Leeds Nuffield Hospital – November 2006 www.johnperrins.com Case Studies in Cardiology Over-Active Implantable Devices!! Dr John Perrins MD FRCP FACC Consultant Cardiologist – Leeds UK Member Committee of Safety of Devices
Apr 01, 2015
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Case Studies in CardiologyOver-Active Implantable Devices!!
Dr John Perrins MD FRCP FACC
Consultant Cardiologist – Leeds UKMember Committee of Safety of
Devices
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Case Studies
An angioplasty balloon which gets stuck inside a heart artery
A Pacemaker lead which stabs the patient through the heart
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
83
87
PCI centres
Angiography onlyCentres
UK PCI CENTRES 2005
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
PCI vs Isolated CABG Numbers (UK)1991 to 2005
0
10000
20000
30000
40000
50000
60000
70000
80000
19
91
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
PCI
CABG
2005 data: Ludman
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Coronary angiography
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Normal Right Coronary Artery
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
The problem
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Angioplasty and Stenting
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
An Actual PCI Procedure
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Boston Scientific Taxus Express Stent SystemMDA/2004/033, MDA/2004/036
Failure of some balloons to deflate following stent insertion.
Very large product recall complicated by shelf life and large stocks
UK recall approx 15000 units- extended to 16,000 taxus and 23,000 express stents in 2004/36 notice.
2 Deaths + 25 severe myocardial infarctions worldwide
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Taxus Express Balloon Design
Inflation/deflation port
Balloon
At high pressure the inflation/deflation tube partially collapses inside the balloon preventing complete emptying of the balloon
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Taxus Express consequences
Very expensive to the company
Boston produced a new manufacturing step which they say eliminates the problem
MHRA says it has reviewed corrective action by the company
Taxus superseded by a new stent the Taxus Liberte which Boston says is unaffected.
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Taxus Express
Who should the User believe? Should the Trust have a view as to a particular
company’s overall propriety? Is follow up required from this notification Are your supplies departments included in the
MDA alert cascade? I personally only use a Boston Stent if there is
no other alternative available.
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Inventory control – Yorkshire Heart Centre
6 Cardiac Catheter Laboratories
4000 Interventions per year
96 % stent usage, 1.7 stents per case
50% of cases are acute transfers
800 separate consumable stock items
Many have short use by dates
£30-50,000 spend per day on intervention
Approx £1,000,000 stock held
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Dual Chamber Pacemaker InsertionPacing rate / million Leeds PCT’s– Age corrected 2005
0 100 200 300 400 500 600 700
Calderdale
Wakefield E
Bradford S&W
Bradford N
Bradford City
N Kirklees
Harrogate
Selby/York
Huddersfield S
Airedale
Huddersfield C
Wakefield W
Leeds NE
Leeds NW
Leeds E
Leeds W
Leeds S
Network average 359
National average 411
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Dual-Chamber Pacing
Atrial ‘J’ Lead
‘Straight’ Ventricular Lead
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Bipolar Pacing Lead Construction
Outer insulationOuter coil
(Anode)
Inner insulation
Inner coil(Cathode )
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
IS-1 / VS-1 Bipolar Lead Connector
Sealing Rings
TerminalPin
ProximalRing
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Fixation Mechanisms
Active fixationScrew-in lead
Passive fixationTined tip
Passive fixationFinned tip
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
The Inside View
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Atrial “J” Lead
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Pacemaker Lead Positioning
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Telectronics Accufix J retention wire Problem MDA Hazard (94)24 November 1994
MDA Technical Note No54 November 1994
MDA Safety Alert No 55 May 1995
MDA Technical Note No59 October 1995
MDA Pacemaker Technical Note No64 Sep 1996
MDA Safety Alert No 69 October 1997
MDA Safety Alert No 72 August 1998
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Accufix Retention Wire – Solid rectangular section stainless steel
Bipolar Conductor
Retention wire is separate and insulated from the main conductors
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Accufix Retention Wire – Solid rectangular section stainless steel
Bipolar Conductor
Retention wire fractures and gradually extrudes outside of the wire body
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Accufix lead problem
Wire fracture very difficult to see
Very high quality X-ray screening needed in a digital cardiac cath lab.
Wire fracture has no effect on lead performance so no simple way to detect it
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Early Fracture
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Near full extrusion
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Accufix lead Problem
Extruded wire could puncture through heart into the aorta
Initially 6 Deaths and 13 serious injuries in the USA from Tamponade (Blood around the heart)
Initially occurred months or even years after implant
But removal of pacemaker leads carries a risk
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Accufix Initial advice
All product withdrawn
All leads to be screened in cath lab 6 monthly
Consider explant of obviously faulty leads
? Explant all leads
2 Deaths in US from lead explantation
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Telectronics J-wire was used in other leads
Warnings extended to all Telectronics leads with a J-wire, company initially notified only one lead type.
Companies Never disclose everything!!!
Telectronics company dissolved
Accufix foundation set up to handle litigation and limit liability
This problem stimulated new devices and technologies for pacemaker lead removal
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Accufix – Personal Experience
124 leads Implanted
23 Extracted
No Deaths
30 leads STILL IMPLANTED!!
Last MDA technical note 1998
I no longer screen the leads but some do
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
Conclusions What is the likely duration of a Device Alert? Should recalls call into question manufacturer’s reputations ? Who should make those judgements ? How do you know if an alert is a balanced risk re action or
inaction ? Please talk to your clinicians more in cardiology. High risk areas are cardiology, interventional radiology, theatres
and ITU. We all need more detailed information from MHRA Alerts
which should either be longer or have a technical appendix Never believe anything anyone tells you!
Leeds Nuffield Hospital – November 2006 www.johnperrins.com
SOD’S Law for DevicesIf it can ******* break Then it will ***** breakNobody likes bad news
ThereforeHazard warnings are always too lateThe Scale of the problem is always
underestimatedThe solution is always over optimistic