Sutureless Valve Outcomes in Isolated Aortic Valve Replacement by Surgical Approach: Results from a Prospective International Real-World Registry

Abstract

Objective:

Perceval sutureless valve (Corcym, Saluggia, Italy) has been in clinical use for more than 15 years. The aim of this study is to report clinical and hemodynamic performance from a real-world registry in patients who underwent aortic valve replacement (AVR) with a Perceval, comparing outcomes of minimally invasive (MICS) versus full sternotomy (FS) settings.

Methods:

This prospective international registry enrolled 1,652 patients implanted with a sutureless aortic valve in 55 institutions from 2011 to 2021. Patients with isolated AVR were analyzed by MICS and FS approaches. Preoperative covariates were adjusted with propensity score matching 2:1, reaching a final cohort of 857 isolated AVR patients with 558 patients in MICS and 299 in FS groups.

Results:

Successful first implantation was 98.0% for both approaches (P > 0.999). As expected, surgical timings were significantly longer in MICS versus FS (P = 0.004 and P < 0.001), but intensive care unit and hospital lengths of stay were significantly lower in the MICS cohort, resulting in about 0.5 days and 1.5 days less spent in the intensive care unit and hospital, respectively. The surgical approach did not show any effect on early or late survival, disabling stroke, leaks greater than 2, pacemaker rate, or hemodynamics.

Conclusions:

Our propensity-matched analysis demonstrates the noninferiority of MICS with regard to hard endpoints and better outcomes for secondary endpoints such as reduced length of intensive care and in-hospital stay.

Keywords

aortic stenosis aortic valve replacement sutureless valves minimally invasive procedures real-world evidence

Central Message

In the largest real-world prospective registry on the Perceval valve, a propensity-matched analysis demonstrated noninferiority of MICS in terms of hard endpoints and better outcomes for reduced lengths of stay.

Introduction

Surgical aortic valve replacement (AVR) remains the gold standard treatment for patients with aortic valve disease.^1,2 The operative risk of AVR has improved in recent years, with a reduction of mortality from 4.3% to 2.6%.^3,4 Despite these results, elderly high-risk patients referred for AVR still have bad outcomes and therefore might benefit from sutureless technology to reduce morbidity and mortality.^5–10 In the past decade, sutureless aortic valve implantation has gained interest because of the rapid development of new prosthesis technologies. The Perceval aortic valve (Corcym, Saluggia, Italy) is a sutureless bioprosthesis, and several reports have shown midterm and long-term follow-up results.^5–10 Sutureless technology facilitates minimally invasive AVR, reducing operating time and avoiding the complications of prolonged cardiopulmonary bypass (CPB) as well as aortic cross-clamp (ACC) time. We present a subanalysis of clinical and hemodynamic performance from the largest real-world prospective registry on 1,652 patients who underwent AVR with Perceval implantation,¹⁰ comparing outcomes of minimally invasive cardiac surgery (MICS) versus full sternotomy (FS) settings in isolated AVR.

Methods

The Sorin Universal REgistry on Aortic Valve Replacement (SURE-AVR) registry (NCT02679404), sponsored by Corcym S.r.l., was a prospective observational registry conducted at 73 sites in 18 countries in Europe, Canada, the United States, and Australia; any of the commercially available Corcym aortic products were eligible for enrollment. Between March 2011 and June 2021, 1,652 patients underwent AVR with a sutureless Perceval aortic bioprosthesis in 55 international institutions. Preoperative, periprocedural, follow-up clinical and echocardiographic parameters, as well as clinical outcomes were analyzed for all patients. The registry was conducted according to the International Conference on Harmonization guidelines, Good Clinical Practice, and local regulations. The ethics committee and/or institutional review board approval was obtained as required by local regulations. All patients gave informed consent to participate. Patients were enrolled in a sequential and prospective manner and were treated based on the standard of care at participating sites. Baseline data were entered into an electronic case report form by trained study coordinators and included demographics, clinical, echocardiographic, and surgical data. Follow-up visits were performed according to the center’s usual practices (by telephone call, referring physician, or clinical visit) at 1 year and annually thereafter to 5 years, with follow-up at 7 years in selected centers. The results presented in this manuscript are limited to 5-year follow-up. No specific inclusion and exclusion criteria other than the indications and contraindications specified in the “instructions for use” of the Perceval valve were implemented, as the aim of the study was to report on the standard of care at participating centers.

