Impact of coronary artery disease in elderly patients undergoing transcatheter aortic valve implantation: Insight from the Italian CoreValve Registry

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Abstract

Background

Coronary artery disease (CAD) commonly coexists with degenerative aortic stenosis. The impact of CAD in patients undergoing transcatheter aortic valve implantation (TAVI) raises concerns due to the lack of comprehensive and consistent data on this topic. We sought to evaluate the impact of CAD on clinical outcomes in patients undergoing TAVI.

Methods

Consecutive patients(N = 663) who underwent TAVI with the 18-French CoreValve ReValving System (CRS) (Medtronic Inc, MN USA) from June 2007 through December 2009 at 14 institutions across Italy were included in this prospective web-based registry. Four patients were excluded from the analysis due to failure to successfully release the prosthesis inside the native aortic valve. Previous percutaneous or surgical myocardial revascularizations were used to identify the existence of concomitant CAD (N = 251; 38%). The primary endpoint was the incidence of Major Adverse Cerebrovascular and Cardiac Events (MACCE) and all-cause death in CAD and no-CAD groups.

Results

Patients with CAD were no more likely to develop MACCE within 12-months of the procedure than those who did not (CAD group vs no-CAD group, 15.7% vs 18.3%; adjusted hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.42 to 1.36; p = 0.353). The 12-month mortality was 14.5% and 15.9% in CAD group and no-CAD group, respectively (adjusted HR 0.74; 95% CI 0.40 to 1.36; p = 0.331).

Conclusions

Coexisting CAD does not impact procedural outcomes and mid-term incidence of MACCE and survival in elderly patients undergoing TAVI with CRS prosthesis.

Introduction

Coronary artery disease (CAD) commonly coexists with degenerative aortic stenosis (AS) [1], [2]. Approximately half of patients undergoing surgical aortic valve replacement (AVR) have concomitant CAD. The presence of concomitant CAD is associated with an increased operative mortality in patients undergoing AVR [3], [4]. The current standard of care is to combine coronary artery bypass grafting (CABG) with AVR in the same session [5] as several studies have documented an improved short and long term survival [6] and lower rate of perioperative myocardial infarction [7] in patients with significant CAD undergoing combined AVR and CABG compared to those receiving only AVR.

In the last few years, Transcatheter Aortic Valve Implantation (TAVI) has rapidly matured into a viable treatment alternative for patients with severe AS at high risk for conventional AVR [8]. However, despite significant experience with two devices under post-marketing surveillance in Europe (the Edwards SAPIEN prosthesis [Edwards Lifesciences, CA, USA] and the CoreValve ReValving System [CRS] [Medtronic Inc, MN, USA]) [9], [10], there is scant data on the impact and optimal timing and extent of revascularization in patients who are currently offered TAVI [11], [12]. Data from large centers with expertise in TAVI, AVR as well as surgical and percutaneous revascularization would help elucidate the most appropriate therapeutic strategy in the management of significant coronary stenosis in patients undergoing TAVI.

In this prospective, multicenter study, we sought to evaluate the impact of CAD on clinical outcomes in a large cohort of patients who underwent TAVI with the 18-Fr CRS device.

Section snippets

Methods

Consecutive patients (N = 663) undergoing TAVI with the 3rd generation 18-Fr CRS between June 2007 through December 2009 at 14 centers across Italy were prospectively enrolled in a dedicated web-based database. All patients met the eligibility criteria for intervention proposed by the Task Force on the management of valvular heart disease of the European Society of Cardiology [5]. For each individual patient, contraindication to conventional AVR was established based on a consensus of a local

Study population

All patients who underwent TAVI (N = 663) were eligible for inclusion. Four patients were excluded from analysis due to failure to successfully release the prosthesis inside the native aortic valve. Thus the study population comprised of 659 patients who underwent a successful TAVI procedure. The study cohort was segregated into two groups based on the presence or absence of historical CAD as defined by previous percutaneous (28.5%) and surgical (15.8%) revascularization (CAD group and no-CAD

Discussion

The main finding of this study, besides confirming the high prevalence of CAD in elderly patients with severe AS (38%), is that acute and mid-term outcomes of patients who underwent TAVI with CRS device were not affected by the presence of concomitant CAD as defined by previous CABG or PCI. Specifically, the procedures were not complicated by events directly related to the presence of concomitant CAD. At 30-days, our results did not show a significant difference in terms of survival among

Study limitations

The present study has several important limitations: first, since our data is entered prospectively into a web database before the introduction of VARC definitions, re-evaluation of clinical source documents relating to clinical events as they classified according to the VARC criteria may result in the underestimation of the true frequency of some events; second, the lack of specific tools such as fractional flow reserve, intravascular ultrasound, quantitative coronary analysis or myocardial

Conclusions

The present multicenter registry showed that coexisting coronary artery disease, as defined by previous CABG or PCI, does not impact procedural outcomes and mid-term incidence of MACCE and survival in elderly patients undergoing TAVI with CRS prosthesis.

Disclosures

Disclosure: Gian Paolo Ussia, Anna Sonia Petronio, Federica Ettori, Angelo Ramondo, Gennaro Santoro and Francesco Bedogni are proctor physicians for Medtronic Incorporation; all other authors have not conflicts of interests to declare.

Acknowledgment

We would like to acknowledge the members of the CoreValve Italian Registry without whose work this paper could not have been written. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology.

References (21)

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