Incidence, Predictors, and Prognostic Impact of Late Bleeding Complications After Transcatheter Aortic Valve Replacement

Généreux, Philippe; Cohen, David J.; Mack, Michael J.; Rodés‐Cabau, Josep; Yadav, Mayank; Xu, Ke; Parvataneni, Rupa; Hahn, Rebecca T.; Kodali, Susheel; Webb, John G.; Leon, Martin B.

doi:10.1016/j.jacc.2014.08.052

Cited by 205 publications

(126 citation statements)

References 42 publications

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“…Recently, Généreux and coworkers draw attention to late bleeding events after hospital discharge 18. With an analysis on the incidence, predictors, and the prognostic impact of late bleeding complications post‐TAVI in the PARTNER patient population, these investigators observed a strong and independent association of late bleeding and mortality after 12 months of follow‐up (HR adj , 3.91; 95% CI, 2.67 to 5.71; P <0.001).…”

Section: Discussionmentioning

confidence: 99%

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Stortecky

Pilgrim

Heg³

et al. 2015

JAHA

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BackgroundThe Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions.Methods and ResultsBetween August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern‐TAVI‐Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870).ConclusionsThe VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.

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Section: Discussionmentioning

confidence: 99%

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Stortecky

Pilgrim

Heg³

et al. 2015

JAHA

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“…27) Therefore, additional clopidogrel seems to increase the risk of bleeding and should therefore be used with caution, since major and life-threatening bleeding complications after TAVI are associated with increased mortality. 4) Our study addressed this issue using PRU and CYP2C19 genotyping. The risk of ischemic and bleeding complications was evaluated in each patient using the VerifyNow system, a commercially available system that uses simple blood sampling.…”

Section: Discussionmentioning

confidence: 99%

“…1,2) However, special attention should be paid to potential periprocedural and early complications, including ischemic (stroke, myocardial infarction) or bleeding (access site complication) events. 3,4) After TAVI, guidelines recommend the use of clopidogrel in addition to aspirin for a 3-to 6-month period. [5][6][7] While this strategy has been accepted as the usual practice following TAVI, the recommendation remains empirical and prospective controlled trials are lacking.…”

Section: T Ranscatheter Aortic Valve Implantation (Tavi) Hasmentioning

confidence: 99%

Hyper-Response to Clopidogrel in Japanese Patients Undergoing Transcatheter Aortic Valve Implantation

et al. 2016

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SummaryDual antiplatelet therapy is empirically recommended following transcatheter aortic valve implantation (TAVI). The aims of the present study were to analyze the effect of clopidogrel on platelet function and to determine the relative contribution of each CYP2C19 loss-of-function genotype undergoing TAVI.Thirty-two patients undergoing TAVI and with clopidogrel treatment were studied. All patients were treated with an Edwards SapienXT valve. Platelet reactivity was measured by the VerifyNow P2Y12 point-of-care assay at 7 days and 30 days after the procedure and a cutoff value of 95 PRU was used to identify a hyper-response of platelet reactivity. The Spartan RX TM sample-to-result point-of-care DNA testing system was used to identify CYP2C19 loss-of-function genotypes. Hyper-response of platelet reactivity was identified in 11 (34.3%) patients, although 24 (80%) were carriers of at least one CYP2C19 reduced-function allele. The PRU values did not change significantly from 7 days to 30 days after TAVI (136.7 ± 73.4 versus 150.4 ± 83.2, P = 0.13). The incidences of life-threatening bleeding, minor bleeding, and transfusion were significantly higher among the hyper-response of platelet reactivity group (27.3% versus 0%, P = 0.03, 36.4% versus 4.8%, P = 0.04, 81.8% versus 42.9%, P = 0.04, respectively).A hyper-response to clopidogrel was observed in one-third of patients undergoing TAVI and was related to bleeding events, even though 80% of the patients were carriers of the CYP2C19 reduced-function allele. (Int Heart J 2016; 57: 190-197) Key words: Platelet function tests, Antiplatelet therapy T ranscatheter aortic valve implantation (TAVI) has emerged as a viable therapeutic option for patients with severe symptomatic aortic stenosis (AS). 1,2)However, special attention should be paid to potential periprocedural and early complications, including ischemic (stroke, myocardial infarction) or bleeding (access site complication) events. 3,4) After TAVI, guidelines recommend the use of clopidogrel in addition to aspirin for a 3-to 6-month period. 5-7)While this strategy has been accepted as the usual practice following TAVI, the recommendation remains empirical and prospective controlled trials are lacking. Few data have been reported regarding the effectiveness of clopidogrel in the TAVI setting or its possible impact on adverse events.Results from previous studies in patients treated with clopidogrel have shown wide variability in platelet responsiveness, and high platelet reactivity under clopidogrel treatment has been linked to stent thrombosis and adverse cardiovascular events after coronary stenting. [8][9][10][11][12][13][14] Notably, there exists a subset of patients with a hyper-response to clopidogrel who may be at increased risk of bleeding complications. 15,16) Genetic polymorphism of the CYP2C19 allele, crucial to the metabolism of clopidogrel into its active metabolite, has been implicated as a mechanism of both hyper-and hypo-response. A loss-of-function polymorphism in CYP2C19, known as the CYP2...

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“…Bleeding and ischemic events following TAVI are common, have significant deleterious clinical impact, and may be modifiable with the optimization of post-procedural pharmacology [39,40]. In the absence of an indication for therapeutic anticoagulation, DAPT with aspirin (indefinitely) and clopidogrel has been empirically recommended by consensus of TAVI experts [16,41].…”

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confidence: 99%

Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey

Cerrato

Nombela‐Franco

Nazif

et al. 2017

International Journal of Cardiology

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Incidence, Predictors, and Prognostic Impact of Late Bleeding Complications After Transcatheter Aortic Valve Replacement

Abstract: MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Cited by 205 publications

References 42 publications

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Hyper-Response to Clopidogrel in Japanese Patients Undergoing Transcatheter Aortic Valve Implantation

Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey

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