139
ORIGINAL SCIENTIFIC ARTICLE
Results of transcatheter aortic valve implantation (TAVI) in MC Medicor
1 International center for 
cardiovascular diseases MC 
Medicor, Izola, Slovenia
2 Department of Intensive 
Internal Medicine, Division 
of Internal Medicine, 
University Medical Centre 
Ljubljana, Ljubljana, 
Slovenia
Correspondence/
Korespondenca:
Marko Noč, e: marko.noc@
mf.uni-lj.si
Key words:
aortic stenosis; 
transcatheter aortic valve 
implantation; results
Ključne besede:
aortna stenoza; katetrska 
vstavitev aortne zaklopke; 
rezultati
Received: 20. 8. 2020
Accepted: 13. 11. 2020
eng slo element
en article-lang
10.6016/ZdravVestn.3150 doi
20.8.2020 date-received
13.11.2020 date-accepted
Cardiovascular system Srce in obtočila discipline
Original scientific article Izvirni znanstveni članek article-type
Results of transcatheter aortic valve implan-
tation (TAVI) in the international centre for 
cardiovascular diseases MC Medicor
Rezultati katetrskega vstavljanja aortne zaklopke 
(TAVI) v mednarodnem kardiovaskularnem centru 
MC Medicor
article-title
Results of transcatheter aortic valve implanta-
tion (TAVI) in MC Medicor
Rezultati katetrskega vstavljanja aortne zaklopke 
(TAVI) v MC Medicor
alt-title
aortic stenosis, transcatheter aortic valve 
implantation, results
aortna stenoza, kateterska vstavitev aortne zak-
lopke, rezultati
kwd-group
The authors declare that there are no conflicts 
of interest present.
Avtorji so izjavili, da ne obstajajo nobeni 
konkurenčni interesi. conflict
year volume first month last month first page last page
2021 90 3 4 139 149
name surname aff email
Marko Noč 1,2 marko.noc@mf.uni-lj.si
name surname aff
Aleš Pleskovič 1
Maja Rojko 1
Nataša Černič Šuligoj 1
Branko Cvetičanin 1
Matjaž Špan 1
Danijel Petrovič 1
Nenad Danojević 1
Miladin Đorđević 1
Metka Zorc 1
eng slo aff-id
International center for 
cardiovascular diseases MC 
Medicor, Izola, Slovenia
Mednarodni kardiovaskularni 
center MC Medicor, Izola, 
Slovenija
1
Department of Intensive 
Internal Medicine, Division of 
Internal Medicine, University 
Medical Centre Ljubljana, 
Ljubljana, Slovenia
Klinični oddelek za intenzivno 
interno medicino, Univerzitetni 
klinični center Ljubljana, 
Ljubljana, Slovenija
2
Results of transcatheter aortic valve 
implantation (TAVI) in the international 
centre for cardiovascular diseases MC 
Medicor
Rezultati katetrskega vstavljanja aortne zaklopke (TAVI) v 
mednarodnem kardiovaskularnem centru MC Medicor
Aleš Pleskovič,1 Maja Rojko,1 Nataša Černič Šuligoj,1 Branko Cvetičanin,1 Matjaž Špan,1 
Danijel Petrovič,1 Nenad Danojević,1 Miladin Đorđević,1 Metka Zorc,1 Marko Noč1,2
Abstract
Background: Transcatheter aortic valve implantation (TAVI) has become a standard of care for 
the treatment of symptomatic aortic stenosis in the elderly. The aim of the present study is to 
describe initial results in the international cardiovascular centre MC Medicor and compare them 
with the results of the recently published pivotal international trials.
Methods: A retrospective analysis of consecutive patients undergoing TAVI was performed. The 
data were obtained from a prospective Medicor registry of percutaneous cardiovascular inter-
ventions.
Results: Between 12 December 2016 and 6 June 2020, a total of 109 TAVI were performed. The 
patients were on average 81 years old and had EuroScore II of 3.95. Mean aortic valve gradient by 
echocardiography was 46 mmHg and aortic valve area 0.8 cm2. Percutaneous femoral approach 
was used in all but one patient. Balloon predilatation was performed in 36.7%. TAVI valve was 
successfully implanted in 98.2% and balloon postdilatation was performed in 15.6%. Mean post 
TAVI gradient was 9 mmHg. Moderate aortic regurgitation was recorded in 3.7% and severe in 
none of the patients. New permanent pacemaker was required in 22.9% (95% confidence interval 
(CI) 15.4% - 32.0%). One patient had a transient ischemic attack. Emergency pericardiocentesis 
was performed in 2.7% (95%, CI 0.6% - 7.8%), open-heart surgery in 1.8% (95%, CI 0.2% - 6.5%), 
vascular surgery in 0.9% (95%, CI 0.0% - 5.0%) and additional haemostasis of the ileofemoral 
artery with covered stents in 1.8% (95%, CI 0.2% - 6.5%) In-hospital and 30-day mortality rates 
were 1.8% (95%, CI 0.2% -6.6%), 1-year mortality 3.1% (95%, CI 0.0% - 6.5%), 2-year mortality 
5.6% (95%, CI 0.0% - 11.4%) and 3-year mortality 14.2% (95%, CI 0.0% - 29.6%).
