Assessing the Accuracy of a Second-Generation Optical Sensor Pressure Wire in a Wire-to-Wire Comparison (The ACCURACY Study).

BACKGROUND: The phenomenon of "pressure drift" increases uncertainty about the correct FFR value. Redesigned and incorporating an optical pressure sensor, the "OptoWire Deux™" is purported to be less prone to the pressure drift seen with piezoelectric coronary pressure wires. The aim of this first in vivo real-world clinical study is to evaluate the performance of OptoWire Deux™ in terms of measurements agreement and propensity to pressure drift in a wire to wire comparison. METHODS: This is a single center, prospective, non-blinded clinical investigation enrolling 45 consecutive patients with a clinical indication for coronary lesion FFR assessment. Lesions were either simultaneously assessed with two optical sensor pressure wires (OSPW) (Group O-O; 30 patients, 34 lesions) or one OSPW and one piezoelectric pressure wire (PEPW) simultaneously (Group O-P; 15 patients, 15 lesions). Significant drift was defined as a pressure ratio deviation of >0.03. RESULTS: Mean FFR measurements in Group OO were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group OP, however, mean FFR measurement with PEPW (0.85±0.09) was numerically lower than that observed with the OSPW (0.88±0.08; P = 0.09). Level of agreement using the Bland-Altman method was higher when 2 OSPW were used for FFR assessment (-0.002 95% CI [-0.033,0.029] vs. 0.026 95% CI [-0.078, 0.130], respectively). The rate of drift was significantly lower with an OSPW compared to a PEPW (4.8% vs. 26.7% respectively, P = 0.02). CONCLUSION: The optical sensor guidewire showed a high level of readings' agreement after simultaneous usage of 2 optical sensor guidewires. There was also significantly less drift when compared to a piezoelectric guidewire.

Percutaneous Mechanical Circulatory Support in Post-Myocardial Infarction Cardiogenic Shock: A Systematic Review and Meta-analysis.

BACKGROUND: Cardiogenic shock (CS) complicates 5%-10% of acute myocardial infarction (AMI) and is the leading cause of early mortality. It remains unclear whether percutaneous mechanical support (pMCS) devices improve post-AMI CS outcome. METHODS: A systematic review of original studies comparing the effect of pMCS on AMI-CS mortality was conducted with the use of Medline, Embase, Google Scholar, and the Cochrane Library databases. RESULTS: Of 8672 records, 50 were retained for quantitative analysis. Four additional references were added from other sources. Four references reported a significant mortality reduction with intra-aortic balloon pump (IABP) in patients with failed primary percutaneous coronary intervention (pPCI) or managed with thrombolysis. Meta-analyses showed no advantage of Impella over conventional therapy (pooled OR 0.55, 95% CI 0.20-1.46; I2 = 0.85) and increased mortality compared with IABP (pooled OR 1.32; 95% CI 1.08-1.62; I2 = 0.85). No study reported a mortality advantage for extracorporeal membrane oxygenation (ECMO) over conventional therapy, IABP, or Impella support. Early mortality might be improved with the addition of IABP or Impella to ECMO. Bleeding Academic Research Consortium ≥ 3 bleeding was increased with every pMCS strategy. CONCLUSIONS: The current evidence is of poor to moderate quality, with only 1 in 5 included articles reporting randomised data and several reporting unadjusted outcomes. Yet, there is some evidence to favour IABP use in the setting of thrombolysis or with failed pPCI, and adding IABP or Impella should be considered for patients requiring ECMO.

Implications of COVID-19 on Time-Sensitive STEMI Care: A Report From a North American Epicenter.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has forced dramatic changes to the healthcare systems throughout the world. Time-sensitive management of cardiovascular emergencies such as ST-elevation myocardial infarction (STEMI) has yet to be evaluated in the context of these new policies, particularly in so-called "hot spot" cities. METHODS: We evaluated the early impact of the pandemic on STEMI performance in the Greater Montreal Area. A total of 167 patients from 3 different study periods were included. Patients presenting in the lockdown period from mid-March to mid-May 2020 (Group C, 53 patients) were compared to those from mid-March to mid-May 2019 (Group A, 60 patients) and the 2020 pre-COVID-19 period (Group B, 54 patients). RESULTS: The number of STEMI admissions was unaffected during the lockdown. However, significantly longer delays between symptom onset and first medical contact (FMC) were noted (Group C 189.0 IQR [70.0, 840.0] min vs. Group A 103.0 IQR [42.5, 263.0] min vs. Group B 91.0 IQR [38.0, 235.5 min], P = 0.007). In contrast, additional safety protocols do not appear to have significantly affected delays between FMC and first intracoronary device activation (Group C 102 IQR [73.0, 133.0] min vs. Group A 104 IQR [87.0, 146.0] min vs. Group B 99.5 IQR [80.0, 150.0] min, P = 0.37). Patients that presented during the outbreak were more likely to be unstable with a higher incidence of Killip classes II-IV compared to groups A and B (28.3% vs. 18.3% vs. 5.6% respectively, P = 0.008). Worse in-hospital outcomes were also noted with a significantly higher rate of major adverse cardiac events (Group A 5.0% vs. Group B 11.1% vs. Group C 22.6%, P = 0.007). CONCLUSION: During the lockdown period, many patients appear to have been reluctant to present to hospitals. This was associated with more unstable STEMI presentations and worse in-hospital course. Importantly, the health care system appears able to ensure timely acute cardiac care while ensuring that COVID-19 protocols are respected.

