Schlüsselwörter ESPRAS - Brustrekonstruktion - freie Lappenplastik - DIEP - Mikrochirurgie - Register
Brustrekonstruktion
Key words ESPRAS - Breast Reconstruction - Free Flap - DIEP - Microsurgery - Breast Reconstruction
Registry
Introduction
In 2020, the European Commission published the breast cancer burden in EU-27 countries
with an estimated incidence of 355,457 new cases and 91,826 deaths [1 ]. The lifetime risk of breast cancer increased to 1 in 7, thus being the most commonly
diagnosed cancer in females [1 ]. While breast cancer is curable in 70–80 % of patients with early-stage, non-metastatic
disease [2 ], locoregional and systemic therapy approaches, including surgery, radio- and chemotherapy
often leave women physically and psychologically impaired. Thus, breast reconstruction
plays a central role in holistic breast cancer therapy, increasing patients’ self-esteem
and quality of life by restoring the femininity that female breast cancer patients
often describe as lost during treatment [3 ], [4 ], [5 ], [6 ], [7 ]. Whilst reconstructive surgery has revolutionized the management of breast cancer
and is now an invaluable part of recovery, the practice of breast reconstruction is
challenged by several controversial topics which are subject to ongoing debate. Harmonization
on an international level with the development of clear evidence-based guidelines
is urgently required.
Due to differences in historical, cultural and health-economic backgrounds, healthcare
in Europe is primarily organized on a national level and provided by a varying range
of systems, from tax-financed national services to private social insurance funds
[8 ]. Naturally, differences also exist in the organization, structure and size of national
plastic surgery societies. The European Society of Plastic, Reconstructive and Aesthetic
Surgery (ESPRAS) is the umbrella organization of all European national societies and,
with its over 7000 members, exists to promote best practice of Plastic, Reconstructive
and Aesthetic Surgery in Europe [9 ].
The Executive Committee (ExCo) ESPRAS organized the first ESPRAS European Leadership
Forum (ELF) in October 2020 to discuss common challenges facing Plastic Surgery national
societies [10 ]. This meeting highlighted a clear need for European standard operating procedures
for breast reconstruction. Based on this and as a first step, the aim of the presented
study was to survey the state and condition, current trends and potential regional
differences in the organization and delivery of breast reconstruction in Europe, with
a particular emphasis on equity of provision and access to breast reconstruction.
It is an attempt to initiate policy development and to identify areas requiring further
clinical research ultimately resulting in international, evidence-based guidelines
leading to coherence and equity in the provision of breast reconstruction in Europe.
Materials and Methods
Design of Survey
A large-scale web-based questionnaire was designed to evaluate European trends in
breast reconstruction, including the availability of different breast reconstructive
methods and the equity of care within these countries. The following items were addressed:
Structure of care, equity and access to breast reconstruction across European countries;
Immediate and Delayed Breast Reconstruction; Risk reduction, symmetrizing procedures,
and corrections; Radiation Therapy; Demand for European guidelines on breast reconstruction.
The questionnaire was created and distributed using an online survey administration
software (Google Forms, Google, California, U. S.) and sent electronically to identified
experts in this field. The study was initiated on December 2020. Data entry was closed
on 14.2.2021. A reminder for survey completion was sent to participants two weeks
after study initiation.
Participants
Purposeful sampling was used to identify participants. Inclusion criteria were consultant
plastic and reconstructive surgeons, experienced in breast reconstruction and with
knowledge of current national trends. Suitable participants were identified via the
ESPRAS Executive committee (ExCo) and national delegates. Members of the European
Leadership Forum (ELF) including delegates to ESPRAS and members of the board (presidents,
vice presidents, secretary generals) of each plastic surgery national society throughout
Europe were included. At least one completed questionnaire for each national society
was included and up to two different participants from each European country were
included.
Ethics
This study was conducted in accordance with the Declaration of Helsinki. Personal
data were treated in accordance with European General Data Protection Regulation.
