Objectives:

To report procedural outcome and short-term follow-up data for the Gore Septal Occluder (GSO), a new device for closure of patent foramen ovale (PFO).

Background:

Transcatheter closure of patent foramen ovale is an established treatment modality but no current device provides a perfect solution. The GORE septal occluder (GSO) has a number of design features which make it potentially attractive for closure of defects in the atrial septum.

Methods:

Data from 9 centres in the United Kingdom implanting the GSO device, submitted to an electronic registry for evaluation.

Results:

229 patients undergoing PFO closure from June 2011 to October 2012 were included. Indications for closure were secondary prevention of paradoxical cerebral emboli (83.4%), migraine (2.1%), platypnoea orthodeoxia (3.9%) and other (10.5%). Median PFO size was 8mm and 34% and 39%, respectively, had long tunnel anatomy or atrial septal aneurysms. A GSO was successfully implanted in all cases. A single device was used in 98% but in 4 patients the initial device was removed and a second device required. Procedural complications occurred in 3% and later complications (e.g. atrial fibrillation, atrial ectopics, device thrombus) in 5.7% of cases. All patients have undergone clinical and echocardiographic follow up and all devices remain in position. Early bubble studies (median 0 months) with Valsalva manoeuvre in 67.2% were negative in 89%.

Conclusions:

The GORE septal occluder is an effective occlusion device for closure of patent foramen ovale of all types. Longer-term follow-up particularly to document later closure rates are required. © 2013 Wiley Periodicals, Inc.

Retroperitoneal fibrosis is a rare condition characterized by the presence of inflammatory and fibrous retroperitoneal tissue that surrounds and often encases abdominal structures. In this report we describe an unusual presentation of retroperitoneal fibrosis and inferior vena cava (IVC) obstruction that was unidentified by noninvasive testing and ultimately diagnosed using exercise right heart catheterization and venography. Exercise hemodynamic catheterization revealed a high pressure gradient across the IVC obstruction during exercise that resulted in reduced preload and inappropriately low cardiac output reserve. The patient ultimately underwent angioplasty and stenting of the obstruction resulting in resolution of his symptoms. © 2013 Wiley Periodicals, Inc.

Acute left main coronary occlusion secondary to a periaortic root hematoma secondary to annular rupture during transcatheter heart valve deployment. © 2013 Wiley Periodicals, Inc.

Transradial percutaneous coronary intervention is associated with significant reductions in access site complications and major bleeding as compared with the transfemoral approach. Bivalirudin is now the most commonly used anticoagulant for transradial percutaneous coronary intervention in the U.S., while weight adjusted unfractionated heparin remains the most common choice outside the U.S. A growing number of reports suggest that transradial intervention may offer improved outcomes across a variety of clinical situations, including those at the highest risk of bleeding complications, such as those with acute myocardial infarction. The following review provides an overview of the studies evaluating anticoagulation in transradial percutaneous intervention and a rationale for the combination of the transradial approach to coronary interventions with an optimal anticoagulant strategy to reduce both access site and non-access site related bleeding. © 2013 Wiley Periodicals, Inc.

Coronary artery occlusion during transcatheter aortic valve replacement is a rare complication. However, it is a very severe and life threatening event. Although there are some possible causes of this phenomenon, definite etiologies and predictors are unknown because of the small number. We describe one case of left main coronary artery occlusion immediately after deployment of a prosthetic valve. The patient became hypotensive and developed cardiopulmonary arrest. However, the coronary artery was successfully stented with a help of cardiopulmonary bypass and he recovered well. In this case, pre-procedural computed tomography (CT) showed the adequately high coronary height and no other significant conventional predictor for coronary occlusion. The examinations were retrospectively reviewed and the CT showed a long leaflet compared to the coronary sinus complex. The fluoroscopy appeared to show the long leaflet covering the left main coronary artery ostium immediately after the valve deployment. The height of the coronary artery ostium from the aortic annulus appeared sufficiently high in this case and did not explain the coronary compromise; leaflet length in relation to the coronary sinus dimension seemed more relevant. The ratio between leaflet length and curved coronary sinus height (L/C) may be one novel predictor for coronary artery occlusion. © 2013 Wiley Periodicals, Inc.

