A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial

Lansky, Alexandra J.; Schöfer, Joachim; Tchétché, Didier; Stella, Pieter R.; Pietras, Cody; Parise, Helen; Abrams, Kevin; Forrest, John K.; Cleman, Michael; Reinöhl, Jochen; Cuisset, Thomas; Blackman, Daniel J.; Bolotin, Gil; Spitzer, Stefan G.; Kappert, Utz; Gilard, Martine; Modine, Thomas; Hildick‐Smith, David; Haude, Michael; Margolis, Pauliina; Brickman, Adam M.; Vörös, Szilárd; Baumbach, Andreas

doi:10.1093/eurheartj/ehv191

Cited by 262 publications

(173 citation statements)

References 25 publications

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“…Eight studies have been included, totaling 1285 patients15, 16, 17, 18, 19, 20, 21, 22 (Figure 1). Five studies were randomized controlled trials17, 18, 19, 20, 21; the remaining 3 were registries 15, 16, 22.…”

Section: Resultsmentioning

confidence: 99%

“…On the other hand, the availability of these devices spurred the cardiological community to increase the use of MRI to assess patients after TAVI, thus leading to the publication of several randomized studies and/or registries specifically focusing on cerebral embolic protection 15, 16, 17, 18, 19, 20, 21. All these studies, regardless of the design, arterial access, type of prosthesis, and the EPD, consistently showed that the rate of silent new ischemic cerebral lesions (as high as 80%) is much higher than the rate of clinically relevant cerebrovascular events (2–6%) 22.…”

Section: Discussionmentioning

confidence: 99%

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Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Testa

Latib

Casenghi

et al. 2018

JAHA

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BackgroundThe use of embolic protection devices (EPD) may theoretically reduce the occurrence of cerebral embolic lesions during transcatheter aortic valve implantation. Available evidence from single studies is inconclusive. The aim of the present meta‐analysis was to assess the safety and efficacy profile of current EPD.Methods and ResultsMajor medical databases were searched up to December 2017 for studies that evaluated patients undergoing transcatheter aortic valve implantation with or without EPD. End points of interest were 30‐day mortality, 30‐day stroke, the total number of new lesions, the ischemic volume per lesion, and the total volume of lesions. Eight studies involving 1285 patients were included. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. The use of EPD was not associated with significant differences in terms of 30‐day mortality (odds ratio 0.43 [0.18–1.05], P=0.3) but it was associated with a lower rate of 30‐day stroke (odds ratio 0.55 [0.31–0.98], P=0.04). No differences were detected with respect to the number of new lesions (standardized mean difference −0.19 [−0.71 to 0.34], P=0.49). The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, −0.52 [−0.85 to −0.20], P=0.002) and smaller total volume of lesions (standardized mean difference, −0.23 [−0.42 to −0.03], P=0.02).ConclusionsThe use of EPD is not associated with a reduced rate of mortality and new ischemic cerebral lesions. The use of EPD during transcatheter aortic valve implantation seems to be associated with a lower 30‐day stroke rate, although this result is driven by a single nonrandomized study. The use of EPD is associated with a smaller volume of ischemic lesions, and smaller total volume of ischemic lesions.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Testa

Latib

Casenghi

et al. 2018

JAHA

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“…When routine neurologist and neuroimaging surveillance is performed, stroke rates are as high as 9% to 28% at 30 days after TAVR, and ischemic cerebral infarction on neuroimaging (mean volumes ranging from 1.5-4.3 cm 3 ) is present in virtually all patients. 8 The recent SENTINEL trial (Cerebral Protection in Transcatheter Aortic Valve Replacement) of the Montage Dual Filter System (Claret Medical, Inc) demonstrated that 99% of deployed filters retrieved periprocedural embolic debris from the cerebral vessels (size range of 0.15 to >1 cm), identified by histopathology as valve-related material (including calcium, thrombus, and valve leaflet tissue), as well as arterial wall and TAVR delivery system catheter fragments. 9 Although these observations have made mechanical reduction of procedural embolization a primary target of periprocedural stroke prevention during TAVR, the complex and multifactorial pathogenesis and variable presentation of neurological injury early and late after these procedures warrants continued attention to additional factors that could modulate the known embolic risk and its clinical consequences.…”

Section: Procedural Stroke Riskmentioning

confidence: 99%

Carotid Disease and Stroke After Transcatheter Aortic Valve Replacement

Lansky

Ghare

Pietras

2018

Circ: Cardiovascular Interventions

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“…Fourth, variability in use of ancillary devices (eg, embolic protection) may have an impact on adverse events. 22 Fifth, increased operator experience has been linked to reductions in procedural complications. Experienced operators can often avoid scenarios in which complications can occur or better manage them if they do occur.…”

Section: Variability In Tavr Practicementioning

confidence: 99%

Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval

et al. 2016

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Abstract-In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. Recent US Food and Drug Administration approval of newgeneration THVs based on single-arm studies has generated interest in alternative study approaches for THV device approval. This review evaluates whether THV device approval could follow a pathway analogous to that of surgical heart valves by incorporating OPC and provides several considerations and recommendations. Factors to be taken into account in the construction of OPC include the maturity of THV technology, variability in transcatheter aortic valve replacement practice, end points included as OPC, follow-up terms for specific OPC, patient populations to which these OPC apply, and (statistical) methods for OPC development. 4 This review provides an overview of OPC, considers the potential role of OPC for THV device approval, and discusses the challenges associated with such an approach. Several recommendations for the future implementation of OPC for THV devices are provided. Objective Performance CriteriaTraditionally, 2 methods of establishing a comparator for single-arm studies have been used: OPC and performance goals (PGs; Table 1). OPC are linearized event rates of safety end points that are derived from historical controls included in meta-analyses of available data. A PG, on the other hand, represents a single point estimate considered sufficient as a comparator. In general, the process of developing a PG is less formal than the process of developing OPC. Therefore, compared with PGs, OPC are thought to be superior because of the increased maturity of device technology and the more robust data from which the comparator is developed.5 For the FDA to allow a device to be considered for approval with OPC, it should fulfill a number of criteria: (1) The device technology should be sufficiently mature; (2) the meta-analysis from which event rates are derived should include an accumulation of studies and all relevant literature from different devices; (3) the OPC should not be developed by companies using only their own data; and (4) the OPC must be contemporary and updated regularly because technology may become obsolete over time, thereby attenuating the rigor and relevance of the OPC. OPC DevelopmentThe OPC for surgical valves were conceived, subsequently developed, and then implemented after 2 major RCTs evaluating mechanical and biological prostheses did not identify significant safety concerns.1 It was thus recognized that traditional randomized evaluations were not feasible because of the large sample sizes required to identify infrequent events. Such large RCTs would also greatly impede the timely introduction of technological advancements to the market. 7 In 1993, the FDA convened an expert workshop to consider alternative study designs for regu...

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A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial

Cited by 262 publications

References 25 publications

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

Carotid Disease and Stroke After Transcatheter Aortic Valve Replacement

Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval

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