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Patrick W Serruys

Publications and source records attributed to Patrick W Serruys.

At least 19 recordsLinked to original sources

Magnetic navigation system used successfully to cross a crushed stent in a bifurcation that failed with conventional wires.

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.

Angioplasty, Balloon, Coronary↗

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.

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.

Aged↗

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.

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.

Adult↗

The long-term value of sirolimus- and paclitaxel-eluting stents over bare metal stents in patients with diabetes mellitus.

AIMS: To investigate the outcome of a real world diabetic patient cohort treated with bare metal stents (BMS), sirolimus-, or paclitaxel-eluting stents (SES and PES, respectively). Due to the different mechanisms of action of both drugs it is currently unknown which device is the best option to treat these high-risk patients. METHODS AND RESULTS: The study compares the 2-year clinical outcome of 708 consecutive diabetic patients (25% insulin treated) treated with either a BMS (n = 252), a SES (n = 206), or a PES (n = 250), as part of the RESEARCH and T-SEARCH registries. Target vessel revascularization was 19.5% in the BMS group, vs. 15.3% in the SES group and 9.7% in the PES group. PES (21.2%), but not SES (28.9%), were superior to BMS (29.7%) in reducing major adverse cardiac events. After propensity analyses, none of the differences remained significant. The incidence of stent thrombosis (ST) was high in both DES groups. CONCLUSION: There was a trend towards a more favourable outcome associated with the use of PES over BMS. There was no significant difference between SES and PES in each of the clinical endpoints, and neither in the NIDDM patients, which are hypothesized to be better-off with PES.

Case-Control Studies↗

Cost-effectiveness of the unrestricted use of sirolimus-eluting stents vs. bare metal stents at 1 and 2-year follow-up: results from the RESEARCH Registry.

AIMS: To assess the cost-effectiveness of sirolimus-eluting stents (SESs) compared with bare metal stents (BMSs) as the default strategy in unselected patients treated in the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) Registry at 1 and 2-years following the procedure. METHODS AND RESULTS: A total of 508 consecutive patients with de novo lesions exclusively treated with SES were compared with 450 patients treated with BMS from the immediate preceding period. Resource use and costs of the index procedure, and clinical outcomes were prospectively recorded over a 2-year follow-up period. Follow-up costs were measured as unit costs per patient based on the incidence of clinically driven target vessel revascularization (TVR), to obtain cumulative costs at 1 and 2-years. Cost-effectiveness was measured as the incremental cost-effectiveness ratio (ICER) per TVR avoided. The use of SES cost euro 3,036 more per patient at the index procedure, driven by the price of SES. Follow-up costs after 1-year were euro 1,089 less with SES when compared with BMS, due to less TVR, resulting in a net excess cost of euro 1,968 per patient in the SES group, and reduced by a further euro 100 per patient in the second year. The incidence of death or myocardial infarction between groups was similar at 1 and 2 years. Rates of TVR in the SES and BMS groups were 3.7% vs. 10.4%, P<0.01 at 1 year, respectively; and 6.4% vs. 14.7%, P<0.001 at 2 years. The ICER per TVR avoided was euro 29,373 at 1 year, and euro 22,267 at 2 years. CONCLUSION: The use of SES, while significantly beneficial in reducing the need for repeat revascularization, was more expensive and not cost-effective in the RESEARCH registry at either 1 or 2-years when compared with BMS. On the basis of these results, in an unselected population with 1 year of follow-up, the unit price of SES would have to be euro 1,023 in order to be cost-neutral.

Coronary Restenosis↗

Meta-analysis of the studies assessing temporal changes in coronary plaque volume using intravascular ultrasound.

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 > or =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 mm(3), 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 mm(3), 95% confidence interval -16.31 to 0.55, p = 0.07), whereas studies in which the achieved level of LDL cholesterol was > or =100 mg/dl, the trend was less evident (WMD -4.22 mm(3), 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 mm(3), 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.

Cholesterol, LDL↗

Type-D personality predicts chronic anxiety following percutaneous coronary intervention in the drug-eluting stent era.

