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OBJECTIVE Patients undergoing transapical aortic valve implantation (TA-AVI) are usually over 80 years old and have a high prevalence of chronic kidney disease. However, transcatheter valve therapies require the use of contrast injections with the risk of nephrotoxicity. The aim of this study was to evaluate post-operative kidney function and survival in patients with pre-existing renal impairment with regard to the amount of contrast media used during TA-AVI. METHODS From January 2008 to March 2011, 50 patients (52% females, mean age 80.7 ± 5.3 years) with a serum creatinine level of >1.3 mg/dl were investigated. Patients receiving a dose of <100 ml of a contrast agent (low-dose group, n = 24) were separated from those who received >100 ml of a contrast agent (high-dose group, n = 26). An acute contrast-induced nephropathy (CIN) was defined as a serum creatinine increase of 0.5 mg/dl or by >25% of a baseline value within 48 h from contrast medium administration. Patients in both groups had similar characteristics in terms of age, sex, body mass index and comorbidities. RESULTS The median pre-contrast creatinine was 1.67 (1.37–1.83) mg/dl in the low-dose group and 1.51 (1.26–1.98) mg/dl in the high-dose group (P = 0.76). The post-contrast creatinine at 48 h was 1.53 (1.33–2.05) and 2.29 (1.67–2.86) mg/dl in the groups receiving low- and high-dose contrast agents, respectively (P = 0.007). CIN occurred in 41.7% (n = 10) of patients in the low-dose contrast group and in 69.2% (n = 18) in the high-dose contrast group (P = 0.046). Haemodialysis is necessary for 16.7% of the low-dose group and 38.5% of the high-dose group (P = 0.12). Trends towards longer intensive care unit and hospital stay were seen in patients with an extensive use of contrast media [4.3 (2.5–6.5) vs. 5 (3–7.8) days and 12 (9–14.3) vs. 13 (9–18) days, P = 0.091 vs. P = 0.546, respectively]. Regarding death, 3-month and 3-year mortality were significantly higher in the high-dose group (8.3 vs. 30.8%, P = 0.036 and 25 vs. 61.5%, P = 0.004, respectively). CONCLUSIONS Our results indicate a possible association between higher CIN and mortality rate and the extensive use of contrast media during TA-AVI among high-risk patients with pre-existing renal impairment. [ABSTRACT FROM AUTHOR]

Purpose: Baroreflex activation therapy (BAT) has been shown to lower blood pressure in patients with resistant hypertension. The purpose of this study was to analyze whether this translates into a reduction of more relevant clinical endpoints. Methods: Patients with resistant hypertension were treated with the second-generation BAT system. Records on hospitalization (dates of admission and discharge, main diagnosis) were obtained from medical insurance companies. Results: Records on hospitalization were available for a period of 1 year before BAT in two patients and 2 years in 22 patients. The total number of hospitalizations per patient was 3.3 ± 3.5/year before BAT and 2.2 ± 2.7/year after BAT (p = 0.03). Hospitalizations related to hypertension were significantly decreased from 1.5 ± 1.6/year before BAT to 0.5 ± 0.9/year after BAT (p < 0.01). The cumulative duration of hypertension-related hospital stays was significantly reduced from 8.0 ± 8.7 days/year before BAT to 1.8 ± 4.8 days/year after BAT (p < 0.01). Office cuff blood pressure was 183 ± 27 mmHg over 102 ± 17 mmHg under 6.6 ± 2.0 antihypertensive drugs before BAT and 157 ± 32 mmHg over 91 ± 20 mmHg (both p < 0.01) under 5.9 ± 1.9 antihypertensive drugs (p = 0.09 for number of drugs) at latest follow-up. Daytime ambulatory blood pressure was 164 ± 21 mmHg over 91 ± 14 mmHg before BAT and 153 ± 21 mmHg (p = 0.03) over 89 ± 15 mmHg (p = 0.56) at latest follow-up. Heart rate was 75 ± 16 bpm before BAT and 72 ± 12 bpm at latest follow-up (p = 0.35). Conclusions: Rate and duration of hypertension-related hospitalizations in patients with severe resistant hypertension were lowered after BAT. Whether the response is mediated through improvements in blood pressure control requires further studies. [ABSTRACT FROM AUTHOR]

