Mariano big data nwac 2015

What “BIG DATA” Can Do for What “BIG DATA” Can Do for Regional AnesthesiologistsRegional Anesthesiologists

What “BIG DATA” Can Do for What “BIG DATA” Can Do for Regional AnesthesiologistsRegional Anesthesiologists

Edward R. Mariano, M.D., Edward R. Mariano, M.D., M.A.S.M.A.S.

Associate Professor of AnesthesiologyAssociate Professor of AnesthesiologyStanford University School of MedicineStanford University School of Medicine

Chief, Anesthesiology and Perioperative Chief, Anesthesiology and Perioperative CareCare

Veterans Affairs Palo Alto Health Care Veterans Affairs Palo Alto Health Care SystemSystem

Edward R. Mariano, M.D., Edward R. Mariano, M.D., M.A.S.M.A.S.

Associate Professor of AnesthesiologyAssociate Professor of AnesthesiologyStanford University School of MedicineStanford University School of Medicine

Chief, Anesthesiology and Perioperative Chief, Anesthesiology and Perioperative CareCare

Veterans Affairs Palo Alto Health Care Veterans Affairs Palo Alto Health Care SystemSystem

@EMARIANOMD@EMARIANOMD

Big Data for Regional Big Data for Regional AnesthesiologistsAnesthesiologists

Financial DisclosuresFinancial DisclosuresFinancial DisclosuresFinancial Disclosures Halyard (formerly I-Flow), B Braun – Halyard (formerly I-Flow), B Braun –

Unrestricted educational program Unrestricted educational program funding paid to my institutionfunding paid to my institution

The contents of the following The contents of the following presentation are solely the presentation are solely the responsibility of the speaker without responsibility of the speaker without input from any of the above input from any of the above companies.companies.

Halyard (formerly I-Flow), B Braun – Halyard (formerly I-Flow), B Braun – Unrestricted educational program Unrestricted educational program funding paid to my institutionfunding paid to my institution

The contents of the following The contents of the following presentation are solely the presentation are solely the responsibility of the speaker without responsibility of the speaker without input from any of the above input from any of the above companies.companies.


How Do We Study Rare How Do We Study Rare Outcomes?Outcomes?

How Do We Study Rare How Do We Study Rare Outcomes?Outcomes?


Private DatabasesPrivate DatabasesPrivate DatabasesPrivate Databases

Premier Perspective database Premier Perspective database (Charlotte, NC, USA)(Charlotte, NC, USA)

382, 236 382, 236 patients in approx 400 US patients in approx 400 US acute care hospitals over 4 yearsacute care hospitals over 4 years

Premier Perspective database Premier Perspective database (Charlotte, NC, USA)(Charlotte, NC, USA)

382, 236 382, 236 patients in approx 400 US patients in approx 400 US acute care hospitals over 4 yearsacute care hospitals over 4 years

Memtsoudis SG, et al. Anesth Memtsoudis SG, et al. Anesth 2013;118:10462013;118:1046


American College of American College of SurgeonsSurgeons

American College of American College of SurgeonsSurgeons

Started in the Veterans Health Started in the Veterans Health Administration in the 1980sAdministration in the 1980s

Adopted and expanded by the American Adopted and expanded by the American College of Surgeons into NSQIPCollege of Surgeons into NSQIP

Started in the Veterans Health Started in the Veterans Health Administration in the 1980sAdministration in the 1980s

Adopted and expanded by the American Adopted and expanded by the American College of Surgeons into NSQIPCollege of Surgeons into NSQIP

Schechter MA, et al. Surgery Schechter MA, et al. Surgery 2012;152:3092012;152:309


Prospective RegistriesProspective RegistriesProspective RegistriesProspective Registries

““AURORA” started with practices in AURORA” started with practices in Australia and New Zealand – now Australia and New Zealand – now internationalinternational

Voluntary reportingVoluntary reporting

““AURORA” started with practices in AURORA” started with practices in Australia and New Zealand – now Australia and New Zealand – now internationalinternational

