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Outcomes after transcatheter aortic valve
implantation: a single centre registry
of 350 consecutive cases
Barbara E. Stählia, Hanna Tasnadya, Lukas A. Altwegga, Ines Bühlera, Jürg Grünenfelderb, Ulf Landmessera,
Felix C. Tannera, Manfred B. Wischnewskyc, Volkmar Falkb, Thomas F. Lüschera, Roberto Cortia, Willibald Maiera
a
University Heart Centre, Department of Cardiology, University Hospital Zürich, Switzerland
b
University Heart Centre, Clinic for Cardiovascular Surgery, University Hospital Zürich, Switzerland
c
FB Mathematics and Computer Science, University of Bremen, Germany
Summary
Introduction: The Valve Academic Research Consortium (VARC) consensus document on outcome reporting in transcatheter valves has recently been revised.
We used these VARC-2 standardised endpoint definitions to report transcatheter aortic valve implantation
(TAVI) outcome at our institution.
Methods: The study included 350 consecutive patients
undergoing TAVI at the University Hospital Zurich between May 2008 and November 2012. The Edwards
SAPIEN (n = 158; 45%), the Medtronic CoreValve (n =
189, 54%), and the Medtronic Engager (n = 3, 1%) prostheses were implanted via either the transfemoral
(83%) or the transapical (17%) access. Mean follow-up
was 389 ± 405 days.
Results: Device success within 72 hours was achieved
in 88% of patients without significant differences between access sites (p = 0.89) and prosthesis types (p =
0.24). Device failure was due to procedural mortality in
12 (3.4%) patients. In survivors, implantation of more
than one prosthesis or malpositioning of the prosthesis
was observed in six (1.7%) patients, an increased transvalvular pressure gradient >20 mm Hg in four (1.1%)
patients, and moderate aortic reFunding / potential
gurgitation in 19 (5.4%) patients,
competing interests:
respectively. Severe aortic regurgiBarbara E. Stähli has partially
tation
was observed in one (0.3%)
been supported by grants of
the Swiss National Research
patient. All-cause mortality was
Foundation (Special Pro9.1% at 30 days (12.0% in the first
gramme University Medicine:
half of the patients vs 6.3% in the
Grant Nr 33CM30-1241112/1
second half; p = 0.07), and 21.2% at
and 3100-068118.02/1). The
1 year. The composite endpoint
authors have received
honoraria and research grants
“early safety” was met in 67 (19.1%)
from Medtronic, Tollochenaz,
patients at 30 days (23% in the first
Switzerland, Edwards
half of the patients vs 15% in the
Lifesciences, Nyon, Switzersecond
half; p = 0.04). Stroke was
land, and St. Jude Medical
observed
in 2.9%, life-threatening
Europe, Brussels, Belgium.
bleeding in 4.6%, vascular compliAuthors’ contribution: BES
cations in 7.4% and acute renal
and HT contributed equally
failure in 5.7% of patients. Coro-
nary obstruction was rarely observed (0.9%). Valve-related dysfunction requiring repeat procedure occurred
in two (0.6%) patients. With multivariate regression
analysis, major and life-threatening bleeding within 30
days (hazard ratio [HR] 4.74, 95% confidence interval
[CI] 2.03–11.07, p <0.001), chronic obstructive pulmonary disease (HR 3.41, 95% CI 1.71–6.81, p = 0.001),
and baseline New York Heart Association (NYHA)
functional class III or IV (HR 3.08, 95% CI 1.18–8.5,
p = 0.02) were found to be the strongest independent
predictors of all-cause mortality at total follow-up.
Conclusion: According to the newly revised VARC-2
standardised endpoint definitions, device success was
met in 88% of patients, and the composite endpoint
“early safety” was reached in 19% of patients. These results compare very favourably with the international
experience using this novel technique. Thus, in selected
patients with severe aortic stenosis TAVI is a valid
therapeutic option.
