Notes to flashcards

Question 1

What are the 5 symptoms of PAD?

Answer 1

1. leg or buttock pain
2. wounds and ulcers
3. leg numbness
4. cold feet
5. tissue loss

Question 2

What %age of PAD symptoms are asymptomatic?

Answer 2

50%

Question 3

What are the classifications of the Rutherford?

Answer 3

0-asymptomatic
claudication
1-mild
2-moderate
3-severe
Critical Limb ischemia
4-ischemic rest pain
5-minor tissue loss
6-major tissue loss (functional foot not salvageable)

Question 4

define “atheromatous”

Answer 4

an abnormal fatty deposit in an artery

Question 5

What is the purpose of Rotarex magnetic slip-clutch?

Answer 5

instant disengagement with obstruction. safety feature.

Question 6

What must the iliac bifurcation be greater than for Rotarex indication?

Answer 6

4cm

Question 7

What must ACT score be higher than for Rotarex cases?

Answer 7

250

Question 8

What are the 3 mechanisms of action for Rotarex?

Answer 8

1. rotating abrading vortex
2. continuous active aspiration
3. modifying beveled tip

Question 9

What are the 8 key benefits of Rotarex?

Answer 9

1. dual indication atherectomy and thrombectomy
2. active aspiration - minimizes embolization
3. dual cutting mechanism - cuts at tip and side windows
4. vessel preparation - may enhance take-up of PTX
5. reduces need for stents
6. reasonable maximum run time
7. no limitation on lesion length
8. no need for distal filter

Question 10

Rotarex meta-analysis

1. how many patients?
2. what is the freedom of TLR @ 6 months?
3. what is the freedom of TLR @ 12 months?

Answer 10

1. how many patients? 2107
2. freedom of TLR @ 6 months- 92.2%
3. freedom of TLR @ 12 months- 88.7%

Question 11

Leipzig Trial (not level 1 data) for Rotarex

1. how many patients?
2. what % of total chronic fem-pop treated
3. what % were CLI (Rutherford 4-6)
4. what was the mean lesion length?
5. What % of occlusions?
6. what % used distal protection? how many vessel run-offs?
7. what is the distal embolization rate?
8. what is the 12 month FTLR?

Answer 11

1. 658 patients
2. 56.7% of total chronic fem-pop treated (373)
3. 60.3% were CLI (Rutherford 4-6)
4. 14.8cm mean lesion length
5. 100% occlusions
6. (41) 6.2% used distal protection. 1 vessel run-off.
7. 3.2% low distal embolization rate
8. 90.1% 12 month FTLR

Question 12

Rotarex 6F stats
1. vessel diameters
2. sheath compatibility
3. max. rotation speed
4. max aspiration speed
5. catheter external diameter
6. guidewire

Answer 12

Rotarex 6F stats
1. 3mm + vessel diameters
2. 6Fr - sheath
3. 60,000 rpm - max. rotation speed
4. 45 ml/min - max aspiration speed
5. 2mm - catheter external diameter
6. .018 guidewire

Question 13

Rotarex 8F stats
1. vessel diameters
2. sheath compatibility
3. max. rotation speed
4. max aspiration speed
5. catheter external diameter
6. guidewire

Answer 13

Rotarex 8F stats
1. 5mm + vessel diameters
2. 8Fr - sheath
3. 45,000 rpm - max. rotation speed
4. 75 ml/min - max aspiration speed
5. 2.7mm - catheter external diameter
6. .018 guidewire

Question 14

Lutonix Indication

Answer 14

PTA, after appropriate vessel preparation, of de novo, restenotic, or in stent restenotic lesions up to 300mm in length native superficial femoral or popliteal arteries with reference vessel diameters of 4-7mm.

Question 15

lutonix mechanism of action and how it works

Answer 15

2 ug/mm^2 of PTX Paclitaxel

stops cell division and cell growth in the metaphase

This prolongs restenosis and intimal hyperplasia

Question 16

lutonix carrier?

How can you prove it limits drug flaking?

Answer 16

polysorbate and sorbitol

limits drug flaking bc data shows <.08% is lost in the sheath and <.1% lost during balloon prep

Question 17

How was lutonix formulation created?

