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Cardiologyannual researchreport2018
WelcomeIt is with great pleasure that I welcome you to the inaugural Cardiology Research Annual Report. GenesisCare cardiologists have been conducting research for over 20 years and Cardiology Research, our national research network, has been operational for three years.
The research network covers many areas of cardiovascular disease, which remains one of the biggest causes of mortality and disease burden worldwide.
It focusses on improving the delivery of evidence-based therapies and ensuring access to appropriate cardiac assessment and treatments.
The network maintains mulitple cardiac patient outcomes registries and participates in clinical trials to ensure that medications and emerging technologies are appropriately researched and can be made available to all Australians.
Our research team has the capacity and clinical experience to undertake trials in all phases – from first in human to phase IV, device and novel therapy trials.
We now have over 80 clinical investigators, 30 dedicated research staff and 7 research sites, making us the leading cardiology research network across Australia.
I would like to acknowledge the efforts of our Australian team – our cardiologists and our research staff, who work every day to improve our patients’ health outcomes.
Professor Stephen WorthleyMBBS, PhD, FRACP, FACC, FCSANZ, FRCPExecutive Manager - Cardiology, Sleep and Respiratory GenesisCare
Research enables us to be at the cutting edge of medicine, and we are in the unique position to be able to put new evidence into practice to continually improve outcomes.
Our clinicians have been publishing peer-reviewed articles in international medical, cardiology and scientific journals and abstracts in national and international scientific meetings for many years. We are pleased to present a list of our most recent publications in this report.
I trust you will enjoy GenesisCare’s inaugural Research Annual Report for Cardiology.
Our Cardiology Research Network is the only one in Australia to provide sponsors with a comprehensive Site Management service with access to multiple sites under one governance structure, one ethics submission, one contract and one indemnity. This increases efficiencies and improves study start up timelines for our Research Network and sponsors.
In 2018 we:
Participated in 20 clinical trials, with 11 commencing in 2018
Entered partnerships with Abbott and Biotronik
•
•
Enrolled the most patients in Australia and fourth highest globally for the ONYX ONE trial (77 patients). This trial is evaluating the clinical safety and effectiveness of the Resolute Onyx stent in participants deemed at high risk for bleeding and/or medically unsuitable for more than 1 month of Dual Anti Platelet Therapy (DAPT) following stent implantation
Enrolled the most patients in Australia for the AMULET trial (67 patients). This trial is evaluating the safety and effectiveness of the AMULET device in patients with non-valvular atrial fibrillation
Enrolled the most patients in Australia for the WASP Registry (54 patients). This registry aims to compile real-world clinical outcomes data in patients who are implanted with the Watchman device
•
•
•
2018 Highlights
Cardiology research network
Clinical and research governance
14 - 15
12 - 13
16 - 21
Introduction, Sonya McColl, National Research Manager - Cardiology, GenesisCare
Cardiology research team
Cardiology research locations
Introduction, Dr Daniel Cehic, Chief Medical Officer – Cardiology, Sleep & Respiratory, GenesisCare
Research register 2018
8 - 9
24 - 33
Clinical trials
MAVERIC trial
CONFIRM Rx trial
AMULET trial
ONYX ONE trial
CLEAR trial
34 - 37
38 - 39
40 - 41
42 - 43
44 - 45
Publications64 - 75
Acknowledgements76 - 79
Abbreviations80 - 81
48 - 49
Outcomes registries
52 - 55
50 - 51
56 - 59
60 - 63
Introduction, A/Prof David Eccleston, Cardiologist and Clinical Director - Cardiology Research, GenesisCare
PCI registry
GenesisCare registry sites Australia
Device registry
Heart failure registry
Contents
Clinical andresearch governance
76
98
Clinical and research governance
GenesisCare conducts internationally-recognised, high-quality clinical trials. Our doctors and research staff have a wealth of knowledge and expertise that is helping to improve health care in Australia and around the world.
“Our clinicians believe that new treatments should only be adopted once adequate assessment takes place to confirm their effectiveness, safety and cost.”
All GenesisCare research conforms to the ethical principles of the Declaration of Helsinki, Good Clinical Practice and all national and international guidelines. Before clinical trials commence they must first be approved by our internal research committee and then submitted to a National Health and Medical Research Council (NHMRC) approved independent ethics committee for review and approval.
We follow the framework for Australian Clinical Quality Registries provided by the Australian Commission on Safety and Quality in Health Care (ACSQHC) for our data and registry projects. We are working toward adopting the minimum data sets recommended by the International Consortium for Health Outcomes Measurement (ICHOM) to ensure we provide relevant and standardised patient outcome measures.
Complying with these clinical and research governance frameworks ensures GenesisCare delivers high-quality care, adheres to best practice and improves patient outcomes.
Dr Daniel CehicMBBS, FRACP, FCSANZChief Medical Officer - Cardiology GenesisCare
Cardiologyresearch network
1110
1312
Cardiology research network
Our research network has the facilities and clinical expertise to undertake a wide variety of clinical trials – from first in patient to phase IV, device and novel therapy trials. With over 30 dedicated staff, most of whom have greater than 10–20 years’ research experience, the team provides an efficient and high-quality research service.
We have worked with the majority of pharmaceutical, biotechnology and device companies, both large and small. Whilst our main focus is in cardiovascular trials, we also undertake trials in related therapeutic areas such as diabetes, sleep and respiratory medicine.
Our cardiology research network has 7 clinical trial sites around the network with access to research staff, nurses, cardiac physiologists, administration staff and over 80 cardiologists.
Sonya McCollNational Research Manager - Cardiology GenesisCare
GenesisCare’s experience18conference, SydneyGenesisCare hosted the inaugural experience18 conference in Sydney, November 2018.
The conference allowed GenesisCare doctors, research teams, clinical and administrative staff to come together to share achievements and outcomes from across the network.
Some highlights from our cardiology team are included.
GenesisCare:
has conducted over 120 clinical trials in the last 10 years•
works with large pharmaceutical and device companies, small start-up pharmaceutical and device companies and many Contract Research Organisations (CROs)
•
covers all cardiometabolic therapeutic areas•
is currently undertaking 30 clinical trials•
3
Brisbane
Bundaberg
Melbourne
Adelaide
1
45
Perth
6
2
7
1514
Our dedicated clinical trials sites and teams are located in Queensland, South Australia, Victoria and Western Australia. The teams liaise with patients, clinicians and sponsors to ensure quality care is delivered to our research study participants. Through the clinical trials program, the research team are constantly improving patient outcomes and providing patients with access to emerging treatments and medical devices.
GenesisCare’s Cardiology Research Network operates at 7 sites across Australia.
Wesley HospitalWesley Testing CentreLevel 2, The Wesley Hospital30 Chasely StreetAuchenflower QLD 4066
Queensland
Friendly Society Private Hospital19–23 Bingera StreetBundaberg QLD 4670
1.
2.
Suites 1 & 235 Cranbourne-Frankston RoadLangwarrin VIC 3910
284 Kensington Road Leabrook SA 5068 Suites 8–10
20 Scholar DriveBundoora VIC 3083
St John of God Wexford Medical CentreLevel 4, Suite 68–72,3 Barry Marshall ParadeMurdoch WA 6150
Western Australia6.
7. Level 3 Shenton House 57 Shenton AvenueJoondalup WA 6027
Victoria
SouthAustralia
3.
5. 4.