Voluntary reportingVoluntary reporting

Barrington MJ, et al. RAPM 2009;34:534Barrington MJ, et al. RAPM 2009;34:534


Potential Limitations of Big Potential Limitations of Big DataData






Anesthesia Type and Anesthesia Type and MortalityMortality


30-day mortality was lower30-day mortality was lower for neuraxial and for neuraxial and neuraxial/GA vs. GA alone for TKAneuraxial/GA vs. GA alone for TKA

Most in-hospital complications were lower for Most in-hospital complications were lower for neuraxial and neuraxial/GA vs. GA aloneneuraxial and neuraxial/GA vs. GA alone

Transfusion requirements lowest for neuraxialTransfusion requirements lowest for neuraxial

30-day mortality was lower30-day mortality was lower for neuraxial and for neuraxial and neuraxial/GA vs. GA alone for TKAneuraxial/GA vs. GA alone for TKA

Most in-hospital complications were lower for Most in-hospital complications were lower for neuraxial and neuraxial/GA vs. GA aloneneuraxial and neuraxial/GA vs. GA alone

Transfusion requirements lowest for neuraxialTransfusion requirements lowest for neuraxial

Memtsoudis SG, et al. Anesth Memtsoudis SG, et al. Anesth 2013;118:10462013;118:1046




No difference in 30-day mortality No difference in 30-day mortality between between regional anesthesia and GAregional anesthesia and GA

Regional anesthesia patients are more likely Regional anesthesia patients are more likely to have shorter operative time and next-day to have shorter operative time and next-day dischargedischarge

No difference in 30-day mortality No difference in 30-day mortality between between regional anesthesia and GAregional anesthesia and GA

Regional anesthesia patients are more likely Regional anesthesia patients are more likely to have shorter operative time and next-day to have shorter operative time and next-day dischargedischarge

Schechter MA, et al. Surgery Schechter MA, et al. Surgery 2012;152:3092012;152:309




N=6009; N=6009; no difference in 30-day mortality no difference in 30-day mortality based on anesthesia typebased on anesthesia type

Increased pulmonary complications and Increased pulmonary complications and length of stay for GA vs. spinal or local/MAClength of stay for GA vs. spinal or local/MAC

N=6009; N=6009; no difference in 30-day mortality no difference in 30-day mortality based on anesthesia typebased on anesthesia type

Increased pulmonary complications and Increased pulmonary complications and length of stay for GA vs. spinal or local/MAClength of stay for GA vs. spinal or local/MAC

Edwards MS, et al. J Vasc Surg Edwards MS, et al. J Vasc Surg 2011;54:12732011;54:1273


Analgesia and Cancer Analgesia and Cancer RecurrenceRecurrence


Retrospective review of patients with Retrospective review of patients with palpable breast lesions who palpable breast lesions who underwent mastectomy and axillary underwent mastectomy and axillary clearance with PVB catheters x 48h clearance with PVB catheters x 48h vs. opioid IV PCAvs. opioid IV PCA

Primary outcome: metastases or Primary outcome: metastases or cancer recurrence over 2.5-4 year cancer recurrence over 2.5-4 year follow-up (fixed time point)follow-up (fixed time point)

Retrospective review of patients with Retrospective review of patients with palpable breast lesions who palpable breast lesions who underwent mastectomy and axillary underwent mastectomy and axillary clearance with PVB catheters x 48h clearance with PVB catheters x 48h vs. opioid IV PCAvs. opioid IV PCA

Primary outcome: metastases or Primary outcome: metastases or cancer recurrence over 2.5-4 year cancer recurrence over 2.5-4 year follow-up (fixed time point)follow-up (fixed time point)

Exadaktylos AK, et al. Anesth Exadaktylos AK, et al. Anesth 2006;105:6602006;105:660




129 patients met inclusion criteria129 patients met inclusion criteria– 50 patients received PVB (2 failures)50 patients received PVB (2 failures)– 79 patients received IV PCA79 patients received IV PCA

No demographic, tumor quality, or No demographic, tumor quality, or therapeutic differences between groupstherapeutic differences between groups

Recurrence/metastasis rates:Recurrence/metastasis rates:– 19/79 (24%) in IV PCA group19/79 (24%) in IV PCA group– 3/50 (6%) in PVB group3/50 (6%) in PVB group– p=0.013p=0.013















Mechanism?Preserving immune

competence?Direct effect?

