Perioperative Bleeding Requiring Blood Transfusions is Associated With Increased Risk of Stroke After Transcatheter and Surgical Aortic Valve Replacement.

OBJECTIVES: The authors aimed to investigate the impact of severe bleeding and use of red blood cell (RBC) transfusion on the development of postoperative stroke after surgical (SAVR) and transcatheter aortic valve replacement (TAVR), taken from the FinnValve registry. DESIGN: Nationwide, retrospective observational study. SETTING: Five Finnish university hospitals participated in the registry. PARTICIPANTS: A total of 6,463 patients who underwent SAVR (n = 4,333) or TAVR (n = 2,130). INTERVENTIONS: Patients who underwent TAVR or SAVR with a bioprosthesis with or without coronary revascularization. MEASUREMENTS AND MAIN RESULTS: The incidence of postoperative stroke after SAVR was 3.8%. In multivariate analysis, the number of transfused RBC units (odds ratio [OR], 1.098; 95% confidence interval [CI], 1.064-1.133) was one of the independent predictors of postoperative stroke. The incidence of stroke increased, along with the severity of perioperative bleeding, according to the European Coronary Artery Bypass Grafting (E-CABG) bleeding grades were as follows: grade 0, 2.2% (reference group); grade 1, 3.4% (adjusted OR, 1.841; 95% CI, 1.105-3.066); grade 2, 5.5% (adjusted OR, 3.282; 95% CI, 1.948-5.529); and grade 3, 14.8% (adjusted OR, 7.103; 95% CI, 3.612-13.966). The incidence of postoperative stroke after TAVR was 2.5%. The number of transfused RBC units was an independent predictor of stroke after TAVR (adjusted OR, 1.155; 95% CI, 1.058-1.261). The incidence of postoperative stroke increased, along with the severity of perioperative bleeding, as stratified by the E-CABG bleeding grades: E-CABG grade 0, 1.7%; grade 1, 5.3% (adjusted OR, 1.270; 95% CI, 0.532-3.035); grade 2, 10.0% (adjusted OR, 2.898; 95% CI, 1.101-7.627); and grade 3, 30.0% (adjusted OR, 10.706; 95% CI, 2.389-47.987). CONCLUSIONS: Perioperative bleeding requiring RBC transfusion and/or reoperation for intrathoracic bleeding is associated with an increased risk of postoperative stroke after SAVR and TAVR. Patient blood management and meticulous preprocedural planning and operative technique aiming to avoid significant perioperative bleeding may reduce the risk of cerebrovascular complications.

Impact of preoperative thrombocytopenia on the outcome after coronary artery bypass grafting.

The impact of thrombocytopenia on postoperative bleeding and other major adverse events after cardiac surgery is unclear. This issue was investigated in a series of patients who underwent isolated coronary artery bypass grafting (CABG) from the prospective, multicenter E-CABG registry. Preoperative thrombocytopenia was defined as preoperative platelet count <150 × 109/L and it was considered moderate-severe when preoperative platelet count was <100 × 109/L. Multilevel mixed-effects regression analysis was performed to adjust the effect of thrombocytopenia on outcomes for baseline and operative covariates as well as for interinstitutional differences in patient-blood management. Among 7189 patients included in this analysis, 599 (8.3%) had preoperative thrombocytopenia. Patient with preoperative thrombocytopenia had an increased chest drainage output at 12 h (mean, 519 vs. 456 mL, adjusted coeff. 39, 95%CI 18-60) and rates of severe-massive bleeding (Universal Definition of Perioperative Bleeding (UDPB) severity grades 3-4: 12.7% vs. 8.1%, adjusted OR 1.47, 95%CI 1.11-1.93; E-CABG bleeding severity grades 2-3: 10.4% vs. 6.1%, adjusted OR 1.78, 95%CI 1.30-2.43). Thrombocytopenia was associated with an increased risk of hospital/30-day death (3.2% vs. 1.9%, adjusted OR 2.02, 95%CI 1.20-3.42), 1-year death (5.7% vs. 3.4%, adjusted HR 1.68, 95%CI 1.16-2.44), deep sternal wound infection (3.5% vs. 2.4%, adjusted OR 1.65, 95%CI 1.02-2.66), acute kidney injury (28.1% vs. 22.2%, OR 1.45, 1.18-1.78), and prolonged stay in the intensive care unit (mean, 3.6 vs 2.8 days, adjusted coeff. 0.74, 95%CI 0.40-1.09). Similar results were observed in a subset of patients with moderate-severe thrombocytopenia (51 patients, 0.7%). In particular, these patients had a markedly higher rate of acute kidney injury (40%, adjusted OR, 1.94, 95%CI 1.05-3.57), resternotomy for bleeding (7.8%, adjusted OR 3.49, 95%CI 1.20-10.21), and severe-massive bleeding (UDPB severity grades 3-4: 23.5%, adjusted OR 3.08, 95%CI 1.52-6.22; E-CABG bleeding severity grades 2-3: 23.5%, adjusted OR 4.43, 95%CI 2.15-9.15) compared to patients with normal preoperative platelet count. Mild preoperative thrombocytopenia is associated with increased risk of severe-massive bleeding, mortality, and other major adverse events after CABG. Such risks are markedly increased in patients with moderate-severe preoperative thrombocytopenia.

