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BARIATRIC SURGERY REGISTRY2018/19 REPORT

CONTENTS

FUNDING PARTNERS 2

ACKNOWLEDGEMENT OF COUNTRY 2

LIST OF FIGURES 3

LIST OF TABLES 4

FOREWORD FROM CHAIR OF STEERING COMMITTEE 5

LIST OF ABBREVIATIONS 6

DATA PERIOD 6

COMMON TERMS AND DEFINITIONS 7

EXECUTIVE SUMMARY 8

SNAPSHOT OF THE BARIATRIC SURGERY REGISTRY 9

BACKGROUND 10

Rationale for a Registry and Collaborators 10Governance 11

REGISTRY METHODOLOGY 12

Eligibility of Participants 12Ethical Review 12Data Capture 12Missing Data 13Data Reporting 13Site and Surgeon Accrual 14

RESULTS FOR THE REGISTRY AS AT 30 JUNE 2019 17

Enrolment in the Registry 17Demographics 18Procedures Captured by the Registry 21Safety Reporting 30Peri-Operative Defined Adverse Events and Complications 31Weight Outcomes 34Diabetes Outcomes 38Follow Up 40

PATIENT REPORTED OUTCOME MEASURES (PROMs) 41

CONCLUSION 41

ACKNOWLEDGEMENTS 42

COMMITTEES AND STAFF 43

APPENDIX 1: DATA ELEMENTS CAPTURED 45

APPENDIX 2: LIST OF SITES CONTRIBUTING DATA TO THIS REPORT 46

Australia 46New Zealand 46

APPENDIX 3: LIST OF SITES WITH ETHICS APPROVAL 47

Australia 47New Zealand 47

REFERENCES 48

Bariatric Surgery Registry Seventh Annual Report: 2018/19 1

LIST OF FIGURES

Figure 1 Surgeons and Hospital Sites Actively Contributing to the Registry per Financial Year 14

Figure 2 Number of Hospital Sites and Number of Surgeons per State Contributing to the Registry for FY 18/19 15

Figure 3 Accumulation Rate of Participants in the Registry by Patient Type from February 2012 to 30 June 2019 17

Figure 4 Participants’ Age Distribution at Time of Primary Procedure (FY 18/19) 19

Figure 5 Participants’ Age Distribution at Time of Revision Procedure (FY 18/19) 19

Figure 6 Participants’ Weight at Time of Primary Procedure (FY 18/19) 20

Figure 7 Change in Procedure Type Captured by Registry 22

Figure 8 Procedures Captured by the Registry by State and Procedure Type (FY 18/19) 22

Figure 9 Primary Procedures Captured by the Registry by State and Public/Private (FY 18/19) 23

Figure 10 Revision Procedures Captured by the Registry by State and Public/Private (FY 18/19) 23

Figure 11 MBS Capture Rates from FY 13/14 to FY 18/19* 24

Figure 12 Primary and Revision Procedures Captured by the Registry in Private vs Public Hospitals in Australia (FY 18/19) 25

Figure 13 Revision Incidence Rates for Primary Bariatric Procedures as at 30 June 2019 27

Figure 14 Reasons Attributed for Defined Adverse Events in all Participants (FY 18/19) 33

Figure 15 Reasons Attributed for Reoperation on Primary Participants (FY 18/19) 33

Figure 16 Initial BMI Classification for Primary Participants from February 2012 to 30 June 2019 (n=56,212) 34

Figure 17 Excess Weight Loss and Total Weight Loss for Primary Participants who have reached 3 Year Annual Follow Up (n=3,330) 36

Figure 18 Excess Weight Loss and Total Weight Loss for Primary Participants who have reached 4 Year Annual Follow Up (n=1,293) 36

Figure 19 Excess Weight Loss and Total Weight Loss for Primary Participants who have reached 5 Year Annual Follow Up (n=515) 37

Figure 20 Primary Participants Identifying as having Diabetes and Treatment at Primary Procedure from February 2012 to 30 June 2019 (n=57,659 primary participants) 39

FUNDING PARTNERS

The Bariatric Surgery Registry received funding in the last 12 months from the Commonwealth Government of Australia and the following supporters:

The Registry would like to acknowledge and thank Medtronic for providing the start-up funding required for the New Zealand arm of the Registry.

The Registry also looks forward to welcoming Johnson&Johnson in the 2019/2020 financial year as Platinum Sponsors.

ACKNOWLEDGEMENT OF COUNTRY

The Bariatric Surgery Registry acknowledges the Traditional Land Custodians of Australia and we pay our respects to ancestors and Elders, past, present and future for the Aboriginal and Torres Strait Islander peoples of Australia. We welcome all Aboriginal and Torres Strait Islander peoples to our Registry.

In recognition that we are a bi-national registry, the Bariatric Surgery Registry acknowledges Māori as Tangata Whenua of Aotearoa New Zealand and as Treaty partners with the Crown.

The Registry collects, stores and uses health data of Indigenous participants with the upmost respect and integrity.

2 Bariatric Surgery Registry Seventh Annual Report: 2018/19 Bariatric Surgery Registry Seventh Annual Report: 2018/19 3

LIST OF TABLES

Table 1 Patient Participation in the Registry from 1 July 2014 to 30 June 2019 17

Table 2 Demographics of Participants at the Time of Their Procedure (FY 18/19) 18

Table 3 Procedures Performed by Type 21

Table 4 Procedures Captured by the Registry by State (FY 18/19) 24

Table 5 Procedures Performed in Public Hospitals in Australia 25

Table 6 Concurrent Renal Transplants 26

Table 7 Concurrent Liver Transplants 26

Table 8 Primary Procedures in the Registry by Type 26

Table 9 Number of Procedures Undergone by Participants from February 2012 to 30 June 2019 27

Table 10a Current Status of Sleeve Gastrectomy Primary Participants as at 30 June 2019 28

Table 10b Current Status of Gastric Banding Primary Participants as at 30 June 2019 28

Table 10c Current Status of Roux-en-y Gastric Bypass Primary Participants as at 30 June 2019 28

Table 10d Current Status of One Anastomosis Gastric Bypass Primary Participants as at 30 June 2019 28

Table 11 Number of Procedures Undergone by Legacy Participants from February 2012 to 30 June 2019 29

Table 12 Deaths Reported to the Registry up to 30 June 2019 30

Table 13 Cause of Death when Death was Likely Related to Bariatric Procedure as at 30 June 2019 30

Table 14 Defined Adverse Events in all Participants up to 30 June 2019 31

Table 15 Primary Procedures by Type with a Defined Adverse Event (FY 18/19) 31

Table 16 Revision Procedures by Type with a Defined Adverse Event (FY 18/19) 32

Table 17 Mean BMI for All Primary Participants from February 2012 to 20 June 2019 35

Table 18 Weight Outcomes at 12 Months for All Primary Procedures from February 2012 to 30 June 2019 35

Table 19 Excess Weight Loss and Total Weight Loss for Primary Participants who have Reached 3, 4 and 5 Year Annual Folllow Up 35

Table 20 Primary Participants Identifying as having Diabetes at Baseline from February 2012 to 30 June 2019 38

Table 21 Treatment for Diabetes at Baseline from February 2012 to 30 June 2019 38

Table 22 Treatment of Participants with Diabetes Reported at Baseline Followed Up at 12 Months 39

Table 23 Follow Up Completion by Type^ 40

FOREWORD FROM CHAIR OF STEERING COMMITTEE PROFESSOR IAN CATERSON

This is the seventh report of the Bariatric Surgery Registry (BSR). It continues to grow at a rapid pace and we now have 70,968 participants in the Registry and over the 12 months have added 20,487 participants. We have had 206 surgeons and 116 hospitals contribute to the Registry over the past financial year, a significant increase from the last reported period.

We have had a successful 12 months of data collection from New Zealand, including the inclusion of 306 participants. Over the next 12 months, we need to strengthen this activity and ensure the continuing contribution to the Registry.

This has meant a great deal of work to ensure that the data is collected, that there is ethics clearance, all processes are followed according to protocol and that those who have had bariatric surgery are followed up regularly. This work is carried out daily by the staff in the Registry, by surgeons, by the staff in their rooms and in theatres and we are really grateful for their hard work, expertise and continuing interest. The Registry can only be as good as the data it gets.

The difficulty of getting the longer-term follow-up continues. We are committed to getting greater than 95% continuing follow-up! Please, please help us to get this data.

There is interest in our registry, its data and potential from overseas, from governments and because we have made as sure as we can that the data is collected properly, that we do have involved surgeons and staff, we are seen as trustworthy and or data output useful.

Now is the time we can start producing outputs on the effectiveness of bariatric surgery in our countries. We are happy to receive research proposals for use of de-identified data and we have established a process for dealing with these requests.

Once again, we must thank the staff of the BSR – they continue to deal with problem issues calmly and efficiently, they are really involved and so helpful.

Thank you all.

.

Professor Ian D Caterson Director, Boden Institute, Charles Perkins Centre, University of SydneyDirector, Charles Perkins Centre Royal Prince Alfred ClinicPast-President, World Obesity Federation

We have now surpassed 70,000 participants on the Registry.


LIST OF ABBREVIATIONS

ACHI Australian Classification of Health Interventions, 8th Edition

AIHW Australian Institute of Health and Welfare

ANZGOSA Australia and New Zealand Gastro-Oesophageal Surgery Association

ANZMOSS Australian and New Zealand Metabolic and Obesity Surgery Society (formally OSSANZ)

ACSQHC Australian Commission on Safety and Quality in Health Care

AMA Australian Medical Association

BMI Body Mass Index

BPD/DS Bilio-Pancreatic Device with Duodenal Switch

BSR Bariatric Surgery Registry

DOS Day Of Surgery

FY Financial Year

ICD-10-AM Australian Modification of the International Statistical Classification of Diseases and Health Related Problems, 10th Revision

ICU Intensive Care Unit

IT Information Technology

LAGB Laparoscopic Adjustable Gastric Banding

LSG Laparoscopic Sleeve Gastrectomy

LTFU Lost To Follow Up

MBS Medical Benefits Schedule

NSW New South Wales

NZ New Zealand

OAGB One Anastomosis Gastric Bypass (previously called Single Anastomosis Gastric Bypass)

OP Operation

PROMs Patient Reported Outcome Measures

QLD Queensland

RACS Royal Australasian College of Surgeons

RYGB Roux-en-y Gastric Bypass

SA South Australia

SPHPM School of Public Health and Preventive Medicine, Monash University

ST DEV Standard Deviation

TAS Tasmania

VIC Victoria

WA Western Australia

DATA PERIODThe data contained in this document was extracted from the Bariatric Surgery Registry as at 15th July 2019 but pertains to procedures that have occurred up to 30 June 2019. As the Registry does not capture data in real time, there may be a lag period between the occurrence of an event and its capture in the Registry’s database, BSR-i.

