Introduction
Italy is a unitary state divided into 20 regions where health care is provided by the National Health Service (NHS), a taxpayer-funded medical assistance program organized and regulated by the Ministry of Health that coordinates each region’s activity. Through the NHS, all citizens are entitled to free, extensive medical assistance that includes a primary care physician and hospital treatment. Some services include a co-pay fee, which differs among regions, depending on the type of service and on the patient’s financial situation. Low-income patients and those affected by serious illness (e.g., ESKD) are entitled to some form of partial or full coverage of health services and drugs.
Both hemodialysis (HD) and peritoneal dialysis (PD) are free for Italian citizens and permanent residents and are mainly provided by renal units located in public hospitals/structures. In order to provide widespread coverage of all regional territories, RRT can be performed in satellite centers that depend on a specific renal unit or in private structures that fulfill NHS standards.
Methods
Data were collected by the Italian Registry of Dialysis and Transplantation (RIDT), linked to the “Società Italiana di Nefrologia,” which is affiliated with the European Renal Association–European Dialysis and Transplant Association (1). Currently, the most recent evaluation of all Italian region dates back to 2015, whereas the subsequent updates contain only partial data. For that reason, we opted to describe both the 2015 experience and the most recent update of 2019 in order to report the most complete description of Italian experience.
Epidemiology
According to RIDT data, in 2015, the unadjusted incidence rate of dialysis in Italy was 154 per million population (pmp) (2), which is higher than the European (121 pmp) average (3). Dialysis incidence rates showed a rapid increase starting from 1999 (130 pmp), until reaching a peak of 168 pmp in 2009; in the second decade of the 21st century, dialysis incidence decreased slightly, with the lowest rate being reported in 2015. Fourteen percent of incident patients were started on PD with an incidence of 25 pmp (1549 incident patients); 56% of PD patients received continuous ambulatory PD. Data regarding ESKD incidence show a broad variation among Italian regions, even though after standardization for age, only four regions show a lower (Veneto 100 pmp and Apulia 126 pmp) or higher (Sardinia 179 pmp and Sicily 184 pmp) incidence than the national data. Interestingly, the greatest variability by region is reported in the age groups 65–74 years and >75 years, whereas the incidence rate in the <45 years age group is substantially homogeneous among the regions. Regional demographic variability may be partially responsible for these differences, which might also depend on different clinical patterns in the management of advanced CKD, including conservative and palliative measures. The most common cause of ESKD was diabetes mellitus, accounting for 19% of incident dialysis patients, followed by arterial hypertension (12%), glomerulonephritis (9%), and autosomal dominant polycystic kidney disease (7%). It is remarkable that 20% of patients who started dialysis in Italy in 2015 have no known cause of ESKD. According to these data, RRT was administered to 70,280 patients: 46,813 (67%) on dialysis and 23,467 (33%) on renal transplant.
An analysis of the data regarding the prevalence of dialysis patients showed a trend similar to data regarding incidence: an increase was observed until 2010 (prevalence 790 pmp) followed by a subsequent slow decline. In 2015, 46,813 patients were on dialysis, with (prevalence 770 ppm). These data are similar to data from Canada (790 pmp) (4), slightly lower than the European Renal Association (ERA) prevalence (823 pmp in 2016), and significantly lower than the prevalence reported in the United States (1582 pmp) (5). HD was by far the most common renal replacement treatment (42,375 prevalent patients; 697 pmp), whereas only 10% of patients requiring dialysis were on PD (4438 prevalent patients; 73 pmp). Although the percentage of patients on PD is still low in Italy, the prevalence of PD has progressively increased since 2010, and is almost two-fold higher than ERA data (9.5% versus 5%) and slightly higher than US data (7%) (4). Variation in PD prevalence among regions is wide, ranging from 8 to 128 pmp (3).
Reported mortality in ESKD patients in 2015 was 16 pmp, with a slight difference between HD (17 pmp) and PD (13 pmp) (3), whereas national mortality in dialysis patients was 15%, ranging from 12% to 20% among regions (3).
The most recent RIDT data refer to 2019; however, the main concern is regarding representativeness because these data were collected from only 13 out of 20 Italian regions. The unadjusted incidence rate of dialysis, which was 162 pmp in 2019, showed an increase starting in 2015. Coherently with 2015 data, 14% of incident patients were started on PD. Data regarding prevalence showed a continuous increase in the prevalence of dialysis patients since 2015, with a prevalence of 811 pmp in 2019; reported prevalence of PD patients was higher than in 2015 (15% versus 10%), but these data may have been influenced by the fact that data from seven Italian regions were not available. Reported mortality in ESKD patients in 2019 was 10.8 pmp, with a slight difference between HD (17 pmp) and PD (11.4 pmp) (2).