Blood Transfusion and Outcome After Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To investigate the prognostic impact of red blood cell (RBC) transfusion on the outcome after transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Nationwide, retrospective multicenter study. SETTING: Five University Hospitals. PARTICIPANTS: The nationwide FinnValve registry included data from 2,130 patients who underwent TAVR for aortic stenosis from 2008 to 2017. After excluding patients who underwent TAVR through nontransfemoral accesses, 1,818 patients were selected for this analysis. INTERVENTION: TAVR with or without coronary revascularization. MEASUREMENTS AND MAIN RESULTS: RBCs were transfused in 293 patients (16.1%). Time-trend analysis showed that the rates of RBC transfusion decreased significantly from 27.5% in 2012 to 10.0% in 2017 (p < 0.0001). Among 281 propensity score matched pairs, RBC transfusion was associated with higher 30-day mortality (7.1% v 0%, p < 0.0001), late mortality (at 5-year, 59.1% v 43.3%, p = 0.008), as well as increased risk of acute kidney injury (17.0% v 4.4%, p < 0.0001), renal replacement therapy (3.6% v 0.4, p < 0.0001) and prolonged hospital stay (mean, 8.5 v 4.7 days, p < 0.0001) compared with patients who did not receive blood transfusion. In the overall series, the risk of adverse events increased significantly with the increasing amount of transfused RBC units and when operation for excessive bleeding was necessary. Consistently with these findings, postoperative hemoglobin drop and nadir level were associated with higher early and late mortality. CONCLUSIONS: Patients who received blood transfusion after TAVR had an increased risk of early and late adverse events. These adverse effects were particularly evident with increasing amount of RBC transfusion and operations for excessive bleeding.

Comparative Analysis of Prothrombin Complex Concentrate and Fresh Frozen Plasma in Coronary Surgery.

BACKGROUND: Recent studies suggested that prothrombin complex concentrate (PCC) might be more effective than fresh frozen plasma (FFP) to reduce red blood cell (RBC) transfusion requirement after cardiac surgery. METHODS: This is a comparative analysis of 416 patients who received FFP postoperatively and 119 patients who received PCC with or without FFP after isolated coronary artery bypass grafting (CABG). RESULTS: Mixed-effects regression analyses adjusted for multiple covariates and participating centres showed that PCC significantly decreased RBC transfusion (67.2% vs. 87.5%, adjusted OR 0.319, 95%CI 0.136-0.752) and platelet transfusion requirements (11.8% vs. 45.2%, adjusted OR 0.238, 95%CI 0.097-0.566) compared with FFP. The PCC cohort received a mean of 2.7±3.7 (median, 2.0, IQR 4) units of RBC and the FFP cohort received a mean of 4.9±6.3 (median, 3.0, IQR 4) units of RBC (adjusted coefficient, -1.926, 95%CI -3.357-0.494). The use of PCC increased the risk of KDIGO (Kidney Disease: Improving Global Outcomes) acute kidney injury (41.4% vs. 28.2%, adjusted OR 2.300, 1.203-4.400), but not of KDIGO acute kidney injury stage 3 (6.0% vs. 8.0%, OR 0.850, 95%CI 0.258-2.796) when compared with the FFP cohort. CONCLUSIONS: These results suggest that the use of PCC compared with FFP may reduce the need of blood transfusion after CABG.

