Advertisement

Usefulness of Periprocedural Bleeding to Predict Outcome After Transcatheter Aortic Valve Implantation

Published:December 12, 2011DOI:https://doi.org/10.1016/j.amjcard.2011.10.034
      Bleeding is a known predictor of poor outcome after a number of cardiac interventions. We investigated whether using the new bleeding definition of the Valve Academic Research Consortium predicts a poor outcome after transcatheter aortic valve implantation. In addition, we sought to identify those patient characteristics that predict periprocedural bleeding and investigated the effect of blood transfusion. This was a retrospective study of 101 patients undergoing transapical or transfemoral transcatheter aortic valve implantation at Kings College Hospital from August 2007 to November 2010. The association among bleeding, blood transfusion, and in-hospital and 6-month mortality was examined. Of the 101 patients, 5 (4.9%) had life-threatening periprocedural bleeding related to vascular or apical complications, 17 (17%) had major bleeding, and 79 (78%) had minor or no bleeding. The in-hospital mortality rate for the cohort was 9.9% (n = 10) and the 6-month mortality rate was 18.8% (n = 19). Those patients with life-threatening bleeding and those who were transfused had significantly greater in-hospital mortality rates than the patients without life-threatening bleeding or transfusion (60.0% vs 7.3%, p <0.05; and 14.8% vs 4.3%, p <0.05, respectively). Life-threatening bleeding, a decrease in hemoglobin >5 g/dl, and a blood transfusion of >2 U were associated with increased mortality at 6 months. In a logistic regression model, coexisting vascular disease, diabetes, and preprocedural anemia significantly affected the incidence of life-threatening or major bleeding. In conclusion, consistent with many other cardiac interventions, life-threatening periprocedural bleeding after transcatheter aortic valve implantation is associated with poorer outcomes.
      The number of transcatheter aortic valve implantations (TAVIs) performed worldwide has increased dramatically in recent years, and this is likely to continue given the aging population and advancing technology.
      • Dworakowski R.
      • MacCarthy P.A.
      • Monaghan M.
      • redwood S.
      • El-Gamel A.
      • Young C.
      • Bapat V.
      • Hancock J.
      • Wilson K.
      • Brickham B.
      • Wendler O.
      • Thomas M.R.
      Transcatheter aortic valve implantation for severe aortic stenosis—a new paradigm for multidisciplinary intervention: a prospective cohort study.
      TAVI is commonly performed in patients with multiple co-morbidities for whom conventional aortic valve replacement is considered too high risk. Bleeding is a common and well-investigated complication after coronary interventions, and in cardiac surgery, it is a well-established predictor of in-hospital mortality.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Eikelboom J.W.
      • Mehta S.R.
      • Anand S.S.
      • Xie C.
      • Fox K.A.
      • Yusuf S.
      Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.
      • DeFoe G.R.
      • Ross C.S.
      • Olmstead E.M.
      • Surgenor S.D.
      • Fillinger M.P.
      • Groom R.C.
      • Forest R.J.
      • Pieroni J.W.
      • Warren C.S.
      • Bogosian M.E.
      • Krumholz C.F.
      • Clark C.
      • Clough R.A.
      • Weldner P.W.
      • Lahey S.J.
      • Leavitt B.J.
      • Marrin C.A.
      • Charlesworth D.C.
      • Marshall P.
      • O'Connor G.T.
      Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting.
      The predictors of bleeding after coronary intervention are well established.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Subherwal S.
      • Bach R.G.
      • Chen A.Y.
      • Gage B.F.
      • Rao S.V.
      • Newby L.K.
      • Wang T.Y.
      • Gibler W.B.
      • Ohman E.M.
      • Roe M.T.
      • Pollack C.V.
      • Peterson E.D.
      • Alexander K.P.
      Baseline risk of major bleeding in non–ST-segment elevation myocardial infarction: the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines) bleeding score.
      Scoring systems such as the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines (CRUSADE) score were developed to predict the risk of major bleeding after coronary intervention and are derived from multinational registries. These data have indicated that certain patient characteristics and procedural risk factors predict bleeding. However, to date, no data are available about the effect of bleeding and blood transfusion on TAVI outcomes. The high reported transfusion rate after the procedure, however, suggests that bleeding and pre- and postoperative anemia are important issues.
      • Thomas M.
      • Schymik G.
      • Walther T.
      • Himbert D.
      • Lefèvre T.
