Interactive CardioVascular and Thoracic Surgery Advance Access published January 19, 2016

Interactive CardioVascular and Thoracic Surgery (2016) 1–6 ORIGINAL ARTICLE – ADULT CARDIAC
doi:10.1093/icvts/ivv388

Cite this article as: Hegazy YY, Rayan A, Sodian R, Hassanein W, Ennker J. Medtronic Freestyle aortic bioprosthesis: a potential option for haemodialysis patients.
Interact CardioVasc Thorac Surg 2016; doi:10.1093/icvts/ivv388.

ORIGINAL ARTICLE
Medtronic Freestyle aortic bioprosthesis: a potential option
for haemodialysis patients†
Yasser Y. Hegazya,b,*, Amr Rayana,b, Ralf Sodiana, Wael Hassaneinb and Jürgen Ennkera,c
a
Department of Cardiac Surgery, Heart Institute Lahr, Lahr, Germany
b
Department of Cardio-Thoracic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt
c
School of Medicine, Faculty of Health, University of Witten Herdecke, Witten, Germany

* Corresponding author. Heart Institute Lahr/Baden, Hohbergweg 2, 77933 Lahr, Germany. Tel: +49-7821-9251019; fax: +49-7821-925391000;
e-mail: yasserhegazy@yahoo.com (Y.Y. Hegazy).

Received 6 September 2015; received in revised form 5 December 2015; accepted 11 December 2015

Abstract
OBJECTIVES: End-stage renal disease patients on regular haemodialysis are at higher risk of calcification. Therefore, many surgeons have
concerns regarding the implantation of bioprostheses in such patients. The haemodynamic advantages of stentless aortic bioprostheses
support their use; however, these have not been studied yet in end-stage renal disease patients. We studied accordingly the early and
mid-term outcomes of aortic valve replacement (AVR) using Medtronic Freestyle stentless aortic bioprostheses in this subset of patients in
comparison with stented aortic bioprostheses.
METHODS: We retrospectively studied two groups of consecutive patients on regular haemodialysis who required AVR between 2007 and
2013. Non-Freestyle (NFS) group received stented aortic bioprostheses (36 patients) and Freestyle (FS) group received Medtronic Freestyle
aortic bioprostheses (48 patients). Follow-up ranged from 2 to 76 months with a mean follow-up of 36.3 ± 25 months.
RESULTS: Patients in both groups showed similar demographic characters regarding age (76.4 ± 8.1 vs 74.9 ± 7.2 years; P = 0.35), male
gender (58 vs 60%; P = 0.57) and diabetes mellitus (42 vs 48%; P = 0.57). Smaller aortic bioprostheses were implanted in the NFS (23.3 ± 1.2
vs 25.4 ± 2.1; P < 0.001) with consequently higher postoperative mean gradients (14.1 ± 4.1 vs 11.9 ± 5.3 mmHg; P = 0.004). No significant
differences were noted regarding postoperative neurological disorder (8 vs 12%; P = 0.73), deep sternal wound infection (3 vs 4%; P = 0.68),
re-exploration (8 vs 8%; P = 0.91) and in-hospital mortality (6 vs 4%; P = 0.92). Mid-term follow-up showed higher prosthetic valve calcifica-
tion and/or sclerosis in NFS group (25 vs 6%; P = 0.015), whereas no significant differences were noticed between the two groups regarding
stroke (0 vs 8%; P = 0.13), endocarditis (0 vs 4%; P = 0.50), 36- and 72-month survival (51 ± 2%, 14 ± 4% vs 55 ± 2%, 19 ± 3%, respectively;
P = 0.45).
CONCLUSIONS: Aortic bioprostheses are a good option for haemodialysis patients requiring AVR, offering acceptable mid-term survival.
The Medtronic Freestyle aortic bioprostheses could allow the implantation of larger bioprostheses inferring consequently lower mean
gradients, with a potentially higher resistance to calcification and sclerosis in haemodialysis patients.
Keywords: Aortic bioprosthesis • Freestyle • Haemodialysis • Calcification