Meta-analysis of the Sources of Bleeding after Adult Cardiac Surgery.

OBJECTIVE: The aim of this study was to pool data on the proportion and prognostic impact of sources of bleeding in patients requiring re-exploration after adult cardiac surgery. DESIGN: Systematic review of the literature and meta-analysis. SETTING: Multistitutional study. MEASUREMENTS AND MAIN RESULTS: A literature review was performed to identify studies published since 1990 evaluating the outcome after reoperation for bleeding or tamponade after adult cardiac surgery. Eighteen studies including 5,1497 patients fulfilled the selection criteria. Reoperation for bleeding/tamponade was performed in 2,455 patients (4.6%; 95% confidence interval [CI] 3.9%-5.2%, I2 92%). These had a significantly higher risk of in-hospital/30-day mortality compared with patients not reoperated for bleeding (pooled rates: 9.3% v 2.3%; risk ratio 3.30; 95% CI 2.52-4.32; I2 47%; 8 studies; 25,463 patients). Surgical sites of bleeding were identified in 65.7% of cases (95% CI 58.3%-73.2%; I2 94%), cardiac site bleeding in 40.9% of cases (95% CI 29.7%-52.0%; I2 94%), and mediastinal/sternum site bleeding in 27.0% of cases (95% CI 16.8%-37.3%; I2 94%). The main sites of bleeding were the body of the graft (20.2%), the sternum (17.0%), vascular sutures (12.5%), the internal mammary artery harvest site (13.0%), and anastomoses (9.9%). In metaregression, surgical site bleeding was associated with a lower risk of in-hospital/30-day mortality compared with diffuse bleeding (p = 0.003). CONCLUSIONS: Surgical site bleeding is identified in two-thirds of patients undergoing re-exploration after adult cardiac surgery. Meticulous surgical technique and systematic intraoperative checking of potential surgical sites of bleeding at the time of the original cardiac surgery may reduce the risk of such a severe complication.

Meta-Analysis of the Outcome After Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation in Adult Patients.

OBJECTIVE: This study was planned to pool existing data on outcome and to evaluate the efficacy of postcardiotomy venoarterial extracorporeal membrane oxygenation (VA-ECMO) in adult patients. DESIGN: Systematic review of the literature and meta-analysis. SETTING: Multi-institutional study. PARTICIPANTS: Adult patients with acute heart failure immediately after cardiac surgery. INTERVENTIONS: VA-ECMO after cardiac surgery. Studies evaluating only heart transplant patients were excluded from this analysis. MEASUREMENTS AND MAIN RESULTS: A literature search was performed to identify studies published since 2000. Thirty-one studies reported on 2,986 patients (mean age, 58.1 years) who required postcardiotomy VA-ECMO. The weaning rate from VA-ECMO was 59.5% and hospital survival was 36.1% (95% CI 31.5-40.8). The pooled rate of reoperation for bleeding was 42.9%, major neurological event 11.3%, lower limb ischemia 10.8%, deep sternal wound infection/mediastinitis 14.7%, and renal replacement therapy 47.1%. The pooled mean number of transfused red blood cell units was 17.7 (95% CI 13.3-22.1). The mean stay in the intensive care unit was 13.3 days (95% CI 10.2-16.4). Survivors were significantly younger (mean, 55.7 v 63.6 years, p = 0.015) and their blood lactate level before starting VA-ECMO was lower (mean, 7.7 v 10.7 mmol/L, p = 0.028) than patients who died. One-year survival rate was 30.9% (95% CI 24.3-37.5). CONCLUSIONS: Pooled data showed that VA-ECMO may salvage one-third of patients unresponsive to any other resuscitative treatment after adult cardiac surgery.

Incidence and prognostic impact of bleeding and transfusion after coronary surgery in low-risk patients.

