Quantitative multi-slice computed tomography assessment of the mitral valvular complex for transcatheter mitral valve interventions part 1: systematic measurement methodology and inter-observer variability.

AIMS: Transcatheter mitral valve replacement (TMVR) is an emerging technology with the potential to treat patients with severe mitral regurgitation at excessive risk for surgical mitral valve surgery. Multimodality imaging of the mitral valvular complex and surrounding structures will be an important component for patient selection for TMVR. Our aim was to describe and evaluate a systematic multi-slice computed tomography (MSCT) image analysis methodology that provides measurements relevant for transcatheter mitral valve replacement. METHODS AND RESULTS: A systematic step-by-step measurement methodology is described for structures of the mitral valvular complex including: the mitral valve annulus, left ventricle, left atrium, papillary muscles and left ventricular outflow tract. To evaluate reproducibility, two observers applied this methodology to a retrospective series of 49 cardiac MSCT scans in patients with heart failure and significant mitral regurgitation. For each of 25 geometrical metrics, we evaluated inter-observer difference and intra-class correlation. The inter-observer difference was below 10% and the intra-class correlation was above 0.81 for measurements of critical importance in the sizing of TMVR devices: the mitral valve annulus diameters, area, perimeter, the inter-trigone distance, and the aorto-mitral angle. CONCLUSIONS: MSCT can provide measurements that are important for patient selection and sizing of TMVR devices. These measurements have excellent inter-observer reproducibility in patients with functional mitral regurgitation.

Quantitative multi-slice computed tomography assessment of the mitral valvular complex for transcatheter mitral valve interventions part 2: geometrical measurements in patients with functional mitral regurgitation.

AIMS: Transcatheter mitral valve replacement (TMVR) is an emerging technology with the potential to treat patients with mitral regurgitation at excessive risk for mitral valve surgery. Geometrical measurements of the mitral valvular complex may have implications for the design of TMVR devices and for patient selection. This study sought to quantify the dynamic geometry of the mitral valvular complex in patients with significant functional mitral regurgitation (FMR) using multi-slice computed tomography (MSCT). METHODS AND RESULTS: MSCT images were acquired in 32 patients with symptomatic, significant FMR. Two independent observers analysed image sets using a dedicated software package and a standard measurement methodology. In patients with FMR, the mean mitral annulus intercommissural and aorto-mural diameters were, respectively, 41.5±5.2 mm and 38.7±5.9 mm in systole, and were 41.5±4.4 mm and 40.0±4.7 mm in diastole. In patients without MR, the diameters were, respectively, 33.6±5.1 mm and 28.8±8.0 mm in systole, and 36.2±4.5 mm and 31.6±7.9 mm in diastole. The obstacle-free zone below the mitral annulus averaged more than 20.0 mm and varied by less than 1 mm between systole and diastole, which is not statistically significant. The aorto-mitral angle was 129.7±10.5° in systole and 131.0±9.4° in diastole. CONCLUSIONS: The mitral annulus is larger in dimension, more circular, and less dynamic in patients with FMR. The obstacle-free zone below the mitral annulus is relatively constant during the cardiac cycle. Measurements of the mitral valvular apparatus vary considerably between patients, which suggests that tridimensional imaging will play an important role in the sizing of TMVR devices.

Transcatheter heart valve failure: a systematic review.

AIMS: A comprehensive description of transcatheter heart valve (THV) failure has not been performed. We undertook a systematic review to investigate the aetiology, diagnosis, management, and outcomes of THV failure. METHODS AND RESULTS: The systematic review was performed in accordance with the PRISMA guidelines using EMBASE, MEDLINE, and Scopus. Between December 2002 and March 2014, 70 publications reported 87 individual cases of transcatheter aortic valve implantation (TAVI) failure. Similar to surgical bioprosthetic heart valve failure, we observed cases of prosthetic valve endocarditis (PVE) (n = 34), structural valve failure (n = 13), and THV thrombosis (n = 15). The microbiological profile of THV PVE was similar to surgical PVE, though one-quarter had satellite mitral valve endocarditis, and surgical intervention was required in 40% (75% survival). Structural valve failure occurred most frequently due to leaflet calcification and was predominantly treated by redo-THV (60%). Transcatheter heart valve thrombosis occurred at a mean 9 ± 7 months post-implantation and was successfully treated by prolonged anticoagulation in three-quarters of cases. Two novel causes of THV failure were identified: late THV embolization (n = 18); and THV compression (n = 7) following cardiopulmonary resuscitation (CPR). These failure modes have not been reported in the surgical literature. Potential risk factors for late THV embolization include low prosthesis implantation, THV undersizing/underexpansion, bicuspid, and non-calcified anatomy. Transcatheter heart valve embolization mandated surgery in 80% of patients. Transcatheter heart valve compression was noted at post-mortem in most cases. CONCLUSION: Transcatheter heart valves are susceptible to failure modes typical to those of surgical bioprostheses and unique to their specific design. Transcatheter heart valve compression and late embolization represent complications previously unreported in the surgical literature.

