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Aims: We aimed to update the logistic clinical SYNTAX score to predict 2 year all-cause mortality after contemporary percutaneous coronary intervention (PCI)., Methods and Results: We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2 year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population., Conclusions: The new model of the logistic clinical SYNTAX score better predicts 2 year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI., (© 2021 Wiley Periodicals LLC.)

Objectives: This study aimed to assess the predictive ability of the Global Registry of Acute Coronary Events (GRACE) risk score 2.0 in contemporary acute coronary syndrome (ACS) patients, and its relation to antiplatelet strategies., Background: The predictive value of the GRACE risk score in the contemporary ACS cohort and the appropriate antiplatelet regimen according to the risk remain unclear., Methods: This is a subgroup analysis of the all-comers, randomized GLOBAL LEADERS trial, comparing ticagrelor monotherapy versus conventional dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The GRACE risk score 2.0 with 1-year mortality prediction was implemented. The randomized antiplatelet effect was assessed in predefined three GRACE risk-groups; low-risk (GRACE <109), moderate-risk (GRACE 109-140), and high-risk (GRACE >140)., Results: The GRACE risk score was available in 6,594 out of 7,487 ACS patients among whom 1,743, 2,823, and 2,028 patients were classified as low-risk, moderate-risk, and high-risk, respectively. At 1 year, all-cause mortality occurred in 120 patients (1.8%). The discrimination ability of the GRACE model was moderate (C-statistic = 0.742), whereas 1-year mortality risk was overestimated (mean predicted mortality rate: 3.9%; the Hosmer-Lemeshow chi-square: 21.47; p = 0.006). There were no significant interactions between the GRACE risk strata and effects of the ticagrelor monotherapy on ischemic or bleeding outcomes at 1 year compared to the reference strategy., Conclusion: The GRACE risk score 2.0 is valuable in discriminating high risk ACS patients, however, the recalibration of the score is recommended for better risk stratification. There is no significant differences in efficacy and safety of ticagrelor monotherapy across the three GRACE risk strata., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: The aim is to assess the experience in the Netherlands using the Xposition S self-apposing stent in complex coronary lesions in clinical practice., Background: Treatment of complex coronary lesions could be accompanied with stent sizing difficulties and complications, particularly due to vessel overdilation or stent underexpansion. The self-apposing feature of the Xposition S stent (STENTYS, Paris, France) supports good strut apposition in complex anatomies and allows for an increase in diameter after implantation., Methods: In this real-world registry, data from patients treated with Xposition S in four Dutch clinical sites were prospectively collected and analyzed. Any patient suitable for implantation with Xposition S according to current recommendations was enrolled. Primary endpoint was major adverse cardiac events (MACE) at 1 year., Results: Between 2015 and 2018, data from 251 patients were collected. Clinical presentation was an acute coronary syndrome in majority of the patients (76.9%). Main angiographic indications were lesions in aneurysmatic or ectatic vessels (32.3%), thrombus containing lesions (13.1%), and bifurcation/left main stenosis (10.4%). Most of the target lesions (TLs) were classified as AHA/ACC Type C (53.6%). Despite lesion complexity, device was successfully implanted at TL in 96.8%. MACE rate, reported on patients having completed 1-year follow-up (n = 203), was 6.6%, with low rate of definite/probable stent thrombosis (1.0%)., Conclusions: In clinical practice of several Dutch sites, STENTYS Xposition S showed good procedural results and low 1-year clinical events rate, despite complex coronary anatomy., (© 2019 Wiley Periodicals, Inc.)