BACKGROUND: Excessive bleeding and blood transfusion are associated with adverse outcome after cardiac surgery, but their mechanistic effects are difficult to disentangle in patients with increased operative risk. This study aimed to evaluate the incidence and prognostic impact of bleeding and transfusion of blood products in low-risk patients undergoing coronary artery bypass grafting (CABG). STUDY DESIGN AND METHODS: Sixteen tertiary European centers of cardiac surgery contributed to the prospective European registry of CABG (E-CABG). The severity of bleeding was defined by the E-CABG bleeding severity classification and universal definition of perioperative bleeding (UDPB) classification. RESULTS: Of 1213 patients with EuroSCORE II of less than 2% (mean, 1.1 ± 0.4%), 18.5% suffered from mild bleeding (E-CABG bleeding Grade 1) and 3.4% experienced severe bleeding (E-CABG bleeding Grade 2-3). Similarly, 19.7% had UDPB Class 2 and 5.9% had UDPB Classes 3 and 4. Mild and severe bleeding defined by the E-CABG and UDPB classifications were associated with an increased risk of several adverse events as adjusted by multiple covariates. The risk of death, stroke, and acute kidney injury was particularly increased in patients with severe bleeding. CONCLUSION: Severe bleeding is rather uncommon in low-risk patients undergoing CABG, but it is associated with an increased risk of major adverse events. Prevention of excessive perioperative bleeding and patient blood management may improve the outcome of cardiac surgery also in low-risk patients.

The Effect of Preoperative Anemia on the Outcome After Coronary Surgery.

BACKGROUND: Preoperative anemia is associated with increased morbidity and mortality after cardiac surgery. Since anemia is ultimately treated with red blood cell transfusions, we investigated the independent impact of anemia and transfusion on the outcome after coronary artery bypass grafting (CABG). METHODS: This study included 2761 consecutive patients who underwent isolated CABG. Anemia was defined as hemoglobin <12.0 g/dL in women and <13.0 g/dL in men. The main outcomes were 30-day and late mortality. RESULTS: Patients with preoperative anemia had an increased prevalence of significant comorbidities and were associated with higher unadjusted risk of early and late adverse events. Propensity score matching resulted in 560 pairs with similar baseline and operative characteristics. In these matched pairs, anemic patients had an increased risk of late all-cause death (P = 0.047) and acute kidney injury (P < 0.0001). However, when adjusted for the severity of perioperative bleeding, preoperative anemia was not associated with an increased mortality risk (HR 1.10, 95% CI 0.86-1.39). Instead, this regression model showed that the European CABG registry (E-CABG) bleeding classification was an independent predictor of late mortality (compared to grade 0: grade 1, HR 1.93, 95% CI 1.37-2.73, grade 2, HR 2.19, 95% CI 1.50-3.18, grade 3, HR 5.59, 95% CI 3.34-9.39, P < 0.0001). CONCLUSIONS: When adjusted for important baseline characteristics and operative factors as well as for the severity of perioperative bleeding and the amount of transfused blood products, anemia was not associated with an increased risk of adverse events. Increased exposure to blood transfusion among anemic patients may be the determinant of their poorer late survival.

Outcome of Jehovah's Witnesses after adult cardiac surgery: systematic review and meta-analysis of comparative studies.

BACKGROUND: The objective was to evaluate the early outcome after adult cardiac surgery in Jehovah's Witnesses (JWs) compared with controls not refusing blood transfusions. STUDY DESIGN AND METHODS: A literature review was performed through PubMed, Scopus, and Google Scholar to identify any comparative study evaluating the outcome of JWs and patients not refusing blood transfusion after adult cardiac surgery. RESULTS: Six studies comparing the outcome of 564 JWs and 903 controls fulfilled the inclusion criteria of this study. All series included a matched control cohort. Baseline characteristics of these two cohorts were similar, but JWs had higher hemoglobin (Hb) levels as reported in three studies. Pooled analysis of postoperative outcomes showed that JWs had higher postoperative levels of Hb (data from four studies: mean, 11.5 g/L vs. 9.8 g/L; p < 0.001) and significantly less postoperative blood loss (mean, 402 mL vs. 826 mL; p < 0.001) compared to controls. JWs and controls had similar early outcome. However, JWs had a nonsignificant trend toward decreased early mortality (2.6% vs. 3.6%; p = 0.318), reoperation for bleeding (3.2% vs. 4.7%; p = 0.070), atrial fibrillation (9.9% vs. 14.3%; p = 0.056), stroke (2.2% vs. 3.1%; p = 0.439), myocardial infarction (0.4% vs. 1.4%; p = 0.203), and length of stay in the intensive care unit (1.5 days vs. 2.0 days; p = 0.081). CONCLUSION: JWs undergoing adult cardiac surgery have a nonsignificant trend toward better early outcome than controls receiving or not blood transfusions. The suboptimal quality of available studies prevents conclusive results on the possible benefits of a transfusion-free strategy in patients not refusing blood transfusion.

