Angiographic Guidance Research Articles

Fluorescein angiography as a primary guide for reduced-fluence photodynamic therapy for the treatment of chronic central serous chorioretinopathy.

The aim of this study is to investigate the results of fluorescein angiography (FA)-guided reduced-fluence photodynamic therapy (PDT) in the treatment of chronic central serous chorioretinopathy (CSCR), with the hypothesis that indocyanine green angiography (ICGA) guidance is avoidable in some cases. This retrospective study includes a consecutive nonrandomized series of chronic CSCR cases. All eyes were examined with FA and the ones that had discrete active leakage areas or points had undergone reduced-fluence PDT. The study included 45 eyes of 41 patients with a mean age of 48.8 ± 10.7. The main duration of last chronic CSCR episode was 13.0 ± 11.9months. Thirty-nine (86.7%) out of 45 consecutive eyes had active leakage area(s) on FA, which enabled them to be treated with PDT. Remaining six eyes had undergone ICGA examination and had received an ICGA-guided PDT. In FA-guided eyes, the mean BCVA improved from 0.44 ± 0.25 Snellen lines to 0.63 ± 0.32 lines in the last control visit (p < 0.001). Both central macular thickness and subfoveal choroidal thickness decreased significantly in treated eyes. Thirty-eight eyes (97.4%) in FA-guided group and six eyes (100.0%) in ICGA-guided group had total resorption of subretinal fluid. This study provides basis to support the hypothesis that FA-guided half-fluence PDT may be justified as an alternative method of treatment in appropriate cases of chronic CSCR without compromising the therapeutic success.

Randomized Comparison of Optical Coherence Tomography Versus Angiography to Guide Bioresorbable Vascular Scaffold Implantation: The OPTICO BVS Study

PurposeWe investigated whether optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation can improve in-scaffold minimal lumen area (MLA) at 6-month compared with angiography guidance. MethodsThe OPTICO BVS was a randomized, international multicenter, assessor blind, superiority trial comparing OCT- versus angiography-guided percutaneous coronary intervention (PCI) (1:1 allocation) in patients with coronary artery disease undergoing Absorb BVS 1.1 implantation. The primary endpoint was in-scaffold MLA at 6-month. ResultsThe trial was prematurely stopped on May 31, 2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe. Patients were randomly assigned to OCT- (n = 19) or angiography-guided PCI (n = 19). Scaffold diameter (OCT 3.0 ± 0.3 mm vs. angiography 3.1 ± 0.3 mm, P = .333) and length (28.8 ± 13.6 mm vs. 23.8 ± 12.3 mm, P = .223) were comparable. There was no significant difference in in-scaffold MLA at 6 months (4.47mm2 vs. 5.08mm2, P = .692). Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010). There was no significant difference in clinical outcomes. ConclusionsAlthough in-scaffold MLA at 6-month did not differ between groups, scaffold expansion was improved following OCT- as compared with angiography-guided PCI. The findings of this study must be interpreted in view of the premature termination with inclusion of 14% of the initially planned study sample.

Quantitative flow ratio–guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial

Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease. Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance. The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.

Transcatheter Intra-Arterial Infusion Combined with Interventional Photothermal Therapy for the Treatment of Hepatocellular Carcinoma.

