Percutaneous mitral valve repair: an attractive perspective and an opportunity for teamwork.
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Angioplasty, Balloon, Coronary↗
Biomedical subjects
Antonio Colombo
Publications and source records attributed to Antonio Colombo.
Percutaneous mitral valve repair procedures.
Percutaneous mitral valve procedures are under investigation as a novel method to treat mitral valve insufficiency with a catheter-based, closed heart, non-surgical approach. The technical opportunities, the expectations for the future and the implications for the conventional surgery are discussed.
Cardiac Catheterization↗
Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial.
BACKGROUND: Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA. CONCLUSIONS: Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.
Angioplasty↗
A randomized trial comparing primary infarct artery stenting with or without abciximab in acute myocardial infarction.
OBJECTIVES: We sought to evaluate the efficacy of abciximab as adjunctive therapy to routine infarct-related artery (IRA) stenting. BACKGROUND: The impact of abciximab on the efficacy of myocardial reperfusion and the outcome of patients with acute myocardial infarction (AMI) undergoing IRA stenting have not yet been defined. METHODS: In a randomized trial, we assigned 400 patients with AMI to undergo IRA stenting alone or stenting plus abciximab. The primary end point was a composite of death, reinfarction, target vessel revascularization (TVR), and stroke at one month. RESULTS: The incidence of the primary end point was lower in the abciximab group than in the stent only group (4.5% and 10.5%, respectively; p = 0.023), and randomization to abciximab was independently related to the risk of the primary end point (odds ratio 0.41, 95% confidence interval 0.17 to 0.97; p = 0.041). Early ST-segment resolution was more frequent in the abciximab group (85% vs. 68%, p < 0.001). Infarct size, as assessed by one-month technetium-99m sestamibi scintigraphy, revealed smaller infarcts in the abciximab group. At six months, the cumulative difference in mortality between the groups increased (4.5% vs. 8%), and the incidence of the composite of six-month death and reinfarction was lower in the abciximab group than in the stent only group (5.5% and 13.5%, respectively; p = 0.006). Six-month repeat TVR and restenosis rates were similar in the two groups. CONCLUSIONS: Abciximab plus IRA stenting should be considered the routine reperfusion strategy in patients with AMI undergoing primary percutaneous mechanical revascularization, especially in high-risk patients.
Abciximab↗
Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis.
BACKGROUND: Incomplete stent apposition (ISA) has been previously documented after sirolimus-eluting stent (SES) implantation. The aim of this study was to investigate the long-term intravascular ultrasound (IVUS) findings of ISA in patients who received SES. METHODS AND RESULTS: A total of 13 patients who received SES and showed ISA at follow-up IVUS (follow-up I) were investigated. IVUS was performed on all of these patients 12 months later (follow-up II). Quantitative ISA area measurement was also performed at follow-up I and II. No vascular remodeling was observed in the vessel segment with ISA; external elastic membrane area was 19.4+/-6.6 versus 19.5+/-6.4 mm2 at follow-up I and II, respectively. There was also no significant change in external elastic membrane area between vessel segment with ISA and without ISA (+1.5% versus -3.0%, respectively; P=0.27) at late follow-up. The ISA area, either including (2.5+/-1.7 versus 3.8+/-6.3 mm2; P=NS) or excluding (2.5+/-1.8 versus 2.4+/-1.7 mm2; P=NS) a single patient with aneurysm formation, was not significantly different between follow-up I and II. One patient manifested a coronary aneurysm in the stented segment at late follow-up that was probably present at the initial follow-up but masked by thrombus. It was successfully treated with a covered stent. All patients were asymptomatic, and no patient experienced late thrombotic occlusion. CONCLUSIONS: Vessel dimensions and area of ISA did not change over time, except for 1 coronary aneurysm that became apparent. ISA after implantation of a SES was not associated with adverse events at late follow-up.
Blood Vessel Prosthesis Implantation↗
Intravascular ultrasound assessment of ulcerated ruptured plaques: a comparison of culprit and nonculprit lesions of patients with acute coronary syndromes and lesions in patients without acute coronary syndromes.
