Editorials Lewis Barry

Wexler, MD T. Katzen, MD

#{149} David

Training Peripheral

I

is well

T

Standards Angioplasty:

known

controversy

C. Levin, MD #{149}Gerald Dorros, A. Spittell, Jr, MD #{149} Spencer

#{149} John

that has

in recent

developed

years, among

several medical specialties (radiology, cardiology, vascular surgery, and vascular medicine) over who is qualified to perform peripheral angioplasty and other

percutaneous

peripheral

vascular

interventions (1-3). While this controversy may never be resolved to everyone’s satisfaction, most physicians would

accept

not have perform just

the

principle

that

an incontrovertible complex invasive

because

they

have

one or another ties. The crucial

right to procedures in

perience and training has received in these

the individual procedures,

the branch of medicine in which she is board-certified or board-eligible. For this reason, attempts have made by several groups training standards for ripheral interventions.

not

he/

been

to establish percutaneous The Society

tempts

and lish

have

been

made

by the

D.C.L., that

attempt

G.D.,

S.P.K.).

members

of the

be familiar it represents

by responsible

with a

terms:

Arteries,

9*2.128

cedures

#{149} Radiology

Radiology

transluminal

#{149} Editorials

a document that is far from and creates a high standard prevent many cardiologists

dabbling

in this

new

arena.

Cardi-

The radiology community take heed of this example

These

standards

were

in at-

own criteria toward a developed

over time, with considerable emphasis on discussion at multidisciplinary meetings and intersociety communications. The history behind them, briefly,

angio-

and

radiologists

1991; 178:19-21

Heart leans,

Association the draft

by members cussion annual Beach.

I

From

the

Department

Center,

Thomas

Jefferson

Clinic, cular

2 ©

(GD.);

the Miami

Diseases,

Center,

Emory

RSNA,

Dr,

Hospital, the

Radiology

Stanford,

CA

were

Department

set of standards

initially

Baptist

Clinic,

Rochester,

Minn

University,

Atlanta accepted vein

Nuclear

developed

(S.B.K.).

(DCL.);

the the

Miami

(J.A.S.);

and

July

August 22. Address and artery involvement.

the

by Levin

and Katzen

(pp 27-28)

Heart

of California,

(B.T.K.);

the Division

Andreas

Gruentzig

revision

requests

1991

See also the editorial

an-

(AHA) in New Orversion was discussed

of the AHA

Council

Radiology.

on

Further

dis-

November

1989

AHA

meet-

SCAI. sisting

The SCAI primarily

pointed

in this issue.

requested to LW.

San

at that

radioloIt was

Subcommittee

meet-

ing that the proposed new peripheral angioplasty guidelines were modeled on guidelines for percutaneous transluminal coronary angioplasty (PTCA) that

the

SCAI

veloped and Interventional

itself

(which is composed 20 senior invasive around the country)

training meeting rectors them.

had

previously

de-

published (4).The SCAI Cardiology Committee of approximately cardiologists from accepted these

standards, and at its annual in May 1990, the Board of Diof the SCAI A statement

formally enumerating

endorsed the

by a

presented

University and

out

is an organization conof invasive cardiolo-

or guide-

of Radiology,

Milwaukee

12, 1990;

reprint

Stanford

Department

University

Hospital, Received

Medicine,

(LW.);

of Radiology,

Institute,

August 21; generalized

and

94305-5105

Philadelphia

Vascular

Mayo

received 9* indicates

of Diagnostic Pasteur

University

Milwaukee

(E.J.R.);

sion

300

at the

of the American

took place in March 1990, at the meeting of the SCVIR in Miami

At the

Vascular Francisco

of CardiovasCardiovascular

July

13; revi-

in

the

context

of

an

open

fo-

rum at the Scientific Conference on Peripheral and Noncoronary Vascular Disease, a consensus conference sponsored by the AHA in Dallas in January 1990. The conference was attended by approximately 150 senior interventional radiologists and vascular surgeons from around the country. The

vast Medical

1989,

sessions

standards has appeared in Cat heterization and Cardiovascular Diagnosis. The proposed standards were also

working group of interventional radiologists and cardiologists that included some of the current authors (L.W., G.D., J.A.S.), who were members of the Peripheral Vascular Committee of the

pro-

in November

and

scientific

(ACC).

in the fall of

gists, with some cardiovascular gists among its membership.

lines

#{149} Interventional

1989,

nual

revised

produced self-serving that will

A proposed Index

of Cardiology

was

cardiol-

is as follows.

plasty,

College

The draft

ing, the standards were also presented for consideration to the Peripheral Interventions Subcommittee of the Interventional Cardiology Committee of the

tempting to establish their or, preferably, in working common standard.

to estabperiph-

#{149}

ogists to recommend stringent guidelines for performance of peripheral interventions that can be applied to all physicians, regardless of specialty. For them it is a new field from which they might benefit financially, yet they have

tioned. should

authors

others, in a limited forum, standards for percutaneous

Cardiovascular

(L.W.,

ologists who do not meet these standards and who apply for privileges in hospitals in which a radiologist does meet them may legitimately be ques-

Cardiovascular and Interventional Radiology (SCVIR) produced a document 2 years ago, but it applied only to radiologists. A true intersociety effort has yet to be organized. Nevertheless, at-

MD

tributors

from

peof

Ring,

American

sincere

of these medical specialdeterminant is the ex-

J.

