Download Management of severe aortic stenosis

CLINICAL 61
Management of
severe aortic stenosis
A team from Trinity College Dublin describes the protocol involved
in the assessment of elderly patients for transcatheter aortic valve
implant (TAVI) and the role of the cardiology CNS
Table 1: Recommendations for the use of
transcatheter aortic valve implantation
Recommendations
ClassA
LevelB
TAVI should only be undertaken with a multidisciplinary ‘heart team’ including I
cardiologists and cardiac surgeons and other specialists if necessary
C
TAVI should only be performed in hospitals with cardiac surgery on-site
I
C
TAVI is indicated in patients with severe symptomatic AS who are not suitable I
for AVR as assessed by a ‘heart team’ and who are likely to gain improvement
in their quality of life and to have a life expectancy of more than one year
after consideration of their comorbidities
B
TAVI should be considered in high-risk patients with severe symptomatic AS IIa
who may still be suitable for surgery, but in whom TAVI is favoured by a ‘heart
team’ based on the individual risk profile and anatomic suitability
B
There are a number of inclusion and
exclusion criteria for TAVI patients.
TAVI exclusion criteria
• Symptomatic native aortic valve stenosis
with an aortic valve area < 1cm2
• Echographic aortic valve annulus diameter: 20-27mm
• Ascending aortic diameter < 43mm
• Iliac and femoral artery diameter > 7mm
• Contraindications for surgery because
of comorbidities including chronic pulmonary disease; chronic kidney disease;
peripheral vascular disease; prior cardiac
surgery (as agreed with cardiologist and
cardiac surgeon); liver cirrhosis; hostile
thoracic/chest radiation; severe cardiothoracic disease; and porcelain aorta (for
femoral and subclavian approach)
• Surgical Risk Score - EuroSCORE
TAVI exclusion criteria
• Femoral, iliac or aortic pathologies
• Aortic aneurysm
• C arotid/vertebral artery obstruction
>70%
• Co-agulopathy
• Cognitive impairment
• MI or CVA previous month
• Left ventricular thrombus
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risk.6 TAVI is recommended under current
ESC 2012 Guidelines for these patients,
who have been deemed unsuitable for
conventional open heart surgery due to
multiple comorbidities.
The first TAVI case performed in an Irish
healthcare setting took place in December
2008, with 93 TAVI procedures performed
in St James’s Hospital, Dublin since then.
TAVI procedure
Prior to TAVI, patients undergo thorough assessment and preparation to
determine their suitability for the procedure and to ensure an informed decision
is made by the patient and family. One of
the first roles of the cardiology CNS is to
partake in patient education to assist the
patient and their family make an informed
decision about their care.
Clinical decision making should be a
shared process between the patient and
the multidisciplinary team. As this is a
relatively new treatment option in Ireland the CNS should have a good level of
knowledge regarding severe AS, TAVI risks,
type of procedures, benefits, perioperative
and post procedural complications to sufficiently inform the patient.
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Aortic stenosis (AS) is the most prevalent valvular heart disease and the third
most common cardiovascular condition,
after coronary artery disease and hypertension.1 Severe AS has been documented
in 2-7% of patients greater than 65 years
of age with incidence higher in men than
in women. 2 Transcatheter aortic valve
implant (TAVI) was introduced for patients
with severe AS in 2002,3 as the shift from
surgery for highly symptomatic elderly
patients, to less invasive procedures
reached the field of heart valves.
This new innovative cardiology procedure is rapidly evolving to treat inoperable
AS patients and has been introduced into
some hospitals in Ireland. This article
describes the protocol and algorithms
involved in the assessment of older
patients for TAVI and the role of the clinical nurse specialist (CNS) in this.
Background
The number of Irish people over the age
of 65 is expected to increase by almost
50% between 2011 and 2026.4 As a result,
the burden of cardiac disease among older
people who are highly symptomatic will
continue to rise. Older age is an independent risk factor for higher mortality and
morbidity in cardiac populations.
Aortic valve replacement (AVR) in otherwise fit octogenarians can be performed
with a relatively low mortality and morbidity rate. Elderly patients who have
a heavy burden of co-morbid diseases,
which are likely to lead to complications
and an increased risk of adverse outcomes,
are not offered this option. However, AS is
progressive and will not improve without
treatment.
Untreated AS can lead to pulmonary
hypertension, arrhythmias, endocarditis,
myocardial infarction, congestive heart
failure and sudden death. 5 Elderly AS
patients who do not have AVR intervention, have a >12 fold increase in mortality
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62 CLINICAL
• Uncontrolled atrial fibrillation
• Sepsis or active endocarditis.
The work-up assessment for TAVI is
performed by the multidisciplinary team;
which currently includes two interventional cardiologists, a cardiothoracic
surgeon, a cardiology Imaging consultant
and a cardiology CNS.
Patients undergo a comprehensive work-up prior to TAVI with a full
comprehensive health history, comprehensive physical examination; full
blood screen including FBC, U&E, coagulation and liver profile; MRSA screen;
ECG; transoesphageal ECHO; CT coronary angiogram; transthoracic ECHO;
coronary and peripheral angiogram;
aortogram; pulmonary function test and
carotid doppler.
