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1.

Objective

To characterize the perfusion bed of the first septal perforator by myocardial contrast echocardiography (MCE) in patients with hypertrophic cardiomyopathy undergoing alcohol septal ablation (ASA).

Background

MCE is used to define the septal perforator anatomy prior to ASA. Occasionally, ASA cannot be performed due to unfavorable septal anatomy or perfusion outside the interventricular septum. Despite the standard use of MCE for septal mapping, there are no reports describing the territory of septal perforator perfusion.

Methods

Forty‐seven consecutive patients underwent ASA between 1/1/2004 and 12/30/2012. Blinded individuals retrospectively evaluated patients for septal perforator anatomic findings. Patients were divided into 2 groups based on presence or absence of extra‐septal perfusion (ESP) as visualized by apical views after intracoronary contrast injection. The groups' procedural outcomes were compared, including infarct size, new conduction abnormalities, and major adverse events.

Results

Over 25% demonstrated ESP, of which 83% predominantly involved the right ventricular (RV) moderator band. The first septal perforator (FSP) was statistically larger in ostial diameter (1.69 mm vs. 1.23 mm, P = 0.04) and numerically more likely dominant in patients with ESP (63.6% vs. 47.2%, P = 0.22). In those with ESP, the odds ratio comparing FSP diameter of 2.0 mm to the mean was 1.96 (95% CI: 1.01–3.80).

Conclusions

Downstream capillary perfusion may be discordant from epicardial territory and this study emphasizes the importance of MCE prior to ASA. Over 25% of our patients demonstrated ESP, most commonly involving the RV moderator band. The size of the FSP was the strongest predictor of ESP.
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2.

Objectives

Investigate the effectiveness of alcohol septal ablation (ASA) and transaortic extended myectomy (TEM) in hypertrophic cardiomyopathy (HCM) with midventricular obstruction (MVO).

Background

MVO is less common than subaortic obstruction. Data on the effectiveness of ASA and TEM in MVO are lacking.

Methods

The clinical profiles of 22 patients undergoing ASA and 37 patients undergoing TEM were compared. No patient had apical aneurysm, abnormal chordae, mitral valve replacement or repair.

Results

Baseline midventricular pressure gradient and symptoms were comparable between the ASA and TEM groups. During follow‐up, both groups demonstrated substantial reduction in pressure gradient (the ASA group: 79.7 ± 21.2 mm Hg to 43.7 ± 28.9 mm Hg, P < 0.001; the TEM group: 69.0 ± 23.9 mm Hg to 15.0 ± 16.9 mm Hg, P < 0.001). The reduction in pressure gradient was greater (78.9 ± 18.6% vs. 46.4 ± 33.4%, P < 0.001) and the residual pressure gradient was lower after TEM versus ASA (P < 0.001). Patients with New York Heart Association class III/IV dyspnea decreased from 59.1 to 18.2% (P = 0.022) in the ASA group and from 56.8 to 5.6% (P < 0.001) in the TEM group. Patients with Canadian Cardiovascular Society class III/IV angina decreased from 40.9 to 9.1% (P = 0.016) in the ASA group and from 32.4 to 0% (P < 0.001) in the TEM group.

Conclusions

While ASA and TEM both improve gradients and symptoms, TEM may provide a more reliable reduction in gradients compared to ASA.
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3.

Objectives

This study compares very late outcomes following primary percutaneous coronary intervention for ST‐elevation myocardial infarction (STEMI) with stenting versus balloon angioplasty (BA).

Background

Stenting compared with BA for STEMI improves outcomes at 6–12 months, but comparisons beyond 6–12 months have not been studied. Recent studies have shown that stent thrombosis (ST) continues to increase beyond 3–5 years and may be higher with drug‐eluting stents (DES) than bare metal stents (BMS). We hypothesized that there may be a very late hazard with stenting versus BA due to very late ST.

Methods

From 1994 to 2010 consecutive patients with STEMI treated with BA (n = 601) or stenting (n = 1,594) were prospectively enrolled in our registry and followed for 1–16 years.

