Intravascular Imaging-Guided Versus Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Trials.

BACKGROUND: Despite the initial evidence supporting the utility of intravascular imaging to guide percutaneous coronary intervention (PCI), adoption remains low. Recent new trial data have become available. An updated study-level meta-analysis comparing intravascular imaging to angiography to guide PCI was performed. This study aimed to evaluate the clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI. METHODS AND RESULTS: A random-effects meta-analysis was performed on the basis of the intention-to-treat principle. The primary outcomes were major adverse cardiac events, cardiac death, and all-cause death. Mixed-effects meta-regression was performed to investigate the impact of complex PCI on the primary outcomes. A total of 16 trials with 7814 patients were included. The weighted mean follow-up duration was 28.8 months. Intravascular imaging led to a lower risk of major adverse cardiac events (relative risk [RR], 0.67 [95% CI, 0.55-0.82]; P<0.001), cardiac death (RR, 0.49 [95% CI, 0.34-0.71]; P<0.001), stent thrombosis (RR, 0.63 [95% CI, 0.40-0.99]; P=0.046), target-lesion revascularization (RR, 0.67 [95% CI, 0.49-0.91]; P=0.01), and target-vessel revascularization (RR, 0.60 [95% CI, 0.45-0.80]; P<0.001). In complex lesion subsets, the point estimate for imaging-guided PCI compared with angiography-guided PCI for all-cause death was a RR of 0.75 (95% CI, 0.55-1.02; P=0.07). CONCLUSIONS: In patients undergoing PCI, intravascular imaging is associated with reductions in major adverse cardiac events, cardiac death, stent thrombosis, target-lesion revascularization, and target-vessel revascularization. The magnitude of benefit is large and consistent across all included studies. There may also be benefits in all-cause death, particularly in complex lesion subsets. These results support the use of intravascular imaging as standard of care and updates of clinical guidelines.

The ability of contemporary cardiologists to judge the ischemic impact of a coronary lesion visually.

BACKGROUND: Landmark trials showed that invasive pressure measurement (Fractional Flow Reserve, FFR) was a better guide to coronary stenting than visual assessment. However, present-day interventionists have benefited from extensive research and personal experience of mapping anatomy to hemodynamics. AIMS: To determine if visual assessment of the angiogram performs as well as invasive measurement of coronary physiology. METHODS: 25 interventional cardiologists independently visually assessed the single vessel coronary disease of 200 randomized participants in The Objective Randomized Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina trial (ORBITA). They gave a visual prediction of the FFR and Instantaneous Wave-free Ratio (iFR), denoted vFFR and viFR respectively. Each judged each lesion on 2 occasions, so that every lesion had 50 vFFR, and 50 viFR assessments. The group consensus visual estimates (vFFR-group and viFR-group) and individual cardiologists' visual estimates (vFFR-individual and viFR-individual) were tested alongside invasively measured FFR and iFR for their ability to predict the placebo-controlled reduction in stress echo ischemia with stenting. RESULTS: Placebo-controlled ischemia improvement with stenting was predicted by vFFR-group (p < 0.0001) and viFR-group (p < 0.0001), vFFR-individual (p < 0.0001) and viFR-individual (p < 0.0001). There were no significant differences between the predictive performance of the group visual estimates and their invasive counterparts: p = 0.53 for vFFR vs FFR and p = 0.56 for viFR vs iFR. CONCLUSION: Visual assessment of the angiogram by contemporary experts, provides significant additional information on the amount of ischaemia which can be relieved by placebo-controlled stenting in single vessel coronary artery disease.

Rationale and design of the INVICTUS Registry: (Multicenter Registry of Invasive and Non-Invasive imaging modalities to compare Coronary Computed Tomography Angiography, Intravascular Ultrasound and Optical Coherence Tomography for the determination of Severity, Volume and Type of coronary atherosclerosiS).

BACKGROUND: Coronary CT angiography (CCTA) is a first-line noninvasive imaging modality for evaluating coronary artery disease (CAD). Recent advances in CCTA technology enabled semi-automated detection of coronary arteries and atherosclerosis. However, there have been to date no large-scale validation studies of automated assessment of coronary atherosclerosis phenotype and coronary artery dimensions by artificial intelligence (AI) compared to current standard invasive imaging. METHODS: INVICTUS registry is a multicenter, retrospective, and prospective study designed to evaluate the dimensions of coronary arteries, as well as the characteristic, volume, and phenotype of coronary atherosclerosis by CCTA, compared with the invasive imaging modalities including intravascular ultrasound (IVUS), near-infrared spectroscopy (NIRS)-IVUS and optical coherence tomography (OCT). All patients clinically underwent both CCTA and invasive imaging modalities within three months. RESULTS: Patients data are sent to the core-laboratories to analyze for stenosis severity, plaque characteristics and volume. The variables for CCTA are measured using an AI-based automated software and assessed independently with the variables measured at the imaging core laboratories for IVUS, NIRS-IVUS, and OCT in a blind fashion. CONCLUSION: The INVICTUS registry will provide new insights into the diagnostic value of CCTA for determining coronary atherosclerosis phenotype and coronary artery dimensions compared to IVUS, NIRS-IVUS, and OCT. Our findings will potentially shed new light on precision medicine informed by an AI-based coronary CTA assessment of coronary atherosclerosis burden, composition, and severity. (ClinicalTrials.gov: NCT04066062).

Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial.

BACKGROUND: Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). AIMS: We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS: This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs. iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS: A total of 2,268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs. low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P =.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs. 29 (2.6%) in the low-osmolarity group (P =.4). CONCLUSION: Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.

A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial.

BACKGROUND: Patients hospitalized with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease. OBJECTIVES: To investigate the efficacy of an acute coronary syndrome regimen in patients hospitalized with COVID-19 and coronary disease risk factors. METHODS: A randomized controlled, open-label trial across acute hospitals (United Kingdom and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28 days. Primary efficacy and safety outcomes were 30-day mortality and bleeding. The key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, or death). RESULTS: Three hundred twenty patients from 9 centers were randomized. The trial terminated early due to low recruitment. At 30 days, there was no significant difference in mortality (intervention vs control, 11.5% vs 15%; unadjusted odds ratio [OR], 0.73; 95% CI, 0.38-1.41; p = .355). Significant bleeds were infrequent and were not significantly different between the arms (intervention vs control, 1.9% vs 1.9%; p > .999). Using a Bayesian Markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (OR, 1.46; 95% credible interval [CrI], 0.88-2.37; Pr [beta > 0], 93%; adjusted OR, 1.50; 95% CrI, 0.91-2.45; Pr [beta > 0], 95%) and median time to discharge to home was 2 days shorter (95% CrI, -4 to 0; 2% probability that it was worse). CONCLUSION: Acute coronary syndrome treatment regimen was associated with a reduction in the length of hospital stay without an excess in major bleeding. A larger trial is needed to evaluate mortality.

Sinus of Valsalva Pseudoaneurysm: An Unusual Cause of Complete Heart Block.

We present a case of a young man with complete atrioventricular block and aneurysm of the right sinus of Valsalva penetrating the interventricular septum and causing severe aortic regurgitation. Chest trauma and inflammatory or infectious diseases are potential causes. Bentall-de Bono surgical repair was performed. Anatomopathologic analysis demonstrated fibrosis, hyalinization, and extensive myxoid material. (Level of Difficulty: Beginner.).

Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Índices fisiológicos não hiperêmicos ­ base teórica, aplicações clínicas e limitações / Non-hyperemic pressure ratios ­ theoretical basis, clinical applications, and limitations

A fisiologia coronariana tornou-se o padrão de tratamento para avaliar o significado funcional da doença aterosclerótica coronariana. Ela permite identificar isquemia miocárdica em nível de vaso, discriminar os padrões funcionais da doença aterosclerótica e orientar a necessidade de revascularização; complementar o planejamento da intervenção coronária percutânea e confirmar o sucesso funcional dessa última. Em uma edição anterior do Journal of Transcatheter Interventions, apresentamos uma revisão abrangente sobre o fluxo fracionado de reserva do miocárdio. Apesar do robusto corpo de evidências que apoiam seu uso, a aceitação clínica do fluxo fracionado de reserva é variável e excessivamente baixa em muitas áreas do mundo. O aumento percebido no tempo do procedimento, o uso de agentes hiperêmicos com seus correspondentes custos e desconforto do paciente, e a dificuldade de interpretação dos resultados em determinadas situações anatômicas contribuíram para a adoção limitada do método. A introdução do índice de fluxo instantâneo no período livre de ondas superou a maioria dessas limitações. Apoiada por uma validação técnica sólida e dados de desfechos clínicos, o índice de fluxo instantâneo no período livre de ondas recebeu as mesmas indicações clínicas que o fluxo fracionado de reserva nas recomendações mais recentes das diretrizes. Isso foi seguido pela introdução de outros índices pressóricos não hiperêmicos, já comercialmente disponíveis. Neste artigo, revisamos as bases fisiológicas que justificam o uso de índices pressóricos não hiperêmicos, sua validação técnica e clínica e dados de desfechos clínicos, além de discutirmos suas aplicações em situações anatômicas específicas, com exemplos de casos dos autores, sempre que aplicável.

