- Email: [email protected]
Urgent Mechanical Thrombectomy by Indigo System® in Acute Thrombosed Popliteal Artery Aneurysms: A Report of Two Cases
Journal Pre-proof URGENT MECHANICAL THROMBECTOMY BY INDIGO SYSTEM® IN ACUTE THROMBOSED POPLITEAL ARTERY ANEURYSMS: A REPORT OF TWO CASES Wassim Mansour, Pasqualino Sirignano, Laura Capoccia, Federica Fornelli, Francesco Speziale PII:
S0890-5096(19)30788-5
DOI:
https://doi.org/10.1016/j.avsg.2019.08.100
Reference:
AVSG 4651
To appear in:
Annals of Vascular Surgery
Received Date: 14 August 2018 Revised Date:
19 August 2019
Accepted Date: 19 August 2019
Please cite this article as: Mansour W, Sirignano P, Capoccia L, Fornelli F, Speziale F, URGENT MECHANICAL THROMBECTOMY BY INDIGO SYSTEM® IN ACUTE THROMBOSED POPLITEAL ARTERY ANEURYSMS: A REPORT OF TWO CASES Annals of Vascular Surgery (2019), doi: https:// doi.org/10.1016/j.avsg.2019.08.100. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Elsevier Inc. All rights reserved.
1
URGENT MECHANICAL THROMBECTOMY BY INDIGO SYSTEM IN ACUTE
2
THROMBOSED POPLITEAL ARTERY ANEURYSMS: A REPORT OF TWO CASES
3
Wassim Mansour, Pasqualino Sirignano, Laura Capoccia, Federica Fornelli, and Francesco Speziale
4
Vascular and Endovascular Surgery Unit
5
Department of Surgery “P Stefanini”
6
Policlinico “Umberto I”, “Sapienza” University of Rome
7 8
Corresponding Author:
9
Pasqualino Sirignano, MD
10
Vascular and Endovascular Surgery Division,
11
Department of Surgery “Paride Stefanini”,
12
“Sapienza” University of Rome, Policlinico Umberto I.
13
Viale del Policlinico, 155.
14
00161 – Rome, Italy
15
Tel/Fax: 0039 06 4940532
16
email: [email protected]
17 18
The authors declare that they have no conflict of interest.
19
Manuscript compliances with Ethical Standards
20 21 22
Key Words: popliteal artery aneurism, PAA, acute limb ischemia, ALI, mechanical thrombectomy,
23
endovascular therapy, bypass.
24
25
ABSTRACT
26
Aim is to report the outcome of immediate and direct revascularization by mechanical
27
thrombectomy in acute limb ischemia (ALI) due to thrombosed popliteal artery aneurysm (PAA).
28
Two patients with acute limb ischemia due to PAA thrombosis were admitted at our hospital, and
29
immediately treated by mechanical thrombectomy (Indigo System). First patient had a complete
30
recanalization after thrombectomy, while the second one required urokinase infusion (12 hours)
31
due to a sub-optimal result. After revascularization, both patients were treated by a PTFE bypass
32
to definitively exclude PAA. Follow-up showed the patency of the femoro-popliteal bypass with
33
good distal outflow. In these two reported cases, the Indigo System® has proven to be safe and
34
effective, allowing an immediate limb reperfusion, reducing the necessity for thrombolytic drugs
35
infusion.
36 37 38 39 40 41 42 43 44 45 46 47 48 49
50 51
INTRODUCTION
52
Acute leg ischemia (ALI) caused by thrombosis of a popliteal aneurysm (PAA) is, still
53
nowadays, an emergent situation with a high incidence of major amputation1 and 1-year mortality
54
rate2. Until now, the two main treatment options have been: direct open surgery and pre-
55
operative thrombolysis, both having their downsides3. In recent reviews it has been shown how
56
thrombolytic therapy is often associated with a high risk of hemorrhagic stroke and other major
57
bleeding complications4,5. On the other hand, urgent surgical intervention in these circumstances
58
carries a high risk, and results are poorer than those in asymptomatic patients6. Surgery is
59
associated with a significant failure rate: a 5% rate of amputation, a 36% rate of graft thrombosis,
60
a 5% rate of nerve injury and a 5% rate of perioperative mortality6,7,8,9.
61
Recently, mechanic thromboembolectomy has become widely used to treat patients in the
62
field of neuroradiology10, and later on in patients with ALI secondary to thromboembolism, with
63
good results11. Moving from those positive experiences, aspiration thrombectomy with the Indigo
64
System® (Penumbra, Alameda, CA – USA) was used in two patients presenting with ALI due to PAA
65
thrombosis.