First-in-human experience with the Medtronic CoreValve Evolut R.

The CoreValve Evolut R with EnVeo R delivery catheter is a novel transcatheter heart valve (THV) system with enhanced features that have the potential to improve the safety of transcatheter aortic valve implantation (TAVI). The newly designed delivery catheter is 14 Fr-equivalent and thus expands the option of transfemoral TAVI to a greater proportion of patients. Most importantly, the EnVeo R delivery catheter allows the valve to be recaptured and repositioned during deployment, thus minimising the consequences of THV malposition. Furthermore, the nitinol frame of the CoreValve Evolut R has been redesigned for superior interaction, consistent radial force and optimised cover index across the sizing range, and conformability with the native annulus, thereby hypothetically reducing stress on the left bundle branch. Although large series with long-term follow-up are required to demonstrate the safety and efficacy of this device, we present the first human experience with the Evolut R system.

Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial.

OBJECTIVES: PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). BACKGROUND: Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. METHODS: Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. RESULTS: A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm(2) or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm(2) (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04). CONCLUSIONS: Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.

Saphenous vein graft perforation during percutaneous coronary intervention: a case series.

INTRODUCTION: The outcomes of perforation during aortocoronary saphenous vein graft (SVG) percutaneous coronary intervention (PCI) are poorly studied. METHODS: We reviewed all 12 SVG perforations that occurred between November 2005 and November 2011 at two tertiary referral centers. The acute and long-term outcomes of these patients were examined. RESULTS: The perforation was located in the SVG body (n = 6), aortic (n = 3), or distal (n = 3) anastomosis. Most perforations occurred after stent implantation (n = 5) or after stent postdilation (n = 3). The perforation was Ellis class I in 1 patient, II in 3 patients, III in 4 patients, and III with cavity spilling in 3 patients. The perforation spontaneously sealed without requiring further treatment in 3 patients. In the remaining 9 patients, the perforation was treated with prolonged balloon inflation (n = 2) or covered stent implantation (n = 5), but could not be treated in 2 patients who died during the procedure. Seven of the 10 survivors underwent follow-up angiography 5 months to 2 years after the perforation. The target SVG was occluded in 5 patients and had developed severe stenosis in the remaining 2 patients. CONCLUSIONS: SVG perforation during PCI carries a high mortality and frequently requires implantation of a covered stent. Perforated SVGs frequently occlude within 2 years post PCI.

Current percutaneous treatment strategies for saphenous vein graft disease.

Coronary artery bypass graft surgery remains one of the most widely performed surgical procedures in North America and aortocoronary saphenous vein grafts (SVG) are the most frequently used surgical conduits. SVG disease (SVGD) remains the leading cause of symptomatic coronary artery disease postcoronary artery bypass graft. When optimal medical therapy is ineffective, repeat surgery is associated with higher mortality combined with less favorable clinical and angiographic results, thus percutaneous revascularization on SVG is currently the standard of care for the revascularization of SVGD. Balloon angioplasty, bare metal stents, polytetrafluoroethylene-covered stents, and drug-eluting stents have been extensively investigated for SVG interventions. Multiple recent randomized trials and meta-analyses have confirmed the pathophysiologic and clinical differences between SVGD and coronary artery disease. Decisions such as patient selection, premedication, stent, and protection device characteristics should be carefully considered to achieve optimal procedural and clinical results. Acute coronary syndromes due to SVG involvement, chronic total occlusions, retrograde approaches, and SVG perforation management are newer fields requesting additional research.

Computer-assisted quantification of myocardial reperfusion after primary percutaneous coronary intervention predicts functional and contrast-enhanced cardiovascular magnetic resonance outcomes in patients with ST-segment elevation myocardial infarction.