Study Device

The Perceval valve is a self-anchoring, self-expanding, sutureless, surgical aortic bioprosthesis indicated for the replacement of damaged or malfunctioning native aortic heart valves or prostheses. This bioprosthesis has a functional component, comprising bovine pericardium, stabilized in buffered glutaraldehyde solution, and a superelastic metal alloy stent, which has the dual role of valve support and anchoring to the aortic root with no permanent sutures. Before implantation, the prosthesis diameter was reduced to a suitable size for loading it onto a holder accessory. The valve was then positioned and released in the aortic root and subsequently post-dilated using a dedicated balloon catheter. The device is available in 4 sizes (small, medium, large, extra-large) covering annular diameters ranging from 19 to 27 mm. Both variants of the Perceval valve, Perceval S and Perceval PLUS (more recently introduced in clinical use and featuring FREE, an advanced tissue treatment), were implanted at the participating centers. Patients were implanted through FS or MICS approaches, either ministernotomy or right anterior thoracotomy (RAT). The choice of the surgical approach was based on surgeon preference after assessment of the technical feasibility.

Clinical Outcomes

Clinical success was defined as a successful valve implantation without the occurrence of major adverse events by the time of hospital discharge. Investigator-reported major adverse events were defined as death (all cause, cardiovascular, noncardiovascular), stroke, and reintervention (surgery or any other cardiac invasive therapy). Serious valve-related adverse events included bleeding, thromboembolism, valve thrombosis, endocarditis, nonstructural dysfunction, and structural valve deterioration. The severity of valve dysfunction was classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+), or severe (grade 4+). Echocardiographic and hemodynamic data were collected. Early outcomes were defined as those occurring up to 30 days after the procedure, whereas late outcomes were those occurring >30 days after the procedure.

Statistical Analysis

Variables are described as mean ± standard deviation or median (Q1, Q3; range) for continuous variables and as number (%) for categorical variables. Outcomes are reported as descriptive statistics. The rates of early adverse events were calculated as the total number of events divided by the total number of patients. Linearized complication rates (with 95% confidence intervals [CIs]) were calculated as the number of late events (>30 days) divided by the number of late patient-years. Normality assessment was conducted via Kolmogorov–Smirnov test.

The propensity score was calculated via logistic regression, with numerous matching algorithms tested (nearest neighbor matching with or without replacement and with or without calipers, full matching, optimal matching, exact matching, genetic matching) before settling on an optimal matching with exact matching for valve size and a 2:1 matching ratio (MICS vs FS); the best method was defined as the one leading to the best balance (i.e., standardized mean differences <0.1) between the covariates of interest. Refer to Figure 1 for the complete list of included variables. Matching was conducted 2:1, leveraging the larger MICS cohort to limit the waste of data and loss of precision of the estimates that are intrinsic in any matching approach.

The primary endpoint was the early clinical success, defined as the nonoccurrence of all-cause death, valve-related reintervention, stroke (disabling and nondisabling), and bleeding in the early period. The secondary endpoints were the intensive care unit (ICU) and hospital length of stay, the long-term clinical success, and the hemodynamic results.

Multivariable regression models were then run to quantify the effect of the surgical approach on the endpoints while adjusting for the covariates that remained unbalanced even after the matching process; logistic, linear, and linear with mixed effects (with patient code as random intercepts) models were built according to the nature of the dependent variables. Late deaths were modeled via multivariable Cox regression; valve-related reinterventions and strokes were instead modeled via multivariable competing risk regressions (Fine and Gray approach), with death included as a competing event.

A P value <0.05 was considered statistically significant. All analyses were run in R (R Foundation for Statistical Computing, Vienna, Austria), and packages included tidyverse, tableone, MatchIt, lme4, surviva, and cmprisk.

Results

A total of 1,652 patients implanted with a sutureless valve were prospectively enrolled in the SURE-AVR registry between March 2011 and June 2021. The characteristics of the study population and the results of the overall study cohort were previously reported.¹⁰ Briefly, there were 891 (53.9%) female patients, and the overall mean age was 75.3 ± 7.0 years with a mean EuroSCORE II of 4.1 ± 6.3. There were 1,060 patients (64.2%) who underwent isolated AVR (mean age, 75.3 ± 7.0 years; EuroSCORE II, 3.5 ± 6.4); among them, 711 cases (67.1%) were performed through a MICS approach (51.8% ministernotomy, 42.7% RAT), whereas 340 (32.1%) were through FS and 9 (0.8%) were unknown.

