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Structural heart disease
August 2013
Transcatheter Valve News Beneficial treatment effect with Sapien XT device
One-year results from the post-approval, large scale SOURCE XT registry of the Sapien XT transcatheter aortic valve implantation (TAVI) valve suggests that the device is associated with a sustained treatment effect, low mortality and low rates of moderate or severe aortic regurgitation
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resenting the results of the registry at EuroPCR (21–24 May, Paris, France), Stephan Windecker (Department of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Bern, Switzerland) stated: “The purpose of the SOURCE XT observational study was to assess the safety and efficacy of the Sapien XT in routine clinical practice and to identify predictors of mortality [in patients treated with the device].” He added that compared with the original Sapien valve, which has a stainless steel frame, the Sapien XT valve has a cobalt chromium frame, semi-closed leaflets, and a reduce crimped profile. In the observational study, 2,688 patients (from 93 centres across 17 countries) who underwent TAVI with the Sapien XT valve were followed for one year. Enrolment was performed from July 2010 to October 2011, and access routes included the transfemoral, transapical, transaortic, or trans-subclavian approach. Windecker reported that the mean
logistic EuroSCORE was 20.4±12.4 and that 39% of patients had a EuroSCORE of <15. He added: “In more than 80% of patients with a EuroSCORE of <15, characteristics were identified that are not routinely assessed as part of the EuroSCORE calculation, including liver disease, porcelain aorta, cancer, and severe pulmonary arterial hypertension.” Windecker noted that, at the one-year follow-up, several of these characteristics were found to independently increase the risk of mortality. All-cause mortality was 19.5% and cardiac mortality was 10.8% at one year, one of the lowest rates reported in comparable high-risk patients undergoing TAVI. The one-year SOURCE XT results also indicated that the Sapien XT device was associated with high rates of both device success (92.7%) and technical success (97%). Additionally, Windecker com- mented: “There was a strong treatment effect [with the Sapien XT] in terms of symptom relief and improved quality of life”. He added that there was a sustained
Performing TAVI in patients with carotid artery disease
RAINER MOOSDORF COMMENT & ANALYSIS
TAVI has become an alternative approach to medical management or surgical aortic valve replacement for the treatment of severe aortic stenosis in surgically inoperable or high-risk patients. The procedure is mostly performed via a transfemoral or a transapical approach. A relevant number of patients with severe aortic stenosis also suffer from symptomatic carotid artery disease. Rainer Moosdorf describes a new combined surgical approach that his centre has developed for patients in this subgroup
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n a patient with high-grade stenoses of both the internal carotid arteries and the right vertebral artery, who had already experienced a stroke without major sequele, a severe aortic stenosis was detected during the preoperative evaluation for carotid endarterectomy. The patient was therefore sent to our department and we decided to go for a combined intervention between heart and vascular surgeons.
The right carotid artery was first reopened under local anaesthetic and then after intubation and induction of general anaesthesia, endarterectomy of the left carotid artery was performed. Thereafter, an 8mm Dacron prosthesis was connected to the right common carotid artery in an end-to-side fashion and a sheath introduced into it. Via this approach, a self-expanding aortic valve prosthesis (Corevalve,
improvement in effective orifice area and there were low rates of moderate or severe aortic regurgitation. However, 26.9% of patients had mild total aortic regurgitation at one year. Windecker acknowledged that there was a lack of clarity about the impact of aortic regurgitation on clinical outcomes, noting that moderate-to-severe aortic regurgitation is associated with impaired outcome whereas there remains debate regarding the significance of mild aortic regurgitation. He said: “In the PARTNER studies, it was suggested that, potentially, mild aortic regurgitation could be associated with impaired outcome. However, this finding was no longer observed in the extended follow-up registry.”
Other findings in the SOURCE
XT registry showed that females had significantly improved survival compared with males and the transfemoral approach was associated with significantly improved survival compared with the transapical approach and the transaortic
Stephan Windecker
approach. According to Windecker, the low mortality rate observed in the transfemoral arm (survival was 85% at one year) was “reassuring”. However, he said: “The mortality rates observed with the other approaches are probably less due to the approach than the conditions of patients that have undergo an alternative approach. Concluding, Windecker stated registries such as SOURCE XT not only showed that operators were becoming better at performing TAVI but also that “pre-procedure evaluation has certainly become more sophisticated. Obviously, we hope that impacts on outcome.”
For a number of elderly patients with severe aortic stenosis and symptomatic carotid artery dis- ease, the combined approach of carotid endarterectomy and transcarotid TAVI offers a real minimally inva- sive one-stop treatment
Medtronic) was placed in typical position after predilatation. Importantly, the introducer sheath was not advanced into the carotid artery, so that antegrade bloodflow was maintained during the entire TAVI procedure without further shunting. In a second case, a severe stenosis was identified in only the left internal ca- rotid artery but a highly significant aortic stenosis was also observed. Therefore, an endarterectomy in the left carotid artery was performed under local anaesthetic before TAVI was performed under a short period of general anaesthesia as previous described.
Both patients showed an uneventful postoperative course without any new neurologic deficits.
For a number of elderly patients with severe aortic stenosis and symptomatic carotid artery disease, the combined approach of carotid endarterectomy and transcarotid TAVI offers a real minimally invasive one-stop treatment. The advantages of this procedure, as developed by our team, are an optimal
neuromonitoring during carotid surgery in local anaesthesia and a simple implantation of the catheter-based aortic valve prosthesis via the same access and during an only short period of general anaesthesia. Importantly, as already mentioned above, the introducer sheath for the TAVI must only be advanced into the “Dacron chimney” and not further into the carotid artery to provide a sufficient antegrade flow throughout the whole procedure. Alternatively, we have also successfully performed a transapical stenting of carotid lesions prior to aortic valve implantation via the same route. In particular, the advancement of wire and sheath into the carotid artery are very straight forward with this approach but it was deemed too risky in these severely diseased patients mentioned above.
Rainer Moosdorf, chairman of the Department for Cardiovascular Surgery, University Hospital Marburg –UKGM, Marburg, Germany
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