Conclusion: Initial TAVI results in MC Medicor are good and comparable with the results of re-
cently published international pivotal trials.
Izvleček
Izhodišče: Katetrska vstavitev aortne zaklopke (TAVI) je v zadnjih letih postala prevladujoča me-
toda za zdravljenje degenerativne aortne stenoze pri starejših bolnikih. Prispevek prikazuje prve 
rezultate zdravljenja s TAVI v mednarodnem kardiovaskularnem centru MC Medicor in jih primer-
ja z najpomembnejšimi mednarodnimi raziskavami zadnjih let.
Slovenian
Medical
Journal
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CARDIOVASCULAR SYSTEM
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1 Introduction
Transcatheter aortic valve implanta-
tion (TAVI) has in recent years become 
the method of choice for the treatment of 
degenerative aortic stenosis in the elderly, 
regardless of the risk of open heart surgery 
(1-3). Treatment with TAVI, which is less 
invasive and enables rapid rehabilitation 
for patients, is at least as effective or even 
more effective than standard aortic valve 
replacement surgery. With technological 
advancements in valve manufacturing, 
with ever smaller diameters of catheter in-
troducers and with greater provider expe-
rience, complications become less frequent 
and the medium and long-term valve 
function is the same or even better than 
with surgically inserted biological valves. 
The goal of our study was to present the 
first results of TAVI in the international 
Metode: V retrospektivno raziskavo smo vključili zaporedno serijo bolnikov, pri katerih smo 
opravili TAVI. Podatke smo pridobili iz lastnega registra perkutanih kardioloških posegov.
Rezulati: Med 12. decembrom 2016 in 6. junijem 2020 smo TAVI opravili pri 109 bolnikih s pov-
prečno starostjo 81 let in EuroScore II 3,95. Srednji ultrazvočni gradient na aortni zaklopki je 
znašal 46 mm Hg, izračunana površina ustja pa 0,8 cm2. Pri vseh bolnikih, razen pri enem, smo 
uporabili perkutani pristop preko femoralne arterije. Balonsko predilatacijo smo izvedli v 36,7 %, 
novo zaklopko vsadili v 98,2 % in jo balonsko postdilatirali v 15,6 %. Srednji ultrazvočni gradient 
po TAVI je znašal 9 mm Hg. Zmerna aortna regurgitacija je bila prisotna v 3,7 % (95 % IZ 1,0–9,1 
%), huda pa pri nobenem od bolnikov. Nov srčni spodbujevalec je potrebovalo 22,9 % bolnikov 
(95 % IZ 15,4–32,0 %). En bolnik je imel tranzitorno ishemično kap. Urgentno perikardiocentezo 
smo opravili v 2,7 % (95 % IZ 0,6–7,8 %), srčno operacijo v 1,8 % (95 % IZ 0,2–6,5 %), žilno ope-
racijo v 0,9 % (95 % IZ 0,0–5,0 %) in hemostazo s prekritimi žilnimi opornicami v 1,8 % (95 % IZ 
0,2–6,5 %). Bolnišnična in 30-dnevna umrljivost sta bili 1,8 % (95 % IZ 0,2–6,5 %), enoletna 3,1 % 
(95 % IZ 0,0–6,5 %), dvoletna 5,6 % (95 % IZ 0,0–11,4 %) in triletna 14,2 % (95 % IZ 0,0–29,6 %).
Zaključek: Začetni rezultati TAVI v Medicorju so ugodni in primerljivi z najpomembnejšimi med-
narodnimimi raziskavami zadnjih let.
Cite as/Citirajte kot: Pleskovič A, Rojko M, Černič Šuligoj N, Cvetičanin B, Špan M, Noč M, et al. Results of 
transcatheter aortic valve implantation (TAVI) in the international centre for cardiovascular diseases MC 
Medicor. Zdrav Vestn. 2021;90(3–4):139–49.
