Abstract
Background
Trifecta™ is an externally wrapped bovine pericardial aortic valve with a favorable hemodynamic performance and acceptable rate of freedom from structural valve degeneration. However, recent reports of early Trifecta valve failure question its durability. Rheumatic valve disease in young population is predominant, there is no data on the Trifecta performance, durability or safety available worldwide over the middle age population, as well as there are no previous similar reports from Middle East region. We report on mid-term clinical and hemodynamic performance of Trifecta valve in middle age population with small aortic annuls, a single center report.
Methods
A retrospective study of all patients who underwent Trifecta™ SAVR between June 2014 and December 2019 at a cardiac center in Riyadh, Saudi Arabia. Hemodynamic performance was analyzed by longitudinal Doppler echocardiography.
Results
During a 5.5-year period, a total of 24 patients underwent SAVR with Trifecta™ valves at our heart center. Patients had a median age of 47.1 years (IQR = 37) and male:female ratio of 1:1. Patients had a median EuroScoreII of 2 (IQR = 1). The 19 mm valve was the most frequently used (29.2%) followed by the 21 mm and 23 mm (both 25.0%). Concomitant procedure was (54.2%). All patients survived their operations and most (87.0%) had their symptoms relieved. A 30-day mortality rate of 4.2%. Patients were followed up for a median of 58.5 months (IQR = 38), during which 8.3% required re interventions, giving an overall freedom from re-intervention of 91.7%. The re-intervention after valve implantation was recorded in two (8.3%). These re-interventions were performed 3 years post initial surgery and were due to structural valve deterioration (SVD). The mean gradient reduced significantly from 43.6 ± 23.9 mmHg (median = 41, IQR = 21) at baseline to 13.0 ± 7.4 mmHg (median = 11, IQR = 5) one-week post intervention (p < 0.001). The average mean gradients were stable from post-operation to follow-up (13.0 ± 7.4 vs 14.1 ± 6.4 mmHg).
Conclusion
Our study confirms excellent mid-term durability, clinical and hemodynamic performance of the Trifecta™ valve in middle age population, despite the fact of non-statically significant trend-up of transvalvular gradient over the follow up period. Further long-term studies with larger sample-size are warranted to confirm these results.
Keywords: AVR, Trifecta, Valve, Small LVOT, Bio prosthesis outcome, Visual abstract
Key question
What is Trifecta™ valve safety in young patients, small LVOT?
Key findings
Trifecta™ could be suitable for complex young patients with small LVOT.
Take home message
Trifecta™ is safe, effective, with acceptable midterm clinical and hemodynamic outcomes concerning young population.
1. Introduction
Bio-prosthetic valves are the most common prosthetic valves used for surgical aortic valve replacement (SAVR) [5], as they avoid anticoagulation-associated complications in a predominantly older adult population. Superior hemodynamics and durability are key criteria for selection from the several bio-prosthetic valves currently on the market. Childbearing age makes bio prosthesis the ideal choice for the young female in our population.
Trifecta™ valve is a 3-leaflet stented bio-prosthetic heart valve with a bovine pericardial sheet externally mounted on a titanium stent. The design of the Trifecta™ valve offers a number of advantages including lower gradients and higher effective orifice area than other stented aortic prostheses, adequate clearance of native coronary arteries and the possibility of further expansion of the prosthesis in high-pressure loading conditions [4]. As such, several reports have described excellent valve performance and hemodynamics, such as low peak and mean trans prosthetic gradients, excellent effective orifice area, low incidence of patient-prosthesis mismatch (PPM) and acceptable rates of freedom from structural valve degeneration (SVD) [2–6].
Nonetheless, recent reports have suggested a more cautious approach in terms of its durability. The Trifecta™ bio-prosthesis appears to be associated with a greater rate of SVD and a higher need for repeat aortic valve replacement for SVD than some other bio-prostheses [7,14,15]. The most common mechanism for Trifecta™ valve failure is cusp tears and leaflet calcification [8].