III, MD

eral interventions that will be acceptable to all parties. The latest efforts come from the Society of Cardiac Angiography and Interventions (SCAI) and have appeared in their official journal Catheterization and Cardiovascular Diagnosis. Several of the authors were con-

radiology community this document because

do

#{149} Ernest

Physicians Performing New Developments’

It is important

they

certification

for

MD B. King

majority

reacted

favorably

proposed

standards,

although

surgeons sis should

commented be placed

that more on clinical

for peripheral

SCAI

emphatraining

interventionalists.

For the purpose diology community, the

to the several

that

has

of informing the rathe statement of been

published

in

Catheterization and Cardiovascular Diagnosis (5) is reproduced in its entirety below. 19

sive assessment of peripheral vascular disease, indications for angioplasty,

GUIDELINES FOR PERFORMANCE OF PERIPHERAL PERCUTANEOUS TRANSLUMINAL

risks and benefits of angioplasty and alternative therapies, technical aspects and usage of x-ray equipment needed for peripheral angioplasty, and the theory and practice of thrombolytic techniques, including experience in at least

ANGIOPLASTY Requirements

Optimal

performance

angioplasty and training

requires as well

of peripheral specialized as adequate

skills cathe-

terization facilities. The need exists the development and implementation

for

of uniform standards and guidelines for certification of competence to perform peripheral angioplasty. Board certification or eligibility in

cardiovascular special

disease

certification

or radiology

follows a standard A vascular surgeon

or

in vascular

medicine

15 thrombolysis procedures in the peripheral circulation. A cardiologist may be able to acquire this training during a 3-year fellowship or as an additional year of training. A

should

training surgery

during fellowship.

Qualifications

cialist,

In addition,

training. 1. The individual ceived peripheral during residency and should have procedures

a minimum

of 12 months

of full-

time experience in the invasive laboratory and performed a minimum of 100 diagnostic peripheral angiographic studies3 with documentation that at least half of these were performed as primary operator. In addition, at least 50 peripheral angioplasty procedures should be accumulated in the candida-

(at least

half

of those

as

primary operator) before attempting to perform independent vascular intervention in the periphery. The fellowship should also include intensive training in the nature and anatomy of peripheral vascular disease, noninva-

procedures.

3

A diagnostic sufficient

of inflow to the

angiographic study views to demonstrate

and organ

er extremity,

status

of downstream

in question.

for example,

tic examination rat,

poptiteal,

20

#{149} Radiology

includes and

temporary

PTA

include

evidence

in peripheral

should

thrombolytic

sites (lesions) encountered,

and a letter stating that

from the program director he/she was adequately

trained and the techniques angioplasty.

is capable of performing necessary for peripheral

2. Physicians

who

have

not

had

all

pre-

formal training in peripheral angioplasty should (a) attend at least one PTA seminar at which live demonstrations are presented; (b) learn the nature

anatomy

of peripheral

indications

risks

and

alternative

tory

where

for

vascular

angioplasty,

disand

benefits

of angioplasty and (c) visit a laboraperipheral angioplasty is

therapies;

tibial

In

the

case

an adequate the vessels.

aorta,

should inadequacy

the theory techniques

circulation

circulation. These

physicians

training ticeship

should also have an apprenwith a senior qualified physi-

of the towdiagnosiliac,

femo-

and practice of thrombolytic as applied in the peripheral without

formal

rate

to

should

occur

and

is comparable

the

to the

area

norm during performance of these 10 procedures, the operator shall continue under proctorship until 25 procedures are accomplished. If, after 25 cases, the success rate has been at least 85% and the complication rate is less than 5%, the candidate can apply for full privileges. review

vious

ease,

director

If no complications

of appropriate

as primary operator, the dilated, the complications

privileges

He/she

actively performed by experienced personnel and observe at least 10 procedures; (d) learn the technical aspects and usage of x-ray equipment needed in peripheral angioplasty; and (e) learn dude

for

Privileges

in peripheral vascular disease, or if there is no such individual in the hos-

angi-

techniques as applied in at least 15 procedures. He/she should provide documentation of the total number of procedures performed and those performed

and

in

meet force

perform 10 procedures under the proctorship of the senior laboratory interventionalist who already has privileges

and extensive experiarterial and venous and, in particular, stud-

circula-

involved

who meets the trainspecified in either of two sections should ap-

training

and infrapopliteal should have

as qual-

requirements.

