DISCLOSURES No conflict of interest and relationships to disclose for this presentation I may be discussing products that are investigational or not l

NO ENTRY SITE Resident(s): Alexandria S. Jo, MD Attending(s): Narasimham L Dasika, MD Program/Dept(s): University of Michigan Department of Interventi...
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NO ENTRY SITE Resident(s): Alexandria S. Jo, MD Attending(s): Narasimham L Dasika, MD Program/Dept(s): University of Michigan Department of Interventional Radiology

DISCLOSURES ▪ No conflict of interest and relationships to disclose for this presentation ▪ I may be discussing products that are investigational or not labeled by FDA for such use under discussion

HPI ▪69 year old male with well known peripheral arterial disease (PAD) and previous episodes of critical limb ischemia (CLI). ▪Now presenting with 3 week history of right foot pain at rest. ▪Sleeping in a chair because his right foot hurts severely while in bed. ▪He gets relief by standing or hanging the right leg from edge of the bed. ▪Currently can walk only 20 feet before he gets disabling right claudication. ▪Also with rapidly worsening right heel ulcer and increased right leg swelling.

HPI ▪His symptoms significantly worsened since an unsuccessful attempt at lysis of ilio-profunda graft thrombosis 2 months back. ▪He was offered right above knee amputation at 2 different outside facilities. ▪He also has long standing left lower extremity symptoms. He feared that right leg amputation would ultimately result in decreased activity and lead to eventual amputation of the other leg. ▪Thus, he came to our PAD clinic for a 3rd minimally invasive option before resorting to amputation of his right leg.

PAST MEDICAL HISTORY ▪Past medical history: Hypertension (HTN), hyperlipidemia (HLD), coronary artery disease (CAD) status post stenting in 2004, asthma, obesity ▪Social history: 50 pack per year smoking, 3-4 beers a day, retired automotive plant supervisor ▪Family history: HTN, CAD, HLD, PAD ▪Home medications: Aspirin, Clopidogrel, Warfarin, Bisoprolol, Hydrochlorothiazide, Rosuvastatin

PAST SURGICAL HISTORY: EXTENSIVE PRIOR ENDOVASCULAR AND SURGICAL PROCEDURES ▪April 2, 2001: Percutaneous translumintal angioplasty of his SFA with S.M.A.R.T. stent placement of the right superficial femoral artery (SFA) ▪April 17, 2001: Left common femoral endarterectomy and PTA of his left SFA. ▪May 6, 2004. A right iliofemoral endarterectomy with a Fem-PT vein graft – occluded post operatively due to in-flow disease in a week. ▪July 15, 2004: PTA and a stent in his right external iliac artery. ▪July 27, 2004: Right common femoral artery to posterior tibial sequential basilic vein bypass. ▪December 27, 2004: A drug-eluting stent in his distal bypass graft at the mid tibial level. ▪April 26, 2005: A drug-eluting stent in his proximal bypass graft. ▪July 26, 2005. A sirolimus stent in his upper leg graft. ▪June 12, 2007: A right ileofemoral to profunda and SFA as well as an SFA endarterectomy. ▪October 9, 2008: A right common femoral artery profundoplasty and endarterectomy. ▪June 4, 2010: Lysis of his right iliac-profunda bypass and laser atherectomy of his right common femoral artery and a proximal graft ▪December 11, 2012: Right SFA intrastent stenosis with thrombus in the graft and recurrence of extensive atheromatous plaque in the right popliteal and tibial arteries. Post arthrectomy, thrombectomy and angioplasty demonstrated three-vessel outflow with no intraluminal thrombus with significant improvement in the Doppler signals in the right foot. ▪October 15, 2013: Angioplasty of the right popliteal SFA.

PHYSICAL EXAMINATION ▪Toes are hypersensitive to touch ▪Bilateral femoral and pedal pulses are not palpable

▪Right leg: Dependent rubor, 1+ pitting edema ▪Right heel: Shallow 1cm ulcer ▪Right foot is cool with very poor capillary refill ▪Left foot: Poor capillary refill, (better than right) with no ulcers ▪Bilateral pedal doppler signals are monophasic

PREVIOUS IMAGING STUDIES: CTA OF THE ABDOMEN, PELVIS AND LOWER EXTREMITY

• • •

Extensive calcified atherosclerotic plaque throughout the aorta and its branch vessels. There is a endoluminal external iliac artery stent extending from common iliac bifurcation to 4 cm proximal to the groin. The stent is proximally partially collapsed and distally there is mild to moderate luminal narrowing.

