The first year of the Venlo percutaneous coronary intervention program: procedural and 6-month clinical outcomes
K. A. Mol
B. M. Rahel
R. P. Th. Troquay
J. G. Meeder
Objectives Analysis of the first results of off-site percutaneous coronary interventions (PCI) and fractional flow reserve (FFR) measurements at VieCuri Medical Centre for Northern Limburg in Venlo. Background Off-site PCI is accepted in the European and American Cardiac Guidelines as the need for PCI increases and it has been proven to be a safe treatment option for acute coronary syndrome. Methods Retrospective cohort study reporting characteristics, PCI and FFR specifications, complications and 6month follow-up for all consecutive patients from the beginning of off-site PCI in Venlo until July 2012. If possible, the data were compared with those of Medical Centre Alkmaar, the first off-site PCI centre in the Netherlands. Results Of the 333 patients, 19 (5.7 %) had a procedural complication. At 6 months, a major adverse cardiovascular event (MACE) occurred in 43 (13.1 %) patients. There were no deaths or emergency surgery related to the PCI or FFR procedures. There was no significant difference in occurrence of a MACE or adverse cerebral event between the Alkmaar and Venlo population in the 30-day follow-up. Conclusion This study demonstrates off-site PCI at VieCuri Venlo to have a high success rate. Furthermore, there was a low complication rate, low MACE and no procedurerelated mortality.
The number of percutaneous coronary interventions
(PCIs) has increased worldwide , as PCIs are widely
accepted as a safe treatment option for stable angina
and acute coronary syndrome (ACS) [2, 3]. This
increase is caused in part by demographic reasons (ageing
population) and lifestyle choices increasing
cardiovascular risk . The need for urgent cardiac surgery due to
complications of PCIs has decreased since the
introduction of coronary stents, better techniques, and improved
antiplatelet drugs [2, 3, 57].
To meet the increase in need for PCIs, it was proposed to
start PCIs at hospitals that do not have on-site facilities for
cardiac surgery back-up, so-called off-site PCIs. Initially,
the American cardiac societies advised against off-site
(non-primary) PCIs [8, 9], but this was adjusted after
numerous studies showed it to be safe . In the Dutch
and British Guidelines off-site PCIs have been accepted for
some time now [19, 20]. However, off-site centres do
require high operator and institutional volumes, as well as
a proven, tested plan for rapid transport to a nearby hospital
with cardiac surgical capability . A good
collaboration with cardiac surgeons, with regular heart team
meetings between cardiac surgeons and cardiologists is another
key factor for success of off-site PCI . Despite this,
there are also contradicting results showing off-site PCIs to
have a higher mortality .
The delay in the treatment of ST-segment elevation
myocardial infarction (STEMI) patients should be 90 min
or less [22, 23]. This should be achieved in the Netherlands
in 90 % of the STEMI patients . In the Venlo area, this
goal is only reached in about 60 % .
Off-site PCI started in the Netherlands in 2003. The
Medical Centre Alkmaar (MCA) was designated by the
Dutch Government as a trial off-site PCI centre . After
the success of this PCI centre, 14 other Dutch hospitals
started performing off-site PCIs. VieCuri Medical Centre
for Northern Limburg in Venlo started off-site PCIs in
2011, firstly driven to shorten the delay in treatment of
STEMI patients .
In this article we report the first results of off-site PCI
and fractional flow reserve (FFR) measurement at our
This is a retrospective cohort study from the start of PCIs at
VieCuri Venlo in September 2011 until July 2012.
All patients scheduled for a PCI and/or FFR procedure at
VieCuri Venlo were included. Patients undergoing FFR
measurements were also included, as the complications of
these patients can be similar [4, 27, 28]. No patients were
excluded after scheduling. The data of our study were, if
possible, compared with data from MCA .
PCI and FFR procedures
Patients were scheduled for a PCI and/or FFR procedure in
Venlo if they had ischaemic coronary artery disease.
Ischaemic coronary artery disease was defined as angina with
proven myocardial ischaemia or ACS. All indications were
discussed and agreed on by the Heart Team, led by an
interventional cardiologist and a cardiothoracic surgeon, from
Maastricht University Medical Centre (MUMC), by using an
advanced webviewer (Evocs, Fysicon, the Netherlands).
Emergency (surgical) back-up was also arranged via MUMC.
Patients did not undergo the procedure in Venlo if they
were eligible for PCI but classified as high risk. These
patients were sent to a tertiary hospital and were (mostly)
patients with unprotected left main artery vessel disease or
3-vessel coronary disease. In our first year most patients in
need of primary PCI were sent to Catharina Hospital
Eindhoven (CZE). No patients were sent for rescue PCI, as
thrombolysis is no longer a treatment option for ACS in
The choice for drug-eluting or bare-metal stent,
intravascular ultrasound and intra-aortic balloon pump was left to
the discretion of the interventional cardiologist. Rotablation
was not available in our hospital.
