PCI in Facilities PCI in Facilities Without Cardiac Surgery On Site:Without Cardiac Surgery On Site:

An Expert Panel ReviewAn Expert Panel ReviewForsgate Country ClubForsgate Country Club

Monroe Township, New JerseyMonroe Township, New JerseyTuesday, November 27, 2012Tuesday, November 27, 2012

Elective PCI Without Cardiac Surgery On Site: Elective PCI Without Cardiac Surgery On Site: NCDR AnalysisNCDR Analysis

PCI in Facilities PCI in Facilities Without Cardiac Surgery On Site:Without Cardiac Surgery On Site:

An Expert Panel ReviewAn Expert Panel ReviewForsgate Country ClubForsgate Country Club

Monroe Township, New JerseyMonroe Township, New JerseyTuesday, November 27, 2012Tuesday, November 27, 2012

Elective PCI Without Cardiac Surgery On Site: Elective PCI Without Cardiac Surgery On Site: NCDR AnalysisNCDR Analysis

Michael A. Kutcher, MD, FACC, FSCAIMichael A. Kutcher, MD, FACC, FSCAI

Director, Interventional CardiologyDirector, Interventional Cardiology

Wake Forest University School of MedicineWake Forest University School of Medicine

Winston-Salem, NCWinston-Salem, NC

Michael A. Kutcher, MD, FACC, FSCAIMichael A. Kutcher, MD, FACC, FSCAI

Director, Interventional CardiologyDirector, Interventional Cardiology

Wake Forest University School of MedicineWake Forest University School of Medicine

Winston-Salem, NCWinston-Salem, NC

Michael A. Kutcher, MDDisclosures

Michael A. Kutcher, MDDisclosures

• Fellowship Grant Support

Abbott Vascular

• Consultant

Boston Scientific

• Fellowship Grant Support

Abbott Vascular

• Consultant

Boston Scientific

Michael A. Kutcher, MDAdditional DisclosuresMichael A. Kutcher, MDAdditional Disclosures

• Originally I did not believe that the development of PCI centers without cardiac surgery on site was a safe and effective practice.

• I had the great privilege to work with a highly skilled team to analyze the National Cardiovascular Data Registry experience.

• Data is data – Now I am a believer !!!!

• Originally I did not believe that the development of PCI centers without cardiac surgery on site was a safe and effective practice.

• I had the great privilege to work with a highly skilled team to analyze the National Cardiovascular Data Registry experience.

• Data is data – Now I am a believer !!!!

Percutaneous Coronary Interventions in Facilities

without Cardiac Surgery On Site: A Report from the National

Cardiovascular Data Registry (NCDR)

Journal of the American College of Cardiology

2009;54:16-24

On Behalf of the National Cardiovascular Data Registry

Michael A. Kutcher, MDLloyd W. Klein, MDFang-Shu Ou, MSThomas P. Wharton, Jr., MDGregory J. Dehmer, MDMandeep Singh, MD, MPHH. Vernon Anderson, MDJohn S. Rumsfeld, MD, PhDWilliam S. Weintraub, MDRichard E. Shaw, PhDMatthew Sacrinty, MPHAlbert Woodward, PhD. MBAEric D. Peterson, MD, MPHRalph G. Brindis, MD, MPH

Wake Forest University School of Medicine Rush University School of MedicineDuke Clinical Research Institute (DCRI) Exeter Hospital, Exeter, NHTexas A&M School of MedicineMayo ClinicUniversity of Texas Health Science, HoustonChief Science Officer, NCDRChristiana Health Care, Wilmington, DESutter Pacific Heart CentersWake Forest University School of MedicineNCDRDCRIChief Executive Officer, NCDR

Special Thanks• Jessica Morris, MBA

Data Clarification Project Contact Staff• Kristi Mitchell, MA, MPH

Data Clarification Project Coordinator• NCDR and DCRI support staff• Tammy Davis and Susan Queen

Wake Forest University School of MedicineManuscript Preparation

All the hospitals and their staff that had committed to participate in the NCDR

Background

• Since the introduction of PCI in 1977 by Andreas Gruntzig, a preferred practice had been to have cardiac surgery capabilities on-site to provide emergency CABG in the event of life threatening acute procedural failures.

Background

• Over the last 15 years, as a result of improvements in technology and pharmacology:The incidence of emergency CABG surgery for

failed PCI is now very infrequent (0.3-0.6%)Seshadri N et al. Circulation 2002;106:2346-50.Yang EH et al. J Am Coll Cardiol 2005;2004-20.

Primary PCI has been shown to be superior to fibrinolytic therapy for the treatment of STEMI

Keely et al. Lancet 2003;361:13-20.