The result of the 2:1 propensity-matched analysis was 2 final cohorts of 558 patients in MICS and 299 in FS approach (Fig. 1). Three variables (endocarditis, New York Heart Association class II to III, and previous cardiac procedures) appeared to be unmatched; therefore, these variables were included in the subsequent regression analyses as covariates. The baseline clinical characteristics of the unmatched and matched cohort are reported in Table 1.

Table 1.

Baseline Characteristics.

	Unmatched				Matched
	MICS (n = 711)	FS (n = 340)	P value	SMD	MICS (n = 558)	FS (n = 299)	P value	SMD
Age, years	75.42 ± 6.6	75.08 ± 7.76	0.46	0.047	75.66 ± 6.5	75.47 ± 7.16	0.697	0.027
Female	425 (59.8)	200 (58.8)	0.821	0.019	339 (60.8)	174 (58.2)	0.512	0.052
Dyslipidemia	405 (58.1)	203 (61.1)	0.39	0.062	327 (58.6)	183 (61.2)	0.505	0.053
Diabetes	206 (29.6)	94 (27.9)	0.622	0.038	157 (28.1)	83 (27.8)	0.97	0.008
Chronic lung disease	107 (15.1)	31 (9.2)	0.012	0.180	67 (12.0)	30 (10.0)	0.45	0.063
Renal insufficiency	61 (8.6)	36 (10.7)	0.333	0.070	50 (9.0)	31 (10.4)	0.583	0.048
Peripheral vascular disease	28 (6.7)	15(5.2)	0.507	0.064	15 (4.4)	14 (5.4)	0.7	0.047
Previous cardiac procedures	93 (13.1)	74 (22.0)	<0.001	0.235	73 (13.1)	59 (19.7)	0.013	0.180
Previous myocardial infarction	36 (5.1)	17 (5.0)	>0.999	0.002	24 (4.3)	15 (5.0)	0.759	0.034
Previous CVA	29 (76.3)	10 (66.7)	0.71	0.215	15 (62.5)	7 (58.3)	>0.999	0.085
LVEF, %	58.82 ± 9.55	57.85 ± 11.17	0.213	0.093	58.31 ± 9.53	58.02 ± 11.05	0.729	0.028
NYHA class II–III	618 (90.9)	268 (83.3)	<0.001	0.281	500 (89.6)	248 (83)	0.007	0.242
Preoperative sinus rhythm	580 (81.6)	273 (80.5)	0.765	0.119	462 (82.8)	244 (81.6)	0.991	0.064
Endocarditis	4 (0.6)	12 (3.6)	0.001	0.213	4 (0.7)	9 (3.0)	0.02	0.170
Bicuspid valve	70 (9.9)	22 (6.5)	0.097	0.122	45 (8.1)	18 (6.0)	0.339	0.080

Abbreviations: CVA, cerebrovascular accident; FS, full sternotomy; LVEF, left ventricular ejection fraction; MICS, minimally invasive cardiac surgery; NYHA, New York Heart Association; SMD, standardized mean difference.

Data are reported as mean ± standard deviation or n (%).

Operative Data

Valve sizes implanted in both the unmatched and matched groups are reported in Table 2. The successful first implant rate was 98.0% for both approaches (P > 0.999).

Table 2.

Operative Data on Valve Size.

Perceval size	Unmatched		Matched
Perceval size	MICS (n = 711)	FS (n = 340)	MICS (n = 558)	FS (n = 299)
Small	121 (17.0)	52 (15.3)	92 (16.5)	46 (15.4)
Medium	224 (31.5)	132 (38.8)	207 (37.1)	111 (37.1)
Large	269 (37.8)	101 (29.7)	176 (31.5)	88 (29.4)
Extra-large	97 (13.6)	55 (16.2)	83 (14.9)	54 (18.1)

Abbreviations: FS, full sternotomy; MICS, minimally invasive cardiac surgery.

Data are reported as n (%).