BackgroundPhotothermal therapy (PTT) has great potential application in the treatment of tumors. However, due to the low penetration of near-infrared light (NIR) and the low concentration of nanomaterials in the tumor site, the application of PTT has been limited.PurposeThe objective of this study was to investigate the therapeutic effect of transcatheter intra-arterial infusion of lecithin-modified Bi nanoparticles (Bi-Ln NPs) combined with interventional PTT (IPTT) on hepatocellular carcinoma.MethodsBi-Ln NPs were prepared by emulsifying the hydrophobic Bi nanoparticles and lecithin, and the photothermal conversion and cytotoxicity of Bi-Ln NPs were then measured by infrared imaging and MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay, respectively. Twenty-four VX2 hepatic carcinoma rabbits were randomly divided into four groups. Rabbits in group A received Bi-Ln NPs by intra-arterial infusion and NIR laser treatment (IA Bi-Ln NPs + Laser), group B received Bi-Ln NPs by intravenous infusion and NIR laser treatment (IV Bi-Ln NPs + Laser), group C received PBS (phosphate buffer saline) via intra-arterial infusion with NIR laser treatment (IA PBS + Laser), group D received PBS via intra-arterial infusion (IA PBS). Transcatheter intra-arterial infusion was conducted by superselective intubation under digital subtraction angiography (DSA) guidance. IPTT was performed by introducing an NIR optical fiber access to the rabbit VX2 hepatic carcinoma under real-time ultrasound guidance. Magnetic resonance imaging (MRI) was performed to evaluate the tumor size. Hematoxylin and eosin (H&E) stain and terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) were conducted 7 days after treatment to evaluate the necrosis rate and viability of tumor, respectively.ResultsThe Bi-Ln NPs have the advantages of good biological compatibility and high photothermal conversion efficiency. Minimally invasive transcatheter intra-arterial infusion can markedly increase the concentration of Bi-Ln NPs in tumor tissues. IPTT can contribute to the significant improvement in the photothermal efficiency of Bi-Ln NPs. Compared to other groups, the group of IA Bi-Ln NPs + Laser showed a significantly higher tumor inhibition rate (TIR) of 93.38 ± 19.57%, a higher tumor necrosis rate of 83.12 ± 8.02%, and a higher apoptosis rate of (43.26 ± 10.65%) after treatment.ConclusionTranscatheter intra-arterial infusion combined with interventional PTT (IPTT) is safe and effective in eradicating tumor cells and inhibiting tumor growth and may provide a novel and valuable choice for the treatment of hepatocellular carcinoma in the future.

844 Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: A Health Economic Analysis

There is increasing evidence that use of intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) is associated with improved clinical outcomes compared with angiography alone. However, concern regarding the cost-effectiveness of IVUS has limited use of this technology worldwide. In this study, we aimed to evaluate the cost-effectiveness of IVUS-guided PCI compared with angiography-guided PCI in patients undergoing drug-eluting stent (DES) implantation. A Markov model was constructed to compare the cost-effectiveness of IVUS-guided to angiography-guided DES implantation from the Australian healthcare system perspective. Procedure-related morbidity and mortality were estimated from the published literature. Costs were obtained from Australian sources. Outcomes of interest included costs, life-expectancy and quality-adjusted life years (QALYs). In the base case analysis, the population of interest was all-comers undergoing PCI. In sensitivity analyses, we explored whether lesion subtype affected cost-effectiveness. In the base case, IVUS-guided DES implantation was cost-effective compared to angiography-guided DES implantation. With 5% annual discounting, IVUS was associated with increased lifetime costs of AUD$799 per person and benefits of 0.10 life-years and 0.11 QALYs compared to angiography, yielding an incremental cost-effectiveness ratio of AUD$9,280/QALY gained. Analysis by lesion subtype revealed greater cost-effectiveness among patients with left main and complex coronary lesions. Results were robust to sensitivity analyses, with IVUS being cost-effective in 98% of 10,000 Monte Carlo iterations assuming a willingness-to-pay threshold of $AUD50,000/QALY gained. Use of IVUS guidance during PCI is likely to be cost-effective compared with angiography guidance alone among patients undergoing DES implantation.

Effect of Intravascular Ultrasound–Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial

ObjectivesThe goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up. BackgroundThe use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up. MethodsThe IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion–related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat. ResultsFive-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031). ConclusionsCompared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486)

In-Hospital and 1-Year Results of Intravascular Ultrasound-Guided Versus Angiography-Guided Intervention for Type C Coronary Lesions

