ORIGINAL ARTICLE Indications and organisational methods for autologous blood transfusion procedures in Italy: results of a national survey Liviana Catalano1, Alessandra Campolongo2, Maurizio Caponera3, Alessandra Berzuini4, Andrea Bontadini5, Giuseppe Furlò6, Patrizio Pasqualetti2, Giancarlo M. Liumbruno7 National Blood Centre, Italian National Institute of Health, Rome; 2Medical Statistics and Information Technology, Fatebenefratelli Association for Research, Rome; 3Service of Immunohaematology and Transfusion Medicine, "Cannizzaro" Hospital, Catania; 4Service of Immunohaematology and Transfusion Medicine, "Manzoni" Hospital, Lecco; 5Service of Immunohaematology and Transfusion Medicine, "S. Orsola-Malpighi" Polyclinic, Bologna; 6 Service of Immunohaematology and Transfusion Medicine, "Bianchi Melacrino Morelli" Hospital, Reggio Calabria; 7Immunohaematology, Transfusion Medicine and Clinical Pathology Units, "San Giovanni Calibita" Fatebenefratelli Hospital, Rome, Italy 1
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Introduction. Pre-operative donation of autologous blood is a practice that is now being abandoned. Alternative methods of transfusing autologous blood, other than predeposited blood, do however play a role in limiting the need for transfusion of allogeneic blood. This survey of autologous blood transfusion practices, promoted by the Italian Society of Transfusion Medicine and Immunohaematology more than 2 years after the publication of national recommendations on the subject, was intended to acquire information on the indications for predeposit in Italy and on some organisational aspects of the alternative techniques of autotransfusion. Materials and methods. A structured questionnaire consisting of 22 questions on the indications and organisational methods of autologous blood transfusion was made available on a web platform from 15 January to 15 March, 2013. The 232 Transfusion Services in Italy were invited by e-mail to complete the online survey. Results. Of the 232 transfusion structures contacted, 160 (69%) responded to the survey, with the response rate decreasing from the North towards the South and the Islands. The use of predeposit has decreased considerably in Italy and about 50% of the units collected are discarded because of lack of use. Alternative techniques (acute isovolaemic haemodilution and peri-operative blood salvage) are used at different frequencies across the country. Discussion. The data collected in this survey can be considered representative of national practice; they show that the already very limited indications for predeposit autologous blood transfusion must be adhered to even more scrupulously, also to avoid the notable waste of resources due to unused units. Users of alternative autotransfusion techniques must be involved in order to gain a full picture of the degree of use of such techniques; multidisciplinary agreement on the indications for their use is essential in order for these indications to have an effective role in "patient blood management" programmes. Keywords: pre-operative autologous donation, patient blood management, intra-operative blood salvage, post-operative blood salvage, acute normovolaemic haemodilution.
Introduction The development and use of strategies to prevent and reduce bleeding and the promotion of alternatives to allogeneic transfusions are included among the principles that the European Recommendation Rec (2002) 11 explains should be applied to improve the quality and intensity of healthcare services in transfusion medicine1. Over the last 20 years we have witnessed the birth, development and subsequent gradual decline of the practice of predeposit of autologous blood2.
This practice expanded from the 1980s, in particular to prevent transfusion-related transmission of viral infections; nowadays, however, a very high level of blood safety is guaranteed by the combined effect of careful selection of donors on the basis of their history and clinical information, serological tests and genomic amplification to screen for transfusion-transmissible infections. The reduction in the role of predeposit has been confirmed by the publication of international Presented in part aat the "3rd National Congress of Transfusion Centres" Genoa, Italy, 16-18 May 2013
Blood Transfus 2014; 12: 497-508 DOI 10.2450/2014.0295-13 © SIMTI Servizi Srl
497 All rights reserved - For personal use only No other uses without permission
Catalano L et al