In the analyzed matched population, those who received a valve via MICS approach resulted in about 4.2 min more ACC time and about 9 min more CPB time. The difference between the 2 approaches in terms of procedural times was statistically significant both in the univariable (ACC, P = 0.003; CPB, P < 0.001) and multivariable (ACC, P = 0.004; CPB, P < 0.001) analyses. The opposite result was found for ICU and hospital stays, such that the length of stay was significantly lower in the MICS cohort in the univariable (ICU, P < 0.001; hospital, P = 0.036) and multivariable (ICU, P = 0.002; hospital, P < 0.001) analyses. Specifically, receiving a valve via MICS approach resulted in about 0.5 days and 1.5 days less spent in the ICU and the hospital, respectively (Table 3).

Table 3.

Operative Data for Matched Cohorts.

	Univariable analysis			Multivariable analysis
	MICS (n = 558)	FS (n = 299)	P value	Estimated coefficient (95% CI)^a	P value
Successful first implant	547 (98.0)	293 (98.0)	>0.999	—	—
ICU stay, days	1.0 (1.0, 2.0)	2.0 (1.0, 3.0)	<0.001	−0.47 (−0.76, −0.18)	0.002
Hospital stay, days	8.0 (7.0, 11.0)	9.0 (7.0, 14.0)	0.036	−1.65 (−2.60, −0.70)	<0.001
Cross-clamp time, min	50.0 (38.0, 60.0)	44.0 (34.0, 58.0)	0.003	4.18 (1.36, 6.70)	0.004
Pump time, min	76.0 (56.75, 98.0)	67.0 (51.0, 85.0)	<0.001	9.02 (4.75, 13.30)	<0.001

Abbreviations: CI, confidence interval; FS, full sternotomy; ICU, intensive care unit; MICS, minimally invasive cardiac surgery.

Data are reported as median (interquartile range) or n (%) unless otherwise noted.

The estimated coefficients and CIs were obtained via multivariable linear regression and refer to the effect of receiving a MICS treatment.

Early Results

Survival probability up to 5-year follow-up did not show a significant difference between the 2 matched groups (Fig. 2). The analysis of early outcomes for the matched cohort are reported in Table 4. The univariable analysis found no statistical differences between the 2 cohorts in terms of all deaths (MICS, 3 [0.5%] vs FS, 2 [0.7%], P > 0.999), valve-related reintervention (MICS, 3 [0.5%] vs FS, 1 [0.3%], P > 0.999), or disabling stroke (MICS, 2 [0.4%] vs FS, 2 [0.7%], P = 0.614). Given the low number of events and the comparable results (similar percentage), performing the multivariable analysis was avoided as not adding value.

Table 4.

Early Results (≤30 Days) in the Matched Cohorts.

	Univariable analysis			Multivariable analysis
	MICS (n = 558)	FS (n = 299)	P value	Estimated OR (95% CI)	P value
All deaths	3 (0.5)	2 (0.7)	>0.999	—	—
Cardiovascular deaths	2 (0.4)	0	—	—	—
Valve-related reintervention	3 (0.5)	1 (0.3)	>0.999	—	—
Disabling stroke	2 (0.4)	2 (0.7)	0.614	—	—
Nondisabling stroke	8 (1.4)	1 (0.3)	0.173	4.75 (0.85, 89)	0.146
Bleeding	7 (1.3)	3 (1.0)	>0.999	—	—
Thromboembolism	1 (0.2)	0	—	—	—
Intraprosthetic regurgitation ≥2	10 (9.3)	0	0.753	—	—
PVL ≥2	1 (0.2)	0	0.633	—	—
Endocarditis	0	0	—	—	—
Valve thrombosis	0	0	—	—	—
Myocardial infarction	2 (0.4)	0	—	—	—
Pacemaker implant	20 (3.6)	20 (6.7)	0.060	0.51 (0.27, 0.98)	0.042

Abbreviations: CI, confidence interval; FS, full sternotomy; MICS, minimally invasive cardiac surgery; OR, odds ratio (MICS/FS); PVL, paravalvular leakage.

Data are reported as n (%) unless otherwise noted.