Background: Class C lesions are considered to have the highest degree of lesion complexity so we compared between Intravascular Ultrasound (IVUS)-guided and angiography-guided PCI for Type C coronary lesions regarding procedural success and occurrence of Major Adverse Cardiac Events (MACE). Results: Our study was conducted on patients undergoing elective PCI for type C coronary lesions. The study included 50 patients who underwent IVUS guided PCI and 50 patients who underwent angiographic guided PCI. We evaluated IVUS guidance on clinical outcomes. MACE, all-cause mortality, ST elevation infarction, and target lesion revascularization, were end points for comparison. Follow-up duration was 12 months. Adding IVUS to the procedure was associated with more procedure time but with less amount of contrast. Patients with IVUS-guided PCI underwent more direct stenting, post-dilatation, larger maximal stent diameter, and greater number of implanted stents. The IVUS guided group had significantly better final diameter stenosis but at 1-year follow up, IVUS use failed to reduce MACE significantly in comparison to angiographic guidance. In conclusion: use of IVUS is associated with lower amount of radiographic contrast used during the procedure, more procedural time, more post dilatation and less postintervention final diameter stenosis. In addition, use of IVUS in complex lesions allows optimizing PCI procedures and stent apposition. A strategy of IVUS for stent implantation in complex coronary lesions didn’t reduce the 1-year MACE rates and thus, isn’t recommended routinely

Effective accuracy of stereoelectroencephalography: robotic 3D versus Talairach orthogonal approaches.

Stereoelectroencephalography (SEEG) was first developed in the 1950s by Jean Talairach using 2D angiography and a frame-based, orthogonal approach through a metallic grid. Since then, various other frame-based and frameless techniques have been described. In this study the authors sought to compare the traditional orthogonal Talairach 2D angiographic approach with a frame-based 3D robotic procedure that included 3D angiographic interoperative imaging guidance. MRI was used for both procedures during surgery, but MRI preplanning was done only in the robotic 3D technique. All study patients suffered from drug-resistant focal epilepsy and were treated at the same center by the same neurosurgical team. Fifty patients who underwent the 3D robotic procedure were compared to the same number of historical controls who had previously been successfully treated with the Talairach orthogonal procedure. The effectiveness and absolute accuracy, as well as safety, of the two procedures were compared. Moreover, in the 3D robotic group, the reliability of the preoperative MRI to avoid vascular structures was evaluated by studying the rate of trajectory modification following the coregistration of the intraoperative 3D angiographic data onto the preoperative MRI-based trajectory plans. Effective accuracy (96.5% vs 13.7%) and absolute accuracy (1.15 mm vs 4.00 mm) were significantly higher in the 3D robotic group than in the Talairach orthogonal group. Both procedures showed excellent safety results (no major complications). The rate of electrode modification after 3D angiography was 43.8%, and it was highest for frontal and insular locations. The frame-based, 3D angiographic, robotic procedure described here provided better accuracy for SEEG implantations than the traditional Talairach approach. This study also highlights the potential safety advantage of trajectory planning using intraoperative frame-based 3D angiography over preoperative MRI alone.

Physiological Versus Angiographic Guidance for Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation.

BackgroundManagement of coronary artery disease in patients undergoing transcatheter aortic valve implantation is uncertain. Fractional flow reserve (FFR) has never been clinically validated in aortic stenosis. The study aim was to analyze the clinical outcome of FFR‐guided revascularization in patients undergoing transcatheter aortic valve implantation.Methods and ResultsPatients with severe aortic stenosis and coronary artery disease at coronary angiography were included in this retrospective analysis and divided in 2 groups: angiography guided (122/216; 56.5%) versus FFR‐guided revascularization (94/216; 43.5%). Patients were clinically followed up and evaluated for the occurrence of major adverse cardiac and cerebrovascular events at 2‐year follow‐up. Most lesions in the FFR group resulted negative according to the conventional 0.80 cutoff value (111/142; 78.2%) and were deferred. The FFR‐guided group showed a better major adverse cardiac and cerebrovascular event–free survival compared with the angio‐guided group (92.6% versus 82.0%; hazard ratio, 0.4; 95% CI, 0.2–1.0; P=0.035). Patients with deferred lesions based on FFR presented better outcome compared with patients who underwent angio‐guided percutaneous coronary intervention (91.4% versus 68.1%; hazard ratio, 0.3; 95% CI, 0.1–0.6; P=0.001).ConclusionsFFR guidance was associated with favorable outcome in this observational study in patients undergoing transcatheter aortic valve implantation. Randomized trials are needed to investigate the long‐term effects of FFR‐guided revascularization against angiographic guidance alone in patients with aortic stenosis.

