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Received: 12 December 2021 | Accepted: 10 January 2022

DOI: 10.1111/jocs.16271

ORIGINAL ARTICLE

Mid‐term outcomes of stentless Bio‐Bentall vs. David


Reimplantation for aortic root replacement

Guglielmo Stefanelli1 | Fabrizio Pirro1 | Emilio Chiurlia1 |


2 2,3
Alessandro Bellisario | Luca Weltert

1
Department of Cardiac Surgery and
Cardiology, Hesperia Hospital, Modena, Italy Abstract
2
Department of Cardiac Surgery, European Objective: To compare the early and midterm clinical outcomes of patients under-
Hospital, Rome, Italy
going two different surgical procedures (stentless biological Bentall [SBB] vs. valve‐
3
Department of Biostatistics, San Camillus
International University of Health Sciences, sparing David Reimplantation [VSDR]) for aortic root dilatation, with or without
Rome, Italy concomitant aortic valve pathology.
Methods: A population of 106 patients underwent aortic root replacement from
Correspondence
Guglielmo Stefanelli, Department of Cardiac 2004 to 2015 at our unit. Mean age at operation was 63.1 ± 10 years. The patients
Surgery and Cardiology, Hesperia Hospital, via
were retrospectively assigned to 2 groups according to surgical procedure. David
Arquà 80, Modena, Italy.
Email: guglielmostefanelli@gmail.com operation was carried out in 52 patients (group A‐VSDR) and stentless biological
Bentall in 54 patients (group B‐SBB). Preoperative characteristics were similar in the
2 cohorts, except for age and EuroSCORE. Mean follow‐up time was 7.09 years
(0.26–14.50 years), and 96% complete. Patients were evaluated and analyzed for
intra‐operative results and long‐term clinical outcomes.
Results: Intraoperative mortality was 0% in both groups. Overall survival probability
at 11 years was 91.8% in group A and 73.8% in group B (p = .004). Cardiac mortality
at 11 years was similar in the 2 groups (p = .116). Freedom from structural valve
deterioration at 11 years was 88.8% (VSDR) and 90.6% (SBB) [p = .689]. Freedom
from reoperation at 11 years did not differ between the groups (83.6% VSDR vs.
98.5% SBB, p = .574). Freedom from major adverse cardiac and cerebrovascular
events at 11 years was 76.7% (VSDR) versus 80.1% (SBB) (p = .542). Mean gradient
at last follow‐up was lower in VSDR group (8.13 vs. 11.70 mmHg, p < .001).
Conclusions: David reimplantation and stentless biological Bentall procedures
achieve excellent and comparable results at midterm follow‐up. David operations
provide superior hemodynamic performance preserved over time and may be pre-
ferred in younger, active patients.

KEYWORDS
aortic root surgery, Bentall operation, David operation

Abbreviations: ABE, acute bacterial endocarditis; ACC, aortic cross clamping; A I, aortic valve insufficiency; AO, aortic; BAV, bicuspid aortic valve; BSA, body surface area; CABG, coronary
artery bypass graft; CPB, cardiopulmonary bypass; EF, ejection fraction; ICU LOS, intensive care unit length of stay; LVEDD, left ventricular end‐diastolic diameter; MACCE, major adverse
cardiac and cerebrovascular events; NYHA, New York Heart Association; ΔP, left‐ventricle‐aorta gradient; SVD, structural valve deterioration.

J Card Surg. 2022;37:781–788. wileyonlinelibrary.com/journal/jocs © 2022 Wiley Periodicals LLC | 781


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782 | STEFANELLI ET AL.