Aims: To identify predictors of paravalvular regurgitation (PVR) and permanent pacemaker implantation (PPI) following TAVR with a next-generation self-expanding device., Methods and Results: Device landing zone (DLZ) calcification, angiographic implantation depth, and baseline and procedural characteristics were analyzed in 212 patients being treated with the ACURATE neo aortic bioprosthesis. PVR was none/trace in 57.1% and ≥ mild in 42.9% (37% mild, 6% moderate). DLZ calcification (705 (IQR 240-624) vs. 382 (IQR 240-624) mm 3 ; P < 0.001) as well as absolute calcium asymmetry (233 ± 159 vs. 151 ± 151 mm 3 ; P < 0.001) was significantly higher in patients with PVR ≥ mild. On multivariate analysis, calcification of the aortic valve cusps (AVC) > 410.6 mm 3 was independently associated with PVR ≥ mild. PPI rate was 10.3% (n = 20). Patients with and without need for PPI had similar total DLZ calcium volume (740 (IQR 378-920) vs. 536 (IQR 315-822) mm 3 ; P = 0.263), but exhibited different calcium distribution patterns: LVOT calcium > 41.4 mm 3 in the sector below the left coronary cusp (LVOT LC ) was associated with increased PPI risk (26.9 vs. 7.7%; P = 0.008)., Conclusions: The quantity of AVC calcium predicts residual PVR. Multivariable analysis identified LVOT LC calcium, pre-existing RBBB, and age > 82.7 years as independent predictors of PPI. Based on these risk factors, a patient's individual PPI risk can be stratified ranging from 3.8 to 100%.

Objectives: The objective of the current work was to evaluate flow and turbulent kinetic energy in different transcatheter aortic valve implants using highly undersampled time-resolved multi-point 3-directional phase-contrast measurements (4D Flow MRI) in an in vitro setup., Materials and Methods: A pulsatile flow setup was used with a compliant tubing mimicking a stiff left ventricular outflow tract and ascending aorta. Five different implants were measured using a highly undersampled multi-point 4D Flow MRI sequence. Velocities and turbulent kinetic energy values were analysed and compared., Results: Strong variations of turbulent kinetic energy distributions between the valves were observed. Maximum turbulent kinetic energy values ranged from 100 to over 500 J/m 3 while through-plane velocities were similar between all valves., Conclusion: Highly accelerated 4D Flow MRI for the measurement of velocities and turbulent kinetic energy values allowed for the assessment of hemodynamic parameters in five different implant models. The presented setup, measurement protocol and analysis methods provides an efficient approach to compare different valve implants and could aid future novel valve designs.

Background: We investigated the application and feasibility of a novel software tool designed for the visualization of the aortic root during transcatheter aortic valve implantation (TAVI). The final positioning of the device prior deployment remains the most critical phase during TAVI., Methods: Philips "Vascular Outlining" prototype application was used during balloon expandable Edwards Lifesciences SapienXT valve deployment. It processes any angiographic sequences, extracting the static outline of vessels and projecting the two-dimensional vessel margins as a roadmap on live fluoroscopy. Preoperational planning, sizing and anatomical assessment of access routes were performed using computed tomography scans and the Philips "HeartNavigator" software., Results: Fifteen high-risk aortic stenosis patients (mean age 82.0±6.6 years) underwent TAVI via transfemoral (N.=8), transapical (N.=4), and transaortic (N.=3) access routes. Mean logistic EuroSCOREs and STS-scores were 19.7±4.3% and 7.9±3.1%, respectively, mean aortic gradient was 66.3±18.3 mmHg. All valves were implanted successfully with none or trivial paravalvular regurgitation in 11 patients, mild in 3 patients, and moderate in 1 patient. TAVI was performed in all cases with only one aortic root contrast media injection during valve deployment. No major stroke or cardiovascular death occurred within 30 days., Conclusions: "Vascular Outlining"-guided implantation of the SapienXT valve is feasible. This new feature might increase the accuracy of valve placement and also may reduce the need for extra contrast media use during valve deployment. However, the lack of real-time motion compensation limits its wide application, as the overlay does not move together with respiratory and cardiac motion.

