Showing papers in "Catheterization and Cardiovascular Interventions in 2006"

Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries.

Abstract: Objective: We aimed to determine the safety and efficacy of biobasorbable magnesium alloy stents in porcine coronary arteries. Bioabsorbable magnesium stents carry the potential to overcome the limitations posed by permanent metallic stents such as chronic inflammation, late stent thrombosis, prolonged antiplatelet therapy, and artifacts when imaged by multislice-computed tomography or magnetic resonance imaging. Methods: Magnesium alloy stents or stainless steel stents were randomly deployed in coronary arteries of domestic or minipigs. Domestic pigs were sacrificed at 3 days (n = 2) or 28 days, and minipigs at 3 months. Results: At 3 days, magnesium alloy stents were intact, but started to show signs of degradation by 28 days. There was no evidence of stent particle embolization, thrombosis, excess inflammation, or fibrin deposition. At 28 days and 3 months, neointimal area was significantly less in magnesium alloy stent segments (2.44 ± 0.88 mm2 and 1.16 ± 0.19 mm2) as compared with the stainless steel stent segments (5.03 ± 1.5 mm2 and 1.72 ± 0.68 mm2, P < 0.001 and 0.02). Quantitative coronary analysis indicates that percentage area stenosis and percentage diameter stenosis in magnesium alloy stent segments improved significantly at 3 months as compared to 28 days. Despite decreased neointimal hyperplasia, lumen area of the magnesium alloy stented vessels did not improve significantly. Conclusion: Magnesium alloy stents are safe and are associated with less neointima formation; however, reduced neointima did not result in larger lumen. © 2006 Wiley-Liss., Inc.

Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results.

Abstract: Background: The BEACH trial evaluated the outcomes of carotid artery stent placement with distal emboli protection, using the Carotid Wallstent® and the FilterWire EX®/EZTM, in patients at high surgical risk for carotid endarterectomy (CEA). Methods: We enrolled 747 patients at high surgical risk for CEA due to prespecified anatomical criteria and/or medical comorbidities. The trial included both symptomatic (>50% carotid artery stenosis) as well as asymptomatic (>80% carotid artery stenosis) high surgical risk patients. Three groups of patients were included in the trial. The Roll-in (R) group (n = 189/747, [25%]) included up to nine patients per site for familiarization of the device and protocol; the Pivotal (P) group (n = 480/747, [65%]) was intended for presentation to the FDA for consideration of device approval; and a Bilateral (B) registry group (n = 78/747, [10%]) was included because of the need to treat patients with bilateral carotid artery disease. In the 480 Pivotal patients, anatomic criteria represented the most frequent high-risk surgical category for enrollment (58.8%), followed by prior CEA (34.2%), multivessel (≥2) coronary artery disease (21.7%), and contralateral carotid occlusion (18.1%). Results: The technical success rate for stent deployment and FilterWire EX/EZ deployment and retrieval was 98.2%. The mean postprocedure angiographic diameter stenosis in the Pivotal group was reduced to 10.8%, while the overall procedure success rate (<50% residual diameter stenosis) after stent deployment was 98%. The 30 day composite major adverse event (MAE) rate for the entire cohort of 747 patients (i.e. inclusive of all 3 groups) was 5.8% (all death = 1.5%, all stroke = 4.4%, and all myocardial infarction (MI) = 1.0%). In subgroup analysis, there was no significant difference in the MAE rate between the three groups (P = 5.8%, R = 6.9%, B = 2.6%, P = 0.42). Conclusion: The similarity in periprocedural event rates for the Pivotal and Roll-in groups suggests a flat learning curve for experienced operators using this carotid stent system. The similarity in event rates for the Bilateral group, when compared with the Roll-in and Pivotal groups, suggests that staged sequential treatment of bilateral stenoses may be performed at the same risk as for unilateral lesions. The 30-day safety of this stent and distal emboli protection system is encouraging and compares favorably with other carotid stent trials in high surgical risk patients. © 2006 Wiley-Liss, Inc.

Failure of transradial approach during coronary interventions: Anatomic considerations

