Mastering Embolic Choices in UFE: Current Evidence · Mastering Embolic Choices in UFE: Current...

Mastering Embolic Choices in

UFE: Current Evidence

Gary Siskin, MD

Professor and Chairman

Department of Radiology

Albany Medical Center

Albany, New York

Gary Siskin, M.D.

• Consultant/Advisory Board: Boston Scientific, Embomedics, Biocompatibles,

Medtronic

• Research Grants: Boston Scientific, Embomedics, Biocompatibles, Medtronic

Embolic Agents: UFE

Perfect

The perfect embolic for UFE will have

the following characteristics.

Great Outcomes (clinical improvement,

fibroid infarction, limited reinterventions)

Documented Comparability/Superiority to

Existing Agents

Ease of Use

Cost Savings

Embolic Agents: UFE

Best-In-Class

There is evidence supporting the

conclusion that these agents represent

the “best-in-class” for UFE.

Embolic Agents: UFE

Runner-Up

There are either fewer studies or less

convincing evidence supporting the use

of these agents for UFE.

Embolic Agents: UFE

Participation Trophy

There is evidence that should convince

you to avoid using these agents for UFE.

Embolic Agents: UFE

Available embolic agents are classified into one of those

categories based on studies evaluating performance.

Single-Agent Studies

These are retrospective or

prospective studies which

highlight the use of one

embolic agent for UFE.

These almost always show

that every embolic agent can

be used safely and effectively

for UFE.

Embolic Agents: UFE

Available embolic agents are classified into one of those

categories based on studies evaluating performance.


These are retrospective or


highlight the use of one

embolic agent for UFE.

These almost always show

that every embolic agent can

be used safely and effectively

for UFE.

Comparative Studies

These are typically


compare the performance of

two or more agents for UFE.

These often show the

comparable nature of most

embolic agents for UFE but

can sometimes reveal

something unexpected.

Embolic Agents: UFE

Best-In-Class

Particulate PVA

Embosphere Microspheres

Gelfoam

Embolic Agents: UFE

Best-In-Class

Particulate PVA

Particulate PVA was the initial “standard” agent used for UFE.

Embolic Agents: UFE

Best-In-Class

Particulate PVA


Ravina JH, et al. Lancet 1995; 346:671-672

Goodwin SC, et al. J Vasc Interv Radiol 1997; 8:517-526

Worthington-Kirsch RL, et al. Radiology 1998; 208:625-629

Spies JB, et al. J Vasc Interv Radiol 1999; 10:1149-1157

Siskin GP, et al. J Vasc Interv Radiol 2000; 11:305-311

Spies JB, et al. Obstet Gynecol 2001; 98:29-34

Pron G, et al. Fertil Steril 2003; 79:120-127 Particulate PVA is

safe and effective for

UFE.

Embolic Agents: UFE

Best-In-Class

Particulate PVA

There are general issues with the use of particulate PVA.

Microcatheter Clogging

Variability of Particle Size

Particle Aggregation with Proximal Occlusion

The spherical agents that we use today were developed in response

to these shortcomings of particulate PVA.

Embolic Agents: UFE

Best-In-Class

Tris-Acryl Gelatin Microspheres (Embosphere Microspheres)



Banovac F, et al. J Vasc Interv Radiol 2002; 13:681-688

Pelage JP, et al. J Vasc Interv Radiol 2003; 14:15-20

Spies JB, et al. Am J Obstet Gynecol 2004; 191:22-31

Lohle PN, et al. J Vasc Interv Radiol 2006; 17:283-287


Scheurig-Muenkler C, et al. J Vasc Interv Radiol

2010; 21:1347-1353

Embosphere

Microspheres are


UFE.

Embolic Agents: UFE

Best-In-Class


At the same time these microspheres were introduced, the criteria

used to define success after UFE changed.

We learned that fibroid infarction is a critical endpoint for UFE and is

responsible for long-term treatment success.

It became important to compare the different embolic agents to

determine if there were advantages in terms of fibroid infarction.

