Cardiovascular Surgery Practice Patterns and Clinical Outcomes After Hybrid Coronary Revascularization in the United States An Analysis From the Society of Thoracic Surgeons Adult Cardiac Database Ralf E. Harskamp, MD; J. Matthew Brennan, MD, MPH; Ying Xian, MD, PhD; Michael E. Halkos, MD, MS; John D. Puskas, MD, MS; Vinod H. Thourani, MD; James S. Gammie, MD; Bradley S. Taylor, MD; Robbert J. de Winter, MD, PhD; Sunghee Kim, PhD; Sean O’Brien, PhD; Eric D. Peterson, MD, MPH; Jeffrey G. Gaca, MD Background—Hybrid coronary revascularization (HCR) involves a combination of surgical and percutaneous techniques, which in selected patients may present an alternative to conventional coronary artery bypass grafting (CABG). Methods and Results—Patients were included who underwent HCR (staged/concurrent) or isolated CABG in the Society of Thoracic Surgeons Adult Cardiac Surgery Database (July 2011 to March 2013). HCR represented 0.48% (n=950; staged=809, concurrent=141) of the total CABG volume (n=198 622) during the study period, and was performed in onethird of participating centers (n=361). Patients who underwent HCR had higher cardiovascular risk profiles in comparison with patients undergoing CABG. In comparison with CABG, median sternotomy (98.5% for CABG, 61.1% for staged HCR, and 52.5% for concurrent HCR), direct vision harvesting (98.9%, 66.0%, and 68.1%) and cardiopulmonary bypass (83.4%, 45%, and 36.9%) were less frequently used for staged and concurrent HCR, whereas robotic assistance (0.7%, 33.0%, and 30.5%) was more common. After adjustment, no differences were observed for the composite of in-hospital mortality and major morbidity (odds ratio, 0.93; 95% confidence interval, 0.75–1.16; P=0.53 for staged HCR, and odds ratio, 0.94; 95% confidence interval, 0.56–1.56; P=0.80 for concurrent HCR in comparison with CABG). There was no statistically significant association between operative mortality and either treatment group (odds ratio, 0.74; 95% confidence interval, 0.42–1.30; P=0.29 for staged HCR, and odds ratio, 2.26; 95% confidence interval, 0.99–5.17; P=0.053 for concurrent HCR in comparison with CABG). Conclusion—HCR, either as a staged or concurrent procedure, is performed in one-third of US hospitals and is reserved for a highly selected patient population. Although HCR may appear to be an equally safe alternative for CABG surgery, further randomized study is warranted. (Circulation. 2014;130:872-879.) Key Words: coronary artery bypass ◼ coronary disease ◼ stents ◼ thoracic surgery H ybrid coronary revascularization (HCR), which involves the combined use of percutaneous and surgical techniques, has emerged as an alternative to conventional coronary artery bypass grafting (CABG) for selected patients with multivessel coronary disease.1–3 In most cases, HCR involves a surgical procedure in which the internal mammary artery (IMA) is grafted to the left anterior descending (LAD) coronary artery, preceded or followed by percutaneous coronary intervention (PCI) of non-LAD coronary lesions, either Editorial see p 869 Clinical Perspective on p 879 performed in 1 setting (concurrent) or as a staged procedure.4 A prerequisite for HCR is that the patient has LAD anatomy that is eligible for surgical revascularization, but also has nonLAD lesions that are amenable for PCI. The concept of HCR stems from the hypothesis that (1) bypass grafting of the LAD with an IMA graft is superior to coronary stenting, and (2) PCI with the latest drug-eluting stents is equal or even superior to other bypass grafts used for non-LAD disease.5,6 Advances in surgical techniques also allowed IMA-to-LAD grafting to be performed by using less invasive techniques than conventional CABG. Although several reports suggested a reduction in perioperative morbidity, length of intensive care and Continuing medical education (CME) credit is available for this article. Go to http://cme.ahajournals.org to take the quiz. Received February 13, 2014; accepted June 20, 2014. From the Duke Clinical Research Institute and Duke University Medical Center, Durham NC (R.E.H., J.M.B., Y.X., S.K., S.O'B., E.D.P., J.G.G.); Academic Medical Center of the University of Amsterdam, Amsterdam, Netherlands (R.E.H., R.J.d.W.); Cardiothoracic Surgery Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, GA (M.E.H., V.H.T); Department of Cardiothoracic Surgery, Mount Sinai Beth Israel, New York, NY (J.D.P.); and Heart Center of the University of Maryland Medical Center, Baltimore, MD (J.S.G., B.S.T.). Correspondence to Ralf E Harskamp, MD, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705. Email [email protected] © 2014 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.114.009479 Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 872 Harskamp et al Hybrid Revascularization in the United States 873 hospital stay, with equal left IMA patency, these studies have generally been limited to a small number of high-volume centers with experienced operators.3,4,7 It is unknown the degree to which HCR is used in routine clinical practice in the United States, and the clinical characteristics or in-hospital outcomes of patients who undergo HCR, as well. To address this paucity of information, we performed a contemporary examination of HCR among isolated CABG procedures by using data from the Society of Thoracic Surgeons (STS) national registry. The objectives of this study were 3-fold: (1) to describe the incidence and variation of HCR, and HCR characteristics among US centers, as well; (2) to assess and compare clinical and operative characteristics between HCR and conventional CABG; (3) to describe and compare in-hospital outcomes between HCR and conventional CABG. Methods Study Population From the STS adult cardiac database version 2.73 we included patients that were enrolled from July 2011 through March 2013. From this starting population, we included patients who underwent a hybrid procedure or isolated CABG, and applied a number of exclusion criteria, which are listed in Figure 1. Procedural Definitions and Outcomes In our study, HCR was considered a planned procedure that included the use of an IMA graft and coronary stent placement that could either be performed concurrently or as a 2-stage procedure performed during the same hospitalization. Other variable definitions followed the standards of the Society of Thoracic Surgeons Adult Cardiac Surgery Database data version 2.73 (http://www.sts.org). The primary outcome was in-hospital mortality or major morbidity, a composite of (peri)operative mortality, the need for reoperation (for bleeding/ tamponade, valvular dysfunction, graft occlusion, or other cardiac reasons), stroke, renal failure, mediastinitis, or prolonged ventilation. The secondary outcomes were the individual components of the composite end point, and postoperative length of hospital stay. Statistical Analysis The incidence of HCR in the study population was presented as a median, interquartile range, minimum and maximum. Variation in the incidence among US hospitals was assessed by histograms, sorted from largest to smallest percentage of HCR use, to graphically display hospital variation. Temporal trends of hospital rates of HCR among the study population were calculated by 3-month intervals during the study period. Clinical and procedural characteristics were displayed in descriptive tables, in which continuous variables are summarized as median and interquartile range, and categorical variables as percentage and frequency counts between parentheses. P values for comparing the distribution of variables among the comparison groups was computed with the χ2 test for categorical variables and the Kruskal-Wallis test for continuous variables. In-hospital outcomes including the composite end point of mortality and major morbidity were presented as odds ratios (ORs) and 95% confidence intervals (CIs) and P values with adjusting for potential confounders using logistic regression with the generalized estimating equations (to account for the correlation in the same site) for the composite end point and for operative mortality. Potential confounders were based on previously developed and validated STS CABG mortality model.8 The following variables were included in the adjustment model: CABG volume, age, race, sex, diabetes mellitus, hypertension, cerebrovascular disease, peripheral vascular disease, dialysis, immunocompromised status, creatinine, chronic lung disease, body surface area, ejection fraction, congestive heart failure, unstable angina, previous myocardial infarction, recent myocardial infarction (<21 days, 6–24 hours, <6 hours), atrial fibrillation, preoperative intraaortic balloon pump, acuity status, inotropes, number of diseased vessels, left main disease and valvular disease, and previous cardiac surgery. Missing variables were imputed by using the most common category for categorical variables and group-specific medians for continuous variables with the exception of outcomes. All continuous variables were tested for linearity, and nonlinear relationships were accounted for by using flexible spines including linear splines or quadratic polynomial. For postoperative length of stay, we presented median, interquartile range, and P value, using linear regression with generalized estimating equations. A P value of <0.05 was considered statistically significant. The study protocol has been reviewed and approved by the Duke