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Mitral regurgitation (MR) is a common condition causing significant morbidity and mortality in the Western world. Although surgical therapy has developed over 5 decades to provide solutions, only a minority of patients undergo surgery. The last decade has seen the emergence and application of multiple transcatheter techniques in attempts to address this undertreated population with the large clinical experience of MitraClip providing the most insight. Clear understanding of the pathophysiology of different MR types as well as the role of particularly secondary MR on patient's clinical syndrome allow for better prediction as to which patient subgroups will benefit from different repair techniques or intervention at all. Most of the techniques are based on surgical technique and are applied as single-device/technique solutions, whether leaflet, chordal, or annular solutions, but with broadening experience, combination therapies are likely to find a place in creating a more complete and surgical-like solution.

Two high-risk patients were successfully treated with concomitant implantation of a transapical off-pump beating heart semirigid D-shape annuloplasty device combined in 1 case with a transfemoral edge-to-edge device and in another with transapical chordal implantation. The significant anteroposterior diameter reduction offered by the annuloplasty implantation maximized the leaflet coaptation obtained by the prolapse correction performed with the leaflet devices. Combining the transcatheter annuloplasty device and leaflet/chordal repair technologies represents progress toward definitive transcatheter treatment of degenerative mitral valve disease.

Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlicDiastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076).The V-LAP left atrium monitoring system appears to be safe and accurate.

There is an important need to develop a transcatheter/trans-septal-like model which will allow deliverability of mitral valve devices at the right angulation and height above the mitral annulus similar to the human patient. A ministernotomy allowing for TEE probe to be introduced transpericardially was performed in seven animals. In three, a standard trans-septal approach was used to attempt to deliver a device to the level of the mitral plane with a human delivery system. In four cases, a Dacron tube was connected to the RPV and the device introduced to the LA. Under TEE equivalent imaging, the device was then successfully steered to the mitral plane in all cases, having failed in all trans-septal attempts. A combination of transpericardial echocardiographic imaging (TPE) and RPV approach to the LA facilitated successful human-like mitral valve device implantation.

AIMS: This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience.METHODS AND RESULTS: Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented.CONCLUSIONS: In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

The V-LAP™ measures left atrial pressure (LAP) and enables bi-directional communications with an external unit, designed to monitor heart failure patients. We hereby describe the pre-clinical experience. Following an ex vivo phase, the system was implanted at the interatrial septum of 10 ovine subjects. LAP readouts were compared with pulmonary capillary wedge pressure (PCWP) at index procedure and 1, 2 and 3–6 months after the implantation, at rest and after volume loading. Histopathology assessment (n = 8) was performed up to 50 weeks post procedure. Procedural success was 100%. Measurements showed a mean difference of 0.19 ± 2.51 mmHg. During this period, correlation of V-LAP™ with PCWP was excellent (R2 = 0.95, for 119 total measurements). There were no major adverse events related to the V-LAP™ system. In an animal model, the implantation of the novel wireless left atrial pressure sensor V-LAP™ was feasible, safe, and showed good accuracy and precision.

Restrictive mitral valve annuloplasty with a rigid closed ring has evolved as a surgical alternative to mitral valve replacement [(1–3)][1] to correct functional mitral regurgitation (MR). By reducing the anteroposterior annular diameter, mitral valve annuloplasty facilitates effective leaflet

