Holger Eggebrecht (Cardioangiological Center Bethanien (CCB) and AGAPLESION Bethanien Hospital, Frankfurt, Germany) and others report in the European Heart Journal that the lack of an on-site cardiac surgery department should not be a contraindication to centres performing transcatheter aortic valve implantation (TAVI). They explain that data indicate that TAVI at hospitals without on-site cardiac surgery departments—providing that a heart team approach is used—is both feasible and safe.
The authors comment that the 2012 European Society of Cardiology (ESC) guidelines for the management of valvular heart disease mandate that TAVI “should be restricted to hospitals with both cardiology and cardiac surgery departments on site”. However, they add that since those guidelines were published, contemporary data from observational and randomised clinical trials “have demonstrated the continued evolution of TAVI to become an effective and safe treatment modality”. “The risk of severe intraprocedural complications and procedural mortality has been constantly declining. Rapid technological advances, better patient selection as well as growing operators experience have been major contributors to improved procedural safety. Thus, the need for emergency cardiac surgery for complications during TAVI is low,” Eggebrecht et al comment. They add that at some hospitals without on-site cardiac surgery, the heart team approach “which is a prerequisite for TAVI” has been achieved with in-hospital cardiologists working together with visiting cardiac surgery teams from external, collaborating hospitals. Preliminary data, the authors report, indicate that this approach for performing TAVI at hospitals without on-site cardiac surgery is feasible.
Therefore, they sought to further determine if the complications and outcomes of TAVI performed at hospitals without on-site cardiac surgery (but with a heart team) were different from those of TAVI performed at hospitals with on-site cardiac surgery. Reviewing data from the prospective German AQUA (aortic valve replacement quality assurance) registry, the authors identified 17,919 patients who had undergone transfemoral TAVI at a centre in Germany between January 2013 and December 2014. Of these, 1,332 patients underwent TAVI at a hospital without on-site cardiac surgery.
The patients who underwent TAVI at hospitals without on-site cardiac surgery had a higher predicted risk of operative mortality (logistic EuroSCORE 23.2±15.8 vs. 21±15.4% for patients who underwent TAVI with on-site cardiac surgery; p<0.001). This was because they were older, had a higher New York Heart Association symptom class, and a higher prevalence of comorbidities (such as coronary artery disease). However, Eggebrecht et al comment: “Particularly dreadful TAVI-specific complications such as annular rupture, aortic dissection, coronary obstruction, and device embolisation were overall rare (<1%) and similar in both groups.” They add that there were no differences in the rate of in-hospital mortality and no differences in the rate of neurologic events between groups.
Furthermore in a matched-pair analysis of 555 patients, the rates of intraprocedural complications, postprocedural, and in-hospital death were similar between those underwent TAVI without on-site cardiac surgery and those underwent TAVI with on-site cardiac surgery. However in this analysis, the rate of post-implantation aortic regurgitation grade ≥2 was higher in the non-cardiac surgery group.
Noting that the heart team is “key to successful TAVI”, Eggebrecht et al conclude that their findings should “stimulate a randomised trial to confirm our results. Until then, the lack of a cardiac surgery department on-site should not be regarded as a contraindication TAVI.”
Eggebrecht presented these data at late-breaking trial session at EuroPCR (17–20 May, Paris, France).