1 ± 57.8 |
|
| |
| Postoperative outcomes (30 days) | |
|
| |
| Stay on ICU (nights), mean ± SD | 2.8 ± 1.9 |
| Permanent pacemaker implantation | 0 |
| Paravalvular regurgitation, n (%) | |
| Mild | 1 (5.9) |
| Moderate or severe | 0 |
| Postoperative mean gradient (mmHg), mean ± SD | 12.5 ± 4.7 |
| Mean gradient in patients with ‘S’ and ‘M’ prosthesis (n = 9) | 14.3 ± 4.8 |
| EOA in patients with ‘S’ and ‘M’ prosthesis (n = 9) | 1.3 ± 0.09 |
| Reoperation for bleeding, n (%) | 1 (5.9) |
| Stroke, n (%) | 1 (5.9) |
| Renal failure, n (%) | 2 (11.8) |
| Mortality, n (%) | 1 (5.9) |
| 30 days device success (VARC-3) | 16 (94.1) |
Patient with failed David’s and failed redo Bioroot, 3rd procedure.
Failed TAVI prosthesis inside a Freestyle (81 years).
BMI: body mass index; CABG: coronary artery bypass grafting; EOA: effective orifice area; GFR: glomerular filtration rate; ICU: intensive care unit; IQR: interquartile range; SD: standard deviation; STS: Society of Thoracic Surgeons; VARC-3: Valve Academic Research Consortium.
The indication for using sutureless prostheses instead of sutured prostheses would in the majority of patients be redo procedure in elderly patients (>70 years), as 14 patients were >70 years (3 over 80 year) and the procedures were frequently combined. Two patients had endocarditis.
Procedural and 30-day results
Results are summarized in Table 1. There was 1 death on day 6 (5.9%). This patient had a rethoracotomy for bleeding on the operative day and developed right heart failure with extracorporal membrane oxygenation and multi-organ failure (76-year-old male with EuroSCORE II 68.4%). Other included 1 stroke (5.9%), severe renal failures (11.8%) and 1 reoperation for bleeding (5.9%). There was no pacemaker implantation, and 1 patient had mild paravalvular regurgitation. All patients showed a mean gradient below 20 mmHg at discharge (see Fig. 1).
Figure 1:
Distribution of EuroSCORE II (%), aortic cross-clamp times (min) and mean gradient at discharge (mmHg).
Follow-up results
A total of 88.2% (15/17) completed 1-year follow-up with no late fatalities. At 1 year, 1 patient had developed a stroke with hemiplegia. Cardiac rehospitalization occurred in 13.3% (2/15). There was 1 case with suspected endocarditis at 1 year, which was treated conservatively and made full recovery. No valve thrombosis or late reoperations occurred.
DISCUSSION
We present outcomes of a sutureless prosthesis used in patients with failed stentless valves or bioroots in a series of 17 patients.
There have been reports of up to 3 cases, which prompted us to analyse our experience [7]. This cohort comprised patients at increased surgical risk since EuroSCORE II was 13.5% and 2 patients had endocarditis, 1 a failed TAVI and 2 patients a 3rd redo procedure. Considering these complex cases, cross-clamp times appeared short—signalling ease of implantation by sutureless prostheses. Haemodynamic results were excellent with no significant paravalvular regurgitation. Mortality was lower than expected.
Baseline characteristics
According to literature, high-risk is often defined as the presence of a EuroSCORE II >9%; our cohort had a higher median EuroSCORE II [8]. In the worldwide valve-in-valve international data/registry (VIVID), patients underwent catheter-based treatment for failed biological prosthesis. In the stentless VIVID group, patients were 74 years of age and EuroSCORE II was 13.6%. In a comparative analysis between ViV and redo surgery for failed stentless valves in 173 patients, age was 58.03 ± 13.86 and 66.57 ± 13.44 years, which was lower than in our cohort. Also, Society of Thoracic Surgeons Scores were significantly lower than in our experience (2.78 ± 2.09 and 4.68 ± 5.51) [3]. We have no information on whether the root was calcified.
Procedural and 30-day results
We were able to show excellent outcomes using sutureless valves in failed stentless prostheses. A comparative analysis between transcatheter treatment and surgery in 173 patients showed different mortality rates (16% for surgery vs 2.78% in ViV, P < 0.005) [3]. In VIVID, 30-day mortality of ViV patients in stentless patients was comparable to our cohort (6.6% in VIVID vs 5.9% here), but rate of adverse events was higher [4]. However, our study included less patients and is not powered for a robust comparison. Of note, in ViV, 12% had moderate or severe paravalvular leakage. Mean postoperative gradient was comparable to our cohort at 12 mmHg [4].
Although redo surgery is more invasive as resternotomy is a less favourable approach especially for patients’ comfort and for risk of myocardial injury, ease of prosthesis implantation seems to be superior once the aorta is clamped. Procedural steps of Perceval implantation are reproducible and simple. Decalcification is the same as in native aortic valve stenosis. Since mode of failure is often aortic regurgitation, extensive decalcification is often not necessary, which facilitates an easier procedure. Use of sutureless valves in this particular situs leads to implant of a new aortic valve prosthesis with less complexity. Sizing and implantation of the valve is very simple and reproducible. Implantation technique does not differ in general. The orientation of coronaries, location of the new annulus should be respected as in the native aortic valve. The aortotomy should be as high as possible—as in native situs. Care must be taken when choosing prosthesis size, since mismatch may produce stent infolding—which we did not observe [9].
