SciELO - Scientific Electronic Library Online

 
vol.34 issue6Anesthesia Management for a Patient Undergoing Pulmonary Endarterctomy without Cardiopulmonary BypassERRATUM author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand

Journal

Article

Indicators

Related links

Share


Brazilian Journal of Cardiovascular Surgery

Print version ISSN 0102-7638On-line version ISSN 1678-9741

Braz. J. Cardiovasc. Surg. vol.34 no.6 São Paulo Nov./Dec. 2019  Epub Dec 02, 2019

https://doi.org/10.21470/1678-9741-2019-0275 

LETTER TO THE EDİTOR

Predictors and Prognostic Impact of In-hospital Bleeding after Transcatheter Aortic Valve Replacement According to BARC and VARC-2 Definitions

Adrian daSilva-deAbreu1  2  3  , MD, MSc(c)
http://orcid.org/0000-0002-6739-5946

Yelin Zhao4  , MSc

Astrid Serauto-Canache4  , MD

Bader Alhafez1  , MD

Katyayini Aribindi1  , MD

Prakash Balan4  , MD

Pranav Loyalka4  , MD

Biswajit Kaaaar4  , MD

Richard Smalling4  , MD

H. Vernon Anderson4  , MD

Abhijeet Dhoble4  , MD

Timo Siepmann2  5  , MD

Salman A. Arain4  , MD

1Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Texas, United States of America.

2Division of Health Care Sciences, Center for Clinical Research and Management Education, Dresden International University, Dresden, Germany.

3Ochsner Clinical School, Faculty of Medicine, The University of Queensland, New Orleans, Louisiana, United States of America.

4Division of Cardiovascular Disease, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Texas, United States of America.

5Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.


Dear Editor,

Bleeding after transcatheter aortic valve replacement (TAVR) is associated with prolonged hospitalization and mortality[1,2]. Most TAVR studies in the United States of America (USA) only report 30-day and one-year outcomes using the definition of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, which is a simplified version of the Valve Academic Research Consortium 2 (VARC-2) scheme that only dichotomizes the presence or absence of bleeding without stratifying its severity[3,4].

Although few studies have evaluated the relationship between severity of bleeding and postprocedural outcomes according to both VARC-2 and Bleeding Academic Research Consortium (BARC) bleeding definitions[5] at 30 days and one year after TAVR, they did not investigate in-hospital bleeding (IHB) events[1,2]. Hence, there is paucity of information about post-TAVR bleeding events during index hospitalization, as well as their impact on outcomes, especially in widespread clinical practice and not just in clinical trials.

We conducted a retrospective cohort study using the TAVR database of the Memorial Hermann-Texas Medical Center, one of the largest TAVR centers in the USA. We included all patients who underwent TAVR between November 2011 and December 2016, using the STS/ACC TVT criteria to identify postprocedural IHB events. A multivariate logistic regression was performed to identify clinical characteristics predictive of IHB. Pearson’s chi-square test, logistic regressions, and Wilcoxon rank test were used to analyze the association between the presence and severity of IHB, according to BARC, STS/ACC TVT, and VARC-2 classifications and the following outcomes: in-hospital mortality, 30-day mortality, length of stay (LOS) (in days), intensive care unit (ICU) LOS (in hours), and discharge location (home vs. intermediate facility [nursing/rehabilitation facilities, funeral home, etc.]). All statistical tests were performed with Stata SE 14 software (StataCorp, College Station, TX). A P-value < 0.05 was considered statistically significant.

Among the 1,036 patients that underwent TAVR, 115 (11.1%) developed postprocedural IHB. Sources of bleeding were the access site (28.5%) and retroperitoneal (16.9%) and pericardial (12.3%) tamponade. Serum albumin level (odds ratio [OR] 0.61 per gram of albumin), hemoglobin level (OR 0.87 per gram of hemoglobin), transaortic access (OR 4.1), and conduit access (OR 4.8) were independent predictors of IHB risk. Patients with IHB experienced higher risk of in-hospital mortality (15.7% vs. 1.2%), 30-day mortality (14.8% vs. 2.1%), vascular complications (20.9% vs. 3.7%), longer LOS (10 vs. 5 days), longer ICU LOS (124 vs. 46 hours), and higher risk of being discharged to an intermediate facility (47.8% vs. 14.7%) than patients without IHB. The incidence of these complications increased with the severity of bleeding by both BARC and VARC-2 criteria (Table 1). All P-values were < 0.05.

Table 1 Postprocedural outcomes of patients undergoing TAVR according to their IHB complications per BARC, STS/ACC TVT, and VARC-2 classifications. 

