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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.

High-frequency QRS (HFQRS) analysis of surface ECG is a reliable marker of cardiac ischemia (CI). This study aimed to assess the response of HFQRS signals from standard intracardiac electrodes (iHFQRS) to CI in swine and compare them with conventional ST-segment deviations. Devices with three intracardiac leads were implanted in three swine in a controlled environment. CI was induced by inflating a balloon in epicardial coronary arteries. A designated signal-processing algorithm was applied to quantify the iHFQRS content before, during, and after each occlusion. iHFQRS time responses were compared to conventional ST-segment deviations. Thirty-three over thirty-nine (85%) of the occlusions presented significant reduction in the iHFQRS signal, preceding ST-segment change, being the only indicator of CI in brief occlusions. iHFQRS was found to be an early indicator for the onset of CI and demonstrated superior sensitivity to conventional ST-segment deviations during brief ischemic episodes.

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.

Background/Introduction Invasive pressure-guided therapy has been shown to improve outcomes in patients with heart failure (HF). Thus far, only right-sided pressure sensors have shown clinical efficacy and safety. The Vectorious Medical Technologies V-LAP™ is a novel battery-less and wireless left-sided pressure monitoring system, directly assessing left-atrial pressure (LAP) in an ambulatory setting. In pre-clinical studies, it was shown to enable accurate and safe measurement of LAP. We hereby describe the first human experience with the device. Methods The V-LAP left atrial monitoring systEm for patients with Chronic sysTOlic and diastolic congestive heart failuRe first-in-human (VECTOR) study is a prospective, multicenter, single arm, open-label clinical trial to assess the safety, performance and usability of the V-LAP system in patients with heart failure. The V-LAP™ wireless sensor is implanted using a trans-septal access, under angiographic and echocardiographic guidance. The system includes an external unit, which both powers the implant and collects data via radio frequency communication upon activation, designed to be operated on a daily basis. We hereby describe the first cases, implanted in the CardioVascular Center, in Frankfurt, Germany. Results At this point in time, there have been two successful implantations of the V-LAP™, performed in two NYHA Class III patients. Both were admitted repeatedly for exacerbations of HF, and demonstrated elevated NT-ProBNP levels. They were therefore considered appropriate candidates for the monitoring system, to enable optimal medical therapy. The procedure was performed in a trans-femoral, trans-septal fashion, under mild sedation, with a successful implantation of a V-LAP™, and calibration for pressure measurement. There were no complications, data showed accurate LAP reading (Figure 1). Conclusions In the first-in-human cases, the implantation of the novel wireless left atrial pressure sensor V-LAP™ was feasible, safe, and showed good accuracy and precision. We now await both short and long-term efficacy and safety outcomes of the device, with the hopes of optimizing care according to ambulatory LAP data for patients with HF. Acknowledgement/Funding Vectorious Medical Technologies

The neuroprotective effects of hypothermia have been demonstrated in experimental models and clinical trials. Experimental studies indicate that improved efficacy and broadened indications can be achieved with moderate to deep hypothermia. The TwinFlo catheter was designed to provide very rapid, deep and selective brain cooling with faster cooling rates, and temperatures much lower than those which can be achieved by any other hypothermia device and technique. This report describes the experimental in vivo studies and initial clinical experience with the TwinFlo catheter.

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.

Background Myocardial ischemia causes contractile dysfunction in ischemic, stunned, and tethered regions with larger infarcted zones having a negative prognostic impact on patients' outcomes. To distinguish the infarcted myocardium from the other regions, we investigated the diagnostic potential of circumferential strain (CS) and radial strain (RS) during the acute and chronic stages of myocardial infarction. Methods Ten pigs underwent 90-minute occlusion of the left anterior descending artery, followed by reperfusion. Echocardiography was performed at baseline, after 90-minute occlusion, and at 2 hours, 30, and 60 days postreperfusion. CS and RS were measured using speckle tracking echocardiography. Subsequently, the pigs were sacrificed, and histological analysis for infarct size was performed. Results After 90-minute occlusion, reduced strains were detected for all segments (infarcted anterior wall – baseline: CS: −17.6 ± 5.7%, RS: 54.4 ± 16.9%; 90 min: CS: −10.3 ± 3.0%, RS: 23.3 ± 7.0%; tethered posterior wall – baseline: CS: −18.4 ± 3.5%, RS: 68.7 ± 21.1%; 90 min: CS: −10.7 ± 6.4%, RS: 34.5 ± 14.7%, P < 0.001). However, postsystolic shortening was detected only in the infarcted segments, and the time-to-peak CS was 25% longer (P < 0.05). At 30 and 60 days postreperfusion, time-to-peak CS could only detect large scars in the anterior and anterior-septum walls (P < 0.05), while peak CS also detected smaller scars in the lateral wall (P < 0.05). RS failed to distinguish between normal, stunned/tethered, and infarcted myocardium. Conclusions During occlusion and 2 hours postreperfusion, time-to-peak CS could distinguish between infarcted and stunned/tethered myocardial segments, while at 30 and 60 days postreperfusion, peak CS was the best detector of infarction.