COMMON TERMS AND DEFINITIONS

Primary Participant Patient whose first entry into the Registry is with their initial bariatric surgical procedure

Legacy Participant Patient whose first entry into the Registry is with a subsequent (or revision) bariatric surgical procedure

Primary Procedure The initial bariatric procedure performed upon a patient

Revision Procedure A subsequent bariatric procedure performed upon a patient who has had a primary procedure

Opt-Out Patients who have been sent Explanatory Statements and who have elected to not have their data included in the Registry

Partial Opt-Out Patients who have been sent Explanatory Statements and will allow the Registry to keep their information but do not want to be contacted by the Registry

Contributing Site Any hospital site currently contributing health information to the Registry

Contributing Surgeon Any surgeon currently contributing health information to the Registry

Class I Obesity Defined as a body mass index (BMI, kg/m2) of 30 or over

Class II Obesity Defined as having a body mass index (BMI, kg/m2) of 35 or over

Class III Obesity Defined as having a body mass index (BMI, kg/m2) of 40 or over

Initial Weight Taken as the higher of the weight at Intention to Treat or weight at Operation of a Primary Participant

Excess Weight Loss (EWL) Measure of the percentage of excess weight a patient has lost from one time point to another where excess weight is defined as the patient’s initial weight minus their ideal weight at BMI 25

Total Weight Loss % (TWL) Measure of the percentage of weight a patient has lost from one time point to another. In the Registry this is measured from the patient’s initial weight

Peri-operative Follow Up Participant observation from any visit between 20-90 days post-operation

Annual Follow Up Participant observation taken from any visit on an annual basis from the Primary operation

Defined Adverse Event Indicated by the presence of a particular event occurring in the peri-operative phase (up to 90 days) in the healthcare setting, these are described as: 1. Unplanned Return to Theatre 2. Unplanned Admission to ICU 3. Unplanned Re-admission to Hospital

Financial Year Defined as the Australian financial year from 1 July to 30 June the following calendar year

Calendar Year Defined as the 12 month period from 1 January to 31 December in the same year


EXECUTIVE SUMMARY

The Bariatric Surgery Registry (BSR) is proud to present the Seventh Annual Report as at 30 June 2019. The Registry has had a successful year of operations where many milestones were achieved, namely:

• A total of 70,968 participants as at 30 June 2019 including the addition of 20,487 new participants in the past year;

• 33.4% increase in surgeons contributing bringing the total who have contributed in FY 18/19 to 206;

• 18.4% increase in hospitals contributing bringing the total who have contributed in FY 18/19 to 116;

• 78% MBS capture achieved so far for the FY 18/19 period;

• Streamlined a multi-site ethics approval where just over 100 hospitals are under the one application; and

• The continued growth in participation of New Zealand based surgeons.

Similar to trends reported in previous years, the cohort of new participants attained during the FY 18/19 remains predominantly female (78.6%) and the mean age at the time of procedure was 44.0 years. For primary procedures, 93.9% of procedures occurred in private hospitals, The mean BMI on day of surgery is 41.8 with 13.6% of participants identifying as having diabetes at this time.

The dominant procedure with 71.5% of all procedure captured in the FY18/19 remains the Sleeve Gastrectomy. Sleeve Gastrectomies account for 83.9% of the total primary procedures captured in the FY 18/19 period.

The Registry has reported 75 deaths within the current participant cohort of which 6 cases are likely to be related to the procedure and another 33 awaiting determination of cause. The remaining 36 deaths have been attributed to something other than the procedure. During the FY18/19 2.1% of primary procedures and 7.6% of revision procedures had a Defined Adverse Event (unplanned return to theatre, admission to ICU or re-admission to hospital) in the peri-operative period. In the primary participant cohort who have been tracked for up to seven years, there were 1,179 participants who have required one or more revisions, which represents 2.0% of the cohort.

A significant shift in diabetes status from baseline to 1-year post-operative was observed with 41.8% no longer identifying as having diabetes. There was also a large reduction in treatment rates at 12 months after surgery to that recorded at baseline.

One key strength of the Registry is the follow up data acquisition. This includes perioperative follow up on all procedures and 10-years of annual follow up for primary participants. The overall collection rate across all follow up time points is 77.4%. Weight, diabetes status and treatment as well as reoperation information is gathered at annual intervals to help strengthen the longitudinal data housed within the Registry. At 30 June 2019, there were 29,693 participants that have had a successful capture of year 1 annual follow up and 57 participants that have now reached the year 7 annual follow up mark.

With funding support from the Commonwealth Government, AVANT and Johnson&Johnson, the Registry commenced a project specific initiative to help introduce Patient Reported Outcome Measures (PROMs) into the Registry, with the pilot phase focusing on quality of life currently being conducting in conjunction with the Cairnmillar Institute in Melbourne. Over the next 12 months, it is anticipated that a standard set of PROMs questions will be developed, implemented and regularly captured by mid-2021.

Looking into the next 12 months, the Registry will be further streamlining the data capture systems and introducing a new website that will be a hub of information for surgeons, stakeholders and bariatric patients. There will also be the implementation of the use of QualitricXM to help improve the annual follow up capture, exploring options of data linkages with State Governments to improve perioperative data quality and strengthening partnerships with surgeon’s electronic medical records to help minimise duplication of data entry. The Registry will also be aiming to have all locality approvals completed for the New Zealand hospital sites and commence capturing valuable surgical outcome data to strengthen the bi-national cohort capture.

Improvements in the next 12 months will help drive efficient and reliable follow up data capture for the Registry.

SNAPSHOT OF THE BARIATRIC SURGERY REGISTRY

39.3%Increase in patient participation in the past 12 months to a total of 70,968 participants.

From 1 July 2018 to 30 June 2019, 20,487 participants joined the Registry.

39.5%Increase in operations captured in the past 12 months to a total of 76,511 primary and revision procedures.

From 1 July 2018 to 30 June 2019, 21,043 operations were added to the Registry.

33.4%Increase in surgeons contributing in the past 12 months to 206 surgeons contributing across Australia and New Zealand.

From 1 July 2018 to 30 June 2019, 59 new surgeons commenced contributing to the Registry.

18.4%Increase in hospitals contributing in the past 12 months to 116 hospitals contributing across Australia and New Zealand.

From 1 July 2018 to 30 June 2019, 18 new hospital sites commenced contributing to the Registry.

78% Of MBS procedure numbers captured across Australia for LAGB, RYGB and LSG in the 2018/2019 period.


BACKGROUND

Rationale for a Registry and Collaborators

Obesity is one of the major challenges facing the Australian and New Zealand population. In 2009, the Australian Federal Parliament published the Georganas Report – Weighing it Up1 which detailed that the increasing obese and overweight population is a “pressing health concern for Australia”. In 2009, it was estimated that 24.6% of the adult population of Australia were obese.

In 2016, the AMA released a Position Statement on Obesity in 20162 which estimated that the obesity rate in the adult population in Australia has increased to 27.9% or approximately 5 million adults. This escalation in obesity was referred to as “at a crisis level” and the call was made for the disease to be recognised as a priority where “a whole of society response to obesity should be strategic and coordinated”.

According to AIHW, for the period of 2017/2018, 1 in 3 (or 31%) of Australian adults are obese3.

In New Zealand, the Ministry of Health’s Annual Update4 from the 2017/2018 Health Survey presented an increase in obesity in adults (aged 15 years and over) from 29% in 2011/2012 to 32% in 2017/2018 or approximately 1.26 million adults. Furthermore, 34% of adults were classified as overweight but not obese.

Research has shown that obesity is a difficult disease to prevent and treat. Lifestyle interventions can be effective in the short term but maintenance of weight loss can be difficult to maintain over a longer period. Effective treatment options appear to be limited but for those that identify as being Class III obese (BMI >35) then bariatric surgery may be beneficial. Both Australia and New Zealand have observed a significant increase in the rate of bariatric surgery performed over the past decade and it was from this context that the Obesity Surgery Society of Australia and New Zealand (now ANZMOSS) supported the commencement of the Registry in 2012.

With the recommendation featured in the Georganas Report that a registry was required, the Registry was piloted in Victoria in 2012. The Commonwealth Government helped fund the Registry into the rollout phase with funding from May 2014 to July 2017 to ensure that the Registry grew to nation-wide. The Commonwealth Government has continued their funding support of the Registry for the period of May 2018 to September 2022. Industry funding from Gore, Medtronic and Applied Medical has greatly helped the Registry commence operations in New Zealand as well as AVANT and Johnson&Johnson providing funding for Registry based research.

Following the promotion of driving change and improvements in patient care and outcomes heavily featured in the Australian Commission on Safety and Quality in Health Care (ACSQHC), The Registry seeks to answer the following:

a. Is this treatment safe? and

b. Is this treatment effective?

To ensure that these questions can be addressed, the Registry has been designed with the underlying principle to provide data that is accurate, complete and valuable. Accuracy and completeness is controlled by the definition, collection, verification, storage, and analysis and reporting as outlined in the Registry’s Data Governance Framework.

The Registry continues to encourage high-level stakeholder engagement and facilitates collaborations with governments, surgeons, private health groups, individual hospitals, medical technology and device industries, private health insurers and medical defence organisations to ensure that the data remains valuable. Most importantly, the Registry engages with participants to address how the Registry can aid in decision-making, assessment of risk and on-going journey of treatment. The involvement of the participants is paramount especially in regard to the data collection that Registry strives to achieve, especially the annual follow up data.

The Registry has largely focused on streamlining ethical oversight over the past 12 months and is now under the National Mutual Acceptance (NMA) Scheme for Australia.

Governance

The Registry aligns with the fundamentals detailed in the ‘Operating Principles and Technical Standards for Australian Clinical Quality Registries 2008’ and the ‘Framework for Australian Clinical Registries 2014’ as published by ACSQHC. This is to ensure that, as a Registry, it aligns and complies with the national standard and provides assurance to all stakeholders.

The Registry is governed by the Steering Committee and this has convened since 2012, chaired by an independent, non-surgical obesity expert, Professor Ian Caterson. The Committee meets on a quarterly basis to advise the Registry on matters such as strategic direction, financial budget, data access, clinical quality and safety, quality development and operations. The BSR Programme Manager, in consultation with the Clinical Director for Australia, Professor Wendy Brown and the Clinical Lead for New Zealand, Associate Professor Andrew MacCormick, oversee the day-to-day operations of the Registry.

Current membership includes representatives from the following organisations and/or societies:

• Monash University

• University of Auckland and UniServices

• Australian and New Zealand Metabolic and Obesity Surgery Society (ANZMOSS)

• Royal Australasian College of Surgeons (RACS)

• Australia and NZ Gastro-Oesophageal Surgical Association (ANZGOSA)

• Medical Technology Association of Australia (MTAA)

• Australian Commonwealth Department of Health

• Community Representation

One of the key achievements of the Steering Committee has been the establishment of the Data Governance Framework and the associated policies and processes that underpin the Registry including:

Study Protocol Data Dictionary

Outlier Policy (currently under development) BSR-i Business Rules

Privacy Policy Data Element Variation Processes

Grievance & Complaint Policy Data Capture Variation Processes

Call Centre Protocol & Scripts BSR-i System Change Request Processes

Data Access & Reporting Policy Reporting Templates

The Registry’s Data Custodian is the School of Public Health and Preventive Medicine (SPHPM) within the Faculty of Medicine, Nursing and Health Sciences at Monash University.