Indirect effect? Both?


Cancer Recurrence and Cancer Recurrence and SurvivalSurvival


Myles PS, et al. BMJ 2011;342:d1491Myles PS, et al. BMJ 2011;342:d1491

N=446; long-term follow-up of RCT N=446; long-term follow-up of RCT subjects GA/epidural vs. GA/opioidsubjects GA/epidural vs. GA/opioid

No difference in recurrence-free No difference in recurrence-free survival survival or overall mortalityor overall mortality






Myles PS, et al. BMJ 2011;342:d1491Myles PS, et al. BMJ 2011;342:d1491








14 studies met criteria EA±GA vs. GA 14 studies met criteria EA±GA vs. GA (including Cummings study, n=42,151)(including Cummings study, n=42,151)

Improved overall survival with EAImproved overall survival with EA No difference in cancer recurrenceNo difference in cancer recurrence

14 studies met criteria EA±GA vs. GA 14 studies met criteria EA±GA vs. GA (including Cummings study, n=42,151)(including Cummings study, n=42,151)

Improved overall survival with EAImproved overall survival with EA No difference in cancer recurrenceNo difference in cancer recurrence

Chen & Miao. PLOS ONE Chen & Miao. PLOS ONE 2013;8:e565402013;8:e56540

Cummings KC, et al. Anesth Cummings KC, et al. Anesth 2012;116:797 2012;116:797


Chronic Pain after Breast Chronic Pain after Breast SurgerySurgery


Survey of 479 women who underwent Survey of 479 women who underwent breast surgery over a 4-year periodbreast surgery over a 4-year period

59% response rate59% response rate Prevalence of pain after >1 year Prevalence of pain after >1 year

postop:postop:– Mastectomy/reconstruction = Mastectomy/reconstruction = 49%49%– Mastectomy alone = Mastectomy alone = 31%31%– Augmentation = Augmentation = 38%38%– Reduction = Reduction = 22%22%

Survey of 479 women who underwent Survey of 479 women who underwent breast surgery over a 4-year periodbreast surgery over a 4-year period

59% response rate59% response rate Prevalence of pain after >1 year Prevalence of pain after >1 year

postop:postop:– Mastectomy/reconstruction = Mastectomy/reconstruction = 49%49%– Mastectomy alone = Mastectomy alone = 31%31%– Augmentation = Augmentation = 38%38%– Reduction = Reduction = 22%22%

Wallace MS, et al. Pain 1996;66:195Wallace MS, et al. Pain 1996;66:195




Meta-analysis: 3 studies assessed this Meta-analysis: 3 studies assessed this outcome (n=167)outcome (n=167)

All PVB-GA vs. GAAll PVB-GA vs. GA At 6 mos, RR=0.16, 95%CI (0.02-1.13)At 6 mos, RR=0.16, 95%CI (0.02-1.13)

– No difference (crosses 1)No difference (crosses 1) At 12 mos, RR=0.61, 95%CI (0.08-4.90)At 12 mos, RR=0.61, 95%CI (0.08-4.90)

– No difference (crosses 1)No difference (crosses 1)

Meta-analysis: 3 studies assessed this Meta-analysis: 3 studies assessed this outcome (n=167)outcome (n=167)

All PVB-GA vs. GAAll PVB-GA vs. GA At 6 mos, RR=0.16, 95%CI (0.02-1.13)At 6 mos, RR=0.16, 95%CI (0.02-1.13)

– No difference (crosses 1)No difference (crosses 1) At 12 mos, RR=0.61, 95%CI (0.08-4.90)At 12 mos, RR=0.61, 95%CI (0.08-4.90)