INTRODUCTION The best aortic prosthesis for haemodialysis patients requiring

End-stage renal disease is one of the health hazards, associated
with debilitating comorbidities and reduced survival. Patients on
haemodialysis are at higher risk of the development of cardiovascu-
lar diseases, especially calcified degeneration of the aortic valves [1].
With the ageing process of the population, it is expected that the
prevalence of end-stage renal disease and its associated cardiovas-
cular disease would continue to increase [2], and accordingly more
patients on haemodialysis would require aortic valve replacement
(AVR).
†
Presented at the 29th Annual Meeting of the European Association for Cardio-
Thoracic Surgery, Amsterdam, Netherlands, 3–7 October 2015.
AVR has been debated over the last two decades. Reports of early
calcific degeneration of aortic bioprostheses discouraged their use
in haemodialysis patients [3]. Consequently, the guidelines of the
American College of Cardiology/American Heart Association (ACC/
AHA) from 1998 recommended the use of mechanical valves in
those patients [4]. This changed gradually over time through larger
studies that showed the increased risk of bleeding associated with
oral anticoagulation therapy after mechanical AVR [5].
Moreover, the limited survival of haemodialysis patients after
AVR, apart from the type of valve implanted, supported the use of
aortic bioprostheses in those patients [6–7]. Therefore, the recom-
mendation to use mechanical valves in haemodialysis patients was
removed in the following AHA/ACC guidelines in 2006 [8]. Later in

© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
2 Y.Y. Hegazy et al. / Interactive CardioVascular and Thoracic Surgery

2012, the guidelines of the joint task force of the European
Society of Cardiology (ESC) and the European Association for
Cardio-Thoracic Surgery (EACTS) made a IIa recommendation to
use bioprostheses in end-stage renal disease patients [9].
However, stentless aortic bioprostheses were not adequately
studied in haemodialysis patients. Therefore, we studied the short-
and mid-term results after AVR using either stented or Medtronic
Freestyle (FS) aortic bioprosthesis (Medtronic, Inc., Minneapolis,
MN, USA) in end-stage renal disease patients undergoing regular
haemodialysis.
MATERIALS AND METHODS
We included all consecutive patients subjected to AVR at Heart
Institute Lahr/Baden from January 2007 till December 2013, with
the preoperative diagnosis of end-stage renal disease undergoing
regular haemodialysis. Two groups of patients were studied: Non-
Freestyle (NFS) group with 36 patients who received stented aortic
bioprostheses; FS group with 48 patients who received stentless
Medtronic Freestyle aortic bioprostheses.
Cardiac catheterization was performed in all patients over the
age of 40 or in younger patients with high risk for coronary artery
disease. All the patients were operated electively and were sub-
jected to haemodialysis the day prior to surgery. We consulted the
nephrologists of our patients to plan the postoperative therapy,
electrolyte management and the settings of haemodialysis.
Data collection
Patient demographics, risk factors, surgical information and post-
operative outcome data were collected from our records. Data
collection and valve-related complications and deaths followed
the ‘Guidelines for Reporting Mortality and Morbidity after
Cardiac Valve Interventions’ [11].
Follow-up data were collected through written questionnaires
sent to the patients and their treating physicians. Missing data
were completed through telephone calls. The aim of those ques-
tionnaires was to control if the patients were still alive, on regular
haemodialysis during the whole period of the study, if they
experienced cerebrovascular stroke, reoperation, the cause of reo-
peration and the cause and date of death for non-survivals.
Additionally, the treating physicians were asked about the incidence
of prosthetic valve thrombo-embolism, significant paravalvular leak
or insufficiency (moderate to severe), endocarditis and the presence
of calcification or sclerosis of the aortic bioprostheses. These data
were derived from the last transthoracic echocardiography per-
formed by the treating cardiologists. Follow-up period was mea-
sured in full months for each patient beginning from the date of the
surgery till the end of December 2014 for survivals or till the date of
death for patients who died during the follow-up period. It ranged
from 2 to 76 months with a mean follow-up of 36.3 ± 25 months.
The completeness of follow-up was 100% as of December 2014.
Statistical analysis

