Comparison of 26-mm Evolut and 23-mm Sapien 3 Valves in TAVR for Small Aortic Annulus

Abstract

Background. Patients with small aortic annuli (SAA) are prone to higher post-transcatheter aortic valve replacement (TAVR) transvalvular gradients and development of prosthesis-patient mismatch (PPM). In many patients with SAA, the choice of TAVR valve commonly involves choosing between the 26-mm Medtronic Evolut 2 (ME26) or the 23-mm Edwards Sapien 3 valve (ES23). We compared echocardiographic and clinical outcomes in patients with SAA undergoing TAVR with either valve. Methods. We queried the Providence St. Joseph Health Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry database for patients undergoing TAVR with either the ES23 or ME26 between July 2015 and December 2018 at 11 hospitals. Post-TAVR echocardiographic and clinical results in-hospital, at 1 month, and at 1 year were examined. High gradient (HG) was defined as mean gradient (MG) ≥20 mm Hg. Results. We identified 1162 patients with SAA undergoing TAVR with either the ME26 (n = 233) or ES23 valve (n = 929). Baseline characteristics between groups were similar. At 1 month, the ME26 was associated with a lower MG than the ES23 (7.7 ± 4.7 mm Hg vs 13.1 ± 4.9 mm Hg; P<.001) and moderate or severe PPM (11% and 3% vs 27% and 13%; P<.001). Occurrence of HG at 1 year was lower with the ME26 valve vs the ES23 valve (0% vs 15%; P<.001). In-hospital and follow-up clinical outcomes to 1 year were similar for both groups. Conclusion. TAVR in SAA with the ME26 is associated with lower incidence of HG or PPM compared with the ES23. While clinical outcomes at 1 year were similar, the long-term implications of these findings remain unknown.

Keywords: TAVR, prosthesis-patient mismatch, small aortic annulus, surgical outcomes, transcatheter aortic valve replacement

Treatment of patients with severe aortic stenosis and small aortic annuli (SAA), most of whom are older females, frequently poses a major clinical challenge.¹ Surgical aortic valve replacement (SAVR) in SAA is associated with elevated transvalvular gradients and a higher risk of prosthesis-patient mismatch (PPM), which is associated with adverse clinical outcomes.^2-4 Aortic annular enlargement or complete aortic root enlargement may be performed at the time of SAVR to allow placement of a larger valve prosthesis in patients with SAA; however, these procedures add to the complexity of the surgery.⁵

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for patients with SAA.⁶ In many patients with SAA undergoing TAVR, the choice of prosthesis is commonly between 2 third-generation transcatheter valves, the 23-mm Sapien 3 valve (Edwards Lifesciences) or the 26-mm Evolut valve (Medtronic). The supra-annular design of the self-expanding Evolut valve compared with the balloon-expandable Sapien valve has been touted as providing superior hemodynamics, especially in patients with SAA.^7,8 In this article, we discuss clinical and echocardiographic outcomes of these 2 valves in patients undergoing TAVR with SAA, particularly regarding occurrence of PPM and evidence of structural valve degeneration (SVD).

Methods

The Spokane institutional review board reviewed and approved this study. Because this was a retrospective data collection study, the requirement for informed consent was waived.

All TAVR cases performed at 11 Providence St. Joseph Health hospitals in Alaska, California, Montana, Oregon, or Washington using the 26-mm Medtronic Evolut valve (ME26) or the 23-mm Edwards Sapien 3 valve (ES23) between July 2015 and December 2018 were included. The date range was inclusive of all cases in which these valves were used. On the basis of implanted valve, patient cohorts were designated as ME26 (inclusive of both 26-mm Evolut R and Evolut Pro valves) or ES23. Cases were excluded if they were aborted, investigational, or valve-in-valve. Valve choice and sizing were at the discretion of the local heart team.

Demographic, clinical, and outcome data were collected according to the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (TVT) registry specifications.⁹

Post-TAVR echocardiography results were assessed before hospital discharge, at 1 month, and at 1 year. In-hospital outcomes were defined in accordance with previously described standardized endpoints¹⁰ and included mortality, significant cardiac events, stroke, acute kidney injury (stage 3), bleeding (disabling or life threatening), vascular complications (any), device complications, aortic regurgitation (AR) (moderate to severe), and conduction/native pacer disturbance requiring a permanent pacemaker or implantable cardioverter defibrillator (ICD). One-year survival status was determined using data from the TVT registry and by searching electronic medical records.