No data on the Trifecta™ valve performance, durability or safety are available from the Middle East region. Our population are younger in presentation with rheumatic heart disease. Therefore, we aimed to report on mid-term clinical and hemodynamic performance after SAVR using the Trifecta™ bio-prosthesis in a single center setting in Saudi Arabia and compare the results with currently available data from the literature.
2. Methodology
2.1. Study design and population
This is a retrospective analysis of all patients who underwent Trifecta™ SAVR between June 2014 and December 2019 at a cardiac center of a tertiary hospital in Riyadh, Saudi Arabia. Patients were followed up prospectively up to 8 years.
2.2. Data collection
The electronic hospital database was used to retrospectively record perioperative patient data. Follow-up data were obtained from outpatient clinic visit reports and the closing date for follow up was set on 23rd April 2023. Haemodynamic performance was analysed by longitudinal Doppler echocardiography. Baseline and follow up echocardiographic evaluation of cardiac, valvular and prosthesis function in SAVR includes the guidelines-recommended imaging pathway. Echo doppler parameters have been collected at baseline, one week after surgery and in the follow up. In the follow up the data of the last echo have been reported. Continuous wave Doppler aortic valve peak and mean gradient values have been analysed in the statistical analysis [9–11].
2.3. Statistical analysis
The statistical analysis was performed with Stata Version 17.0 (College Station, Texas, USA). Continuous variables are presented as mean and standard deviation (SD), or median and interquartile range when not normally distributed. Frequencies and percentages were calculated for categorical variables. Differences in medians were evaluated using the Wilcoxon signed-rank test, while the Chi-Square or Fisher's Exact tests were used, as appropriate, for categorical variables. A result was considered significant for a two-tailed P-value of <0.05.
3. Results
3.1. Baseline patient characteristics
During a 5.5-year period (June 2014 and December 2019), a total of 24 patients underwent SAVR with Trifecta™ valves at our cardiac centre. Patients had a median age of 47.1 years (IQR = 37) and male:female ratio of 1:1 (Table 1). The median (IQR) body mass index for patients were 25 kg/m2 (7). Comorbidities were common among patients (Table 1), particularly diabetes mellitus (33.3%), hypertension (29.2%) and dyslipidemia (25.0%). Four patients (16.7%) had a history of coronary artery disease (CAD), three (12.5%) had a history of stable angina and two (8.3%) had myocardial infarction (MI) in the previous 21 days. Nearly half (45.8%) of patients had priori valve surgery, mainly redo of aortic valve replacement (29.2%), and 8.3% had a history of prosthesis-patient mismatch (PPM). Patients had a median EuroScore-II of 2 (IQR = 1) and 33.3% had a left ventricular ejection fraction (LVEF) ≤50% at baseline. Left ventricular hypertrophy was identified in 37.5% of patients, most of which was mild. Severe aortic stenosis (45.8%) or severe aortic regurgitation (41.7%) were the main indications for surgery (Table 1).
Table 1.
Baseline pre-operative characteristics. Includes the baseline characteristics prior to intervention on aortic valve using Trifecta valve, demographic data, past medical history, past surgical history, baseline investigations, baseline echocardiographic parameters, and indications for surgery.
