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merit (closed without payment), to being settled (paid) with or without admission of
negligence or liability, or (in only a minority) to legal proceedings in court when a
judgement is made for or against the hospital or doctor involved. This dynamic situation
makes description of claims somewhat difficult and makes it important to be explicit about
the types of claims being described.
Another major difficulty is lack of collation of data about medicolegal claims: there
is still no single, central database in most countries (3–4). Claims may be handled by a
variety of different organizations, even in nationalized health services. In the United
Kingdom, National Health Service claims were handled by private defense organizations
until 1989, then at regional level until 1995, and since 1995, by a central litigation
authority (even since that time, many smaller claims have been handled locally). All this
means that there has traditionally been no ready access to national figures. When figures
are available, it may be difficult to obtain a reliable or meaningful denominator with which
to gauge the risk of litigation.
VARICOSE VEINS
Data from the Medical Defense Union in the United Kingdom (a major indemnity insurer
for private surgical practice) showed that varicose veins were the most common reason for
litigation against all kinds of general surgeons (2). They remain (in 2004) the most
common reason for settled (paid) claims, followed (in descending order) by surgery on the
bile ducts, bowel, benign tumours and the breast. A summation of claims notified to the
Medical Defense Union and the National Health Service Litigation Authority (NHSLA)
for England are shown in Table 1.
There are a number of possible reasons that medicolegal claims for varicose vein
treatments have been relatively frequent. Although varicose veins are properly the
province of vascular surgeons with special interest and expertise in their management,
they have often been dealt with by other disciplines. In the United Kingdom it was normal
until the 1990s for varicose veins to be dealt with by any general surgeon and this still
applies in many parts of the world. In addition, many “vascular surgeons” have actually
been “arterial surgeons” (just as the phrase “peripheral vascular disease” is still used to
refer to arterial disease). Many well-known vascular surgeons have, in the past, regarded
Table 1 Frequency of Medicolegal Claims After Varicose Vein Surgery
Underlying allegation Number (%) notified claims
Nerve damage 69 (36)
Incorrect/inadequate/unsatisfactory surgery 38 (20)
Femoral or popliteal vein damage 20 (10)
Infection 11 (6)
Venous thromboembolism 10 (5)
Femoral artery damage 10 (5)
Scarring/blemishing 5 (3)
Tourniquet damage 3 (2)
Miscellaneous 25 (13)
Total 191
Number (% of total) claims notified to the Medical Defense Union (United Kingdom and Republic of Ireland) and
the National Health Service Litigation Authority (NHSLA) for England relating to treatment of varicose veins
during 1995–2003, classified according to the main underlying allegation.
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varicose veins as being insufficiently important or interesting to merit their serious
attention. This culture is changing, but it has meant that varicose veins have often been
dealt with by surgeons whose expertise may have been insufficient, with resultant
problems and legal action.
Many people with varicose veins are troubled largely by their appearance and
request treatment in the private sector, where a variety of clinicians may offer treatments
which they use infrequently, practicing in isolation. Novel “office based” treatments such
as foam sclerotherapy may add to the list of treatments which are used without sufficient
expertise, precipitating legal action against clinicians (see below).
The fact that varicose veins are very common and seldom cause medical harm has
meant that they are afforded low priority by health services generally. In the United
Kingdom they have formed a major component of “waiting lists” and have often been
treated by trainees, sometimes without adequate supervision. This is another circumstance
with a special risk of adverse events and litigation.
NEW TREATMENTS FOR VARICOSE VEINS
The rapid advance of new treatments for varicose veins may lead to litigation. Each of the
new methods (including foam sclerotherapy, radiofrequency, laser, and transilluminated
powered phlebectomies) seems relatively safe in experienced hands, but their novelty,
their use by relatively inexperienced practitioners, particularly in “office practice,” and the
need for really good patient counseling all mean that there are special medicolegal risks.