In addition to aortic valve (AV) mean gradient (MG), the incidence of high gradient (defined as MG ≥20 mm Hg) and the presence of moderate/severe AR were assessed, as these are indicators of SVD.^11,12

PPM was represented by the effective orifice area index (EOAi) determined at the hospital discharge echocardiogram, which is the effective orifice area of the prosthesis divided by the patient’s body surface area (BSA).⁴ We defined the severity of PPM per the Valve Academy Research Consortium (VARC-2) criteria, wherein EOAi >0.85 cm²/m² is none or mild, 0.65-0.85 cm²/m² is moderate, and ≤0.65 cm²/m² is severe.^13,14

Occurrence of SVD at 1 year was defined as AV-MG ≥20 mm Hg or moderate/severe AV regurgitation, based on part of the definition by the VARC-2.¹³

Statistical analysis. Continuous data are summarized as mean and standard deviation and compared between groups by t test. Categorical data were presented as proportions and compared by Chi-square test or Fisher’s exact test, as appropriate. Long-term survival and readmission were analyzed using the Kaplan-Meier estimate and compared by log rank test. The relationship between the EOAi and the AV-MG was visualized with the locally estimated scatterplot smoothing regression tool using a span of 0.75 and a degree of the polynomials of 1.15 linear modeling was performed to evaluate the relationship between postoperative AV-MG and valve type, adjusting for other factors. Factors with a P-value <.20 in the univariable analysis were selected as candidates for multivariable models. A backward-elimination method was used until all of the factors met the criterion of P<.05 for staying in the model. There are some missing data (46 in fluoroscopy time, 44 in contrast volume, 43 in AV annulus size, 25 in glomerular filtration rate, 17 in AV area, 7 in MG, 7 in New York Heart Association [NYHA] class, 6 in AR, and 6 in mitral valve regurgitation), with the number of patients included in the calculations noted in the results tables where appropriate. Missing data were not imputed and were excluded from the analysis. Statistical analyses were performed using R, version 4.0.2.¹⁶ Significance was set at P<.05.

Results

There were 4011 TAVRs during the study period, including 1299 patients who received either a ME26 or ES23 valve. From these, excluding 7 clinical trial cases, 28 cases that were aborted, and 102 valve-in-valve cases, 1162 patients with SAA treated with either ME26 (n = 233; 55% Evolut R/45% Evolut Pro) or ES23 (n = 929) remained in the study (Figure 1). Three patients who received other valves during the same hospitalization, after the initial ME26 or ES23 valve implantation, were excluded from the echocardiography results.

The ME26 and ES23 patients were similar except for a higher proportion of females (92.3% vs 85.8%; P<.01) and a smaller AV annulus size (21.6 ± 1.6 mm vs 21.9 ± 1.7 mm; P=.03) in the ME26 group vs the ES23 group (Table 1). Other pre-TAVR imaging characteristics, including AV area, AV-MG, and moderate/severe AR were similar between groups (P>.05).

The ME26 group compared with the ES23 group required significantly more contrast volume (109.0 ± 61.0 mL vs 94.5 ± 57.5 mL; P<.01), more fluoroscopy time (18.4 ± 9.1 min vs 13.0 ± 9.0 min; P<.001), and longer procedure time (96.8 ± 48.4 min vs 74.0 ± 37.5 min; P<.001) (Table 2). Device success rates were similar in the 2 groups (96.1% vs 96.1%; P=.53). One ES23 and 2 ME26 cases received a second identical valve in the same cath lab visit. One case received a 29-mm Evolut R valve in the same procedure after the initial ME26 embolized and another ME26 embolization case underwent SAVR. One case received a 26-mm Sapien 3 valve after initial implantation with an ES23. One ME26 case and 3 ES23 cases had open heart surgery to repair a left ventricular myocardial perforation. The ME26 group had a longer postoperative length of stay compared with the ES23 group (2.7 ± 2.3 days vs 2.3 ± 2.6 days; P=.02), likely related to the higher percentage of cases with conduction/native pacer disturbances requiring a pacemaker or ICD (12.1% in the ME26  group vs 4.0% in the ES23 group; P<.001).