      • Treede H.
      • Eggebrecht H.
      • Rubino P.
      • Michev I.
      • Lange R.
      • Anderson W.N.
      • Wendler O.
      Thirty-day results of the SAPIEN aortic bioprosthesis European outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
      We aimed to establish whether bleeding and blood transfusion after TAVI are associated with increased in-hospital and 6-month mortality. We also investigated the risk factors that predict periprocedural bleeding and blood transfusion in this clinical setting.

      Methods

      This was a retrospective study involving 101 patients undergoing transapical or transfemoral TAVI at King's College Hospital from August 2007 to November 2010. Patient characteristics, preoperative investigations, postprocedural complications, and in-hospital and 6-month mortality were collated from a contemporaneous database. Information regarding admission hemoglobin levels, postprocedural hemoglobin nadirs, and whether packed red blood cells were transfused was collected from the patient notes.
      We used the Valve Academic Research Consortium (VARC) definition of bleeding complications.
      • Leon M.B.
      • Piazza N.
      • Nikolsky E.
      • Blackstone E.H.
      • Cutlip D.E.
      • Kappetein A.P.
      • Krucoff M.W.
      • Mack M.
      • Mehran R.
      • Miller C.
      • Morel M.A.
      • Petersen J.
      • Popma J.J.
      • Takkenberg J.J.
      • Vahanian A.
      • van Es G.A.
      • Vranckx P.
      • Webb J.G.
      • Windecker S.
      • Serruys P.W.
      Standardized end point definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
      This defines life-threatening bleeding as fatal bleeding or bleeding from an organ causing hypovolemic shock or severe hypotension requiring vasopressors or surgery or bleeding from an overt source with a decrease in hemoglobin of ≥5 g/dl or blood transfusion of ≥4 U. Major bleeding is classified as overt bleeding, either associated with a decrease in hemoglobin of ≥3.0 g/dl or that requiring transfusion of 2 or 3 U of blood without meeting “life-threatening” criteria. Minor bleeding is any bleeding of clinical mention (e.g., access site hematoma) that does not qualify as life-threatening or major. A correlation was made between the bleeding events and mortality. We also investigated how periprocedural blood transfusion affected these outcomes. The predictors of bleeding were investigated using univariate and multivariate analyses. The predictors included age (<85 years and ≥85 years), gender, body mass index (<25 and >25 kg/m2), estimated glomerular filtration rate (<60 and ≥60 ml/min), logistic euroSCORE, diabetes mellitus, coexisting vascular disease (defined as previous coronary artery bypass grafting/percutaneous coronary intervention, peripheral vascular disease, significant stenosis in the carotid arteries or previous cerebrovascular accident), or a preprocedural hemoglobin (Hb) level <11.5 g/dl.
      Statistical analyses were performed using the Statistical Package for Social Sciences, version 19 (SPSS, Chicago, Illinois). The data are expressed as the mean ± SEM. A comparison of the categorical variables was done using chi-square tests. A comparison of continuous variables between groups was done using an unpaired Student's t test. Logistic regression analysis was used to assess the effect of multiple variables on periprocedural bleeding. For all statistical tests, a significance level of p <0.05 was used.

      Results

      A total of 101 patients (50 men, 49.5%) underwent TAVI during the specified period. Of the 101 procedures, 56 were performed transapically and 45 transfemorally. The baseline patient characteristics are listed in Table 1. Using the VARC definitions, 5 patients (4.9%) had life-threatening periprocedural bleeding related to vascular or apical complications, 17 (17%) had major bleeding, 2 (2%) had minor bleeding, and 77 (76%) had no overt bleeding. In addition, 8 patients (7.8%) developed major vascular injuries such as femoral arteriovenous fistula or pseudoaneurysm, 4 (4.0%) developed late vascular complications such as groin hematoma, and 2 (2.0%) required immediate reintervention for bleeding complications.
