Risk Stratification in Spinal Surgery the development of a Spine Center of Excellence
J.C. Leveque, MD
Virginia Mason Medical Center
Seattle, WA, USA
Disclosures
• Industrial Insurance Medical Advisory Committee (member)
•Scoliosis Research Society (committee member)
•Nuvasive (speakers bureau)
•K2M (advisory board)
• Some slides courtesy of Rajiv Sethi, MD and Robert Mecklenburg, MD
We can think about adult spinal deformity better
58 yo female D, LL-PI++, PT++, SVA++Preop PI-LL=45 degrees, SVA-9 cm+, L3 PSO
Fixing iatrogenic problems: PSO of L2 and L4 needed to achieve spinopelvic balance
Preop PI-LL= 70 degrees, SVA- 24 cm+; Postop PI-LL-3, SVA 3 cm
Our complications are sobering:Is this sustainable from a payor perspective?
Studies quote a 10-86 % complication rate in spinal deformity surgery, a wide variation
Implant failure necessitating revision
Stroke, MI, blindness, DVT/PE
Wound infection
Pneumonia
Death
Neural complications◦ Postop radiculopathy
◦ Spinal Cord Injury
• The true incidence of intra and postoperative complications is greatly underestimated due to the lack of prospective data collection
The literature guides us• SD Glassman, FJ Schwab, KH Bridwell, SL Ondra, S Berven, LG Lenke. The
selection of operative versus nonoperative treatment in patients with adult scoliosis. Spine. 2007;32:93-97.
• SD Glassman, CL Hamill, KH Bridwell, FJ Schwab, JR Dima and TG Lowe. The impact of perioperative complications on clinical outcome in adult deformity surgery. Spine. 2007;32:2764-2770.
• KS Delank, HW Delank, DP Konig, et al. Iatrogenic paraplegia in spinal surgery. Arch Orthop Trauma Surg 2005;125:33–41.
• DS Bradford, BK Tay, SS Hu. Adult scoliosis: surgical indications, operative management, complications, and outcomes. Spine. 1999;24:2617-2629.
• JT Dearborn, SS Hu, CB Tribus, et al. Thromboembolic complications after major thoracolumbar spine surgery. Spine 1999;24:1471–6.
• Y Qiu, S Wang, B Wang, Y Yu, F Zhu, and Z Zhu. Incidence and risk factors of neurological deficits of surgical correction for scoliosis analysis of 1373 cases at one Chinese institution. Spine. 2008 Mar 1;33(5):519-26.
• O Delattre, P Thoreux, P Liverneaux, et al. Spinal surgery and ophthalmic complications: a French survey with review of 17 cases. J Spinal DisordTech 2007;20(4):302-307.
•
Spine surgery in America today is a mess!
Here is what we know•Risk of pulmonary or cardiac complications is significant
• Increased LOS, cost to patient and society, compromised outcomes
•Our spine procedures are getting more complex (revision, # levels, age of patient)
•Can we minimize the risk of complications with preop or perioperative optimization?
The Employer-Led Health
Care RevolutionPatricia A. McDonaldRobert S. MecklenburgLindsay A. MartinFrom the July–August 2015
Issue
“Providers’ services were too costly and their quality variable. Health plans weren’t reimbursing providers on the basis of quality and were willing to pay for unnecessary visits, procedures, and medicines”
Patricia A. McDonaldRobert S. MecklenburgLindsay A. Martin
The Problem for Healthcare PurchasersLack of transparency predictability and accountability
When purchasing healthcare, both quality and price are under the table.
An avalanche of unnecessary medical care is harming patients physically and financially.
- Atul Gawande, New Yorker, May 11, 2015
… the occurrence of surgical complications was associated with higher hospital contribution margins.
-Eappen, et al, JAMA, April 17, 2013
•We are and will be inundated by elderly patients with degenerative spinal deformities
•Unsustainable healthcare costs, yet there is increasing demand
• Nonoperative management doesn’t work
• Multiple studies reveal that only surgery can provide improved HRQOL
However it is expensive and the result has to last 10 years without a revision operation!
