A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal

Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI.We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest.Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001).There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular mass (IS/LV) by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group.The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events

Correction: Cardiovascular Risk Factors and Clinical Outcomes among Patients Hospitalized with COVID-19: Findings from the World Heart Federation COVID-19 Study.

This article details a correction to: Prabhakaran D, Singh K, Kondal D, Raspail L, Mohan B, Kato T, et al. Cardiovascular Risk Factors and Clinical Outcomes among Patients Hospitalized with COVID-19: Findings from the World Heart Federation COVID-19 Study. Global Heart. 2022; 17(1): 40. DOI: http://doi.org/10.5334/gh.1128

Appropriateness of myocardial revascularization assessed by SYNTAX Score II in a country with high gross domestic product and an institution with cardiac surgery nearby as well as in a country with low gross domestic product and an institution without cardiac surgery nearby

Einführung: Der SYNTAX Score II (SSII) wurde entworfen als ein Instrument zur objektiven, individualisierten Entscheidungsfindung hinsichtlich der optimalen myokardialen Revaskularisierung, entweder mittels perkutaner Coronarintervention (PCI) oder mittels coronar-arterieller Bypass-Operation (CABG). Wir haben untersucht, wieviele Leben mittels SSII in einem Real-World-Kollektiv gerettet werden könnten. Methoden: Wir inkludierten konsekutiv sämtliche Patienten aus dem Wilhelminenspital (WSP, Wien, Österreich) sowie aus dem Universitätsspital der Republika Srpska (UCC RS, Banja Luka, Bosnien und Herzegovina), welche zwischen 1. Jänner 2008 und 31. Dezember 2010 aufgrund angiographisch (Stenose > 50% des Durchmessers) diagnostizierter koronarer 3-Gefäß-Erkrankung und/oder ungeschützter links-koronarer Hauptstammstenose mittels elektiver PCI behandelt wurden oder zur elektiven CABG-Operation transferiert wurden. Die Gesamtmortalität wurde mittels telefonischer Kontaktaufnahme oder über Sterberegister ermittelt. Der SSII wurde für jeden Patienten individuell mittels Online-Kalkulator errechnet (www.syntaxscore.com). Resultate: Wir untersuchten 1041 konsekutive Patienten (390 aus dem WSP sowie 651 aus dem UCC RS), welche mittels PCI oder CABG therapiert wurden. Der Alters-Median im WSP lag bei 65.0 (58.0-73.0), im UCC RS bei 61.0 (54.0-67.0). Entsprechend dem SSII lag die Empfehlung im WSP bei 85/390 Patienten zugunsten CABG, von diesen wurden 34 (40.0%) tatsächlich CABG unterzogen, der Rest (51/85, 60.0%) wurde mittels PCI therapiert. Drei Patienten von 390 wurden ausschließlich für PCI klassifiziert. Die restlichen 302/390 Patienten wären laut SSII gleich geeignet für PCI sowie CABG gewesen, von diesen wurden 137 (45.4%) mittels CABG sowie 165 (54.6%) mittels PCI behandelt. Entsprechend der Behandlungsempfehlung durch den SSII wären im UCC RS 257/651 (39.5%) mit CABG zu behandeln gewesen, 7 (1.1%) mittels PCI, sowie 387 (59.4%) sowohl mit CABG als auch PCI. Von den 257 Patienten, für die vom SSII CABG empfohlen wurde, wurden 113 (44.0%) tatsächlich CABG unterzogen, die restlichen 144 Patienten (56.0%) wurden PCI unterzogen. Von den 387 Patienten, welche sowohl für CABG als auch für PCI geeignet gewesen wären, wurden 125 (32.3%) mittels CABG sowie 262 (67.7%) mittels PCI therapiert. Diejenigen Patienten in beiden Institutionen, welche PCI unterzogen wurden trotz SSII-CABG-Empfehlung, wiesen eine höhere Mortalität auf verglichen mit Patienten mit konkordanter PCI-Behandlung (WSP: 13.7% vs 8.4%, Log Rank P=0.11; UCC RS: 12.5% vs 6.8%, Log Rank P=0.04). Dementsprechend hat die vorliegende Analyse gezeigt, dass die Anwendung des SSII bei 19 Patienten einen Todesfall in 4 Jahren