Does the Ncdr Have a Test Site to Upload
Circulation. Author manuscript; available in PMC 2020 January 22.
Published in final edited course equally:
PMCID: PMC6340715
NIHMSID: NIHMS1507726
Relationship between operator volume and long-term outcomes afterward percutaneous coronary intervention: A Written report from the NCDR CathPCI Registry
Alexander C Fanaroff
1Division of Cardiology and Vascular Institute
2Knuckles Clinical Research Foundb, Duke University, and Vascular Establish
Pearl Zakroysky
2Duke Clinical Research Instituteb, Duke Academy, and Vascular Institute
Daniel Wojdyla
2Duke Clinical Inquiry Instituteb, Duke University, and Vascular Institute
Lisa A Kaltenbach
2Duke Clinical Inquiry Plantb, Knuckles Academy, and Vascular Institute
Matthew W Sherwood
2Duke Clinical Research Instituteb, Duke University, and Vascular Institute
3Division of Cardiology, Inova Heart and Vascular Institute, Falls Church building, VA;
Matthew T Roe
1Division of Cardiology and Vascular Institute
twoKnuckles Clinical Research Constituteb, Duke Academy, and Vascular Found
Tracy Y Wang
1Sectionalization of Cardiology and Vascular Institute
iiDuke Clinical Enquiry Instituteb, Duke University, and Vascular Institute
Eric D Peterson
iSectionalisation of Cardiology and Vascular Institute
iiDuke Clinical Research Instituteb, Duke Academy, and Vascular Institute
Hitinder S Gurm
4Sectionalisation of Cardiology, Academy of Michigan, Ann Arbor, MI;
Mauricio G Cohen
5Division of Cardiology, University of Miami, Miami, FL;
John C Messenger
6Division of Cardiology, University of Colorado, Aurora, CO
Sunil V Rao
oneSectionalization of Cardiology and Vascular Institute
2Duke Clinical Inquiry Constituteb, Duke University, and Vascular Establish
Abstruse
Introduction:
Although many studies testify an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer term outcomes is unknown.
Methods:
Using the National Cardiovascular Data Registry (NCDR) CathPCI registry information linked with Medicare claims data, we examined the association between operator PCI book and long-term outcomes amid patients aged ≥ 65 years. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (< fifty PCIs), intermediate- (fifty–100), and high-volume operators (> 100). I-year unadjusted rates of death and major agin coronary events (MACE, divers as expiry, readmission for myocardial infarction [MI], or unplanned coronary revascularization) were calculated using Kaplan-Meier methods. The proportional hazards assumption was not met and hazard-adjusted associations betwixt operator volume and outcomes were calculated separately from the time of PCI to infirmary discharge and from hospital discharge to 1-year follow-upwards.
Results:
Between July one, 2009 and December 31, 2014, 723,644 PCI procedures were performed by viii,936 operators: ii,553 high-, 2,878 intermediate-, and three,505 low-volume. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI and their patients had fewer cardiovascular comorbidities. Over 1 year follow-up, 15.9% of patients treated by low-volume operators had a MACE event compared with 16.nine% of patients treated by high-book operators (p = 0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital expiry than low-volume operators (OR 0.91, 95% CI 0.86–0.96 for intermediate vs. depression; OR 0.79, 95% CI 0.75–0.83 for high vs. low). There were no significant differences in rates of MACE, death, MI, or unplanned revascularization between operator cohorts from hospital discharge to 1-yr follow-up (adjusted HR for MACE: 0.99, 95% CI 0.96–i.01 for intermediate vs. low; Hr 1.01, 95% CI 0.99–1.04 for high versus low).
Conclusions:
Unadjusted one-year outcomes following PCI were worse for older adults treated by operators with higher annual volume; all the same, patients treated past these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in post-discharge MACE.
Keywords: percutaneous coronary intervention, outcomes research, morbidity/mortality, complex stenting, volume-issue relationship
INTRODUCTION
Multiple studies have demonstrated an clan between percutaneous coronary intervention (PCI) operator book and short-term outcomes, including in-hospital mortality, major bleeding, acute kidney injury, and need for urgent coronary artery featherbed grafting surgery, but absolute differences across operators are modest.ane–10 Other gimmicky studies have failed to testify any association between operator volume and outcomes and between hospital book and outcomes in patients undergoing PCI for ST segment peak myocardial infarction (STEMI).11–xiii Moreover, most all studies evaluated simply in-hospital outcomes. Patients undergoing PCI remain at high risk for adverse outcomes over longer-term follow-up, with a ~twenty% risk of decease, myocardial infarction (MI), and repeat revascularization in the offset twelvemonth following PCI.14, fifteen Suboptimal stent deployment (underexpansion, incomplete apposition, incomplete lesion coverage, and/or edge dissection) may occur with greater frequency among low volume operators and is associated with greater risk of adverse outcomes over long-term follow-up.xvi–20 Depression-book operators also utilize drug-eluting stents less oftentimes than high-book operators and endeavor fewer lesions per cardiac catheterization lab visit, both of which may ultimately result in higher rates of long-term agin events due to re-stenosis and progression of untreated lesions.x The relationship betwixt operator volume and outcomes informs professional society recommendations,21 merely a complete understanding of the volume-consequence human relationship should accept into business relationship differences in long-term outcomes.
We analyzed data from the National Cardiovascular Data Registry'due south (NCDR) CathPCI registry to Centers for Medicare and Medicaid (CMS) claims data to evaluate the association between operator PCI volume and i-year outcomes, including all-cause death, hospitalization for MI, or unplanned coronary revascularization.
METHODS
The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedure.
Study sample
The NCDR CathPCI registry, jointly administered by the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI), has been previously described.22 It collects information from consecutive patients undergoing PCI at > 1500 hospitals in the United States (~90% of PCI centers), recording information on patient and hospital characteristics, including patient presentation, lesion and procedural details, peri-procedural and discharge medications, and in-infirmary outcomes.23 Variables collected are determined and defined by physician work groups; data collection forms and dictionaries are bachelor at the NCDR'south website. Data nerveless are field of study to the NCDR'southward comprehensive data quality programme, which includes data quality report specifications for capture and manual, too every bit auditing.24 For patients ≥ 65 years erstwhile with fee-for-service Medicare, CathPCI data take been linked with CMS claims data using straight patient identifiers, assuasive for ascertainment of longitudinal outcomes.
For this report, we included all PCI procedures in the linked dataset from July one, 2009 through Dec 31, 2014. The CathPCI data collection form first collected National Provider Identification (NPI) number, which allows for unique identification of the operator for each PCI, in July i, 2009, and CMS-linked data was available through Dec 31, 2014. Starting with patients ≥ 65 undergoing PCI during the report period (n = 1,297,833), we excluded patients unable to be linked to CMS claims information (n = twenty,248), those ineligible for fee-for-service Medicare (n = 546,636), and any procedure missing operator's NPI number (n = 7,305). Characteristics of included and excluded patients are described in Supplemental Tabular array 1. For analyses of post-belch events, we excluded patients that died during the index hospitalization (north = 15,280).