PREVIOUS IMAGING STUDIES: CTA OF THE ABDOMEN, PELVIS AND LOWER EXTREMITY Evaluation of the right lower extremity ▪Common femoral: Occluded grafts from the CFA to the proximal SFA and to branch of the profunda. ▪Superficial femoral: Almost completely occluded throughout ▪Deep femoral: Partially occluded proximally with extensive collaterals down the thigh and into the proximal leg. ▪Popliteal: occluded ▪Tibioperoneal trunk: heavily calcified and possibly occluded. ▪Anterior tibial: Patent ▪Posterior tibial: Patent ▪Peroneal: Patent with dense calcification at origin that may cause stenosis.

SEGMENTAL PRESSURES AND ABI/TBI RIGHT

LEFT

No signal

BRACHIAL

126 (0.74)

No signal

PROXIMAL THIGH

80 (0.47)

No signal

HIGH CALF

64(0.37)

45 (0.26)

ANKLE PT

46 (0.27)

34 (0.20)

ANKLE DP

40 (0.23)

9 (0.05)

FIRST TOE

22 (0.13)

Results: R ABI of 0.26 (monophasic) R TBI of 0.05 (pressure of 9) L ABI of 0.27 (monophasic) L TBI of 0.13 (pressure of 22) R right iliac to profunda bypass graft is occluded.

DIAGNOSIS AND STAGING ▪Rutherford 2b – Rest pain ▪Clinical Category 5 – minor tissue loss ▪ (Ankle pressure55 cm) chronic total occlusion. ▪Occlusion of the distal right external iliac, CFA, SFA and proximal profunda. ▪Small right internal iliac artery with reconstituting discontinuous profunda. ▪Occluded prior right SFA stents. ▪Excessive diffuse calcification and hostile groin from previous interventions. ▪Occluded right popliteal artery. ▪Ostial occlusion of the right tibial arteries, But patent anterior tibial, distal posterior tibial and peroneal arteries. ▪Deformed posterior tibial artery from previous stent placement. ▪In addition, the patient had advanced contralateral left lower extremity disease.

DECISION MAKING ▪Now what? ▪The patient had come to our institution as a last resort before considering above the knee amputation of his right leg. ▪With his bilateral disease, amputation of the right leg will inevitably lead to decreased activity levels which will most likely lead to disease progress in his left lower extremity. ▪With his extensive disease, conservative medical treatment alone would not control his symptoms or stop/delay the progression of the disease process. ▪Vascular surgical or surgical/endovascular intervention was not feasible due the extent of vessel involvement and hostile surgical field due to multiple previous interventions.

ENCOURAGING FINDINGS ▪Despite the extensive above knee vessel disease, the patient still had: ▪Patent distal 2/3 of right anterior tibial artery with patent dorsalis pedis ▪Patent distal ½ of right posterior tibial artery with preserved continuity to the plantar arch ▪Diseased but segmental patency of the right peroneal artery

Deformed posterior tibial artery due to previous stenting

Intact posterior tibial artery

Intact dorsalis pedis artery

Intact posterior tibial artery

FINAL CLINICAL DECISION  With these findings, we decided to perform a stepwise, multilevel, sharp, subintimal recanalization through subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) with artherectomy and stenting.

INTERVENTION: ACCESS #1 ACCESS THROUGH THE LEFT COMMON FEMORAL ARTERY ▪Initial access through the left common femoral artery. ▪Placement of 5 french arterial sheath. ▪Advancement of glidewire into the right external iliac

and upsizing of the sheath to a 6-french Ansell sheath ▪5 Fr VERT catheter advanced over guidewire through arterial sheath to the level of obstruction at the right distal external iliac artery ▪Recanalization of the right common femoral artery from the left femoral arterial access was attempted but was unsuccessful.

INTERVENTION: ACCESS #2 ACCESS THROUGH THE RIGHT SFA STENT ▪With the calcification as guidance, right mid SFA was accessed and a Glidewire was advanced retrograde to the right groin. ▪Sharp recanalization of the occluded right common femoral and distal external iliac artery was performed with the stiff end of a Glidewire. ▪This wire was snared from the left common femoral access site and the recanalized common femoral artery and the proximal SFA was balloon dilated. ▪Sequential subintimal recanalization with angioplasty of the right distal external iliac, common femoral and proximal superficial femoral artery was performed. ▪Most of the recanalized segment of the right common femoral and the right superficial femoral artery was performed subintimal.