Surgical management Quantitative data were expressed as mean ± standard deviations

and compared using Student’s t-test and the Mann–Whitney
All the patients have been operated upon through a standard U-test. Qualitative data were described using numbers and per-
median sternotomy, with arterial cannulation of the ascending centages and compared using χ 2 test or Fisher’s exact test.
aorta. Two-stage venous cannulation of the right atrium was the Statistical significance was considered whenever P-values were
technique of choice, unless other valves have been operated sim- ≤0.05. Overall survival was defined as the time from surgery to
ultaneously, where we used separate cannulation of the superior death as a result of any cause. Survival curves were generated
and inferior vena cava. using Kaplan–Meier plots and compared using a log-rank test
Typically, conventional normothermia CPB was performed (Fig. 1). The statistical analysis was done with the SPSS 16 software
utilizing roller head pumps, membrane oxygenators, cardiotomy (SPSS, Inc., Chicago, IL, USA).
suction, arterial filters, cold antegrade and retrograde blood
cardioplegia. The decision to implant a stented or a stentless valve
was taken according to the surgeon preference without objective
criteria.
Two types of stented aortic bioprostheses have been implanted:
Hancock II aortic bioprostheses (Medtronic, Inc.) or Epic aortic
bioprostheses (St Jude Medical, Inc., St Paul, MN, USA). The
stented aortic bioprostheses have been implanted using inter-
rupted horizontal mattress sutures in the supra-annular position.
The FS bioprostheses have been implanted using the subcoronary
technique except for 2 patients, who received a total root replace-
ment. The subcoronary technique implies two lines of fixation: the
proximal line at the level of the deepest point of every aortic sinus
(nadir), the distal line beginning at the highest point of each com-
missure and going down under the coronary ostia. The total root
technique has been described before in our work [10].
Near the discontinuation of CPB, a zero-balance ultrafiltration
was initiated for all patients. The operative field was routinely
flooded with carbon dioxide and removal of air manoeuvres was
performed in all cases prior to releasing the cross-clamp.
Haemodialysis resumed on the first postoperative day, and
was repeated according to the recommendations of the treating Figure 1: Kaplan–Meier survival curve for overall survival in the two studied
nephrologists. groups.
 Y.Y. Hegazy et al. / Interactive CardioVascular and Thoracic Surgery 3

RESULTS patients in FS group had more incidence of trivial to mild aortic

insufficiency (0% in the NFS group vs 17% in the FS group;
There were no significant differences between the two studied P = 0.009) (Table 3).