Abstract: The anatomy of the radial artery has yet to be systematically studied from the perspective of using it as a route for catheter access. We prospectively performed angiography of the arteries of the upper limb to delineate the anatomic features of the radial artery as a way to determine the feasibility of using it as a route for coronary intervention. We studied 2,211 consecutive patients submitted to transradial cardiac catheterization. In all patients, an angiography of the upper limb arteries was performed before and after procedure. Radial puncture was successful in 98.9% of patients. At angiography, anatomic variations of upper limb arteries were noted in 505 patients (22.8%) and included tortuous configurations (3.8%), stenosis (1.7%), hypoplasias (7.7%), radioulnar loop (0.8%), abnormal origin of the radial artery (8.3%), and lusoria subclavian artery (0.45%). Overall procedural success by transradial approach was 97.5%. Patients with anatomic variations of radial artery had a significantly lower puncture (96.2% vs 99.7%, P < 0.0001) and procedural (93.1% vs 98.8%, P < 0.0001) success. The procedure was successfully performed by radial approach in 98.8% of patients with tortuous configurations, 91.9% of radial stenosis, 93.9% of hypoplastic radial artery, 83.3% of radioulnar loop, 96.7% of radial axillary origin, and 60% of lusoria subclavian artery setting. Anatomic variations of the radial artery are not rare. However, they do not represent an important limitation in transradial approach if they are well documented previously.

Transcatheter closure of perimembranous ventricular septal defects using the amplatzer membranous VSD occluder: immediate and midterm results of an international registry.

Abstract: Objective: To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD). Methods: Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7–58 years) and the median weight was 27.5 kg (7–121 kg). Results: A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5–13 mm), median device size 10 mm (4–16 mm) and median fluoroscopy time 22.1 min (8.9–96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1–763 days). There were no procedure-related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6-months follow-up (P = 0.0012). Left ventricle end-diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6-months postprocedure (P = 0.0015). Conclusion: Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow-up period is warranted prior to the wide spread use of this device. © 2006 Wiley-Liss, Inc.

Bioabsorbable metal stents for percutaneous treatment of critical recoarctation of the aorta in a newborn.

Abstract: In neonates and infants with critical aortic coarctation, balloon angioplasty is considered for rescue therapy of heart failure. The use of conventional stents is limited because of further vessel growth, the need of redilation, and later surgical removal. However, a novel bioabsorbable magnesium stent (AMS) might overcome such restrictions of vessel stenting in newborns. Presented is the first use of an AMS for acute treatment of a newborn with severely impaired heart function due to a long segment recoarctation after a complex surgical repair. We hypothesize that bioabsorbable stents will dramatically change the treatment of coarctation and recoarctation in newborns.

Percutaneous closure of prosthetic paravalvular leaks: case series and review.

Abstract: Background: Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valve replacement Most are asymptomatic and benign, but some may cause symptoms due to a large regurgitant volume or hemolysis Medical therapy is palliative, while reoperation carries significant morbidity and mortality Percutaneous transcatheter closure techniques, now routinely applied in the management of pathological cardiac and vascular communications, may be adaptable to PVL closure, potentially offer symptomatic relief Methods: We reviewed our experience with attempted percutaneous closure of PVLs, using data from medical and procedural records Results: Between 2001 and 2004, 14 procedures were performed in 10 patients, all under general anesthesia, with transesophageal and radiographic guidance Mitral (9) and aortic (1) valve replacements were involved, both mechanical and bioprosthetic A variety of devices were used, including atrial septal occluders, patent ductus arteriosus occluders, and coils (all of label use) Six had a single procedure, which was technically successful in four: in two, the PVL could not be crossed Four underwent a second procedure, which was technically successful in three; in one the previously deployed device was dislodged necessitating urgent, but ultimately uneventful, surgical removal and leak repair One patient had transient severe hemolysis, which resolved after 1 week At 1-year follow-up (9/10 pts) three had died, five had sustained symptomatic improvement while 1 patient with a residual leak still required regular blood transfusions Conclusions: Percutaneous closure of PVLs is time-consuming but feasible in selected patients, with a reasonable degree of technical and clinical success A second procedure may be necessary and a variety of complications can occur © 2006 Wiley-Liss, Inc

Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies.

Abstract: The objective of this study was to bench-test provisional bifurcation stenting strategies to provide insights on how best to perform these with drug-eluting stents (DESs). Bifurcation stenting with DESs reduces restenosis compared with bare metal stents (BMSs). Outcomes with a single DES are better than with two DESs but if the main branch is stented, there needs to be a reliable strategy for provisionally stenting the side-branch with full ostial scaffolding and drug application. Stents were photographed in a phantom after deployment with different strategies. With provisional T-stenting, placement of the side-branch stent without gaps is difficult. The internal (or reverse) crush strategy fully scaffolds the side-branch ostium but is experimental. The culotte technique providing excellent side-branch ostial coverage is easier to perform with open-cell or large-cell stent design. In general, kissing balloon post-dilation improves stent expansion, especially at the ostium, and corrects distortion. However, a main-branch kissing balloon of smaller diameter than the deploying balloon causes distortion. Final main-branch postdilatation or sequential postdilatation prevents distortion after the internal crush strategy.