Effect of Real-Time Physician Oversight of Prehospital STEMI Diagnosis on ECG-Inappropriate and False Positive Catheterization Laboratory Activation.

BACKGROUND: ST-elevation myocardial infarction diagnosis at first medical contact (FMC) and prehospital cardiac catheterization laboratory (CCL) activation are associated with reduced total ischemic time and therefore have become the dominant ST-elevation myocardial infarction referral method in primary percutaneous coronary intervention systems. We sought to determine whether physician oversight was associated with improved diagnostic performance in a prehospital CCL activation system and what effect the additional interpretation has on treatment delay. METHODS: Between 2012 and 2015, all patients in 2 greater Montreal catchment areas with a chief symptom of chest paint or dyspnea had an in-the-field electrocardiogram (ECG). A machine diagnosis of "acute myocardial infarction" resulted either in automatic CCL (automated cohort without oversight) or transmission of the ECG to the receiving centre emergency physician for reinterpretation before CCL activation. System performance was assessed in terms of the proportion of false positive and inappropriate activations (IA), as well as the proportion of patients with FMC-to-device times ≤ 90 minutes. RESULTS: Four hundred twenty-eight (428) activations were analyzed (311 automated; 117 with physician oversight). Physician oversight tended to decrease IAs (7% vs 3%; P = 0.062), but was also associated with a smaller proportion of patients achieving target FMC-to-device (76% vs 60%; P < 0.001). There was no significant effect on the proportion of false positive activation. CONCLUSIONS: Real-time physician oversight might be associated with fewer IAs, but also appears to have a deleterious effect on FMC-to-device performance. Identifying predictors of IA could improve overall performance by selecting ECGs that merit physician oversight and streamlining others. Larger clinical studies are warranted.

CONTEXTE: Un diagnostic d'infarctus du myocarde avec élévation du segment ST au moment du premier contact avec un professionnel de la santé et l'activation du processus de cathétérisme cardiaque avant l'arrivée à l'hôpital sont associés à une réduction de la durée totale de l'épisode ischémique, et sont donc désormais la méthode de préférence en cas d'infarctus du myocarde avec élévation du segment ST dans les établissements où l'intervention coronarienne percutanée primaire est possible. Nous avons voulu déterminer si la supervision par un médecin était associée à une amélioration de la justesse du diagnostic dans un tel contexte et les répercussions d'une interprétation additionnelle sur les délais de traitement. MÉTHODOLOGIE: De 2012 à 2015, tous les patients de deux zones desservies du Grand Montréal qui présentaient comme principal symptôme une douleur à la poitrine ou une dyspnée ont subi un électrocardiogramme (ECG) sur le terrain. Un diagnostic d'infarctus aigu du myocarde posé par l'appareil a automatiquement donné lieu à l'activation du processus de cathétérisme cardiaque (cohorte automatisée sans supervision) ou à la transmission de l'ECG à l'urgentologue de l'établissement où le patient était conduit pour la réinterprétation des résultats avant l'activation du processus de cathétérisme cardiaque. La performance du système a été évaluée en fonction de la proportion de faux positifs et d'activations inappropriées, ainsi que de la proportion de patients chez qui le délai entre le premier contact avec un professionnel de la santé et l'intervention était ≤ 90 minutes. RÉSULTATS: Quatre cent vingt-huit (428) activations du processus ont été analysées (311 automatisées; 117 après la supervision par un médecin). La supervision par un médecin était associée à une baisse non significative des activations inappropriées du processus (7 % vs 3 %; p = 0,062), mais était aussi associée à une plus faible proportion de patients chez qui le délai visé entre le premier contact avec un professionnel de la santé et l'intervention était respecté (76 % vs 60 %; p < 0,001). Aucun effet significatif quant à la proportion de faux positifs n'a été observé. CONCLUSIONS: La supervision en temps réel par un médecin pourrait être associée à une réduction des activations inappropriées du processus de cathétérisme cardiaque urgent, mais pourrait également nuire aux résultats quant au délai entre le premier contact avec un professionnel de la santé et l'intervention. L'identification des facteurs prédictifs d'une activation inappropriée du processus pourrait améliorer les résultats globaux en permettant de choisir les résultats d'ECG qui mériteraient d'être passés en revue par le médecin, et en déclenchant le processus habituel pour les autres. Des études cliniques de plus grande envergure sont de mise.