1 | INTRODUCTION Guidelines reported by Akins et al. were used to define the endpoints
of the analysis.5
1
The Bentall operation, as first described in the late 1960s and later
modified by Kochoukos 2 in the “button‐ Bentall” technique, remains
the standard procedure for patients with dilated aortic root asso- 2.2 | Surgical technique
ciated with aortic valve pathology. Due to increasing patient's re-
quest for biological devices, most Bentall procedures are now All procedures were performed by a single surgeon in a single in-
performed using a tube vascular graft including an aortic bioprosth- stitution. Patients older than 75 years, or having retracted, thickened,
esis. As alternative to biological Bentall, and in addition to homograft and partly calcified aortic leaflets, or with dilatation of the aortic
and Ross procedure, aortic valve sparing operation, first proposed by annulus >35 mm or affected by aortic valve ABE were not considered
3 4
David and Yacoub, although surgically more demanding, offers good candidates for David reimplantation, and underwent a biological
excellent short‐ and long‐term results, due to improved hemody- Bentall procedure. All operations were performed by median ster-
namic performance and durability, provided the indication and sur- notomy, moderately hypothermic cardiopulmonary bypass (CPB) and
gical technique are accurate. In this retrospective study we aimed to cardiac arrest obtained by antegrade and retrograde Custodiol™
analyze two groups of patients affected by aneurismal dilatation of (Dr. Franz Köhler Chemie GmbH) cardioplegic solution, after aortic
the aortic root, isolated or associated with aortic valve pathology, cross‐clamping (ACC). Cardiocirculatory arrest at 25°C and brain
who underwent aortic root replacement either by David valve sparing protection by selective perfusion of neck vessels was adopted in
procedure technique or by Bentall operation using a factory‐ cases of aortic arch replacement. Reimplantation operation was
produced or a self‐assembled stentless bioprosthetic conduit, and to performed as originally described by David in 52 patients. As a first
evaluate the outcomes and the drawbacks related to each of these step, after transverse aortotomy, resection of the aortic sinuses was
surgical options. The choice of a stentless bioroot for the Bentall carried out, followed by accurate dissection of the peri‐annular soft
procedure instead of the commonly used stented one, aimed to im- tissue. Aortic leaflet repair, required in 14 patients, was achieved at
prove the hemodynamic performance and durability, by avoiding the this time, and consisted mostly of one or more cusp plication by
rigid strut of a stented prosthesis and by allowing a bigger im- central 5‐0 polypropylene stitch or by cusp resuspension using
plant size. continuous 7‐0 gore‐tex suture. Next, the native aortic valve was
implanted inside a straight tube woven graft using 15 braided U
stitches for the annulus and 3 polypropylene continuous sutures for
2 | M E TH O D S the outflow. A water test to check the aortic valve competence was
performed and, if necessary, further gestures on aortic leaflets were
2.1 | Population accomplished to obtain optimal valve competence. Reimplantation of
the coronary ostia and Teflon reinforced distal aortic anastomosis
Between 2004 and 2015, a cohort of 106 patients underwent re- completed the procedure. A residual aortic insufficiency greater than
placement of the aortic root for dilatation of the ascending aorta mild or with asymmetrical regurgitant jet at a postprocedural trans-
isolated or in association with aortic valve disease at our unit by a esophageal echocardiography control were considered signs of pro-
single surgeon. cedural failure; indeed these circumstances did not occur in any of
Patients without significant (>45 mm) aortic root dilatation and our patients. The modified biological Bentall operation was carried
patients with aortic valve stenosis were excluded from the study. out in 54 patients, using a Shelhigh NR‐2000 (Shelhigh, Inc.) in 24
Patients in the Bentall group with acute aortic dissection and patients patients, and a self‐made bioconduit, constructed by inclusion of a 3F
with acute bacterial endocarditis (ABE) were excluded from our equine pericardial stentless prosthesis (Medtronic, Dublin, Ireland)
analysis since they do not fit with the comparator group of the David into a Hemashield (Getinge, Göteborg, Sweden) straight tube graft in
procedure. All patients received a preoperative evaluation by echo- 30 patients. (Supporting Information Video). In all 54 cases the bio‐
cardiography and computed tomography. The study was approved by conduit was secured to the native aortic annulus by three different
the Institutional Ethical Committee (EC #0011/2019). Preoperative, surgical techniques, namely: interrupted, multiple U braided stitches
intraoperative, and postoperative data were collected from the hos- reinforced with supra‐annular Teflon pledgets, or alternatively by a
pital medical records and informed consent to use their data was single or by three running polypropylene sutures reinforced with a
obtained from all patients. Follow‐up of patients consisted of one strip of pericardium (Figure 1).
time point evaluation of postoperative events. Endpoints of our
analysis included early/in‐hospital mortality, late overall and cardiac
mortality, rate of major adverse cardiac and cerebrovascular events 2.3 | Statistical analysis
(MACCE) and ABE at follow‐up, which were compared between the
David and Bentall groups of patients. The incidence of structural Categorical variables were presented as numbers and percentages
valve deterioration (SVD) and valve‐related reoperation was also and were analyzed by Pearson's χ2 or Fisher's exact test. Continuous
evaluated, along with hemodynamic performance over time. variables were expressed as mean ± SD or median with interquartile
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STEFANELLI ET AL. | 783

