Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

Wendt, Daniel; Kleinbongard, Petra; Knipp, Stephan; Al–Rashid, Fadi; Gedik, Nilgün; El-Chilali, Karim; Schweter, Sebastian; Schlamann, Marc; Kahlert, Philipp; Neuhäuser, Markus; Forsting, Michael; Erbel, Raimund; Heusch, Gerd; Jakob, Heinz; Thielmann, Matthias

doi:10.1016/j.athoracsur.2015.03.119

Cited by 72 publications

(54 citation statements)

References 7 publications

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“…Five studies were randomized controlled trials17, 18, 19, 20, 21; the remaining 3 were registries 15, 16, 22. The mean age was 81.7 years, and 50.2% were female.…”

Section: Resultsmentioning

confidence: 99%

“…Three studies17, 19, 20 used the National Institutes of Health Stroke Scale, and the proportion of patients with EPD showing worsening neurocognitive function ranged from 0% to 17.9% and from 4.5% to 22.5% in patients without EPD. The Mini‐Mental State Examination was used in 1 study15 and did not show differences between EPD versus without EPD strategies (Table 2).…”

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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“…Five studies were randomized controlled trials17, 18, 19, 20, 21; the remaining 3 were registries 15, 16, 22. The mean age was 81.7 years, and 50.2% were female.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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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“…[14][15][16][17][18][19][20][21][22][23][26][27][28][29] The presence of baseline atrial fibrillation was reported in 9 studies, [17][18][19]21,22,26,27,29 with a prevalence of 31.6% (285/902 patients). Previous stroke was reported in 14 studies, [14][15][16][17][18][19][20][21][22][23][26][27][28][29] with a prevalence of 10.8% (111/1028 patients). More details can be appreciated in the Results and Tables I and II in the online-only Data Supplement).…”

Section: Study Populationmentioning

confidence: 99%

“…All-cause mortality was reported in 9 studies [17][18][19][20][21][22][27][28][29] and occurred in 3.0% (27/907) of patients: 9 studies with EPD 17-22,27-29 with a 2.4% (15/626) rate and 6 studies without EPD 17,18,22,[27][28][29] with a 2.8% (8/281) rate. The incidence of stroke was reported in 15 studies [14][15][16][17][18][19][20][21][22][23][25][26][27][28][29] …”

mentioning

confidence: 99%

Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation

Bagur

Solo

Alghofaili

et al. 2017

Stroke

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T ranscatheter aortic valve implantation (TAVI) procedures have been associated with silent ischemic cerebral embolism as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) or high-intensity transient signals as assessed by transcranial Doppler. [1][2][3][4][5][6] Embolic protection devices (EPD) might reduce the risk of cerebral embolic ischemic lesions, either clinically evident cerebrovascular accidents or silent ischemic lesions in patients undergoing TAVI. Nonetheless, the efficacy of EPD in the TAVI setting has only been investigated in studies with relatively small sample sizesBackground and Purpose-Silent ischemic embolic lesions are common after transcatheter aortic valve implantation (TAVI). The use of embolic protection devices (EPD) may reduce the occurrence of these embolic lesions. Thus, a quantitative overview and credibility assessment of the literature was necessary to draw a robust message about EPD. Therefore, the aim of this meta-analysis was to study whether the use of EPD reduces silent ischemic and clinically evident cerebrovascular events associated with TAVI. Methods-We conducted a comprehensive search to identify studies that evaluated patients undergoing TAVI with or without EPD. Random-effects meta-analyses were performed to estimate the effect of EPD compared with no-EPD during TAVI using aggregate data. Results-Sixteen studies involving 1170 patients (865/305 with/without EPD) fulfilled the inclusion criteria. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. Meta-analyses evaluating EPD versus without EPD strategies could not confirm or exclude any differences in terms of clinically evident stroke (relative risk, 0.70; 95% confidence interval [CI], 0.38-1.29; P=0.26) or 30-day mortality (relative risk, 0.58; 95% CI, 0.20-1.64; P=0.30). There were no significant differences in new-single, multiple, or total number of lesions. The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, −0.52; 95% CI, −0.85 to −0.20; P=0.002) and smaller total volume of lesions (standardized mean difference, −0.23; 95% CI, −0.42 to −0.03; P=0.02). Subgroup analysis by type of valve showed an overall trend toward significant reduction in new lesions per patient using EPD (standardized mean difference, −0.41; 95% CI, −0.82 to 0.00; P=0.05), driven by self-expanding devices. Conclusions-The use of EPD during TAVI may be associated with smaller volume of silent ischemic lesions and smaller total volume of silent ischemic lesions. However, EPD may not reduce the number of new-single, multiple, or total number of lesions. There was only very low quality of evidence showing no significant differences between patients undergoing TAVI with or without EPD with respect to clinically evident stroke and mortality. that are underpowered for the end points studied and, thus, subject to selection biases. Hence, a comprehensive systematic review with a rigorous methodology for quality and credibilit...

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Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use

et al. 2022

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In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018.OBJECTIVE To evaluate the association between CMS TAVR reimbursement rates and EPD use.

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Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

Cited by 72 publications

References 7 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

Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation

Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use

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