Objective To assess the cumulative experience of a single operator using a strict set of deployment and release criteria for the Amplatzer Cardiac Plug™ (ACP) and the impact of these criteria on procedural success and complications. Background Following strong evidence that the left atrial appendage (LAA) is the site of the majority of thrombus formation within the left atrium in patients with non-valvular atrial fibrillation, non-pharmacological approaches to LAA exclusion have been developed and shown to be effective. Methods Procedural and in-hospital outcomes of LAA occlusion performed by or under the supervision of a single operator using the ACP™ in 100 anticoagulant ineligible patients with a high stroke risk were assessed. Results One hundred patients with a mean CHADS 2 score of 3.21±1.23 underwent catheterization for closure of LAA with the ACP™. The mean landing zone as assessed by TEE was 20.01±3.21mm, and 20.8±3.19mm by fluoroscopy. The mean difference between the TEE and the fluoroscopic measurements was 0.8±1.13mm. Device deployment was successful in 100/100 attempted cases with a mean deployed device size of 24.36±3.27mm. Procedural complications were limited to a single case of pericardial tamponade and one post-procedural pulmonary edema both of which were adequately treated with no long-term sequelae. Conclusions In this single operator report, LAA occlusion using the double element ACP™ can be safely performed with excellent success rates. Using very specific deployment success, stability and release criteria, this device can achieve LAA occlusion with extremely low complication rates in an extremely frail oral anticoagulant ineligible population with multiple co-morbidities.

Background Despite lower risks of access site–related complications with transradial approach (TRA), its clinical benefit for percutaneous coronary intervention (PCI) is uncertain. We conducted a systematic review and meta-analysis of clinical studies comparing TRA and transfemoral approach (TFA) for PCI. Methods Randomized trials and observational studies (1993-2011) comparing TRA with TFA for PCI with reports of ischemic and bleeding outcomes were included. Crude and adjusted (for age and sex) odds ratios (OR) were estimated by a hierarchical Bayesian random-effects model with prespecified stratification for observational and randomized designs. The primary outcomes were rates of death, combined incidence of death or myocardial infarction, bleeding, and transfusions, early (≤30 days) and late after PCI. Results We collected data from 76 studies (15 randomized, 61 observational) involving a total of 761,919 patients. Compared with TFA, TRA was associated with a 78% reduction in bleeding (OR 0.22, 95% credible interval [CrI] 0.16-0.29) and 80% in transfusions (OR 0.20, 95% CrI 0.11-0.32). These findings were consistent in both randomized and observational studies. Early after PCI, there was a 44% reduction of mortality with TRA (OR 0.56, 95% CrI 0.45-0.67), although the effect was mainly due to observational studies (OR 0.52, 95% CrI 0.40-0.63, adjusted OR 0.49 [95% CrI 0.37-0.60]), with an OR of 0.80 (95% CrI 0.49-1.23) in randomized trials. Conclusion Our results combining observational and randomized studies show that PCI performed by TRA is associated with substantially less risks of bleeding and transfusions compared with TFA. Benefit on the incidence of death or combined death or myocardial infarction is found in observational studies but remains inconclusive in randomized trials. (Am Heart J 2012;163:632-48.)

The objective of this study was to perform a hemodynamic evaluation of moderate (50-90%) renal artery stenosis (RAS) under conditions of rest and maximum hyperemia. Identifying patients with RAS who have hemodynamically significant stenoses and are most likely to benefit from revascularization is clinically important. Current methods used to evaluate RAS, including angiography, have limitations. Physiologic evaluation of RAS may have a role in identifying patients with hemodynamically significant stenosis. Patients with suspected renovascular hypertension due to aorto-ostial RAS were included in the study. Hyperemia was induced by administration of intrarenal papavarine. Translesional pressure gradients were measured and renal fractional flow reserve (FFR) was calculated using a 0.014'' pressure guidewire. Thirteen patients and 14 arteries with moderately severe (50-90%) RAS were studied. The mean translesional pressure gradient rose from a baseline of 6.3 +/- 3.9 to 17.5 +/- 10.8 mm Hg with maximal hyperemia. The renal FFR ranged from 0.58 to 0.95. There was a poor correlation between angiographic stenosis measurement and the renal FFR (r = -0.18; P = 0.54) and the hyperemic translesional mean pressure gradient (r = 0.22; P = 0.44). There was an excellent correlation between renal FFR and the resting mean translesional pressure gradient (r = -0.76; P = 0.0016) and the hyperemic mean translesional pressure gradient (r = -0.94; P < 0.0001). Selective renal arterial papavarine administration induces maximum hyperemia, permitting the calculation of renal FFR in renal arteries with aorto-ostial stenoses. The renal FFR correlates well with other hemodynamic parameters of lesion severity, but poorly with angiographic measures of lesion severity.