Introduction
In individuals above 75 years of age, aortic valve calcification is a common condition with a prevalence of almost 40% [1]. Among these, moderate to severe aortic
stenosis (AS) is observed in 5% [2]. With the growing
elderly population in Western societies, the prevalence
of AS will increase further in the near future. For
symptomatic patients, surgical aortic valve replacement (SAVR) is the standard of care as a result of
proven long-term efficacy and safety [3, 4]. However, a
Correspondence:
Professor Willibald Maier, MD
Department of Cardiology, University Heart Centre
University Hospital Zürich
Rämistrasse 100
CH-8091 Zürich
Switzerland
Karmaiew[at]usz.uzh.ch
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substantial number of patients is not referred for
SAVR because of a high operative risk, severe comorbidities or advanced age [5–7]. Patients with severe
symptomatic AS managed conservatively have an extremely poor prognosis with an average survival of two
to four years.[5, 7]. In recent years, transcatheter aortic
valve implantation (TAVI) has extended the therapeutic options in these patients, and has become an established alternative to SAVR [8, 9]. In the randomised
PARTNER trial (Placement of AoRTic traNscathetER
valve trial), superiority to standard medical therapy in
nonoperable patients, and noninferiority to open heart
surgery in high surgical risk patients has been demonstrated in terms of all-cause and cardiovascular mortality, rehospitalisation and cardiac symptoms [10, 11].
Favourable clinical and haemodynamic outcomes for
up to 5 years after successful TAVI have been reported
in different registries, with survival rates over 70% at
two years follow-up [12, 13, 14, 15].
For the comparison of devices, implantation techniques and TAVI centers, standardised outcome reporting is essential. Hence, in January 2011, the first Valve
Academic Research Consortium (VARC) definitions
were published in order to harmonise outcome reporting for transcatheter valves [16]. These consensus definitions have already been widely adopted in clinical
and research practice. With increasing experience with
this technique, certain definitions were considered unsuitable or ambiguous, with need for adaption or extension [13, 17]. Accordingly, the revised standardized
endpoint definitions were proposed in October 2012
[17]. In this consensus manuscript, outcome measures
and composite endpoints were redefined to make them
more suitable for present and future needs, in particular for clinical trials.
The aim of this study was to report TAVI experience of the Zurich University Hospital in accordance
with the recently revised VARC-2 endpoint definitions.
Methods
Patients and procedures
The present analysis includes 350 consecutive patients
undergoing TAVI at the Zurich University Hospital between May 2008 and November 2012. Indications for
TAVI included severe symptomatic AS (mean transaortic systolic pressure gradient of ≥40 mm Hg, or an
aortic valve area of <1.0 cm2 or <0.6 cm2/m2) in individuals not eligible for SAVR because of an increased risk
of mortality. Preprocedural patient assessment included transthoracic (TTE) and transoesophageal echocardiography (TEE), coronary angiography and multislice computed tomography (MSCT). All patients were
evaluated by a multidisciplinary heart team consisting
of cardiologists, cardiac surgeons, cardiac anaesthesiologists and imaging specialists [11].
Initially, the procedures were performed in the car-
diac catheterisation laboratory, but since April 2011 all
procedures were performed in a newly installed hybrid
operating room. The procedure was performed under
general anaesthesia with the exception of nine patients
operated upon with local anaesthesia because of specific comorbidities. Prior to the implantation of the
prosthesis, balloon valvuloplasty was performed under
burst rapid right ventricular pacing.
Outcome reporting according to the VARC-2
endpoint definitions
Outcome was reported according to the revised VARC-2
standardised endpoint definitions [17]. These definitions include complication rates and clinical endpoints,
partially summarised in the composite endpoints device success and “early safety”. In brief, device success
is defined as the absence of procedural mortality, correct positioning of a single prosthetic heart valve into
the proper anatomical location and intended performance of the prosthetic heart valve (no prosthesis-patient mismatch, mean aortic valve gradient <20 mm Hg
or peak velocity <3 m/s, and no moderate or severe aortic regurgitation). The composite endpoint “early
safety” includes all-cause mortality, disabling and nondisabling stroke, life-threatening bleeding, acute kidney injury stage 2 or 3 including renal replacement
therapy, coronary artery obstruction requiring intervention, major vascular complications, and valve-related dysfunction requiring repeat procedure (balloon
valvuloplasty, TAVI or SAVR) [17]. Data were collected
retrospectively from baseline and postinterventional
case records as well as from angiographic and echocardiographic findings. The study was approved by the
local ethics committee and all patients gave written
informed consent.
