Dataset Information

Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study.

ABSTRACT:

Aims

To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR).

Methods and results

We enrolled 2514 patients who underwent successful TAVR during 2013-17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2-4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07-1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17-1.32; P < 0.001).

Conclusions

The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.

SUBMITTER: Mizutani K

PROVIDER: S-EPMC9263883 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study.

Mizutani Kazuki K Nakazawa Gaku G Yamaguchi Tomohiro T Ogawa Mana M Okai Tsukasa T Yashima Fumiaki F Naganuma Toru T Yamanaka Futoshi F Tada Norio N Takagi Kensuke K Yamawaki Masahiro M Ueno Hiroshi H Tabata Minoru M Shirai Shinichi S Watanabe Yusuke Y Yamamoto Masanori M Hayashida Kentaro K

European heart journal open 20211115 3

<h4>Aims</h4>To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR).<h4>Methods and results</h4>We enrolled 2514 patients who underwent successful TAVR during 2013-17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 ...[more]

PMID: 35919885

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Project description:AimsMitral stenosis (MS) occasionally coexists with aortic stenosis (AS). Limited data are available regarding the functional class and clinical outcomes of patients who undergo transcatheter aortic valve implantation (TAVI) for combined AS and MS. This study compared the clinical outcomes in patients with and without MS who underwent TAVI for severe AS and assessed the impact of mitral annulus calcification (MAC) severity, transmitral gradient (TMG) and mitral valve area (MVA) on outcomes in patients with combined AS and MS.MethodsWe investigated patients in the OCEAN-TAVI registry who underwent TAVI. MS was defined as an MVA ≤ 1.5 cm2 or TMG ≥ 5 mmHg. The composite of all-cause death and admission for heart failure was compared between patients with and without MS. The impact of MAC, TMG and MVA on outcomes was assessed in patients with combined AS and MS.ResultsWe identified 106 patients with MS (MAC 84%; TMG 6.4 ± 2.6 mmHg; MVA 1.10 ± 0.31 cm2) and 6570 without MS as controls. The MS group was older (85 ± 5 vs. 84 ± 5 years, P = 0.033), more of women (85 vs. 67%, P < 0.01), and had a higher risk of surgery (the Society of Thoracic Surgeons Mortality Score 8.7 ± 5.1 vs. 7.6 ± 5.9, P = 0.047) than the controls. In the MS group, the New York Heart Association Functional Class was 3 or 4 in 56% of the patients at baseline and 6% at 1 year after TAVI. Thirty-day mortality (2.8% vs. 1.3%, P = 0.18) and early composite outcomes (17% vs. 15%, P = 0.56) were comparable between patients with and without MS. During a median follow-up of 2.1 years, the presence of MS was associated with a higher incidence of adverse events compared with controls (adjusted hazard ratio [HR] 1.84; 95% confidence interval [CI] 1.34-2.51, P < 0.01), even on propensity score matched analysis (adjusted HR 1.91; 95% CI 1.14-3.22, P < 0.01). Moderate or severe MAC contributed to increased risk of adverse events in patients with MS (adjusted HR 2.89; 95% CI 1.20-6.99, P = 0.018), but TMG and MVA did not.ConclusionsIn patients undergoing TAVI for severe AS, those with moderate or severe MS experienced worse outcomes after TAVI compared with those without MS. Patients with combined AS and MS sustained symptom improvement at 1-year post-TAVI. MAC severity was a useful predictor of adverse events compared with MS haemodynamics such as TMG and MVA in patients with combined AS and MS.

Project description:BackgroundThe Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population.MethodsMulticenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.ResultsPatients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).ConclusionsThe VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.

Dataset Information

Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study.

Aims

Methods and results

Conclusions

Publications

Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study.

Similar Datasets

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