Correlates and outcomes of retroperitoneal hemorrhage complicating percutaneous coronary intervention

Abstract: BACKGROUND: Retroperitoneal hemorrhage (RPH) is an infrequent but occasionally fatal complication of percutaneous coronary intervention (PCI). Therefore, it has been studied in relatively small numbers of patients. METHODS: Prospectively collected data on 28,378 consecutive patients treated between 1992 and 2003 were examined, supplemented by a date-based case control cohort study (76 RPH and 76 non-RPH patients) to examine elements not routinely recorded prospectively. Independent correlates of RPH were determined using logistical regression analysis. RESULTS: One hundred sixty-three patients (0.57%) developed RPH; of these 73.5% required blood transfusions and 10.4% expired during hospitalization (P < 0.001 for both compared with patients without RPH). RPH was independently associated with femoral artery sheath placement superior to the inferior epigastric artery (P < 0.001), female sex (P < 0.001), use of Angioseal™ Device (P < 0.001), glycoprotein IIb/IIIa inhibitor use (P = 0.001), and patient presentation with the acute myocardial infarction (P = 0.035), and was inversely related to patient weight (P = 0.014). Of the 17 patient deaths, 6 were directly related to RPH, 2 of which occurred in association with delays in resuscitation efforts consequent to attempts to obtain diagnostic confirmation with CT imaging. CONCLUSIONS: RPH remains an infrequent but serious complication of PCI. Appropriate management of the femoral access site and the patient once this complication is suspected may minimize adverse outcomes. © 2006 Wiley-Liss, Inc.

Randomized comparison of operator radiation exposure during coronary angiography and intervention by radial or femoral approach.

Abstract: Controversial data have been published on the amount of radiation exposure during radial coronary procedures. We hypothesized that in the current era, high-volume operators with optimal technique would not be exposed to higher radiation doses during radial procedures. A total of 297 patients undergoing cardiac catheterization (195 elective diagnostic coronary angiograms and 102 elective coronary interventions) were prospectively assigned in a random fashion to the radial access (RA) or femoral access (FA). All procedures were performed by the same operator with vast experience in radial procedures and standard measures for radiation protection were used. Operator radiation exposure was measured with an electronic radiation dosimeter attached to the breast pocket of the operator on the outside of the lead apron and estimates of the ambient dose equivalent were derived. For coronary angiograms, fluoroscopy time (2.8 +/- 2.1 vs. 1.7 +/- 1.4 min; P < 0.001) and dose-area product (15.1 +/- 8.4 vs. 13.1 +/- 8.5 Gy x cm(2); P < 0.05) were increased by 18% and 15%, respectively, for RA vs. FA. Operator radiation exposure was 100% higher for the RA compared to the FA (64 +/- 55 vs. 32 +/- 39 microSv; P < 0.001). For coronary interventions, fluoroscopy time (11.4 +/- 8.4 vs. 10.4 +/- 6.8 min; P = NS) and dose-area product (46.3 +/- 28.7 vs. 51.0 +/- 29.4 Gy x cm(2); P = NS) for RA and FA were not statistically different. However, operator radiation exposure was increased by 51% for the RA compared to the FA (166 +/- 188 vs. 110 +/- 115 microSv; P < 0.05). This study demonstrates that the radial approach is burdened with a 100% increase in operator radiation exposure during diagnostic coronary catheterization procedures and a 50% increase during coronary interventions, provided that no special devices for radiation protection are used. Measurements of radiation dose, such as fluoroscopy time and dose-area product, substantially underestimate the disproportionate rise in radiation exposure. Special precautions are warranted to improve radiation protection during invasive coronary procedures via the radial approach.

Prevalence of unfavorable angiographic characteristics for percutaneous intervention in patients with unprotected left main coronary artery disease.

Abstract: Objectives: The goal of this study was to determine the proportion of patients with left main coronary disease (LMCD) with unfavorable characteristics for percutaneous coronary intervention (PCI). Background: Published series suggest that LMCD can be treated percutaneously, however, the proportion of patients in whom PCI is an option based on angiographic criteria is unknown. Methods: In 13,228 consecutive coronary angiograms, 476 (3.6%) patients had ≤60% stenosis of the left main. In 232 patients with unprotected LMCD, the clinical characteristics and angiograms were reviewed with six features chosen as “unfavorable” for PCI: (1) Bifurcation LMCD, (2) occlusion of a major coronary, (3) ejection fraction <30%, (4) occlusion of a dominant RCA, (5) left dominant circulation, and (6) coexisting three-vessel disease. Treatment modality and 1 year mortality were determined. Results: The mean age was 69 years and 68% were male. Unfavorable characteristics were common with at least one unfavorable characteristic seen in 80%. Bifurcation disease was the most common unfavorable characteristic observed (53%) and coexisting three-vessel disease was seen in 38%. Treatment consisted of CABG in 205 (88%), medical therapy in 24 (10%) and PCI in 3 (1%). Among patients referred for CABG, 1 year survival was 88% with similar rates of survival for those with favorable characteristics (86%) compared to those with at least one unfavorable characteristic (88%). Conclusions: Most patients with LMCD have at least one unfavorable characteristic for PCI suggesting that PCI may be a technically difficult option for most patients with LMCD. © 2006 Wiley-Liss, Inc.