Impact of STEMI Diagnosis and Catheterization Laboratory Activation Systems on Sex- and Age-Based Differences in Treatment Delay.

BACKGROUND: Women and the elderly with ST-elevation myocardial infarction (STEMI) experience longer treatment delays despite prehospital STEMI diagnosis and catheterization laboratory activation systems. It is not known what role specific STEMI referral systems might play in mediating this gap in care. We therefore examined sex- and age-based differences in STEMI treatment delay (TD) in different STEMI activation systems. METHODS: This observational comparative effectiveness study comprised 3 retrospective STEMI cohorts: a traditional hospital-based activation cohort (Cohort 1), an automated "physician-blind" prehospital activation cohort (Cohort 2), and a prehospital activation with real-time physician oversight cohort (Cohort 3). Outcomes of interest included sex and age group (< or ≥ 75 years) differences in suboptimal (> 90 minutes) first medical contact-to-device time (FMC-to-device) within each cohort, as well as independent predictors of suboptimal FMC-to-device and in-hospital mortality across cohorts. RESULTS: Five hundred-sixty STEMI activations were analyzed. In Cohort 1 (n = 179), women and those ≥ 75 were more likely to experience suboptimal FMC-to-device times (78.7% vs 36.4%, P = 0.02 and 85.0% vs 58.3%, < 0.01, respectively). Similar findings were observed in Cohort 3 (n = 109) (53.5% vs 32.9%, 56.5% vs 33.3%, respectively; P = 0.05, for both). In Cohort 2 (n = 272), however, there was no significant age-based difference (30.4% vs 21.7%, P = 0.18), and the gap was numerically lower but still significant for women (32.1% vs 20.1%, P = 0.04). When examining prehospital activation cohorts only, female sex (P = 0.03), off-hours presentation (P < 0.01), and physician oversight (P < 0.01) were independent predictors of longer FMC-to-device times. Age ≥ 75 (P < 0.01), Killip class (P < 0.01), and female sex (P = 0.04) were independently associated with in-hospital mortality. CONCLUSIONS: Automated "physician-blind" STEMI activation was associated with a reduced TD gap in women and the elderly, suggesting possible systemic bias. Appropriately powered confirmatory studies are required, but incorporating automated diagnosis and catheterization laboratory activation may be a solution to treatment gaps in STEMI care.

INTRODUCTION: Les femmes et les personnes présentant ont un infarctus du myocarde avec élévation du segment ST (STEMI) subissent de plus longs retards de traitement en dépit du diagnostic préhospitalier de STEMI et des systèmes d'activation de laboratoires de cathétérisme. On ignore le rôle que pourraient jouer les systèmes d'aiguillage des personnes atteintes de STEMI pour combler cette lacune en matière de soins. Nous avons donc examiné les différences selon le sexe et l'âge dans le retard de traitement du STEMI des différents systèmes d'activation de laboratoire en présence de STEMI. MÉTHODES: La présente étude comparative sur l'efficacité regroupait trois cohortes rétrospectives de STEMI : une cohorte traditionnelle d'activation à l'hôpital (cohorte 1), une cohorte d'activation du laboratoire lors de diagnostic préhospitalier automatisé « à l'insu du médecin ¼ (cohorte 2) et une cohorte d'activation du laboratoire de diagnostic préhospitalier dont la surveillance est assurée par un médecin en temps réel (cohorte 3). Les critères d'intérêt étaient les différences selon le sexe et le groupe d'âge (< ou ≥ 75 ans) dans le taux d'intervalle sous-optimal entre la première prise de contact avec les services médicaux et la pose d'un dispositif (> 90 minutes) au sein de chaque cohorte, ainsi que les prédicteurs indépendants de l'intervalle sous-optimal entre la première prise de contact avec les services médicaux et la pose d'un dispositif et la mortalité à l'hôpital de toutes les cohortes. RÉSULTATS: Cinq cents soixante (560) activations de diagnostic de STEMI ont fait l'objet d'une analyse. Dans la cohorte 1 (n = 179), les femmes et les personnes ≥ 75 ans étaient plus susceptibles de subir des intervalles sous-optimaux entre la première prise de contact avec les services médicaux et la pose d'un dispositif (78,7 % vs 36,4 %, P = 0,02 et 85,0 % vs 58,3 %, < 0,01, respectivement). Nous avons observé des résultats similaires dans la cohorte 3 (n = 109) (53,5 % vs 32,9 %, 56,5 % vs 33,3 %, respectivement ; P = 0,05, pour les deux). Toutefois, dans la cohorte 2 (n = 272), il n'y avait aucune différence significative selon l'âge (30,4 % vs 21,7 %, P = 0,18) et l'écart était numériquement plus faible, mais encore significatif chez les femmes (32,1 % vs 20,1 %, P = 0,04). Lorsque nous examinions seulement les cohortes d'activation du laboratoire lors de diagnostic préhospitalier, le sexe féminin (P = 0,03), la survenue dans les heures creuses (P < 0,01) et la surveillance du médecin (P < 0,01) étaient des prédicteurs indépendants d'intervalles plus longs entre la première prise de contact avec les services médicaux et la pose d'un dispositif. L'âge ≥ 75 ans (P < 0,01), la classification de Killip (P < 0,01) et le sexe féminin (P < 0,04) étaient indépendamment associés à la mortalité à l'hôpital. CONCLUSIONS: L'activation du laboratoire lors de diagnostic automatisé du STEMI « à l'insu du médecin ¼ a été associée à une réduction de l'écart dans le retard de traitement chez les femmes et les personnes âgées. Ceci indique un possible biais systémique. Des études confirmatives d'une puissance suffisante sont nécessaires, mais l'incorporation du diagnostic et de l'activation du laboratoire de cathétérisme atuomatisés peut être une solution aux écarts de traitement dans les soins de STEMI.