verhindern könnte. Konklusion: Die vorliegende Studie hat demonstriert, dass sich die intuitive Entscheidungsfindung hinsichtlich der myokardialen Revaskularisationsmethode für den individuellen Patienten (CABG vs PCI) von den SSII Empfehlungen nur für CABG unterschieden hatte (PCI wurde tatsächlich bei 57% durchgeführt). Diskordanz zwischen den SSII Empfehlungen sowie der klinischen Entscheidung hat in höherer 4-Jahres-Mortalität resultiert. Dementsprechend scheint der SSII ein zielführendes Instrument zur Entscheidungsfindung im Management von Patienten mit komplexer koronarer Herzerkrankung zu sein.Introduction: The SYNTAX Score II (SSII) was proposed as a novel approach for objective, indvidualized decision-making for optimal myocardial revascularization i.e. percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. We sought to investigate how many lives may be saved by SSII use in everyday life. Methods: From the Wilhelminenspital, Vienna, Austria (WSP) and University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina (UCC RS), between January 1, 2008, and December 31, 2010, consecutive patients with angiographically (&#8805;50% diameter stenosis) proven 3-vessel CAD and/or significant unprotected left main CAD, who were treated with elective PCI or referred to other institutions for elective CABG surgery were included. All-cause mortality was ascertained by telephone contacts or from Mortality Registries. The SSII was calculated for each patient by using an electronic calculator available on the website www.syntaxscore.com. Results: We evaluated 1041 consecutive patients (390 from WSP and 651 from UCC RS) who underwent PCI or CABG. The median age in WSP and UCC RS was 65.0 (58.0-73.0) and 61.0 (54.0-67.0) years, respectively. According to the SSII in WSP, 85/390 patients had treatment recommendations in favor of CABG, of which 34/85 (40.0%) patients had actually CABG, with the remainder (51/85, 60.0%) who were treated with PCI. Three patients out of 390 were classified for PCI only. The remaining 302/390 patients were allocated by the SSII in a group favoring equally CABG and PCI of which 137/302 (45.4%) underwent CABG and 165/302 (54.6%) underwent PCI. Based on treatment recommendations by SSII in UCC RS, CABG would have been the treatment of choice in 257/651 (39.5%) patients, PCI in 7/651 (1.1%) patients and CABG or PCI in 387/651 (59.4%) patients. Out of 257 patients in whom the treatment recommendations by the SSII was CABG, 113/257 (44.0%) patients had actually CABG, while the remaining 144/257 (56.0%) underwent PCI. Out of 387 patients with the SSII recommendations favoring equally CABG and PCI, 125/387 (32.3%) underwent CABG and 262/387 (67.7%) underwent PCI. Patients who underwent PCI but who should have been treated with CABG according to the SSII in both institutions showed higher mortality compared to patients with concordant PCI treatment (WSP: 13.7% vs. 8.4%, respectively, log rank P=0.11; UCC RS: 12.5% vs. 6.8%, log rank P=0.04). Therefore, the present analysis has shown that if SSII was used in 19 patients, one death would be avoided at 4 years. Conclusion: The present study demonstrated that intuitive decision-making on myocardial revascularization method for individual patient (CABG or PCI) differed from the SSII recommendation for CABG only (as PCI was actually performed in 57%). Discordance between the SSII recommended revascularization strategy and the clinical decision was met with a higher 4-year mortality. Therefore, the SSII appears to be an appropriate decision-making tool to assist the management of patients with complex CAD.submitted by dr.med.univ. Bojan StaneticZusammenfassung in deutscher SpracheMedizinische Universität Wien, Dissertation, 2017OeBB(VLID)192328

Risk stratification in 3-vessel coronary artery disease: Applying the SYNTAX Score II in the Heart Team Discussion of the SYNTAX II trial