University Health System institutional review board, and informed consent was waived. All statistical tests were performed by the Duke Clinical Research Institute, Durham, NC, with the use of SAS 9.3 (SAS Institute, Cary, NC). Results Incidence, Variation, and Temporal Trends of HCR Among US Hospitals Figure 1. Flow chart of study population. CABG indicates coronary artery bypass grafting; HCR, hybrid coronary revascularization; IMA, internal mammary artery; PCI, percutaneous coronary intervention; and STEMI, ST-segment elevation myocardial infarction. Among 198 622 patients with multivessel disease who underwent isolated CABG surgery, 950 patients underwent either staged or concurrent HCR between July 2011 and March 2013. These patients represented 0.48% of the total CABG volume over this period. Of the 1050 hospitals that performed isolated CABG, 361 (34.4%) hospitals performed at least 1 HCR, of whom 322 (30.7%) performed at least 1 staged HCR and 83 (7.9%) performed at least 1 concurrent HCR in this period. The annual CABG volume of hospitals that performed at least 1 staged HCR was higher (median, 143; 25th to 75th percentile, 83–232) in comparison with centers that performed at least 1 concurrent HCR procedure (median, 120; 25th to 75th percentile, 79–232) or no HCR procedures (median, 128; 25th to 75th percentile, 75–210; P=0.0005). The distribution of percentage of HCR use (staged and concurrent) among hospitals is shown in Figure 2. The median Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 874 Circulation September 9, 2014 Figure 3. Recent temporal trends in the use of hybrid coronary revascularization. CABG indicates coronary artery bypass grafting; and HCR, hybrid coronary revascularization. of HCR over the measured time period (P=0.42). Hospital characteristics associated with the use of HCR, included the availability of surgeons who performed less invasive, sternalsparing CABG procedures. In these centers, the use of staged or concurrent HCR was significantly higher than in centers that did not perform minimally invasive procedures (median [%], 0.22 versus 0.0, P<0.0001). Presenting Features and Clinical Characteristics Figure 2. Hospital variation in the use of HCR among US sites that performed at least 1 hybrid procedure. Displayed is the hospital variation in the use of HCR procedures (as a percentage of total CABG volume) among hospitals that performed at least 1 hybrid procedure. Top, this variation in use is shown when considering all HCR procedures. Middle, staged HCR procedures. Bottom, of concurrent HCR procedures only. CABG indicates coronary artery bypass grafting; and HCR, hybrid coronary revascularization. percentage of use of HCR among hospitals that performed at least 1 HCR was 0.76% and an interquartile range of 0.44 to 1.54. The maximum percentage of HCR use was ≈13% of total CABG volume. The largest number of HCR cases performed per site during the study period was 54. We also assessed the percentage of HCR use per quarter, as shown in Figure 3. No temporal trend could be observed in the use The clinical characteristics are displayed in Table 1. Overall, in comparison with patients who underwent conventional CABG, patients who underwent staged or concurrent HCR more frequently presented with non–ST-segment elevation myocardial infarction (23.7%, 32.8%, and 34.8%), more frequently had a history of myocardial infarction (47.0%, 63.0%, and 58.2%), had previous PCI (25.3%, 59.0%, and 50.4%), and were more frequently on dialysis (4.8%, 6.8%, and 8.5%). Patients who underwent concurrent HCR, also more frequently had peripheral vascular disease (14.4%, 14.5%, and 16.3%) and a history of stroke (7.3%, 7.1%, and 10.6%) in comparison with the other groups. Other cardiovascular risk factors, such as hypertension, diabetes mellitus, and dyslipidemia were comparable. At coronary angiography, patients undergoing HCR has less significant left main coronary involvement and 3-vessel disease. Continuation of dual-antiplatelet therapy was more frequent among patients who underwent staged or concurrent HCR, as is illustrated by the recent use of ADP inhibitor (<5 days) which was 25.2% and 27.0% after staged and concurrent HCR, respectively, versus 11.3% in the conventional CABG group. Also, the use of glycoprotein IIb/IIIa inhibitors was higher in the HCR groups than in patients undergoing CABG (2.0%, 10.8%, and 5.0%). Operative Characteristics Among patients who underwent staged HCR, surgical revascularization was performed first in 540 patients (66.8%), and PCI was performed first in 269 patients (33.2%). In the concurrent HCR group, surgical revascularization also occurred first in the majority of cases (70.2%). As shown in Table 