50 peripheral

peripheral and

for PTA

The physician ing requirement the preceding ply

should have reangioplasty training and/or fellowship participated in a mini-

of 100 diagnostic

Application

in-

renal candidate

half

in PTCA.

success

to the peripheral

in

procedures should of the ACC/AHA task

should

should

be acceptable

cardiologists

interventional the criteria

as proctor.

surgeon

candidate

for at least performed

these

the laboratory

tion, including vessels. The

te’s experience

will

for meeting

serve

or vascular

the

operator Those

pital,

ies referable

spent

be the primary of all procedures.

ifying

for Temporary

angioplasty

training for the cardiolovascular medicine spe-

dude intensive ence in general catheterization

instruct

documented,

For physicians to obtain temporary privileges to perform peripheral angioplasty, they should be required to have either of the two following types of

mum

will

be the primary operator in at least half of these procedures. These procedures

Training

Fellowship gist, radiologist,

residency.

would acquire this an extended vascular

Privileges

ography

Fellowship

radiology

who

the performance of not less than 100 peripheral diagnostic angiography procedures and 50 peripheral angioplasty procedures. These should include application of thrombolytic techniques in at least 15 cases. The candidate should

during a standard radiology residency program will qualify for meeting these requirements. In some instances, more senior physicians will have obtained their experience during an era when formal instruction or apprenticeship was unavailable. This experience, if

radiologist would acquire this training during a 1- or 2-year fellowship that

surgery be an mitial requirement for the performance of percutaneous transluminal angioplasty (PTA). Candidates in cardiology should have completed the full cardiovascular training program meeting the requirements of the American Board of Internal Medicine (ABIM) and the subspecialty of cardiovascular disease. Candidates in vascular medicine should have completed the full training program meeting the requirements of the ABIM plus an additional 2-3-year program in the specialty of vascular medicine.

or vascular

cian

A multidisciplinary all cases annually

panel should and make rec-

ommendations to the department chairperson or credentialing committee regarding the continuance of privilege. If serious ceptable

complications success rates

dentialing authority

or less than occur, the cre-

committee

should

to withdraw

have

ac-

the

privileges.

Recourse If privileges for cause of complications

PTA

rates,

should

the operator

to return

for

to attempting close

additional

other

are denied beor low success

be required training

prior

procedures

under

supervision.

Simple versus Angioplasty Peripheral

Complex

Peripheral

angioplasty

may

involve

stenotic or occlusive lesions of vascular beds. Angioplasty

in a variety proce-

dures for treatment of short less than 5 cm in length and

stenoses occlusions

January

1991

less oral

than 2 cm in length or proximal popliteal

in the iliofemartery, or

grafts to these vessels, are generally considered to be simple. These simple cases will form the bulk of an individual’s training experience and Longer lesions; those involving aorta and its visceral branches,

chiocephalic ies;

and try sites complex

and

practice. the the bra-

infrapopliteal

arter-

those that require unusual enor surgical cutdown are more because of the potential corn-

plications

that

may

ensue.

It is recommended

the simpler

that

procedures

expertise

should

a complex

before

is performed.

can receive

by an additional

as the

primary

continuing

medical

(CME)

in-

and

with

appropriate

nized der

that hospitals intense

leges

are currently

pressure

to grant

to cardiologists

who

un-

have

dorses the standards by the SCAI. While

these

are rigorous, priate form

originally

PTCA

training

we believe

for physicians complex and

interventional

Volume

of Physicians

they

developed

tenance

of skills

of its approved

erators by some of practice (7). Although

this

ferred

reasonable

statement

to guidelines

principle ripheral

originally

#{149} Number

1

the

joint

ACC/AHA

Task

Discussions and

with

organizations

cardiology, vascular

and

vascular

medicine

will

surbe

It now

appears

likely

that

the

Raon

similar

de-

in

scope

to those

previously

veloped for PTCA. Through this report, we invite further comments from the radiology community. #{149}

(JCAHO),

principles

also

pertaining

includes

of physicians

who

medical

(8). In discuss-

staffs

rules,

privileges,

the

and regulations,

criteria

for granting

should

include

practice

6.

7.

on

clinical

evidence

JCAHO

re-

and the privileges of relevant

standards

these

to ensure

that patients will receive quality care. In conclusion, although the training standards described in this document are rigorous, we believe the nature, Va-

criteria

5.

important

hospital clinical

4.

