Kidney transplantation is no doubt today the most valid and effective therapeutic alternative for end-stage kidney failure.
Many favourable events have made this treatment the highest ambition of patients undergoing haemodialysis, of health professionals and of social policies as, besides a total recovery of the person, successful kidney transplantation leads to a considerable economic saving for the National Health Service, for welfare institutions and for insurance companies.
Survival following organ transplantation is today very good thanks to new immunosuppressive treatments, the perfecting of surgical techniques, the improvement of organ preservation, the collecting of the same at an earlier stage (from the former 24 hours to 6 hours after death) and new legal and organizational patterns (Law No. 91/99; Guide Lines in the Official Gazette No.144 dated 21.6.02). Kidney transplantation is the only treatment that, along with the excretory function, can correct even metabolic, haematological and endocrine alterations, which form the picture of chronic renal failure.
Besides transplantation is the form of treatment that offers the highest levels of rehabilitation, resumption of work and good subjective Quality of Life (QOL): the majority of studies published, both prospective and especially retrospective, state that the individual who has undergone a transplant attains a considerably higher recovery of his sexual, family, social and professional life than dialysed individuals.
The recovered working capacity achieved in most cases subsequently places the welfare forensic expert before the need to have extremely objective evaluation criteria that no doubt converge in different evaluations of patients who have undergone a transplant compared to those undergoing alternative treatment such as haemodialysis and peritoneal dialysis.
Forensic evaluations concerning individuals who have undergone a kidney transplant do not detect just one trend, probably due to the incomplete knowledge of these patients’ past experiences.
For this reason this paper means to establish “updated” landmarks on the real health conditions of these individuals, in order to reach a welfare evaluation of their natural working capacity that is as correct and realistic as possible.
Italian welfare services are regulated by Law No. 222 dated June 12 1984, which protects patients in two main risky conditions, the invalid status and disability, with the right, when they occur, respectively to an allowance and a disability pension.
Law No. 222/84, Art.1 that protects the invalid status thus defines the invalid individual in paragraph No. 1: “the insured party, whose working capacity in jobs that suit his natural skills is permanently reduced to less than one third due to infirmity or a physical or mental defect”; while Art. No. 2, which deals with disability, states that the disabled person is “the insured party or the owner of a disability allowance…who, due to infirmity or a physical or mental defect, is absolutely and permanently prevented from performing all working activities”. As can be deduced from the legal wording, both the invalid status and disability are conventionally defined on the basis of a certain reduction in or loss of individual production potential.
Hence, the welfare sector is not concerned about an infirmity from an aetiopathogenetic viewpoint, but rather in relations with the functional decline or loss that it causes.
Each case’s clinical picture is essential to place the disablement that affects the insured party in various levels of gravity.
But the “biological” condition, even when it is considerably compromised, cannot automatically be related with the invalid status, which instead represents a condition of existential disadvantage that can be identified by provisions, with the reduction of working capacity in jobs that suit the individual’s natural skills. In other words the investigated disease must be compared with the entire range of possible jobs that are compatible with the global identity of the individual insured party, that is with the complex formed by his working, natural and historical “personality”.
The evaluation of “activities that suit the natural skills”, as specified by our legislation, enables to form an adequately personalized opinion, which hence refers to the individual worker. Another concept inherent in the evaluation of the invalid status and disability is that the reduction or loss of working capacity caused by infirmity or physical or mental defects must have the requisite of permanency.
This evaluation must be based on statistical and prognostic criteria keeping in mind that, in the medical legal sphere, “permanent” does not mean unchangeable and neither certainly incurable, but it can refer to a non-transitory situation that develops with no time limit, without expecting healing and improvements in the short term, in relations with the medical knowledge of the moment. Hence the “invalid status“ and “disability“ are terms that define permanently non-existent or almost non-existent working conditions.
On the other hand the word “rehabilitation“ means restoring to primary skills and returning to a useful and constructive health and activity condition.
This is, to be precise, the objective of organ transplantation, whose favourable result, coinciding with the restoration of the organ’s function, in short automatically involves, from a theoretical viewpoint, the removal of the invalid condition and disability. Our prognostic categories must hence change course with the progress of transplantation surgery.
We must start considering that replacement surgery can enable the patient at a more or less end-stage to regain cardiac, uropoietic and hepatic functions and so on. The typical development of diseases that lead to death, that almost take on a clinical profile, which can be superimposed to that of acute infectious diseases, where we are accustomed to observe sensational solutions to extremely serious pathological pictures, is hence roughly altered.