Rapid pacing to facilitate transcatheter prosthetic heart valve implantation

Abstract: Objectives: We describe the technique of, and our experience with, rapid ventricular burst pacing to facilitate transcatheter heart valve implantation. Background: Endovascular therapeutic procedures frequently require the precise placement of implantable devices. The precision of transcatheter device deployment may be hampered by cardiac motion or the effects of intravascular flow. Burst pacing is associated with a reduction in stroke volume, cardiac output, transvalvular flow, and cardiac motion. Methods: Rapid pacing was used in 40 consecutive patients with severe aortic stenosis undergoing implantation of catheter-delivered prosthetic valves. Clinical, procedural, and hemodynamic records were reviewed. Results: A mean of 5 ± 2 burst pacing sequences at rates of 150–220 min−1 were used during balloon valvuloplasty and valve deployment. The duration of pacing required during valve deployment was 12 ± 3 sec. Pacing was relatively well tolerated when cautiously used with judicious recovery intervals and pressor support. Rapid pacing was associated with a rapid and effective reduction in systemic blood pressure, pulse pressure, transvalvular flow as well as cardiac and catheter motion. Conclusions: Rapid pacing is a relatively reliable technique to facilitate precise transcatheter deployment of prosthetic heart valves and other endovascular therapeutic devices. © 2006 Wiley-Liss, Inc.

Prevention of arterial spasm during percutaneous coronary interventions through radial artery: the SPASM study.

Abstract: Aims: Radial artery spasm remains the major limitation of transradial approach for percutaneous coronary interventions. The aim of our study was to evaluate the efficacy of vasodilators in the prevention of radial artery spasm during percutaneous coronary interventions. Methods and results: 1,219 patients were consecutively randomized to receive placebo (n = 198), molsidomine 1 mg (n = 203), verapamil 2.5 mg (n = 409), 5 mg (n = 203) or verapamil 2.5 mg and molsidomine 1 mg (n = 206). All drugs were administered through the arterial sheath. The primary end point was the occurrence of a radial artery spasm defined by the operator as severe limitation of the catheter movement, with or without angiographic confirmation. Main characteristics including age, sex, wrist and arterial sheath diameters and procedure duration were identical across the groups. The rate of radial artery spasm was lowest in patients receiving verapamil and molsidomine (4.9%), compared to verapamil 2.5 mg or 5 mg (8.3 and 7.9%), or molsidomine 1 mg (13.3%); and placebo (22.2%) (P < 0.0001). Conclusion: Radial artery spasm during transradial percutaneous interventions was effectively prevented by the administration of vasodilators. The combination of verapamil 2.5 mg and molsidomine 1 mg provided the strongest relative risk reduction of spasm compared to placebo and should therefore be recommended during percutaneous coronary interventions through the radial approach. © 2006 Wiley-Liss, Inc.

Very late thrombosis after drug-eluting stents.

Abstract: Stent thrombosis is a rare but potentially fatal complication of percutaneous treatment of coronary disease. Its occurrence after drug eluting stent (DES) placement has raised concerns, especially when it occurs late after the stent implantation. The mechanisms of late thrombosis after DES have yet to be completely understood. By means of serial angiography and intravascular (IVUS) images we described a relatively new and unusual vessel response to drug-eluting stents (e.g. huge positive remodeling in all vessel extension), leading to impressive late-acquired incomplete stent apposition and finally causing stent thrombosis and acute myocardial infarction. After describing the two cases, one after Cypher stent implantation and one after Taxus stent implantation, we briefly reviewed the literature available on stent thrombosis with special emphasis on its late occurrence.

Origin and distribution anomalies of the left anterior descending artery in 70,850 adult patients: multicenter data collection.