The COVID-19 Pandemic and Coronary Angiography for ST-Elevation Myocardial Infarction, Use of Mechanical Support, and Mechanical Complications in Canada: A Canadian Association of Interventional Cardiology National Survey.

BACKGROUND: As a result of the COVID-19 pandemic first wave, reductions in ST-elevation myocardial infarction (STEMI) invasive care, ranging from 23% to 76%, have been reported from various countries. Whether this change had any impact on coronary angiography (CA) volume or on mechanical support device use for STEMI and post-STEMI mechanical complications in Canada is unknown. METHODS: We administered a Canada-wide survey to all cardiac catheterization laboratory directors, seeking the volume of CA use for STEMI performed during the period from March 1 2020 to May 31, 2020 (pandemic period), and during 2 control periods (March 1, 2019 to May 31, 2019 and March 1, 2018 to May 31, 2018). The number of left ventricular support devices used, as well as the number of ventricular septal defects and papillary muscle rupture cases diagnosed, was also recorded. We also assessed whether the number of COVID-19 cases recorded in each province was associated with STEMI-related CA volume. RESULTS: A total of 41 of 42 Canadian catheterization laboratories (98%) provided data. There was a modest but statistically significant 16% reduction (incidence rate ratio [IRR] 0.84; 95% confidence interval 0.80-0.87) in CA for STEMI during the first wave of the pandemic, compared to control periods. IRR was not associated with provincial COVID-19 caseload. We observed a 26% reduction (IRR 0.74; 95% confidence interval 0.61-0.89) in the use of intra-aortic balloon pump use for STEMI. Use of an Impella pump and mechanical complications from STEMI were exceedingly rare. CONCLUSIONS: We observed a modest 16% decrease in use of CA for STEMI during the pandemic first wave in Canada, lower than the level reported in other countries. Provincial COVID-19 caseload did not influence this reduction.

INTRODUCTION: Après la première vague de la pandémie de COVID-19, de nombreux pays ont déclaré une réduction de 23 % à 76 % des soins invasifs de l'infarctus du myocarde avec élévation du segment ST (STEMI). On ignore si ce changement a entraîné des répercussions sur le volume d'angiographies coronariennes (AC) ou sur l'utilisation des dispositifs d'assistance mécanique lors de STEMI et des complications mécaniques post-STEMI au Canada. MÉTHODES: Nous avons réalisé un sondage pancanadien auprès de tous les directeurs de laboratoire de cathétérisme cardiaque pour obtenir le volume d'utilisation des AC lors des STEMI réalisées durant la période du 1er mars 2020 au 31 mai 2020 (période de pandémie) et durant 2 périodes témoins (1er mars 2019 au 31 mai 2019 et 1er mars 2018 au 31 mai 2018). Le nombre de dispositifs d'assistance ventriculaire gauche utilisés et le nombre de cas de communications interventriculaires et de ruptures du muscle papillaire diagnostiqués ont également été enregistrés. Nous avons aussi évalué si le nombre de cas de COVID-19 enregistrés dans chaque province était associé au volume d'AC liées aux STEMI. RÉSULTATS: Au total, 41 des 42 laboratoires canadiens de cathétérisme (98 %) ont fourni des données. Lors de la comparaison de la première vague de la pandémie aux périodes témoins, nous avons noté une réduction modeste, mais significative, sur le plan statistique de 16 % (ratio du taux d'incidence [RTI] 0,84; intervalle de confiance à 95 % 0,80-0,87) des AC lors de STEMI. Le RTI n'était pas associé au nombre provincial de cas de COVID-19. Nous avons observé une réduction de 26 % (RTI 0,74; intervalle de confiance à 95 % 0,61-0,89) de l'utilisation de pompes à ballonnet intra-aortique lors de STEMI. L'utilisation d'une pompe Impella et les complications mécaniques après les STEMI étaient extrêmement rares. CONCLUSIONS: Nous avons observé une diminution modeste de 16 % de l'utilisation des AC lors de STEMI durant la première vague de la pandémie au Canada, soit une diminution plus faible que ce que les autres pays ont signalé. Le nombre provincial de cas de COVID-19 n'a pas influencé cette réduction.

