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Top 10 innovations in Primary Care (in the past year)

Top 10 innovations in Primary Care (in the past year). Robert Dachs , MD, FAAFP Assistant Director, Dept of Emergency Medicine Ellis Hospital, Schenectady, NY Clinical Associate Professor Ellis Family Medicine Residency Program Albany Medical College Mark Graber, MD, FACEP

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Top 10 innovations in Primary Care (in the past year)

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  1. Top 10 innovations in Primary Care(in the past year) Robert Dachs, MD, FAAFP Assistant Director, Dept of Emergency Medicine Ellis Hospital, Schenectady, NY Clinical Associate Professor Ellis Family Medicine Residency Program Albany Medical College Mark Graber, MD, FACEP Professor of Family and Emergency Medicine University of Iowa Carver College of Medicine Iowa City, Iowa

  2. Disclosure Statement Drs. Dachs and Graber have no affiliations with any product or pharmaceutical manufacturer. We are clinicians so you are about to hear what we think may be paradigm changers from this year’s literature. We will run through “bonus” topics at the end: things we don’t have time for but might tweak your interest. 2

  3. I. Atrial fibrillation Management Dabigatran: Boon, Bust or Hype?

  4. Atrial fibrillation Management • Who gets anticoagulation? • Who is at risk for hemorrhages? • And is dabigatran (Pradaxa) everything its cracked up to be?

  5. Atrial Fibrillation and StrokeWhy do we anticoagulate? • The older the patient with atrial fibrillation, the higher the risk of cardioembolic stroke. • Strokes due to Afib have higher mortality and morbidity. • Warfarin decreases absolute annual risk from 4.5% --> 1.4% (NNT=30). CVA rate (% per yr)

  6. Atrial Fibrillation: Who Gets Warfarin? ACC/AHA 2011 Guideline Risk Category Recommended Therapy • No risk factors………………. • One moderate risk factor…… • Any high-risk factor OR > 2 moderate risk factors……. ASA 81-325mg q d ASA or warfarin Warfarin (INR 2.0-3.0) Moderate-risk factors Age > 75yrs HTN CHF LV ejection fraction < 35% DM High-risk factors Previous CVA,TIA,embolism Mitral stenosis Prosthetic heart valve

  7. Atrial fibrillation Management: 1) Who gets anticoagulation? • Last year----- CHADS2 • This year--- CHA2DS2- Vasc

  8. Atrial Fibrillation: the CHADS2 Score CHADS2 Risk Criteria Score 1 1 1 1 2 Risk Category 0: Low-risk (ASA) 1: Moderate (ASA or warfarin) 2+: High-risk (warfarin) • CHF • HTN • Age >75 yrs • DM • Prior Stroke or TIA Pts. (N=1733) CVA Rate (%/yr) (95%CI) CHADS2 Score 120 1.9 (1.2 - 3.0) 0 463 2.8 (2.0 - 3.8) 1 523 4.0 (3.1 - 5.1) 2 337 5.9 (4.6 - 7.3) 3 220 8.5 (6.3 - 11.1) 4 65 12.5 (8.2 - 17.5) 5 5 18.2 (10.5 -27.4) 6

  9. CHADS2 vs. CHA2DS2-VASc? CHADS2 Score 1 1 1 1 2 Score 1 1 2 1 2 1 1 1 CHA2DS2-VASc • CHF • HTN • Age >75 yrs • DM • Prior Stroke or TIA • Vascular disease • Age 65-74 yrs • Female sex • CHF • HTN • Age >75 yrs • DM • Prior Stroke or TIA N=1733 vs. N= 1,084 pts with afib, not on warfarin 1 year in Euro Heart study Gage BF, et al JAMA 2001; 285:2864-70 Yip GB, et al. Chest 2010; 137:263-72

  10. CHADS2 vs. CHA2DS2-VASc? CHADS2 CHA2DS2-VASc CVA Rate @ 1yr 1.67% vs. 0.78% 4.75% vs. 2.0% - Low risk = 0 points - Low risk = 0 points - Intermediate = 1 pt - Intermediate = 1 pt N= 73,538 pts with afib, not on warfarin 10 year period in Denmark A large external validation study - That’s what we like to see… Olesen, JB, et al. BMJ 2011; 342:d124

  11. Atrial Fibrillation: Anticoagulation Risks/Benefits • Decreases CVA by approx 3%/yr • Rate of ICH 0.1 - 0.6% • Increased with advanced age, HTN • Major bleeding rates: 1.2%/yr 2. So which patients need to avoid anticoagulation???