2, the operative approach in the HCR groups more frequently Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 Harskamp et al Hybrid Revascularization in the United States 875 Table 1. Patient and Angiographic Characteristics Isolated CABG (n=197 672) Age, y 65 (58–73) Staged HCR (n=809) 65 (57–73) Table 2. Operative Characteristics Concurrent HCR (n=141) 65 (59–72) Isolated CABG (n=197 672) Elective Male 74.83 (147 919) 71.9 (582) 75.9 (107) Operative approach White 81.3 (160 795) 78.2 (633) 76.6 (108) Full sternotomy BMI, kg/m2 29.1 (25.9–33.1) 28.7 (25.6–32.9) 28.7 (25.4–34.5) Partial sternotomy Diabetes mellitus 46.1 (91 062) 44.0 (62) Parasternal incision 45.1 (365) 42.2 (83 390) Staged HCR (n=809) Concurrent HCR (n=141) 44.1 (357) 50.4 (71) 98.5 (194 704) 61.1 (494) 52.5 (74) 0.34 (665) 0.87 (7) 0.04 (84) 0.99 (8) 4.3 (6) 1.4 (2) Current smoker 21.7 (42 908) 22.6 (183) 21.3 (30) Lateral thoracotomy Dyslipidemia 87.4 (172 802) 88.9 (719) 83.7 (118) Minimally invasive 0.43 (841) 18.5 (150) 27.0 (38) Family history of CAD 28.7 (56 709) 24.4 (197) 21.3 (30) Planned as OPCAB 17.2 (34 029) 55.8 (451) 63.1 (89) OPCAB as treated 16.6 (32 833) 55.0 (445) 63.1 (89) Hypertension 88.3 (174}476) 87.4 (707) 85.8 (121) Time on CPB, min 7.3 (14 337) 7.1 (57) 10.6 (15) Skin incision time, min 225 (183–275) 199 (154–253) 226 (163–278) 14.4 (28 423) 14.5 (117) 16.3 (23) Time in OR, min 301 (253–359) 287 (237–344.5) 307 (241–390) Previous stroke PVD 0.5 (972) 18.3 (148) 14.9 (21) 91 (71–115) 83.5 (62–112) 88 (60–110) Dialysis 4.8 (9390) 6.8 (55) 8.5 (12) IMA harvest technique Creatinine, mg/dL* 1.0 (0.8–1.2) 1.0 (0.8–1.2) 1.0 (0.8–1.2) Direct vision 98.9 (195 454) 66.0 (534) 68.1 (96) 0.71 (1) Previous MI 47.0 (92 835) 63.0 (510) 58.2 (82) Thoracoscopy 0.13 (252) 0.74 (6) Previous CABG 1.32 (2603) 0.87 (7) 0.71 (1) Combination 0.04 (70) 0.12 (1) 0.71 (1) Previous PCI 25.3 (49 953) 59.0 (477) 50.4 (71) Robotic assisted 0.66 (1302) 33.0 (267) 30.5 (43) LVEF, % 53 (45–60) 55 (45–60) 55 (45–60) IMA artery use β-Blockers 89.4 (176 727) 90.5 (732) 91.5 (129) LIMA 94.0 (185 850) 94.4 (764) 94.3 (133) Lipid-lowering agent 78.4 (154 935) 83.7 (677) 82.3 (116) RIMA 0.84 (1652) 0.87 (7) 0.71 (1) Aspirin 82.2 (162 559) 83.8 (678) 87.9 (124) Both IMAs ADP inhibitor <5 days 11.3 (22 323) 25.2 (204) 27.0 (38) No distal targets IMA 1 (1–1) 1 (1–1) 1 (1–1) 2.0 (3890) 10.8 (87) 5.0 (7) No distal targets vein grafts 2 (2–3) 0 (0–2) 0 (0–2) 23.7 (46 881) 32.8 (265) 34.8 (49) No distal targets arterial grafts 0 (0–0) 0 (0–0) 0 (0–0) GP IIb/IIIa inhibitor Presentation of NSTEMI 5.1 (10 170) 4.7 (38) 4.96 (7) CABG volume 128 (75–210) 143 (83–232) 120 (79–232) Three-vessel disease 79.4 (157 032) 72.1 (583) 66.7 (94) Any blood products used 2 (0–2) 2 (1–3) 33.8 (66 790) 27.6 (223) 27.7 (39) RBC units, 1 million/μL 2 (1–2) Left main disease Prox LAD disease 56.9 (112 500) 60.6 (490) 60.3 (85) Frozen plasma units, 1 million/μL 0 (0–1) 0 (0–0) 0 (0–1) Platelet units, 1 million/μL 0 (0–1) 1 (0–2) 0 (0–1) Continuous variables are presented by median (interquartile range), and categorical variables are presented by percentage (n). BMI indicates body mass index; CABG, coronary artery bypass grafting; CAD, coronary artery disease; HCR, hybrid coronary revascularization; LAD, left anterior descending coronary artery; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NSTEMI, non–ST-segment elevation myocardial infarction; PCI, percutaneous coronary intervention; and PVD, peripheral vascular disease. *Creatinine measured in nondialysis patients. consisted of less invasive techniques than median sternotomy in comparison with conventional CABG. Additionally, cardiopulmonary bypass was less commonly used in the HCR groups than in CABG (83.4%, 45.0%, and 36.9% after CABG, staged HCR, and concurrent HCR, respectively). Conversion to the use of cardiopulmonary bypass was similar among the groups (CABG, 0.6%; staged HCR, 0.8%; and concurrent HCR, 0.0%). When cardiopulmonary bypass was used, the on-pump times tended to be shorter after HCR. In all groups the use of the left IMA was primarily used alone (≈94%), but sometimes also in combination with the right IMA (≈5%). Robotic technology to assist in IMA harvesting was used in 33.0% and 30.5% of patients 31.4 (62 082) 28.2 (228) 19.9 (28) Continuous variables were presented by median (interquartile range), and categorical variables were presented by percentage (n). CABG indicates coronary artery bypass grafting; CPB, cardiopulmonary bypass; HCR, hybrid coronary revascularization; IMA, internal mammary artery; LIMA, left internal mammary artery; OPCAB, off-pump coronary artery bypass grafting; OR, operating room; RBC, red blood cell; and RIMA, right internal mammary artery. undergoing staged and concurrent HCR, respectively, versus only 0.66% in the CABG group. As expected, the total number of vein grafts was higher in the CABG group (median, 2; interquartile range, 2–3) in comparison with both HCR groups (both medians equal zero; interquartile range, 0–2). Procedural time, as measured by skin incision time and total time in the operating room, was shorter after staged HCR procedures than after concurrent HCR and CABG. The use of blood products was lower after concurrent HCR in comparison with staged HCR and conventional CABG (31.4%, 28.2%, and 19.9%), as well. Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 876 Circulation September 9, 2014 Table 3. Unadjusted and Adjusted Outcomes for Isolated CABG and Staged and Concurrent HCR Major morbidity or mortality Operative mortality Isolated CABG % (n) Staged HCR % (n) 11.8 (23 385) 12.0 (97) 1.5 (2984) 1.4 (11) P Value Concurrent HCR % (n) 0.93 (0.75–1.16)* 0.53* 11.4 (16) 0.94 (0.56–1.56)* 0.80* 0.74 (0.42–1.30)* 0.29* 3.6 (5) 2.26 (0.99–5.17)* 0.053* OR (95% CI) OR (95% CI) P Value Permanent stroke 1.2 (2446) 0.5 (4) 0.39 (0.15–1.07) 0.069 1.4 (2) 1.16 (0.30–4.49) 0.83 Reoperation 2.2 (4354) 2.4 (19) 1.06 (0.68–1.66) 0.80 3.6 (5) 1.58 (0.66–3.78) 0.30 Renal failure† 1.8 (3365) 1.7 (13) 0.97 (0.59–1.60) 0.91 1.6 (2) 0.96 (0.30–3.05) 0.94 Prolonged ventilation 8.2 (16 181) 7.8 (63) 0.94 (0.71–1.25) 0.68 6.4 (9) 0.79 (0.44–1.42) 0.43 Mediastinitis 0.35 (691) 0.0 (0) NA‡ NA‡ 0.0 (0) NA‡ Surgical site infection 1.23 (2438) 0.74 (6) 0.60 (0.27–1.34) 0.21 0.71 (1) 0.57 (0.08–4.09) Sepsis 0.72 (1417) 0.99 (8) 1.38 (0.69–2.79) 0.36 0.0 (0) NA‡ NA‡ 0.58 NA‡ Displayed are the event rates for in-hospital outcomes, and odds ratios (ORs) and 95% confidence intervals (CIs), as well, using the isolated CABG group as a reference. CABG indicates coronary artery bypass grafting; HCR, hybrid coronary revascularization; and NA, not available. *For the composite outcome and operative mortality, the ORs and 95% CIs were adjusted for differences in baseline risk; for the remaining, nonfatal outcomes, unadjusted ORs are presented. †Among patients without previous renal failure. ‡ORs could not be calculated because there is no event for the outcome of interest in at least 1 of the comparison groups. In-Hospital Outcomes The in-hospital outcomes are displayed as event rates and unadjusted and adjusted odds ratios in Table 3. The composite end point of in-hospital mortality, stroke, reoperation, renal failure, prolonged ventilation, and mediastinitis was comparable between CABG and staged HCR (adjusted OR, 0.93; 95% CI, 0.75–1.16; P=0.53) and between CABG and concurrent HCR (adjusted OR, 0.94; 95% CI, 0.56– 1.56; P=0.80). Statistically, operative mortality was similar between CABG and staged HCR (adjusted OR, 0.74; 95% CI, 0.42–1.30; P=0.29), and CABG and concurrent HCR; although a trend toward higher mortality was observed among patients who underwent concurrent HCR (adjusted OR, 2.26; 95% CI, 0.99–5.17; P=0.053). The 5 reported deaths in the concurrent HCR group were either cardiac related (n=4) or attributable to pulmonary causes (n=1). Among the nonfatal end points, a trend toward lower risk of stroke after staged HCR was found in comparison with the CABG group. Postoperative length of stay tended to be shorter after concurrent HCR and CABG (median [interquartile range]=5 [4–7] days versus 6 [4–7] days, P=0.101), and also after staged HCR and CABG (5 [4–7] days versus 6 [4–7] days, P=0.098). Discussion This study represents the first nationwide assessment of the use, characteristics, and in-hospital outcomes of hybrid coronary procedures among patients with multivessel coronary artery disease. In contemporary practice, HCR, either performed as staged or concurrent procedures, remains uncommon, because it represents only a mere 0.5% of the total CABG volume. Moreover, even among the hospitals that performed HCR (approximately one-third of all hospitals with CABG capabilities), the use of HCR was <1% of the total CABG volume. The low adoption of HCR among US hospitals can in part be attributed to the low use of minimally invasive surgical techniques, because hospitals that performed HCR without minimally invasive techniques were also less likely to perform HCR. Additionally, the low use of concurrent HCR is likely attributable to the limited availability of hybrid operating rooms. Over a relatively short time period for which we have data available (<2 years), no temporal trend could be observed for the use of HCR in current US practice. In comparison with CABG, patients who underwent concurrent HCR or staged HCR had higher-risk profiles, but less extensive coronary