Jaegere, P. de

Timing and potential mechanisms of new conduction abnormalities during the implantation of the Medtronic CoreValve System in patients with aortic stenosis (Article)

2011-08-01T00:00:00Z

AimsNew-onset left bundle branch block (LBBB) and complete atrioventricular block (AV3B) frequently occur following transcatheter aortic valve implantation (TAVI). We sought to determine the timing and potential mechanisms of new conduction abnormalities (CAs) during TAVI, using the Medtronic CoreValve System (MCS).Methods and resultsSixty-five consecutive patients underwent TAVI with continuous 12-lead ECG analysis. New CAs were defined by the occurrence of LBBB, RBBB, and/or AV3B after the following pre-defined time points: (i) crossing of valve with stiff wire, (ii) positioning of balloon catheter in the aortic annulus, (iii) balloon valvuloplasty, (iv) positioning of MCS in the left ventricular outflow tract (LVOT), (v) expansion of MCS, (vi) removal of all catheters. A new CA occurred during TAVI in 48 patients (74) and after TAVI in 5 (8). Of the 48 patients with procedural CAs, a single new CA occurred in 43 patients (90) and two types of CAs in 5 (10). A new LBBB was seen in 40 patients (83), AV3B in 9 (19), and RBBB in 4 (8). The new CA first occurredin descending order of frequencyafter balloon valvuloplasty in 22 patients (46), MCS expansion in 14 (29), MCS positioning in 6 (12), positioning of balloon catheter in 3 (6), wire-crossing of aortic valve in 2 (4), and after catheter removal in 1 patient (2). Patients who developed a new CA during balloon valvuloplasty had a significantly higher balloon/annulus ratio than those who did not (1.10 ± 0.10 vs. 1.03 ± 0.11, P 0.030). No such relationship was found with the valve/annulus ratio.ConclusionTranscatheter aortic valve implantation with the MCS was associated with new CAs in 82 of which more than half occurred before the actual valve implantation. It remains to be elucidated by dedicated studies whether new CAs can be reduced by appropriate balloon sizinga precept that also holds for valve size given the observed directional signal of the valve size/aortic annulus ratio.

Correlates on MSCT of paravalvular aortic regurgitation after transcatheter aortic valve implantation using the medtronic corevalve prosthesis (Article)

2011-07-27T00:00:00Z

Background: To investigate the causes of paravalvular aortic regurgitation (PAR) after the implantation of the Medtronic CoreValve prosthesis (MCRS). Methods and Results: Fifty-six patients underwent MSCT before TAVI with a MCRS and PAR was assessed with transthoracic echocardiography (TTE) between 5 and 10 days after TAVI. The aortic annulus smallest and largest orthogonal diameters and the mean diameter from the area were determined on MSCT on an axial image at the nadir of all three native leaflets. PAR was related to relevant anatomical structures on MSCT according to a clockface in the orientation of the parasternal short axis view on TTE. PAR ≥ 1 was present in 25% of the patients and was associated with a larger annulus, a lower degree of over sizing and with more aortic root calcification. On MSCT post TAVI malapposition was seen predominantly at the aorto-mitral fibrous continuity and the aspect of the largest diameter of the aortic annulus on the inside curve of the ascending aorta. PAR was predominantly seen at these two anatomic locations and less frequent in the area that contains the ventricular membranous septum and the area between the non- and right coronary sinus. Conclusions: Mild to moderate PAR is common after TAVI with the MCRS. The availability of additional (larger) prosthesis sizes in combination with improved sizing based on mean annulus diameter (e.g., DCSA) may help to reduce PAR.

Antithrombotic drug candidate ALX-0081 shows superior preclinical efficacy and safety compared with currently marketed antiplatelet drugs (Article)

2011-07-21T00:00:00Z

Neutralizing the interaction of the platelet receptor gpIb with VWF is an attractive strategy to treat and prevent thrombotic complications. ALX-0081 is a bivalent Nanobody which specifically targets the gpIb-binding site of VWF and interacts avidly with VWF. Nanobodies are therapeutic proteins derived from naturally occurring heavy-chain - only Abs and combine a small molecular size with a high inherent stability. ALX-0081 exerts potent activity in vitro and in vivo. Perfusion experiments with blood from patients with acute coronary syndrome on standard antithrombotics demonstrated complete inhibition of platelet adhesion after addition of ALX-0081, while in the absence of ALX-0081 residual adhesion was observed. In a baboon efficacy and safety model measuring acute thrombosis and surgical bleeding, ALX-0081 showed a superior therapeutic window compared with marketed antithrombotics. Pharmacokinetic and biodistribution experiments demonstrated target-mediated clearance of ALX-0081, which leads to a self-regulating disposition behavior. In conclusion, these preclinical data demonstrate that ALX-0081 combines a high efficacy with an improved safety profile compared with currently marketed antithrombotics. ALX-0081 has entered clinical development.

Transaortic flow velocity from dual-source MDCT for the diagnosis of aortic stenosis severity (Article)

2011-07-01T00:00:00Z

Objectives: To describe a method for the estimation of transaortic flow from multidetector computer tomography (MDCT). Background: Cardiac MDCT may not allow instantaneous flow measurement yet the components of flow, namely, volume change over time and lumenal area are recorded. Methods: In 36 patients, the transaortic flow velocity was determined on transthoracic echocardiography and also with cardiac MDCT as follows: On MDCT an axial orientation through the aortic root was obtained so that the nadir of all three aortic leaflets could be seen simultaneously in one axial image. Aortic valve area (AVA) was determined by planimetry and left ventricular volumes by endocardial border mapping at every 5% increment of the RR intervals. Flow velocity was then calculated as the incremental ejection volume Ã· duration of the increment Ã· AVA. Results: The transthoracic echocardiography (TTE) peak velocity and MDCT peak velocity were highly correlated (r = 0.75, P < 0.01). Transaortic peak velocity was higher when measured by MDCT as compared to TTE, with respectively a median [IQ-range] of 4.5 [2.9-5.3] and 4.0 [3.0-4.6], P < 0.01. For the diagnosis of severe aortic stenosis greater concordance with TTE peak velocity was seen with MDCT peak velocity (sensitivity 100%, specificity 76%) than with MDCT AVA (sensitivity 74%, specificity 76%). Conclusions: We show for the first time that transaortic flow velocity can be estimated by dual-source MDCT and has a better sensitivity for the detection of severe aortic stenosis than AVA planimetry when compared to the gold standard of TTE peak flow velocity. Copyright