Background

• These developments formed the justification for some hospitals without on-site cardiac surgery to develop PCI programs based on a strategy to:Provide more rapid and superior care for STEMI

in the form of primary PCI Increase the availability of primary and elective

PCI to patients residing in geographically underserved areas.

Background

• The safety and efficacy of performing primary PCI in facilities without on site surgical back-up had been documented in several trials.

Wharton TP Jr. et al. J Am Coll Cardiol 1999;33:1257-65.Aversano T el. C-PORT trial. JAMA 2002;287:1943-51.Wharton TP Jr. et al. PAMI-NoSOS Study. J Am Coll Cardiol

2004;43:1943-50.

• There had been numerous observational reports that extended the Off-Site concept to both primary and elective PCI.

Background

At the time of the NCDR study:• The ACC/AHA/SCAI 2005 PCI Guidelines

indications for PCI at centers that do not have surgery on-site were: Primary PCI – Class IIb “may be considered” Elective PCI – Class III “not recommended”

Smith SC Jr. et al. J Am Coll Cardiol 2006;47:216-35.

• The 2007 Focused PCI Guideline Update did not address or change these designations.

King SB III et al. J Am Coll Cardiol 2008;51:172-209.

Background

• At the time of the NCDR study, there were few published large studies that examined whether the procedural outcomes at PCI facilities that do not have surgery on-site are as safe and effective compared to those facilities that have cardiac surgery on-site.

Wennberg DE et al. JAMA 2004;292:1961-68.Ting HH et al. J Am Coll Cardiol 2006;47:1713-21.Carlsson J et al. SCARR. Heart 2007;93:335-8.

Background

• The National Cardiovascular Data Registry (NCDR) CathPCI Registry is a large ongoing multi-center registry that offers a unique opportunity to provide contemporary insights into this controversial issue.

Standard data sets Written definitions Uniform data entry Secure transmission requirements Data quality and auditing checks Risk adjustment algorithms

Study Population

NCDR CathPCI Registry Consecutive PCI cases

January 1, 2004 to March 30, 2006308,161 patients

465 centers

OFF-SITE Surgery Back-Up8,736 patients

60 centers

ON-SITE Surgery Back-up299,425 patients

405 centers

Statistical Analysis

Data Analysis was performed by DCRI: • To test for independence of a patient’s

baseline characteristics, in-hospital care patterns and outcomes with respect to Off-Site vs. On-Site centers were analyzed.

• The Wilcoxon rank-sum test was used for continuous variables.

• The Pearson chi-square test was used for categorical variables.

Statistical Analysis

• A multivariable logistic regression was utilized to estimate the association surgical status (On-Site versus Off-Site) and outcomes.

• The Generalized Estimate Equation (GEE) method was applied to account for within-hospital clustering, assuming patients at the same hospital are more likely to have similar responses relative to patients in other hospitals.

Statistical Analysis• These aggregates were further divided and

analysis performed in:– Patients who underwent Primary PCI as first-line

therapy for reperfusion in the setting of STEMI– The remainder of patients – those who underwent

Non-Primary PCI in a less urgent setting.

• This division permitted a more comprehensive assessment and risk-adjustment analysis of the major clinical endpoints in emergency versus non-urgent PCI cases.

Statistical Analysis

• The Non-Primary PCI cohort may not have been a reflection of purely Elective PCI, as this group included some ACS, NSTEMI, and late post STEMI patients.

• However, the consideration of Non-Primary PCI as “non-urgent” and a reasonable surrogate for Elective PCI was consistent with differentiations made in the Off-Site vs On-Site PCI literature.

Statistical Analysis• Major endpoints

In-hospital death from all causes following PCI Incidence of emergency surgery (version 3.04 definitions):

Emergency – CABG performed within <24 hours following PCI in which there was evidence of active ischemia or mechanical dysfunction.

Emergent/Salvage – patient required cardiopulmonary resuscitation en route to the OR or before anesthesia.

• Secondary endpoints Total complications:

General Complications: (MI, shock, CHF, CVA, tamponade, thrombocytopenia, contrast reaction, renal failure)

Bleeding Complications Vascular Complications

Reperfusion time in cases of primary PCI

Results

Institutional CharacteristicsOff-Site On-Site(N=60) (N=405)

Number of CMS Certified Beds* Mean + SD 212+109 403+188 <0.001<200 31 (52%) 40 (10%) <0.001>200 and <400 27 (45%) 178 (44%)>400 2 (3%) 185 (46%)Rural 21 (35%) 67 (17%) <0.001Suburban 24 (40%) 115 (28%)Urban 15 (25%) 223 (55%)

Average Annual PCI Volume Mean + SD 166+138 745+551 <0.001<200 43 (72%) 23 (6%) <0.001>200 and <400 14 (23%) 98 (24%)>400 3 (5%) 284 (70%)