Methods of performing the predeposit (timing, manner and any related pharmacological treatments). - Amount of use of predeposited units in 2012 and a comparative analysis with use since 1996 (data supplied by the National Blood Centre). - Diffusion and level of use per area of care (general surgery, cancer surgery, trauma, thoracic surgery, heart surgery, vascular surgery, neurosurgery, urology, obstetrics, gynaecology, orthopaedic surgery) of the various techniques of autologous transfusion (predeposit, haemodilution and perioperative blood salvage). - Degree of involvement of the TS in the management of alternatives to predeposit, according to criteria conforming with SIMTI standards: in particular, definition of the indications, evaluation of the appropriateness and collection of data concerning the procedures. - Degree of use of systems that do or do not involve washing blood products derived from the perioperative salvage procedures and degree of use of leucodepletion filters prior to infusion of these products. The filters applied to enable responses to questions 17 to 22 were a positive response to the question on the use a specific alternative technique to predeposit together with a positive response to the question on collecting data on the procedures. Univariate and multivariate data analyses were performed on all the questionnaires received, taking into consideration all the questions to which responses had been given. In order to assess possible differences and/or variables related to different geographical locations, the TS were grouped into the macro-areas described by the Italian Institute of Statistics (ISTAT - Istituto Nazionale di Statistica)12: - North-East (Trentino Alto Adige, Veneto, FriuliVenezia-Giulia, Emilia Romagna); - North-West (Piedmont, Valle d'Aosta, Lombardy, Liguria); - Centre (Tuscany, Umbria, Marche, Lazio); - South (Abruzzo, Molise, Campania, Puglia, Basilicata, Calabria); - Islands (Sicily, Sardinia). The percentage frequencies of the variables related to the different categories of questions were calculated and any differences were evaluated using the chi-square test or Fisher's exact test, as appropriate. Furthermore, multiple correspondence analysis was performed, representing the "distances" between some characteristics of the TS graphically, in order to show the salient features common to most TS. The responses selected for multivariable analysis were those to nine questions (1, 2, 5, 6, 7, 9, 11, 12, 15 - Appendix 1),
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guidelines that do not recommend this practice "other than in exceptional clinical circumstances" and that suggest, when appropriate, the use of peri-operative blood salvage techniques3-5. Indeed, intra-operative blood salvage currently appears to be the most effective and efficient technique of saving autologous blood6. In Italy, Law n. 219 of 21 October, 20057 ("New legislation on transfusions and domestic production of blood derivatives") provides for the coordination and organisation of peri-operative blood salvage among the diagnostic and therapeutic services of transfusion medicine. Furthermore, the Ministry of Labour, Health and Social Policies, in its "Manual of safety in the operating theatre: recommendations and checklists"8, includes the prevention and management of bleeding among objectives to be pursued and specifies that "in operations in which there is a predicted risk of loss of large volumes of blood, it is advisable to have available a system for peri-operative recovery of blood and a device for rapid infusion of fluids". Finally, according to the Standards of Transfusion Medicine recently published by the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI - Società Italiana di Medicina Trasfusionale e Immunoematologia), transfusion structures (TS) should define and formalise the autologous transfusion services they provide and ensure the coordination and organisation of pre-operative haemodilution and intra-operative and post-operative blood salvage9. The coordination and organisation of these techniques includes defining the indications for their appropriate and safe use, evaluating the appropriateness of their use, defining and organising integrated autologous transfusion programmes, collecting data on procedures performed, as well as taking actions aimed at evaluating the quality and safety of the blood products obtained from the peri-operative salvage procedures. This survey on the use of autotransfusion procedures, promoted by SIMTI more than 2 years after the publication of national recommendations on the subject4,10,11, was intended to collect information on the indications for predeposit of blood in Italy and on some organisational aspects of autologous transfusion techniques.
Materials and methods A structured questionnaire comprising 22 questions, with filters able to prevent unreasonable answers, was placed on a web platform from 15 January to 15 March, 2013 (see Appendix 1). The 232 TS in Italy were invited by e-mail to respond to the online survey, which contained questions aimed at collecting information on the following aspects: - Clinical-organisational protocols in use and criteria for enrolling candidates for predeposit autologous transfusion.