OBJECTIVE: We investigated whether the Quantitative Blush Evaluator (QuBE) value predicts functional and contrast-enhanced cardiovascular magnetic resonance (CMR) outcomes at 4-6 months after primary percutaneous coronary intervention (PCI) inpatients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: QuBEis a computer-assisted open source program to quantify myocardial reperfusion.Although a higher QuBE value is associated with improved myocardial reperfusion measures and lower 1-year mortality, the association with intermediate functional parameters after STEMI has not yet been investigated. METHODS: QuBE values were quantified retrospectively on angiograms of patients enrolled in the ancillary CMR study of the proximal embolic protection in acute myocardial infarction and resolution of ST-elevation trial. QuBE en CMR outcomes were independently assessed by reviewers blinded to clinical data. RESULTS: A higher QuBE value was significantly associated with a smaller left ventricular (LV) end-diastolic and end-systolic volume, a higher LV ejection fraction and systolic wall thickening in the infarct area, and a smaller final infarct size and extent of transmural segments (P ≤ 0.008). In a multivariable model, including age, gender, infarct location, time to treatment, history of myocardial infarction, and postprocedural thrombolysis in myocardial infarction flow grade,only the QuBE value and infarct location remained as independent predictors of LV ejection fraction (P 5 0.018 for QuBE value). CONCLUSION: Higher QuBE values are independently associated with improved functional and contrast-enhanced CMR outcomes including LV ejection fraction at 4-6 months after primary PCI and may therefore aid in identifying high-risk patients who benefit most from adjunctive therapies sustaining myocardial function after PCI.

Comparison of usefulness of N-terminal pro-brain natriuretic peptide as an independent predictor of cardiac function among admission cardiac serum biomarkers in patients with anterior wall versus nonanterior wall ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

The purpose of the present study was to determine the prognostic value of N-terminal pro-brain natriuretic peptide (NT-pro-BNP), among other serum biomarkers, on cardiac magnetic resonance (CMR) imaging parameters of cardiac function and infarct size in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. We measured NT-pro-BNP, cardiac troponin T, creatinine kinase-MB fraction, high-sensitivity C-reactive protein, and creatinine on the patients' arrival at the catheterization laboratory in 206 patients with ST-segment elevation myocardial infarction. The NT-pro-BNP levels were divided into quartiles and correlated with left ventricular function and infarct size measured by CMR imaging at 4 to 6 months. Compared to the lower quartiles, patients with nonanterior wall myocardial infarction in the highest quartile of NT-pro-BNP (> or = 260 pg/ml) more often had a greater left ventricular end-systolic volume (68 vs 39 ml/m(2), p <0.001), a lower left ventricular ejection fraction (42% vs 54%, p <0.001), a larger infarct size (9 vs 4 g/m(2), p = 0.002), and a larger number of transmural segments (11% of segments vs 3% of segments, p <0.001). Multivariate analysis revealed that a NT-pro-BNP level of > or = 260 pg/ml was the strongest independent predictor of left ventricular ejection fraction in patients with nonanterior wall myocardial infarction compared to the other serum biomarkers (beta = -5.8; p = 0.019). In conclusion, in patients with nonanterior wall myocardial infarction undergoing primary percutaneous coronary intervention, an admission NT-pro-BNP level of > or = 260 pg/ml was a strong, independent predictor of left ventricular function assessed by CMR imaging at follow-up. Our findings suggest that NT-pro-BNP, a widely available biomarker, might be helpful in the early risk stratification of patients with nonanterior wall myocardial infarction.

Role of rheolytic thrombectomy in massive pulmonary embolism with contraindication to systemic thrombolytic therapy.

AIMS: Mortality of massive pulmonary embolism remains exceedingly high despite thrombolytic therapy. Despite initial encouraging results, rheolytic thrombectomy has not been considered the first choice of treatment in the current European Guidelines for massive pulmonary embolism, even in cases of major contraindication to thrombolysis. Our objective was to assess the efficacy of rheolytic thrombectomy in the specific treatment of massive pulmonary embolism with contraindication to systemic thrombolytic therapy. METHODS AND RESULTS: Between January 2003 and April 2008 a total of 10 patients with massive pulmonary embolism referred for rheolytic thrombectomy were included. Clinical data including medical history, haemodynamic status, procedural characteristic, in-hospital complications and survival were collected. Seven patients survived after undergoing the procedure, three patients died in during their initial hospitalisation however, two of these deaths were not attributable to the pulmonary embolism or the procedure. Rheolytic thrombectomy resulted in reduction of mean pulmonary artery pressures from 34.6+/-13.1 mmHg to 26.9+/-8.2 mmHg immediately following the procedure. Additionally, the Miller index improved from 22.4+/-2.8 to 9.8+/-2.7. There were no periprocedural bleeding complications associated with the procedure. CONCLUSIONS: Rheolytic thrombectomy might be an effective and safe treatment for massive pulmonary embolism when systemic thrombolytic therapy is contraindicated. These data form the basis for further clinical investigation of this novel therapy among patients with massive pulmonary embolism.