There are uncertainties with any new method—for example the real risk of systemic
embolization using sclerosant foam. This may be very rare but if a patient is harmed then
litigation may allege that an “experimental” treatment was used, particularly if the patient
was not well informed of the known risks and the uncertainties. In the United Kingdom the
National Institute for Clinical Excellence (NICE) publishes guidance on the safety and
efficacy of new procedures (5). This may help to protect clinicians against allegations of
using new procedures inappropriately, so long as they observe NICE advice about
informing patients, training, and audit.
The fact that these treatments can be used in an “office” setting increases the risk of
litigation: this applies particularly to foam sclerotherapy, which is disseminating very
quickly worldwide in the private sector. The published reports of foam sclerotherapy have
been from enthusiasts and experts. The apparent simplicity of the technique have led to its
rapid adoption not only by vascular specialists, but also by a variety of other doctors with
little experience in the treatment of varicose veins. Use of foam sclerotherapy by
practitioners working in relative isolation, without great experience in dealing with
varicose veins, with predominantly financial motives, and without a mandate for good
audit means that substandard practice may well occur. If patients have not been counseled
thoroughly about potential risks and benefits, then litigation seems likely.
VENOUS THROMBOEMBOLISM AS A COMPLICATION
OF VARICOSE VEIN OPERATIONS
Varicose veins have featured high on some lists of risk factors for DVT, based on evidence
of an increased risk of DVT (detected by radioisotope scanning) after major abdominal
and pelvic surgery in people with varicose veins (6–7). This has been translated in to a
general fear about the specter of DVT as a result of varicose veins, in the minds of both lay
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people and many doctors. Available evidence suggests that DVT is uncommon after
varicose vein surgery (8), but vascular specialists should be mindful of the perceived risk,
which probably puts them at increased medicolegal risk if DVT complicates varicose vein
surgery (or any other invasive treatment for varicose veins) (9).
Failure to note other risk factors (for example, previous DVT or hormone treatment)
and to provide “demonstrable prophylaxis” to patients at risk (including those whose
surgery takes more than 30 minutes or who are obese) might well be indefensible
if thromboembolism occurs. What constitutes “demonstrable prophylaxis” is a real
dilemma: the only practical perioperative measure is low dose heparin, but since most
patients are in hospital less than 24 hours, special arrangements need to be made
for administration of more than one dose. A record of explicit advice about early
mobilization and prescription of anti-embolism stockings in addition would seem sensible
and adequate, but controversy between experts is still likely if a high risk patient develops
thromboembolism and sues.
VENOUS THROMBOEMBOLISM REQUIRING EXPERT OPINION
Vascular specialists who provide expert opinions in malpractice claims will not
infrequently be asked about patients who have suffered DVT or pulmonary embolism
following treatment by other doctors. If there has been an obvious failure to provide
appropriate prophylaxis then giving a clear opinion is straightforward. It is more difficult
when some prophylaxis has been given (see preceding paragraph about varicose veins) to
provide a fair and pragmatic opinion about whether this was adequate and what the
likelihood would have been of preventing DVT if more had been done. It is important that
even the best prophylaxis simply reduces the risk of thromboembolism—it does not
guarantee prevention.
SWOLLEN LEGS—POSTPHLEBITIC SYNDROME
AND LYMPHATIC DISEASE
These conditions are dealt with together because similar cautions apply from a
medicolegal point of view. These patients have chronic and distressing limb swelling
(and associated problems) which are difficult to treat and impossible to cure. If the onset of
their condition was iatrogenic or associated with any perceived failure of medical
management they may have a low threshold for complaint or for medicolegal action
against those caring for them. Attempts at treatment by any surgical means may be high
risk with limited prospect of improvement. Very careful counseling and recording of such
discussions is essential in this.