disease. As expected, HCR was more frequently performed by using less invasive surgical approaches, including minimally invasive thoracic access, use of robotic assistance, and avoidance of cardiopulmonary bypass. The use of blood products was lower after concurrent HCR than after staged HCR and conventional CABG, as well, and in-hospital outcomes were overall comparable, although operative mortality tended to be higher in the concurrent HCR than in staged HCR and CABG. Clinical Outcomes In the past 5 years, several studies have been published on in-hospital clinical outcomes after concurrent and staged HCR procedures.7,9–17 In Table 4, we have summarized the key findings from these studies. The number of patients who underwent HCR in these studies ranged from 5 to 300 patients, and most operators used a partial sternotomy or a small lateral thoracotomy approach with or without the use of robotic assistance. Overall, low mortality rates are seen in studies that used minimally invasive techniques (0%– 1.3%), with equally low rates for stroke (0%–1.0%) and reoperation for bleeding (0%–4.2%). However, in 1 larger study by Zhao et al11 (n=112), HCR was performed by using conventional median sternotomy with open IMA harvesting and with fewer restrictions for study eligibility. In-hospital mortality in this cohort was 2.7%, with stroke rates of 1.8% and reoperation for bleeding of 2.7%. It should be noted that, in this study, unplanned procedures, in which PCI was performed because intraoperative findings such as graft defects, poor conduits, or poor target vessel, made up 40% of the patient population, which could explain some of the excess of adverse events in this study. Unlike the findings Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 Harskamp et al Hybrid Revascularization in the United States 877 Table 4. Summary of Recent Studies That Published Information on In-hospital Outcomes Following HCR Author, y Kon, 2008 Ref. No. of Patients Concurrent Approach Mortality, % Stroke, % Reoperation for Bleeding, % Hospital Stay, days 9 15 Yes MIDCAB 0 0 0 3.7±1.4 Bonatti, 2008 10 5 Yes Endo-ACAB 0 0 0 6 (5–7) Zhao, 2009 11 112 Yes Median sternotomy 2.7 1.8 2.7 6 (1–97) Bachinsky, 2012 13 25 Yes Robotically assisted 0.0 0.0 0.0 5.1±2.8 Adams, 2013 12 96 Yes Robotically assisted 0.0 1.0 4.2 4 (3–7) Zhou, 2013 16 141 Yes Partial sternotomy 0.7 0.7 2.8 8.2±2.5 Delhaye, 2010 17 18 No Median sternotomy 0.0 0.0 0.0 10 (10–11) Repossini, 2012 14 166 No MIDCAB 1.2 0.0 0.0 6.5±1.8 Srivastava, 2013 15 238 Both Robotically assisted 1.3 0.8 4.2 6 (3–54) 7 300 Both Robotic / endo-ACAB 1.3 1.0 2.0 5 (2–76) Halkos, 2013 Endo-ACAB indicates endoscopic atraumatic coronary artery bypass, HCR, hybrid coronary revascularization; and MIDCAB, minimally invasive direct coronary artery bypass. from these highly experienced HCR institutions, our analysis presented outcome data from all CABG centers that participate in the STS registry of which the vast majority only perform HCR occasionally. Despite the higher use of conventional techniques (≈40% of HCR procedures were performed with median sternotomy and cardiopulmonary bypass) and differences in patient populations, the overall event rates of staged HCR in our study appear to be comparable to those reported previously. However, the reported rates for in-hospital mortality and the need for reoperation after concurrent HCR seem to be higher than in previous studies. Although speculative, this may suggest that these procedures are more often used in patient populations that are at higher risk for complications, as reflected by the higher preoperative incidence of stroke, peripheral vascular disease, and renal failure. Bleeding Outcomes and the Use of Anticoagulants There are concerns that HCR, particularly when performed concurrently, carries an increased bleeding risk because of the necessity for 2 distinct anticoagulation protocols for the surgical and percutaneous aspects of the procedure. However, as shown in our study, the use of blood products was markedly lower in concurrent HCR group, and the need for reoperation including bleeding were comparable between concurrent HCR and CABG and staged HCR and CABG, as well, despite the higher rates of recent ADP inhibitor use, and glycoprotein IIb/IIIa inhibitors among HCR patients. New antiplatelet agents, such as the direct thrombin inhibitor bivalirudin, have been proposed as an anticoagulant in HCR cases to facilitate the use of a single anticoagulation protocol, which may alleviate concerns about bleeding complications.18 Hospital Stay Given the use of more minimally invasive techniques, it was anticipated that postoperative hospital length of stay would be shorter in patients who