Answer 17

50k balloons
>250 formulations, >225 carriers
45 pre clinical studies
1 balloon

Question 18

Lutonix Levant 1 study

1. what is it?
2. who did it?
3. study arms?
4. what did it show a. at 30 days b. 60 days c. 90 days d. distal embolization? at what dose?

Answer 18

Lutonix Levant 1 study

1. what is it? Pre clinical safety data
2. who did it? Dr. Vermani
3. study arms? units of PTX vs 8 units.
4. what did it show at:
   a. 30 days - sustained presence
   b. 60 days - peak effect
   c. 90 days - pharmacological effects
   d. NO distal embolization or downstream effect at 4x dose

Question 19

Levant 2 study

1. what level of data and where is it published?
2. What were the primary patency results at 12 months?
3. What was the freedom of TLR at 12 months?
4. 3 unique study considerations?

Answer 19

Levant 2 study

1. Level 1 data published in the NEW ENDLAND JOURNAL OF MEDICINE.
2. primary patency results at 12 months:
   DCB - 73.5% (improved to 79% when sized appropriately)
   PTA - 56.8%
3. What was the freedom of TLR was 89.7% (9/10 patients did not require reintervention at 1 year.)
4. 3 unique study considerations?
   a. exclude stenting (to study effects of drug)
   b. extensive blinding strategy
   c. stent bail-out not considered a failure

Question 20

Levant 2 study procedural technique discoveries

1. how did it improve primary patency?
2. what are the 4 technique improvements?
3. What is the suggestions for optimal results?

Answer 20

1. from 72% to 79% in DCB.
2. technique improvements:

IPTS (I Pray To snow!)

a. inflation time greater than 120 seconds
b. pressure greater than 7 atm
c. transit time to legion < 30 seconds
d. residual Stenosis less than 20%

Question 21

Global Real World Registry - Lutonix

1. patient #, countries, sites
2. FTLR…
   a. @ 12 months
   b. @ 24 months
   c. in long lesion @ 12 months
   d. in long lesions at 24 months
   e. in ISR at 12 months
   f. in ISR at 24 months

Answer 21

Global Real World Registry - Lutonix

1. 691 patient #, 38 countries, 10 sites
2. FTLR…

a. 94.1% @ 12 months
b. 90.3% @ 24 months
c. 93.4% in long lesion @ 12 months
d. 89.4% in long lesions at 24 months
e. 90.7% in ISR at 12 months
f. 85.5% in ISR at 24 months

Question 22

MDT IN.PACT DCB

1. what is carrier?
2. PTX dose?
3. Half - life ?

Answer 22

MDT IN.PACT DCB

1. Urea carrier
2. PTX dose - 3.5 units/mm^2
3. Half - life - 72.5 hours

Question 23

LEVANT 2 vs. IN.PACT SFA I & II

4 main takeaways

Answer 23

PATIENT POPULATION was much more impressice with LEvant 2 study than with IN.PACT study.

1. levant 2 had higher rutherford class and more restenotic lesions
2. no middle pop or distal pop lesions in SFA1/2
3. provisional stents 3x higher (bd 2.5% vs. mdt 7.3%)
4. bd>mdt for patients with vessel run off

Question 24

BD lutonix Levant 2 study vs. MDT IN.PACT in the GLOBAL REAL WORLD REGISTRY

FTLR @ 24 months difference

Answer 24

90.3% - BD lutonix
83.3% - MDT in.pact

FTLR @ 24 months difference

Question 25

BD lutonix vs. MDT in.pact shake test results?

Answer 25

lutonix = .05% drug lost inpact = 10.61% drug lost

Question 26

How much do you upsize LIFESTREAM?

Answer 26

upsize 5-20%

Question 27

What is LIFESTREAM indicated for?

Answer 27

common and external iliac arteries between 4.5mm-12mm in diameter and up to 100mm in length

Question 28

What are the 4 pros of LIFESTREAM in reference to aortoiliac occlusive disease?