Statistical analysis
Continuous variables are presented as mean ± standard deviation (SD). Categorical variables are given as
numbers and proportions. Normality of distribution
was assessed with the Shapiro-Wilk test. Continuous
variables were tested for differences with the unpaired
t-test or the Mann-Whitney U-test as appropriate. Categorical variables were tested for differences with the
Pearson’s chi-square-test or the Fisher’s exact test as
appropriate. Time-to-event relations were constructed
on the basis of all available follow-up data, presented
as Kaplan-Meier curves. For the Cox model, univariate
analysis of predictors of the outcome variable (cumulative all-cause mortality) were tested, hazard ratios
(HR) and 95% confidence intervals (CIs) of baseline
and procedural characteristics are given. All variables
with a p-value of <0.05 in univariate analysis were included in a multivariate model by the backward Wald
method to determine independent predictors of the outcome variable. A two-sided p-value of <0.05 was considered statistical significant. All statistical analyses
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were performed with the use of SPSS version 21 (SAS
Institute Inc, Cary, NC).
Table 2
Procedural characteristics. Results are presented as numbers
and percentages.
Procedural characteristics
Results
Access site
Patient characteristics
transapical
In total, 350 consecutive patients with severe symptomatic AS underwent TAVI (mean age, 82.4 ± 7.1
years; 48.9% male) from May 2008 to November 2012
at the Zurich University Hospital. Mean systolic pressure gradient was 43 ± 19 mm Hg. Most patients presented with symptoms of congestive heart failure (n =
259, 74%), angina (n = 60, 17%), or syncope (n = 31, 9%).
At baseline, most patients were in NYHA class III or IV
(n = 253; 72%). Patients were at high surgical risk,
with a logistic EuroScore >20% in most of them. Patients who were not at increased surgical risk as estimated by the logistic EuroScore had specific comorbidities or surgical contraindications not incorporated in
this risk score such as very advanced age >88 years
(15%; n = 52), porcelain aorta (8%; n = 27) or immunosuppressive therapy (7%; n = 23).
The following three prostheses were used: the
Medtronic CoreValve (26, 29 and 31 mm; n = 189, 54%),
the Edwards SAPIEN (23, 26, and 29 mm; n = 158,
transfemoral
Table 1
Baseline characteristics. Results are presented as mean and SD,
or numbers and percentages.
CABG = coronary artery bypass grafting; COPD = chronic obstructive
pulmonary disease; LVEF = left ventricular ejection fraction; NT-pro BNP
= N-terminal pro-brain-natriuretic peptide; NYHA = New York Heart
Association.
Baseline characteristics
Age, years
82.4 ± 7.1
Male
171 (49)
Body mass index (kg/m2)
26.3 ± 4.4
Coronary artery disease
203 (58)
Pevious CABG
78 (22)
Previous valve surgery
19 (5)
Diabetes mellitus
83 (24)
Hypertension
266 (76)
Atrial fibrillation
103 (29)
Previous pacemaker
38 (11)
COPD
69 (20)
Peripheral vascular disease
81 (23)
Cerebrovascular disease
80 (23)
Pulmonary hypertension >60 mmHg
44 (13)
Porcelain aorta
27 (8)
NYHA class III and IV
95 (27)
Log Euroscore (%)
22.1 ± 13.8
Creatinine (μmol/L)
115 ± 69
NT-proBNP (ng/L)
5257 ± 8470
LVEF (%)
55±13
Aortic valve gradient (echo; mmHg)
43 ± 19
Aortic valve area (cm2)
0.72 ± 0.19
61 (17)
289 (83)
Valve type
Edwards SAPIEN
158 (45)
Medtronic CoreValve
189 (54)
Engager
3 (1)
Prosthesis size
23 mm
73 (21)
26 mm
153 (43)
29 mm
104 (30)
31 mm
20 (6)
Type of anesthesia
general anesthesia
local anesthesia
341 (97)
9 (3)
45%), and the Medtronic Engagr (formerly Ventor Embracer; 26 mm; n = 3, 0.8%) prosthesis. The size of the
prosthesis was selected on the basis of aortic annulus
dimensions measured in preprocedural MSCT and
TEE studies. Access was either transfemoral (n = 289,
83%) or transapical (n = 61, 17%). Mean follow-up was
389 ± 405 days. Baseline characteristics are summarised in table 1 and procedural characteristics in
table 2.
