Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3876_Библиотеки_им_академика_М_И_Перельмана
.pdf
230
https://t.me/medicina_free
11 Intermittent Claudication
11.1.2 American College ofCardiology/American
Heart Association
The American College of Cardiology/American Heart Association guidelines [2]
recommend:
11.1.2.1 Medical Therapy
• Antiplatelet therapy with aspirin alone (range 75–325mg per day) or clopidogrel
alone (75mg per day) is recommended to reduce myocardial infarction (MI),
stroke, and vascular death in patients with symptomatic peripheral artery disease
(PAD). (Recommendation class I/Level of evidence A).
• Treatment with a statin medication is indicated for all patients with
PAD. (Recommendation class I/Level of evidence A).
• The usefulness of anticoagulation to improve patency after lower extremity
autogenous vein or prosthetic bypass is uncertain. (Recommendation class IIb/
Level of evidence B-R).
• Cilostazol is an effective therapy to improve symptoms and increase walking
distance in patients with claudication. (Recommendation class I/Level of evidence A).
• Patients with PAD who smoke cigarettes should be assisted in developing a plan
for quitting that includes pharmacotherapy (i.e., varenicline, bupropion, and/or
nicotine replacement therapy) and/or referral to a smoking cessation program.
(Recommendation class I/Level of evidence A).
11.1.2.2 Structured Exercise Therapy
• In patients with claudication, a supervised exercise program is recommended to
improve functional status and QoL and to reduce leg symptoms. (Recommendation
class I/Level of evidence A).
• A supervised exercise program should be discussed as a treatment option for
claudication before possible revascularization. (Recommendation class I/Level
of evidence B-R).
• In patients with PAD, a structured community- or home-based exercise program
with behavioral change techniques can be benecial to improve walking ability
and functional status. (Recommendation class IIa/Level of evidence A).
• In patients with claudication, alternative strategies of exercise therapy, including
upper-body ergometry, cycling, and pain-free or low-intensity walking that
avoids moderate-to-maximum claudication while walking, can be benecial to
improve walking ability and functional status. (Recommendation class IIa/Level
of evidence A).
11.1 Guidelines
https://t.me/medicina_free
11.1.2.3 Revascularization forClaudication
• Revascularization is a reasonable treatment option for the patient with lifestyle-
limiting claudication with an inadequate response to GDMT (guideline-directed
management and therapy). (Recommendation class IIa/Level of evidence A).
• Endovascular procedures are effective as a revascularization option for patients
with lifestyle-limiting claudication and hemodynamically signicant aortoiliac
occlusive disease. (Recommendation class I/Level of evidence A).
• Endovascular procedures are reasonable as a revascularization option for patients
with lifestyle-limiting claudication and hemodynamically signicant femoropopliteal disease. (Recommendation class IIa/Level of evidence B-R).
• The usefulness of endovascular procedures as a revascularization option for
patients with claudication due to isolated infrapopliteal artery disease is unknown.
(Recommendation class IIb/Level of evidence C-LD).
• Endovascular procedures should not be performed in patients with PAD solely to
prevent progression to CLI. (III: Harm/Level of Evidence B-NR).
• When surgical revascularization is performed, bypass to the popliteal artery with
autogenous vein is recommended in preference to prosthetic graft material.
(Recommendation class I/Level of evidence A).
• Surgical procedures are reasonable as a revascularization option for patients with
lifestyle-limiting claudication with inadequate response to GDMT, acceptable
perioperative risk, and technical factors suggesting advantages over endovascular procedures. (Recommendation class IIa/Level of evidence B-NR).
• Femoral-tibial artery bypasses with prosthetic graft material should not be used
for the treatment of claudication (III: Harm/Level of evidence B-R).
• Surgical procedures should not be performed in patients with PAD solely to pre-
vent progression to CLI. (III: Harm/Level of Evidence B-NR).
231
Note: R=randomized; NR=Nonrandomized; LD=Limited data.
11.1.3 Society forVascular Surgery (SVS)
The SVS guidelines [3] are in accordance with the other guidelines referred here
regarding medical therapy and noninterventional management. These recommendations are therefore—in order to avoid redundancy—not listed here. Recommendations
for revascularization are among others:
11.1.3.1 General Recommendations
• We recommend EVT (endovascular therapy) or surgical treatment of IC for
patients with signicant functional or lifestyle-limiting disability when there is a
reasonable likelihood of symptomatic improvement with treatment, when phar-
232
https://t.me/medicina_free
11 Intermittent Claudication
macologic or exercise therapy, or both, have failed, and when the benets of
treatment outweigh the potential risks.