Background: The relationship between vessel angulation and large changes in vessel geometry after stent implantation and the occurrence of stent failure still remains unclear. We sought to investigate the association of the change in the coronary bending angle after stenting and the risk for late stent failure by three-dimensional quantitative coronary angiography (3D QCA)., Methods: The bending angle in coronary lesions that presented with late stent failure and those without stent failure was computed during the cardiac cycle, before and after stenting using a recently developed 3D QCA software., Results: A total of 40 lesions with stent failure (cases) were successfully matched to 47 lesions without stent failure (controls).The mean duration to follow-up coronary angiography was 1,011 days in cases and 1,109 days in the control group (P = 0.14). In stent failure, the systolic bending angle after stenting was smaller (14.45° [12.18, 17.68] versus 18.20° [14.00, 20.30], P = 0.01), while the stent-induced change in systolic bending angle was significantly larger (4.15° [1.13, 7.20] versus 1.80° [-1.90, 4.40], P = 0.004). Multivariable logistic regression analysis suggested that systolic bending angle after stenting (odds ratio: 0.88; 95% CI: 0.79-0.99; P = 0.03), and decrease in systolic bending angle after stenting (odds ratio: 1.13; 95% CI: 1.02-1.26; P = 0.03) were predictors of stent failure., Conclusions: Our study suggests that a change in the natural tortuous course of the coronaries by stent implantation with the decrease in coronary bending angle is a potentially major contributor in stent failure., (© 2018 Wiley Periodicals, Inc.)

Objectives: We aimed to develop a model to predict long-term mortality after percutaneous coronary intervention (PCI), to aid in selecting patients with sufficient life expectancy to benefit from bioabsorbable scaffolds., Background: Clinical trials are currently designed to demonstrate superiority of bioabsorbable scaffolds over metal devices up to 5 years after implantation., Methods: From 2000 to 2011, 19.532 consecutive patients underwent PCI in a tertiary referral hospital. Patients were randomly (2:1) divided into a training (N = 13,090) and validation (N = 6,442) set. Cox regression was used to identify determinants of long-term mortality in the training set and used to develop a risk model. Model performance was studied in the training and validation dataset., Results: Median age was 63 years (IQR 54-72) and 72% were men. Median follow-up was 3.6 years (interquartile range [IQR] 2.4-6.8). The ratio elective vs. non-elective PCIs was 42/58. During 88,620 patient-years of follow-up, 3,156 deaths occurred, implying an incidence rate of 35.6 per 1,000. Estimated 5-year mortality was 12.9%.Regression analysis revealed age, body mass index, diabetes mellitus, renal insufficiency, prior myocardial infarction, PCI indication, lesion location, number of diseased vessels and cardiogenic shock at presentation as determinants of mortality. The long-term risk model showed good discrimination in the training and validation sets (c-indices 0.76 and 0.74), whereas calibration was appropriate., Conclusions: A simple risk model, containing 9 baseline clinical and angiographic variables effectively predicts long-term mortality after PCI and may possibly be used to select suitable patients for bioabsorbable scaffolds., (© 2017 Wiley Periodicals, Inc.)

