A Direct Comparison of Self-Expandable Portico Versus Balloon-Expandable Sapien 3 Devices for Transcatheter Aortic Valve Replacement: A Case-Matched Cohort Study

Abstract: Objectives. Pairwise comparisons of clinical and hemodynamic outcomes with new transcatheter aortic valve replacement (TAVR) prostheses are needed to help interventionists select the most appropriate device. The self-expandable Portico valve (Abbott Vascular) was compared with the balloon-expandable Sapien 3 valve (Edwards Lifesciences) at a high-volume center in a real-world setting. Methods. All patients undergoing TAVR with a new-generation device from March 2015 to September 2017 at a single center were included. Baseline, peri-interventional, and prospective 30-day follow-up data were obtained. A nearest-neighbor propensity-score matching procedure (2:1) was used, based on age, STS score, EuroScore II, New York Heart Association (NYHA) status, and sex. Primary endpoint was 30-day all-cause mortality. Secondary endpoints included procedural results, complications according to Valve Academic Research Consortium (VARC)-2 criteria, and echocardiographic findings. Results. A total of 177 out of 273 patients were matched (104 Portico valves and 73 Sapien 3 valves). Procedural success rates were 99.0% vs 98.6%, respectively; P=NS). Contrast dye use (160 mL for Portico vs 120 mL for Sapien 3; P<.001) and fluoroscopy time (19.0 min for Portico vs 15.5 min for Sapien 3; P=.048) were significantly lower with the Sapien 3 device. Thirty-day mortality rate was 5.8% for the Portico group vs 4.1% for the Sapien 3 group (P=.74). Complication rates were similar between Portico and Sapien 3 groups: stroke (2.9% vs 4.1%, respectively; P=.31), major bleeding (3.8% vs 5.5%, respectively; P=.51), major vascular complications (5.8% vs 5.5%, respectively; P=.99), and pacemaker implantation (21.9% vs 17.5%, respectively; P=.55). A more-than-mild paravalvular leak was observed in 8.2% vs 4.5%, respectively (P=NS). Conclusions. Short-term clinical and hemodynamic outcomes were similar with Portico and Sapien 3 prostheses; no statistically significant differences were observed in mortality and major complication rates. An individually tailored prosthesis choice is suggested.

J INVASIVE CARDIOL 2019;31(7):E199-E204.

Key words: aortic stenosis, new-generation device, Portico, Sapien 3, transcatheter aortic valve replacement, Valve Academic Research Consortium (VARC)-2 criteria

New-generation devices for transcatheter aortic valve replacement (TAVR) have been developed to overcome limitations of first-generation devices and to reduce complications after TAVR. Several direct comparisons have been performed between different kinds of new-generation valves, none to our knowledge has directly compared the Portico valve (Abbott Vascular) with the Sapien 3 valve (Edwards Lifesciences).

The Portico valve, a self-expandable device first introduced in 2012, is a repositionable and recapturable prosthesis made of a trileaflet pericardium sutured in an auto-expandable nitinol stent allowing annular deployment, with large-cell geometry.¹ It is available in 23 mm, 25 mm, 27 mm, and 29 mm sizes, covering an annulus size range from 19-27 mm.²

The new-generation balloon-expandable Sapien 3 valve prosthesis was introduced in 2015. It is based on its previous version (Sapien XT) and has an added distal skirt aiming to reduce paravalvular leak (PVL).³ It is available in 20 mm,  23 mm, 26 mm, and 29 mm sizes, covering an annulus size range from 18-29 mm.⁴

Previous comparative studies have shown better results with new-generation valves than with first-generation options.^3,5,6 Clinical trials comparing first-generation balloon-expandable vs self-expandable valves, such as the CHOICE study,⁷ reported higher device success rates for balloon-expandable valves; however, 1-year rates of cardiovascular and non-cardiovascular death and stroke were similar with both prosthesis types.⁸ Currently published series reporting the results with various new-generation valves have been reviewed by Barbanti et al,⁹ and direct comparisons have already been performed for several devices (eg, Sapien 3 vs Evolut R¹⁰ and Evolut R vs Symetis¹¹). Pairwise direct comparisons for other commonly used new-generation valves are needed to help interventional cardiologists select the most appropriate device for their patients.

