Author + information
- S1936879816315163-0db614f86a59cde054de87cc254fa391Fadi J. Sawaya, MD∗ ( and )
- S1936879816315163-e7654f9a721121cabcbad93fa34152a0Ole De Backer, MD, PhD
- ↵∗Reprint requests and correspondence:
Dr. Fadi J. Sawaya, Rigshospitalet – Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
The number of transcatheter aortic valve replacement (TAVR) procedures worldwide has now exceeded 250,000, with a high TAVR penetration in northwestern Europe (1). In current practice in northwestern Europe, elderly frail patients (>80 years of age) and patients with elevated Society of Thoracic Surgeons surgical risk score (>6%) are considered higher risk for surgical aortic valve replacement (SAVR) and have almost exclusively been treated by TAVR in the last couple of years with good clinical outcomes (2). Patients with aortic stenosis and prior coronary artery bypass grafting (CABG) represent yet another group of patients with increased surgical risk and adverse outcomes after redo cardiac surgery (3). Patients with prior CABG usually experience multiple comorbidities and technical challenges of redo-cardiac surgery, which include a risk of mammary graft injury, increased calcification, inadequate myocardial protection, and structural injury during mediastinal re-entry (4).
Three important questions are essential in deciding the optimal approach for patients with previous CABG: what are the outcomes of TAVR in patients with prior CABG versus patients with no prior CABG? What are the outcomes of SAVR in patients with prior CABG versus patients with no prior CABG? Are the outcomes of TAVR better than SAVR in patients with prior bypass surgery?
Data from the FRANCE-2 (French Aortic National CoreValve and Edwards) TAVR registry showed previously that all-cause mortality and Valve Academic Research Consortium-2–defined procedural complications—including myocardial infarction, stroke, and vascular or bleeding complications—were not different in patients with or without a history of CABG for up to 1 year of follow-up (5). Similar results have been reported in 2 other single-center retrospective studies (6,7). In contrast, aortic stenosis patients with prior CABG undergoing SAVR have been reported to have a worse outcome with increased mortality and morbidity as compared with patients without prior CABG undergoing SAVR (8,9).
In this issue of JACC: Cardiovascular Interventions, Reinöhl et al. (10) report in-hospital outcome data from patients with or without prior CABG receiving isolated SAVR or TAVR between 2007 and 2013—on the basis of the data from a large nationwide German Diagnosis Related Groups-based dataset. A direct comparison between the SAVR and TAVR groups is difficult, as patients undergoing TAVR have typically been higher risk as compared to the SAVR patients. Still, the analysis shows that in-hospital mortality is higher for SAVR patients with prior CABG compared to those without, but not different for TAVR patients with or without prior CABG. In total, 7% of all AVR procedures were performed in prior CABG patients. The annual number of prior CABG patients treated by AVR nearly tripled from 2007 to 2013, indicating the increased willingness to treat this specific patient population. Patients with prior CABG undergoing AVR were treated by TAVR in <5% of cases in 2007 versus in almost 90% of cases in 2013. Very similar findings can be reported for Eastern Denmark with 7% to 8% of total AVR procedures performed in patients with prior CABG—in accordance with the German Diagnosis Related Groups registry data, more than 85% of patients with prior CABG undergoing AVR were treated by transcatheter-based technology in the period 2014 to 2015 (2).
Are the outcomes of TAVR better than SAVR in patients with prior bypass surgery? No randomized controlled trials (RCTs) specifically comparing TAVR versus SAVR in patients with prior CABG have been conducted. All results currently available are from retrospective or secondary analysis from RCTs. In a CoreValve U.S. Pivotal trial subanalysis of patients with prior CABG, TAVR was found to offer a significant morbidity advantage and a strong trend toward improved survival over SAVR at 1 year of follow-up. The SAVR group had longer intensive care unit and hospital stays, increased incidence of acute kidney injury, life-threatening or disabling bleeding, and major adverse cardiac and cerebrovascular events (11). This is in accordance with a subanalysis from the PARTNER (Placement of AoRtic TraNscathetER Valves) trial reporting that patients with prior CABG had a markedly higher mortality rate at 2 years if randomized to SAVR, but this was not the case for patients with TAVR (12). A recent meta-analysis showed that patients with prior CABG who underwent TAVR had similar perioperative and long-term survival while experiencing more pacemaker implantation, but with shorter hospital stay and lower resource use as compared with prior CABG patients who had SAVR—and this despite the higher risk profile of the TAVR population (13).
The trend toward more and more TAVR seems to continue worldwide, and in particular for patients with an increased surgical risk. As previous cardiac surgery is associated with an increased surgical risk—as also reflected by the European System for Cardiac Operative Risk Evaluation and STS surgical risk score—we believe that the main topic of this editorial and Reinöhl et al. (10) study should be expanded to the question of whether TAVR should be the new standard treatment in patients with prior cardiac surgery, and not only prior CABG. Several studies have shown that cardiac surgery requiring resternotomy is technically more challenging and carries a higher operative risk than a first-time operation. As a result, it makes sense to treat this specific patient population with the least invasive technique.
Recently, a review article by Tourmousoglou et al. (14) tried to answer the question what is the best approach for patients with a failed aortic bioprosthetic valve, TAVR or redo SAVR? Limited data show that both valve-in-valve (ViV)-TAVR and redo-SAVR provide good clinical results in high-risk patients, leading to the conclusion that both techniques could be seen as complementary approaches. Interestingly, Papadopoulos et al. (15) showed that 30-day mortality was 8% in the ViV-TAVR group versus 16% in the redo-SAVR group by using propensity analysis of matched subgroups of 40 patients. Survival rates at 4 years were not different between both groups (75 ± 3% in the ViV-TAVR group vs. 73 ± 4% in the redo-SAVR group). Kaplan–Meier estimates of major adverse events (death and permanent neurological deficits) at 4 years were 25% for the ViV-TAVR group versus 43% for the redo-SAVR group. However, a small sample size and different possible types of bias make most of these studies have important limitations. No RCTs investigating this topic are currently available and probably will never be conducted. In addition, RCT subanalyses are not available, as these patients have typically been excluded from the large RCTs.
Similar findings were reported from the Eastern Denmark Heart Registry, with 2% to 3% of total AVR procedures performed in patients with a failing aortic bioprosthesis. In the period of 2009 to 2013, approximately 10% to 30% of these procedures were performed by TAVR. Interestingly, the use of TAVR has increased to more than 75% of all redo-AVR procedures for the period of 2014 to 2015, indicating a shift toward TAVR for nearly all patients with previous cardiac surgery in Eastern Denmark (2).
How should we translate the observations of this and other studies to guide our daily clinical practice? Well, approximately 10% of all AVR procedures are performed in patients with previous cardiac surgery, either CABG or valve surgery. Despite the absence of dedicated RCTs evaluating TAVR versus SAVR in these specific patient populations, an increasing amount of evidence supports the trend away from redo surgery. Of course, further and continuous evaluation of this less invasive approach will be needed as our aortic valve therapies continue to evolve.
↵∗ Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.
Dr. Sawaya has no relationships relevant to the contents of this paper to disclose. Dr. De Backer is a consultant for St. Jude Medical and Boston Scientific.
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