Comparison of Outcomes in Patients Having Isolated Transcatheter Aortic Valve Implantation Versus Combined With Preprocedural Percutaneous Coronary Intervention

Comparison of Outcomes in Patients Having Isolated Transcatheter Aortic Valve Implantation Versus Combined With Preprocedural Percutaneous Coronary Intervention Mohamed Abdel-Wahab, MDa,*, Ahmad E. Mostafa, MDa, Volker Geist, MDa, Björn Stöcker, MDa, Ken Gordian, MDa, Constanze Merten, MDa, Doreen Richardt, MDb, Ralph Toelg, MDa, and Gert Richardt, MDa Coronary artery disease negatively affects the outcome of patients undergoing surgical aortic valve replacement and practice guidelines recommend revascularization at time of surgery. In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of preprocedural percutaneous coronary intervention (PCI) on TAVI outcome has not been examined. We aimed in the present study to assess the feasibility and safety of performing PCI before TAVI and to evaluate procedural, 30-day, and 6-month clinical outcomes. We retrospectively analyzed 125 patients who underwent successful TAVI at a single institution and divided them into an isolated TAVI and a PCI ⴙ TAVI group. During the study period, a strategy of preprocedural PCI of all significant (>50%) lesions in major epicardial vessels was adopted. Study end points were adjudicated in accordance with the Valve Academic Research Consortium consensus on event definition. All patients were treated with the Medtronic CoreValve prosthesis (n ⴝ 55 with PCI ⴙ TAVI and n ⴝ 70 with isolated TAVI). Thirty-day mortality was 2% versus 6% for patients treated with PCI ⴙ TAVI versus isolated TAVI, respectively (p ⴝ 0.27). Neither periprocedural nor spontaneous myocardial infarction occurred in either group. Rates of 30-day stroke, major bleeding, major vascular complications, and the Valve Academic Research Consortium– defined combined safety end point (11% vs 13%, p ⴝ 0.74) did not differ between the 2 groups. Patients’ symptoms significantly improved in the first month after TAVI, and extent of improvement did not differ between groups. Adverse events at 6 months were comparable. In conclusion, PCI before TAVI appears feasible and safe. Based on these early results revascularization should become an important consideration in patients with coronary artery disease undergoing TAVI. © 2012 Elsevier Inc. All rights reserved. (Am J Cardiol 2012;109:581–586) Transcatheter aortic valve implantation (TAVI) has recently emerged as a promising treatment method for patients with severe symptomatic aortic stenosis with high or prohibitive surgical risk.1,2 The presence of concomitant coronary artery disease (CAD) might have a negative impact on the safety of TAVI, and concerns about access to coronary arteries after TAVI argue for percutaneous coronary intervention (PCI) before TAVI. However, the impact of PCI before TAVI on the outcome of patients undergoing TAVI has not been examined, and there is no settled consensus about how these patients should be managed. Therefore, we aimed in the present study to assess the feasibility

a

Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel and Hamburg, Bad Segeberg, Germany; b Department of Cardiovascular Surgery, University Hospital Lübeck, Lübeck, Germany. Manuscript received July 31, 2011; revised manuscript received and accepted September 29, 2011. Dr. Mostafa is currently at Ain Shams University Hospital, Cairo, Egypt. *Corresponding author: Tel: 49-4551-802-9723; fax: 49-4551-8024805. E-mail address: [email protected] (M. Abdel-Wahab). 0002-9149/12/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.amjcard.2011.09.053