Role of optical coherence tomography for distal left main stem angioplasty.

The objective is to analyze the acute and midterm angiographic outcome of percutaneous treatment of left main coronary stem (LM-PCI) guided by optical coherence tomography (OCT). LM-PCI is a complex procedure, and several anatomical factors may impair its outcome. Intravascular imaging is emerging as a useful tool to guide the procedure. We conducted a retrospective analysis of patients undergoing LM-PCI at three European centers between 2014 and 2017 with a control angiography at 6-12 months. Patients were divided into two groups: OCT-guidance (pre- and post-PCI) and control group (standard angiographic guidance with/out intravascular ultrasound [IVUS]). A blinded core lab analyzed all angiographic images. Primary endpoint was late lumen loss (LLL) after 6 months. A total of 112 patients entered the study, 55 in the OCT group and 57 in the control group (10 IVUS). Baseline and procedural characteristics were similar between groups. Overall, reference vessel diameter of the LM was 3.98 ± 0.65 mm. OCT guidance detected four cases of stent underexpansion (7.2%) and six cases of acute malapposition (10.9%). After a median of 207 ± 23 days, LLL of LM tended to be lower in the OCT group (0.12 ± 0.41 vs. 0.26 ± 0.52 mm, p = .10), and was significantly reduced in the distal portion of the main vessel (0.03 ± 0.45 vs. 0.24 ± 0.53 mm, p = .025). Percent diameter stenosis was also lower (14 ± 9 vs. 19 ± 16%, p = .05). Adverse event rates were similar in the two groups. In this study, systematic OCT guidance during LM-PCI allowed a timely detection and correction of acute stent underexpansion and malapposition, and was associated with signs of improved angiographic outcome at midterm, compared to standard practice.

P4505VECTOR-HF: The first human experience with the V-LAP, a wireless left atrial pressure monitoring system for patients with heart failure

Abstract Background/Introduction Invasive pressure-guided therapy has been shown to improve outcomes in patients with heart failure (HF). Thus far, only right-sided pressure sensors have shown clinical efficacy and safety. The Vectorious Medical Technologies V-LAP™ is a novel battery-less and wireless left-sided pressure monitoring system, directly assessing left-atrial pressure (LAP) in an ambulatory setting. In pre-clinical studies, it was shown to enable accurate and safe measurement of LAP. We hereby describe the first human experience with the device. Methods The V-LAP left atrial monitoring systEm for patients with Chronic sysTOlic and diastolic congestive heart failuRe first-in-human (VECTOR) study is a prospective, multicenter, single arm, open-label clinical trial to assess the safety, performance and usability of the V-LAP system in patients with heart failure. The V-LAP™ wireless sensor is implanted using a trans-septal access, under angiographic and echocardiographic guidance. The system includes an external unit, which both powers the implant and collects data via radio frequency communication upon activation, designed to be operated on a daily basis. We hereby describe the first cases, implanted in the CardioVascular Center, in Frankfurt, Germany. Results At this point in time, there have been two successful implantations of the V-LAP™, performed in two NYHA Class III patients. Both were admitted repeatedly for exacerbations of HF, and demonstrated elevated NT-ProBNP levels. They were therefore considered appropriate candidates for the monitoring system, to enable optimal medical therapy. The procedure was performed in a trans-femoral, trans-septal fashion, under mild sedation, with a successful implantation of a V-LAP™, and calibration for pressure measurement. There were no complications, data showed accurate LAP reading (Figure 1). Conclusions In the first-in-human cases, the implantation of the novel wireless left atrial pressure sensor V-LAP™ was feasible, safe, and showed good accuracy and precision. We now await both short and long-term efficacy and safety outcomes of the device, with the hopes of optimizing care according to ambulatory LAP data for patients with HF. Acknowledgement/Funding Vectorious Medical Technologies