BACKGROUND: Anxiety is an often overlooked risk factor in coronary artery disease (CAD). Hence, little is known about predictors of unremitting chronic anxiety in CAD patients. We examined whether the distressed personality (type-D) predicts chronic anxiety post percutaneous coronary intervention (PCI). METHODS: Unselected patients (n=167) treated with PCI using sirolimus-eluting or bare metal stents as part of the RESEARCH registry, who were anxious 6 months post-PCI, qualified for inclusion. Patients completed the Hospital Anxiety and Depression Scale at 6 and 12 months and the Type-D Scale (DS14) 6 months post-PCI. RESULTS: Of 167 patients anxious at 6 months, 108 (65%) were still anxious 12 months post-PCI. Significant univariable predictors of chronic anxiety were type-D personality (OR: 3.17; 95% CI: 1.64-6.14) and sirolimus-eluting stent implantation (OR: 0.51; 95% CI: 0.27-0.98), with sirolimus-eluting stent showing a protective effect. In multivariable analyses, type-D personality (OR: 3.31; 95% CI: 1.59-6.87) and sirolimus-eluting stent implantation (OR: 0.44; 95% CI: 0.21-0.92) remained significant independent predictors of chronic anxiety adjusting for depressive symptoms at 6 months, demographic and clinical risk factors. LIMITATIONS: All psychological measures were based on self-report, and we had no information on cardiac rehabilitation or use of pharmacotherapy; however our sample represented patients seen in daily clinical practice. CONCLUSIONS: These findings suggest that type-D personality is a risk factor and sirolimus-eluting stent implantation a protective factor for the occurrence of chronic anxiety. The protective effect of sirolimus-eluting stents in relation to anxiety warrants replication in future studies.

Aged↗

Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry.

Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.

Age Factors↗

Multislice spiral computed tomography for the evaluation of stent patency after left main coronary artery stenting: a comparison with conventional coronary angiography and intravascular ultrasound.

BACKGROUND: Surveillance conventional coronary angiography (CCA) is recommended 2 to 6 months after stent-supported left main coronary artery (LMCA) percutaneous coronary intervention due to the unpredictable occurrence of in-stent restenosis (ISR), with its attendant risks. Multislice computed tomography (MSCT) is a promising technique for noninvasive coronary evaluation. We evaluated the diagnostic performance of high-resolution MSCT to detect ISR after stenting of the LMCA. METHODS AND RESULTS: Seventy-four patients were prospectively identified from a consecutive patient population scheduled for follow-up CCA after LMCA stenting and underwent MSCT before CCA. Until August 2004, a 16-slice scanner was used (n = 27), but we switched to the 64-slice scanner after that period (n = 43). Patients with initial heart rates > 65 bpm received beta-blockers, which resulted in a mean periscan heart rate of 57 +/- 7 bpm. Among patients with technically adequate scans (n = 70), MSCT correctly identified all patients with ISR (10 of 70) but misclassified 5 patients without ISR (false-positives). Overall, the accuracy of MSCT for detection of angiographic ISR was 93%. The sensitivity, specificity, and positive and negative predictive values were 100%, 91%, 67%, and 100%, respectively. When analysis was restricted to patients with stenting of the LMCA with or without extension into a single major side branch, accuracy was 98%. When both branches of the LMCA bifurcation were stented, accuracy was 83%. For the assessment of stent diameter and area, MSCT showed good correlation with intravascular ultrasound (r = 0.78 and 0.73, respectively). An intravascular ultrasound threshold value > or = 1 mm was identified to reliably detect in-stent neointima hyperplasia with MSCT. CONCLUSIONS: Current MSCT technology, in combination with optimal heart rate control, allows reliable noninvasive evaluation of selected patients after LMCA stenting. MSCT is safe to exclude left main ISR and may therefore be an acceptable first-line alternative to CCA.

Adrenergic beta-Antagonists↗

Global characterization of coronary plaque rupture phenotype using three-vessel intravascular ultrasound radiofrequency data analysis.

