ENDOVASCULAR SOLUTION IN

PERIPHERAL ARTERY DISEASE

Dr. dr. K. Putu Yasa, SpB, SpBTKV

Cardiac Thorax Vascular and Endovascular Surgery Division

Department of Surgery, Udayana University-Sanglah General Hospital
Denpasar, Bali

PIT IX HBTKVI MALANG, 2017

Endovascular is a Stratagem ?
Endovascular Revolution

230%

42%
Goodney PP. et al. JOURNAL OF VASCULAR SURGERY 2009
 T.J. Fogarty, R.A. White (eds.), Peripheral Endovascular Interventions,
Diversity
• Maturity of Vascular Surgery as a Specialty
-vascular surgery as a specialty is not well developed in Asia.
• Language
-language barrier
• Health Statistics
-no organized national database or health registry of peripheral vascular disease.
• Economy and Health-Care Structure
-no universal health insurance, and the costs of devices
• DeviceMarket
-difficulties of making all devices available
• Government Regulations
-strict FDA approval
• Anatomy
-Asians are generally smaller in stature and have smaller vessels, small access limitation
Endovascular - Overview of New Technologies

Rogers, J. H. et al. Circulation 2007;116:2072-

2085
 PAD
Current Trend Management

Market Research Report

Global Peripheral Artery Disease Market
Report: 2016 Edition
Treatment Options for Peripheral Artery Disease
1. Percutaneous Trans Luminal Angioplasty (PTA)
2. Drug-Coated Balloons (DCBs) Stents
3. Drug-Eluting Stents (DES)
4. Arterial Bypass
5. Atherectomy
 Indication and choice of revascularization
in PAD
TASC II Recommendation 24
Optimal treatment for patients with critical limb ischemia (CLI)
● Revascularization is the optimal treatment for patients with CLI [B].

Claudicatio should be revascularized only after a trial of exercise and

pharmacotherapy. An exception may be isolated iliac artery stenosis.

Revascularization chosen depends to pre-morbid condition, risk of intervention

,and the expected patency and durability. Multi-level disease , adequate inflow
must be established prior to improvement in the outflow.

Contraindications : patients not fit for revascularization; revascularization not

technically possible; benefit cannot be expected (widespread ulceration-gangrene)

Norgren et al. JOURNAL OF VASCULAR SURGERY S10A January 2007

Patient Selection
 Recommendations for CLI: Endovascular and
Open Surgical Treatment for Limb Salvage
I IIa IIb III For patients with limb-threatening lower extremity ischemia and
an estimated life expectancy of <2 years or in patients in whom
an autogenous vein conduit is not available, balloon angioplasty
is reasonable to perform when possible as the initial procedure
NEW to improve distal blood flow.

I IIa IIb III For patients with limb-threatening ischemia and an estimated
life expectancy of >2 years, bypass surgery, when possible and
when an autogenous vein conduit is available, is reasonable to
perform as the initial treatment to improve distal blood flow.
NEW

(ACCF/AHA Practice Guidelines 2011 .Circulation. 2013;127:00-00.)

 ENDOVASCULAR RESULTS
• The revised Society for Vascular Surgery Lower
Extremity Ischemia Reporting Standards
(Rutherford guidelines)

Definitions of Successful Intervention

– Clinical Response
– Technical Success
– Hemodynamic Success
– Primary Patency
– Assisted Primary Patency
– Secondary Patency
(J Vasc Surg 2016;64:e1-e21.)
 A systematic review of endovascular treatment
of extensive aortoiliac occlusive disease

• Conclusions:
Endovascular treatment of extensive AIOD can be performed successfully by
experienced interventionists in selected patients.

Although primary patency rates are lower than those reported for surgical
revascularization, reinterventions can often be performed percutaneously,
with secondary patency comparable to surgical repair.

(J Vasc Surg 2010;52:1376-83.)

Clinical outcomes of 5358 patients undergoing direct open bypass or
endovascular treatment for aortoiliac occlusive disease:
a systematic review and meta-analysis

CONCLUSION:
Although this study was limited by a paucity of randomized
control trials, these results demonstrate superior durability for
open bypass, although with longer LOS and increased risk for
complications and mortality, when compared to the
endovascular approach

J Endovasc Ther. 2013 Aug;20(4):443-55

 A meta-analysis of endovascular versus surgical
reconstruction of femoropopliteal arterial disease

( J Vasc Surg 2013;57:242-53.)

 A meta-analysis of endovascular versus surgical
reconstruction of femoropopliteal arterial disease

( J Vasc Surg 2013;57:242-53.)

 A meta-analysis of endovascular versus surgical
reconstruction of femoropopliteal arterial disease

Conclusions:
• High-level evidence demonstrating the superiority of one
method over the other is lacking.
• An endovascular-first approach may be advisable in patients
with significant comorbidity, whereas for fit patients with a
longer-term perspective a bypass procedure may be offered
as a first-line interventional treatment.

( J Vasc Surg 2013;57:242-53.)

Percutaneous Transluminal Angioplasty in Patients
With Infrapopliteal Arterial Disease
Systematic Review and Meta-Analysis

Circ Cardiovasc Interv. 2016;9:e003468.

Percutaneous Transluminal Angioplasty in Patients
With Infrapopliteal Arterial Disease
Systematic Review and Meta-Analysis

Circ Cardiovasc Interv. 2016;9:e003468.

 Percutaneous Transluminal Angioplasty in Patients
With Infrapopliteal Arterial Disease
Systematic Review and Meta-Analysis

Conclusions
Contemporary studies of the use of percutaneous
transluminal angioplasty as primary treatment for
patients with infrapopliteal arterial disease reveal
suboptimal procedural and 1-year clinical outcomes.

Circ Cardiovasc Interv. 2016;9:e003468.