Participants provided written informed consent to participate in the study, prior
to study initiation.
Results
The survey was completed by 33 participants from 29 European countries ([
Table 1
], [
Fig. 1
]).
Table 1 Overview of participating national societies (number of participants).
European national society (No.)
Participants from ESPRAS mandated societies
Guest participants
1
Austria
Belgium
2
Azerbaijan
France (2)
3
Bosnia and Hercegovina
4
Croatia
5
Cyprus
6
Denmark
7
Estonia
8
Finland
9
Germany
10
Greece
11
Ireland
12
Italy (2)
13
Montenegro
14
Netherlands (2)
15
North Macedonia
16
Norway
17
Poland
18
Portugal
19
Romania
20
Serbia
21
Slovakia
22
Slovenia
23
Spain
24
Sweden
25
Switzerland
26
Turkey (2)
27
U. K.
Fig. 1 Countries all over Europe participating in the questionnaire including: Austria,
Azerbaijan, Belgium, Bosnia and Herzegovina, Croatia, Cyprus, Denmark, Estonia, Finland,
France, Germany, Greece, Ireland, Italy, Montenegro, Netherlands, Norway, North Macedonia,
Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey, UK.
Structure of care, equity and access to breast reconstruction across European countries
([
Fig. 2
])
Breast reconstruction is covered by public health insurance across Europe, as reported
by 91 % of respondents. A majority of respondents (72 %) reported that plastic surgeons
belong to a multidisciplinary team treating breast cancer in their respective countries.
Plastic surgeons are involved early on in the mastectomy process (partially or complete)
only in a minority of countries (Are plastic surgeons involved in the mastectomy (partial or complete)? Yes: 32 %, No: 36 %, Other: 32 %). 84 % of participants stated that geographic location
is not a limiting factor for access to breast reconstruction. However, over 25 % of
respondents found that geographic location has an impact on the type of reconstruction
offered to women.
Fig. 2 Pie charts depicting participants response to relevant items addressing structure
of care, equity and access to breast reconstruction across European countries.
Immediate and Delayed Breast Reconstruction ([
Fig. 3
])
Fig. 3 Pie charts depicting participants response to relevant items addressing immediate-
and delayed breast reconstruction across European countries.
Breast reconstruction, both immediate and delayed, is not exclusively performed by
plastic surgeons, but also by general/breast cancer surgeons as well as gynecologists
(Who performs immediate/delayed breast reconstruction in your country? Mark all boxes
which apply. Plastic Surgeons (IBR/DBR): 100/100 %; general, breast cancer surgeons: 31/13 %;
gynecologists: 16/13 %). Incidence of breast reconstruction after mastectomy is low
across Europe. EUSOMA guidelines recommending a rate of 40 % of immediate breast reconstruction
(IBR) are applied in only 19 % of respondents’ countries. Over a third of respondents
in this study noted that IBR was conducted only in 1–20 % of cases on a national level,
while another 18.8 % reported IBR to be performed in 21–40 % of all cases. The responses
for the rate of delayed breast reconstruction (DBR) were similar, with approximately
twice as many respondents claiming 41–60 % reconstruction rates (DBR: 16 % vs. IBR:
9 %).
Risk reduction, symmetrizing procedures,
Fig. 4
])
Fig. 4 Pie charts depicting participants response to relevant items addressing symmetrizing
procedures, and corrections after breast cancer surgery across European countries.
In most countries, prophylactic, risk-reducing mastectomy is offered to patients with
mutations, or patients with high life-time risk of breast cancer (Which patients are offered prophylactic risk-reducing mastectomies? Mark all boxes
which apply. Patients with mutations: 94 %; patients with high life-time risk of breast cancer
(no mutation): 69 %; Patients who have had breast cancer and want contralateral risk-reducing
mastectomy: 50 %; All patients that want one: 13 %; It is not offered: 0 %). Overall,
rates of symmetrizing procedures are high across Europe. In over 81 % of cases, all
women are offered symmetrization, including breast reduction, mastopexy, implant-based
augmentation, augmentation mastopexy, and lipofilling provided by the public health
care system. The number of secondary corrective operations is not limited in most
countries (78 %). Lipofilling is an option for reconstruction after breast conserving
therapy in most European countries, at least in a selected patient population.