Patients with acute coronary syndromes (ACS) have high levels of inflammatory mediators such as C-reactive protein (CRP) and interleukin (IL)-6.To evaluate whether patients with ACS treated with rofecoxib, a COX-2 inhibitor, will have reduced CRP, IL-6, and soluble tumor necrotic factor receptor-1 (sTNF-R1) levels and improved endothelial function.Thirty-four patients hospitalized with ACS were randomized to receive rofecoxib, 25 mg/d plus aspirin 100 mg/d, or placebo plus aspirin, 100 mg/d, for a period of 3 months. Blood samples for CRP, IL-6, and sTNF-R1 levels were drawn prior to randomization, and after 1 month and 3 months. CRP levels in the rofecoxib group (n = 18) were significantly lower both at 1 month and 3 months compared to the baseline levels (p0.02). IL-6 levels were significantly lower at 1 month (p0.02) in the rofecoxib group, but not at 3 months. There was no change in endothelial function or sTNF-R1 levels.Patients recovering from ACS had lower levels of CRP and IL-6 at 1 month and lower CRP levels at 3 months when treated with rofecoxib plus aspirin. Suppression of inflammatory processes may lead to retardation of coronary atherosclerosis and coronary events.

Use of transradial intervention (TRI) is becoming more popular, and recent studies suggest an advantage for TRI in high-risk patients presenting with acute coronary syndrome (ACS). The aim of our study was to describe current utilization and outcomes of transradial intervention (TRI) in real-world patients presenting with ACS.Data were derived from the ACS Israeli Survey (ACSIS 2010), a nationwide prospective survey of patients presenting with ACS over a 2-month period. Follow-up was continued for up to 1 year.Of 1815 ACS patients undergoing coronary angiography, 613 (34%) underwent TRI, which was more likely to be employed among patients with lower-risk characteristics. Patients undergoing TRI had significantly lower 30-day mortality and in-hospital bleeding. On multivariate analysis, the risk of in-hospital major bleeding was reduced by 60% in patients undergoing TRI (P=.04). However, no significant differences in other components of major adverse cardiac events or mortality were demonstrated at 30 days. All-cause mortality at 1 year was significantly lower among patients who underwent TRI. However, after multivariate adjustment, this effect was no longer significant.In our study of real-world patients, better TRI outcomes are related largely to lower baseline risk of patients allocated to this approach, suggesting that TRI may be underutilized in high-risk ACS patients.

The aim of this study was to determine the natural history of postangioplasty intravascular ultrasound (IVUS)-detected dissections and to assess the influence of intracoronary beta-radiation on dissection resolution.Intracoronary radiotherapy is considered to impair exaggerated vessel healing. Conversely, excessive healing impairment may increase the risk of complications due to unhealed dissection. Alternatively, residual dissection may represent an innocent marker of adequate therapy.Immediate postangioplasty and six-month follow-up IVUS studies of 94 patients in the IVUS substudy of the MultiVitamins and Probucol (MVP) trial and 26 nonstented patients in the Beta Energy Restenosis Trial (BERT) were analyzed for the presence or absence of dissection.Of the 28 patients with postangioplasty dissections in MVP, only one had evidence of residual dissection at six months (95% confidence interval [CI] for failure rate 0.2%; 20.2%). Conversely, 9 of 16 dissections had healed in BERT (95% CI for failure rate 30.6%; 79.2%) (p0.0002). Nevertheless, an index based on dissection arc and length demonstrated improvement in the irradiated patients. Irradiated patients with residual dissections showed significant increase in lumen area at six-months (5.10 +/- 0.98 to 7.11 +/- 2.61 mm2, p0.02) not noted when there was resolution of the dissection (6.03 +/- 2.38 to 6.36 +/- 3.33 mm2, p = NS). In both groups the external elastic membrane area was unchanged at follow-up.Resolution appears to be the natural history of IVUS-detected dissections in most cases. Significant resolution of dissection occurs following intracoronary beta-radiation as reflected in reduced dissection index at six-months in these patients, although significant impairment of vessel wall healing was noted.