ORIGINAL ARTICLE
groups regarding the preoperative patient characteristics (Table 1). Follow-up ranged from 2 to 76 months with a mean follow-up
Isolated AVR was performed in 39% in the NFS group and in 48% of 36.3 ± 25 months. No significant differences were noted
in the FS group. Other concomitant procedures are listed (Table 2). between the two groups regarding 36- and 72-month survival
Early outcomes showed that patients in the NFS group received (51 ± 2%, 14 ± 4% vs 55 ± 2%, 19 ± 3% respectively; P = 0.45) (Fig. 1).
significantly smaller aortic bioprostheses (23.3 ± 1.2 vs 25.4 ± 2.1; No cases of valvular thrombo-embolism or significant (moderate
P < 0.001), and had accordingly higher mean gradients across their to severe) prosthetic valve insufficiency or paravalvular leak were
valves (14.1 ± 4.1 vs 11.9 ± 5.3 mmHg; P = 0.004). The other post- noted in both groups.
operative early outcomes were similar in both groups; however, However, more prosthetic valve calcification and/or sclerosis
were noticed in the NFS group (25 vs 6%; P = 0.015) (Table 4). One
patient from the FS group required reoperation due to Staphylococcus
aureus endocarditis, which occurred 2 years postoperatively. The
Table 1: Patient characteristics
infected FS bioprosthesis was replaced with a new one with the
same size after removal of all the infected material.
Non-Freestyle Freestyle P-value During the follow-up period, 22 patients (61%) died in the NFS
(n = 36) (n = 48)
group; 7 patients died from cardiac causes (4 from heart failure, 2
Males 21 (58%) 29 (60%) 0.57 from myocardial infarction and 1 from arrhythmia), 5 from sepsis,
Age (years) 76.4 ± 8.1 74.9 ± 7.2 0.35 5 from malignancies, 3 from respiratory insufficiency, 1 from liver
BMI (kg/m2) 27.2 ± 4.8 25.9 ± 5 0.23 failure and 1 from unknown cause. In the FS group, a total of 27
PHT 2 (6%) 4 (8%) 0.70 patients (56%) died during the follow-up period; 8 from cardiac
NYHA class
I 2 (6%) 2 (4%) 0.51 causes (3 from heart failure, 3 from myocardial infarction and 2
II 16 (44%) 20 (42%) from arrhythmia), 5 from sepsis, 5 from respiratory insufficiency, 5
III 17 (47%) 23 (48%) from malignancies, 1 from endocarditis, 1 from liver failure and 1
IV 1 (3%) 3 (6%) from gastrointestinal bleeding.
Hypertension 32 (89%) 36 (82%) 0.15
Hyperlipidaemia 22 (61%) 21 (44%) 0.12
Smoking 9 (25%) 7 (15%) 0.23
Diabetes 15 (42%) 23 (48%) 0.57 DISCUSSION
Cancer 0 (0%) 2 (4%) 0.50
PVD 9 (25%) 7 (15%) 0.23
End-stage renal disease patients on regular haemodialysis are at
COPD 5 (14%) 1 (2%) 0.08
Aortic annular 24.6 ± 1.6 24.9 ± 2.1 0.37 great risk of calcification. The high uremic burden, secondary
diameter (mm) hyperparathyroidism and the associated disturbances in calcium
Indication for AVR and phosphate metabolism may be responsible for this calcifica-
Aortic stenosis 32 (89%) 38 (79%) 0.10 tion, especially of the cardiac valves [12].
Aortic insufficiency 3 (8%) 6 (12%) 0.73
Aortic endocarditis 0 (0%) 4 (8%) 0.13
The rate of progression of native aortic valve stenosis is more
rapid in haemodialysis patients in comparison with non-dialysis
AVR: aortic valve replacement; BMI: body mass index; COPD: chronic
patients, with a mean annual reduction of the aortic valve
obstructive pulmonary disease; NYHA: Classification of the New York opening area of 0.14–0.19 cm2/year in haemodialysis patients vs
Heart Association; PHT: pulmonary hypertension; PVD: peripheral 0.06–0.07 cm2/year in non-dialysis patients [13].
vascular disease. These changes affect the implanted aortic bioprostheses after
AVR as well; nevertheless, the actual recommendations of the
EACTS and ESC of 2012 recommend the use of aortic bioprosth-
eses in haemodialysis patients as described before, as the durabil-
ity of the aortic bioprostheses exceeds the life expectancy of the
Table 2: Operative data
haemodialysis patients [9]. However, with advances in medical
service, the survival of end-stage renal disease patients improved
Non-Freestyle (n = 36) Freestyle (n = 48) P-value over decades [14]. Thus, a more durable bioprosthesis would be
CCT (min) 90.4 ± 31 94.2 ± 25 0.84
required. Therefore, we hypothesized that the FS aortic bioprosth-
ECCT (min) 129 ± 35 137 ± 40 0.22 esis (Medtronic, Inc.) with its characters, especially the anticalcifi-
Valve size 23.3 ± 1.2 25.4 ± 2.1 <0.001* cation treatment, could be a better option for end-stage renal
Isolated AVR 14 (39%) 23 (48) 0.49 disease patients on haemodialysis.
Concomitant procedures
This bioprosthesis is a stentless porcine aortic root with ligated
CABG 15 (42%) 23 (48%) 0.57
MVR/R 4 (11%) 4 (8%) 0.64 coronary arteries, prepared using a zero-pressure fixation process,
TVR 2 (6%) 2 (4%) 0.82 and treated with the anticalcification agent, alpha amino oleic
AAR 0 (0%) 2 (4%) 0.50 acid, which was shown to mitigate aortic cusp calcification in
animal models [15].
AAR: ascending aorta replacement; AVR: aortic valve replacement; The bioprosthesis can be implanted using sub-coronary, total
CABG: coronary artery bypass grafting; CCT: cross-clamp time; ECCT: aortic root or root inclusion techniques. It showed excellent
extracorporeal circulation time; MVR/R: mitral valve repair/
replacement; TVR: tricuspid valve repair.
haemodynamic [16] and long-term durability, with a 15-year
*Statistical significance. freedom from reoperation due to structural valve deterioration
ranging from 83 to 88% [17, 18].
4 Y.Y. Hegazy et al. / Interactive CardioVascular and Thoracic Surgery