GenesisCare Cardiology Clinical Trial Sites in Australia
Cardiology research locations
1716
Cardiology research team(as at 31 December 2018)
NationalProfessor Stephen G. Worthley MBBS, PhD, FRACP, FACC, FCSANZ, FRCP, Executive Manager – Cardiology, Sleep & Respiratory, GenesisCare
Dr Daniel Cehic MBBS, MBA, FRACP, FCSANZ, Chief Medical Officer, Cardiology, Sleep & Respiratory, GenesisCare
Stuart Behncken PhD, National Program Manager, Cardiology, Sleep & Respiratory, GenesisCare
Dr David Eccleston, MBBS, MMedSci, FRACP, FCSANZ, FSCAI, FACC, Clinical Services Director, Cardiology Research, GenesisCare
Mrs Sonya McColl National Research Manager
Dr Sinny Delacroix Research and Development Manager
Mrs Arlene Ewan National Research Operations Lead
Ms My-Ngan Duong Clinical Research Officer
Mrs Megan Lehnert National Research Governance Coordinator
Giri Chokka Clinical Research Data AnalystDr
Mrs Anthea Byers National Research Administration Assistant
Research Team:
Dr Deepak ArumugamMBBS, BSc (Hons), FRACP, FCSANZ
Dr Anthony CamugliaMBBS (Hons1), FRACP, FCSANZ
Dr Andre ConradieMBCHB, MMED, FCP(SA), FRACP, FCSANZ
Dr Michelle ButlerMBBS (Melb), FRACP, FCSANZ
Dr Gerard ConnorsMBBS (Hons), FRACP, FCSANZ, GAICD
Dr Stephen CoxMBBS, FRACP, FCSANZ
Mater Private Hospital Brisbane, The Wesley Hospital
Mater Private Hospital Brisbane, The Wesley Hospital, Princess Alexandra Hospital, St Vincent’s Private Hospital Toowoomba, Friendly Society Private Hospital Bundaberg, The University of Queensland
Friendly Society Private Hospital Bundaberg, Bundaberg Base Hospital
Mater Private Hospital Brisbane
Greenslopes Private Hospital, Princess Alexandra Hospital
The Wesley Hospital, Mater Hospital Rockhampton, Princess Alexandra Hospital, Lady Bjelke-Petersen Community Hospital
Cardiologists: Affiliations:
Queensland
Dr David CrossMBBS, FRACP, FCSANZ
Dr Robert FathiMBBS, PhD, FRACP, FCSANZ
Dr David Di FioreMBBS, FRACP, FCSANZ
Dr David GroutMBBS, FRACP
The Wesley Hospital, Sunshine Coast University Private Hospital, Royal Brisbane and Women’s Hospital, Wesley Medical Research (Cardiology and Cardiac Surgery Research Committee)
The Wesley Hospital
Friendly Society Private Hospital Bundaberg, Bundaberg Base Hospital
Friendly Society Private Hospital Bundaberg, Bundaberg Base Hospital
Dr Georgy ChackoMBBS, MRCP (IRELAND), MRCP (UK), FRACP
Dr Patrick DisneyMBBS, FRACP, FCSANZ
Dr Jamie MortonMBBS, PhD, FRACP, FCSANZ, FESC
Dr Luay SamaraieMBChB, FRACP
Dr Charles TieMBChB, FRACP
Dr Samuel SidhartaMBBS, BMedSci, FRACP, PhD, FCSANZ
A/Prof Glenn YoungMBBS, FRACP, FCSANZ
Dr Sinny DelacroixMD, MSc, PhD
Dr Joseph MontarelloMBBS, FRACP, FCSANZ
Dr Peter SageMBBS, FRACP, PhD, FCSANZ
Dr Maria SantosMD, FRACP, FCSANZ
Dr Srini SrinivasanMBBS, FRACP
Prof Stephen WorthleyMBBS, PhD, FRACP, FACC, FCSANZ, FRCP
St Andrew’s Hospital, Calvary Wakefield Hospital
Royal Adelaide Hospital, Women’s and Children’s Hospital, St Andrews Hospital
St Andrew’s Hospital
St Andrew’s Hospital
St Andrew’s Hospital
St Andrew’s Hospital, Calvary Wakefield Hospital
Royal Adelaide Hospital, The University of Adelaide, Cardiac Society of Australia and New Zealand
Royal Adelaide Hospital, University of Adelaide
Royal Adelaide Hospital, Queen Elizabeth Hospital, St Andrews Hospital, University of Adelaide
Queen Elizabeth Hospital, St Andrews Hospital, The University of Adelaide, Royal Adelaide Hospital
St Andrew’s Hospital, Calvary Wakefield Hospital
St Andrew’s Hospital
Royal Adelaide Hospital, Queen Elizabeth Hospital, St Andrews Hospital
Cardiologists: Affiliations:
1918
South Australia
Mrs Renae Deans Lead Clinical Research Coordinator
Ms Kristen Fragnito Clinical Research Coordinator
Mr Michael Contibas Clinical Research Coordinator
Mrs Joanna Cole Clinical Research Assistant
Research Team:
Dr Terri HallBSc, MBBS (Hons), FRACP
Dr Peter MooreBSc, MBBS (Hons), FRACP
Dr Karen PhillipsMBBS (Hons), FRACP, FCSANZ, FHRS
Dr Andrew RainbirdMBBS, FRACP, FCSANZ
Dr Anders TaylorMBBS, FRACP, FCSANZ
Dr Julie HumphriesMBBS, FRACP, FCSANZ, FASE, BHMS (Ed) (Hons-1st Class)
Dr Stephen PaviaMBBS, FRACP, FCSANZ
Dr Anthony RafterBPharm, MBBS (Hons), FRACP
Prof Gregory ScaliaMBBS (Hons), MMedSc, FRACP, FCSANZ, FACC, FASE, JP
Dr Hermann WittmerMBBCH, DTM&H, FCP(SA), FRACP
Mater Private Hospital Brisbane, Greenslopes Private Hospital, Mater Hospital Gladstone
The Wesley Hospital, Sunshine Coast University Private Hospital, Sunshine Coast University Hospital, St Vincent’s Private Hospital Toowoomba
Greenslopes Private Hospital
The Wesley Hospital, Mater Hospital Gladstone
Greenslopes Private Hospital
Greenslopes Private Hospital, The Prince Charles Hospital
The Wesley Hospital, Mater Hospital Rockhampton
The Wesley Hospital, Sunshine Coast University Private Hospital, Mater Hospital Gladstone, St Vincent’s Private Hospital Toowoomba
The Wesley Hospital, The Prince Charles Hospital, The University of Queensland
Friendly Society Private Hospital Bundaberg, Bundaberg Base Hospital
Cardiologists: Affiliations:
Mrs Sonia Nelson Lead Clinical Research Coordinator
Mrs Olivia Shelton Clinical Research Coordinator
Mrs Lesley Bryant Clinical Research Coordinator
Ms Kassandra Howes Clinical Research Coordinator
Mrs Judy Jeffrey Clinical Research Coordinator
Karen Fox Clinical Research CoordinatorMrs
Mrs Jill Morgan Clinical Research Coordinator
Research Team:
Dr Stefan BuchholzMBBS, MD (Hons) MRCP (UK), FRACP, FCSANZ
Dr Ben KingMBBS (HONS), FRACP, GRAD DIP (EP), FCSANZ
Dr Vincent PaulBSc, MBChB, MD, FRCP, FRACP, FCSANZ
Prof Peter ThompsonAM, MD, MBBS, MBA, FRACP, FACP, FACC, FCSANZ
Dr Xiao-Fang XuMBBS, PhD, FRACP, FCSANZ
Dr Pradyot SaklaniMBBS (Hons) FRACP, FCSANZ
Dr Randall HendriksBMedSc, MBBS, FRACP, FCSANZ
Dr Stefan (Mark) NidorfMD, MBBS, FRACP, FACC, FCSANZ
Dr Peter PurnellMBBS, FRACP, FCSANZ
Dr Isabel TanMBBS (HONS1), FRACP, FCSANZ
Dr Alan WhelanMBBS, BSc, MRCP (UK), FRACP, FCSANZ
St John of God Bunbury
Mount Hospital, St John of God Murdoch, Royal Perth Hospital, Fiona Stanley Hospital
St John of God Murdoch, St John of God Bunbury, Fiona Stanley Hospital
Sir Charles Gairdner Hospital, Heart & Vascular Research Institute, Harry Perkins Institute for Medical Research
Fiona Stanley Hospital, St John of God Murdoch, Mount Hospital, Hollywood Private Hospital
Mount Hospital, St John of God Murdoch, Royal Perth Hospital, Sir Charles Gardiner Hospital
St John of God Murdoch, St John of God Bunbury, Mount Hospital
Heart Research Institute
Joondalup Health Campus, Mount Hospital, Joondalup Cardiovascular Trials Foundation
Mount Hospital, Joondalup Health Campus, Hollywood Private Hospital
St John of God Murdoch, Fiona Stanley Hospital, Mount Hospital
Cardiologists: Affiliations:
Western Australia
Ms Hanne Files Clinical Research Coordinator
Mrs Christine McNally Clinical Research Assistant
Ms Kimberley D’Costa Clinical Research Coordinator
Mrs Joy Vibert Lead Clinical Research Coordinator
Miss Hayley Mammatt Clinical Research Coordinator
Ms Jo Crittenden Clinical Research Coordinator
Mrs Leonie Perrett Clinical Research Coordinator
Katherine MacLean Clinical Research CoordinatorMs
Mrs Gill Tulloch Clinical Research Coordinator
Research Team:
Dr Joseph AminMBBCh, MSc, FRACP, FCSANZ
Dr John CotroneoMBBS, FRACP, FCSANZ, FASE
Dr Rosanna Hage-AliMBBS, FRACP
Dr Rajika KarunadasaMBBS, FRACP
Dr Mohammad LatifMBChB (NZ), FRACP
Dr Pey Wen LouMBBCh, FRACP, MRCP (UK)
Dr David O’DonnellMBBS, FRACP, FCSANZ