Average Annual primary PCI volume Mean + SD 35+22 78+52 <0.001>36 25 (42%) 324 (80%) <0.001

Primary PCI Reperfusion Times Mean + SD (hours) 2.1+5.1 2.6+8.4 <0.001(Patient feature) Median (hours) 1.4 1.5

P-value

Location / Community Type

Variable Hospitals

* Two sites had missing CMS bed data

Off-Site Capabilities SurveyTransportation Logistics

Off-Site(n=53)

Average travel distance to surgical facility Miles (mean + SD) 36±59<10 miles 11 (21%)>10 and <20 miles 18 (34%)>20 and <40 miles 11 (21%)>40 miles 13 (25%)

Average transit time to surgical facility Minutes (mean + SD) 25±17<10 minutes 4 (8%)>10 and <20 minutes 16 (30%)>20 and <30 minutes 19 (36%)>30 minutes 14 (26%)Ground ambulance 28 (53%)Helicopter 11 (21%)Fixed wing aircraft 1 (2%)Combo of ground or air 13 (25%)

Predominant transportation mechanism

Variable Level

Average travel distance to surgical facility

Average transit time to surgical facility

Off-Site Capabilities SurveyOrganization and Staff

Off-Site(n=53)

24 hours - 7 days a week (24/7) 49 (92%)Daytime during weekdays only 3 (6%)Variable time frames 1 (2%)Only Primary PCI for acute MI 11 (21%)Both Primary PCI and Elective PCI 42 (79%)Only Elective PCI 0 (0%)Work only at off-site PCI center 41 (77%)Rotate between Off-Site and On-Site center 11 (21%)N/A 1 (2%)

Interventional operators at facility Mean + SD 5±41 5 (9%)2 to 3 18 (34%)4 to 5 11(21%)6 or more 19 (36%)Work only at off-site PCI center 9 (17%)Rotate between Off-site and On-Site center 43 (81%)N/A 1 (2%)

Interventional operators experience

LevelVariable

Dedicated staff and facilities for PCI

Type of PCI provided

Cath Lab staff experience

Interventional operators at facility

Patient CharacteristicsOff-Site On-Site

(N=8,736) (N=299,425)Age Mean + SD 63.5+12 64.1+12 <0.001Male 5,817 (67%) 198,656 (66%) 0.639Previous MI ( >7 days) 2,285 (26%) 87,521 (29%) <0.001Previous CHF 839 (10%) 30,953 (10%) 0.026Diabetes 2,534 (29%) 95,160 (32%) <0.001Previous Renal Failure 367 (4%) 15,868 (5%) <0.001Cerebrovascular Disease 817 (9%) 33,865 (11%) <0.001Peripheral Vascular Disease 895 (10%) 35,519 (12%) <0.001Hypertension 6,226 (71%) 225,404 (75%) <0.001Dyslipidemia 5,827 (67%) 220,220 (74%) <0.001Previous PCI 2,711 (31%) 105,133 (35%) <0.001Previous CABG 1,068 (12%) 56,815 (19%) <0.001

Characteristic P-value

Lesion Characteristics

Off-Site On-Site(N=8,736) (N=299,425)

> 2 Lesions in lab visit 2,503 (29%) 99,309 (33%) <0.001

Segment in SVG 396 (5%) 20,644 (7%) <0.001

High Risk C Lesion 3,426 (39%) 123,207 (41%) <0.001

Characteristic P-value

Procedural Success and Complications

Off-Site Backup On-Site Backup(N=8,736) (N=299,425)

PCI Procedure Success 8,194 (94%) 278,84 (93%) 0.01

Any Complications 567 (6.5%) 18,796 (6.3%) 0.399

Variable P-value

Observed Outcomes: All PCI Patients

1.71.7

13.6

0.31.21.2

12.8

0.4

0.0

5.0

10.0

15.0

20.0

EmergencyCABG

Mortality:Emergency

CABG

Mortality: NoEmergency

CABG

Overall Mortality

% O

utc

om

es

Off-Site Backup (N=8,736)

On-Site Backup (N=299,425)

(P=0.2709)(P=0.9070) (P<.0001)

(P<.0001)

Observed Outcomes: Primary PCI Patients

5.15.0

16.7

0.7

5.25.0

16.5

1.2

0.0

5.0

10.0

15.0

20.0

EmergencyCABG

Mortality:Emergency

CABG

Mortality: NoEmergency

CABG

Overall Mortality

% O

utc

om

es

Off-Site Backup (N=1,934)

On-Site Backup (N=31,099)

(P=0.0911)

(P=0.9898) (P=0.9745)

(P=0.8688)

