SAME DAY DISCHARGE CORONARY

INTERVENTION IN 2014

Van Crisco, MD, FACC, FSCAI First Coast Heart and Vascular

Center Jacksonville, FL (678-313-6695)

Disclosures/Conflicts Speakers Bureau: St. Jude Medical Bayer HealthCare Astra-Zeneca

Consultant: Cook Medical

Same Day Discharge PCI: State of the Art Prevalence Safety Current Recommendations Potential Cost Benefits Barriers to Utilization Tips and Techniques to Increase Utilization The Future of Elective Coronary Revascularization Care

Strategies

Why Stay in the Hospital? Most patients say they don't like staying in the

hospital….shocking Hospitals are not safes places Hospital-acquired infections don’t happen at home No patient sleeps well in a hospital Fall Risk Increases in a hospital (sundowning) Well-publicized risk of medication errors while in the

hospital

Same Day Discharge PCI: Frequency Data on 107,018 patients 65 years or older undergoing elective PCI procedures at 903 sites participating in the CathPCI Registry between November 2004 and December 2008. The prevalence of same-day discharge was 1.25% (95% CI, 1.19%-1.32%; n = 1339 patients) with significant variation across facilities. Much greater prevalence OUS Almost uniformly femoral access

Rao SV, Kaltenbach LA, Weintraub WS, et al. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older adults. JAMA 2011; 306: 1461-1467.

Same Day Discharge PCI: Safety Outcome Same-day discharge, n=1339 (%)

Overnight stay, n=105 679 (%)

p

2-d death or rehospitalization

0.37 0.50 0.51

2-d death 0.07 0.02 0.10 2-d rehospitalization

0.30 0.48 0.30

30-d death or rehospitalization

9.63 9.70 0.94

30-d death 0.30 0.22 0.53 30-d rehospitalization 9.56 9.60 0.96

Rao SV, Kaltenbach LA, Weintraub WS, et al. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older adults. JAMA 2011; 306: 1461-1467.

Two-day and 30-day rates of death and re-hospitalization (adjusted for risk)

Same Day Discharge PCI: Safety Outcome Same-day discharge, n=1339 (%)

Overnight stay, n=105 679 (%)

p

2-d death or rehospitalization

0.37 0.50 0.51

2-d death 0.07 0.02 0.10 2-d rehospitalization

0.30 0.48 0.30

30-d death or rehospitalization

9.63 9.70 0.94

30-d death 0.30 0.22 0.53 30-d rehospitalization 9.56 9.60 0.96

Rao SV, Kaltenbach LA, Weintraub WS, et al. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older adults. JAMA 2011; 306: 1461-1467.

Two-day and 30-day rates of death and re-hospitalization (adjusted for risk)

JAMA. 2011;306(13):1461-1467. doi:10.1001/jama.2011.1409

Prevalence and Outcomes of Same-Day Discharge After Elective Percutaneous Coronary Intervention Among Older Patients

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Cumulative Incidence of Death and Re-Hospitalization Over Time

Same Day Discharge PCI: Safety Same-Day

Discharge N = 403 n = %

Overnight Stay N = 397 n = %

4–24 h 1–30 d 4–24 h 1–30 d Composite primary end point 1 0 2 3 Any MACCE 0 0 0 3 Death 0 0 0 0 Myocardial infarction 0 0 0 2 Cardiac surgery 0 0 0 1 Repeat PCI 0 0 0 1 Stroke 0 0 0 0 False aneurysm 1 0 2 0 AV fistula 0 0 0 0 Readmission 1 8 2 13 Hematoma >5 cm 17 15 11 18

EPOS Trial: Occurrence of Cardiac Events and Puncture-Related Complications in Patients Deemed Suitable for Same-Day Discharge

Same Day Discharge PCI: Safety

Same-Day Discharge

n (%)

Overnight Stay n (%)

Absolute Risk Difference, % (95% CI)

All patients, n (%) 403 397 Composite primary end point

<24 h 9 (2.2) 17 (4.2) 2.0 (−0.4–4.5)

Composite primary end point <30 d

15 (3.7) 21 (5.3) 1.6 (−1.3–4.4)

Any MACCE <24 h 6 (1.5) 16 (4.0) 2.5 (−0.3–4.8) Any MACCE <30 d 12 (2.9) 19 (4.8) 1.8 (−0.9–4.5) Patients deemed suitable for early

discharge, n (%) 326 312

Composite primary end point <24 h

1 (0.3) 2 (0.6) 0.3 (−0.7–1.4)

Composite primary end point <30 d

1 (0.3) 5 (1.6) 1.3 (−0.2–2.8)

Any MACCE<24 h 0 (0) 0 (0) Any MACCE<30 d 0 (0) 3 (1.0) 1.0 (−1.0–2.0)

EPOS Trial MACCE indicates major adverse cardiac or cerebral event. All values for non-inferiority were P<0.0001.