Echocardiographic outcomes at prehospital discharge, at 1 month, and 1 year for both valve groups are depicted in Table 3 and Figure 2. At all 3 time frames, the ES23 valve was associated with a higher MG by 34%, 70%, and 81%, respectively (all P<.001) (Figure 2). The gradients for ME26 were not significantly increased over time (P>.05), while the gradients for the ES23 increased (P<.001). In addition, the proportion of ES23 valves with a MG ≥20 mm Hg increased from 7.9% before hospital discharge to 9.8% at 1 month and to 15.4% at 1 year compared with the ME26 valves, which did not increase (4.4% before discharge, 1.0% at 1 month, and 0% at 1 year). Moderate/severe AR was infrequent, but was more common in the ES23 group at 1 year (P=.055).

The incidence of postoperative PPM is shown in Table 3 and Figure 3. The ME26 group had 3% severe and 11% moderate PPM compared with 13% severe and 27% moderate PPM in the ES23 group (P<.001). The relationship between EOAi and postoperative AV-MG in both the ME26 and ES23 groups is shown in Figure 4. Patients with smaller EOAi had higher AV-MG. At the same EOAi level, ES23 had higher postoperative AV-MG than ME26 (P<.001). This was also confirmed by linear regression of the postoperative AV-MG adjusted by age, body mass index, atrial fibrillation/flutter, left ventricular ejection fraction, nonelective operation, preoperative AV-MG, and EOAi. The postoperative AV-MG for patients with ES23 was 2.4 mm Hg higher than for similar patients with ME26 (P<.001).

At 1 year, 108 ES23 patients (19.5%) met the criteria for SVD out of 553 patients who had follow-up status compared with none of the 122 patients who received an ME26 valve (P<.001). One-year survival was similar for patients who received either the ME26 or ES23 (92.2% vs 91.2%, respectively; P=.61) (Figure 5). There were no significant differences between groups in readmission and NYHA class at 1 month or 1 year (Table 4).

Discussion

Results of this study of 1162 patients with SAA and severe aortic stenosis undergoing TAVR show overall comparable clinical postoperative outcomes in-hospital, at 1 month, and at 1 year following TAVR with either the ME26 or ES23 valve. TAVR with the ME26 was associated with greater use of contrast and fluoroscopy as well as longer procedure times compared with ES23, possibly reflecting less operator expertise and/or higher use of preballoon or postballoon valvuloplasty (not captured in the TVT registry) with the Evolut system. Consistent with previous reports of self-expanding vs balloon-expandable TAVR devices, the ME26 was associated with a more frequent requirement for pacemaker or ICD to treat new conduction abnormalities.¹⁷ However, in contrast to the similar short and intermediate clinical outcomes, hemodynamic characteristics differed markedly between these 2 TAVR valves. While hemodynamics remained stable with the ME26 over 1 year, the MG in the ES23 group increased over time and was 81% higher than the ME26 group. In addition, at 1 year, 15% of ES23 valves had a MG ≥20 mm Hg and 19% met the criteria for SVD vs none in the ME26 cohort. Similarly, moderate to severe predischarge PPM was almost 3 times higher in the ES23 cohort compared with the ME26 cohort (40% vs 14%, respectively; P<.001).

We are not the first to demonstrate hemodynamic differences in TAVR patients with SAA treated with the Sapien 3 and Evolut R valves. At 1 month post TAVR, we observed similar results in MG to those from the echocardiography core lab findings for the randomized pivotal studies for the ME26 (7.7 ± 4.7 mm Hg vs 7.5 ± 2.7 mm Hg) and the ES23 (13.1 ± 4.9 mm Hg vs 12.8 ± 4.7 mm Hg).¹⁸ There are limited data available for intermediate or long-term echocardiography results with the ES23. Küling et al examined echocardiographic outcomes of the Sapien 3 valves over 1 year.¹⁹ Similar to our findings of a 2.2 mm Hg increase in the ES23 MG over 1 year, they noted a 1.8 mm Hg (17%) increase in the ES23 MG over 1 year, but the difference did not reach significance, possibly because of small sample size (n = 43).¹⁹ In the CHOICE trial and CHOICE-Extend registry, the MG at 30 days in TAVR patients with SAA treated with the Sapien 3 valve was also higher than in the Evolut R valve group (13.3 ± 4.3 mm Hg vs 6.6 ± 3.1 mm Hg; P<.001).²⁰ The occurrence of moderate or severe paravalvular regurgitation was rare in both groups. A recent report of the OCEAN-TAVI registry in patients with SAA also reported higher MG at 30 days in those treated with the Sapien 3 valve compared with the Evolut valve (12.0 mm Hg [median, 10.0-14.8 mm Hg] vs 9.0 mm Hg [median, 6.0-12.0 mm Hg]; P<.001).²¹ The occurrence of moderate and severe PPM trended higher in the Sapien 3 treated patients, but did not reach significance, compared with our study, which was possibly related to smaller sample size and lower body surface area in the Japanese patients compared with our cohort (1.4 m² vs 1.8 m², respectively). As in our study, clinical outcomes at 1 year were similar for patients treated with either valve.