FIGURE 1 Stentless bio‐root assembly

range. Normality of the data was assessed using the Shapiro–Wilk TABLE 1 Preoperative patients characteristics
test. Differences between groups were compared using Student's t Bentall David
test for normally distributed continuous variables whereas for non- Mean/N° Mean/N°
normally distributed continuous variables the Mann–Whitney U test (SD/%) (SD/%) p
was used. The Kaplan–Meier method was used to plot graphs, with Age 67 (±9.68) 59 (±8.76) <.001
confidence intervals drawn as thinner lines for sake of visual clarity, Gender (male) 40 (74.1%) 44 (84.6%) <.001
number at risk is plotted in the lower row, and all curves are cut when
BSA 1.82 (±0.19) 1.88 (±0.19) .151
10% of total patients at risk is reached. The Log Rank method was
used after testing for the proportional hazard assumption to verify NYHA III–IV 15 (27.8%) 12 (23.1%) .087

significance of differences between curves. Cox regression was then Log EUROSC % 12.98 (±9.95) 8.16 (±3.64) .001
used to test the impact of different covariates on study endpoints. All EF_PRE 57 (±7.62) 56 (±7.58) .43
p values of <.05 were considered statistically significant. All statistical
LVEDD_PRE 54 (±8.5) 52 (±5.9) .164
analyses were performed using JMP® Version 13.1.0 and SAS Soft-
ware, Version 9.4 (SAS Institute Inc.). AV 6 (11.1%) 6 (±11.5) .945

AO. DISSECT. 0 (0%) 0 (0%) n.a

MARFAN 0 (0%) 0 (0%) n.a


3 | RESULTS
ABE_PRE 0 (0%) 0 (0%) n.a

3.1 | Early results REDO_pre 4 (7.4%) 4 (7.7%) .95

Abbreviations: ABE, acute bacterial endocarditis; AO, aortic; BAV,


Patients were retrospectively assigned to two groups, according to bicuspid aortic valve; BSA, body surface area; EF, ejection fraction;
LVEDD, left ventricular end‐diastolic diameter; NYHA, New York Heart
the surgical procedure. Group A had a David Reimplantation opera-
Association.
tion (n = 52; average 5 pts/year) and group B had a stentless biolo-
gical Bentall operation (n = 54; average 5.2 pts/year). Table 1
summarizes the preoperative patient details demonstrating sig- group B [p < .001]). Concomitant aortic valve repair occurred for 14
nificant differences between the two groups related to lower age at patients in group A (26.9%). Hemashield straight vascular prosthesis
surgery in group A (p < .001), higher logistic EuroSCORE in group B (Getinge) was used for all cases in group A, whereas 30 patients of
(p = .001), but the number of patents in New York Heart Association group B received a self‐assembled 3F bioconduit using a Vascutek
(NYHA) Class III–IV did not differ (p = .09) and ejection fraction was Gelweave straight vascular prosthesis (Terumo Aortic). In the two
similar between the groups (p = .43). A bicuspid aortic valve was cases requiring aortic arch replacement, a Shelhigh pericardial valve
present in 12 patients, including 6 patients of group A (11.50%) and conduit was used for the Bentall procedure and concomitant aortic
in 6 patients of group B (11.10%). A total of 8 patients had undergone arch reconstruction. CPB and ACC times were significantly longer in
a previous cardiac operation, including 4 in group A (7.70%) and 4 in group A compared to group B. Incidence of reexploration for bleeding
group B (7.40%). Intraoperative patient details and hospital discharge was not different between the two groups; overall length of stay in
data are presented in Table 2. The mean aortic graft size was sub- the intensive care unit was similar as well. Trivial to mild aortic in-
stantially different (30.5 ± 1.9 mm in group A and 27.6 ± 2.2 mm in sufficiency at discharge was reported in 7 patients of group A (13.4%)
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784 | STEFANELLI ET AL.