BACKGROUND The current cornerstone treatment of myocardial infarction (MI) is restoration of coronary blood flow by means of thrombolytic therapy or primary percutaneous coronary intervention. However, reperfusion of ischemic myocardium can actually provoke tissue damage, defined as "ischemia-reperfusion (I/R) injury." TVP1022 [the S-isomer of rasagiline (Azilect), FDA-approved anti-Parkinson's drug] was found to exert cardioprotective activities against various cardiac insults, such as chronic heart failure and I/R, in rat models. Therefore, we tested the hypothesis that TVP1022 will provide cardioprotection against I/R injury and post-MI remodeling in a pig model. METHODS For inducing MI, we used an I/R model of midleft anterior descending artery occlusion for 90 minutes followed by follow-up for 8 weeks in 18 farm pigs (9 pigs in each group, MI + TVP1022 or MI + Vehicle). Echocardiographic measurements were performed and cardiac scar size was calculated using histopathological methods. For fibrosis evaluation, we measured the interstitial collagen volume fraction in the remote noninfarcted tissue. RESULTS TVP1022 administration significantly decreased cardiac scar size, attenuated left ventricular dilation, and improved cardiac function assessed by segmental circumferential strain analysis. Furthermore, TVP1022 significantly reduced myocardial fibrosis 8 weeks post-MI. CONCLUSIONS Collectively, these findings indicate that TVP1022 provides prominent cardioprotection against I/R injury and post-MI remodeling in this I/R pig model.

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

Heart failure (HF) is a leading cause of hospital admissions. Advancements in monitoring of right-sided parameters have shown promise in reducing readmissions. To this date, a left-sided pressure monitoring system is not available. The Vectorious Medical Technologies V-LAPTM is a novel intracardiac

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.

Primary percutaneous coronary intervention, where available, has become the therapy of choice in myocardial reperfusion during ST-elevation myocardial infarction. However, in a significant proportion of patients, owing to a high thrombus burden, myocardial perfusion is not fully achieved in the epicardial vessel. This phenomenon has been attributed predominantly to the distal embolization of thrombus particles and atherosclerotic plaque debris resulting in an association with poorer short- and long-term outcomes, including heart failure and death. Pharmacological measures, such as adequate antiplatelet therapy, glycoprotein IIb/IIIa antagonists and coronary vasodilators, have been employed with the aim of reducing this phenomenon, with limited success. This clinical need has led to the development of devices dedicated to evacuating or trapping thrombus during intervention to reduce the risk of distal embolization during percutaneous coronary intervention. Controversies regarding the benefits that have bee...

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.)

Use of the radial artery as the access site for cardiac interventions has been increasing over the last decade. With this, its application to primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) has also become more common and continues to rise, with increasing interest across Europe and more recently the USA. The most obvious benefits of this approach are the increased mobility and patient comfort that is afforded by avoiding a femoral approach. However, as more data is generated for PCI in general and specifically for PCI for STEMI, the benefits of reductions in access site complications, and possibly major adverse cardiovascular events, are becoming apparent. These benefits are achieved without any significant reduction in efficacy. This combination suggests that the current trend of increasing adoption of the transradial approach in STEMI should continue to broaden.

Ischemic embolic stroke occurring secondary to atrial fibrillation is a devastating complication with significant morbidity and mortality. The functional impairment of the left atrium and left-atrial appendage in combination with specific anatomical characteristics results in altered hemodynamics and a prothrombotic environment. This scenario sets the stage for subsequent systemic and often cerebral emboli. In addition to the well-established approach of systemic anticoagulation, the restriction or separation of the LAA from the systemic cardiovascular space can provide a local solution with reduction of stroke, however, with limited systemic adverse events. This approach has particular attraction to the subgroup of patients at high risk of stroke as well as complications from systemic anticoagulation.

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 .