66 67
CASE 1
68
A 76 years old male patient was admitted to the Emergency Room with acute limb
69
ischemia of his right leg. A Duplex ultrasound scan (DUS) was performed showing a thrombosed
70
PAA, of 40 mm of maximum transverse diameter, with poor distal run-off. Eleven months earlier,
71
he was electively treated at our Vascular Center for a left PAA by a surgical femoro-popliteal
72
bypass implantation. At that time, patient refused any further treatment for the right contralateral
73
PAA. Scheduled 1, 3, and 6-month follow-up visits showed a patent bypass and a stable right PAA.
74
At hospital admission, the patient was brought directly to the operatory room to perform a
75
bridge endovascular intervention. Via a percutaneous controlateral access 8 Fr. (Flexor Introducer;
76
Cook Medical, Bloomington, IN - USA) the right superficial femoral artery was selectively
77
catheterized. The initial angiography showed a patent superficial femoral artery (SFA) and the
78
thrombosed PAA without below-the-knee (BTK) vessels visualization (Fig.1A). Using a standard
79
guide (Zip Wire; Boston Scientific, Marlborough, MA – USA) an 8 Fr XTORQ catheter (Penumbra
80
Inc) was placed at the proximal edge of the thrombus and the thromboaspiration was initiated.
81
Due to the tortuous anatomy, XTORQ catheter could not progress more than 6cm without
82
support. Therefore, using a standard guide the aneurysm was crossed and the infrarticular
83
popliteal artery was gained (Fig.1B), followed by continuation of thromboaspiration and
84
immediate blood flow reestablishment (Fig.1C). Using smaller catheters (CAT-6, -5, and -3Fr,
85
Penumbra Inc), thrombus from tibio-peroneal trunk, anterior tibial artery (ATA) and posterior
86
tibial artery (PTA) was successfully removed.
87
After thrombus removal a 40 cm long McNamara catheter (Medtronic Inc, Santa Rosa, CA –
88
USA) was left in place for a local heparin infusion lasting 24 hours, maintaining a PTT ratio
89
between 2 and 3. The post-operative angiographic control at 24 hours and the DUS showed the
90
patency of the PAA (Fig.2A,2B,2c) and the BTK vessels, so a definitive treatment was performed
91
with a femoro-poplital bypass with an 8 mm reinforced PTFE graft (Gore Propaten; W.L. Gore &
92
Ass, Flagstaff, AZ – USA).
93
Post-operative course was uneventful, and no Intensive Care Unit was needed. At post-
94
operative day II a DUS scan was performed showing a patent bypass with a direct flow on ATA and
95
PTA. The patient was discharged at day VI, with a mono anti-platelet therapy (Acetylsalycilic Acid
96
100 mg/die). Scheduled 1-month computed tomographic angiography (CTA) showed the patency
97
of the femoro-popliteal bypass with good outflow on the BTK vessels (Fig.2D) confirmed by a
98
Duplex ultrasound scan performed at 8-month follow-up.
99 100
CASE 2
101
A 51 years old male patient was admitted to the Emergency Room with left leg ALI. DUS
102
and CTA performed at admission showed a 37mm thrombosed left PAA, associated with a
103
contralateral 34mm patent PAA. After diagnosis, patient was immediately conducted to the
104
operating theatre and submitted to an endovascular procedure. As in the case previously
105
described, patient was treated under local anaesthesia, via percutaneous contralateral access.
106
The initial angiography showed a patent SFA and the thrombosed PAA without BTK vessels
107
visualization. Without guidewire support, an 8 Fr XTORQ catheter (Penumbra Inc) was placed at
108
the proximal edge of the thrombus and the thromboaspiration was initiated and progressed
109
through the PAA (Fig.3), the distal poplitea artery and the BTK vessels, using smaller catheters
110
(CAT-6, -5, and -3Fr, Penumbra Inc). At completion angiography, tibio-peroneal trunk and origin of
111
the ATA was still occupied by a not-negligible thrombus amount. For those, despite flow
112
restoration, 100.000UI of urokinase were locally administered intraoperatively and a 40cm long
113
McNamara catheter (Medtronic Inc) was left in place for fibrinolytic therapy lasting 12 hours
114
(60.000UI/h).
115
The post-operative angiographic control at 12 hours showed the patency of the PAA (Fig.3)
116
and the BTK vessels, except for a segmental ATA occlusion at its origin. Also in this case, a
117
definitive treatment was performed with a femoro-poplital bypass with an 6mm reinforced PTFE
118
graft (Gore Propaten; W.L. Gore & Ass), after ATA recanalization by surgical embolectomy.
