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