Procedural Results and One-Year Clinical Outcomes of Treatment of Bioresorbable Vascular Scaffolds Restenosis (from the RIBS VII Prospective Study).

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).

Spontaneous Coronary Artery Dissection: Mechanisms, Diagnosis and Management.

Spontaneous coronary artery dissection (SCAD) is a relatively infrequent cause of acute coronary syndrome that usually affects young to middle-aged women. Mainly because of its low prevalence, until recently, most of the evidence on this condition was derived from case reports and small series. Over the last 5 years, more robust evidence has become available from larger retrospective and prospective cohorts of patients with SCAD. The increase in knowledge and recognition of this entity has led to the publication of expert consensus on both sides of the Atlantic. However, new data are continuously accumulating from larger cohorts of patients with SCAD, bringing new light to this little-understood condition. The aim of this article is to update the knowledge on SCAD, including new information from recent studies published since the consensus documents from the European Society of Cardiology and the American Heart Association.

Procedural, Functional and Prognostic Outcomes Following Recanalization of Coronary Chronic Total Occlusions. Results of the Iberian Registry.

INTRODUCTION AND OBJECTIVES: There is current controversy regarding the benefits of percutaneous recanalization (PCI) of chronic total coronary occlusions (CTO). Our aim was to determine acute and follow-up outcomes in our setting. METHODS: Two-year prospective registry of consecutive patients undergoing PCI of CTO in 24 centers. RESULTS: A total of 1000 PCIs of CTO were performed in 952 patients. Most were symptomatic (81.5%), with chronic ischemic heart disease (59.2%). Previous recanalization attempts had been made in 15%. The mean SYNTAX score was 19.5 ± 10.6 and J-score was > 2 in 17.3%. A retrograde procedure was performed in 92 patients (9.2%). The success rate was 74.9% and was higher in patients without previous attempts (82.2% vs 75.2%; P = .001), those with a J-score ≤ 2 (80.5% vs 69.5%; P = .002), and in intravascular ultrasound-guided PCI (89.9% vs 76.2%, P = .001), which was an independent predictor of success. In contrast, severe calcification, length > 20mm, and blunt proximal cap were independent predictors of failed recanalization. The rate of procedural complications was 7.1%, including perforation (3%), myocardial infarction (1.3%), and death (0.5%). At 1-year of follow-up, 88.2% of successfully revascularized patients showed clinical improvement (vs 34.8%, P < .001), which was associated with lower mortality. At 1-year of follow-up, the mortality rate was 1.5%. CONCLUSIONS: Compared with other national registries, patients in the Iberian registry undergoing PCI of a CTO showed similar complexity, success rate, and complications. Successful recanalization was strongly associated with functional improvement, which was related to lower mortality.

Spontaneous coronary artery dissection: from expert consensus statements to evidence-based medicine.

Spontaneous coronary artery dissection (SCAD) represents an increasingly recognized cause of acute coronary syndrome (ACS), especially in young females. Novel diagnostic insights obtained from intracoronary imaging and the frequent association with fibromuscular dysplasia (FMD), have recently enriched our understanding of this unique clinical entity. Recently, two scientific statements from both sides of the Atlantic, summarizing the available information on SCAD, have been simultaneously published. These should help to guide the clinical management of these challenging patients. Major collaborative research efforts are required to move from expert-based recommendations to evidence-based [corrected] medicine.

Effectiveness of a mandibular advancement device in obstructive sleep apnea patients: a prospective clinical trial.

PURPOSE: This study aimed to determine the effectiveness of a mandibular advancement device in a sample of obstructive sleep apnea syndrome patients by the evaluation of respiratory and neurophysiologic parameters and clinical symptoms. Second, the influence of certain predictor factors related with the patient and the intraoral device, were considered in the final response with this treatment option. METHODS: Forty-one patients constituted the final sample. Outcomes were measured using polysomnography, Epworth sleepiness scale and an analogue visual snoring scale, before treatment and once the device was properly titrated. RESULTS: Mean apnea-hypopnea index decreased from 22.5 ± 16.8 to 9.1 ± 11.6 (p ≤ 0.05), influencing only gender and Fujita index as predictor factors. The oxygen saturation, arousal index, percentages of sleep stages and sleep efficiency significantly improved with the mandibular advancement device (MAD) placement. The snoring index improved in absolute terms in 6.1 units and the excessive daytime sleepiness was reduced from 12.2 ± 4.7 to 8.5 ± 3.8 (p ≤ 0.00). CONCLUSIONS: The successful treatment rate with the MAD was 65.8%. The placement and posterior regulation of the intraoral appliance efficiently reduced the apnea-hypopnea index, improved the sleep quality and the clinical symptomatology associated. Obstructive sleep apnea syndrome is a highly prevalent disease. and dentists should be aware of the benefits enhanced by this prosthetic device, considered the first treatment option by certain physicians.

Current management of spontaneous coronary artery dissection.