Definitions and outcomes
All study definitions were derived from the CathPCI data dictionary. The principal outcome for this analysis was one-yr major adverse coronary events (MACE), divers equally the composite of all-crusade death, hospitalization for MI, or unplanned coronary revascularization, occurring from the fourth dimension of PCI to i-twelvemonth follow-upwardly. Hospitalization for MI was defined as readmission with a primary diagnosis code of 410.x1. Unplanned coronary revascularization was defined equally either PCI or coronary artery bypass grafting surgery (CABG) > 60 days following the index PCI, or, for procedures occurring ≤ 60 days post-obit the index PCI, PCI or CABG associated with a primary discharge diagnosis of MI, unstable angina, heart failure, arrhythmia, or cardiac arrest.25–28 Secondary outcomes were the individual components of the MACE outcome likewise as major haemorrhage, defined as a hemorrhagic stroke, hemoglobin drib ≥ iii g/dl, red blood jail cell transfusion, or procedural intervention to stop haemorrhage during the index hospitalization, or readmission for bleeding (ICD-ix codes 430–432, 578.X, 719.1X, 423.0, 599.7, 626.2, 626.6, 626.8, 627.0, 627.ane, 786.3, 784.seven, 459.0).29 We also report ceremoniousness of PCI by operator book stratum, which was based on the 2012 Appropriate Employ Criteria for Coronary Revascularization, and determined using a validated algorithm.30–32 We performed landmark analyses of in-hospital deaths, death and major haemorrhage from the time of PCI to xxx-day follow-upwards, and MACE from the fourth dimension of hospital discharge to 1-year follow-upwards.
The total number of PCI procedures performed or attempted for each operator was counted using each operator's unique NPI number, and each operator's boilerplate almanac volume was calculated by dividing the operator's total number of PCI procedures by the number of days the operator was active during the study menstruation (appointment of last PCI process – date of outset PCI procedure) to derive PCIs per twenty-four hours and multiplying by 365. Operator book was counted in the CathPCI database prior to CMS linkage or the exclusion of any patients bated from those that underwent procedures missing operator's NPI number (< ane% of procedures in CathPCI),x and then each operator'southward full number of PCI procedures included those performed in all patients, < 65 besides as ≥ 65 years old. Since the NPI number is a unique ID that carries beyond hospitals, operator volumes could be counted without regard to where procedures were performed, as long as procedures were performed in hospitals that participate in the CathPCI registry.
As the American Heart Association (AHA)/ACC/SCAI clinical competence statement recommends that operators perform an boilerplate of ≥ 50 PCIs/yr to maintain competence, operators performing < 50 PCIs/year were defined as low-volume operators.21 Operators performing 50–100 and > 100 PCIs/year were divers every bit intermediate- and high-book operators, respectively.
To judge lifetime experience, we counted the number of years each operator performed at least one PCI between 2009 and 2013, and divided operators into groups past years of experience: 0–ane, ii–4, > 4.
Statistical analysis
Patient, procedural, and hospital characteristics are presented for high-, intermediate-, and depression-volume operators, with categorical variables presented as frequencies (percentages) and continuous variables presented as medians (25th, 75thursday percentiles). Pearson χ2 tests and Kruskal-Wallis tests were used for comparison categorical and continuous variables, respectively. A p-value threshold of < 0.05 was used to ascertain statistical significance.
For 30-day mortality and major bleeding, nosotros performed logistic regression with a robust sandwich covariance matrix to generate unadjusted and chance-adjusted odds ratios with 95% confidence intervals (CI) for intermediate- and high-volume operators with low-book operators every bit a reference. Covariates for adjustment included all variables comprising variables included in the CathPCI in-infirmary bloodshed run a risk score,33 along with year of PCI and other variables selected by expert stance, including demographic variables, cardiac risk factors, details of the coronary anatomy and index PCI process, and discharge medications (Full list of covariates in Supplemental Methods). The use of a robust sandwich covariance matrix accounts for clustering of patient outcomes within operators. Nosotros repeated these analyses within the subgroups of patients with ST segment elevation MI (STEMI), unstable angina/not-ST segment elevation MI (UA/NSTEMI), and stable angina.
To examine outcomes from the fourth dimension of PCI until 1-year follow-upwards, nosotros plotted unadjusted cumulative incidence curves for MACE and its individual components for high-, intermediate-, and low-book operators. Unadjusted MACE and mortality were compared for patients undergoing PCI past high-, intermediate-, and low-book operators using the log-rank test; for unadjusted comparisons of the incidence of readmission for MI and unplanned revascularization by operator volume, Fine and Gray sub-distribution hazards were used to business relationship for the competing risk of mortality.34 To quantify the effect of operator volume on MACE and all-cause mortality from time of PCI to 1-year post-PCI, we estimated a Cox proportional hazards model with a robust sandwich covariance matrix to account for clustering inside operators. Take a chance-adjusted risk ratios comparison loftier- and intermediate-volume operators with low-volume operators were derived. Due to violation of the proportional take a chance assumption for operator volume, separate risk ratios were estimated for in-infirmary and mail-discharge periods. Nosotros repeated this process for the outcomes of readmission for MI and unplanned revascularization at one year. Covariates for aligning were the same as for in-infirmary and 30-day outcomes. For all outcomes, we written report unadjusted and adjusted take a chance ratios (HRs) with 95% CIs for high- and intermediate-book operators, with low-volume operators as the reference. Nosotros repeated these analyses treating operator volume as a continuous variable, and report unadjusted and run a risk-adjusted HRs with associated 95% confidence interval (CI) for a fifty unit increase in annual PCI volume.
Regression models were created for the overall dataset, and separately for the STEMI subgroup, the unstable angina/not-STEMI (UA/NSTEMI) subgroup, the stable angina subgroup, and subgroups of patients undergoing left chief PCI, PCI of bifurcation lesions, and PCI of chronic total occlusions (CTO). To judge the interaction betwixt operator book and estimated lifetime experience, we adamant the association betwixt operator book and outcomes in the cohort of patients that underwent PCI in 2014, and separately among patients that underwent PCI by operators with 0–1, 2–four, and > iv years of experience between 2009 and 2013.
For all analyses, a HR or OR < 1 indicates that higher PCI operator volume is associated with lower odds of the outcome compared with lower operator volume, and a HR or OR > 1 indicates that higher PCI operator volume is associated with college odds of the upshot compared with lower operator book.
All statistical analyses were performed by the Duke Clinical Research Establish using SAS version nine.3. The Duke University Medical Center Institutional Review Board granted a waiver of informed consent and authorization for this study, equally data are nerveless for CathPCI without individual patient identifiers.
RESULTS
From July 1, 2009 to December 31, 2014, eight,936 operators performed 723,644 PCIs at ane,460 sites (Figure 1). We classified three,505 (39.2%) operators that performed < 50 PCIs/year as depression-book operators, 2,878 (32.2%) that performed l–100 PCIs/year as intermediate-volume operators, and 2,553 (28.6%) that performed > 100 PCIs/year equally high-volume operators.