The rate of nondisabling stroke was comparable between the 2 cohorts (MICS, 8 [1.4%] vs FS, 1 [0.3%], univariable P = 0.173, multivariable P = 0.146). The permanent pacemaker implant rate was significantly lower in the MICS cohort (3.6% vs 6.7%, univariable P = 0.06, multivariable P = 0.042). No events of cardiovascular death, thromboembolism, intraprosthetic regurgitation (≥2), paravalvular leakage (≥2), endocarditis, valve thrombosis, or myocardial infarction were registered for the FS cohort; therefore, no comparison was possible.

Late Results

The analysis of late outcomes for the matched cohort are displayed in Table 5. At long-term follow-up, the surgical approach was not associated with death (MICS, 8.1% vs FS, 5.4%, univariable P = 0.48, multivariable P = 0.858), disabling stroke (MICS, 1.1% vs FS, 0.3%, univariable P = 0.46), nondisabling stroke (MICS, 2.2% vs FS, 0.7%, univariable P = 0.156), or bleeding (MICS, 1.1% vs FS, 1.0%, univariable P = 0.432). The difference in the probability of late valve-related reintervention in the 2 groups was statistically significant (MICS, 2.7% vs FS, 0%, univariable P = 0.036), with MICS having higher probability. Due to the lack of events in the FS cohort, building a model was not possible.

Table 5.

Late Results (>30 Days) in the Matched Cohorts.

	Univariable analysis			Multivariable analysis
	MICS (n = 558)	FS (n = 299)	P value	OR (95% CI)	P value
All deaths	45 (8.1)	16 (5.4)	0.48	0.95 (0.51, 1.74)	0.858
Cardiovascular deaths	22 (3.9)	8 (2.7)	—	—	—
Valve-related reintervention	15 (2.7)	0	0.036	—	—
SVD	8 (1.4)	0	—	—	—
TIA	8 (1.4)	1 (0.3)	—	—	—
Disabling stroke	6 (1.1)	1 (0.3)	0.46	—	—
Nondisabling stroke	12 (2.2)	2 (0.7)	0.156	—	—
Thromboembolism	0	0	—	—	—
Bleeding	6 (1.1)	3 (1.0)	0.432	—	—
Intraprosthetic regurgitation ≥2	12 (2.2)	0	—	—	—
PVL ≥2	0	0	—	—	—
Endocarditis	7 (1.3)	0	—	—	—
Valve thrombosis	0	0	—	—	—
Myocardial infarction	5 (0.9)	0	—	—	—

Abbreviations: CI, confidence interval; FS, full sternotomy; MICS, minimally invasive cardiac surgery; OR, odds ratio (MICS/FS); PVL, paravalvular leakage; SVD, structural valve degeneration; TIA, transient ischemic attack.

Data are reported as n (%) unless otherwise noted.

For all deaths, the univariable P value is from a stratified Kaplan–Meier curve (MICS vs FS), and the multivariable P value is from the Cox regression model. For valve-related reinterventions and disabling strokes, the univariable P value is from competing risk analysis (MICS vs FS) with death as a competing event and the multivariable P value is not available, as there were 0 events in the FS cohort and models could not be built. For bleeding, the univariable P value is from the Fisher’s exact test.

No events of thromboembolism, intraprosthetic regurgitation (≥2), paravalvular leakage (≥2), endocarditis, valve thrombosis, or myocardial infarction were registered for the FS cohort; therefore, no comparison was possible.

Hemodynamic Results

The hemodynamic results are reported in Table 6. The comparison between the 2 approaches was evaluated in terms of mean pressure gradient, and no difference was found through time with respect to the surgical approach. Values remained stable during follow-up.

Table 6.

Hemodynamic Data in the Matched Cohorts.

	MICS	FS	Univariable analysis
Preoperative	n = 282	n = 537
Effective orifice area, cm²	0.70 (0.60, 0.86)	0.72 (0.60, 0.90)
Mean gradient, mm Hg	47.00 (38.25, 57.00)	47.95 (41.00, 58.00)	0.17
Peak gradient, mm Hg	77.00 (64.00, 92.00)	78.00 (65.00, 94.00)
Discharge	n = 468	n = 194
Effective orifice area, cm²	1.62 (1.40, 2.10)	1.43 (1.21, 1.72)
Mean gradient, mm Hg	13.00 (10.00, 17.00)	13.00 (10.00, 16.00)	0.25
Peak gradient, mm Hg	24.00 (19.00, 31.00)	23.00 (18.00, 29.00)
1 year	n = 196	n = 89
Effective orifice area, cm²	1.60 (1.30, 2.00)	1.80 (1.35, 2.25)
Mean gradient, mm Hg	11.00 (8.00, 15.00)	12.00 (9.00, 15.75)	0.388
Peak gradient, mm Hg	19.00 (14.00, 25.00)	20.25 (15.25, 26.00)
5 years	n = 107	n = 11
Effective orifice area, cm²	1.40 (1.05, 1.80)	1.8 (1.35, 1.90)
Mean gradient, mm Hg	11.00 (9.00, 15.00)	10.00 (9.00, 15.00)	0.839
Peak gradient, mm Hg	20.00 (15.00, 25.75)	20.00 (15.00, 27.00)