and safety of performing PCI before TAVI and to evaluate procedural, 30-day, and 6-month clinical outcomes in a consecutive series of patients at a single institution. Methods From September 2007 through March 2011, 129 consecutive patients with severe symptomatic aortic stenosis (aortic valve area ⬍1.0 cm2 or body surface area–indexed aortic valve area ⬍0.6 cm2/m2) were treated with TAVI at our institution. Surgical aortic valve replacement (SAVR) was not performed by a cardiac surgeon based on high morbidity and mortality scores (ⱖ80 years of age and logistic European System for Cardiac Operative Risk Evaluation score ⱖ20% or logistic European System for Cardiac Operative Risk Evaluation score ⬍20% in the presence of liver cirrhosis, chronic pulmonary disease, or porcelain aorta) or after discussing patients’ data within the institutional heart team. During this period a strategy of preprocedural percutaneous revascularization of all significant (⬎50%) lesions in the major epicardial coronary vessels was adopted. In 4 patients the valve could not be implanted in the proper anatomic position and these patients were excluded from analysis. Thus, the present study is based on 125 patients www.ajconline.org

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The American Journal of Cardiology (www.ajconline.org) Table 1 Baseline clinical and angiographic characteristics Variable

Figure 1. Study flowchart.

who were retrospectively divided into 2 groups; the first group included patients who underwent PCI before or combined with TAVI (PCI ⫹ TAVI group) and the second group included patients with no significant or previously revascularized CAD who underwent only TAVI (isolated TAVI group; Figure 1). A full laboratory assessment including cardiac markers of necrosis was performed before and immediately after TAVI and at 30 days and 6 months. Baseline transthoracic echocardiography and transesophageal echocardiography were performed in all patients, as were routine coronary angiography, right heart catheterization, and peripheral angiography. Transthoracic echocardiography was repeated after the procedure and at 30 days and 6 months. Clinical events were recorded for the in-hospital period, at 30 days, 6 months, and yearly thereafter. Percutaneous revascularization was done in the preparatory stage before proceeding to TAVI (up to 3 months provided that TAVI was already planned at time of PCI) or as a combined procedure and was performed transfemorally. Patients were preloaded with clopidogrel 600 mg and intravenous aspirin 500 mg immediately before intervention and continued on aspirin indefinitely and on clopidogrel 75 mg for 6 months after TAVI. Patients with an indication for oral anticoagulation received a combination of an oral vitamin K antagonist and clopidogrel (no aspirin). During PCI patients received unfractionated heparin guided by the activated clotting time. Drug-eluting stents were used unless contraindicated. The femoral artery puncture site was closed using the Starclose vascular closure device (Abbott Vascular, Abbott Park, Illinois) at the end of the PCI procedure unless the 2 procedures were performed in combination. After informed consent TAVI using the CoreValve bioprosthesis (Medtronic, Inc., Minneapolis, Minnesota) through the transfemoral route was performed (1 patient underwent TAVI through the trans-subclavian route). Description of the valve and a review of the implantation technique have been described elsewhere.3 Clinical and anatomic selection criteria and device size selection were in line with the published investigational study for the thirdgeneration (18f) CoreValve device.3 Selection of the pros-

Age (years) Men Weight (kg) Height (cm) Body mass index (kg/m2) Diabetes mellitus Hypertension Dyslipidemia Peripheral vascular disease Carotid disease Previous stroke Logistic EuroSCORE (%) Coronary artery disease* Number of diseased coronary arteries 1 2 3 Previous myocardial infarction Previous percutaneous coronary intervention Previous coronary bypass surgery

PCI ⫹ TAVI (n ⫽ 55)

Isolated TAVI (n ⫽ 70)

p Value

81 ⫾ 7.06 26 (47%) 78.84 ⫾ 16.64 168.51 ⫾ 8.59 27.87 ⫾ 6.52 18 (33%) 46 (84%) 39 (71%) 11 (20%)

81 ⫾ 6.20 34 (49%) 75.17 ⫾ 13.51 167.87 ⫾ 8.55 26.40 ⫾ 4.27 14 (20%) 56 (80%) 42 (60%) 10 (14%)

0.99 0.89 0.18 0.68 0.13 0.11 0.6 0.21 0.4

9 (16%) 4 (7%) 25.08 ⫾ 12.58 55 (100%)