119
Post-operative curse was uneventful. Patient was discharged in V postoperative day in
120
good clinical status under single antiplatelet therapy (Acetylsalycilic Acid 100 mg/die). Scheduled 1
121
and 6-month follow-up showed the patency of the femoro-popliteal bypass with good outflow on
122
the BTK vessels.
123 124
DISCUSSION
125
Popliteal artery aneurysm (PAA) is defined as a segment of the popliteal artery with a
126
diameter at least 1.5 times wider than the adjacent segments of the artery12. The overall incidence
127
is 0.1%, and in half the cases the PAA is bilateral12. It accounts up to 80% of diagnosed peripheral
128
artery aneurysms. Still today the two main treatment options were open repair (OR) and
129
endovascular repair (ER)1,2,3. OR as an urgent treatment, consisting in a femoro-popliteal bypass,
130
either with a patient’s vein or with a prosthesis, carries a higher incidence of complications and a
131
lower technical success rate compared to an elective treatment4,5. Reilly et al. reported a 35% rate
132
of amputation in 66 patients with acute thrombosis of popliteal aneurysms, with a 5% rate of
133
perioperative mortality7. Halliday et al. compared results of surgical intervention in asymptomatic
134
patients (limb salvage and primary patency rates of 100%) with those obtained in urgent surgery
135
for acute ischemia (a 5% rate of amputation, a 36% rate of graft thrombosis, a 5% rate of
136
permanent nerve injury)8. ER, consisting in a catheter-directed thrombolysis, is reported to give
137
sub-optimal results, especially in acute ischemia due to occluded popliteal aneurysm, with a 78.4%
138
rate of successful thrombolysis, an 82.4% rate of adjuvant revascularization procedures
139
(endovascular 33.3%, open 55.4%, hybrid 11.9%) and a 25.5% rate of major amputation rate at 30
140
days. Furthermore, it carries a rate of major bleeding complications of 21.6%13.
141
In the past two decades, percutaneous mechanical thrombectomy devices have been
142
introduced in order to minimize the use of thrombolytic agents on one hand, and accelerate the
143
process of thrombus removal on the other14. Starting from manual aspiration thrombectomy as
144
first percutaneous approach for clot removal, innovation moved to a series of mechanical
145
thrombectomy based on different mechanism of action (mechanical fragmentation, aspiration,
146
rheolytic thrombectomy, and their combination)15.
147
The Indigo System® (Penumbra Inc), is a device consisting in 3 components: aspiration
148
catheter, separator and pump. The aspiration catheter has a tapered configuration, allowing a
149
better clot accommodation inside its lumen and at the same time maintaining a sufficient gradient
150
pressure to deliver the clot into the canister. There are various catheter sizes (from 3 to 8 Fr) and
151
length (132 cm or 150 cm), to better adapt to the target vessel caliber. The separators are used to
152
mobilize the clot and clean the catheter lumen and the operator has to move the separator back
153
and forth, during the aspiration. The pump is able to apply near pure vacuum aspiration pressure
154
of -29 mmHg16. Aspiration thrombectomy with the Indigo System® has the greatest advantage of
155
not increasing systemic risk of bleeding, promoting active thrombectomy using a vacuum pump
156
that generate substantial suction, enabling aspiration of clots of varying sizes and lengths and
157
providing immediate flow reestablishment. Moreover, the availability of an angled catheter (CAT-
158
8XTORQ) allows the possibility to create a lumen greater than nominal catheter’s diameter.
159
This system was initially designed for neurological patient with thrombosis of intracranial
160
vessels and it has proven to be effective in restoring blood flow with good immediate and long-
161
term patency rate. Risks associated with these interventions, as per IFU, comprise acute occlusion,
162
air embolism, arteriovenous fistula, device malfunction, distal embolization, emboli, false
163
aneurysm formation, inability to completely remove thrombus, intracranial hemorrhage, ischemia,
164
neurological deficits including stroke, vessel spasm and thrombosis.
165
results achieved in the Cerebrovascular field, this system was adapted also to patients with ALI
166
due to thromboembolism or distal emboli occurred during endovascular procedure. The PRISM
167
trial proved how the Indigo system could be used safely and effectively in ALI patients, with an
168
87.2% successful revascularization rate, increased to 96.2% if other endovascular intervention
169
were performed (e.g. angioplasty and stent placement) 10. Moreover, the Indigo System in Acute
Later on, given the good
170
Lower-Limb Malperfusion (INDIAN) Registry, intended as a national platform where every
171
physician can register his or her own data procedure, will enroll 150 patients suffering from ALI, in
172
order to prove safety and efficacy of the Indigo System17.
