European Experience with the Self-Expanding Nitinol Coil: Pilot Phase Evaluation in Cardiovascular Applications

BACKGROUND: The Cardiocoil (InStent) is a self-expanding nitinol coil that is restrained on a delivery catheter in a compressed state and deployed by a wire based release mechanism. We provide the initial data on the acute results of the use of this stent in a multi-center study in Europe. We also briefly review the other non-coronary applications of this stent. METHODS: One-hundred two stents were implanted in 76 patients for suboptimal results or dissections. There were 39 LAD lesions, 28 RCA lesions and 9 Circumflex lesions. There were eight total occlusions. Lesions were short in 41% (< 10 mm), tubular (between 10 and 20 mm) in 37%, and diffuse (> 20%) in 22%. Stent deployment included predilatation to the reference arterial side and post dilatation after stent deployment. RESULTS: Stent deployment was successful in all cases in which lesions could be crossed. In cases where the stent did not cross the lesion (n=3) it was removed uneventfully. There were no stent losses. Complications included subacute thrombosis in 4/76 (5.3%) patients (1- a long total RCA lesion, 2- diffuse proximal LAD diseases). There were no late acute events after stenting and no stent related mortality. Angiographic quantitative analysis showed that the stent expands by both its intrinsic self-expanding properties and by post deployment balloon assistance. CONCLUSIONS: The self-expanding coil stent for cardiovascular interventions is safe and effective in treating a variety of complex lesions. It provides adequate support to the arterial wall, preventing acute recoil and tacking dissections to the arterial wall. The long-term efficiency of this stent awaits further clinical testing.     

Self-Expanding Metal Stents for Palliation of Inoperable Carcinoma of the Esophagus and Gastroesophageal Junction

Objectives: Rapid palliation of malignant dysphagia is usually possible with endoscopic implantation of plastic prosthesis, but this device has a high rate of complications. Recently expandable metal stents have become available that may have a reduced complications rate.
Methods: This report details our experience with 32 patients treated from September of 1992 through June of 1994. Twenty-three patients were treated primarily with the Ultraflex esophageal prosthesis, and five patients were treated with postoperative malignant stricture, three with failed laser therapy and one with postradiation therapy malignant stricturing. Implantation was successful in 30/32 patients (94%). No major bleeding or perforation followed placement. The dysphagia score improved dramatically from 3 to 0.5. Twenty-six patients had a follow-up of at least 30 days. No stent migration occurred. Food impaction was seen in three patients, tumor ingrowth in three, and overgrowth in one patient. The median survival was 6.2 months with a range of 1.8–11.3 months.
Conclusions: Expandable metal stents are effective and safe for palliation of malignant obstruction of the esophagus and gastro-esoph-ageal junction. However, long term problems remain to be addressed, such as ingrowth by tumor, food impaction, and limitation of stent expansion by tumor rigidity.     

Clinical Manifestation and Prognosis of Early versus Late Stent Thrombosis of Drug-Eluting Stents

Background: Stent thrombosis (ST) is a serious complication of drug-eluting stents (DES), leading to catastrophic events. ST can occur early or late following the percutaneous coronary intervention (PCI) with different possible consequences.
Methods: The records of 91 consecutive patients who presented with a definite ST (as defined by the Academic Research Consortium) from 2003 to 2007 were reviewed. Clinical presentation and outcome were compared based on the time of the event. Fifty-one patients presented with an early ST versus 40 with a late ST. The primary end-point was a composite of death-recurrent myocardial infarction (MI)-recurrent ST at 1 year.
Results: Baseline characteristics were similar. Patients with early ST had more initial stent implantation for an acute MI indication and presented more with cardiogenic shock when compared to patients with late ST: 43.1% versus 17.5% (P = 0.007) and 39.2% versus 20% (P = 0.042), respectively. There was no difference in the ST treatment except for more intraaortic balloon pump (IABP) use in the early ST group (28% vs. 10%, P = 0.034). Angiographic success rates were similar. The incidence of the composite primary end-point was 52.9% in the early ST group versus 30% in the late ST group (P = 0.034).
Conclusion: Early definite ST is associated with more dramatic presentation and worse long-term prognosis when compared with definite late ST. This could be explained at least in part by the occurrence of two successive MIs within 30 days in almost 45% of the patients with early ST, leading to a higher rate of cardiogenic shock.     