Our aim was to compare short-term clinical and hemodynamic outcomes of two new-generation valves – Portico and Sapien 3 – at a high-volume center.

Methods

Study design and population. A single-center analysis of patients with symptomatic severe aortic stenosis (AS) who underwent transfemoral TAVR at our tertiary hospital from March 2015 to September 2017 was performed. Patients with transapical or TAVR through a non-transfemoral route were excluded. The present study focused on Sapien 3 and Portico prostheses; patients receiving other valves were excluded from the analysis. We also excluded patients with an isolated aortic regurgitation and those receiving a valve-in-valve procedure to ensure consistency in indications. Baseline characteristics and echocardiographic parameters were retrospectively collected. Postprocedural data were also gathered and a 30-day follow-up was prospectively performed.

Procedure. Based on the institutional heart-team decision, a TAVR was performed in 273 patients. Annulus measurements were carried out either by computed tomography (3mensio Medical Imaging) or by transesophageal echocardiography. Two different valve types were implanted: the self-expandable Portico valve and the balloon-expandable Sapien 3 valve. Valve choice was left to the discretion of the heart team or operator in most cases. All procedures were performed by two experienced interventional cardiologists. Femoral access was used in all procedures and local anesthesia with conscious sedation was favored in all patients. The study protocol was approved by the ethics committee of the Goethe University Hospital of Frankfurt (study protocol 296/16).

Rapid pacing was employed during predilation for both prostheses, but was only used for balloon-expandable valves during implantation. The new recapturing and resheathing feature of the Portico valve was used in patients who received this prosthesis, if needed. Corrective interventions such as postdilation, use of a second prosthesis, or snaring were performed as needed in both groups. After the intervention, patients were monitored at the intensive care unit for at least 3 days and for a longer time in patients with newly developed conduction disturbances after TAVR.

Outcome definitions. The primary endpoint was 30-day mortality. Secondary endpoints were procedural results, in-hospital mortality, complications according to Valve Academic Research Consortium (VARC)-2 criteria,¹² and echocardiographic findings including PVL and reduction in mean transaortic gradients.

Statistical analysis. We performed a nearest-neighbor propensity-score match using the variables age, logarithmic STS score, and EuroScore II to calculate the weights, with the restriction to obtain exact matching for sex, log₁₀ EuroScore II rounded to 0.1, and New York Heart Association (NYHA) class (I-II vs III vs IV). Overall, a ratio of 1 Sapien 3 device to 2 Portico devices was attempted, but in some cases only a 1:1 match was possible. Propensity-score matching was performed with R software (R Foundation for Statistical Computing) using the MatchIt package. Mean ± standard deviation or median (min-max) were reported for continuous variables, based on their normal or non-normal distribution, which was assessed using the Kolmogorov-Smirnov test. Frequencies were used for categorical variables. Fisher’s exact test was used for dichotomous variables when expected values were <5; Chi-squared test was used for dichotomous variables when cell sizes were expected to be large. Student t-tests was used for parametric variables, and Mann-Whitney U-test was used for non-parametric variables. Wilcoxon rank-sum test was used for non-parametric paired variables. Statistical significance was based on a P-value <.05. All analyses were performed with SPSS statistical software package, version 24.0.

Results

Study population. Out of 400 patients with severe symptomatic AS who underwent TAVR between March 2015 and September 2017, a total of 310 were treated with a transfemoral TAVR, whereas a transapical approach was used in 90 patients. Twenty-seven of the 310 transfemoral TAVR patients were excluded because they received non-study valves; of the remaining 283 patients, a further 7 were excluded due to pure aortic regurgitation or a valve-in-valve procedure and 3 were excluded due to missing follow-up data. Of these 273 patients, a total of 177 patients were matched, with 104 patients receiving a self-expandable Portico valve and 73 patients receiving a balloon-expandable Sapien 3 valve. The study flow chart is illustrated in Figure 1.