T A B L E 2 Intraoperative and hospital discharge patients TABLE 3 Follow‐up data


characteristics
Bentall David
Bentall David Mean/N° Mean/N°
Mean/N° Mean/N° (SD/%) (SD/%) p
(SD/%) (SD/%) p Overall deaths (actual) 12 (22.2%) 2 (3.8%) .002
ASSOC. PROC. 14 (25.9%) 8 (15.4%) .002
Cardiac deaths (actual) 5 (9.3%) 1 (1.9%) .102
CABG 7 (13%) 8 (15.4%) .720
NYHA follow‐up I–II 49 (90.7%) 49 (92.6%) 1.000
MITRAL 5 (9.09%) 0 (0%) .025
NYHA follow‐up III–IV 5 (8.3%) 4 (7.4%) .345
AORTIC ARCH 2 (3.6%) 0 (0%) .49
ΔPmed follow‐up 11.74 (±4.83) 8.13 (±1.54) <.001
AO GRAFT_SIZE 27.63 (±2.2) 30.46 (1.92) <.001
AOI (mild) follow‐up 14 (25.9%) 18 (3.8%) .003
CUSP REPAIR 0 (0%) 14 (26.9%) <.001
ABE (actual) 1 (1.85%) 1 (1.92%) .977
ECC 138 (±61) 169 (±18) <.001
SVD (actual) 4 (7.4%) 2 (3.8%) .428
AXCL 106 (±32) 139 (±15) <.001
Valve Rel. REop 2 (3.7%) 3 (5.8%) .616
ICU_LOS 34 (±24) 29 (±110) .717 (actual)

Re Expl. For 4 (7.4%) 6 (11.5%) .224 Valve RelComplic. 2 (3.6%) 0 (0%) .232
bleeding (actual)

Deep sternal 1 (1.85%) 1 (1.9%) 1.00 MACCE (actual) 10 (18.5%) 6 (11.5%) .634
infection
Note: ΔP = left‐ventricle‐aorta gradient.
PMK implant 1 (1.85%) 2 (3.8%) .06 Abbreviations: ABE, acute bacterial endocarditis; AOI, aortic insufficiency;
MACCE, major adverse cardiac and cerebrovascular events; NYHA, New
Acute renal failure 0 (0%) 1 (1.9%) .07
York Heart Association; SVD, structural valve deterioration.
HOSP death 0 (0%) 0 (0%) .161