VARC-2 composite endpoints: device success
and early safety
Device success within 72 hours was achieved in 88% of
patients without significant differences between access
sites (p = 0.89) and prosthesis types (p = 0.24). Device
failure was due to procedural mortality (within 72
hours) in 12 (3.4%) patients. In survivors, implantation
of more than one prosthesis or malpositioning of the
prosthesis was observed in 6 (1.7%) patients and prosthesis valve dysfunction in 24 (6,9%) patients. Prosthetic valve dysfunction was due to an increased transvalvular pressure gradient >20 mm Hg in 4 (1.1%)
patients and due to moderate aortic regurgitation in
19 (5.4%) patients. Severe aortic regurgitation was observed in one (0.3%) patient. Mean aortic valve gradient decreased from 43 ± 19 mm Hg at baseline to 10 ±
3 mm Hg 1 month after valve replacement (p = 0.001),
and remained stable for up to 3 years of follow-up.
In the whole patient cohort, all-cause mortality
was 9.1% at 30 days [18]. Causes of death at 30 days
were cardiovascular in 96.8% (31 of 32) of patients. One
patient died from a disabling stroke, all other patients
died of cardiovascular causes according to the VARC-2
criteria. Stroke was observed in 2.9% of patients,
life-threatening bleeding in 4.6%, vascular complications in 7.4% and acute renal failure in 5.7%. Coronary
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obstruction was rarely observed (0.9%). Valve-related
dysfunction requiring a repeat procedure occurred in
two (0.6%) patients. The combined endpoint “early
safety” at 30 days was met in 67 (19.1%) patients
(fig. 1).
Myocardial infarction not due to coronary obstruction was observed in 2.0% of patients at 30 days, and
was periprocedural in 1.4%. Conversion to open heart
surgery and unplanned use of cardiopulmonary bypass
was rare (1.7% and 2.3%, respectively). Cardiac tamponade occurred in 2.3% of patients, and was due to annulus rupture in 0.6%. TAVI-related complications are
summarised in table 3.
New left bundle-branch block was observed in
21.1% of patients at 30 days follow-up, with increased
incidence after implantation of the Medtronic Core
Valve prosthesis (28.2%) compared with the Edwards
SAPIEN prosthesis (12.0%; p = 0.001). Permanent
pacemaker implantation within 30 days was needed in
18.9% of patients, with an increased need after implantation of the Medtronic CoreValve prosthesis (25.5%)
compared with the Edwards SAPIEN prosthesis
(10.8%; p = 0.004).
Figure 1
The combined endpoint “early safety” at 30 days.
AKI = acute kidney injury.
Procedural learning curve
Device success at 72 hours was 84% in the first 175 patients, and 91% in the second (p = 0.02). All-cause mortality was 9.1% at 30 days (12% in the first half of the
patients and 6.3% in the second half; p = 0.07).[18] Major vascular complications and acute kidney injury decreased from 9.7% to 5.1% (p = 0.29), and from 6.9% to
4.6% (p = 0.36), respectively, without reaching statistical significance. Overall, the combined endpoint “early
safety” at 30 days was met in 19.1% of participants. Of
note, “early safety” decreased significantly from 23% in
the first 175 patients to 15% in the second (p = 0.04).
