Avoiding Thor s Thunderbolt!

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1 Avoiding Thor s Thunderbolt! The Urologist s Role in Managing the Peri-operative Risk of Cardio-Ischemic and Embolic Events Philip J. Walther, MD, PhD, MBA, FACS Professor of Urologic Surgery Duke U. School of Medicine

2 Philip J. Walther, MD, PhD, MBA, FACS Disclosures: None Off-Label Recommendations: None

3 Myocardial Infarction Evolving Diagnostics 1970 s: Primarily Sxs and EKG changes 1980 s: Developing cardiac biomarkers LDH isoenzymes, CPK and then CPK-MB 1990 s: Onset of troponin Dxtics, but criteria for ischemic Sx and EKG still dominant 2000 s: Greater sensitivity: 4 th and 5 th Gen 2017: 5 th Gen ctnt just approved by FDA Impact of Better Dx & Rx: mortality rate Fewer have STEMI than N-STEMI MI s

4 Major Peri-Operative Cardiac Complications Account for at least 1/3 of perioperative deaths. Challenge: Ischemic Sx masked by patient s obtundation (Eg. Narcotics) or misinterpreted coinciding symptoms (abd. incisional pain) Impact: Substantial morbidity & prolonged hospitalization Increased medical cost Affects intermediate and long-term prognosis. Deceppe E, et al: Canad. J. Cardiology 2017; 33, 17-32

5 Revised Cardiac Risk Index Computation: Components (1 point / component present) Lee TH, et al: Circulation 100: , 1999

6 Revised Cardiac Risk Index RCRI Class Validation Cohort Index Sum Major Cardiac Complication Rate* (%) I II III IV > *V.Fib/Cardiac arrest, Complete heart block, acute MI, or Pulmonary Edema Lee TH, et al: Circulation 100: , 1999

7 Ann Internal Med 2011; 154: 523-8

8 Perioperative MI (PMI) after Non-Cardiac Surgery: Characteristics and Short-Term Prognosis Of those who had MI, 65% did not have ischemic Sx 30-Day Mortality: PMI-11.6%; no PMI-2.2% With ischemic Sx: 9.7% Without ischemic Sx: 12.5% 8.3% had elevated cardiac markers only Devereaux PJ et al: Ann Internal Med 2011; 154: 523-8

VISION Investigators JAMA 2012; 307:2295-304 Prospective cohort study (15,133 pts) Troponins drawn daily

9 VISION Investigators JAMA 2012; 307: Prospective cohort study (15,133 pts) Troponins drawn daily (POD 1,2,3) NOTE: 4 th Gen ctnt was utilized Clinical outcomes reviewed: 30-day mortality was determined.

10 Postoperative Troponin and 30-Day Mortality Kaplan-Meier Estimates of 30-Day Mortality Based on Peak Troponin T Levels Peak Troponin level correlated with risk of death within 30 d VISION Investigators JAMA 2012; 307:

11 MINS Many surgical patients sustain myocardial injury perioperatively that will not satisfy diagnostic criteria for MI, but portend diminished survival outcomes. (M)yocardial (I)njury after (N)on-cardiac (S)urgery- defined as: myocardial injury detected by troponin -caused by ischemia (that may or may not result in necrosis), has prognostic relevance, and occurs with 30 days of surgery. VISION Investigators. Anesthesiology 2014; 307:564-78

12 MINS: Clinical Outcomes Eight % of patients suffered MINS 52.8% would not have fulfilled universal definition of MI. Only 15.8% of MINS experienced ischemic symptoms. Conclusion: MINS is common and is associated with substantial mortality. VISION Investigators. Anesthesiology 2014; 307:564-78

JAMA 2017; 317: 1642-51 21,842 participants Outcome: Death within 30 d.: 266 (1.

