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Joyce Peper,1,2,* Leonie M Becker,1,2,* Jan-Peter van Kuijk,1 Tim Leiner,2 Martin J Swaans1 1Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands; 2Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands*These authors contributed equally to this workCorrespondence: Joyce PeperDepartment of Cardiology, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, 3435 CM, The NetherlandsTel +31 88 320 09 22Email j.peper@antoniusziekenhuis.nlAbstract: The aim of this review was to discuss the current practice and patient selection for invasive FFR, new techniques to estimate invasive FFR and future of coronary physiology tests. We elaborate on the indication and application of FFR and on the contraindications and concerns in certain patient populations.Keywords: coronary artery disease, fractional flow reserve, patient selection, revascularisation

Aims: Complete non-culprit (NC) revascularization may help reduce recurrent events after NSTEMI, especially if NC lesions would harbor high-risk plaque features similar to STEMI. The study aimed to assess differences in fractional flow reserve (FFR)-negative NC plaque morphology in patients presenting with NSTEMI versus STEMI and assess the association of high-risk plaque morphology and clinical outcome., Methods and Results: In the prospective PECTUS-obs study, 438 patients presenting with myocardial infarction (MI) underwent optical coherence tomography (OCT) of all FFR-negative intermediate NC lesions. The primary endpoint was the occurrence of major adverse cardiovascular events (MACE, all-cause mortality, non-fatal MI or unplanned revascularization) at two-year follow-up. Four hundred and twenty patients had at least one analyzable OCT, including 203 (48.3%) with NSTEMI and 217 (51.7%) with STEMI. The prevalence of high-risk plaques (HRP), including thin-cap fibroatheromas (TCFA), plaque rupture and thrombus, was comparable between groups. MACE occurred in 29 (14.3%) NSTEMI patients and 16 (7.4%) STEMI patients (Punivariable=0.025 and Pmultivariable=0.270). Incidence of MACE was numerically higher among patients with HRP, irrespective of the clinical presentation at index (Pinteraction=0.684). Among high-risk plaque criteria, plaque rupture was associated with MACE in both NSTEMI (p<0.001) and STEMI (p=0.020)., Conclusion: Presence of NC HRP is comparable between NSTEMI and STEMI and leads to numerically higher event rates in both. These results call for additional research on complete revascularization in NSTEMI and treatment of HRP., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Patients with refractory angina are often ineligible for revascularization and have poor quality of life despite optimal medical therapy. The coronary sinus (CS) Reducer (Shockwave Medical Inc) was safe and effective in the treatment of refractory angina in the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) randomized sham-controlled trial., Objectives: This study sought to perform the primary endpoint analysis of the complete REDUCER-I (An Observational Study of the Neovasc Reducer System) study cohort., Methods: REDUCER-I is a nonrandomized, "real-world" study of patients with refractory angina treated with the CS Reducer conducted at 25 centers from 9 European countries. The primary effectiveness endpoint was an improvement in Canadian Cardiovascular Society (CCS) class at 6 months. The primary safety endpoints were major adverse cardiac events and device- or procedure-related serious adverse events through 30 days. Study follow-up is planned through 5 years with some interim 3-year analyses included here., Results: From 2016 to 2023, 400 patients were enrolled, including 78.0% (312/400) male patients, 54.3% (216/398) with previous myocardial infarction, 73.6% (293/398) with previous revascularization, and 72.0% (280/389) CCS class III/IV. Major adverse cardiac event and serious adverse event rates were 1.6% (95% CI: 0.7-3.6) and 1.1% (4/371), respectively, with no deaths within 30 days. At 6 months, 69.8% (240/344) of patients improved by ≥1 CCS class. Six-minute walk distances improved by 34.1 ± 85.8 m at 6 months (P < 0.0001). Interim 3-year results showed CCS class and Seattle Angina Questionnaire quality of life improvements were sustained (P < 0.0001)., Conclusions: The complete primary endpoint analysis of the REDUCER-I study shows patients with refractory angina were safely and effectively treated with the CS Reducer. Improvements in angina and quality of life appear sustained through 3 years., Competing Interests: Funding Support and Author Disclosures The REDUCER-I study is sponsored by Shockwave Medical Inc, although no specific funding was provided for this analysis. Dr Verheye serves as a proctor for Shockwave Medical Inc; and has received honoraria from Shockwave Medical Inc. Dr de Silva serves as a proctor for Shockwave Medical Inc; and has received honoraria from Shockwave Medical Inc. Dr West is an employee of Shockwave Medical Inc. Dr Banai has received honoraria from Shockwave Medical Inc; and is on the Advisory Board for Shockwave Medical Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting., Methods: In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha., Results: Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; P =0.02 for noninferiority at a 0.025 significance level and P =0.55 for 2-sided superiority at a 0.05 significance level)., Conclusions: Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912., Competing Interests: Dr Smits reports personal fees from Terumo and Abiomed, institutional grants and personal fees from Abbott Vascular and Microport, and institutional grants from SMT. Dr Hofma reports an institutional grant from Terumo. Dr Oemrawsingh reports speaker fees from Abbott Vascular and Philips. Dr Paradies reports speaker fees from Boston Scientific and Abbott Vascular and institutional grants from Abbott Vascular. The other authors report no conflicts.