Objectives: To compare the occurrence of acute stent recoil in two different stent types (platinum chromium and cobalt chromium) and identify the potential predictors of significant acute stent recoil., Background: Acute stent recoil is frequently observed after percutaneous coronary intervention and has been associated with in-stent restenosis and in-stent thrombosis. Different stent designs may result in varying degrees of stent recoil., Methods: From a registry of "all-comers" treated with either the Xience Prime Cobalt Chromium or Promus Premier Platinum Chromium stent, a random sample of 100 patients was drawn. Acute stent recoil was defined as the minimal luminal diameter (MLD) of the last inflated balloon minus the MLD after, divided by the MLD of the last inflated balloon. Significant acute stent recoil was defined as recoil ≥10%., Results: A total of 123 lesions (61 Xience Prime vs 62 Promus Premier) in 100 patients were analyzed. Acute stent recoil of 8.6 ± 4.9% was observed in the Xience Prime group versus 8.7 ± 4.2% in the Promus Premier group, P = 0.970. In a multivariate model for significant acute stent recoil, a stent/vessel ratio ≥1 (hazard ratio 4.64 [1.94-11.12], P = 0.001), a balloon/stent ratio >1 (hazard ratio 3.83 [1.12-13.14], P = 0.032) and direct stenting (hazard ratio 0.42 [0.18-0.96], P = 0.039) were identified as predictors., Conclusions: No significant differences were observed in the extent of acute stent recoil between the Xience Prime and the Promus Premier stent. A larger stent/vessel ratio, a larger balloon/stent ratio, and direct stenting were associated with significant acute stent recoil ≥10%. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Bioresorbable vascular scaffolds have been recently introduced as a novel paradigm for coronary artery disease treatment allowing temporary vessel support and drug delivery without indefinite coronary caging, potentially reducing the long-term limitation of metallic stents. The scientific community has rapidly embraced this concept and bioresorbable devices have been introduced in clinical practice. However, despite the fact that bifurcation lesions represent a large and challenging subset in the field of interventional cardiology, this subgroup of lesions have been avoided in the initial experience with bioresorbable scaffolds and clear recommendations on methodological approaches are lacking. In the present report, we describe the various techniques for bifurcation treatment with bioresorbable scaffolds and the theoretical advantages and disadvantages of this technology in different scenarios, with a glimpse to challenging subsets and possible complications. Therefore, we aim to provide experience based insights and practical guidance for bioresorbable scaffold implantation in bifurcation lesions. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: An increased body mass index (BMI) is associated with a high risk of cardiovascular disease and reduction in life expectancy. However, several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases. The aim of the present study is to investigate the impact of BMI on long-term clinical outcomes after implantation of zotarolimus eluting stents., Methods: Individual patient data were pooled from the RESOLUTE Clinical Program comprising five trials worldwide. The study population was sorted according to BMI tertiles and clinical outcomes were evaluated at 2-year follow-up., Results: Data from a total of 5,127 patients receiving the R-ZES were included in the present study. BMI tertiles were as follow: I tertile (≤ 25.95 kg/m(2) -Low or normal weight) 1,727 patients; II tertile (>25.95 ≤ 29.74 kg/m(2) -overweight) 1,695 patients, and III tertile (>29.74 kg/m(2) -obese) 1,705 patients. At 2-years follow-up no difference was found for patients with high BMI (III tertile) compared with patients with normal or low BMI (I tertile) in terms of target lesion failure (I-III tertile, HR [95% CI] = 0.89 [0.69, 1.14], P = 0.341; major adverse cardiac events (I-III tertile, HR [95% CI] = 0.90 [0.72, 1.14], P = 0.389; cardiac death (I-III tertile, HR [95% CI] = 1.20 [0.73, 1.99], P = 0.476); myocardial infarction (I-III tertile, HR [95% CI] = 0.86 [0.55, 1.35], P = 0.509; clinically-driven target lesion revascularization (I-III tertile, HR [95% CI] = 0.75 [0.53, 1.08], P = 0.123; definite or probable stent thrombosis (I-III tertile, HR [95% CI] = 0.98 [0.49, 1.99], P = 0.964., Conclusions: In the present study, the patients' body mass index was found to have no impact on long-term clinical outcomes after coronary artery interventions., (© 2015 Wiley Periodicals, Inc.)