DOI: https://doi.org/10.6016/ZdravVestn.3150
Copyright (c) 2021 Slovenian Medical Journal. This work is licensed under a
Creative Commons Attribution-NonCommercial 4.0 International License.
cardiovascular centre MC Medicor and 
compare them to recently published piv-
otal international studies.
2 Patients and methods
We performed a retrospective descrip-
tive study, which included consecutive 
patients in whom we performed TAVI 
in Medicor. We obtained the data from 
our own register of percutaneous cardiac 
procedures, which was approved by the 
National Medical Ethics Committee on 
December 7, 2012. The register provides 
the patient with anonymity, and the ob-
tained data are used for real-time analysis 
of results, improvement of the quality of 
work and as a source for our own research, 
which is published in both domestic (4-7) 
141
ORIGINAL SCIENTIFIC ARTICLE
Results of transcatheter aortic valve implantation (TAVI) in MC Medicor
and international literature (8-9). All pa-
tients received a comprehensive explana-
tion, after which they signed a consent 
form for their data to be entered into the 
register.
We performed a clinical exam, trans-
thoracic cardiac ultrasound, coronarogra-
phy and a CT angiography using a TAVI 
protocol (CTA-TAVI) in all TAVI can-
didates in the planning phase; the latter 
was additionally analyzed by a specialist 
of each type of valve’s manufacturer. All 
patient’s reports were then presented to a 
TAVI medical council, consisting of the 
patient’s cardiologist, an echocardiogra-
phy specialist, a radiologist, specializing in 
CTA-TAVI, a cardiovascular surgeon and 
an interventional cardiologist. We then 
informed the patient of the council’s opin-
ion and obtained written consent if they 
agreed with the procedure. Whenever 
there was a concurrent indication for per-
cutaneous coronary intervention (PCI), we 
had it performed 1-2 weeks before TAVI. 
Our strategy for PCI, which is based on 
revascularization of angiographically sig-
nificant stenosis (>70% of the diameter) in 
initial and middle parts of main coronary 
arteries, was summarized after the expe-
rience of leading international experts, 
as there is a lack of relevant randomized 
studies in this field. An anaesthesiologist 
saw the patient immediately prior to the 
procedure and led the patient through the 
procedure itself.
The procedure was performed under 
general anaesthesia in the initial period, 
and later conscious sedation and local 
anaesthesia for arterial puncture were 
used. Using the recommended proce-
dure, we inserted the valve through the 
right or left femoral artery, and we did 
not use alternative approaches. We used 
either a self-expanding valve (Evolut R/
Pro, Medtronic, Minneapolis, MN, USA) 
or a balloon-expandable valve (SAPIEN 
3, Edwards Lifescience, Irvine, CA, USA). 
We based the decision on the type and size 
of the valve on CTA-TAVI, by which we al-
so assessed whether there was a significant 
likelihood of coronary artery occlusion. In 
such cases we inserted a catheter introduc-
er, coronary guide wire and stent though 
the radial artery into the left descending 
coronary artery prior to valve insertion 
(10). If partial or complete occlusion of a 
coronary artery occurred or was probable 
during valve insertion, we moved the stent 
to the ostium of the coronary artery and 
set it there. For valve placement we initial-
ly used the recommended coplanar projec-
tion of three cusps, and from 11 December 
2019, in most patients with a self-expand-
ing valve, the projection with cusp-overlap 
(overlapping of the right and left coronary 
cusps (Figure 1). An echocardiographer 
was present during the procedure and, if 
necessary, performed transthoracic echo-
cardiography during the procedure, and 
always after the procedure, with the help 
of which we assessed the pericardium, 
left ventricular function and the artificial 
valve. During TAVI a cardiovascular team 
and an operating theatre were on stand-
by, which enabled immediate surgery in 
case of complications. After the procedure 
we woke the patient in the catheter labo-
ratory itself and then admitted them to a 
non-intensive ward, where we monitored 
the electrocardiogram, arterial pressure 
and oxygen saturation of arterial hemo-
globin with pulse oximetry for the next 
48 hours. In case of delayed recovery from 
anaesthesia or hemodynamic/respiratory 
instability following TAVI we admitted 
the patient into a post-operative intensive 
care unit. Temporary pacemakers were 
usually removed after 48 hours, except 
in patients who already had a permanent 
pacemaker. In case of significant brady-
cardia we inserted a permanent pacemak-
er. All patients were completely mobilized 
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prior to discharge and had a transthoracic 
cardiac ultrasound performed, with which 
we once again confirmed proper aortic 
valve function, absence of significant re-
gurgitation and measured pressure gra-
dients. After the procedure, patients usu-
ally received acetylsalicylic acid 100 mg 
daily for life and clopidogrel 75 mg daily 
for 3 months. In patients with prior anti-
coagulation therapy we continued with it 
without adding acetylsalicylic acid and/or 
clopidogrel, unless they needed dual anti-
platelet therapy for a prior PCI. 