The need for permanent pacemaker implantation
within 30 days was 22.3% in the first half of patients
and 15.4% in the second half (p = 0.10).
Symptomatic improvement
At baseline, 4% (n = 14) of patients were in NYHA class
I, 24% (n = 83) in NYHA class II, 53% (n = 187) in
NYHA class III and 19% (n = 66) in NYHA class IV. At
30 days, 1 year, and 2 years follow-up, most patients
were in NYHA class I and II (p <0.001 vs baseline;
fig. 2). Nine percent of patients required rehospialisation because of congestive heart failure or other
valve-related complications within the first year after
TAVI. Up to 1 year after the procedure, 61/106 (58%)
patients were living independently at home.
Overall survival
The Kaplan-Meier survival analysis is depicted in
fig. 3. Survival was 79% at 1 year, 69% at 2 years, and
53% at 3 years. Most deaths were observed within the
first 6 months after the procedure. In our patient cohort, no significant survival differences were observed
between prosthesis types (p = 0.23), access sites (p =
0.07), gender (p = 0.27) and presence or absence of coronary artery disease (p = 0.39).
Table 3
TAVI-related complications. CPB = cardiopulmonary bypass;
TAV = transcatheter aortic valve.
Figure 2
Symptoms at baseline and after transcathetheter aortic valve implantation (TAVI).
NYHA = New York Heart Association.
TAVI-related complications
Myocardial infarction
periprocedural
7 (2.0)
5 (1.4)
Conversion to open surgery
6 (1.7)
Unplanned use of CPB
8 (2.3)
Cardiac tamponade
8 (2.3)
Annulus rupture
2 (0.6)
Endocarditis
0 (0)
Valve thrombosis
3 (0.9)
Valve malpositioning
8 (2.3)
TAV-in-TAV deployment
2 (0.6)
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Figure 3
Kaplan-Meier survival curve. Overall survival in the whole
patient cohort.
Predictors of all-cause mortality
survival
In a univariate Cox regression analysis, predictors of
all-cause mortality in descending order of HR were major vascular complications (HR 4.17, 95% CI 2.33–7.49,
p <0.001), major and life-threatening bleeding within
30 days (HR 3.86, 95% CI 2.15–6.93, p <0.001), baseline
NYHA class III or IV symptoms (HR 2.64, 95% CI 1.36–
5.15, p = 0.004), chronic obstructive pulmonary disease
(HR 1.92, 95% CI 1.17–3.16, p = 0.01), atrial fibrillation
(HR 1,74, 95% CI 1.10–2.76, p = 0.02), baseline creatinine levels (HR 1.01, 95% CI 1.00—1.01, p <0.001) and
baseline N-terminal pro brain natriuretic peptide (NTproBNP) (HR 1.00, 95% CI 1.00–1.00, p = 0.001).
In a multivariate Cox regression analysis, major
and life-threatening bleeding within 30 days (HR 4.74,
95% CI 2.03–11.07, p <0.001), chronic obstructive pulmonary disease (HR 3.41, 95% CI 1.71–6.81, p <0.001)
and NYHA class III or IV at baseline (HR 3.08, 95% CI
1.18–8.05, p = 0.02) were the strongest independent
predictors of all-cause mortality. Further predictors in-
follow-up (days)
Table 4
Cox regression analysis of all-cause mortality.
CABG = coronary artery bypass grafting; LBBB = left bundle-branch block; LVEF = left ventricular ejection fraction; NYHA = New York Heart Association.