• Definition of complex spine:
1. ≥ 6 levels of fusion
1. Staged surgery
1. Multiple comorbidities
• Case presentation and approval for surgery by a live multidisciplinary spine conference
• Mandatory completion of patient education course in preparation for surgery and post-op care
• Two attending surgeons trained in neurosurgery and orthopedics
• Intraoperative standardized protocol without case to case variability
• 3 fold reduction in readmissions and 12 fold decrease in return to surgery in the first year
Strategies for a center of excellence in spine surgery• Multidisciplinary care model for choosing the best
patients and mitigating risk
• Knowing when to say “NO”
• Building a “complex spine team” that consists of “complex spine” specific anesthesia and medicine
• Two attending surgeons for 3 column osteotomies, complex cases, or emerging technology
Deeper understanding of current state
Toyota Improvement Pathways Applied to Medicine and Surgery
Kaizen:Continuous
Improvement of your current state
Kaikaku:Reinvent your services
and/or products
Understand your current state
RPIWKaizen Events
3P
RPIWKaizen Events
Everyday Lean Ideas
Everyday Lean Ideas
Variation STANDARDIZATION Improvement
“Without Standards There can be no Improvement”
Adopt Standard Work
Building cars?
When you fly an airplane or buy a car, you expect SAFETY
– Taiichi OhnoFounder of the Toyota Production System
Standard Work
“ ”Without standards, there can be no improvement.
© 2013 Virginia Mason Medical Center
In your center, are there 5 different standards on choosing an operative patient?
TransportationConveying, transferring, picking up, setting down, piling up and otherwise moving unnecessary items.
DefectsWaste related to costs for inspection of defects in materials and processes, customer complaints and repairs
ProcessingUnnecessary processes and operationsTraditionally accepted as necessary
OverproductionProducing what is unnecessary, when it is unnecessary, and in unnecessary amounts
Motion•Unnecessary movement or movement that does not add value.•Movement that is done too quickly or slowly.
Inventory•Maintaining excessive amounts of supplies, materials, or information for any length of time.•Having more on hand than what is needed and used.
Time•Waiting for people or services to be provided.•Time when processes, people or equipment are idle.
7 Wastes
TransportationConveying, transferring, picking up, setting down, piling up and otherwise moving unnecessary items.
OverproductionProducing what is unnecessary, when it is unnecessary, and in unnecessary amounts
Waste:
Waste is any task or item that does not add value from the perspective of the
customer.
The 7 wastes (MUDA) of the Toyota Production System
Patient Patient PatientPatient
Patient
Patient Patient
Surgeon
Testing
Surgeon
Anesthesiologist
Pain
Surgeon
PMR
CCU
Anesthesiologist
Surgeon
Blood Bank Lab
Consent
Consent
STOPPatient
AnesthesiologistAnesthesiologist
Time
Waits and delays
Non value-added
Evidence-based value
PCP PCP MRI PCP Neuro 15 PT visitsRehab
Before Systems Re-engineeringAfter Systems Re-engineering
Spine Clinic 2.8 PT visits
Virginia Mason’s Collaborative, 2005A better, faster, more affordable path to recovery
SOURCE: Fuhrmans, Vanessa. "A Novel Plan Helps Hospital Wean Itself Off Pricey Tests." The Wall Street Journal. N.p., 12 Jan. 2007. Web. 04 Aug. 2015. <http://www.wsj.com/articles/SB116857143155174786>.
Results
▪ 55% reduction in spend per episode of
back pain
▪ 1/3 fewer diagnostic imaging procedures
performed
▪ 67% fewer missed days of work
▪ 91% patient satisfaction
▪ Same day access for patients
▪ Concurrent visits with doctors and
physical therapists
▪ Over-the-counter pain medicine and
structured follow-up
▪ Downstream referral if red flag symptoms
New best practice for back pain Details
Virginia Mason’s CollaborativeEmployer and provider redesign care
© 2013 Virginia Mason Medical Center
Communication flow in the Complex Spine Dedicated OR using the principles of TPSSethi et al, LEAN in Orthopaedic Surgery, JAAOS, In Press, 2017
Seattle risk flow map, a convergence of standardized pathways
Buchlak, Sethi et al., Reducing Complications in Adult Scoliosis Surgery, CCMM, 2016
•Dedicated spine physicians representing multiple specialties
•Working in teams
• Standardization of pre, during and post phases
Is adult spinal deformity surgery sustainable from the payor perspective in 2017
•Risk of pulmonary or cardiac complications is significant
• Increased LOS, cost to patient and society, compromised outcomes
•Our spine procedures are getting more complex (revision, # levels, age of patient)
•Can we minimize the risk of complications with preop or perioperative optimization?