Crude Rates and Absolute Risk Difference for Combined Primary End Points and Major Adverse Cardiac or Cerebral Event

Same Day Discharge PCI: Safety

Same-Day Discharge (n=403), n (%)

Overnight Stay (n=397), n (%)

<24 h <4 h 4–24 h 1–30 d <24 h <4 h 4–24 h 1–30 d

Composite primary end point 9 (2.2) 3 6 6 17 (4.2) 2 15 4

Any MACCE 6 (1.5) 1 5 6 16 (4.0) 2 14 3

Death 0 0 0 0 1 (0.25) 1 0 1

Myocardial infarction 6 (1.5) 0 6 1 14 (3.5) 0 14 2

Cardiac surgery 1 (0.3) 1 0 3 2 (0.50) 1 1 2

Repeat PCI 1 (0.3) 1 0 4 1 (0.25) 0 1 6

Stroke 0 0 0 0 0 0 0 0

False aneurysm 3 (0.8) 2 1 0 2 (0.5) 0 2 1

Arteriovenous fistula 0 0 0 0 1 (0.25) 0 1 0

Readmission 1 (0.3) 0 1 16 2 (0.5) 0 2 18

Hematoma >5 cm MACCE indicates major adverse

cardiac or cerebral event.

20 (5.0) 0 20 23 18 (4.5) 0 18 23

Occurrence of Cardiac Events and Puncture-Related Complications Among all Randomized Patients (EPOS Trial)

Assessment of clinical outcomes related to early discharge after elective percutaneous coronary intervention in 200 pts

Muthusamy, P. et. al Catheterization and Cardiovascular Interventions, Vol 81, Issue 1, pages 6–13, 1 January 2013

Table IV. Complications and Re-Admissions

Post-discharge events

Within 24 hrs 1–7 days Overall

MACE 0 (0%) 0 (0%) 0 (0%)

Major bleeding 0 (0%) 0 (0%) 0 (0%)

Vascular complications

0 (0%) 1(0.5%)a 1 (0.5%)

Minor bleeding 5 (2.5%) 3(1.5%) 8 (4%)

ER visits 3 (1.5%) 0 (0%) 3 (1.5%)

Urgent care visits 0 (0%) 0 (0%) 0 (0%)

Re-admissions 1 (0.5%) 3 (1.5%) 4 (2%)

75.5% underwent PCI procedures using a TF approach. Anticoag: Bivalirudin (50.5%), heparin (49.5%), and GP IIb/IIIa inhibitors (16%). Of the total 151 patients who underwent TF-PCI, approximately 80% received vascular closure device to achieve early hemostasis. Early ambulation through the use of radial access or vascular closure devices was achieved in 85.5% of our study population. The mean procedural durations for the TF and TR PCI groups were 45.3 ± 21.3 and 38.4 ± 13.5 minutes, respectively. Time to ambulation after procedure completion for the TF and TR groups was 4.5 ± 1.9 and 3.9 ± 1.3 hrs, respectively.

Pooled Estimate of Composite Endpoint of Death, MI, TLR in RCTs

J Am Coll Cardiol. 2013;62(4):275-285. doi:10.1016/j.jacc.2013.03.051

CI = confidence interval; MI = myocardial infarction; OR = odds ratio; RCTs = randomized controlled trials; TLR = target lesion revascularization.

Pooled Estimate of Composite Endpoint of Major Bleeding, Vascular, Complications in RCTs

J Am Coll Cardiol. 2013;62(4):275-285. doi:10.1016/j.jacc.2013.03.051

Sample Protocol for a Same-Day Percutaneous Coronary Intervention Program

J Am Coll Cardiol. 2013;62(4):275-285. doi:10.1016/j.jacc.2013.03.051

CTO = chronic total occlusion; EF = ejection fraction; GFR = glomerular filtration rate; PCI = percutaneous coronary intervention.