Radiation Therapy ([
Fig. 5
])
Fig. 5 Pie charts depicting participants response to relevant items addressing radiotherapy
and breast reconstruction across European countries.
Responses varied greatly with regard to the optimal timing for breast reconstruction
in irradiated patients (When is delayed breast reconstruction performed after adjuvant radiotherapy? 6 months: 22 %; 12 months: 41 %; 24 months: 3 %; Other: 34 %) The overwhelming majority
of respondents (> 90 %) encountered failed implant-based reconstruction after radiation
therapy, often or occasionally. Immediate implant-based breast reconstruction in patients
who are expected to receive radiotherapy was generally rejected as an option by 44 %
of respondents. Delayed implant-based reconstruction was performed in over 50 % of
respondents in irradiated patients. Over 78 % of participants responded that autologous
IBR is performed in patients receiving radiotherapy in their respective countries.
Demand for European guidelines on breast reconstruction ([
Fig. 6
])
Fig. 6 Pie charts depicting participants response to relevant items addressing the demand
for European guidelines on breast reconstruction.
Only 45 % of respondents reported the existence of national guidelines for breast
reconstruction. National guidelines providing information regarding the choice of
reconstructive technique were available in only 32 %. 88 % of respondents would value
European guidelines, recommendations, and requirements for best practice in breast
reconstruction. There was great interest in international European multi-center studies
and the majority (> 90 %) of participants would like to be included along with their
respective countries. Almost 100 % of respondents wished to participate in a plastic
surgical task force to strengthen plastic surgical breast reconstruction in Europe.
Discussion
Joint European efforts moderated by the ExCo of ESPRAS have recently identified common
challenges for the respective plastic surgery national societies under the umbrella
of ESPRAS and shared solutions on a European level in different survey-based studies
[10 ], [11 ], [12 ]. The aim of this study was to follow up one of the major challenges facing Plastic
Surgery in Europe identified at the ELF in 2020 [10 ], namely the structure of care of breast reconstruction in European countries.
Structure of care, equity and access to breast reconstruction across European countries
Although the life-expectancy is generally high in Europe, there remain considerable
differences in health between different countries and within countries [13 ]. WHO Europe state that among the most important drivers in creating health equity
are policy coherence and accountability [14 ]. In terms of breast reconstruction, the European Society of Breast Cancer Specialists
(EUSOMA) guidelines stipulate that plastic surgeons with expertise in breast reconstruction
should be available for consultation in all cases [15 ], [16 ]. In addition, the European Parliament Resolution on breast cancer aims to protect
the psychological well-being and physical integrity of women by ensuring that ‘breast-conserving surgery is available to every woman in every instance where it
is medically justified and that, wherever possible, breast reconstruction operations
are performed using the patient’s own tissue and within the shortest possible time’ (§ 7c) [17 ]. It is possible to identify several factors contributing to inequity in breast reconstruction,
including insurance cover, geographic location and access to care. For the majority
of the European population, breast reconstruction is covered by public health insurance
(reported by > 90 % of respondents). While a large majority of participants in
this study also stated that geographic location is not a limiting factor for patients
to access breast reconstruction in general, regional differences with regard to the
type of reconstruction offered were acknowledged in European countries.
It could be speculated that regional inequity of the type of reconstruction offered
could indicate any of the three following points:
No plastic surgical expertise available in certain regions,
Institutional reluctance to transfer patients to units with access to plastic surgical
expertise [18 ], [19 ],
Lack of patient awareness and information regarding the different reconstructive options
available [20 ].