Background and Aims: Recurrent events after myocardial infarction (MI) are common and often originate from native non-culprit (NC) lesions that are non-flow limiting. These lesions consequently pose as targets to improve long-term outcome. It is, however, largely unknown whether these lesions differ between sexes. The aim of this study was to assess such potential differences., Methods: From the PECTUS-obs study, we assessed sex-related differences in plaque characteristics of fractional flow reserve (FFR)-negative intermediate NC lesions in 420 MI-patients., Results: Among the included patients, 80 (19.1 %) were female and 340 (80.9 %) male. Women were older and more frequently had hypertension and diabetes. In total, 494 NC lesions were analyzed. After adjustment for clinical characteristics and accounting for within-patients clustering, lesion length was longer in female patients (20.8 ± 10.0 vs 18.3 ± 8.5 mm, p = 0.048) and minimum lumen area (2.30 ± 1.42 vs 2.78 ± 1.54 mm 2 , p < 0.001) and minimum lumen diameter (1.39 ± 0.45 vs 1.54 ± 0.44 mm, p < 0.001) were smaller. The minimum fibrous cap thickness was smaller among females (96 ± 53 vs 112 ± 72 μm, p = 0.025), with more lesions harboring a thin cap fibroatheroma (39.3 % vs 24.9 %, p < 0.001). Major adverse cardiovascular events at two years occurred in 6.3 % of female patients and 11.8 % of male patients (p = 0.15)., Conclusions: FFR-negative NC lesions after MI harbored more high-risk plaque features in female patients. Although this did not translate into an excess of recurrent events in female patients in this modestly sized cohort, it remains to be investigated whether this difference affects clinical outcome., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background/Objectives: The literature reports high complication rates in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who undergo balloon pulmonary angioplasty (BPA), especially in patients with poor pulmonary hemodynamics. Here, we describe the complications of BPA based on the new definitions. Methods: All patients with CTEPH who completed BPA treatment before 15 September 2023 were selected from the CTEPH database. Peri-procedural complications were collected and classified according to the 2023 consensus paper on BPA treatment. Complications were analyzed in subgroups of patients with pulmonary vascular resistance (PVR), ≤ or >6.6 WU, and mean pulmonary artery pressure (mPAP), ≤ or >45 mmHg, at first BPA. Results: In this analysis, 87 patients (63% women; mean age 61.1 ± 14.0 years; 62% on dual PH targeted medical therapy) underwent 426 (mean 4.9 ± 1.6 per patient) BPAs. Only non-severe complications occurred in 14% of BPA treatments and in 47% of the patients; 31% patients had a thoracic complication. The thoracic complications were mild (71%) or moderate (29%). Patients with a PVR > 6.6 WU ( n = 8) underwent more BPA treatments (6.6 ± 1.5 versus 4.6 ± 1.5, p = 0.002), had more complications (88% versus 41% of patients, p = 0.020), and had more thoracic complications (17% vs. 7% of BPAs, p = 0.013) than patients with PVR ≤ 6.6 WU. Patients with mPAP > 45 mmHg ( n = 13) also had more BPA treatments (6.5 ± 1.7 versus 4.6 ± 1.4, p < 0.001), more complications (77% versus 44% of patients, p = 0.027) and more thoracic complications (14% versus 8% of BPAs, p = 0.039) than patients with mPAP ≤ 45 mmHg. Conclusions: Complications occurred in 14% of BPAs and were mostly mild. Patients with severe pulmonary hemodynamics suffered more (thoracic) complications.

Background: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasound-guided puncture is unclear., Aims: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation., Methods: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions., Results: A total of 544 patients undergoing complex PCI mandating large-bore (≥7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopy-guided access and 2.6% for ultrasound-guided access (p=0.32)., Conclusions: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for large-bore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access., Clinicaltrials: gov identifier: NCT04837404.

This study evaluates the early and long-term clinical and echocardiographic outcome of edge-to-edge (E2E) mitral valve repair (MVr) concomitant to septal myectomy (SM) in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM). A retrospective single-center analysis was performed of patients who underwent isolated SM or SM with E2E MVr from 2011 to 2022. Exclusion criteria were primary mitral valve (MV) disease or concomitant valve surgery. Early and long-term safety, functional and echocardiographic outcomes were compared between groups. Between January 2011 and April 2022, 76 consecutive patients underwent SM for HOCM: 42 patients (55%) underwent SM without additional E2E MVr (Group 1) and 34 patients (45%) underwent SM with additional E2E MVr (Group 2). At latest follow-up, 87% of patients were in New York Heart Association (NYHA) class I-II with no significant differences in NYHA class between groups. Incidence of safety events was comparable between groups. Echocardiographic relief of left ventricular outflow tract (LVOT) obstruction was comparable at early follow-up (P = 0.68), with a significant but small difference in maximum LVOT pressure gradient at latest follow-up in favor of E2E MVr (P = 0.04). Furthermore, patients who underwent SM with E2E MVr showed less residual systolic anterior motion at early and latest follow-up (P = 0.020; P = 0.178). Reintervention on the MV was absent in both groups at 1 year and equally low at follow-up (P = 0.27). This study demonstrates that adding E2E MVr to septal myectomy is as safe as isolated myectomy for the treatment of HOCM. Moreover, the addition of E2E MVr is associated with similar excellent functional improvement and freedom from MV reintervention., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper, (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

The optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention (PCI) is complex and remains a subject of debate. Current guidelines advise a stepwise provisional approach with optional two-stent strategy. However, a two-stent strategy, both upfront and stepwise provisional, is technically demanding. Therefore, there is increasing interest in the use of drug-eluting balloons (DEB) in bifurcation lesions, mainly after a provisional approach with unsatisfactory result of the side branch. Some small pilot studies already showed that the use of DEB in bifurcation lesions is safe and feasible. However, a randomized comparison of this hybrid DEB strategy with a two-stent strategy is currently lacking., Trial Design: The Hybrid DEB study is a prospective, multicenter, randomized controlled trial investigating noninferiority of a hybrid DEB approach, using a combination of a drug-eluting stent (DES) in the main vessel and DEB in the side branch, compared to stepwise provisional two-stent strategy in patients with true bifurcation lesions. A total of 500 patients with de novo true coronary bifurcation lesions, treated with a stepwise provisional approach and an unsatisfactory result of the side branch after main vessel stenting (≥ 70% stenosis and/or < thrombolysis in myocardial infarction III flow), will be randomized in a 1:1 ratio to receive either treatment with a DEB or with a DES in the side branch. The primary endpoint is a composite endpoint of the occurrence of all-cause death, periprocedural or spontaneous myocardial infarction and/or target vessel revascularization at the anticipated median 2-year follow-up., Conclusion: The Hybrid DEB study will compare in a multicenter, randomized fashion a hybrid DEB approach with a stepwise provisional two-stent strategy in patients with true bifurcation lesions., Trial Registration: ClinicalTrials.gov no. NCT05731687., Competing Interests: Disclosure Koen Teeuwen reports research grant from DaVinci Medical B.V. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Up to 45% of patients who underwent percutaneous coronary intervention (PCI) may have a high bleeding risk (HBR), depending on the bleeding risk definition. 1 This condition is often associated with an enhanced risk of thrombotic events with a negative impact on short- and long-term outcomes, 2-8 making the choice of an appropriate antithrombotic regimen after PCI particularly challenging. Advances in stent technologies, in which the introduction of newer generations of thinner strut drug-eluting stents (DES), have significantly reduced the rate of thrombotic complications and may justify a shorter dual antiplatelet therapy (DAPT) duration. Both in vitro and in vivo studies have shown that local hemodynamic factors may critically affect the natural history of atherosclerosis. Strut thickness correlates with flow disturbances and endothelial shear stress. Flow separation within struts determines areas of recirculation with low endothelial shear stress which promotes local concentration of activated platelets. 9 By mitigating inflammation, vessel injury, and neointimal proliferation, thin and streamlined struts have been associated with faster vascular healing and re-endothelization and have resulted in lower rates of thrombotic events after PCI. 10 , 11 The use of thin strut and ultra-thin strut stents may lead to a favorable trade-off in bleeding and ischemic events in patients with HBR. However, dedicated studies evaluating the performance of thin strut versus ultrathin strut stents in patients with HBR are lacking., Competing Interests: Declaration of Competing Interest The authors have no competing interest to declare., (Copyright © 2023. Published by Elsevier Inc.)