Results

Patients treated with BA were older, were more often female, had more three‐vessel disease, and had smaller vessels. Stented patients had trends for less stent/lesion thrombosis (ST/LT) and target vessel (TV) reinfarction at 1 year. In landmark analyses >1 year, stented patients had more very late ST/LT (6.1% vs. 2.9%, P = 0.002) and more TV reinfarction (7.9% vs. 3.1%, P < 0.001) which remained significant after adjusting for baseline risk. The greatest differences in very late outcomes were between DES and BA, but there were also significant differences between BMS and BA.

Conclusions

There appears to be a very late hazard with stenting versus BA for STEMI. These data should encourage new strategies for prevention of very late ST with both BMS and DES including the development of bio‐absorbable polymers and stent platforms. (J Interven Cardiol 2014;27:21–28)
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4.

Objectives

To investigate the outcomes of a cohort of acute and elective percutaneous coronary intervention (PCI) patients who were discharged home 6 hours postprocedure.

Background

Contemporary PCI is safe with a low rate of acute complications. It is well established as a day procedure in elective cases; however, data are lacking in acute cases.

Methods

We describe a prospective observational audit of routine clinical practice in the 3 PCI centers in Northern Ireland. Patients were selected for same‐day discharge after 6 hours of post‐PCI observation. Both elective and acute coronary syndrome (ACS) cases were included. Criteria for same‐day discharge were based on the technical result of the procedure rather than lesion complexity or clinical presentation. Radial access was preferred but not mandatory. Patients were contacted directly to assess for 30‐day major adverse cardiovascular events (MACE). Reported events were corroborated with the general practitioner or hospital notes.

Results

A total of 1,059 patients were selected for same‐day discharge with 30‐day follow‐up available for all cases. Of these, 766 (72.3%) were elective and 293 (27.7%) were ACS patients. Radial access was almost universal (98%). A total of 1,224 lesions were stented, of which 432 (40.8%) were high risk (highest risk lesion in each case by AHA/ACC classification). MACE rate at 30 days was 0.85% with a sub‐acute stent thrombosis rate of 0.4%. There were no MACE events from discharge to 24 hours.

Conclusions

Selected acute and elective patients with a range of lesion complexity and risk can be discharged safely home early after PCI.
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5.

Objectives

To compare morbidity and mortality of patients with ST‐elevation myocardial infarction (MI) undergoing coronary artery bypass graft (CABG) surgery within 24 hours with those who had surgery delayed >24 hours.

Background

Patients with ST‐elevation MI are currently managed by emergency percutaneous coronary intervention (PCI). If PCI is unsuccessful, or if there is severe coronary artery disease not amenable to PCI, CABG is considered. If the patient is clinically stable, surgeons wait several days before performing surgery, as very early surgery carries a prohibitive risk.

Methods

One hundred and eighty‐four patients with acute ST elevation MI (STEMI) who had undergone CABG were divided into two groups based on their surgery timing (<24 hours vs. >24 hours). Mortality and complication rates were studied between the two groups by Fischer test. Time‐to‐event analyses were performed for five primary variables: all‐cause mortality, cardiac events, congestive heart failure, stroke, and renal failure.

Results

At one month post‐CABC, all‐cause mortality was noted in 10.6% of patients who had CABG within 24 hours of STEMI diagnosis, compared with 8.9% in patients who had CABG after 24 hours (P = 0.3). Cardiac events including re‐exploration, atrial fibrillation, graft occlusion, and arrhythmias requiring shock occurred in 17.1% versus 13.9% between the two groups, respectively (P = 0.68). One year post‐coronary artery bypass surgery, there was no difference in individual or combined events between the two groups.

Conclusions

In patients with ST‐elevation myocardial infarction who required emergency coronary artery bypass surgery, there was no difference in procedure complications or mortality between early (within 24 hours) or later (more than 24 hours). That was noted at one month and one year after the index myocardial infarction. (J Interven Cardiol 2015;28:14–23)
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6.