Abstract: Objectives To present the clinical and angiographic properties of the left anterior descending artery anomalies. Background Coronary artery anomalies are discovered in less than 1% of angiography series. Since the number of angiographies and coronary bypass operations are increasing significantly every day, these anomalies are of clinical importance. However, data about left anterior descending artery anomalies in literature is still scarce. Methods We reviewed the records of 70,850 patients who had undergone coronary angiographies at 4 different cardiology center from 1999 to 2005 years. Results Major congenital coronary anomalies were discovered in 171 of these cases (0,24%). The mean age of these patients was 61 ± 11 (18–84) years. Ninety nine patients (58%) were male. Left anterior descending artery was involved in 12 patients (0.017%). In nine patients with the anomalous LAD there were concomittant congenital coronary artery anomalies. Concurrent coronary artery anomalies encountered were double left anterior descending artery type 4 (2 cases), double left anterior descending artery type 4 with double right coronary artery (1), double right coronary artery (1), double circumflex artery with anomalous left anterior descending artery (1), circumflex artery from right sinus of Valsalva (1), separate septal perforator and myocardial bridging of posterior descending artery (1), intercoronary communication, and ostial atresia of the left anterior descending artery and anomalous circumflex artery (1). Conclusion Our series is the biggest series where relatively sufficient clinical and angiographic information about the LAD anomalies were provided. © 2006 Wiley-Liss, Inc.

Aortic counterpulsation: a review of the hemodynamic effects and indications for use.

Abstract: In the ever evolving field of cardiovascular medicine and coronary intervention, the intra-aortic balloon pump (IABP) is a mature technology, which still plays an important role. The balloon pump invasively supports patient hemodynamics by augmenting diastolic perfusion and increasing diastolic blood pressure, thereby increasing coronary perfusion and reducing afterload. Its efficacy has been demonstrated in a multitude of clinical situations, including acute coronary syndromes, high-risk coronary interventions, cardiogenic shock, and cardiovascular surgery. The potential complications of aortic counterpulsation are serious, although much lower than once feared. With proper patient selection, insertion technique, and management, the IABP is a powerful tool to assist in the treatment of patients with cardiovascular disease. This article will review the hemodynamics, indications, and complications associated with its use.

Evaluation of the AMPLATZER vascular plug for embolization of peripheral vascular malformations associated with congenital heart disease

Abstract: Objective: The purpose of this study is to evaluate the recently FDA-approved AMPLATZER® Vascular Plug in the embolization of vascular lesions associated with congenital heart disease (CHD). Background: Fistulas and arteriovenous malformations have been occluded using various devices. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device, used for embolization in the peripheral vasculature. Methods: A total of 84 vessels in 52 patients with CHD from 11 centers were occluded with 89 AMPLATZER Vascular Plugs, delivered through a coronary guide catheter in various vascular sites, including collaterals, pulmonary arterio-venous and coronary artery fistulas, transhepatic tracts, central shunts, patent ductus arteriosus (PDA), and excluded hepatic vein. Complete vessel occlusion was demonstrated within 10 min in 94% of patients. Results: There was no device embolization, vascular disruption, or procedure-related complication. One vascular plug implanted in a large type C PDA required surgical removal followed by PDA ligation, after 5 weeks from successful implant because of significant residual flow through the device. Conclusions: The AMPLATZER Vascular Plug is an effective transcatheter occlusion device in the embolization of a wide variety of vascular lesions associated with CHD. Based on our early experience, caution should be used when considering the Vascular Plug as a closure device for large PDA. © 2005 Wiley-Liss, Inc.

Distal embolic protection during femoropopliteal atherectomy.

Abstract: We report on a series of 10 consecutive cases of superficial femoral and popliteal artery atherectomy with the SilverHawk device, carried out for the treatment of peripheral vascular atherosclerosis. All cases were done with the use of a distal embolic protection device. Debris were retrieved in the filter in each case. Implications are discussed, along with a review of the available literature on this device.

The StarClose Vascular Closure System: interventional results from the CLIP study.

Abstract: Background The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. Methods A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. Results The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different. Conclusions The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

Incidental findings with cardiac CT evaluation—Should we read beyond the heart?

Abstract: Cardiac computed tomographic angiography (CTA) allows for simultaneous evaluation of the lung fields and associated structures. There is a debate as to the benefit of or need for routine overread of the lung fields for incidental findings. The possible improvement in cancer diagnosis with routine overreads is balanced against the major limitations of CT lung screening. Current limitations include (a) a high rate of nodule detection given that >50% of participants may have at least one noncalcified nodule; (b) the increased costs and radiation exposure associated with the resulting follow-up CT scans; (c) the cost and the morbidity of follow-up, including further testing, as well as biopsy or resection of benign noncalcified nodule (at least 25% of such procedures in several trials); (d) a small but difficult to quantify potential risk of cancer associated with multiple follow-up CT scans; and (e) a potential for increased anxiety of both the patient and the physician about nonsignificant pathology. All of these limitations are balanced against a possibility that this could lead to an earlier detection of lung cancer with the consequent improvement in the chances of the patients' survival. Extensive studies of screening CT in older smokers have revealed the prevalence of cancer to be between 0.3 and 1%. However, when applied to an ambulatory population of patients presenting for an evaluation of angina, the prevalence of lung cancer or significant non-cardiac findings may be significantly lower. We have reviewed all the relevant literature and sought to determine the potential benefits and harms of specifically overreading CTA for non-cardiac pathology. The weight of the evidence suggests that it is most prudent to not specifically reconstruct and re-read CTA scans for lung nodules. If a non-cardiac abnormality is visualized by the primary interpreter of the cardiac CT, appropriate referral or follow-up is prudent. © 2006 Wiley-Liss, Inc.