Feasibility and applicability of computer-assisted myocardial blush quantification after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

OBJECTIVES: The aim of the study was to evaluate whether the "Quantitative Blush Evaluator" (QuBE) score is associated with measures of myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) treated in two hospitals with 24/7 coronary intervention facilities. BACKGROUND: QuBE is an open source computer program to quantify myocardial perfusion. Although QuBE has shown to be practical and feasible in the patients enrolled in the Thrombus Aspiration during Percutaneous Coronary Intervention in Acute Myocardial Infarction Study (TAPAS), QuBE has not yet been verified on reperfusion outcomes of primary percutaneous coronary intervention (PCI) patients treated in other catheterization laboratories. METHODS: Core lab adjudicated angiographic outcomes and QuBE values were assessed on angiograms of patients who were enrolled in the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation (PREPARE) trial. ST-segment resolution immediately after PCI measured by continuous ST Holter monitoring was calculated by a blinded core lab. RESULTS: The QuBE score could be assessed on 229 of the 284 angiograms (81%) and was significantly associated with visually assessed myocardial blush grade (P < 0.0001). Patients with improved postprocedural Thrombolysis in Myocardial Infarction-graded flow, myocardial blush grade, ST-segment resolution immediately after PCI, or a small infarct size measured by peak CK-MB had a significant better QuBE score. CONCLUSIONS: QuBE is feasible and applicable at angiograms of patients with STEMI recorded at other catheterization laboratories and is associated with measures of myocardial reperfusion.

Percutaneous transvenous mitral annuloplasty: initial human experience with a novel coronary sinus implant device.

BACKGROUND: We assessed the safety and feasibility of permanent implantation of a novel coronary sinus mitral repair device (PTMA, Viacor Inc). METHODS AND RESULTS: Symptomatic (New York Heart Association class 2 or 3) patients with primarily functional mitral regurgitation (MR) were included. A diagnostic PTMA procedure was performed in the coronary sinus venous continuity. MR was assessed and the PTMA device adjusted to optimize efficacy. If MR reduction (> or =1 grade) was observed, placement of a PTMA implant was attempted. Implanted patients were evaluated with echocardiographic, quality of life, and exercise capacity metrics. Nineteen patients received a diagnostic PTMA study. Diagnostic PTMA was effective in 13 patients (MR grade 3.2+/-0.6 reduced to 2.0+/-1.0), and PTMA implants were placed in 9 patients. Four devices were removed uneventfully (7, 84, 197, and 216 days), 3 for annuloplasty surgery due to observed PTMA device migration and/or diminished efficacy. No procedure or device-related major adverse events with permanent sequela were observed in any of the diagnostic or implant patients. Sustained reductions of mitral annulus septal-lateral dimension from 3D echo reconstruction dimensions were observed (4.0+/-1.2 mm at 3 months). CONCLUSIONS: Percutaneous implantation of the PTMA device is feasible and safe. Acute results demonstrate a possibly meaningful reduction of MR in responding patients. Sustained favorable geometric modification of the mitral annulus has been observed, though reduction of MR has been limited. The PTMA method warrants continued evaluation and development.

Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study.

OBJECTIVES: The purpose of this study was to evaluate the effectiveness of combined proximal embolic protection with thrombus aspiration (Proxis Embolic Protection System [St. Jude Medical, St. Paul, Minnesota]) in ST-segment elevation myocardial infarction patients. BACKGROUND: Embolization during primary percutaneous coronary intervention (PCI) may result in microvascular obstruction, reduced myocardial perfusion, and impaired prognosis. METHODS: Two hundred eight-four patients were randomized to primary PCI with the Proxis system versus primary PCI alone after angiography. The primary end point was the occurrence of complete (> or =70%) ST-segment resolution (STR) at 60 min measured by continuous ST-segment Holter. RESULTS: There was no significant difference in the occurrence of the primary end point (80% vs. 72%, p = 0.14). However, immediate complete STR (at time of last contrast) occurred in 66% of Proxis-treated patients and 50% in control patients (absolute difference, 16.3%; 95% confidence interval: 4.3% to 28.2%; p = 0.009). A significant lower ST-segment curve area (0 to 3 h after primary PCI) was observed in the Proxis arm (5,192 microV/min vs. 6,250 microV/min, p = 0.037). Major adverse cardiac and cerebral events at 30 days occurred with similar frequency in both groups (6 vs. 10). CONCLUSIONS: There was no significant difference in complete STR at 60 min in this proof-of-concept study. However, we observed a significant difference in immediate complete STR in Proxis-treated patients, better STR at later time points, and a reduction of electrocardiogram injury current over time, compared with control patients. The results suggest that primary PCI with the Proxis system may lead to better immediate microvascular flow in ST-segment elevation myocardial infarction patients. (The PREPARE Study; ISRCTN71104460).