Objectives

We sought to investigate the radiation exposure and contrast utilization associated with using a strategy of transradial access and rotational angiography (radial‐DARCA) compared to the traditional approach of transfemoral access and standard angiography (femoral‐SA).

Background

There is an increased focus on optimizing patient safety during cardiac catheterization procedures. Professional guidelines have highlighted physician responsibility to minimize radiation doses and contrast volume. Dual axis rotational coronary angiography (DARCA) is the most recently investigated type of rotational angiography. This new technique permits complete visualization of the left or right coronary tree with a single injection, and is felt to reduce contrast and radiation exposure.

Methods

A total of 56 consecutive patients who underwent radial‐DARCA were identified. From the same time period, an age‐ and gender‐matched group of 61 patients who had femoral‐SA were selected for comparison. Total volume of contrast agent used, fluoroscopy time, and 2 measures of radiation dose (dose area product and air kerma) were recorded for each group.

Results

Mean contrast agent use and patient radiation exposure of the radial‐DARCA group were significantly less than that of the femoral‐SA group. There was no significant difference in fluoroscopy time between the 2 groups.

Conclusions

Physicians can successfully employ an innovative safety strategy of transradial access combined with DARCA that is feasible and is associated with lower radiation doses and contrast volume than femoral artery access and traditional coronary angiography approach. (J Interven Cardiol 2013;26:524‐529)
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7.

Objectives

The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel‐eluting balloon (PEB) and Genous stent.

Background

This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis.

Methods

From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis ≥50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow‐up were intended at 6 and 9 months, respectively.

Results

The mean age of patients was 61 ± 11 years, with male predominance (83%). Diabetes mellitus and end‐stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 ± 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 ± 0.46 mm and 28 ± 9 mm vs. 2.98 ± 0.36 mm and 23 ± 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 ± 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 ± 0.37 mm. At 9‐month follow‐up, no stent thrombosis was observed.

Conclusions

The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis.
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8.

Objectives

To describe the particular assessment and closure strategy that was followed in patients with left atrial appendages (LAA) with an early and severe bend.

Background

The presence of a chicken‐wing morphology with an early and severe bend constitutes one of the most difficult anatomical settings for transcatheter LAA occlusion.

Methods

Between November 2009 and December 2012, patients who presented chicken‐wing LAA with an early (<20 mm from the ostium) and severe bend (<180°) were identified and included in the analysis. A particular implanting strategy consisting of deploying the distal lobe of the device inside the chicken‐wing bend was used in all cases.

Results

Among 42 patients who underwent LAA occlusion during the study period, 5 (12%) presented the pre‐specified anatomy. Following the mentioned implanting strategy, all patients underwent successful LAA occlusion using the Amplatzer Cardiac Plug (n = 2) and the Amplatzer Amulet (n = 3). Successful occlusion was achieved in all patients. None of them presented any procedural complication. Follow‐up transesophageal echocardiography at 3 months showed successful LAA sealing in all patients and no device embolization or thrombosis.

Conclusions

According to our results, the pre‐specified closing implantation technique for chicken‐wing LAAs with an early and severe bend might be a valid strategy for this challenging anatomical setting. Further cases will be necessary to confirm the results. (J Interven Cardiol 2013;26:509‐514)
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9.

Background

Patients after cardiac arrest or in cardiogenic shock due to acute coronary syndrome (ACS) are at high risk for stent thrombosis (ST) and recurrent cardiovascular events after primary percutaneous coronary intervention (PCI). High post‐interventional platelet reactivity (HPR) might be an additional risk factor for ST in these critically ill patients.

Methods

Between 2006 and 2016, 401 critically ill patients from a cardiologic intensive care unit underwent platelet function testing after primary PCI using whole blood impedance aggregometry. After exclusion of patients with an abnormal platelet count, 357 patients have been included into the final analysis of this retrospective observational study.