Cox Regression Analysis of All-Cause Mortality
Univariate Analysis
Multivariate Analysis
Variable
HR
95% Cl
P-value
Use of Medtronic CoreValve prosthesis
1.36
0.85–2.18
0.20
HR
95% Cl
P-value
Transapical access
1.54
0.93–2.55
0.1
Age (>80 years)
1.16
0.71–1.91
0.55
Female sex
0.84
0.67–1.06
0.13
Diabetes mellitus
1.17
0.69–1.97
0.56
Hypertension
1.43
0.80–2.56
0.23
Atrial fibrillation
1.74
1.10–2.76
0.02*
1.41
0.75–2.65
0.29
Chronic obstructive pulmonary disease
1.92
Peripheral vascular disease
1.20
1.17–3.16
0.01*
3.41
1.71–6.81
0.001*
0.73–1.98
0.46
Cerebrovascular disease
Coronary artery disease
0.91
0.54–1.52
0.72
1.34
0.82–2.18
0.23
Previous CABG
1.03
0.60–1.74
0.93
Previous valve surgery
0.72
0.23–2.28
0.57
LogEuroSCORE (>20%)
1.15
0.65–2.03
0.63
NYHA class III/IV
2.64
1.36–5.15
0.004*
3.08
1.18–8.05
0.02*
NT-proBNP (pg/ml)
1.00
1.00–1.00
<0.001*
1.00
1.00–1.00
0.03*
Creatinine (μmol/l)
1.01
1.00–1.01
<0.001*
1.00
1.00–1.01
0.02*
LVEF (<35%)
1.84
0.98–3.44
0.06
Moderate to severe aortic regurgitation
1.26
0.73–2.18
0.41
Major/life-threatening bleeding
(30 days)
3.86
2.15–6.93
<0.001*
4.74
2.03–11.07 <0.001*
Major vascular complications (30 days)
4.17
2.33–7.49
<0.001*
0.75
0.22–2.53
New permanent pacemaker
0.77
0.43–1.40
0.40
New LBBB
1.51
0.89–2.55
0.12
0.64
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cluded increased NT-proBNP (HR 1.00, 95% CI 1.00–
1.00, p = 0.03), and creatinine levels (HR 1.00, 95% CI
1.00–1.01, p = 0.02). Uni- and multivariate predictors
of all-cause mortality at total follow-up are summarised in table 4.
Discussion
This study reports the Zurich University Hospital
TAVI experience in accordance with the revised
VARC-2 standardised endpoint definitions. During the
past 5 years, TAVI was performed with favourable clinical outcome as assessed using VARC-2. Indeed, the
composite endpoint “device success” was met in 88%,
and the composite endpoint “early safety” occurred in
19% of patients.
Device success was high without any differences
between access sites or prosthesis types. The difference
from previously reported success rates of up to 97% in
other registries is explained by the fact that the
VARC-2 standardised endpoint definitions for the first
time include absence of procedural mortality within 72
hours [17, 19, 20].
Complication rates observed in the patient cohort
treated at the Zurich University Hospital are comparable to previously reported ones [13, 21]. Mortality in
the whole patient cohort was 9.1% at 30 days without
any differences between access sites or prosthesis
types. Indeed, 30-day mortality rates ranging from
5.4% to 12.7% have been reported, with a marked decrease over time with the growing experience of operators, centres and the field at large [20, 22, 23]. The survival rates in our patient cohort are comparable to
other registries, with the majority of deaths occurring
within the first 3 months after the procedure [14, 24].
In the United Kingdom TAVI Registry survival was
92.9% at 30 days and 73.7% at 2 years [19]. Subgroup
analyses in TAVI patients have demonstrated that a
worse survival was observed in nontransfemorally
treated patients, which may at least in part be explained by the more adverse risk profile in those patients, including peripheral artery disease among other
problems [17]. Causes of death were cardiovascular in
most patients; in accordance with the VARC-2 criteria,
death of unknown cause and death caused by noncoronary vascular conditions including stroke are classified
cardiovascular [17]. Stroke rates of 2.9% are comparable to rates in other registries. Indeed, mostly silent
cerebrovascular events after TAVI are a major concern.
In a magnetic resonance imaging study, cerebral defects were reported in over 80% of TAVI patients [25].