Background One of the most daunting complications of cardiac catheterization is a cerebrovascular event ( CVE ). We aimed to assess the real‐life incidence, etiology, and risk factors of cardiac catheterization‐related acute CVE s in a large cohort of patients treated in a single center. Methods and Results We undertook a retrospective analysis of 43 350 coronary procedures performed on 30 907 procedure days over the period 1992‐2011 and compared patient and procedural characteristics of procedures complicated by CVE s with the remaining cohort. CVE s occurred in 47 cases: 43 were ischemic, 3 intracerebral hemorrhages, and 1 undetermined. The overall CVE rate was 0.15%, with percutaneous coronary intervention ( PCI ) and diagnostic coronary angiography rates 0.23% and 0.09%, respectively. Using a forward stepwise multivariate logistic regression model including patient demographic and procedural characteristics, a total of 5 significant predictors were defined: prior stroke ( OR =15.09, 95% CI [8.11 to 28.08], P OR =2.79, 95% CI [1.25 to 6.22], P =0.012), age >75 years ( OR =3.33, 95% CI [1.79 to 6.19], P OR =2.24, 95% CI [1.20 to 4.18], P =0.011), and performance of intervention ( OR =2.21, 95% CI [1.12 to 4.33], P =0.021). An additional analysis excluded any temporal change of CVE rates but demonstrated a significant increase of all high‐risk patient features. Conclusion In a single‐center, retrospective assessment over nearly 20 years, cardiac catheterization‐related CVE s were very rare and nearly exclusively ischemic. The independent predictors for these events were found to be the performance of an intervention and those associated with increased atherosclerotic burden, specifically older age, triple vessel disease, and prior stroke. The presence of intracoronary thrombus appears also to raise the risk of procedure‐related CVE .

The recently released Amplatzer Ductal Occluder 2 (ADO2) was designed specifically for use in small children with moderate-sized shunts and larger children with small patent ductus arterioses (PDA). We report our initial experience with this device.Patients referred with PDA underwent occlusion using the ADO2. This is a fabric-free nitinol wire 3-lobed device. All cases underwent pre-, intra- and post-procedural echocardiography, with follow up at 1 day and one month. Device sizing for device waist diameter and width was based on aortography.Seven patients with a median age of 3 years and 4 months (range 7 months-23 years) and a median weight of 12 kg (range 7-56 kg) underwent successful PDA closure. The median ductal diameter was 1.5 mm (range 0.4-4 mm). Both transpulmonary (6/7) and transaortic approaches (1/7) were used. Recurrent patency at 24 hours with complete occlusion at 1 month was noted in a single case. A specific device-based length assessment applied resulted in shorter than recommended device selection.The ADO2 broadens the spectrum of PDAs that can be simply and safely treated with devices. The flexibility of the articulations, coupled with the alternative deployment techniques, allow for increased ease of treatment in a range of small patients and specific ductal anatomies. An alternative device-specific length measurement of the duct length may result in less retaining disc protrusion. Broader experience is required to further delineate device and patient selection as well as to document its long-term efficacy and safety.

Objectives: The aim of this study was to compare lesion dimensions as determined by a three-dimensional quantitative coronary angiographic (QCA) system to that of a validated two-dimensional QCA system. Background: In an era of drug-eluting stents, device sizing has become an important clinical application of online QCA. The CardiOp-B system integrates two standard angiographic projections to provide a three-dimensional reconstruction of the arterial segment of interest. Methods: Phase 1 — 47 stenoses from consecutive coronary angiograms were assessed in two projections with both systems providing two data sets for the CMS-Medis system and a single data set for CardiOp-B. Phase 2 — a perspex phantom with a known lesion length, was analyzed at increasing degrees of foreshortening with acceptance criteria set at 5% from the absolute value. Results: Phase 1 demonstrated an adequate correlation between the CardiOp-B and Medis systems when minimal luminal diameter was measured in the optimal view (1.32 ± 0.47 mm vs 1.42 ± 0.49 mm respectively; r = 0.82). A stronger correlation was noted when length was measured (25.27 ± 10.76 mm and 21.32 ± 8.08 mm, respectively; r = 0.95); however CardiOp-B provided a consistently longer length (P < 0.0001). On phantom length measurements the mean accuracy result for the CardiOp-B system was −1.3%. This compared favorably with the two-dimensional system where all measures performed at greater than 20 degrees of forshortening were beyond the 5% criteria from the known length. Conclusions: Three-dimensional QCA provides accurate and precise vessel diameter assessments. Length assessments are consistently longer than two-dimensional measures and are significantly less affected by foreshortened projections. (J Interven Cardiol 2010;23:152-159)