Outcomes of contrast-induced nephropathy: experience in patients undergoing cardiovascular intervention.

Abstract: Use of iodinated contrast media for diagnostic and interventional procedures is increasing as computed tomography and percutaneous coronary intervention (PCI) technologies provide increasing patient benefit. Although some complications associated with contrast media are mild and transient, contrast-induced nephropathy (CIN) can negatively affect long-term patient morbidity and mortality. The incidence of and outcomes from CIN have been carefully studied in cardiology patients. A number of studies have identified CIN-associated complications in PCI patients, including bleeding, hematoma, stroke, adult respiratory distress syndrome, electrolyte imbalances, and sepsis. In post-PCI patients, rates of myocardial infarction and vessel reocclusion are more common in patients with CIN. Therefore, in-hospital mortality is increased in patients with CIN. In patients requiring dialysis after PCI, several studies have shown the 1-year mortality rate to be >55%. Even moderate renal dysfunction not requiring dialysis is associated with increased mortality in patients with coronary artery disease. Precautionary measures before, during, and after the use of contrast media that reduce the incidence of CIN, such as discontinuation of nephrotoxic medications, adequate hydration, and use of appropriate volumes and types of contrast media, should be considered in all patients with renal insufficiency or with other risk factors for CIN.

Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy.

Abstract: This study examined the outcomes of patients who underwent sirolimus-eluting stent (SES) implantation for the treatment of heavily calcified coronary lesions (HCCL) with and without the use of rotational atherectomy (rotablator). We investigated 150 consecutive patients with angiographic evidence of HCCL who underwent SES implantation. Sixty-nine patients underwent SES implantation without the need of rotablator (SES), and 81 patients required rotational atherectomy to modify the plaque and facilitate the delivery of the stent (SES + rotational atherectomy). Clinical success was equivalent in both groups (>98%) and there were no in-hospital outcome differences. At 6 months, the target lesion revascularization rate was 4.9% in SES vs. 4.2% in SES + rotational atherectomy groups, respectively (P = NS). Mortality at 6 months was 7.9% in the SES group vs. 6.8% in the SES + rotational atherectomy group (P = NS). SES performs well in patients with complex HCCL, with a relative low event rate. Lesions requiring rotational atherectomy to facilitate dilation and stenting had similar outcomes after SES implantation to those that could be stented without the need for rotablator.

Transulnar versus transradial artery approach for coronary angioplasty: the PCVI-CUBA study.

Abstract: Objectives: To compare in terms of efficacy and safety the transulnar to the transradial approach for coronary angiography and angioplasty. Background: Opposite to the transradial approach, which is now widely used in catheterization laboratories worldwide, the ulnar artery approach is rarely used for cardiac catheterization. Methods: Diagnostic coronarography, followed or not by angioplasty, was performed by transulnar or transradial approach, chosen at random. A positive (normal) direct or reverse Allen's test was required before tempting the radial or the ulnar approach, respectively. MACE were recorded till 1-month follow-up. Doppler ultrasound assessment of the forearm vessels was scheduled for all the angioplastied patients. Results: Successful access was obtained in 93.1% of patients in the ulnar group (n = 216), and in 95.5% of patients in the radial group (n = 215), P = NS. One hundred and three and 105 angioplasty procedures were performed in 94 and 95 patients in ulnar and radial group, with success in 95.2% and 96.2% of procedures in ulnar and radial group, respectively (P = NS). Freedom from MACE at 1-month follow-up was observed in 93 patients in both groups (97.8% for ulnar group and 95.8% for radial group), P = NS. Asymptomatic access site artery occlusion occurred in 5.7% of patients after transulnar and in 4.7% of patients after transradial angioplasty. A big forearm hematoma, and a little A-V fistula were observed, each in one patient, in the ulnar group. Conclusion: The transulnar approach for diagnostic and therapeutic coronary interventions is a safe and effective alternative to the transradial approach, as both techniques share a high success rate and an extremely low incidence of entry site complications. The transulnar approach has the potential to spare injury to the radial artery in anticipation of its use as a coronary bypass conduit. © 2006 Wiley-Liss, Inc.