| Variable | Study population (n = 24) |
|---|---|
| Male, % (N) | 50 (12) |
| Age, median (IQR) | 47 (37) |
| KSA region, % (N) | |
| Central | 45.8 (11) |
| Southern | 12.5 (3) |
| Eastern | 16.7 (4) |
| Western | 12.5 (3) |
| Northern | 12.5 (3) |
| BMI, median (IQR) | 25 (7) |
| BSA, median (IQR) | 2 (2) |
| Comorbidities | |
| Smoking, % (N) | 12.5 (3) |
| Hypertension, % (N) | 29.2 (7) |
| Diabetes Mellitus, % (N) | 33.33 (8) |
| Dyslipidemia, % (N) | 25.0 (6) |
| COPD, % (N) | 8.3 (2) |
| Cancer, % (N) | 4.2 (1) |
| Radiotherapy, % (N) | 4.2 (1) |
| History of renal failure, % (N) | 4.2 (1) |
| Peripheral vascular disease, % (N) | 8.3 (2) |
| Deep vein thrombosis (DVT) | 4.2 (1) |
| Left iliac and renal embolization | 4.2 (1) |
| History of Cerebrovascular accident, % (N) | 8.3 (2) |
| Chronic atrial fibrillation % (N) | 8.3 (2) |
| History of MI % (N) | 8.3 (2) |
| MI < 21 days, % (N) | 8.3 (2) |
| History of Angina % (N) | 12.5 (3) |
| Stable Angina, % (N) | 12.5 (3) |
| History of coronary artery disease, % (N) | 16.7 (4) |
| Prior cardiac procedures | |
| Percutaneous coronary intervention, % (N) | 4.2 (1) |
| Prior valve surgeries, % (N) | 45.8 (11) |
| Redo AV replacement, % (N) | 29.2 (7) |
| History of prosthesis-patient mismatch, % (N) | 8.3 (2) |
| Baseline pre-operative parameters | |
| EuroScore II, median (IQR) | 2 (1) |
| Hemoglobin, median (IQR) | 130 (13) |
| Urea, median (IQR) | 5 (4) |
| Creatinine, median (IQR) | 70 (33) |
| Total bilirubin, median (IQR) | 6 (5) |
| Glomerular filtration rate, % (N) | |
| >60% | 95.8 (23) |
| <45% | 4.2 (1) |
| Baseline LVEF | |
| ≥55% | 66.7 (16) |
| 50% | 16.6 (4) |
| 45% | 8.3 (2) |
| 40% | 4.2 (1) |
| 35% | 4.2 (1) |
| Baseline left ventricular hypertrophy, % (N) | |
| None | 62.5 (15) |
| Mild | 33.3 (8) |
| Severe | 4.2 (1) |
| Baseline AR degree, % (N) | |
| Mild | 33.3 (8) |
| Moderate | 12.5 (3) |
| Severe | 37.5 (9) |
| Baseline MR degree, % (N) | |
| Mild | 29.2 (7) |
| Moderate | 12.5 (3) |
| Severe | 12.5 (3) |
| Trace | 12.5 (3) |
| Baseline AS degree, % (N) | |
| Mild | 8.3 (2) |
| Moderate | 8.3 (2) |
| Severe | 50.0 (12) |
| Indications for surgery | |
| Severe AS | 45.8 (11) |
| Severe AR | 41.7 (10) |
| Moderate AS | 8.3 (2) |
| Stuck aortic valve | 4.2 (1) |
| Baseline AV haemodynamics | |
| Baseline AV area, mean (SD) [median (IQR)] | 1.4 (1.3) [1 (1)] |
| Baseline AV mean gradient, mean (SD) [median (IQR)] | 43.6 (23.9) [41 (21)] |
| Baseline AV peak gradient, mean (SD) [median (IQR)] | 63.6 (37.3) [60 (45)] |
| Baseline AV volume, mean (SD) [median (IQR)] | 99.3 (48.5) [86 (38)] |
COPD: chronic obstructive pulmonary disease, IQR: interquartile range, SD: standard deviation, BMI: body mass index, BSA: body surface area, KSA: Kingdom of Saudi Arabia, LVEF: left ventricular ejection fraction, AR: aortic regurgitation, MR: mitral regurgitation, MS: mitral stenosis, AS: aortic stenosis, AV: aortic valve.
3.2. Operative characteristics
The 19 mm valve was the most frequently used (29.2%) followed by the 21 mm and 23 mm (both 25.0%). Full sternotomy was performed in most patients (95.8%), and 29.2% of patients underwent coronary artery bypass graft (CABG), most of which was planned (Table 2).
Table 2.