Cardiac hazard associated with eating habits. A case of infected intrapericardial foreign body due to an ingested toothpick.

An unusual case of a toothpick perforating the distal one-third of the duodenum, penetrating the inferior vena cava and thereafter migrating to the right atrium with extensive pericardial fibrosis is reported. A 60-year-old man was admitted to the emergency department because of epigastric pain, which had progressively worsened. After partial recovery, he was discharged. However, after four episodes of different gastrointestinal bacteria septicemias of unknown origin over a period of five months, the patient was transferred to Laval Hospital (Laval, Quebec) for clinical investigation. Cardiac echocardiography demonstrated a right atrial mass, suggestive of the presence of a thrombus. Thus, after exploratory thoracotomy was performed to remove the so-called thrombus, a toothpick was found in the right atrium.

VEGF gene therapy fails to improve perfusion of ischemic myocardium in patients with advanced coronary disease: results of the NORTHERN trial.

Despite the promise of proangiogenic gene therapy most clinical trials have failed to show benefit for the primary end point analysis. The NOGA angiogenesis Revascularization Therapy: assessment by RadioNuclide imaging (NORTHERN) trial was a double-blind, placebo-controlled study of intramyocardial vascular endothelial growth factor (VEGF165) gene therapy versus placebo, involving seven sites across Canada, designed to overcome major limitations of previous proangiogenic gene therapy trials. A total of 93 patients with refractory Canadian Cardiovascular Society (CCS) class 3 or 4 anginal symptoms were randomized to receive 2,000 microg of VEGF plasmid DNA or placebo (buffered saline) delivered via the endocardial route using an electroanatomical NOGA guidance catheter. There was no difference between the VEGF-treated and the placebo groups in the primary end point of change in myocardial perfusion from baseline to 3 or 6 months, assessed by single photon emission tomography (SPECT) imaging, although a significant reduction in the ischemic area was seen in both groups. Also, similar improvements in exercise treadmill time and anginal symptoms were seen in the VEGF and the placebo groups at 3 and 6 months, although again there were no differences between these groups. Despite the intramyocardial administration of a high "dose" of plasmid DNA using a percutaneous guidance catheter system, there was no benefit of VEGF gene therapy at 3 or 6 months for any of the end points studied.

High energy excimer laser to treat coronary in-stent restenosis in an underexpanded stent.

Balloon refractory calcific coronary plaques remain a technical challenge. Stent underexpansion is known as a major cause of restenosis and thrombosis. We report a case of in-stent restenosis 5 months after stent suboptimal implantation in a noncompliant calcific atherosclerotic plaque which could not be disrupted by repeated prolonged high-pressure balloon inflations. High-energy excimer laser use altered underlying lesion morphology, allowing full stent apposition. Advances in equipment and technique have allowed more frequent use of high energy excimer laser technology during percutaneous coronary angioplasty with very low rates of complications. Laser technology represents a useful tool to overcome resistant lesions during percutaneous coronary interventions.

Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant.