All patients are regularly followed in the 
cardiology clinic at MC Medicor, where 
they have cardiac ultrasounds performed, 
usually 3-6 months and 12 months after 
the procedure. In case of clinical wors-
ening or elevation of the mean pressure 
gradient above 20 mmHg, we perform 
a CTA-TAVI due to suspicion of cusp 
thrombosis to confirm or refute the exis-
tence of a phenomenon known as HALT/
RELM (hipoattenuated leaflet thicken-
ing/reduced leaflet movements), which 
Figure 1: Standard coplanar projection of the three cusps (A) and the projection with cusp-
overlap (overlapping of the left and right coronary cusps) (B).
Legend: N = non-coronary cusp; R = right cusp; L = left cusp.
N
R
L
N
Overlap of 
the R and 
L cusps
RAO 16°/Caudal 25°LAO 12°/Caudal 11°
A-Standard projection of the three cusps B-Projection with cusp-overlap
requires treatment with anticoagulants for 
several months (11). During the Covid-19 
epidemic we additionally contacted all pa-
tients by telephone and instructed them to 
stay in their home environment and avoid 
contact with people from another envi-
ronment. Numerical data were present-
ed as mean values with 95% confidence 
interval (95% CI) or as medians with 1st 
and 3rd quartiles. Variability was addition-
ally demonstrated by standard deviation. 
Categorical data were expressed as abso-
lute values, percentages and 95% CI. Data 
on the exact date of death of deceased 
patients were obtained via the informa-
tion system “BIRPIS” with the help of the 
health insurance card. Long-term survival 
was shown with the Kaplan-Meier curve. 
To compare the frequency of insertion of 
a new permanent pacemaker according 
to the insertion technique and the type 
of valve we used the chi-squared test. 
P-values of less than 0.05 were considered 
statistically significant.
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ORIGINAL SCIENTIFIC ARTICLE
Results of transcatheter aortic valve implantation (TAVI) in MC Medicor
General patient characteristics n = 109
Age (years), mean value + SD 81 + 6
Men 56 (51.4%)
EuroScore ll
• Mean value + SD 3.95 + 3.56
• Median (1.-3. quartiles) 2.85 (1.75–4.67)
Logistic EuroScore
• Mean value + SD 18.46 + 14.65 (1.66–80.44)
• Median (1.-3. quartiles) 13.48 (8.97–22.39)
STS for mortality
• Mean value + SD 3.07 + 2.03 (0.43–12.07)
• Median (1.-3. quartiles) 2.58 (1.73–3.75)
Concomitant obstructive coronary disease 44 (40.4%)
Prior PCI/CABG 41 (37.6%)
Left ventricle ejection fraction (%) 57 + 12
Significant electrocardiographic characteristics
• Left bundle branch block 12 (11.0%)
• Right bundle branch block 8 (7.3%)
• Bifascicular block 2 (1.8%)
• Trifascicular block 3 (2.8%)
• First-degree AV block 14 (12.8%)
• Atrial fibrillation with bradycardia 2 (1.8%)
• Permanent cardiac pacemaker already 
present 6 (5.5%)
Ultrasound characteristics of the aortic stenosis
Maximum gradient, mm Hg
• Mean value +SD 74 + 19
• Median (1.–3. quartiles) 74 (62–86)
Mean gradient, mm Hg
• Mean value + SD 46 + 13
• Median (1.-3. quartiles) 44 (38–55)
Aortic valve area, cm2
• Mean value + SD 0.8 + 0.2
• Median (1.-3. quartiles) 0.8 (0.7–0.9)
Table 1: General characteristics of patients who had TAVI performed in 
Medicor.
3 Results
Between 12 December 2016 and 6 June 
2020, we performed TAVI in 109 consec-
utive patients at our institution. Their av-
erage age was 81 years, and men predom-
inated (51.4%) (Table 1). The mean and 
median values for EuroScore II were 3.95 
and 2.85, respectively, and for the Society 
of Thoracic Surgeons score (STS) for hos-
pital mortality 3.07 and 2.58, respectively. 
The ejection fraction of the left ventricle 
averaged 57%, and 40.4% of patients had 
concomitant obstructive coronary heart 
disease. Some patients already had elec-
trocardiographic features, which predict a 
higher likelihood of the need for a perma-
nent pacemaker, prior to the procedure. 