12 (17%) 9 (13%) 23.62 ⫾ 15.10 36 (51%)

0.91 0.31 0.56 ⬍0.0001

15 (27%) 26 (47%) 14 (26%) 14 (26%)

9 (13%) 6 (8%) 21 (30%) 18 (26%)

0.97

15 (27%)

23 (33%)

0.5

8 (15%)

16 (23%)

0.24

Values are expressed as number (percentage) or mean ⫾ SD. EuroSCORE ⫽ European System for Cardiac Operative Risk Evaluation. * Defined as presence of lesions with ⱖ50% diameter stenosis on angiogram before transcatheter aortic valve implantation and/or previous myocardial infarction, percutaneous coronary intervention, or bypass surgery.

thetic valve size was based on measurements of aortic valve annulus diameter obtained by transesophageal echocardiography. Femoral artery puncture site was closed using the Progilde vascular closure device (Abbott Vascular) at the end of the TAVI procedure. Baseline clinical, echocardiographic, and procedural characteristics (for TAVI and PCI) were prospectively recorded for all enrolled patients and entered into an institutional database. Thirty-day and 6-month clinical assessments and transthoracic echocardiographic and laboratory evaluations were routinely performed at our institution. Thirty-day outcomes were adjudicated in accordance with the Valve Academic Research Consortium (VARC) consensus on event definition.4 Cardiovascular mortality was defined as any death from a proximate cardiac cause, nonwitnessed death, death of unknown cause, or procedure-related death. Periprocedural myocardial infarction (⬍72 hours after index procedure) was defined as new ischemic symptoms or new ischemic signs with increased cardiac biomarkers (creatine kinase-MB) within 72 hours after the index procedure. Spontaneous myocardial infarction (⬎72 hours after index procedure) was defined as an increase of cardiac biomarkers (troponin) and evidence of myocardial ischemia with ⱖ1 of the following: electrocardiographic changes indicative of new ischemia (new ST-T changes, new left

Valvular Heart Disease/PCI and TAVI Table 2 Baseline echocardiographic data Variable Ejection fraction (%) Aortic valve area (cm2) Indexed aortic valve area (cm2/m2) Mean pressure gradient (mm Hg) Peak pressure gradient (mm Hg) Aortic regurgitation 0 1 2 ⬎2 Mitral regurgitation 0 1 2 3 Systolic pulmonary artery pressure (mm Hg)

PCI ⫹ TAVI (n ⫽ 55)

Isolated TAVI (n ⫽ 70)

p Value

46.92 ⫾ 13.85 0.68 ⫾ 0.20 0.36 ⫾ 0.11

48.54 ⫾ 15.25 0.69 ⫾ 0.21 0.38 ⫾ 0.12

0.55 0.75 0.38

49.88 ⫾ 13.74

50.32 ⫾ 16.90

0.88

77.00 ⫾ 19.85

78.54 ⫾ 26.14

0.74

13 (24%) 38 (69%) 4 (7%) 0 (0%)

23 (33%) 34 (49%) 7 (10%) 6 (8%)

9 (16%) 34 (62%) 11 (20%) 1 (2%) 46.81 ⫾ 16.93

10 (14%) 38 (54%) 18 (26%) 4 (6%) 46.72 ⫾ 14.12

0.03

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Table 3 Procedural characteristics for patients treated with percutaneous coronary intervention before transcatheter aortic valve implantation Stents/patient Minimal stent diameter (mm) Total stent length (mm) Target vessel Left main coronary artery Left anterior descending coronary artery Left circumflex coronary artery Right coronary artery Vein graft 26-mm inflow CoreValve device Operative time for transcatheter aortic valve implantation (minutes)*

2.04 ⫾ 1.37 2.91 ⫾ 0.41 30.89 ⫾ 22.68 7 (9%) 24 (30%) 22 (28%) 20 (25%) 6 (8%) 22 (40%) 71.3 ⫾ 23.3