Anchoring technique to improve guiding catheter support in coronary angioplasty of chronic total occlusions

Abstract: The primary reason for unsuccessful angioplasty of chronic total occlusions (CTOs) is an inability to pass the guidewire through the occlusion. Optimal guiding catheter support is a prerequisite for successful angioplasty of CTO. We performed guidewire manipulation by anchoring a balloon in a side-branch vessel in order to achieve adequate guiding catheter support. With this novel anchoring technique, we successfully achieved guidewire passage through the CTO.

Percutaneous edge‐to‐edge mitral valve repair: 2‐year follow‐up in the first human case

Abstract: We report the first-in-human mitral valve repair using percutaneous technology that creates a "surgical-like" edge-to-edge repair. A catheter-delivered clip was introduced transseptally from the femoral vein, advanced through the mitral orifice, retracted to grasp the leaflets, and detached to create a functional double-orifice valve. The patient had an uncomplicated post-procedural course. Echocardiography at 1- and 2-years post procedure showed mild mitral regurgitation and positive ventricular remodeling. The success of this case suggests that percutaneous mitral valve repair may be a feasible therapy for certain patients suffering from mitral regurgitation.

Provisional T-stenting and kissing balloon in the treatment of coronary bifurcation lesions: Results of the French multicenter “TULIPE” study

Abstract: Background: In previous prospective studies, a strategy of (a) stenting of the main branch, (b) provisional T-stenting of the side branch, and (c) final kissing balloon inflation, was associated with high success and low target lesion revascularization (TLR) rates on the long-term. Objectives: To examine the performance of this strategy in a multicenter study. Methods: Consecutive patients were treated at 14 French medical centers for de novo coronary bifurcation lesions with the same technique used. Immediate results and clinically-driven TLR at 7 months were examined. Results: The mean reference diameters of the main and side branches were 3.2 ± 0.6 mm and 2.4 ± 0.5 mm, respectively. The side branch was stented in 34% of patients. A <30% residual stenosis in the main branch was achieved in 99%, <50% in the side branch in 90%, and both in 89% of procedures. The in-hospital major adverse cardiovascular event were a Q-wave and 5 non-Qwaves MI (0.54% and 2.7%). At 7 months of follow-up, 3 patients (1.76%) had died, 1 suffered a non-Q-wave MI (0.59%), and 28 (15.88%) underwent TLR. By multivariate analysis, a lower left ventricular ejection fraction (OR: 0.934), moderate calcifications (OR: 7.86), and non-use of the “jailed” wire technique (OR: 4.26) were associated with reinterventions during follow-up. Conclusions: A strategy of provisional T-stenting with a tubular stent and final kissing balloon angioplasty for the treatment of coronary bifurcation lesions was safe and associated with a low TLR rate at 7 months. This strategy should be applicable to the new era of drug eluting stents. © 2006 Wiley-Liss, Inc.

Percutaneous replacement of pulmonary valve using the Edwards‐Cribier percutaneous heart valve: First report in a human patient

Abstract: We report on the use of the Edwards-Cribier percutaneous heart valve (PHV) in a stenotic right ventricle to pulmonary artery homograft in a 16-year old patient who underwent the Ross operation. Initially, the homograft was stented and at the same procedure, the PHV was deployed inside it. This is the first human case of the application of this valve in the pulmonary valve position.

Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation.

Abstract: Introduction: The Endovascular Valve Edge-to-Edge REpair STudies (EVEREST) are investigating a percutaneous technique for edge-to-edge mitral valve repair with a repositionable clip. The effects on the mitral valve gradient (MVG) and mitral valve area (MVA) are not known. Methods: Twenty seven patients with moderate to severe or severe mitral regurgitation (MR) were enrolled. Echocardiography was performed preprocedure, at discharge, and at 1, 6, and 12 months. Mean MVG was measured by Doppler and MVA by planimetry and pressure half-time, and evaluated in a central core laboratory. Pre- and postclip deployment, simultaneous left atrial/pulmonary capillary wedge and left ventricular pressures were obtained in eight patients. Results: Three patients did not receive a clip, six patients had their clip(s) explanted by 6 months (none for mitral stenosis), and four were repaired with two clips. Results are notable for a slight increase in mean MVG by Doppler postclip deployment (1.79 ± 0.89 to 3.31 ± 2.09 mm Hg, P < 0.01) and an expected decrease in MVA by planimetry (6.49 ± 1.61 to 4.46 ± 2.14 cm2, P < 0.001) and by pressure half time (4.35 ± 0.98 to 3.01 ± 1.42 cm2, P < 0.05). There were no significant changes in hemodynamic parameters postclip deployment by direct pressure measurements. There was no change in MVA by planimetry from discharge to 12 months (3.90 ± 1.90 to 3.79 ± 1.54 cm2, P = 0.78). Conclusions: Echocardiographic and hemodynamic measurements after percutaneous mitral valve repair with the MitraClip show an expected decrease in mitral valve area with no evidence of clinically significant mitral stenosis either immediately after clip deployment or after 12 months of follow-up. © 2006 Wiley-Liss, Inc.