Thus, right bundle branch was found in 
7.3%, bifascicular block in 1.8%, and tri-
fascicular block in 2.8% of patients. The 
mean aortic valve gradient by echocar-
diography was 46 mm Hg and the calcu-
lated valve area was 0.8 cm2. Two patients 
had bicuspid valves and one patient had a 
degenerated surgical biological valve. In 
30% of patients, PCI was performed pri-
or to TAVI as part of preparations for the 
procedure. 
The procedure was performed under 
conscious sedation in majority of pa-
tients (Table 2). A percutaneous approach 
through the right or left femoral artery 
was performed in all patients, except one. 
Pre-implantation balloon aortic valvu-
loplasty of the native valve was performed 
in 36.7%, and a new valve was success-
fully inserted in 107 patients (98.2%). 
Balloon post-dilation of the new valve was 
performed in 15.6%. In two patients, de-
layed stent insertion into the left sinus of 
Valsalva had to be performed immediately 
following TAVI due to partial occlusion of 
the trunk of the left coronary artery. The 
mean aortic valve gradient by echocardi-
ography following TAVI was 9 mm Hg, 
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General patient characteristics n = 109
Gradient on the tricuspid valve, mm Hg (n=43)
• Mean value + SD 35 + 11
• Median (1.-3. quartiles) 33 (27–40)
Bicuspid valve 2 (1.8%)
Degenerated surgical valve 1 (0.9%)
Prior TAVI as part of TAVI preparations 33 (30%)
Legend: SD = standard deviation; STS = Society of Thoracic Surgeons 
score; PCRI = percutaneous coronary intervention; CABG = coronary artery 
bypass grafting.
Table 2: Description, results and complications of TAVI in Medicor.
Description, results and complications
Conscious sedation 82 (75.2%)
Vascular approach for TAVI
• Percutaneous 108 (99.1%)
• Surgical preparation 1 (0.9%)
Pre-implantation balloon aortic valvuloplasty 40 (36.7%)
Percutaneous valve successfully inserted 107 (98.2%)
• Self-expanding valve (Medtronic Evolut) 94 (87.9%)
• Balloon-expandable valve (Edwards SAPIEN 3) 13 (12.1%)
Balloon post-dilation of the TAVI valve 17 (15.6%)
PCI during TAVI 2 (1.8%)
TAVI results
Mean aortic valve gradient by echocardiography, mm Hg
• Mean value + SD 9 + 3
• Median (1.-3. quartiles) 9 (7–11)
Moderate aortic insufficiency (% and 95% CI) 4 (3.7%; 1.0–9.1%)
Severe aortic insufficiency (% and 95% CI) 0 (0%; 0.0–3.3%)
Percutaneous occlusion of the femoral artery  (%  
and  95% CI)
106/106 (100%; 
96.6–100%)
New permanent cardiac pacemaker (% and 95% 
CI) 25 (22.9%; 15.4–32.0%)
Hospital complications of TAVI (% in 95% IZ)
Emergency pericardiocentesis 3 (2.7%; 0.6–7.8%)
Emergency open-heart surgery – LV perforation 2 (1.8%; 0.2–6.5%)
moderate aortic regurgitation was present 
in 3.7%.
Emergency pericardiocentesis was per-
formed in two patients with perforation 
of the left ventricle with a wire which was 
used for valve implantation. In one pa-
tient, during the catheter procedure, we 
continued with an unsuccessful attempt to 
surgically close a left ventricle perforation. 
The patient died during the procedure. 
Another patient was hemodynamical-
ly stabilized with pericardiocentesis and 
transferred to the operating theatre, where 
the surgical team closed the perforation 
and surgically replaced the aortic valve as 
the perforation occurred before TAVI. The 
post-operative course was normal and the 
patient survived. We performed addition-
al pericardiocentesis and a 2-day catheter 
pericardium drainage in a patient with 
right heart perforation, which was prob-
ably caused by the wire of a temporary 
pacemaker. Surgery was not needed in this 
patient. In one patient, perforation of the 
common iliac artery, followed by hemor-
rhagic shock, occurred during insertion 
of the catheter introducer for TAVI before 
valve insertion. Despite successful hemo-
stasis with the help of 3 covered vascular 
stents, additional vascular surgery with a 
femorofemoral bypass was required due 
to femoral artery occlusion and the need 
for additional hemostasis. This patient 
died on the 3rd post-operative day due to 
lower limb ischemia, refractory shock and 
organ failure. A covered vascular stent 
was also used in one patient for addition-
al hemostasis of the puncture site, and a 
pseudoaneurysm of the femoral artery at 
the secondary vascular approach was re-
solved percutaneously with fibrin glue in 2 
patients. One patient had a transient isch-
emic attack, which completely resolved in 
a few hours.