Blood Transfus 2014; 12: 497-508 DOI 10.2450/2014.0295-13 498 All rights reserved - For personal use only No other uses without permission
Survey of autotransfusion in Italy
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Results Of the 232 TS invited to respond to the survey, 160 (69%) did so, with a decreasing gradient from North to South and the Islands. Indeed, 81% of the TS in the North-East responded to the survey, 71% in the North-West and Centre, 68% in the South and only 46% in the Islands (p=0.057). The percentages of TS that responded to the survey in the various geographic macro-areas with respect to the total TS that adhered
to the initiative were as follows: North-East: 18.1%; North-West: 28.1%; Centre: 21.2%; South: 24.4%; Islands: 8.1%. The clinical and organisational protocol for predeposit that has been defined and is in use in 160 TS was agreed with the applicants in 149 TS (93%) and in 139 (87%) cases the protocol specifies the indications for the predeposit. These indications are those recommended by SIMTI (patients with rare blood groups for whom it is difficult to obtain allogeneic blood; patients with multiple alloimmunisation for whom it is difficult to obtain compatible allogeneic blood; patients who refuse consent to allogeneic transfusion for personal reasons; scoliosis surgery in children; patients with a bleeding diathesis [but who do not have anaemia or active bleeding])4 in 106 of the 139 TS (76%), whereas in 10 TS (7%) they are more restricted and in 23 TS (17%) they are broader. The reasons for not enrolling candidates in a programme of predeposit of autologous blood are not homogeneous among the TS and there are some statistically significant differences between the ISTAT geographical macro-areas with regards to: (i) haemoglobin (Hb)>150 g/L (p=0.03); (ii) Hb
©
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Introduction. Pre-operative donation of autologous blood is a practice that is now being abandoned. Alternative methods of transfusing autologous blood, other than predeposited blood, do however play a role in limiting the need for transfusion of allogeneic blood. This survey of autologous blood transfusion practices, promoted by the Italian Society of Transfusion Medicine and Immunohaematology more than 2 years after the publication of national recommendations on the subject, was intended to acquire information on the indications for predeposit in Italy and on some organisational aspects of the alternative techniques of autotransfusion. Materials and methods. A structured questionnaire consisting of 22 questions on the indications and organisational methods of autologous blood transfusion was made available on a web platform from 15 January to 15 March, 2013. The 232 Transfusion Services in Italy were invited by e-mail to complete the online survey. Results. Of the 232 transfusion structures contacted, 160 (69%) responded to the survey, with the response rate decreasing from the North towards the South and the Islands. The use of predeposit has decreased considerably in Italy and about 50% of the units collected are discarded because of lack of use. Alternative techniques (acute isovolaemic haemodilution and peri-operative blood salvage) are used at different frequencies across the country. Discussion. The data collected in this survey can be considered representative of national practice; they show that the already very limited indications for predeposit autologous blood transfusion must be adhered to even more scrupulously, also to avoid the notable waste of resources due to unused units. Users of alternative autotransfusion techniques must be involved in order to gain a full picture of the degree of use of such techniques; multidisciplinary agreement on the indications for their use is essential in order for these indications to have an effective role in "patient blood management" programmes. Keywords: pre-operative autologous donation, patient blood management, intra-operative blood salvage, post-operative blood salvage, acute normovolaemic haemodilution.
Introduction The development and use of strategies to prevent and reduce bleeding and the promotion of alternatives to allogeneic transfusions are included among the principles that the European Recommendation Rec (2002) 11 explains should be applied to improve the quality and intensity of healthcare services in transfusion medicine1. Over the last 20 years we have witnessed the birth, development and subsequent gradual decline of the practice of predeposit of autologous blood2.
This practice expanded from the 1980s, in particular to prevent transfusion-related transmission of viral infections; nowadays, however, a very high level of blood safety is guaranteed by the combined effect of careful selection of donors on the basis of their history and clinical information, serological tests and genomic amplification to screen for transfusion-transmissible infections. The reduction in the role of predeposit has been confirmed by the publication of international Presented in part aat the "3rd National Congress of Transfusion Centres" Genoa, Italy, 16-18 May 2013
Blood Transfus 2014; 12: 497-508 DOI 10.2450/2014.0295-13 © SIMTI Servizi Srl
497 All rights reserved - For personal use only No other uses without permission
Catalano L et al