Background:

Surveillance endomyocardial biopsy (EMB) with right heart catheterization (RHC) is the standard of care for the assessment of post cardiac transplantation rejection. This procedure has traditionally relied upon fluoroscopy, which exposes both patient and staff to the risks of ionizing radiation. These risks may be of particular concern in the transplant patient who must undergo many such procedures lifelong. We present data on a new "ALARA - As Low As Reasonably Achievable" protocol to reduce radiation exposure during the performance of RHC with EMB.

Methods:

All cardiac transplantation patients < 21 years of age who underwent RHC with EMB at The Children's Hospital at Montefiore from 6/11-12/11 were included. EMB was performed after all right heart pressures including wedge pressure and thermodilution cardiac output were measured. A novel ALARA protocol consisting of multiple features including ultra-low frame rates (2-3fps), low fluoro dose/frame (10-18 nGy/frame), use of the "air-gap" technique for patients < 20 kg, and multiple other techniques aimed at minimizing use of fluoroscopy were employed in all cases. Demographics, procedural data and patient radiation exposure levels were collected and analyzed.

Results:

18 patients underwent 45 surveillance RHC with EMB in the study period and were the subject of this analysis. The mean age was 5.9± 6.1 yrs, weight was 20.4 kg ±16.6 kg, and BSA was 0.75 ±45 m². PA fluoroscopy was used exclusively in 45/45. Vascular access was RFV (21/45; 47%), RIJV (17/45; 38%), LFV (4/45; 9%) and LIJV (3/45; 7%). The median number of EMB specimens obtained was 5 (range 4-7). The median fluoroscopy time was 3.7 minutes (range 1.2-9). The median air Kerma product (K) was 1.4 mGy (range 0.4-14), and dose area product (DAP) was 15.8 uGym² (range 3.5-144.5). The K and DAP are substantially lower than any prior published data for RHC/EMB in this patient group. There were no procedural complications.

Conclusions:

The use of a novel ALARA protocol for RHC and EMB in pediatric cardiac transplantation patients markedly reduced radiation exposure to levels far below any previously reported values without negatively affecting the safety or efficacy of these procedures. © 2013 Wiley Periodicals, Inc.

Background In left main coronary artery (LMCA) bifurcation lesions, hemodynamic and geometrical change in left circumflex artery (LCX) ostium after main branch (MB) stenting has not been known. This study evaluated how accurately intravascular ultrasound (IVUS) predicts the functional compromise of the sidebranch. Methods A single-stent cross-over technique was used to treat LMCA bifurcation lesions in 43 patients with LCX ostial diameter stenosis (DS) of <50%. The fractional flow reserve (FFR) in the LCX was measured after MB stenting, MB and sidebranch pullback IVUS was performed pre- and post-stenting. Results After MB stenting, angiographic DS >50% at the LCX ostium was observed in 18 (42%) patients, while only 3 (7%) showed FFR<0.80. A pre-procedural minimal lumen area (MLA) of <3.7mm(2) within the LCX ostium was predictive of a post-stenting FFR <0.80, with a sensitivity of 100%, specificity of 71%, a positive predictive value (PPV) of 16%, and a negative predictive value (NPV) of 100% (area under curve 0.80, p<0.001). Moreover, pre-procedural plaque burden of >56% at the LCX ostium predicted FFR <0.80, with a sensitivity of 100%, specificity of 65%, a PPV of 14% and a NPV of 100% (area under curve 0.80, p<0.001). A post-stenting LCX ostial DS >57% predicted FFR <0.80 with a sensitivity of 100%, specificity of 88%, a PPV of 38% and a NPV of 100% (area under curve 0.962, p<0.001). However, the post-stenting MLA within the LCX ostium showed no significant correlation with FFR (r=0.197, p=0.391).

Conclusions.

In LMCA bifurcation lesions with mild LCX ostial disease, the use of single-stent technique rarely resulted in the functional LCX compromise. Because the functional LCX stenosis is poorly predicted by a small MLA, sidebranch treatment should be based on the post-stenting FFR. © 2013 Wiley Periodicals, Inc.