Importance: Even after fractional flow reserve (FFR)-guided complete revascularization, patients with myocardial infarction (MI) have high rates of recurrent major adverse cardiovascular events (MACE). These recurrences may be caused by FFR-negative high-risk nonculprit lesions., Objective: To assess the association between optical coherence tomography (OCT)-identified high-risk plaques of FFR-negative nonculprit lesions and occurrence of MACE in patients with MI., Design, Setting, and Participants: PECTUS-obs (Identification of Risk Factors for Acute Coronary Events by OCT After STEMI [ST-segment elevation MI] and NSTEMI [non-STEMI] in Patients With Residual Non-flow Limiting Lesions) is an international, multicenter, prospective, observational cohort study. In patients presenting with MI, OCT was performed on all FFR-negative (FFR > 0.80) nonculprit lesions. A high-risk plaque was defined containing at least 2 of the following prespecified criteria: (1) a lipid arc at least 90°, (2) a fibrous cap thickness less than 65 μm, and (3) either plaque rupture or thrombus presence. Patients were enrolled from December 14, 2018, to September 15, 2020. Data were analyzed from December 2, 2022, to June 28, 2023., Main Outcome and Measure: The primary end point of MACE, a composite of all-cause mortality, nonfatal MI, or unplanned revascularization, at 2-year follow-up was compared in patients with and without a high-risk plaque., Results: A total of 438 patients were enrolled, and OCT findings were analyzable in 420. Among included patients, mean (SD) age was 63 (10) years, 340 (81.0) were men, and STEMI and non-STEMI were equally represented (217 [51.7%] and 203 [48.3%]). A mean (SD) of 1.17 (0.42) nonculprit lesions per patient was imaged. Analysis of OCT images revealed at least 1 high-risk plaque in 143 patients (34.0%). The primary end point occurred in 22 patients (15.4%) with a high-risk plaque and 23 of 277 patients (8.3%) without a high-risk plaque (hazard ratio, 1.93 [95% CI, 1.08-3.47]; P = .02), primarily driven by more unplanned revascularizations in patients with a high-risk plaque (14 of 143 [9.8%] vs 12 of 277 [4.3%]; P = .02)., Conclusions and Relevance: Among patients with MI and FFR-negative nonculprit lesions, the presence of a high-risk plaque is associated with a worse clinical outcome, which is mainly driven by a higher number of unplanned revascularizations. In a population with a high recurrent event rate despite physiology-guided complete revascularization, these results call for research on additional pharmacological or focal treatment strategies in patients harboring high-risk plaques.

Background: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain., Methods: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years., Results: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group., Conclusions: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)., (Copyright © 2023 Massachusetts Medical Society.)

Objectives: The addition of CT-derived fractional flow reserve (FFR-CT) increases the diagnostic accuracy of coronary CT angiography (CCTA). We assessed the impact of FFR-CT in routine clinical practice on clinical decision-making and patient prognosis in patients suspected of stable coronary artery disease (CAD)., Methods: This retrospective, single-center study compared a cohort that received CCTA with FFR-CT to a historical cohort that received CCTA before FFR-CT was available. We assessed the clinical management decisions after FFR-CT and CCTA and the rate of major adverse cardiac events (MACEs) during the 1-year follow-up using chi-square tests for independence. Kaplan-Meier curves were used to visualize the occurrence of safety outcomes over time., Results: A total of 360 patients at low to intermediate risk of CAD were included, 224 in the CCTA only group, and 136 in the FFR-CT group. During follow-up, 13 MACE occurred in 12 patients, 9 (4.0%) in the CCTA group, and three (2.2%) in the FFR-CT group. Clinical management decisions differed significantly between both groups. After CCTA, 60 patients (26.5%) received optimal medical therapy (OMT) only, 115 (51.3%) invasive coronary angiography (ICA), and 49 (21.9%) single positron emission CT (SPECT). After FFR-CT, 106 patients (77.9%) received OMT only, 27 (19.9%) ICA, and three (2.2%) SPECT (p < 0.001 for all three options). The revascularization rate after ICA was similar between groups (p = 0.15). However, patients in the CCTA group more often underwent revascularization (p = 0.007)., Conclusion: Addition of FFR-CT to CCTA led to a reduction in (invasive) diagnostic testing and less revascularizations without observed difference in outcomes after 1 year., Key Points: • Previous studies have shown that computed tomography-derived fractional flow reserve improves the accuracy of coronary computed tomography angiography without changes in acquisition protocols. • This study shows that use of computed tomography-derived fractional flow reserve as gatekeeper to invasive coronary angiography in patients suspected of stable coronary artery disease leads to less invasive testing and revascularization without observed difference in outcomes after 1 year. • This could lead to a significant reduction in costs, complications and (retrospectively unnecessary) usage of diagnostic testing capacity, and a significant increase in patient satisfaction., (© 2023. The Author(s).)

Background: Hybrid minimally invasive left ventricular reconstruction is used to treat patients with ischemic heart failure with reduced ejection fraction (HFrEF) and antero-apical scar. Pre- and post-procedural regional functional left ventricular assessment with current imaging techniques remains limited. We evaluated 'inward displacement' as a novel technique of assessing regional left ventricular function in an ischemic HFrEF population who underwent left ventricular reconstruction with the Revivent System., Methods: Inward displacement adopts three standard long-axis views obtained during cardiac MRI or CT and assesses the degree of inward endocardial wall motion towards the true left ventricular center of contraction. For each of the standard 17 left ventricular segments, regional inward displacement is measured in mm and expressed as a percentage of the maximal theoretical distance each segment can contract towards the centerline. The left ventricle was divided into three regions, obtaining the arithmetic average of inward displacement or speckle tracking echocardiographic strain at the left ventricular base (segments 1-6), mid-cavity (segments 7-12) and apex (segments 13-17). Inward displacement was measured using computed tomography or cardiac magnetic resonance imaging and compared pre- and post-procedurally in ischemic HFrEF patients who underwent left ventricular reconstruction with the Revivent System ( n = 36). In a subset of patients who underwent baseline speckle tracking echocardiography, pre-procedural inward displacement was compared with left ventricular regional echocardiographic strain ( n = 15)., Results: Inward displacement of basal and mid-cavity left ventricular segments increased by 27% ( p < 0.001) and 37% ( p < 0.001), respectively, following left ventricular reconstruction. A significant overall decrease in both the left ventricular end systolic volume index and end diastolic volume index of 31% ( p < 0.001) and 26% ( p < 0.001), respectively, was detected, along with a 20% increase in left ventricular ejection fraction ( p = 0.005). A significant correlation between inward displacement and speckle tracking echocardiographic strain was noted within the basal (R = -0.77, p < 0.001) and mid-cavity left ventricular segments (R = -0.65, p = 0.004), respectively. Inward displacement resulted in relatively larger measurement values compared to speckle tracking echocardiography, with a mean difference of absolute values of -3.33 and -7.41 for the left ventricular base and mid-cavity, respectively., Conclusions: Obviating the limitations of echocardiography, inward displacement was found to highly correlate with speckle tracking echocardiographic strain to evaluate regional segmental left ventricular function. Significant improvements in basal and mid-cavity left ventricular contractility were demonstrated in ischemic HFrEF patients following left ventricular reconstruction of large antero-apical scars, consistent with the concept of reverse left ventricular remodeling at a distance. Inward displacement holds significant promise in the HFrEF population being evaluated pre- and post-left ventriculoplasty procedures.