MONASH PUBLIC HEALTH AND PREVENTIVE MEDICINE


REGISTRY METHODOLOGY

Eligibility of Participants

Anyone who undergoes bariatric surgery for the treatment for obesity in Australia or New Zealand is eligible for inclusion in the Bariatric Surgery Registry.

Ethical Review

The Bariatric Surgery Registry was established for the purposes of health research and is considered to be in the public’s interest.

To function as a clinical quality registry, the Bariatric Surgery Registry collects, stores, and uses identifiable, personal and sensitive health information about bariatric patients for research into the quality, safety and effectiveness of bariatric surgery as treatment for obesity.

To date, 40 Australian human research ethics committees (HRECs) have approved the study and certified that it meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). New Zealand’s Southern Health and Disability Ethics Committee approved the study in accordance with the requirements of the Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012). Amongst the 145 hospital sites across Australia and New Zealand which had been approved as at 30 June 2019 to participate in the Registry, 128 have contributed to this report.

Over the past year, an application was made to the Registry’s lead ethics committee, The Alfred Hospital Human Research Ethics Committee, to consider the study under the National Mutual Acceptance (NMA) scheme. The Alfred HREC’s approval under the scheme, which was granted in March 2019, allows for the streamlining of the ongoing ethical oversight of the study, reducing the number of Australian ethics committees requiring full review from the previous 40 to only 12 HRECs.

In accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research, all paper and electronic data are securely stored at Monash University, Melbourne, with restricted access to authorised Bariatric Surgery Registry staff only. The Bariatric Surgery Registry has been granted an Acceptance Status from the New Zealand Ministry of Health for personal health information to be stored at Monash University.

In addition, the Registry complies with the Commonwealth Privacy Act 1988 (2014) and for New Zealand the Privacy Act 1993 and Health Information Privacy Code 1994.

Data Capture

Surgeons or hospital data collectors provide data about the patients and their procedures using one of the following options:

• Web browser with secure authorised entry using the Registry Interface (BSR-i); or

• Paper based data forms (secure fax or posted, Australia only)

Upon receipt of this information, the Registry sends a Participant Fact Sheet that details the Registry and what participation entails. The patient has a two-week period to opt-out of the Registry by calling a Free-call 1800- number for Australia or 0800- number for New Zealand. Patients have the option to completely opt-out, meaning that no data is held in the Registry other than that needed to identify them in the future should they have another procedure, or partial opt-out, meaning that they will allow their data to be held in the Registry but they do not wish to be called or contacted by the Registry. Participants have the right to opt-out at any stage during the follow-up period.

To ensure that all bariatric procedures are capture, the Registry engages with the Hospital Information Services (HIS) at each hospital site provide regular ICD-10 coding (ACHI codes) reports for bariatric procedures performed by surgeons who participate in the Registry. The coding reports include patient demographic and procedure information and data is sent to the Registry using Monash University’s secure file transfer platform (SFTP) on a scheduled basis. ICD-10 coding reports provided by HIS are used to verify data submitted by surgeons/ hospital data collectors. If the surgeon and/or hospital has not previously provided information of a bariatric patient, the reports are used as the primary source of data. When ICD-10 coding is the primary source, surgeons are asked to complete the missing data elements not made available from the hospitals (e.g. device/stapling information, whether it is a primary or revision operation, height/ weight information and diabetes treatment).

Surgeons or public hospital clinics provide follow-up data, either by return of a paper form or through submission on the BSR-i. If surgeons and/or public data collectors indicate they have not seen the participant, the Registry’s Call Centre staff will contact the participant for a brief 5-minute phone call to collect the follow-up information related to the peri-operative period and/or 12-month intervals after surgery. Five attempts are made to contact the participant and if those attempts are not successful, the participant categorised as “Lost to Follow-Up” (LTFU).

Missing Data

The need for near complete data capture is required to ensure the reliability of the Registry. The collected data provides information on the participant (to allow tracking and to identify risk factors), the participant’s weight and BMI, the participant’s health (diabetes status and treatment), the type of surgery undertaken, whether a concurrent liver or renal transplant took place, the device utilised, the need for revision or repeat surgery, unplanned admissions to ICU or readmissions to hospital as well as mortality.

Missing data for most of the data elements collected is kept to a minimum. The Registry periodically validates and cleans the information submitted to ensure that data verification is complete and the data collated is accurate in nature.

The minimum data set can be reviewed in Appendix 1.

Data Reporting

The Registry follows a reporting cycle throughout the year to provide valuable data back to the key stakeholders. These reports include:

Released to: Report Type Reporting

Public Annual Report As at 30 June each year

Public Semi-Annual Update As at 31 December each year

Surgeon Individual Surgeon Reports As at 30 September each year

Device Manufacturer (Funder) Individual Industry Reports As at 31 March each year

Hospital Group (Participant) Hospital Group Reports As at 31 March each year

The Registry also publishes a quarterly newsletter that is distributed to all internal and external stakeholders, hospitals and surgeons as well as potential new hospitals and surgeons that the Registry will seek to recruit. This newsletter is also published on the Registry’s website for participants to access.


FIGURE 2 – NUMBER OF HOSPITAL SITES AND NUMBER OF SURGEONS PER STATE CONTRIBUTING TO THE REGISTRY FOR FY 18/19

* Please note there are surgeons in Australia that contribute to the Registry in multiple states

Site and Surgeon Accrual

In 2013, members of the Australian and New Zealand Metabolic and Obesity Surgery Society (ANZMOSS) were encouraged to contribute to the pilot and initial phase of the BSR and from this, in June 2014, 185 surgeons across Australia and 15 surgeons in New Zealand that registered their interest for contributing to the Registry. This initial registration of interest helped created annual targets in which the Registry can strive to achieve.

Prior to commencing data collection at any given hospital site, the Registry requires approval from the relevant ethics committee. After this approval, a Memorandum of Understanding (MoU) where a Local Principal Investigator is nominated, is signed between the Registry and the hospital site. Locality approvals and governance approvals are also obtained, if required, at each hospital site.

Figure 1 illustrates this exponential growth across Australia and New Zealand since the commencement of the Registry. Over the past 12 months, there has been a 18.4% increase in hospital site participation and a 33.4% increase in surgeon participation across Australia and New Zealand.

FIGURE 1 – SURGEONS AND HOSPITAL SITES ACTIVELY CONTRIBUTING TO THE REGISTRY PER FINANCIAL YEAR

The Registry has observed an exponential increase over the past 12 months and as at 30 June 2019, the Registry had 206 surgeons from 116 hospitals across Australia and New Zealand contributing to the Registry

32

5808

45

22

6169

29

1

114

3

9

2274

228

884

11

34

4735

59

7

306

12

3

197

2

SURGEONS

HOSPITALS

PARTICIPANTS


The Registry’s opt out rate continues to decline and is now 3.16% with only 2,340 bariatric patients having chosen not to participate in the Registry since 2012.

RESULTS FOR THE REGISTRY AS AT 30 JUNE 2019

Enrolment in the Registry

As at 30 June 2019, there have been 74,012 Participant Fact Sheets delivered, inviting bariatric patients to participate in the Registry from both Australia and New Zealand. Recruitment commenced as of February 2012 in Australia and May 2018 for New Zealand. For a patient to receive a Participant Fact Sheet, they must have had their procedure on or before 30 June 2019.

Of the 74,012 patients that have been invited to participate in the Registry, 2,340 (3.16%) have chosen to opt out and from the total number of patients invited, 562 (0.76%) have elected to partially opt out, where their data will be kept but no further contact would be made. At the time of the data extraction, there were a further 704 (0.95%) bariatric patients pending participation status.

As at 30 June 2019, the Registry confirmed the participation of 70,968 bariatric patients and their data and it is from this cohort the report is derived.

Table 1 demonstrates the exponential growth of the Registry from 1 July 2014 to 30 June 2019. In the past financial year, there was a 39.3%% increase in participant enrolment from the previous reported year and the Registry has maintained the opt out rate below 4%.

TABLE 1 – PATIENT PARTICIPATION IN THE REGISTRY FROM 1 JULY 2014 TO 30 JUNE 2018

As at 30 June 2015

As at 30 June 2016

As at 30 June 2017

As at 30 June 2018

As at 30 June 2019^

Participating 5,788 15,643 28,308 47,649* 70,968*

Opt Out 213 554 1,146 1,898 2,340

Opt Out Rate 3.5% 3.4% 3.8% 3.77% 3.16% * includes 95 participants who only had an abandoned procedure ^ includes Australia and New Zealand participants

There have been some notable trends observed since the national roll out in 2014 including exponential uptake of sleeve gastrectomy procedures which continues to increase. Figure 3 illustrates the accumulation rate of participants in the Registry by type during this period.

Bariatric Surgery Registry Seventh Annual Report: 2018/19 17

FIGURE 3 ACCUMULATION RATE OF PARTICIPANTS IN THE REGISTRY BY PATIENT TYPE FROM FEBRUARY 2012 TO 30 JUNE 2019

Demographics As consistently reported by the Registry, bariatric procedures are performed predominately on female participants. As at 30 June 2019, there were 55,709 (78.6%) females, 15,147 (21.4%) males and 17 (0.00%) intersex and/or indeterminate persons enrolled in the Registry who have had a bariatric procedure.

The distribution of sex in primary and revision procedures also shows a similar trend where females account for 77.5% of all primary procedures and 84.4% of revision procedures, males account for 22.8% of primary procedures and 15.6% of revision procedures and intersex and/or indeterminate persons account for 0.03% of primary procedures.

Table 2 demonstrates the key demographic indicators of participants enrolled in the Registry who have had a procedure in the last financial year (2018/2019 year). The contents of this table compares primary and revision procedures as well as private and public hospital procedures.

The mean age for all procedures was 44.0 years old with both female (42.1) and male (45.0) participants with primary procedures having a lower mean age than the female (48.4) and male (51.3) participants with revision procedures. For primary participants in the Registry, males are older age than females (+2.9 years), a slightly higher BMI (+1.0) and have a high incidence of diabetes at the time of operation. For primary participants, the difference in age and BMI is statistically significant.