Methods of performing the predeposit (timing, manner and any related pharmacological treatments). - Amount of use of predeposited units in 2012 and a comparative analysis with use since 1996 (data supplied by the National Blood Centre). - Diffusion and level of use per area of care (general surgery, cancer surgery, trauma, thoracic surgery, heart surgery, vascular surgery, neurosurgery, urology, obstetrics, gynaecology, orthopaedic surgery) of the various techniques of autologous transfusion (predeposit, haemodilution and perioperative blood salvage). - Degree of involvement of the TS in the management of alternatives to predeposit, according to criteria conforming with SIMTI standards: in particular, definition of the indications, evaluation of the appropriateness and collection of data concerning the procedures. - Degree of use of systems that do or do not involve washing blood products derived from the perioperative salvage procedures and degree of use of leucodepletion filters prior to infusion of these products. The filters applied to enable responses to questions 17 to 22 were a positive response to the question on the use a specific alternative technique to predeposit together with a positive response to the question on collecting data on the procedures. Univariate and multivariate data analyses were performed on all the questionnaires received, taking into consideration all the questions to which responses had been given. In order to assess possible differences and/or variables related to different geographical locations, the TS were grouped into the macro-areas described by the Italian Institute of Statistics (ISTAT - Istituto Nazionale di Statistica)12: - North-East (Trentino Alto Adige, Veneto, FriuliVenezia-Giulia, Emilia Romagna); - North-West (Piedmont, Valle d'Aosta, Lombardy, Liguria); - Centre (Tuscany, Umbria, Marche, Lazio); - South (Abruzzo, Molise, Campania, Puglia, Basilicata, Calabria); - Islands (Sicily, Sardinia). The percentage frequencies of the variables related to the different categories of questions were calculated and any differences were evaluated using the chi-square test or Fisher's exact test, as appropriate. Furthermore, multiple correspondence analysis was performed, representing the "distances" between some characteristics of the TS graphically, in order to show the salient features common to most TS. The responses selected for multivariable analysis were those to nine questions (1, 2, 5, 6, 7, 9, 11, 12, 15 - Appendix 1),
iz i
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-
©
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guidelines that do not recommend this practice "other than in exceptional clinical circumstances" and that suggest, when appropriate, the use of peri-operative blood salvage techniques3-5. Indeed, intra-operative blood salvage currently appears to be the most effective and efficient technique of saving autologous blood6. In Italy, Law n. 219 of 21 October, 20057 ("New legislation on transfusions and domestic production of blood derivatives") provides for the coordination and organisation of peri-operative blood salvage among the diagnostic and therapeutic services of transfusion medicine. Furthermore, the Ministry of Labour, Health and Social Policies, in its "Manual of safety in the operating theatre: recommendations and checklists"8, includes the prevention and management of bleeding among objectives to be pursued and specifies that "in operations in which there is a predicted risk of loss of large volumes of blood, it is advisable to have available a system for peri-operative recovery of blood and a device for rapid infusion of fluids". Finally, according to the Standards of Transfusion Medicine recently published by the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI - Società Italiana di Medicina Trasfusionale e Immunoematologia), transfusion structures (TS) should define and formalise the autologous transfusion services they provide and ensure the coordination and organisation of pre-operative haemodilution and intra-operative and post-operative blood salvage9. The coordination and organisation of these techniques includes defining the indications for their appropriate and safe use, evaluating the appropriateness of their use, defining and organising integrated autologous transfusion programmes, collecting data on procedures performed, as well as taking actions aimed at evaluating the quality and safety of the blood products obtained from the peri-operative salvage procedures. This survey on the use of autotransfusion procedures, promoted by SIMTI more than 2 years after the publication of national recommendations on the subject4,10,11, was intended to collect information on the indications for predeposit of blood in Italy and on some organisational aspects of autologous transfusion techniques.
Materials and methods A structured questionnaire comprising 22 questions, with filters able to prevent unreasonable answers, was placed on a web platform from 15 January to 15 March, 2013 (see Appendix 1). The 232 TS in Italy were invited by e-mail to respond to the online survey, which contained questions aimed at collecting information on the following aspects: - Clinical-organisational protocols in use and criteria for enrolling candidates for predeposit autologous transfusion.
Blood Transfus 2014; 12: 497-508 DOI 10.2450/2014.0295-13 498 All rights reserved - For personal use only No other uses without permission
Survey of autotransfusion in Italy
Se
rv
iz i
Results Of the 232 TS invited to respond to the survey, 160 (69%) did so, with a decreasing gradient from North to South and the Islands. Indeed, 81% of the TS in the North-East responded to the survey, 71% in the North-West and Centre, 68% in the South and only 46% in the Islands (p=0.057). The percentages of TS that responded to the survey in the various geographic macro-areas with respect to the total TS that adhered
to the initiative were as follows: North-East: 18.1%; North-West: 28.1%; Centre: 21.2%; South: 24.4%; Islands: 8.1%. The clinical and organisational protocol for predeposit that has been defined and is in use in 160 TS was agreed with the applicants in 149 TS (93%) and in 139 (87%) cases the protocol specifies the indications for the predeposit. These indications are those recommended by SIMTI (patients with rare blood groups for whom it is difficult to obtain allogeneic blood; patients with multiple alloimmunisation for whom it is difficult to obtain compatible allogeneic blood; patients who refuse consent to allogeneic transfusion for personal reasons; scoliosis surgery in children; patients with a bleeding diathesis [but who do not have anaemia or active bleeding])4 in 106 of the 139 TS (76%), whereas in 10 TS (7%) they are more restricted and in 23 TS (17%) they are broader. The reasons for not enrolling candidates in a programme of predeposit of autologous blood are not homogeneous among the TS and there are some statistically significant differences between the ISTAT geographical macro-areas with regards to: (i) haemoglobin (Hb)>150 g/L (p=0.03); (ii) Hb