Objectives: To evaluate survival and cause of death in a consecutive patient cohort undergoing Transcatheter Aortic Valve implantation (TAVI)., Background: TAVI is a valid treatment option in patients with severe Aortic Stenosis (AS) who are deemed at (very) high operative risk. Because of (non-)cardiac comorbidities life expectancy in this patient, population is reduced when compared with the general population., Methods: Consecutive patients with symptomatic aortic stenosis undergoing TAVI between November 2005 and December 2011 were included. (1) Survival status was obtained from the Dutch Civil Registry, (2) cause of death was derived by reviewing hospital charts, and (3) contacting referring physicians and patients' general practitioners., Results: Two hundred and thirty-seven consecutive patients were included with an overall all-cause mortality of 31% at a median follow up of 13 months (IQR 2-24 months). Four patients (1.6%) died < 48 hr of the TAVI procedure, and another 16 patients died up to the 30-day interval representing an all-cause 8.4% 30-day mortality. Between 30 days and 1-year another 30 patients died. Twenty-four patients died >1 year post TAVI. The predominant cause of death >48 hr post TAVI was noncardiac. One third of these deaths were due to sepsis/infection, one-fifth to cancer and stroke in 16%., Conclusions: In our series of AS patients undergoing TAVI, the cause of death >48 hr post procedure was predominantly noncardiac at every time interval. Mortality was driven by sepsis/infection, cancer, and stroke. Rigorous patient selection may improve outcome after TAVI., (Copyright © 2012 Wiley Periodicals, Inc., a Wiley company.)

Background: There is few information on the long-term efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS) in all-comer percutaneous coronary intervention (PCI)-patients complicated by renal insufficiency (RI)., Objective: Our aim was to assess the 6-year clinical outcome of PCI-patients with RI treated exclusively with BMS, SES, or PES in our academic hospital., Methods: A total of 1382 patients, included in three cohorts of consecutive PCI-patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft-Gault formula (normal kidney function ≥ 90; mild RI = 60-89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE)., Results: Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan-Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox-regression analysis, SES and PES decreased the occurrence of target-vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28-0.84; aHR = 0.75, 95% CI: 0.57-0.97, respectively] with no significant effect on mortality. Safety- and efficacy end points were comparable for the three stent types in patients with mild- and moderate renal function., Conclusion: Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES- or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug-eluting stents over BMS in safety and efficacy end points for patients with impaired renal function., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: The aim was to investigate the 7-year clinical outcomes of patients treated with either drug-eluting stents (DES) or bare-metal stents (BMS) for saphenous vein graft disease (SVG)., Background: Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long-term safety and efficacy results for DES in SVG have been published., Methods: Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus- or paclitaxel-eluting stents) or with BMS. Yearly follow-up was performed., Results: At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P-value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39-1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67-1.3)., Conclusions: In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years- and the use of DES resulted in a clinically relevant lower rate of TVR., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: Due to the limited distensibility of the everolimus-eluting bioresorbable vascular scaffold (ABSORB) compared to metallic platform stents, quantitative coronary arteriography (QCA) is a mandatory requirement for ABSORB deployment in the on-going ABSORB EXTEND Single-Arm Study. Visual assessment of vessel size in the ABSORB Cohort B study often lead to under and over-sizing of the 3 mm ABSORB in coronary vessels (recommended range of the vessel diameter ≥ 2.5 mm and ≤ 3.3 mm), with an increased risk of spontaneous incomplete scaffold apposition post ABSORB deployment. We report whether mandatory QCA assessment of vessel size pre-implantation, utilizing the maximal luminal diameter (Dmax) and established interpolated reference vessel diameter (RVD) measurements, has improved device/vessel sizing., Methods: Pre-implantation post-hoc QCA analyses of all 101 patients from ABSORB Cohort B (102 lesions) and first consecutive 101 patients (108 lesions) from ABSORB EXTEND were undertaken by an independent core-laboratory; all patients had a 3 mm ABSORB implanted. Comparative analyses were performed., Results: Within ABSORB Cohort B, a greater number of over-sized vessels (> 3.3 mm) were identified utilizing the Dmax compared to the interpolated RVD (17 vessels, 16.7% vs. 3 vessels, 2.9%; P = 0.002). Comparative analyses demonstrated a greater number of appropriate vessel-size selection (75 vessels, 69.4% vs. 48 vessels, 47.1%; P = 0.001), a trend towards a reduction in implantation in small (< 2.5 mm) vessels (29 vessels, 26.9% vs. 40 vessels, 39.2%; P = 0.057) and a significant decrease in the implantation in large (> 3.3 mm) vessels (4 vessels, 3.7% vs. 17 vessels, 16.7%; P = 0.002) in ABSORB EXTEND. Bland-Altman plots suggested a good agreement between operator and core-laboratory calculated Dmax measurements., Conclusions: The introduction of mandatory Dmax measurements of vessel size prior to ABSORB implantation significantly reduced the under-sizing of the 3.0 mm scaffold in large vessels validating the use of this technique in vessel sizing prior to ABSORB implantation., (Copyright © 2011 Wiley-Liss, Inc.)