COMMUNICATING RISKS AND BENEFITS
Medical litigation is often precipitated by poor communication rather than by poor clinical
performance (10). A key to avoiding litigation is the rule: “The patient’s expectations
should be the same as yours.” Especially when treatment is being considered for a
condition that poses no medical threat—as for most people presenting with varicose
veins—a full explanation the good prognosis without treatment, alternative treatments,
the likely benefits, and the potential adverse outcomes of treatment are fundamental to
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avoiding possible litigation (11). The less “severe” the veins, the more thorough this
explanation should be. Patients with the smallest “cosmetic” varicosities or with thread
veins usually have high expectations and also low thresholds for dissatisfaction if any
kind of adverse event occurs.
With regard to likely benefits from treatment, patients need a good explanation of
the prognosis if they have no treatment (usually very good). They also need to be told and
to understand precisely which of their symptoms are likely to be relieved by treatment. By
no means will all discomfort in the legs be cured by treating varicose veins, and patients
may be disgruntled to the extent of taking legal action if they are disappointed.
Disclosure of potential risks must be thorough. Clinicians vary greatly in the
amount they tell patients by word of mouth (12–13), but there can be no excuse for
failing to provide people with really thorough written information about proposed
treatment and its risks (13). Provision of this written information needs to be clearly
recorded (some doctors ask patients to sign confirming they have received it) and it needs
to be archived for reference in case of litigation at a later date (all revisions of written
information should be dated and archived for medicolegal use). Unfortunately,
documentation of many aspects of doctor–patient consultations in secondary care is
often poor (14).
Striking a balance between concise, easily readable information for patients and
lengthy screeds of small print is not easy. Provision of really good “patient friendly”
information is time consuming, and it is a shame that this is not readily available on a
national basis in each country. There certainly do seem to be differences in the
general approach to patient information in different countries—large amounts of
indigestible information are common in the United States while in parts of Europe a
total lack of written information has been common. The provision of thorough
information largely parallels and the level of litigation and both are gradually
increasing worldwide. There is, however, still a long way to go in supplying patients
with good written information to make informed choices and to reduce the chance of
litigation if complications occur.
The place and use of consent forms is variable—particularly for “office based” or
outpatient treatments. In some medical and legal systems, these are regarded as essential;
but a signature on a form will never compensate for proper understanding by the patient or
a record of having provided good information, including a warning of whatever damage
has prompted a patient to take legal action. Ideally, any consent form should be
“dovetailed” with the written information given to the patient (15).
SPOTTING HIGH-RISK CASES
The most unexpected patients may take medicolegal action. However, it is useful to try to
spot those patients who are most likely to suffer problems, to complain, or to sue. They
merit particularly thorough counseling and recording of discussions. They include:
† Patients with minor cosmetic veins, with odd symptoms, or with bizarre ideas
about their veins and the problems associated with them
† Patients who do not seem to want to listen, who seem unable to grasp what they
are told, or who press for inappropriate or questionable treatment
† Patients who have complained or taken legal action before
† Patients with a high risk of complications, particularly the obese and those with
recurrent varicose veins
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† Patients with pale skin—any blemish from treatment is more obvious
† All patients with leg swelling—any intervention runs a risk of making
them worse
When talking to patients who seem high risk for litigation, it is always desirable to
involve close relatives in discussion, and ideally also another member of the medical or
nursing team (record their presence as well as what was said).
WHEN THINGS GO WRONG
When a serious complication occurs, then patients may sue successfully, even if they were
warned of the risk beforehand: for example, damage to a major nerve is likely to be
construed as malpractice or negligence even if a warning was given. From the moment
damage has occurred, first-class management is fundamental to minimize the harm
caused; to demonstrate good care to the patient; and to reduce both the likelihood and
magnitude of any medicolegal claim. This damage limitation should include:
† Immediate repair, by the most appropriate person (for example, repair of the
common peroneal nerve by a plastic surgeon or repair of the femoral vein by a
senior vascular surgeon)
† All adjunctive measures to reduce harm or disability (for example, neurological
advice, splinting, early physiotherapy for nerve injury; or prophylactic anti-
coagulants, compression hosiery, mobilization or foot pump after venous injury)
† Advising the patient fully and sympathetically about exactly what has happened
and what is being done to correct the situation. It is entirely appropriate
to apologize
† Reporting the problem without delay to clinical incident or legal liaison teams
(when treatment took place in a hospital or clinic). In private practice indemnity
insurers should be informed at an early stage, and it seems wise to involve all
colleagues who might be able to offer help to the patient and support to the
responsible clinician
† Being sure that the patient is followed up assiduously by the responsible clinician
and all others who can offer help
These measures not only lay the foundations for the best possible medicolegal
defense, they will hopefully avoid litigation altogether if the patients feel that they have
been dealt with in a thoroughly professional and caring way.