Written report flow PCI, percutaneous coronary intervention; CMS, Centers for Medicare and Medicaid Services; NPI, National Provider Identification. Low-book operators performed < 50 PCIs/year; intermediate-volume operators performed 50–100 PCIs/year; high-volume operators performed > 100 PCIs/year
Compared with high- and intermediate-volume operators, depression-volume operators were more probable to practice in the western region of the U.S. (Table one). They less frequently skillful at teaching hospitals and their hospitals had lower median annual PCI volumes (484 vs. 541 vs. 770 PCIs/year for low- vs. intermediate- vs. high-volume operators; p < 0.0001).
Table 1:
Infirmary and patient characteristics by operator volume
| Overall (n = 723,644 PCIs; 8,936 operators) | High (> 100 PCIs/yr) (n = 437,977 PCIs; ii,553 operators) | Intermediate (50–100 PCIs/year) (northward = 210,946 PCIs; ii,878 operators) | Depression (< 50 PCIs/year) (due north = 74,721 PCIs; iii,505 operators) | P value | |
|---|---|---|---|---|---|
| Hospital characteristics | |||||
| Infirmary region | < 0.0001 | ||||
| Northeast | 104,044 (14.4%) | 68,760 (15.7%) | 27,577 (13.1%) | 7,707 (ten.3%) | |
| Midwest | 204,514 (28.3%) | 133,946 (xxx.vi%) | 56,238 (26.7%) | 14,330 (nineteen.2%) | |
| South | 316,948 (43.8%) | 192,835 (44.0%) | 89,851 (42.6%) | 34,262 (45.9%) | |
| W | 98,114 (thirteen.6%) | 42,436 (9.vii%) | 37,280 (17.7%) | 18,398 (24.six%) | |
| Urban location | 395,016 (54.6%) | 249,338 (56.nine%) | 106,636 (50.6%) | 39,042 (52.iii%) | < 0.0001 |
| No. of beds | 393 (261, 576) | 404 (270, 587) | 364 (250, 540) | 366 (250, 569) | < 0.0001 |
| Annual PCI volume | 663 (406, 1083) | 770 (490, 1231) | 541 (340, 859) | 484 (268, 847) | < 0.0001 |
| Teaching infirmary* | 333,131 (46.0%) | 220,510 (l.four%) | 85,423 (40.5%) | 27,207 (36.iv%) | < 0.0001 |
| Individual/community infirmary | 641,075 (88.6%) | 386,876 (88.3%) | 187,723 (89.0%) | 66,476 (89.0%) | < 0.0001 |
| Patient characteristics | |||||
| Historic period | 74 (69, 80) | 74 (69, 80) | 74 (69, 80) | 74 (69, 79) | 0.0002 |
| Male | 448,322 (62.0%) | 270,732 (61.8%) | 130,939 (62.1%) | 46,651 (62.4%) | 0.002 |
| White | 662,486 (91.6%) | 404,367 (92.iii%) | 192,200 (91.1%) | 65,919 (88.ii%) | < 0.0001 |
| Acknowledge source | < 0.0001 | ||||
| Emergency dept | 251,165 (34.7%) | 142,341 (32.five%) | lxxx,119 (38.0%) | 28,705 (38.four%) | |
| Transfer in | 129,335 (17.9%) | 85,911 (nineteen.six%) | 33,633 (fifteen,9%) | 9,791 (13.1%) | |
| Other | 342,418 (47.3%) | 209,294 (478%) | 96,978 (46.0%) | 36,146 (48.iv%) | |
| BMI | 28 (25, 32) | 28 (25, 32) | 28 (25, 32) | 28 (25, 32) | < 0.0001 |
| GFR | 67 (52, 85) | 67 (52, 85) | 68 (52, 85) | 68 (53, 86) | < 0.0001 |
| Prior MI | 196,693 (27.ii%) | 121,856 (27.eight%) | 55,706 (26.4%) | xix,131 (25.half dozen%) | < 0.0001 |
| Prior CHF | 111,603 (15.4%) | 70,498 (xvi.one%) | 30,937 (14.7%) | x,168 (13.half dozen%) | < 0.0001 |
| HF within ii weeks | 97,340 (13.5%) | lx,451 (13.8%) | 27,913 (thirteen.2%) | 8,976 (12.0%) | < 0.0001 |
| LV systolic dysfunction | 90,579 (12.five%) | 56,565 (12.9%) | 25,884 (12.3%) | 8,130 (ten.9%) | < 0.0001 |
| Cardiogenic shock within 24 hours | 21,785 (3.0%) | 12,321 (ii.8%) | half dozen,976 (three.three%) | ii,488 (3.3%) | < 0.0001 |
| Cardiac arrest within 24 hours | 12,573 (1.vii%) | 7,093 (1.6%) | 4,020 (1.9%) | i,460 (2.0%) | < 0.0001 |
| Diabetes | 269,926 (37.iii%) | 165,231 (37.7%) | 77,520 (36.8%) | 27,175 (36.4%) | < 0.0001 |
| Cerebrovascular disease | 122,238 (16.9%) | 76,600 (17.5%) | 34,323 (16.iii%) | xi,315 (15.1%) | < 0.0001 |
| Peripheral vascular affliction | 115,744 (xvi.0%) | 72,681 (sixteen.half dozen%) | 32,577 (15.four%) | 10,486 (14.0%) | < 0.0001 |
| Hypertension | 626,220 (86.v%) | 381,203 (87.0%) | 171,054 (85.8%) | 63,963 (85.6%) | < 0.0001 |
| Chronic lung disease | 133,221 (18.4%) | 83,611 (19.1%) | 37,596 (17.8%) | 12,014 (16.1%) | < 0.0001 |
| Current/contempo smoker | 100,217 (13.nine%) | 61,172 (fourteen.0%) | 29,156 (xiii.8%) | ix,889 (xiii.two%) | 0.05 |
| Dyslipidemia | 583,235 (80.6%) | 356,374 (81.4%) | 168,008 (79.7%) | 58,853 (78.8%) | < 0.0001 |
| Prior PCI | 246,607 (34.one%) | 152,378 (34.8%) | 69,455 (32.9%) | 24,774 (33.two%) | < 0.0001 |
| Prior CABG | 163,621 (22.6%) | 102,379 (23.4%) | 45,590 (21.6%) | 15,652 (21.0%) | < 0.0001 |
| Admission symptoms | < 0.0001 | ||||
| No symptoms | 55,855 (7.seven%) | 32,540 (seven.iv%) | xvi,674 (seven.9%) | 6,641 (viii.9%) | |
| Atypical chest pain | 23,541 (3.3%) | 14,395 (three.3%) | half-dozen,747 (3.2%) | 2,399 (iii.two%) | |
| Stable angina | 133,145 (16.ix%) | 73,951 (16.9%) | 34,787 (16.v%) | 13,407 (17.nine%) | |
| Unstable angina | 280,997 (38.8%) | 175,768 (forty.1%) | 78,456 (37.2%) | 26,773 (35.8%) | |
| NSTEMI | 146,333 (twenty.2%) | 89,260 (twenty.iv%) | 43,130 (20.5%) | 13,943 (18.7%) | |
| STEMI | 94,616 (xiii.one%) | 51,988 (eleven.9%) | 31,099 (14.7%) | 11,529 (15.4%) | |
| Advisable PCI | 576,831 (79.vii%) | 350,648 (80.ane%) | 158,186 (79.7%) | 57,997 (77.vi%) | < 0.0001 |
| PCI status | < 0.0001 | ||||
| Constituent | 321,495 (44.iv%) | 195,377 (44.6%) | 91,413 (43.3%) | 34,705 (46.5%) | |
| Urgent | 294,611 (40.7%) | 183,490 (41.9%) | 84,228 (39.ix%) | 26,893 (36.0%) | |
| Emergency | 104,729 (xiv.5%) | 57,576 (thirteen.2%) | 34,369 (xvi.3%) | 12,784 (17.i%) | |
| Salvage | 2,517 (0.iv%) | ane,360 (0.three%) | 853 (0.4%) | 304 (0.iv%) | |
| Discharge Medications | |||||
| Aspirin | 671,417 (96.1%) | 408,429 (96.5%) | 194,610 (95.8%) | 68,378 (95.1%) | < 0.0001 |
| P2Y12 inhibitor | 674,862 (95.7%) | 410,615 (96.0%) | 195,493 (95.three%) | 68,754 (94.8%) | < 0.0001 |
| Statin | 609,710 (88.4%) | 369,974 (88.6%) | 177,470 (88.4%) | 62,266 (87.three%) | < 0.0001 |