underwent concurrent HCR versus CABG. In other studies, the average hospital stay for concurrent HCR ranged from ≈4 to 8 days (see Table 4). Among studies that compared intensive care and postoperative hospital length of stay between 1-stage HCR and conventional CABG, both time of recovery at the intensive care unit and time to discharge were shorter in the HCR group.3,9,13 In our study, postprocedural length of hospital stay tended to be shorter after HCR than after CABG, but did not reach statistical significance. A number of reasons may be attributable to this finding: (1) the use of minimally invasive techniques was lower in our cohort than in others; (2) HCR occurred in a more heterogenous (and generally sicker) patient population; (3) HCR procedures performed do not only represent those performed by high-volume operators in specialized HCR centers but instead present an overall experience among US hospitals. Decision-Making Process: HCR Versus CABG In our study, data were not collected on why surgeons and cardiologists opted for HCR instead of conventional CABG or multivessel PCI. Other studies, also seldom provided data on why HCR was performed instead of CABG. In an attempt to assess this, Zhao et al11 retrospectively showed that, in the majority of cases, HCR was preferred over CABG to either minimize surgical risk (47.8%) or because of ungraftable vessels (43.3%). Given the differences in clinical and procedural characteristics in our study, we speculate that similar reasons may have been involved in the decision making for performing HCR in our study population. Additionally, our study showed that centers that have experience with less invasive CABG techniques are also more likely to adopt HCR as a revascularization strategy for patients with multivessel coronary disease. Defining Hybrid Procedures Ever since the first publication on the combined use of surgical and percutaneous techniques for coronary revascularization in the late 1990s, there has been debate on what should be defined as HCR and what should not.1 For this analysis, we used the STS version 2.73 definition of HCR, from which we then included planned HCR cases involving IMA use and coronary stenting during 1 hospitalization, in a broad population and without restriction on surgical techniques used. In previous single-center registries that reported outcomes on HCR, more stringent definitions have been Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 878 Circulation September 9, 2014 used, which may explain some of the difference between these observations and our own. A more standardized definition for HCR, as recently proposed, may therefore be helpful to compare outcomes between various studies.19 Limitations There are a number of limitations of the current study. First, the current analysis involves registry data that, owing to their nonrandomized nature, are by definition biased. Second, although we adjusted properly for known/measured confounding, unmeasured confounding is still present. Third, although this study represents the largest cohort of HCR patients to date, the sample size and the number of events, as well, are small, and the inferences on in-hospital outcomes should therefore be done with caution. Fourth, although the STS database collects information on hybrid procedures, it only captures information on patients who survived at least the first stage of a hybrid procedure. As such, information on intention to treat was not available. Although this poses a limitation for concurrent HCR cases, it poses an even greater challenge for patients who underwent staged HCR because of concerns of survival bias. Fifth, because of the inherent limitation of the STS data collection form, which only collects information on procedures performed during 1 hospitalization, staged HCR procedures in which the 2 stages are not performed within the same hospitalization or center, were not captured. As such, the number of staged HCR procedures is underreported in the STS database. Sixth, for the current analysis only planned HCR cases were considered, and unplanned HCR cases were excluded. Although the STS states clear definitions for what is considered planned and unplanned, data managers might have misclassified patients. Seventh, because of the limitations of the STS data collection form, we could not assess detailed information on percutaneous coronary intervention, including the location and length of the treated lesion, stent (type) use, and residual stenosis. Hence we could not quantify which vessels were revascularized by using percutaneous means and which by surgical means. Finally, information on long-term clinical outcomes (including cardiac death, nonfatal myocardial