ΔPmax DIS 18.75 (±5.71) 13.71 (±1.92) <.001

ΔPmed DIS 11.04 (±6.82) 8.45 (±1.5) .009 parameters. All death causes were carefully assessed at the best of
the possibility accessing medical records of patients when available.
AOI trivial to 4 (7.4%) 7 (13.5%) .03
The follow‐up consisted of one time point evaluation of post-
mild DIS
operative events. Follow‐up data are presented in Table 3. Sixteen
Note: ΔP = left‐ventricle‐aortic gradient.
patients died during follow‐up including 2 patients from group A
Abbreviations: AOI, aortic valve insufficiency; AXCL, aortic cross
(3.8%) and 14 patients from group B (22.2%, p = .002). In group A,
clamping; CABG, coronary artery bypass graft; Dis, discharge; ECC,
extracorporeal circulation; ICU LOS, intensive care unit length of stay; 1 patient died for noncardiac causes and another died suddenly for
PMK, pace‐maker. malignant arrhythmia a few months after operation. In group B,
1 patient died for acute myocardial infarction 10 years after the
and in 4 patients of group B (7.4%, p = .03). Permanent pacemaker operation, 1 patient died for aortic dissection 3 years after the op-
implantation was necessary for 2 patients in group A and 1 patient in eration, 1 patient with uncontrolled diabetes died a few months after
group B (p = .06). Acute renal failure necessitating of continuous the operation due to severe acute hypoglycemia, and 9 patients died
veno‐venous ultrafiltration occurred in one patient of group A and in due to noncardiac causes, mostly because of cancer or aging. Late
no patients in group B (p = .07). Mean transvalvular aortic gradient mortality related to direct cardiac causes was not statistically dif-
evaluated by echocardiography at hospital discharge was lower in ferent between the two groups (1.9% vs. 9.3%, p = .102). Overall
group A while early perioperative mortality was 0% in both groups. actuarial survival probability was 100% at 5 years and 91.8% at 11
years for David procedures versus 77.7% at 5 years and 73.8% at 11
years for stentless Bentall procedures (p = .004; Figure 2A). Freedom
3.2 | Late results from cardiac‐related mortality at 11 years was 96.7% for group A
versus 90.4% for group B (p = .116; Figure 2B).
Median follow‐up time was 7.09 years (range: 0.26–14.51 years) Cox regression analysis in such a relatively small cohort does not
corresponding to 352 patient‐years, and follow‐up was 96% com- grant solid results, however, patients undergoing the Bentall proce-
plete. No substantial difference in follow up time was present be- dure seems to be at higher risk of late overall death (p = .016). Logistic
tween the two cohorts. To gain all follow‐up data, all patients were EuroSCORE (p < .001), body surface area BSA (p = .038), and NYHA
contacted by the same researcher using a brief questionnaire and class at follow‐up (p < .001) seems to be risk factors for late cardiac
echocardiography data and clinical examinations were gathered from and noncardiac death in both groups. Age at operation (p = .015) and
the patient's cardiologist or from referring hospitals, with specific concomitant mitral valve surgery (p = .015) were risk factors for
requirements regarding a full assessment of the aortic valve overall death. Duration of CPB resulted an additional risk factor for
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STEFANELLI ET AL. | 785

FIGURE 2 Overall and cardiac death

FIGURE 3 Freedom from endocarditis and major adverse cardiac and cerebrovascular events (MACCE) at follow‐up

late cardiac mortality (p < .001). Reported adverse events were too between the groups (88.8% in group A vs. 90.6% in group B, p = .689)
few to make solid inference and plot meaningful freedom curves: (Figure 4A). Five patients underwent a reoperation during follow‐up to
ABE occurred during follow‐up in two cases, one in each group. In replace the aortic valve. Three patients in group A (5.8%) were re-
both cases the reoperation of aortic valve replacement was un- operated, 1 patient after ABE and 2 patients for SVD. Two patients in
eventful (Figure 3A). group B (3.7%) were reoperated, respectively 1 patient after ABE and 1
Freedom from MACCE at 11 years was 76.7% versus 80.1% patient for SVD. This last patient had received a Bentall procedure with
(p = .542) (Figure 3B). a Shelhigh conduit and underwent a successfull trans‐catheter aortic
Mild aortic valve insufficiency at follow‐up was diagnosed by valve implant 10 years later. Albeit with the limitations inherent to such
echocardiography for 2 patients in group A (3.80%) and 14 patients in a low rate of events, incidence of reoperation was not significantly
group B (25.9% p = .003). In group A, it was central and remained quite different between the 2 groups (p = .574) (Figure 4B). As expected,
stable over time. SVD was considered present with an echocardio- trans‐valvular mean gradient at follow‐up control was significantly lower
graphy diagnosis of mean aortic valve gradient >20 mmHg or aortic in patients receiving a David procedure compared to Bentall
insufficiency greater than moderate. Aortic insufficiency was severe for (8.13 ± 1.54 mmHg vs. 11.74 ± 4.83 mmHg, p < .001), confirming a bet-
two patients in group A and both received an aortic valve replacement. ter function of the spared native aortic valve (Figure 5).
The four patients in group B with SVD continue to be followed because Finally, overall clinical condition of patients according to NYHA
they are in good clinical condition and the aortic valve pathology still class evaluation at follow‐up did not differ significantly between the
moderate. Freedom from SVD at 11‐year follow‐up was similar two groups.
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786 | STEFANELLI ET AL.