Introduction: Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date., Methods and Analysis: A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups., Ethics and Dissemination: Ethical approval for the study was granted by the local Ethics Committee ('Medisch Ethische Toetsing Commissie Isala Zwolle') for all Dutch sites, 'Comité Medische Ethiek Ziekenhuis Oost-Limburg' for Hospital Oost-Limburg, 'Comité d'éthique CHU-Charleroi-ISPPC' for Centre Hospilatier Universitaire de Charleroi and 'Ethik Kommission de Ärztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ul trasound guided tra nsfemoral access in co mplex l arge b or e PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752., Registration Details: ClinicalTrials.gov identifier: NCT03846752., Competing Interests: Competing interests: Maarten van Leeuwen: speakers/consulting services honoraria from Terumo, Daiichi-Sankyo and Abbott. Research grants from AstraZeneca, Top Sector Life Sciences & Health, Terumo, Top Medical B.V and Abbott. Adriaan Kraaijeveld: research grants from Xenios AG. Lecture fees from Abiomed, Novartis and Inari. Consultancy fees from Dekra and Boston Scientific. All other authors have no competing interests to declare., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Left ventricular (LV) remodeling after anterior myocardial infarction (AMI) can cause a pathological increase in LV volume, reduction in LV ejection fraction (EF), and symptomatic heart failure (HF). This study evaluates the midterm results of a hybrid transcatheter and minimally invasive surgical technique to reconstruct the negatively remodeled LV by myocardial scar plication and exclusion with microanchoring technology., Methods: Retrospective single-center analysis of patients who underwent hybrid LV reconstruction (LVR) with the Revivent TransCatheter System. Patients were accepted for the procedure when they presented with symptomatic HF (New York Heart Association class ≥ II, EF < 40%) after AMI, in the presence of a dilated LV with either akinetic or dyskinetic scar in the anteroseptal wall and/or apex of ≥50% transmurality., Results: Between October 2016 and November 2021, 30 consecutive patients were operated. Procedural success was 100%. Comparing echocardiographic data preoperatively and directly postoperatively, LVEF increased from 33 ± 8% to 44 ± 10% ( p < 0.0001). LV end-systolic volume index decreased from 58 ± 24 mL/m 2 to 34 ± 19 mL/m 2 ( p < 0.0001) and LV end-diastolic volume index decreased from 84 ± 32 mL/m 2 to 58 ± 25 mL/m 2 ( p  < 0.0001). Hospital mortality was 0%. After a mean follow-up of 3.4 ± 1.3 years, there was a significant improvement of New York Heart Association class ( p = 0.001) with 76% of surviving patients in class I-II., Conclusions: Hybrid LVR for symptomatic HF after AMI is safe and results in significant improvement in EF, reduction in LV volumes, and sustained improvement in symptoms., Competing Interests: The authors report no conflict of interest., (© 2022 The Author(s).)

Negative left ventricular (LV) remodeling consequent to acute myocardial infarction (AMI) is characterized by an increase in LV volumes in the presence of a depressed LVEF. In order to restore the shape, size, and function of the LV, operative treatment options to achieve volume reduction and shape reconstruction should be considered. In the past decade, conventional surgical LV reconstruction through a full median sternotomy has evolved towards a hybrid transcatheter and less invasive LV reconstruction. In order to perform a safe and effective hybrid LV reconstruction, thorough knowledge of the technical considerations and adequate use of multimodality imaging both pre- and intraoperatively are fundamental. In addition, a comprehensive understanding of the individual procedural steps from both a cardiological and surgical point of view is required.

Coronary sinus Reducer (CSR) implantation is currently recommended to relieve angina in patients with refractory symptoms despite optimal medical therapy and maximally achievable revascularization. The impact of diabetes mellitus on outcome after CSR implantation is at present unknown. We aimed to explore the impact of CSR in refractory angina patients with diabetes mellitus. Data from consecutive patients undergoing CSR implantation at four different centres between 2014 and 2018 were included. Patients were divided according to the presence or absence of diabetes mellitus. Primary objective of this analysis was to evaluate the clinical response to CSR implantation defined as an improvement of ≥ 1 classes of the Canadian Cardiovascular Society (CCS) Classification. A total of 219 patients were included, 116 (53%) of whom had diabetes mellitus. The median age of the population was 69 years and 167 patients (76%) were male. There were no significant differences between groups of patients with and without diabetes mellitus with respect to CCS class at baseline (p value = 0.32) and at follow-up (p = 0.75). Over a median follow-up of 393 [224-1004] days, 84 (72%) of the patients with diabetes mellitus met the primary outcome, similarly to those without diabetes mellitus (p = 0.28). Fifty-three patients (24%) did not have an improvement in CCS class and no one experienced worsening of angina. CSR implantation was equally effective in improving angina symptoms among patients with refractory angina and diabetes mellitus compared to patients without diabetes mellitus., (© 2021. Springer Japan KK, part of Springer Nature.)

