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J. P. Bloom et al.
Not infrequently, multiple guidelines on the same topic will be produced by
medical and surgical subspecialty groups with disturbingly frequent disagreements
and discrepancies. Moreover, the language used and the process employed in creating these guidelines, including issues as fundamental as the specic level of evidence acceptable is not standardized and the processes used to develop them varies
signicantly from one society to another. With numerous organizations of multinational origin and multidisciplinary composition writing about complex topics each
from its own perspective, both inconsistencies in specic recommendations and
glaring gaps are inevitable [3]. Shaneyfelt etal. conducted a structured review of
279 guidelines focused on the process whereby they were constructed. They concluded that guidelines published in the peer-reviewed medical literature do not
adhere well to established methodological standards. They went on to say that the
greatest improvement is needed in the identication, evaluation and synthesis of the
scientic evidence [4].
In response to this chaos, guidelines for guidelines have been established. The
Institute of Medicine (Clinical Practice Guidelines We Can Trust. Report Brief
2011) has published standards [5]. They state specically that practice guidelines
must be based on a systematic review of the evidence, be developed by a multidisciplinary panel of experts, consider important patient subgroups, be based on a
transparent process that minimizes biases and conicts of interest, explain clearly
alternative care options and be revised as appropriate. In particular, there is a focus
on the composition of the writing group and management of conicts of interest.
As adopted by the American College of Cardiology, this includes a requirement
that the chairperson and at least 51% of the members have no relationships with
industry. Attention to the importance of including methodologists is also
increasing.
One of the major problems guideline writing groups face is the paucity of “high
quality” evidence. Accordingly, an explicit system of grading evidence is employed
by the American Heart Association and American College of Cardiology Task Force
on Clinical Practice Guidelines. The classication of recommendations and level of
evidence is shown in Table1. The class represents the strength of recommendation
and ranges from Class I (strong) to Class III (harm), with many recommendations
being IIa (“it is reasonable to consider”) and IIb (“may be considered”). The level
of evidence is based not on the strength of opinion of the authors, but on the quality
of evidence ranging from level A (multiple high quality randomized clinical trials)
to level C-EO (consensus based on expert opinion). In this way, there is transparency about the evidence base for the recommendation. It should be apparent that
there should be few Class I recommendations based on Level C evidence.
A nal note should be made regarding the application of guideline recommendations to individual patients in the clinical setting. Since the data on which the recommendations are based are, of necessity, derived from application of statistical
methodologies to populations of patients, the statistical probabilities are informative for the population as a whole but not directly for individuals [3]. The guidelines
cannot account for all of the comorbidities and risk factors of the individual patient.
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Table 1 Denitions of classication of recommendations and level of evidence
Classication of recommendation
Class I Conditions for which there is evidence and/or general agreement that a given treatment
is useful or effective
Class IIConditions for which there is conicting evidence and/or a divergence of opinion about
the usefulness/efcacy of a procedure or treatment
IIa: Weight of evidence is in favor of usefulness/efcacy
IIb: Usefulness/efcacy is less well established by evidence/opinion
Class
Conditions for which there is evidence and/or general agreement that the procedure
III
treatment is not useful/effective, and in some cases may be harmful
Level of evidence
LOE AData derived from multiple randomixed clinical trials
LOE BData derived from a single randomized trial or non-randomized studies
LOE CConsensus opinion of experts
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Accordingly, guideline recommendations can only be considered a foundation upon
which a patient specic recommendation can be made. They are the beginning of
the conversation, not the end.
Societal Guidelines
Acute aortic syndromes consist of three related conditions with similar clinical
characteristics and include aortic dissection, intramural hematoma and penetrating
aortic ulcer. Current societal guidelines pertaining to these entities include the 2010
US ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM [6], the 2011
Japanese Circulation Society (JCS) [7], the 2014 European Society of Cardiology
(ESC) [8] and the 2016 Canadian CCS/CSCS/CSVS guidelines [9]. All of these
guidelines dene Acute AD as occurring within 14days.