Baseline clinical and echocardiographic characteristics. The two groups were well balanced in baseline characteristics (Table 1). No significant differences were found between the Portico and Sapien 3 groups in demographic characteristics, main comorbidities, and NYHA classification. Baseline echocardiographic data did not show statistically significant differences between groups. Baseline left ventricular ejection fraction was 60% (15%-65%) in the Portico group and 55% (15%-75%) in the Sapien 3 group. Left atrium enlargement was present in 83.3% of the Portico group and 80.8% of the Sapien 3 group. More-than-mild baseline aortic regurgitation was found in 24.7% of the Portico group and 27.7% of the Sapien 3 group.

Procedural outcomes. Procedural success, defined as postprocedural immediate survival rate, was achieved in 99.0% of the Portico group and 98.6% of the Sapien 3 group (P=NS; Fisher’s exact test). Predilation was used in most interventions. Resheathing was performed once in 53% of patients who received a Portico valve. Implanted prosthesis sizes are summarized in Table 2. A 29 mm prosthesis was the most commonly used size in the Portico group, whereas the 26 mm device was most commonly used in the Sapien 3 group.

Median contrast dye use (160 mL [60-500 mL] in the Portico group vs 120 mL [40-550 mL] in the Sapien 3 group; P<.001) and median fluoroscopy time (19 minutes [8.20-46.1 min] in the Portico group vs 15.5 min [8.77-230 min] in the Sapien 3 group; P=.048) were significantly lower in the Sapien 3 group.

Some corrective intraprocedural interventions were needed. Postdilation was performed in 30.8% of patients in the Portico group and 4.1% patients in the Sapien 3 group. One patient in the Portico group needed a second prosthesis due to severe PVL, whereas none of the patients in the Sapien 3 group required such a major corrective intervention. One patient had a Portico valve initially selected by the operator, but received a Sapien 3 valve because the Portico valve could not be appropriately positioned due to the patient’s aortic anatomy.

Survival and clinical outcomes. Thirty-day mortality was 5.8% in the Portico group vs 4.1% in the Sapien 3 group (P=.74; Fisher’s exact test). Causes of death in the Portico group were periprocedural cardiac tamponade, bradycardial escape rhythm with unsuccessful pacing, urosepsis and hospital-acquired pneumonia, pulseless electrical activity with unsuccessful cardiopulmonary resuscitation, life-threatening gastrointestinal bleeding, and cardioembolic stroke (1 case each). Causes of death in the Sapien 3 group were periprocedural cardiac tamponade, annulus rupture with subsequent cardiac tamponade and intractable bleeding despite emergency sternotomy, and hospital-acquired pneumonia (1 case each). All deaths in both groups occurred during hospital stay; no additional deaths occurred in the 30-day follow-up period after discharge. Thus, in-hospital mortality was the same as 30-day mortality.

Complications according to VARC-2 criteria did not show statistically significant differences between Portico and Sapien 3 patients (Figure 2). Indications for permanent pacemaker (PPM) implantation are shown in Table 3.

Echocardiographic results. An effective reduction of mean echocardiographic transaortic gradients from 47 mm Hg to 8 mm Hg (P<.001; Wilcoxon rank-sum test) and from 41 mm Hg to 10 mm Hg (P<.001; Wilcoxon rank-sum test), was achieved in Portico and Sapien 3 groups, respectively. A more-than-mild PVL was observed in 8.2% of the Portico group vs 4.5% of the Sapien 3 group (P=.54; Fisher’s exact test).