Introduction: Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy., Methods: The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke., Results: At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively., Conclusions: CSR implantation is safe and reduces angina in patients with refractory angina., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Introduction: In patients with myocardial infarction, the decision to treat a nonculprit lesion is generally based on its physiological significance. However, deferral of revascularisation based on nonischaemic fractional flow reserve (FFR) values in these patients results in less favourable outcomes compared with patients with stable coronary artery disease, potentially caused by vulnerable nonculprit lesions. Intravascular optical coherence tomography (OCT) imaging allows for in vivo morphological assessment of plaque 'vulnerability' and might aid in the detection of FFR-negative lesions at high risk for recurrent events., Methods and Analysis: The PECTUS-obs study is an international multicentre prospective observational study that aims to relate OCT-derived vulnerable plaque characteristics of nonflow limiting, nonculprit lesions to clinical outcome in patients with myocardial infarction. A total of 438 patients presenting with myocardial infarction (ST-elevation myocardial infarction and non-ST-elevation myocardial infarction) will undergo OCT-imaging of any FFR-negative nonculprit lesion for detection of plaque vulnerability. The primary study endpoint is a composite of major adverse cardiovascular events (all-cause mortality, nonfatal myocardial infarction or unplanned revascularisation) at 2-year follow-up. Secondary endpoints will be the same composite at 1-year and 5-year follow-up, target vessel failure, target vessel revascularisation, target lesion failure and target lesion revascularisation., Ethics and Dissemination: This study has been approved by the Medical Ethics Committee of the region Arnhem-Nijmegen. The results of this study will be disseminated in a main paper and additional papers with subgroup analyses., Trial Registration Number: NCT03857971., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Refractory angina is a growing and major health-care problem affecting millions of patients with coronary artery disease worldwide. The Coronary Sinus Reducer (CSR) is a device that may be considered for the relief of symptoms of refractory angina. It causes increased venous pressure leading to a dilatation of arterioles and reduced arterial vascular resistance in the sub-endocardium. This study describes the 5‑year Dutch experience regarding safety and efficacy of the CSR., Methods: One hundred and thirty-two patients with refractory angina were treated with the CSR. The primary efficacy endpoint of the study was Canadian Cardiovascular Society (CCS) class improvement between baseline and 6‑month follow-up. The primary safety endpoint was successful CSR implantation in the absence of any device-related events., Results: Eighty-five patients (67%) showed improvement of at least 1 CCS class and 43 patients (34%) of at least 2 classes. Mean CCS class improved from 3.17 ± 0.61 to 2.12 ± 1.07 after implantation (P < 0.001). The CSR was successfully implanted in 99% of the patients and only minor complications during implantation were reported., Conclusion: The CSR is a simple, safe, and effective option for most patients with refractory angina. However, approximately thirty percent of the patients showed no benefit after implantation. Future studies should focus on the exact underlying mechanisms of action and reasons for non-response to better identify patients that could benefit most from this therapy.

Invasive fractional flow reserve (FFR) adoption remains low mainly due to procedural and operator related factors as well as costs. Alternatively, quantitative flow ratio (QFR) achieves a high accuracy mainly outside the intermediate zone without the need for hyperaemia and wire-use. We aimed to determine the diagnostic performance of QFR and to evaluate a QFR-FFR hybrid strategy in which FFR is measured only in the intermediate zone. This retrospective study included 289 consecutive patients who underwent invasive coronary angiography and FFR. QFR was calculated for all vessels in which FFR was measured. The QFR-FFR hybrid approach was modelled using the intermediate zone of 0.77-0.87 in which FFR-measurements are recommended. The sensitivity, specificity, and accuracy on a per vessel-based analysis were 84.6%, 86.3% and 85.6% for QFR and 88.0%, 92.9% and 90.3% for the QFR-FFR hybrid approach. The diagnostic accuracy of QFR-FFR hybrid strategy with invasive FFR measurement was 93.4% and resulted in a 56.7% reduction in the need for FFR. QFR has a good correlation and agreement with invasive FFR. A hybrid QFR-FFR approach could extend the use of QFR and reduces the proportion of invasive FFR-measurements needed while improving accuracy.

The coronary sinus reducer (CSR) has been introduced as therapy for patients with refractory angina with no other treatment options. Aim of this study is to investigate the efficacy of the CSR in patients with refractory angina and presence of coronary chronic total occlusions (CTO). In this multicentre, international retrospective study, patients undergoing CSR implantation were screened and divided in 2 groups according to the presence/absence of CTO lesions. Baseline and clinical characteristics were analyzed in the 2 groups. Primary-outcome consisted of the variation in Canadian Cardiovascular Society (CCS) class at 6-month follow-up. Between January 2014 and December 2018, 205 patients with refractory angina were consecutively treated with the study device in the participating centers, 103 (50.2%) of which had a CTO lesion at coronary angiogram and formed the CTO-group. Baseline characteristics of the study population were well balanced between the 2 groups. CSR was successfully implanted in all cases. Baseline CCS class was 3  ±  0.5 in the CTO-group versus 3.1  ±  0.6 in the non-CTO group (p = 0.45), and improved at follow-up to 1.6  ±  0.9 versus 2  ±  1.1 respectively (p <0.01), with a significantly higher improvement in CCS class in the CTO-group (1.4  ±  0.9 vs 1.1  ±  1 respectively, p = 0.01). Any improvement in CCS class was registered in 79 (80.6%) CTO-patients, while a significantly lower percentage (65 patients, 66.3%) of the non-CTO patients reported benefits in CCS class (p = 0.03). In conclusions, patients suffering from refractory angina with non-revascularized CTO lesions have a better response to CSR implantation than patients without CTOs. CSR implantation should be considered a valid complementary therapy to CTO-PCI in these patients., Competing Interests: Conflict of Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual-access and large bore catheters, with trans-femoral approach adoption in most cases., Objectives: Aim of this manuscript is to describe the outcomes of an alternative hybrid algorithm, called "Minimalistic Hybrid Algorithm," which has the purpose to minimize the use of double access, large bore catheters, and femoral approach in order to minimize the risk of vascular complications and patient's discomfort, without compromising efficacy., Methods: In this single-center registry, a "minimalistic" approach was attempted in consecutive patients undergoing CTO PCI between March 2016 and October 2017. Data regarding the applicability of this algorithm and the related procedural success rates were collected, together with common demographic and angiographic characteristics., Results: Of the 100 CTO PCI performed in the study period, 91(91%) were successfully approached according to the novel algorithm. Mean J-CTO score of all minimalistic procedures was 1.9 ± 1.2, with 31(34%) patients presenting with J-CTO score ≥3. In 52 procedures, the approach consisted of single-catheter access, 49(94.2%) of which were trans-radial. Out of the 39 patients approached with dual-catheters, 26(69.2%) were biradial, and 8(21%) radial-femoral. Procedural success in patients approached with the minimalistic algorithm was 89%, in line with the results of large-multicenter experiences nowadays available., Conclusions: Our results show that an alternative algorithm limiting the routine use of large bore catheters and trans-femoral approach is feasible in the clinical practice and yields good procedural outcomes., (© 2019 Wiley Periodicals, Inc.)

Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual access and large bore catheters, with trans-femoral approach adoption in most of the cases. Aim of this manuscript is to describe an alternative algorithm, that we called "Minimalistic Hybrid Algorithm", in order to minimize the use of double access, large bore catheters, and femoral approach thus reducing patient's discomfort and possibly procedural complications. This algorithm can be interpreted as an evolution of the classic "Hybrid Algorithm" and requires the operator to be confident with all techniques known in this conventional algorithm. Indeed, all possible techniques and approaches of the conventional hybrid approach to treat CTOs are included in a novel diagram for procedural strategy, which offers an alternative sequence of steps to limit, whenever possible, the invasiveness of the procedure. After dividing the cases in "simple" or "complex" CTO lesions according to the available complexity scores and to the "feeling", knowledge and expertise of the operator, a systematic description of the procedural steps is provided. This includes antegrade and retrograde approaches, as well as sub-intimal and intra-luminal techniques, in order to maintain the simpler single-catheter transradial strategies in the first line for the simple CTO, and the adoption of more complex, double access and transfemoral ones in the further steps. The minimalistic hybrid algorithm herein described is a possible alternative sequence of steps in the setting of CTO recanalization, with the potential of limiting the use of double access, large bore catheters, and femoral approach., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions., Objectives: Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting., Methods and Results: This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed., Conclusions: The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions., (© 2018 Wiley Periodicals, Inc.)