Abbreviations: FS, full sternotomy; MICS, minimally invasive surgery.

Data are reported as median (interquartile range).

Discussion

This study reports outcomes in 1,652 patients undergoing AVR, included in the SURE-AVR registry, comparing MICS versus FS settings. Our analysis demonstrates the noninferiority of MICS with regard to mortality and stroke and better outcomes for reduced length of ICU and in-hospital stay. Unlike previous reports, this study was prospective and the largest multicenter cohort of patients with a Perceval bioprosthesis.

Sutureless bioprosthesis represents an innovative approach for surgical AVR and has been designed to allow faster implantation, reducing CPB and ACC times. This is an advantage for all patients, regardless of the risk profile. The first clinical results of the Perceval bioprosthesis were reported in 2011 by Flameng and colleagues.¹¹ Fischlein et al. reported low 1-year event rates in intermediate-risk patients undergoing AVR from a large multicenter cohort study.⁵

In our experience with isolated AVR, 30-day cardiovascular death was 0.4% (2 of 558) in the MICS group and no deaths were recorded in the FS group, whereas late deaths were 3.9% and 2.7%, respectively. Early and late outcomes showed a low rate of neurologic events and reinterventions. Relative to other series, we found similar results in terms of paravalvular leakage and hemodynamic performance. The median mean transvalvular gradient at 5-year follow-up was 11 mm Hg and 10 mm Hg, respectively. These results are the same as the largest European multicenter experience.¹²

The reduced time needed for implantation is a potential advantage of this prosthesis. A meta-analytical study showed a CPB time of 104.4 min in the minimal access group who underwent AVR versus 94.0 min in the conventional access group (P < 0.001).¹³ Our experience with AVR with a Perceval valve showed a median CPB time of 76 (56.75, 98.00) min. Obviously, ACC and CPB times were shorter in the FS group; although the Perceval facilitates minimally invasive implantation, the times for removal of the native valve and decalcification of the aortic annulus are longer in the MICS approach due to greater technical difficulties. Regardless, surgical timings recorded for the MICS group favorably compared with previously published experience in FS and MICS.¹³ Because MICS AVR has shown longer CPB and ACC times versus conventional surgery, we strongly believe that sutureless technology might be the solution for less invasive approaches. The advantages of Perceval implantation in the ministernotomy approach have already been described by Fischlein et al. with good results,⁶ whereas the Massa experience reported the advantages of AVR with sutureless implantation through a right minithoracotomy.¹⁴

In our propensity-matched analysis, the MICS group did not have significant differences in terms of survival, disabling stroke, or paravalvular leaks greater than 2 compared with the FS group. Hemodynamic data were similar in the 2 groups, with a mean pressure gradient of 11 mm Hg and 10 mm Hg at 5 years in the MICS and FS groups, respectively (P = 0.83). The pacemaker implantation rate was significantly lower in the MICS group with 20 implants (3.6%) compared with the FS group. Indeed, FS can be associated with a higher rate of pacemaker implantation compared with less invasive approaches, such as MICS, primarily due to the more extensive surgical trauma related to the larger incision and more extensive manipulation of the heart and surrounding tissues, which can affect the heart’s conduction system with consequent potential need for a pacemaker implant.¹⁵ Moreover, the difference can be related to the individual center’s practice. Considering that this study is based on the “standard of care” at each participating center, the differences in the policy and protocols of rhythm disorder management in each center may play a role in the different rate of pacemaker implant in the 2 study cohorts.¹⁶ In addition, the different level of experience with the Perceval valve can be considered as a factor influencing the difference in this rate. It has indeed been reported that the tendency to oversize the valve or placing it too low in the left ventricular outflow track may lead to a higher rate of pacemakers.¹⁷