BACKGROUND: Transradial approach (TRA) for percutaneous coronary interventions (PCI) has been performed since 1994. Despite lower risks of access-site related complications compared to the femoral approach (FA), the clinical benefit of TRA is uncertain. We undertook a systematic review and meta-analysis comparing TRA and FA for PCI. METHODS: A literature search aimed at identifying all clinical trials and observational studies comparing TRA with FA for PCI with reports of clinical outcomes was performed. Odds ratios (OR) were estimated by a hierarchical Bayesian randomeffects model with prespecified stratification for observational and randomized designs. The primary outcomes examined were rates of death, combined incidence of death or myocardial infarction (MI), bleeding and transfusions, early ( 30 days) and late after PCI. RESULTS: We collected data from 73 studies (14 randomized, 59 observational) involving a total of 1,022,123 patients (prior to RIVAL Trial). There was a strong association between TRA and mortality early after intervention (OR 0.52, 95% credible interval (CrI) 0.43-0.62), although the effect was mainly due to observational studies (OR 0.49, 95% CrI 0.39-0.59), with an OR 0.74 (95% CrI 0.38-1.40) in randomized trials. An association between TRA and death or MI was observed over shortterm follow-up (OR 0.66, 95% CrI 0.51-0.82), with an OR of 0.72 (95% CrI 0.41-1.14) for long-term follow-up. Compared with FA, TRA was associated with a major reduction in bleeding (OR 0.22, 95% CrI 0.16-0.29) and in transfusions (OR 0.20, 95% CrI 0.10-0.31). These findings were consistent in both randomized and observational studies. CONCLUSIONS: Our results suggest that PCI performed by TRA is associated with lower risks of death, death or MI, bleeding and transfusions when compared to FA. Our results suggest that greater adoption of TRA has the potential to substantially improve outcomes among patients undergoing PCI. This meta-analysis will be updated with RIVAL Trial results for presentation at the meeting. Fonds de la Recherche en Sante du Quebec

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.

Balloon angioplasty results in a combination of plaque compression and fracture, creation of intimal flaps and localized medial dissection, as well as the stretching and remodeling of the arterial wall. The application of eccentric pressure to the vessel wall allows for the balloon force to be focused along a specified line resulting in a reduction in vessel resistance with an improved or equivalent result at a lower pressure. The FX miniRAIL is a novel balloon angioplasty catheter that has two external wires that are compressed by the inflating balloon into the vessel wall. It was tested in comparison to conventional balloon injury in a porcine coronary model. At equivalent balloon artery ratios no increase in the length of dissections occurred, but a characteristic longitudinal "cut" was noted in the presence of the FX miniRAIL. A similar finding was demonstrated in sample human cases when interrogated by IVUS and OCT.

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.

Transmyocardial laser revascularization (TMLR) has potential benefit for patients with end-stage coronary artery disease and intractable angina not amenable to conventional revascularization techniques. Neovascularization has been proposed to occur around the laser channels. Our aim was to determine the feasibility of a novel nonlaser myocardial revascularization technique and its effect on angiogenesis in a nonischemic porcine model.In the first phase, six transmyocardial stainless steel coil implants (TMI) were deployed to the lateral wall of the left ventricle in each of 6 pigs. The animals were sacrificed at 8 and 12 weeks, with a single animal dying prematurely at 4 weeks, and the myocardium was assessed for new vessel growth. In the second phase, 8 implants were deployed in each of 12 pigs with regular fluoroscopic follow-up until sacrifice at 2 weeks to assess implant stability.The deployment procedure was safe and feasible with no complications evident. A significant increase in new vessels at implant sites with 5.43 +/- 3.67, 4.97 +/- 2.44, and 3.57 +/- 2.29 seen per high power field at 12, 8, and 4 weeks, respectively, compared to 1.00 +/- 1.06 (p0.0001) in control myocardium. There was no evidence of implant migration in Phase 2.TMIs can feasibly be deployed in the nonischemic pig model with a high success rate. The presence of angiogenesis at the implant site and the maintenance of this reaction for 3 months implies that TMI may offer an alternative to TMLR while providing a platform for delivery of angiogenic factors.

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.

Obstructive coronary lesions involving a branch origin or extending into the branch itself, remain one of the main challenges in the rapidly developing world of interventional cardiology. Acutely, these lesions are prone to the complications resulting in significant residual stenosis or loss of one of the branches. Long-term follow up has also been disappointing with a high incidence of restenosis. Numerous techniques have been developed, aimed at optimizing the acute and long-term results by adapting standard angioplasty hardware, with limited success, particularly in the long term. This article describes a fully dedicated system for bifurcation lesions with stenting of the main vessel to the main branch, yet ensuring side branch patency, with limited risk of branch origin stenosis or stent jailing, allowing for provisional stenting of the branch as dictated by the angiographic outcome.