In the current daily practice of acute coronary syndromes, patients experiencing non-ST-elevation acute coronary syndrome (NSTE-ACS) represent the majority of this population. In these patients it is of utmost importance to estimate both ischaemic and bleeding risk, with subsequent, and preferably tailored pharmacological and, if indicated, invasive treatment. In this paper we describe the several risk scores and evaluate which are most applicable to the Dutch health-care system. Furthermore, we provide an overview of the recommended pharmacological treatment in keeping with the European Society of Cardiology guidelines. An important topic of this paper is how to decide between early or delayed invasive strategies. We describe the recommendations of the European Society of Cardiology and evaluate to which level these should be applied to the Dutch health-care system.

Introduction: Primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI) can cause great haemodynamic instability. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide haemodynamic support in patients with STEMI but data on outcome and complications are scarce., Methods: An in-hospital registry was conducted enrolling all patients receiving VA-ECMO. Patients were analysed for medical history, mortality, neurological outcome, complications and coronary artery disease., Results: Between 2011 and 2016, 12 patients underwent pPCI for STEMI and received VA-ECMO for haemodynamic support. The majority of the patients were male (10/12) with a median age of 63 (47-75) years and 4 of the 12 patients had a history of coronary artery disease. A cardiac arrest was witnessed in 11 patients. The left coronary artery was compromised in 8 patients and 4 had right coronary artery disease. All patients were in Killip class IV. Survival to discharge was 67% (8/12), 1‑year survival was 42% (5/12), 2 patients have not yet reached the 1‑year survival point but are still alive and 1 patient died within a year after discharge. All-cause mortality was 42% (5/12) of which mortality on ECMO was 33% (4/12). Patient-related complications occurred in 6 of the 12 patients: 1 patient suffered major neurological impairment, 2 patients suffered haemorrhage at the cannula site, 2 patients had limb ischaemia and 1 patient had a haemorrhage elsewhere. There were no VA-ECMO hardware malfunctions., Conclusion: VA-ECMO in pPCI for STEMI has a high survival rate and neurological outcome is good, even when the patient is admitted with a cardiac arrest.

Objective: Despite the minimally invasive nature of transcatheter aortic valve implantation (TAVI), the incidence of acute kidney injury (AKI) and mortality is of major concern. Several studies showed that outcome was influenced by the systemic inflammatory response syndrome (SIRS) in patients undergoing percutaneous TAVI. The purpose of this study was to investigate whether SIRS after transapical TAVI was associated with short-term outcome., Design: Retrospective analysis of prospectively collected data., Setting: Intensive care unit in a tertiary-care hospital., Participants: In 121 patients undergoing transapical TAVI for severe aortic stenosis between March 2010 and October 2013, the incidence of SIRS during the first 48 hours was studied. The relation between the occurrence of SIRS and any adverse event during hospital stay was investigated. Any adverse event was defined as the composite of mortality, AKI, infection, stroke, myocardial infarction, and bleeding., Intervention: none., Measurements and Main Results: Sixty-five (53.7%) patients developed SIRS during 48 hours after transapical TAVI. The occurrence of SIRS was associated independently with an increased risk of any adverse event (adjusted odds ratio: 4.0, 95% confidence interval [CI]: 1.6-9.6; p=0.002), which was mainly an increased risk of death (odds ratio: 5.5, 95% CI: 1.1-25.9; p=0.031). Patients with SIRS had a longer median duration of intensive care unit stay compared with patients without SIRS (2 v 1 day; p<0.001)., Conclusions: SIRS predicts short-term outcome in patients undergoing transapical TAVI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) is an established treatment option for symptomatic patients with severe aortic valvular disease who are not suitable for conventional surgical aortic valve replacement. Despite improving experience and techniques, ischaemic and bleeding complications after TAVI remain prevalent and impair survival in this generally old and comorbid-rich population. Due to changing aetiology of complications over time, antiplatelet and anticoagulant therapy after TAVI should be carefully balanced. Empirically, a dual antiplatelet strategy is generally used after TAVI for patients without an indication for oral anticoagulation (OAC; e. g. atrial fibrillation, mechanical mitral valve prosthesis), including aspirin and a thienopyridine. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. This review shows that current registries are unfit to directly compare antithrombotic regimens. Small exploring studies suggest that additional clopidogrel after TAVI only affects bleeding and not ischemic complications. However, these studies are lack in quality in terms of Cochrane criteria. Currently, three randomised controlled trials are recruiting to gather more knowledge about the effects of clopidogrel after TAVI.

Background: Both preoperative left ventricular dysfunction (LVD) and acute kidney injury (AKI) in the postoperative period are independently associated with mortality. We evaluated the prevalence and prognostic implications of AKI in a cohort of vascular surgery patients., Methods: Before vascular surgery, 1,158 patients were screened for LVD. Development of AKI, defined by RIFLE classification, was detected by serial serum creatinine measurements at days 1 to 3 after surgery. Primary end point was cardiovascular mortality during a median follow-up of 2.2 years (interquartile range [IQR] 1.0-4.0)., Results: LVD was present in 558 patients (48%), and 120 patients (10%) developed postoperative AKI. Subjects with LVD developed postoperative AKI more often than patients without LVD (8% vs. 13%, p=0.01). Patients were categorized as (i) no LVD, without AKI (n=551, 48%), (ii) LVD without AKI (n=487, 42%), (iii) no LVD, with AKI (n=49, 4%) and (iv) LVD with AKI (n=71/6%). Patients with LVD prior to surgery who developed postoperative AKI had the highest cardiovascular mortality risk (hazard ratio = 4.9; 95% confidence interval, 2.9-8.2)., Conclusion: Patients with preoperatively LVD have an increased risk of developing AKI after vascular surgery. The occurrence of AKI in patients with LVD has an incremental predictive value toward cardiovascular mortality risk during long-term follow-up.