Table 3: Early outcomes

Non-Freestyle (n = 36) Freestyle (n = 48) P-value

Atrial fibrillation 15 (42%) 18 (38%) 0.76

Re-exploration 3 (8%) 4 (8%) 0.91
Mean gradient (mmHg) 14.1 ± 4.1 11.9 ± 5.3 0.004*
Paravalvular leak (≤mild) 0 (0%) 2 (4%) 0.50
Insufficiency (≤mild) 0 (0%) 8 (17%) 0.009*
Pacemaker implantation 1 (2%) 2 (4%) 0.68
DSWI 1 (3%) 2 (4%) 0.68
Neurological disorder 3 (8%) 6 (12%) 0.73
Pneumonia 2 (6%) 3 (6%) 0.84
In-hospital mortality 2 (6%) 2 (4%) 0.92

DSWI: deep sternal wound infection.

*Statistical significance.

which might be attributed to deviations during positioning of the

Table 4: Late outcomes
Non-Freestyle Freestyle
(n = 36) (n = 48)
Leaflet calcification or 9 (25%) 3 (6%)
sclerosis
Stroke 0 (0%) 4 (8%)
Endocarditis 0 (0%) 2 (4%)
Reoperation 0 (0%) 1 (2%)
Mortality 22 (61%) 27 (56%)
*Statistical significance.
One of the well-known advantages of FS is that it allows the im-
plantation of larger prostheses, which would be translated in
terms of lower gradients across the valve and better left ventricular
mass regression [19]. We noted similarly in our study the implant-
ation of larger bioprostheses and the lower postoperative gradi-
ents in the FS group, which can be attributed to the absence of
the stent with its sewing cuff, providing a larger opening area.
El-Hamamsy et al. randomized 166 patients with a mean age of
66 years to receive either cryopreserved aortic homograft or FS
aortic bioprostheses. They measured the Agatston calcium score
using electron beam computed tomography every 0.5, 1, 1.5, 2, 3
and 8 years and evaluated the regular echocardiography findings.
They demonstrated significantly lower calcification in the FS bio-
prostheses, especially in the first 3 years. This result was supported
with 100% freedom from reoperation after 8 years in the FS group
against 93% in the homograft group (P = 0.01) [20].
These findings correlate with our work, where we noted a sig-
nificantly lower rate of calcification and/or sclerosis in the FS
group in comparison with the NFS group (6 vs 25%; P = 0.015).
This can be referred to the anticalcification treatment, the fixation
process, the design of the valve or all of these factors together.
Interestingly, the long-term follow-up of the FS aortic bioprosth-
eses showed that, after up to 15 years, the most common cause of
failure is leaflet tear, and not calcification [17, 19]. Therefore, we
suggest that the anticalcification technique of the FS aortic bio-
prostheses might be effective concerning the calcification, espe-
cially in haemodialysis patients with their high risk of calcification.
On the other hand, patients receiving FS bioprostheses might
show more incidence of trivial to mild prosthetic valve insufficiency,
FS bioprosthesis in the aortic root, especially the commissures.
This finding was noted in our study, where we recorded even
P-value cases with trivial insufficiency, which seems to be clinically insig-
nificant as it was associated with neither progression nor the need
for reoperation in our cohort. Similarly, studies with longer follow-
0.015* up periods showed no significant progression to moderate or
0.13
severe prosthetic aortic insufficiency after the implantation of FS
0.50 bioprostheses over a period of 15 years, unless one of the leaflets
0.72 was torn causing severe acute aortic insufficiency, and indicating
0.66 consequently a reoperation [17].
Survival of end-stage renal disease patients on haemodialysis is
limited, and differs according to the country, quality of medical
service, cause of end-stage renal disease, age of the patient and
other associated medical conditions. For example, the estimated
5-year survival of patients on regular haemodialysis is 35% in the
USA, whereas it reaches 54–60% in Japan [14, 21]. In Europe, the
5-year survival for all haemodialysis patients is 59.7% which falls to
39.3% in patients of 65–74 years and 21.3% in patients of ≥75
years [22].
Most of the studies addressing haemodialysis patients who