Background: The aim of this study was to evaluate the effects of rapid deployment aortic valve replacement (RDAVR) on surgical outcome and hemodynamics compared with standard aortic valve replacement (AVR)., Methods: One hundred sixty-three RDAVR patients (isolated, n = 67; combined with coronary artery bypass graft surgery [CABG], n = 96) were compared with a propensity matched control group (n = 163). Primary endpoints included association between valve type and procedure times, prosthesis size, transvalvular gradient, and indexed effective orifice area. Secondary endpoints were postoperative mortality and morbidity., Results: Aortic cross-clamp and cardiopulmonary bypass times in the RDAVR group were 55 ± 23 and 88 ± 38 minutes, respectively, compared with 77 ± 22 and 105 ± 38 minutes in the control group (p < 0.001). In the subgroup of patients undergoing isolated RDAVR (n = 67 of 163), the aortic cross-clamp and cardiopulmonary bypass times were 38 ± 13 and 66 ± 22 minutes, respectively, compared with 55 ± 14 and 81 ± 18 minutes in the control group (n = 67 of 163; p < 0.001). The RDAVR patients received larger prostheses (23.3 ± 1.8 mm) compared with standard AVR (22.8 ± 1.5 mm; p = 0.002). Mean transvalvular gradients and indexed effective orifice areas were 9 ± 5 mm Hg and 1.11 ± 0.11, respectively, in the RDVAR group compared with 13 ± 5 mm Hg and 0.95 ± 0.08 in the control group (p < 0.001). Hospital mortality was similar in both groups (1.8%, n = 3 of 163; p = 1.000). Postoperative pacemaker rates were 3.5% (n = 3 of 67) for isolated RDAVR versus 3.0% (n = 2 of 67; p = 0.649) for isolated AVR and 12.5% (n = 12 of 96) for RDAVR/CABG versus 4.2% (n = 4 of 96; p = 0.032) for AVR/CABG., Conclusions: RDAVR facilitates reduced aortic cross-clamp and cardiopulmonary bypass times compared with standard AVR, particularly in patients undergoing concomitant procedures, allowing the use of larger prostheses and resulting in lower transvalvular gradients and higher indexed effective orifice area compared with standard AVR. Therefore, RDAVR may help to overcome patient-prosthesis mismatch in some patients., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Previous research suggests that female gender is associated with increased mortality rates after surgery for Stanford A acute aortic dissection (AAD). However, women with AAD usually present with different clinical symptoms that may bias outcomes. Moreover, there is a lack of long-term results regarding overall mortality and freedom from major cerebrovascular events. We analysed the impact of gender on long-term outcomes after surgery for Stanford A AAD by comparing genders with similar risk profiles using propensity score matching., Methods: A total of 240 patients operated for Stanford A AAD were included in this study. To control for selection bias and other confounders, propensity score matching was applied to gender groups., Results: After propensity score matching, the gender groups were well balanced in terms of risk profiles. There were no statistically significant differences regarding duration of cardiopulmonary bypass ( P  = 0.165) and duration of aortic cross-clamp time ( P  = 0.111). Female patients received less fresh frozen plasma ( P  = 0.021), had shorter stays in the intensive care unit ( P  = 0.031), lower incidence of temporary neurological dysfunction ( P  < 0.001) and lower incidence of dialysis ( P  = 0.008). There were no significant differences regarding intraoperative mortality ( P  = 1.000), 30-day mortality ( P  = 0.271), long-term overall cumulative survival ( P  = 0.954) and long-term freedom from cerebrovascular events ( P  = 0.235) with up to a 9-year follow-up., Conclusions: Considering patients with similar risk profiles, female gender per se is not associated with worse long-term survival and freedom from stroke after surgical aortic repair. Moreover, female patients might even benefit from a smoother early postoperative course and lower incidence of early postoperative complications., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim of this study was to identify predictors of permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter valve (Edwards SAPIEN 3)., Background: New-onset conduction disturbances requiring PPMI remain