– No difference (crosses 1)No difference (crosses 1)

Schnabel A, et al. BJA 2010;105:842Schnabel A, et al. BJA 2010;105:842


Chronic Pain after Chronic Pain after ThoracotomyThoracotomy

Chronic Pain after Chronic Pain after ThoracotomyThoracotomy

Incidence is approximately Incidence is approximately 50%50%– 3-16% report pain as moderate-severe3-16% report pain as moderate-severe

Heterogeneity in study designsHeterogeneity in study designs Many contributing factors: patients, Many contributing factors: patients,

surgical technique, pre- and postop surgical technique, pre- and postop painpain

To date, To date, no convincing evidenceno convincing evidence that that PVB decreases chronic pain after PVB decreases chronic pain after thoracotomythoracotomy

Incidence is approximately Incidence is approximately 50%50%– 3-16% report pain as moderate-severe3-16% report pain as moderate-severe

Heterogeneity in study designsHeterogeneity in study designs Many contributing factors: patients, Many contributing factors: patients,

surgical technique, pre- and postop surgical technique, pre- and postop painpain

To date, To date, no convincing evidenceno convincing evidence that that PVB decreases chronic pain after PVB decreases chronic pain after thoracotomythoracotomy

Wildgaard & Kehlet. Eur J CTS Wildgaard & Kehlet. Eur J CTS 2009;36:1702009;36:170


Ultrasound and Patient Ultrasound and Patient SafetySafety


Overall incidence of nerve injury due to Overall incidence of nerve injury due to block=0.4 per 1000 blocks block=0.4 per 1000 blocks

Overall incidence of LAST=0.98 per 1000 Overall incidence of LAST=0.98 per 1000 blocksblocks

No difference with or without ultrasoundNo difference with or without ultrasound

Overall incidence of nerve injury due to Overall incidence of nerve injury due to block=0.4 per 1000 blocks block=0.4 per 1000 blocks

Overall incidence of LAST=0.98 per 1000 Overall incidence of LAST=0.98 per 1000 blocksblocks

No difference with or without ultrasoundNo difference with or without ultrasound

Barrington MJ, et al. RAPM Barrington MJ, et al. RAPM 2009;34:5342009;34:534




22 cases of LAST in 25,336 blocks 22 cases of LAST in 25,336 blocks (overall incidence=0.87 per 1000)(overall incidence=0.87 per 1000)

LAST cases: 12/20,401 blocks with US vs. LAST cases: 12/20,401 blocks with US vs. 10/4745 blocks without US (10/4745 blocks without US (p=0.004p=0.004))

22 cases of LAST in 25,336 blocks 22 cases of LAST in 25,336 blocks (overall incidence=0.87 per 1000)(overall incidence=0.87 per 1000)

LAST cases: 12/20,401 blocks with US vs. LAST cases: 12/20,401 blocks with US vs. 10/4745 blocks without US (10/4745 blocks without US (p=0.004p=0.004))

Barrington MJ, et al. RAPM Barrington MJ, et al. RAPM 2013;38:2892013;38:289


SummarySummarySummarySummary Big data may offer means to study Big data may offer means to study

rare outcomes but has limitationsrare outcomes but has limitations Anesthesia and analgesia choice may Anesthesia and analgesia choice may

affect survivalaffect survival No convincing evidence to date that No convincing evidence to date that

analgesia affects cancer recurrence analgesia affects cancer recurrence or persistent postsurgical painor persistent postsurgical pain

Ultrasound may reduce incidence of Ultrasound may reduce incidence of LASTLAST

Big data may offer means to study Big data may offer means to study rare outcomes but has limitationsrare outcomes but has limitations

Anesthesia and analgesia choice may Anesthesia and analgesia choice may affect survivalaffect survival

No convincing evidence to date that No convincing evidence to date that analgesia affects cancer recurrence analgesia affects cancer recurrence or persistent postsurgical painor persistent postsurgical pain

Ultrasound may reduce incidence of Ultrasound may reduce incidence of LASTLAST

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Mariano big data nwac 2015