Modified implantation height of the Sapien3™ transcatheter heart valve.

Objectives: During transcatheter aortic valve implantation (TAVI), ideal positioning is crucial. The latest-generation balloon expandable Sapien3™ transcatheter heart valve (THV) comes with a marker, which is recommended to be exactly centered at the aortic annular level. We aimed to evaluate a higher "aortic" marker positioning.Material and methods: A total of 119 high-risk patients presenting with aortic stenosis were treated with the Sapien3™ THV. After having placed the THV more "aortic", clinical and hemodynamic data, especially postoperative pacemaker implantation and paravalvular leakages, were evaluated at 30-days according to VARC-2.Results: The Sapien3™ THV was implanted in 92 patients via the transapical, in 13 patients via the transaortic and in 14 patients via the tranfemoral access. Mean age was 80.6 ± 5.7 years. Aortic valve area increased significantly (0.9 ± 0.3 vs. 1.80 ± 0.35cm2, p < .0001) and mean pressure gradients decreased from 41.0 ± 15.0 to 10.4 ± 3.5 mmHg (p < .0001). The majority of patients showed no or mild paravalvular aortic regurgitation (99.1%, 112/113), confirmed by transthoracic echocardiography at 30-days: PVL was absent or trace in 91.2% (103/113), mild in 7.9% (9/113) and moderate in 0.9% (1/113), whereas no patient developed severe PVL. Thirty days mortality was 5.0% (6/119). All patients (n = 113) were in NYHA functional class I or II at 30 days and three patients (2.5%) needed pacemaker implantation.Conclusions: In conclusion, a modified higher "aortic" implantation of the Sapien3™ THV holds promise to further reduce paravalvular leakage as well as permanent pacemaker implantation in TAVI. This trial showed an extremely low postoperative pacemaker implantation rate of 2.5%.

Remote monitoring of implantable cardioverter defibrillators: Patient experiences and preferences for follow-up.

BACKGROUND: Patient satisfaction with remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) seems to be high, yet knowledge on long-term patient experiences is limited. The European REMOTE-CIED study explored patients' experiences with RPM, examined patient's preferences for ICD follow-up, and identified determinants of patient's preferences in the first 2 years postimplantation. METHODS: European heart failure patients (N = 300; median age = 66 years [interquartile range (IQR) = 59-73], and 22% female) with a first-time ICD received a Boston Scientific LATITUDE RPM system (Marlborough, MA, USA) and had scheduled in-clinic follow-ups once a year. Patients completed questionnaires at 1-2 weeks and also at 3, 6, 12, and 24 months postimplantation and clinical data were obtained from their medical records. Patient evaluation data were analyzed descriptively, and Student's t-tests/Man-Whitney U tests or Chi-square tests/Fisher's exact tests were performed to examine determinants of patient preferences. RESULTS: At 2 years postimplantation, the median patient satisfaction score with the RPM system was 9 out of 10 (IQR = 8-10), despite 53% of the patients experiencing issues (eg, failure to transmit data). Of the 221 patients who reported their follow-up preferences, 43% preferred RPM and 19% preferred in-clinic follow-up. Patients with a preference for RPM were more likely to be higher educated (P = 0.04), employed (P = 0.04), and equipped with a new LATITUDE model (P = 0.04), but less likely to suffer from chronic obstructive pulmonary disease (P = 0.009). CONCLUSION: In general, patients were highly satisfied with RPM, but a subgroup preferred in-clinic follow-up. Therefore, physicians should include patients' concerns and preferences in the decision-making process, to tailor device follow-up to individual patients' needs and preferences.

Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low-gradient aortic stenosis.