a major concern following TAVR. Predictors are not yet well defined., Methods: The influence of angiographic implantation depth, device landing zone calcium volume, oversizing, pre- and post-dilation, and baseline conduction disturbances on PPMI rate was analyzed in 229 patients undergoing TAVR with the SAPIEN 3 device., Results: PPMI was performed in 14.4% of patients. Patients requiring PPMI had higher left ventricular outflow tract (LVOT) calcium volume in the area below the left coronary cusp (LVOT LC ) and the area below right coronary cusp (LVOT RC ) (LVOT LC median calcium 23.7 mm 3 vs. 3.0 mm 3 ; p < 0.001; LVOT RC median calcium 6.6 mm 3 vs. 0.3 mm 3 ; p = 0.014), a higher prevalence of pre-existing right bundle branch block (15% vs. 2%, p = 0.004), and lower implantation depth (ventricular portion of the stent frame 29 ± 12% vs. 21 ± 5%; p < 0.001). On multivariate regression analysis, LVOT LC calcium volume >13.7 mm 3 , LVOT RC calcium volume >4.8 mm 3 , pre-existing right bundle branch block, and implantation depth >25.5% emerged as independent predictors of PPMI. Upon modification of the implantation technique, aiming at a high final valve position, implantation depth decreased from 24% ventricular portion to 21% (p = 0.012), accompanied by a decrease in PPMI rate (19.2% vs. 9.2%; p = 0.038)., Conclusions: LVOT LC and LVOT RC calcium load, baseline right bundle branch block, and implantation depth were identified as independent predictors of the need for PPMI post-TAVR. Patient groups with different PPMI risk could be stratified using these 4 predictors. A slightly higher valve implantation site may prevent excessive PPMI rates., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The choice of an optimal cannulation site for aortic repair in patients with Stanford A acute aortic dissection remains controversial. The aim of this study was to compare the early results and long-term outcomes of axillar and direct aortic cannulation., Methods: A total of 235 consecutive patients who underwent surgical aortic repair with the use of axillar or direct aortic cannulation from January 2006 to April 2015 were analyzed. The primary end points were long-term overall cumulative survival and freedom from major cerebrovascular events with up to 10 years of follow-up. The secondary end points were early postoperative clinical characteristics and rates of adverse events. To control for confounders, a 1:3 propensity score matching was performed., Results: After matching, there were no statistically significant differences between the two groups regarding baseline characteristics. Both groups were associated with comparable outcomes; among other things, the length of stay in the intensive care unit (ICU) (p = 0.220), mechanical ventilation (p = 0.177), total hospital stay (p = 0.243), and hospital rates of adverse events. There were no statistically significant differences (p = 0.625) in terms of freedom from major cerebrovascular events. However, both early (p = 0.009) and late (p = 0.016) overall survival were significantly poorer for patients undergoing aortic cannulation., Conclusions: The outcomes were comparable regarding early hospital outcomes and rates of adverse events. Whereas postoperative freedom from major cerebrovascular events was similar, survival over long-term follow-up was significantly poorer when direct aortic cannulation was used. More investigations are needed to enable an understanding of the underlying factors for potentially higher late mortality when direct aortic cannulation is used during a surgical procedure for acute Stanford A dissection., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Contrast-induced nephropathy (CIN) is the third most common cause of acute renal failure and is associated with increased morbidity and in-hospital mortality. Some recent studies identified female sex as a risk factor of CIN. The aim of this study was to determine the relative impact of female sex on the development and clinical outcome of CIN in patients with preexisting renal impairment after transapical transcatheter aortic valve implantation (TAVI)., Methods: From February 2008 to February 2011, a total of 55 TAVI patients [82.4 (6.5) years] with preprocedural serum creatinine level of greater than 