Effect of experience on results of transcatheter aortic valve implantation using a medtronic CoreValve system (Article)

2011-06-15T00:00:00Z

Outcome after transcatheter aortic valve implantation (TAVI) depends on the patient risk profile, operator experience, progress in technology, and technique. We sought to compare the results of TAVI during the initiation phase and after certification to perform TAVI with the Medtronic CoreValve System without proctoring. A total of 165 consecutive patients was categorized into a first cohort of 33 patients treated before certification (November 2005 to December 2007) and a second cohort of 132 patients treated after certification (January 2008 to October 2010). The study end points were selected and defined according to the Valve Academic Research Consortium recommendations. Compared to cohort 2, the patients in cohort 1 more frequently had New York Heart Association class IIIIV (100% vs 71%, p <0.001), hypertension (67% vs 39%, p = 0.004), and aortic regurgitation grade IIIIV (46% vs 22%, p = 0.006) before TAVI. Over time, the patients in cohort 2 more frequently underwent a truly percutaneous approach (98% vs 82%, p = 0.002) without circulatory support (96% vs 67%, p <0.001) but with more concomitant percutaneous coronary intervention (11% vs 0%, p = 0.042) than the patients in cohort 1. They also more often received a 29-mm prosthesis (72% vs 24%, p <0.001), required less postimplantation balloon dilation (10% vs 27%, p = 0.008), and had less aortic regurgitation grade IIIIV after TAVI (12% vs 30%, p = 0.010). The clinical outcome showed a nonsignificant reduction in the combined safety end point (30% to 17%) but a significant reduction in cerebrovascular events (21% to 7%, p = 0.020) and life-threatening bleeding (15% to 5%, p = 0.044) in cohort 2. However, the reduction in overall bleeding and vascular complications (25% and 14%, respectively) was not significant. In conclusion, TAVI became significantly less complex and was associated with better results over time but remained associated with a high frequency of periprocedural major cardiovascular complications. Crown Copyright

NIRS and IVUS for characterization of atherosclerosis in patients undergoing coronary angiography (Article)

2011-06-01T00:00:00Z

Objectives: The aim of this study was to compare the findings of near-infrared spectroscopy (NIRS), intravascular ultrasound (IVUS) virtual histology (VH), and grayscale IVUS obtained in matched coronary vessel segments of patients undergoing coronary angiography. Background: Intravascular ultrasound VH has been developed to add tissue characterization to the grayscale IVUS assessment of coronary plaques. Near-infrared spectroscopy is a new imaging technique able to identify lipid core-containing coronary plaques (LCP). Methods: We performed NIRS and IVUS-VH pullbacks in a consecutive series of 31 patients with a common region of interest (ROI) between 2 side branches. For each ROI, we analyzed the chemogram blocks by NIRS, plaque area and plaque burden by grayscale IVUS, and tissue types by IVUS-VH. The chemogram block is a summary metric of a 2-mm vertical slice of the chemogram. The value ranges from 0 to 1 according to the presence of lipids and represents the probability of LCP with a color scale from red (low probability) through orange and tan to yellow (high probability). Results: Plaque area (mm2) increases as percentage VH derived-necrotic core (NC) content (4.6 ± 2.7 vs. 7.4 ± 3.5 vs. 8.6 ± 3.4 vs. 7.9 ± 3.3, grouped in percentage NC quartiles, p < 0.001) and chemogram block probability color bin thresholds increase (4.9 ± 3.8 red, 7.3 ± 3.6 orange, 8.1 ± 3.4 tan, and 8.7 ± 3.4 yellow, p < 0.001). The correlation between the block chemogram detection of lipid core and percentage NC content by VH was weak (r = 0.149). Correction for the presence of calcium does not improve this correlation. Conclusions: Larger plaque area by grayscale IVUS was more often associated with either elevated percentage VH-NC or LCP by NIRS; however, the correlation between the detection of LCP by NIRS and necrotic core by VH is weak.

In-hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitions (Article)

2011-05-13T00:00:00Z

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.

Frequency, determinants, and prognostic effects of acute kidney injury and red blood cell transfusion in patients undergoing transcatheter aortic valve implantation (Article)

2011-05-01T00:00:00Z

Objectives: To determine the frequency and independent predictors of acute kidney injury (AKI) in addition to the prognostic implications of both AKI and periprocedural red blood cell (RBC) transfusions on 30 day and cumulative late mortality in patients undergoing transcatheter aortic valve implantation (TAVI). Background: RBC transfusions have been reported to predict AKI following TAVI. Data on the prognostic implications of both factors, however, are lacking. Methods: 126 consecutive patients underwent TAVI with the Medtronic CoreValve Revalving System. AKI was defined according to the valve academic research consortium definitions as an absolute increase in serum creatinine ≥0.3 mg dL-1(≥26.4 μmol L-1) or a percentage increase ≥50% within 72 hr following TAVI. Results: Five patients on chronic haemodialysis and three intraprocedural deaths were excluded, leading to a final study population of 118 patients. AKI occurred in 19% of the patients necessitating temporary haemodialysis in 2%. Independent predictors of AKI included: previous myocardial infarction (OR: 5.72; 95% CI: 1.64-19.94), periprocedural (<24 hr) RBC transfusions (OR: 1.29; 95% CI: 1.01-1.70), postprocedural (<72 hr) leucocyte count (OR: 1.18; 95% CI: 1.02-1.37), and logistic EuroSCORE (OR: 1.08; 95% CI: 1.01-1.14). In patients with AKI, 30-day mortality was 23% and cumulative late mortality (median: 13 months) was 55%. AKI (OR: 5.47; 95% CI: 1.23-24.21) and postprocedural leucocyte count (OR: 1.20; 95% CI: 1.03-1.38) were independent predictors of 30-day mortality while AKI (HR: 2.79; 95% CI: 1.36-5.71) was the only independent predictor of late mortality. Conclusions: AKI following TAVI occurred in 19% of the patients. RBC transfusion was found to be an independent predictor of AKI, which in turn predicted both 30-day and cumulative late mortality.