Results

The incidence of definite early ST was 19.2% in patients with HPR to P2Y12 antagonists and 1.2% in patients without HPR. Likewise, the incidence of early ST in patients with HPR to acetylsalicylic acid (ASA) was 21.4% versus 1.8% in patients without HPR. In contrast, the incidence of late ST or recurrent myocardial infarction in untreated lesions was not associated with HPR to ASA or P2Y12 antagonists.

Conclusions

Platelet function testing in critically ill ACS patients identified patients at high risk for early ST and might be beneficial for risk stratification.
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10.

Objectives

This study assessed and compared vascular complications in CATHs and PCIs using an Angio‐Seal? vascular closure device (VCD) versus manual compression (MC).

Methods

Secondary data analysis of a population‐based multiyear cohort database was conducted to compare femoral access‐related vascular outcomes in cardiac procedures using VCD and MC between May 1, 2006 and December 31, 2010. The primary outcome was any vascular complication. Propensity score adjusted analysis was conducted to reduce bias associated with covariate imbalance between the groups compared.

Results

Of the 11,897 procedures, 7,063 (59.4%) used a VCD. Vascular complications occurred in 174/8,796 (2.0%) of CATHs and 82/3,004 (2.7%) of PCIs. In the CATH sample, the odds of vascular complication were 57% lower if a VCD was used (OR = 0.43, 95% CI 0.31–0.60). For the PCI sample, the risk was 49% lower if a VCD was used (OR = 0.51, 95% CI 0.31–0.81).

Conclusions

A low incidence of vascular complications was observed with the use of an Angio‐Seal VCD relative to MC for both procedures.
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11.

Background

To date, no published data are available regarding long‐term follow‐up of new generation DES implanted in coronary artery bypass graft (CABG) lesions.

Objectives

To assess the long‐term clinical outcome of patients receiving the new generation Biolimus A9‐coated drug‐eluting stent (DES) with biodegradable polymer in saphenous vein grafts (SVG).

Methods

Three thousand sixty‐seven patients were included in the NOBORI 2 registry: 71 patients with a total of 117 lesions received at least 1 biolimus A9 DES in SVG lesions and 2,959 patients received percutaneous coronary intervention in other lesions. Clinical follow‐up was performed at 1, 6, and 12 months, and annually up to 3 years.

Results

Compared to the non‐CABG group, patients with CABG lesions were older (P < 0.001), had a higher Charlson Comorbidity Index (P = 0.004), and presented more often with acute coronary syndrome (P = 0.02). At 3‐year follow‐up, cardiac death occurred in 9.7% versus 2.1% (P < 0.001), myocardial infarction (MI) in 8.3% versus 3.0% (P = 0.02), target lesion failure in 13.9% versus 6.4% (P = 0.03), and major adverse cardiac event in 18.1% versus 8.6% (P = 0.01). No differences were observed in TV‐MI and TLR, nor stent thrombosis (ST) which was generally low in both groups (1.4% vs 0.8%, P = NS).

Conclusion

Albeit 3‐year outcomes were less favorable in the CABG group, the higher cardiac mortality was apparently not driven by ST, target vessel MI, or TLR, but is likely due to advanced disease and age as well as comorbidity. The low TLR rate as well as the absence of late and very late ST suggest that BES are safe and effective for the treatment of CABG lesions. (J Interven Cardiol 2013;26:425‐433)
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12.

Background

TAVR has become an established treatment for severe symptomatic aortic stenosis in patients with high surgical risk. The latest generation of the balloon‐expandable Edwards Sapien device, the Sapien 3, together with its new transfemoral Commander delivery system has been designed to reduce paravalvular regurgitation and vascular access site complications.

Objectives

To evaluate procedural results and short term outcome with the third generation Sapien 3 device.

Methods

We retrospectively evaluated 125 consecutive TAVR patients and analyzed the first 51 patients in whom we implanted the new Sapien 3 device via transfemoral access.