Objectives: To determine the prevalence of impaired left ventricular (LV) systolic function and its impact on the in-hospital and long-term outcome in patients who underwent Transcatheter Aortic Valve Implantation (TAVI)., Background: Although impaired LV function may be considered a contra-indication for aortic valve replacement, the hemodynamic characteristics of transcatheter valves may offer procedural and long-term clinical benefit in such patients., Methods: 230 consecutive patients underwent TAVI with the Medtronic-CoreValve System. Impaired LV function was defined by a Left Ventricular Ejection Fraction (LVEF) ≤ 35% (European Multicenter Study on Operative Risk Stratification and Long-term Outcome in patients with Low-Flow/Low-Gradient Aortic Stenosis). Study endpoints were selected and defined according to the Valve Academic Research Consortium recommendations., Results: Compared with patients with a LVEF > 35% (n = 197), those with LVEF ≤ 35% (n = 33) were more often male (78.8 % vs. 46.7%, P < 0.001), more symptomatic (NYHA class III or IV, 97.0% vs. 77.2%, P = 0.008) and had a higher prevalence of prior coronary artery disease (63.6% vs. 43.1%, P = 0.029). The Logistic EuroSCORE was 14.8% and 22.8, respectively (P = 0.012). No difference was observed between the two groups in in-hospital or 30-day mortality (3.0% vs. 9.6%, P = 0.21), the Combined Safety Endpoint at 30 days (24.2% and 24.4%, P = 0.99) and survival free from readmission at one year (69.2% and 69.7%, P = 0.85). After adjustment, LVEF ≤ 35% was not associated with an increased risk of 30-day mortality, in-hospital complications and survival free from readmission at follow-up., Conclusion: The immediate and long-term outcome after TAVI did not differ between patients with an impaired and preserved LVEF. LVEF ≤ 35% did not predict adverse immediate and long-term outcome. These findings suggest that TAVI should not be withheld in selected patients with impaired LV function., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: To investigate the adequacy of visual estimate regarding the percent diameter stenosis (DS) in bifurcation lesions., Background: Quantitative coronary angiography (QCA) is more accurate and precise compared to visual estimate in assessing stenosis severity in single-vessel lesions., Methods: Thirty-six experts in the field of bifurcation PCI visually assessed the DS in cine images of five precision manufactured phantom bifurcation lesions, experts being blinded to the true values. Expert DS estimates were compared with the true values and they were also used to define the Medina class of each individual bifurcation. Results were pooled together both for proximal main vessel (PMV), distal main vessel (DMV) and side-branch (SB) segments and for vessel segments with similar DS values., Results: Individual performance was highly variable among observers; pooled values and range of accuracy and precision were 2.79% (-6.67% to 17.33%) and 8.69% (4.31-16.25%), respectively. On average, DS was underestimated in the PMV (-1.08%, P = 0.10) and overestimated in the DMV (3.86% P < 0.01) and SB segments (5.58%, P < 0.01). Variability in visual estimates was significantly larger in lesions of medium severity compared to the clearly obstructive ones (P < 0.01); the latter were consistently overestimated. Inter-observer agreement was moderate (κ = 0.55) over the entire number of estimates. However, if the segments with true DS = 0% were excluded, agreement was diminished (κ = 0.27). Inter-observer agreement in Medina class was rather low (κ = 0.21). True bifurcation lesions were misclassified as non-true ones in 14/180 estimates., Conclusions: Visual assessment by experts is more variable and less precise in the analysis of bifurcation lesions compared to bifurcation QCA software., (Copyright © 2011 Wiley Periodicals, Inc.)