Assessment of the aortic annulus by multislice computed tomography, contrast aortography, and trans-thoracic echocardiography in patients referred for transcatheter aortic valve implantation (Article)

2011-05-01T00:00:00Z

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.

Left ventricular mass regression one year after transcatheter aortic valve implantation (Article)

2011-03-01T00:00:00Z

Background: Left ventricular (LV) hypertrophy is associated with LV diastolic dysfunction and constitutes a risk factor for cardiac morbidity and mortality. The objective of this study was to investigate the degree of LV mass regression and the changes of LV diastolic function one year after transcatheter aortic valve implantation (TAVI). Methods Echocardiography was performed at baseline, before discharge, and at one-year follow-up in 63 consecutive patients with severe aortic stenosis who underwent TAVI with the Medtronic CoreValve System (Medtronic Inc, Minneapolis, MN). The LV mass was calculated using the Devereux formula and indexed to body surface area. Results One-year all-cause mortality was 29%. The LV mass index decreased from 126 ± 42 g/m2at baseline to 110 ± 30 g/m2at one-year follow-up (p < 0.001). Left ventricular ejection fraction and LV diastolic function did not change significantly. Mean transaortic gradient decreased from 47 ± 19 mm Hg at baseline to 9 ± 5 mm Hg at discharge and 9 ± 4 mm Hg at one year (p < 0.001), and was accompanied by significant clinical improvement. More than mild paravalvular aortic regurgitation was found in 24% and 15% of patients at discharge and one-year follow-up, respectively. Conclusions A significant regression in LV mass was found one year after TAVI. However, regression was incomplete and was not accompanied by an improvement in LV diastolic function.

Interpreting the current data on transcatheter aortic valve implantation: A difficult task (Article)

2010-09-01T00:00:00Z

Three dimensional evaluation of the aortic annulus using multislice computer tomography: Are manufacturer's guidelines for sizing for percutaneous aortic valve replacement helpful? (Article)

2010-04-01T00:00:00Z

AimsTo evaluate the effects of applying current sizing guidelines to different multislice computer tomography (MSCT) aortic annulus measurements on Corevalve (CRS) size selection.Methods and resultsMultislice computer tomography annulus diameters [minimum: Dmin; maximum: Dmax; mean: Dmean= (Dmin+ Dmax)/2; mean from circumference: Dcirc; mean from surface area: DCSA] were measured in 75 patients referred for percutaneous valve replacement. Fifty patients subsequently received a CRS (26 mm: n = 22; 29 mm: n = 28). Dmin and Dmax differed substantially [mean difference (95 CI) = 6.5 mm (5.7-7.2), P < 0.001]. If Dmin were used for sizing 26 of 75 patients would be ineligible (annulus too small in 23, too large in 3), 48 would receive a 26 mm and 12 a 29 mm CRS. If Dmax were used, 39 would be ineligible (all annuli too large), 4 would receive a 26 mm, and 52 a 29 mm CRS. Using Dmean, Dcirc, or DCSAmost patients would receive a 29 mm CRS and 11, 16, and 9 would be ineligible. In 50 patients who received a CRS operator choice corresponded best with sizing based on DCSA and Dmean(76, 74), but undersizing occurred in 20 and 22 of which half were ineligible (annulus too large).ConclusionEligibility varied substantially depending on the sizing criterion. In clinical practice both under-and oversizing were common. Industry guidelines should recognize the oval shape of the aortic annulus.

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving System-A Bern-Rotterdam Study (Article)

2010-02-01T00:00:00Z

Background: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or "inoperable" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. Objective: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. Methods: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. Results: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% ± 13.9% vs STS 6.7% ± 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES ≥15%, 16% had an STS ≥10%, and 40% had an LES ≥20% or STS ≥10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. Conclusions: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.

Adherence to patient selection criteria in patients undergoing transcatheter aortic valve implantation with the 18F CoreValve ReValving system (Article)

2010-01-01T00:00:00Z

Background: Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications. Methods: To assess the frequency and outcomes associated with "off-label" use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (CRS). Label status (on-label vs off-label) was determined by following (1) inclusion/exclusion criteria indicated in the 18F CRS safety and efficacy trial and (2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criterion or "non-acceptable" criteria based on the patient selection matrix. Results: Off-label implantation was identified in 42 patients (67%)-40% had one, 19% had two and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8 (11.2) vs 14.5 (7.3), p=0.029). There was no significant difference in the procedural success rates between the on-label and off-label groups (91% vs 95%, respectively, p=0.47). The frequency of angiographic moderatesevere aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the "on-label" and three deaths in the "off-label" group. Conclusion: In this study we found that "off-label" implantation of the CRS was common. Further studies are needed to evaluate the consequences of "label status" for patients undergoing TAVI.

Changes in mitral regurgitation after transcatheter aortic valve implantation (Article)

2010-01-01T00:00:00Z

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.

Transapical implantation of a self-expanding aortic valve bioprosthesis - animal feasibility study (Article)

2009-11-01T00:00:00Z

Background: Severe peripheral arterial disease may pose a limitation to the applicability of trans-arterial aortic valve implantation in patients who are otherwise candidates. For this reason, transapical aortic valve implantation has been proposed as a possible alternative. Objective: To evaluate the acute safety and performance of a specially designed delivery system, the CoreValve Tranzap™ delivery catheter, for the transapical implantation of a self-expandable aortic valve prosthesis in a porcine animal model. Methods: Thirteen pigs were implanted with a self-expandable aortic valve bioprosthesis using a 21F catheter delivery system through a transapical approach. The delivery system was evaluated for: (1) the ability to access the implantation site; (2) the ability to precisely position the delivery catheter; (3) control of the delivery of the prosthesis; (4) safe retrieval of the delivery catheter; and (5) the ability to close the apical access site of the heart. Results: Successful implantation was achieved in 100% of the cases. The following points were achieved in all animals: (1) passage of the delivery catheter through an incision in the left ventricular apex; (2) positioning of the delivery catheter on the implantation site; (3) controlled deployment of the aortic valve prosthesis; (4) the safe retrieval of the delivery catheter system; and (5) the adequate closure of the apex of the heart. Conclusion: This study demonstrates the acute safety and feasibility of the CoreValve Tranzap™ delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.

Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention (Article)

2009-10-01T00:00:00Z

Purpose: We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents. Methods: Consecutive PCI patients (n = 562) completed the Global Mood Scale at baseline to assess affect and the EuroQoL-5D (EQ-5D) at baseline and 12-month follow-up to assess health status. Results: Negative affect [F(1, 522) = 17.14, P < .001] and positive affect [F(1, 522) = 5.11, P = .02] at baseline were independent associates of overall health status at 12-month follow-up, adjusting for demographic and clinical factors. Moreover, there was a significant interaction for negative by positive affect [F(1, 522) = 6.11, P = .01]. In domain-specific analyses, high negative affect was associated with problems in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the risk being two to fivefold. Low positive affect was only associated with problems in self-care (OR: 8.14; 95% CI: 1.85-35.9; P = .006) and usual activities (OR: 1.87; 95% CI: 1.17-3.00; P = .009). Conclusions: Baseline negative and positive affect contribute independently to patient-reported health status 12 months post PCI. Positive affect moderated the detrimental effects of negative affect on overall health status. Enhancing positive affect might be an important target to improve patient-centered outcomes in coronary artery disease.

Geometry and Degree of Apposition of the CoreValve ReValving System With Multislice Computed Tomography After Implantation in Patients With Aortic Stenosis (Article)

2009-09-01T00:00:00Z

Objectives: Using multislice computed tomography (MSCT), we sought to evaluate the geometry and apposition of the CoreValve ReValving System (CRS, Medtronic, Luxembourgh, Luxembourgh) in patients with aortic stenosis. Background: There are no data on the durability of percutaneous aortic valve replacement. Geometric factors may affect durability. Methods: Thirty patients had MSCT at a median 1.5 months (interquartile range [IQR] 0 to 7 months) after percutaneous aortic valve replacement. Axial dimensions and apposition of the CRS were evaluated at 4 levels: 1) the ventricular end; 2) the nadir; 3) central coaptation of the CRS leaflets; and 4) commissures. Orthogonal smallest and largest diameters and cross-sectional surface area were measured at each level. Results: The CRS (26-mm: n = 14, 29-mm: n = 16) was implanted at 8.5 mm (IQR 5.2 to 11.0 mm) below the noncoronary sinus. None of the CRS frames reached nominal dimensions. The difference between measured and nominal cross-sectional surface area at the ventricular end was 1.6 cm2(IQR 0.9 to 2.6 cm2) and 0.5 cm2(IQR 0.2 to 0.7 cm2) at central coaptation. At the level of central coaptation the CRS was undersized relative to the native annulus by 24% (IQR 15% to 29%). The difference between the orthogonal smallest and largest diameters (degree of deformation) at the ventricular end was 4.4 mm (IQR 3.3 to 6.4 mm) and it decreased progressively toward the outflow. Incomplete apposition of the CRS frame was present in 62% of patients at the ventricular end and was ubiquitous at the central coaptation and higher. Conclusions: Dual-source MSCT demonstrated incomplete and nonuniform expansion of the CRS frame, but the functionally important mid-segment was well expanded and almost symmetrical. Undersizing and incomplete apposition were seen in the majority of patients.

Implantation of two self-expanding aortic bioprosthetic valves during the same procedure - Insights into valve-in-valve implantation ("Russian Doll Concept") (Article)

2009-03-01T00:00:00Z

Transcatheter aortic value implantation has gained acceptance as a treatment for elderly patients considered high risk for surgical aortic valve replacement. There are still, however, many unresolved clinical and technical issues. The occurrence of transcatheter aortic valve-in-valve implantation has been reported anecdotally. Aside from a single case report, there is little literature on this topic. This study was conducted to evaluate the procedural, imaging, and clinical outcomes of patients who underwent transcatheter valve-in-valve implantation with two self-expanding aortic valve bioprostheses during the same procedure. We discuss also the potential valve of on-line quantitative angiography for assessing the depth of valve implantation and the need to implant a second valve.

Feasibility of complex coronary intervention in combination with percutaneous aortic valve implantation in patients with aortic stenosis using percutaneous left ventricular assist device (TandemHeart®) (Article)

2009-02-26T00:00:00Z

Coronary atherosclerosis is a common finding in patients with severe aortic stenosis. Indeed, aortic stenosis is associated with risk factors similar those of coronary atherosclerosis such as older age, hypertension, diabetes, hypercholesterolemia and smoking. In light of the evolution of percutaneous aortic valve implantation (PAVI) and ongoing improvements in techniques of PCI, a combined approach using PCI and PAVI can be proposed for patients with complex coronary artery and aortic valve disease. This report describes the feasibility of the combination of percutaneous coronary intervention and percutaneous aortic valve implantation with peripheral left ventricular assist device (TandemHeart) support in 3 elderly patients with complex coronary altery disease and aortic stenosis considered too high risk for conventional surgical therapy.

Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions-Need for a Reappraisal? (Article)

2009-02-01T00:00:00Z

Two cases of aneurysm of the anterior mitral valve leaflet associated with transcatheter aortic valve endocarditis: A mere coincidence? (Article)

2009-01-01T00:00:00Z

Two-year outcome of the use of paclitaxel-eluting stents in aorto-ostial lesions (Article)

2008-10-13T00:00:00Z

Background: Percutaneous treatment of stenoses involving aorto-ostial lesions is technically demanding and has been associated with lower procedural success and poorer clinical and angiographic outcomes when compared with non-ostial lesions. This study evaluated the immediate and long-term (2-year) outcome of aorto-ostial stenoses treated with paclitaxel-eluting stents (PES). Methods: From February 2003 to December 2004, a total of 76 consecutive patients with 76 lesions underwent percutaneous intervention with PES for aorto-ostial lesions (right coronary artery, 37; left main, 26; saphenous vein graft, 13). All patients were clinically followed for the occurrence of major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR). Results: All stents (1.7/lesion) were successfully deployed. Three lesions (3.9%) were pre-treated with debulking devices. Thirty-seven lesions (48.7%) were post-dilated with non-compliant balloons (balloon/artery ratio, 1.2). Stents were positioned protruding into the aortic lumen in 29 lesions (38.2%). Cumulative 2-year event-free survival was 68.4%. There was one angiographically-proven stent thrombosis occurring 427 days after TLR for restenosis after the index procedure. The restenosis rate at 7 months (median) was 20.0% and in-stent late lumen loss was 0.48 mm in 40 patients with angiographic follow-up. Conclusions: Utilization of PES in this complex lesion subset is feasible and associated with favorable angiographic results at 7 months. However, the gradual increase in later events up to 2 years suggests that aorto-ostial disease remains problematic even in the era of drug-eluting stents.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) (Article)