OBJECTIVES: To evaluate the impact of baseline left ventricular ejection fraction (LVEF) and its interaction with low-gradient aortic stenosis (LGAS) on all-cause mortality after transfemoral aortic valve implantation (TF-TAVI). METHODS: We reviewed mortality data of 624 consecutive single center TF-TAVI patients and categorized LVEF according to current ASE/EACVI recommendations (normal, mildly-, moderately-, and severely abnormal). RESULTS: Baseline LVEF was normal in 336 (53.8%), mildly abnormal in 160 (25.6%), moderately abnormal in 91 (14.6%), and severely abnormal in 37 (5.9%) patients, and 1-year mortality was 19%, 17%, 23%, and 43% (P = 0.002), respectively. Patients with LGAS had a similar 1-year mortality compared to those without LGAS in groups with normal (19% vs 19%, P = 0.899) and mildly abnormal LVEF (16% vs 17%, P = 0.898). One-year mortality of patients with LGAS was significantly greater than in those without LGAS in presence of moderately abnormal LVEF (31% vs 11%, P = 0.022), and it was numerically greater than in those without LGAS in presence of severely abnormal LVEF (48% vs 25%, P = 0.219). In multivariate analysis, only the combination of moderately/severely abnormal LVEF and LGAS predicted increased 1-year mortality (HR: 2.12, 95% CI: 1.4-3.2, P < 0.001). Other variables, including EuroSCORE I did not affect this result. CONCLUSIONS: Moderately/severely abnormal LVEF (≤40%) at baseline is associated with increased mortality after TF-TAVI, especially when the mean transvalvular aortic gradient is <40 mm Hg (LGAS), while outcomes in patients with normal and mildly abnormal LVEF are comparable regardless of the pressure gradient across the native aortic valve. (DRKS00013729).

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Epicardial Adipose Tissue Thickness Independently Predicts Severe Aortic Valve Stenosis.

BACKGROUND AND AIM OF THE STUDY: Epicardial fat tissue (EAT) is associated with coronary as well as aortic valve calcification. The study aim was to determine whether EAT thickness is different in patients with and without aortic valve stenosis (AVS). METHODS: A cohort of 200 consecutive patients with severe AVS and 200 matched patients without AVS were included retrospectively in the study. EAT thickness was quantified, using transthoracic echocardiography, as the space between the epicardial wall of the myocardium and the visceral layer of the pericardium. Unadjusted and risk factor-adjusted logistic regression analysis was used to determine the association of EAT thickness with the presence of AVS. RESULTS: Overall, 400 patients (182 males, 218 females; mean age 79.6 ± 6.5 years) were included in the study. EAT thickness was significantly higher in patients with severe AVS (7.4 ± 0.3 mm versus 5.8 ± 0.2 mm; p <0.0001 for patients with and without AVS, respectively). In logistic regression analysis, an increase in EAT by one standard deviation was associated with a two-fold increased occurrence of AVS (OR [95%CI]: 2.10 [1.65-2.68]; p <0.0001). Associations remained stable upon adjustment for age, gender and traditional cardiovascular risk factors (2.08 [1.59-2.72]; p <0.0001). Body mass index (BMI) -specific subgroup analysis showed that the link between EAT and AVS was independent of BMI (1.78 [1.15-2.75], 2.62 [1.71- 4.02], and 2.22 [1.36- 3.62], for BMI <25 kg/m2, 25-30 kg/m2, and >30kg/ m2, respectively). EAT, in addition to traditional cardiovascular risk factors, significantly improved the area under the receiver operating characteristic curve (from 0.70 to 0.76; p = 0.003). CONCLUSIONS: EAT thickness is significantly associated with severe AVS, independent of traditional risk factors. While further studies are needed to confirm these results, the present findings support the hypothesis that EAT may influence sclerosis of the aortic valve.

Influence of stent implantation on erythrocyte aggregation in human native coronary arteries and saphenous vein grafts.