Operative data. Includes the operative data, Trifecta valve size used, surgical incision type, concomitant procedures in addition to Trifecta valve in aortic position, and ECMO use.
| Variable | Study population (n = 24) |
|---|---|
| Implant prosthesis size, % (N) | |
| 19 | 29.2 (7) |
| 21 | 25 (6) |
| 23 | 25 (6) |
| 25 | 16.7 (4) |
| 27 | 4.2 (1) |
| Sternotomy, % (N) | 100 (24) |
| Full, % (N) | 95.8 (23) |
| Minimal invasive, % (N) | 4.2 (1) |
| Concomitant Procedure, % (N) | 54.2 (13) |
| Tricuspid valve involvement, % (N) | 8.3 (2) |
| Mitral valve involvement, % (N) | 25 (6) |
| Ascending Aorta involvement, % (N) | 4.2 (1) |
| CABG, % (N) | 29.2 (7) |
| Planned | 25.0 (6) |
| Unplanned | 4.2 (1) |
| ECMO, % (N) | 12.5 (3) |
IQR: interquartile range, SD: standard deviation, ECMO: Extra-corporeal membrane oxygenation, CABG: coronary artery bypass graft.
3.3. Surgery outcome and early adverse events
All patients survived their operations and most (87.0%) had their symptoms relieved. There were no incidents of cardiac arrest, need for resuscitation, severe bleeding, cardiac tamponade or thrombo-embolism (Table 3). One patient suffered a transient ischaemic attack (TIA), and another a cerebrovascular accident (CVA). Infection was documented in two (8.3%) patients. The median length of hospital stay was 12 days (IQR = 10) and the 30-day readmission rate was 16.7% due to cardiopulmonary symptoms. One patient died from multi-organ failure 27 days post-surgery, giving a 30-day mortality rate of 4.2%.
Table 3.
Intra and postoperative data. Includes intra and post -operative data, success rate, complications encountered and event, mortality, length of stay, and readmission rate.
| Variable | Study population (n = 24) |
|---|---|
| Operative Survival, % (N) | 100 (24) |
| Symptoms relieved, % (N) | 87.0 (20) |
| Transient ischaemic attack, % (N) | 4.2 (1) |
| Cerebrovascular accident, % (N) | 4.2 (1) |
| Symptoms improved | 4.2 (1) |
| Atrioventricular block, % (N) | 4.2 (1) |
| Infections, % (N) | 8.3 (2) |
| Vascular complication, % (N) | 4.2 (1) |
| 30-day mortality, % (N) | 4.2 (1) |
| Multi-organ failure, % (N) | 4.2 (1) |
| Length of stay, median (IQR) | 12 (10) |
| 30 days readmission, % (N) | 16.7 (4) |
IQR: interquartile range, SD: standard deviation.
3.4. Patient follow up
Patients were followed up for a median of 58.5 months (IQR = 38). At one week post-surgery, 39.1% of patients had LVEF ≤50% compared to 18.2% at their last follow up (p = 0.19). In general, the proportion of patients with LVEF ≤50% reduced in follow-up compared to baseline (33.3% vs 18.2%) but not statistically significantly (p = 0.32). Reintervention after valve implantation was recorded in two (8.33%) patients, one was a redo aortic valve replacement (AVR), had Trifecta™ valve size (21 mm) and replaced with SJM™ Masters Valved Graft (25 mm) in bentall procedure and another underwent Valve in Valve transcatheter aortic valve implantation (TAVI) with Edwards SAPIEN 3 size (23 mm), over Trifecta size (21 mm). These re-interventions were performed 3 years post initial surgery and were due to (SVD). No mortality was documented following patients’ discharge during the follow-up period.
3.5. Haemodynamic results
Hemodynamic results (Table 4) are summarized in Fig. 1. The peak aortic valve gradient dropped significantly from 63.6 ± 37.3 mmHg (median = 60, IQR = 45) preoperatively to 23.4 ± 13.1 mmHg one-week post-surgery (p < 0.0001). The peak gradient did not increase significantly during follow up (p = 0.09). Similarly, the mean gradient reduced significantly from 43.6 ± 23.9 mmHg (median = 41, IQR = 21) at baseline to 13.0 ± 7.4 mmHg (median = 11, IQR = 5) one-week post intervention (p < 0.001). Further increase in mean gradient was not statistically significant during follow up (p = 0.10).
Table 4.