BACKGROUND: It is not clear why some plaque ruptures lead to acute coronary syndromes (ACS) but others do not. METHODS AND RESULTS: We analyzed 80 plaque ruptures in 74 patients and compared culprit lesions of ACS patients with nonculprit lesions of ACS patients and lesions of non-ACS patients; both culprit and nonculprit plaque ruptures were studied in 6 of 54 ACS patients. Intravascular ultrasound findings suggesting thrombus were observed more frequently in culprit lesions of ACS patients (n=35) compared with nonculprit lesions of ACS patients (n=19) and lesions of non-ACS patients (n=26): 60% versus 32% versus 8% (P<0.001). At the minimal lumen site, smaller lumen areas (3.3+/-1.5 versus 5.4+/-2.6 versus 6.1+/-2.0 mm2, P<0.001) and greater area stenosis (61+/-15% versus 50+/-14% versus 46+/-18%, P=0.002) and plaque burden (80+/-8% versus 71+/-8% versus 69+/-10%, P<0.001) were observed in culprit lesions of ACS patients compared with nonculprit lesions of ACS patients and lesions of non-ACS patients. Lesions were longer (18.7+/-6.4 versus 154.9+/-6.1 versus 12.0+/-4.9 mm, P<0.001) and rupture site remodeling indices were greater (1.26+/-0.21 versus 1.24+/-0.21 versus 1.09+/-0.05, P=0.002). Independent predictors of culprit plaque ruptures in ACS patients were smaller minimum lumen areas (P=0.02) and presence of thrombus (P=0.01). CONCLUSIONS: Ruptured plaques in culprit lesions of ACS patients have smaller lumens; greater plaque burdens, area stenosis, and remodeling indices; and more thrombus. Plaque rupture itself does not lead to symptoms. The association of plaque rupture with a smaller lumen area and/or thrombus formation causes lumen compromise and leads to symptoms.
Acute Disease↗
Influence of residual stenosis after coronary stent implantation on development of restenosis and stent thrombosis.
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Angioplasty, Balloon, Coronary↗
From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part II.
Atherosclerotic cardiovascular disease results in >19 million deaths annually, and coronary heart disease accounts for the majority of this toll. Despite major advances in treatment of coronary heart disease patients, a large number of victims of the disease who are apparently healthy die suddenly without prior symptoms. Available screening and diagnostic methods are insufficient to identify the victims before the event occurs. The recognition of the role of the vulnerable plaque has opened new avenues of opportunity in the field of cardiovascular medicine. This consensus document concludes the following. (1) Rupture-prone plaques are not the only vulnerable plaques. All types of atherosclerotic plaques with high likelihood of thrombotic complications and rapid progression should be considered as vulnerable plaques. We propose a classification for clinical as well as pathological evaluation of vulnerable plaques. (2) Vulnerable plaques are not the only culprit factors for the development of acute coronary syndromes, myocardial infarction, and sudden cardiac death. Vulnerable blood (prone to thrombosis) and vulnerable myocardium (prone to fatal arrhythmia) play an important role in the outcome. Therefore, the term "vulnerable patient" may be more appropriate and is proposed now for the identification of subjects with high likelihood of developing cardiac events in the near future. (3) A quantitative method for cumulative risk assessment of vulnerable patients needs to be developed that may include variables based on plaque, blood, and myocardial vulnerability. In Part I of this consensus document, we cover the new definition of vulnerable plaque and its relationship with vulnerable patients. Part II of this consensus document will focus on vulnerable blood and vulnerable myocardium and provide an outline of overall risk assessment of vulnerable patients. Parts I and II are meant to provide a general consensus and overviews the new field of vulnerable patient. Recently developed assays (eg, C-reactive protein), imaging techniques (eg, CT and MRI), noninvasive electrophysiological tests (for vulnerable myocardium), and emerging catheters (to localize and characterize vulnerable plaque) in combination with future genomic and proteomic techniques will guide us in the search for vulnerable patients. It will also lead to the development and deployment of new therapies and ultimately to reduce the incidence of acute coronary syndromes and sudden cardiac death. We encourage healthcare policy makers to promote translational research for screening and treatment of vulnerable patients.
Animals↗
From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I.