173
Moving from these experiences we decided to apply this technique to two cases of
174
thrombosed PAA. To our best knowledge, this technical solution has never been described before.
175
Both reported patients were admitted to the Emergency Room with acute limb ischemia, and in
176
both cases an urgent approach was adopted to prevent ALI related complications. A massive
177
thrombosis of PAA and BTK vessels was present in all treated cases, so a direct surgical solution by
178
femoro-popliteal bypass reconstruction was judged unfeasible due to the lack of out-flow vessels.
179
Moreover, ALI related symptoms were severe in both patients, so we tried to perform a prompt
180
revascularization. For that, fibrinolysis was not considered as first-line therapy because of the time
181
needed for revascularization, up to 3 days in previous reported experience3.
182
Consequently, mechanical thrombectomy by Indigo System® was adopted with satisfactory
183
early results. In the first case thrombus removal was immediately effective without needing drugs
184
infusion, while the second patient required 24 hours urokinase infusion. Of note, in one case CAT-
185
8 catheter was unable to proceed through PAA without guidewire support, differently to standard
186
practice in ALI procedure described in absence of dilatative pathology10.
187
After revascularization, both described patients underwent definitive surgical treatment
188
by surgical femoro-popliteal bypass via reinforced PTFE graft interposition, because of the absence
189
of a suitable great saphenous vein.
190 191
CONCLUSION
192
In our opinion, the Indigo System® could be used to treat ALI due to peripheral
193
aneurysmatic pathology, since it’s been proven to be safe and effective, with acceptable operative
194
risks. Proposed technique achieves an immediate limb reperfusion avoiding, or at least drastically
195
reducing, necessity for thrombolytic drugs infusion.
196 197
FIGURES LEGEND
198
Figure 1: A) intraoperative angiography confirming PAAA thrombosis; B) CAT-8
199
advancement on Zip Wire support; C) completion angiography demonstrating PAA, tibio-perneal
200
trunk and BTK vessels immediate reperfusion.
201
Figure 2: DUS control at 24 hours after thrombectomy showing PAA patency in axial (A),
202
and longitudinal (B) view, and direct flow on PTA (C); one-month CTA follow-up (D) showing good
203
patency of the reinforced PTFE graft and all BTK vessels.
204
Figure 3: A) CAT-8 advancement without wire support; B) completion angiography
205
demonstrating PAA and distal popliteal artery patency; C) patency of the tibio-peroneal trunk,
206
peroneal and posterior tibial arteries, anterior tibial artery appears occluded at its origin, while
207
distally is patent.
208 209 210
DECLARATION OF CONFLICTING INTERESTS The authors declared no potential conflicts of interest with respect to the research,
211 212
authorship, and/or publication of this article.
213 214
FUNDING The authors received no financial support for the research, authorship, and/or publication
215 216
of this article.
217 218
REFERENCES 1
Varga ZA, Locke-Edmunds JC, Baird RN. A multicenter study of popliteal aneurysms. Joint
Vascular Research Group. J Vasc Surg. 1994 Aug;20(2):171-7. 2
Creager MA, Kaufman JA, Conte MS. Clinical practice. Acute limb ischemia. N Eng J Med 2012;
366:2198-2206. 3
Dorigo W, Pulli R, Turini F, et al. Acute leg ischaemia from thrombosed popliteal artery
aneurysms: role of preoperative thrombolysis. Eur J Vasc Endovasc Surg. 2002 Mar;23(3):251-4. 4
Berridge DC, Kessel DO, Robertson I. Surgery versus thrombolysis for initial management of acute
limb ischaemia. Cochrane Database Syst Rev. 2013 Jun 6;(6):CD002784. 5
Ouriel K. Comparison of surgical and thrombolytic treatment of peripheralarterial disease. Rev
CardiovascMed 2002;3(Suppl 2):S7-16.