      Table 1Baseline patient characteristics (n = 101)
      VariableValue
      Women51%
      Age (years)83.1 ± 0.6
      Body mass index (kg/m2)25.7 ± 0.6
      Estimated glomerular filtration rate (ml/min)60.4 ± 1.8
      Logistic euroSCORE22 ± 0.9
      Baseline hemoglobin (g/dl)12.1 ± 0.2
      Peripheral vascular disease32 (32%)
      Hypertension70 (69%)
      Diabetes mellitus22 (22%)
      Previous cardiovascular disease66 (65%)
      The in-hospital mortality rate for the cohort was 9.9% (n = 10), and the 6-month mortality rate was 18.8% (n = 19). The most common cause of death was sepsis, occurring in 12 cases, and was most frequently relating to pneumonia, followed by multiorgan failure in 5 cases. Three of the group who died in-hospital had life-threatening bleeding and 1 had major bleeding. Of those who had died at 6 months, 3 had life-threatening bleeding and 2 major bleeding. Those patients with life-threatening bleeding had significantly greater in-hospital mortality rates than those without such bleeding (60% vs 7.3%, p <0.05). Major bleeding was not associated with significantly greater in-hospital mortality rates (6% vs 8%, p = NS), although it was associated with a significantly longer in-hospital stay (20 ± 4 vs 12 ± 1 days; p <0.05).
      The Kaplan-Meier analysis demonstrated that life-threatening bleeding predicts a worse survival for ≤6 months compared to the “major bleeding” group and the “others” group (Figure 1) . The relation between blood transfusion and survival and Hb decrease and survival is shown in Figure 2. A decrease in Hb >5 g/dl and blood transfusion of >2 U were associated with increased mortality at 6 months (Figure 2).
      Figure thumbnail gr1
      Figure 1Six-month mortality for patients with life-threatening bleeding and major bleeding versus others (Kaplan-Meier curves compared using log-rank test).
      Figure thumbnail gr2
      Figure 2Six-month survival for patients with decrease in Hb >3 g/dl (A) and >5 g/dl versus others (B), who received blood transfusions (C) and those who received blood transfusion ≤2 U and >2 U (D) (Kaplan-Meier curves compared using log-rank test).
      A total of 54 patients (53.4%) were transfused packed red blood cells; 7 (6.9%) of the patients were transfused ≥4 U, 12 (11%) were transfused 3 U, 26 (26%) were transfused 2 U, and 9 (9%) were transfused 1 U. The mean number of units transfused was 2.5 ± 0.2. Those patients who were transfused not only had a significantly greater in-hospital mortality rate (14.8% vs 4.3%; p <0.05) but also a significantly longer in-hospital stay (17 ± 2 vs 7 ± 1 days; p <0.05). Of the patients who were given ≥4 U, 2 had life-threatening bleeding, 4 had major bleeding, and 1 had no overt bleeding. Of the patients who were given 3 U, 9 had no overt bleeding, and 3 had major bleeding. A total of 13 patients (25%) received ≥2 U of blood without an overt source of bleeding. The indication for blood transfusion was a Hb decrease of <8 g/dl in the postoperative period. The Kaplan-Meier relation between a blood transfusion of >2 U and survival to 6 months is shown in Figure 2. Of the 19 patients who were transfused >2 U of blood, 2 had life-threatening bleeding and 7 had major bleeding.
      We investigated potential risk factors of major or life-threatening bleeding using logistic regression model, including female gender, logistic euroSCORE, diabetes, glomerular filtration rate, baseline Hb, and vascular disease. In this model, diabetes, baseline Hb, and coexisting vascular disease were predictors of life-threatening or major bleeding complications (logistic regression model, p <0.05). No difference was found between the mode of delivery and the occurrence of major bleeding (Figure 3) .
      Figure thumbnail gr3
      Figure 3Association between mode of device delivery and major bleeding and life-threatening bleeding (chi-square test, p = NS).

      Discussion

      This is the first study from a single center reporting the bleeding complications using the new bleeding scoring system proposed by VARC.
      • Leon M.B.
      • Piazza N.
      • Nikolsky E.
      • Blackstone E.H.
      • Cutlip D.E.
      • Kappetein A.P.
      • Krucoff M.W.
      • Mack M.
      • Mehran R.
      • Miller C.
      • Morel M.A.
      • Petersen J.
      • Popma J.J.
      • Takkenberg J.J.
      • Vahanian A.
      • van Es G.A.
      • Vranckx P.
      • Webb J.G.
      • Windecker S.
      • Serruys P.W.
      Standardized end point definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
      We demonstrated that life-threatening bleeding, related to periprocedural vascular or apical complications and blood transfusion, is associated with greater in-hospital mortality. We also demonstrated that life-threatening bleeding, a decrease in Hb >5 g/dl, and blood transfusion of >2 U were associated with increased mortality at 6 months. We found that the Hb level on admission, diabetes, and coexisting vascular disease are independent risk factors for post-TAVI bleeding complications. This is the first study to investigate bleeding complications and blood transfusion and its links with clinical outcome in a large cohort of TAVI patients.