OBJECTIVE: Stent implantation into atherosclerotic coronary vessels induces the release of particulate debris and soluble vasoactive substances, which impair downstream microvascular function. Microvascular perfusion, however, is also determined by hemorheological parameters. We therefore analyzed now changes in erythrocyte (RBC) aggregation in coronary arterial blood during stent implantation. METHODS: Symptomatic male patients with stable angina pectoris and stenosis in their native right coronary artery (RCA) or saphenous vein graft on right coronary artery (SVG-RCA) were enrolled. Coronary arterial blood was taken before and coronary aspirate during stent implantation with a distal occlusion/aspiration device. RBC aggregation was determined using the erythrocyte adhesiveness/aggregation test. The ratio of clot-free area to whole area of a spread blood drop was quantified (rCFA). To evaluate the impact of soluble factors within aspirate plasma on RBC aggregation, separated RBCs of healthy volunteers were exposed to patients' coronary arterial blood and aspirate samples. RESULTS: rCFA was comparably increased in coronary aspirate of RCAs and SVG-RCAs after stent implantation (RCA: 25.7±2.1% vs 32.2±2.1%; SVG-RCA: 28.9±1.9% vs 33.3±2.0%, P<.01). The rCFA of healthy volunteers was increased after adding coronary aspirate plasma. CONCLUSIONS: Stent implantation into atherosclerotic coronary arteries induces an increase in RBC aggregation, potentially contributing to impaired microvascular perfusion.

Thoracic Endovascular Repair of Complicated Penetrating Aortic Ulcer: An 11-Year Single-Center Experience.

PURPOSE: To analyze an 11-year single-center experience of treating complicated penetrating aortic ulcer (PAU) using thoracic endovascular aortic repair (TEVAR). METHODS: This study included 63 consecutive patients (mean age 69.1±11.5 years; 40 men) with complicated PAU (42 symptomatic, 22 with rupture) who underwent TEVAR between 2002 and 2013. The PAUs were located in the aortic arch (n=11), the descending thoracic aorta (n=43), and the thoracoabdominal aorta (n=9). RESULTS: TEVAR was performed within 14 days of diagnosis in 33 (52.3%) cases (19 ruptures treated immediately); the other 30 (47.6%) patients had an average interval between diagnosis and intervention of 40±39 days. Technical success was 98.4% (62/63). One patient had a type I endoleak after stent-graft repair of a PAU in the aortic arch without great vessel transposition; another procedure was required for carotid-subclavian bypass and proximal stent-graft extension. No patient experienced spinal cord ischemia after TEVAR. Five (7.9%) patients died in-hospital; 3 had severe cardiac complications, 1 died from complications of aortic rupture, and the other succumbed to septic shock. Mean follow-up was 45.6±47.2 months, during which 12 (19.0%) patients needed a secondary intervention because of late endoleaks (n=4, 6.3%) or new complications due to disease progression. Multivariate analysis indicated that a PAU depth >15 mm was an independent predictor of mortality (hazard ratio 6.92, p=0.03). In the biomarker analysis, symptomatic patients had significantly higher D-dimer and troponin levels compared to asymptomatic patients [559.5±460.7 vs 283.2±85.2 µg/L (p=0.016) and 0.22±0.61 vs 0.02±0.03 ng/mL (p=0.04), respectively]. CONCLUSION: Patients with PAU suffer from underlying severe atherosclerotic disease and have a significant number of cardiovascular comorbidities that lead to relevant mortality and morbidity after TEVAR. As a PAU diameter >15 mm represented high risk for disease progression, these patients may be candidates for early intervention. D-dimer levels may help identify patients at risk and with progression of PAU.

Early prediction of acute kidney injury after transapical and transaortic aortic valve implantation with urinary G1 cell cycle arrest biomarkers.