THE UNCERTAINTIES OF MEDICOLEGAL DECISIONS
Unfortunately, there are no dependable rules for the judgements made in medicolegal
cases. Some—for example a recent English court decision against the liability of
manufacturers for venous thromboembolism from third generation oral contraceptives
(16)—may seem illogical based on objective appraisal of the evidence. Courts may be
swayed by persuasive and biased presentation of evidence by experts, and different
judges may reach apparently different conclusions. These vagaries of the law are
particularly disturbing to clinicians who are used to scientific objectivity. They also mean
that it is difficult to provide unequivocal guidance or confident answers to many
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questions about specific medicolegal matters. The best that a chapter like this can
achieve is to highlight particular areas of risk and to give advice on how best to avoid
and to defend medicolegal claims. The fundamentals remain good communication; good
record keeping; meticulous technique; and thoughtful management when adverse
outcomes do occur.
REFERENCES
1. Fenn P, Diacon S, Gray A, Hodges R, Rickman N. Current cost of medical negligence in NHS
hospitals: analysis of claims database. BMJ 2000; 320:1567–1571.
2. Goodwin H. Litigation and surgical practice in the UK. Br J Surg 2000; 87:977–979.
3. Rotker J, Trosch F, Deng MC, Roeder N, Scheld HH. Medical liability disputes involving
thoracic and cardiovascular surgeons. Thorac Cardiovasc Surg 2001; 49:60–63.
4. Campbell WB, France F, Goodwin HM. On behalf of the Research and Audit Committee of the
Vascular Surgical Society of Great Britain and Ireland Medico-legal claims in vascular surgery.
Ann R Coll Surg Engl 2002; 84:181–184.
5. National Institute for Health and Clinical excellent intervention procedures; avilable at
www.nice.org.uk/ip.
6. Thromboembolic Risk Factors (THRIFT) Consensus Group. Risk of and prophylaxis for
venous thromboembolism in hospital patients. BMJ 1992; 305:567–574.
7. European Consensus Statement. Prevention of Venous Thromboembolism. London: Med-
Orion, 1992.
8. van Rij AM, Chai J, Hill GB, Christie RA. Incidence of deep vein thrombosis after varicose
vein surgery. Br J Surg 2004; 91:1582–1585.
9. Campbell WB, Ridler BMF. Varicose veins and deep vein thrombosis. Br J Surg 1995;
82:1494–1497.
10. Fischer JE. The effect of litigation on surgical practice in the USA. Br J Surg 2000;
87:833–834.
11. Reference Guide to Consent for Examination or Treatment. London: Department of Health,
2001.
12. Meredith P, Emberton M. The NHS patient information lottery: it is whom you see rather than
what you need. Ann R Coll Surg 2000; 82:217–222.
KEY POINTS
† Varicose veins are the most common reason for litigation against general and
vascular surgeons. Nerve damage is the most frequent complaint.
† Counseling patients thoroughly about the risks and potential benefits of
treatment (including written information) and good documentation reduce the
chance of successful litigation.
† Problems following treatment for small varicose veins and cosmetic concerns
may well be followed by medicolegal action. Remember: “The patient’s
expectations should be the same as yours.”
† Spotting patients at high risk allows special care in counseling and record
keeping. When problems do occur, damage limitation by good remedial
treatment and thorough explanation may avoid or minimize medicolegal
consequences.
