Combined elective percutaneous coronary intervention and transapical transcatheter aortic valve implantation

INSTITUTIONAL REPORT Interactive CardioVascular and Thoracic Surgery 14 (2012) 463–468 doi:10.1093/icvts/ivr144 Advance Access publication 9 January 2012 Combined elective percutaneous coronary intervention and transapical transcatheter aortic valve implantation Miralem Pasic*, Stephan Dreysse, Axel Unbehaun, Semih Buz, Thorsten Drews, Christoph Klein, Giuseppe D’Ancona and Roland Hetzer German Heart Center, Berlin, Germany * Corresponding author. Deutsches Herzzentrum Berlin, Augustenburger Platz 1, D-13353 Berlin, Germany. Tel: +49-30-45932108; fax: +49-30-45932018; e-mail: (M. Pasic). There is no established strategy of how and when to treat coronary artery disease (CAD) in patients referred for transcatheter aortic valve implantation (TAVI). Simultaneous, single-stage treatment of both pathologies is a possible solution. We report our initial results of simultaneously performed transapical TAVI and elective percutaneous coronary interventions (PCI) in high-risk patients with severe aortic valve stenosis. Between April 2008 and July 2011, a total of 419 patients underwent transapical TAVI. Combined elective PCI and TAVI were performed in 46 (11%) patients. Only the most significant coronary lesion or lesions were treated. Technical success of the combined approach was 100%. The mean count of implanted stents per patient was 1.6 ± 1.0 (range, 1–5 stents). The 30-day mortality rates in the PCI and TAVI group was 4.3%. Survival at 12, 24 and 36 months of the PCI and TAVI group 87.1 ± 5.5, 69.7 ± 10.3 and 69.7 ± 10.3%, respectively. The results showed that the single-stage approach with combined elective PCI and TAVI is feasible and safe. It has become our primary choice for treatment of high-risk patients with severe aortic valve stenosis and CAD. Keywords: Transcatheter aortic valve implantation • Percutaneous coronary intervention INTRODUCTION Coronary artery disease (CAD) is found in 60–70% of patients referred for transcatheter aortic valve implantation (TAVI) [1–3]. There is no clear policy on how to treat concomitant CAD in these patients. It might be that only medical treatment of CAD is enough when TAVI eliminates severe aortic valve stenosis in elderly patients [4]. Another option is to treat CAD by percutaneous coronary intervention (PCI). This can be performed before or after TAVI, in a double-stage procedure. The possible alternative is to treat both pathologies simultaneously. Data about a single-stage, combined approach in a larger cohort of patients are still missing, and only anecdotal institutional reports are present [5–7]. We report our initial institutional experience with single-stage approach (combined PCI and TAVI) for treatment of severe aortic valve stenosis and CAD in very high-risk patients. PATIENTS AND METHODS Patients Between April 2008 and July 2011, transapical TAVI was performed in 419 patients with severe aortic valve stenosis. Forty six (11%) patients underwent combined, single-staged PCI and TAVI. The results of the preoperatively planned single-staged procedure (TAVI and PCI of the stenosed native coronary artery) were evaluated. PCI performed because of iatrogenic coronary artery obstruction during TAVI was not considered in this report. Written informed consent was obtained from all patients or their representatives. The study was approved by our institutional review board. Transcatheter aortic valve implantation team, operative settings and specific technical considerations Our TAVI team consisted of five cardiac surgeons, two cardiologists and two anaesthesiologists with expertise in echocardiography. A perfusionist and a heart–lung machine were present in the hybrid operating room. Transapical TAVI was performed through a left anterior mini-thoracotomy using balloon-expandable transcatheter stent-prosthetic xenograft valves of 23, 26 or 29 mm diameters with their delivering systems (both valves and the valve delivering systems; Edwards SAPIEN THV, Edwards Lifesciences, Irvine, CA, USA). It was performed under rapid ventricular pacing (160–180 beats/min) during balloon valvuloplasty and valve deployment as it has been originally described [8] with some modifications [9]. The procedure was monitored by fluoroscopy, angiography and continuous intra-operative transoesophageal echocardiography (TEE). TAVI was always done first, before PCI. PCI was principally performed via trans-femoral access. Standard catheters, guide-wires © The Author 2012. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. CARDIAC GENERAL Abstract Received 21 October 2011; received in revised form 23 November 2011; accepted 28 November 2011 464 M. Pasic et al. / Interactive CardioVascular and Thoracic Surgery and stents of different manufacturers were used as for standard PCI at our institution. The contrast agent iopromide (ULTRAVIST®-370, Bayer AG, Leverkusen, Germany) was used for angiography. All procedures were performed under general anaesthesia in our hybrid operating room with a monoplane angiography system (Siemens Artis zee, Siemens AG, Munich, Germany). prospectively collected in an electronic database. The information about deaths of German patients was additionally obtained from the official state administrative office. Qualitative data are presented as number (n) and per cent. For quantitative data mean ± standard deviation (SD) were calculated. Analysis of survival was calculated according to Kaplan–Meier estimation. SPSS for Windows version 18.01 was used for statistical analysis. A P-value of < 0.05 was considered statistically significant. Principles for elective percutaneous coronary intervention during transcatheter aortic valve implantation RESULTS Intra-procedural anticoagulant medications Immediately before the procedure, each patient received an intravenous bolus of heparin according to body weight (100 IU per kilogram). During the procedure, the activated coagulation time (ACT) was measured at intervals to achieve and maintain a steady level of heparin anticoagulation (ACT > 250 s, according to the valve manufacturer’s recommendations). If cardiopulmonary bypass (CPB) was used, the initial dose of heparin was 300 IU/kg of body weight, and later on according to the ACT. At the end of the procedure, if there was no bleeding tendency, heparin was generally not neutralized with protamine. Post-procedural anticoagulant and antiplatelet medications Patients continuously received intravenous heparin until good mobilization of the patient was reached. The dose was maintained according to the partial thromboplastin time. All patients received standard dual antiplatelet therapy (aspirin, 100 mg daily; clopidogrel, 75 mg daily). Patients who underwent combined PCI and TAVI received an additional loading dose of 300 mg of clopidogrel. The therapy was given for at least 6 months. Data collection and statistical analysis All data concerning patients’ comorbiditie (...truncated)