BACKGROUND: Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) leading to increased mortality and morbidity. Urinary G1 cell cycle arrest proteins TIMP-2 and IGFBP7 have recently been suggested as sensitive biomarkers for early detection of AKI in critically ill patients. However, the precise role of urinary TIMP-2 and IGFBP7 in patients undergoing TAVI is unknown. METHODS: In a prospective observational trial, 40 patients undergoing TAVI (either transaortic or transapical) were enrolled. Serial measurements of TIMP-2 and IGFBP7 were performed in the early post interventional course. The primary clinical endpoint was the occurrence of AKI stage 2/3 according to the KDIGO classification. RESULTS: Now we show, that ROC analyses of [TIMP-2]*[IGFBP7] on day one after TAVI reveals a sensitivity of 100 % and a specificity of 90 % for predicting AKI 2/3 (AUC 0.971, 95 % CI 0.914-1.0, SE 0.0299, p = 0.001, cut-off 1.03). In contrast, preoperative and postoperative serum creatinine levels as well as glomerular filtration rate (GFR) and perioperative change in GFR did not show any association with the development of AKI. Furthermore, [TIMP-2]*[IGFBP7] remained stable in patients with AKI ≤1, but its levels increased significantly as early as 24 h after TAVI in patients who developed AKI 2/3 in the further course (4.77 ± 3.21 vs. 0.48 ± 0.68, p = 0.022). Mean patients age was 81.2 ± 5.6 years, 16 patients were male (40.0 %). 35 patients underwent transapical and five patients transaortic TAVI. 15 patients (37.5 %) developed any kind of AKI; eight patients (20 %) met the primary endpoint and seven patients required renal replacement therapy (RRT) within 72 h after surgery. CONCLUSION: Early elevation of urinary cell cycle arrest biomarkers after TAVI is associated with the development of postoperative AKI. [TIMP-2]*[IGFBP7] provides an excellent diagnostic accuracy in the prediction of AKI that is superior to that of serum creatinine.

Predictors of aortic pulse wave velocity in the elderly with severe aortic stenosis.

UNLABELLED: Predictors of aortic pulse wave velocity (AoPWV) were not previously studied in the elderly with severe aortic stenosis (AS). We aimed to compare the AoPWV in these patients with matched controls and to study the predictors of AoPWV in this population. We measured the AoPWV during cardiac catheterisation in 40 patients with severe AS and 20 matched controls. AoPWV in both groups was similar (p = 0.198) and lied within normal reference value for age in 68 % of elderly with severe AS. Central systolic blood pressure (SBP) (adjusted ß = 0.45, p = 0.001) and glomerular filtration rate (GFR) (adjusted ß = -0.29, p = 0.023) were the only independent predictors of AoPWV in AS group. Central SBP >140 mmHg was the best predictor of abnormal AoPWV (≥14.6 m/s) with 100 % sensitivity and 70 % specificity, p < 0.001. CONCLUSION: AoPWV is not increased in the elderly with severe AS compared to controls, and lies within the reference value for age in the majority of these patients. Central SBP >140 mmHg best predicts abnormal AoPWV in the elderly with severe AS.

Thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry.

OBJECTIVES: This study analyzed the mechanism and risk factors of thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry (dSINE). BACKGROUND: This late complication of thoracic endovascular aneurysm repair (TEVAR) for aortic dissection is under-recognized but potentially life-threatening. METHODS: In 142 patients who underwent TEVAR with endovascular entry sealing for acute and chronic aortic type B dissection, using commercially available straight (nontapered) stent-grafts, we examined the oversizing rate, the aortic taper ratio, and the need for reintervention. RESULTS: Nine of 142 patients developed thoracic aortic aneurysm expansion due to dSINE after TEVAR. The median follow-up was 47.5 ± 37.4 months. There was a significant difference in the distal stent-aorta angle between the patients with and without dSINE (149.08 ± 15.09° vs. 166.72 ± 12.47°, P < 0.005). Patients with dSINE showed a significantly higher taper ratio of the true lumen of the aorta (40.9 ± 14.13% vs. 25.36 ± 20.2%, P < 0.05). There was also a significant difference in the oversizing of the stent-graft in the distal landing zone (95.88 ± 49.3% vs. 55.94 ± 36.23%, P < 0.01). All patients with dSINE underwent a secondary endograft procedure without any complications or deaths. In 7 cases we used a custom-made, highly tapered stent-graft. CONCLUSIONS: Lifelong follow-up of patients is mandatory after TEVAR. A stent-graft with a tapered design should be used in aortic dissection to avoid oversizing and devastating late complications.

Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice. METHODS: From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed. RESULTS: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort. CONCLUSION: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.

Validation of intravascular ultrasound for measurement of aortic diameters: Comparison with multi-detector computed tomography.