Glycated Hemoglobin and Risk of Sternal Wound Infection After Isolated Coronary Surgery.

BACKGROUND: Glycated hemoglobin (HbA1c) is a suspected risk factor for sternal wound infection (SWI) after CABG.Methods and Results:Data on preoperative HbA1c and SWI were available in 2,130 patients undergoing isolated CABG from the prospective E-CABG registry. SWI occurred in 114 (5.4%). Baseline HbA1c was significantly higher in patients with SWI (mean, 54±17 vs. 45±13 mmol/mol, P<0.0001). This difference was also observed in patients without a diagnosis of diabetes (P=0.027), in insulin-dependent diabetic (P=0.023) and non-insulin-dependent diabetic patients (P=0.034). In the overall series, HbA1c >70 mmol/mol (NGSP units, 8.6%) was associated with the highest risk of SWI (20.6% vs. 4.6%; adjusted OR, 5.01; 95% CI: 2.47-10.15). When dichotomized according to the cut-off 53 mmol/mol (NGSP units, 7.0%) as suggested both for diagnosis and optimal glycemic control of diabetes, HbA1c was associated with increased risk of SWI in the overall series (10.6% vs. 3.9%; adjusted OR, 2.09; 95% CI: 1.24-3.52), in diabetic patients (11.7% vs. 5.1%; adjusted OR, 2.69; 95% CI: 1.38-5.25), in patients undergoing elective surgery (9.9% vs. 2.7%; adjusted OR, 2.09; 95% CI: 1.24-3.52) and in patients with bilateral mammary artery grafts (13.7% vs. 4.8%; adjusted OR, 2.35; 95% CI: 1.17-4.69). CONCLUSIONS: Screening for HbA1c before CABG may identify untreated diabetic patients, as well as diabetic patients with suboptimal glycemic control, at high risk of SWI.

Validation of a New Classification Method of Postoperative Complications in Patients Undergoing Coronary Artery Surgery.

OBJECTIVE: The authors aimed to validate the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) classification of postoperative complications in patients undergoing coronary artery bypass grafting (CABG). DESIGN: Retrospective, observational study. SETTING: University hospital. PARTICIPANTS: A total of 2,764 patients with severe coronary artery disease. Complete baseline, operative, and postoperative data were available for patients who underwent isolated CABG. INTERVENTIONS: Isolated CABG. MEASUREMENTS AND MAIN RESULTS: The E-CABG complication classification was used to stratify the severity and prognostic impact of adverse postoperative events. Primary outcome endpoints were 30-day, 90-day, and long-term all-cause mortality. The secondary outcome endpoints was the length of intensive care unit stay. Both the E-CABG complication grades and additive score were predictive of 30-day (area under the receiver operating characteristics curve 0.866, 95% confidence interval [CI] 0.829-0.903; and 0.876; 95% CI 0.844-0.908, respectively) and 90-day (area under the receiver operating characteristics curve 0.850, 95% CI 0.812-0.887; and 0.863, 95% CI 0.829-0.897, respectively) all-cause mortality. The complication grades were independent predictors of increased mortality at actuarial (log-rank: p<0.0001) and adjusted analysis (p<0.0001; grade 1: hazard ratio [HR] 1.757, 95% CI 1.111-2.778; grade 2: HR 2.704, 95% CI 1.664-4.394; grade 3: HR 5.081, 95% CI 3.148-8.201). When patients who died within 30 days were excluded from the analysis, this grading method still was associated with late mortality (p<0.0001). The grading method (p<0.0001) and the additive score (rho, 0.514; p<0.0001) were predictive of the length of intensive care unit stay. CONCLUSIONS: The E-CABG postoperative complication classification seems to be a promising tool for stratifying the severity and prognostic impact of postoperative complications in patients undergoing cardiac surgery.