received AVR showed their limited survival apart from the valve
implanted. Herzog et al. studied the data of 5858 patients on
haemodialysis who received AVR from the US Renal Data System.
They reported a 5-year survival of only 14.8% [6]. This low survival
rate can be explained by the fact that they studied patients over 2
decades (from 1978 to 1998), during which a great improvement
in the quality and availability of medical services has been
achieved leading to improvement of the survival. Later studies
reported better 5-year survival, improving with time and ranging
from 31 to 49% [23, 24].
Thourani et al. reported a longer follow-up, with a 10-year
adjusted survival of 18.1% regardless the type of the valve
implanted. However, the mean age in their cohort was 58.4 years,
which allowed the relatively longer follow-up and the better sur-
vival [25].
Patients in our study showed acceptable survival. Although the
mean age of the patients in our study was 74.8–76.4 years;
however, the 36-month survival ranged from 51 to 55%, whereas
the 72-month survival ranged from 14 to 19% in both studied
groups. This acceptable survival in relation to the advanced mean
age of the patients reflects the improvement of the quality of the
medical services in Germany in the last few years, which applies to
many developed countries.
 Y.Y. Hegazy et al. / Interactive CardioVascular and Thoracic Surgery
The Freestyle bioprosthesis offers the general advantages of
aortic bioprostheses, especially avoiding the need for life-long oral
anticoagulation with the associated risk of bleeding. However, with
its possible resistance to calcification, it might be of benefit for
younger patients on regular haemodialysis, who have a relatively
longer life expectancy, thus needing more durable prostheses.
CONCLUSIONS
This study shows that aortic bioprostheses are a good option for
haemodialysis patients requiring AVR as they offer acceptable
mid-term survival. On the other hand, the FS bioprostheses could
allow the implantation of larger bioprostheses with consequently
lower mean postoperative gradients. In addition, they seem to be
more resistant to calcification and sclerosis than stented bio-
prostheses in haemodialysis patients with their high risk of calcifi-
cation. On the basis of these data, we suggest that the Medtronic
Freestyle aortic bioprostheses could be a potential option for
haemodialysis patients.
Study limitations
This study is associated with the same limitations inherent to any
retrospective observational study. We observed only two types of
stented bioprostheses; therefore, we are not able to generalize the
findings on the other non-studied types. The inability to identify
the main cause of end-stage renal disease with its influence on
survival is another limitation to our study. Additionally, we were
not able to quantify the degree of sclerosis or calcification or to
identify the timing of this finding in our patients. Despite calcifica-
tion of the bioprostheses was not the main target of our study,
nevertheless, our data show that the FS aortic bioprostheses might
be more resistant to calcification and sclerosis. Further studies are
recommended to address this issue.
Conflict of interest: none declared.
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APPENDIX. CONFERENCE DISCUSSION
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Dr A. Kaya (Amsterdam, Netherlands): From your manuscript we could read
that the only significant difference between the groups was actually the size of
the substitutes that you used, 25 versus 23, with consequently a higher post-
operative gradient for the non-Freestyle group. And you also conclude in your
results section, you say that the non-Freestyle group showed a higher prosthetic
valve calcification.
6 Y.Y. Hegazy et al. / Interactive CardioVascular and Thoracic Surgery
So that’s my first question: How do you define higher calcification? How did
you measure it? Because you mentioned other reports of El-Hamamsy with