FIGURE 4 Freedom from structural valve deterioration and valve‐related reoperation during follow‐up

FIGURE 5 Peak and mean gradients at hospital discharge and at last follow‐up (FU)

4 | DISC US SION duration resulted significant predictors of late overall and cardiac
mortality in both groups. Indeed, the overall late mortality was sig-
A stentless bio‐Bentall operation may represent, in young and active nificantly higher in the biological Bentall group, and this could be
patients who wish to avoid anticoagulation,6–9 a valid alternative to explained by the older age and worse clinical status of the patients
homograft, often difficult to supply in most cardiac units,10 and to the from this cohort. SVD and incidence of valve‐related reoperation at
Ross operation11 that requires a certain amount of surgical training long‐term follow‐up was instead similar in the two groups of patients.
and skill. Valve sparing procedures, introduced by David3 and Occurrence of MACCE and ABE during follow‐up was not sig-
4
Yacoub in the early 1990s, remain a valid alternative to Bentall in nificantly different between the two groups. Conversely, significantly
selected cases, and have proven excellent long‐term results in several better hemodynamic performance at last follow‐up was reported in
reported large series of patients.12 However, compared to Bentall, the group of patients receiving a David procedure and was well stable
aortic valve sparing surgery is more technically demanding and re- over time. While several authors have reported their results com-
sults are closely related to a correct indication. We analyzed a cohort paring aortic valve sparing operation versus the Bentall procedure
of patients affected by aortic root and ascending aorta dilatation who using composite mechanical and biological aortic grafts,13–15 only a
underwent surgical repair by David reimplantation or by biological few papers published in literature analyze the long‐term outcomes
stentless Bentall procedure. Criteria for assignment of patients to after David reimplantation versus Bentall operation performed with
either technique have been illustrated in the Methods section. We sole bioprosthetic valve conduits. Two recent publications compare
aimed to investigate possible differences at long‐term follow‐up David versus only biological Bentall operation. The first was a paper
between the patients undergoing the two surgical techniques, related from Esaki et al.16 from Emory University. They reported a 7‐year
to overall and cardiac mortality rate, incidence of MACCE, ABE, SVD, retrospective review by propensity score matching analysis based on
and valve‐related reoperation, and finally to compare hemodynamic 20 preoperative characteristics resulting in 123 pairs out of 282 and
performance over time. It is not surprising that age at operation, 425 patients undergoing David or biological Bentall operation, re-
logistic EuroSCORE, and patient BSA, as well as NYHA class and CPB spectively. Not different from our experience, they concluded that
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STEFANELLI ET AL. | 787

both procedures resulted in similar early and late mortality and CONFLIC T OF INTERESTS
morbidity, without a difference in valve durability. In another retro- The authors declare no conflict of interest.
17
spective, propensity score‐matched study Gaudino et al. analyzed
the results of 749 consecutive patients from two institutions un- ORC I D
dergoing either biological Bentall or aortic reimplantation for aneur- Guglielmo Stefanelli http://orcid.org/0000-0002-7789-0967
ysmal dilatation of the aortic root associated to aortic valve Luca Weltert http://orcid.org/0000-0001-6094-8280
pathology at a mean follow‐up of 28 months. They concluded that
both surgical techniques provide excellent results. In our series, pa-
RE F ER EN CES
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