INTERVENTION: ACCESS #3 PEDAL (AT) ACCESS

▪We then attempted to perform subintimal recanalization of the distal SFA and the popliteal artery. ▪A pre-existing occluded Nitinol stent in the distal SFA extensive heavy calcified arteries made this procedure extremely difficult. ▪With the help of multiple quick cross catheters and multiple guidewires, we were finally able to enter the occluded Nitinol stent and through the stent reached to the level of intercondylar fossa. However we could not re-enter the true lumen of the popliteal artery. ▪We then decided to recanalize the leg arteries through a pedal access. The right anterior tibial artery was accessed at the level of the ankle. ▪A 4-French stiff micropuncture sheath was advanced into the distal anterior tibial artery.

INTERVENTION: ACCCESS #4 ACCESS THROUGH PROXIMAL AT DIRECTLY FACING THE BEND ▪Retrograde recanalization of proximal AT and the tibioperoneal trunk was performed with a combination of 0.018 compatible quick cross catheter, V18 wire, and multiple 0.018 glide wires. Once again we could not enter into the popliteal artery at the knee joint.

▪We then advanced a 2.5 mm x 15cm sleek mono rail balloon into the distal tibioperoneal trunk and balloon dilated the recanalized tibioperoneal trunk. Through the inflated balloon, popliteal artery was bluntly dissected. ▪The balloon catheter was taken out, and a 4 Fr sheath was advanced into the distal right AT. Through this sheath a 64 cm 4 Fr angled glide catheter was advanced into the popliteal artery. ▪Blunt dissection up to the level of the adductor canal from the proximal popliteal artery was performed using a 0.035 stiff Glidewire.

RETROGRADE 2 LEVEL SAFARI VIA 4TH ACCESS  A 300 cm long PT graphics wire was advanced through the right AT access into the popliteal artery.  This wire was snared from the contralateral access to obtain a through and through access.  Over the through and through wire, the distal popliteal artery and the tibioperoneal trunk were balloon dilated with 4mm savvy balloons.  Multiple balloons ruptured due to extensive calcification.

HIGH PRESSURE POBA ▪From the contralateral access, through the a 6-French Ansell sheath, a 0.035 quick cross catheter was advanced into the recanalized the subintimal channel of the right SFA. The quick cross catheter was then exchanged for an Amplatz wire. ▪The heavily calcified recanalized subintimal channel was repeatedly dilated with Fox balloons, 4 to 6 mm in diameter. Several balloons ruptured due to spikes of calcium protruding into the subintimal channel. ▪A communication was created with sharp dissection between the subintimal channel of the SFA and the retrograde access from the popliteal artery. Predilatation of the popliteal artery and the entire subintimal channel was performed with Fox and OPTA balloons. ▪Segment of the new channel created was deliberately passed through the center of the previously placed and occluded right SFA Nitinol stent. Further dilation of the entire proximal popliteal artery and the subintimal channel of flow common femoral and superficial femoral arteries was dilated to 6 mm with Dorado balloons.

HIGH PRESSURE POBA FAILED TO RESTORE FLOW ▪Angiogram of this extensive recanalization revealed no flow through the recanalized segments due to collapse of the subintimal channel from heavy calcification.

STENTING OF THE ENTIRE RECANALIZED SEGMENT ▪The groin sheath from the left common femoral access was upsized to 8-French 45 cm long Ansell sheath. ▪Two overlapping 6 mm X 15 cm Viabahn grafts were deployed from the intercondylar fossa and extending to the level of proximal thigh. ▪A 7 mm x 10cm Viabahn graft was then deployed from the origin of the common femoral artery into the proximal stent graft. ▪Finally the common femoral artery and the distal external iliac artery was stented with a 8mm diameter SMART stent. ▪All the Viabahn grafts were then balloon dilated with gonadal 6 mm x 15 cm long balloons. ▪Multiple dilations were performed to expand the grafts properly. ▪The distal popliteal artery was balloon dilated to 5 mm with op balloon.

INTERVENTION: ACCESS #5 THROUGH PT AND RECANALIZATION OF TP TRUNK •

Finally kissing balloon dilatation of the distal popliteal artery from the retrograde right anterior tibial access, and a second balloon from the contralateral access was performed to dilate the distal popliteal artery to 5 mm.



A combination of 3 mm diameter savvy and 2.5 mm diameter sleek balloons were used.



Furthermore, the distal popliteal artery was balloon dilated to 5 mm with opt a balloon.



The tibioperoneal trunk was balloon dilated 4 mm diameter savvy balloon.