(Recommendation grade I/Level of evidence B).
• We recommend an individualized approach to select an invasive treatment for
IC. The modality offered should provide a reasonable likelihood of sustained
benet to the patient (>50% likelihood of clinical efcacy for at least 2years).
For revascularization, anatomic patency (freedom from hemodynamically signicant restenosis) is considered a prerequisite for sustained efcacy.
(Recommendation grade I/Level of evidence C).
11.1.3.2 Recommendations forInterventions inAortoiliac Occlusive
Disease (AIOD) inIC
• We recommend endovascular procedures over open surgery for focal AIOD
causing IC. (Recommendation grade1/Level of evidence B).
• We recommend endovascular interventions as rst-line revascularization therapy
for most patients with common iliac artery or external iliac artery occlusive disease causing IC. (Recommendation grade 1/Level of evidence B).
• We recommend the selective use of BMS (bare-metal stent) or covered stents for
aortoiliac angioplasty for common iliac artery or external iliac artery occlusive
disease, or both, due to improved technical success and patency. (Recommendation
grade 1/Level of evidence B).
• We recommend the use of covered stents for treatment of AIOD in the presence
of severe calcication or aneurysmal changes where the risk of rupture may be
increased after unprotected dilation. (Recommendation grade 1/Level of evidence C).
• In all patients undergoing revascularization for AIOD, we recommend assessing
the CFA (common femoral artery). If hemodynamically signicant CFA disease
is present, we recommend surgical therapy (endarterectomy) as rst-line treatment. (Recommendation grade 1/Level of evidence B).
• We recommend direct surgical reconstruction (bypass, endarterectomy) in
patients with reasonable surgical risk and diffuse AIOD not amenable to an endovascular approach, after one or more failed attempts at EVT, or in patients with
combined occlusive and aneurysmal disease. (Recommendation grade 1/Level of
evidence B).
11.1.3.3 Recommendations forIntervention forFemoropopliteal
Occlusive Disease (FPOD) inIC
• We recommend endovascular procedures over open surgery for focal occlusive
disease of the SFA (supercial femoral artery) not involving the origin at the
femoral bifurcation. (Recommendation grade 1/Level of evidence C).
11.1 Guidelines
https://t.me/medicina_free
• For focal lesions (<5cm) in the SFA that have unsatisfactory technical results
with balloon angioplasty, we suggest selective stenting. (Recommendation grade
2/Level of evidence C).
• For intermediate-length lesions (5–15 cm) in the SFA, we recommend the
adjunctive use of self-expanding nitinol stents (with or without paclitaxel) to
improve the midterm patency of angioplasty. (Recommendation grade 1/Level of
evidence B).
• We recommend against [negative recommendation] EVT of isolated infrapopli-
teal disease for IC because this treatment is of unproven benet and possibly
harmful. (Recommendation grade 1/Level of evidence C).
• We recommend surgical bypass as an initial revascularization strategy for
patients with diffuse femoropopliteal disease, small caliber (<5mm), or extensive calcication of the SFA, if they have favorable anatomy for bypass (popliteal artery target, good runoff) and have average or low operative risk.
(Recommendation grade 1/Level of evidence B).
• We recommend using the saphenous vein as the preferred conduit for infraingui-
nal bypass grafts. (Recommendation grade 1/Level of evidence A).
• In the absence of suitable vein, we suggest using prosthetic conduit for femoro-
popliteal bypass in claudicant patients, if the above-knee popliteal artery is the
target vessel and good runoff is present. (Recommendation grade 2/Level of evidence C).
233
11.1.4 “Appropriate Use”: Criteria oftheSVS forIC
Appropriate use criteria (AUC) for the management of intermittent claudication
were created by the SVS [4]. The recommendations are:
• First, exercise therapy is the preferred initial management strategy for all patients
with IC.
• Second, for patients who have not completed exercise therapy, invasive therapy
might provide net a benet for selected patients with IC who are nonsmokers, are
taking optimal medical therapy, are considered to have a low physiologic and
technical risk, and who are experiencing severe lifestyle limitations and/or a
short walking distance.
• Third, considering the long-term durability of the currently available technology,
invasive interventions for femoropopliteal disease should be reserved for patients
with severe lifestyle limitations and a short walking distance.