Objective: To compare the geometrical parameters of a bioresorbable vascular scaffold (BVS) with a standard metallic stent., Background: The introduction of polymeric bioresorbable materials in the design of novel coronary scaffolds may affect some geometrical parameters, such as eccentricity and symmetry indices, previously introduced as IVUS criteria for optimal metallic stent deployment., Methods: From ABSORB Cohort A, ABSORB Cohort B, SPIRIT I, and SPIRIT II, all patients implanted with BVS 1.0, BVS 1.1, or XIENCE V, respectively and intravascular ultrasound analyses post-implantation were selected. The eccentricity index was calculated frame by frame and expressed as an average per device (minimum diameter/maximum diameter). The symmetry index of the device was reported as ([maximum diameter - minimum diameter]/maximum diameter). Six months major adverse cardiac events (MACE) were analyzed., Results: A total of 242 patients were selected (BVS 1.0: n = 28, BVS 1.1: n = 94, XIENCE V: n = 120). The BVS exhibited a significantly lower eccentricity index (BVS 1.0: 0.83 ± 0.09; BVS 1.1: 0.85 ± 0.08; XIENCE V: 0.90 ± 0.06; P < 0.01) and a significantly higher symmetry index (BVS 1.0: 0.30 ± 0.07; BVS 1.1: 0.31 ± 0.06, XIENCE V 0.26 ± 0.07; P < 0.01) as compared to the XIENCE V. An inverse correlation was found between the symmetry and eccentricity indices for both (BVS r = -0.69, P < 0.01; XIENCE V r = -0.61, P < 0.01). No differences in MACE were detected between the groups according to their geometrical parameters., Conclusions: The introduction of a new polymeric material in the design of BVS resulted in a lower eccentricity index and a higher symmetry index as compared to metallic stents, without detectable impact in MACE, at 6 months., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: To determine the occurrence of in-hospital complications after transcatheter aortic valve implantation (TAVI) according to the Valve Academic Research Consortium (VARC) criteria in addition to the length of stay (LOS)., Background: The absence of uniformity in endpoint definitions challenges the comparison between previously reported major adverse cerebro- and cardiovascular event rates after TAVI. To address this, in 2009, the VARC was established aiming to provide standardized endpoint definitions for TAVI clinical trials., Methods: Between November 2005 and September 2010, we prospectively enrolled 150 consecutive patients who underwent TAVI with the Medtronic CoreValve System in our institution. Complications, prosthetic valve associated endpoints, and therapy-specific endpoints were defined according to the definitions provided by the VARC., Results: The mean age (±SD) was 81 (±7) years and 55% were female. Thirty-day or in-hospital mortality was 11%, and the 30-day combined safety endpoint was 22%. Seventy-six patients (51%) had ≥1 cardiovascular and/or noncardiovascular complication of whom 16 also underwent a new permanent pacemaker implantation (PPI). In the 74 patients with uneventful TAVI, 12 patients (8%) underwent PPI. TAVI was truly uneventful in 62 patients (41%). Bleeding complications were observed most frequently (31%), followed by acute kidney injury (18%), vascular complications (16%), and stroke/TIA (11%). The median LOS in patients with a complicated and a truly uncomplicated TAVI was 14.0 (8.0-20.5) and 8.0 (7.0-10.8) days, respectively (P < 0.001)., Conclusion: TAVI was associated with ≥1 cardiovascular and/or noncardiovascular event in 51% of the patients; new PPI was needed in another 8%, and TAVI was truly uncomplicated in 41%. Complications and need for new PPI significantly prolonged LOS., (Copyright © 2011 Wiley-Liss, Inc.)

