SAME DAY DISCHARGE CORONARY INTERVENTION

IN 2013

Van Crisco, MD, FACC, FSCAI

First Coast Heart and Vascular Center, PLLC

Jacksonville, FL(678-313-6695)

Disclosures/Conflicts

§ Co-Founder and Financial Interest in Radial Assist, LLC (radial-specific medical device company)

§ Speakers Bureau: Astra-Zeneca

§ Consultant: Cook Medical, St. Jude 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

§ Hospitals are not safe 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: SafetyOutcome 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: SafetyOutcome 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)

No Differences in Outcome Between

Same-day Discharge and Overnight Stay

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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Same Day Discharge PCI: Safety

Same-Day DischargeN = 403

n = %

Overnight StayN = 397

n = %

4–24 h 1–30 d 4–24 h 1–30 dComposite primary end point 1 0 2 3Any MACCE 0 0 0 3Death         0 0 0 0Myocardial infarction         0 0 0 2Cardiac surgery         0 0 0 1Repeat PCI 0 0 0 1Stroke         0 0 0 0False aneurysm 1 0 2 0AV fistula     0 0 0 0Readmission 1 8 2 13Hematoma >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-DayDischarge

n (%)

OvernightStayn (%)

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 TrialMACCE 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

h4–24

h1–30

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

(0.25)

0 1 0

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

Defining the length of stay following percutaneous coronary intervention. An expert consensus document from the SCAI, endorsed by the American College of Cardiology Foundation

Charles E. Chambers MD, Gregory J. Dehmer MD, David A. Cox MD, Robert A. Harrington MD, Joseph D. Babb MD, Jeffrey J. Popma MD, Mark A. Turco MD, Bonnie H. Weiner MD, Carl L. Tommaso MDCatheterization and Cardiovascular Interventions Vol 73, Issue 7, pages 847–858, 1 June 2009

“The current standard of care for a patient who has undergone an uncomplicated elective PCI is an overnight stay in the facility performing PCI. This is based on the following concerns: (1) abrupt vessel closure and its resulting complications, (2) access site complications, and (3) management of co-morbidities, such as renal insufficiency, diabetes, hypertension, congestive heart failure (CHF), etc. Stents, newer antithrombotic regimens, and arterial closure devices have not completely eliminated these concerns.”

Same Day Discharge PCI: Current Recommendations

Inclusions Exclusions

Clinical

Stable angina Asymptomatic but abnormal stress test Ad hoc PCI planned Normal LVEF Pre-loaded with theinopyridine

Unstable coronary syndrome Abnormal renal function (eGFR < 60 ml/min) Laboratory abnormalities (anemia, electrolytes, etc…) Insulin-requiring diabetes Age > 70 Dialysis patient

Co-morbidities None Contrast allergy PVD, CHF, COPD on medications

Anatomic Single-vessel diseaseOne-vessel PCI in the setting of MV disease LM,

proximal LAD, SVG, IMA or bifurcation PCI

Procedural

Single-vessel PCI Single stent < 28 mm Radial, or femoral access with successful use of closure device, or secure manual compression

Balloon angioplasty alone Atherectomy (DCA, Rotablator) CTO attempt

Use of GP IIb/IIIa infusion Need for follow-up labs

Complication None

Threatened or abrupt closure Distal embolization Side-branch loss or compromise

Hematoma Continuing chest pain Rhythm disorders

Other

Lives or stays <20 miles from PCI facility

Adequate home support Adequate EMS support

Lives >20 miles from PCI facility Inadequate home support Inadequate local EMS

Proposed Criteria for Outpatient (same-day discharge) PCI (SCAI/ACCF 2009)

Assessment of clinical outcomes related to early discharge after elective PCI: clinical outcomes of 200 consecutive SDD PCI pts, prospectively studied, mostly TF-PCI

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.

Ambulatory transradial PCI: A safe, effective, and cost-saving strategy

Single Center, Prospective, outcomes

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

Ambulatory transradial PCI: 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 savings for Ambulatory PCI

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

Ambulatory transradial PCI: A safe, effective, and cost-saving strategy

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: SJH-ATL (STRIDE)

§ 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

Jabara R, Gadesam R, Pendyala L, Chronos N, Crisco LV, King SB, Chen JP. Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study). Am Heart J. 2008 Dec;156(6):1141-6. doi: 10.1016/j.ahj.2008.07.018. Epub 2008 Oct 9. Saint Joseph's Cardiovascular Research Institute, Saint Joseph's Hospital of Atlanta, Atlanta, GA 30342, USA

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

TheRadial 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

Same Day Discharge PCI: Potential Cost Benefits§ Cost benefit estimate per case to the Hospital:

§ $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 non–ST-segment elevation MI

§ 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, FL67-8-313-6695 (mobile)

Questions?