Atherosclerotic cardiovascular disease results in >19 million deaths annually, and coronary heart disease accounts for the majority of this toll. Despite major advances in treatment of coronary heart disease patients, a large number of victims of the disease who are apparently healthy die suddenly without prior symptoms. Available screening and diagnostic methods are insufficient to identify the victims before the event occurs. The recognition of the role of the vulnerable plaque has opened new avenues of opportunity in the field of cardiovascular medicine. This consensus document concludes the following. (1) Rupture-prone plaques are not the only vulnerable plaques. All types of atherosclerotic plaques with high likelihood of thrombotic complications and rapid progression should be considered as vulnerable plaques. We propose a classification for clinical as well as pathological evaluation of vulnerable plaques. (2) Vulnerable plaques are not the only culprit factors for the development of acute coronary syndromes, myocardial infarction, and sudden cardiac death. Vulnerable blood (prone to thrombosis) and vulnerable myocardium (prone to fatal arrhythmia) play an important role in the outcome. Therefore, the term "vulnerable patient" may be more appropriate and is proposed now for the identification of subjects with high likelihood of developing cardiac events in the near future. (3) A quantitative method for cumulative risk assessment of vulnerable patients needs to be developed that may include variables based on plaque, blood, and myocardial vulnerability. In Part I of this consensus document, we cover the new definition of vulnerable plaque and its relationship with vulnerable patients. Part II of this consensus document focuses on vulnerable blood and vulnerable myocardium and provide an outline of overall risk assessment of vulnerable patients. Parts I and II are meant to provide a general consensus and overviews the new field of vulnerable patient. Recently developed assays (eg, C-reactive protein), imaging techniques (eg, CT and MRI), noninvasive electrophysiological tests (for vulnerable myocardium), and emerging catheters (to localize and characterize vulnerable plaque) in combination with future genomic and proteomic techniques will guide us in the search for vulnerable patients. It will also lead to the development and deployment of new therapies and ultimately to reduce the incidence of acute coronary syndromes and sudden cardiac death. We encourage healthcare policy makers to promote translational research for screening and treatment of vulnerable patients.
Acute Disease↗
Association of insulin resistance, hyperleptinemia, and impaired nitric oxide release with in-stent restenosis in patients undergoing coronary stenting.
BACKGROUND: Previously undiagnosed diabetes, impaired glucose tolerance, and insulin resistance are common in patients with acute myocardial infarction and coronary heart disease (CHD) and might be involved in early restenosis after stent implantation. To evaluate whether markers of insulin resistance syndrome, including leptin, and endothelial dysfunction are related to increased rate of early restenosis, we studied nondiabetic patients with CHD after successful coronary stenting. METHODS AND RESULTS: Both patients with CHD undergoing coronary stenting (120 patients) and control subjects (58 patients) were submitted to an oral glucose tolerance test (OGTT). Fasting leptin levels and fasting and postglucose load insulin sensitivity were assessed. Endothelial function was measured by nitrite and nitrate release (NOx) during OGTT. More than 50% of patients treated with stent implantation presented impaired glucose tolerance or type 2 diabetes, which was previously undiagnosed. These patients also had higher glucose, insulin, and leptin levels than control subjects. Among the stented patients, insulin and leptin levels were higher in patients with restenosis than in patients without restenosis. A significant increase in NOx levels was found during OGTT both in patients without restenosis and in control subjects. On the contrary, NOx profiles were blunted in patients with restenosis. At multiple regression analysis, only DeltaAUC-NOx areas and insulin sensitivity index showed an independent correlation with the minimal lumen diameter at follow-up. CONCLUSIONS: We demonstrated that insulin resistance and endothelial dysfunction are independent predictors of early restenosis after coronary stenting.
Area Under Curve↗
Effectiveness of treatment of in-stent restenosis with an 8-French compatible atherectomy catheter.
The study reports the results of directional atherectomy with an 8Fr guiding catheter-compatible atherectomy catheter in a series of 31 in-stent restenotic lesions. This preliminary experience indicates a favorable safety profile, with events limited to non-Q-wave myocardial infarction occurring in 3.6% of patients. The secondary end point regarding the incidence of angiographic restenosis at 6 months showed a high restenosis rate (65%).
Aged↗
Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.
BACKGROUND: Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. METHODS AND RESULTS: We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients. CONCLUSIONS: Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
Coated Materials, Biocompatible↗
Correlation of coronary arterial remodeling determined by intravascular ultrasound with angiographic diameter reduction of 20% to 60%.
Negative remodeling is commonly observed in stenotic coronary lesions. It is unknown whether negative remodeling is an early or late event. This study was designed to elucidate when negative remodeling occurs in the development of coronary stenosis. Remodeling was assessed by preintervention intravascular ultrasound in 104 native coronary lesions with intermediate stenosis (20% to 60% of diameter stenosis measured by quantitative coronary angiography). Positive remodeling was defined as lesion external elastic membrane (EEM) cross-sectional area (CSA) greater than the proximal reference, intermediate remodeling as lesion EEM CSA between those of the proximal and distal references, and negative remodeling as lesion EEM CSA less than the distal reference. Positive, intermediate, and negative remodeling were observed in 18%, 32%, and 50%, respectively, of lesions with intermediate stenosis. Lesions with negative and intermediate remodeling had more hard plaque compared with those with positive remodeling (79% vs 70% vs 42%, p = 0.02). Calcium was more frequent in lesions with negative and intermediate remodeling than in those with positive remodeling (52% vs 55% vs 16%, p = 0.01). Lesions with negative remodeling had smaller EEM CSA (11.5 +/- 5.2 vs. 13.7 +/- 3.4 vs 14.5 +/- 5.6 mm(2), p = 0.03) and less plaque (7.9 +/- 4.6 vs 10.8 +/- 3.4 vs 10.8 +/- 4.9 mm(2), p = 0.004) compared with positive and intermediate remodeling lesions, although lumen CSA (3.7 +/- 1.7 vs 2.8 +/- 0.8 vs 3.6 +/- 1.3 mm(2), p = 0.1) and area stenosis (57 +/- 15% vs 59 +/- 14% vs 56 +/- 10%, p = 0.7) were similar. Negative remodeling is frequently observed in lesions with intermediate stenosis. This suggests that negative remodeling occurs early in lesion formation.