Introduction: Cardiac arrhythmias are a major cause for morbidity and mortality in patients undergoing non-cardiac vascular surgery., Report: An implantable loop recorder (Reveal(®) XT) was used for continuous heart rhythm monitoring to detect perioperative arrhythmias in a 69-year-old man undergoing major vascular surgery for an infected aortobifemoral prosthesis. The Reveal(®) detected several episodes of asymptomatic new-onset atrial fibrillation postoperatively, associated with elevated serum levels of troponin-T and N-terminal pro-B-type natriuretic peptide NT-proBNP)., Discussion: Continuous heart rhythm monitoring with assessment of serum cardiac biomarkers may allow early identification and treatment of patients at high risk of perioperative cardiovascular complications, in particular, cardiac arrhythmias., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Plasma N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) levels improve preoperative cardiac risk stratification in vascular surgery patients. However, single preoperative measurements of NT-pro-BNP cannot take into account the hemodynamic stress caused by anesthesia and surgery. Therefore, the aim of the present study was to assess the incremental predictive value of changes in NT-pro-BNP during the perioperative period for long-term cardiac mortality. Detailed cardiac histories, rest left ventricular echocardiography, and NT-pro-BNP levels were obtained in 144 patients before vascular surgery and before discharge. The study end point was the occurrence of cardiovascular death during a median follow-up period of 13 months (interquartile range 5 to 20). Preoperatively, the median NT-pro-BNP level in the study population was 314 pg/ml (interquartile range 136 to 1,351), which increased to a median level of 1,505 pg/ml (interquartile range 404 to 6,453) before discharge. During the follow-up period, 29 patients (20%) died, 27 (93%) from cardiovascular causes. The median difference in NT-pro-BNP in the survivors was 665 pg/ml, compared to 5,336 pg/ml in the patients who died (p = 0.01). Multivariate Cox regression analyses, adjusted for cardiac history and cardiovascular risk factors (age, angina pectoris, myocardial infarction, stroke, diabetes mellitus, renal dysfunction, body mass index, type of surgery and the left ventricular ejection fraction), demonstrated that the difference in NT-pro-BNP level between pre- and postoperative measurement was the strongest independent predictor of cardiac outcome (hazard ratio 3.06, 95% confidence interval 1.36 to 6.91). In conclusion, the change in NT-pro-BNP, indicated by repeated measurements before surgery and before discharge is the strongest predictor of cardiac outcomes in patients who undergo vascular surgery., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Obesity is a risk factor for atherosclerosis, a polyvascular process associated with reduced survival. In nonvascular surgery populations, a paradox between body mass index (BMI) and survival is described. This paradox includes reduced survival in underweight patients, whereas overweight and obese patients have a survival benefit. No clear explanation for this paradox has been given. Therefore, we evaluated the presence of the obesity paradox in vascular surgery patients and the influence of polyvascular disease on the obesity paradox., Methods: In this retrospective study, 2933 consecutive patients were classified according to their preoperative BMI (kg/m(2)) and screened for polyvascular disease and cardiovascular risk factors before surgery. In addition, medication use at the time of discharge was noted. Outcome was all-cause mortality during a median follow-up of 6.0 years (interquartile range, 2-9 years)., Results: BMI (kg/m(2)) groups included 68 (2.3%) underweight (BMI <18.5), 1379 (47.0%) normal (BMI 18.5-24.9, reference), 1175 (40.0%) overweight (BMI 25-29.9), and 311 (10.7%) obese (BMI ≥ 30) patients. No direct interaction between BMI, polyvascular disease, and long-term outcome was observed. Underweight was an independent predictor of mortality (hazard ratio, 1.65; 95% confidence interval, 1.22-2.22). In contrast, overweight protected for all-cause mortality (hazard ratio, 0.79; 95% confidence interval, 0.700-0.89). Cardioprotective medication usage in underweight patients was the lowest (P < .001), although treatment targets for risk factors were equally achieved within all treated groups., Conclusion: Overweight patients referred for vascular surgery were characterized by an increased incidence of polyvascular disease and required more extensive medical treatment for cardiovascular risk factors at discharge. Long-term follow-up showed a paradox of reduced mortality in overweight patients., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Cardiac troponin T (cTnT) assays with increased sensitivity might increase the number of positive tests. Using the area under the curve (AUC) with serial sampling of cTnT an exact quantification of the myocardial damage size can be made. We compared the prognosis of vascular surgery patients with integrated cTnT-AUC values to continuous and standard 12-lead electrocardiography (ECG) changes., Methods: 513 Patients were monitored. cTnT sampling was performed on postoperative days 1, 3, 7, 30 and/or at discharge or whenever clinically indicated. If cTnT release occurred, daily measurements of cTnT were performed, until baseline was achieved. CTnT-AUC was quantified and divided in tertiles. All-cause mortality and cardiovascular events (cardiac death and myocardial infarction) were noted during follow-up., Results: 81/513 (16%) Patients had cTnT release. After adjustment for gender, cardiac risk factors, and site and type of surgery, those in the highest cTnT-AUC tertile were associated with a significantly worse cardiovascular outcome and long-term mortality (HR 20.2; 95% CI 10.2-40.0 and HR 4.0; 95% CI 2.0-7.8 respectively). Receiver operator analysis showed that the best cut-off value for cTnT-AUC was <0.01 days*ng m for predicting long-term cardiovascular events and all-cause mortality., Conclusion: In vascular surgery patients quantitative assessment of cTnT strongly predicts long-term outcome., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Diabetes mellitus (DM) and left ventricular dysfunction (LVD) are often coexistent and invariably associated with increased mortality. Data on long-term prognosis of "isolated" diastolic LVD in diabetics are lacking; therefore, we evaluated these prognostic implications in patients with peripheral arterial disease (PAD) and DM. Using echocardiography, 1321 patients were screened for diastolic, systolic (ejection fraction <50%) or combined LVD. Diastolic LVD was diagnosed based on the ratio of early rapid filling to late filling due to atrial contraction, pulmonary vein flow, and deceleration time. Patients using glucose-lowering drugs or insulin or with a fasting glucose level >6.1 mmol/L were diagnosed with DM. The primary end point was occurrence of cardiovascular death during a mean follow-up of 2.5 +/- 1.9 years. In the total population, DM was diagnosed in 518 patients (39%), and diastolic, systolic, or combined LVD was present in 356 patients (27%), 102 patients (8%), or 156 patients (12%), respectively. In diabetic patients, diastolic and systolic LVDs were associated with increased cardiovascular mortality (hazard ratio 1.8, 95% confidence interval 1.03 to 3.03; hazard ratio 3.1, 95% confidence interval 1.46 to 6.38). In nondiabetic patients, the same association between diastolic or systolic LVD and outcome was observed (hazard ratio 2.2, 95% confidence interval 1.30 to 3.74; hazard ratio 3.9, 95% confidence interval 2.00 to 7.52). Combined systolic and diastolic LVD had the worst prognosis. In conclusion, diabetic patients with PAD have an increased prevalence of isolated systolic and combined LVD. In patients with PAD the presence of isolated diastolic, systolic, or combined LVD was independently and equally associated with increased cardiovascular mortality, irrespective of the concomitant presence of DM., (Copyright 2010 Elsevier Inc. All rights reserved.)