TABLE 2 – DEMOGRAPHICS OF PARTICIPANTS AT TIME OF THEIR PROCEDURE (FY 18/19)

Primary Procedures Revision Procedures Total Procedures

Public Private All Public Private All Public Private All

Procedure Number 918 15,915 16,833 370 3,840 4,210 1,288 19,755 21,043

Females undergoing procedure714 12,275 12,989 311 3,241 3,552 1,025 15,516 16,541

77.8% 77.1% 77.2% 84.1% 84.4% 84.4% 79.6% 78.5% 78.6%

Males undergoing procedure203 3,630 3,833 59 597 656 262 4,227 4,489

22.1% 22.8% 22.8% 16.0% 15.6% 15.6% 20.3% 21.4% 21.3%

Indeterminate undergoing procedure

1 10 11 0 2 2 1 12 13

Mean Age at Op 43.9 42.7 42.8 47.9 48.9 48.8 45.1 43.9 44.0

Mean Age at Op - Female 43.3 42 42.1 47.4 48.5 48.4 44.5 43.4 43.4*

Mean Age at Op - Male 46.2 45 45 50.4 51.4 51.3 47.2 45.9 46.0*

Min Age at Op 18.9 14.3 14.3 21.9 18.3 18.3 18.9 14.3 14.3

Min Age at Op - Female 18.9 14.3 14.3 21.9 18.3 18.3 18.9 14.3 14.3

Min Age at Op - Male 20.8 15 15 27.1 18.6 18.6 20.8 15 15.0

Max Age at Op 72.1 97.1 97.1 73.8 99.9 99.9 73.8 99.9 99.9

Max Age at Op - Female 71.8 97.1 97.1 73.8 81.5 81.5 73.8 97.1 97.1

Max Age at Op - Male 72.1 79.5 79.5 71.3 99.9 99.9 72.1 99.9 99.9

Mean BMI at Op 45 42.2 42.3 40.5 39.7 39.8 43.8 41.6 41.8

Mean BMI at Op - Female 44.9 41.9 42.1 40.5 39.4 39.5 43.7 41.3 41.5**

Mean BMI at Op - Male 45.4 42.9 43.1 40.7 41.3 41.2 44.4 42.7 42.8**

Max Weight at Op (Kg) 271.5 378 378 193 236.8 236.8 271.5 378 378.0

Max Weight at Op - Female (Kg) 271.5 248 271.5 193 221 221 271.5 248 271.5

Max Weight at Op - Male (Kg) 220 378 378 190 236.8 236.8 220 378 378.0

% Diabetes at baseline 28.8% 12.7% 13.6%

N/A% Diabetes at baseline - Female 25.6% 10.8% 11.6%

% Diabetes at baseline - Male 39.9% 19.0% 20.1%

* p-value < 0.001 (Two-sample t-test) statistically significant difference in mean age at operation between males and females ** p-value < 0.001 (Two-sample t-test) statistically significant difference in mean BMI at operation between males and females

Figure 4 and 5 below illustrate the age range of both primary and revision participants at the time of procedure during the last financial year (2018/2019)

FIGURE 4 – PARTICIPANTS’ AGE DISTRIBUTION AT TIME OF PRIMARY PROCEDURE (FY 18/19)

FIGURE 5 – PARTICIPANTS’ AGE DISTRIBUTION AT TIME OF REVISION PROCEDURE (FY 18/19)


Similarly, with weight at the time of procedure, those participants undergoing a primary procedure typically have a higher weight at operation than those participants undergoing a revision procedure. Figure 6 explores this relationship.

FIGURE 6 – PARTICIPANTS’ WEIGHT AT TIME OF PROCEDURE (FY 18/19)

Procedures Captured by the Registry

Overview

In total, the Registry has captured 76,511 procedures performed on 70,795 participants (this excludes 173 participants who have only had an abandoned procedure). The Registry has captured 173 abandoned procedures since February 2012 with 41 of abandoned procedures occurring in the last FY 18/19.

Table 3 below demonstrates the total capture of procedures by the Registry as at 30 June 2019 and the FY 18/19. The Registry successfully captured 18,899 of the 24,226 procedures recorded for the MBS. This accounts for 78% of MBS procedures captured in the Registry for the FY 18/19.

TABLE 3 – PROCEDURES PERFORMED BY TYPE

Total BSR (Feb 2012 to 30 June 2019)

BSR FY 18/19 (1 July 2018 to 30 June 2019)

MBS Data FY 18/19

(Est of % collected in brackets)Primary Revision Total Primary Revision Total

Sleeve gastrectomy (LSG) 45,499 3,970 49,469 14,125 923 15,048 19,562 (76.9%)

Gastric Banding (LAGB) 5,777 1732 7,509 479 141 620 656 (94.5%)

Roux-en-y Gastric Bypass (RYGB) 3,543 3,623 7,166 1,158 969 2,1274,008 (88.2%)One anastomosis gastric bypass

(OAGB)2,611 1,345 3,956 992 417 1,409

Surgical Reversals of Bands 0 6,191 6,191 0 1,267 1,267 3,631 (34.9%)

Other Procedures 229 1,991 2,220 79 493 572

NATotal Procedures (excl Abandon) 57,659 18,852 76,511 16,833 4,210 21,043

Abandoned Procedures 102 71 173 21 20 41

The types of procedures captured by the Registry have evolved over the years. There has been an increase in LSG procedures from 49.2% in the FY 14/15 to 71.5% in the FY 18/19. One decrease that has been noticeable is that of the LAGB where the Registry had captured 26.4% in FY 14/15 and now has a rate of 2.9% in the FY 18/19. Figure 7 illustrates the changes the Registry has observed over the reporting years and the trends detailed above.


FIGURE 7 – CHANGE IN PROCEDURE TYPE CAPTURED BY REGISTRY

FIGURE 8 – PROCEDURES CAPTURED BY THE REGISTRY BY STATE AND PROCEDURE TYPE (FY 18/19)

Figure 9 below indicates the procedures captured by state for both private and public hospitals during the last financial year. Although there have been improvements in capture rates across all states and territories for Australia, Victoria remains the Registry’s strongest contributor for public hospitals.

FIGURE 9 – PRIMARY PROCEDURES CAPTURED BY THE REGISTRY BY STATE AND PUBLIC/PRIVATE (FY 18/19)

Note: N = number of primary procedures in FY 18/19. Abandoned procedures are excluded.

FIGURE 10 – REVISION PROCEDURES CAPTURED BY THE REGISTRY BY STATE AND PUBLIC/PRIVATE (FY 18/19)

Note: N = number of revision procedures in FY 18/19. Abandoned procedures are excluded.

LSG

LAGB

RYGB

OAGB

BAND REVERSALS

OTHER PROCEDURES


Since 2014, the Registry has successfully measured its procedure capture rates against that of the MBS. For the FY 18/19 period, the Registry has tentatively captured 78% of MBS recorded procedures. Figure 11 illustrates the MBS capture growth for the Registry since 2014 whilst Table 4 below examines the MBS data capture by state for the FY 18/19.

Unlike the MBS capture, the Registry does not capture procedures in real time and therefore there is a lag between MBS and Registry comparison figures. In the previous annual report (sixth edition), it was reported that the Registry successfully captured 64.9% of MBS procedures for the period. However, the Registry can now report that there has been a 17% increase on this rate and the true capture for the FY17/18 period was 82%. It is anticipated that the actual MBS capture rate for the FY 18/19 period will exceed 78% and an update will be provided in the eighth annual report.

FIGURE 11 – MBS CAPTURE RATES FROM FY 13/14 TO FY 18/19*

* MBS data for LSG, LAGB and RYGB/OAGB only. Final figures of MBS data extracted on 24th July 2019

TABLE 4 – PROCEDURES CAPTURED BY THE REGISTRY BY STATE (FY 18/19)*

NSW & ACT VIC QLD SA & NT WA TAS

MBS Data 8,824 4,859 7,849 1,527 4,325 473

MBS Data Captured by Registry 5,627 4,242 5,947 888 2,073 122

% MBS Data Captured by Registry 63.8% 87.3% 75.9% 58.2% 47.9% 25.8%

* MBS data for LSG, LAGB, RYGB/OAGB and reversals only. Final figures of MBS data extracted on 24th July 2019

Over the last 12 months, of procedures captured by the Registry 94.5% of primary procedures and 91.2% of revision procedures occurred at private hospitals across Australia and New Zealand. These statistics remain consistent with past reported trends for private and public procedure mix. Table 5 illustrates the procedures performed in public hospitals in Australia for both the last 12 months and since commencement in February 2012.

TABLE 5 – PROCEDURES PERFORMED IN PUBLIC HOSPITALS IN AUSTRALIA

Total BSR (Feb 2012 to 30 June 2019)

BSR Last 12 months (1 July 2018 to 30 June 2019)

Primary in Public Revision in Public Primary in Public Revision in Public

# % of That Procedure

Type


Type


Type


Type

Sleeve Gastrectomy (LSG) 2,946 6.5% 305 7.7% 673 4.8% 53 5.7%

Gastric Banding (LAGB) 905 15.7% 315 18.2% 75 15.7% 20 14.2%

Roux-en-y Gastric Bypass (RYGB)

332 9.8% 291 8.1% 74 7.3% 54 5.75%

One Anastomosis Gastric Bypass (OAGB)

79 3.1% 46 3.4% 18 1.8% 6 1.4%

Surgical Reversal of Bands NA NA 885 14.3% NA NA 162 12.8%

Other Procedures 18 7.9% 395 19.8% 2 2.5% 70 14.2%

Total Procedures 4,280 7.5% 2,237 11.9% 842 5.1% 365 8.7%

FIGURE 12 – PRIMARY AND REVISION PROCEDURES CAPTURED BY THE REGISTRY IN PRIVATE VS PUBLIC HOSPITALS IN AUSTRALIA (FY 18/19)


Of the 76,968 primary and revision procedures captured, 12 procedures have reported to have had a concurrent renal transplant and one reported liver transplant since February 2012 as demonstrated in Tables 6 and 7 below.

TABLE 6 CONCURRENT RENAL TRANSPLANTS

Concurrent Renal Transplant with: Primary Bariatric Procedure Revision Bariatric Procedure

Financial Year 18/19 5 2

February 2012 to 30 June 2019 7 5

TABLE 7 CONCURRENT LIVER TRANSPLANTS

Concurrent Liver Transplant with: Primary Bariatric Procedure Revision Bariatric Procedure

Financial Year 18/19 1 0

February 2012 to 30 June 2019 1 0

Primary Participants

Participants who undergo a primary procedure have quality and safety measured recorded peri-operatively as well as annual tracking of weight, diabetes status and treatments, and any complications that have arisen including the need for reoperation. As at 30 June 2019, there were 57,659 primary procedures recorded in the Registry.