INTRODUCTION: Intravascular ultrasound (IVUS) provides real-time imaging of aortic pathology during aortic interventions. The objective of the present study was to validate IVUS measurements using computed tomography (CT) angiography in a sufficiently large cohort. MATERIAL AND METHODS: From October 2010 to February 2014, 57 consecutive patients with acute aortic syndrome underwent both IVUS and spiral CT for a total of 509 comparable thoracic aorta segments. Minimum, maximum, and mean diameters were determined at each measurement point. RESULTS: IVUS measurements of the thoracic aorta (aortic root, brachiocephalic trunk, left common carotid artery, left subclavian artery) ranged from 18-48.5 (mean 33.0) mm, versus 18-48.4 (mean 31.7) mm on CT, with a significant mean difference of 5.1% (p < 0.05). The correlation between methods was generally good, but IVUS tended toward larger diameters than CT in the aortic arch, especially the left subclavian artery. In 78% of measurement sites, total mean diameters were larger on IVUS measurements of the thoracic aorta than on CT measurements. CONCLUSION: IVUS is a reliable tool for measuring aortic diameter, especially in the descending part of the aorta. However, its pitfalls must be considered to prevent choosing an incorrectly sized stent graft in the acute setting of thoracic endovascular aortic repair.

Safety and effectiveness of a novel vascular closure device: a prospective study of the ExoSeal compared to the Angio-Seal and ProGlide.

PURPOSE: To prospectively assess the safety and efficacy of a novel absorbable vascular closure device (ExoSeal) in patients undergoing cardiac catheterization with femoral access compared to the established collagen-based (Angio-Seal) and suture-mediated (ProGlide) closure devices. METHODS: This prospective, observational, dual-center, non-randomized, non-blinded study enrolled 1013 patients (65.1 ± 11.8 years) undergoing cardiac catheterization via a common femoral artery access in which hemostasis was achieved using a vascular closure device (255 Angio-Seal, 258 ProGlide, and 500 ExoSeal). In hospital complications (bleeding, hematoma, pseudoaneurysm, vessel occlusion, dissection, and arteriovenous fistula) of the puncture site and device failures (persistent bleeding) were recorded and compared for ExoSeal vs. the established devices (Angio-Seal + ProGlide). RESULTS: There were more complications after utilization of ExoSeal compared to established devices (3.6% vs. 1.2%, p=0.012). No significant difference was observed in the device success rate between the established vascular closure devices (96.3%) and the novel device (94.8%, p=0.28). Considering each closure system, Angio-Seal had the lowest complication rate (0.4%) and the highest efficacy (99.2%); the latter differed significantly from ExoSeal (94.8%, p=0.001). Logistic regression analysis revealed a >3-fold odds of complications when using ExoSeal, which remained unchanged in multivariate analysis. CONCLUSION: Utilization of the novel vascular closure device is associated with a higher complication rate and a similar device failure rate compared to collagen-based and suture-mediated devices, with Angio-Seal having the lowest complication and device failure rates.

Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear. METHODS AND RESULTS: Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCV(TF)], n=32; Edwards Sapien [ES(TF)], n=26) and transapical (ES(TA): n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ES(TF), 259.9 [184.8-334.9]; ES(TA), 206.1[162.5-249.7]; MCV(TF), 78.5 [25.3-131.6]; P<0.001) and the self-expandable MCV prosthesis during implantation (MCV(TF), 397.1 [302.1-492.2]; ES(TF), 88.2 [70.2-106.3]; ES(TA), 110.7 [82.0-139.3]; P<0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group. CONCLUSIONS: Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

Aspirate from human stented native coronary arteries vs. saphenous vein grafts: more endothelin but less particulate debris.