After discharge from hospital, one pa-
tient experienced sudden dyspnea on the 
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ORIGINAL SCIENTIFIC ARTICLE
Results of transcatheter aortic valve implantation (TAVI) in MC Medicor
Description, results and complications
Hemostasis with covered vascular stents 2 (1.8%; 0.2–6.5%)
Urgent vascular repair of the iliac artery 1 (0.9%; 0.0–5.0%)
Pseudoaneurysm of the femoral artery/
percutaneous occlusion 2 (1.8%; 0.2–6.5%)
Transient ischemic attack (TIA) 1 (0.9%; 0.0–5.0%)
Cerebrovascular insult (CVI) 0 (0%; 0.0–3.3%)
Length of hospitalization (days), mean value + SD 8 + 4
In-hospital mortality (% and 95% CI) 2 (1.8%; 0.2–6.5%)
New severe aortic valve insufficiency and SAVR 1 (0.9%; 0.0–5.0%)
30-day mortality rate 2 (1.8%; 0.2–6.5%)
Legend: PCI = percutaneous coronary intervention; SD = standard 
deviation; CI = confidence interval; LV = left ventricle; SAVR = surgical aortic 
valve replacement.
14th day following a successful TAVI. With 
transesophageal ultrasound we found a 
new severe valvular and partially paraval-
vular aortic insufficiency, which, accord-
ing to a repeat CTA-TAVI, was caused by 
an unexplained shift of the valve by an 
additional 5-6 mm into the left ventricle 
outflow tract. We surgically removed the 
TAVI valve and implanted a new valve. 
The surgery was without complications 
and the post-operative course was normal. 
The in-hospital and 30-day mortality 
were 1.8% (95% CI 0.2-6-5%). One-year 
mortality was 3.1% (95% CI 0.0-6-5%), 
two-year mortality 5.6% (0.0-11.4%), and 
three-year mortality 14.2% (0.0–29.6%) 
(Figure 2). The mean follow-up time, ex-
pressed as median and 1st and 3rd quartiles, 
was 441 days (197-599 days).
4 Discussion
Due to ever growing numbers of el-
derly patients with severe aortic stenosis 
and numerous comorbidities we started 
with TAVI at our institution in 2016. For 
this purpose, we established a TAVI med-
ical council and team in accordance with 
international recommendations. By June 
2020, we had performed 109 procedures. 
We compared our results to the recent-
ly published randomised study SOLVE 
TAVI, which was done in top German 
centres with large numbers of yearly pro-
cedures and using the same valves as at 
our institution. We must keep in mind 
that comparison can only be approximate 
due to methodological differences be-
tween the two studies. Our study is much 
smaller in terms of the number of proce-
dures performed and consists of consecu-
tive patients in one centre, while SOLVE 
TAVI was a large multicenter random-
ized study in which patients were selected 
and included by researchers on the basis 
of previously established inclusion cri-
teria. We used the Evolut R/Pro valve in 
more than 80% of cases, while in SOLVE 
TAVI, the proportions of the Evolut R/
Pro and SAPIEN 3 valves were the same. 
We would especially like to emphasize 
that the values of individual parameters 
Figure 2: Kaplan-Meier curve showing patient survival following TAVI 
at MC Medicor. The dotted lines show the 95% confidence interval. The 
mean follow-up time, shown as a median and 1st and 3rd Quartiles, was 
441 days (197 – 599 days).
P
ro
b
a
b
il
it
y 
o
f 
su
rv
iv
a
l
Days since TAVI
0 200 600 1000400 800
0
.0
0
.2
0
.4
0
.6
0
.8
1
.0
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from SOLVE TAVI, which were used for 
comparison, were calculated as the aver-
age of both groups with different types 
of valves. Taking into account all the de-
scribed limitations, our patients were of 
comparable age (81 years versus 82 years), 
and the medians and 1st and 3rd quartiles 
in the pre-surgery risk assessment also 
overlapped. In our patients the Euroscore 
II was 2.9 (1.8-4.7); in SOLVE TAVI, it 
was 4.1 (2.5-7.5). STS in our study was 2.6 
(1.8-3.8), while in SOLVE TAVI, it was 4.9 
/2.9-9.9). The medians of the aortic valve 
areas (0.8 vs 0.7 cm2) and mean aortic 
valve gradients by echocardiography (44 
mm Hg vs 39 mmHg) were comparable. 