TABLE 8 – PRIMARY PROCEDURES IN THE REGISTRY BY TYPE

DescriptionFY12/13 FY13/14 FY14/15 FY15/16 FY16/17 FY17/18 FY18/19

# % # % # % # % # % # % # %

Sleeve gastrectomy

18 2.7% 122 14.0% 2232 62.0% 6078 74.7% 8506 81.1% 11816 84.4% 14,125 83.9%

Gastric banding 645 97.3% 732 83.9% 1051 29.2% 1265 15.6% 913 8.7% 591 4.2% 479 2.8%

Roux-en-y gastric bypass

0 0% 17 1.9% 255 7.1% 486 6.0% 635 6.1% 865 6.2% 1,158 6.9%

One anastomosis gastric bypass

0 0% 0 0% 54 1.5% 288 3.5% 405 3.9% 661 4.7% 992 5.9%

Gastric imbrication

0 0% 0 0% 0 0 0 0% 1 0% 2 0% 0 0%

Gastric imbrication, plus gastric band (iBand)

0 0% 0 0% 5 0.1% 4 0% 2 0% 0 0% 0 0%

Gastroplasty 0 0% 0 0% 1 0% 3 0% 0 0% 14 0.1% 19 0.1%

Bilio pancreatic bypass/duodenal switch

0 0% 1 0.1% 1 0% 10 0.1% 23 0.2% 17 0.1% 31 0.2%

Other (specify) 0 0% 0 0% 0 0% 0 0% 5 0% 37 0.3% 28 0.2%

Not stated/inadequately described

0 0% 0 0% 0 0% 0 0% 0 0% 4 0% 1 0.0%

TOTAL 663 100% 872 100% 3599 100% 8134 100% 10490 100% 14007 100% 16,833 100%

Of the 57,659 primary participants in the Registry, 2.6% have gone on to have one or more revision procedures as shown in Table 9 below.

TABLE 9 – NUMBER OF PROCEDURES UNDERGONE BY PARTICIPANTS FROM FEBRUARY 2012 TO 30 JUNE 2019

Primary Participants who have had: Number %

Only an Abandoned Procedure 62 NA

Only a Primary Procedure 56,184 97.4%

A Primary Procedure & 1 Revision 1,179 2.0%

A Primary Procedure & 2 Revisions 231 0.4%

A Primary Procedure & 3 Revisions 45 0.1%

A Primary Procedure & 4 Revisions 9 0%

A Primary Procedure & 5 Revisions 8 0%

A Primary Procedure & more than 5 revisions 3 0%

TOTAL PRIMARY PARTICIPANTS* 57,659 100%

* Excludes those participants with only an abandoned procedure

Revision incidence rates are analysed by calculating the time between the primary bariatric procedure and the first revision procedure demonstrated in Figure 13 below. To analyse this data, survival analysis techniques were used (5). The Nelson-Aalen cumulative probability estimates show a low revision incidence rate of bariatric procedures. At one-year post primary procedure, 1.2% (95% CI 1.1% to 1.3%) of participants are estimated to have had their first revision procedure. At two years post primary procedure, 2.2% (95% CI 2.0% to 2.3%) are estimated to have had their first revision procedure.

FIGURE 13 – REVISION INCIDENCE RATES FOR PRIMARY BARIATRIC PROCEDURES AS AT 30 JUNE 2019


Of the 57,659 primary procedures recorded, 97.4% of participants have had no recorded revisions. Tables 10a, b, c and d explore the four main primary procedure types and revisions that have occurred as at 30 June 2019.

TABLE 10A – CURRENT STATUS OF SLEEVE GASTRECTOMY PRIMARY PARTICIPANTS AS AT 30 JUNE 2019

No. of Sleeve Gastrectomy Primary Participants who currently have:

Only a Primary LSG 45,099

Any Revision of LSG 400

- Re-sleeve 47

- Conversion to RYGB 164

- Conversion to OAGB 33

- Required just Lavage 34

- Required just Dilitation 29

- Required just to Control Bleeding 21

- Other Revision 140

Total 45,499

TABLE 10B – CURRENT STATUS OF GASTRIC BANDING PRIMARY PARTICIPANTS AS AT 30 JUNE 2019

No. of Gastric Band Participants who currently have:

Only a Primary Gastric Band 4,893

Any Revision of Band 884

- Port Revision 253

- Band Revision 174

- Band Reversal 243

- Conversion to LSG 133



- Other Revision(s) Required 14

Total 5,777

TABLE 10C – CURRENT STATUS OF ROUX-EN-Y GASTRIC BYPASS PRIMARY PARTICIPANTS AS AT 30 JUNE 2019

No. of Roux-en-y Gastric Bypass Primary Participants who currently have:

Only a Primary RYGB 3,411

Any Revision of RYGB 132

- Revision of RYGB 15

- Reversal of RYGB 9




- Required just Division of Adhesions 13

- Band Added/Removed 21


Total 3,543

TABLE 10D – CURRENT STATUS OF ONE ANASTOMOSIS GASTRIC BYPASS PRIMARY PARTICIPANTS AS AT 30 JUNE 2019

No. of One Anastomosis Gastric Bypass Primary Participants who currently have:

Only a Primary OAGB 2,566

Any Revision of OAGB 45

- Revision of OAGB 2

- Reversal of OAGB 3





Total 2,611

Legacy Participants

Legacy participants have the quality and safety measures recorded peri-operatively but do not have annual follow ups. As at 30 June 2019, there were 13,214 legacy participants recorded in the Registry.

Further revision procedures have been recorded for 3,361 Legacy Participants (25.4%). Compared to the primary participant cohort there is a higher rate of further revision procedures but this statistic reflects the complexity of the revision surgery.

TABLE 11 – NUMBER OF PROCEDURES UNDERGONE BY LEGACY PARTICIPANTS FROM FEBRUARY 2012 TO 30 JUNE 2019

# Legacy Participants who have had: Number %

Only an Abandoned Revision Procedure 0 NA

Only One Revision Procedure 9,853 74.6%

2 Revision Procedures on BSR 3,092 23.4%

3 Revision Procedures on BSR 213 1.6%



More than 5 Revision Procedures on BSR 9 0.1%

TOTAL LEGACY PARTICIPANTS* 13,214 100%

* excludes those participants with only an abandoned procedure


Safety Reporting

Deaths are rare in the Registry but as a longitudinal registry, there is an expectation that reporting the death of some participants will occur. Causes of death vary considerably and the Registry ensures through Coroner’s reports and/or autopsy reports that confirmation of cause of death is received prior to attributing the death to be likely related to the bariatric procedure. Since our last Annual Report as at 30 June 2018, there has been a further twenty-six (26) reported deaths.

There are now 75 participants reported as deceased in the Registry, which equates to 0.1% of total number of participants. Of the 75 deaths reported, 36 are confirmed cases where the cause of death was not related to the bariatric procedure whilst 33 cases are yet to be determined.

Table 12 and 13 below outline the total number of deaths reported and the cause of death for those cases that were likely related to the bariatric procedure in Australia and New Zealand.

TABLE 12 – DEATHS REPORTED TO THE REGISTRY UP TO 30 JUNE 2019

As at 30 June 2018

Unrelated to procedure 36 (48%)

Likely related to procedure 6 (8%)

Not yet determined 33 (44%)

TOTAL 75

TABLE 13 – CAUSE OF DEATH WHEN DEATH WAS LIKELY RELATED TO BARIATRIC PROCEDURE AS AT 30 JUNE 2019

Date of Death Patient Group Procedure Cause of Death

2014 Legacy LAGB to LSG Staple line leak

2014 Primary OAGB Anastomotic leak, multi organ failure

2015 Primary RYGB Anastomotic leak, multi organ failure

2015 Legacy RYGB Fistula track

2015 Primary LAGB Sepsis

2017 Primary RYGB Complications of bariatric surgery, pulmonary embolism

Peri-Operative Defined Adverse Events and Complications

As at 30 June 2019, there have been 2,088 Defined Adverse Events reported to the Registry from 2,077 procedures in Australia. For procedures with completed peri-operative data, it is possible to have more than one Defined Adverse Event recorded. These events resulted from procedures performed on 1,810 participants and the data was recorded within the peri-operative window (up to 90 days post-operative).

There have been 24 Defined Adverse Events reported for New Zealand participants from 22 procedures as at 30 June 2019. These events resulted from procedures performed on 22 participants and the data was recorded within the peri-operative window (up to 90 days post-operative).

TABLE 14 – DEFINED ADVERSE EVENTS IN ALL PARTICIPANTS UP TO 30 JUNE 2019

Resulting In Primary Procedures Revision Procedures All Procedures

Unplanned Return to Theatre 539 734 1,273

Unplanned Admission to ICU 74 65 139

Unplanned Re-Admission to Hospital 686 436 1,122

Any Defined Adverse Event 1,077 1,035 2,112

Tables 15 and 16 demonstrate the incidence of Defined Adverse Events by both primary and revision procedures from 1 July 2018 to 30 June 2019.

TABLE 15 – PRIMARY PROCEDURES BY TYPE WITH A DEFINED ADVERSE EVENT (FY 18/19)

Primary ProceduresNo. Procedures with Any Defined Adverse

Event

Total No. Procedures with Peri-Op Follow Up

Percentage with a Defined Adverse Event

Sleeve Gastrectomy (LSG) 156 9,945 1.6%

Gastric Banding (LAGB) 7 308 2.3%

Roux-en-y Gastric Bypass (RYGB) 57 909 6.3%

One Anastomosis Gastric Bypass (OAGB) 29 744 3.9%

Other Primary Procedures 2 22 9.12%

TOTAL 251 11,928 2.1%


TABLE 16 – REVISION PROCEDURES BY TYPE WITH A DEFINED ADVERSE EVENT (FY 18/19)

Revision ProceduresNo. Procedures with Any Defined Adverse

Event

Total No. Procedures with Peri-Op Follow

Up

Percentage with a Defined Adverse

Event

Sleeve Gastrectomy (LSG) 27 656 4.1%

Gastric Banding (LAGB) 8 99 8.1%

Roux-en-y Gastric Bypass (RYGB) 87 737 11.8%

One Anastomosis Gastric Bypass (OAGB) 14 284 4.9%

Port Revision 7 109 6.4%

Reversal of Gastric Band 19 885 2.1%

Reversal of Gastric Bypass 1 7 14.3%

Lavage/washout ± drainage 11 22 50.0%

Stent (insertion or removal) 5 17 29.4%

Dilitation of Stricture 27 58 46.6%

Division of Adhesions 2 25 8.0%

Control of Post-Operative Bleed 4 7 57.1%

Sub-Total Gastrectomy 2 7 28.6%

Ring/Band over Bypass or Sleeve (Insertion or Removal)

2 22 9.1%

Other Revision Procedures 12 80 15.0%

TOTAL 228 3,015 7.6%

One complication can lead to more than one Defined Adverse Event and a patient may experience multiple complications causing a single Defined Adverse Event. It is because of this there is not a one to one relationship between the number of complications and the number of Defined Adverse Events recorded.

The complications attributing to a Defined Adverse Events are displayed in Figure 14. The “other” category accounts for 41.6% of complications recorded.

FIGURE 14 – REASONS ATTRIBUTED FOR DEFINED ADVERSE EVENTS IN ALL PARTICIPANTS (FY 18/19)

Figure 15 outlines the complications detailed during the annual follow up data collection pertaining to why a revision procedure has occurred and the complications that had arisen resulting in a revision procedure. The data collection period for this analysis is from 1 July 2018 to 30 June 2019.