Despite the lack of differences in clinical outcomes between the ES23 and ME26 groups at 1 year, it remains unclear if the higher rates of SVD and PPM with the ES23 will ultimately translate to worse long-term clinical outcomes. A recent report by Anand et al of more than 400 TAVR patients with a transvalvular MG of ≥20 mm Hg noted a higher readmission rate, but not mortality, compared with those with lower MGs.²² Clearly the development of PPM following SAVR is associated with worse clinical outcomes.^2-4 In a report from the TVT registry, the occurrence of severe, but not moderate, PPM after TAVR was associated with higher 1-year mortality.²³ However, a recent analysis of the TVT registry limited to TAVR patients receiving the Evolut valve in either de novo native valves or failed surgical bioprostheses did not identify an association of severe PPM with either valve related to hospital readmission or mortality at 1 year.²⁴ In patients undergoing SAVR, the presence of any degree of PPM was associated with higher long-term mortality and hospital readmission rates.²⁵ Additionally, in SAVR patients, the development of hemodynamic valve deterioration, especially when occurring early, was associated with higher long-term mortality.²⁶ Importantly, duration of follow-up in the SAVR studies extended up to 10 years.

In addition to comparing the ES23 and ME26 valves, it is relevant to compare the ES23 with previous iterations of the 23-mm Sapien valve family. In the previously mentioned echocardiography core lab results from the pivotal studies, the MG at 1 month with ES23 (12.8 ± 4.7 mm Hg) was higher than both the Sapien 23 mm and Sapien XT (9.9 ± 4.3 mm Hg and 10.4 ± 3.7 mm Hg, respectively).¹⁸ Theron et al retrospectively compared outcomes after TAVR with the 23-mm Sapien XT and Sapien 3 and found that the 23-mm Sapien 3 was associated with a lower EOAi, higher MG, and markedly higher chance of moderate and severe PPM vs the 23-mm Sapien XT.²⁷ It is important to note that in the PARTNER A study, the benefit of TAVR relative to SAVR was most pronounced in patients with SAA—a result that was attributed to the superior hemodynamics of the 23-mm Sapien valve relative to surgical valves.⁶ Given the less-favorable hemodynamic profile of the 23-mm Sapien 3 relative to its predecessors, it is uncertain if the clinical benefits of TAVR with the ES23 in SAA would be comparable.

The current study relies heavily on singular measurements of echocardiogram gradient and indexed EOA. Echocardiogram and catheterization MGs differ related to pressure recovery and assumptions in the Bernoulli equation.²⁸ Pressure recovery may account for significant differences in evaluating valve severity; one study with native aortic stenosis showed clinically relevant pressure recovery in 24.8% of 697 patients.²⁹ There are data showing that echocardiographic MG is higher for smaller balloon-expandable valves than larger, while catheterization gradients were similar.³⁰ The effect of pressure recovery on valve gradients and subsequent energy loss coefficient can be estimated, and some recommend doing so in patients with proximal ascending aorta diameter ≤3.0 cm.³¹ This would likely be associated, although not always, in patients with smaller valves. Correction for this would be an important area of study when comparing balloon-expandable and self-expanding valves, and reporting this may help differentiate where clinically significant vs calculated PPM. While these data were not present for our study, we hope to see these calculations in randomized trials, such as the SMART (SMall Annuli Randomized To Evolut or Sapien) postmarket trial.³²

Given the smaller body habitus of females, the issue of SAA predominately affects older women.¹ In the PARTNER II studies of the Sapien 3 valve in TAVR patients at high and intermediate risk for SAVR, the 23-mm valve was used in 66% of women compared with only 11% of men.³³ Accordingly, the clinical dilemma of implanting the 23-mm Sapien 3 vs the 26-mm Evolut (or even the 29-mm Evolut in a small fraction of patients) is a relatively frequent occurrence, particularly in females. Study results would suggest potential hemodynamic and valve durability advantages for the Evolut over the Sapien 3 valve in SAA patients. The choice of specific valve type in individual patients must also factor in anatomic variables (eg, horizontal aorta) and clinical variables (eg, future coronary access) as well as the TAVR team experience and confidence with each valve implantation technique.