Dr Wai-ee ThaiMBBS (Hons), FRACP
A/Prof Piyush SrivastavaMBBS, FRACP, FCSANZ, FESC, FACC, FAHA
Dr Jaya ChandrasekharMBBS, MRCP, FRACP, MS
Dr Mark HorriganMBBS, FRACP, FCSANZ
Dr Tina LinMBBS, BMedSci, FRACP
Dr Ken LuMBBS, FRACP
Dr Ali SafaaMBChB, FRACP, FCSANZ
Dr Matthew SwaleMBBS (Hons), FRACP, BMedSci
Dr Bryan WaiMBBS, FRACP
Dr Leighton KearneyBMedSci, MBBS (Hons), PhD, FRACP
A/Prof David EcclestonMBBS, MMedSci, FRACP, FCSANZ, FSCAI, FACC
Mulgrave Private Hospital
Austin Health
Warringal Private Hospital, NorthPark Private Hospital
Mulgrave Private Hospital, St John of God Berwick
Warringal Private Hospital
The Alfred, Bendigo Hospital
Austin Health, Warringal Private Hospital
Mulgrave Private Hospital
Austin Health, Mulgrave Private Hospital, Epworth Richmond, The University of Melbourne
Warringal Private Hospital, Box Hill Hospital, Monash University, Eastern Health Clinical School
Austin Health, Warringal Private Hospital
Warringal Private, Austin, Eastern Health Box Hill, Epworth Richmond, Epworth Eastern
Austin Health, Warringal Private Hospital
Mulgrave Private Hospital, St John of God Berwick
Mulgrave Private Hospital, St John of God Berwick, Warringal Private Hospital, Albury Private Hospital
Mulgrave Private Hospital, St John of God Berwick, The University of Melbourne, Austin Health
Austin Health, Warringal Private Hospital
The Royal Melbourne Hospital, Melbourne Private, The University of Melbourne, Warringal Private Hospital, Epworth Richmond
Cardiologists: Affiliations:
Victoria
Ms Michelle Ord Lead Clinical Research Coordinator
Ms Patzy Low Clinical Research Coordinator
Mrs Melissa Sarah Clinical Research Coordinator
Research Team:
2120
Clinical trials
2322
2524
Research Register 2018GenesisCare participated in the following clinical trials in 2018.
MAVERIC
As Abbreviated Title Title Description Location
Mitral valve repair clinical trial
An evaluation of the treatment of patients with mitral regurgitation with the new mitral valve repair system called the MVRx ARTO™ System
Device –Mitral Valve Regurgitation (first in human)
Pharma –Statin Intolerance (Phase III)
Pharma –Heart Failure (Heart Failure reduced Ejection Fraction) (Phase III)
Amgen
Esperion
MVRx GenesisCare South Australia- LeabrookGenesisCare Queensland- BrisbaneGenesisCare Victoria- WarringalGenesisCare Western Australia - Murdoch
GenesisCare South Australia- LeabrookGenesisCare Queensland- BrisbaneGenesisCare Western Australia - Murdoch
GenesisCare South Australia- LeabrookGenesisCare Queensland- Brisbane, BundabergGenesisCare Western Australia - Joondalup, Murdoch
GenesisCare Victoria- Bundoora
A randomised, double-blind, placebo-controlled study to assess the effects of Bempedoic Acid (ETC-1002) on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are statin intolerant
To determine if treatment with a new drug Bempedoic Acid reduces the risk of major cardiovascular (heart and blood vessel-related) events in participants with, or at high risk for, heart disease who have had complications related to taking statins
AmplatzerTM AmuletTM Left Atrial Appendage Occluder randomised controlled trial
A double-blind, randomized, placebo-controlled, multi-centre study to assess the efficacy and safety of Omecamtiv Mercabil on mortality and morbidity in subjects with chronic heart failure with reduced ejection fraction
To evaluate a new drug called Omecamtiv Mecarbil in people with chronic heart failure
To demonstrate the safety and effectiveness of the Amulet device in patients with non-valvular atrial fibrillation
Device –Left Atrial Appendage
AbbottAMULET
CLEAR
GALACTIC-HF
Type Sponsor
2726
AMG986
COAST
RIVER
As Abbreviated Title Title Description Location
A phase I, randomised, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 986 in healthy subjects and heart failure patients.
CardioMEMS™ HF System OUS Post Market Study
Prospective, multi-centre, international registry of male and female patients newly diagnosed with atrial fibrillation and treated with Rivaroxaban
To test whether a new compound is effective in treating heart failure and how it works in the body
An evaluation of the use of the new CardioMEMS HF System in in the routine care of Class III heart failure patients and to provide more information on the safety, effectiveness and reliability of the system
An observational study to discover the outcomes of patients treated with Rivaroxaban for atrial fibrillation
Pharma –Heart Failure (Heart Failure preserved Ejection Fraction)(Phase III)
Device –Pulmonary Artery pressure sensor for Heart Failure
Registry –Anti-thrombotic
Amgen
Abbott
Thrombosis Research Institute
GenesisCare South Australia- LeabrookGenesisCare Queensland- Brisbane, BundabergGenesisCare Victoria- Berwick, Bundoora
GenesisCare South Australia- LeabrookGenesisCare Queensland- Brisbane, BundabergGenesisCare Victoria- Warringal, ValleyGenesisCare Western Australia- Perth
GenesisCare Queensland- Brisbane
GenesisCare Queensland- Brisbane
GenesisCare Queensland- BrisbaneGenesisCare Western Australia - Joondalup
Semaglutide effects on cardiovascular outcomes in people with obesity or who are overweight
Effects of patient posture and physical activity
To evaluate if Semaglutide may reduce the risk of cardiovascular events in overweight or obese patients with prior cardiovascular disease
To evaluate the clinical safety and effectiveness of the implantable cardiac monitor called Confirm Rx™ in monitoring participants’ heart rate and rhythm during changes in their posture and physical activities
Pharma –CVOT (Phase III)
Device – Implantable Cardiac Monitor
Novo Nordisk
Abbott
SELECT
Confirm Rx
Type Sponsor
2928
ASSURE
PARAGON
As Abbreviated Title Title Description Location
Clinical Study to confirm MRI safety and effectiveness using St Jude Medical (SJM) Cardiac Rhythm Management System
A multi-centre, randomised, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction
To confirm the safety and effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber Implantable Cardioverter-Defibrillators (ICD), and Cardiac Resynchronization Therapy Defibrillators (CRT-D) in patients during an MRI
To evaluate the effect of a new drug LCZ696 in patients with Class II -IV heart failure with preserved ejection fraction
Device – MRI
Pharma –Heart Failure (Heart Failure preserved Ejection Fraction)(Phase III)
Abbott
Novartis
GenesisCare Queensland- BrisbaneGenesisCare Western Australia- Murdoch
GenesisCare Victoria- BundooraGenesisCare Queensland- Brisbane
GenesisCare South Australia- LeabrookGenesisCare Queensland- Bundaberg
GenesisCare Queensland- Brisbane
GenesisCare Queensland- Brisbane
Watchman Asia Pacific Registry
International Registry to assess medical practice with longitudinal observation for treatment of heart failure
A randomised controlled trial with Resolute Onyx in one-month DAPT (Dual Anti-Platelet Therapy) for high-bleeding risk patients
To compile real-world clinical outcomes data in patients who are implanted with the Watchman device
To observe the current medical care of patients with heart failure
To evaluate the clinical safety and effectiveness of the Resolute Onyx stent in participants deemed at high risk for bleeding and/or medically unsuitable for more than 1 month Dual Anti Platelet Therapy (DAPT) following stent implantation
Registry –Left Atrial Appendage
Registry –Heart Failure
Device – Stent