Results

In patients implanted with the Sapien 3 device significant residual paravalvular regurgitation after TAVR was virtually absent with the vast majority having none or trace postinterventional aortic regurgitation on angiography or echocardiography (92.2% and 80.4% respectively). None of the patients had more than mild paravalvular regurgitation. Major vascular access site complications or major bleeding according to the VARC II criteria were not observed in our cohort, minor vascular complications and minor bleeding occurred in 7.8% and 5.9% respectively. If vascular complications occurred, they were related to closure device failure. Thirty day outcome showed a 1.9% major stroke rate and 3.9% death rate. However, we observed a 25.5% permanent pacemaker rate in our Sapien 3 cohort.

Conclusions

Implantation of the new third generation Sapien 3 device resulted in excellent procedural and short term outcome. Significant paravalvular regurgitation was virtually absent. However, the increased rate of postinterventional pacemaker implantations needs to be analyzed in a larger cohort of patients. (J Interven Cardiol 2015;28:109–116)
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13.

Objective

To evaluate the additional value of StentBoost® (SB), a motion‐corrected X‐ray technique that enhances stent visualization, for the assessment of stent deployment and procedure optimization during routine percutaneous coronary interventions (PCI).

Background

Underdeployment and malapposition of stents during PCI may lead to in‐stent thrombosis and restenosis. Coronary angiography (CA) is of limited value for the assessment of stent deployment. Intravascular ultrasound and optical imaging techniques are the gold standard, but are used in <10% of routine PCIs.

Methods

We retrospectively analyzed 260 coronary lesions treated by stent implantation and assessed by SB during 168 consecutive PCI procedures. The immediate results of SB analysis and CA were assessed by 2 independent interventional cardiologists and compared.

Results

A total of 275 stents were implanted; 45% were drug‐eluting stents (DES). Direct stenting was performed in 78%. Results of SB and angiography were concordant for 210 lesions: 194 stents were correctly deployed (75%) and 16 were underdeployed (6%), shown by both techniques. In 47 patients (18%), SB detected an underdeployment of the stent whereas the angiographic result was good. Postdilatation was performed on the basis of SB in 89% of these cases. The additional contribution of SB was higher for left main lesions and for DES, and was not affected by coronary calcifications.

Conclusions

This study confirmed the usefulness of the stent visualization enhancement technique StentBoost® in current PCI practice. SB revealed about 20% underdeployed stents not detected by CA, and allowed for optimizing PCI by ad hoc effective postdilatation. (J Interven Cardiol 2013;26:444‐453)
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14.

Introduction and Objectives

In primary angioplasty, bivalirudin is superior to treatment with heparin plus glycoprotein inhibitors for reducing cardiovascular events, although bivalirudin increases the risk of stent thrombosis. Our hypothesis is that the use of prasugrel plus bivalirudin in primary angioplasty would reduce stent thrombosis and cardiovascular events.

Method

Consecutive patients with acute ST‐segment elevation myocardial infarction who were treated by primary angioplasty within 12 hours of the onset of symptoms received bivalirudin plus clopidogrel (Group A) or bivalirudin plus prasugrel (Group B). We compared the groups using propensity score matching. The combined end‐point was cardiac death, thrombosis, acute myocardial infarction, and cerebrovascular accident at 30 days.

Results

We assessed 168 patients. The approach was preferentially radial (95.7%). No differences in baseline characteristics were observed between Groups A (n = 70) and B (n = 70). The total mortality and rate of major bleeding complications at 30 days were 0% for both of the groups. The rate of acute and subacute thrombosis was 4.3% in Group A and 0% in Group B (P = 0.08). We observed an increased rate of events in Group A (5.7%) versus Group B (0%) (P = 0.042).

Conclusions

The administration of bivalirudin plus prasugrel in primary percutaneous coronary intervention reduces cardiovascular effects compared to bivalirudin plus clopidogrel without increasing major bleeding complications during the first 30 days following primary angioplasty performed with a preferentially radial approach. (J Interven Cardiol 2013;26:463‐469)
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15.

Objectives

We aimed to explore the relationship between brain natriuretic peptide (BNP) levels and right ventricular (RV) function in patients with mitral stenosis (MS), and to investigate the hemodynamic parameters that predict reduction of BNP levels after percutaneous mitral valvuloplasty (PMV).