| Beta blocker | 568,723 (83.0%) | 347,100 (83.7%) | 164,628 (82.5%) | 56,995 (80.7%) | < 0.0001 |
There were too significant differences in patient characteristics for PCIs performed past depression-, intermediate-, and high-book operators. Low-book operators more frequently performed PCI on patients admitted through the emergency section than intermediate- or loftier-book operators, and more oftentimes performed PCI for STEMI (15.four vs. 14.7 vs. 11.9% for low- vs. intermediate- vs. high-volume operators, p < 0.0001) and PCI with an emergency indication (17.1 vs. xvi.three vs. 13.two% for depression- vs. intermediate- vs. high-volume operators, p < 0.0001). Patients undergoing PCI by low-volume operators had a lower prevalence of known chronic vascular illness and risk factors than those undergoing PCI by high- and intermediate-volume operators. Belch prescription rates of aspirin, P2Y12 inhibitors, statins, and beta blockers were like amongst operator types.
Depression-volume operators, as compared with intermediate- and loftier-volume operators, less oft attempted 2 or more than lesions in a single visit to the cardiac catheterization lab (22.eight vs. 25.4 vs. 28.8% for depression- vs. intermediate- vs. loftier-volume operators) (Table 2). Loftier-volume operators used drug eluting stents slightly more oft than depression and intermediate volume operators (69.3% vs. 68.4% vs. 71.6% for depression- vs. intermediate- vs. high-volume operators) Depression-volume operators less frequently attempted left main, bifurcation, or chronic total occlusion lesions, but differences in the proportion of PCIs these types of procedures comprised between loftier- and low-volume operators were small (< 2%).
Tabular array 2:
PCI characteristics past operator volume
| Overall (north = 723,644 PCIs; 8,936 operators) | High (> 100 PCIs/twelvemonth) (n = 437,977 PCIs; ii,553 operators) | Intermediate (50–100 PCIs/year) (n = 210,946 PCIs; 2,878 operators) | Low (< fifty PCIs/year) (n = 74,721 PCIs; 3,505 operators) | P value | |
|---|---|---|---|---|---|
| Lesion segment | < 0.0001 | ||||
| Left main | 17,508 (2.4%) | 12,006 (2.7%) | 4,263 (2.0%) | 1,239 (1.7%) | |
| Proximal LAD | 107,708 (14.ix%) | 64,314 (fourteen.7%) | 74,108 (35.1%) | 26,577 (35.6%) | |
| pRCA/mLAD/pLCx | 253,480 (35.0%) | 152,795 (34.9%) | 74,108 (35.1%) | 26,577 (35.6%) | |
| Other | 342,147 (47.3%) | 207,207 (47.three%) | 99,952 (47.4%) | 34,988 (46.8%) | |
| Previously treated lesion | 58,792 (8.1%) | 35,826 (8.2%) | sixteen,842 (viii.0%) | 6,124 (8.ii%) | 0.03 |
| Vein graft lesion | 55,062 (7.half dozen%) | 33,465 (7.6%) | 16,058 (vii.6%) | 5,539 (vii.four%) | 0.19 |
| Chronic total occlusion | 17,545 (17.v%) | 10,695 (xviii.7%) | 4,997 (15.eight%) | one,853 (16.3%) | < 0.0001 |
| Bifurcation lesion | 80,112 (11.1%) | 49,305 (11.3%) | 23,363 (eleven.1%) | 7,444 (10.0%) | < 0.0001 |
| Lesion length | 16 (12, 23) | 16 (12, 24) | 15 (12, 23) | 15 (12, twenty) | < 0.0001 |
| No. lesions attempted in lab visit | < 0.0001 | ||||
| 1> | 527,321 (72.9%) | 312,128 (71.3%) | 157,489 (74.7%) | 57,704 (77.2%) | |
| 2 | 155,520 (21.five%) | 98,319 (22.v%) | 43,211 (twenty.5%) | 13,990 (xviii.7%) | |
| ≥ 3 | xl,803 (v.vi%) | 27,530 (6.3%) | 10,246 (4.ix%) | three,027 (iv.1%) | |
| Radial admission | 87,714 (12.1%) | 59,479 (13.6%) | 23,483 (11.i%) | four,752 (6.4%) | < 0.0001 |
| Unfractionated heparin | 367,617 (50.9%) | 226,456 (51.viii%) | 106,509 (50.6%) | 34,652 (46.5%) | < 0.0001 |
| Bivalirudin | 434,174 (60.0%) | 259,810 (59.iv%) | 127,792 (threescore.6%) | 56,582 (62.iv%) | < 0.0001 |
| Glycoprotein IIb/IIIa inhibitor | 159,510 (22.1%) | 88,154 (20.ii%) | 53,116 (25.ii%) | 18,240 (24.5%) | < 0.0001 |
| Drug eluting stent | 509,776 (70.5%) | 313,739 (71.6%) | 144,233 (68.4%) | 51,804 (69.3%) | < 0.0001 |
| Fluoroscopy fourth dimension (minutes) | 12 (8, xix) | 12 (7, xix) | 13 (eight, 20) | thirteen (8, 21) | < 0.0001 |
| Contrast book (mL) | 180 (130, 235) | 175 (126, 230) | 180 (140, 240) | 185 (140, 250) | < 0.0001 |
| IVUS performed | thirteen,358 (20.8%) | 8,862 (22.1%) | 3,406 (18.6%) | 1,090 (18.7%) | < 0.0001 |
| Successful PCI | 673,076 (93.five%) | 409,851 (94.0%) | 194,666 (92.8% | 68,559 (92.3%) | < 0.0001 |
Association betwixt operator volumes and short-term outcomes
Overall, xv,319 patients (2.2%) died while hospitalized. The incidence of in-hospital death was 2.four% for depression-volume operators, 2.three% for intermediate-book operators, and 2.0% for high-book operators (Tabular array iii) (OR 0.95, 95% CI 0.89–1.01 for intermediate vs. low; OR 0.82, 95% CI 0.77–0.87 for high vs. low). When patients were stratified by type of presentation, patients undergoing PCI for STEMI past loftier- and intermediate-volume operators had a significantly lower incidence of death than those undergoing PCI by low book operators, simply operator volume category was not associated with mortality for patients presenting with UA/NSTEMI or stable angina. When patients were stratified by lesion type, patients undergoing PCI for bifurcation, left primary, and CTO lesions had lower in-hospital mortality when procedures were performed by high-volume operators compared with low-volume operators; only patients undergoing PCI for CTO lesions had lower bloodshed when procedures were performed by intermediate-volume operators compared with low-volume operators. After aligning for baseline patient and infirmary characteristics, both loftier- and intermediate-volume operators had lower in-hospital mortality than low-volume operators (OR 0.92, 95% CI 0.86–0.96 for intermediate vs. low; OR 0.79, 95% CI 0.75–0.83 for high vs. low). Risk-adjusted outcomes in subgroups largely paralleled unadjusted outcomes and are presented in Table 3.