6
Pulli R, Turini F, Dorigo W et al. Risultati in base alla modalita`di presentazione clinica. In: Pratesi
C, Pulli R, eds. Gli aneurismi poplitei. Aspetti di clinica, diagnostica e trattamento. Torino, MinervaMedica, 2001: 77–82. 7
Reilly MK, Abbott WM, Darling RC. Aggressive surgical management of popliteal artery
aneurysms. Am J Surg1983; 145:498–502. 8
Halliday AW, Taylor PR, Wolfe JH, Mansfield AO. The management of popliteal artery aneurysm:
the importance of early surgical repair. Ann R CollSurgEngl 1991; 73: 253–257. 9
Ouriel K, Veith FJ, Sasahara AA. A comparison of recombinant urokinase with vascular surgery as
initial treatment for acute arterial occlusion of the legs. Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators. N Engl J Med. 1998 Apr 16;338(16):1105-11. 10
Saxon RR, Benenati JF, Teigen C, et al. Utility of a Power Aspiration-Based Extraction Technique
as an Initial and Secondary Approach in the Treatment of Peripheral Arterial Thromboembolism: Results of the Multicenter PRISM Trial. J Vasc Interv Radiol. 2018 Jan;29(1):92-100. 11
Yamada R, Adams J, Guimaraes M, et al. Advantages to Indigo mechanical thrombectomy for
ALI: device and technique. J Cardiovasc Surg (Torino). 2015 Jun;56(3):393-400. 12
Joshi D, James RL, Jones L. Endovascular versus open repair of asymptomatic popliteal artery
aneurysm. Cochrane Database SystRev. 2014;31(8):CD010149. 13
Grip O, Wanhainen A, Acosta S, et al. Long-term Outcome after Thrombolysis for Acute Lower
Limb Ischaemia. Eur J Vasc Endovasc Surg. 2017 Jun;53(6):853-861. 14
Zeller T, Tepe G. Treatment of acute limb ischemia with focus on endovascular techniques. Vasa 2009: 38:123-33. 15 de Donato G, Pasqui E, Setacci F, et al, Acute on chronic limb ischemia: From surgical embolectomy and thrombolysis to endovascular options. Semin Vasc Surg 2018 Jun-Dec;31(24):66-75. 16
Kaesmacher J, Mordasini P, Arnold M, et al. Direct mechanical thrombectomy in tPA-ineligible
and -eligible patients versus the bridging approach: a meta-analysis. J Neurointerv Surg. 2018 Apr 28. pii: neurintsurg-2018-013834. doi: 10.1136/neurintsurg-2018-013834. [Epub ahead of print] 17
de Donato G, PAsqui E, Giannace G, et al. The Indigo System in Acute Lower-Limb Malperfusion
(INDIAN) Registry: Protocol. JMIR Res Protoc. 2019 Mar 14;8(3):e9972.
S0890-5096(19)30788-5
DOI:
https://doi.org/10.1016/j.avsg.2019.08.100
Reference:
AVSG 4651
To appear in:
Annals of Vascular Surgery
Received Date: 14 August 2018 Revised Date:
19 August 2019
Accepted Date: 19 August 2019
Please cite this article as: Mansour W, Sirignano P, Capoccia L, Fornelli F, Speziale F, URGENT MECHANICAL THROMBECTOMY BY INDIGO SYSTEM® IN ACUTE THROMBOSED POPLITEAL ARTERY ANEURYSMS: A REPORT OF TWO CASES Annals of Vascular Surgery (2019), doi: https:// doi.org/10.1016/j.avsg.2019.08.100. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Elsevier Inc. All rights reserved.
1
URGENT MECHANICAL THROMBECTOMY BY INDIGO SYSTEM IN ACUTE
2
THROMBOSED POPLITEAL ARTERY ANEURYSMS: A REPORT OF TWO CASES
3
Wassim Mansour, Pasqualino Sirignano, Laura Capoccia, Federica Fornelli, and Francesco Speziale
4
Vascular and Endovascular Surgery Unit
5
Department of Surgery “P Stefanini”
6
Policlinico “Umberto I”, “Sapienza” University of Rome
7 8
Corresponding Author:
9
Pasqualino Sirignano, MD
10
Vascular and Endovascular Surgery Division,
11
Department of Surgery “Paride Stefanini”,
12
“Sapienza” University of Rome, Policlinico Umberto I.
13
Viale del Policlinico, 155.
14
00161 – Rome, Italy
15
Tel/Fax: 0039 06 4940532
16
email: [email protected]
17 18
The authors declare that they have no conflict of interest.
19
Manuscript compliances with Ethical Standards
20 21 22
Key Words: popliteal artery aneurism, PAA, acute limb ischemia, ALI, mechanical thrombectomy,
23
endovascular therapy, bypass.
24
25
ABSTRACT
26
Aim is to report the outcome of immediate and direct revascularization by mechanical
27
thrombectomy in acute limb ischemia (ALI) due to thrombosed popliteal artery aneurysm (PAA).