Boston Scientific
Novartis
Medtronic
WASP
REPORT-HF
ONYX ONE
Type Sponsor
3130
STRENGTH
CANTOS
As Abbreviated Title Title Description Location
A long-term outcomes study to assess statin residual risk reduction with Epanova in high cardiovascular risk patients with hypertriglyceridemia
A randomised, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP
To evaluate the effectiveness of adding a new drug Epanova to statin therapy for high cardiovascular risk patients with persistent hypertriglyceridemia and low HDL- cholesterol
To evaluate if the drug Canakinumab is both safe and beneficial in reducing cardiovascular events such as heart attack or stroke in the treatment of patients who have had a heart attack. The extension phase of the study is to collect additional long-term safety data on Canakinumab
Pharma –Lipids (Phase III)
Pharma –Coronary Artery Disease (Phase III)
AstraZeneca
Novartis
GenesisCare Queensland- Brisbane
GenesisCare Victoria- Bundoora
GenesisCare Queensland- Brisbane
GenesisCare Queensland- Brisbane
International long-term follow up study of patients implanted with a PORTICO™ Valve
A randomised, double-blind, placebo-controlled, parallel-group study to evaluate the effect of long-term treatment with BELVIQ (Lorcaserin HCl) on the Incidence of major adverse cardiovascular events and conversion to Type 2 Diabetes Mellitus in obese and overweight subjects with cardiovascular disease or multiple cardiovascular risk factors
To assess the performance and safety of the Portico Valve implanted in patients with severe symptomatic aortic stenosis
To assess if a new drug Lorcaserin affects the risk of developing cardiovascular disease in obese or overweight subjects with cardiovascular disease and/or multiple cardiovascular risk factors
Device –Aortic Stenosis
Pharma –Coronary Artery Disease (Phase III)
Abbott
Eisai
PORTICO I
CAMELLIA TIMI61
Type Sponsor
3332
RevElution
Entresto Patient Characteristics
Fabry DiseasePhase 1 & 2
As Abbreviated Title
Data Projects
Title Description
Description
Location
Location
A clinical evaluation of the Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions: Revascularization using a non-polymeric drug-eluting stent with internal drug loading
To educate clinicians who are currently not prescribing Entresto as to the characteristics that would make a patient suitable for Entresto treatment
To reduce the time to diagnosis and collect valuable data on the epidemiology of Fabry disease
To evaluate the safety and provide information on this new polymer-free drug-eluting coronary stent system
Device – Stent
Database
Database
Medtronic
Novartis
Sanofi
GenesisCare Queensland- Brisbane
A randomised parallel-group, placebo-controlled, double-Blind, event-driven, multi-centre pivotal phase III clinical outcome trial of efficacy and safety of the Oral sGC – Stimulator Vericiguat in subjects with Heart Failure With Reduced Ejection Fraction (HFrEF) – Vericiguat Global Study in subjects with heart failure with reduced ejection fraction
To evaluate the safety and effect of a new drug Vericiguat in subjects with heart failure with reduced ejection fraction
Pharma –Heart Failure (Heart Failure reduced Ejection Fraction) (Phase III)
MerckVICTORIA
Type
Type
Sponsor
Sponsor
GenesisCare Queensland- BrisbaneGenesisCare South Australia- Leabrook
N/A
N/A
3534
Clinical trial feature - MAVERIC
Sponsor MVRx
Description The MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) is the first in-human trial of the ARTO transcatheter mitral valve repair system.
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
The ARTO system is designed to reshape and tighten the mitral valve, enabling the “forward” flow of blood and alleviating mitral valve regurgitation. This procedure will reduce symptoms of heart failure, such as shortness of breath and fatigue and improve overall quality of life.
Percutaneous treatment of functional mitral regurgitation remains an unmet clinical need in the field of adult structural heart disease. Percutaneous therapies have the potential to provide a treatment option to patients who are not currently offered surgery.
Trial aims To evaluate the safety and performance of the ARTO system in patients with mitral valve regurgitation associated with congestive heart failure.
GenesisCare is the only Australian group participating in this study. This is an early phase innovative study for mitral valve repair, with favourable 12 and 24 month outcomes data.
Adelaide, Brisbane, Melbourne, PerthLocations
Key outcomes Initial 12-month results indicate that the procedure can be performed safely with a clinically meaningful reduction in mitral regurgitation. Larger trials with longer term follow up are planned.
Primary Outcome Measures
Secondary Outcomes Measures
Safety: Major Adverse Events at 30 days•
NYHA Class•
Efficacy: MR Grade at 30 days•
Heart Failure Hospitalisation•
Device success•
30 days 6 months 1 year 2 yearsTreatment
n=45
100%of patients had MR > 2+ pre-op
92%of patients had MR ≤ 2+ at 1 year
70%of patients classified as NYHA Class III/IV pre-op
80%of patients classified as NYHA Class I/II at 1 year
91%of patients had been hospitalised for HF at least once in the 2 years prior
27%of patients had been hospitalised for HF at 1 year post treatment
Multi-centre, Single Arm Patient Safety and Efficacy Study One Year ResultsClinical and echocardiographic follow up schedule
3736
Professor Stephen WorthleyMBBS, PhD, FRACP, FACC, FCSANZ, FRCPExecutive Manager - Cardiology, Sleep and Respiratory GenesisCare
Maveric Team in QueenslandLeft: Drs Rafter, Worthley, Rainbird, Camuglia, Keys and Scalia
Maveric team at The Wesley Hospital, Brisbane
Heart failure is a serious medical condition, and is often caused by previous heart attacks … This is a field of medicine that’s exploring new devices and techniques – with the aim of giving patients hope – for those who have very limited options.
Professor Stephen Worthley
3938
Clinical trial feature - CONFIRM Rx
Sponsor Abbott
Description
Key point ofdifference
This study evaluates the effects of patient posture and physical activity on the CONFIRM insertable cardiac monitor.
Trial aims To characterise the safety and performance of CONFIRM Rx by assessing the quality of signal attained from the device with changes in posture and physical activity at implant and 30 days post procedure.
Cardiac monitors are leadless devices which are implanted for the long-term monitoring of the heart’s rhythm. There is very little data available on the signal sensing variations due to posture and movement. This study is being conducted only by GenesisCare.
This project monitors the sensing and analysis of the devices and allows for ongoing improvement and better patient outcomes. Our investigators are working with project sponsor Abbott, to improve the diagnosis of arrythmias and therefore improve patient outcomes.
Locations
Dr Sinny DelacroixMD (Hons), PhDNational Research and Development Manager - Cardiology, GenesisCare
Adelaide, Brisbane, Bundaberg, Melbourne, Perth, Bunbury, Hervey Bay
Trial aims To evaluate the safety and effectiveness of the Amulet device.
4140
Clinical trial feature - AMULET
Sponsor Abbott
Description This study evaluates the safety and effectiveness of the Amulet device. The Amulet device is a left atrial appendage occluder intended to reduce the risk of thromboembolism from the left atrial appendage.