Table 3:
In-infirmary mortality by operator volume
| Unadjusted Hr (95% CI) | Adjusted HR (95% CI) | |
|---|---|---|
| Overall | ||
| High vs. low book | 0.81 (0.77–0.87) * | 0.79 (0.75–0.83) * |
| Intermediate vs. low volume | 0.95 (0.89–1.01) | 0.91 (0.86–0.96) * |
| STEMI but | ||
| Loftier vs. depression book | 0.90 (0.85–0.96) * | 0.87 (0.82–0.92) * |
| Intermediate vs. low book | 0.92 (0.86–0.99) * | 0.90 (0.84–0.95) * |
| UA/NSTEMI only | ||
| High vs. low book | 0.95 (0.87–1.05) | 0.87 (0.lxxx–0.95) * |
| Intermediate vs. low book | 1.02 (0.92–1.thirteen) | 0.98 (0.89–1.08) |
| Stable angina just | ||
| High vs. low volume | 0.82 (0.55–1.22) | 0.76 (0.51–i.12) |
| Intermediate vs. low book | 1.09 (0.72–one.65) | 1.05 (0.69–1.58) |
| Chronic total occlusion | ||
| High vs. depression book | 0.55 (0.45–0.67) * | 0.71 (0.sixty–0.86) * |
| Intermediate vs. low volume | 0.fourscore (0.66–0.98) * | 0.86 (0.72–1.04) |
| Bifurcation lesion | ||
| High vs. low volume | 0.78 (0.68–0.90) * | 0.77 (0.67–0.88) * |
| Intermediate vs. low volume | 0.91 (0.79–1.06) | 0.89 (0.77–i.02) |
| Left main lesion | ||
| Loftier vs. low book | 0.72 (0.57–0.91) * | 0.73 (0.sixty–0.89) * |
| Intermediate vs. low volume | 1.15 (0.91–i.46) | 1.07 (0.87–1.31) |
In the commencement thirty days, 24,097 patients died; the cumulative incidence of mortality was three.five% for low-volume operators, 3.v% for intermediate volume operators, and iii.two% for high volume operators (OR 1.00, 95% CI 0.95–1.06 for intermediate vs. low; OR 0.92, 95% CI 0.88–0.97 for high vs. depression) (Supplement Table 2). Later on run a risk aligning, thirty-mean solar day mortality remained lower for patients treated by high-book operators compared with depression-book operators, just non for intermediate-volume operators compared with low-volume operators. By contrast, operator book group had no clan with the incidence of 30-day bleeding, on unadjusted or risk-adjusted analyses (take a chance-adjusted OR one.00, 95% CI 0.94–1.06 for intermediate vs. low; take chances-adjusted OR 0.96, 95% CI 0.91–one.01 for high vs. low) (Supplement Tabular array 2). In the subgroup of patients with UA/NSTEMI, patients treated past intermediate- and high-volume operators had a lower incidence of 30-twenty-four hour period bleeding than those treated by depression-volume operators on chance-adjusted analyses.
Association betwixt operator volumes and 1-yr outcomes
Overall 109,735 patients (15.2%) had a MACE result over the class of 1-yr follow-upwards. The unadjusted 1-year cumulative incidence of MACE was xv.9% for low-volume operators, sixteen.two% for intermediate-volume operators, and 16.5% for high-book operators (Figure 2 and Supplemental Table 3) (p = 0.004 by log-rank test). When patients were stratified by presentation subgroup, those undergoing PCI for UA/NSTEMI and stable angina had cumulative incidences of MACE that were significantly dissimilar by operator volume stratum. When stratified by lesion subtype, patients undergoing PCI for CTO and bifurcation lesions had cumulative incidences of MACE that were significantly different by operator volume stratum.
1-twelvemonth cumulative incidence of MACE by operator book overall (A), in patients presenting with STEMI (B), UA/NSTEMI (C), and stable angina (D), and those undergoing PCI of chronic total occlusion (East), bifurcation (F), and left main (Thousand) lesions MACE, major adverse cardiovascular events (all-cause decease, readmission for myocardial infarction, unplanned revascularization); STEMI, ST segment elevation myocardial infarction; UA, unstable angina; NSTEMI, non-ST segment elevation myocardial infarction; CTO, chronic full occlusion. Operator volume defined every bit in Effigy one.
The proportional hazards assumption was not satisfied for the outcome of MACE or mortality from the time of PCI to 1-year follow-upwards, then Cox modeling could not be performed. The proportional hazards assumption was satisfied for the time from hospital discharge to one-twelvemonth follow-up for both outcomes.
On unadjusted analyses, both high- and intermediate-volume operators had a college incidence of MACE from infirmary discharge to 1-year follow-up, but these differences were attenuated and non-significant afterwards adjustment for baseline risk factors (adapted 60 minutes 0.99, 95% CI 0.96–1.01 for intermediate vs. low; adjusted 60 minutes ane.01, 95% CI 0.99–one.04 for high vs. low) (Table 4). There were no significant differences in 1-yr post-discharge MACE in any presentation or lesion subgroup on unadjusted analyses; patients undergoing PCI for stable angina by intermediate-volume operators had a nominally significant lower run a risk of MACE than depression-book operators on adventure-adjusted analysis.