AIMS: To compare the global characteristics of patients with and without evidence of plaque rupture (PR) in their coronary tree and to evaluate the phenotype of ruptured plaques using intravascular ultrasound (IVUS) radiofrequency data analysis (IVUS-VH). METHODS AND RESULTS: Forty patients underwent three-vessel IVUS-VH interrogation. Twenty-eight PRs were diagnosed in 26 vessels (25.7% of the vessels studied) of 20 patients (50% of the population). Ruptures located in the left anterior descending were clustered in the proximal part of the vessel, whereas ruptures located in the right coronary artery were more distally located (P=0.02). Patients with at least one PR presented larger body mass index (BMI) (28.4+/-3.7 vs. 25.8+/-2.6 kg/m(2), P=0.01) and plaque burden (40.7+/-7.6 vs. 33.7+/-8.4%, P=0.01) than patients without rupture, despite showing similar lumen cross-sectional area (9.6+/-3.3 vs. 9.2+/-2.3 mm(2), P=0.60). Among current smokers, 66.7% presented a PR in their coronary tree. Finally, PR sites showed a higher content of necrotic core compared with minimum lumen area sites (17.48+/-10.8 vs. 13.10+/-6.5%, P=0.03) and a trend towards higher calcified component. CONCLUSION: Patients with at least one PR in their coronary tree presented larger BMI and worse IVUS-derived characteristics compared with patients without PR.

Body Mass Index↗

Impaired health status in Type D patients following PCI in the drug-eluting stent era.

BACKGROUND: Drug-eluting stenting reduces restenosis post-percutaneous coronary intervention (PCI), but subgroups of patients may not benefit optimally from this procedure. We examined the impact of Type D personality on health status over time and the clinical relevance of Type D as a predictor of impaired health status at 12 months in unselected post-PCI patients. METHODS: Consecutive patients (n=692) participating in the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry completed the Type D Scale at 6 months and the Short Form Health Survey 36 (SF-36) at 6 and 12 months post-PCI. RESULTS: Although there was a significant improvement in health status over time (p<0.001), Type D patients reported a substantially lower score on all health status domains of the SF-36 compared with non-Type D patients (p<0.001). Type D personality was an independent predictor of impaired health status on all SF-36 sub domains at 12 months except for physical functioning, adjusting for baseline demographic and clinical variables and health status at 6 months. In these adjusted analyses, Type D personality increased the likelihood of impaired health status at 12 months post-PCI from 60% (OR: 1.60; 95% CI: 1.04-2.46) to almost 300% (OR: 3.99; 95% CI: 2.52-6.32), varying among the parameters analyzed. CONCLUSIONS: Type D personality was associated with impaired health status in post-PCI patients treated in the drug-eluting stent era. The role of personality factors as determinants of clinical outcome and health status should not be overlooked as these factors may have much explanatory power.

Adult↗

Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome.

OBJECTIVES: The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting. BACKGROUND: The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes. METHODS: We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001). CONCLUSIONS: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.

Angina Pectoris↗

Intravascular palpography for vulnerable plaque assessment.

Palpography assesses the local mechanical properties of tissue using the deformation caused by the intraluminal pressure. The technique was validated in vitro using diseased human coronary and femoral arteries. Especially between fibrous and fatty tissue, a highly significant difference in strain (p = 0.0012) was found. Additionally, the predictive value to identify the vulnerable plaque was investigated. A high-strain region at the lumen vessel wall boundary has 88% sensitivity and 89% specificity for identifying these plaques. In vivo, the technique is validated in an atherosclerotic Yucatan minipig animal model. This study also revealed higher strain values in fatty than in fibrous plaques (p < 0.001). The presence of a high-strain region at the lumen-plaque interface has a high predictive value to identify macrophages. Patient studies revealed high strain values (1% to 2%) in noncalcified plaques. Calcified material showed low strain values (0% to 0.2%). With the development of three-dimensional palpography, identification of weak spots over the full length of a coronary artery becomes available. Patients with myocardial infarction or unstable angina have more high-strain spots in their coronary arteries than patients with stable angina. In conclusion, intravascular palpography is a unique tool to assess lesion composition and vulnerability. Three-dimensional palpography provides a technique that may develop into a clinically available tool for decision making to treat hemodynamically nonsignificant lesions by identifying vulnerable plaques. The clinical utility of this technique is yet to be determined, and more investigation is needed.