Pelage, et al. Radiology 2004; 230:803

Embolic Agents: UFE

Best-In-Class


Comparative Studies

Spies JB, et al. J Vasc Interv Radiol 2004; 15:793

Prospective, randomized study evaluating the effectiveness of particulate PVA

(n=46) and tris-acryl gelatin microspheres (n=54).

No differences in recovery, improvement in symptom severity and health-related

quality of life, patient satisfaction, and fibroid infarction.

Embolic Agents: UFE

Best-In-Class


Comparative Studies

Spies JB, et al. J Vasc Interv Radiol 2004; 15:793

Galvez JA, et al. J Comput Assist Tomogr 2008; 32:356

Abramowitz SD, et al. Radiology 2008; 250:482

Embosphere

Microspheres and

particulate PVA are

equally safe and

effective for UFE.

Embolic Agents: UFE

Best-In-Class

Gelfoam

Let’s not forget about gelfoam.

There are inherent advantages to gelfoam (availability, cost)

There is a significant body of experience from Asia demonstrating its

success when used for UFE.

Embolic Agents: UFE

Best-In-Class

Gelfoam


Katsumori T, et al. AJR 2002; 178:135-139

Huang LY, et al. Fertil Steril 2004; 81:1375-

1382

Katsumori T, et al. AJR 2006; 186:848-854

Katsumori T, et al. Cardiovasc Intervent

Radiol 2007; 30:398-404

Sone M, et al. JVIR 2010; 21:1665-1671

Butori N, et al. Eur J Radiol 2011; 79:1-6

Katsumori T, et al. Cardiovasc Intervent

Radiol 2011; 34:513-521

Song YG, et al. Min Inv Ther Allied Technol

2016; 25:35

Gelfoam is safe and

effective for UFE.

Embolic Agents: UFE

Best-In-Class

Gelfoam

Comparative Studies

Song YG, et al. Minim Inv Ther Allied Technol 2013; 22:364

Gelfoam vs. Particulate PVA in 60 patients (30 in each group)

The use of gelfoam was associated with greater improvement in bleeding and a

greater mean fibroid volume reduction compared with PVA.

The fibroid infarction rate was similar between the two groups.

Embolic Agents: UFE

Best-In-Class

Gelfoam

Comparative Studies

Song YG, et al. Minim Inv Ther Allied Technol 2013; 22:364

Vilos AG, et al. J Obstet Gynaecol Can 2014; 36:983

Railton N, et al. JVIR 2010; 21(2):S23

Gelfoam,

Embosphere

Microspheres and

particulate PVA are

equally safe and

effective for UFE.

Embolic Agents: UFE

Best-In-Class

Gelfoam

Things to Remember

There are several different ways to prepare gelfoam for use, so

standardization of technique and comparability of data across studies may

be difficult.

If you like microcatheters to reduce the likelihood of uterine artery spasm,

it may be difficult to use gelfoam.

Embolic Agents: UFE

Best-In-Class

Summary

Participate PVA, Tris-Acryl Gelatin Microspheres, and Gelfoam appear

to have equivalent clinical performance for UFE.

There are delivery advantages inherent to spherical embolic agents

which should make Embosphere Microspheres the current standard

of care for UFE.

Gelfoam is an effective alternative to these two agents, especially in an

era of cost control, but standardization of technique may be difficult.

Embolic Agents: UFE

Runner-Up

Acrylamido PVA Microspheres (Bead Block Microspheres)

Polyzene-F Microspheres (Embozene Microspheres)

Embolic Agents: UFE

Runner-Up


Polyzene-F Microspheres (Embozene Microspheres)

There have not been adequate

comparative studies performed.

The studies that have been

performed have had mixed

results.

Runner-Up



Chrisman HB, et al. JVIR 2010; 21:484

Good clinical improvement but high rates

of residual fibroid perfusion with 500-700μ

microspheres; enrollment was terminated

early.

Kroencke TJ, et al. JVIR 2008; 19:47

High rate of treatment failure (residual

fibroid perfusion) with 500-700μ

microspheres; better clinical and imaging

outcomes with 700-900μ microspheres.

Embolic Agents: UFE

The results are

mixed with Bead

Block Microspheres.