Of note, surgeons experienced in using the Perceval prosthesis performed implantations. There is another report on outcomes of sutureless and rapid deployment valves in patients with failed Bioroots, which presented favourable outcomes using Perceval but also rapid deployment valves (Intuity, Edwards Lifesciences Inc., Irvine, Calif., USA) [10]. We did not observe late fatalities.
Limitations
This is an observational feasibility study. The inclusion of patients with combined procedures are potential confounding factors. There was no control group for comparison, which prevents robust conclusions as to the superiority of 1 technique. Furthermore, this is a heterogeneous group of patients, which limits further conclusions.
CONCLUSION
We present the largest cohort of sutureless valves using the Perceval sutureless prosthesis implanted in bioroots and stentless valves so far. In our experience, clinical outcomes were favourable, as rate of mortality was lower than expected and haemodynamic outcomes were excellent. This was a feasibility study on a relatively small number of patients; further studies are needed to evaluate this surgical technique. Heart teams should consider this treatment concept in patients with failed stentless valves and bioroots.
Glossary
ABBREVIATIONS
- VARC-3
Valve Academic Research Consortium
- ViV
Transcatheter valve-in-valve treatment
- VIVID
Valve-in-valve international data/registry
Contributor Information
Farhad Bakhtiary, Department of Cardiac Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Miriam Silaschi, Department of Cardiac Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Ali El-Sayed Ahmad, Department of Cardiac Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Saad Salamate, Department of Cardiac Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Bart Meuris, Department of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium.
FUNDING
No funding.
Conflict of interest: Farhad Bakhtiary and Miriam Silaschi: received research grants from LSI solutions and Artivion. Miriam Silaschi: received research grants from Medtronic, advisory board member of JenaValve Technologies. Bart Meuris: consultant to Corcym.
DATA AVAILABILITY
Data can be made available upon reasonable request.
Author contributions
Farhad Bakhtiary: Conceptualization; Methodology; Supervision. Miriam Silaschi: Project administration; Writing—original draft; Writing—review and editing. Ali Ahmad El-Sayed: Data curation; Formal analysis; Validation. Saad Salamate: Data curation; Formal analysis; Validation. Bart Meuris: Conceptualization; Methodology; Supervision.
Reviewer information
Interactive CardioVascular and Thoracic Surgery thanks Borut Gersak, Stefan Thelin and the other anonymous reviewers for their contribution to the peer review process of this article.
Presented at the 37th annual EACTS meeting on 6 October 2023 in Vienna, Austria.
REFERENCES
- 1. Yang B, Makkinejad A, Fukuhara S, Clemence J Jr, Farhat L, Malik A. et al. Stentless versus stented aortic valve replacement for aortic stenosis. Ann Thorac Surg 2022;114:728–34. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2. Schneider AW, Hazekamp MG, Versteegh MIM, de Weger A, Holman ER, Klautz RJM. et al. Reinterventions after freestyle stentless aortic valve replacement: an assessment of procedural risks. Eur J Cardiothorac Surg 2019;56:1117–23. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. Choi CH, Cao K, Malaver D, Kincaid EH, Lata A, Kon N. et al. Redo-aortic valve replacement in prior stentless prosthetic aortic valves: transcatheter versus surgical approach. Cathet Cardio Intervent 2022;99:181–92. [DOI] [PubMed] [Google Scholar]
- 4. Duncan A, Moat N, Simonato M, de Weger A, Kempfert J, Eggebrecht H. et al. Outcomes following transcatheter aortic valve replacement for degenerative stentless versus stented bioprostheses. JACC Cardiovasc Interv 2019;12:1256–63. [DOI] [PubMed] [Google Scholar]
- 5. Sá MP, Van den Eynde J, Erten O, Sicouri S, Ramlawi B.. Sternal-sparing aortic valve replacement with sutureless valve in bicuspid valve. J Card Surg 2022;37:5653–62. [DOI] [PubMed] [Google Scholar]
- 6. Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P. et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol 2021;77:2717–46. [DOI] [PubMed] [Google Scholar]
- 7. Stefanelli G, Pirro F, Smorto V, Chiurlia E, Weltert L.. Successful reoperation in 3 cases of failed Sorin freedom stentless aortic valve using the LivaNova perceval sutureless prosthesis. Innovations (Phila) 2020;15:572–6. [DOI] [PubMed] [Google Scholar]
- 8. Onorati F, Quintana E, El-Dean Z, Perrotti A, Sponga S, Ruggieri VG et al Aortic valve replacement for aortic stenosis in low-, intermediate-, and high-risk patients: preliminary results from a prospective multicenter registry. J Cardiothorac Vasc Anesth 2020;34:2091–9. [DOI] [PubMed] [Google Scholar]
- 9. Pfeiffer S, Wilbring M, Kappert U, Santarpino G.. The ‘entangled’ stent: a preventable cause of paravalvular leak of the Perceval bioprosthesis. Interact CardioVasc Thorac Surg 2017;25:987–9. [DOI] [PubMed] [Google Scholar]
- 10. Vendramin I, Lechiancole A, Piani D, Nucifora G, Benedetti G, Sponga S. et al. Use of sutureless and rapid deployment prostheses in challenging reoperations. J Cardiovasc Dev Dis 2021;8:74. [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data can be made available upon reasonable request.