† New treatments for varicose veins may pose special risks—for example, foam
sclerotherapy if done by inexperienced practitioners in an “office
based” practice.
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13. McManus PL, Wheatley KE. Consent and complications: risk disclosure varies widely between
individual surgeons. Ann R Coll Surg Engl 2003; 85:79–82.
14. Fernando KJ, Siriwardena AK. Standards of documentation of the surgeon–patient consultation
in current surgical practice 2001; 88:309–312.
15. Campbell B. Informed consent. Ann R Coll Surg Engl 2004; 86:457–458.
16. Skegg DCG. Oral contraceptives, venous thromboembolism and the courts. BMJ 2002;
325:504–505.
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SECTION E: CHRONIC VENOUS INSUFFICIENCY
27
Pathophysiology of Leg Ulceration
Peter J. Pappas, Brajesh K. Lal, and Walter N. Dura
´
n
New Jersey Medical School, Newark, New Jersey, U.S.A.
Frank T. Padberg, Jr.
New Jersey Health Care System–Veterans Affairs Medical Center, East Orange,
New Jersey, U.S.A.
Robert W. Zickler
UMDNJ–New Jersey Medical School, Newark, New Jersey and New Jersey Health Care
System–Veterans Affairs Medical Center, East Orange, New Jersey, U.S.A.
INTRODUCTION
Ten to 35% of adults in the United States have some form of chronic venous insufficiency
(CVI) with venous ulcers affecting 4% of people over the age of 65 (1,2). Treatment of
patients with CVI and venous ulcers cost the U.S. government over one billion dollars a year.
In addition, 4.6 million work days per year are lost secondary to chronic venousdisease (3,4).
The recurrent nature of the disease, the high cost to the healthcare system and the
ineffectiveness of current treatment modalities, underscore the need for CVI related research.
The past decade has refined our understanding of leukocyte mediated injury and elucidated
the role of inflammatory cytokines in lower extremity dermal pathology. In addition, our
understanding of pathologic cellular function and the molecular regulation of these processes
is increasing. This chapter will discuss the potential causes of varicose vein and venous ulcer
formation and the scientific evidence supporting these theories.
THE VENOUS MACROCIRCULATION
Unlike arteries, veins are thin walled, low pressure conduits whose function is to return
blood from the periphery to the heart. Muscular contractions in the upper and lower
extremities propel blood forward and a series of intra-luminal valves prevent retrograde
flow or reflux. Venous reflux is observed when valvular destruction or dysfunction occurs.
Valvular reflux causes an increase in ambulatory venous pressure and a cascade of
pathologic events that manifest themselves clinically as varicose veins, lower extremity
edema, pain, itching, skin discoloration, and in its severest form, venous ulceration. These
clinical signs and symptoms collectively refer to the disorder known as chronic venous
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insufficiency (CVI) (5). Classification of CVI according to the signs and severity of the
disease is discussed elsewhere in this book.
Primary valvular incompetence can involve all veins participating in the macro-
circulation: the superficial, deep and the perforating venous systems, alone or in
combination. In patients with post-thrombotic syndrome, destruction of the valves results
in secondary valvular incompetence. Chronic obstruction of deep veins due to previous
deep vein thrombosis is another important etiology of persistent ambulatory venous
hypertension. The role of the perforating veins is still under much debate.
VARICOSE VEINS
Etiology
Age, gender, pregnancy, weight, height, race, diet, bowel habits, occupation, posture,
previous deep venous thrombosis (DVT) and genetics have all been proposed as pre-
disposing factors associated with varicose vein formation (6). Except for previous deep
vein thrombosis and genetics, there is poor evidence that indicates a causative relationship
between these predisposing factors and the formation of varicose veins.