• Fourth, in the common femoral segment, open common femoral endarterectomy
will provide greater net benet than endovascular intervention for the treatment of IC.
• Finally, in the infrapopliteal segment, invasive intervention for the treatment of
IC is of unclear benet and could be harmful.
234
https://t.me/medicina_free
11 Intermittent Claudication
11.1.5 Reporting Standards oftheSVS forEndovascular
Treatment ofChronic Lower Extremity Peripheral
Artery Disease
The purpose of this document is to provide an overview and summary for the reporting of endovascular revascularization techniques in the setting of chronic disease [5].
11.1.5.1 Intervention
1. Reports should characterize anatomic location (vessel-specic reporting) and
primary vs. secondary intervention.
2. Angioplasty trials should report denitive balloon diameter and length.
3. Stent trials should document predilation and other adjuncts in addition to denitive diameter and length.
4. Atherectomy trials should report device-specic data, such as treatment time,
quantitative measures of plaque excision, and use of embolic protection device.
5. Radiation dose, contrast volume, total treatment time, and intraprocedural pharmacology should be recorded.
11.1.5.2 Outcome Measures: Procedural
1. Technical success is dened as successful use of a device or technique to establish vessel patency with a residual stenosis <30%. Procedural success is dened
as technical success and completion of the procedure without complications
(see later).
2. Hemodynamic success is dened as a pressure gradient <10 mmHg across a
lesion or corresponding increase in ABI of 0.10 or toe pressure of 0.10. Other
measures of hemodynamic success (such as pulse volume recording amplitude)
may be acceptable.
3. Patency is evaluated by an accepted imaging technique of the specic arterial
site treated that clearly shows ow through the lesion.
4. Within the context of a clinical trial, duplex ultrasound should be considered the
standard for patency and restenosis surveillance. A peak systolic velocity>300cm/s or peak systolic velocity ratio>3.0 indicates restenosis.
5. Target lesion revascularization can be driven by clinical, anatomic, and hemodynamic indications and as such does not always contribute to the assessment of
clinical failure. It should not be used as a primary end point.
11.1 Guidelines
https://t.me/medicina_free
11.1.5.3 Outcome Measures: Disease Specic
1. In addition to anatomic and hemodynamic measures of success, claudication trials should include disease specic quality of life outcome measures and functional assessment.
2. Critical limb ischemia trials should use the objective performance goals as measures of efcacy and safety in addition to disease-specic and overall quality of
life measures.
3. Lower extremity endovascular therapy for PAD should be reported at minimum
for 30-day, 1-year, and 2-year follow-up, promoting standardization and hence
more clinically meaningful comparisons of peripheral vascular interventions.
Five-year follow-up is preferable.
11.1.5.4 Complications
1. Complications are categorized into procedural or device related.
2. A minimum of 30days of complication reporting is required; subacute and late
complication reporting is suggested.
235
11.1.6 Optimal Exercise Programs forPatients withPeripheral
Artery Disease: AScientic Statement
fromtheAmerican Heart Association [6]
Although SET (supervised exercise therapy) programs for patients with PAD should
be individualized with regard to duration, intensity, frequency of exercise, and the
work-to-rest ratio, currently available evidence suggests parameters for these program elements. Exercise sessions should progress up to a target goal of accumulating 30 to 45min of treadmill walking per session. Exercise should be carried out at
an intensity that elicits mild claudication pain within 5min and moderate to moderately severe claudication within 10min followed by rest until claudication pain
subsides. Randomized trials of SET that demonstrate signicant improvement in
walking performance have typically asked patients with PAD to walk for exercise 3
times per week.
Exercise prescription for supervised exercise treadmill training in patients with
claudication:
• Intensity: 40%–60% maximal workload based on baseline treadmill test or
workload that brings on claudication within 3–5min during a 6-min walk test
(6-MWT).
• Session duration: 30–50min of intermittent exercise; goal is to accumulate at
least 30min of walking exercise.
• Claudication intensity: moderate to moderate/severe claudication as tolerated.
236
https://t.me/medicina_free
• Work-to-rest ratio: walking duration should be within 5–10min to reach moder-
ate to moderately severe claudication followed by rest until pain has dissipated
(2–5min).
• Frequency: 3 times per week supervised.
• Program duration: at least 12weeks.
• Progression: every 1–2week. Increase duration of training session to achieve
50 min. As individuals can walk beyond 10min without reaching prescribed
claudication level, manipulate grade or speed of exercise prescription to keep the
walking bouts within 5–10min.