Outcomes TVT P-value BARC* P-value VARC-2 P-value
No bleeding Bleeding Type 3A Type 3B Type 3C Type 5 Minor Major Life-threatening/Disabling
n=921 n=115 n=38 n=62 n=3 n=12 n=17 n=27 n=71
In-hospital mortality 11 (1.2) 18 (15.6) <.001 2 (5.3) 3 (4.8) 1 (33.3) 12 (100) <.001 2 (11.8) 0 (0) 16 (22.5) <.001
30-day mortality 19 (2.1) 17 (14.7) <.001 2 (5.3) 3 (4.8) 1 (33.3) 11 (91.6) <.001 2 (11.8) 0 (0) 15 (21.1) <.001
Length of stay (days) 5±6 10±9 <.001 8±8 11±8 21±2 10±11 <.001 8±8 8±8 12±9 <.001
ICU length of stay (hours) 46±73 124±128 <.001 86±100 128±115 373±265 162±160 <.001 93±130 76±72 150±138 <.001
Discharge to intermediate facility 136 (14.7) 55 (47.8) <.001 11 (28.9) 29 (46.8) 3 (100) 12 (100) <.001 3 (17.6) 10 (37) 42 (59.2) <.001
Vascular complications 34 (3.7) 24 (20.9) <.001 7 (18.4) 14 (22.6) 0 3 (25) <.001 2 (11.8) 7 (25.9) 15 (21.1) <.001

*Discharge to intermediate facility included nursing or rehabilitation facilities and funeral home. Values in n (%) or mean ± standard deviation.

Discharge to intermediate facility included nursing or rehabilitation facilities and funeral home. Values in n (%) or mean ± standard deviation.

BARC=Bleeding Academic Research Consortium; IHB=in-hospital bleeding; STS/ACC TVT=The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy; TAVR=transcatheter aortic valve replacement; VARC-2=Valve Academic Research Consortium 2

In patients with BARC 3C (intracranial, intraocular, etc.), IHB had longer LOS and ICU LOS than in those with BARC 5 (fatal bleeding), and no vascular complications, as patients with BARC 3C bleeding required further treatment and longer monitoring and those with BARC 5 may have died earlier. Most of the patients with VARC-2 major bleeding had access site hematoma or retroperitoneal hematoma, but none of them died.

This study has some limitations. Firstly, it included cases from early phases of the commercial TAVR program in our center. Secondly, as a major referral center, some of our high-or-prohibitive surgical risk patients may have had more complex clinical situations than their counterparts in community hospitals.

Nevertheless, our study has multiple strengths. It is one of the few studies to focus on IHB; hence, it provides valuable insight to the specific risk factors and outcomes associated during the index hospitalization for TAVR, which is the critical period for bleeding complications. Furthermore, this large cohort reflects a real-world population and provides new knowledge that can contribute to improve patient selection and early planning for prevention and treatment during hospitalization for TAVR.

Patients at higher risk of IHB, such as those with hypoalbuminemia, anemia, and/or planned conduit or transaortic access, may benefit from a more careful selection process and discussions about the higher risk for complications. Further studies should be done on potential interventions to address these risk factors, such as improving nutritional status, treating underlying anemia, etc. These results also suggest that both BARC and VARC-2 definitions may be used to classify the severity of IHB after TAVR and predict outcomes.

ACKNOWLEDGEMENTS

This work is part of a master’s thesis of the Master’s Program in Clinical Research, Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, Dresden, Germany.

REFERENCES

1 Stortecky S, Stefanini GG, Pilgrim T, Heg D, Praz F, Luterbacher F, et al. Validation of the valve academic research consortium bleeding definition in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation. JAHA. 2015;4(10):e002135. doi:10.1161/jaha.115.002135. [ Links ]

2 Piccolo R, Pilgrim T, Franzone A, Valgimigli M, Haynes A, Asami M, et wal. Frequency, timing, and impact of access-site and non-access-site bleeding on mortality among patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2017;10(14):1436-46. doi:10.1016/j.jcin.2017.04.034 [ Links ]

3 Cardiology TSoTSACo. STS-ACC TVT Registry data collection forms and Coder's Data Dictionary 2019 [cited 2019 May 28]. Available from: https://www.ncdr.com/webncdr/tvt/home/data-collection. [ Links ]

4 Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012;42(5):S45-S60. doi:10.1093/ejcts/ezs533. [ Links ]

5 Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-47. doi:10.1161/circulationaha.110.009449. [ Links ]

Correspondence Address: Adrian daSilva-deAbreu, https://orcid.org/0000-0002-6739-5946. adrianjdasilva@gmail.com

Creative Commons License This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.