We used conscious sedation and local an-
aesthesia more often at our centre (75% vs 
50%) and we were as successful at percu-
taneous closing the puncture of the fem-
oral artery (100% vs 94%). If we add up 
all our severe (0.9%) and less severe (3.6%) 
vascular complications, we get a frequency 
of 4.5%, which is also comparable to 5.7% 
in SOLVE TAVI. As SOLVE TAVI did not 
report on the need for emergency open 
heart surgery and pericardiocentesis, we 
cannot compare it to our study in this 
particular segment. Our 30-day mortality 
of 1.8% (95% CI 0.2-6.5%) was compa-
rable to SOLVE TAVI (2.7%). Taking in-
to account the 95% confidence intervals, 
as shown in Table 2, this can also be said 
for the incidence of stroke (0% vs. 2.6%), 
the proportion of moderate/severe aor-
tic insufficiency (4.6% vs. 2.4%) and the 
need for a permanent cardiac pacemaker 
(22.9% vs. 21.0%) (12). 
As the SOLVE TAVI study currently 
reports only on the 30-day mortality, we 
compared our long-term survival to sur-
vival in other high-profile internation-
al randomized trials in moderate-risk 
patients, including SURTAVI (3) and 
PARTNER 2 (1). Researchers in these 
studies, unlike those in SOLVE TAVI, 
include mean instead of median values. 
Our patients were of comparable ag-
es, while STS for mortality was lower in 
our patients (3.1) than in the PARTNER 
2 (5.8) and SURTAVI studies (4.4). Our 
one-year mortality, which was 3.1% (95% 
CI 0.0-0.6%) was at least comparable to 
the PARTNER 2 (12,3%) and SURTAVI 
studies (6,7%), which, unfortunately, do 
not include confidence intervals. The 
same is true for the two-year mortality, 
which was 5.6% in our study (95% CI 0.0-
11%), in the PARTNER 2 study 16.7%, and 
11.4% in the SURTAVI study. Our thesis, 
that the pre-procedure morbidity has a de-
cisive influence on long-term survival in 
patients who had a successful TAVI with-
out complications, was also confirmed by 
the PARTNER 3 study, performed in low-
risk patients; such patients were also in-
cluded in our study. In these patients, with 
a mean age of 73 years, mean Euroscore 
II 1.5 and STS 1.9, the one-year mortali-
ty was only 1% (2). Unfortunately, apart 
from survival rates, we currently do not 
have long-term echocardiographic data 
on valve pressure gradients, rate of aortic 
insufficiency, and possible improvement 
or worsening of left ventricular ejection 
fraction, which would further contribute 
to the portrayal of the patient's post-TAVI 
condition. Regardless of the fact that the 
proportion of our patients who needed a 
permanent pacemaker after TAVI, even 
in light of our 95% confidence interval, 
is comparable to the SOLVE TAVI study 
(12) for self-expanding (27% vs. 23%) and 
balloon-expandable valves (23% vs. 19%), 
it is still too high. Part of the reason may 
be that a significant proportion of our pa-
tients already had electrocardiographic 
features prior to TAVI (bifascicular/tri-
fascicular block, bradycardia, right bun-
dle branch block) which would probably 
have caused them to receive a permanent 
pacemaker earlier in Germany. Such cases 
147
ORIGINAL SCIENTIFIC ARTICLE
Results of transcatheter aortic valve implantation (TAVI) in MC Medicor
wouldn’t, of course, count in the “new car-
diac pacemaker after TAVI” category. This 
hypothesis is supported by the fact that 
10.8% of patients in SOLVE TAVI had a 
permanent pacemaker before the proce-
dure; this figure was only 5.5% in Slovenia. 
As, according to some studies, the need 
for a permanent pacemaker is linked to 
worse long-term left ventricular function, 
and definitely with additional costs, we 
used a new cusp-overlap technique with 
self-expanding valve insertion. Our pre-
liminary results confirm the effectiveness 
of this technique, as the need for insertion 
of a permanent pacemaker dropped from 
27.4% to 9.5% when using a self-expand-
ing valve. We cannot exclude the possi-
bility that the previously described drop 
could be a consequence of the provider’s 
learning curve, who, with more experi-
ence, implanted the self-expanding valve 
higher. 
The influence of the learning curve 
probably also applies to complications 
which we have described and that are oth-
erwise comparable to other studies, and 
which we expect to be further reduced 
with growing numbers of interventions. 