Patients who have atrial fibrillation are at a high risk of developing a thromboembolism however not all patients are suitable for anticoagulant therapy. This closure procedure, therefore, may be recommended for patients who have atrial fibrillation where anticoagulant therapy is not suitable.
There is currently limited real-world data evaluating left atrial appendage closure.
This is a large international study with 119 sites participating. Of the 4 Australian sites, 3 sites are from GenesisCare.
Adelaide, Brisbane, PerthLocationsNormal
Right atrium
Left atrium
Sinoatrial node(pacemaker)
Atrioventricular node
Atrial Fibrillation
4342
Clinical trial feature - ONYX ONE
Sponsor Medtronic
Description ONYX One is a randomised controlled study with Resolute Onyx in 1-month DAPT (Dual Anti-Platelet Therapy) for high-bleeding risk patients. The Resolute Onyx stent is a 4th generation drug-eluting stent.
Trial aims To evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Adelaide, BundabergLocations
GenesisCare enrolled the most patients in Australia and fourth highest globally for the ONYX-ONE trial (77 patients).
GenesisCare in Adelaide enrolled 42 patients (11th highest enrolling site globally and Bundaberg enrolled 35 patients (15th highest enrolling site globally).
ONYX One was the first study to be undertaken by GenesisCare’s cardiology research team in Bundaberg.
GenesisCare now provides a regional research service to the Wide Bay community in Queensland.
L:R: Karen Fox (Clinical Research Coordinator), Dr David Grout, Dr David Di Fiore, Dr Andre Conradie, Kassandra
Howes (Clinical Research Coordinator), Dr Herman Wittmer.
Key point ofdifference
Patients who are statin intolerant have an unmet medical need for therapeutic options to lower their LDL-Cholesterol and reduce their risk of cardiovascular disease. This study highlights the national approach to clinical trial participation being developed by GenesisCare. This was the first study conducted where the participating sites spanned across the entire GenesisCare network.
GenesisCare has 6 sites participating in this trial across Western Australia, South Australia, Victoria and Queensland.
Trial aims To evaluate whether long-term treatment with Bempedoic Acid reduces the risk of major adverse cardiovascular events.
4544
Clinical trial feature - CLEAR
Sponsor Esperion
Description A phase III study to assess the effects of Bempedoic Acid in patients who are statin intolerant.
Adelaide, Brisbane, Bundaberg, Melbourne, PerthLocations
This trial includes more than 12,000 people aged 18 or older worldwide who have cardiovascular or heart disease, or who are at high risk for cardiovascular disease.
Outcomesregistries
4746
4948
GenesisCare Cardiovascular Outcomes Registry (GCOR)GenesisCare’s national cardiology clinical quality registries aim to improve the quality of care provided to patients with cardiovascular disease. The registries enable the collection and reporting of clinical data to identify patient outcomes; identify issues that may impede more successful outcomes and ways to improve patient outcomes; collect patient reported outcomes; and benchmark our performance against national and international standards.
The registries commenced in 2008 and have been the basis for the development of performance and quality metrics, site-level quality improvement programs and peer-reviewed research.
GCOR collects information on:
This large dataset provides unique opportunities to explore the varied aspects of health care and outcomes, including population characteristics, risk factor identification, prediction (diagnostic or prognostic) models, medication compliance and medium and long-term safety of devices and procedures.
Patients undergoing angioplasty (PCI Registry)•
Patients attending Heart Failure Clinics (Heart Failure Registry)•
Patients undergoing cardiac imaging protocols (Echo Database)•
Patients undergoing a cardiac implantable device eg. pacemaker or defibrillator (Device Registry)
•
Improving Quality Care & Guideline Compliance in Australia With National Outcome Registries
We aim to:
capture 100% of patients•
monitor and benchmark compliance, care and outcomes•
support evidence-based therapies•
create efficiencies in healthcare•
contribute to reducing mortality and morbidity•
provide a national set of risk-adjusted, consumer-focused & current clinical performance indicators to reflect clinical variations and patient outcomes
•
inform research and the scientific community on coronary disease through publications/presentations
•
MBBS MMedSci FRACP FCSANZ FSCAI FACCClinical Services Director- Cardiology Research, GenesisCare
A/Prof David Eccleston
As Australia’s leading private provider of cardiac treatment services, GenesisCare’s patient databases and outcomes registries provide significant real-world data on patients, procedures, treatments and outcomes. Our quality data collection,
collected over many years, allows GenesisCare to create new registries and models of care to facilitate better health outcomes for our patients and invest in technologies that support ongoing data improvement and use.
QueenslandClayfield
Greenslopes Private Hospital
Capalaba
Mater Private Hospital BrisbaneMount OmmaneyThe Wesley HospitalSunshine Coast University Private HospitalWestside Private HospitalBeaudesert
EmeraldGladstoneGympieJimboombaKingaroyMaryboroughRockhamptonRomaSpringfieldToowoomba
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Hervey Bay22.
Friendly Society Private Hospital (Bundaberg)
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Bundaberg Base Hospital (Bundaberg West)
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South AustraliaAdelaide
LeabrookMalvernModburyGawlerNuriootpaClare
Mount Barker
Broken Hill
KadinaMurray Bridge
Cockburn
Karratha Mandurah
Port Hedland
ManjimupMargaret River
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Western Australia
Joondalup Kalamunda Midland Murdoch Nedlands Mount HospitalYokineAlbany Bunbury Busselton Denmark Dunsborough
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41
4546
51
49
47 48
16
1310
17
1
2
118
5 7 12
19
15
9
1418
35
39
24
3438
25
26
33 32
40
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5044
36
4
42
36
31
2327
2829
30
58
North Melbourne
Parkville
Ringwood
BerwickBundoora
Langwarrin
PakenhamDoncaster East
Lilydale
MoeMulgrave53.
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VictoriaAlbury 52.
Vermont South
Whittlesea
Balwyn
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East Melbourne Heidelberg Surrey Hills
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6757
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GenesisCareRegistrySitesAustralia
5150
5352
Percutaneous Coronary Intervention (PCI) registry - patients undergoing angioplasty
Key information
Outcome measuresThe Percutaneous Coronary Intervention (PCI) Registry data collection commenced in November 2008. The registry aims to improve patient care by evaluating care provided through PCI interventions to ensure it is within current clinical care guidelines, meets national/international cardiovascular standards and demonstrates evidence based care.
Commenced 2008•
Clinical characteristics and risk factors (smoking, Body Mass Index)•
Approx. 200 data points•
Biomedical (lipids, blood pressure, diabetes)•
Surgical (bare metal stent/drug eluting stent)•
Readmission rate (unplanned readmission rate for cardiac related condition)
•
Health outcomes (complications – haemorrhage, stroke, myocardial infarction, age/condition adjusted mortality rates)
•
Patient Reported Outcome Measures (PROMs) – Quality of Life•
>12,500 procedures•
Pharmacological (Guideline medication adherence – statins & antiplatelet therapy)
•
Only national PCI database in Australia•
> 30 national and international papers and presentations•
5554
GCOR is GenesisCare’s Cardiovascular Outcomes Registry.Source: Eccleston D, Horrigan M, Rafter T, Holt G, Worthley SG, Sage P, Whelan A, Reid C, Thompson PL Improving Guideline Compliance in Australia With a National Percutaneous Coronary Intervention Outcomes Registry. Heart, Lung and Circulation, Volume 26, Issue 12, 1308.
Mean age (y)
% ISAR-COOL TIMACS Euro-Aspire IV NCDR-Angio/PCI GCOR baselineOPTIMA
70 65 69 72 6462
67 65 67 67 7572Male
Diabetes
Previous MI
Received Antiplatelet
29 27 27 22 2520
23 20 21 19 2623
99 98 93 100 1009
86 N/A 83 55 6643
67 57 68 64 100100
85 85 85.7 85 94.4
Hypertension
Received PCI
Received Statin
Current smoker 21 N/A 27 N/A 2538
12 7 7 13 86Previous CABG
Comparison of Patient Clinical Characteristics and Guideline Treatment Compliance Between PCI Trials, Coronary Artery Disease Registries and GCOR Cohort
GenesisCare’s rigorous data collection and analysis of patients provides evidence of excellence in cardiac care.