Asymptomatic Left Ventricular Dysfunction and Metabolic Syndrome: Results from an Italian Multicenter Study

Context:

Metabolic syndrome (MS) is a cluster of interrelated common clinical disorders, including obesity, insulin resistance, glucose intolerance, hypertension and dyslipidemia, associated with a greater risk of atherosclerotic cardiovascular disease than any of its individual components. Although MS is associated with increased cardiovascular risk (CVR), its relationship with heart failure (HF) and left ventricular (LV) dysfunction is not fully understood.

Aims:

We sought to determine whether MS is associated to LV systolic and diastolic dysfunction in a sample of patients with MS and no symptoms for HF.

Subjects and Methods:

We enrolled 6422 consecutive asymptomatic patients admitted to echo-lab for a routine echocardiogram. We calculated LV systolic and diastolic function, by Simpson biplane method and validated Doppler parameters, respectively. MS was diagnosed if three or more CVR factors were found.

Results:

LV systolic function was evaluated in 6175 patients (96.2%). In the group of patients without MS (n = 5630), the prevalence of systolic dysfunction was 10.8% (n = 607) while in the group of patients with MS (n = 545) it was 12.5% (n = 87), (RR1.57; CI 95% 1.2-2.0; P < 0.001). Diastolic function was evaluated in 3936 patients (61.3%). In the group of patients without MS (n = 3566) the prevalence of diastolic dysfunction was 33.3% (n = 1187), while in patients with MS (n = 370) it was 45.7% (n = 169), (RR1.68; CI95% 1.3-2.0; P < 0.001). After adjustment for age and gender, MS proved to be an independent predictor of LV systolic and diastolic dysfunction.

Conclusions:

Our data show that asymptomatic LV systolic and diastolic dysfunction, is correlated with MS and demonstrate that echocardiography is a useful tool to detect patients at high risk for HF. Echocardiography in asymptomatic patients with MS may lead to a therapy initiation at early stages to prevent future cardiovascular events and HF.     

Fracture of a Popliteal Nitinol Stent: Case Report and Review of the Literature

IntroductionEndovascular stenting of popliteal occlusion is a common procedure in vascular practice.Stent fractures normally cause restenosis or occlusion of the arterial segment treated.ReportWe present a case of a large aneurysm of the popliteal artery that was observed 14 months after popliteal stenting with self-expandable nitinol stent.We describe the endovascular approach that has been used to solve this severe complication.DiscussionStent fractures are often a hidden complication of femoro-popliteal stenting that can be associated with important disease; a careful follow-up and prompt management in expert hands in the majority of the cases lead to a favourable resolution.     

Overweight,Obesity, and the Likelihood of Achieving Sustained Remission in Early Rheumatoid Arthritis: Results From a Multicenter Prospective Cohort Study

Objective

Obesity is implicated in rheumatoid arthritis (RA) development, severity, outcomes, and treatment response. We estimated the independent effects of overweight and obesity on ability to achieve sustained remission (sREM) in the 3 years following RA diagnosis.

Methods

Data were from the Canadian Early Arthritis Cohort, a multicenter observational trial of early RA patients treated by rheumatologists using guideline‐based care. sREM was defined as Disease Activity Score in 28 joints (DAS28) <2.6 for 2 consecutive visits. Patients were stratified by body mass index (BMI) as healthy (18.5–24.9 kg/m²), overweight (25–29.9 kg/m²), and obese (≥30 kg/m²). Cox regression was used to estimate the effect of the BMI category on the probability of achieving sREM over the first 3 years, controlling for age, sex, race, education, RA duration, smoking status, comorbidities, baseline DAS28, Health Assessment Questionnaire disability index, C‐reactive protein level, and initial treatment.

Results

Of 982 patients, 315 (32%) had a healthy BMI, 343 (35%) were overweight, and 324 (33%) were obese; 355 (36%) achieved sREM within 3 years. Initial treatment did not differ by BMI category. Compared to healthy BMI, overweight patients (hazard ratio [HR] 0.75 [95% confidence interval (95% CI) 0.58–0.98]) and obese patients (HR 0.53 [95% CI 0.39–0.71]) were significantly less likely to achieve sREM.