OBJECTIVE: This study evaluated human feasibility and acute efficacy of a novel percutaneous transvenous mitral annuloplasty (PTMA) device (Viacor) placed temporarily in the coronary sinus (CS): the implant allows in-situ incremental adjustment to optimally reduce the anterior-posterior mitral annulus (MA) dimension, and improve leaflet co-aptation and reducing mitral regurgitation (MR). BACKGROUND: Surgical annuloplasty remains the standard treatment of severe ischemic MR but its application is limited by high morbidity and mortality. The effectiveness of PTMA device (Viacor) to reduce MR in the short-term has been demonstrated in animals studies but not in humans. METHODS: Symptomatic patients with ischemic MR graded 2+ to 4+ requiring surgical mitral annuloplasty were screened. Patients with any mitral leaflet or mitral apparatus abnormality were excluded. Preoperatively, under general anesthesia and transesophageal echocardiography guidance, a temporary PTMA device was placed via the right internal jugular or subclavian vein. RESULTS: Four patients were studied. After device placement and adjustment, regurgitant volume was substantially reduced (45.5 +/- 24.4 to 13.3 +/- 7.3 ml) via MA anterior-posterior diameter reduction (40.75 +/- 4.3 to 35.2 +/- 1.6 mm) in 3 patients. In one patient, the PTMA device could not be deployed due to extreme angulated anatomy. CONCLUSIONS: PTMA in human is feasible and reduces ischemic MR (to grade 1+) by reducing MA anterior-posterior diameter. Temporary placement of the PTMA device may assist in the development of permanent implants and ensure optimal efficacy.

Successful early percutaneous closure of acute ventricular septal rupture complicating acute myocardial infarction with Amplatzer ventricular septal occluder.

Acute ventricular septal rupture - ventricular septal defect (VSD) following acute myocardial infarction remains a critical condition. We present an 80 year-old patient with an acute VSD following an acute inferior myocardial infarction. Percutaneous VSD closure with an Amplatzer ventricular septal occluder (AVSO) was performed successfully, two days after initial admission. In-hospital follow-up was uneventful. We speculate that percutaneous VSD closure with an AVSO can be an alternative to surgical correction for these patients. Despite the impressive result, this innovative approach needs further investigation and refinements before it can be recommended as the treatment of choice for acute ischemic VSD. (Cardiol J 2007; 14: 411-414).

'Fused-Gold' vs. 'Bare' stainless steel NIRflex stents of the same geometric design in diseased native coronary arteries. Long-term results from the NIR TOP Study.

OBJECTIVES: We evaluated the long-term clinical and angiographic results of 'fused-gold' (NIRFlex Royal) and 'bare' (NIRFlex) stainless steel stents in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Recent studies have shown high clinical and angiographic restenosis rates following the intracoronary implantation of 'gold-coated' stainless steel stents. The new 'fused-gold' stent, with improved surface characteristics and flexibility, was developed to improve procedural and long-term results, while maintaining enhanced radiopacity. METHODS: A total of 305 patients (358 lesions) with symptomatic native coronary artery disease (CAD) undergoing native vessel PCI were randomised to receive a 'fused-gold' (n=147) or 'bare' (n=158) stent. Primary endpoint was minimal luminal diameter (MLD) at 6 months angiographic follow-up. Secondary endpoints included technical and procedural success, major adverse cardiac events (MACE), target vessel failure (TVF), angiographic binary restenosis rates, and additional angiographic comparisons. RESULTS: There were no major differences in the baseline angiographic variables or patient characteristics between the two groups, however there was a trend towards a higher risk in the 'fused-gold' stent group. Clinical and angiographic follow-up was 100% and 87% respectively. MLD at 6 months follow-up was smaller in the 'fused-gold' stent group compared to the 'bare' stent group (1.61+/-0.65 vs. 1.81+/-0.60 mm, respectively); Therefore, the null hypothesis of non-inferiority cannot be rejected (p=0.49); equivalency cannot be claimed for the two stent types. The 'fused-gold' stents were also associated with a higher angiographic binary and clinical restenosis rates (33 vs. 18%; p=0.002 & 26.9 vs. 20.3%; p<0.001, respectively). CONCLUSION: The 'bare' NIRflex stent was associated with excellent long-term clinical and angiographic results. Taking into account the equivalence margin, the null hypothesis of non-equivalence between the 'fused-gold' NIRflex Royal stent and the 'bare' NIRflex stent cannot be rejected (p=0.49), so equivalence cannot be claimed for the two stent types.

Left main coronary artery thrombectomy and stenting using a paclitaxel-eluting stent in the setting of acute myocardial infarction.

A 41-year-old man was referred to the Montreal Heart Institute, Montreal, Quebec, for primary angioplasty of an acute anterolateral wall myocardial infarction. Coronary angiography revealed the culprit lesion to be a subtotal left main coronary artery with Thrombolysis In Myocardial Infarction (TIMI) trial grade 1 flow associated with a filling defect compatible with an aggressive thrombotic process. The use of rheolytic thrombectomy and a drug-eluting stent for this distal left main target lesion are described.