Safety and Performance of the Orsiro Sirolimus-Eluting Stent in the Treatment of All-Comers Patient Population in Daily Clinical Practice.

BACKGROUND: The BIOFLOW-III Canada registry aimed to evaluate the safety and efficacy of Orsiro sirolimus-eluting stents (SES) with biodegradable polymer, in an all-comers patient population. METHODS: We conducted a prospective, non-randomized, multi-center, observational all-comers registry of patients undergoing percutaneous coronary intervention (PCI) with Orsiro SES at two high-volume Canadian centers. The primary endpoint was one-year target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (MI), coronary artery bypass grafting and clinically driven target lesion revascularization. Four subgroups were pre-defined: i) diabetic patients; ii) small vessels (≤2.75 mm); iii) chronic total occlusions (CTO) and iv) acute MI. RESULTS: From May 2014 to July 2016, 250 patients (mean age 66.2 ± 10.8 years, 75.6% males, 30% diabetes) underwent PCI with Orsiro SES for 385 coronary lesions. The mean stent diameter was 2.98 ± 0.50 mm and the mean stent length was 22 ± 8 mm. Clinical device and procedural success rates were with 99.5% and 97.6%, respectively. The overall one-year TLF rate was 2.8% [95% confidence interval (CI) 1.4-5.8%], whereas TLF rates were 4.1% [95%CI 1.3-12.2%], 3.2% [95%CI 1.2-8.4%], 8.3% [95%CI 2.2-29.4%], and 2.6% [95%CI 0.7-9.9%] in patients with diabetes, small vessels, CTO, and acute MI, respectively. One case of possible stent thrombosis (ST) was reported (0.4% [95%CI 0.1-2.8%]), while no cases of definite/probable ST was observed at one year. CONCLUSION: Our data provide further evidence of the safety and clinical performance of Orsiro SES in an unselected, real-world, complex patient population. CONDENSED ABSTRACT: The BIOFLOW-III Canada registry is a prospective, non-randomized, multi-center, observational all-comers registry designed to evaluate the safety and performance of the Orsiro SES in non-selected, real-world patients. A total of 250 patients (mean age 66.2 ± 10.8 years, 75.6% males, 30% diabetes) who underwent PCI with Orsiro SES, were enrolled at two high-volume Canadian centers. The overall rate of TLF at one year was 2.8% [95%CI 1.4-5.8%], whereas TLF rates were 4.1%, 3.2%, 8.3%, and 2.6% in patients with diabetes, small vessels ≤2.75 mm, CTO, and acute MI, respectively. No case of definite/probable ST was observed.

Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.

BACKGROUND: Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking. METHODS: COMPARE-AMI is a double-blind, placebo-controlled phase II clinical trial evaluating the safety and efficacy of IC injection of CD133+ enriched hematopoietic BMSC in patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI). Herein, we report outcomes up to ten years of follow-up. RESULTS: Between November 2007 and July 2012, we enrolled 38 patients in our study. Males were 89% and the median age was 50.5 years. Baseline left ventricular ejection fraction (LVEF) was 40.0%, and 90% of lesions were located in the left anterior descending (LAD) artery. The median follow-up time was 8.5 years IQR [7.9, 10.0]. Using Kaplan-Meier methods, MACE-free survival up to 10 years was 77.3% overall. IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37). Two cancer cases in each group were recorded. No malignant arrhythmias were observed. CONCLUSIONS: IC injection of CD133+ BMSC is safe up to 10 years of follow-up. The long-term efficacy needs to be confirmed by a larger randomized trial.

Time-trends and treatment gaps in the antithrombotic management of patients with atrial fibrillation after percutaneous coronary intervention: Insights from the CHUM AF-STENT Registry.