Values are expressed as number (percentage) or mean ⫾ SD. * From vascular puncture to closure. 0.55

0.98

Values are expressed as number (percentage) or mean ⫾ SD.

bundle branch block, or new pathologic Q waves in ⱖ2 contiguous leads), imaging evidence of new loss of viable myocardium, or a new wall motion abnormality. Sudden unexpected cardiac death involving cardiac arrest with symptoms suggestive of myocardial ischemia and accompanied by presumably new ST-segment elevation or new left bundle branch block and/or evidence of fresh thrombus by coronary angiography and/or at autopsy examination was also defined as spontaneous myocardial infarction according to the VARC. The combined safety end point at 30 days included all-cause mortality, major stroke, life-threatening (or disabling) bleeding, stage 3 acute kidney injury (including renal replacement therapy), periprocedural myocardial infarction, major vascular complication, and repeat procedure for valve-related dysfunction (surgical or interventional therapy). Other end points are defined in detail elsewhere.4 Results are reported according to the adopted treatment strategy (PCI ⫹ TAVI vs isolated TAVI). Continuous variables are expressed as mean ⫾ SD or median and interquartile range and were analyzed with Student’s t test or Mann–Whitney test, as appropriate. Discrete variables are presented as count and percentage and were analyzed by Pearson chi-square or Fisher’s exact test, as appropriate. Kaplan–Meier survival plots were constructed from index procedure up to 3 years of follow-up and compared using log-rank test. A p value ⬍0.05 was deemed statistically significant. Statistical analysis was performed using SPSS 13.0 for Windows (SPSS, Inc., Chicago, Illinois). Results Of 125 patients treated with TAVI, 55 patients received PCI before TAVI (PCI ⫹ TAVI group) and 70 patients were

Figure 2. Bar diagrams showing Canadian Cardiovascular Society classes 0 (pale gray bars), 1 (light gray bars), 2 (medium gray bars), and 3/4 (dark gray bars) in the 2 study groups before and after transcatheter aortic valve implantation.

treated with isolated TAVI. Most baseline clinical characteristics were comparable between groups. Men constituted 47% of patients in the PCI ⫹ TAVI group compared to 49% in the isolated TAVI group (p ⫽ 0.89) and diabetes mellitus was prevalent in 33% versus 20% (p ⫽ 0.11). Overall, 91 patients (73%) had CAD. In the isolated TAVI group 51% of patients had a history of CAD; 33% had previous PCI and 23% had previous coronary artery bypass grafting. Patients who underwent PCI plus TAVI were more symptomatic at baseline, with a larger percentage with Canadian Cardiovascular Society class III/IV angina (21% vs 8%, p ⫽ 0.1) and a significantly larger percentage with New York Heart Association class IV dyspnea (36% vs 16%, p ⫽ 0.008) at presentation. Baseline clinical and angiographic data are presented in Table 1. Most baseline echocardiographic characteristics were similar in the 2 groups. Significant baseline aortic regurgitation was higher in patients who underwent isolated TAVI (9%), whereas no patients in the PCI ⫹ TAVI cohort had a baseline aortic regurgitation higher than grade 2. Other echocardiographic data are presented in Table 2.

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The American Journal of Cardiology (www.ajconline.org) Table 5 Cumulative six-month outcome

All-cause mortality Coronary events Coronary reintervention Reintervention for transcatheter aortic valve implantation Stroke Bleeding Renal dialysis Permanent pacemaker

PCI ⫹ TAVI (n ⫽ 48)

Isolated TAVI (n ⫽ 59)

p Value

4 (9%) 2 (4%) 1 (2%) 1 (2%)

8 (14%) 0 (0%) 0 (0%) 0 (0%)

0.42 0.11 0.26 0.26

2 (4%) 10 (21%) 0 (0%) 16 (34%)

3 (5%) 13 (22%) 1 (2%) 11 (19%)

0.84 0.93 0.37 0.07

Values are expressed as number (percentage).