Objective: We sought to determine the level of agreement and the reproducibility of trans-thoracic echocardiography (TTE), contrast aortography (CA) and multislice computed tomography (MSCT) for the assessment of the aortic annulus, in patients referred for Transcatheter Aortic Valve Implantation (TAVI)., Background: Correct measurement of the aortic annulus is important for TAVI., Methods: The dimensions of the aortic annulus were measured using TTE, CA and MSCT in 70 patients with severe aortic stenosis, referred for TAVI. Agreement between imaging techniques and interobserver variability was assessed using the Bland - Altman method and a linear regression model., Results: The MSCT Coronal view provided the largest mean annulus diameter (26.3 mm) followed by CA (24.4 mm), MSCT Mean (23.7 mm), TTE (22.6 mm), and MSCT Sagittal (21.8 mm) view. Differences in the annulus measurements were significant: MSCT Coronal view versus CA (mean, 95% confidence interval, Pearson's correlation) 2.0 mm, -1.9 to 6.0 mm, r = 0.72, CA versus MSCT Mean 0.2 mm, -3.3 to 3.7 mm, r = 0.76, MSCT Mean versus TTE 1.3 mm, -2.9 to 5.5 mm, r = 0.61, TTE versus MSCT Sagittal view 0.9 mm, -3.6 to 5.4 mm, r = 0.59, CA versus TTE 1.5 mm, -3.0 to 5.9 mm, r = 0.57. Interobserver variability was: TTE (mean, 95% confidence interval, Pearson's correlation) 0.29 mm, -4.2 to 4.8 mm, r = 0.57, CA 0.14 mm, -3.5 to 3.8 mm, r = 0.77, MSCT Mean 0.20 mm, -1.4 to 1.8 mm, r = 0.95., Conclusions: We found significant differences in the dimensions of the aortic annulus measured by MSCT, CA, and TTE. Interobserver variability for TTE and CA was substantially higher compared with MSCT., (Copyright © 2011 Wiley-Liss, Inc.)

Treatment of vein graft disease remains a challenge in interventional cardiology because of the risk of embolization and no-reflow phenomenon. Currently available distal protection devices have their limitations. The PTFE-covered stents may be well suited for venous graft lesion treatment, but those available commercially to date have poor crossing profiles, and deliverability and high rates of restenosis. We report the first use of over-and-under pericardium-covered stent in combination with drug-eluting balloon to treat venous graft disease., (Copyright 2010 Wiley-Liss, Inc.)

Objectives: To assess the acute and intermediate changes in mitral regurgitation (MR) severity after transcatheter aortic valve implantation (TAVI) with the CoreValve Revalving SystemTM (CRS)., Background: Following surgical aortic valve replacement, improvement in MR is reported in 27-82% of the patients. The changes in MR severity following CRS implantation are unknown., Methods: Transthoracic echocardiography was performed in 79 consecutive patients before and after treatment, and at the first outpatient visit. Left ventricular dimensions and ejection fraction (LVEF), left atrial (LA) size, and aortic gradient were measured. MR was assessed by color flow mapping and was graded as none, mild, moderate, or severe. It was defined as organic or functional. The depth of CRS implantation was measured by angiography., Results: Post-treatment, the mean gradient decreased from 48 +/- 16 mm Hg to 9 +/- 5 mm Hg (P < 0.0001). There was no significant change in the left ventricular dimensions, LA size, and LVEF. MR pretreatment was mild, moderate, or severe in 57%, 18%, and 1% of the patients, respectively. It was defined as organic in 27 patients (36%) and functional in 27 patients (36%). The degree of MR remained unchanged in 61% of the patients, improved in 17%, and worsened in 22%. MR improvement was associated with a lower baseline LVEF (P = 0.02). There was no association between the changes in MR severity and the depth of CRS implantation., Conclusions: Most patients who underwent TAVI had some degree of MR. Overall there was no change in the degree of MR post-treatment. Patients in whom MR improved had a lower LVEF at baseline., (Copyright 2009 Wiley-Liss, Inc.)