2008-07-01T00:00:00Z

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. Methods and results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Transcatheter valve implantation for patients with aortic stenosis: A position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) (Article)

2008-06-01T00:00:00Z

Early and Persistent Intraventricular Conduction Abnormalities and Requirements for Pacemaking After Percutaneous Replacement of the Aortic Valve (Article)

2008-06-01T00:00:00Z

Objectives: In this retrospective study, we examined the incidence of post-procedural conduction abnormalities and the need for pacing in patients undergoing percutaneous implantation of the aortic valve. Background: Safety and feasibility studies have suggested anecdotally the occurrence of conduction abnormalities and requirements for pacing after percutaneous implantation of the aortic valve. Methods: We examined the standard 12-lead electrocardiograms (ECGs) of 40 consecutive patients in whom a CoreValve Revalving System (CoreValve, Paris, France) was implanted between November 2005 and March 2008. We examined the 12-lead ECG before treatment, after treatment, and at 1-month follow-up. We documented the requirements for temporary or permanent pacemaking. Results: The mean age of patients was 82 ± 7 years. Post-procedural mortality at 72 h was 0%. There was a significant increase in the frequency of left bundle branch block (LBBB) after percutaneous aortic valve replacement (15% before treatment vs. 55% after treatment, p = 0.001). Although the incidence of LBBB had decreased after follow-up of 1 month, it did not reach statistical significance, with the proportion decreasing from 55% to 48% (p = 0.63). The only 2 patients with pre-treatment right bundle branch block became dependent on temporary pacing immediately after valve implantation and subsequently needed permanent pacing. A temporary and permanent pacemaker was required in 20% and 18% of patients, respectively. Conclusions: In this study, there was a significant increase in the frequency of LBBB after percutaneous insertion of the aortic valvar prosthesis. Patients with pre-existing right bundle branch block may be at risk for the development of complete heart block and subsequent need for pacing.

Quantification of coronary plaque by 64-slice computed tomography: A comparison with quantitative intracoronary ultrasound (Article)

2008-05-01T00:00:00Z

BACKGROUND: Noninvasive assessment of coronary atherosclerotic plaque may be useful for risk stratification and treatment of atherosclerosis. MATERIALS AND METHODS: We studied 47 patients to investigate the accuracy of coronary plaque volume measurement acquired with 64-slice multislice computed tomography (MSCT), using newly developed quantification software, when compared with quantitative intracoronary ultrasound (QCU). Quantitative MSCT coronary angiography (QMSCT-CA) was performed to determine plaque volume for a matched region of interest (regional plaque burden) and in significant plaque defined as a plaque with ≥50% area obstruction in QCU, and compared with QCU. Dataset with image blurring and heavy calcification were excluded from analysis. RESULTS: In 100 comparable regions of interest, regional plaque burden was highly correlated (coefficient r = 0.96; P < 0.001) between QCU and QMSCT-CA, but QMSCT-CA overestimated the plaque burden by a mean difference of 7 ± 33 mm (P = 0.03). In 76 significant plaques detected within the regions of interest, plaque volume determined by QMSCT-CA was highly correlated (r = 0.98; P < 0.001) with a slight underestimation of 2 ± 17 mm (P = not significant) when compared with QCU. Calcified and mixed plaque volume was slightly overestimated by 4 ± 19 mm (P = ns) and noncalcified plaque volume was significantly underestimated by 9 ± 11 mm (P < 0.001) with QMSCT-CA. Overall, the limits of agreement for plaque burden/volume measurement between QCU and QMSCT-CA were relatively large. Reproducibility for the measurements of regional plaque burden with QMSCT-CA was good, with a mean intraobserver and interobserver variability of 0% ± 16% and 4% ± 24%, respectively. CONCLUSIONS: Quantification of coronary plaque within selected proximal or middle coronary segments without image blurring and heavy calcification with 64-slice CT was moderately accurate with respect to intravascular ultrasound and demonstrated good reproducibility. Further improvement in CT resolution is required for more reliable measurement of coronary plaques using quantification software.

Four-Year Clinical Follow-Up of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital Registry (Article)

2008-04-15T00:00:00Z

Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem.

Type-D personality and depressive symptoms predict anxiety 12 months post-percutaneous coronary intervention (Article)

2007-11-01T00:00:00Z

Background: We examined whether type-D personality exerts a stable effect on anxiety over time and the clinical relevance of type-D personality as a predictor of anxiety 12 months post-percutaneous coronary intervention (PCI). Methods: Consecutive patients (n = 416) with stable or unstable angina pectoris treated with PCI completed the Type-D Scale (DS14) at baseline and the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months. Results: At baseline, 26% of the patients were anxious, with 67% of these patients still being anxious 12 months post-PCI (p < 0.001). There was no significant change in anxiety between baseline and 12 months (p = 0.96) nor was the interaction effect type-D personality by time significant (p = 0.41). However, type-D patients experienced significantly higher levels of anxiety than non-type-D patients (p < 0.001). Type-D personality (OR: 2.89; CI: 1.57-5.34), depressive symptoms (OR: 3.27; CI: 1.73-6.18) and anxiety at baseline (OR: 8.38; CI: 4.65-15.12) were independent predictors of anxiety 12 months post-PCI, adjusting for baseline demographic and clinical characteristics. Limitations: A limitation of the study is the attrition rate of 105 patients who did not complete the HADS at 12 months. No information was available on the use of psychotropic medication and participation in cardiac rehabilitation, which could serve as confounders. Conclusion: Type-D exerted a stable effect on anxiety over time and was an independent predictor of anxiety 12 months post-PCI together with depressive symptoms and anxiety at baseline. The DS14 could be used as a screening tool in clinical practice to identify high-risk patients post-PCI.