Stent implantation into atherosclerotic coronary arteries releases particulate debris and soluble substances that contribute to impaired microvascular perfusion. Here we addressed the potential for microvascular obstruction in patients with stenotic native right coronary arteries (nRCA) compared with saphenous vein grafts on right coronary arteries (SVG-RCA). We enrolled symptomatic, male patients with stable angina pectoris and a flow-limiting stenosis in their nRCA or SVG-RCA (n = 18/18). Plaque volume and composition were analyzed using intravascular ultrasound before stent implantation. Coronary aspirate was retrieved during stent implantation under protection with a distal occlusion/aspiration device and divided into particulate debris and plasma. The release of catecholamines, endothelin, serotonin, thromboxane B2, and tumor necrosis factor-α was measured. The response of rat mesenteric arteries with intact (+E) and denuded (-E) endothelium to aspirate plasma (without and with selective endothelin receptor blockade) was normalized to that by potassium chloride (KClmax = 100%). Plaque volume and composition were not different between nRCA and SVG-RCA. There was less particulate debris (65 ± 8 vs. 146 ± 23 mg; P < 0.05) and more endothelin release (5.8 ± 0.8 vs. 1.3 ± 0.7 pg/ml; P < 0.05) in nRCA than in SVG-RCA, whereas the release of the other mediators was not different. Aspirate from nRCA induced stronger vasoconstriction than that from SVG-RCA [nRCA, 78 ± 6% (+E)/84 ± 5% (-E); SVG-RCA, 59 ± 6% (+E)/68 ± 3% (-E); P < 0.05 nRCA vs. SVG-RCA], which was attenuated by a nonspecific endothelin and a specific endothelin receptor A antagonist. Thus coronary aspirate from stented nRCA is characterized by less debris but more endothelin and stronger vasoconstrictor response than that from SVG-RCA.

Hemodynamic assessment of paravalvular aortic regurgitation after TAVI: estimated myocardial supply-demand ratio and cardiovascular mortality.

A relevant (at least moderate) paravalvular regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is found in up to 20% of cases and associated with increased mortality. The ratio of the diastolic over the systolic pressure time integral (DPTI:SPTI) has been proposed to reflect an estimate of myocardial oxygen supply versus demand and the propensity for myocardial ischemia. We have now evaluated the potential of this ratio to predict PAR-associated cardiovascular mortality after TAVI, retrospectively analyzing data from 167 consecutive TAVI patients. PAR was graded angiographically, and the myocardial supply-demand ratio was estimated from the planimetric integration of the diastolic and systolic pressure-time area (DPTI and SPTI), respectively. PAR was observed in 113 patients (67%) and angiographically graded as mild in 89 (78.8%), moderate in 21 (18.6%) or moderate to severe in 3 (2.7%) cases. The DPTI:SPTI ratio decreased with increasing Sellers grade of PAR (P < 0.001). A DPTI:SPTI of ≤0.7 predicted cardiovascular mortality (area under the curve = 0.96). Cardiovascular mortality at 30 days and 1 yr was increased in patients with DPTI:SPTI ≤ 0.7 over those with DPTI:SPTI > 0.7 (42 vs. 2% and 63 vs. 3%, respectively; P < 0.001). In conclusion, DPTI:SPTI provides an excellent cutoff value of ≤0.7 for the prediction of PAR-associated mortality.

Coronary aspirate TNFα reflects saphenous vein bypass graft restenosis risk in diabetic patients.

BACKGROUND: Patients with diabetes mellitus (DM) have an increased risk for periprocedural complications and adverse cardiac events after percutaneous coronary intervention. We addressed the potential for coronary microvascular obstruction and restenosis in patients with and without DM undergoing stenting for saphenous vein bypass graft (SVG) stenosis under protection with a distal occlusion/aspiration device. METHODS: SVG plaque volume and composition were analyzed using intravascular ultrasound before stent implantation. Percent diameter stenosis was determined from quantitative coronary angiography before, immediately after and 6 months after stent implantation. Coronary aspirate was retrieved during stent implantation and divided into particulate debris and plasma. Total calcium, several vasoconstrictors, and tumor necrosis factor (TNF)α in particulate debris and coronary aspirate plasma were determined. RESULTS: Patients with and without DM had similar plaque volume, but larger necrotic core and greater particulate debris release in patients with than without DM (20.3±2.7 vs. 12.7±2.6% and 143.9±19.3 vs. 75.1±10.4 mg, P<0.05). The TNFα concentration in particulate debris and coronary aspirate plasma was higher in patients with than without DM (15.9±6.6 vs. 5.1±2.4 pmol/mg and 2.2±0.7 vs. 1.1±0.2 pmol/L, P<0.05), whereas total calcium and vasoconstrictors were not different. Patients with DM had a greater percent diameter stenosis 6 months after stent implantation than those without DM (22.17±5.22 vs. 6.34±1.11%, P<0.05). The increase in TNFα immediately after stent implantation correlated with restenosis 6 months later (r=0.69, P<0.05). CONCLUSION: In diabetics, particulate debris and coronary aspirate plasma contained more TNFα, which might reflect the activity of the underlying atherosclerotic process. TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov/ct2/results?term=NCT01430884; unique identifier: NCT01430884.

