Mark J. Alberts, MD, FAHA, FANA Vice-Chair, Dept of Neurology Professor of Neurology UT Southwestern Medical Center Dallas, TX

Transcription

1 Interventional Therapies for Cerebrovascular Diease: The Good, The Bad, The Needed, and The Few 1 Mark J. Alberts, MD, FAHA, FANA Vice-Chair, Dept of Neurology Professor of Neurology UT Southwestern Medical Center Dallas, TX

2 2 Presenter Disclosure Information Relevant Financial Disclosures: Speakers Bureau/Consultant: Genentech, Inc. Unpaid Consultant: The Joint Commission, HFAP UNLABELED/UNAPPROVED USES DISCLOSURE: None

3 3 Figure 4. a, Native image, Anterior-posterior projection showing the Enterprise stent across the area of occlusion. THE GOOD Kelly M E et al. Stroke. 2008;39: Copyright American Heart Association, Inc. All rights reserved.

4 THE GOOD. Roth C et al. Stroke. 2010;41: Copyright American Heart Association, Inc. All rights reserved.

5 THE BAD. Pfefferkorn T et al. Neurology 2001;57: by Lippincott Williams & Wilkins

6 THE BAD Nakano S et al. Stroke. 2001;32: Copyright American Heart Association, Inc. All rights reserved.

7 THE NEEDED 800,000 NEW AND RECURRENT STROKES EACH YEAR 4 TH LEADING CAUSE OF DEATH IN US; 2 ND LEADING CAUSE GLOBALLY

8 8 The Needed Recurrent stroke rate with intracranial stenosis: 23%/year (medical therapy) Recurrent stroke rate with symptomatic ICA stenosis: 19% over 2 years (medical Rx) Mortality rate of unclipped unruptured aneurysm: 44% at 10 years NASCET, NEJM 1991; Britz et al, Stroke 2004; Chimowitz et al., NEJM, 2011

9 Inverse Pyramid of Acute Stroke Care AIS Patients --Only present within a good Rx time window --Only have no medical contraindications --Only have favorable Imaging --Technical success in Clinical success in 5-6 THE FEW

10 Challenges of Interventional Procedures for Cerebrovascular Disease vs Coronary Disease or PAD 10 Time windows for brain interventions are more narrow than heart, leg Exception for young patients, VB disease Limited availability of facilities and cerebral interventionalists (CSC, some PSCs) vs thousands of Heart Centers Some of our procedures do not work in a significant % of cases ( but CAD, PAD are usually successful) Brain complications are often serious or catastrophic

11 11 Current Status of CSC Certification Several options: The Joint Commission, DNV, HFAP (coming soon) Latest numbers from TJC About 95 organizations have applied for CSC certification About 82 approved so far Several awaiting initial visit, second visit, or approval Several found deficient and not approved

12 Neurointerventional Staffing at a CSC 12 NIR services must be available 24/7 but staff does not need to be in-house 24/7 Cannot have only one NIR physician cover > 1 hospital Nursing and support staff are a KEY aspect of the CSC review process Must have a PLAN for how your organization would deal with 2 simultaneous cases that require NIR services Coiling an aneurysm and another patient needs endovascular Rx for AIS

13 Procedures and Numbers at a CSC 13 Procedure Estimated National Volume* Cerebral Angiogram 150,680 Carotid endarterectomy 124,265 Carotid stent 17,580 Aneurysm embolization 13,430 Aneurysm clipping 5,615 Endovascular Rx AIS 5,090 Intracranial stent/angioplasty 1,870 * Data based on 2008 statistics Grigoryan et al., Stroke, 2012

14 Procedures and Numbers at a CSC 15 Procedure Number of Hospitals Meeting Level* Cerebral Angiogram 530 Carotid 1365 endarterectomy Carotid stent 245 Aneurysm 130 embolization Aneurysm clipping 160 Endovascular Rx AIS 130 * Based on 5000 acute care hospitals in the US Grigoryan et al., Stroke, 2012

15 Hospital NIR Staffing About 800 NIRs live within 50 miles of a large metro area 4% to 14% of AIS patients may be eligible for IA therapy 16 2 major caveats: * This was before IMS3 and other results * Having 1 or more NIR does not = a CSC Zaidat et al, Neurology, vol 79, S 35-41, 2012

16 17 NIR and Case Distribution JC survey of PSCs showed that NIR procedures were VERY common among PSCs Assume 30 coiling procedures/yr in a medium sized city 10 hospitals could each do 3 procedures/yr, or 3 hospitals could each do 10 procedures/yr NIR cannot be viewed in isolation Need diagnostic support, nursing support, NICU care, vascular neurology support Also need 24/7 coverage Lack of such support was a major reason for failing JC site visit for CSCs

17 Joint Commission Survey of EVTs and Primary Stroke Centers 18 Sent survey to 942 PSCs 352 returned responses Hospital demographics Availability of procedures Training of EVT operators Hospitals covered Track outcomes Alberts, Hampel, Cantwell, Range, Spencer; presented at ISC, Feb 2014

18 Majority of Respondents Were Community Hospitals Community Hospital / General Acute Care Hospital 82 Academic Medical Center / Teaching Hospital 3 Critical Access Hospital 2 Specialty Hospital