Figure 3. Bar diagrams showing New York Heart Association classes I (pale gray bars), II (light gray bars), III (medium gray bars), and IV (dark gray bars) in the 2 study groups before and after transcatheter aortic valve implantation. Table 4 Thirty-day outcome Variable All-cause mortality Cardiovascular mortality Periprocedural myocardial infarction Spontaneous myocardial infarction Stroke Minor bleeding Major bleeding Life-threatening bleeding Minor vascular complication Major vascular complication Renal dialysis Combined safety end point Permanent pacemaker Aspirin Clopidogrel Oral anticoagulation

PCI ⫹ TAVI (n ⫽ 55)

Isolated TAVI (n ⫽ 70)

p Value

1 (2%) 1 (2%) 0 (0%)

4 (6%) 3 (4%) 0 (0%)

0.27 0.44

0 (0%)

0 (0%)

1 (2%) 4 (7%) 6 (11%) 4 (7%) 8 (15%) 3 (6%) 0 (0%) 6 (11%) 16 (29%) 43 (78%) 55 (100%) 11 (20%)

4 (6%) 3 (4%) 8 (11%) 4 (6%) 10 (14%) 2 (3%) 2 (3%) 9 (13%) 11 (16%) 50 (71%) 70 (100%) 19 (27%)

0.27 0.47 0.93 0.72 0.97 0.46 0.21 0.74 0.07 0.39 1.0 0.35

Values are expressed as number (percentage).

Median duration from PCI to TAVI was 10 days (range 0 to 90); only 3 patients had PCI at the time of TAVI. Thirty-nine patients (71%) of those who underwent PCI before TAVI received drug-eluting stents, 13 patients (24%) received bare-metal stents, and only 3 patients (5%) were treated with drug-eluting and bare-metal stents. No valverelated complications (low cardiac output, pulmonary edema, or need for urgent valvular intervention) occurred during PCI. Only 1 patient underwent TAVI through the trans-subclavian approach; all other patients underwent TAVI through the transfemoral route. Procedural time for TAVI was similar in the 2 groups, namely 71.3 ⫾ 23.3 minutes in patients who underwent PCI compared to 69.7 ⫾ 25.0 minutes in the other group. Further procedural details are listed in Table 3.

Figure 4. Kaplan–Meier curves for overall survival in the group with percutaneous coronary intervention plus transcatheter aortic valve implantation (top curve) and the group with isolated transcatheter aortic valve implantation (bottom curve) up to 3 years (p ⫽ 0.36, log-rank test).

Thirty-day follow-up data were available for 100% of patients. Overall, all VARC-adjudicated end points did not differ between the patient cohorts. Thirty-day all-cause mortality was 2% versus 6% for patients treated with PCI plus TAVI versus isolated TAVI, respectively (p ⫽ 0.27). Neither periprocedural nor spontaneous myocardial infarction occurred in either group. Rates of 30-day stroke (2% vs 6%, p ⫽ 0.27), life-threatening bleeding (7% vs 6%, p ⫽ 0.72), and major vascular complications (6% vs 3%, p ⫽ 0.46) did not differ significantly between the 2 groups. The VARC-defined combined safety end point did not differ between the 2 groups (11% vs 13% for patients treated with PCI plus TAVI vs isolated TAVI, respectively, p ⫽ 0.74). In contradiction to baseline symptom status, symptoms according to Canadian Cardiovascular Society and New York Heart Association classes did not differ between the 2 groups (Figures 2 and 3). Thirty-day outcomes are listed in Table 4. Six-month follow-up data were available for 107 patients (99.2% of patients eligible for 6-month follow-up). Cumulative 6-month events were also similar between the 2 groups. All-cause mortality at 6 months was 9% versus 14% for patients who had PCI plus TAVI versus isolated TAVI, respectively (p ⫽ 0.42). Two patients (4%) in the PCI ⫹