      Our findings are consistent with studies investigating bleeding after percutaneous coronary intervention.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Eikelboom J.W.
      • Mehta S.R.
      • Anand S.S.
      • Xie C.
      • Fox K.A.
      • Yusuf S.
      Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.
      • Rao S.V.
      • O'Grady K.
      • Pieper K.S.
      • Granger C.B.
      • Newby L.K.
      • Van de Werf F.
      • Mahaffey K.W.
      • Califf R.M.
      • Harrington R.A.
      Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes.
      Different mechanisms have been proposed to explain the association between bleeding and poor outcomes in these settings. Some have hypothesized that bleeding is merely a marker of those with severe illness and might not contribute directly to death.
      • Spencer F.A.
      • Moscucci M.
      • Granger C.B.
      • Gore J.M.
      • Goldberg R.J.
      • Steg P.G.
      • Goodman S.G.
      • Budaj A.
      • FitzGerald G.
      • Fox K.A.
      GRACE Investigators
      Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction?.
      Others have proposed that it might be related to hypoperfusion of the myocardium or a reduced oxygen-carrying ability of blood because of low hemoglobin levels.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Spencer F.A.
      • Moscucci M.
      • Granger C.B.
      • Gore J.M.
      • Goldberg R.J.
      • Steg P.G.
      • Goodman S.G.
      • Budaj A.
      • FitzGerald G.
      • Fox K.A.
      GRACE Investigators
      Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction?.
      • Sabatine M.S.
      • Morrow D.A.
      • Giugliano R.P.
      • Burton P.B.
      • Murphy S.A.
      • McCabe C.H.
      • Gibson C.M.
      • Braunwald E.
      Association of hemoglobin levels with clinical outcomes in acute coronary syndromes.
      An additional explanation might be that postprocedural bleeding often necessitates blood transfusion, which might be associated with detrimental physiologic changes. Transfused red blood cells are depleted of 2,3 diphosphoglycerate, thereby increasing the affinity of transfused hemoglobin for oxygen, perhaps adversely affecting already compromised organs.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Spiess B.D.
      Blood transfusion for cardiopulmonary bypass: the need to answer a basic question.
      Moreover, stored red blood cells also have low nitric oxide levels, stimulating the hypothesis that transfused red blood cells “steal” nitric oxide from the circulation, leading to adverse vasomotion and a reduction in blood flow.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Wallis J.P.
      Nitric oxide and blood: a review.
      Evidence-based indications for blood transfusion are lacking in many situations, including after TAVI, and this therapeutic intervention remains controversial. Johnson et al
      • Johnson R.G.
      • Thurer R.L.
      • Kruskall M.S.
      • Sirois C.
      • Gervino E.V.
      • Critchlow J.
      • Weintraub R.M.
      Comparison of two transfusion strategies after elective operations for myocardial revascularization.
      failed to show any outcome benefit with an aggressive transfusion strategy, maintaining a hematocrit >32%, in the setting of elective coronary revascularization. This is perhaps not surprising, because blood transfusion could be a major confounder and is likely to be a marker of postoperative complications and severe illness. However, others have reported a benefit with transfusion when given to elderly patients admitted with myocardial infarction and a hematocrit <30%.
      • Wu W.C.
      • Rathore S.S.
      • Wang Y.
      • Radford M.J.
      • Krumholz H.M.
      Blood transfusion in elderly patients with acute myocardial infarction.
      Our findings are similar to those from Gurvitch et al
      • Gurvitch R.
      • Toggweiler S.
      • Willson A.B.
      • Wijesinghe N.
      • Cheung A.
      • Wood D.A.
      • Ye J.
      • Webb J.G.
      Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines.
      in that we noted that a significant proportion of patients undergoing TAVI have a postprocedural decrease in Hb without any obvious source of bleeding. The TAVI population is elderly, and many patients have preprocedural anemia. We propose that the combination of this with the periprocedural loss of blood and postoperative hemodilution (after fluid replacement) results in a decrease in Hb. The multidisciplinary Task Force for Advanced Bleeding Care in Trauma recommends a target Hb of 7 to 9 g/dl.
      • Rossaint R.
      • Bouillon B.
      • Cerny V.
      • Coats T.J.