The ACCF/AHA, JCS and ESC guidelines are categorized by the Class of
Recommendation (COR) and Level of Evidence (LOE) (Table 1). While COR
reects the magnitude of benet over risk and corresponds to the strength of the
recommendation, the LOE denotes the condence in or certainty of the evidence
supporting the recommendation based on quality of pertinent research ndings.
Therefore, COR and LOE are assessed independently. When a recommendation is
designated as LOE C, that does not imply that the recommendation itself is weak.
In some cases, clinical benet is self-evident and the intervention is unlikely to
undergo randomized study [10].
The guidelines from the Canadian panel were developed using Grading of
Recommendations Assessment, Development and Evaluation (GRADE) methodology, with “Values and Preferences” to provide context to the recommendations [11].
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Acute Type AAortic Dissection (AAD), Intramural Hematoma
(IMH) andPenetrating Aortic Ulcer (PAU)
The most widely utilized classication scheme for acute aortic dissection (AAD) is
the Stanford classication system in which any aortic dissection involving the
ascending aorta is an AAD [12, 13]. The alternative DeBakey scheme subdivides
those AAD involving the ascending and descending aorta as Type I and a dissection
involving only the ascending aorta as Type II [12, 13].
The recommendations for initial management of AAD are fairly uniform across
society guidelines (Table2). All societies advocate for therapeutic reduction in wall
stress to limit the extension of the dissection and reduce the risk of developing endorgan damage and rupture. Both the US and European guidelines specically
recommend titrating intravenous beta-blockers as rst-line agents (Class I LOE C)
Table 2 Summary table of guidelines for the management of acute aortic syndromes from the
discussed international societies
Recommendations
Any thoracic
aortic
dissection
regardless of
anatomic
location
Type A acute
dissection
Type A IMH,
PAU
Urgent surgical
consultation
recommended
Initial
management
with medical
therapy
including pain
relief and blood
pressure control
is recommended
Denitive
management
with urgent
surgery
recommended
With organ
malperfusion—a
hybrid approach
should be
considered
Urgent treatment
recommended is
ACCF/
AHA 2010 JCS 2011
Class I,
LOE C
Class I,
LOE C
(vasodilator
therapy
should not
be initiated
prior to rate
control:
Class III,
LOE C)
Class I,
LOE B
Class I,
LOE C
b
Surgery
Class IIa,
LOE C
No specic
recommendation
No specic
recommendation
Class I, LOE C Class I,
Class IIa, LOE CClass
c
Medical, Class
I, LOE C
ESC
2014 CCS 2016
Class I,
LOE C
Class I,
LOE C
LOE C
IIa,
LOE B
Surgery
Class I,
LOE C
No specic
recommendation
No specic
recommendation
Strong
Recommendation,
Low-Quality
Evidence
(continued)
a
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109
Table 2 (continued)
Recommendations
Uncomplicated
type B aortic
dissection
Medical therapy
is always
recommended
ACCF/
AHA 2010 JCS 2011
Class I,
Class I, LOE C Class I,
LOE B
ESC
2014 CCS 2016
Strong
LOE C
Recommendation,
Medium Quality
Evidence
Consider
TEVAR
n/a Class IIb, LOE
C
Surgery: Class
III, LOE C
Class
IIa,
LOE B
First-line
Strong
Recommendation,
Medium Quality
Evidence
Complicated
type B aortic
dissection
TEVAR is
recommended
Surgery is
recommended
n/a Class I, LOE C Class I,
LOE C
n/a Class I, LOE C
d
Class
IIb,
n/a
n/a
LOE C
Uncomplicated
type B IMH,
PAU
Initial approach
is medical
treatment
Repetitive
imaging (MRI/
n/a n/a Class I,
LOE C
n/a n/a Class I,
LOE C
n/a
n/a
CT) is indicated
Complicated
type B IMH/
PAU
TEVAR should
be considered
Surgery may be
considered
n/a n/a Class
IIa,
LOE C
n/a n/a Class
IIb,
n/a
n/a
LOE C
a
Extended distal arch repair, if presenting with primary intimal tear or signicant aneurys-
mal disease
b
Hybrid approach—Ascending aorta and/or arch replacement associated with any percutaneous
aortic or branch artery procedure
c
For patients with ascending thoracic aortic dissection, all of the aneurysmal aorta and the proximal
extent of the dissection should be resected. A partially dissected aortic root may be repaired with