Follow up data. Includes echocardiogram parameters post intervention at one week point of time and last date of patient follow up with echocardiogram, to assess hemodynamic performance of the Trifecta valve post implantation. As well as, re intervention in surgical form or valve in valve data.
| Variable | Study population (n = 23) |
|---|---|
| Follow up duration (months), median (IQR) | 41 (33) |
| 1 week post operation Echo mean gradient, mean (SD) [median (IQR)] | 13.0 (7.4) [11 (5)] |
| 1 week post operation Echo peak gradient, mean (SD) [median (IQR)] | 23.4 (13.1) [19 (7)] |
| 1 week post operation Echo LVEF, % (N) | |
| ≥55% | 60.9 (14) |
| 50% | 13.0 (3) |
| 45% | 17.4 (4) |
| 40% | 4.3 (1) |
| 35% | 4.3 (1) |
| 1 week post operation Echo left ventricular hypertrophy, % (N) | |
| None | 45.4 (10) |
| Mild | 50.0 (11) |
| Moderate | 4.6 (1) |
| 1 week post operation Echo paravalvular regurgitation, % (N) | |
| None | 65.2 (15) |
| Trace | 26.1 (6) |
| Mild | 8.7 (2) |
| 1 week post operation Echo perivalvular regurgitation, % (N) | |
| None | 95.6 (22) |
| Trace | 4.3 (1) |
| Reintervention after valve implantation, % (N) | 8.3 (2) |
| Redo | 4.2 (1) |
| TAVI | 4.2 (1) |
| Last Echo mean gradient, mean (SD) [median (IQR)] | 14.1 (6.4) [12.8 (7.4)] |
| Last Echo max gradient, mean (SD) [median (IQR)] | 27.2 (13.8) [21.0 (20.7)] |
| Last Echo LVEF, % (N) | |
| ≥55% | 81.8 (18) |
| 50% | 9.1 (2) |
| 45% | 9.1 (2) |
| Last Echo left ventricular hypertrophy, % (N) | |
| None | 50.0 (11) |
| Mild | 45.5 (10) |
| Moderate | 4.5 (1) |
| Last Echo AR degree, % (N) | |
| None | 72.7 (16) |
| Trace | 18.2 (4) |
| Mild | 9.1 (2) |
IQR: interquartile range, SD: standard deviation, LVEF: left ventricular ejection fraction, TAVI: transcatheter aortic valve implantation, AR: aortic regurgitation.
Fig. 1.
Aortic valves peak and mean gradients at baseline and at follow-up. Boxplot Legend diagram, showing mean and peak gradients of aortic valve at baseline, post Trifecta implantation 1 week and last follow up. It summarizes the key finding of the Trifecta hemodynamic performance in our study.
4. Discussion
In this study, performance of the Trifecta™ valve in a younger patient population with a median age of 47 years (IQR = 37) provides a unique perspective on its durability and functionality, especially in comparison to the results of previously published studies with an older patient population touching mean of 70 years old [1–3,13,15]. It is worth to mention also high small LVOT sample represented by valve size implanted being 19 mm the most commonly used that would made the gradients expectations even higher, unlike other publications where the most commonly used valve size was 23mm13. Yet in our sample, we found a significant reduction in the mean gradient from 43.6 ± 23.9 mmHg (median = 41, IQR = 21) at baseline to 13 ± 7.4 mmHg (median = 11, IQR = 5) one-week post intervention, with no statistically significant change during the follow-up period, which had a median of 58.5 months (IQR = 38).
In addition, our study sample presented with a higher proportion of patients having undergone previous aortic valve intervention (45.8%), the significance of redo aortic surgery lies in its complexity, as it poses greater challenges to surgeons, and in the substantial risks it can present to the patients. However, it is has been studied that aortic re operation carries almost same risk of primary surgery, allowing for the middle age group of patients to receive bio-prosthesis such as Trifecta™ valve [12]. Furthermore, 54.2% of our patients had concomitant procedures with Trifecta valve replacement, with coronary artery bypass grafting (CABG) being the most common, followed by mitral valve replacement, matching previous publications [1–3]. Despite the fact that the concomitant procedures, re operation and the younger age of our patients may have contributed to the overall performance and durability observed in our cohort, it is surprisingly acceptable when questionable Trifecta™ valve early failure is considered.