Gadolinium‐based contrast agents and nephrotoxicity in patients undergoing coronary artery procedures

Abstract: Objective: We tested whether gadolinium-based contrast agent is less nephrotoxic than iodinated-contrast media. Background: Iodinated contrast agents are nephrotoxic. Some data suggest that gadolinium-based contrast agent may be less nephrotoxic than iodinated-contrast media. Methods: Twenty-five consecutive patients with chronic renal insufficiency (creatinine concentration ≥2.0 mg/dl and/or clearance ≤40 ml/min), referred to our institution for coronary procedures, were assigned to receive gadolinium-based contrast agents, a solution of gadolinium chelates diluted 3:1 by iso-osmolality contrast media (Gadolinium-based group). A control group of 32 patients with comparable clinical characteristics and treated with iodinated iso-osmolality contrast agent alone (Iodinated-based group) was selected from our database and compared with the Gadolinium-based group. In all cases, prophylactic administration of 0.45% saline intravenously and NAC (1200 mg orally twice daily) was used. Results: Baseline creatinine levels and creatinine clearance were similar in the 2 groups (Gadolinium-based group = 2.30 [IQR: 2.01–2.68] mg/dl and 33 ± 13 ml/min; Iodinated-based group = 2.24 [IQR: 2.05–2.65] mg/dl and 30 ± 10 ml/min; P >0.05 for all). Increase of at least 0.5 mg/dl of the creatinine concentration 48 hr after the procedure occurred in 7/25 (28%) patients in the Gadolinium-based group and in 2/32 (6.5%) patients in the Iodinated-based group (P = 0.034; OR = 4.48; 95% CI = 1.01–19.17). Renal failure requiring temporary dialysis occurred in 2 (8%) patients in the Gadolinium-based group and in none in the Iodinated-based group (P = 0.19). Conclusions: The strategy of gadolinium-based contrast agent administration does not seem to reduce the rate of CAN, as compared to the iodinated iso-osmolality contrast agent in patients with chronic renal insufficiency.© 2006 Wiley-Liss, Inc.

Transcatheter closure of secundum atrial septal defects

Abstract: The atrial septum is composed of septum primum and septum secundum. The septum primum, also known as the septum ovale, is the thin portion of the atrial septum that is cradled by the septum secundum, also known as the thick portion of the atrial septum. Secundum atrial septal defect (ASD) is a defect in the septum primum. It is the most common type of ASD. These defects can range in size from a tiny perforation of the atrial septum (small ASD) to complete absence of the atrial septum (large ASD). Sometimes, in large defects, the septum secundum may also be deficient, making transcatheter closure of the ASD challenging.

Sirolimus for below the knee lesions: mid-term results of SiroBTK study.

Abstract: Objectives: To assess the safety and efficacy of sirolimus-eluting stents (SESs) in the treatment of severe intermittent claudication and critical limb ischaemia with “below-the-knee” lesions, unsuitable for surgery. Background: Limited published evidence suggests that drug-eluting stents may offer significant improvements in the treatment of infrapopliteal lesions. Methods: Thirty consecutive patients with either severe intermittent claudication or critical limb ischemia (CLI), category 3–6 of Rutherford classification, and multivessel disease of infrapopliteal arteries (≥2 vessels) were treated with SES. Sixty-two arteries were treated with 106 SES. Mean age was 73.9 years, 77% of patients were male and 36% diabetic. The primary endpoint was clinical improvement and healing of ulcers at short term (1 month) and mid term (7.7 months). The secondary endpoint was primary vessel patency rate (angiographic or duplex assessment). All patients received clopidogrel (75 mg daily) or ticlopidine (150 mg daily) for 2 months or longer. Results: Angiographic and procedural success was achieved in all patients. At 7 months (7.7 ± 5.8), it was necessary to amputate 1 toe in one patient and 1 mid-foot in another. Limb salvage was obtained in 100% of patients. Other events were: two cardiac deaths unrelated to CLI, one stroke with hemiparesia, one initial reperfusion syndrome, one contralateral CLI, and three recurrent homolateral claudication cases. All surviving patients had a mid-term clinical improvement with 97% of primary patency (56 patent arteries on 58 arteries). Conclusion: Treatment of “below-the-knee” lesions with SES may provide an alternative treatment for patients with CLI. © 2006 Wiley-Liss, Inc.