Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Proposed practical anatomical-procedural classification systems for evaluating carotid lesions and carotid artery stenting.

AIMS: The aim of this study was to propose new anatomical-procedural classification systems for evaluating carotid lesions and carotid artery stenting (CAS). METHODS AND RESULTS: The methodology used to propose new concepts to be applied in the carotid district was based on three steps: 1) research in PubMed with the terms "carotid artery" (CA) plus "classification" was performed in August 2010 to verify the existence of any classification system for the CA that could be applied for evaluating CAS; 2) formulation of the "stenting segment" concept and elaboration of two classification systems - (a) the "ABC" system for classifying carotid lesions according to their location, and (b) the "five arterial zones" system for identifying specific arterial zones of the CA concerning the basics steps of CAS; and 3) retrospective testing of the applicability of these classification systems on two hundred and fifty consecutive CA angiograms, in which an obstructive lesion was identified. It was possible to delimit the "stenting segment", to classify the carotid lesions according to the "ABC" classification system and to identify the arterial zones according to the "five arterial zones" classification system in all (100%) CA angiograms studied. CONCLUSIONS: The "ABC" and the "five arterial zones" anatomical-procedural classification systems are applicable in patients with obstructive disease of the extracranial CA. These systems may contribute to the standardisation of CAS technical evaluation.

Cutting balloon angioplasty in percutaneous carotid interventions.

PURPOSE: To report a prospective feasibility study of cutting balloon angioplasty (CBA) applied in the predilation phase of carotid artery stenting (CAS) in highly calcified lesions. METHODS: From January 2003 to February 2007, 178 consecutive patients (109 men; mean age 73.1+/-7.3 years) with highly calcified carotid lesions underwent CAS with CBA applied as a pre-specified strategy in the predilation phase of the procedure. All steps in the procedure were performed under cerebral filter protection. The cutting balloon ranged in diameter from 3 to 4 mm and was inflated at nominal pressures in the target lesion. Pre-CBA dilation with a low-profile coronary balloon was performed only when the cutting balloon was not able to cross the lesion. Selection of the filters and stents was at the operator's discretion. Primary endpoints were the all stroke and death rates at 30 days and 6 months. Secondary endpoints included cutting balloon success (positioning and full balloon inflation), CAS technical success (residual angiographic stenosis <30%), CAS procedural success (technical success and no complications), and in-hospital major complications. RESULTS: Cutting balloon success was achieved in all 178 patients. In 32 (18.0%), pre-CBA dilation was necessary due to inability to cross the lesion with the cutting balloon initially. CAS technical success was achieved in all patients. One (0.6%) patient suffered transient neurological intolerance due to flow cessation from massive debris in the distal filter; this event was completely resolved after the filter was removed (CAS procedural success 99.4%). One patient suffered a major stroke at day 15 (0.6% 30-day all stroke and death rate). At the 6-month follow-up, 174 (97.7%) patients were evaluated; 1 patient died from myocardial infarction at day 35, and 2 patients died from non-neurological or cardiac causes at days 103 and 158. The cumulative all stroke and death rate was 2.2%. CONCLUSION: These data suggest that CBA performed during the predilation phase of CAS in highly calcified lesion is a safe and useful method to prepare this lesion subset for stenting.