Answer 28

aortoiliac occlusive disease - vessel recoil, neointimal hyperplasia, fear of vessel, rupture, improper stent landing. 1. Prevents elastic recoil 2. Removes impact of BMS design on intimal thickening 3. Barrier to tissue in-growth, reduces in-stent restenosis 3. Reduces the risk of complication w/ ePTFE covering R - recoil vessel prevention I - impact removal of BMS intimal thickening B - barrier to tissue ePTFE - reduces complications

Question 29

LIFESTREAM stent design and balloon compliance

Answer 29

316L SS with DUAL layer of ePTFE non-compliant balloon

Question 30

LIFESTENT indication

Answer 30

SFA and full popliteal artery indication up to 240mm length 4.0-6.5mm vessel diameter

Question 31

LIFESTENT clinical data resilient trial 1. What did it prove? 2. What level data? 3. 12 month patency? 4. 12 month FTLR? 5. 24 month FTLR? 6. 36 month FTLR? 7. 12 month fx rate? 8. 18 month fx rate?

Answer 31

1. What did it prove? LIFESTENT is a safe and effective product. 2. LEVEL 1 DATA 3. 12 mo patency - 81.5% 4. 12 mo FTLR - 87% 5. 24 mo FTLR - 78% 6. 36 mo FTLR - 75.5% 7. 12 mo fx rate - 3.1% 8. 18 mo fx rate - 4.1%

Question 32

LIFESTENT etap trial 1. what did it prove? 2. 12 mo patency? 3. 12 mo FTLR? 4. 12 mo fx rate? 5. 24 mo fx rate?

Answer 32

LIFESTENT etap trial 1. Looked at the difference between PTA and BE stent in popliteal artery 2. 12 mo patency - 67.4% 3. 12 mo FTLR - 85.3% (higher than PTA) 4. 12 mo fx rate - 3.4% 5. 24 mo fx rate - 4.6%

Question 34

What is the freedom from TLR at 300 days reported during the Bolster trial?

Answer 34

96.1%

Question 35

What is the primary patency at 12 months of the Resilient Trial?

Answer 35

81.5%

Question 36

What is an example of a DIRECTIONAL atherectomy device? What is its mechanism of action?

Answer 36

directional means it has a side cutter canula with the ability to "direct" the cutter toward specific areas. ex. Medtronic HAWK ONE

Question 37

What is an example of a ORBITAL atherectomy device? What is its mechanism of action?

Answer 37

Orbital means diamond cutting burrs which use centrifugal force to sand calcium. Ex. CSI

Question 38

What is an example of a LASER atherectomy device? What is its mechanism of action?

Answer 38

UV lights produced to break molecular bonds by creating constant vapor bubbles ex. Auryon

Question 39

Rotarex vs. HAWK What are three advantages?

Answer 39

1. there is no stopping mechanism for directional atherectomy devices. 2. Embolization risk is higher with directional devices. 3. a distal protection device is recommended for directional devices.

Question 40

What is an example of a ROTATIONAL atherectomy device? What is its mechanism of action?

Answer 40

This means there are different mechanisms of removing material via a tip or a burr that rotates and shaves plaque with or without an aspiration removal component. ex. Jetstream

Question 41

What is the indication of True?

Answer 41

Indicated for balloon aortic valvuloplasty.

Question 42

What are the 4 key points of True?

Answer 42

1. Precise: ultra-non-compliant 2. Fast: inflate and deflate times 3. Rupture resistant 4. Tight re-wrap : low withdrawal profile

Question 43

What is the indication of Crosser IQ?

Question 44

Crosser IQ facilitates ______ crossing.

Answer 44

intraluminal

Question 45

T/F: Crosser IQ selectively ablates inelastic material.

Answer 45

True

Question 46

Lutonix indication

Answer 46

PTA of de novo, restenotic, or ISR lesions UP TO 300MM in length in SFA or popliteal arteries, 4-7mm in diameter. NO BELOW THE KNEE INDICATION.

Question 47

Lutonix showed a _____% over PTA in patency improvement in Levant 2.

Answer 47

29.4%

Question 48

What catheter "usable lengths" are available for the 6F and 8F rotarex system?

Answer 48

6F: 110cm, 135cm 8F: 85cm, 110cm

Question 49

Lifestream diameters, lengths, and sheath profiles

Answer 49

diameters: 5-12mm lengths: 16, 26, 38, 58 sheath: 6F, 7F, 8F post-dil options: 5-10mm or 9-12mm

Question 50

Lutonix diameters, lengths, and sheath profiles

Answer 50

diameters: lengths: 40-300mm **018 4F break point to 5F is 220mm.** sheath profiles: 4F/5F/6F-7F wire platforms: 035/018