HD Practice
HD in Italy is provided by more than 600 nephrology clinics, with a national prevalence of public nonprofit hospitals (54%), although private centers are predominant in some regions, accounting for 46% of the total. Large central hospitals usually handle more complex patients with a high incidence of comorbidities and those on PD. HD treatments administered in the main hospitals account for 70% of the total, whereas 29% are administered in satellite centers without the compulsory presence of a physician during treatment; home HD accounts for <1% of all treatments (6). Almost half of all HD patients receive convective-diffusive treatments (6), and typically the treatments last for 4 hours each and are carried out three times per week. Nevertheless, depending upon the patient’s wishes and needs, treatment length and frequency can be modulated. Home-based therapy, such as short daily dialysis, can be proposed to stable patients wishing to limit their in-center treatments. Furthermore, in numerous institutions, an incremental HD program is available in which the treatment schedule takes into account and preserves the presence of residual renal function. Vascular access (VA) data are not up-to-date due to the lack of a national VA registry. Existing evidence from a recent census among Italian renal centers confirms the global increase in tunneled catheter prevalence, which exceeded 25% of prevalent patients. Every year, almost 9700 arteriovenous fistulas (AVFs) are created in 330 renal centers throughout the national territory; nephrologists are responsible for the creation in >60% of cases (7).
Dialysis Economics
HD treatments in Italy are available to all patients around the country at no cost to them through the taxpayer-funded NHS, and the delivering centers are reimbursed according to a per case payment system on the basis of diagnosis-related group. The reimbursement, which is on the basis of estimated treatment costs, is indicated for each dialysis modality by the central government (Table 1) and may vary slightly across regions. Presently, the mean payment for one session of ambulatory bicarbonate dialysis in a central hospital is €170 (approximately US$195), which increases to €262 for hemodiafiltration treatments (approximately US$305) (8). Reimbursement is low for treatments administered to inpatients or at home (around US$123 for each dialysis session) (8). Reimbursement includes the cost of personnel, dialysis supplies, medical evaluations, some laboratory tests (complete blood count, sodium, potassium, and arterial and mixed venous blood gases), and the medication of VA. Furthermore, the infusion of intravenous drugs during treatment and the administration of dialysis-related drugs. including phosphorus binders, calcitriol, and erythropoietin-stimulating agents, are all free of charge to the patient. Small co-payments are required from outpatients to sustain the cost of certain drugs and supplements (i.e., l-carnitine). Other procedures that are reimbursed by the central government on a diagnosis-related group basis include AVF or arteriovenous graft (AVG) creation and mechanical thrombectomy, tunneled catheter placement and removal (from around US$5,000 to $10,000), and AVF or AVG angioplasty (around US$5000). The differences in the amount of reimbursement depend on the length of hospital stay (1 day admission versus >1 day) and are characterized by a substantial interregional variability.
Table 1. -
Characteristics of
dialysis therapy in
Italy
| Number of dialysis patients |
46,813 (prevalent patients)
154 pmp (incident patients) |
| Number of patients on peritoneal dialysis |
4438 (prevalent patients) |
| Number of kidney transplant patients |
24,467 |
| Dialysis sessions: covered by insurance versus private-paying patients |
All sessions covered by the National Health Service |
| Dialysis units: hospital based or freestanding |
Both |
| Dialysis units: economic model |
Nonprofit in public hospitals, for profit in private units |
| Mean reimbursement per dialysis session (in US$) |
$180 (hemodialysis)
$280 (hemodiafiltration) |
| Dialysis delivery staff |
Only dialysis nurses |
| Typical patient-to-RN ratio in the dialysis unit |
4:1 |
| Average length of a dialysis session |
240 minutes |
| Number of times per month patients are seen by a nephrologist during dialysis sessions |
At least four times per month; most of the time, every dialysis session |
| Proportion of prevalent HD patients using an AVF, AVG, and CVC |
No registry data; 40% of dialysis units have >20% of patients using a CVC |
| Number of kidney transplant patients |
24,467 |
pmp, per million population; RN, registered nurse; HD, hemodialysis; AVF, arteriovenous fistula; AVG, arteriovenous graft; CVC, central venous catheter.