Further advancements in TAVI technol-
ogy will also probably contribute to this, 
as will better preparations for the proce-
dure following detailed CTA TAVI analy-
sis. Based on this, we expect that in a few 
years, the TAVI procedure will become the 
same as PCI in our region. Due to favor-
able results of randomized trials and the 
growing number of better informed pa-
tients who want less invasive procedures, 
the indications for TAVI are spreading 
rapidly. In the most developed centres in 
Western Europe and the United States of 
America the classic open heart surgery is 
reserved only for younger patients with 
bicuspid aortic valves and concomitant 
disease of the ascendent aorta. In re-
cent years, there appears an additional 
important indication for TAVI in patients 
with degenerated biological valves, insert-
ed either surgically or with TAVI. Such 
patients, in which TAVI represent a signif-
icant technical challenge for the provider, 
will only grow in number. An important 
challenge for the TAVI medical council 
are the decisions with patients with severe 
comorbidities, in which TAVI would not 
significantly contribute to improvement 
to quality of life and would only prolong 
it. To make the best possible decision, it is 
necessary to carefully consider the impact 
of comorbidities. Only if aortic stenosis 
is the main problem is TAVI the correct 
solution for the patient. 
All our patients have the option to be 
followed by non-invasive cardiologists fol-
lowing TAVI in our clinic at MC Medicor. 
Most of them choose this option, but 
some return to their cardiologists, which 
of course isn’t problematic if their cardi-
ologists know how to follow patients after 
TAVI. TAVI providers and the Slovenian 
Society of Cardiology, led by appropriate 
working groups, thus have an important 
mission to provide non-invasive cardiolo-
gists with specific, in particular echocar-
diographic, knowledge to identify possible 
complications such as endocarditis, valve 
leaflet thrombosis (HALT/RELM) (11) 
and late TAVI valve degeneration. If such 
complication is suspected, it is best to refer 
the patient to their TAVI provider. 
Finally, it should be emphasized that 
the current bottleneck for performing a 
large number of TAVIs at MC Medicor are 
undoubtedly the administrative and finan-
cial constraints of the Health Insurance 
Institute of Slovenia (ZZZS) and the 
Ministry of Health, not the lack of suitable 
patients or the inability of the TAVI team 
to carry out all necessary interventions. 
Given our good starting results, which 
we have shown to be comparable with the 
most important international studies of 
148
CARDIOVASCULAR SYSTEM
Zdrav Vestn | On-line first: 02. 03. 2021 | Volume 90 | https://doi.org/10.6016/ZdravVestn.3150
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recent years, it is our hope that the deci-
sion-makers of our health care system will 
recognize this and also enable our centre 
to shorten the waiting period with a larger 
number of interventions.
5 Conclusion
We have shown the first results of treat-
ment of aortic stenosis with TAVI at MC 
Medicor, which are good and compara-
ble with the most important international 
studies of recent years.
6 Ackwnoledgment
We would first like to thank Prof. Dr. 
Oscar Mendiz of the Fundación Favaloro, 
Buenos Aires (Argentina) and Prof. Dr. 
Flavio Ribichini of the University of 
Verona (Italy), who taught TAVI to us 
as proctors. We owe special thanks to 
our surgical instrumentalist nurse Ana 
Čerpnjak, radiology technician Tjaša 
Godeša and anaesthesiology nurse Mirko 
Jović. We would also like to thank the team 
of our outpatient clinic (Dr. Nataša Gorkič, 
Assistant Professor Dr. Vojka Gorjup, 
Prof. Dr. Aleš Žemva, Senior Physician 
Dr. Borut Kolšek) and departmental car-
diologists  of MC Medicor (Dr. Milan 
Ignjatovič, Dr. Zoran Konstantinovič, Dr. 
Mirjana Čenanovič, Dr. Dragan Zečevič) 
and nurses under the leadership of Ms. 
Jasmina Grahovac for their contributions. 
For administrative help, we would like 
to thank Ms. Marija Grahovac and Ms. 
Mojca Luznar. Last but not least, we sin-
cerely thank Prof. Dr. Roberto Favaloro 
of the Fundación Favaloro, Buenos Aires 
(Argentina), without whom we would not 
be able to take the first steps into the field 
of TAVI.
149
ORIGINAL SCIENTIFIC ARTICLE
Results of transcatheter aortic valve implantation (TAVI) in MC Medicor
11. Rojko M, Cernič Šuligoj N, Cvetičanin B, Zorc M, Mendiz O, Noč M. Leaflet thrombosis after transcatheter 
aortic valve implantation-a case report. Zdr Vestn. 2019;88(7-8):371-7.
12. Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Eitel I, et al. Comparison of newer generation self-
expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized 
SOLVE-TAVI trial. Eur Heart J. 2020;41(20):1890-9. DOI: 10.1093/eurheartj/ehaa036 PMID: 32049283