      • Duranteau J.
      • Fernández-Mondéjar E.
      • Hunt B.J.
      • Komadina R.
      • Nardi G.
      • Neugebauer E.
      • Ozier Y.
      • Riddez L.
      • Schultz A.
      • Stahel P.F.
      • Vincent J.L.
      • Spahn D.R.
      Task Force for Advanced Bleeding Care in Trauma
      Management of bleeding following major trauma: an updated European guideline.
      The American Society of Anesthetists and Society of Thoracic Surgeons advise transfusing after cardiac surgery if the Hb is <7 in patients >65 years old.
      • Ferraris V.A.
      • Ferraris S.P.
      • Saha S.P.
      • Hessel II, E.A.
      • Haan C.K.
      • Royston B.D.
      • Bridges C.R.
      • Higgins R.S.
      • Despotis G.
      • Brown J.R.
      • Spiess B.D.
      • Shore-Lesserson L.
      • Stafford-Smith M.
      • Mazer C.D.
      • Bennett-Guerrero E.
      • Hill S.E.
      • Body S.
      Society of Thoracic Surgeons Blood Conservation Guideline Task ForceSociety of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion
      Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists clinical practice guideline.
      Even using a conservative approach and transfusing when the Hb is <8 g/dl, 54% of all patients in our series received a blood transfusion. Within this group, 67% received only 1 or 2 U of blood. The inclusion of all patients transfused 2 U of blood resulted in a large number of patients included in the major bleeding group, possibly explaining the lack of an association between major bleeding and poorer outcomes. However, an association was found between a transfusion of >2 U of blood and increased mortality. It might be that transfusion beyond the frequent “starting point” of 1 or 2 U is a better measure of clinically significant bleeding and a poor outcome. This suggests that the VARC definition of major bleeding could benefit from revision. The VARC criteria are different from stricter definitions of major bleeding used in the Randomized Evaluation of PCI [percutaneous coronary intervention] Linking Angiomax to Reduced Clinical Events-2 (REPLACE-2) and Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) studies, when major bleeding was defined as needing ≥3 U of blood.
      • Kinnaird T.
      Bleeding during percutaneous intervention: tailoring the approach to minimize risk.
      In a multivariate analysis, we found that preprocedural anemia, diabetes, and vascular disease predict serious bleeding complications (major or life-threatening bleeding). This is consistent with previous studies, which demonstrate that patients with anemia and with cardiovascular disease undergoing coronary intervention have a poorer prognosis and are at a greater risk of bleeding.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Eikelboom J.W.
      • Mehta S.R.
      • Anand S.S.
      • Xie C.
      • Fox K.A.
      • Yusuf S.
      Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.
      • DeFoe G.R.
      • Ross C.S.
      • Olmstead E.M.
      • Surgenor S.D.
      • Fillinger M.P.
      • Groom R.C.
      • Forest R.J.
      • Pieroni J.W.
      • Warren C.S.
      • Bogosian M.E.
      • Krumholz C.F.
      • Clark C.
      • Clough R.A.
      • Weldner P.W.
      • Lahey S.J.
      • Leavitt B.J.
      • Marrin C.A.
      • Charlesworth D.C.
      • Marshall P.
      • O'Connor G.T.
      Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting.
      • Wu W.C.
      • Rathore S.S.
      • Wang Y.
      • Radford M.J.
      • Krumholz H.M.
      Blood transfusion in elderly patients with acute myocardial infarction.
      In addition these patients are older and more likely to be women with a lower mean body mass index.
      • McKechnie R.S.
      • Smith D.
      • Montoye C.
      • Kline-Rogers E.
      • O'Donnell M.J.
      • DeFranco A.C.
      • Meengs W.L.
      • McNamara R.
      • McGinnity J.G.
      • Patel K.
      • Share D.
      • Riba A.
      • Khanal S.
      • Moscucci M.
      Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2)
      Prognostic implication of anemia on in-hospital outcomes after percutaneous coronary intervention.
      Preprocedural anemia is likely to be an indicator of general frailty, and it should be taken into account during patient selection before TAVI.
      In contrast to the studies in the setting of percutaneous coronary intervention and myocardial infarction, we did not find any association between periprocedural bleeding and age or renal function.
      • Kinnaird T.D.
      • Stabile E.
      • Mintz G.S.
      • Lee C.W.
      • Canos D.A.
      • Gevorkian N.
      • Pinnow E.E.