Landmark trials comparing carotid endarterectomy (CEA) with medical therapy in patients with symptomatic or asymptomatic atherosclerotic stenosis of extracranial carotid arteries have favored carotid revascularization. Carotid artery stenting (CAS) has emerged as a minimally invasive option for revascularization of carotid artery stenoses and has been shown to be non-inferior to CEA, regardless of patient symptom status. Debate continues regarding the importance of periprocedural myocardial infarction (PMI) as an endpoint in carotid revascularization trials. Recent randomized comparisons of CEA and CAS pre-specify PMI as an endpoint. Understanding PMI in CEA and CAS, the need for routine biomarker assessment surrounding both revascularization strategies, the effect of PMI on long-term morbidity and mortality, and the groups most at risk for PMI are of critical importance when choosing a carotid revascularization strategy for symptomatic and asymptomatic patients, since decreasing the incidence of PMI will make revascularization safer. This review examines available data regarding the relevance of PMI in vascular and carotid-specific outcomes. © 2013 Wiley Periodicals, Inc.

Objective:

To compare the use of regadenoson to adenosine for measurement of fractional flow reserve (FFR).

Background:

FFR is an accepted method to assess the functional significance of intermediate coronary artery stenoses and uses adenosine to induce maximal hyperemia. The use of the selective A2a receptor agonist regadenoson for FFR is not established.

Methods:

Fifty-seven patients undergoing clinically indicated FFR assessment of intermediate coronary stenoses were included. For the initial assessment of FFR, hyperemia was achieved by a standard intravenous adenosine infusion (140mcg/kg/min). After a washout period of 10 minutes, FFR was reassessed using regadenoson as a single 0.4 mg intravenous bolus. FFR measurements were recorded at baseline and following maximal hyperemia with both agents.

Results:

Mean age was 57±8 years and 47 were male. Sixty coronary lesions were evaluated and were located in the left anterior descending in 34, the left circumflex in 9, right coronary in 15 and left main coronary artery in 2. Mean (±SD) FFR following adenosine and regadenoson was 0.79(±0.09) and 0.79(±0.09), respectively, p=NS. Time to FFR nadir was shorter with regadenoson compared to adenosine, 36.6±24 versus 66±0.19 seconds, p <0.0001, respectively. No patients experienced any significant side effects related to regadenoson.

Conclusions:

Regadenoson is a viable alternative to intravenous adenosine for achieving maximal hyperemia during FFR assessment. Compared to adenosine, regadenoson has a similar hemodynamic response, achieves more rapid hyperemia, is easier to use and has an excellent side effect profile. © 2013 Wiley Periodicals, Inc.

Objectives.

To assess coronary plaque composition by virtual histology intravascular ultrasound (VH-IVUS) in young adult recipients and to correlate these findings with time from heart transplant (HTx) and long-term outcomes. Backgroud. Rapid progression of coronary allograft vasculopathy after heart transplantation is a powerful predictor of mortality and clinical events at long-term. Methods. Forty consecutive young adult recipients transplanted during childhood undergoing VH-IVUS during coronary surveillance have been prospectively included in this study. According to the time interval from HTx to VH-IVUS assessment, our cohort was divided into two groups (group A: ≤5 years, n=13; group B: >5 years, n=27).

Results.

Group B showed an higher percentage of necrotic core and dense calcium (12±2 vs 5±1%, p=0.04; and 8.2 vs 2.1%, p=0.03; respectively). An "inflammatory plaque" (necrotic core and dense calcium ≥30%) was detected in 34.8% of patients in group B and in none among group A patients (p=0.03). Patients in group B had a number of adverse clinical events significantly higher than group A patients (53.8 vs 14.3%; HR 4.45; 95% CI 1.62 to 12.16; p=0.029) at long-term follow-up (4.2 years). The multivariate regression analysis showed that age (HR 1.5; 95% CI 1.1-2.0; p=0.007), time from HTx (HR 1.8; 95% CI 1.6-4.8; p=0.02), and inflammatory plaque (HR 2.4; 95% CI 1.1-5.3; p=0.03) were independent predictors of adverse clinical events.

Conclusions.

This study supports the hypothesis that time-dependent differences in plaque composition, as assessed by VH-IVUS, occur after HTx in young adult recipients, probably determining an increased risk of long-term clinical events. © 2013 Wiley Periodicals, Inc.