Table iv:
i-twelvemonth post-discharge MACE and all-cause mortality by operator book
| MACE | Mortality | |||
|---|---|---|---|---|
| Unadjusted 60 minutes (95% CI) | Adjusted HR (95% CI) | Unadjusted 60 minutes (95% CI) | Adjusted HR (95% CI) | |
| Overall | ||||
| High vs. low book | ane.07 (one.04–one.eleven) * | 1.01 (0.99–1.04) | 1.xi (ane.07–1.15) * | ane.04 (1.00–ane.08) |
| Intermediate vs. low volume | 1.03 (1.00–1.06) * | 0.99 (0.96–ane.01) | 1.07 (1.03–1.eleven) * | 1.01 (0.97–1.05) |
| STEMI only | ||||
| High vs. depression volume | 1.04 (0.98–1.ten) | 0.98 (0.93–1.04) | 1.07 (1.00–one.xv) | one.01 (0.94–1.09) |
| Intermediate vs. low volume | ane.01 (0.95–1.07) | 0.97 (0.91–ane.03) | one.06 (0.98–1.xiv) | ane.00 (0.93–1.08) |
| UA/NSTEMI only | ||||
| High vs. low book | 1.07 (i.04–i.11) * | 1.00 (0.97–ane.04) | ane.thirteen (i.08–one.nineteen) * | 1.04 (i.00–ane.09) |
| Intermediate vs. low volume | 1.03 (0.99–1.06) | 1.00 (0.97–1.04) | 1.08 (1.03–ane.xiii) * | 1.04 (0.99–1.09) |
| Stable angina only | ||||
| High vs. low book | i.04 (0.97–1.eleven) | 0.98 (0.92–1.04) | 1.01 (0.92–1.11) | 0.93 (0.84–i.02) |
| Intermediate vs. depression volume | 0.96 (0.89–1.03) | 0.93 (0.87–0.99) * | 0.94 (0.85–i.04) | 0.89 (0.84–one.02) |
| Chronic total occlusion | ||||
| Loftier vs. low volume | 0.92 (0.82–1.04) | i.06 (0.93–1.21) | 0.92 (0.78–1.08) | i.10 (0.93–1.31) |
| Intermediate vs. low volume | i.00 (0.88–i.14) | 1.01 (0.87–1.xvi) | i.02 (0.86–1.21) | 1.03 (0.85–1.23) |
| Bifurcation lesion | ||||
| High vs. low volume | 1.13 (1.05–ane.22) * | ane.07 (0.99–1.sixteen) | 1.11 (ane.01–ane.23) * | ane.05 (0.95–1.16) |
| Intermediate vs. low volume | 1.03 (0.95–1.12) | i.00 (0.92–1.09) | 0.99 (0.89–one.10) | 0.95 (0.85–1.06) |
| Left main lesion | ||||
| High vs. low volume | 1.05 (0.91–1.twenty) | 0.97 (0.84–one.12) | one.13 (0.94–1.35) | 1.01 (0.84–1.22) |
| Intermediate vs. low volume | 0.91 (0.79–1.06) | 0.97 (0.84–ane.12) | 1.00 (0.83–1.22) | 0.89 (0.73–1.10) |
The unadjusted cumulative incidence of i-twelvemonth mortality was 9.5% for depression-volume operators, 9.9% for intermediate-book operators, and nine.8% for high-volume operators (Figure 3 and Supplemental Table three) (p = 0.03 past log-rank test). When patients were stratified by presentation subgroup, only those presenting with UA/NSTEMI had a cumulative incidence of 1-year bloodshed that was significantly different by operator volume stratum. When stratified past lesion subtype, patients undergoing PCI for CTO had a cumulative incidence of bloodshed that was significantly different by operator volume stratum.
ane-twelvemonth cumulative incidence of all-cause mortality by operator book overall (A), in patients presenting with STEMI (B), UA/NSTEMI (C), and stable angina (D), and those undergoing PCI of chronic total occlusion (E), bifurcation (F), and left primary (G) lesions All abbreviations as in Effigy 2; operator volumes defined equally in Figures one and 2.
On unadjusted analyses, both high- and intermediate-volume operators had a higher incidence of mortality from hospital belch to 1-year follow-upward than low-volume operators, but there was no departure in mortality on gamble-adjusted analyses (adjusted Hour 1.01, 95% CI 0.97–1.05 for intermediate vs. low; adjusted HR 1.04, 95% CI ane.00–one.08 for high vs. depression) (Table 4). In that location were no differences in mortality by operator volume stratum among any presentation or lesion subgroup on risk-adapted analyses.
The unadjusted rate of readmission for MI and unplanned repeat revascularization was higher for high-book operators than low-volume operators. After risk adjustment, these differences were attenuated and not-meaning, and rates of readmission for recurrent MI and unplanned revascularization did non differ significantly past operator cohort in the overall population (Supplemental Table 4). Take chances-adjusted rates of readmission for recurrent MI and unplanned revascularization were not different by operator cohort in whatsoever presentation or lesion subgroup except for patients undergoing left main PCI, in which patients undergoing PCI past intermediate-volume operators had a nominally significant lower risk of unplanned revascularization than low-volume operators.
Operator volume, when analyzed as a continuous variable, was linearly associated with mortality from the fourth dimension of PCI to 1-year follow-upward, up to a threshold of 200 PCIs annually: For every 50 PCI increase in operator book up to 200, in that location was a corresponding i% decrease in the gamble-adapted hazard of 1-year expiry (60 minutes 0.99, 95% CI 0.98–one.00, p = 0.02) (Supplemental Table v). This finding was driven by an inverse association betwixt operator volume and in-hospital mortality (OR 0.95, 95% CI 0.94–0.97); in that location was no association betwixt operator volume and hazard-adjusted post-discharge mortality (Hr 1.00, 95% CI 0.99–1.01). No significant association was observed between operator book and 1-year mortality in any presentation subgroup. There was no significant association between operator volume, expressed continuously, and the risk-adapted incidence of one-year MACE (HR one.00, 95% CI 0.99–ane.00 per 50 PCI increase in annual operator book) nor the risk-adjusted incidence of MACE from discharge to 1-twelvemonth follow-upwardly (HR i.01, 95% CI one.00–one.01 per fifty PCI increment in annual operator volume). In that location was a direct clan betwixt operator volume and the incidence of 1-yr unplanned revascularization, which persisted after aligning for baseline risk factors (risk-adapted HR 1.02, 95% CI 1.01–1.03 per 50 PCI increase in annual operator book up to 200).
Interaction between operator experience and outcomes
In 2014, 6,524 operators performed 115,137 PCIs; 652 of these operators (10.0%) had been active 0–1 years betwixt 2009 and 2013, ane,469 (22.5%) 2–iv years, and 4,403 (67.5%) > 4 years. Operators with 0–1 yr of feel were more probable to exist low volume operators than those with more experience (58.v% of operators with 0–1 twelvemonth experience, 32.6% of those with 2–4 years experience, 30.v% of those with > iv years feel, p < 0.001) (Supplemental Tabular array half-dozen).