Discussion

This first comparison of two commonly used new-generation valves in a homogeneous population treated at a single center does not show statistically significant differences in results with the Portico and Sapien 3 devices. Thirty-day mortality was comparable in both groups (5.8% for Portico vs 4.1% for Sapien 3) and was in line with previously reported results in case series and trials for each type of prosthesis.^2,9,13-15 Although mortality in the Sapien 3 group was slightly lower than expected based on EuroScore II, and mortality in the Portico group was slightly higher than expected based on EuroScore II, other preprocedural comorbidities not considered in this score may have had an impact on this variation. Post-TAVR complications, according to VARC-2, such as major stroke and major bleeding, showed no significant differences between groups and were also in line with the results reported in series on Portico and Sapien 3 valves.^2,16 Despite the differences in the introducer sheath between both valves (14 and 16 Fr E-sheath for the Sapien 3 device, and 18 and 19 Fr introducer sheath for the Portico device), vascular complication rates were not significantly different between groups. This is in accord with a previous study demonstrating that sheath size did not have an impact on vascular complication rate.¹⁷

Interestingly, PPM implantation, the most common complication in our series, was slightly lower in the Sapien 3 group, but did not reach statistical significance. As with some previous observational data (15.2%¹⁸ and 17.5%¹⁹ for the Portico valve and 12.0%²⁰ and 14.4%²¹ for the Sapien 3 valve), the incidence of PPM implantation in our study showed a tendency to be lower with Sapien 3 valve. A previous study reported a higher frequency of PPM with the new Sapien 3 valve compared with its previous generation.²² Potential reasons for this could be the outer skirt of the new valve and its deeper implantation.

However, the need for PPM is multifactorial; potential factors may include preconduction abnormalities, degree of calcification,  device features such as a longer stent (which can cause more protrusion into the left ventricular outflow tract), and implantation techniques.^23-25 Therefore, the design of next-generation devices should aim to reduce this frequent complication when extending the indication of TAVR to a lower-risk population.²⁶

A recent systematic review of a number of new-generation valves (Sapien 3, Evolut R, Lotus, Symetis, and Portico) including 10,882 patients from 37 studies showed low rates of mortality and complications, except for the PPM rate (16.2.%).⁹ This PPM rate is also reflected in our study (21.9% in the Portico group vs 17.5% in the Sapien 3 group). This is consistent with the suggestion by Schaefer et al that real-world studies usually show higher PPM rates than clinical trials.¹⁹ This could be possibly due to the inclusion criteria used in clinical trials. Real-world studies could include some patients with a higher preprocedural risk.

As expected, the most common indication for PPM in both groups was a complete heart block. As shown in Table 3, absolute and relative indications for PPM did not show statistically significant differences between the devices. The overall PPM rate for both devices can depend on the implantation policy for a particular medical center, which could have an influence on the PPM rate for both valve types. While some centers prefer to implant a PPM in all patients with a relative indication for implantation before discharge, other centers choose to perform short-term follow-up exams in order to re-evaluate the indication for PPM with time.

Echocardiographic findings showed excellent hemodynamic results, with mean echocardiographic transaortic gradients reduced to levels well below 40 mm Hg (ie, below the current threshold of severe AS for TAVR indication according to European guidelines)²⁷ with both valve types. Although a more-than-mild PVL occurred more frequently in patients who received a Portico valve (8.2% vs 4.5%), this difference did not achieve statistical significance. This needs to be interpreted cautiously due to the limited sample size. Such results are in line with overall findings in cohort studies for each individual valve.^2,28

Regarding specific procedural differences between the two valves, the resheathing feature of the Portico was used in more than half of our patients receiving this valve, with successful results. All Sapien 3 prostheses were implanted directly. Contrast dye use and fluoroscopy time were both significantly lower in the Sapien 3 group; this is most likely due to the different implantation techniques for each valve. This advantage could be taken into account for a patient-tailored selection of the prosthetic valve in some specific populations, such as very old or fragile patients, or patients with renal impairment. Although our study showed that Sapien 3 use required less contrast media, a benefit with one specific prosthesis could not be demonstrated with our data.