“Not enough cerebral time spent before surgery”
• Live preop evaluation• Pulmonary• Cardiac• Nutritional • Psychologic, all patients
need eval before surgery• Social , preop complex
spine class for patients
•Preparation for surgery
•Ted Wagner MD, UW
The Seattle multidisciplinary live conferenceFrom 2010-2015, 1100 patients discussed, all with proposed complex spinal surgical procedures
In attendance: Neurosurgery, Ortho Spine, Medicine, Complex Spine Anesthesia, Physiatry-Rehab, Psychiatry, Nurses, PAs, Research staff, visiting healthcare providers
IMAST COPENHAGEN 2011: A multidisciplinary preoperative adult spinal deformity conference leads to a significant rejection rate
Rajiv K. Sethi, MDSteve Olivar MDSteve Lavine MDJC Leveque, MDPamela Girres MDChong Lee, MD, PhDKyle Kim, MD, PhDJoan Poochoon RN, MSN
Vishal Gala MDSarah Hipps MDRyan Pong MDSteven Rupp MD
Group Health Departments of Neurosurgery, Anesthesia and Internal MedicineVirginia Mason Department of Anesthesia
Virginia Mason Medical CenterSeattle, WA, USA
The Seattle complex spine protocol
All adult spinal deformity patients get presented at least 6-8 weeks prior to surgery.
Committee consists of orthopaedic spinal surgeons, neurosurgeons, internal medicine, physiatry, and anesthesia
We have an approximate 25 % no go rate based on this conference, usually anesthesia and medicine issues.
All deformity patients get:
• DEXA Scanning. Hesitant to operate if T<-2.5, consider Forteo, endocrine consult, etc first
• Neuropsych testing: Green-yellow-orange-red
(ORANGES AND REDS DO NOT GO TO SURGERY)
• Formal 2.5 hr class on the rehab associated with complex spine surgery
• Live presentation in front of the conference
• Every member of the conference gets an equal vote as to the suitability of the case—REMOVE PERVERSE ECONOMIC INCENTIVES!!
All patients get formal neuropsych evals• Comorbid psychological conditions in at least 50
percent of spine patients
• History of opiate medication use addressed
• Home situation addressed
• Social support addressed
• Does the patient actually understand the risk after the 2.5 hr spine class
•Does the surgeon have time to do this on his/her own? Does “Send them to the internist” get this done
•
• Document Type: Multidisciplinary Complex Spine Clearance Conference
• Document Date: August 26, 2016 10:52
• Document Title/Subject: Multidisciplinary Complex Spine Clearance Conference
• Performed By/Author: Nold PA-C, Kellen A on September 01, 2016 10:55
• Virginia Mason Medical Center
• Multidisciplinary Complex Spine Conference
• Patient was discussed at multidisciplinary complex spine conference on 08/26/2016. Representatives from the departments of Anesthesia, Physical Medicine and Rehab, VM Neurosurgery Spine, Physical Therapy, Anesthesia Pain Service, VM Ortho spine and UW Ortho Spine were present for the discussion.
• Concerns:
• -History of left main albation, would like cardiology clearance
• -Smoking cessation with 2 documented negative urine cotinine
• -Neuro psych pending, needs to be completed, patient should be re-presented if Orange/Red
• -Otherwise clear to proceed for surgery. Represent if problems/concerns arise.
TEAM TRANSPARENCY
So is this what the market and patients want?
Jet Blue, WM , Lowes, and othersPatients referred from 47 states, 2012-2016
Multidisciplinary Conference Evaluation of Patients Recommended Lumbar Fusion by Solitary Surgeons
Yanamadala, Sethi et al., In Press, Spine (Phila).