Background Heart Team (HT) and the SYNTAX Score II (SSII) have been integrated to the contemporary guidelines with the aim to provide a multidisciplinary decision-making process between coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI). Aims To prospectively assess the agreement between the HT decision and the SSII recommendation regarding the revascularization strategy in patients with 3-vessel coronary artery disease (CAD) of the SYNTAX II trial. Methods The SSII predicts the 4-year mortality of an individual patient both after PCI and after CABG. Patients were treated by PCI when the SSII predicted a mortality risk favoring PCI or when risk predictions were equipoise between PCI and CABG. However, the HT could overrule the SSII and recommend either CABG or PCI. Results A total of 202 patients have been screened and 24 did not fulfill inclusion criteria. The median age was 67.0 (IQR 59.0-73.3), and 167 (82.7%) were male. The HT endorsed SSII treatment recommendation, for CABG or PCI, in 152 patients (85.4%). Three patients had preference for PCI, irrespective of the HT decision. The main reason for the HT to overrule the SSII and recommend CABG was the prospect of a more complete revascularization (21 of 25 patients). Patients recommended for CABG by the HT had significantly higher anatomical SYNTAX score (P = 0.03) and higher predicted mortality risk for PCI (P = 0.04) when compared with patients that were enrolled in the trial. Conclusion The SYNTAX score II showed to be a suitable tool for guiding treatment decisions of patients with 3-vessel coronary artery disease being endorsed by the HT in the vast majority of the patients that have been enrolled in the SYNTAX II trial

Early, late and very late incidence of bioresorbable scaffold thrombosis: a systematic review and meta-analysis of randomized clinical trials and observational studies

The aim of this paper was to determine the incidence of bioresorbable vascular scaffold thrombosis. A systematic review of the published literature between October 2012 and August 2016 was performed using PubMed, Medline and Embase databases. Articles published in the English language that reported the rate of bioresorbable scaffold thrombosis according to Academic Research Consortium criteria were included. Titles and abstracts were screened independently by two authors and further evaluated and assessed for study details, population characteristics and scaffold thrombosis rates. Scaffold thrombosis rates were pooled with meta-analysis using a random effect model. Meta-regression was performed to explore the predictors of device thrombosis. Randomized clinical trials (RCT), observational registries and case series of patients with obstructive coronary artery disease treated with the ABSORB bioresorbable scaffolds (BVS) that reported the rate of definite or probable scaffold thrombosis and the time of the event after implantation (i.e., acute, sub-acute, late and very late) were selected. Overall, 16,830 patients treated with ABSORB BVS in 59 studies were included. A total of 256 definite or probable scaffold thrombosis (ScT) were identified and included in the present analysis. The overall rate of definite or probable ScT was 1.8% (CI 95% 1.5% to 2.0%) the median follow-up was 12.0 months (interquartile range 7.5 to 15). The rate of very late definite or probable ScT was 1.0% (95% CI 0.6% to 1.5%; 10 studies, 2331 patients). A higher rate of definite and probable scaffold thrombosis was found in studies with patients presenting with acute myocardial infarction (3.6% vs. 1.8%, Q=13.9, df=1, P=0.010). In the meta-regression analysis, the residual per cent diameter stenosis was the only factor associated with ST after scaffold implantation (coefficient 0.091, 95% CI -0.0009 to 0.183, P=0.052). Using the largest available dataset of patients treated in randomized trials and observational registries, the present meta-analysis shows that the overall rate of definite or probable ScT is 1.8%, with a rate of very late ST of 1.0%. Residual stenosis after scaffold implantation was associated with the occurrence of scaffold thrombosi

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial

Background: Despite primary PCI (PPCI), STEMI can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signal for reduction in IS in anterior STEMI. Aims: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to primary PCI (PPCI) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. Methods: Hypothermia was induced using ZOLL® Proteus™ Intravascular Cooling System. After randomization of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischemic delay in hypothermia group (232 vs 188 minutes; p <0.001). Results: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular mass (IS/LV) by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in hypothermia group and 20.0% in control group (p=0.540). Major adverse cardiac events (MACE) at 30 days were non significantly increased in hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in hypothermia group. Conclusion: Intravascular ZOLL TM Proteus Cooling System reduced temperature to 33.3oC before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in longer ischemic delay, did not reduce IS/LV mass and was associated with increased adverse events