20%
40%
60%
80%
100%
98.42% 92.82%
Antiplatelet therapy
3.32% 8.86%
Readmissions
93.44% 92.26% 4.22%
Statin therapy
25.24% 21.35%
PROMs - quality of Life
Patients prescribed statins at baselinePatients prescribed statins at 12 monthsPatients on no lipid-lowering therapy at 12 months
Patients with moderate or extreme anxiety or depression at baselinePatients with moderate or extreme anxiety or depression at 12 months
Patients with unplanned readmission to hospital within 30 days for cardiac related conditionPatients with unplanned readmission to hospital within 12 months for cardiac related condition
PCI registry outcomes - as at December 2018(Number of Patients = 12,860)
Comparison of PCI Outcomes Registries globally(PCI Database Comparisons)
Device registry- patients undergoing a cardiac implantable device eg. pacemaker or defibrillator
The Cardiac Implantable Electronic Devices (CIED) Database, also known as the Device registry, was established in 2016. Several large registries have reported outcomes after CIED implantation in the USA and Europe, however there were no prospectively collected national data regarding outcomes after CIED implantation in Australia at that time.
This registry aims to improve patient care by:
Auditing the success and complication rates associated with the implantation of CEIDs by GenesisCare cardiologists
•
Evaluating prespecified fields that are procedurally related in order to determine whether these factors play a clinically significant role in success and complication rates during CEID implants
•
Key informationCommenced 2016•
Approx. 100 data points•
> 5,000 procedures•
First national paper and presentation in 2017•
With ethics approval, GCOR collects de-identified data on consecutively enrolled patients in an electronic database. With national ethics approval baseline demographic and procedural data, medication use and in-hospital and 30-day outcomes including device-related complications, readmission and mortality are collected. Performance and outcome measure feedback is provided to participating hospitals and cardiologists, to allow benchmarking against national and international results, although these data are de-identified in reports to hospitals and implanting physicians
•
50
0
100
150
200
250
300
350
400
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500
60-69Age (years): 70-79
53 62 112 154 276 426 404 444 130 140< 60 80-89 >=90
Num
ber
of p
ati
ents
Female Male
Initial reports at national meetings in 2017 (n= 1331) and 2018 (n= 4006) demonstrated that clinical practice and 30-day outcomes after CIED implantation in Australian private hospitals are consistent with international reports. There was no difference in procedural complication rates or other outcomes between women and men, regardless of age or CIED system implanted. Both 30-day mortality (0.05%) and major complication rates (0.79%) were low, in comparison with international series.
Our initial report as at 2017 with 1,331 entries demonstrates favourable outcomes – 97.16% of patients had the intended device successfully implanted.
Outcome measuresImplants (type – new/replacement)•
Indication for implant•
Health Outcomes (complications – major, minor, stroke, mortality) in-hospital and at 30 days and 1 year
•
Success of implantation (implanted/intended)
Readmission rate (cardiac-related condition) at 30 days and 1 year
•
•
Device registry outcomes - as at 31 December 2018*(Number of Patients = 5,583)
Figure 1. Number of dual-chamber pacemaker implants according to gender and age decade
5756
Complication Rate
2.51%Overall minor complication rate
0.47%Overall major complication rate
1.45%Minor complication within 12 months
0.27%Major complication within 12 months
3.13%Minor complication within 30 days
0.39%Major complication within 30 days
Readmissions
1.27% Patients with readmission to hospital within 30 days for cardiac related condition
1.93% Patients with readmission to hospital within 12 months for cardiac related condition
The December 2018 report provides outcome data on 5,583 devices implanted. The results include:
0
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0.8
1.0
1.2
Com
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GenesisCare @ Implantation US @ Implant Cleveland Clinic @ 30 daysCleveland Clinic @ 90 days Danish Cohort @ 180 days
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Extr
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Eros
ion
Phre
nic
Ner
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Ob
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Arr
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Com
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5958
GenesisCare¹
United States– Cleveland Clinic²
United States4(hospital dischargeabstracts from the 1997-2004Healthcare Cost and Utilization ProjectNationwide InpatientSamples)
Denmark³
Study population Complication Rate Time Period
5,583
872 ICD & Pacemaker implants
Approximately 67,000 AICDs and 178,000 PMs were implanted in 2004 in the United States
5,918
2016–18
2016
1997 – 2004
May 2010 – April 2011
2.51% (aggregated data)
3.44% Initial Implantation Complications
3.26%-16.8% (depending on device type)
9.5% (562 patients experienced at least one complication)
Source:
1. O’Donnell, D, Cehic, D, Lin, T, Pavia S, Salklani, P, Eccleston, D, Outcomes After Cardiac Device Implantation in Australia: 1-Year Results from the GenesisCare National Multicentre Registry. Heart Lung and Circulation, 2018 Volume 27, Supplement 2, Pages S181–S182
2. Sydell and Arnold Miller Family, Heart & Vascular Institute, 2016 Outcomes, Cleveland Clinic
3. Kirkfeldt RE1, Johansen JB, Nohr EA, Jørgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18) https://www.ncbi.nlm.nih.gov/pubmed/24347317
4. Zhan C1, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis. J Gen Intern Med. 2008 Jan;23 Suppl 1:13–9 https://www.ncbi.nlm.nih.gov/pubmed/18095038
Complication rates from CIED implantation for GenesisCare vs US (median), Cleveland Clinic (30 & 90 days) and Danish Registries
Heart failure registry- patients attending GenesisCare Heart Failure Management Clinics
Heart failure is a huge problem, and getting worse. Heart failure (HF) is a growing epidemic affecting an estimated 40 million people worldwide¹ and over 500,000 Australians².
Burden to the patient
Prevalence and impact
Frequent visits to hospital25% re-admission within 30 days•
50% re-admission within 6 months•
Mortality10th leading cause of mortality•
50% survival rate at 5 years post diagnosis•
Quality of Life90% of patients have trouble breathing•
30% of patients cannot breathe when lying flat•
511,000 (2.1% Australians) /year
67,000 new cases
$3.1 billion in health care /year
$2 billion in hospital care
158,000 admissions /year
1.1 million days of hospital stay
+146,000 case /10 years
657,000 cases by 2025
61,000 HF-related deaths /year
9,300 deaths within 1 year of de novo admission
6160
Source: Heart Foundation 2013, Australian Bureau of Statistics 2012,Beach Study 2017.
2 (SS Chan YK, Gerber T, Tuttle C, Ball J, Teng TH, Ahamed Y, Carrington MJ, Steward S. Rediscovering Heart Failure: The contemporary burden and profile of heart failure in Australia. Aug 2015. Mary MacKillop Institute Heart Health Res., Melbourne, Australia.
1 Heart Foundation 2013, Australian Bureau of Statistics 2012, Beach Study 2017.
GenesisCare’s Heart Failure Management Clinics
Team BasedApproach
IntegratedIT system
OutcomeMonitoring
EvidenceBased
Guidelines
RegularMonitoring
IndividualCare Plan
Educationand
BehaviourStrategies
GenesisCare’s Heart Failure Management Clinics are a cardiologist led and nurse facilitated model of care. They utilise a unified patient health record, a web-based application with inbuilt quality adherence support technology, and a team based approach involving specialists, nurses and General Practitioners to deliver efficient and optimised workflow.
The clinics are a privatised service that provide comprehensive pharmacological and non-pharmacological management, HF education and a HF-nurse support.
GenesisCare’s consulting model for heart failure management is designed to meet the needs of patients now and well into the future.
6362
Outcome measures:
Outcomes:
GenesisCare’s Heart Failure registryCommenced 2014•
The registry provides real world data regarding heart failure causes, management and outcomes in the Australian population
Early data suggests that GenesisCare’s Heart Failure Management Clinics result in low rates of heart failure hospitalisation, improved survival and high patient satisfaction
•
•
Heart failure hospitalisation
All-cause mortality
Quality of life measures
•
•
•
> 1,300 patients•
Senior Cardiologist and Clinical Services Director - Heart Failure and New Models of CareBMedSci MBBS (Hons) PhD FRACP
Dr Leighton Kearney,
Dr Kearney founded the international best-practice Heart Failure Management Clinic at GenesisCare Bundoora, which has subsequently expanded across Australia within the GenesisCare cardiology network.