For PCIs performed in 2014, the association between operator volume and in-hospital mortality among all operators was similar to that during the entire study period; loftier and intermediate volume operators had lower unadjusted and gamble-adapted in-hospital mortality than low book operators. For operators with 0–i year feel, there was no significant association betwixt operator volume and in-infirmary mortality and the point estimate for the effect approached 1.0 (Table five). Past contrast, for operators with ii–4 and > 4 years experience, high volume operators had significantly lower unadjusted and risk-adapted in-hospital mortality than low volume operators. Similar to the overall cohort, there was no clan betwixt operator book and one-year post-belch mortality or MACE in any operator experience subset.
Table v:
Outcomes by operator volume and overall experience
| In-hospital mortality | 1-yr mail service-discharge mortality | 1-year post-belch MACE | ||||
|---|---|---|---|---|---|---|
| Unadjusted 60 minutes (95% CI) | Adjusted 60 minutes (95% CI) | Unadjusted HR (95% CI) | Adapted Hr (95% CI) | Unadjusted Hr (95% CI) | Adjusted 60 minutes (95% CI) | |
| Overall † | ||||||
| High vs. low volume | 0.77 (0.68–0.87) * | 0.76 (0.68–0.85) * | 1.x (1.00–i.21) * | 1.04 (0.94–1.15) | 1.12 (1.04–1.21) * | ane.05 (0.97–1.14) |
| Intermediate vs. low volume | 0.92 (0.80–1.05) | 0.88 (0.78–0.99) * | 1.07 (0.96–i.xviii) | 1.01 (0.91–1.thirteen) | 1.08 (0.99–one.17) | one.02 (0.94–one.xi) |
| 0–1 years experience ‡ | ||||||
| High vs. depression volume | 0.99 (0.69–1.43) | ane.02 (0.72–1.45) | 0.97 (0.75–1.20) | 0.94 (0.72–1.24) | 0.99 (0.79–1.23) | 0.98 (0.77–ane.25) |
| Intermediate vs. low book | 0.92 (0.63–one.34) | 0.95 (0.67–1.35) | 0.89 (0.66–1.20) | 0.83 (0.61–one.13) | 0.90 (0.70–i.16) | 0.87 (0.66–1.13) |
| 2–4 years experience ‡ | ||||||
| Loftier vs. low volume | 0.77 (0.59–1.00) * | 0.75 (0.60–0.95) * | one.21 (0.99–1.49) | 1.12 (0.90–1.38) | 1.10 (0.94–1.29) | i.02 (0.87–1.twenty) |
| Intermediate vs. low volume | 0.xc (0.68–1.19) | 0.83 (0.65–ane.06) | ane.16 (0.93–ane.45) | 1.fifteen (0.92–one.45) | one.02 (0.86–1.21) | 1.00 (0.84–one.twenty) |
| > 4 years feel ‡ | ||||||
| Loftier vs. low volume | 0.77 (0.66–0.90) * | 0.74 (0.64–0.85) * | i.14 (1.02–one.28) * | ane.08 (0.95–1.22) | 1.19 (1.08–1.30) * | ane.10 (1.00–1.22) |
| Intermediate vs. low volume | 0.93 (0.79–1.10) | 0.88 (0.76–ane.02) | 1.10 (0.97–i.25) | 1.03 (0.90–1.18) | 1.15 (ane.04–i.27) * | 1.07 (0.97–1.19) |
DISCUSSION
In this nationally representative study, we found that operators performing fewer than 50 PCIs annually, the ACC/AHA/SCAI recommended minimum number of procedures to maintain competency, had a college risk-adjusted rate of in-hospital mortality, but did not have a higher run a risk-adapted hazard of death or MACE over i-year mail service-discharge follow-up than higher volume operators. On unadjusted analyses, high-volume operators had a higher incidence of long-term MACE and mortality than depression volume operators, simply loftier-book operators performed more complex PCI on patients at higher take a chance of long-term cardiovascular events. When operator volume was analyzed continuously, college operator volume was associated with lower risk-adjusted mortality over i-year follow-up, but this finding is driven entirely by in-hospital death, and there was no association between operator volume and postal service-discharge mortality or MACE. Overall, given that 44% of operators nationwide perform fewer than 50 PCIs annually,10 these findings are reassuring that the small inverse association betwixt operator volume and short-term outcomes is not compounded past a like association between operator volume and long-term outcomes given current case option patterns.
Over two dozen studies accept now considered the clan betwixt PCI operator volume and outcomes.10–12, 35 The most largest contemporary study, an analysis of the nationally-representative CathPCI database, found a pocket-size, though significant, inverse relationship between operator book and in-hospital bloodshed, broadly consistent with the totality of show from the stent era.10 Withal, just two studies have described the clan between operator book and > thirty day outcomes. Mueller et al. constitute no association between operator experience and the 24-calendar month incidence of death, myocardial infarction or clinically-driven revascularization in a 300-patient, 6-operator, single-middle study.36 A substudy of the Enhanced Suppression of the Platelet glycoprotein IIb/IIIa Receptor with Integrilin Therapy (Camaraderie) trial involving 1338 patients divided operators into those performing < 100 PCIs (n = 91) and ≥ 100 PCIs annually (northward = 1136), and found that there was no clan between operator book cohort and 1-year death, MI, or target vessel revascularization.37 Though our study includes only patients ≥ 65 years quondam, information technology represents the largest, near gimmicky, and about nationally representative examination of the association between operator book and long-term outcomes.
We found, nigh chiefly, that the association betwixt operator volume and outcomes, including MACE and mortality, is not static from the time of PCI to 1-year follow-up. On unadjusted and run a risk-adjusted analyses, high- and intermediate- book operators have a lower incidence of in-infirmary mortality than low-volume operators, defined as per the ACC/AHA/SCAI's clinical competency document, which is consequent beyond presentation and lesion type subgroups. Still, from the time of infirmary belch to 1-year follow-up, depression-volume operators had a lower unadjusted rate of 1-year MACE, mortality, and unplanned revascularization than intermediate- or high-book operators. However, example mix differed for depression-, intermediate-, and high-volume operators, with depression-volume operators more than frequently performing PCI for STEMI and less frequently performing PCI on patients with established cardiovascular disease and cardiovascular risk factors. Though differences in case mix were modest, subsequently aligning for baseline patient and lesion characteristics, differences in MACE and mortality between operator cohorts were adulterate and non-significant from the time of hospital discharge to 1-year follow-up. When we analyzed operator volume as a continuous variable, an arroyo that affords maximal power to detect a pregnant association between operator book and outcomes, we constitute a small inverse association between operator book and 1-year bloodshed post-obit PCI. This clan is driven past in-hospital events, as in that location was no significant association betwixt operator volume and one-year post-discharge MACE or mortality, though there was a direct association between operator book, analyzed continuously, and hazard-adjusted unplanned revascularization. However, this clan may be related to exercise patterns of high-volume operators: Higher book operators more than often perform PCIs in patients with clinical and angiographic risk factors for restenosis (multi-vessel PCI, chronic full occlusion, diabetes mellitus),38, 39 and may be more likely than lower book operators to perform PCI for worsening angina.