FIGURE 15 – REASONS ATTRIBUTED FOR REOPERATION ON PRIMARY PARTICIPANTS (FY 18/19)

Other - 42%

Leak - 11%

DVT / PE - 2%

Abdominal Pain - 2%

Haemorrhage - 5%

Vomiting - 5%

Dysphagia NOS - 3%

Bowel Obstruction- Operative - 4%

Abdominal Wall Haematoma / Seroma - 2%

Port - 2%

Wound Infection - 3%

Anastomotic Stricture - 10%

Dehydration / Electrolyte Imbalance - 7%

Other - 59%

Gall Bladder Trauma /Injury - 14%

Stenosis - 1%

Vomiting - 3%

Leak - 2%

Abdominal Pain - 2%

Dysphagia NOS - 2%

Dehydration / Electroyte Imbalance - 2%Bowel Obstruction - Operative - 1%

Anastomotic Stricture - 1%

Port Site Hernia / Incisional Hernia - 2%

Port - 5%

Refractory Reflux - 4%


Weight Outcomes

The start BMI for participants undergoing primary procedures was 44 (st dev 7.8) with a mean BMI of 42.6 (st dev 7.3) on the day of surgery. Figure 16 illustrates the variation of obesity classifications represented in the Registry from February 2012 to 30 June 2019 and highlights the trend in the cohort’s BMI and classification distribution. This cohort consists of 56,212 primary participants where initial BMI at the time of operation was calculated.

FIGURE 16 – INITIAL BMI CLASSIFICATION FOR PRIMARY ADULT PARTICIPANTS FROM FEBRUARY 2012 TO 30 JUNE 2019 (N=56,212)

Table 17 exhibits the differences in start BMI compared to day of surgery BMI, as well as comparing male, female, private, and public variations that the Registry captures. Interestingly, there are clear differences in these comparisons, particularly when comparing public and private hospitals.

TABLE 17 – MEAN BMI FOR ALL PRIMARY PARTICIPANTS FROM FEBRUARY 2012 TO 20 JUNE 2019

WEIGHT MEASURE FEMALE MALE ALL

Mean Start BMI 43.7 45.0 44.0

(Standard Deviation) 7.7 8.0 7.8

Mean DOS BMI 42.4 43.4 42.6


Mean Start BMI – Public 47.5 49.0 47.8


Mean DOS BMI – Public 45.8 46.4 45.9


Mean Start BMI – Private 43.4 44.7 43.7


Mean DOS BMI – Private 42.0 43.1 42.3


There are 24,256 primary participants that are both over the age of 18 years old and have had their weight at 12 months captured. Their mean BMI at this 12 month mark was 31.7 (st dev 6.7), their mean Excess Weight Loss (EWL) is calculated as 69.4% and their mean Total Weight Loss (TWL) is 27.7%, as demonstrated in Table 18 below.

TABLE 18 – WEIGHT OUTCOMES AT 12 MONTHS FOR ALL PRIMARY PROCEDURES FROM FEBRUARY 2012 TO 30 JUNE 2019

WEIGHT MEASURE ALL*

Mean BMI at 12 Months 31.7

(Standard Deviation) 6.7

Mean EWL at 12 Months 69.4


Mean TWL at 12 Months 27.7


* Excludes participants under 18 years of age at the time of the primary procedure

TABLE 19 – EXCESS WEIGHT LOSS AND TOTAL WEIGHT LOSS FOR PRIMARY PARTICIPANTS WHO HAVE REACHED 3, 4 AND 5 YEAR ANNUAL FOLLOW UP

N EWL TWL

At Year 3 3,330 59.3% 24.3%

At Year 4 1,293 52.4% 20.9%

At Year 5 515 47.6% 18.9%

Males (n=12,772) and Females (n=43,440)


The Registry has successfully collected 3, 4 and 5-year follow up data for primary participants where EWL and TWL can be calculated. Figures 17, 18 and 19 below illustrates this for all primary participants where 3, 4 or 5 year follow up data has been obtained.

FIGURE 17 – EXCESS WEIGHT LOSS AND TOTAL WEIGHT LOSS FOR PRIMARY PARTICIPANTS WHO HAVE REACHED 3 YEAR ANNUAL FOLLOW UP (N=3,330)

FIGURE 18 – EXCESS WEIGHT LOSS AND TOTAL WEIGHT LOSS FOR PRIMARY PARTICIPANTS WHO HAVE REACHED 4 YEAR ANNUAL FOLLOW UP (N=1,293)

FIGURE 19 – EXCESS WEIGHT LOSS AND TOTAL WEIGHT LOSS FOR PRIMARY PARTICIPANTS WHO HAVE REACHED 5 YEAR ANNUAL FOLLOW UP (N=515)


Diabetes Outcomes

At 30 June 2019, the Registry successfully obtained diabetes at baseline for 51,849 primary participants with 8,162 (13.6%) of this cohort indicating that they have diabetes at the time of the primary procedure. As demonstrated in Table 20, males tend to have a higher incidence of diabetes at time of procedure than females and there is a higher incidence of diabetes amongst the public participants than in private participants.

TABLE 20 – PRIMARY PARTICIPANTS IDENTIFYING AS HAVING DIABETES AT BASELINE FROM FEBRUARY 2012 TO 30 JUNE 2019

FEMALE MALE ALL

Public 23.2% 37.5% 26.4%

Private 11.2% 19.7% 13.2%

All 12.1% 21.1% 14.2%

Non-insulin (mono) therapy, which accounts for 34.3% of the cohort and diet and exercise which accounts for 21.1% are the two largest treatment types for the cohort, as demonstrated in Table 21 below. Interestingly, the female cohort has a higher rate of diet and exercise and non-insulin (mono) therapy as baseline treatment than males who have higher incidence rates of non-insulin (poly) therapy and insulin as treatment at baseline than females.

TABLE 21 – TREATMENT FOR DIABETES AT BASELINE FROM FEBRUARY 2012 TO 30 JUNE 2019

TREATMENT FOR DIABETES FEMALES MALES ALL

Diet/Exercise 1,272 23.5% 449 16.3% 1,721 21.1%

Non-Insulin (mono) Therapy 1,917 35.5% 882 32.0% 2,799 34.3%

Non-Insulin (poly) Therapy 770 14.2% 544 19.7% 1,314 16.1%

Insulin 1,006 18.6% 665 24.1% 1,671 20.5%

Not Stated 440 8.1% 217 7.9% 657 8.0%

TOTAL 5,405 100% 2,757 100% 8,162 100%

Figure 20 illustrates the entire primary participant cohort that have both the diabetes status and the treatment recorded at the time of operation (baseline). It remains that there is no statistical difference amongst the treatment options.

FIGURE 20 – PRIMARY PARTICIPANTS IDENTIFYING AS HAVING DIABETES AND TREATMENT AT PRIMARY PROCEDURE FROM FEBRUARY 2012 TO 30 JUNE 2019 (N= 57,659 PRIMARY PARTICIPANTS)

The Registry has successfully collected annual follow up data for 4,972 of these primary participants. The variation between baseline treatments to 12-month follow up treatment is demonstrated in Table 22 below.

TABLE 22 – TREATMENT OF PARTICIPANTS WITH DIABETES REPORTED AT BASELINE FOLLOWED UP AT 12 MONTHS

TREATMENT FOR DIABETES BASELINE AT 12 MONTHS

Diet/Exercise 1,019 20.5% 381 7.7%

Surgery Alone NA NA 2,079 41.8%

Non-Insulin (mono) Therapy 1,703 34.3% 469 9.4%

Non-Insulin (poly) Therapy 755 15.2% 108 2.2%

Insulin 1,052 21.2% 304 6.1%

Not Stated 443 8.9% 1,055 21.2%

Lost to Follow Up NA NA 576 11.6%

TOTAL 4,972 100% 4,972 100%

* The Registry has commenced distinguishing between “Not Stated” and “Lost to Follow Up” to ensure each category is a true reflection of data capture.

Twelve months after surgery, 49.5% of this cohort no longer require treatment for diabetes, as demonstrated by the “Surgery Alone” and/or “Diet/Exercise” categories. Participants requiring insulin has significantly decreased from 21.2% at baseline to 6.1% at 12 months post-surgery. However, treatment outcomes at 12 months post-surgery is not known for 21.2% of the cohort.

No Diabetes - 76%

Diabetes Status Unknown - 10%

Yes - Diet / Exercise - 3%

Yes - Non-Insulin (Mono) - 5%

Yes - Non-Insulin (Poly) - 2%

Yes - Insulin - 3%

Yes - Not Stated - 1%


Follow Up Demonstrated in Table 23 are the follow up rates achieved at each data point by the Registry. Data is defined as “due” on the appropriate anniversary from the date of the operation where the peri-operative follow up data is due 30 days after the operation date, year 1 data is due one year after the surgery date and so on.

Within the Registry’s outstanding follow up, there were 1,849 (7.7%) participants could not be contacted for annual follow up at the time of this report. There are 10,970 (7.1%) participants that are recognised as Lost to Follow Up (LTFU). LTFU indicates that participants are no longer contacted for peri-operative and/or annual data follow up. However, a patient will be contacted again if they undergo another bariatric procedure for the collection of follow up data relating to that procedure.

The Registry’s Call Centre have completed 15,551 follow up calls for 11,352 (16%) participants from February 2012 to 30 June 2019.

TABLE 23 – FOLLOW UP COMPLETION BY TYPE^

PERI-OPYEAR

1YEAR

2YEAR

3YEAR

4YEAR

5YEAR

6YEAR

7TOTAL

Total Follow Ups 76,323 40,343 21,885 10,597 3,743 1,166 471 57 154,585

Total Complete with Data 65,681 29,693 14,022 6,491 2,466 878 343 43 119,617

% Complete with Data 86.06 73.6 64.07 61.25 65.88 75.3 72.82 75.44 77.38

Total Outstanding 8,246 6,824 4,906 2,748 963 197 103 11 23,998

% Outstanding 10.8 16.91 22.42 25.93 25.73 16.9 21.87 19.3 15.52

Awaiting BSR to Call for Follow Up 146 765 553 282 74 22 7 0 1,849

% Awaiting BSR to Call for Follow Up 1.77 11.21 11.27 10.26 7.68 11.17 6.8 0 7.7

Total Lost to Follow Up 2,396 3,826 2,957 1,358 314 91 25 3 10,970

% Lost to Follow Up 3.14 9.48 13.51 12.81 8.39 7.8 5.31 5.26 7.1

^ Australia and New Zealand peri-operative and annual follow up data have been combined for this report due to the low enrolment numbers for New Zealand. Future annual reports will allow for the distinction between Australia and New Zealand for follow up statistics.

PATIENT REPORTED OUTCOME MEASURES (PROMS)

In March 2017, the Registry engaged with the Cairnmillar Institute (Melbourne) to commence the pilot phase study to examine a range of different psychosocial factors that affect the health and wellbeing of patients who have undergone bariatric surgery. The study “Patients’ Expectations and Satisfaction following Bariatric Surgery – a study exploring the feasibility of including patient reported outcome measures in a national bariatric surgery registry” commenced with focus groups in December 2017. Twelve (12) participants in total contributed discussions to the focus groups, held at the Cairnmillar Institute. Participants selected were located within a 20km radius of Melbourne and invited to participate via letter. This aspect of the project was designated as Stage 1.