13 JAMA 2017; 317: ,842 participants Outcome: Death within 30 d.: 266 (1.2%) Protocol: ctnt drawn postop: At 6-12 hr, D1, 2, 3 If >14 ng/l, assessed for: Ischemic features (Sxs, EKGs) Excluding sepsis, PE, AF

14 Post-Operative Complications Troponin Occurrence and 30-Day Mortality Complication % Occurrence Deaths (% of Occurrence) MINS Major Bleeding Sepsis New Atrial Fib Stroke Pulmonary embolus DVT Pneumonia VISION Study Investigators. JAMA 2017;317:

15 Post-Operative Complications Troponin Occurrence and 30-Day Mortality VISION Study Investigators. JAMA 2017;317:

16 Brain (B-Type) Natriuretic Peptide (BNP) Synthesized as Pro-BNP. Released by cardiomyocytes with multiple stimuli: Ischemia, stretch, inflammation, neuroendocrine stimuli. Inhibits renin Aldosterone production Natriuresis Causes vasodilation

17 Brain (B-Type) Natriuretic Peptide (BNP) Strongly prognostic of cardiac injury and decompensation. N-terminal peptide (NT-ProBNP and BNP very similar in prognostic value.) Blood test is inexpensive.

18 Peri-Op Cardiac Risk Assessment / Management for Elective Non-Cardiac Surgery: Canadian Cardiovascular Society Guidelines 2017 (Duceppe, 2017: Can. J. Card.) Patient Population: (Surgery requiring overnight admission) Age: yrs + known signif. CV (SigCV) disease* Age: 45 yrs Risk Stratification with Revised Cardiac Risk (Lee) Index Draw BNP/NT-proBNP (Neg. / Threshold- NT-pro: <300 mg/l BNP <92 mg/l) If Neg: No additional Routine Postop monitoring If: 65 yrs and RCRI 1, yrs with Sig CV, If Pos: EKG in PACU (? Troponin) Daily troponin x hrs Consider in-hospital sharedcare management If NOT: No further testing necessary * Sig. CV Disease: Known CAD, CBVD, PAD, CHF, Severe PHTN, Severe obstructive intra-cardiac abnormality

Anesth Analg 2014; 119:1053-63 Retrospective, case-controlled study Site: Paris, France All

19 Anesth Analg 2014; 119: Retrospective, case-controlled study Site: Paris, France All patients aged >18 years who underwent major vascular surgery Note: All patients had 30d of enoxaparin

20 Therapy Intensification (TI) for Post- Operative Troponin Elevation Focus on 4 major drug groups: Anti-platelet agents Beta-blockers ACE inhibitors Statins 66 pts with Pos. ctp: 43 had TI; 23- no change Fourcrier A, et al.: Anesth Analg 2014; 119:

21 Therapy Intensification (TI) for Post- Operative Troponin Elevation Fourcrier A, et al: Anesth Analg 2014; 119:

22 Gettysburg, 1863 SURGEON THE GOOD OLD DAYS

23 THE GOOD OLD DAYS Surgical therapeutic objectives were straightforward. Since the tools of the trade were few (scalpel, saw, and thread), outcome expectations were limited. The surgeon was a HERO when the patient lived! No one kept track of complications; they kept track of SAVES. Gettysburg, 1863

24 NOT the GOOD OLD DAYS Anymore!! Joint Commission inspections & mandates provide a regulatory framework for constant surveillance of physician practice patterns National Surgical Quality Improvement Program (NSQIP) Plaintiff Bar Filing Malpractice Torts

25 EVERY BUSY SURGEON S NEMESIS CMS considers Venous Thromboembolism a preventable EMBOLUS complication!!!

NOT the GOOD OLD DAYS Anymore!! Payors are now monitoring physician performance (scorecards ): Complications Length of Stay Re-admission rates Deaths!

26 NOT the GOOD OLD DAYS Anymore!! Payors are now monitoring physician performance (scorecards ): Complications Length of Stay Re-admission rates Deaths! Since CMS considers venous thromboembolism a preventable complication, it becomes a major cost to the hospital and. SURGEON PRACTICE PATTERNS BECOME AN ISSUE!

27 DVT Occurrence Correlates in Tandem with No. of Risk Factors Anderson FA, Spencer FA. Circulation 2003; 107:I9-I16

28 Risk of VTE in Perioperative Period Bahl V, Et al: Ann Surg 2010; 251: 344

29 Radical Cystectomy: A Setup for VTE? Of GU cancer cases, highest rate of VTE Independent risk for VTE Contemporary VTE incidence: % In pelvic surgeries, Gyn and Gen Surg literature suggests that risk extends beyond discharge date.