Suture-mediated arterial access site closure after transfemoral aortic valve implantation.

OBJECTIVES: To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF-TAVI) using a single, commercially available six French monofilament suture-mediated vascular closure device (VCD) in "preclosure" technique. BACKGROUND: Currently, TF-TAVI is evolving into a completely percutaneous procedure. However, percutaneous access site closure still remains a major technical challenge with room for improvement. METHODS: 94 of 144 consecutive patients underwent completely percutaneous TF-TAVI using following technique for access site closure: After puncture of the common femoral artery using fluoroscopy and contralateral angiography for guidance, the VCD was deployed prior further predilatation of the vessel and insertion of the large-bore introducer sheath. At the end of the procedure, the preloaded sutures were tied for final hemostasis and crossover angiography was used for postprocedural evaluation of the access vessel. RESULTS: Application of the VCD was technically successful in all cases, resulting in an efficient hemostasis with cessation of any bleeding within 10 min of final knot-tying in 83 of the 94 patients, and there was only one closure-failure with continuous bleeding despite prolonged manual compression requiring endovascular treatment. In addition, we observed four closure-related access vessel stenoses of hemodynamic relevance requiring endovascular treatment in three and surgical repair in one patient. However, interventional and surgical repair was not associated with death or irreversible end-organ damage and all patients recovered without sequelae. CONCLUSION: "Preclosure" of the arterial access site with a single six French suture-mediated VCD is relatively easy, safe and efficient method for access site closure after TF-TAVI which, along with ongoing profile reductions of TAVI devices, should further simplify and broaden the way toward a routine, completely percutaneous procedure.

Incidence, predictors, origin and prevention of early and late neurological events after transcatheter aortic valve implantation (TAVI): a comprehensive review of current data.

Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

A new self-expandable transcatheter aortic valve for transapical implantation: feasibility in acute and chronic animal experiments.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is currently expanding worldwide, however all available prostheses share some fundamental design drawbacks. We investigated the feasibility, safety and hemodynamic performance of the innovative transapical Acurate TA™ self-expandable device, which has the unique advantage of offering anatomically correct self-alignment within the aortic root. DESIGN: Transapical TAVI was performed in six acute swine and six chronic sheep procedures, with follow-up of 7, 14, 21, 28, 60 and 90 days. TAVI was performed under TEE and angiographic guidance without rapid pacing. RESULTS: A partial sternotomy approach was used to access the LV-apex. All valve implantations were performed as planned and all animals survived the implantation procedure. After deployment, no migration, embolization or coronary obstruction was observed during the observation period. Intraoperative TEE examination identified no signs of intravalvular leakage or valve dysfunction. Transvalvular mean pressure gradients were 5.4 ± 2.2 mmHg decreasing during follow-up (1.6 ± 0.8 mmHg, 1.8 ± 0.8 mmHg, 1.3 ± 0.2, 1.8 ± 0.7 mmHg, 1.6 ± 0.8 mmHg), with a slight increase atday 90 (4.0 ± 2.4 mmHg, P < 0.05). Macroscopic examination at necropsy showed correct anatomical positioning of the valve stent without any signs of structural valve deterioration. CONCLUSIONS: These first results of the innovative self-expandable transapical ACURATE TA™ device explore the feasibility and safety of anatomically correct off-pump implantation with optimal hemodynamic results.