Valvular Heart Disease/PCI and TAVI

TAVI group had an acute coronary syndrome during the follow-up period; 1 of them underwent successful repeated coronary intervention owing to in-stent restenosis in the left anterior descending coronary artery and a de novo lesion in the left circumflex coronary artery. Symptom status according to Canadian Cardiovascular Society and New York Heart Association classes continued to be similar in patients in the 2 cohorts. Other outcomes at 6 months are listed in Table 5. Kaplan–Meier survival analysis was performed for the 2 groups up to 3 years after TAVI (Figure 4). In the long term there was no significant difference in survival rates between those who underwent PCI plus TAVI and those who underwent isolated TAVI (p ⫽ 0.36, log-rank test). Discussion The present analysis represents the first report of shortand midterm outcomes of a systematic strategy of preprocedural PCI in patients with nonrevascularized CAD treated with TAVI. The most important finding from this analysis is that PCI before TAVI is not associated with an increased 30-day or 6-month adverse event rate. Hence, PCI before TAVI appears feasible and safe. Although treating concomitant CAD has been shown to negatively affect the safety of SAVR,5–7 combined SAVR and coronary artery bypass grafting remains the gold standard in treating patients with aortic stenosis and significant CAD.8 Although this almost doubles the operative risk, practice guidelines recommend surgical revascularization to correct myocardial ischemia in addition to SAVR to avoid the risk of reoperation if indicated at a later stage. However, for patients at high risk for SAVR, presence of CAD adds to the operative risk and surgery might be avoided. Limited published data have been controversial about the impact of CAD on the safety of TAVI in patients with the 2 disease entities. Dewey et al9 examined 171 patients with TAVI (treated through the transapical or transfemoral route), 84 of whom had CAD. Overall mortality after TAVI was significantly higher in the CAD group (35.7%) compared to the non-CAD group (18.4%, p ⫽ 0.01) and logistic regression analysis showed that patients who had CAD were 10.1 times more likely to die within 30 days than those who did not. Conversely, Masson et al11 compared 104 patients with varying severity of CAD (classified according to the Duke Myocardial Jeopardy Score)10 to patients without CAD undergoing TAVI. In that study differences in adverse outcome did not reach statistical significance. In the only published randomized clinical trial comparing SAVR to TAVI in patients with high operative risk,12 patients with CAD requiring revascularization were not included. Nevertheless, and similar to the surgical recommendations, when TAVI devices were first introduced in Europe, the original protocol was that significant CAD had to be treated with PCI before TAVI and that was the accepted wisdom. Many concerns arise when undergoing TAVI in the presence of nonrevascularized CAD such as possible coronary access limitations and worsening of myocardial ischemia during rapid ventricular pacing. In contrast, performing PCI in a patient with severe aortic stenosis may be problematic and PCI before TAVI may increase bleeding and vascular com-