Coronary physiology has become the standard of care to assess the functional significance of coronary atherosclerotic disease. It allows for identification of myocardial ischemia on a vessel level, discrimination of the functional patterns of atherosclerotic disease, guidance for the need of revascularization, complements the planning of percutaneous coronary intervention and verification of the functional success of percutaneous coronary intervention. On a previous issue of the Journal of Transcatheter Interventions, we presented a comprehensive review about fractional flow reserve. Despite the robust body of evidence supporting its use, the clinical use of fractional flow reserve is variable, and unreasonably low in many areas around the globe. The perceived increase in procedure time, the use of hyperemic agents with its related costs and patient discomfort, and difficulty in interpreting results in certain anatomical scenarios have contributed to the limited adoption of fractional flow reserve. The introduction of instantaneous wave-free ratio overcame most of these limitations. Supported by sound technical validation, and clinical outcomes data, instantaneous wave-free ratio received the same clinical indications as fractional flow reserve in the most recent guidelines recommendations. This was followed by the introduction of other non- hyperemic pressure ratios for commercial use. In the current manuscript we review the physiological basis that supports the use of non-hyperemic pressure ratios, their technical and clinical validation, clinical outcomes data, and discuss its applications on specific anatomic scenarios, with examples of cases from the authors, whenever applicable.

Fluxo fracionado de reserva do miocárdio: bases fisiológicas, aplicações clínicas e limitações / Fractional flow reserve: physiological bases, clinical applications and limitations

A avaliação fisiológica invasiva da circulação coronariana emergiu nos últimos anos como uma abordagem diagnóstica valiosa no manejo de pacientes com síndrome coronariana crônica, contornando limitações importantes como avaliar função a partir da anatomia e a baixa resolução espacial associada à angiografia ou testes não invasivos. O valor das medidas de fluxo hiperêmico para estimar a relevância funcional das estenoses coronárias é suportado por um grande número de estudos. O objetivo do presente artigo é rever as principais bases fisiológicas, aplicações clínicas e limitações do fluxo fracionado de reserva do miocárdio, o principal índice utilizado na avaliação funcional invasiva da circulação coronariana.

Invasive physiological assessment of the coronary circulation has emerged in recent years as a valuable diagnostic approach in the management of patients with chronic coronary syndrome, overcoming important limitations such as evaluating function from the anatomy and the low spatial resolution associated with angiography or non-invasive tests. The value of hyperemic flow measurements to estimate the functional relevance of coronary stenoses is supported by many studies. The aim of this paper is to review the physiological bases, clinical applications and limitations of myocardial fractional flow reserve, the main index used in the invasive functional assessment of the coronary circulation.

Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions: The iSIGHT Randomized Trial.

[Figure: see text].

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Healing and early stent coverage after ultrathin strut biodegradable polymer-coated sirolimus-eluting stent implantation: SiBi optical coherence tomography study.

AIMS: The aim of SiBi study was to evaluate the early vascular healing and neointimal coverage after implantation of ultrathin (60 µm) biodegradable polymer-coated Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent (SES) using optical coherence tomography (OCT) at 4 to 6 weeks after implantation. METHODS: SiBi was a single-center, observational, investigator-initiated study. From January 15, 2018 to April 15, 2018, total 29 consecutive patients who had consented and underwent OCT examination at 4-6 weeks after Tetriflex SES implantation were enrolled. All OCT images were analyzed at an independent core laboratory by analysts who were blinded to patient and procedural information. RESULTS: Of 29 patients, four patients were excluded, as those OCT images were technically inadequate for analysis. Therefore, 25 patients were included in final OCT analysis. Average OCT analysis was performed after 35.3 ± 5 days of Tetriflex implantation. Total 14,024 stent struts in 1,520 cross sections were analyzed. Strut tissue coverage was observed in 91.26 ± 5.53% of struts and malapposed struts were seen in 0.89 ± 1.67%. The mean neointimal hyperplasia (NIH) thickness on the covered struts was 50 ± 30 µm. CONCLUSION: A large percentage of struts were found to be covered with thin layer of NIH evenly distributed along the stent length at around 1 month from stent implantation. The results of this pilot study serve as ethical and scientific backbone to conduct an adequately powered clinical trial to evaluate outcomes of short dual-antiplatelet therapy in context of ultrathin strut stent.

Comparison of neointimal coverage between ultrathin biodegradable polymer-coated sirolimus-eluting stents and durable polymer-coated everolimus-eluting stents: 6 months optical coherence tomography follow-up from the TAXCO study.