The proximal posterior tibial artery was balloon dilated to 3 mm with savvy balloon.

POST INTERVENTION ANGIOGRAM ▪The final angiogram shows continuous flow through the very long Viabahn stent grafts placed from right distal external iliac artery to the level of distal popliteal artery.

POST INTERVENTION ANGIOGRAM

▪Recanalization of the tibia peroneal trunk and the proximal tibial vessels resulted in widely open proximal arteries with continuous flow into the foot.

INTERVENTION ▪Fluoro time: 120 minutes. ▪Contrast used: Isovue-300, 100cc ▪Estimated blood loss: 50 cc ▪Heparin 13,000 units ▪ACT: 250 to 300 ▪Post procedure anticoagulation ▪Loading dose of plavix

POST INTERVENTION DISCHARGE ▪Aspirin 81 mg, Clopidogrel 75 mg, Coumadin 5 mg daily with target INR of 2.5-3 ▪Continue Statin. ▪Strong recommendation for left lower extremity revascularization in 2-3 weeks. ▪Advised to start supervised exercise program since the left lower extremity arterial disease may limit his activity.

FOLLOW UP: 2 WEEKS AFTER IR INTERVENTION Before intervention

2 weeks after intervention

Right PT

45 (0.26)

78 (0.66)

Right DP

34 (0.20)

73 (0.61)

Right ABI

0.26

0.66

ADDITIONAL INTERVENTIONS AFTER THE INITIAL IR INTERVENTION ▪He underwent additional interventions in his left lower extremity. ▪Left lower extremity subintimal recanalization of long segment occlusion of SFA and popliteal artery and post recanalization PTA and stenting.

▪He also underwent additional intervention in his right lower extremity: ▪Recurrent popliteal lesion requiring atherectomy, drug coated balloon angioplasty, and stent graft placement in the right superficial femoral artery and popliteal artery.

FOLLOW-UP AND CLINICAL OUTCOME ▪He is much more active at home and has no pain or difficulty with yard work outside. Tolerating supervised exercise program.

▪He is sleeping in his bed rather than in a chair. ▪He does feel that his activity now due to fatigue rather than leg pain and feels that his stamina is increasing with exercise.

▪He continues on oral anticoagulation and dual antiplatelet regimen.

MOST RECENT RESULTS: 3.5 YEARS AFTER IR INTERVENTION ▪No symptoms ▪Continues regular exercises and medications ▪Palpable femoral and popliteal pulses and feeble pedal pulses

▪No focal lesions on graft scan ▪Normal segmental velocities Before intervention

2 weeks after intervention

Most recent results

Right PT

45 (0.26)

78 (0.66)

1.36 (0.84)

Right DP

34 (0.20)

73 (0.61)

117 (0.72)

Right ABI

0.26

0.66

0.84

TAKE HOME POINTS ▪Patients with extensive proximal occlusive disease and patent tibial and pedal arteries show long term benefit from endovascular revascularization. ▪Stepwise progression of recanalization with multiple accesses should be considered in heavily calcified and occluded arteries even in the presence of stents. ▪Consider post stent graft intentional rupture for luminal gain. ▪Operator should aim to restore uninterrupted flow to to DP and plantar arch.

▪Operator should also strive to open two or more tibial arteries and plantar arch. ▪Treat both sides so the patient can start a supervised exercise program, which provides the most benefit post procedurally. ▪Frequent surveillance by Doppler and graft scans is essential. ▪Clinician should have low threshold for re-intervention with recurrence of symptoms and/or abnormal graft scans.

▪Patient with long segment Viabahn grafts are treated with oral anticoagulation in accordance to similar interventions performed by vascular surgery.

REFERENCE ▪Conroy RM, Gordon IL, Tobis JM, et al. (2000) Angioplasty and stent placement in chronic occlusion of the superficial femoral artery: Technique and results. J Vasc Intervent Radiol 11:1009–1020.

▪Spinosa DJ, Harthun NL, Bissonette EA, et al. (2005) Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) for subintimal recanalization to treat chronic critical limb ischemia. J Vasc Intervent Radiol 16:37–44. ▪Spinosa DJ, Leung DA, Harthun NL, et al. (2003) Simultaneous antegrade and retrograde access for subintimal recanalization of pheripheral arterial occlusion. J Vasc Intervent Radiol 14:1449–1454. ▪Yilmaz S, Sindel T, Yegin A, et al. (2003) Subintimal angioplasty of long superficial femoral artery occlusions. J Vasc Intervent Radiol 14:997–1010.

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