28
Two patients with acute limb ischemia due to PAA thrombosis were admitted at our hospital, and
29
immediately treated by mechanical thrombectomy (Indigo System). First patient had a complete
30
recanalization after thrombectomy, while the second one required urokinase infusion (12 hours)
31
due to a sub-optimal result. After revascularization, both patients were treated by a PTFE bypass
32
to definitively exclude PAA. Follow-up showed the patency of the femoro-popliteal bypass with
33
good distal outflow. In these two reported cases, the Indigo System® has proven to be safe and
34
effective, allowing an immediate limb reperfusion, reducing the necessity for thrombolytic drugs
35
infusion.
36 37 38 39 40 41 42 43 44 45 46 47 48 49
50 51
INTRODUCTION
52
Acute leg ischemia (ALI) caused by thrombosis of a popliteal aneurysm (PAA) is, still
53
nowadays, an emergent situation with a high incidence of major amputation1 and 1-year mortality
54
rate2. Until now, the two main treatment options have been: direct open surgery and pre-
55
operative thrombolysis, both having their downsides3. In recent reviews it has been shown how
56
thrombolytic therapy is often associated with a high risk of hemorrhagic stroke and other major
57
bleeding complications4,5. On the other hand, urgent surgical intervention in these circumstances
58
carries a high risk, and results are poorer than those in asymptomatic patients6. Surgery is
59
associated with a significant failure rate: a 5% rate of amputation, a 36% rate of graft thrombosis,
60
a 5% rate of nerve injury and a 5% rate of perioperative mortality6,7,8,9.
61
Recently, mechanic thromboembolectomy has become widely used to treat patients in the
62
field of neuroradiology10, and later on in patients with ALI secondary to thromboembolism, with
63
good results11. Moving from those positive experiences, aspiration thrombectomy with the Indigo
64
System® (Penumbra, Alameda, CA – USA) was used in two patients presenting with ALI due to PAA
65
thrombosis.
66 67
CASE 1
68
A 76 years old male patient was admitted to the Emergency Room with acute limb
69
ischemia of his right leg. A Duplex ultrasound scan (DUS) was performed showing a thrombosed
70
PAA, of 40 mm of maximum transverse diameter, with poor distal run-off. Eleven months earlier,
71
he was electively treated at our Vascular Center for a left PAA by a surgical femoro-popliteal
72
bypass implantation. At that time, patient refused any further treatment for the right contralateral
73
PAA. Scheduled 1, 3, and 6-month follow-up visits showed a patent bypass and a stable right PAA.
74
At hospital admission, the patient was brought directly to the operatory room to perform a
75
bridge endovascular intervention. Via a percutaneous controlateral access 8 Fr. (Flexor Introducer;
76
Cook Medical, Bloomington, IN - USA) the right superficial femoral artery was selectively
77
catheterized. The initial angiography showed a patent superficial femoral artery (SFA) and the
78
thrombosed PAA without below-the-knee (BTK) vessels visualization (Fig.1A). Using a standard
79
guide (Zip Wire; Boston Scientific, Marlborough, MA – USA) an 8 Fr XTORQ catheter (Penumbra
80
Inc) was placed at the proximal edge of the thrombus and the thromboaspiration was initiated.
81
Due to the tortuous anatomy, XTORQ catheter could not progress more than 6cm without
82
support. Therefore, using a standard guide the aneurysm was crossed and the infrarticular
83
popliteal artery was gained (Fig.1B), followed by continuation of thromboaspiration and
84
immediate blood flow reestablishment (Fig.1C). Using smaller catheters (CAT-6, -5, and -3Fr,
85
Penumbra Inc), thrombus from tibio-peroneal trunk, anterior tibial artery (ATA) and posterior
86
tibial artery (PTA) was successfully removed.
87
After thrombus removal a 40 cm long McNamara catheter (Medtronic Inc, Santa Rosa, CA –
88
USA) was left in place for a local heparin infusion lasting 24 hours, maintaining a PTT ratio
89
between 2 and 3. The post-operative angiographic control at 24 hours and the DUS showed the
90
patency of the PAA (Fig.2A,2B,2c) and the BTK vessels, so a definitive treatment was performed
91
with a femoro-poplital bypass with an 8 mm reinforced PTFE graft (Gore Propaten; W.L. Gore &
92
Ass, Flagstaff, AZ – USA).
93
Post-operative course was uneventful, and no Intensive Care Unit was needed. At post-
94
operative day II a DUS scan was performed showing a patent bypass with a direct flow on ATA and
95
PTA. The patient was discharged at day VI, with a mono anti-platelet therapy (Acetylsalycilic Acid
96
100 mg/die). Scheduled 1-month computed tomographic angiography (CTA) showed the patency
97
of the femoro-popliteal bypass with good outflow on the BTK vessels (Fig.2D) confirmed by a
98
Duplex ultrasound scan performed at 8-month follow-up.