Objective: A randomized comparison of the magnetic navigation system (MNS) to conventional guidewire techniques in percutaneous coronary interventions., Background: The MNS precisely directs a magnetized guidewire in vivo through two permanent external magnets., Methods: A total of 111 consecutive patients were enrolled. Crossing success, crossing-/fluoroscopy times, and contrast usage were directly compared. Lesions were classified according to the AHA/ACC criteria. Three tertiles of vessel/lesion complexity [low (<5), medium (6-10) and high (>10)] were defined using 3D reconstructions and angiographic information., Results: The crossing success for magnetic and the conventional wires were 93.3 and 95.6%, respectively. Crossing and fluoroscopy times were longer with the magnetic wires (72.9 +/- 50.3 sec vs. 58.1 +/- 47.2 sec, P < 0.001 and 66.2 +/- 44.1 sec vs. 55.2 +/- 44.4 sec, P = 0.03, respectively). In vessels with low and medium complexity the magnetic wires had significantly longer times (P < 0.001) but for those with high scores (>10) a trend towards shorter times was observed. The MNS resulted in a small but significant reduction in contrast usage (2.3 +/- 3.5 ml vs. 4.5 +/- 4.4 ml, P < 0.001). Moreover by superimposing a virtual roadmap of the vessel on the live fluoroscopy image 48% of the lesions were crossed without requiring contrast agents with the MNS., Conclusion: The MNS has comparable crossing success to conventional PCI. It is relatively slower but there is a trend to support a potential advantage in more complex vessels. By simultaneously employing a virtual roadmap there is a small but significant reduction in contrast usage., ((c) 2008 Wiley-Liss, Inc.)

Objectives: To directly compare the magnetic navigation system (MNS) guidewires with conventional guidewires in branching tortuous phantoms with operators of varying MNS and percutaneous coronary intervention experience., Background: Vessel tortuosity, angulation, and side branches remain limiting factors in coronary interventions. The MNS addresses these limitations by precisely directing the tip of a magnetised guidewire in vivo aided by two permanent adjustable external magnets., Methods: Crossing and fluoroscopy times of six operators were evaluated in five tortuous Perspex(R) phantom vessels in three consecutive attempts. Standard guidewire (SG) usage was unrestricted. Two 2nd generation magnetic guidewires (MG) were used. Failure was noted if the cross was unsuccessful within 5 min., Results: The magnetic navigation was vastly superior to SG techniques with increasingly tortuous phantoms. It dramatically decreased both the crossing and fluoroscopy times with maximal reduction from 201.7 +/- 111 to 36.4 +/- 13 sec, P < 0.001 and 204.7 +/- 24 to 47.2 +/- 19 sec, P < 0.001, respectively. The MNS had a 98.8% procedural success rate compared to 68% with SG techniques. Moreover it considerably limited the amount of wire usage from 5.5 to 1.3. Operators with prior MG experience performed significantly better than those without, except in the simplest phantom where the difference was nonsignificant (33.8 +/- 13 sec vs. 41.7 +/- 17 sec, P = 0.2)., Conclusion: MNS significantly reduces both the crossing and fluoroscopy times in tortuous coronary phantom models achieving excellent success rates with dramatic reductions in guidewire usage. Operators with prior MNS experience had an advantage over the inexperienced., ((c) 2007 Wiley-Liss, Inc.)

Bifurcation lesions can be technically demanding to manage, and even in the era of drug eluting stents, their procedural success is variable. The use of the crush technique followed by "kissing" balloon postdilatation has been shown to improve the overall outcome. However, crossing the crushed stent is essential to allow performance of a final dilatation with "kissing" balloons and is regarded as the main Achilles' heel of this technique. In this report, we describe the first reported, planned procedure to use a magnetic navigation system to steer a wire through the crushed stent to use "kissing" balloons that had previously failed with conventional wires., ((c) 2006 Wiley-Liss, Inc.)