Patients who underwent MICS Perceval implantation had a shorter length of ICU stay (P = 0.002) and hospital stay (P < 0.001) compared with the FS group. This finding is aligned with recent clinical evidence showing that MICS not only can provide better cosmetic results but also, thanks to the reduction of the surgical trauma, may lead to a lower complication rate and blood loss reduction as well as a shortened recovery time. A recent meta-analysis showed indeed that ICU and total hospital stay were significantly shorter in MICS AVR compared with FS.¹⁸

There were more late valve-related reinterventions in the matched MICS group, but the number of events in the FS group was 0, and for this reason, the comparison is not reliable.

Conclusions

Our multicenter, real-world experience with the Perceval sutureless valve showed favorable clinical and hemodynamic results at midterm follow-up. Propensity-matched analysis demonstrated the noninferiority of MICS in terms of mortality and stroke and better outcomes for reduced length of ICU and in-hospital stay.

Footnotes

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Giovanni Troise and Mattia Glauber are consultants for CORCYM. The other authors report no conflict of interest.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by CORCYM S.r.l.; CORCYM S.r.l. funded all trial-related activities and participated in site selection, data monitoring, trial management, and statistical analysis.

ORCID iDs

Giovanni Concistré

Mattia Glauber

References

Isselbacher

Preventza

Hamilton Black

III , et al. 2022 ACC/AHA guideline for the diagnosis and management of aortic disease: a report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. J Thorac Cardiovasc Surg 2023; 166: e182–e331.

Vahanian

Alfieri

Andreotti

, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2012; 42: S1–S44.

Goodney

O’Connor

Wennberg

, et al. Do hospitals with low mortality rates in coronary artery bypass also perform well in valve replacement? Ann Thorac Surg 2003; 76: 1131–1137.

Brown

O’Brien

, et al. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in The Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg 2009; 137: 82–90.

Fischlein

Meuris

Hakim-Meibodi

, et al. The sutureless aortic valve at 1 year: a large multicenter cohort study. J Thorac Cardiovasc Surg 2016; 151: 1617–1626.

Fischlein

Pfeiffer

Pollari

, et al. Sutureless valve implantation via mini J-sternotomy: a single center experience with 2 years mean follow-up. Thorac Cardiovasc Surg 2015; 63: 467–471.

Zannis

Joffre

Czitrom

, et al. Aortic valve replacement with the Perceval S bioprosthesis: single-center experience in 143 patients. J Heart Valve Dis 2014; 23: 795–802.

Shrestha

Fischlein

Meuris

, et al. 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.

Concistrè

Bianchi

Margaryan

, et al. Ten-year experience with sutureless Perceval bioprosthesis: single-centre analysis in 1157 implants. J Cardiovasc Med 2023; 24: 506–513.

10.

Concistré

Baghai

Santarpino

, et al. Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry. Interdiscip Cardiovasc Thorac Surg 2023; 36: ivad103.

11.

Flameng

Herregods

Hermans

, et al. 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.

12.

Laborde

Fischlein

Hakim-Meibodi

, et al. 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.

13.

Leon

Smith

Mack

, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374: 1609–1620.

14.

Solinas

Bianchi

Chiaramonti

, et al. Right anterior mini-thoracotomy and sutureless valves: the perfect marriage. Ann Cardiothorac Surg 2020; 9: 305–313.

15.

Glaser

Persson

Dalén

, et al. Long-term outcomes associated with permanent pacemaker implantation after surgical aortic valve replacement. JAMA Netw Open 2021; 4: e2116564.

16.

Matthews

Fazal

Bates

, et al. In patients undergoing aortic valve replacement, what factors predict the requirement for permanent pacemaker implantation? Interact Cardiovasc Thorac Surg 2011; 12: 475–479.

17.

Szecel

Lamberigts

Rega

, et al. Avoiding oversizing in sutureless valves leads to lower transvalvular gradients and less permanent pacemaker implants postoperatively. Interact Cardiovasc Thorac Surg 2022; 35: ivac157.

18.

El-Andari

Fialka

Shan

, et al. Aortic valve replacement: is minimally invasive really better? A contemporary systematic review and meta-analysis. Cardiol Rev 2024; 32: 217–242.