64-Slice CT coronary angiography in patients with non-ST elevation acute coronary syndrome (Article)

2007-11-01T00:00:00Z

Background: A high diagnostic accuracy of 64-slice CT coronary angiography (CTCA) has been reported in selected patients with stable angina pectoris, but only scant information is available in patients with non-ST elevation acute coronary syndrome (ACS). Objectives: To study the diagnostic performance of 64-slice CTCA in patients with non-ST elevation ACS. Patients and methods: 64-slice CTCA was performed in 104 patients (mean (SD) age 59 (9) years) with non-ST elevation ACS. Two independent, blinded observers assessed all coronary arteries for stenosis, using conventional quantitative angiography as a reference. Coronary lesions with ≥50% luminal narrowing were classified as significant. Results: Conventional coronary angiography demonstrated the absence of significant disease in 15% (16/104) of patients, and the presence of single-vessel disease in 40% (42/104) and multivessel disease in 44% (46/104) of patients. Sensitivity for detecting significant coronary stenoses on a patient-by-patient analysis was 100% (88/88; 95% CI 95 to 100), specificity 75% (12/16; 95% CI 47 to 92), and positive and negative predictive values were 96% (88/92; 95% CI 89 to 99) and 100% (12/12; 95% CI 70 to 100), respectively. Conclusion: 64-slice CTCA has a high sensitivity to detect significant coronary stenoses, and is reliable to exclude the presence of significant coronary artery disease in patients who present with a non-ST elevation ACS.

64-Slice Computed Tomography Coronary Angiography in Patients With High, Intermediate, or Low Pretest Probability of Significant Coronary Artery Disease (Article)

2007-10-09T00:00:00Z

Objectives: We assessed the usefulness of 64-slice computed tomography coronary angiography (CTCA) to detect or rule out coronary artery disease (CAD) in patients with various estimated pretest probabilities of CAD. Background: The pretest probability of the presence of CAD may impact the diagnostic performance of CTCA. Methods: Sixty-four-slice CTCA (Sensation 64, Siemens, Forchheim, Germany) was performed in 254 symptomatic patients. Patients with heart rates ≥65 beats/min received beta-blockers before CTCA. The pretest probability for significant CAD was estimated by type of chest discomfort, age, gender, and traditional risk factors and defined as high (≥71%), intermediate (31% to 70%), and low (≤30%). Significant CAD was defined as the presence of at least 1 ≥50% coronary stenosis on quantitative coronary angiography, which was the standard of reference. No coronary segments were excluded from analysis. Results: The estimated pretest probability of CAD in the high (n = 105), intermediate (n = 83), and low (n = 66) groups was 87%, 53%, and 13%, respectively. The diagnostic performance of the computed tomography (CT) scan was different in the 3 subgroups. The estimated post-test probability of the presence of significant CAD after a negative CT scan was 17%, 0%, and 0% and after a positive CT scan was 96%, 88%, and 68%, respectively. Conclusions: Computed tomography coronary angiography is useful in symptomatic patients with a low or intermediate estimated pretest probability of having significant CAD, and a negative CT scan reliably rules out the presence of significant CAD. Computed tomography coronary angiography does not provide additional relevant diagnostic information in symptomatic patients with a high estimated pretest probability of CAD.

Detection and characterization of coronary bifurcation lesions with 64-slice computed tomography coronary angiography (Article)

2007-08-01T00:00:00Z

Aims: To compare the performance of 64-slice computed tomography coronary angiography (CTCA) and invasive coronary angiography (ICA) in the detection and classification (according to the Medina system) of bifurcation lesions (BLs). Methods and results: We studied 323 consecutive patients undergoing 64-slice CTCA prior to ICA. All coronary segments ≥2 mm in diameter were evaluated for the presence of a significant (≥50% diameter reduction on quantitative coronary angiography) BL. Evaluation of BL by CTCA included the assessment of significant lumen obstruction in both main and side branch vessels. Forty-one out of 43 patients (46/48 lesions) with significant BL were identified by CTCA. Excluding coronary segments with non-diagnostic image quality (5%), the sensitivity, specificity, and positive and negative predictive values of CTCA for detecting significant BL were 96, 99, and 85 and 99%, respectively. In 39 of these 41 patients, CTCA assessment was concordant with the Medina lesion classification on ICA. Conclusion: Sixty-four-slice CTCA allows accurate assessment of complex BL.

A Clinical Randomized Trial to Evaluate the Safety of a Noninvasive Approach in High-Risk Patients Undergoing Major Vascular Surgery. The DECREASE-V Pilot Study (Article)

2007-05-01T00:00:00Z

Objectives: The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia. Background: Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy. Methods: One thousand eight hundred eighty patients were screened, and those with ≥3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (≥5 segments or ≥3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up. Results: Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48). Conclusions: In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.

Comparison of Three-Year Clinical Outcome of Sirolimus- and Paclitaxel-Eluting Stents Versus Bare Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction (from the RESEARCH and T-SEARCH Registries) (Article)

2007-04-15T00:00:00Z

Sirolimus-eluting stents (SESs) recently proved to be superior to bare metal stents (BMSs) in decreasing the need for repeat revascularization in patients with ST-segment elevation myocardial infarction (STEMI) at 1 year. Whether this also holds for paclitaxel-eluting stents (PESs) is currently unclear and the long-term relatively efficacy of the 2 drug-eluting stents is currently unknown. We investigated the 3-year efficacy of SESs and PESs versus BMSs in patients with STEMI. Primary angioplasty was performed in a consecutive group of 505 patients (BMSs in 183, SESs in 186, PESs in 136). At 3 years, the cumulative mortality rate was comparable in the 3 groups: 13.3% in the BMS group, 11.5% in the SES group, and 12.4% in the PES group (nonsignificant for all). The rate of target vessel revascularization (TVR) was 12.0% in the BMS group compared with 8.0% and 7.7% in the SES and PES groups, respectively (p = 0.12 for BMS vs SES, 0.30 for BMS vs PES, 0.62 for SES vs PES). The cumulative incidence of death, MI, or TVR was 25.5% in the BMS group compared with 17.9% and 20.6% in the SES and PES groups, respectively (p = 0.06 for BMS vs SES, 0.32 for BMS vs PES, 0.45 for SES vs PES). Angiographic stent thrombosis occurred in 2.4% of all patients (BMS 1.6%, SES 2.7%, PES 2.9%). In conclusion, in this relatively small consecutive patient cohort, the use of SESs and PESs was no longer associated with significantly lower rates of TVR and major adverse cardiace events in patients with STEMI after 3 years of follow-up. A high frequency of stent thrombosis was observed in the 2 drug-eluting stent groups.