Observational retrospective study: 1,037 cystectomy patients Source: NSQIP data base of ACS Timeframe of surgery: 2005-2011 Findings: 6% were diagnosed with VTE (DVT

30 Observational retrospective study: 1,037 cystectomy patients Source: NSQIP data base of ACS Timeframe of surgery: Findings: 6% were diagnosed with VTE (DVT only- 2.9%; PE only- 1.7%; Both-1.4%) 55% were diagnosed after initial discharge (65% of PE, 50% of DVT) Of pts with VTE, 30-day mortality rate was 6.4% J. Urol 191: 943, 2014

31 Timing of Postoperative VTE Events Median and Mean Time: 14d &15.2d, respectively VanDlac AA, et al. J. Urol 191: 943, 2014

32 DVT Prophylaxis: Changing Patterns of Care-Need for New Paradigm? Large clinical experience (outside GU) has demonstrated risk of thromboembolism for several weeks after surgery (multiple abdominal sites) Utilization Review initiatives in late 1990 s: Impact: substantially shorter postoperative hospital stays. When used, postop inpatient DVT prophylaxis (SCD s,? pharma) had a substantially shorter duration of use => potentially adverse outcomes Time for new paradigm? (Post-discharge prophylaxis!!) But if so, extent of duration?

33 New Engl. J. Med. 346: 975, 2002 Prospective, Double-blind, Placebo-controlled Randomized Trial All 332 pts: Everyone- Enoxaparin 40 mg qd (starting hrs preop) for 6-10 d => then randomized. Randomization: Placebo vs. Drug for d. Compression stockings but no SCD s All pts had venograms at 25d (after not earlier for Sxs)

36 DVT Prophylaxis-Postoperative Ortho LMWH (Enoxaparin) vs. Placebo Study: 100 pts undergoing hip surgery Regimen: Randomization. Enoxaparin 30 mg bid starting 12 hr postop x 14d (or discharge) Monitoring: Daily 125 I-Fb scans (confirmed by venography if positive) Turpie AGG, et al. et al. New Eng. J. Med. 315: 925, 1986

37 DVT Prophylaxis-Postoperative LMWH (Enoxaparin) vs. Placebo (10.8%) (51.2%) ( 5.4%) (23.1%) Turpie AGG, et al.: New Eng. J. Med. 315: 925, 1986

38 Caprini Method of Risk Stratification Bahl V, et al: Ann Surg 2010; 251: 344

39 Bahl V, Et al: Ann Surg 2010; 251: 344

41 SHOCKING!!! 10,966 AUA members queried; 11% responded. Question: FAMILIAR WITH RECOMMENDATIONS of the AUA Best Practice Statement? Yes 50.7% No 19.4% 49.3% Unaware of AUA-BPS 29.9% Sterious S, et al.: J. Urol. 190: 992 (2013)

42 DVT Prophylaxis: Technique Mechanical: Early ambulation Graduated compression stockings Intermittent (sequential) pneumatic compression (SCD s) Pharmacologic: Low-dose unfractionated heparin (LDUF-H) Indirect Factor X inhibitors: Low molecular weight heparin (WMWH)- Ex., enoxaparin Synthetic- fondaparinux Vitamin K antagonists (VKA)- warfarin Oral therapies: Factor IIa & Xa inhibitors (dabigatran,rivaroxaban) Developmental: Anti-sense anti-factor XI inhibitors

43 Stratifying Patient Risk of DVT: Intrinsic Patient Risk AND Type of Procedure Risk Stratification AUA Best Practice Statement-DVT Prophylaxis, 2008

44 Risk-Adapted VTE Prophylaxis: AUA-Best Practice Statement In selected very high-risk pts, consider post-discharge enoxaparin *If patient >150 kg, consider Enoxaparin 40 mg q12h AUA-BPS DVT Prophylaxis, 2008

CCS Perioperative Guidelines When to order a BNP and What to do with a Positive Troponin

Canadian Society of Internal Medicine Annual Meeting 2017 Toronto, ON CCS Perioperative Guidelines When to order a BNP and What to do with a Positive Troponin Dr. Vikas Tandon Associate Professor, Cardiology