Background: Major vascular surgery patients are at high risk for developing asymptomatic perioperative myocardial ischemia reflected by a postoperative troponin release without the presence of chest pain or electrocardiographic abnormalities. Long-term prognosis is severely compromised and characterized by an increased risk of long-term mortality and cardiovascular events. Current guidelines on perioperative care recommend single antiplatelet therapy with aspirin as prophylaxis for cardiovascular events. However, as perioperative surgical stress results in a prolonged hypercoagulable state, the postoperative addition of clopidogrel to aspirin within 7 days after perioperative asymptomatic cardiac ischemia could provide improved effective prevention for cardiovascular events., Study Design: DECREASE-VII is a phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of early postoperative dual antiplatelet therapy (aspirin and clopidogrel) for the prevention of cardiovascular events after major vascular surgery. Eligible patients undergoing a major vascular surgery (abdominal aorta or lower extremity vascular surgery) who developed perioperative asymptomatic troponin release are randomized 1:1 to clopidogrel or placebo (300-mg loading dose, followed by 75 mg daily) in addition to standard medical treatment with aspirin. The primary efficacy end point is the composite of cardiovascular death, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. The evaluation of long-term safety includes bleeding defined by TIMI criteria. Recruitment began early 2010. The trial will continue until 750 patients are included and followed for at least 12 months., Summary: DECREASE-VII is evaluating whether early postoperative dual antiplatelet therapy for patients developing asymptomatic cardiac ischemia after vascular surgery reduces cardiovascular events with a favorable safety profile., (2010 Mosby, Inc. All rights reserved.)

During noncardiac surgery, patients may be at risk for developing cardiac events, related to underlying coronary artery disease. Therefore, perioperative cardiac complications remain an area of clinical interest and concern in patients undergoing noncardiac surgery. Over the years, perioperative risk assessment has evolved significantly to detect surgical patients with myocardium at risk due the coronary artery disease. In addition, many efforts have been made to reduce the cardiac risk of patients undergoing noncardiac surgery. The present review article will focus on the definition of high cardiac risk surgery and will discuss patient-related cardiac risk factors. In addition, the preoperative cardiac tests available to detect patients with coronary artery disease and strategies to reduce perioperative cardiac risk, as recommended in most recent perioperative guidelines, will be outlined.

Background and Objectives: Acute kidney injury is an independent predictor of short- and long-term survival; however, data on the relationship between reversible transitory decline of kidney function and chronic kidney disease (CKD) are lacking. We assessed the prognostic value of temporary renal function decline on the development of long-term CKD., Design, Setting, Participants, & Measurements: The study included 1308 patients who were undergoing major vascular surgery (aortic aneurysm repair, lower extremity revascularization, or carotid surgery), divided into three groups on the basis of changes in Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated GFR (eGFR) on days 1, 2, and 3 after surgery, compared with baseline: Group 1, improved or unchanged (change in CKD-EPI eGFR+/-10%); group 2, temporary decline (decline>10% at day 1 or 2, followed by complete recovery within 10% to baseline at day 3); and group 3, persistent decline (>10% decrease). Primary end point was the development of incident CKD during a median follow-up of 5 years., Results: Perioperative renal function was classified as unchanged, temporary decline, and persistent decline in 739 (57%), 294 (22%), and 275 (21%) patients, respectively. During follow-up, 272 (21%) patients developed CKD. In multivariate logistic regression analyses, temporary and persistent declines in renal function both were independent predictors of long-term CKD, compared with unchanged renal function., Conclusion: Vascular surgery patients have a high incidence of temporary and persistent perioperative renal function declines, both of which were independent predictors for development of long-term incident CKD.

Background: Patients undergoing vascular surgery are at increased risk for developing cardiac complications. Majority of patients with perioperative myocardial damage are asymptomatic. Our objective is to review the available literature addressing the prevalence and prognostic implications of perioperative myocardial damage in vascular surgery patients., Methods: An Internet-based literature search was performed using MEDLINE to identify all published reports on perioperative myocardial damage in vascular surgery patients. Only those studies published from 2000 to 2010 evaluating myocardial damage using troponin I or T, with or without symptoms of angina pectoris were included., Results: Thirteen studies evaluating the prevalence of perioperative myocardial ischaemia or infarction were included in the study. The incidence of perioperative myocardial ischaemia ranged from 14% to 47% and the incidence of perioperative myocardial infarction ranged from 1% to 26%. In addition, 10 studies evaluating the prognostic value of perioperative myocardial ischaemia towards postoperative mortality or the occurrence of major adverse cardiac events were included. In the retrieved studies, hazard ratios varied from 1.9 to 9.0., Conclusion: The high prevalence and asymptomatic nature of perioperative myocardial damage, combined with a substantial influence on postoperative mortality of vascular surgery patients, underline the importance of early detection and adequate management of perioperative myocardial damage. This article provides an extended overview regarding the prevalence and prognostic value of perioperative myocardial ischaemia and infarction in vascular surgery patients. In addition, treatment options to reduce the risk of perioperative myocardial damage are provided based on the current available literature., (Copyright 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: Metabolic syndrome (MetSyn) is a well-known risk factor for cardiovascular (CV) disease in the general population; however, the additional predictive value for CV events in high-risk patients with peripheral arterial disease (PAD) is unknown. The aims of the current study were to assess and compare: (1) prevalence of MetSyn, and (2) predictive value of MetSyn for CV events, in patients with either occlusive or aneurysmatic PAD., Methods: We screened 2069 patients scheduled for lower occlusive arterial revascularization (n=1031) or abdominal aortic aneurysm repair (n=1038) for the presence of MetSyn. Adult Treatment Panel III report (ATP III) was used for defining MetSyn. Central obesity was defined as body-mass-index>30 kg/m2. Main outcomes were the occurrence of CV events and CV mortality during a median follow-up of 6 years (IQR 2-9 years)., Results: Metabolic syndrome was diagnosed in 421 (41%) and 432 (42%) patients with occlusive and aneurysmatic PAD, respectively (p=0.72). Patients with occlusive or aneurysmatic PAD and MetSyn had an increased risk for the development of CV events, when compared to patients without MetSyn (27% vs. 18% and 27% vs. 19%, p<0.001, respectively). In occlusive and aneurysmatic PAD, MetSyn was independently associated with an increased risk of CV events (HR=1.6; 95%CI 1.2-2.1 and HR=1.4; 95%CI 1.1-1.8). No significant association between the presence of MetSyn and CV mortality was observed., Conclusions: Metabolic syndrome is highly prevalent in high-risk PAD patients. In occlusive and aneurysmatic PAD patients, MetSyn is an independent predictor of long-term CV events., (Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.)