BACKGROUND: The management of atrial fibrillation and flutter (AF) patients undergoing percutaneous coronary intervention (PCI) has undergone a rapid recent evolution. In 2016, the Canadian Cardiovascular Society (CCS) published expert recommendations to help guide clinicians in balancing bleeding and thrombotic risks in these patients. HYPOTHESIS: Antithrombotic regimen prescriptions for AF patients undergoing PCI evolved after the publication of the 2016 CCS AF guidelines. METHODS: A prospective cohort of AF patients undergoing PCI with placement of a coronary stent from a single tertiary academic center was analyzed for the recommended antithrombotic regimen at discharge. Prescribing behavior was compared between three time periods (Cohort A [2010-2011]; Cohort B [2014-2015]; Cohort C [2017]) using the χ2 test. In addition, antithrombotic management in Cohorts B and C were compared to guideline-recommended therapy. RESULTS: A total of 459 patients with AF undergoing PCI were identified. Clinical and procedural characteristics were similar between cohorts, with the exception of an increase in drug-eluting stent (DES) use over time (P < .01). Overall, the rate of oral anticoagulation (OAC) increased over time (P < .01), associated with an increase in nonvitamin K OAC prescription (P < .01) and a concomitant decrease in vitamin K antagonist prescription (P < .01). Despite this, the overall rate of anticoagulation remains below what would be predicted with perfect guideline compliance (75% vs 94%, P < .01). CONCLUSION: There has been a dramatic shift in clinical practice for AF patients requiring PCI, with increases in prescription of OAC even in the context of an increase in the use of DES. However, room for further practice optimization still exists.

A multi-centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol.

OBJECTIVES: This international, multicentre study will inform the final data collection tools and processes which will comprise the first international, clinical research registry for complex regional pain syndrome (CRPS). This study will: (a) test the feasibility and acceptability of collecting outcome measurement data using a patient reported, questionnaire core measurement set (COMPACT [Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies]); and (b) test and refine an electronic data management system to collect and manage the data. METHODS: A maximum of 240 adults, meeting the Budapest diagnostic clinical criteria for CRPS type I or II, will be recruited across eight countries. The COMPACT questionnaire will be completed on two occasions: at baseline (T1) and 6 months later (T2). At T2, participants will choose to complete COMPACT using a paper or electronic version. Participants will be asked to feed back on their experience of completing COMPACT via a questionnaire. A separate questionnaire will ask clinicians to feed back their experience of data collection. ANALYSIS: The study is not aiming to derive statistically significant data but to ascertain the practicalities of collecting data, using the COMPACT questionnaire set, across a range of different cultures and populations. At the end of the study, a single workshop will be convened to review the findings and agree the final documents and processes for the international registry.

Longer Inflation Duration and Predilation-Sizing-Postdilation Improve Bioresorbable Scaffold Outcomes in a Long-term All-Comers Canadian Registry.

BACKGROUND: Real-world long-term safety and efficacy of the ABSORB (Abbott Vascular, Santa Clara, CA) bioresorbable vascular scaffold has not been well characterized in the literature, particularly in the setting of acute coronary syndromes (ACS). Herein, we report outcomes up to 4 years in such a high-risk cohort, with identification of parameters associated with better outcomes. METHODS: ReABSORB is a Canadian dual-centre, prospective, nonrandomized, all-comers registry consisting of 125 consecutively enrolled nontrial patients between October 2012 and December 2016. Angiographic and clinical follow-up is now available up to 4 years. RESULTS: Average age was 59 ± 11 years and 69% were male. Most (70.4%) presented with ACS and the median available follow-up was 1330 days (interquartile range, 1035-1483). Treated lesions (n = 163) were type A in 23%, type B (1 or 2) in 64%, and type C in 13%. Procedural success and device success were 98.2% and 98.8%, respectively. Using Kaplan-Meier methods, major adverse cardiac event-free survival (EFS) up to 4 years of clinical follow-up was 90.7% overall. However, use of a predilation-sizing-postdilation (PSP) technique was associated with an EFS rate of 95.8% vs 74.0% without PSP (P = 0.001). No significant differences in major adverse cardiac EFS rates were found between patients with or without ACS (92.7% vs 86.0%, respectively, P = 0.239). Use of PSP as well as inflation time ≥ 60 seconds were independent predictors of EFS at 2 years. CONCLUSIONS: In this prospective, real-world registry with mostly ACS patients, use of the recommended PSP implantation technique and longer inflations times were associated with significantly higher EFS.

Potential shift from coronary bypass surgery to percutaneous coronary intervention for multivessel disease and its economic impact in the drug-eluting stent era.