Wexler L, Ginsburg R, Mitchell RS, Mehigan JT. The vascular war of 1988. JAMA 1989; 261:418-419. Cooke JP, Dzau VJ. The time has come for vascular medicine. Ann Intern Med 1990; 112:138-139. Zarins CK. The vascular war of 1988: the enemy is met. JAMA 1989; 261:416-417. Cowley MJ, King S. Baim D, et al. Guidelines for credentiating and facilities for performance of coronary angioplasty. Cathet Cardiovasc Diagn 1988; 15:136-138. Wexler L, Dorros G, Levin DC, et al. Guidelines for performance of peripheral percutaneous transluminal angioplasty. Cathet Cardiovasc Diagn 1990; 21:128-129. Ryan TJ, Klocke FJ, Reynolds WA, et al. Clinical competence in percutaneous transluminal coronary angioplasty: a statement for physicians from the ACP/ACC/AHA Task Force on Clinical Privileges in Cardiology. J Am CoIl Cardiol 1990; 15:1469-1474. Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty: a report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommitte on Percutaneous Transluminal Coronary Angioplasty). J Am Coil Cardiol 1988; 12:529-545. Joint Commission on Accreditation of Healthcare Organizations. Medical staff; required characteristics. In: Accreditation manual for hospitals: 1990. Chicago: JCAHO, 1989; 104.

to the back-

grounds ing

3.

8.

applicable to peprocedures.

The Accreditation Manual for Hospitals, published by the Joint Commission on Accreditation of Healthcare Organizations

2.

re-

are appro-

same

their

AHA will agree to a formal request from its Council on Cardiovascular diology to sponsor a position paper guidelines for peripheral angioplasty,

the

and current state that

By the

In

held to determine if these standards will be acceptable to most physicians working in the field of cardiovascular

standard

for PTCA,

is equally interventional

op-

training and/or experience competence. They further

who wish to pertechnically demanding

procedures.

178

have (6) on fully en-

and

force.

they seem to achieve the goals set forth by the

Force on Assessment of Diagnostic Therapeutic Cardiovascular Proce-

not

had adequate training so as to protect the hospitals’ referral base. This practice should not be condoned; rather, the responsible leadership of institutions offering coronary angioplasty as part of their health care program should insist on the documentation of accredited training and the main-

laws,

College

issued a joint statement privileges for PTCA that

JCAHO

privi-

and American recently clinical

task

present form, aforementioned

1.

quires that delineated clinical privileges should be granted in accordance with the (hospital’s) medical staff by-

in

terdisciplinary

gery,

for

PTCA and to perform 125 PTCAS under supervision of an experienced operator, with at least 75 of these as primary operator. Of note is the fact that the ACC, AHA,

struction

carefully plicable speciality,

representing

an-

Cardiovascu-

of peripheral innecessitate defined standards that are apto all physicians, regardless of and are acceptable to an inprocedures

disease.

Therapeutic stated:

complexity

terventional

dures.

a

training and demonstrated competence in the performance of angioplasty are those who should receive proper credentialing to perform angioplasty in hospitals. It is recog-

Further-

education

peripheral

and

riety,

References

more, he/she must perform at least 125 PTCAS, with a minimum of 75 of those as primary operator. An alternative method of certification was also made available for those individuals not undertaking a

cardiologists already in practice who did not wish to go back for another fellowship. Such individuals were expected to have had a minimum of 3 years experience and to have performed 500 diagnostic coronary angiographic procedures without supervision. They were then required to obtain 50 hours of category 1

in

which

of standards

The physicians

appropri-

formal PTCA fellowship training program; these standards were to apply to

with

can undertake training.

Diagnostic lar Procedures

year of training

operator.

used

training and clinical privileges of the type discussed here must be based on certam underlying principles, which have been previously enunciated. In developing guidelines for PTCA in 1988, the joint ACC/AHA Task Force on Assessment of

in a structured fellowship program in PTCA. During this time, a candidate should have performed a minimum of 300 diagnostic coronary angiographic procedures, with documentation in 200 of these

those

a background

The development

ate training. For those undertaking forma! cardiology fellowships, a minimum of 1 year of diagnostic training in a cardiac catheterization laboratory is required,

followed

from

PTCA and the clinical considerations are quite dissimilar. Therefore, training in PTCA is not a substitute for training in peripheral angioplasty, but PTCA traincardiologist gioplasty

Because some of the impetus for developing a statement on physician training for peripheral angioplasty came from the PTCA standards that were developed previously by the SCAI (5), it is of interest to review these. The PTCA standards are quite specific and call for two alternate pathways by

a physician

different

undertakes the and surgical

DISCUSSION

which

are

ing provides

be obtained

procedure

plasty

be demonstrat-

ed before an individual more complex procedures,

consultation

in

token, peripheral angioplasty is also a complex and demanding procedure requiring instruction and training similar in order of magnitude to that required to achieve competency in PTCA. The numbers of procedures specified in the preceding peripheral angioplasty training standards are somewhat fewer than those for PTCA. The techniques and instruments used to perform peripheral angio-

are designed

Radiology

#{149} 21