• Maintenance: Lifelong maintenance at least 2 times per week.
11 Intermittent Claudication
11.1.7 French Guidelines fortheManagement ofAmbulatory
Endovascular Procedures forLower Extremity
Peripheral Artery Disease
The French Society of Vascular and Endovascular Surgery (SCVE) established
guidelines to facilitate the development of ambulatory procedures in France [7].
Eligibility for ambulatory peripheral arterial repair:
Medical
• No limit of age is imposed.
• Body mass index >40kg/m2 should be considered as a contraindication, except
in specic patients after extensive evaluation.
• Only ASA I, II and III stable patients.
• Critical limb ischemia and complex lesions have not been considered as exclu-
sion criteria.
• Evaluate the need for hyperhydration in case of chronic renal failure.
• The use of antiplatelet is not considered as a contraindication.
Sociological
• Sufcient comprehension skills.
• Proper compliance to the medical prescriptions.
• Equivalent hygiene and housing conditions to those available during
hospitalization.
• Available person on hand to accompany the patient.
• Medical care should be available less than 1h from patient’s home.
• Convenient and rapid telephone access.
Recommendations regarding the procedure
• Ultrasound-guided femoral artery puncture is recommended.
• Radial or brachial approaches can be used in addition to the femoral approach for
complex procedures.
11.2 Results
https://t.me/medicina_free
• The use of percutaneous closure devices is recommended for ambulatory inter-
vention involving 7F or more sheath and/or in the presence of clinical elements
raising concerns to get hemostasis at the puncture point (obesity, coagulation
disorder, and so forth).
• For 7F sheaths or less, manual compression with compression dressing or arte-
rial closure device could be considered.
Recommendations for postoperative monitoring
• A minimum of 4h of monitoring after the procedure is required to allow patient’s
discharge from hospital after approved clinical assessment.
• A medical letter reporting the reason for hospitalization, a brief summary of the
procedure and potential complications, as well as the detailed prescriptions and
scheduled follow-up has to be issued to the patient.
• Emergency telephone number, reachable 24/7, has to be provided. Phone call or
text message, on the day after the procedure, is recommended and might be
charted.
237
11.2 Results
11.2.1 Meta-Analyses/Systematic Reviews/Randomised Trials
11.2.1.1 Exercise Therapy
The effects of alternative modes of supervised exercise therapy compared to traditional walking exercise in patients with intermittent claudication were assessed by
Jansen etal. [8] in a Cochrane Review. 10 studies that randomised a total of 527
participants with IC were included. The studies compared supervised walking programmes against exercises to strengthen the leg muscles, Nordic walking, cycling,
arm ergometry (pedalling with the arms on an exercise machine), and a combination
of different types of exercise. According to GRADE criteria, the certainty of the
evidence was downgraded to low, due to the relatively small sample sizes, clinical
inconsistency, and inclusion of three studies with risk of bias concerns. This review
found no clear difference between alternative exercise modes and supervised walking exercise in improving the maximum and pain-free walking distance in patients
with intermittent claudication.
Supervised exercise programs (SEP) are effective for improving walking distance in patients with IC, but provision and uptake rates are suboptimal. The aim of
a review by Pymer etal. [9] was to provide a comprehensive overview of the evidence for home-based exercise programs (HEP). 23 studies with 1907 participants
were included. HEPs were inferior to SEPs which was reected in the meta- analysis.
Monitoring was an important component, because HEPs adopting this strategy were
equivalent to SEPs. For HEPs vs. basic exercise advice, narrative review suggested
HEPs can be superior, although not always signicantly so. Other elements such as
238
https://t.me/medicina_free
11 Intermittent Claudication
appropriate frequency (≥3× a week), intensity (to moderate-maximum pain), duration (20 progressing to 60min) and type (walking) of exercise were important, as
was education, self-regulation, goal setting, feedback, and action planning. Remote
and self-monitoring should be done via pedometers, step activity monitoring or
techniques that include these components (e.g. smartphones). Monitor information
should be recorded, either by the patient in an exercise diary or remotely, with regular feedback to the patient.