Red blood cell storage time and the outcome after coronary surgery.

BACKGROUND: The impact of transfusion of aged red blood cells (RBCs) on the outcome after coronary artery bypass grafting (CABG) is controversial. This issue has been investigated in the present study. MATERIALS AND METHODS: Data on perioperative blood transfusion, storage time of RBCs, and adverse events were available for 819 consecutive patients who underwent isolated CABG and received two to four units of RBCs. The maximum RBC storage time was 35 d. RESULTS: Repeated-measure test showed that transfusion of all RBC units >14 d and at least one RBC unit >14 d was associated with similar postoperative C-reactive protein (P = 0.245 and P = 0.103, respectively) or creatinine levels (P = 0.414 and P = 0.259, respectively) compared with newer RBC units. Propensity score-adjusted analysis showed similar immediate and late outcome in patients receiving only newer RBCs compared with those who received only older RBCs. Similar findings were observed in patients receiving only newer RBCs compared with patients who received at least one unit of older RBCs. Logistic and proportional hazards analyses adjusted for the number of RBC units showed that the median storage duration of RBCs was not associated with either any of the immediate outcome end points or late mortality. CONCLUSIONS: These findings suggest that, when the maximum RBC storage time is 35 d, the duration of storage of transfused RBCs does not affect the immediate and late outcome of patients with moderate bleeding after CABG.

Use of Blood Products and Diseased Ascending Aorta Are Determinants of Stroke After Off-Pump Coronary Artery Bypass Grafting.

OBJECTIVE: To examine the effect of blood products on the occurrence of stroke after coronary artery surgery. DESIGN: Institutional retrospective analysis. SETTING: University hospital. PARTICIPANTS: One thousand three hundred fourteen patients undergoing coronary artery surgery. INTERVENTIONS: Off-pump coronary artery bypass grafting (OPCAB). Epiaortic ultrasound was performed in all patients. MEASUREMENTS AND MAIN RESULTS: Complete pre-, intra- and postoperative data including the number of transfused blood products as well as the timing, type, and course of stroke were available in all patients. Postoperative stroke occurred in 23 patients (1.8%). Logistic regression identified transfusion of platelets (3.6% v 1.1%, p = 0.003, OR 3.34, 95%CI 1.46-7.67) and diseased ascending aorta (3.0% v 1.2%, p = 0.022, OR 2.64, 95% CI 1.15-6.06) as independent predictors of stroke. When these variables were adjusted for CHA2DS2VASc (p = 0.005, OR 1.44, 95% CI 1.12-1.86), only transfusion of platelets (p = 0.012, OR 2.91, 95% CI 1.26-6.70) was associated with stroke. Neither nadir hematocrit on the day of surgery nor nadir hematocrit during the perioperative period was an independent predictor of stroke. Chi-squared automatic interaction detection analysis identified solvent/detergent-treated plasma (Octaplas; Octapharma AG, Lachen, Switzerland) units >2 and platelet units >4 along with diseased ascending aorta as independent predictors of stroke. The stroke rate was 8.9% in patients receiving >2 units of Octaplas and having a diseased ascending aorta. In patients receiving ≤2 units of Octaplas, the stroke rate was as high as 3.8% in patients receiving >4 units of platelets. CONCLUSIONS: The results of this study indicated that atherosclerosis of the ascending aorta as well as transfusion of platelets and/or Octaplas were independent predictors of stroke after OPCAB.

Patient-Prosthesis Mismatch Worsens Long-Term Survival: Insights From the FinnValve Registry.