Runner-Up


Comparative Studies

Abramowitz SD, et al Radiology 2009;

250:482

Lower rates of fibroid infarction compared

with PVA and Embosphere Microspheres.

Liaw JVP, et al. Eur J Radiol 2012; 81:1371

Noninferior to Embosphere Microspheres.

Worthington-Kirsch R, et al. CVIR 2011;

34:493

Noninferior to Embosphere Microspheres.

Embolic Agents: UFE

The results are

mixed with Bead

Block Microspheres.

Embolic Agents: UFE

Runner-Up

Polyzene-F Coated Microspheres (Embozene Microspheres)


These are important for this embolic agent because this is all we have.

Runner-Up



Smeet AJ, et al. JVIR 2010; 21:830

Good imaging outcomes (fibroid infarction,

volume reduction) and significant

improvement on UFS-QOL.

Stampful U, et al. CVIR 2011; 34:295

Good imaging outcomes (fibroid infarction,

volume reduction) and significant clinical

improvement.

Embolic Agents: UFE

Embozene

Microspheres are


UFE

Embolic Agents: UFE

Runner-Up


Comparative Studies

A prospective, randomized, comparative trial between Embozene and

Embosphere Microspheres was underway, but the study failed to enroll due

to strict requirements from the FDA for patient assessment (e.g., pad

collection).

The study was stopped by the sponsor.

Embolic Agents: UFE

Runner-Up


Ultimately, Embozene Microspheres received 510(k) clearance from

the FDA for use in UFE procedures.

This means that the device has similar technologic characteristics and the

same intended use as a pre-existing, legally marketed device.

It does not mean that the safety and efficacy of Embozene Microspheres

has been evaluated with a clinical trial.

510(k) clearance does not eliminate the need for

comparative studies.

Embolic Agents: UFE


PVA Microspheres (Contour SE Microspheres)

Embolic Agents: UFE




Siskin GP, et al. J Vasc Interv Radiol 2006; 17:1287-1295



Comparative Studies

- Rasuli P, et al. JVIR 2008; 19:42

- Duvnjak S, et al. CVIR 2016; 39:204

Embolic Agents: UFE

- Spies JB, et al. JVIR 2005; 16:1431

- Siskin GP, et al. JVIR 2008; 19:58

- Yu SCH, et al. JVIR 2011; 22:1229

- Abramowitz SD, et al. Radiology 2008;

250:482

- Galvez JA, et al. J Comput Assist

Tomogr 2008; 32:356

Tris-Acryl Gelatin Microspheres has

better rates of clinical improvement

and fibroid infarction.

Particulate PVA has better rates of

clinical improvement, fibroid

infarction, and reinterventions.

- Shlansky-Goldberg RD, et al. JVIR

2014; 25:823Contour SE and Embosphere are

equivalent (technique-related).

Embolic Agents: UFE



Comparative Studies

The legacy of Contour SE Microspheres is the importance of comparative

studies.

Single-agent series can be deceiving.

There are differences between the embolic agents and how they perform with

UFE.

TAKE HOME POINT: We must base embolic agent selection for UFE on

well-designed comparative studies.

Embolic Agents: UFE

Conclusions

Based on the data …

Particulate PVA, tris-acryl gelatin microspheres (Embospheres), and

gelfoam have the best reported outcomes for UFE.

Contour SE Microspheres should not be used for UFE.

Acrylamido PVA Microspheres (Bead Block): Comparative studies

have shown noninferiority to tris-acryl gelatin microspheres but the

data has been mixed on the outcomes after UFE.

Polyzene-F Microspheres (Embozene): Comparative studies have not

been performed, which should limit its use for UFE at this time.

Embolic Agents: UFE

Conclusions

Advice

Interventionalists performing UFE procedures must look beyond

single-agent studies because they all seem OK.

As new agents are developed, they most certainly will (and probably

should) attempt to obtain 510(k) clearance from the FDA for use

during UFE procedures.

Post-market studies MUST BE PERFORMED to insure that new

agents are equivalent to our “best-in-class” embolic agents for UFE.

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