 Drug-eluting stents for revascularization of infrapopliteal
arteries: updated meta-analysis of randomized trials.

CONCLUSIONS:
In focal disease of infrapopliteal arteries, DES therapy reduces
the risk of reintervention and amputation compared with plain
balloon angioplasty or BMS implantation without any impact on
mortality and Rutherford class at 1-year follow-up.

JACC Cardiovasc Interv. 2013 Dec;6(12):1284-93.

Angiosome-directed revascularization
Angiosome-targeted Lower Limb Revascularization for Ischemic
Foot Wounds: Systematic Review and Meta-analysis

Eur J of Vas Endovas Surg (2014) 47 , 517e522

Systematic Review and Meta-analysis of Direct Versus Indirect
Angiosomal Revascularisation of Infrapopliteal Arteries
Differential Impact of Bypass Surgery and Angioplasty on
Angiosome-Targeted Infrapopliteal Revascularization

Eur J Vasc Endovasc Surg (2015) 49, 412e419

 Systematic Review and Meta-Analysis of Drug-Eluting Balloon
and Stent for Infrapopliteal Artery Revascularization

Conclusion:
The present meta-analysis suggests that compared with standard
PTA/BMS, DES may decrease the risk of clinically driven TLR,
restenosis rate, and amputation rate without any impact on
mortality. However, DEB has no obvious advantage in the
treatment of infrapopliteal disease. Due to the limitations of our
study, more randomized controlled trials, especially those for
DEB, are necessary.

J. Vascular and Endovascular Surgery, 2017

Bypass versus Angioplasty in Severe Ischaemia of
the Leg (BASIL) trial
Amputation Free Survival Overall Survival

Bradbury AJ, et al. J Vasc Surg 2010;51:5S-17S

 Endovascular outcomes
Sanglah General Hospital experience

• Cross sectional study

• On 28 of PAD patients post PTA ± Stent
Between June 2015 - July 2017
• Endpoint outcomes of study : clinical response
– Amputation
– Pain
 KARAKTERISTIK SUBJEK
Pasien PAD Pasca PTA ± Stent di RSUP Sanglah
PERSENTASE
VARIABEL JUMLAH
(%)
Umur (mean) 59,82 ± 12,34 tahun

Jenis kelamin
Laki-laki 18 64,3
Perempuan 10 35,7
Diabetes mellitus
Ada 12 42,9
Tidak 16 57,1
Hipertensi
Ya 14 50
Tidak 14 50
Lokasi lesi vaskular
Femoro poplitea 70 89,7%
Infrapoplitea 8 10,3%
 PERSENTASE
VARIABEL JUMLAH
(%)
Derajat PAD
Rutherford <4 15 53,6
Rutherford ≥ 4 13 46,4
Jenis PTA
PTA 15 53,6
PTA + stent 13 46,4
Amputasi
Ya 10 35,7
Tidak 18 64,3
Mortalitas
Meninggal 2 7,1
Hidup 26 92,9
Follow up (mean) 12,89 30 ± 10,87 bulan
 HASIL ANALISIS

UMUR TERHADAP NYERI DAN AMPUTASI

Umur
P
n mean
Ya 10 65,5 0,023*
Amputasi
Tidak 18 56,7 (p<0,05)
Ya 9 60,89
Nyeri post op 0,759
Tidak 19 59,32
DM TERHADAP NYERI POST OP

Nyeri Post Op
DM P OR
Ya Tidak
Ya 8 (66,7%) 4 (33,3%)
0,001*(p<0,05) 30,00
Tidak 1 (6,3%) 15 (93,7%)

DM TERHADAP AMPUTASI

Amputasi
DM P OR
Ya Tidak
Ya 9 (75%) 3 (25%)
0,001*(p<0,05) 45,00
Tidak 1 (6,3%) 15 (93,7%)
DERAJAT PAD TERHADAP NYERI POST OP

Nyeri Post Op
Derajat PAD P OR
Ya Tidak
Rutherford <4 3 (20%) 12 (80%)
0,228 0,292
Rutherford ≥4 6 (46,2%) 7 (53,8%)

DERAJAT PAD TERHADAP AMPUTASI

Amputasi
Derajat PAD P OR
Ya Tidak
Rutherford <4 2 (13,3%) 13 (86,7%)
0,016*(p<0,05) 0,096
Rutherford ≥4 8 (61,5%) 5 (38,5%)
JENIS PTA TERHADAP NYERI POST OP

Nyeri Post Op
Jenis PTA P OR
Ya Tidak
PTA 2 (13,3%) 13(86,7%)
0,042*(p<0,05) 0,132
PTA + stent 7 (53,8%) 8 (46,2%)

JENIS PTA TERHADAP AMPUTASI

Amputasi
Jenis PTA P OR
Ya Tidak
PTA 3 (20%) 12 (80%)
0,114 0,214
PTA + stent 7 (53,8%) 6 (46,2%)
ANALISIS MULTIVARIAT NYERI POST OP

Variabel F P
DM 12,261 0,002* (p<0,05)
Lokasi lesi vaskular 0,141 0,710
Jenis PTA 2,325 0,140

ANALISIS MULTIVARIAT AMPUTASI POST OP

Variabel F P
DM 2,583 0,001*(p<0,05)
Lokasi lesi vaskular 0,100 0,380
Jenis PTA 0,109 0,361
 Summary
Endovascular in PAD
• Aortoiliac : Primary patency rates are lower, secondary patency
comparable to surgical repair.

• Femoropoplitea : endovascular-first approach may be advisable in

patients with significant comorbidity

• Infrapoplitea :
– Suboptimal procedural
– In focal disease , DES reduces the risk of reintervention and
amputation
• CLI : Angiosome-directed revascularization improves wound healing
and major amputation rates