The absence of antegrade flow in a coronary artery during an intervention is an ominous finding requiring diagnosis of the underlying cause and rapid treatment to limit myocardial necrosis. The Twin-Pass dual access catheter allows for distal coronary contrast injection without loss of wire position. The aim of this analysis was to determine the opacification and flow features of patients with abrupt arrest of antegrade flow to determine the underlying pathology.Coronary angiograms of patients with abrupt arrest of antegrade flow during an intervention that underwent distal vessel contrast injection with the Twin-Pass catheter were retrospectively analyzed for five features: antegrade flow, retrograde flow, myocardial blush, presence of contrast stasis in the vessel wall and evidence of an intraluminal filling defect. The features were then correlated with the underlying pathological process and treatment.Seven patients underwent distal contrast injections. Four specific pathological processes were identified: presence of a proximal occlusive lesion; no-reflow due to distal vascular bed dysfunction; long dissection of the vessel with the distal wire residing in the true lumen or alternatively in the dissection plane. The patients were treated according to the pathology with stenting, intracoronary adenosine or wire repositioning.Distal vessel contrast injection using the Twin-Pass catheter in the presence of no-reflow is a simple and rapid technique that allows for the definition of four distinct clinical scenarios. This allows for rapid treatment of the underlying pathological process, reducing the period of end-organ ischemia, limiting occasional unnecessary stent deployment and further improving procedural results.

Transcatheter occlusion of coronary cameral fistulae has been well reported. In large fistulae multiple devices with prolonged procedures are often required for complete occlusion. We present the case of a large right coronary artery-to-right atrial fistula that was rapidly and simply occluded with the three-lobed Amplatzer Vascular Plug 2.

Background: Percutaneous coronary intervention (PCI) of coronary bifurcation lesions remains a subject of debate. Many studies have been published in this setting. They are often small scale and display methodological flaws and other shortcomings such as inaccurate designation of lesions, heterogeneity, and inadequate description of techniques implemented. Methods: The aim is to propose a consensus established by the European Bifurcation Club (EBC), on the definition and classification of bifurcation lesions and treatments implemented with the purpose of allowing comparisons between techniques in various anatomical and clinical settings. Results: A bifurcation lesion is a coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch. The simple lesion classification proposed by Medina has been adopted. To analyze the outcomes of different techniques by intention to treat, it is necessary to clearly define which vessel is the distal main branch and which is (are) the side branche(s) and give each branch a distinct name. Each segment of the bifurcation has been named following the same pattern as the Medina classification. The classification of the techniques (MADS: Main, Across, Distal, Side) is based on the manner in which the first stent has been implanted. A visual presentation of PCI techniques and devices used should allow the development of a software describing quickly and accurately the procedure performed. Conclusion: The EBC proposes a new classification of bifurcation lesions and their treatments to permit accurate comparisons of well described techniques in homogeneous lesion groups. (c) 2008 Wiley-Liss, Inc. Udgivelsesdato: 2007-Nov-5