INTRODUCTION: Spontaneous coronary artery dissection (SCAD) remains an infrequent and elusive clinical entity of unknown etiology. However, our knowledge of SCAD has been significantly enriched in recent years. Large and prospective contemporary series have increased the interest in this disease with fewer patients misdiagnosed and a growing number of cases recognized in daily clinical practice. Classically, SCAD was thought to present mainly in young women without traditional atherosclerotic risk factors but, actually, most patients are middle-aged and are not free from coronary risk factors. A high number of associated conditions have been reported. Of these, fibromuscular dysplasia emerges as a major association with intriguing pathophysiological implications. Areas covered: This review aims to present a contemporary update on SCAD. We concentrate on the clinical scenario, related conditions, practical management and treatment strategies. Expert commentary: Recognition of SCAD is currently much more frequent and accurate as a result of increased clinical awareness and the widespread use of intravascular imaging techniques. Hopefully, in the near future an improvement in the management of SCAD patients will come not only from empirical evidence but also from dedicated clinical trials.

Diagnostic accuracy of a hybrid approach of instantaneous wave-free ratio and fractional flow reserve using high-dose intracoronary adenosine to characterize intermediate coronary lesions: Results of the PALS (Practical Assessment of Lesion Severity) prospective study.

OBJECTIVES: We sought to investigate the diagnostic accuracy of instantaneous wave-free ratio (iFR) and high-dose intracoronary adenosine fractional flow reserve (IC-FFR) compared with classical intravenous adenosine fractional flow reserve (IV-FFR) to assess coronary stenosis severity. The usefulness of two hybrid strategies combining iFR and high-dose IC-FFR was also evaluated. BACKGROUND: Physiological assessment of intermediate coronary stenoses to guide revascularization is currently recommended. METHODS: Consecutive real-world patients with angiographically intermediate coronary stenosis (40-80% diameter stenosis) were prospectively included in the PALS (Practical Assessment of Lesion Severity) study. In every target lesion iFR, high-dose IC-FFR and IV-FFR were systematically measured to assess the accuracy of an hybrid sequential approach combining iFR and IC-FFR. RESULTS: A total of 106 patients with 121 intermediate coronary lesions were analyzed. Both, iFR and IC-FFR showed a significant correlation with IV-FFR (iFR: r = 0.60, 95%CI 0.48-0.70; IC-FFR: r = 0.88; 95%CI: 0.83-0.92). High-dose IC-FFR provided lower FFR values than IV-FFR (0.81 ± 0.08 vs. 0.82 ± 0.09, P = 0.25). Using a receiver-operating-characteristic curve an optimal iFR threshold of 0.91 for the screening test was identified. A sequential test strategy (initial iFR followed by IC-FFR only in lesions with iFR <0.91) yielded an excellent diagnostic accuracy (96.7%, 95%CI 96.7-99.1%) with a sensitivity, specificity, positive and negative predicted values of 100%, 94.7%, 91.8%, and 100%, respectively. A hybrid approach using the previously described iFR gray zone (0.85-0.94) also provided an excellent diagnostic accuracy (95%, 95%CI: 89.5-98.1%). CONCLUSIONS: In patients with intermediate coronary lesions a hybrid strategy by using a sequential approach of iFR and high-dose IC-FFR, provided a very good diagnostic performance to identify physiologically significant stenoses. © 2017 Wiley Periodicals, Inc.

A pooled analysis of the efficacy of fesoterodine for the treatment of overactive bladder, and the relationship between safety, co-morbidity and polypharmacy in patients aged 65 years or older.

Background: overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity. Methods: data from 10 double-blind, placebo-controlled studies were analysed. A logistic regression analysis, where TEAE incidence was predicted by treatment, prior antimuscarinic treatment, number of coexisting medications, number of concomitant diseases and all possible combinations of two-way interaction terms with treatment was conducted. Results: of 4,040 patients who participated in trials; fesoterodine treatment was associated with statistically significant reductions in all disease-related and patient-reported outcomes compared to placebo. There was a significant increase in the likelihood of reporting a TEAE in association with the number of coexistent medications (odds ratio (OR) = 1.028, 95% CI: 1.0143-1.044, P < 0.003). The OR of having a TEAE with increase in the number of concomitant diseases was 1.058 (95% CI: 1.044-1.072, P < 0.0001). Central nervous system (CNS) events were few. Discussion: fesoterodine treatment led to clinically meaningful improvements across all included patient reported outcomes. The number of concomitant conditions had the greatest influence on the likelihood of an adverse event being reported. CNS TEAE were not associated with fesoterodine dose and were low across all categories of concomitant disease and coexisting medication.

Reliability of physiological assessment of coronary stenosis severity using intracoronary pressure techniques: a comprehensive analysis from a large cohort of consecutive intermediate coronary lesions.