Observed Outcomes: Non-Primary PCI Patients

0.80.8

10.0

0.20.80.7

11.0

0.30.0

5.0

10.0

15.0

20.0

EmergencyCABG

Mortality:Emergency

CABG

Mortality: NoEmergency

CABG

Overall Mortality

% O

utc

om

es

Off-Site Backup (N=6,802)

On-Site Backup (N=268,312)

(P=0.1073)

(P=0.9183) (P=0.5869)

(P=0.6999)

MI PresentationOff-Site Backup N=8,736 patients

5,128(59%)

2,166(25%)

1,442(17%)

On-Site Backup N=299,425 patients

212,806(71%)

41,723(14%)

44,896(15%)

No MI Non-STEMI STEMI P < .0001

Variables in Risk Adjusted Mortality Model

• Age • Gender • Insulin treated diabetes • Hypercholesterolemia• Hypertension• GFR/dialysis• Cerebrovascular disease• COPD• PVD• CHF• Prior CABG• Prior PCI• Prior MI

• Cardiogenic shock • MI presentation (STEMI,

NSTEMI, no MI) • Preoperative IABP• PCI status (salvage,

emergent, urgent, elective)• Subacute thrombosis• Treated left main lesion• Treated total occlusion • Treated lesion TIMI flow = 0• Treated lesion High/C • Total number of lesions

treated

Variables in Risk Adjusted Emergency Surgery Model

• Cardiogenic shock• MI Presentation

STEMINSTEMINo MI

• Pre-operative IABP• PCI status

SalvageEmergentUrgentElective

• Any treated left main lesion

Risk Adjusted Outcomes

Limitations

• The study was subject to the usual concerns regarding observational registry data.

• In-hospital outcomes were analyzed – long term follow-up was not available.

• NCDR outcomes were assessed and analyzed on an institutional level, not an individual operator level.

• Specific in-depth details regarding clinical presentation, case selection, procedural complications, morbidity, and mortality were sometimes beyond the purview of the basic database.

Limitations

• At the time of this study, the 60 Off-Site programs represented only a quarter of the estimated 250 PCI centers in the US without surgical back-up on-site

• Of those remaining, it was estimated that one third may submit data to another peer-reviewed registry, a spoke-hub partner database, or a multi-center trial.

• The results reported from the NCDR may not be applicable to all PCI centers without surgical back-up on-site, particularly those that did not participate in any formal registry or clinical trial.

Discussion

• At the time of publication, this study provided the largest clinical analysis and comparison of diverse PCI centers in the United States with and without on-site cardiac surgery support.

• The results of the Off-Site Capabilities Survey provided unique information regarding the organization and logistics of the Off-Site PCI programs participating in the NCDR.

Conclusions

• Off-Site PCI centers participating in the NCDR were well organized with good logistical plans:Dedicated staff and facilities.Travel time, distances, and modality of

transport were appropriate for timely transfer to the off-site surgery center.

92% provided 24/7 coverage.All sites were committed to provide primary PCI

for STEMI.

Conclusions

• Compared to On-Site PCI centers, Off-Site PCI programs participating in the NCDR:Had smaller bed capacities.Were predominantly located in non-urban areas. Had lower annual PCI volume.Treated a higher percentage of patients who

present with subsets of MI (STEMI and NSTEMI).Had better reperfusion times in primary PCI.

Conclusions

• Compared to On-Site PCI centers, Off-Site PCI programs had similar observed:Procedure successMorbidityEmergency surgery ratesMortality in cases that require emergency

surgery

Conclusions

• The risk-adjusted mortality rate in Off-Site facilities was comparable to those PCI centers that had cardiac surgery on-site.

• These outcomes were comparable regardless of whether PCI was performed as primary therapy for STEMI or in a non-primary, less urgent or elective setting.

Implications

• Off-Site PCI centers can provide excellent care to patients – if the organization of the program is thoughtfully developed.

• The Off-Site programs in this study had demonstrated a strong commitment to key structure, process, and outcomes measurements (Donabedian Triad).

• Without such a commitment, similar results may not be achievable.

Implications

• The findings of this study should not be extrapolated to encourage the wide-spread proliferation of Off-Site PCI programs.

• Our study did confirm the safety of an Off-Site strategy at existing PCI centers where rigorous clinical, operator, and institutional criteria are in place and are monitored to assure high quality outcomes.

Implications

• The efficacy of truly elective PCI at Off-Site PCI facilities can be best answered by a large randomized prospective trial such as C-PORT Elective Trial (which at the time this study was still underway).

• A comprehensive large database such as the NCDR CathPCI Registry continues to offer a contemporary quality assurance standard to monitor these and other issues regarding interventional cardiovascular strategies.

Thank You !!!Questions ?????