Femoral artery vascular complications are the most common adverse events following cardiac catheterization. Smaller diameter introducer sheaths and catheters are likely to lower the puncture site complication rate but may hinder visualization.To evaluate the safety and angiographic quality of 4 French catheters.The study was designed to simulate real-life operator-based experience. Diagnostic angiography was performed with either 4F or 6F diagnostic catheters; the size of the catheter used in each patient was predetermined by the day of the month. Patients undergoing 4F and 6F diagnostic angiography were ambulated after 4 and 6 hours, respectively. The following technical parameters were recorded by the operator: ease of introducer sheath insertion, ease of coronary intubation, ease of injection, coronary opacification, collateral flow demonstration, and overall assessment. Adverse events were recorded in all patients and included minor bleeding, major bleeding (necessitating blood transfusion), minor hematoma, major hematoma, pseudo-aneurysm formation and arteriovenous fistula.The study group included 177 patients, of whom 91 were in the 4F arm and 86 in the 6F arm. Demographic and procedural data were similar in both groups. Seventy-seven percent of 6F and 50% of 4F procedures were evaluated as excellent (P0.05). This difference was attributed to easier intubation of the coronary ostium and contrast material injection, increased opacification of the coronary arteries, and demonstration of collateral flow with 6F catheters. Complications occurred in 22% of patients treated with 6F catheters and in 10% of those treated with 4F catheters (P = 0.11). Of the 50 patients who switched from 4F to 6F 12% had complications. In patients undergoing diagnostic angiography, the complication rate was 10% vs. 27% (most of them minor) in the 4F and 6F groups, respectively (P0.05).Patients catheterized with 4F have fewer complications compared with 6F diagnostic catheters even when ambulated earlier. Although 4F had a reduced quality compared to 6F angiographies, they were evaluated as satisfactory or excellent in quality 85% of the time. 4F catheters have a potential for reduced hospitalization stay and are a good option for primary catheterization in patients not anticipated to undergo coronary intervention.

Progressive minituarization of angioplasty hardware has resulted in a reduction of access site complications. This has limited to some degree the equipment used with small delivery systems. The buddy wire technique is a potential solution for resistant lesions with an underexpanded stent that can be used without having to upsize the introducer and guiding catheter.

Purpose The purpose of this article is to review the current literature pertaining to intracoronary brachytherapy for the prevention of restenosis after percutaneous coronary revascularization (PCR). Methods English-language articles were identified through a MEDLINE search (January 1984 to January 2003) using the keywords brachytherapy, radioactive stents, and coronary arteries. In addition, pertinent reference citations from relevant articles were reviewed. Results Restenosis after PCR is a complex process, thought to be due to a combination of vessel wall remodeling and neointimal proliferation. To date, catheter-based delivery of intracoronary brachytherapy has been found to prevent vessel wall remodeling and causes a reduction in the proliferation of the neointima. Neointimal proliferation, as measured by mean neointimal area, was reduced in all animal studies (range 26%–91%). In contrast, animal studies examining radioactive stents demonstrated an increase in neointimal proliferation, suggesting that they may not be helpful at preventing post-PCR restenosis. All human studies using catheter-based intracoronary brachytherapy for in-stent restenosis have employed either β (beta) or γ (gamma) radiation sources with variable doses of radiation (range 7–56 Grays [Gy]). Restenosis occurred in 12% to 40% of patients in nonrandomized studies, and clinical events occurred in 13% to 50% of patients. To date, there have been 7 published randomized trials in humans comparing catheter-based intracoronary brachytherapy to placebo, with a total of 1047 patients. The dose of radiation in the trials ranged from 14 Gy to 30 Gy. During follow-up, 8% to 33% of patients who received brachytherapy had restenosis versus 39% to 64% of patients receiving placebo. Clinical events occurred in 19% to 50% among patients who received brachytherapy versus 29% to 79% among patients receiving placebo. The majority of human studies examining radioactive stents do not demonstrate a reduction in restenosis in patients post-PCR. There are no randomized trials examining radioactive stents in humans. Conclusion Nonrandomized studies of radioactive stents suggest they are not effective at preventing in-stent restenosis. In contrast, data from animal and human studies suggest that catheter-based intracoronary brachytherapy can prevent in-stent restenosis and reduce clinical events post-PCR.