Our findings may seem at odds with volume-consequence analyses in other specialties. For example, in patients undergoing surgical procedures for colon cancer, breast cancer, head and cervix cancer, college surgeon volume is associated with a reduced incidence of long-term mortality.40 While at that place are diverse explanations for the operator book-outcome relationship, the about unremarkably acknowledged one is the "do makes perfect" hypothesis, which holds that college volumes lead to meliorate operative decision-making and technique.41 This holds true for in-infirmary outcomes, with a modest, but statistically significant, relationship between greater operator PCI volume and lower risk of mortality.10 When examining longer-term outcomes we hypothesized that the same relationship would hold based on an assumption that lower volume operators would be technically less proficient than college volume operators. High-volume operators employ techniques that are associated with reduced agin outcomes post-obit PCI like radial admission and greater drug-eluting stent use.10 It is possible that they may likewise use techniques to reduce suboptimal stent deployment, which is associated with higher rates of stent thrombosis and re-stenosis, ultimately leading to unplanned revascularization, recurrent MI, or death.sixteen–twenty The CathPCI dataset does not allow for granularity regarding stent implantation technique; even so, the difference in curt-term in-hospital outcomes and lack of deviation in long-term outcomes between high-, intermediate-, and low-volume operators indicates that if operator book is associated with technical proficiency, the effect is manifest prior to hospital discharge. Long-term outcomes post-obit PCI may be more than likely to be a consequence of underlying disease than annihilation that happened during the process itself.
Our results have implications for professional guild guidelines. Though operators performing fewer than the ACC/AHA/SCAI'south minimum recommendation of 50 PCIs annually accept a higher charge per unit of in-infirmary mortality following PCI, the relationship between operator volume and short-term mortality is small and of uncertain clinical significance, especially considering that these low-volume operators may play a office in maintaining critical admission to primary PCI for STEMI.10 Intriguingly, this clan does not appear to hold for operators in their first years of independent practice, suggesting that high-intensity fellowship training may take residue benefits as an operator transitions to independent do, or that hospitals may exercise greater oversight over these new operators. When composing operator volume recommendations, professional person social club guideline committees need to balance maximizing patient safety with maintaining access to disquisitional emergency procedures, and an approach that focuses on identifying and disseminating best practices amid all operators, regardless of volume, may be preferable to strict book recommendations.10, 42 Since operator volume is not associated with long-term outcomes among patients surviving the index hospitalization, the guidelines should consider volume standards in the context of overall care quality, including process performance measures relevant to the post-PCI population, such every bit prescription of secondary prevention strategies aimed at improving in-hospital and long-term outcomes.
Limitations
This report is a retrospective analysis, and is field of study to unmeasured misreckoning. Though our risk-adjusted analyses business relationship for measured severity of patient presentation, it is possible, for case, that higher volume operators are more probable to attempt PCI in patients with unmeasured variables indicating poor long-term prognosis, which would mask truthful differences in long-term outcomes. With regard to short-term outcomes, it is possible that operators with poorer outcomes and/or less skill receive fewer referrals and have low volumes for that reason. PCIs analyzed in this report were performed betwixt 2009 and 2014, and practice patterns may have changed in the intervening years; yet, PCI has mostly grown safer over the years, attenuating the operator-book association.1, 10 As we did not discover an association between operator book and long-term outcomes during our study menses, it is non expected that one would be at present. Furthermore, this analysis only includes patients ≥ 65 years old, only older adults comprise a growing percentage of patients undergoing PCI,43, 44 and at that place is no reason to doubtable that the relationship between operator volume and outcomes should be afflicted by patient age. Our analysis does exclude a number of low-volume operators who performed PCI on younger patients, but did not perform a single PCI on a patient in the linked database, so our descriptive analysis of the proportion of high-, intermediate-, and low-book operators underestimates the proportion of low-book operators; an assay of PCIs performed on all patients in CathPCI, non just those > 65 years quondam, found that 44% of operators performed < l PCIs annually, compared with 39% in this assay.10 Moreover, as we were unable to capture unplanned index vessel or index lesion revascularization, we examined all unplanned revascularizations; differences in operator technique would not affect the take chances of future unplanned revascularization in non-index vessels, and including non-index vessel revascularization may add statistical noise that obscures true operator-related differences in rates of index vessel or index lesion revascularization. In addition, CathPCI does not include variables that could be used to approximate overall experience, such every bit number of years in practice, full lifetime volume, or lath certification. We were able to estimate number of years in practice, merely this estimation is imprecise, and operators who performed PCIs in non-CathPCI hospitals may accept been counted among the operators with 0–1 years of experience. Though the CathPCI registry captures PCI procedures performed in > 90% of U.S. cardiac catheterization labs, it does not capture procedures performed in Veterans Administration or Department of Defense hospitals, and operators performing PCIs in these hospitals and hospitals that participate in the CathPCI registry volition have their procedure volumes undercounted. Despite the higher up limitations, CathPCI is a nationally-representative, quality-controlled database, and our analysis of > 700,000 PCIs performed by nearly 9,000 operators represents the most comprehensive examination of the association between operator volume and long-term outcomes to date.
CONCLUSIONS
Low annual operator PCI volume, defined as fewer than l PCIs annually, is associated with worse in-infirmary outcomes compared with higher operator book, but is not associated with higher rates of 1-year MACE or mortality amidst patients older than 65 years.
Supplementary Material
Online Only Supplemental Materials
Acknowledgments
FUNDING SOURCES
This research was supported by the American College of Cardiology Foundation's National Cardiovascular Data Registry. Dr. Fanaroff was funded past career development grants from the National Institutes of Health (5T32HL069749–13) and American Heart Association (17FTF33661087) during the acquit of the study.
Footnotes
DISCLOSURES
AC Fanaroff: Dr. Fanaroff reports research funding from Gilead Sciences exterior the submitted work
P Zakroysky: Ms. Zakroysky reports no relevant disclosures
LA Kaltenback: Ms. Kaltenbach reports no relevant disclosures
D Wojdyla: Mr. Wojdyla reports no relevant disclosures
MW Sherwood: Dr. Sherwood reports honoraria/consulting fees from Janssen
MT Roe: Dr. Roe reports no relevant disclosures
TY Wang: Dr. Wang reports no relevant disclosures
ED Peterson: Dr. Peterson reports no relevant disclosures
HS Gurm: Dr. Gurm reports inquiry funding from the National Institutes of Health and Bluish Cross Blueish Shield of Michigan, and consulting fees from Osprey Medical
MG Cohen: Dr. Cohen reports no relevant disclosures
JC Messenger: Dr. Messenger reports no relevant disclosures
SV Rao: Dr. Rao reports no relevant disclosures
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340715/
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