BACKGROUND: Drug-eluting stents (DES) may promote percutaneous coronary intervention (PCI) procedures in patients traditionally referred for coronary artery bypass graft (CABG) surgery and may save money. OBJECTIVES: The purpose of the present study was to quantify the potential shift from CABG surgery to multivessel PCI in the DES era and to model the economic consequences. METHODS: Based on predefined criteria, the feasibility of PCI was evaluated in patients with multivessel coronary artery disease who underwent CABG surgery before the availability of DES at the Centre Hospitalier de l'Université de Montréal's Notre-Dame Hospital (Montreal, Quebec). Modelling was used to evaluate the potential cost savings using multivessel PCI instead of CABG surgery. Equal one-year outcomes in both groups were assumed, with the exception of a 10% repeat revascularization (RR) rate in the DES group and a 4% RR rate in the CABG group. The impact of those assumptions was evaluated using 1000 Monte Carlo simulations. RESULTS: The authors retrospectively evaluated that, of 289 patients who underwent CABG without concomitant valve surgery between January and December 2003, only 22 patients (8%) were good candidates for multivessel DES implantation. The procedures would have involved an average of 3.6 DES per patient. The average cost per revascularization procedure was $14,402 with surgery and $11,220 for multivessel DES implantation (using $2,200 DES), leading to a savings of $3,182 per patient. However, after including RR procedures, PCI would only have been associated with savings of $812 per surgery avoided. Monte Carlo analysis revealed that surgery may be less expensive than PCI in 36% of patients. CONCLUSIONS: Most patients who underwent CABG surgery in 2003 were retrospectively judged to be ineligible for multivessel PCI with DES. In the rare eligible patient, multivessel PCI with DES is not expected to produce savings to health care costs in Canada unless the DES purchase cost continues to decrease.

Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population.

BACKGROUND: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). OBJECTIVE: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. METHODS: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. RESULTS: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). CONCLUSION: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.

Sustained Performance of a "Physicianless" System of Automated Prehospital STEMI Diagnosis and Catheterization Laboratory Activation.

BACKGROUND: Treatment times for primary percutaneous coronary intervention frequently exceed the recommended maximum delay. Automated "physicianless" systems of prehospital cardiac catheterization laboratory (CCL) activation show promise, but have been met with resistance over concerns regarding the potential for false positive and inappropriate activations (IAs). METHODS: From 2010 to 2015, first responders performed electrocardiograms (ECGs) in the field for all patients with a complaint of chest pain or dyspnea. An automated machine diagnosis of "acute myocardial infarction" resulted in immediate CCL activation and direct transfer without transmission or human reinterpretation of the ECG prior to patient arrival. Any activation resulting from a nondiagnostic ECG (no ST-elevation) was deemed an IA, whereas activations resulting from ECG's compatible with ST-elevation myocardial infarction but without angiographic evidence of a coronary event were deemed false positive. In 2012, the referral algorithm was modified to exclude supraventricular tachycardia and left bundle branch block. RESULTS: There were 155 activations in the early cohort (2010-2012; prior to algorithm modification) and 313 in the late cohort (2012-2015). Algorithm modification resulted in a 42% relative decrease in the rate of IAs (12% vs 7%; P < 0.01) without a significant effect on treatment delay. CONCLUSIONS: A combination of prehospital automated ST-elevation myocardial infarction diagnosis and "physicianless" CCL activation is safe and effective in improving treatment delay and these results are sustainable over time. The performance of the referral algorithm in terms of IA and false positive is at least on par with systems that ensure real-time human oversight.

Adult Congenital Heart Disease Intervention: The Canadian Landscape.

Once considered a childhood disease, the number of adults living with congenital heart disease (CHD) has now exceeded the number of pediatric patients. The landscape of percutaneous intervention for adult congenital heart disease (ACHD) has evolved over the past decade and has yet to be characterized in Canada. The aim of this study was to begin to understand the current infrastructure underlying ACHD interventions in Canada and to characterize the type and number of interventions being carried out across the country. A cross-sectional national survey was distributed by e-mail to all cardiac catheterization laboratory directors in 2015. All Canadian laboratories involved in ACHD interventions responded, encompassing 19 institutions spanning 69 cardiac catheterization laboratories. A total of 1451 percutaneous interventions were recorded. Nationwide, the most common simple ACHD interventions were for atrial septal defect and patent foramen ovale closures. The most common ACHD interventions of increased complexity were for coarctation stenting and transcatheter pulmonary valve implantation. There was a marked clustering of procedures in Ontario, Québec, British Columbia, and Alberta in keeping with Canada's population-density distribution. A total of 23 ACHD operators were identified, half of whom had ACHD-specific fellowship training. These data can be used as a starting point to inform the present state of affairs in the area and lay the groundwork for further work to assess resource allocation and human resource planning for the care of patients with ACHD in Canada.

Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT).

Complex regional pain syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers, and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations. The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. "What is the clinical presentation and course of CRPS, and what factors influence it?" was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as follows: pain, disease severity, participation and physical function, emotional and psychological function, self-efficacy, catastrophizing, and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and 1 clinician-reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally.

Impact of intracoronary injection of CD133+ bone marrow stem cells on coronary atherosclerotic progression in patients with STEMI: a COMPARE-AMI IVUS substudy.