These findings underline the importance of stroke prevention and support the development of novel embolism protection devices in the context of TAVI. In our
patient cohort, new left bundle-branch block was observed in 21% of patients, with an increased incidence
with the Medtronic CoreValve prosthesis as compared
with the Edwards SAPIEN prosthesis. This difference
has been attributed to the longer prosthesis skirt of the
device comprising the conduction system; however,
compression of the left ventricular outflow tract by the
dilatory balloon has also been debated [26, 27, 28]. In
previous reports, the incidence of TAVI-induced left
bundle-branch block varies considerably with incidences between 7% and 83% [26, 27, 29, 30].
In our patient cohort, the strongest independent
predictors of all-cause mortality were chronic obstructive pulmonary disease, NYHA class III or IV symptoms at baseline, and major or life-threatening bleeding within the first 30 days after TAVI. Major and
life-threatening bleeding has clearly been associated
with an increased mortality at 30 days, as well as
during 3 years of follow-up [10, 15, 31]. Chronic obstructive pulmonary disease and NYHA functional
class III or IV symptoms have previously been identified as strong independent predictors of mortality in
multivariate models, as were reduced left ventricular
ejection fraction or the presence of significant aortic regurgitation [12, 19, 32]. Impaired renal function, new
left bundle-branch block and the use of transapical access were further predictors of mortality after TAVI in
most studies [15, 19, 30, 32]. In our patient cohort,
these results could not be confirmed, which might be
largely owing to the retrospective nature of the registry
and the smaller number of patients included compared
with multicentre registries. Interestingly, in contrast to
patients undergoing SAVR, previous cardiac surgery
does not seem to influence survival after TAVI. Indeed,
consistent with our results, both previous coronary artery bypass grafting (CABG) and previous SAVR were
not identified as mortality predictors after TAVI [19,
24, 30, 33]. In the Transcatheter Valve Treatment Sentinel Pilot Registry, advanced age predicted higher
mortality in a multivariate analysis [21]. However, in
accordance with our patient cohort, other registries
failed to show this association [19, 24, 33]. These findings underline the observation that additional comorbidities rather than mere age itself determine longterm survival in those patients [15].
In line with worldwide TAVI experience, we observed a learning curve with this technique since its introduction at our institution in May 2008. The combined endpoints device success and “early safety”, including most important complications after TAVI, were
significantly reduced in the second half of patients
compared with the first half. Thirty-day-mortality, major vascular complications, the need for new permanent
pacemaker implantation, as well as acute kidney injury following TAVI, tended to be lower in the second
half of the patients, albeit without reaching statistical
significance. Learning curves in transcatheter valve
implantation have been investigated in detail at other
centres [34, 35]. Gurvitch et al showed a clear reduction
in 30-day mortality from 13.3% in the first half of the
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patients to 5.9% in the second half [35]. Trends in TAVI
outcome including significant reductions in major vascular complications, life-threatening bleedings and
acute kidney injury, as well as improved 1-year surviva, have recently also been demonstrated by the
PRAGMATIC Plus initiative [36]. These impressive results demonstrate that both operator and centre experience, as well as constant device optimisation, importantly affect outcome after TAVI. Furthermore, next
generation prosthesis designs already on the horizon
may address unresolved issues such as aortic regurgitation or conduction disturbances in near future.
VARC standardised endpoint definitions introduced into research practice in January 2011 have established a novel standard in outcome reporting,
thereby improving comparison of complications with
transcatheter valves. The revised version includes
some changes in outcome definitions and composite
endpoints including device success, clinical efficacy and
time-related valve safety [17]. These endpoint definitions warrant a concise and systemic analysis of outcome measures in this high-risk patient population,
and might further strengthen a standardised reporting
of complications.
Limitations of this study are its retrospective nature and the relatively small number of patients, which
might affect the validity of the regression analysis.
However, this registry defines characteristics and outcomes in a real-world patient population treated with
TAVI in Switzerland.
In conclusion, our data confirm the safety and feasibility of TAVI in an elderly high-risk patient population. Reporting TAVI-outcome according to the newly
revised VARC-2 standardized definitions, device success is met in 88% of patients, and the composite endpoint “early safety” is observed in 19% of patients.
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