The CNS currently plays a major part in
collating the patient history, performing a
full physical examination, assessing their
quality of life and level of frailty. Centres
in Ireland and across Europe have dedicated advanced nurse practitioners (ANPs)
for patient screening, assessment and ANP
clinic evaluation. Clinical history taking
is the first step in assessing AS severity.
Severity is indicated by progressive symptoms such as decreased exercise tolerance
or shortness of breath on exertion,7 which
will need to be assessed. 8 Heart failure,
angina and syncope are late manifestations of this challenging disease process
and may also be present.
Additional symptoms associated with
underlying co morbidities, which are
also important to note, need also to be
assessed. Tailoring individual patient
assessment, planning and intervention
can be enhanced by ensuring the CNS/
ANP has a good understanding of TAVI
clinical outcomes. Once the full work-up
is completed and patients are deemed
suitable and agree to TAVI, the procedure is performed using the technique
most appropriate for the patient. There
are multiple access routes whereby a
transcatheter valve can be deployed:
transfemoral, transapical, trans-subclavian and transaortic.
Direct transaortic insertion by way of
a mini-thoracotomy is the latest method
over transapical approach. Percutaneous
TAVI is mainly performed using a retrograde transfemoral route under local
anaesthetic. In cases where there is evidence of diseased, tortuous, calcified
femoral and iliac arteries the trans-subclavian, transapical, transaortic routes
are assessed for suitability. All three of
Figure 1: Management of severe aortic stenosis
ESC/EACTS Guidelines 2012
AS = aortic stenosis
AVR = aortic valve replacement
BSA = body surface area
LVEF = left ventricular ejection fractionMed Rx = medical therapy
TAVI = transcatheter aortic valve implantation.
b Surgery should be considered (IIaC) if one of the following is present: peak velocity >5.5m/s; severe valve calcification + peak velocity progression ≥0.3 m/s/year. Surgery may be considered (IIbC) if one of the following is
present: markedly elevated natriuretic peptide levels; mean gradient increase with exercise >20 mmHg; excessive
LV hypertrophy.
c The decision should be made according to individual clinical characteristics and anatomy
these methods of insertion require general anaesthetic. There are two valves
currently on the market; CoreValve and
Edwards Sapien. The CoreValve is a nitinol
stent with porcine pericardium leaflets.
The Edwards Sapien stent has a balloon
expandable cobalt chromium frame with
bovine pericardial tissue.
TAVI procedure requires a dedicated
expert cardiac catheterisation laboratory
team including nurses, doctors and cardiac
technicians and in addition, coronary care
unit (CCU) nurses for post procedural care.
TAVI patient outcomes
The first multicentre prospective randomised control trial of TAVI patients, the
Placement of AoRtic TraNscathetER Valves
(PARTNER) trial, took place in 2010. The
PARTNER trial compared TAVI patient
outcomes to either conventional AVR or
standard medical therapy, both for severe
symptomatic elderly patients. TAVI was
identified as reducing mortality, when
compared to surgical patients; 30-day
mortality: 3.4% versus 6.5% respectively
and one-year mortality 24.2% versus
26.8% respectively.9 After one year, there
was no significant difference between
TAVI and AVR in relation to cardiovascular
death 14.3% versus 13%.10
Following this, the German Aortic Valve
Registry (GARY Trial, 2011) was designed
to review and govern current outcomes
and to evaluate safety and effectiveness
of TAVI.11 The GARY trial did not observe
a significant difference in mortality
between TAVI patients and CABG but it
did observe a reduction in cerebrovascular complications. Similarly of the 93
patients undergoing TAVI in this Irish
centre none of the patients had a complicated cerebrovascular accident, which
is consistent with the experience of the
GARY Registry.
Throughout the literature, the
p e r i p ro c e d u r a l s t ro ke r a t e r a n g e d
between 0%-8%. 8,12,13 It is important to
note although AVR stroke rate occurred
in 3% of octogenarians,14 TAVI patients
have multiple co-morbidities including
atherosclerosis which predisposes these
patients to stroke. TAVI procedural suc-
CLINICAL 63
cess currently in the literature is achieved
in 86-100% of cases using the transfemoral approach.12,15,16 Presently procedural
mortality rates account for <10% for
transfemoral implant and <14% for
transapical approach.11 The Irish procedural
mortality rate of 2% was in line with international findings.
Improvement in HRQOL is recognised
as a therapeutic benefit specifically for
elderly valve surgery patients, particularly
when increased survival may be neither
likely nor sought by the patient.17 There is a
demonstrable lack of research focusing on
HRQOL and no consensus on the definition
and measurement of QOL despite Macduff
highlighting the need to assess health care
outcomes using HRQoL in addition to
mortality and morbidity.18 The PARTNER
trial, Cohort A, highlighted a remarkable
improvement in HRQoL within one month
of TAVI when compared to AVR; however,
similar benefits occurred over the one year
follow-up in both groups.
Sinéad Teehan is a cardiology clinical nurse specialist
at St James’s Hospital, Dublin; Gabrielle McKee is
associate professor of biological sciences, School of
Nursing and Midwifery, TCD; and Dr Orla Dempsey is
quantitative healthcare lead at the Centre for Practice
and Healthcare Innovation, TCD
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