During the procedure, patients were given intravenous
heparin. All patients were treated with double antiplatelet therapy.
records. Lesion types are given according to the guidelines
The primary endpoint of this study was major adverse
cardiovascular events (MACE) at 6 months, a combined
endpoint of mortality, myocardial infarction (MI) and/or
revascularisation. The secondary endpoint was major adverse
cardiovascular and cerebral events (MACCE) at 6 months,
including (non-)cardiac mortality, (non-)target vessel MI,
target, non-target or FFR vessel re-PCI, emergency or
semielective coronary artery bypass graft (CABG), and ischaemic
or haemorrhagic cerebrovascular accident, major or minor
bleeding described by the thrombolysis in myocardial
infarction bleeding criteria (TIMI)  and the need for blood
transfusion. Follow-up was found in medical records or
acquired through the general practitioner.
Only elective PCIs were compared between Venlo and
Alkmaar as the study from Alkmaar included patients who
underwent PCI (and not FFR measurement), and our study
primarily consisted of elective PCIs. As Alkmaar only
started elective PCIs in their second year, our first-year
results are compared with their second-year results. The
endpoints are compared at 30-day follow-up.
Data were collected and analysed by an independent
investigator in SPSS version 19. Frequencies, means
and medians were calculated and the 2 or Fishers
exact test was used to compare the results of the two
hospitals. A p-value of <0.05 was considered to be
A total of 333 patients underwent a PCI and/or FFR
procedure in the study period at VieCuri. In these patients 330
lesions were treated with PCI and 143 lesions were
evaluated with FFR. No patients were excluded.
Baseline characteristics including risk factors and
comorbidities are summed up in Table 1. All characteristics
were normally distributed among the PCI and FFR groups. A
P2Y12 inhibitor was prescribed in 94.0 % of the patients. In
the group of patients who underwent a PCI, a P2Y12 inhibitor
was prescribed in 100 % of the patients before the procedure.
Data and outcome measures
Baseline characteristics, PCI and FFR characteristics and
complications were retrospectively found in medical
Of the 257 PCIs, 23 were primary PCIs. Overall, the
procedures were successful in 94.9 % of the patients.
MultiTable 1 Baseline characteristics and prescribed medication
CAD coronary artery disease, TIA transient ischaemic attack, LVEF
left ventricular ejection fraction, ACE angiotensin-converting-enzyme
vessel PCI was performed in 26 patients. The patients with
4 lesions all had at least one FFR measurement.
The procedure was unsuccessful in 20 cases. This
was mostly due to failure to cross the lesion with a
wire or the need for rotablation. Causes for the inability
to pass a wire across the lesions were small vessels,
extensive calcifications or 90 bends in the vessels.
Lesion types were as followed: type A 25.2 %, type
B1 20.1 %, type B2 31.1 % and type C 23.7 %.
Further angiographic characteristics are mentioned in
In total, 19 (5.7 %) patients had a procedural complication.
In three patients PCI was complicated by no-reflow.
The first patient had a PCI of a venous graft and
suffered an inferior MI due to no-reflow. No embolic
protection device was used, as it was judged not
PCI percutaneous coronary intervention, DES drug-eluting stent, LM
left main coronary artery, LAD left anterior descending coronary
artery, RCX ramus circumflex coronary artery, RCA right coronary
necessary in this patient. In the other two patients,
noreflow in native vessels during PCI was accepted and
treated conservatively. One of these patients suffered
from a non-STEMI, the other had a minimal isolated
rise in troponin.
No patients died due to a complication of the procedure
or required cardiac surgery as a result of the procedure. One
patient did, however, require surgery at the arterial access
site due to excessive bleeding. The median fluoroscopy
time was 7.13 min This was longer during PCIs then during
FFR procedures (7.27 vs. 4.26 min) and the longest in
patients who required both FFR measurement and PCI
Table 3 Procedural complications of PCI and/or FFR
MI myocardial infarction, CVA cerebrovascular accident, TIMI
thrombolysis in myocardial infarction, Bleeding as described by the TIMI
There were 32 (9.6 %) patients with minimal bleeding.
This was not defined as a complication. In Table 3 an account
of the complications in the study population is given.
Follow-up at 6 months
At the 6-month follow-up a MACE occurred in 43 (13.1 %)
patients. In the follow-up period of 6 months, seven
patients died. None of the deaths were related to the PCI or
Among the seven deaths, there were three
noncardiac deaths. One patient died of severe chronic
obstructive pulmonary disease. The second patient died of
cerebral haemorrhage (using double antiplatetet therapy)
and the third patient died of hypoxic respiratory failure
due to pneumonia. The other four patients had
cardiacrelated deaths. In two patients, admitted with severe
haemodynamic instability due to acute MI, primary
PCIs were performed in our hospital as transportation
to CZE was judged impossible. Neither of these patients
had had a PCI before this event. One of these patients
suffered from a massive subacute anterior wall MI.
Despite thrombosuction and stent placement during
PCI, the flow was not restored. The patient developed
pneumonia and died 2 days later. The other patient
suffered from an inferior MI with expansion to the right
ventricle. Coronary flow was restored during PCI.