Controversy exists regarding the most appropriate reconstructive techniques following
tumor resection. Autologous breast reconstruction has been associated with long-term
patient satisfaction and higher quality of life by yielding superior aesthetic, more
natural and long-lasting results, as compared to implant reconstruction [21 ], [22 ], [23 ], [24 ], [25 ], [26 ] but further high-quality data is required to verify this finding. Autologous reconstruction
is not feasible for all women, and implant-based reconstruction should not be disregarded.
It is therefore an imperative that breast cancer surgeons discuss selected cases with
plastic surgeons prior to tumor resection and reconstruction in order to identify
the most appropriate reconstructive technique for the individual patient. European
clarification is required regarding the timing of plastic surgery involvement as part
of multidisciplinary teams (MDT) treating breast cancer. Currently, 70 % of respondents
reported participation in an MDT but disappointingly only 30 % stated that plastic
surgeons are involved (partially or completely) in the mastectomy/primary resection,
highlighting considerable potential for improvement on a European level. This is not
to suggest that plastic surgeons be involved in all breast cancer cases, as skilled
microsurgeons are scarce and resources can be limited. To summarize, all European
patients should have equal access to healthcare and surgical teams competent to perform
all types of breast reconstructions thus ensuring that breast cancer patients are
afforded the most appropriate breast reconstruction. Strengthening the role of the
plastic and reconstructive surgeon in breast reconstruction and policy development
has potential to achieve more equitable distribution of limited resources.
Immediate and Delayed Breast Reconstruction
The number of women opting for breast reconstruction has increased over recent years
[27 ]. According to data published by the Agency for Healthcare Research and Quality,
breast reconstruction after mastectomy rose by 62 % from 2009 to 2014 in the U. S.
[28 ] but still remains underperformed overall, with a total rate of ~ 40 % [27 ], [29 ].
The data presented here also demonstrates a relatively low number of immediate and
delayed breast reconstructions in Europe in comparison to the total number of mastectomies.
Given the benefits of breast reconstruction, there is considerable room for improvement.
Importantly, almost 30 % of respondents reported that data was not available to provide
a clear answer to the rate of IBR and DBR performed in their countries. This further
emphasizes the need for collaboration to increase transparency and visibility regarding
breast reconstruction in Europe. EUSOMA guidelines recommending a rate of 40 % of
IBR are applied in merely 19 % of respondents’ countries. These guidelines, however,
are not evidence-based and are subject of much debate. Whether these guidelines are
appropriate is also a source of concern, especially in those cases where post-mastectomy
radiation therapy is required [30 ].
Symmetrizing procedures, and corrections
Symmetrization procedures to create symmetrical breast mounds are common and are offered
to a majority of women after breast cancer surgery in Europe. These include breast
reduction, mastopexy or augmentation. Yet, results showed that one in five women is
not offered symmetrization, further emphasizing need for European harmonization. Future
studies will need to focus on the timing of symmetrization, as this may be performed
either at the time of reconstruction or be delayed [31 ]. Overall, a majority of respondents claimed to consider lipofilling in selected
patients after breast conserving therapy for volumization. While concerns have been
raised as to whether lipofilling may cause dormant breast cancer cell growth, to date,
most studies suggest the oncologic safety of lipofilling in breast reconstruction
[32 ], [33 ].