Conclusion

Rates of overweight and obesity were high (69%) in this early RA cohort. Overweight patients were 25% less likely, and obese patients were 47% less likely, to achieve sREM in the first 3 years, despite similar initial disease‐modifying antirheumatic drug treatment and subsequent biologic use. This is the largest study demonstrating the negative impact of excess weight on RA disease activity and supports a call to action to better identify and address this risk in RA patients.

     

Comparison Between Botulinum Injection and Removable Covered Self-Expanding Metal Stents for the Treatment of Achalasia

Background

Intrasphincteric injection of botulinum toxin (BTX) and removable self-expanding metal stents (SEMS) have both been used for the treatment of achalasia.

Aim

To compare the effectiveness and long-term outcome of SEMS placement and BTX injection in patients with achalasia.

Methods

A total of 110 patients with newly diagnosed achalasia were enrolled in the study between July 2003 and December 2009. The patients received either BTX injection (n = 51) or SEMS placement (n = 59). Clinical symptoms, objective parameters, and long-term clinical outcomes were evaluated after 7 and 30 days and then every 6 months until withdrawal from the study. The mean duration of follow-up was 28 months (range 10–36 months).

Results

Improvements in global symptom and dysphagia scores and in basal lower esophageal sphincter pressure were significantly more marked in the SEMS group than in the BTX group (all P < 0.05). After 12 months, the remission rate in the SEMS group (81.28 %) was statistically significantly higher than that in the BTX group (64.58; P < 0.05). At 36 months, the remission rates in the two groups were 49.1 and. 4.2 %, respectively (P < 0.01). The symptom-free interval was 831 ± 46 days in the SEMS group and 522 ± 42 days in the BTX group (P < 0.01). No side effects were reported with BTX treatment. In the SEMS group there were 13 episodes of chest pain, nine cases of regurgitation, and four stent migrations. No serious complications occurred.

Conclusion

Removable SEMS was associated with better long-term outcomes than BTX injection in patients with achalasia.     

Optimum Palliation of Inoperable Hilar Cholangiocarcinoma: Comparative Assessment of the Efficacy of Plastic and Self-Expanding Metal Stents

Background  

Endoscopic retrograde biliary drainage (ERBD) with plastic or self-expanding metal stents (SEMS) is often performed for palliative care for cholangiocarcinoma.     

Effects of Omalizumab in Non-Atopic Asthma: Results from a Spanish Multicenter Registry

Aim. To evaluate the effectiveness of omalizumab in non-atopic asthma. Methods. Using data from a multicenter registry of severe asthma, we evaluated and compared the clinical outcome of 29 omalizumab-treated severe non-atopic asthmatics with 266 omalizumab-treated severe allergic asthmatics. Effectiveness was assessed by considering severe exacerbations, pulmonary function, the Global Evaluation of Treatment Effectiveness (GETE) scale, and Asthma Control Test (ACT). Results. Omalizumab demonstrated significant improvement in the clinical status of non-atopic asthmatics as measured by GETE, which rose from 1.6 ± 1.1 to 2.8 ± 0.8 at 4 months (p = .0215) to 2.9 ± 0.9 at 1 year (p = .0093) and to 3.4 ± 0.6 at 2 years (p = .0078), and by the ACT, which increased from 13.0 ± 5.5 to 17.5 ± 5.4 at 4 months (p = .0236) to 17.9 ± 4.8 at 1 year (p = .0136) and to 20.6 ± 3.9 at 2 years (p = .0024). Forced expiratory volume in 1 second (FEV₁) improved from 61.0 ± 19.4% to 65.1 ± 17.2 at 4 months to 64.1 ± 24.7 at 1 year and to 67.3 ± 23.0 at 2 years, but without significant differences between initial and follow-up measurements (p = .52, .91, and .45, respectively) and exacerbations decreased from 3.1 ± 3.5 to 1.9 ± 2.8 at 1 year (p = .1709) to 1.8 ± 4.4 at 2 years (p = .2344). The results were not significantly different from those obtained in atopic asthmatics. Conclusion. Anti-IgE therapy can be effective in non-atopic severe asthma.     

2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study

ObjectivesThe aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics.BackgroundDES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating.MethodsWithin a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes.ResultsAt 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores.ConclusionsThe 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676)