Hence the concept of permanency changes for many diseases that have so far been considered too serious, with a tendency to worsen and a negative prognosis to even deem it necessary, in most cases, to resort to the organ for the re-examination of health conditions, which generally checks the persistence of medical legal conditions that have lead to welfare services.
Hence the following equation dies out:
Serious and chronic organ failure = Permanent reduction or loss of working capacity.
Progress in this special field of medicine has practically altered the typical development of those diseases marked by serious or chronic organ failure, which unfailingly lead to the invalid status and death, removing the concept of permanency from them. In fact organ function is restored (in some cases the kidney) through transplants with favourable results, hence removing, in short, the disability to work.
Besides, for prognostic purposes, this concerns both the individual patient carrying the transplant (whatever the organ concerned), who has recovered as far as possible, and from a functional viewpoint, his quality of life (QOL), in which work plays an essential role. Concerning this point it is known that rehabilitation requires times that vary according to the type of transplant, coinciding, in some cases, with the end of postoperative progress, while in others, as in heart transplants, the rehabilitation programme foresees gradual and differentiated training.
But once the final result has been reached, in other words once the transplanted organ has re-established the previously lost functions, medical legal forensic evaluation issues are basically the same, notwithstanding the organ transplanted.
Besides the patient’s commitment to periodical medical follow-ups is not too costly from a working viewpoint.
Case histories of survival are certainly important towards the evaluation of the results of transplantation surgery, but recently data concerning the quality of life has been increasingly highlighted: on this issue we cannot help noticing the importance all authors give today to ensuring patients who have undergone a transplant a more or less normal life that enables them physical efforts, as this aspect is the real and main factor that completes the result achieved with the transplant.
Reintegration in the working world is one of the goals of transplantation surgery and it is achieved in a good percentage of cases.
Data in many case histories clearly highlights a real working rehabilitation following kidney transplantation when compared to the dialysis period; hence most transplanted individuals are concretely employed.
The work performed mainly involves light energy consumption, but often these individuals perform considerably exerting activities outside working hours, which clearly shows there is a biological willingness to accept exertion.
All the same there are cases in which the individual is only partly fit to perform his job or is able to provide only for himself. We must also note that while some individuals (professionals, executives), who already worked during the dialysis period, despite their poor clinical conditions, continue to work, others who have undergone a transplant, despite being in satisfactory clinical conditions, enjoy invalid status benefits also because they number among those who benefit from an opinion expressed before the transplant.
As the study of literature reveals, the degree of employment, besides many other reasons, tends to increase with higher cultural standards: it is closely related to qualifications because these very individuals clearly favour medium to light activities, which are often intellectual ones.
Evaluation issues presented by patients who have undergone a transplant are no doubt many and complex. However we can no doubt hope for an approach to evaluation that gives the due importance to factors that possibly contribute to damage the transplanted organ and/or the guest organism (such as diseases related with nephropathy and dialysis, which in themselves gain medical legal value notwithstanding the transplant) and yet contributes to free the field from all forms of “ethical” disablement. At times predicted complications, which are considered unavoidable, could influence the opinion, but if we keep in mind that statistical predictability must always refer to the group and not to the individual patient and that possible complications can occur in a greatly variable time span, while evaluation in the medical legal sphere must concern the current functional situation, we shall certainly reach an unbiased opinion.
Well, a correct evaluation approach must necessarily consider in the first place the time that has passed from transplantation surgery to the moment of evaluation.
Most authors agree in believing that generally one year must pass (the necessary period for an adequate clinical stabilization of both the transplanted organ and the guest) before a medical legal opinion can be expressed without qualms.
Should there arise the need to form an opinion before this period, for example at the medical legal follow-up to renew the disablement allowance (former Law No. 222/84, article 1) of an individual whose invalid status was recognized during the dialysis period and who had meanwhile undergone a transplant, the rational use of the re-examination organ is no doubt useful.
The possibility of defining requests and performing periodical reviews in a short time enables to later adjust the services supplied to the rights and needs of the insured party.
As has been amply reported, many factors can positively or negatively influence the result of a transplant and they must necessarily be considered for evaluation purposes.
However, the starting point for an adequate and personalized evaluation approach can only be the special functional condition of the individual’s kidneys, duly considered in relations with his clinical conditions and other functional parameters that are useful in the positive or negative prognostic terms present in the case and that lead us to a new concept of permanency, referred this time to the individual who has undergone a transplant.