Notably, our study reported only two mortality cases (8.33%) and two aortic valve reinterventions (8.33%) during the follow-up period. Nonetheless, this might suggest that the Trifecta™ valve could still be questionable in terms of early failure, it demonstrates acceptable durability and overall excellent clinical outcomes in our patient cohort, although the mortality rate should be interpreted cautiously given the small sample size.
The lack of a statistically significant increase in mean gradient during follow-up in our study could be attributed among other factors, to the relatively fewer comorbidities, and a different spectrum of aortic valve disease, rheumatic causes being dominated given the younger age of our sample. It is warranted to conduct further studies to confirm these findings and to elucidate possible mechanisms.
When comparing the study outcomes with previously published data, the Trifecta™ valve in our younger cohort appears to provide reliable durability and clinical outcomes, defying earlier reports of early failure in the published literature. However, it is essential to consider that the sample size of our study was small, which may limit the strength of our findings and generalizability.
In conclusion, our retrospective study demonstrated acceptable valve performance and durability of the Trifecta™ valve in a younger patient population. The outcomes are encouraging, suggesting satisfactory functionality within this age group in middle east region. Larger prospective multicentre studies with a more diverse patient population are warranted to corroborate these findings and to better understand the role of patient-specific factors in influencing Trifecta™ valve performance and durability.
4.1. Study limitations
This study has the inherent limitations of a retrospective and single centre study. Although we included all patients who underwent Trifecta SAVR during 5.5-years, our sample size was small, which impacts the generalizability of our results. Despite the non-normally distribution of some variables, they were also presented as mean (SD) to allow comparison with other studies. Finally, while our maximum follow-up duration was 8 years, the median follow-up was shorter. As such, more cases of SVD, re-intervention and mortality may be expected with time.
Abbreviation
- AVR
Aortic Valve Replacement
- CABG
Coronary Artery Bypass Grafting
- CAD
Coronary Artery Disease
- CVA
Cerebrovascular Accident
- ECMO
Extracorporeal Membrane Oxygenator
- IQR
Interquartile Range
- IRB
Institutional Review Board
- LVEF
Left Ventricular Ejection Fraction
- LVOT
Left Ventricular Outflow Tract
- MI
Myocardial Infarction
- PPM
Patient Prosthesis Mismatch
- RAC
Research Advisory Council
- SAVR
Surgical Aortic Valve Replacement
- SD
Standard Deviation
- SVD
Structural Valve Deterioration
- TAVI
Transcutaneous\Transcatheter Aortic Valve Implantation
- TIA
Transient Ischemic Attack
- USA
United States of America
Footnotes
Conflicts of interest: We have no conflicts of interest to disclose.
Ethical approval: The study was approved by the hospital's Institutional Review Board (IRB log: RAC#2201160) and conducted in accordance with the relevant guidelines and regulations and the ethical principles contained in the Helsinki Declaration (2000). Given the retrospective nature of the study, patient consent was waived.
Author contributions: Conception and design of Study: FHK, MSA. Literature review: FHK, MSA, SAA, SY. Acquisition of data: FHK, MSA, SAA, SY, EAA, BA, DG. Analysis and interpretation of data: FHK, MSA, SAA, SY, EAA, BA, DG. Research investigation and analysis: FHK, MSA, SAA, SY, EAA, BA, DG. Data collection: FHK, MSA, SAA. Drafting of manuscript: FHK, MSA, SAA, SY, EAA, BA, DG. Revising and editing the manuscript critically for important intellectual contents: FHK, MSA, SAA, SY, EAA, BA, DG. Data preparation and presentation: FHK, MSA, SAA, SY, EAA, BA, DG. Supervision of the research: FHK, MSA. Research coordination and management: FHK, MSA, SAA, SY, EAA, BA, DG. Funding for the research: FHK, MSA, SAA, SY, EAA, BA, DG.
Data availability
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to patient health information privacy.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to patient health information privacy.