aortic valve resuspension. Extensive dissection of the aortic root should be treated with aortic root
replacement with a composite graft or with a valve sparing root replacement. If a Debakey Type II
dissection is present, the entire dissected aorta should be replaced
d
With severe complications directly related to aortic dissection where surgery is expected to
achieve improvement or stop progression
and non-dihydropyridine calcium channel-blocking agents as second line (Class I,
LOE C) to a heart rate of 60 beats per minute or less. Both societies suggest adding
additional agents such as other vasodilators or angiotensin-converting enzyme
inhibitors if necessary, to reduce systolic blood pressure less than 120mm Hg (Class
I, LOE C). Both societies warn that beta blockers should be used cautiously in the
setting of acute aortic regurgitation because they will block the compensatory
tachycardia (Class I, LOE C).
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The recommendations for denitive management of AAD are also similar across
the society guidelines. The US guidelines recommend urgent surgical consultation
for all patients diagnosed with thoracic aortic dissection regardless of the anatomic
location (ascending versus descending) as soon as the diagnosis is made or highly
suspected (Class I, LOE C). All three societies recommend emergency surgical
intervention for acute thoracic aortic dissection involving the ascending aorta
because of the high risk of associated life-threatening complications such as rupture
(Class I, LOE B). The Canadian guidelines specically recommend replacement of
the ascending aorta during systemic circulatory arrest with an open distal anastomosis to be used routinely for repair of acute type A dissections (Strong Recommendation,
Low-Quality Evidence). They go on to recommend that an extended distal arch
repair technique be considered for patients who present with acute type A dissection
and one of the following:
(a) Primary intimal entry tear in the arch or descending aorta
(b) Signicant aneurysmal disease of the arch (Strong Recommendation, Low-
Quality Evidence).
According to the US guidelines, in patients with ascending thoracic aortic dissection all of the aneurysmal aorta and the proximal extent of the dissection should
be resected. A partially dissected aortic root may be repaired with aortic valve resuspension. Extensive dissection of the aortic root should be treated with aortic root
replacement with a composite graft or with a valve sparing root replacement. If a
DeBakey Type II dissection is present, the entire dissected aorta should be replaced.
(Class I, LOE C).
There are certain scenarios where non-operative management of AAD is recommended. The JCS guidelines suggest medical treatment to be started under certain
conditions for type A dissection without complications or persistent pain where the
false lumen of the ascending aorta is thrombosed (Class IIa, LOE C). The European
guidelines suggest that a ‘wait-and-watch’ strategy (optimal blood pressure and
pain control with serial imaging) may be an option to be considered on an individual
patient basis, particularly in the case of substantial surgery risk (advanced age and
severe co-morbidities), smaller aortic dimensions (<50mm), and decreased IMH
thickness (<11mm) (Class I, LOE C).
Type AIntramural Hematoma andPenetrating Aortic Ulcers
ACC and ESC recognize IMH as separate but related conditions, however JCS does
not use the term IMH, and instead considers it to be a non-communicating aortic
dissection and apply those treatment guidelines to IMH.
The ACC and ESC guidelines conclude that the guidelines for treatment of Type
A IMH and PAU correspond to the treatment guidelines described for Type A
AAD.Therefore, emergency surgery is indicated in complicated cases of with pericardial effusion, periaortic hematoma, or large aneurysms and urgent surgery (<24h
after diagnosis) is required in most Type A IMHs (Class I, LOE C). It is worth
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noting that PAUs are less frequently located in the aortic arch and involvement of
the ascending aorta is rare. Surgical intervention is recommended in case of Type A
PAU (Class IIa, LOE C).