  12. “But I Am Fearful of My Elderly Patient Falling (ie, Subdural)” • Using an analytic model … • A patient over age 65 with Afib must sustain 295 falls in one year for the risk of subdural to outweigh benefit of stroke prevention Man-Son-Hing, et al.Arch Intern Med. 1999;159(7):677-85. Note 1: Patients on warfarin,spontaneous ICH more common than subdural Note 2: Model uses assumptions - are they correct? That’s last year - this year….

  13. Previously…. • HEMORR2HAGES (2006) • 1604 pts derived from NRAF database • 10 variables - not all easy to obtain (eg “Genetic factors such as CYP 2C9 polymorphism) • Shireman, et al. (2006) • 26,345 pts from NRAF database • 8 variables…but score too complicated!!!!!!! Risk Score = 0.49*X age70+ + 0.32*Xfemale + 0.58*Xremote Bleed + 0.62*XRecentBleed + 0.71*Xalcohol/Drug Abuse + + 0.86*Xanemia + 0.32*Xantiplatelet Agent That’s last year - this year….

  14. Two new scoring systems:HAS-BLED and ATRIA • A novel User-friendly Score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation. Pisters R, et al. Chest 2010; 138: 1093-1100. • A new risk scheme to predict Warfarin-associated hemorrhage: The ATRIA study. Fang MC, et al. J AM Coll Card 2011; 58: 395-401

  15. Who needs to avoid anticoagulation?? HAS-BLED Points Definition 1 HHypertension Sys BP > 160 1 or2 AAbnormal Renal and/or dialysis/transplant (1pt each)liver function cirrhosis/T. Bili 2x or AST/ALT 3x normal 1 SStroke 1 BBleeding previous bleed/predisposition 1 LLabile INR < 60% in therapeutic range 1 EElderly (> 65 yrs) 1 or2 DDrugs or alcohol excess antiplatelet or NSAID’s (1pt each) A score of > 3 is considered “high risk” ESC recommends “caution” using warfarin1 1ESC Guidelines for the management of atrial fibrillation, 2011

  16. HAS- BLED: Results Derivation Cohort Validation Cohort # of bleeds Bleeds per 100 pt yrs # of bleeds Bleeds per 100 pt yrs n Score n 0 1517 9 0.59 798 9 1.13 1589 24 1.51 1286 13 1.02 219 7 3.20 744 14 1.88 ------------------------------------------------------------------------------------ 41 8 19.51 187 7 3.74 14 3 21.43 46 4 8.70 1 0 - 8 1 12.50 - - - 2 0 0 - - - - - - - - - - - - 9 - - - - - - Major bleeds defined as any below: • 1) bleeding requiring hospitalization 2) require transfusion • 3) drop in Hgb > 2 g/L 4) Hemorrhagic CVA

  17. ATRIA: Results Derived from 13,559 pts in Kaiser systemDerivation:Validation = 2 :1 ratio Score 3 3 2 1 1 • Low risk (0-3) 0.72 0.83 • Intermediate (4) 2.71 2.41 • High (5-10) 5.99 5.32 • Anemia: Hgb <13 male, <12 female • GFR < 30 • Age >75 yrs • Any prior hemorrhage Dx • HTN Risk category, pointsEvents/100 pt/yrs DerivationValidation One of my favorite websites: mdcalc.com

  18. Atrial fibrillation Management Dabigatran: Is it really 35% better?????

  19. What about dabigatran (Pradaxa)? • RE-LY trial:NEJM 2009; 361: 1139-51. • Methods: 18,113 pts with afib, randomized to: dabigatran dabigatran warfarin 110mg BID150mg BID • Results • CVA/embolism 1.53% 1.11%* 1.69% • Major bleeding/yr 2.71% 3.11% 3.36% • Mortality rate/yr 3.75% 3.64% 4.13% followed for 2yrs NNT=172 Cost: Pradexa = $230 per month, $2760 per year Price accessed @ drugstore.com - 3/25/11

  20. Pet Peeve….. …….Benefits in: Relative Risk ……Harm in: Absolute numbers

  21. And there will be more to come.. • Rivaroxaban (Xarelto) • ROCKET-AF trial, non-inferior to warfarin Published online, NEJM Aug 10, 2011 NEJM Sept 8, 2011 • Apixaban (Eliquis) • ARISTOTLE trial, non-inferior to warfarin Presented at European Society of Cardiology, Aug 2011 NEJM; Sept 15, 2011

  22. Reservations….. • Cost • Even with INR monitoring, warfarin is cheaper Shah SV, et al. Circulation 2011; 123: 2562-70 • Efficacy vs. effectiveness (in the community) • How about we do a better job with warfarin? Weekly home monitoring (vs. monthly outpt.) • improves therapeutic range from 50-60% to 85% • Decreases VTE events, mortality and hemorrhages!! Heneghan C, et al. Lancet 2006; 367:404-11 Cochrane review, April 2010