Background

Few studies have evaluated BNP in the context of MS, specifically the impact of the RV stroke work (RVSW) on serum BNP levels has not been defined.

Methods

Thirty patients with symptomatic rheumatic MS in sinus rhythm who were referred for a PMV were enrolled. Right and left heart pressures were obtained before and after valvuloplasty. RVSW index (RVSWI) was calculated by cardiac catheterization.

Results

Basal BNP levels were elevated in MS patients and correlated with several hemodynamic parameters including pulmonary pressure, pulmonary vascular resistance index, cardiac index (CI), and RVSWI. In multivariate analysis, CI and RVSWI were independent predictors of raised basal BNP levels. PMV resulted in a significant decrease in the RVSWI with a concurrent increase in CI (2.4 ± 0.43 to 2.9 ± 0.8 L/min/m2, P = 0.010). Overall, plasma BNP levels significantly decreased from 124 (63/234) to 73 (48/148) pg/ml postvalvuloplasty. Multivariate analysis revealed that the reduction of left atrial (LA) pressure post‐PMV was an independent predictor of change in BNP levels.

Conclusions

Elevated baseline BNP level in MS patients was independently associated with CI and RVSWI. Plasma BNP levels were reduced after successful PMV, which was associated with the reduction of the LA pressure. (J Interven Cardiol 2013;26:501‐508)
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16.

Objectives

This study focused on how catheter size affects transseptal puncture, what transseptal indication means, and whether the swine model is predictive for humans.

Background

Transseptal puncture is a common procedure that gains access to the left atrium, allowing percutaneous mitral valve repair, left atrial appendage closure, and left‐sided ablations. The basic approach has not changed in many years; however, the frequency of transseptal punctures and the size of devices are increasing with emerging treatments.

Methods

A broad range of devices (4 F to 18 F) were advanced through atrial septa of swine hearts; some devices were inserted in both swine and human hearts using 10 F catheters.

Results

Greater forces were required to puncture through the septa of human hearts compared to those of swine. Larger catheters used in swine hearts required greater force to advance them through the septa, causing greater dilation of tissue and sometimes tearing the floor of the fossa ovalis; analyses indicated an exponential increase in the size of the iatrogenic atrial septal defect. Specific tissue property testing of the septum primum showed that this tissue sheared at a lower exerted force in a superior to inferior direction.

Conclusions

Results may provide physicians with important knowledge about what to expect when treating a possible iatrogenic atrial septal defect or help them understand the consequences of transseptal punctures. Comparative data between swine and human atrial septal tissue properties provide critical insights between the species and offer clinicians and device designers important information relative to differences in tissue behaviors. (J Interven Cardiol 2015;28:98–108)
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17.

Objectives

To investigate the use of the GuideLiner “mother‐and‐child” guide catheter extension system as a simple solution to facilitate initial device delivery in balloon uncrossable chronic total occlusions (CTOs) undergoing percutaneous coronary intervention (PCI).

Background

During PCIs for CTO lesions, an important reason for procedural failure is the inability to deliver a balloon or microcatheter across the lesion.

Methods

We retrospectively accessed our interventional registry for 07/01/2010 to 03/21/2012 and extracted data on all CTO lesions involving GuideLiner catheter use. Cine review was performed to identify cases where a guidewire had crossed the CTO and the use of a GuideLiner catheter facilitated initial device delivery.

Results

We identified 28 patients that underwent PCI for CTO with a GuideLiner catheter used to assist initial balloon or microcatheter advancement across the culprit lesion. Mean overall CTO length was 26.3 ± 18.1 mm. The GuideLiner catheter was successful in delivering a small balloon to the CTO lesion in 85.7% of cases (24/28). A single CTO PCI resulted in a distal guidewire perforation, but there was no hemodynamic compromise or pericardial effusion and the patient was discharged the next day. Overall procedural success in these selected cases (where a guidewire had already crossed the CTO) was 89.3% (25/28).