Following the analyses of results from Stage 1 of the project, Stage 2 will commence in the latter half of 2019 with the development of a large comprehensive item bank incorporating all potential items for the PROMs. From this, the development of a concise questionnaire to complement the longitudinal study of health and wellbeing outcomes for patients undergoing bariatric surgery will be finalised and implemented into the Registry by June 2021.

The Bariatric Surgery Registry appointed a Research Assistant in July 2019 to drive this PROMs initiative with the focus on quality of life, diabetes and health economics outcomes.

CONCLUSION

There has been a significant growth in the numbers of participants enrolled in the Registry over the past 12 months. The Registry now has good coverage across most states and territories with an excellent uptake from hospitals and clinicians alike.

The data to date confirms the safety and efficacy of bariatric surgery although data must be interpreted with caution until the entire population is captured.

The numbers of procedures performed around Australia continues to grow at a rapid pace. In this setting, it is more critical than ever that the Registry continues to monitor our outcomes and constantly seeks to improve the care provided to bariatric patients. Over the next 6 months, we will strive to achieve complete total enrolment of hospitals and surgeons across Australia. One of the key focuses for the Registry will be endeavouring to capture a minimum of 81% of procedures recorded annually in the MBS.

The Registry has had a successful first year of participant, surgeon and hospital recruitment in New Zealand over the past 12 months. The next 12 months will be focused on on-boarding all hospitals and surgeons performing bariatric procedures as well as welcoming the growth in New Zealand participant numbers.

Into the next reporting period, the Registry will be implementing a new website designed to be a hub of information for all stakeholders, a SMS based follow up system to help capture the annual follow up data adequately, the expansion of PROMs and Registry based research and the enhancement of data capture methods through data linkages and collaborations.

Surgeons, hospitals, industry and government are sincerely thanked for their ongoing support to the Registry. The Registry looks forward to presenting the bariatric surgery activity across Australia and New Zealand over the next year and improving its strength and coverage, as well as the implementation of PROMs and research based activities.


NEW ZEALAND

We would like to thank our funders for their on-going support: Applied Medical, Medtronic and Gore Medical. Their commitment to best quality care is much appreciated. Their funding has allowed the establishment and rollout of the BSR in Aotearoa New Zealand.

We could not have started in Aotearoa New Zealand without the support of the staff at National Institute of Health Innovation (NIHI), University of Auckland. Thanks to Anna-Marie Rattray, Karen Carter, Nick Kearns, Benjamin Pearson and Professor Chris Bullen. Thank you for your dedication to get this project off the ground.

I would also like to acknowledge the considerable effort that every bariatric surgeon in Aotearoa New Zealand, their teams and the participating hospital sites have put into the establishment of this Registry.

We acknowledge the extra work, it is time consuming, yet the universal enthusiasm to make the BSR work has been amazing. Thank you so much for making the BSR possible. It is so heartening to see how committed we all are as a bariatric surgical community to improving the quality of the care we provide our patients.

Finally thank you to our participants who generously share their information with us to improve the quality of Bariatric Surgery. We are indebted to all of you!

Associate Professor Andrew MacCormick BHB MBChB PhD FRACSClinical Lead Aotearoa New Zealand

ACKNOWLEDGEMENTS

AUSTRALIA

We would like to thank the Commonwealth Government of Australia (Department of Heath) for their ongoing support of the BSR. We are so grateful that they recognise the value of prospectively collected data to inform better patient care and we look forward to strong on-going collaborations.

We would also like to thank our other funders for their on-going support: Applied Medical, Medtronic, Avant, Johnson&Johnson and Gore Medical. Their commitment to best quality care is much appreciated.

Many thanks to the staff of the BSR who make not only this report but the BSR possible. There are now over 15 staff members and each of them is invaluable to the success of our Registry.

Brooke Backman is an outstanding Programme Manager. She brings wisdom and empathy to the role and I am so grateful for her dedication and expertise. Whilst we farewelled our Project Manager Dianne Brown last year, we are grateful that she has been able to consult for us and bring her expertise on governance and data management. This year we welcomed Srikanth Kommireddy as our IT manager. He has made a major impact on our ability to manage our IT requirements. We also welcomed Simone Wilkins as our Executive Assistant who basically just makes our BSR work day-to-day.

We are so fortunate to have our long-serving Data Manager Aileen Heal and Customer Relationship Manager Jenifer Cottrell. They continue to contribute at the highest level and are the lynch pins that hold our Registry together.

This year we farewelled Administrative Officer Marlene Jacobs, Database Support Officer Adrian Heal and Data Operations Analyst Sonya Palmer. All three did an amazing job and we were lucky to have their expertise for the time they were with us.

The Monash University Registry Sciences Unit provide us with the expertise necessary to ensure that these data are collected, stored and analysed according to rigorous standards. Many thanks to John McNeil, Breanna Pellegrini, Arul Earnest and Susannah Ahern for all of your support. You keep us focused, and we appreciate this more than you know.

Our Steering Committee provides expert advice and support. Every member has freely provided their expertise and we value the strength of the governance this process provides. Particular thanks go to our Chair, Professor Ian Caterson. His enthusiasm, knowledge and wise counsel is much appreciated.

It would be remiss of me not to acknowledge the considerable effort that every bariatric surgeon in Australia, their teams and the participating hospital sites have put into the establishment and now ongoing function of the BSR. It is extra work and it is time consuming. Despite our best efforts to streamline this and minimise the impact of practice, it cannot be denied that participation in the registry adds to an already busy work life. Despite this, the BSR remains a priority for the overwhelming majority of bariatric surgeons and we are encouraged by their enthusiasm and goodwill.

Most importantly, thank you to our patients who generously share their information with us to improve the quality of Bariatric Surgery in Australia. We are indebted to each and every one of you! We hope, and promise you, that the data you so generously share with us will be put to best use to improve the outcomes of each and every patient that chooses to have bariatric surgery in Australia. We can’t thank you enough.

Professor Wendy Brown MBBS (hons) PhD FACS FRACS Clinical Director BSR Clinical Lead, Australia

We hope, and promise you, that the data you so generously share with us will be put to best use to improve the outcomes of each and every patient that chooses to have bariatric surgery in Australia.

It is so heartening to see how committed we all are as a bariatric surgical community to improving the quality of the care we provide our patients.


COMMITTEES AND STAFF

STEERING COMMITTEE MEMBERS

Prof Ian Caterson Committee Chair Prof Wendy Brown Deputy Chair, BSR Clinical Director Assoc. Prof Andrew MacCormick NZ Clinical Lead, ANZMOSS RepresentativeMs. Brooke Backman BSR Programme Manager Prof John McNeil AO BSR Data Custodian, Sir John Monash Distinguished Professor, Monash UniversityA/Prof Susannah Ahern Monash University Registry Science UnitDr. Samuel Baker ANZMOSS RepresentativeA/Prof Michael Talbot ANZMOSS RepresentativeProf Neil Merrett ANZGOSA RepresentativeProf Chris Bullen NIHI RepresentativeMs. Meron Pitcher Independent RACS Representative Assoc. Prof Arul Earnest Senior Biostatistician, Monash University Registry Science UnitMs. Corinna Musgrave Community RepresentativeMs. Sandra Marjanovic MTAA Representative (June 2018 - May 2019)

CLINICAL LEADS

Professor Wendy Brown (Australia) Associate Professor Andrew MacCormick (New Zealand)

BSR STAFF – AUSTRALIA

Prof Wendy Brown BSR Clinical Director Ms. Brooke Backman Programme ManagerDr. Jenifer Cottrell Customer Relationship ManagerMr. Srikanth Kommireddy Database Manager Ms. Aileen Heal Data ManagerMs. Dianne Brown BSR Consultant Ms. Simone Wilkins Administration OfficerMr. Angus Brian Campbell Data Support OfficerMr. Henry Truong Technical Officer Mr. Declan Wain Technical OfficerMr. Jared Cox Technical OfficerMs. Rebecca Tourogianis Technical OfficerMs. Jazmin Padarath Administration Assistant (Data Entry)Ms. Hayley Cottrell Administration Assistant (Data Entry)Ms. Roxana Ruiz Guevara Administration Assistant (PFS Statements)Ms. Nilab Hamidi Administration Assistant (Ethics)Ms. Tiasha Fernando Administration Assistant (Call Centre)Ms. Katy Shaw Administration Assistant (Call Centre)Ms. Zahli Hansen Administration Assistant (Call Centre)Ms. Anagi Wickremasinghe Administration Assistant (Call Centre)

Past staff recognition during the reporting period: Ms. Marlene Jacobs, Ms. Sonya Palmer, Mr. Pari D’Cruz, Mr. Alex Lukacz, Ms. Rebecca Argento, Ms. Tjuntu Muhlen-Schulte, Ms. Eddy Woldemareyam, Ms. Alli Holt and Ms. Seba Joseph.

BSR STAFF – NEW ZEALAND

Assoc. Prof Andrew MacCormick BSR Clinical LeadMs. Kristin Sutherland NIHI Project Manager Ms. Anne-Marie Rattray Research Assistant

APPENDIX 1: DATA ELEMENTS CAPTURED Day of Surgery Perioperative Follow Up

Name Date of follow up

Date of Birth Mortality

Sex If yes –

Address Date of Death

Phone Numbers Cause of Death

Medicare & DVA Information Death Related to Procedure?

Hospital UR Number Defined Adverse Event

Name of Hospital & State Unplanned Return to Theatre

Indigenous Status (Aus) / Ethnicity (NZ) Unplanned ICU Admission

Date of Surgery Unplanned Re-Admission to Hospital

Weight – Day Decision Made to Undergo Surgery If yes – Reason

Weight – Day of Surgery BSR to Follow Up

Height

Diabetes Status Annual Follow Up*

Diabetes Treatment Date of Follow Up

Diet/Exercise; Weight

Non-Insulin Therapy (mono) Diabetes Status

Non-Insulin Therapy (poly) Diabetes Treatment

Insulin Diet/Exercise;

Status of Procedure (Primary vs Revision) Non-Insulin Therapy (Mono)

If Revision – Last Bariatric Procedure Non-Insulin Therapy (Poly)

If Revision – Planned or Unplanned Insulin

If Unplanned – Reason Reoperation in Last 12 Months?

Procedure Abandoned vs Completed If yes – Reason

Type of Procedure Mortality

Device Type If yes –

Device Brand Date of Death

Device Model Cause of Death

If stapling – Buttress? Death Related to Procedure?