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plications because of the necessity of dual antiplatelet therapy and could potentially increase the risk of stroke and contrast-related kidney injury in this elderly co-morbid group of patients. Data on the safety and feasibility of this strategy are limited to a single-center experience in 28 patients13; 21 of them were treated with a staged approach and 7 were treated in a single-stage procedure. In this small series of patients, no periprocedural myocardial infarction or stroke occurred in any patient and 30-day mortality was 7.1%. More recently, the feasibility of an ad hoc singlestage PCI and TAVI procedure in a patient with an acute coronary syndrome has been reported.14 In our analysis we aimed to evaluate whether performing PCI before TAVI is as safe as performing isolated TAVI. Thirty-day outcome measurements according to the VARC showed no difference between the 2 patient cohorts and long-term mortality rates were comparable. No valve-related adverse events occurred during PCI, although 7 patients (9%) had left main coronary artery interventions. Although patients who underwent PCI before TAVI had a higher incidence of atherosclerotic vascular disease and were subjected to more invasive procedures, no increase in stroke rate or acute kidney injury was observed. Incidence of bleeding and vascular complications was comparable despite dual antiplatelet therapy and repeated groin punctures. It is worth mentioning that patients who received PCI before TAVI had numerically higher pacemaker implantation rates after TAVI (29.1% vs 15.7%); however, the cause for this observation remains unclear. Although a combined approach of single-stage PCI and TAVI is feasible, a staged approach (PCI before TAVI, median 10 days) was performed in most patients in our study and this probably significantly decreased the rate of complications, although this has to be verified in larger studies. Interestingly, despite being more symptomatic at baseline, patients in the PCI ⫹ TAVI group had a similar symptom status compared to the isolated TAVI group after the procedure and up to 6 months, indicating a marked clinical improvement. These initial results suggest that performing PCI before TAVI in this complex group of elderly patients is feasible and safe and, in contrast to the surgical experience, does not increase procedural risk. However, whether and when myocardial revascularization is needed before TAVI cannot be answered by the present study. Because elderly patients with severe aortic stenosis and CAD usually have overlapping symptoms and TAVI alone significantly improves their survival,2 a randomized trial to determine whether additional PCI would add to this survival advantage is justified and needed. This is a single-center retrospective analysis with all of its inherent limitations. Nevertheless, data collection and follow-up were prospectively performed. The sample remains small and the follow-up period is relatively short, but this is an ongoing and expanding single-center experience. 1. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2010;122:62– 69.

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2. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607. 3. Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol 2007;50:69 –76. 4. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol 2011;57:253–269. 5. Lund O, Nielsen TT, Pilegaard HK, Magnussen K, Knudsen MA. The influence of coronary artery disease and bypass grafting on early and late survival after valve replacement for aortic stenosis. J Thorac Cardiovasc Surg 1990;100:327–337. 6. Iung B, Drissi MF, Michel PL, de Pamphilis O, Tsezana R, Cormier B, Vahanian A, Acar J. Prognosis of valve replacement for aortic stenosis with or without coexisting coronary heart disease: a comparative study. J Heart Valve Dis 1993;2:430 – 439. 7. Edwards FH, Peterson ED, Coombs LP, DeLong ER, Jamieson WR, Shroyer ALW, Grover FL. Prediction of operative mortality after valve replacement surgery. J Am Coll Cardiol 2001;37:885– 892. 8. Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL,

9.

10.

11.

12.

13.

14.

Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D; Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Association for Percutaneous Cardiovascular Interventions (EAPCI). Guidelines on myocardial revascularization. Eur Heart J 2010;31:2501–2555. Dewey TM, Brown DL, Herbert MA, Culica D, Smith CR, Leon MB, Svensson LG, Tuzcu M, Webb JG, Cribier A, Mack MJ. Effect of concomitant coronary artery disease on procedural and late outcomes of transcatheter aortic valve implantation. Ann Thorac Surg 2010;89: 758 –767. Califf RM, Phillips HR III, Hindman MC, Mark DB, Lee KL, Behar VS, Johnson RA, Pryor DB, Rosati RA, Wagner GS. Prognostic value of a coronary artery jeopardy score. J Am Coll Cardiol 1985;5:1055– 1063. Masson JB, Lee M, Boone RH, Al Ali A, Al Bugami S, Hamburger J, John Mancini GB, Ye J, Cheung A, Humphries KH, Wood D, Nietlispach F, Webb JG. Impact of coronary artery disease on outcomes after transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2010;76:165–173. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364: 2187–2198. Conradi L, Seiffert M, Franzen O, Baldus S, Schirmer J, Meinertz T, Reichenspurner H, Treede H. First experience with transcatheter aortic valve implantation and concomitant percutaneous coronary intervention. Clin Res Cardiol 2011;100:311–316. Mostafa AE, Geist V, Abdel-Wahab M. Ad-hoc percutaneous coronary intervention and transcatheter aortic valve implantation as a combined transfemoral procedure. J Invasive Cardiol 2011;23(suppl): E102–E105.