The Role of Genetics
There are few reported epidemiologic investigations that suggest a relationship between
varicose vein formation and a genetic predisposition (7,8). It was previously thought that
axial destruction of venous valves led to transmission of ambulatory venous hypertension
causing reflux and varix formation (6). However, a publication by Labropoulos et al.
indicated that the most frequent location for initial varicose vein formation was in the
below knee great saphenous vein (GSV) and its tributaries, followed by the above knee
GSV, and the saphenofemoral junction (9). This study clearly indicates that vein wall
degeneration with subsequent varix formation can occur in any segment of the superficial
and deep systems at any time and suggests a genetic component to the disease. In 1969,
Gunderson and Hauge reported on the epidemiology of varicose veins observed in their
vein clinic in Malmo, Sweden over a two month period (7). Of 250 patients, 154 female
and 24 male patients provided complete survey information on their parents and siblings.
Although biased by the predominance of women and dependence on survey data, this
report suggested that patients with varicose veins had a higher likelihood of developing
varicosities if their fathers had varicose veins. Furthermore, the risk of developing
varicose veins increases if both parents had varicosities. Cornu-Thenard et al. prospec-
tively examined 67 patients and their parents. Patients non-affected spouses and parents
were used as controls for a total of 402 subjects (8). These investigators reported that the
risk of developing varicose veins was 90% when both parents were affected, 25% for
males and 62% for females if one parent is affected and 20% when neither parent is
affected. These data suggest an autosomal dominant with variable penetrance mode of
genetic transmission. The decreased incidence in males with an affected parent and the
spontaneous development in patients without affected parents, suggests that males are
more resistant to varix formation and that other multi-factorial etiologies in patients with
pre-dispositions to the disease must exist. To further elucidate the genetic component of
the disease, molecular analyses with gene chip technologies is required. The chromosome
responsible for the disease and its protein by-products are currently unknown.
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The Role of DVT
An injury to the venous endothelium or local pro-coagulant environmental factors, leads
to thrombus formation in the venous system. It is currentlywell acceptedthat avenous thrombus
initiates a cascade of inflammatory events that contributes to or causes vein wall fibrosis (10).
Thrombus formation at venous confluences and valve pockets leads to activation of neutrophils
and platelets. Activation of these cells leads to formation of inflammatory cytokines, pro-
coagulants and chemokines leading to thrombin activation and further clot formation.
Production of inflammatory mediators creates a cytokine/chemokine gradient leading to
leukocyte invasion of the vein wall at the thrombus wall interface and from the surrounding
adventitia. Up-regulation of adhesion molecules perpetuates this process, eventually leading to
vein wall fibrosis, valvular destruction and alteration of vein wall architecture (10,11). Although
the mechanisms associated with vein wall damage secondary to venous thrombosis are
beginning to be unraveled, the majority of varicose veins occur in patients with no prior history
of deep venous thrombosis. The etiology of primary varicose veins continues to be a mystery.
Vein Wall Anatomy and Histopathology
Whatever the initiating event, several unique anatomic and biochemical abnormalities
have been observed in patients with varicose veins. Normal and varicose great saphenous
veins (GSVs) are characterized by three distinct muscle layers within their walls. The
media contains an inner longitudinal and an outer circular layer, while the adventitia
contains a loosely organized outer longitudinal layer (12–14). In normal GSVs, these
muscle layers are composed of smooth muscle cells (SMCs) which appear spindle shaped
(contractile phenotype) when examined with electron microscopy (Fig. 1) (15). These
cells lie in close proximity to each other, are in parallel arrays and surrounded by bundles
of regularly arranged collagen fibers.
In varicose veins, the orderly appearance of the muscle layers of the media is replaced
by an intense and disorganized deposition of collagen (15–17). Collagendeposits separate the
normally closely opposed SMCs and are particularly striking in the media. SMCs appear
elliptical, ratherthan spindle shaped and demonstrate numerous collagencontainingvacuoles
imparting a secretory phenotype (Fig. 2) (15). What causes SMCs to dedifferentiate from a
Figure 1 Electron micrograph of normal greater saphenous vein (magnification 11,830!). Note
organized structure of alternating smooth muscle cells (long arrows) with spindle shaped contractile
phenotype, interspersed by longitudinally arranged collagen bundles (short arrows).
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