infarction, and need for repeat revascularization) could not be assessed, which is of major importance when assessing the efficacy of HCR as an alternative approach to surgical coronary revascularization. Conclusions HCR is occasionally performed in approximately one-third of all STS participating hospitals, and represents a fraction of the total CABG volume in the United States. Patients who undergo HCR are sicker, but they have less extensive coronary disease. In comparison with isolated CABG, both concurrent and staged HCR more frequently involved the use of minimally invasive surgical techniques and less use of cardiopulmonary bypass. Adjusted in-hospital clinical outcomes were overall comparable. Randomized clinical trials are warranted to assess the safety and efficacy of HCR in comparison with CABG or multivessel PCI among patients who are deemed appropriate candidates. Sources of Funding Funding for the statistical analysis on this article was provided by the Society of Thoracic Surgeons. Disclosures Dr Thourani serves on the advisory boards of Edwards Lifesciences, St. Jude Medical, Sorin group, Maquet, Direct Flow Medical Inc., and receives research grants from Edwards Lifesciences and Soring group. Dr Halkos serves as a consultant for Intuitive Surgical Inc. and Medtronic Inc. Dr Peterson is a consultant for Boehringer Ingelheim, Genentech, Janssen Pharmaceutical Products, Merck, SanofiAventis, and receives research grants from Eli Lilly, and Janssen Pharmaceutical Products. The other authors report no conflicts. References 1. Angelini GD, Wilde P, Salerno TA, Bosco G, Calafiore AM. Integrated left small thoracotomy and angioplasty for multivessel coronary artery revascularisation. Lancet. 1996;347:757–758. 2. Halkos ME, Vassiliades TA, Douglas JS, Morris DC, Rab ST, Liberman HA, Samady H, Kilgo PD, Guyton RA, Puskas JD. Hybrid coronary revascularization versus off-pump coronary artery bypass grafting for the treatment of multivessel coronary artery disease. Ann Thorac Surg. 2011;92:1695–1701; discussion 1701. 3. Shen L, Hu S, Wang H, Xiong H, Zheng Z, Li L, Xu B, Yan H, Gao R. 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The survival advantage of CABG is primarily attributable to the left internal mammary artery–to–left anterior descending graft. In the current era of drug-eluting stents, the utility of vein grafts over percutaneous coronary intervention in non–left anterior descending target vessels has been questioned. Hybrid coronary revascularization (HCR) may present an appealing alternative revascularization strategy for these patients, because it combines the longevity of the left internal mammary artery–to–left anterior descending graft with drug-eluting stent implantation in non–left anterior descending lesions. Although the most recent American College of Cardiology/American Heart Association guidelines on coronary revascularization endorse HCR with a class IIa recommendation, evidence is limited. Therefore, we sought to describe the practice patterns and in-hospital outcomes in the use of HCR by analyzing data from the Society of Thoracic Surgeons Adult Cardiac Database. We found that HCR is performed in approximately one-third of US hospitals, where it represents a small fraction of total CABG volume, and it tends to be performed more often in patients with higher cardiovascular risk profiles. The majority of HCR procedures were performed as staged procedures. Overall, in-hospital clinical outcomes did not significantly differ between CABG and HCR, which suggests that HCR may present an equally safe alternative for CABG surgery in a carefully selected patient population. However, owing to the limitations of this analysis, future study is needed, and randomized clinical trials are warranted to assess the safety and long-term efficacy of HCR in comparison with CABG or multivessel percutaneous coronary intervention in patients with multivessel coronary artery disease. Go to http://cme.ahajournals.org to take the CME quiz for this article. Downloaded from http://circ.ahajournals.org/ by guest on February 4, 2015 Practice Patterns and Clinical Outcomes After Hybrid Coronary Revascularization in the United States: An Analysis From the Society of Thoracic Surgeons Adult Cardiac Database Ralf E. Harskamp, J. Matthew Brennan, Ying Xian, Michael E. Halkos, John D. Puskas, Vinod H. Thourani, James S. Gammie, Bradley S. Taylor, Robbert J. de Winter, Sunghee Kim, Sean O'Brien, Eric D. Peterson and Jeffrey G. Gaca Circulation. 2014;130:872-879; originally published online July 23, 2014; doi: 10.1161/CIRCULATIONAHA.114.009479 Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. 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