Fatigue, depressive symptoms, and hopelessness as predictors of adverse clinical events following percutaneous coronary intervention with paclitaxel-eluting stents (Article)

2007-04-01T00:00:00Z

Objective: We investigated the relative effects of fatigue, depressive symptoms, and hopelessness on prognosis at 2-year follow-up in percutaneous coronary intervention (PCI) patients. Methods: Consecutively admitted PCI patients (n=534) treated with paclitaxel-eluting stent as the default strategy completed the Maastricht Questionnaire (MQ) at baseline. Apart from an overall vital exhaustion score, the MQ also assesses fatigue (seven items; Cronbach's α=.87) and depressive symptoms (seven items; Cronbach's α=.83), with hopelessness (one item) comprised in the depressive symptom items. Patients were followed up for adverse clinical events (mortality and nonfatal myocardial infarction) at 2 years. Results: At 2-year follow-up, there were 31 clinical events. In univariable analyses, overall vital exhaustion and depressive symptoms, but not fatigue, were associated with adverse prognosis; in multivariable analysis, depressive symptoms [hazard ratio (HR)=2.69; 95% confidence interval (95% CI)=1.31-5.55] remained the only predictor of clinical outcome. Among the depressive symptoms, hopelessness (HR=3.44; 95% CI=1.65-7.19) was the most cardiotoxic symptom. The incidence of clinical events was higher in the high-hopelessness patients (11% vs. 3%; P=.001) than in the low-hopelessness patients. Hopelessness (HR=3.36; 95% CI=1.58-7.14; P=.002) remained an independent predictor of clinical outcome at 2 years in adjusted analysis. Conclusion: Symptoms of depression, but not fatigue, predicted adverse clinical events. Hopelessness was the most cardiotoxic symptom, associated with a more than three-fold risk of clinical events 2 years post-PCI. Screening for hopelessness may lead to the identification of high-risk patients.

Cognitive and cardiac outcomes 5 years after off-pump vs on-pump coronary artery bypass graft surgery (Article)

2007-02-21T00:00:00Z

Context: Conventional coronary artery bypass graft surgery with use of cardiopulmonary bypass (on-pump CABG) is associated with excellent long-term cardiac outcomes but also with a high incidence of cognitive decline. The effect of avoiding cardiopulmonary bypass (off-pump CABG) on long-term cognitive and cardiac outcomes is unknown. Objective: To compare the effect of off-pump CABG and on-pump CABG surgery on long-term cognitive and cardiac outcomes. Design, Setting, and Participants: The Octopus Study, a multicenter randomized controlled trial conducted in the Netherlands, which enrolled 281 low-risk CABG patients between 1998 and 2000. Five years after their surgery, surviving patients were invited for a follow-up assessment. Intervention: Patients were randomly assigned to receive either off-pump (n=142) or on-pump (n=139) CABG surgery. Main Outcome Measure: The primary measure was cognitive status 5 years after surgery, which was determined by a psychologist blinded to treatment allocation who administered 10 standardized validated neuropsychological tests. Secondary measures were occurrence of cardiovascular events (all-cause mortality, stroke, myocardial infarction, and coronary reintervention), anginal status, and quality of life. Results: After 5 years, 130 patients were alive in each group. Cognitive outcomes could be determined in 123 and 117 patients in the off-pump and on-pump groups, respectively. When using a standard definition of cognitive decline (20% decline in performance in 20% of the neuropsychological test variables), 62 (50.4%) of 123 in the off-pump group and 59 (50.4%) of 117 in the on-pump group had cognitive decline (absolute difference, 0%; 95% confidence interval [CI], -12.7% to 12.6%; P>.99). When a more conservative definition of cognitive decline was used, 41 (33.3%) in the off-pump group and 41 (35.0%) in the on-pump group had cognitive decline (absolute difference, -1.7%; 95% CI, -13.7% to 10.3%; P=.79). Thirty off-pump patients (21.1%) and 25 on-pump patients (18.0%) experienced a cardiovascular event (absolute difference, 3.1%; 95% CI, -6.1% to 12.4%; P=.55). No differences were observed in anginal status or quality of life. Conclusion: In low-risk patients undergoing CABG surgery, avoiding the use of cardiopulmonary bypass had no effect on 5-year cognitive or cardiac outcomes.

Plaque Composition in the Left Main Stem Mimics the Distal But Not the Proximal Tract of the Left Coronary Artery. Influence of Clinical Presentation, Length of the Left Main Trunk, Lipid Profile, and Systemic Levels of C-Reactive Protein (Article)

2007-01-02T00:00:00Z

Objectives: We sought to investigate whether plaques located in the left main stem (LMS) differ in terms of necrotic core content from those sited in the proximal tract of the left coronary artery. Background: Plaque composition, favoring propensity to vulnerability, might be nonuniformly distributed along the vessel, which might explain the greater likelihood for plaque erosion or rupture to occur in the proximal but not in the distal tracts of the coronary artery or in LMS. Methods: A total of 72 patients were included prospectively; 48 (32 men; mean age 57 ± 11 years; 25 with stable angina and 23 affected by acute coronary syndromes) underwent a satisfactory nonculprit vessel investigation through spectral analysis of intravascular ultrasound radiofrequency data (IVUS-Virtual Histology, Volcano Corp., Rancho Cordova, California). The region of interest was subsequently divided into LMS and LMS carina, followed by 6 consecutive nonoverlapping 6-mm segments in left anterior descending artery in 34 patients or in circumflex artery in 14 patients. Results: Necrotic core content (%): 1) was minimal in LMS (median [interquartile range]: 4.6 [2 to 7]), peaked in the first 6-mm coronary segment (11.8 [8 to 16]; p < 0.01), and then progressively decreased distally; 2) was overall greater in patients with acute coronary syndromes (11.4 [5.5 to 19.8]) than stable angina (7.3 [3.2 to 12.9]; p < 0.001); 3) was largely independent from plaque size; and 4) did not correlate to systemic levels of C-reactive protein or lipid profile. Conclusions: Plaques located in the LMS carry minimal necrotic content. Thus, they mimic the distal but not the proximal tract of the left coronary artery, where plaque rupture or vessel occlusion occurs more frequently.