99 100
CASE 2
101
A 51 years old male patient was admitted to the Emergency Room with left leg ALI. DUS
102
and CTA performed at admission showed a 37mm thrombosed left PAA, associated with a
103
contralateral 34mm patent PAA. After diagnosis, patient was immediately conducted to the
104
operating theatre and submitted to an endovascular procedure. As in the case previously
105
described, patient was treated under local anaesthesia, via percutaneous contralateral access.
106
The initial angiography showed a patent SFA and the thrombosed PAA without BTK vessels
107
visualization. Without guidewire support, an 8 Fr XTORQ catheter (Penumbra Inc) was placed at
108
the proximal edge of the thrombus and the thromboaspiration was initiated and progressed
109
through the PAA (Fig.3), the distal poplitea artery and the BTK vessels, using smaller catheters
110
(CAT-6, -5, and -3Fr, Penumbra Inc). At completion angiography, tibio-peroneal trunk and origin of
111
the ATA was still occupied by a not-negligible thrombus amount. For those, despite flow
112
restoration, 100.000UI of urokinase were locally administered intraoperatively and a 40cm long
113
McNamara catheter (Medtronic Inc) was left in place for fibrinolytic therapy lasting 12 hours
114
(60.000UI/h).
115
The post-operative angiographic control at 12 hours showed the patency of the PAA (Fig.3)
116
and the BTK vessels, except for a segmental ATA occlusion at its origin. Also in this case, a
117
definitive treatment was performed with a femoro-poplital bypass with an 6mm reinforced PTFE
118
graft (Gore Propaten; W.L. Gore & Ass), after ATA recanalization by surgical embolectomy.
119
Post-operative curse was uneventful. Patient was discharged in V postoperative day in
120
good clinical status under single antiplatelet therapy (Acetylsalycilic Acid 100 mg/die). Scheduled 1
121
and 6-month follow-up showed the patency of the femoro-popliteal bypass with good outflow on
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the BTK vessels.
123 124
DISCUSSION
125
Popliteal artery aneurysm (PAA) is defined as a segment of the popliteal artery with a
126
diameter at least 1.5 times wider than the adjacent segments of the artery12. The overall incidence
127
is 0.1%, and in half the cases the PAA is bilateral12. It accounts up to 80% of diagnosed peripheral
128
artery aneurysms. Still today the two main treatment options were open repair (OR) and
129
endovascular repair (ER)1,2,3. OR as an urgent treatment, consisting in a femoro-popliteal bypass,
130
either with a patient’s vein or with a prosthesis, carries a higher incidence of complications and a
131
lower technical success rate compared to an elective treatment4,5. Reilly et al. reported a 35% rate
132
of amputation in 66 patients with acute thrombosis of popliteal aneurysms, with a 5% rate of
133
perioperative mortality7. Halliday et al. compared results of surgical intervention in asymptomatic
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patients (limb salvage and primary patency rates of 100%) with those obtained in urgent surgery
135
for acute ischemia (a 5% rate of amputation, a 36% rate of graft thrombosis, a 5% rate of
136
permanent nerve injury)8. ER, consisting in a catheter-directed thrombolysis, is reported to give
137
sub-optimal results, especially in acute ischemia due to occluded popliteal aneurysm, with a 78.4%
138
rate of successful thrombolysis, an 82.4% rate of adjuvant revascularization procedures
139
(endovascular 33.3%, open 55.4%, hybrid 11.9%) and a 25.5% rate of major amputation rate at 30
140
days. Furthermore, it carries a rate of major bleeding complications of 21.6%13.
141
In the past two decades, percutaneous mechanical thrombectomy devices have been
142
introduced in order to minimize the use of thrombolytic agents on one hand, and accelerate the
143
process of thrombus removal on the other14. Starting from manual aspiration thrombectomy as
144
first percutaneous approach for clot removal, innovation moved to a series of mechanical
145
thrombectomy based on different mechanism of action (mechanical fragmentation, aspiration,
146
rheolytic thrombectomy, and their combination)15.