Until now, the Portico valve has only been directly compared with the previous generation of balloon-expandable valves (Sapien XT) in a single-center study in 62 patients.²⁹ This study was performed in patients with small aortic annuli, and showed similar results both clinically and hemodynamically between both valve types.²⁹ In the present study, we compared the Portico valve with the newest generation of balloon-expandable valve (Sapien 3) and did not find statistically significant differences in results. Furthermore, our study confirms that excellent outcomes can be achieved in patients with larger annuli up to 27 mm using the largest Portico valve size of 29 mm.

The Sapien 3 valve has been previously compared with other widely used self-expandable valves. A recent single-center comparison between Evolut R and Sapien 3, with no case-matching, showed comparable short-term and long-term cardiovascular outcomes with both valves; long-term all-cause mortality was higher with Evolut R.¹⁰ A further case-matched comparison between these two prostheses showed a significantly lower rate of PVL in the Sapien 3 group.³⁰ In the present study, the balloon-expandable Sapien 3 showed a numerically lower rate of PVL compared with the self-expandable Portico valve; however, this did not reach statistical significance.

Careful preprocedural evaluation and progress in the technical development of new-generation TAVR prostheses have both led to better outcomes and decreased complications. We therefore suggest an individualized prosthesis choice based on the patient’s preprocedural characteristics and known prognostic factors for a personalized TAVR approach.

Head-to-head comparisons between individual valves are scarce; our study provides useful comparative data for two recently developed new-generation prostheses. Moreover, our findings provide a detailed description of the results with both valves in a real-world setting. Our short-term clinical and echocardiographic results need to be interpreted cautiously and will need to be confirmed in the long term. Ongoing prospective trial results from studies such as PORTICO IDE (Portico Re-sheathable Transcatheter Aortic Valve System US IDE; NCT02000115) are eagerly awaited for long-term comparisons. Besides further improving outcomes with new-generation valves, durability evaluation will be needed before their use can be extended to lower-risk populations in the future.

Study limitations and strengths. The lack of randomization is an obvious limitation of the present study; however, the main strength of the present study is the use of a case-matching procedure using a propensity score to achieve comparable groups of patients with both valves to be included in the analysis. This is a real-world study and reflects the current clinical practice in a high-volume center performing TAVR in a European country. The single-center population ensures the protocol and population were homogeneous. Some limitations should also be considered. First, although the follow-up results were collected prospectively, baseline data were retrospectively acquired; however, the use of a strict protocol in our center suggests a bias is unlikely. Second, our results are based on a single high-volume center and cannot be extrapolated to other settings. Confirmation of our results at a multicenter level is needed. Third, our study reports short-term results, and future long-term confirmation is essential.

Conclusion

In this case-matched comparison, short-term clinical and hemodynamic outcomes did not show statistically significant differences between Portico and Sapien 3 prostheses. Also, no significant differences were observed in mortality and major complication rates as defined by VARC-2 criteria. The lower contrast dye volume needed with the Sapien 3 valve may be useful in patients with renal failure. Further studies with these two devices, including long-term randomized trials, are warranted.

Acknowledgments. We would like to thank Professor Eva Herrmann for her invaluable help in the matching procedure.

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From the Departments of ¹Cardiology and ²Cardiothoracic Surgery, University Hospital Frankfurt am Main, Germany.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Vasa-Nicotera reports proctor income from Abbott Vascular, Boston Scientific, and Medtronic. Dr Fichtlscherer and Dr Walther report proctor and consultant income from Abbott Vascular and Edwards Lifesciences. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted January 8, 2019, provisional acceptance given January 21, 2019, final version accepted January 25, 2019.

Address for correspondence: Silvia Mas-Peiro, MD, MSc, Department of Cardiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main,  Germany. Email: silvia.mas@kgu.de