Reasons for Alternative Approaches for 1-2 levels of spine fusion offered for back pain
Number of
Patients
Percentag
e
Misdiagnosis by Outside
Surgeon
3 6%
Morbid Obesity (BMI > 40) 5 10%
Active Smoking 5 10%
Likely to Benefit from
Additional Physical Therapy
11 22%
Likely to Benefit from ESI 3 6%
Yanamadala et al., In Press, Spine
Change in Surgical Plan as a result of the wisdom of crowds
• Less invasive approaches selected over more invasive approaches• Decompression rather than fusion• LLIF rather than revision PSIF for adjacent segment disease
“Aggregating the independent judgments of doctors
outperforms the best doctor in a group”
On teams…..
• A complex spine anesthesia team is defined
•No begging and pleading for TXA, FFP, etc
• The same anesthesiologists evaluate the patients at a live multidisciplinary conference
Human Factors, Volume 51(2), pp 181-192, 2009.
Fourcade et al. BMJ Qual Saf, Volume 21, Number 3, pp 191-197, 2012.
“…the findings suggest that operating room staff practices are rooted in a time-honoured hierarchy”
ISSG. Spine Journal, Volume 15 (supplement), pp 156S, 2015.
1-surgeon(%)
2-surgeon(%)
p
Overall complication rate 11.1 1.3 =0.006
Chan and Kwan. Spine, Volume 41(11), pp E694-E699, 2016.
1-surgeon 2-surgeon p
OR duration 248 ± 49.9 173 ± 27 0.000
Blood loss 1.25 ± 0.6 L 0.92 ± 0.4 0.01
PCA morphine (mg) 42.5 ± 24 20.4 ± 11.5 0.000
LOS 4.1 ± 0.9 3.2 ± 0.4 0.000
Kwan and Chan. Eur opean Spine Journal, 2016.
257
164
0 50 100 150 200 250 300
Operative Time (min)
2 surgeons 1 surgeon
1254
893
0 500 1000 1500
Blood Loss (cc)
2 surgeons 1 surgeon
Xu et al. Annals of Surgery, Volume 258, Number 6, 2013.
Operative time was independently associated with the operative experience of the attending (P = 0.02) and assisting surgeons (P = 0.03) and the number of prior collaborations between them (P < 0.001).
Scheer et al. in press.
Wahr et al. Circulation, Volume 128, pp 1139-1169, 2013.
“Empirical research has shown that when teams have high levels of collective efficacy, members exert more effort and take more strategic risks, which leads to better performance and higher satisfaction.”
“High-Value Care” of the Future
The Surgical Warranty and Bundles. Is this possible for severe adult spinal deformities?
Warranty provision of bundleNo additional payment for avoidable readmissions
1. Seven-day window of accountabilitya.Acute myocardial infarction
b.Pneumonia
c.Sepsis
2. Thirty-day window of accountabilitya.Surgical site bleeding
b.Wound infection
c.Pulmonary embolism
d.Death
3. Ninety-day window of accountabilitya. Mechanical complication related to surgery
b. Infection of implant
As surgeons, we need to be more cognizant of value based healthcare and drive changes to make our results sustainable
The current state
• Spinal surgery is in the national spotlight
• Mechanisms needed to improve safety, reduce variability and cost
• Hospitals will be pitted against one another as readmission dashboards are assembled
Don’t want to be in the 4th quartile
This a life changing intervention!
58 yo female D, LL-PI++, PT++, SVA++Preop PI-LL=45 degrees, SVA-9 cm+, L3 PSO
Summary
• Standardization enhances patient safety
• Pathways, protocols and dashboards can help us enhance the durability of what we do
•High level medical center administrative support is necessary to make the change
• The Seattle Spine Team or equivalent interventions provide an algorithm to reduce complications and continually improve
Finally, we have to do better!
• Choosing patients better, we cant fix everything, we have to say “NO” much more than we currently do
• Remove perverse fee for service incentives, e.gempower the team AND the surgeon.
•Reward centers who do it better and standardize care, this is already happening
• Surgeons lead the efforts, not administrators or outside parties