Staff
HD centers are staffed by registered nurses with a nurse-to-patient ratio of 1:3–1:4, which in some circumstances may increase to 1:2, depending upon the patient’s needs; a technician is usually available in every main center and is also available on-call for any technical issues in satellite centers and in-home dialysis. Medical supervision is usually provided by nephrologists that regularly check each patient, decide the treatment plan, and review medications. Routine laboratory results are checked monthly for all patients or more frequently if medically indicated. Recently, other health care professionals, such as dietitians, psychologists, and physiotherapists, have been added to the HD center staff; the availability of these workers varies across centers and across the country.
Coronavirus Disease 2019 Pandemic: A Challenge for Dialysis Management
Since the first reported case of coronavirus disease 2019 (COVID-19) in Italy on February 21, 2020, the infection spread rapidly, with an increasing number of deaths, and Italy was among the countries most severely affected by the disease. Data regarding COVID-19 spread among the Italian dialysis population during the first phase of the pandemic (March–April 2020) were recently published in a survey of the Italian Society of Nephrology (9). The survey population included 30,821 HD and 4139 PD patients from 365 centers (80% of all national dialysis centers) and showed an overall rate of COVID-19 infection of 2%, with a significant difference depending on treatment modality (HD 4% versus PD 1%). The mortality rate was 33%, almost two-and-a-half times higher than in the general population (13%), with the highest case fatality rate among PD patients (46% versus 34% among HD patients).
The policy that was adopted in order to prevent COVID-19 spread among in-center HD patients and dialysis facilities is on the basis of two main cornerstones: protection of patients and HD staff, and early identification of cases among patients and HD team (Figure 1).
;)
Figure 1.: Example of strategy for the prevention of coronavirus disease 2019 in-center spread adopted in most Italian dialysis units. Telephone triage is carried out before the hemodialysis session in order to early check to identify severe acute respiratory syndrome coronavirus 2 symptomatic patients or contacts.
The Italian Ministry of Health recommended prioritizing the COVID-19 vaccination for people at very high risk of death, including dialysis and kidney transplant patients, regardless of their age. The use of mRNA vaccines is recommended for these patients, and COVID-19 vaccines are free of charge. Data regarding vaccination coverage among the entire dialysis population in Italy have not yet been published. Recently published data from two single centers in Italy showed that between 5% and 7% of dialysis patients refused the COVID-19 vaccination. Concerns about safety and about lack of efficacy were associated with a higher rate of vaccine refusal (10). As of September 2021, the Italian Ministry of Health recommended a third-dose vaccination in dialysis patients. There are no official published data regarding third-dose vaccination coverage in Italian dialysis patients: some reports from several Italian regions describe coverage of >95% of patients. On March 1, 2022, administration of a fourth dose for dialysis patients was recommended by the Ministry.
Conclusions and Future Challenges
HD treatments in Italy are widely available to all patients, usually close to their place of residence, and are free of charge and of a high standard. Although there has been a widespread increase in financial restrictions, all HD techniques can still be performed according to clinical requirements. Similar to other nations, elderly individuals are predominant among HD patients, and transfer to central hospitals for the treatment of important comorbidities is not always available. Currently, some Italian centers have fallen behind in updating HD registries, including data regarding vascular access; this represents a critical challenge for the near future. The COVID-19 outbreak has had a huge effect among more fragile individuals, including HD patients. This prompted the Italian Society of Nephrology to distribute guidelines and procedures whose efficacy in controlling the epidemic is now under evaluation in dedicated trials.
Disclosures
All authors have nothing to disclose.
Funding
None.
Acknowledgments
The authors would like to express their gratitude to all members of the Registro Italiano di Dialisi e Trapianto (RIDT) for their strenuous efforts in collecting and analyzing all registry data. In particular, the authors thank Dr. Maurizio Postorino and Aurelio Limido (past National RIDT coordinator and secretary), and Dr. Maurizio Nordio and Pietro Manuel Ferrario (current National RIDT coordinator and secretary) for their collaboration.
The content of this article reflects the personal experience and views of the authors and should not be considered medical advice or recommendation. The content does not reflect the views or opinions of the American Society of Nephrology (ASN) or Kidney360. Responsibility for the information and views expressed herein lies entirely with the authors.
Author Contributions
Both authors were responsible for conceptualization, wrote the original draft of the manuscript, and reviewed and edited the manuscript.
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