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Acute Type B Aortic Dissection (AAD), Intramural Hematoma
(IMH) andPenetrating Aortic Ulcer (PAU)
Aortic dissection isolated to the descending aorta is classied as Type B according
to the Stanford system, or Type III according to the Debakey system [14]. Ascending
aortic dissections are almost twice as common as descending dissections. Aortic
IMHs more commonly involve the descending aorta [15]. Most penetrating ulcers
are also located in the descending thoracic aorta (85–95%) [16]. This section will
discuss management and treatment guidelines for Type B dissections, intramural
hematomas and penetrating aortic ulcers.
Initial Management
As with Type A dissections, the ACCF guidelines recommend that Type B aortic
dissections are also initially managed medically with the goal of decreasing aortic
wall stress and controlling pain (Class I, LOE B). While the ACCF guidelines do not
offer detailed recommendations for management of TBAD, the ESC and JCS offer
more detailed guidelines regarding endovascular and surgical repair. An urgent surgical consult is recommended as soon as the diagnosis is made or suspected (Class
I, LOE C).
Contrary to Type A AD, surgical intervention is typically reserved for patients
with dissection associated complications—including end-organ malperfusion,
recurrent and refractory pain or refractory hypertension, rapid expansion of the false
lumen found during imaging surveillance, or dissection expansion and impending
rupture (Class II, LOE C). Broadly, the recommendations for treatment overlap
across the guidelines with minor differences in the level of evidence.
Uncomplicated Type B AD
Medical therapy is unequivocally recommended for all uncomplicated TBAD (Class
I, LOE B by ACC, Class I, LOE C by JSC and ESC, Strong Recommendation,
Medium Quality Evidence by CCS).
There remains some controversy with regard to the benecial role of early
Thoracic endovascular aortic repair (TEVAR) in uncomplicated TBAD compared to
medical therapy alone (Class IIa, LOE B by ESC and Class II, LOE C by JCS). The
CCS suggests that TEVAR may be considered for patients with uncomplicated disease to improve aorta-specic endpoints (Weak Recommendation, Low Quality
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Evidence). Two trials have been conducted to assess the benet of elective TEVAR
in uncomplicated TBAD.
The INSTEAD trial randomized 140 patients with sub-acute (>14days) type
B AD.Two year follow up indicated that TEVAR is effective in aortic remodeling (91.3 vs. 19.4% with medical therapy, P<0.001), however, no survival benet was observed [17]. The INSTEAD-XL trial included extended follow up of
the INSTEAD trial, and showed that aorta related mortality (6.9 vs. 19.3%,
respectively; P= 0.04) and disease progression (27.0 vs. 46.1%, respectively;
P=0.04) were lower after 5years in TEVAR patients compared to those receiving medical therapy. As with the initial trial, no difference was found in overall
mortality [18].
The ADSORB trial compared medical therapy alone vs. medical therapy +
TEVAR in acute complicated TBAD and showed that TEVAR conferred benets in
terms of aortic remodeling and lower rates of incomplete false lumen thrombosis.
This trial was underpowered to draw conclusions regarding survival benet [19].
Further studies are required to determine predictors of complications in patients
presenting with uncomplicated TBAD.
Complicated Type B AD
Based on IRAD data, a signicant one-third of patients with acute TBAD present
with complications such as malperfusion or hemodynamic instability. ESC and
JCS recommend TEVAR for complicated Type B AD (Class I, LOE C). The CCS
also recommends that endovascular repair be rst-line therapy for these patients
(Strong Recommendation, Medium Quality Evidence). TEVAR helps to close the
primary entry tear and perforation sites in the descending aorta, redirecting blood
ow into the true lumen. This leads to improved distal perfusion by decompression. It also helps resolve malperfusion of visceral or peripheral arteries and promotes thrombosis of the false lumen, which is the initiation for aortic remodeling
and stabilization.