Concurrent Liver Transplant BSR to Follow Up

Concurrent Renal Transplant

* Primary Participants Only


APPENDIX 2: LIST OF SITES CONTRIBUTING DATA TO THIS REPORT

Australia Sites that have contributed data for analysis during the period of 01.07.2018 – 30.06.2019

NSW

Albury-Wodonga Private Hospital Baringa Private Hospital- Brisbane Waters Private Hospital Calvary Riverina Hospital Campbelltown Private Hospital Concord Repatriation General Hospital* Dubbo Private Hospital Gosford Private Hospital Hurstville Private Hospital Kareena Private Hospital Lake Macquarie Private Lingard Private Hospital Mater Hospital, North Sydney Nepean Private Hospital Newcastle Private Hospital North Shore Private Hospital Norwest Private Hospital Nowra Private Hospital Port Macquarie Private Hospital Prince of Wales Private Hospital Royal North Shore Hospital Southern Highlands Private Hospital St George Private Hospital Strathfield Private Hospital Sydney Adventist Hospital Sydney South West Private Hospital Wagga Wagga Rural Referral Hospital Westmead Private Hospital Wollongong Private Hospital

VICAustin Hospital Box Hill Hospital* Cabrini Brighton Hospital Cabrini Malvern Hospital Epworth Eastern Hospital Epworth Freemasons Epworth Geelong Epworth Richmond Glen Iris Private Hamilton Base Hospital Heidelberg Repatriation Hospital Holmesglen Private Hospital Jessie McPherson Private Hospital John Fawkner Hospital Knox Private Hospital Latrobe Regional Hospital Maryvale Private Hospital Mildura Health Private Hospital Monash Medical Centre Mulgrave Private Hospital Northpark Private Hospital Peninsula Private Hospital Shepparton Private Hospital St John of God Ballarat Hospital St John of God Bendigo Hospital St John of God Berwick Hospital St John of God Geelong Hospital St John of God Warrnambool Hospital St Vincent’s Private Hospital Fitzroy The Alfred Hospital The Avenue Private Hospital Wangaratta Private Hospital Warringal Private Hospital Western Private Hospital

QLDBuderim Private Hospital Gold Coast Private Hospital Greenslopes Private Hospital Hillcrest Rockhampton Private Hospital Ipswich General Hospital John Flynn Private Hospital Kawana Private Hospital Mater Health Services - North Queensland Mater Misericordiae Hospital - Rockhampton Noosa Private Hospital North West Private Hospital (Brisbane) Pindara Private Hospital Princess Alexandra Hospital Royal Brisbane and Women’s Hospital St Andrew’s War Memorial Hospital St Andrew’s-Ipswich Private Hospital St Vincent’s Private Hospital Northside Sunnybank Private Hospital Sunshine Coast University - Private Hospital The Wesley Hospital

SAAshford Private Hospital Calvary Central Districts Hospital Calvary North Adelaide Hospital Calvary Wakefield Hospital Flinders Medical Centre Flinders Private Hospital Queen Elizabeth Hospital Hospital Western Hospital

WAFiona Stanley Hospital Glengarry Private Hospital Hollywood Private Hospital Joondalup Health Campus* Mount Hospital St John of God Bunbury Hospital St John of God Mt Lawley Hospital St John of God Murdoch Hospital St John of God Subiaco Hospital

TAS Calvary St Vincent’s Hospital Launceston Hobart Private Hospital Launceston General Hospital North West Private Hospital (Burnie) Royal Hobart Hospital

NT Darwin Private Hospital

APPENDIX 3: LIST OF SITES WITH ETHICS APPROVAL

Australia As at 30 June 2019 where both ethics and site governance approvals have been achieved:

NSW

Albury-Wodonga Private Hospital Baringa Private Hospital Belmont District Hospital Brisbane Waters Private Hospital Calvary Riverina Hospital Campbelltown Private Hospital Concord Repatriation General Hospital Dubbo Private Hospital Dudley Private Hospital Gosford Hospital Gosford Private Hospital Hurstville Private Hospital John Hunter Hospital Kareena Private Hospital Lake Macquarie Private Hospital Lakeview Private Hospital Lingard Private Hospital Mater Hospital, North Sydney Nepean Private Hospital Newcastle Private Hospital North Shore Private Hospital Norwest Private Hospital Nowra Private Hospital Port Macquarie Private Hospital Prince of Wales Private Hospital Royal North Shore Hospital Royal Prince Alfred Hospital Southern Highlands Private Hospital St George Private Hospital Strathfield Private Hospital Sydney Adventist Hospital Sydney Southwest Private Hospital Wagga Wagga Rural Referral Hospital Westmead Private Hospital Wollongong Private Hospital

VICAustin Hospital Box Hill Hospital Cabrini Brighton Hospital Cabrini Malvern Hospital Epworth Eastern Epworth Freemasons Epworth Geelong Epworth Richmond Footscray Hospital Glen Iris Private Hamilton Base Hospital Heidelberg Repatriation Hospital Holmesglen Private Hospital Jessie McPherson Private Hospital John Fawkner Hospital Knox Private Hospital Latrobe Regional Hospital Linacre Private Hospital Maryvale Private Hospital Mildura Base Hospital Mildura Health Private Hospital Mitcham Private Hospital Monash Medical Centre Mulgrave Private Hospital Northpark Private Hospital Peninsula Private Hospital Shepparton Private Hospital St John of God Ballarat Hospital St John of God Bendigo Hospital St John of God Berwick Hospital St John of God Geelong Hospital St John of God Warrnambool Hospital St Vincent’s Hospital - Melbourne St Vincent’s Private Hospital Fitzroy Sunshine Hospital The Alfred Hospital The Avenue Private Hospital Wangaratta Private Hospital Warringal Private Hospital Waverley Private Hospital Western Private Hospital Williamstown Hospital

QLDBuderim Private Hospital Cairns Private Hospital Gold Coast Private Hospital Greenslopes Private Hospital Hillcrest Rockhampton Private Hospital Ipswich General Hospital John Flynn Private Hospital Kawana Private Hospital Mater Health Services - North Queensland Mater Hospital Brisbane Mater Hospital Bundaberg Mater Misericordiae Hospital - Rockhampton Mater Private Hospital Brisbane Mater Private Hospital Redland Mater Private Hospital Springfield Nambour Selangor Private Hospital Noosa Private Hospital North West Private Hospital, Brisbane Pindara Private Hospital Princess Alexandra Hospital Queen Elizabeth II Jubilee Hospital Royal Brisbane and Women’s Hospital St Andrew’s War Memorial Hospital St Andrew’s-Ipswich Private Hospital St Vincent’s Private Hospital Northside St Vincent’s Private Hospital Toowoomba Sunnybank Private Hospital Sunshine Coast University Private Hospital The Wesley Hospital

SAAshford Private Hospital Calvary Central Districts Hospital Calvary North Adelaide Hospital Calvary Wakefield Hospital Flinders Medical Centre Flinders Private Hospital Queen Elizabeth Hospital Repatriation General Hospital Western Hospital

WABethesda Hospital Fiona Stanley Hospital Glengarry Private Hospital Hollywood Private Hospital Joondalup Health Campus Mount Hospital St John of God Bunbury Hospital St John of God Mt Lawley Hospital St John of God Murdoch Hospital St John of God Subiaco Hospital Waikiki Private Hospital

TAS Calvary St Vincent’s Hospital Launceston Hobart Private Hospital Launceston General Hospital North West Private Hospital, Burnie Royal Hobart Hospital

NT Darwin Private Hospital

ACT National Capital Private Hospital

* Hospital sites where both private and public patients are treated.

New Zealand

Grace Hospital Middlemore Hospital Southern Cross Hospital - Christchurch Southern Cross Hospital - Hamilton Southern Cross North Hospital - Harbour Southern Cross Hospital - Wellington St George’s Hospital

New Zealand As at 30 June 2019 where both ethics and site governance approvals have been achieved:

Auckland City Hospital Chelsea Hospital Trust Gisborne Hospital Grace Hospital Middlemore Hospital Ormiston Hospital

Southern Cross Hospital Christchurch Southern Cross Hospital Hamilton Southern Cross Hospital North Harbour Southern Cross Hospital Wellington Southland Hospital St George’s Hospital


REFERENCES

1 Australian Parliament House of Representatives Standing Committee on Health and Ageing. Weighing it up : obesity in Australia, http:/ / www.aph.gov.au/ Parliamentary_Business/ Committees/ House_of_Representatives_Committees?url= haa/ ./ obesity/ report/ fullreport.pdf

2 Australian Medical Association, AMA Position Statement – Obesity 2016, https://ama.com.au/position-statement/obesity-2016

3 Australian Institute of Health and Welfare 2019, Data sources for monitoring overweight and obesity in Australia, AIHW, Canberra.

4 Ministry of Health. 2017. Annual Data Explorer 2016/17: New Zealand Health Survey [Data File]. URL: https://minhealthnz.shinyapps.io/nz-health-survey-2016-17-annual-update

5 Revision incidence rates can be analysed by calculating the time between primary bariatric procedure to the first subsequent revision procedure. Those patients with a primary procedure soon after February 2012 are observed for longer periods than those with a primary procedure later in the observation period. Survival analysis techniques (ie. Nelson Aalen method) estimate the probability of revision at each follow up time point based on the number at risk of revision and the number of revisions at that time point. This method censors patients that are revision free at the end of the observation period and truncates patients who have already experienced a revision prior to the observation period. The Nelson Aalen cumulative probability estimates in Figure X show a low revision incidence rate of bariatric procedures. At one-year post primary procedure, 1.2% (95% CI 1.3% to 1.3%) of patients are estimated to have had their first revision procedure. At two years post primary procedure, 2.2% (95% CI 2.5% to 2.3%) are estimated to have had their first revision procedure.

How to access BSR data The BSR collects and analyses information on bariatric procedures across Australia and New Zealand. Requests for information can be lodged via the data request form obtained by contacting the Registry’s Programme Manager, Brooke Backman on +61 3 9903 0589 or [email protected]

Registry Staff Clinical Director: Professor Wendy Brown Clinical Lead, New Zealand: Associate Professor Andrew MacCormick Programme Manager: Ms. Brooke Backman Customer Relationship Manager: Dr. Jenifer Cottrell Database Manager: Mr. Srikanth Kommireddy Data Manager: Ms. Aileen HealRegistry Consultant: Ms. Dianne Brown Data Analyst: Ms. Breanna Pellegrini

BARIATRIC SURGERY REGISTRY2018/19 REPORT

48 Bariatric Surgery Registry Seventh Annual Report: 2018/19

DESIGNED AND PRODUCED BY MPS MONASH: 316765 AUGUST 2019. CRICOS PROVIDER: MONASH UNIVERSITY 00008C.

Contact the Registry at:Bariatric Surgery RegistryMonash University Level 6, The Alfred Centre99 Commercial Road, Melbourne Victoria, 3004Phone: +61 3 9903 0725 Email: [email protected]

All information and publications of the Bariatric Surgery Registry can be found on our internet home page: www.monash.edu/medicine/sphpm/registries/bariatric

2018/19 report - monash university€¦ · missing data 13 data reporting 13 site and surgeon...

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