Animals↗

Influence of catheter design on lumen wall temperature distribution in intracoronary thermography.

Intracoronary thermography is a currently used vulnerable plaque detection method. We studied how catheter design and catheter location influence the temperature readings, and thus its capacity to detect vulnerable plaques. Finite element calculations were performed on geometries representing the coronary artery, the vulnerable plaque and the catheter. Catheter material, diameter and location with respect to the plaque were varied. Both flow and no-flow situations were studied. Maximal lumen wall temperature difference without a catheter (DeltaT=0.12 degrees C, flow=75 cm(3) min(-1)) was considered the reference. Presence of a 1.0mm nitinol catheter right under the plaque increased DeltaT to 0.14 degrees C, whereas a 1.0 mm polyurethane catheter increased DeltaT to 0.51 degrees C. The location at which a thermosensitive element should be placed for most optimal temperature readings during a pullback was shown to lie at the catheter edge for the nitinol catheter and at 1.1mm from the catheter edge for the polyurethane catheter. Temperature readings decreased to background temperature when the catheter was in close proximity but not overlapping the plaque. DeltaT decreased approximately by 70% when a gap of 0.2 mm existed between the catheter and the lumen wall. Occlusion of blood flow increased DeltaT values in all cases, but most pronounced for nitinol catheters. A polyurethane catheter increased the temperature readings, since its heat conductivity is lower than that of blood, which makes it a very good choice for heat source detection. Catheter design can contribute to enhanced temperature readings and thus can enable more optimal vulnerable plaque detection.

Cardiac Catheterization↗

Reproducibility of intravascular ultrasound radiofrequency data analysis: implications for the design of longitudinal studies.

OBJECTIVES: The purpose of this study was to assess in vivo the reproducibility of tissue characterization using spectral analysis of intravascular ultrasound (IVUS) radiofrequency data (IVUS-VH). BACKGROUND: Despite the need for reproducibility data to design longitudinal studies, such information remains unexplored. METHODS AND RESULTS: IVUS-VH (Volcano Corp., Rancho Cordova, USA) was performed in patients referred for elective percutaneous intervention and in whom a non-intervened vessel was judged suitable for a safe IVUS interrogation. The IVUS catheters used were commercially available catheters (20 MHz, Volcano Corp., Rancho Cordova, USA). Following IVUS-VH acquisition, and after the disengagement and re-engagement of the guiding catheter, an additional acquisition was performed using a new IVUS catheter. Fifteen patients with 16 non-significant lesions were assessed by 2 independent observers. The relative inter-catheter differences regarding geometrical measurements were negligible for both observers. The inter-catheter relative difference in plaque cross-sectional area (CSA) was 3.2% for observer 1 and 0.5% for observer 2. The limits of agreement for (observer 1 measurements) lumen, vessel, plaque and plaque burden measurements were 0.82, -1.10 mm(2); 0.80, -0.66 mm(2); 1.08, -0.66 mm(2); and 5.83, -3.89%; respectively. Limits of agreement for calcium, fibrous, fibrolipidic and necrotic core CSA measurements were 0.22, -0.25 mm(2); 1.02, -0.71 mm(2); 0.61, -0.65 mm(2); and 0.43, -0.38 mm(2) respectively. Regarding the inter-observer agreement, the limits of agreement for lumen, vessel, plaque and plaque burden measurements were 2.61, -2.09 mm(2); 2.20-3.03 mm(2); 1.70, -3.04 mm(2); and 9.16, -16.41%; respectively, and for calcium, fibrous, fibrolipidic and necrotic core measurements of 0.08, -0.09 mm(2); 0.89, -1.28 mm(2); 0.74, -1.06 mm(2); and 0.16, -0.20 mm(2); respectively. CONCLUSIONS: The present study demonstrates that the geometrical and compositional output of IVUS-VH is acceptably reproducible.

Coronary Disease↗