Study limitations. One limitation of this study was its retrospective design. The decision for the specific valve size and vendor was completed according to the local heart teams’ discretion and was likely influenced by varying familiarity with the different devices. Nonetheless, the clinical and preprocedure imaging characteristics of both the MS26 and ES23 cohorts were remarkably similar. Additionally, this study was limited to SAA patients who were implanted with either the ME26 or ES23 valve. Thus, it was not possible to compare outcomes with SAA patients who may have received other sizes of valve implants, including patients with extreme SAA who received either the 23-mm Evolut or the 20-mm Sapien 3 valves. Because of the retrospective nature of the study and the fact that data were gathered from records at 11 different hospitals, clinical and echocardiographic data are not standardized as they would be if performed by a central laboratory. Similarly, results of the computed tomography analysis of the AV annulus were not included in this analysis as these data were incomplete and variable between the hospital and vendor analysis. The lack of reliable computed tomography data does not allow us to include patients who received 29-mm Evolut valves in lieu of an ES23 valve. Finally, as is common with registry studies, there were missing data, especially at 1 year after TAVR; these missing data points were excluded from the analysis. Additionally, it is important to note that recently the Sapien 3 valve has been commercially replaced by the Sapien 3 Ultra valve, which incorporates an improved external-sealing skirt; however, there does not appear to be any difference in the hemodynamic performance between these otherwise similar valves.³⁴ Finally, VARC-2 criteria were used for this study, although the updated VARC-3 criteria were recently published.³⁵

Conclusion

In TAVR patients with SAA, implantation of the ES23 valve compared with the ME26 valve was associated with significantly higher AV-MGs that increased over the 1-year study period. The ES23 valve was also associated with a greater incidence of PPM and SVD, mainly driven by high MG (≥20 mm Hg) compared with the ME26 valve. These findings may have important implications on long-term valve durability and clinical outcomes.

Acknowledgments. Facilities in the following states assisted with data collection for this study: Alaska: Providence Alaska Medical Center (Anchorage). Washington: Providence Regional Medical Center Everett; Swedish Medical Center Cherry Hill (Seattle); Providence St. Peter Hospital (Olympia); Sacred Heart Medical Center (Spokane). Oregon: Providence St. Vincent Medical Center (Portland). California: Little Company of Mary Hospital (Torrance); St. Joseph Hospital Orange. Montana: St. Patrick Hospital and Health Sciences Center (Missoula).

Affiliations and Disclosures

From the ¹Center for Cardiovascular Analytics, Research and Data Science (CARDS), Providence Heart Institute, Providence St. Joseph Health, Portland, Oregon; ²Providence Medical Research Center, Spokane, Washington; ³Providence Sacred Heart Medical Center, Spokane, Washington; ⁴Providence St. Vincent Medical Center, Portland, Oregon; ⁵Providence St. Patrick Hospital, Missoula, Montana; ⁶Swedish Heart and Vascular Institute, Swedish Medical Center, Seattle, Washington; and ⁷Cardiovascular Center Frankfurt, Frankfurt, Germany.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Curtis is a consultant with Pfizer, Inc. Dr Hodson is a paid proctor for Edwards Lifesciences and a consultant with Abbott Vascular. Dr Gafoor is a consultant with Medtronic, Boston Scientific, and Abbott. Dr Forrester is a paid proctor and consultant with Edwards Lifesciences. Dr Ring is a paid proctor for Medtronic, sits on the advisory board for Boston Scientific, and received institutional research grants from Medtronic, Edwards Lifesciences, and Daiichi Sankyo. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted August 18, 2021.

Address for correspondence: Michael E. Ring, MD, FACC, 62 W Seventh Ave, Suite 450, Spokane, WA 99204. Email: michael.ring@providence.org

Related Articles

• Comparing the Safety and Effectiveness of 5 Leading New-Generation Devices for TranscatheterAortic Valve Implantation: 12-Month Results From the RISPEVA Study
• Performance of the Edwards Sapien 3 Ultra Transcatheter Aortic Valve System in Patients With Aortic Stenosis and Annulus Diameter in Proximity to Valve Size
• The ALSTER-TAVI All-Comers Registry: Procedural and 1-Year Clinical Outcomes of Balloon-Expandable vs Self-Expanding Contemporary TAVI Valves
• Comparison of 26-mm Evolut and 23-mm Sapien 3 Valves in TAVR for Small Aortic Annulus
• Reframing Optimal Implantation of the Sapien 3 Transcatheter Heart Valve

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