147
The Indigo System® (Penumbra Inc), is a device consisting in 3 components: aspiration
148
catheter, separator and pump. The aspiration catheter has a tapered configuration, allowing a
149
better clot accommodation inside its lumen and at the same time maintaining a sufficient gradient
150
pressure to deliver the clot into the canister. There are various catheter sizes (from 3 to 8 Fr) and
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length (132 cm or 150 cm), to better adapt to the target vessel caliber. The separators are used to
152
mobilize the clot and clean the catheter lumen and the operator has to move the separator back
153
and forth, during the aspiration. The pump is able to apply near pure vacuum aspiration pressure
154
of -29 mmHg16. Aspiration thrombectomy with the Indigo System® has the greatest advantage of
155
not increasing systemic risk of bleeding, promoting active thrombectomy using a vacuum pump
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that generate substantial suction, enabling aspiration of clots of varying sizes and lengths and
157
providing immediate flow reestablishment. Moreover, the availability of an angled catheter (CAT-
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8XTORQ) allows the possibility to create a lumen greater than nominal catheter’s diameter.
159
This system was initially designed for neurological patient with thrombosis of intracranial
160
vessels and it has proven to be effective in restoring blood flow with good immediate and long-
161
term patency rate. Risks associated with these interventions, as per IFU, comprise acute occlusion,
162
air embolism, arteriovenous fistula, device malfunction, distal embolization, emboli, false
163
aneurysm formation, inability to completely remove thrombus, intracranial hemorrhage, ischemia,
164
neurological deficits including stroke, vessel spasm and thrombosis.
165
results achieved in the Cerebrovascular field, this system was adapted also to patients with ALI
166
due to thromboembolism or distal emboli occurred during endovascular procedure. The PRISM
167
trial proved how the Indigo system could be used safely and effectively in ALI patients, with an
168
87.2% successful revascularization rate, increased to 96.2% if other endovascular intervention
169
were performed (e.g. angioplasty and stent placement) 10. Moreover, the Indigo System in Acute
Later on, given the good
170
Lower-Limb Malperfusion (INDIAN) Registry, intended as a national platform where every
171
physician can register his or her own data procedure, will enroll 150 patients suffering from ALI, in
172
order to prove safety and efficacy of the Indigo System17.
173
Moving from these experiences we decided to apply this technique to two cases of
174
thrombosed PAA. To our best knowledge, this technical solution has never been described before.
175
Both reported patients were admitted to the Emergency Room with acute limb ischemia, and in
176
both cases an urgent approach was adopted to prevent ALI related complications. A massive
177
thrombosis of PAA and BTK vessels was present in all treated cases, so a direct surgical solution by
178
femoro-popliteal bypass reconstruction was judged unfeasible due to the lack of out-flow vessels.
179
Moreover, ALI related symptoms were severe in both patients, so we tried to perform a prompt
180
revascularization. For that, fibrinolysis was not considered as first-line therapy because of the time
181
needed for revascularization, up to 3 days in previous reported experience3.
182
Consequently, mechanical thrombectomy by Indigo System® was adopted with satisfactory
183
early results. In the first case thrombus removal was immediately effective without needing drugs
184
infusion, while the second patient required 24 hours urokinase infusion. Of note, in one case CAT-
185
8 catheter was unable to proceed through PAA without guidewire support, differently to standard
186
practice in ALI procedure described in absence of dilatative pathology10.
187
After revascularization, both described patients underwent definitive surgical treatment
188
by surgical femoro-popliteal bypass via reinforced PTFE graft interposition, because of the absence
189
of a suitable great saphenous vein.
190 191
CONCLUSION
192
In our opinion, the Indigo System® could be used to treat ALI due to peripheral
193
aneurysmatic pathology, since it’s been proven to be safe and effective, with acceptable operative
194
risks. Proposed technique achieves an immediate limb reperfusion avoiding, or at least drastically
195
reducing, necessity for thrombolytic drugs infusion.
196 197
FIGURES LEGEND
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Figure 1: A) intraoperative angiography confirming PAAA thrombosis; B) CAT-8
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advancement on Zip Wire support; C) completion angiography demonstrating PAA, tibio-perneal
200
trunk and BTK vessels immediate reperfusion.
201
Figure 2: DUS control at 24 hours after thrombectomy showing PAA patency in axial (A),
202
and longitudinal (B) view, and direct flow on PTA (C); one-month CTA follow-up (D) showing good
203
patency of the reinforced PTFE graft and all BTK vessels.
204
Figure 3: A) CAT-8 advancement without wire support; B) completion angiography
205
demonstrating PAA and distal popliteal artery patency; C) patency of the tibio-peroneal trunk,
206
peroneal and posterior tibial arteries, anterior tibial artery appears occluded at its origin, while
207
distally is patent.
208 209 210
DECLARATION OF CONFLICTING INTERESTS The authors declared no potential conflicts of interest with respect to the research,
211 212
authorship, and/or publication of this article.
213 214
FUNDING The authors received no financial support for the research, authorship, and/or publication
215 216
of this article.
217 218
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