TCT-71 Impact of Intravascular Ultrasound Guidance on Long-Term (10-Year) Mortality and Adverse Cardiovascular Events in Percutaneous Coronary Intervention for Unprotected Left Main Coronary Artery Disease

Compared with angiographic guidance, intravascular ultrasound (IVUS)–guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes. However, the very long-term clinical effects of IVUS-guided PCI are still unclear in patients receiving complex PCI for unprotected left

TCT-206 Conservative Versus Aggressive Treatment Strategy With Angiographic Guidance Alone in Patients With Intermediate Coronary Lesions: 3-Year Outcome of the SMART-CASE Trial

TCT-206 Conservative Versus Aggressive Treatment Strategy With Angiographic Guidance Alone in Patients With Intermediate Coronary Lesions: 3-Year Outcome of the SMART-CASE Trial

V-LAP Left Atrial Monitoring systEm for Patients with Chronic sysTOlic and Diastolic Congestive Heart FailuRe First-in-Human

Despite advancements in diagnostic and therapeutic modalities, the rate of HF hospitalizations (HFH) has not changed substantially in recent years. While non-invasive monitoring approaches have generally failed to reduce the risk of HFH, management guided by intracardiac or pulmonary artery pressure has. Purpose: To present the initial experience with a novel battery-less and wireless left-sided pressure system, directly assessing left-atrial pressure (LAP) in ambulatory HF patients, from the V-LAP monitoring systEm for patients with Chronic sysTOlic and diastolic congestive heart failuRe first-in-human (VECTOR) study. Methods: The V-LAP™ sensor is able to directly measure absolute pressures in the LA in high resolution, compensate for pressure drift, transmit daily hemodynamic feedback, and detect common comorbidities such as Afib and MR. It is implanted using a TS approach, under angiographic and echocardiographic guidance. The V-LAP™ system includes an external unit, which powers the implant remotely and collects data via RF communication on a daily basis. The system is undergoing initial clinical evaluation in the VECTOR-HF Trial, in order to assess the safety, performance and usability of the system in patients with HF. Results: In pre-clinical studies, the device was shown to enable accurate and safe LAP measurement. Currently, two patients have been successfully implanted with the device. In the first case the patient has great variability in LAP on a daily basis, likely due to rapid changes in preload due to variability in venous capacitance and possibly volume status, accompanied by preload-dependent changes in the severity of functional MR, which was well observed during both TTE and LAP waveform morphology. This patient might be at high-risk for HFH. In the second case the LAP is well-controlled with little variability. During the conference we will describe and discuss the first 8 cases, and discuss the potential role of the V-LAP™ wireless sensor in the management of patients with HF in the future. Conclusions: The VECTOR-HF trial currently enrolled the first two patients, who were safely implanted with the V-LAP™ wireless sensor. Clinical trials will demonstrate whether the system enables optimal therapy for HF patients, reduces readmissions and detects co-morbidities in a personalized manner. Daily hemodynamic feedback from the heart opens a new era in the management of HF patients and scientific outcomes based on LAP data.

The factors contributing to the total radiation exposure of patients during uterine artery embolisation.

Uterine artery embolisation (UAE) is an interventional angiography procedure for the treatment of symptomatic fibroids and/or adenomyosis in women. UAE is a less invasive and non‐surgical alternative to hysterectomy or myomectomy. However, ionising radiation is used for both fluoroscopic and angiographic image guidance to visualise and access the uterine arteries for embolisation and treatment of these benign conditions. Identifying the contributors and implementing dose reduction techniques are particularly important as UAE patients are usually of child‐bearing age. The purpose of this review was to examine the progression of literature on radiation exposure measurements and identifying the factors contributing to the total radiation exposure of female patients undergoing UAE. A Medline, ProQuest Central, ScienceDirect and Scopus database search from 2000 to 2018 was performed and forty articles were deemed acceptable for review following the inclusion and exclusion criteria set. UAE is a viable alternative to hysterectomy and myomectomy, as the reviewed literature demonstrated that the reported radiation exposure doses appear to be below the threshold for any deterministic radiation risks. The total radiation exposure of UAE patients is affected independently by multiple patient, operator expertise and technique, angiographic imaging and x‐ray unit variables. Uterus preservation can be attained post‐UAE with dose reduction and optimisation, however, a longitudinal study on UAE patients and their risk of radiation‐induced deterministic and/or stochastic effects is recommended.