Conclusions

The GuideLiner mother‐and‐child catheter is a simple, safe and efficacious adjunctive device for difficult CTO PCIs where despite standard measures it is not possible to deliver an initial balloon or microcatheter across the occluded segment.
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18.

Background

Postconditioning is a potential cardioprotective strategy that has demonstrated conflicting and variable reductions in infarct size in human trials.

Objectives

To determine whether postconditioning could increase the extent of myocardial salvage in patients with acute ST‐segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (PPCI).

Methods

One hundred two patients (aged 57 ± 11 years; 88% male) were randomly assigned to a postconditioning or standard protocol. Cardiovascular magnetic resonance imaging was performed 3 days after PPCI to measure the volumetric extent of myocardial necrosis and the area at risk.

Results

With similar time‐to‐reperfusion (170 ± 84 minutes in the postconditioning group vs. 150 ± 70 minutes in the standard group, P = 0.22), the myocardial salvage index was not significantly different between the postconditioned group and the control group, averaging 42 ± 22% vs. 33 ± 21%, respectively (P = 0.08). Furthermore, postconditioning was not associated with a smaller infarct size compared to controls (13 ± 7 g/m2 vs. 15 ± 8 g/m2, respectively, P = 0.18).

Conclusions

Postconditioning does not significantly increase myocardial salvage or reduce infarct size in patients with STEMI undergoing PPCI. However, the possibility of a more modest impact of postconditioning cannot be excluded with our sample size. (J Interven Cardiol 2013;26:482‐490)
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19.

Objectives

We evaluated the safety and effectiveness of the Resolute? zotarolimus‐eluting stent (R‐ZES) in real‐world clinical practice through 3 years.

Background

A randomized comparison of the R‐ZES and the XIENCE V? everolimus‐eluting stent showed no difference in any outcomes through 3‐year follow‐up in high‐volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R‐ZES in real‐world clinical practice.

Methods

RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end‐point was the composite of cardiac death and target vessel myocardial infarction (TV‐MI) at 1 year. Secondary end‐points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST).

Results

At 3 years 97.2% of patients completed clinical follow‐up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV‐MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively.

Conclusions

The safety and effectiveness of the R‐ZES through 3 years in this real‐world all‐comer study was consistent with previously reported all‐comer trials. (J Interven Cardiol 2013;26:515‐523)
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20.

Objectives

This study aimed to examine clinical efficacy, safety, and intermediate clinical outcomes with everolimus‐eluting stents (EESs) in patients with transplant coronary artery disease (TCAD).

Background

TCAD is a major cause of mortality in patients following orthotopic heart transplantation (OHT). Systemic everolimus in OHT patients has been shown to reduce TCAD. The safety and efficacy of an EES, the Xience V, have not been evaluated in this population.

Methods

Patients post‐OHT with hemodynamically significant CAD who underwent percutaneous coronary intervention (PCI) with EES were included. Participants were maintained on dual antiplatelet therapy for 1‐year post‐PCI. We examined procedural success, in‐hospital and 1‐year mortality, stent thrombosis, angiographic restenosis, and myocardial infarction rates. All patients had follow‐up angiography 1‐year after PCI. Target vessel revascularization (TVR), target lesion revascularization (TLR), in‐segment restenosis, target vessel failure (TVF), and lumen late loss were noted.

Results

PCI was performed in 34 de novo lesions in 21 patients, and 40 EES were placed. Procedural success rate was 100%. Average stent was 16.5 ± 5.1 mm long and 3.0 ± 0.6 mm in diameter. All patients had angiographic follow‐up (409 ± 201 days). There was no stent thrombosis, deaths, or myocardial infarctions during follow‐up. Two patients had focal in‐stent restenosis. TLR rate was 5.9% (2/34), and TVR rate was 11.1% (3/27). Quantitative coronary angiography (QCA) showed stenosis diameter to be 19.98 ± 17.57%.

Conclusions

Use of an EES is associated with a low incidence of TVR and TLR in patients with TCAD. Further studies are needed to determine whether PCI with EES changes long‐term outcomes. (J Interven Cardiol 2014;27:73–79)
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