Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients

Gilard, Martine; Eltchaninoff, Hélène; Iung, Bernard; Donzeau–Gouge, Patrick; Chevreul, Karine; Fajadet, Jean; Leprince, Pascal; Leguerrier, Alain; Lièvre, Michel; Prat, Alain; Teíger, Emmanuel; Lefèvre, Thierry; Himbert, Dominique; Tchétché, Didier; Carrié, Didier; Albat, Bernard; Cribier, Alain; Rioufol, Gilles; Sudre, Arnaud; Blanchard, Didier; Collet, F; Santos, Pierre Dos; Méneveau, Nicolas; Tirouvanziam, Ashok; Caussin, Christophe; Guyon, Philippe; Boschat, J; Breton, Hervé; Collart, Frédéric; Houël, Rémi; Delpine, Stephane; Souteyrand, Géraud; Favereau, Xavier; Ohlmann, Patrick; Doisy, Vincent; Grollier, Gilles; Gommeaux, Antoine; Claudel, Jean-Philippe; Bourlon, F; Bertrand, Bernard; Belle, Éric Van; Laskar, Marc

doi:10.1097/01.sa.0000426523.25196.4e

Cited by 136 publications

(100 citation statements)

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“…22) This interpretation has been further supported by the results of the recently published registry, in which TAVI was performed from the TF access mainly with 18 French sheaths, and the outcomes were reported according to the VARC-2 criteria. 23) At 30 days the frequency of LT/D was similar to that in our study, reaching 8.3% and 6.6% in the surgical cutdown and complete percutaneous approach, respectively.…”

Section: Discussionsupporting

confidence: 62%

Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation

et al. 2016

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SummaryThere are differences in reporting bleeding complications after transcatheter aortic valve implantation (TAVI), which is a consequence of the lack of consensus for their definition. Furthermore, the amount of data on the impact of peri-procedural bleeding on the mid-term prognosis is still limited. The aim of this study was to investigate the incidence, predictors, and impact of life-threatening and major bleedings as defined by the Valve Academic Research Consortium 2 (VARC-2) in patients after TAVI over the mid-term prognosis.Consecutive patients who underwent TAVI from March 2010 to December 2013 were included. All data were classified according to the VARC-2 criteria. We assessed the incidence and the predictors of serious bleeding events (SBE), defined as life-threatening/disabling (LT/D) or major bleeding, and analyzed their impact on 30-day and 1-year clinical outcome.A total of 129 patients were included (79.1 ± 8.3 years; mean EuroSCORE = 17.8 ± 12.7). The SBE occurred in 25 patients (19.4%), of which 9 (7.0%) had LT/D and 16 (12.4%) had major bleeding. Trans-subclavian (TS) access (OR 4.38, 95% CI 2.13-14.29, P = 0.01) and diabetes (OR 2.93, 95% CI 1.08-7.93, P = 0.03) were identified as independent predictors of SBE. Patients with SBE had higher 30-day mortality (20.0% versus 4.0%, P = 0.02) and 1-year mortality (40.0% versus 11.1%, P < 0.002). SBE independently predicted 1-year, all-cause mortality (HR 5.88, 95% CI 1.73-19.94, P = 0.005).SBE are frequent after TAVI and are associated with decreased short and mid-term survival. Diabetes and TS access are independent risk factors for SBE. (Int Heart J 2016; 57: 35-40) Key words: Long term prognosis, TAVR, Complications O ver the last several years we have been witnessing a substantial technical improvement and dynamic expansion of transcatheter aortic valve implantation (TAVI). Increasing operator experience and encouraging clinical outcomes data, revealing favorable results for TAVI in selected populations, have led to major changes in the management of patients with severe aortic stenosis (AS). In recent guidelines, TAVI has been recognized as an alternative method to surgical aortic valve replacement (SAVR) in high-risk patients and superior over conservative therapy in those disqualified from surgery. 1,2) Nevertheless, this procedure carries a substantial risk of numerous cardiovascular complications, among which the bleeding events are reported as the most frequent.3-7) Still, the body of evidence regarding the frequency of bleeding complications is relatively small, with significant differences in incidence between the studies, which is probably the result of differences in the applied methodology. [8][9][10] The clinical and procedural predictors of bleeding complications are not yet fully identified, and neither is their prognostic value. 3,7,8,10) Although the impact of bleeding on short-term mortality has been demonstrated, the influence on mid-term outcomes remains unclear. 11)To address the issue of heterogeneous reporting of out...

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Section: Discussionsupporting

confidence: 62%

Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation

et al. 2016

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“…The 30-day and midterm mortality rates in this large group of patients were 7.5% and 21.6%, respectively, signifying that nearly 30% of deaths occurred within the first 30 days after TAVI, well in line with data previously reported by several real-world registries and 1 meta-analysis. 42,43 myocardial injury, as an increase in the troponin level above the URL is observed in nearly all patients. 21,53,54 A single study demonstrated a strong association between biomarkerdetermined myocardial injury (defined as peak values of cardiac troponin T and/or creatine kinase-MB >5 times the URL, not fulfilling the criteria for myocardial infarction) and 30-day and 1-year survival rates.…”

Section: Discussionmentioning

confidence: 99%

Meta-Analysis of Predictors of All-Cause Mortality After Transcatheter Aortic Valve Implantation

Giordana

D’Ascenzo

Nijhoff

et al. 2014

The American Journal of Cardiology

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“…As described in Table 1, 30-day all-cause mortality rates were comparable ranging from 3.3% to 5.1%, while 1-year all-cause mortality was increased to PARTNER trials compared to CUSPT (24.2% and 30.7% versus 14.2% respectively). Thromboembolic events as myocardial infarction and stroke at 30 days demonstrated no significant differences varying between 0-0.8% and 2.6-6.7%, respectively, whereas 30-day major vascular access related complications were significant decreased in CUSPT compared to PARTNER A, B and CHOICE trials (5 There are also six VARC reporting registries with a great variance in sample size, baseline characteristics, mean logistic EuroSCORE, previous stroke and coronary artery disease history, as described in Table 2 (5-10). Regarding the antiplatelet therapy, low dose aspirin 75-100 mg recommended indefinitely, while clopidogrel duration varied mainly between 1 and 6 months.…”

mentioning

confidence: 94%

Antithrombotic treatment following transcatheter valve replacement: current considerations

2017

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Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients

Cited by 136 publications

References 0 publications

Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation

Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation

Meta-Analysis of Predictors of All-Cause Mortality After Transcatheter Aortic Valve Implantation

Antithrombotic treatment following transcatheter valve replacement: current considerations

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