Prior studies have suggested that women are at higher risk for morbidity and mortality during coronary angioplasty, although long-term prognosis is similar after successful procedures.To examine the role of gender in coronary stenting, including immediate procedural success as well as early and late outcomes.The study group comprised 560 consecutive patients (119 women and 441 men) who had undergone stenting over a 3 year period.The indications for coronary stenting were similar among women and men, and stents were successfully deployed at similar rates without complications (92 vs. 90% respectively). Cardiac death or myocardial infarction within 30 days of the procedure was observed in 5% of women and men, whereas none of the women, compared to 1.4% of men, had early revascularization. Bleeding complications occurred in 4% of women and 2% of men. During 10 +/- 2.8 months of follow-up, 58% of women and men underwent repeat cardiac catheterization, revealing similar rates of restenosis, 36 vs. 32% respectively. During the study period, 3.3% of women as compared to 0.9% of men had a cardiac death (not significant). Cardiac death or myocardial infarction was observed in 7% of women and 8% of men, and the combined endpoint of death, myocardial infarction or revascularization, was noted in 24% and 26% respectively. Multivariate Cox analyses of the clinical, angiographic and procedural characteristics revealed that multiple stent deployment was the only predictor of major adverse cardiac event among men, whereas none of these characteristics predicted outcome in women.Coronary stenting is performed with similar success rates among women and men, with similar restenosis rates as well as early and late major adverse cardiac events.

The significance of heavily calcified proximal left anterior descending coronary artery stenosis in a 57-year-old man was assessed physiologically using a Doppler flow wire. Intravascular ultrasound guidance allowed for adequate dilatation with a cutting balloon and optimization of stent deployment. The cutting balloon offers an effective alternative in this challenging scenario.

Background — Postcoronary angioplasty vascular brachytherapy (VBT) has emerged as a successful intervention for restenosis prevention in some clinical scenarios. Longer-term follow-up after VBT in de novo nonstented lesions has not been reported. Methods and Results — Thirty patients treated with post–percutaneous transluminal coronary angioplasty (PTCA) VBT with Sr 90 underwent clinical and angiographic follow-up at 6 and 24 months. Specific vessel segment quantitative coronary angiographic analyses were performed to identify radiation edge effects. Nineteen patients who had not undergone index procedure stenting or target vessel revascularization (TVR) over the 2-year period were analyzed separately. Of the 30 patients, 3 underwent TVR by 6-month follow-up. An additional 4 patients required TVR between 6 and 24 months. In the total cohort of 26 patients undergoing angiographic follow-up at 6 and 24 months, an increase in minimal lumen diameter of the initial target segment was noted at 6 months compared with postprocedure analysis (2.31±0.48 versus 2.04±0.43 mm, P Conclusions — Although some late failures of post-PTCA VBT are seen between 6 and 24 months, most treated vessels remain stable with no late loss or additional luminal increase beyond the 6-month period. This suggests that late aneurysm formation and significant late edge restenosis are unlikely in VBT after PTCA of de novo lesions for up to 2 years.

In most patients with atrial fibrillation (AF) and stroke, there is thrombotic embolization from the left atrial appendage (LAA). Percutaneous closure of the LAA is a novel alternative for the treatment of patients with AF at a high risk of stroke, in whom long-term anticoagulation therapy is not possible or not desired. This study details the initial experience with the Amplatzer Cardiac Plug (ACP) in humans.Investigator-initiated retrospective preregistry data collection to evaluate procedural feasibility and safety up to 24 hr after implantation of the ACP, a nitinol device designed for percutaneous trans-septal implantation in LAA of patients with paroxysmal, permanent, or persistent AF.In 137 of 143 patients, LAA occlusion was attempted, and successfully performed in 132 (96%). There were serious complications in 10 (7.0%) patients (three patients with ischemic stroke; two patients experienced device embolization, both percutaneously recaptured; and five patients with clinically significant pericardial effusions). Minor complications were insignificant pericardial effusions in four, transient myocardial ischemia in two, and loss of the implant in the venous system in one patient.The implantation of the ACP device is a feasible method for percutaneous occlusion of the LAA.