There are no RCTs comparing TEVAR with open surgery in patients with
acute complicated TBAD.In a propensity analysis from IRAD, open surgical
repair was associated with an independent increased risk of in-hospital mortality
(OR: 3.41, 95% CI, 1.00–11.67, P = 0.05) [14]. In-hospital complications
occurred in 20% of patients subjected to endovascular techniques, and in 40%
after open surgical repair. In-hospital mortality was signicantly higher after
open surgery (33.9%) than after endovascular treatment (10.6%, P=0.002) [15].
Additionally, in the IRAD series, endovascular treatment seems to offer better
short term outcomes in terms of mortality and associated complications compared to open repair [16].
Results from the single arm, STABLE trial suggests that TEVAR therapy is associated with increased true lumen size, and favorable clinical and anatomic results
[20]. Subsequently, 1 year follow up from STABLE II demonstrated that
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113
TEVAR+medical therapy is associated with favorable clinical and anatomical outcomes for rupture and malperfusion in acute complicated TBAD [21]. TEVAR
might therefore offer better outcomes compared with open surgical approaches in
complicated cases.
Indications for open surgery in acute complicated TBAD include—lower extremity artery disease, severe tortuosity of iliac arteries, sharp angulation of the aortic
arch, and the absence of a proximal landing zone for the stent graft (Class
IIb, LOE C).
The aim of open surgical repair is to replace the descending aorta with a Dacron
prosthesis and redirect the ow into the true lumen of the downstream aorta by closing the false lumen at the distal anastomotic site, thereby improving perfusion and
TL decompression, which may resolve malperfusion [22].
Although the results of open surgical repair have improved over the last decades,
they still have an in-hospital mortality rate of about 25–50%. Predictors of poor
prognosis include patient age>70, hypotension/shock, severe visceral malperfusion and spinal cord ischemia preoperatively. In addition, extensive co-morbidity,
such as end stage malignant disease and severe chronic obstructive pulmonary disease are considered contraindications for surgical aortic repair.
Type B Intramural Hematoma andPenetrating Aortic Ulcers
As with TBAD, the initial approach to Type B IMH and PAU is medical treatment
(Class I, LOE C). The recommendations for endovascular therapy (Class IIa, LOE
C) and surgery (Class IIb, LOE C) are similar to those for Type B ADs as well. The
subgroup of patients with aortic dilation or ulcer-like projection (ULP) should be
followed up closely and treated more aggressively if symptoms persist or reappear,
or if progressive aortic dilation is observed [23] (Class I, LOE C). For patients presenting with expansion of the IMH despite medical therapy, or disruption of intimal
tear on CT with contrast enhancement in the acute phase, the recommended intervention is TEVAR rather than surgery.
The most common location of PAU is the middle and lower descending thoracic
aorta. The aim of treatment for PAU is to prevent propagation of the ulcerative process, leading to IMH, pseudoaneurysm or aortic rupture and progression to acute
AD.Studies have suggested that indications for intervention include refractory or
recurrent symptoms, penetration of the lesion through the aortic wall, expansion of
aortic diameter and PAU diameter> 20 mm and depth > 10 mm [24, 25]. While
unrelenting pain and rupture are clear indications for repair, the other indications are
not as absolute [26].
As for IMH, there are no RCTs directly comparing TEVAR vs. open surgery in
patients with acute PAU.Since these patients are more likely to be older and with
comorbidities, TEVAR is increasingly being used, with encouraging results
[27, 28].
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Future Directions
Further studies are required to clarify the association of aortic remodeling with
improved mid and long-term outcomes. Newer therapy such as proximal covered
stents and distal bare metal stents as used in the STABLE trial, as well as adjunctive
techniques like fenestration or branched graft stenting are in development.
Consensus regarding optimal timing for endovascular therapy in uncomplicated dissection in terms of patient selection and timing is required.
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