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Background: Renal denervation is a new treatment considered for several possible indications. As new systems are introduced, the incidence of acute renal artery wall injury with relation to the denervation method is unknown. We investigated the acute repercussion of renal denervation on the renal arteries of patients treated with balloon-based and nonballoon-based denervation systems by quantitative angiography, intravascular ultrasound, and optical coherence tomography (OCT)., Methods and Results: Twenty-five patients (50 renal arteries) underwent bilateral renal denervation with 5 different systems, 3 of which balloon-based (Paradise [n=5], Oneshot [n=6], and Vessix V2 [n=5)]) and 2 nonballoon-based (Symplicity [n=6] and EnligHTN [n=3]). Analysis included quantitative angiography and morphometric intravascular ultrasound measurements pre and post procedure and assessment of vascular trauma (dissection, edema, or thrombus) by OCT after denervation. A significant reduction in lumen size by quantitative angiography and intravascular ultrasound was observed in nonballoon denervation but not in balloon denervation. By postdenervation OCT, dissection was seen in 14 arteries (32.6%). The percentage of frames with dissection was higher in balloon-based denervation catheters. Thrombus and edema were detected in 35 (81.4%) and 32 (74.4%) arteries, respectively. In arteries treated with balloon-based denervation that had dissection by OCT, the balloon/artery ratio was higher (1.24 [1.17-1.32] versus 1.10 [1.04-1.18]; P<0.01)., Conclusions: A varying extent of vascular injury was observed after renal denervation in all systems; however, different patterns were identified in balloon-based and in nonballoon-based denervation systems. In balloon denervation, the presence of dissections by OCT was associated with a higher balloon/artery ratio., (© 2015 American Heart Association, Inc.)

Background: As bioresorbable vascular scaffolds (BVSs) are being increasingly used in complex real-world lesions and populations, BVS thrombosis cases have been reported. We present angiographic and optical coherence tomography (OCT) findings in a series of patients treated in our center for definite bioresorbable scaffold thrombosis., Methods and Results: Up to June 2014, 14 patients presented with definite BVS thrombosis in our center. OCT was performed in 9 patients at the operator's discretion. Angiographic and OCT findings were compared with a control group comprising 15 patients with definite metallic stent thrombosis. In the BVS group, time interval from index procedure to scaffold thrombosis ranged from 0 to 675 days. Incomplete lesion coverage by angiography was identified in 4 of 14 cases, malapposition by OCT in 5 of 9 cases, strut discontinuity in 2 of 9 cases, and underexpansion in 2 of 9 cases. Five patients had discontinued dual antiplatelet therapy, and in 3 of them discontinued dual antiplatelet therapy discontinuation had occurred the week preceding the event. There were no significant differences in angiographic or OCT findings between BVS and metallic stent thrombosis., Conclusions: Suboptimal implantation with incomplete lesion coverage, underexpansion, and malapposition comprises the main pathomechanism for both early and late BVS thrombosis, similar to metallic stent thrombosis. Dual antiplatelet therapy discontinuation seems to also be a secondary contributor in several late events. Our observations suggest that several potential triggers for BVS thrombosis could be avoided., (© 2015 American Heart Association, Inc.)

Background: There is scant information on the prevalence and factors associated with preoperative anemia in patients undergoing transcatheter aortic valve implantation (TAVI) and whether it is associated with mortality. We sought to determine the prevalence and factors associated with preoperative anemia in addition to the prognostic effects of the various levels of preoperative hemoglobin level on mortality in patients undergoing TAVI., Methods and Results: Ten-center observational study encompassing 1696 patients with aortic stenosis who underwent TAVI was conducted. Anemia was defined by the World Health Organization criteria (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men). The prevalence of preoperative anemia was 57%. Patient-related factors associated with preoperative anemia were (descending order of odds ratio [95% confidence interval]) as follows: anemia-related medication (4.90 [3.08-7.80]), history of heart failure (1.77 [1.43-2.20]), male sex (1.69 [1.32-2.16]), mitral regurgitation grade ≥III (1.61 [1.15-2.25]), history of malignancy (1.44 [1.03-2.09]), and peripheral vascular disease (1.33 [1.04-1.70]). The creatinine clearance was inversely associated with preoperative anemia (odds ratio, 0.92 [0.87-0.97]). In multivariable analyses, preoperative anemia was not associated with 30-day mortality (1.72 [0.96-3.12]; P=0.073) but showed the strongest association with 1-year mortality with a hazard ratio (95% confidence interval) of 2.78 (1.60-4.82) in patients with hemoglobin <10 g/dL. Patients with anemia received ≥1 blood transfusion 2× more often, but the indication of transfusion was unrelated to overt bleeding in 60%. Blood transfusion was associated with mortality at 30 days (odds ratio, 1.25 [95% confidence interval, 1.08-3.67]) and during follow-up (hazard ratio, 1.09 [95% confidence interval, 1.03-1.14])., Conclusions: Preoperative anemia is prevalent in >50% of patients undergoing TAVI. Various baseline factors were related to anemia, which in turn was associated with 1-year mortality. Patients with anemia received more transfusions but mostly for indications unrelated to overt bleeding, whereas transfusion was independently associated with both early and 1-year mortality. These findings indicate that optimization of baseline factors related to preoperative anemia, in addition to more strict criteria of the use of blood products, may improve outcome after TAVI.