DocumentedScreening fordepression89% 9%
Evidence of referralfor Cardiac Rehab20% 7%
Documentedexercise advice88% 7%
Prescriptionfor Beta Blocker90% 84%
Prescription for ACEInhibitor/ARNI/ARB65% 78%
Prescriptionfor MRA51.5% 24%
Performance outcome measures
Heart Failure Management Clinic Traditional Clinic Percentage of patients%
Heart Failure Management Clinic
1.7%readmission rate within 30 day
8.1%readmission rate within 1 year
Heart Failure Management Clinic
0.5%Mortality rate within 30 day
5.6%Mortality rate within 1 year
Early data suggests that the new Heart Failure Management Clinic is achieving excellent outcomes for patients
65
GenesisCare PublicationsThe following includes publications from GenesisCare’s cardiology research team for the period 2017–2018.
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Khoo K, Lew J, Neef P, Kearney L, Churilov L, Robbins R, Tan A, Hachem M, Owen-Jones L, Lam Q, Hart G.K, Wilson A, Sumithran P, Johnson D, Srivastava P.M, Farouque O, Burrell L.M., Zajac J.D. & Ekinci E.I. (2018). Routine use of HbA1c amongst inpatients hospitalised with decompensated heart failure and the association of dysglycaemia with outcomes. Nature scientific reports, September 10 2018.
5. Ha FJ, Han HC, Sanders P, Teh AW, O’Donnell D, Farouque O, Lim HS. (2018). Challenges and limitations in the diagnosis of atrioesophageal fistula. J Cardiovasc Electrophysiol. 2018 Jun;29(6):861–871.
Toner L, Flannery D, Sugumar H, Ord M, Lin T, O’Donnell D. (2018). Electrical remodelling and response following cardiac resynchronization therapy: A novel analysis of intracardiac electrogram using a quadripolar lead. J Arrhythm. 2018 Apr 27;34(3):274–280.
Varma N, O’Donnell D, Bassiouny M, Ritter P, Pappone C, Mangual J, Cantillon D, Badie N, Thibault B, Wisnoskey B. (2018). Programming cardiac resynchronization therapy for electrical synchrony: reaching beyond left bundle branch block and left ventricular activation delay. J Am Heart Assoc. 2018 Feb 6;7(3).
Hayman S, Lavi S, Davey R, De S, Smith S, Bagur R. (2018). Transradial-guided percutaneous transaxillary intra-aortic balloon pump insertion. Canadian journal of cardiology volume 34, Issue 1, January 2018, Pages 92.e5–92.e7.
Robison S, Hong K, Kim D, Lloyd R, Ramchand J, Hornsey E, Srivastava P, Smith G, Kearney L, Lim R. (2018). Evaluation of modified look-locker inversion recovery and arrhythmia-Insensitive rapid cardiac T1 mapping pulse sequences in cardiomyopathy patients. .J Comput Assist Tomogr. 2018 Sep/Oct;42(5):732–738.
Huang R, Newbigin K, McBean R, Kennan J, Camuglia A, Rafter T. (2018). Aortic valve calcium scoring as a predictor of paravalvular leakage in transcatheter aortic valve replacement. Heart, lung and circulation, 27(2):S220.
Hamilton G, O’Donnell D, Han HC. (2018). Brugada syndrome and undifferentiated syncope: use of an implantable loop recorder to document causation. Med J Aust. 2018 Aug 6;209(3):113–114.
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13. Di Santo P, Harnett DT, Simard T, Ramirez FD, Pourdjabbar A, Yousef A, Moreland R, Bernick J, Wells G, Dick A, Le May M, Labinaz M, So D, Motazedian P, Jung RG, Chandrasekhar J, Mehran R, Chong AY, Hibbert B. (2018). Photoplethysmography using a smartphone application for assessment of ulnar artery patency: a randomized clinical trial. CMAJ. 2018 Apr 3;190(13):E380-E388. doi: 10.1503/cmaj.170432.
Burrage, M., Moore, P., Cole, C., Cox, S., Lo, W., Rafter, A., Garlick, B., Garrahy, P., Mundy, J. and Camuglia, A. (2017). Transcatheter aortic valve replacement is associated with comparable clinical outcomes to open aortic valve surgery but with a reduced length of in-patient hospital stay: A systematic review and meta-analysis of randomised trials. Heart, lung and circulation, 26(3), pp.285–295.
Dias, K., Spence, A., Sarma, S.Oxborough, D., Timilsina, A., Davies, P., Cain, P., Leong, G., Ingul, C. and Coombes, J. (2017). Left ventricular morphology and function in adolescents: Relations to fitness and fatness. International journal of cardiology.
Fitzgerald, B., Bashford, J. and Scalia, G. (2017). Regression of the anatomic cardiac features of amyloid light chain cardiac amyloidosis accompanied by normalization of global longitudinal strain. case, 1(2), pp.46–48.
Chandrasekhar J, Baber U, Sartori S, Aquino M, Kini AS, Rao S, Weintraub W, Henry TD, Farhan S, Vogel B, Sorrentino S, Ge Z, Kapadia S, Muhlestein JB, Weiss S, Strauss C, Toma C, DeFranco A, Effron MB, Keller S, Baker BA, Pocock S, Dangas G, Mehran R. (2018). Associations between complex PCI and prasugrel or clopidogrel use in patients with acute coronary syndrome who undergo PCI: From the prometheus study. Can J Cardiol. 2018 Mar;34(3):319–329. doi: 10.1016/j.cjca.2017.12.023. Epub 2017 Dec 27.
Chandrasekhar J, Baber U, Sartori S, Stefanini GG, Sarin M, Vogel B, Farhan S, Camenzind E, Leon MB, Stone GW, Serruys PW, Wijns W, Steg PG, Weisz G, Chieffo A, Kastrati A, Windecker S, Morice MC, Smits PC, von Birgelen C, Mikhail GW, Itchhaporia D et al. (2018). Effect of increasing stent length on 3-year clinical outcomes in women undergoing percutaneous coronary intervention with new-generation drug-eluting stents: patient-level pooled analysis of randomized trials from the win-des Initiative. JACC cardiovasc interv. 2018 Jan 8;11(1):53–65. doi: 10.1016/j.jcin.2017.11.020.
Chandrasekhar J, Moalem K, Vogel B, Mehran R. (2018). Women in interventional cardiology: past, present, and future-small numbers, growing impact. JACC cardiovasc interv. 2018 Jan 8;11(1):104–106. doi: 10.1016/j.jcin.2017.11.027.
9. Hayman S, Lavi S. (2018). Healing of Iatrogenic coronary dissection and intramural hematoma: insights from OCT. Journal of invasive cardiology 2018:30(1):E12-E13.
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Fitzgerald, B., Bashford, J., Newbigin, K. and Scalia, G. (2017). Regression of cardiac amyloidosis following stem cell transplantation: a comparison between echocardiography and cardiac magnetic resonance imaging in long-term survivors. IJC heart & vasculature, 14, pp.53–57.
21. Shukla, A., Wong, D., Humphries, J., Fitzgerald, B., Newbigin, K., Bashford, J. and Scalia, G. (2017). Transthyretin cardiac amyloidosis: a noninvasive multimodality approach to diagnosis using transthoracic echocardiography, 99m-Tc-labeled phosphate bone scanning, and cardiac magnetic resonance imaging. case, 1(2), pp.49–53.
22. Ramchand J, Sampaio Rodrigues T, Kearney LG, Patel SK, Srivastava PM, Burrell LM. (2017). The peguero-lo presti electrocardiographic criteria predict all-cause mortality in patients with aortic stenosis. J Am Coll Cardiol. 2017 Oct 3;70(14):1831–1832.