AIM: The TAXCO study was designed to compare the degree of neointimal coverage and the prevalence of malapposition at 6 months subsequent to implantation of ultrathin biodegradable polymer-coated sirolimus-eluting stents (SES) and durable polymer-coated everolimus-eluting stents (EES) of thin strut thickness using optical coherence tomography (OCT). METHODS: The TAXCO study included a total of 42 patients who gave consent and underwent OCT examination between August 2017 and September 2017. Of 42, five patients' OCT examinations were of insufficient quality for quantitative analysis. Thus, the OCT analysis group consisted of 37 patients. Among them, 16 patients were treated with Xience (Abbott Vascular) and 21 with Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), 6 (±1) months earlier at our institution. The OCT was performed using a C7 Dragonfly™ imaging catheter (St. Jude Medical Inc.). All OCT images were analyzed at an independent core laboratory (Cardiovascular Research Center, São Paulo, Brazil) by analysts who were blinded to patient and procedural information. RESULTS: A total of 763 crosssections (6,882 struts) were analyzed in Xience group, and 1,127 crosssections (9,968 struts) in Tetriflex group. At 6 months, on per-lesion basis, no significant differences were observed between Xience group and Tetriflex group in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137) and malapposed struts (0.05 ± 0.2 vs. 0.21 ± 0.69, p = .302). Strut-level neointimal thickness also did not differ between Xience group and Tetriflex group (0.18 ± 0.12 vs. 0.14 ± 0.08 mm, p = .286). CONCLUSION: This OCT study found no significant difference in strut coverage and neointimal thickness at 6 months after implantation of biodegradable polymer-coated Tetriflex, when compared with durable polymer-coated Xience.

Adequação das práticas do laboratório de cateterismo durante a pandemia de COVID-19: o protocolo do Instituto Dante Pazzanese de Cardiologia / Adapted Catheterization Laboratory Practices during the COVID-19 Pandemic: The Instituto Dante Pazzanese de Cardiologia Protocol

Introdução A pandemia global da doença de coronavírus 2019 (COVID-19) causada pelo novo vírus de síndrome respiratória aguda grave coronavírus 2 (SARS-CoV-2) começou em Wuhan, China, em dezembro de 2019 e afetou mais de 4,4 milhões de pessoas em todo o mundo, com 302.169 mortes até o dia 16 de maio de 2020.1 Embora os sintomas respiratórios sejam a apresentação mais comum de COVID-19, o envolvimento cardíaco é uma característica proeminente dessa doença, ocorrendo em 20% a 30% dos pacientes hospitalizados e contribuindo para 40% dos óbitos.2-4 O envolvimento cardíaco relacionado à COVID-19 tem sido documentado por elevações em biomarcadores cardíacos e frequentemente apresenta alterações no segmento ST-T no eletrocardiograma (ECG) de 12 derivações, motivo pelo qual a equipe do laboratório de cateterismo é frequentemente ativada. Além disso, as atividades do laboratório de cateterismo devem continuar no atendimento a pacientes não COVID-19 que apresentam síndrome coronariana aguda (SCA) verdadeira, infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST) e doença cardíaca isquêmica estável muito sintomática. Devido à escalada no número de casos de COVID-19 na cidade de São Paulo, epicentro da doença no Brasil, reformularam-se a logística e as práticas no laboratório de cateterismo cardíaco do Instituto Dante Pazzanese de Cardiologia, que entraram em vigor em abril de 2020 e continuarão durante o período da pandemia. Os objetivos são fornecer atendimento otimizado à população que necessita de procedimentos cardíacos invasivos durante a pandemia, com a proteção adequada aos profissionais de saúde (PS), pacientes e seus familiares. Os protocolos aqui descritos representam os esforços multidisciplinares e dinâmicos do Departamento de Cardiologia Invasiva do Instituto Dante Pazzanese de Cardiologia validados pelo Comitê de Controle de Infecção da instituição. Essas práticas estão sujeitas a alterações em função do estado epidemiológico local, a fase da epidemia e a disponibilidade de equipamento de proteção individual (EPI). Estes protocolos podem não se aplicar a outras localidades sem casos (ou casos esporádicos) de COVID-19 ou a serviços que atendem diferentes perfis populacionais com logísticas e disponibilidade de EPI diversas.

Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system.

AIMS: We aimed to assess the safety and efficacy of the DynamX Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements. METHODS AND RESULTS: This multicentre study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Up to 12 months, two target lesion failures occurred: both were cardiac deaths (day 255 and day 267 post procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility, with an approximate lumen area variance of 11% between systole and diastole. CONCLUSIONS: The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy up to one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomised trials are required to assess the benefit of this device on events beyond one year.