1.1 mg/dL were retrospectively investigated. The incidence of postprocedural CIN, lengths of intensive care unit and hospital stay, and short-term mortality among men and women were compared. Contrast-induced nephropathy was defined as a creatinine increase of greater than 0.5 mg/dL or greater than 25% from baseline within 3 days after contrast medium (CM) exposure., Results: The women had significantly lower body surface area [1.8 (0.18) vs 1.95 (0.17) m2; P = 0.002), lower hemoglobin levels [11.5 (1.3) vs 12.7 (1.6) g/dL, P < 0.001], and lower estimated glomerular filtration rate [34.2 (9.7) vs 49.4 (12.3) mL/min per 1.73 m2, P = 0.002]. The amount of CM given was significantly higher in the women relative to body surface area [67.3 (42.5) vs 48.3 (16.6) mL/m2, P = 0.043]. The women received a higher number of blood cell transfusion units [4.4 (3.4) vs 2.1 (2.7) U, P = 0.006]. The frequency of CIN within 72 hours after CM exposure was significantly higher in the women (62.1% vs 26.9%, P = 0.009). A total of 31% of the women (n = 9) versus 7.7% of the men (n = 2) needed hemodialysis (P = 0.031). Analysis of the postoperative morbidity in terms of length of intensive care unit and hospital stay revealed no significant difference between the two groups. Mortality results reached a significant difference at 60 days, with 31% (n = 9) mortality in the women compared with 7.7% (n = 2) in the men (P = 0.031)., Conclusions: Women with preexisting renal impairment are at higher risk than men for CIN, with resultant higher early mortality after transapical TAVI.

Background and Aim of the Study: Positioning of a mechanical prosthesis outside the native annulus facilitates mitral valve replacement, especially when the annulus is small and calcified, and preservation of the posterior leaflet (PML) is desired. Herein is described the authors' initial experience with a new mechanical bileaflet prosthesis comprising a sheltered leaflet housing and a novel, modified asymmetrical sewing ring for an 'atrialized' implantation technique., Methods: Forty-seven patients (24 males, 23 females; mean age 65.8 +/- 10.9 years) were operated on for isolated mitral regurgitation or combined stenosis and insufficiency. Ten of the patients underwent valve replacement due to active endocarditis. Preoperative cardiac insufficiency was reflected by a mean NYHA class of 2.6 +/- 0.7. The On-X Conform-X bileaflet mitral valve prosthesis (25/33 mm) was implanted in either an epiannular (43 patients) or intra-annular (four patients) fashion, and the PML and its chordae tendineae were preservable in 33 patients (70.2%). All patients were monitored intraoperatively by transesophageal echocardiography (TEE) and post-operatively by transthoracic echocardiography (TTE)., Results: TEE and TTE exhibited excellent function with low mean transvalvular gradients early after surgery (4.9 +/- 2.7 mmHg) and after three months (4.8 +/- 1.4 mmHg). Paravalvular leakage was not detected. Initial postoperative left ventricular (LV) function was almost identical to preoperative findings (ejection fraction: preop. 55.1 +/- 13.7%, early postop. 53.7 +/- 13.6%) and improved slightly after three months (60.1 +/- 6.4%). Clinically significant hemolysis was not apparent (LDH at postoperative day 7: 5.3 +/- 0.8 micromol/l x s). Two patients died from multiorgan failure (4.2%) and four are currently in a reduced condition requiring long-term hospitalization (morbidity 8.5%). After three months all other patients were in an excellent clinical state (mean NYHA class 1.5 +/- 0.6) and being followed up as outpatients., Conclusion: Current designs of mechanical bileaflet valves require redundant space in the LV cavity for undisturbed leaflet movement. A small annulus, marked fibrosis and calcification of the valvular apparatus can lead to an impedance of prosthetic leaflet motion. Consequently, the native leaflets are often removed. The cylindrical housing of the On-X valve shelters almost the entire motion of the leaflets, allowing an undisturbed function and improved transvalvular flow pattern. The newly developed asymmetrical sewing ring facilitates anchoring of the ring in an 'atrialized' fashion, while the flexibility of the cuff adapts to all native ring diameters larger than 25 mm.