Background: The objective of this study was to evaluate the timing, predictive factors, and prognostic value of cerebrovascular events (CVEs) after transcatheter aortic valve implantation., Methods and Results: The study included 1061 consecutive patients who underwent transcatheter aortic valve implantation with a balloon-expandable (64%) or self-expandable (36%) valve. CVEs were classified as acute (≤24 hours), subacute (1-30 days), or late (>30 days). CVEs occurred in 54 patients (5.1%; stroke, 4.2%) within 30 days after transcatheter aortic valve implantation (acute in 54% of cases). The predictors of acute CVEs were balloon postdilation of the valve prosthesis (odds ratio, 2.46; 95% confidence interval,1.07-5.67) and valve dislodgment/embolization (odds ratio, 4.36; 95% CI, 1.21-15.69); new-onset atrial fibrillation (odds ratio, 2.76; 95% CI, 1.11-6.83) was a predictor of subacute CVEs. Late CVEs occurred in 35 patients (3.3%; stroke, 2.1%) at a median follow-up of 12 months (3-23 months). The predictors of late CVEs were chronic atrial fibrillation (2.84; 95% CI, 1.46-5.53), peripheral vascular disease (hazard ratio, 2.02; 95% CI, 1.02-3.97), and prior cerebrovascular disease (hazard ratio, 2.04; 95% CI, 1.01-4.15). Major stroke was associated with 30-day (odds ratio, 7.43; 95% CI, 2.45-22.53) and late (hazard ratio, 1.75; 95% CI, 1.01-3.04) mortality., Conclusions: In a large cohort of patients undergoing transcatheter aortic valve implantation, the rates of acute and subacute CVEs were 2.7% and 2.4%, respectively. While balloon postdilation and valve dislodgment/embolization were the predictors of acute CVEs, new-onset atrial fibrillation determined a higher risk for subacute events. Late events were determined mainly by a history of chronic atrial fibrillation and peripheral and cerebrovascular disease. The occurrence of major stroke was associated with increased early and late mortality. These results provide important insights for the implementation of preventive measures for CVEs after transcatheter aortic valve implantation.

Background: Blood transfusion is associated with acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI). We sought to elucidate in more detail the relation between blood transfusion and AKI and its effects on short- and long-term mortality., Methods and Results: Nine hundred ninety-five patients with aortic stenosis underwent TAVI with the Medtronic CoreValve or the Edwards Valve in 7 centers. AKI was defined by the Valve Academic Research Consortium (absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours). Logistic and Cox regression was used for predictor and survival analysis. AKI occurred in 20.7% (n=206). The number of units of blood transfusion ≤24 hours was the strongest predictor of AKI (≥5 units, OR, 4.81 [1.45-15.95], 3-4 units, OR, 3.05 [1.24-7.53], 1-2 units, OR, 1.47 [0.98-2.22]) followed by peripheral vascular disease (OR, 1.48 [1.05-2.10]), history of heart failure (OR, 1.43 [1.01-2.03]), leucocyte count ≤72 hours after TAVI (OR, 1.05 [1.02-1.09]) and European System for Cardiac Operative Risk Evaluation (EuroSCORE; OR, 1.02 [1.00-1.03]). Potential triggers of blood transfusion such as baseline anemia, bleeding-vascular complications, and perioperative blood loss were not identified as predictors. AKI and life-threatening bleeding were independent predictors of 30-day mortality (OR, 3.15 [1.56-6.38], OR, 6.65 [2.28-19.44], respectively), whereas transfusion (≥3 units), baseline anemia, and AKI predicted mortality beyond 30 days., Conclusions: AKI occurred in 21% of the patients after TAVI. The number of blood transfusions but not the indication of transfusion predicted AKI. AKI was a predictor of both short- and long-term mortality, whereas blood transfusion predicted long-term mortality. These findings indicate that outcome of TAVI may be improved by more restrictive use of blood transfusions.