      • Kent K.M.
      • Pichard A.D.
      • Satler L.F.
      • Weissman N.J.
      • Lindsay J.
      • Fuchs S.
      Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
      • Eikelboom J.W.
      • Mehta S.R.
      • Anand S.S.
      • Xie C.
      • Fox K.A.
      • Yusuf S.
      Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.
      • DeFoe G.R.
      • Ross C.S.
      • Olmstead E.M.
      • Surgenor S.D.
      • Fillinger M.P.
      • Groom R.C.
      • Forest R.J.
      • Pieroni J.W.
      • Warren C.S.
      • Bogosian M.E.
      • Krumholz C.F.
      • Clark C.
      • Clough R.A.
      • Weldner P.W.
      • Lahey S.J.
      • Leavitt B.J.
      • Marrin C.A.
      • Charlesworth D.C.
      • Marshall P.
      • O'Connor G.T.
      Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting.
      This might be the result of a relatively small study population that was homogenous, because most patients are elderly with a low baseline glomerular filtration rate. Additional investigation in a larger study population is necessary to identify other bleeding risk factors.
      The obvious limitations of the present study were its retrospective nature and the number of patients involved. We believe that a larger number of patients would allow more accurate statistical modeling and prediction of more subtle clinical features that might predict bleeding. Moreover, the greater statistical power afforded by larger patient numbers would help dissect the important issue of whether transfusion worsens outcome or is merely a confounding variable.

      References

        • Dworakowski R.
        • MacCarthy P.A.
        • Monaghan M.
        • redwood S.
        • El-Gamel A.
        • Young C.
        • Bapat V.
        • Hancock J.
        • Wilson K.
        • Brickham B.
        • Wendler O.
        • Thomas M.R.
        Transcatheter aortic valve implantation for severe aortic stenosis—a new paradigm for multidisciplinary intervention: a prospective cohort study.
        Am Heart J. 2010; 160: 237-243
        • Kinnaird T.D.
        • Stabile E.
        • Mintz G.S.
        • Lee C.W.
        • Canos D.A.
        • Gevorkian N.
        • Pinnow E.E.
        • Kent K.M.
        • Pichard A.D.
        • Satler L.F.
        • Weissman N.J.
        • Lindsay J.
        • Fuchs S.
        Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions.
        Am J Cardiol. 2003; 92: 930-935
        • Eikelboom J.W.
        • Mehta S.R.
        • Anand S.S.
        • Xie C.
        • Fox K.A.
        • Yusuf S.
        Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.
        Circulation. 2006; 114: 774-782
        • DeFoe G.R.
        • Ross C.S.
        • Olmstead E.M.
        • Surgenor S.D.
        • Fillinger M.P.
        • Groom R.C.
        • Forest R.J.
        • Pieroni J.W.
        • Warren C.S.
        • Bogosian M.E.
        • Krumholz C.F.
        • Clark C.
        • Clough R.A.
        • Weldner P.W.
        • Lahey S.J.
        • Leavitt B.J.
        • Marrin C.A.
        • Charlesworth D.C.
        • Marshall P.
        • O'Connor G.T.
        Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting.
        Ann Thorac Surg. 2001; 71: 769-776
        • Subherwal S.
        • Bach R.G.
        • Chen A.Y.
        • Gage B.F.
        • Rao S.V.
        • Newby L.K.
        • Wang T.Y.
        • Gibler W.B.
        • Ohman E.M.
        • Roe M.T.
        • Pollack C.V.
        • Peterson E.D.
        • Alexander K.P.
        Baseline risk of major bleeding in non–ST-segment elevation myocardial infarction: the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines) bleeding score.
        Circulation. 2009; 119: 1873-1882
        • Thomas M.
        • Schymik G.
        • Walther T.
        • Himbert D.
        • Lefèvre T.
        • Treede H.
        • Eggebrecht H.
        • Rubino P.
        • Michev I.
        • Lange R.
        • Anderson W.N.
        • Wendler O.
        Thirty-day results of the SAPIEN aortic bioprosthesis European outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
        Circulation. 2010; 122: 62-69
        • Leon M.B.
        • Piazza N.
        • Nikolsky E.
        • Blackstone E.H.
        • Cutlip D.E.
        • Kappetein A.P.
        • Krucoff M.W.
        • Mack M.
        • Mehran R.
        • Miller C.
        • Morel M.A.
        • Petersen J.