19 Most Responding PSCs provided some EVT services Provide EVS Do not provide EVS Preparing to provide EVS

20 Average Daily Census at Responding Hospitals 21 1,000 or more to to to to to to Fewer than Number of Organizations

21 22 Availability of EVT on 24/7 basis 80.0% 70.0% 60.0% 50.0% 40.0% 56.1% 62.3% 67.4% 70.7% 30.0% 20.0% 10.0% 0.0% Coiling of Aneurysms (n=129) IA Mechanical (n=144) IA Lytic (n=159) Stenting of Neck Vessels (n=157)

22 23 Number of Hospitals Covered 4% 3% 9% 7% 14% 21% 43% Other

23 24 Training of Interventionalist Interventional Neuroradiologist Endovascular Neurosurgeon (i.e., WITH Endovascular Fellowship) Interventional Radiologist (i.e., WITHOUT Neuro Fellowship) Endovascular Neurologist (i.e., WITH Interventional Fellowship) Other (please specify)

24 Participation in a National Audited Registry 25

25 IV TPA Compared with Interventional Procedures 26 Parameter IV TPA Interventional Time Window hr Up to 12 hours?? Imaging Head CT CT, CTP, MRI, MRA, Agram Infrastructure Minimal Extensive Staffing Minimal, off-site Substantial, On-site Treatment duration 60 min 1-3 hours

26 IV TPA for Acute Ischemic Stroke 27 National Hospital Discharge Survey 23,000 patients Rate of IV TPA use increased from 1% to 2.4% between 2001 to 2006 Maximum rate = 5% if you change sampling model Overall 15% to 30% of stroke patients present within 3 hours of Sx onset Of those only 40% to 50% are medically eligible for IV TPA therapy Fang et al., J Hosp Med, 2010

27 IV TPA Treatment Rates 28

28 Figure 2 Change in alteplase use by hospital pair and treatment group *Pair 11 was excluded in the target-population analysis. Phillip A Scott, William J Meurer, Shirley M Frederiksen, John D Kalbfleisch, Zhenzhen Xu, Mary N Haan, Robe... A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a clusterrandomised controlled trial The Lancet Neurology, Volume 12, Issue 2, 2013,

29 Endovascular Treatment of Basilar Occlusion patients All treated with either IV TPA (76) or IA therapy (344) Examined recanalization rates, death, dependency rates Recanalization rates 65% with IAT 53% with IV therapy Lindsberg et al., Stroke, 2006

30 32 Figure 1. Case mix of baseline variables. Lindsberg P J, and Mattle H P Stroke. 2006;37: Copyright American Heart Association, Inc. All rights reserved.

31 33 Figure 2. The ORs and 95% CIs for death, dependence, and death/dependence. Lindsberg P J, and Mattle H P Stroke. 2006;37: Copyright American Heart Association, Inc. All rights reserved.

32 34 Figure 3. The ORs and 95% CIs for post-thrombolytic signs of recanalization and the likelihood of avoiding symptomatic hemorrhage or parenchymal hematoma as listed in Table 1. Lindsberg P J, and Mattle H P Stroke. 2006;37: Copyright American Heart Association, Inc. All rights reserved.

33 CAS and Medicare Outcomes Data 35 Medicare administrative data 2005 through ,701 patients 2339 interventionalists About 1800 were new operators Nallamothu et al., JAMA 2011

34 Carotid Stenting---Operator Experience 36 Nallamothu et al., JAMA, 2011

35 Experience and Stent Outcomes 37

36 Possible Solutions to the Inverse Pyramid 38 Increase treatment time window May increase patient numbers but pay the price of reducing efficacy time = brain Decrease time delay to increase efficacy Give IV TPA in the field Challenge to do EVT in the field Increase recognition of stroke Can achieve short time effects; need continual campaign

37 39 The Problems Need for Rapid Therapies Need for Experienced NIR personnel Mal-distribution of NIR Facilities

38 40 Possible Solutions Train more NIR personnel But lack of cases may limit the efficacy of this approach Transport the patient to CSC or some PSCs Current approach Still time delays NEW APPROACH Send NIR operator from CSC to outside hospital BUT, have local person begin procedure while NIR expert is en route Logistical challenges But addresses need for speed, need for expertise Transfer patient to CSC after the intervention

39 41 Other Novel Approaches Goals 1. Avoid need for catheter based therapy Takes time, limits Rx venues, leads to complications 2. Use techniques that can be started in the field Reduces time delays; eliminates need for expensive infrastructure 3 Improve overall efficacy and safety This will lead to wider adoption, might improve overal Rx approach

40 52 Future Challenges and Opportunities Improve the functionality of endovascular devices (smaller, more flexible, more versatile) Develop less invasive devices and approaches (ultrasound, lasers, energy transfer) Use biomarkers and genetics for patient selection (very effective when treating neoplasms) Use transdermal approaches to deliver agents to some lesions (low-dose TPA) Use biologics to enhance the response rate of some lesions, malformations, etc. (workers for some neoplasms)

41 Conclusions 53 Interventional cases will remain a major focus of advanced stroke care, especially for aneurysmal SAH and patients who cannot or do not receive IV TPA therapy Expertise is clearly related to outcomes Transferring ELECTIVE cases to a CSC makes sense for many reasons For some acute cases, beginning the case in the field while NIR goes to the patient is a novel but testable approach to address current limitations