Same Day Discharge PCI vs Usual Care RCT data suggest Death, MI, TLR Favors SDDPCI RCT data suggests Major Bleeding, Vascular, Complications Favors Overnight Stay (Usual Care) Sample protocol allows d/c within 6 hrs in most cases, now routinely 4 hrs

Trans-Radial PCI Benefits Lower Risk of vascular access complications compared to Femoral with Closure (Femoral 3.7% vs Radial 0%) Earlier Ambulation Increased patient satisfaction Less Bodily pain and Movement Limitation Increased Speed of Recovery and Ease of Daily

Activities Accommodates Typical Sizing of Standard Devices

Acceptable Discharge Criteria at 4hrs post-PCI Trans-Radial PCI TIMI 3 flow No Chest Pain No ECG changes No side-branch compromise Willing ambulatory patient Drugs in hand Contact info with a readily available care provider next

24 hrs

Same Day Discharge PCI: Barriers to Utilization Medico-Legal “Hospital Accepted Strategy of Care” Do a registry Hospital Resource Allocation Pt. Education Nursing Patient Flow Absence of Economic Incentive Old Dogs, New Tricks

Same Day Discharge PCI: Tips and Techniques to Increase Utilization

Physician Champion The Team: IC’s, Nursing, Pharmacy, Clinical Care Coordinator, Cathlab personnel, Administration, Mid-level care providers Incentivize the Program Radial Access (not mandatory, but helpful) Dedicated Space

The Radial Lounge

Essential Features: Coffee Bar, Wireless Internet, Comfort, Semi-privacy, Entertainment, Reclining Hospital Chair Goal: Change the Culture and the Experience

Same Day Discharge PCI: The Future of Elective Coronary Revascularization Care Strategies Patients with low clinical risk Stable angina ACS, NL LV, no arrhythmia, no CHF

Uncomplicated Procedure Absence of procedural complications Trans-radial Trans-femoral w closure Adequate and Effective Early Dual Anti-platelet Therapy

Amenable, Responsible, Appropriate Patients with Supportive Caregivers Care-delivery strategies for appropriate close follow-up

Same Day Discharge PCI: Potential Cost Benefits Reimbursement is the same despite the post-procedure triage destination, in most elective cases CMS PCI = Outpateint What does a hospital stay cost per day? Overhead Can the bed be used otherwise? Utilization opportunity

Ambulatory transradial percutaneous coronary intervention: A safe, effective, and cost-saving strategy: Outcomes

Philippe Le Corvoisier et. Al.. Catheterization and Cardiovascular Interventions; Volume 81, Issue 1, pages 15–23, 1 January 2013

Cost difference: E2304 – E1230 = E1074 Translates into US$1405 savings per case for Ambulatory PCI

Philippe Le Corvoisier et. Al.. Catheterization and Cardiovascular Interventions; Volume 81, Issue 1, pages 15–23, 1 January 2013

Ambulatory transradial percutaneous coronary intervention: A safe, effective, and cost-saving strategy

Rinfret, S. et al. J Am Coll Cardiol Intv 2010;3:1011-1019 (CANADIAN w ReoPro)

Average Per-Patient Cost Components of Health Services

Use Within 30 Days Post-PCI

Cumulative Health Care Costs Within 30 Days Post-Percutaneous Coronary

Intervention

Remove cost of GPI infusion Cost Difference: –$1,018 (–$849 to –$1,186)

Same Day Discharge PCI: Potential Cost Benefits Cost benefit estimate per case: $750 to $1,018 (depending on indirect costs)

35% Same-Day Discharge PCI Approx. 1 million PCIs performed annually in U.S. Elective PCIs and uncomplicated PCIs in low-risk patients

with unstable angina or ACS Health care savings would be between $200 million and $500

million In addition, an increase in inpatient capacity (potentially

500,000 bed-nights/year) might reflect an increase in hospital revenues.

Although this extrapolation has its obvious limitations, the potential savings must be considered in an era with limited health care resources.

Hospitals are high-risk places for low-risk patients Change the access, change the culture, then change the discharge destination in appropriate patients

Van Crisco, MD, FACC, FSCAI First Coast Heart and Vascular

Center, PLLC Jacksonville, FL

67-8-313-6695 (mobile)