Meta-Analysis of the Studies Assessing Temporal Changes in Coronary Plaque Volume Using Intravascular Ultrasound (Article)

2007-01-01T00:00:00Z

To assess the temporal effect of statin therapy on coronary atherosclerotic plaque volume measured by intravascular ultrasound (IVUS), we searched PubMed for eligible studies published between 1990 and January 2006. Inclusion criteria for retrieved studies were (1) IVUS volume analysis at baseline and follow-up and (2) statin therapy in ≥1 group of patients. All data of interest were abstracted in prespecified structured collection forms. Statistical analysis was performed with Review Manager 4.2. Random-effect weighted mean difference (WMD) was used as summary statistics for comparison of continuous variables. Nine studies of 985 patients (with 11 statin treatment arms) were selected. After a mean follow-up of 9.8 ± 4.9 months, we found a significant decrease in coronary plaque volume (WMD -5.77 mm3, 95% confidence interval -10.36 to -1.17, p = 0.01), with no significant heterogeneity across studies (p = 0.47). Prespecified subgroup analyses showed similar trends. Studies in which the achieved low-density lipoprotein (LDL) cholesterol level was <100 mg/dl showed a trend for plaque regression (WMD -7.88 mm3, 95% confidence interval -16.31 to 0.55, p = 0.07), whereas studies in which the achieved level of LDL cholesterol was ≥100 mg/dl, the trend was less evident (WMD -4.22 mm3, 95% confidence interval -10.27 to 1.82, p = 0.17). Plaque volume remained essentially unchanged in patients not treated with statins (WMD 0.13 mm3, 95% confidence interval -4.42 to 4.68, p = 0.96). In conclusion, statin therapy, particularly when achieving the target LDL level, appears to promote a significant regression of coronary plaque volume as measured by IVUS.

Two-year clinical outcome after coronary stenting of small vessels using 2.25-mm sirolimus- and paclitaxel-eluting stents: Insight into the research and T-search registries (Article)

2007-01-01T00:00:00Z

Objectives: To evaluate long-term outcomes after drug-eluting stents (DES) implantation in small coronary vessels. Background: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been reported to improve both the angiographic and clinical outcomes compared with bare metal stents even in 'real world' settings. Currently, no data is available on long-term outcomes after DES implantation in small vessels. Methods: Since April 2002, our institution has implanted DES, either SES or PES, as a default strategy in all patients irrespective of their clinical presentation. Between October 2002 and September 2003, 197 consecutive patients were enrolled: 107 consecutive patients received at least one 2.25-mm SES (SES group) and 90 consecutive patients received at least one 2.25-mm PES (PES group). Results: The two cohorts presented with high-risk characteristics. At 2 years, the cumulative incidence of major adverse cardiac events (MACE) in the SES group was significantly lower than that in the PES group (10.3% vs. 23.3%, P = 0.02). There were two subacute angiographic stent thromboses in the PES group and none in the SES group. By multivariate analysis, PES utilization (HR 2.37, 95% CI 1.07-5.26), presentation with acute coronary syndromes (ACS) (HR 3.34, 95% CI 1.44-7.70) and multi-vessel disease (MVD) (HR 3.91, 95% CI 1.27-12.0) were identified as independent predictors of MACE. Conclusions: In an unselected population treated for small vessel disease, SES were associated with significantly better 2-year clinical outcomes than PES. The use of PES and the presentation with ACS and MVD were identified as independent predictors of MACE.

Management and outcome of patients with established coronary artery disease: the Euro Heart Survey on coronary revascularization. (Article)

2005-06-01T00:00:00Z

AIMS: The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive diagnosis and treatment of patients with established coronary artery disease (CAD). METHODS AND RESULTS: Between November 2001 and March 2002, 7769 consecutive patients undergoing invasive evaluation at 130 hospitals (31 countries) were screened for the presence of one or more coronary stenosis >50% in diameter. Patient demographics and comorbidity, clinical presentation, invasive parameters, treatment options, and procedural techniques were prospectively entered in an electronic database (550 variables+29 per diseased coronary segment). Major adverse cardiac events (MACE) were evaluated at 30 days and 1 year. Out of 5619 patients with angiographically proven coronary stenosis (72% of screened population), 53% presented with stable angina while ST elevation myocardial infarction (STEMI) was the indication for coronary angiography in 16% and non-ST segment elevation myocardial infarction or unstable angina in 30%. Only medical therapy was continued in 21%, whereas mechanical revascularization was performed in the remainder [percutaneous coronary intervention (PCI) in 58% and coronary artery bypass grafting (CABG) in 21%]. Patients referred for PCI were younger, were more active, had a lower risk profile, and had less comorbid conditions. CABG was performed mostly in patients with left main lesions (21%), two- (25%), or three-vessel disease (67%) with 4.1 diseased segments, on average. Single-vessel PCI was performed in 82% of patients with either single- (45%), two- (33%), or three-vessel disease (21%). Stents were used in 75% of attempted lesions, with a large variation between sites. Direct PCI for STEMI was performed in 410 cases, representing 7% of the entire workload in the participating catheterization laboratories. Time delay was within 90 min in 76% of direct PCI cases. In keeping with the recommendations of practice guidelines, the survey identified under-use of adjunctive medication (GP IIb/IIIa receptor blockers, statins, and angiotensin-converting enzyme-inhibitors). Mortality rates at 30 days and 1 year were low in all subgroups. MACE primarily consisted of repeat PCI (12%). CONCLUSION: The current Euro Heart Survey on coronary revascularization was performed in the era of bare metal stenting and provides a global European picture of the invasive approach to patients with CAD. These data will serve as a benchmark for the future evaluation of the impact of drug-eluting stents on the practice of interventional cardiology and bypass surgery.

Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). (Article)

2005-03-22T00:00:00Z

BACKGROUND: The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown. METHODS AND RESULTS: From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P=0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P=0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P=0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events. CONCLUSIONS: When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy.

Irish Cardiac Society - Proceedings of the Annual General Meeting held November 1993 (Article)

1994-08-01T00:00:00Z