Indicative criteria to form a clinical and functional picture of patients who have undergone a kidney transplant It is well known that permanent damage can be evaluated only from the moment it can be considered stabilized.

In kidney transplantation the stabilization period depends on certain factors that can thus be summarized:
pre-transplant risk factors;
early postoperative complications; and, late
postoperative complications.
We can indicatively state that a clinical situation stabilizes one year after surgery.

Case history and physical examination
The first step towards a correct evaluation is no doubt an accurate case history and a thorough physical examination of the general conditions, keeping in mind the following parameters.

Pre-transplant risk factors
·Recipient’s age.
Organ survival is better in individuals < 25 years and in older patients (> 45 years) compared to intermediate ages.
·Sex.
Survival to transplantation surgery appears better in females during the first year. The differences are non-existent after 2 years; hence they are not very significant.
·Race. The presence, for example, of hypertension and diabetes mellitus is more frequent in the black population.
·Initial nephropathy.
Organ survival is better in non-diabetics.
·Concurrent diseases.
Survival worsens in patients with stable hypertension, in heart patients and in individuals suffering from systemic diseases. ·Donor type. Survival is better with live donors.
·HLA compatibility. Organ survival is better.

Early complications:
·surgical;
·infectious; and,
·systemic.
Type and dosage of the immunosuppressive treatment pattern followed Transplantation survival has clearly improved with the use of cyclosporine and last generation drugs.

Late complications
Almost all originate from the use of immunosuppressive treatment, especially steroid treatment, which is today gradually being given up.
·Malignant tumours
·Infections
·Ischaemic heart disease and vasculopathies
·Obesity
·Gastric ulcers
·Liver diseases
·Diabetes mellitus
·All other diseases that can be statistically predicted

Evaluation of the kidney function
This is no doubt the next step. The universally accepted essential parameters are blood creatinine and endogenous creatinine clearance.
Blood creatinine ranges from 0.6 to 1.2 mg/dl in normal adults. We must however stress that these values depend on the method. In fact 1.5 mg/dl is still a normal value in certain methods, while 1.3 mg/dl is already a pathological value in others.
Most authors have reported that blood creatinine levels around 1.5-1.6 mg/dl can be considered “normal” in patients who have undergone a transplant and are treated with cyclosporine.
Creatinine clearance, which reflects glomerular filtration and whose normal value, depending on the methods used, is around 120 ml/min, requires the knowledge of both blood creatinine and 24-hour diuresis values.
If the latter is not available, Calculated Creatinine Clearance can validly be used both clinically and in the medical legal sector.
This value is calculated on the individual’s age, weight and height. We can trace the creatinine clearance from these parameters, starting from blood creatinine values and applying Crockroft and Gault’s following mathematical formula:

Creatinine .............(140 – age) x body weight in Kg
Clearance ........=... ———————————
(ml/min) .................72 x blood creatinine in mg/dl

This formula applies for male adults; for females the creatinine clearance thus calculated must be multiplied by 0.85 (Andreucci). Renal function in patients who have undergone kidney transplantation is thus considered, depending on their creatinine clearance:
Good: > 60 ml/min
Discrete: 40-60 ml/min
Poor: 20-40 ml/min
Inadequate: < 20 ml/min

Indicative criteria to evaluate the “valid status” of patients who have undergone a kidney transplant It is necessary to shift from a clinical-biological evaluation to judging the working capacity, which is neither general nor specific, but lies in suitable employment.

Besides a careful evaluation of the insured party’s Quality of Life, the parameters to be considered must basically be the same that are considered whenever a medical legal opinion must be formed in the welfare sector: the evaluation of suitable activities.
Hence, after considering the overall morbid picture (and not each infirmity considered individually, nor can we sum the disablement percentages of each infirmity noticed, as in a price list), it is necessary to refer to its incidence on the activity performed previously and on all other suitable ones, which are those the insured party can perform due to age, skill and experience without exposing his health to further damage (from sentence No. 10949 dated October 21 1996 of the Court of Cassation - labour department) with neither usage nor wastage of remaining energy. In the case of individuals who have undergone a kidney transplant, as aforementioned, it is necessary to focus on their degree of rehabilitation.
The medical legal evaluation of individuals who have undergone transplantation surgery differs from case to case according to the many aspects of this clinical condition.
Complications must obviously be evaluated at their onset from a medical legal viewpoint, as statistical predictability can be referred to the group and not to the individual.
However, a positive case history based on frequency and gravity of complications can meet the invalid status requisites.
A successful kidney transplant determines the shift from an invalid status often involving disability to a situation marked by a recovery of working capacity that is almost always above the limits placed by law for the recognition of the right to currently enforced welfare services.
There can be the premise for the invalid status (former Law No. 222/84, article.1) to be recognised when functional parameters, blood creatinine and/or creatinine clearance show:
· a moderate to serious functional impairment of the transplanted organ; and,
· an adequate prejudice of the individual’s natural skills, proved by career setback or the job’s exertion, relevant physical involvement or stressful features.
The invalid status, as revealed by the many case histories, is often an opinion formed on the basis of an evaluation that had already been made at a time prior to the transplant and cannot be revoked only on the basis of the transplant as a biological event but on the basis of a real functional recovery that only creatinine clearance and the examination of all factors listed above can adequately prove. Only the presence of serious functional organ impairment, of multiple complications or of the most feared complications, such as tumours underway, can lead to an opinion of disablement, as per former Law No. 222/84, article No. 2.
The careful evaluation of the clinical and functional condition underway, considering the individual’s natural skills, his possibility to maintain former employment or to re-qualify for a new one, enables to form an opinion that shuns all welfarism and reflects the clinical conditions and the working capacity concretely possessed.
(prima parte)

Antonietta Trinchillo
Medico Legale