  23. Bolland MJ et al. Calcium supplements with or without vitamin D and risk of cardiovascular events: Reanalysis of the Women's Health Initiative limited access dataset and meta-analysis. BMJ 2011 Apr 19; 342:d2040. (http://dx.doi.org/10.1136/bmj.d2040) andWarensjo E et al. Dietary calcium intake and risk of fracture and osteoporosis prospective longitudinal cohort study BMJ 2011; 342:d1473 doi: 10.1136/bmj.d1473 (Published 24 May 2011) II. Calcium intake: heart disease and bone health

  24. First Study Reanalysis of Women’s Health Initiative Randomized 36, 282 to placebo or calcium 1000mg/d and 400 IU daily of Vit. D. Primary endpoint was fracture. This is a second analysis of the randomized data looking for cardiac outcomes. Original study included serial EKGs

  25. What did they find? Hazard ratio for cardiovascular event (MI, CVA, Revascularization: 1.13-1.22 (significant p value) only in those not taking supplements already. In those taking supplements at randomization, overall mortality was less. NNH: 178, NNT: 302

  26. Second study Cohort study of 61,433 women born 1914-1948. Randomized study started 1987 and was of fracture risk. Based on the Swedish Mammography Cohort 5022 in the sub-cohort that looked at Dexa scans. Followed for 19 years. Calcium intake as reported by patients.

  27. 24% of women had a fracture and 6% had a hip fracture. Calcium intake of 750mg-882mg/day (second quintile) was as good at preventing fractures and osteoporosis as were higher levels of calcium intake. In fact, highest quintile had Hazard ratio = 1.19 (95%CI 1.06-1.32) for hip Fx.

  28. Conclusion? Cardiac disease: who knows? But, shoot for lower dose calcium supplementation. 28

  29. III. HIV Update: This will be in the new guidelines… http://www.nih.gov/news/health/may2011/niaid-12.htm(In press….)andThe H IV-CAUSAL Collaboration. When to initiate combined antiretroviral therapy to reduce mortality and AIDS-defining illness in HIV-infected persons in developed countries: An observational study. Ann Intern Med 2011 Apr 19; 154:509.

  30. We know early treatment helps the patient • Kitahata MM et al. Effect of early versus deferred antiretroviral therapy for HIV on survival. N Engl J Med 2009 Apr 1; [e-pub ahead of print]. (http://dx.doi.org/doi:10.1056/NEJMoa0807252) • Sax PE and Baden LR. When to start antiretroviral therapy — Ready when you are? N Engl J Med 2009 Apr 1; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMe0902713)

  31. 1,763 couples. 97% heterosexual. • One HIV+ partner • Randomized to HAART immediately or after CD4<250 cells/mm3 • Total cases: 39 • 28 cases from partner to partner transmission based on genetics. • 27 in the late HAART group. • Early treatment prevents transmission

  32. Second study • 8392 patients • Observational study • If started HAART at 350/mm3 instead of at 500/mm3 40% increase in AIDS-defining illness + death. • NNT 48

  33. IV. Cancer screening:One step up,____ step back? The National Lung Screening Trial. NEJM 2011; 365: 395-409. • Methods: 53,454 adults, age 55-74 yrs • 30+ pack yr smokers • Randomized to: • enrolled 2002 - 04, followed to 12/31/09 3 annual chest CT’s vs. 1 Chest x-ray

  34. The National Lung Screening Trial. NEJM 2011; 365: 395-409. • Results: Chest CTChest x-ray Deaths per 100,000 247 309 Person/years • Author’s Conclusion “…representing a relative risk reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95%CI, 6.8 -26.7) p=0.004”

  35. The National Lung Screening Trial. NEJM 2011; 365: 395-409. • Results: Chest CTChest x-ray Deaths per 100,000 247 309 Person/years • Author’s Conclusion “…representing a relative risk reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95%CI, 6.8 -26.7) P=0.004” When will we stop allowing RRR? (and insist on absolute risk reduction and NNT)

  36. The National Lung Screening Trial. NEJM 2011; 365: 395-409. • Results: Chest CT Chest x-ray N=26,722 N=26,732 Lung Ca Deaths 356 443 Lung cancer deaths 1.33% 1.65% NNT 312

  37. The National Lung Screening Trial. NEJM 2011; 365: 395-409. • Results: Chest CTChest x-ray Deaths per 100,000 247 309 Person/years Lung cancer deaths 1.33% 1.65% NNT 312 NNH >1 in 3 false (+) CT scan 1 in 30 unnecessary surgery 1 in 161 with surgical complication One of my favorite websites: TheNNT.com

  38. Putting those risks into perspective…. • Chest CT group: 26,722 • Any (+) test 10,448 (39.1%) • Lung CA confirmed 649 (3.6%) False (+) rate = 96.5% More CT’s, bronchoscopy, needle biopsy, ect….