Radiation Therapy
The ideal timing of breast reconstruction in irradiated patients remains a cause of
controversy and much debate in literature [34 ], [35 ], [36 ]. Unfortunately, to date no clear recommendations have been defined regarding the
timing of any reconstruction. Nava et al. conducted an extensive literature review
on radiotherapy and breast reconstruction and published an international multidisciplinary
expert panel consensus concluding that there is a lack of evidence-based guidelines,
with a clear need for high-quality data from randomized clinical trials or large registries
to deduce the optimal type and timing of breast reconstruction in the irradiated patient
[37 ]. This is also reflected in the respondents’ answer to this question in the presented
study, varying greatly with delayed reconstruction being performed from 3 to 12 months
post-radiation. Over 75 % of participants responded that autologous IBR is performed
in patients receiving radiotherapy in their respective countries, corresponding to
recent literature showing that neoadjuvant radiotherapy can facilitate IBR post-mastectomy
[38 ]. A majority of respondents reported encountering failed implant-based reconstruction
after radiation therapy. Concurrently, ethical reasons have been advanced to decline
implant-based IBR when post-mastectomy radiation therapy is anticipated [30 ]. Several studies implicate impaired outcome of implant-based reconstruction and
radiation therapy with frequent complications and decreased aesthetic results, whereas
autologous reconstruction can yield superior patient-reported outcomes with lower
complication rates in irradiated patients [22 ], [39 ], [40 ], [41 ], [42 ], [43 ]. A further source of controversy is that only ~40 % of respondents generally rejected
immediate implant-based breast reconstruction in patients who are expected to receive
radiotherapy, and approximately 50 % of respondents provide delayed implant-based
reconstruction in irradiated patients. This study clearly identifies the need for
evidence-based guidelines and the development of a European strategy to approach these
cases. There is a clear lack of evidence regarding this topic and future research
should prioritize the field of breast reconstruction in irradiated patients, both
in regard to technique and timing of any reconstruction.
Demand for European guidelines on breast reconstruction
40 % of respondents reported that while national guidelines for breast reconstruction
exist, only a minority of these stipulate which patients should be offered what type
of breast reconstruction. Thus, there is great potential for a streamlined European
consensus. The desire for European guidelines is reflected by over 85 % of respondents
who would value recommendations and requirements to achieve best practice. An equal
number of respondents would participate in international European multi-center studies
and ~ 100 % of respondents would participate in a plastic surgical task force to strengthen
plastic surgical breast reconstruction in Europe. European harmonization and perspectives
can also support smaller European societies, with less manpower and organizational
resources.
Limitations
This study is not without limitation, and the results presented must be considered
and interpreted with caution. First, the design of the study, being an electronically
disseminated survey, merely provides descriptive data of limited quality. Responses
were obtained from a very selected study population, which can be considered both
a strength and a limitation of the study. Participants were exclusively selected by
the ExCo and national delegates of ESPRAS. All were consultant plastic and reconstructive
surgeons, experienced experts in the field of breast reconstruction and with knowledge
of the national situation in their country. Thus, although sample size was limited,
the data obtained can be regarded as reliable. While the data give a broad overview
of breast reconstruction in Europe, the production of clear recommendations or guidelines
is not possible. On the contrary, the authors highlight that the aim of this study
was to outline the current status of care, initiate further European collaboration,
and to identify areas for further research. As a next step, and utilizing the relationship
built between the ExCo and delegates from national societies under the umbrella of
ESPRAS, the proposed survey will be modified and distributed to members of the respective
national societies to reach a larger group of respondents. In addition, large-scale
and multi-center European clinical trials must be conducted to further elucidate the
presented areas of interest. The implementation of European registries for breast
reconstruction, as has been successfully executed on a national level yielding high-quality
data in regard to several outcome parameters [18 ], [44 ], [45 ], [46 ], [47 ], [48 ], [49 ], [50 ], could provide the basis for further data acquisition. Finally, using evidence-based
data acquired through European collaboration and efforts will fuel the establishment
of European guidelines on breast reconstruction and enable uniform best practice.
Conclusions
Health care in Europe differs within countries based on the individual historical,
cultural and health-economic backgrounds. Similarly, national societies of plastic
surgery differ with regard to size, structure and organization. The umbrella of ESPRAS,
with its 7000 members and 40 European member countries, provides large potential to
establish coherence and equity in breast reconstruction in Europe in a united approach.
This study has identified a distinct lack of coherence in international practice patterns
across European countries plus a strong demand for coherent European guidance. Large-scale
and multi-center European clinical trials must follow to further elucidate the presented
areas of interest and to define European standard operating procedures. ESPRAS is
appropriately positioned to facilitate this process through its contact with national
societies.