King B, Porta-Sanchez A, Masse S, Zimiri N, Balasundaram K, Kusha M, Jackson N, Haldar S, Umapathy K, Nanthakumar N. (2017). Effect of spatial resolution and flitering on mapping cardiac fibrillation. Heart rhythm.2017 April; (14)4:608–15.
Porta-Sanchez A, Jackson NM, Lukac P, Kristiansen SB, Nielsen JM, Gizurarson S, Masse S, Labos C, Viswanathan K, King BJ, Ha ACT, Downar E, Nanthakumar K. (2017). Mulitcenter study of a mechanistic ventricular tachycardia ablation strategy with Decrement Evoked Potential (DEEP) Mapping. JACC clinical electrophysiology.
Eccleston D, Horrigan M, Rafter T, Holt G, Worthley S, Sage P, Whelan A, Reid C, Thompson P. (2017). Improving guideline compliance in Australia with a national percutaneous coronary intervention outcomes registry. Heart, lung and circulation, 26(12);pp1303–1309.
Worthley S, Erglis A, Redwood S, Hildick-Smith D, Rafter T, Whelan A. (2017). TCT-461 Six month outcomes of transcatheter annular reduction therapy (TART) with the ARTO system for functional mitral regurgitation. JACC, 70(18):B190.
Fogarty, S., Hart, G., Nicklin, J., Venkatesh, B., Boyne, N., Wong, D., Stone, J. and Rainbird, A. (2017). Intracardiac leiomyomatosis – an unusual cause of syncope in a middle-aged woman. Heart, lung and circulation, 26(4), pp.e22-e25.
Salman, K., Cain, P., Fitzgerald, B., Sundqvist, M. and Ugander, M. (2017). Cardiac amyloidosis shows decreased diastolic function as assessed by echocardiographic parameterized diastolic filling. Ultrasound in medicine & biology, 43(7), pp.1331–1338.
Scalia, I., Riha, A., Kwon, A., Newbigin, K., Scalia, G. (2017). Dramatic normalization of the echocardiographic pulmonary–to–left atrial ratio with thrombolysis in a case of life-threatening submassive pulmonary emboli. case, 3(2), pp. 124–127.
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Burrage M, Moore P, Cole C, Cox S. (2017). Transcatheter. Heart, lung and circulation March 2017 Volume 26, issue3, pages 285–295.
31. Phillips K, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok S, Senatore G, Stein KM, Razali O, Gordon N and Boersma L. (2017). Combining watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace (2017) 19 (7): 1091–1095.
32. Bagur R, Solo K, Alghofaili S, Nombela-Franco L, Kwok CS, Hayman S, Siemieniuk RA, Foroutan F, Spencer FA, Vandvik PO, Schaufele TG, Mamas MA. (2017). Cerebral embolic protection devices during transcather aortic valve implantation: systematic review and meta-analysis. Stroke 2017;48(5):1306-1315.
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Acknowledgements
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AcknowledgementsGenesisCare acknowledges the support of our affiliated hospitals and research institutions, our clinical trial sponsors and partners.
Hospital affiliations
GenesisCare cardiologists have affiliations with thefollowing hospitals:
Melbourne Private HospitalMulgrave Private HospitalNorthPark Private HospitalSt John of God HospitalThe Alfred HospitalThe Royal Melbourne HospitalWarringal Private Hospital
University affiliations
GenesisCare cardiologists have affiliations with the following universities:The University of AdelaideThe University of MelbourneThe University of Queensland
PartnershipsClinical Trial Sponsors
GenesisCare has the following strategic research partnerships:
AbbottAmgenAstraZenecaBoston ScientificEisai
AbbottBiotronik
EsperionMedtronicMerckMVRxNovartis
Novo NordiskSanofiThrombosisResearchInstitute
QueenslandBundaberg Base HospitalFriendly Society Private HospitalGreenslopes Private HospitalLady Bjelke-Petersen Community HospitalMater HospitalMater HospitalMater Private HospitalPrincess Alexandra HospitalRoyal Brisbane and Women’s HospitalSt Vincent’s Private HospitalSunshine Coast University HospitalSunshine Coast University Private HospitalThe Prince Charles HospitalThe Wesley Hospital
BundabergBundabergBrisbaneKingaroyGladstoneRockhamptonBrisbaneBrisbaneBrisbaneToowoombaBirtinyaBirtinyaBrisbaneBrisbane
ParkvilleMulgraveBundooraBerwickMelbourneParkvilleWarringal
VictoriaAlbury Private HospitalAustin HealthBendigo HospitalBox Hill HospitalEastern Health Clinical SchoolEpworth
AlburyHeidelbergBendigoBox HillBox HillRichmond
Western AustraliaFiona Stanley HospitalHollywood Private HospitalJoondalup Health CampusMount HospitalRoyal Perth HospitalSir Charles Gairdner HospitalSt John of God HospitalSt John of God Hospital
MurdochNedlandsJoondalupPerthPerthNedlandsBunburyMurdoch
Research affiliations
GenesisCare cardiologists have affiliations with the following research institutions:Harry Perkins Institute for Medical ResearchHeart & Vascular Research InstituteJoondalup Cardiovascular Trials FoundationWesley Medical Research
Perth, WAAdelaide, SAPerth, WABrisbane, QLD
South AustraliaCalvary Wakefield HospitalQueen Elizabeth HospitalRoyal Adelaide HospitalSt Andrews HospitalWomen’s and Children’s Hospital
AdelaideWoodvilleAdelaideAdelaideNorth Adelaide
78 79
AbbreviationsThe following abbreviations are used throughout this report.
AM
ARB
BMedSci
BSc
CIED
CVD
DTM&H
FACC
FAHA
FCP
FESC
FRACP
FSCAI
GCOR
HF
NHMRC
MBA
MBChB
MD
MR
MSc
NYHA
NHMRC
NZ
PhD
QoL
BHMS
ACE inhibitors
ACSQHC
BPharm
CHF
CRO
DAPT
EP
FACP
FASE
FCSANZ
FHRS
FRCP
GAICD
GRAD DIP
JP
ICHOM
MBBS
MBBCH
MMedSci
MRA
MRCP
PCI
PROM
SMO
SA
US
UK
Member of the Order of Australia
Angiotensin II Receptor Blockers
Bachelor of Medical Science
Bachelor of Science
Cardiac implantable electronic devices
Cardiovascular disease
Diploma in Tropical Medicine and Hygiene
Fellow of the American College of Cardiology
Fellow of Australian Academy of the Humanities
Fellow of the College of Physicians
Fellow of the European Society of Cardiology
Fellow of Royal Australasian College of Physicians
Fellow of the Society for Cardiovascular Angiography and Interventions
GenesisCare Cardiovascular Outcomes Registry
Heart failure
National Health and Medical Research Council
Master of Business Administration
Bachelor of Medicine, Bachelor of Surgery
Doctor of Medicine
Mitral valve regurgitation
Master of Science
New York Heart Association
National Health and Medical Research Council
New Zealand
Doctorate
Quality of Life
Bachelor of Homeopathic Medicine and Surgery
Angiotensin-converting enzyme inhibitors
Australian Commission on Safety and Quality in Health Care
Bachelor of Pharmacy
Congestive heart failure
Contract research organisations
Dual anti platelet therapy
Electrophysiology
Fellow of the American College of Physicians
Fellow of the American Society of Echocardiography
Fellow of the Cardiac Society of Australia and New Zealand
Fellow of the Heart Rhythm Society
Fellow of the Royal College of Physicians
Graduate Member Australian Institute of Company Directors
Graduate Diploma
Justice of the Peace
International Consortium for Health Outcomes Measurement
Bachelor of Medicine, Bachelor of Surgery
Bachelor of Medicine, Bachelor of Surgery
Master of Medical Science
Mineralocorticoid Receptor Antagonist
Member of the Royal College of Physicians
Percutaneous coronary intervention
Patient reported outcome measures
Site management organisation
South Australia
United States of America
United Kingdom
80 81
(c) 2019 GenesisCare Pty. Ltd