BACKGROUND: The impact of patient-prosthesis mismatch (PPM) on long-term outcome after surgical aortic valve replacement (SAVR) is controversial. We sought to investigate the incidence of PPM and its impact on survival and reinterventions in a Finnish nationwide cohort. METHODS: In the context of the nationwide FinnValve registry, we identified 4097 patients who underwent SAVR with a stented bioprosthesis with or without myocardial revascularization. The indexed effective orifice areas (EOAs) of surgical bioprostheses were calculated using literature-derived EOAs. PPM was graded as moderate (EOA 0.65-0.85 cm2/m2) or severe (EOA ≤0.65 cm2/m2). RESULTS: The incidence of PPM was 46.0%. PPM was moderate in 38.8% (n = 1579) patients and severe in 7.2% (n = 297) patients. Time-trend analysis showed that the proportion of PPM decreased significantly from 74% in 2009 to 18% in 2017 (P < .01). Severe PPM was associated with increased 5-year all-cause mortality (adjusted hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.07-2.76; P = .02). Severe PPM was not associated with an increased risk of repeat AVR (adjusted HR, 5.90; 95% CI, 0.95-36.5; P = .06). In a subanalysis of patients greater than or equal to 70 years of age, in comparison with no PPM, any PPM (adjusted HR, 1.23; 95% CI, 1.05-1.45; P = .01) and severe PPM (HR, 1.53; 95% CI, 1.17-2.00; P < 0.01) were associated with increased risk of 5-year mortality. CONCLUSIONS: Severe PPM after SAVR had a negative impact on survival. This study demonstrated that the effects of PPM should not be overlooked in elderly undergoing SAVR.

Acute Kidney Injury Following Aortic Valve Replacement in Patients Without Chronic Kidney Disease.

BACKGROUND: The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD. METHODS: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2. AKI was defined according to the Kidney Disease Improving Global Outcomes criteria. For sensitivity analysis, propensity-score matching between TAVR and SAVR was performed. RESULTS: The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P < 0.001, multivariable analysis: odds ratio, 0.29, 95% confidence interval [CI], 0.20-0.41; matched 5.9% vs 19.0%, P < 0.001). Patients with AKI had significantly increased 5-year mortality compared with those without AKI (unmatched 36.0% vs 19.1%, log-rank P < 0.001; matched 36.3% vs 24.0%, log-rank P < 0.001). The adjusted hazard ratios for 5-year mortality were 1.58 (95% CI, 1.20-2.08) for AKI grade 1, 3.27 (95% CI, 2.09-5.06) for grade 2, and 4.82 (95% CI, 2.93-8.04) for grade 3. CONCLUSIONS: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality.

Comparison of Survival of Transfemoral Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Risk Patients Without Coronary Artery Disease.

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　- Results From the FinnValve Registry.

Background: The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR). Methods and Results: The FinnValve registry enrolled consecutive TAVR patients from 2008 to 2017. MVC was divided into 2 groups: non-access site-related MVC (i.e., MVC in aorta, aortic valve annulus or left ventricle); and access site-related MVC (i.e., MVC in iliac or femoral arteries). Severity of access site-related MVC was measured as units of red blood cell (RBC) transfusion. Of 1,842 patients who underwent TF-TAVR, 174 had MVC (9.4%; non-access site related, n=29; access site related, n=145). Patients with MVC had a significantly higher 3-year mortality than those without MVC (40.8% vs. 24.3%; HR, 2.01; 95% CI: 1.16-3.62). Adjusted 3-year mortality risk was significantly increased in the non-access site-related MVC group (mortality, 77.8%; HR, 4.30; 95% CI: 2.63-7.02), but not in the access site-related MVC group (mortality, 32.6%; HR, 1.38; 95% CI: 0.86-2.15). In the access site-related MVC group, only those with RBC transfusion ≥4 units had a significantly increased 3-year mortality risk (mortality, 51.8%; HR, 2.18; 95% CI: 1.19-3.89). Conclusions: In patients undergoing TF-TAVR, MVC was associated with an increased 3-year mortality risk, incrementally correlating with anatomical site and bleeding severity.

Trifecta Versus Perimount Magna Ease Aortic Valve Prostheses.

BACKGROUND: Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability. METHODS: This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017. RESULTS: Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P = .009). CONCLUSIONS: The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings.

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis.

BACKGROUND: There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. METHODS: In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. RESULTS: A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. CONCLUSIONS: The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03385915 .