First-in-Human Use of the Next-generation ProtEmbo Cerebral Embolic Protection System During Transcatheter Aortic Valve-in-valve Implantation

Cerebral embolic protection (CEP) devices aim to reduce the risk of periprocedural cerebrovascular events during transcatheter aortic valve implantation (TAVI). Here, the authors describe the first-in-human experience with the ProtEmbo Cerebral Protection System (Protembis), a next-generation CEP device, during TAVI. This case is part of a larger European trial evaluating the safety and performance of this device. After deployment of the ProtEmbo in the aortic arch, a first transcatheter heart valve was implanted. Despite postdilatation, moderate to severe aortic regurgitation persisted. The operating team decided to perform a valve-in-valve procedure using a second transcatheter heart valve. The ProtEmbo demonstrated good coverage of all three head vessels and no interaction with TAVI catheters in the aortic arch throughout the entire procedure. No adverse events were observed during hospitalisation or follow-up, and there was a significant reduction in aortic regurgitation at follow-up echocardiography. Despite a challenging overall procedure with presumably high embolic burden, diffusion-weighted MRI at follow-up showed a low number (n=3) and volume (156 mm3) of new hyperintense lesions. The first-in-human use of the ProtEmbo was safe and feasible, despite a challenging TAVI valve-in-valve procedure.

ORBITA: What Goes Around, Comes Around… Or Does It?

Current guidelines recommend percutaneous coronary intervention (PCI) in patients with ongoing stable angina symptoms despite optimal medical therapy (OMT), although trials have shown no reduction in death or myocardial infarction. The recently published ORBITA trial compared OMT + PCI with OMT + ‘placebo’ PCI in patients with angina and single-vessel coronary artery disease (CAD), and found no significant difference in treadmill exercise time between the two groups after six weeks. The trial concluded that invasive procedures can be assessed with placebo control while numerous editorials interpreted the trial as showing that PCI has no role in the management of stable angina. However, the highly selected patient population, low ischaemic burden and level of symptoms and high proportion of nonflow-limiting stenoses on invasive physiological testing mean that, while ground-breaking in terms of its methodology, ORBITA does not add to the current evidence base supporting ischaemia-guided revascularisation if symptoms are not controlled on medical therapy alone.

Alternate Access for TAVI: Stay Clear of the Chest

Transcatheter aortic valve implantation (TAVI) is currently performed through an alternative access in 15 % of patients. The transapical access is progressively being abandoned as a result of its invasiveness and poor outcomes. Existing data does not allow TAVI operators to favour one access over another — between transcarotid, trans-subclavian and transaortic — because all have specific strengths and weaknesses. The percutaneous trans-subclavian access might become the main surgery-free alternative access, although further research is needed regarding its safety. Moreover, the difficult learning curve might compromise its adoption. The transcaval access is at an experimental stage and requires the development of dedicated cavo-aortic crossing techniques and closure devices.

Annular Rupture During Transcatheter Aortic Valve Implantation: Predictors, Management and Outcomes

Transcatheter aortic valve implantation (TAVI) is the treatment of choice in patients with symptomatic severe aortic stenosis who are either inoperable or at high risk for conventional surgical aortic valve replacement. Recent data have also shown favourable outcomes in patients deemed to be at intermediate operative risk, which expands the application of this novel technology. Despite its success, TAVI has been associated with rare life-threatening complications. Of these, aortic annular rupture is considered to be the most devastating. Advances in pre-procedural screening and patient selection have reduced the incidence of annular rupture. When this complication occurs, early recognition and prompt management are essential. This article is intended to provide a comprehensive review of the predictors, management and clinical outcomes of aortic annular rupture.