AIMS: We sought to assess the reliability of the most frequently used intracoronary physiologic indices (including intravenous adenosine FFR [IV-FFR], intracoronary low-dose adenosine FFR [LD-IC-FFR], intracoronary high-dose adenosine FFR [HD-IC-FFR], Pd/Pa and iFR). We also sought to analyse factors affecting their reproducibility in a real-world patient population. METHODS AND RESULTS: A total of 91 lesions in 86 consecutive patients were included. Measurements of all physiological indices were repeated within a systematic standardised prospective protocol. All measured indices showed excellent test-retest reliability, with intraclass correlation coefficient (ICC) over 0.96. IV-FFR showed the highest coefficient of variation (CV) values among the studied measurements (Pd/Pa: 0.05; iFR: 0.10; LD-IC-FFR: 0.10; HD-IC-FFR: 0.08; IV-FFR: 0.12). Pd/Pa was significantly less variable than the other indices. On multivariate analysis, female gender, distal lesion location, history of hypertension or kidney failure, as well as presentation as an acute coronary syndrome, were associated with more variability in all physiological intracoronary measurements. CONCLUSIONS: The reliability of most frequently used intracoronary physiologic indices is high. Clinical and anatomic factors significantly influence the reliability of these physiologic indices.

Spontaneous coronary artery dissection: new insights into diagnosis and treatment.

Spontaneous coronary artery dissection (SCAD) remains an infrequent, elusive, and challenging clinical entity of unknown etiology eight decades after its initial description. Our understanding of the pathophysiology of SCAD, initially limited to information from early pathological studies, case reports, and very short series, has been enriched recently by relatively large contemporary series of patients studied prospectively. The typical presentation involves a young woman without coronary risk factors suffering an acute coronary syndrome but, actually, most patients are middle-aged and have coronary risk factors. A high number of conditions have been related to SCAD, but fibromuscular dysplasia has shown a major intriguing association with potential pathophysiological implications. SCAD may present (a) with an intimal tear and the classic angiographic 'flap' leading to the appearance of two lumens (true and false), or (b) without an intimal rupture, as an intramural hematoma. An increased clinical awareness together with new diagnostic tools have led to a major surge in the diagnosis of SCAD. High-resolution intracoronary techniques provide unique diagnostic insights into the underlying pathophysiology and facilitate identification of the disease in patients misdiagnosed previously. After the initial acute ischemic insult, most patients stabilize and have a benign clinical course and eventually experience spontaneous healing of the vessel wall during follow-up. However, recurrences may still occur in up to 10-20% of cases. Accordingly, a conservative medical management (watchful waiting strategy) has been recommended as the initial approach. Revascularization remains particularly challenging and may be associated with suboptimal results, acute complications, and poor long-term outcome. Nevertheless, in patients with ongoing or refractory ischemia and adequate anatomy, revascularization should be attempted. Some novel and attractive coronary interventions have been proposed in this uniquely challenging anatomic scenario. This review aims to present a comprehensive and contemporary update on this elusive and intriguing clinical entity.

Drug-Coated Balloon Treatment of Very Late Stent Thrombosis Due to Complicated Neoatherosclerosis / Tratamento por Balão Farmacológico de Trombose de Stent Muito Tardia Causada por Neoaterosclerose Complicada

Abstract We describe the treatment of a patient presenting with very-late stent thrombosis with the use of a drug-coated balloon. In this patient, optical coherence tomography disclosed that ruptured and complicated neoatherosclerosis was the underlying substrate responsible for the episode of very-late stent thrombosis. The potential use of drug-coated balloons in this unique scenario is discussed.

Resumo Descrevemos o tratamento de um paciente apresentando trombose de stent muito tardia com a utilização de um balão farmacológico. Nesse paciente, a tomografia de coerência ótica revelou que a neoaterosclerose apresentava-se complicada e com ruptura, sendo portanto o substrato subjacente responsável pelo episódio de trombose de stent muito tardia. O uso potencial de balões farmacológicos nesse cenário especial é discutido.

Factors Associated With Delays in Seeking Medical Attention in Patients With ST-segment Elevation Acute Coronary Syndrome.

INTRODUCTION AND OBJECTIVES: Prompt coronary reperfusion is crucial in patients with ST-segment elevation acute coronary syndrome. The aim of this study was to determine factors associated with a delay in seeking medical attention after the onset of symptoms in patients with this condition. METHODS: Prospective cohort study in consecutive patients with ST segment elevation infarction. Multiple logistic regression analysis was used to identify factors independently associated with a longer delay in requesting medical help. RESULTS: In total, 444 consecutive patients were included (mean age, 63 years; 76% men, 20% with diabetes). Median total ischemia time was 225 (160-317) minutes; median delay in seeking medical attention was 110 (51-190) minutes. Older patients (age > 75 years; odds ratio = 11.6), women (odds ratio = 3.4), individuals with diabetes (odds ratio = 2.3), and those requesting medical care from home (odds ratio = 2.2) showed the longest delays in seeking medical attention. Lengthy delay was associated with higher in-hospital mortality (9.8% vs 2.7%; P<.005) and 1-year mortality (7.3% vs 2.9%; P<.05) than when attention was promptly solicited. CONCLUSIONS: Elderly patients, women, and diabetic individuals with ST-segment elevation myocardial infarction show longer delays in seeking medical attention for their condition. Delays in seeking medical attention are associated with greater in-hospital and 1-year mortality.