electron beam CT. Did you also do that kind of research, or is it only based on
echocardiography? So is your definition of calcification, higher, moderate or
low?
Dr Hegazy: It’s a very good point, and I would come to it if you didn’t ask
about it. First of all, it’s a retrospective study with its limitations. We stated also
in our manuscript that the quantification of calcification and sclerosis was one
of our limitations. These data were collected from our cardiologists. We didn’t
examine the patients ourselves in our centre. We get patients from a circle of
400 km, that’s why most of the patients would be followed through their own
cardiologist. We just sent this questionnaire to the patients regarding their clin-
ical state and to their cardiologist to collect their clinical data. Also, we con-
tacted the cardiologists directly when it was not clear enough about any topic.
Every patient has one cardiologist, so we have around 80 cardiologists that’s
why the quantification cannot be totally accurate 100%. It’s a limitation. We just
stated that it seems to be, it could be, which needs to be verified with further
studies to confirm the accuracy of this finding.
Dr Kaya: But you didn’t have a protocol where you defined the way of
grading the calcification which is sent to the cardiologists?
Dr Hegazy: Unfortunately, this is true. Therefore we don’t want to focus on
this point as the main finding in our work, it’s only an indication which was sup-
ported in the literature with similar studies and needs to be controlled with
more accurate parameters.
Dr Kaya: Another point which was not clear from your manuscript is the
Freestyle group. How did you implant it? Was it a full root replacement? Was it
a sub-coronary implantation technique?
Dr Hegazy: It’s in the manuscript. We studied 48 patients in the Freestyle
group; the sub-coronary technique was used in 46 patients, while the total root
technique was used in 2 patients.
Dr Kaya: Did you see any clamp time difference between the stented and
the non-stented groups?
Dr Hegazy: We have a good experience with Freestyle valve. We have
implanted more than 4000 Freestyle valves in the last 20 years, in our centre in
Heart Institute, Lahr. Consequently, the cross-clamp time does not differ mark-
edly. For the beginners, we need 10 to 20 minutes more for the Freestyle valve;
but the experienced surgeons can implant both of them in the same time.
Dr Kaya: You have experience with the Freestyle stent less valve as you
described, but would you also consider another stent less valve, like the
Freedom SOLO valve, which maybe doesn’t need more clamp time?
Dr Hegazy: Maybe, but we don’t have experience with Freedom SOLO. We
used only the Freestyle valve. That’s why it’s open for other investigations about
this topic.
Dr L. Abouzahr (Sidon, Lebanon): Did you look at the age amongst those
patients, the younger patients, how quickly they calcified versus the older
patients and with respect to the two valve options? That’s one.
Second, what was the non-Freestyle, I don’t know if I missed that in your talk,
was it all treated the same way for anti-calcification as the Freestyle is treated?
Dr Hegazy: The non-Freestyle were Hancock II from Medtronic and Epic
from St. Jude. That’s the second question. And regarding the first question, the
number of patients is small. We don’t have many patients with haemodialysis
who need aortic valve replacement. Therefore it is not feasible to make sub-
groups from this small group of patients.
However, this is a very good point, because I think that the Freestyle valve
has a potential for younger patients who don’t want to get oral anticoagulation
with the risks of bleeding and at the same time they want to get a bio prosthesis
which has the potential to last for a longer time. We don’t say that Freestyle is
the best for those patients, it’s only our data with some clues which are avail-
able with us, we wanted to drive the attention to this point to be reconsidered
and re-evaluated in the future.