However, the patient had pulseless electrical activity on the
intensive care unit during hypothermia treatment despite
pacing and medication. The third cardiac-related death
was a patient who died due to a posterior wall rupture
during weaning from the heart-lung machine after mitral
valve surgery for endocarditis. The former PCI was a
work-up before surgery. The last patient, with an
extensive history including pulmonary disease and a recently
operated rectal carcinoma, died after resuscitation for
sudden bradycardia followed by asystole. This happened
4 months after bare-metal stent implantation for diffuse
stenosis of the right coronary artery. The family did not
consent to autopsy.
All bleeding during follow-up was of gastrointestinal
origin (Table 4).
Characteristics and follow-up compared with MCA
When comparing the populations from Venlo and Alkmaar,
most characteristics and specifications did not differ
significantly. However, the Alkmaar population had significantly
more patients with two lesions and significantly less
patients with one lesion (Table 5).
MACE major adverse cardiac events, MI myocardial infarction, PCI
percutaneous coronary intervention, CABG coronary artery bypass
graft, Bleeding as described by the TIMI bleeding criteria
Table 4 Six-month follow-up
Table 5 Comparison Venlo and Alkmaar
PCI percutaneous coronary intervention, LM left main coronary artery,
LAD left anterior descending coronary artery, RXC ramus circumflex
coronary artery, RCA right coronary artery, LVEF left ventricular
The 30-day MACCE-free survival is not significantly
different between the Venlo and Alkmaar populations.
The other endpoints did not occur enough to compare
statistically (Table 6).
Table 6 Thirty-day follow-up at Venlo and Alkmaar
PCI percutaneous coronary intervention, CABG coronary artery
bypass graft, AMI acute myocardial infarction, CVA cerebrovascular
accident, MAC(C)E major adverse cardiovascular (and cerebral)
events, Cath lab catheterisation laboratory
This study reports the first results of off-site PCI and/or
FFR procedures in Venlo. The results show a low
occurrence of complications and MACE resulting in a successful
early outcome of off-site PCIs.
In the study population 19 (5.7 %) patients suffered from
a procedural complication. In the 6-month follow-up a
MACE occurred in 43 (13,1 %) patients, mostly re-PCI.
Only seven patients died. None of the deaths were directly
related to the PCI or FFR procedure. The success rate was
high at 94.9 %.
Patients who underwent FFR without subsequent PCI
were either proven to have significant 3-vessel disease by
FFR evaluation and considered eligible for CABG, or were
proven to have no significant vessel disease at all.
For the first stage of off-site PCIs at VieCuri it was
decided to perform only elective PCIs. Despite this, 23
primary PCIs were performed in the study period, mostly
because the condition of the patients was judged to be too
critical for transportation to a tertiary hospital. Two of these
patients died within 2 days due to the extent and
complications of the acute MI. Around-the-clock intervention of
primary PCIs will be introduced in a second stage after
which the delay in STEMI patients in our region is
expected to be significantly reduced as transportation to a
tertiary centre is no longer needed. The goal of 90 % of the
patients within 90 min should be achieved when primary
PCIs are introduced in the Venlo area .
As all patients scheduled for a PCI with stent placement
require a P2Y12 inhibitor , analysis of prescribed
medication in our study population was performed. In total
94.0 % of the patients received a P2Y12 inhibitor. All of
the 20 patients not receiving a P2Y12 inhibitor only had a
FFR measurement performed. There were two reasons why
these patients did not receive a P2Y12 inhibitor. They were
either scheduled for a diagnostic coronary catheterisation
during which the interventional cardiologist decided to
evaluate a moderate stenosis with FFR, or they were
scheduled for CABG and further evaluation of a moderate
stenosis was needed.
When comparing the elective PCIs of this study with the
elective PCIs of the first off-site PCI centre, Alkmaar, most
baseline characteristics and PCI specifications are not
significantly different. However, a significant difference is the
number of lesions per patient. This can partly be explained
by the fact that we compared our first-year data to their
second-year data. At the start of the off-site PCIs in Venlo it
was decided to perform high-risk procedures at a tertiary
hospital. Excluding high-risk patients from treatment at an
off-site PCI centre is recommended by the Society for
Cardiac Angiography and Interventions . However, more
high-risk procedures could be performed in Venlo as
numerous studies have shown acceptable outcomes in
highrisk patients [1214, 31].
The 30-day follow-up in the two study groups does not
differ significantly, thus showing the early outcome of
offsite PCI at Venlo to be as successful as Alkmaar.
As this is a retrospective study, not all data could be
obtained. Also, not all our data could be compared with
the study population from Alkmaar as the studies looked
into different baseline characteristics and specifications of
the PCI procedures. We did not compare our data to an
onsite PCI centre.
This study reports the outcome of the first stage of off-site
PCIs and FFR measurements at VieCuri Medical Centre for
Northern Limburg in Venlo. It demonstrates that, though in
a limited patient group, off-site PCI at VieCuri Venlo has a
high success rate. Furthermore it shows a low complication
rate, low MACE and no procedure-related mortality.
Acknowledgments The authors thank Dr. J.O.J. Peels for providing
the data from the Medical Centre Alkmaar.
Conflict of interests
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