Aged↗
Dominant contribution of negative remodeling to development of significant coronary bifurcation narrowing.
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Coronary Angiography↗
Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.
BACKGROUND: Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. METHODS AND RESULTS: We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). CONCLUSIONS: The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.
Adult↗
Preliminary observations regarding angiographic pattern of restenosis after rapamycin-eluting stent implantation.
BACKGROUND: Restenosis after implantation of drug-eluting stents (DES) is a rare phenomenon, occurring more frequently peri-stent. METHODS AND RESULTS: We evaluated the pattern of restenosis occurring after implantation of DES in unselected lesions. From April 15 to December 6, 2002, we treated 368 patients with 735 lesions by using 841 rapamycin-eluting stents (Cypher, Cordis, a Johnson & Johnson Company). Mean baseline lesion length was 17.48+/-12.19 mm, and mean stent length was 27.59+/-14.02 mm. Follow-up ischemia-driven angiography was performed in 24 patients. Eleven patients had angiographic restenosis (> or =50% diameter stenosis) in 14 stented segments (stent and 5 mm proximal and distal to the stent). The pattern of restenosis in all 14 stented segments was focal, and in 6 of them it was multifocal, occurring inside the stents. Mean length of restenotic lesions was 5.62+/-1.90 mm, with a range from 2.54 to 8.44 mm. One multifocal restenosis involved also the distal stent margin. Intravascular ultrasound evaluation at follow-up, performed in 2 patients, showed significant lumen obstruction attributable to in-stent hyperplasia in both cases. Individual cases can be viewed in the Data Supplement. CONCLUSIONS: The pattern of restenotic lesions after rapamycin-eluting stent implantation was focal and mostly inside the stent.
Aged↗
A new dedicated stent and delivery system for the treatment of bifurcation lesions: preliminary experience.
We report the first clinical experience in eight patients with a new stent and delivery system specifically designed for the treatment of bifurcational lesions. The device (AST SLK-View system) consists of a premounted stent and a delivery system. The stent has a side aperture, which orients toward the ostium of the side branch. The system allows deployment of the stent while the access to both main and side branches is maintained by two wires. We evaluated this system in nine bifurcations. The location of bifurcations was left descending artery/diagonal branch in four lesions, left circumflex/obtuse marginal branch in three lesions, and postero-lateral branch/posterior descending artery in two lesions. Predilation was performed in six lesions of the main branches and in five lesions of the side branches. The stent was effectively delivered to all bifurcations except for one, in which the target lesion was located at a distal segment and the device could not be delivered. Following stent implantation in the main branch, two lesions at the side branches were treated by stent, while the other lesions were treated by balloon angioplasty without difficulty. Final kissing balloon was performed in four bifurcation lesions. No adverse event was observed during 1 month of clinical follow-up. Treatment of bifurcation lesions with this new dedicated device appears to be feasible. This new device may introduce a new approach for the treatment of coronary bifurcation lesions.
Aged↗
Initial multicenter experience with a novel distal protection filter during carotid artery stent implantation.
Atheroembolization resulting in transient or permanent neurologic impairment is the most common complication of catheter-based percutaneous carotid artery intervention. Protection of the distal cerebral vasculature during carotid stent implantation may enhance procedural safety. Carotid stent implantation with distal cerebral protection using the FilterWire EX was performed in 35 consecutive patients undergoing 36 procedures at six centers. The FilterWire was delivered and deployed successfully in all 36 cases, and embolic material was retrieved from 74% of procedures. The 30-day rate of major adverse events (death, major or minor stroke) was 0%. Transient ipsilateral periprocedural neurologic ischemia developed in two patients (5.7%), both resolving within 30 min. Distal cerebral protection with the FilterWire during carotid stenting is feasible and safe, results in capture and extraction of atheroembolic debris in the majority of patients while affording uninterrupted cerebral perfusion, and in this initial multicenter experience was associated with a high rate of procedural success without major complications.
Aged↗