Background —Endovascular radiation is emerging as a potential solution for the prevention and treatment of restenosis. Its effects on the morphology of unstented vessels cannot be determined by angiography and therefore require the use of intravascular ultrasound. Methods and Results —Through a 5F noncentered catheter for delivery of a 90 Sr/Y source train, 12, 14, or 16 Gy at 2 mm was delivered to native coronary arteries after successful balloon angioplasty in 30 patients. Four patients required stent deployment in the first week. Quantitative coronary angiography and IVUS were performed during the initial procedure and at 6-month follow-up. Binary angiographic restenosis was present in 3 of 30 patients, with target lesion and vessel revascularization performed in 3 and 5 patients, respectively. Angiographic late loss was −0.02±0.60 mm, with a −0.09±0.46 loss index. IVUS demonstrated no significant reduction in lumen area (from 5.69±1.72 mm 2 after treatment to 6.04±2.63 mm 2 at follow-up), with no significant change in external elastic membrane area (13.71±4.54 to 14.22±4.71 mm 2 ) over the 6-month follow-up. Wall area was 8.01±3.85 mm 2 after radiation therapy and 8.19±3.44 mm 2 at follow-up ( P =NS). No significant differences were noted between the different dose groups. Conclusions —β-Radiation therapy resulted in a low restenosis rate with negligible late loss by angiography. By IVUS, β-radiation was shown to inhibit neointima formation, with no reduction of total vessel area at 6-month follow-up.

Restenosis remains a major limitation of coronary angioplasty in spite of major advances in techniques and technology. Recent studies have demonstrated that ionizing radiation may limit the degree of this problem. Gamma radiation has been shown to be effective in reducing in stent restenosis in humans, and beta radiation following encouraging results in animals has been shown to be feasible in humans. The objective of this study was to assess the feasibility of a 5 F non-centered catheter to deliver beta radiation emitting seeds to the lesion site post angioplasty and its effect on restenosis. Following successful angioplasty, patients were randomized to treatment with 12, 14 or 16 Gy at the angioplasty site. This was delivered with a 5 F non-centered catheter. Twelve beta radiation emitting seeds (90Sr/Y) were delivered to an area 3 cm in length to cover the angioplasty site. Angiographic follow-up was performed at 6 months. Baseline and follow-up angiograms were performed by blinded investigators at a core laboratory. This interim report comprises the first 35 patients to complete 6-month angiographic follow-up. There were no major radiation incidents. Four patients had evidence of angiographic restenosis. The MLD (mm) and percent stenosis were 0.77 +/- 0.27/72.5 +/- 8.6 pre angioplasty, 2.08 +/- 0.4/25.7 +/- 9.8 post angioplasty and radiation and 2.05 +/- 0.59/25.7 +/- 19.8 at follow-up respectively.Beta radiation can be feasibly and safely delivered post coronary angioplasty with a very encouraging reduction of restenosis.

Background. The interrelation between plasma cell dyscrasia and myelofibrosis or agnogenic myeloid metaplasia (AMM) is unclear. The existence of two distinct syndromes has been proposed: (1) plasma cell dyscrasia associated with simple marrow fibrosis caused by the secretion of lymphokines and (2) myeloma coexisting with AMM representing two distinct clonal diseases. Methods. The authors report the case of a 68 year-old man seen initially with severe anemia, massive splenomegaly, a leukoerythroblastic blood morphology, and myelofibrosis coexisting with massive bone marrow infiltration with IgA lambda-producing plasmacytoid cells. Results. Cyclic therapy with vincristine, carmustine, cyclophosphamide, melphalan, and prednisone resulted in clinical remission of the myeloma lasting for 2 years and complete resolution of all the clinical features resembling AMM. Conclusions. The authors' observations and the report of two other patients in whom remission of AMM has been observed after myeloma treatment underline the broad spectrum of secondary abnormalities ranging from moderate bone marrow fibrosis to the full clinical expression of a syndrome closely mimicking AMM. These secondary abnormalities are potentially reversible even in the presence of advanced bone marrow fibrosis and massive splenomegaly.