OBJECTIVES: Adverse effects of intracoronary injection of stem cells on in-stent restenosis and atherosclerotic progression remain unclear. We sought to evaluate the adverse effects of intracoronary injection of CD133 cells on in-stent restenosis and atherosclerotic progression in the infarct-related and contralateral arteries using serial intravascular ultrasound (IVUS) analysis. METHODS: Baseline and 4-month follow-up IVUS images were obtained from 17 patients treated with intracoronary stem cell injection and 20 placebo patients after primary percutaneous coronary intervention in the COMPARE-AMI trial. In the infarct-related artery, the stented segment, 5 mm proximal and distal reference segments, and proximal and distal nonstented segments were analyzed every 1 mm; the entire segment of a contralateral artery was also analyzed every 1 mm. RESULTS: In the infarct-related artery analysis, the median percentage of in-stent neointimal hyperplasia (12.1 vs. 7.6%, P=0.95), the reduction in the minimum lumen area (MLA; -1.6 vs. -1.5 mm(2), P=0.97), and the MLA at follow-up (4.3 vs. 5.3 mm(2), P=0.21) were found to be similar between the stem cell and placebo groups. Changes in proximal and distal nonstented segment lumen areas and plaque burden were also similar between the stem cell and placebo groups; however, there was a decrease in the maximum arc of the attenuated plaque behind the stent from baseline to follow-up in the placebo group (P=0.004), but not in the stem cell group. In the contralateral artery, there were no differences in changes in MLA, plaque burden, or attenuated plaque between stem cell and placebo patients. CONCLUSION: Intracoronary injection of CD133(+) bone marrow stem cells has no IVUS-detectable effect on neointimal hyperplasia or atherosclerosis progression in either infarct-related or contralateral arteries.

Thrombus formation on guide wires during routine PTCA procedures: a scanning electron microscopic evaluation.

BACKGROUND: Various coatings are used on catheters and guide wires to improve resistance to surface thrombus formation. However, little is known about the thrombogenicity of 0.014" angioplasty guide wires and the protection offered by these coatings. OBJECTIVES: To evaluate the thrombogenicity of five different guide wires used in coronary angioplasty. METHODS: Five different 0.014" guide wire types were evaluated in 50 consecutive angioplasty procedures. At the end of the procedure, the distal part of the guide wire was cut, put in formalin and prepared for scanning electron microscopic evaluation. The condition of each guide wire was then classified into one of three predefined categories: no thrombus, limited thrombus and significant thrombus formation. RESULTS: Silicone (n=10, Guidant, USA), phosphorylcholine polymer (n=8, Biocompatibles, Ireland), hydrophilic polymer (n=8, Scimed, USA) and two Teflon-based coatings (n=16, Schneider, USA; n=8, Cordis, USA) were evaluated. On microscopic examination, 48% of guide wires had a significant amount of thrombus, 18% had limited thrombus formation and 34% had no thrombus. The results were very dissimilar among the groups. Significant thrombus was found on 80% of Guidant guide wires, 69% of Schneider guide wires, 38% of Scimed guide wires and 25% of Cordis guide wires, while none was found on Biocompatibles guide wires (P<0.0001). CONCLUSIONS: Significant thrombus formation on angioplasty guide wires was a frequent finding, occurring in 48% of cases. Resistance to thrombus formation was very dissimilar among coatings, with only the Biocompatibles phosphorylcholine-coated guide wires showing no thrombus formation at all. Whether subclinical thromboembolization occurred in some patients is unknown, and the clinical implications of this study remain to be defined.

Comparison of 5 French versus 6 French guiding catheters for transradial coronary intervention: a prospective, randomized study.

We compared 5 versus 6 French (Fr) guiding catheters in coronary intervention using the transradial approach. Smaller guiding catheters may have advantages over larger ones in transradial coronary intervention. However, there is uncertainty about how small is small enough, and when smaller would become too small. Eligible patients were randomized between the 5 and 6 Fr groups before the procedure. The primary endpoint was procedural success. A total of 216 patients were randomized. Procedural success was obtained in 95% of the 6 Fr group versus 90% of the 5 Fr group (p = 0.25). Most of the failures in the 5 Fr group were because of cross-over to the 6 Fr group. Crossover to the 5 Fr group occurred in 1 patient in the 6 Fr group (0.9%; p = 0.05) because of a small radial artery. Transradial intervention using 5 Fr guiding catheters necessitates crossover to a 6 Fr catheter in 6.8% of cases, and offers no clear advantages over the 6 Fr technique.

Contained rupture of the aortic annulus after transcatheter aortic valve implantation: uncommon presentation of a rare complication.

We report the case of a contained rupture of the aortic annulus after transcatheter aortic valve implantation. The landing zone tear extended cranially to the aortic root and caudally into the perimembranous septum, creating a restrictive ventricular septal defect and severe paravalvular regurgitation into both ventricles, but no pericardial effusion or hemodynamic collapse. We elected conservative management, which proved to be a reasonable option.