11.2.1.2 Exercise Therapy andEndovascular Revascularization
The aim of a meta-analysis presented by Shirasu etal. [10] was to analyze the risk
of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients
with intermittent claudication (IC). A total of 9 RCTs comprising 1477 patients
(invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of
3.6-year follow-up, progression to CLTI after invasive and noninvasive treatment
were not statistically different Incidence of amputation (RR: 1.69; 95% CI,
0.54–5.26; P=0.36, I2=0%) and all-cause mortality (hazard ratio: 1.26; 95% CI,
0.91–1.74; P=0.16, I2=0%) also did not differ between the groups. However, the
invasive treatment group underwent signicantly more revascularizations (RR:
4.15; 95% CI, 2.80–6.16; P<0.00001, I2=83%). This meta-analysis of RCTs for
treatment of IC found that progression to CLTI, risk of major amputation, and allcause mortality were not affected by the choice of invasive versus noninvasive initial treatment strategy. The study supports the current guideline recommendation
that noninvasive, exercise-based treatment in addition to best medical therapy
should be rst-line treatment for IC.
Thanigaimani etal. [11] conducted a network meta-analysis of randomized trials
comparing the relative efcacy of cilostazol, home exercise therapy, supervised
exercise therapy (SET), endovascular revascularization (ER) and ER + SET in
improving maximal walking distance over short (< 1year), moderate (1 to <2years)
or long-term (> 2 years) follow-up in people with IC. 46 trials involving 4256
patients were included. At short-term follow-up, home exercise therapy, SET, and
ER + SET, but not ER and cilostazol signicantly improved maximum walking
distance (MWD) (in meters) compared with controls. At moderate-term follow-up,
SET and ER+ SET, but not home exercise therapy or ER, signicantly improved
MWD compared to controls. At long-term follow-up, none of the tested treatments
signicantly improved MWD compared to controls. This network meta-analysis
suggested that SET and ER+SET are effective at improving MWD over the moderate term (<2year) but not beyond this. More durable therapies are needed for intermittent claudication.
The ERASE trial is the largest randomized trial assessing the long-term effectiveness of endovascular revascularization plus SET (n = 106) or SET alone
(n = 106) in patients with IC [12]. Median long-term follow-up was 5.4 years.
11.2 Results
https://t.me/medicina_free
239
Whereas the difference in maximum walking distance signicantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer
signicant. No difference in pain-free walking distance, ankle-brachial index, and
quality of life was found during long-term follow-up. Supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up.
Combination therapy resulted in a lower number of revascularization procedures
during follow-up but a higher total number of revascularizations including the randomized treatment. In the treatment of patients with intermittent claudication, there
is an advantage of combination therapy compared with supervised exercise only
during the rst year. These results do not support a sustained advantage at 5-year
follow-up (Table11.1).
The randomized SUPER trial compared the effectiveness of SET vs. endovascular revascularization (ER) in patients with IC caused by iliac artery obstruction [13].
114 patients were allocated to SET, and 126 to ER.The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%)
after 6 months. Ten patients allocated to ER (8%) did not receive this intervention.
One year follow up was complete for 90/114 (79%) SET patients and for 104/126
(83%) ER patients. The mean MWD improved from 187 to 561m in SET patients
and from 196 to 574m in ER patients (p=.69). VascuQol sumscore improved from
4.24 to 5.58in SET patients, and from 4.28 to 5.88in ER patients (p=.048). After
a mean of 5.5years, 49% of SET patients and 27% of ER patients underwent an
additional intervention for IC. This multicentre RCT found no statistically
Table 11.1 Endovascular revascularization plus supervised exercise compared with supervised
exercise only for intermittent claudication. Results of the randomized ERASE trial (according to
Klaphake etal. [12])
Functional performance
measures
Maximum walking distance
(meters)
– Baseline 285 (244–326) 246 (228–300)
– 12months 955 (786–1124) 1237 (1058–1418) 0.001
– 5years 981 (764–1199) 1034 (825–1244) 0.620
Pain-free walking distance
(meters)
– Baseline 135 (113–157) 117 (96–138)
– 12months 712 (549–876) 1120 (948–1293) <
– 5years 865 (657–1074) 976 (773–1178) 0.281
Ankle-brachial index at rest
– Baseline 0.68 (0.64–0.72) 0.71 (0.67–0.76)
– 12months
– 5years
a
Data are expressed as mean improvement compared with baseline
a
a
Supervised exercise only
(n=106)
0.03 (−0.02–0.08) 0.16 (0.11–0.21) <
0.08 (−0.15–0.06) 0.13 (0.07–0.19) 0.149
Combination therapy
(n=106) P
0.001
0.001
Соседние файлы в папке Библиотека им академика М.И. Перельмана