        • Popma J.J.
        • Takkenberg J.J.
        • Vahanian A.
        • van Es G.A.
        • Vranckx P.
        • Webb J.G.
        • Windecker S.
        • Serruys P.W.
        Standardized end point definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
        J Am Coll Cardiol. 2011; 57: 253-269
        • Rao S.V.
        • O'Grady K.
        • Pieper K.S.
        • Granger C.B.
        • Newby L.K.
        • Van de Werf F.
        • Mahaffey K.W.
        • Califf R.M.
        • Harrington R.A.
        Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes.
        Am J Cardiol. 2005; 96: 1200-1206
        • Spencer F.A.
        • Moscucci M.
        • Granger C.B.
        • Gore J.M.
        • Goldberg R.J.
        • Steg P.G.
        • Goodman S.G.
        • Budaj A.
        • FitzGerald G.
        • Fox K.A.
        • GRACE Investigators
        Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction?.
        Circulation. 2007; 116: 2793-2801
        • Sabatine M.S.
        • Morrow D.A.
        • Giugliano R.P.
        • Burton P.B.
        • Murphy S.A.
        • McCabe C.H.
        • Gibson C.M.
        • Braunwald E.
        Association of hemoglobin levels with clinical outcomes in acute coronary syndromes.
        Circulation. 2005; 111: 2042-2049
        • Spiess B.D.
        Blood transfusion for cardiopulmonary bypass: the need to answer a basic question.
        J Cardiothorac Vasc Anesth. 2002; 16: 535-538
        • Wallis J.P.
        Nitric oxide and blood: a review.
        Transfus Med. 2005; 15: 1-11
        • Johnson R.G.
        • Thurer R.L.
        • Kruskall M.S.
        • Sirois C.
        • Gervino E.V.
        • Critchlow J.
        • Weintraub R.M.
        Comparison of two transfusion strategies after elective operations for myocardial revascularization.
        J Thorac Cardiovasc Surg. 1992; 104: 307-314
        • Wu W.C.
        • Rathore S.S.
        • Wang Y.
        • Radford M.J.
        • Krumholz H.M.
        Blood transfusion in elderly patients with acute myocardial infarction.
        N Engl J Med. 2001; 345: 1230-1236
        • Gurvitch R.
        • Toggweiler S.
        • Willson A.B.
        • Wijesinghe N.
        • Cheung A.
        • Wood D.A.
        • Ye J.
        • Webb J.G.
        Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines.
        EuroIntervention. 2011; 7: 41-48
        • Rossaint R.
        • Bouillon B.
        • Cerny V.
        • Coats T.J.
        • Duranteau J.
        • Fernández-Mondéjar E.
        • Hunt B.J.
        • Komadina R.
        • Nardi G.
        • Neugebauer E.
        • Ozier Y.
        • Riddez L.
        • Schultz A.
        • Stahel P.F.
        • Vincent J.L.
        • Spahn D.R.
        • Task Force for Advanced Bleeding Care in Trauma
        Management of bleeding following major trauma: an updated European guideline.
        Crit Care. 2010; 14: R52
        • Ferraris V.A.
        • Ferraris S.P.
        • Saha S.P.
        • Hessel II, E.A.
        • Haan C.K.
        • Royston B.D.
        • Bridges C.R.
        • Higgins R.S.
        • Despotis G.
        • Brown J.R.
        • Spiess B.D.
        • Shore-Lesserson L.
        • Stafford-Smith M.
        • Mazer C.D.
        • Bennett-Guerrero E.
        • Hill S.E.
        • Body S.
        • Society of Thoracic Surgeons Blood Conservation Guideline Task Force
        • Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion
        Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists clinical practice guideline.
        Ann Thorac Surg. 2007; 83: S27-S86
        • Kinnaird T.
        Bleeding during percutaneous intervention: tailoring the approach to minimize risk.
        Heart. 2009; 95: 15-19
        • McKechnie R.S.
        • Smith D.
        • Montoye C.
        • Kline-Rogers E.
        • O'Donnell M.J.
        • DeFranco A.C.
        • Meengs W.L.
        • McNamara R.
        • McGinnity J.G.
        • Patel K.
        • Share D.
        • Riba A.
        • Khanal S.
        • Moscucci M.
        • Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2)
        Prognostic implication of anemia on in-hospital outcomes after percutaneous coronary intervention.
        Circulation. 2004; 110: 271-277