  39. What happens when you go after those “nodules” with needle transthoracic (CT) needle biopsy? • Methods: 15,865 pts with CT needle biopsy • From 2006 State Ambulatory Surgery Databases in California, NY, Michigan, FL • Results: • Pneumothorax 15.0% • Needing chest tube 6.6% of all procedures NNH = 6.6 and 15 • Hemorrhage 1.0% • Needing transfusion 17% of “hemorrhages” Weiner RS, et al. Ann of Intern Med 2011; 155: 137-144

  40. Not another infectious disease guideline! Urinary Tract Infection: Clinical Practice Guideline for the Diagnosis and Management of the Initial UTI in Febrile Infants and Children 2 to 24 Months SUBCOMMITTEE ON QUALITY IMPROVEMENT AND STEERING MANAGEMENT SUBCOMMITTEE ON URINARY TRACT INFECTION and STEERING Pediatrics; originally published online August 28, 2011;DOI: 10.1542/peds.2011-1330 40

  41. What we know? Treatment and diagnosis is all over the place. Workup after 1st episode? Workup after 2nd episode? And what workup should be done. 41

  42. Some answers Analysis of medical literature. UTI defined as pyuria and at least 50,000 cfu 42

  43. What do they recommend? US for all children after first febrile UTI (Level of evidence: C). NO VCUG unless US shows scarring of kidneys, hydronephrosis, etc. (Level of evidence: B) Modelling: Only 1:100 will have grade V NO prophylactic antibiotics if grade I-IV reflux (Level of evidence: ??? But RCT) 43

  44. VI. The potential PE patient… • The problem: excessive CT utilization • The answer: Risk stratification • Last year: Well’s Criteria • This year: PERC Rule How to risk stratify?

  45. CT use in USA • 75 million in 2009 • - 7% (5 million) in children • -60% are women

  46. CT scan and radiation risks • Children/young adults: greater Cancer risk • tissues are more radiosensitive • more years of life to develop radiation induced cancer • Est. lifetime risk of cancer from one 64 slice Chest CT • 20 y/o female = 1 in 142 • 40 y/o female = 1 in 284 • 60 y/o female = 1 in 466 • 80 y/o female = 1 in 1338 Einstein AJ, et al. JAMA 2007; 298: 317-23.

  47. PE Wells Clinical Prediction Rules for: Points • Clinical Symptoms of DVT 3 • Other diagnosis less likely that PE 3 • Pulse > 100 1.5 • Immobilization or surgery within 4 weeks 1.5 1 • Previous DVT or PE 1.5 • Hemoptysis 1 • Malignancy (actively treated in past 6 mos) 1 High risk >6 Moderate risk 2-6 Low risk <2 78% PE 27.8% PE 3.4% PE Wells PS, et al. Thromb Haemost 2000

  48. The PERC rule • low clinical gestalt (<15% chance) with • Age <50 • Pulse <100 • SaO2 > 95% • No previous VTE - No hemoptysis - No estrogen use - No unilateral leg swelling - No surgery/trauma requiring hospitalization in past 4 weeks Derived from 3148 patients Kline JA, et al. Jour Thromb Haemostasis, 2004

  49. PERC Rule:Validation Study • Methods: 13 ED’s, 8183 patients • 85% with CC of chest pain or dyspnea • Enrolled if study for PE was ordered • Measures: PE or death within 45 days • Results: 1666 pts. very low risk: PERC (-)neg • 15 with PE, 1 death = 1.0% (95%CI; 0.6 - 1.6%) Kline JA, et al. J Thromb Haemost May 2008; 6: 772-80.

  50. How about a community hospital?or “Why I believe in PERC..” • Methods: 308 pts with chest CT • 7/1/08 - 10/31/08, @ Ellis Hospital ED • 213 (69%) to “R/O PE” • 2 reviewers applied PERC rule • Results: 48 (of the 213) met PERC rule • All 48 were negative for PE (100% sensitive)! (95% CI; 83.4 - 100%) • Of the remaining 165 pts, 18 had (+) PE • Negative Predictive value = 100%(95% CI,93.8-100%) Dachs R, Kulkani D, Higgins,G. published ahead of print, Am J Emerg Med 2010

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