Online three-dimensional OFDI-guided versus angiography-guided PCI in bifurcation lesions: design and rationale of the randomised OPTIMUM trial.

The feasibility of offline optical coherence tomography (OCT) guidance in bifurcation (with either two-dimensional or three-dimensional images) and its potential benefits have been demonstrated in retrospective studies; however, these have not yet been investigated prospectively. The aim of this trial is to determine the superiority of online three-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition (ISA) at the bifurcation segment. The OPTIMUM trial is a randomised, superiority, multicentre clinical trial. The primary endpoint of this trial is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing balloon dilatation (FKBD). A total of 106 patients will be randomly allocated to either 3D-OFDI guidance or angiography guidance PCI. Bifurcation lesions will be treated with a provisional single-stent strategy using the Ultimaster sirolimus-eluting stent. Patients randomised to the 3D-OFDI guidance arm will undergo OFDI assessment in the main branch (MV) after rewiring into the jailed side branch following stent implantation, while in the angiography guidance arm re-crossing of a wire into the side branch will be performed using conventional fluoroscopic/angiographic guidance. In patients in the 3D-OFDI guidance arm, if the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm the re-crossing position. The proximal optimisation technique and FKBD are mandatory in this trial. The study will provide a 90% power to show superiority of 3D-OFDI guidance PCI compared with angiography-guided PCI. The OPTIMUM trial will be the first prospective, randomised trial to evaluate the efficacy and safety of online 3D-OFDI-guided PCI in bifurcation lesions. ClinicalTrials.gov Identifier: NCT02972489.

Damage Control Vascular Surgery

Exsanguination is one of the most fearsome sequelae of trauma and is responsible for a large portion of both civilian and military mortality. The concept of damage control surgery is a critical development in the field of trauma largely driven by the growing understanding that coagulopathy and physiologic derangements are the primary cause of death in critically ill trauma patients. Damage control vascular surgery focuses on the rapid temporization of vascular injuries. Balloon occlusion can be utilized for rapid hemorrhage control (REBOA, foley catheter, retrohepatic caval balloon, etc.). In the setting of damage control, most veins can and should be ligated. Consideration of shunting should be made regarding the suprarenal inferior vena cava, the portal vein, and the superior mesenteric vein. The named arteries should be shunted and repaired when possible; however, redundant arterial beds can be safely ligated. Vessels of all sizes can be safely shunted with commercially available or improvised devices. Systemic heparinization is not necessary to maintain patency. More recently, the concept of using endovascular stents as long-term shunts has gained attention. These can be deployed traditionally under angiographic guidance or using the novel direct site endovascular repair (DSER) technique. The rapidly evolving field of endovascular trauma management has afforded a host of new management strategies for the physiologically deranged critically ill trauma patient.

Intravascular Ultrasound-Guidance Is Associated With Lower Cardiovascular Mortality and Myocardial Infarction for Drug-Eluting Stent Implantation - Insights From an Updated Meta-Analysis of Randomized Trials.

Randomized trials have been underpowered to determine an effect of intravascular ultrasound (IVUS) guidance on hard outcomes for drug-eluting stent (DES) implantation.Methods and Results:Randomized trials that compared IVUS guidance vs. angiographic guidance for DES implantation were included; 10 trials with 5,060 patients. IVUS guidance was associated with a lower incidence of cardiovascular death (odds ratio [OR] 0.44, 95% CI 0.26-0.75), and myocardial infarction (OR 0.55, 95% CI 0.32-0.94). IVUS-guidance is associated with a lower incidence of cardiovascular death and myocardial infarction in the era of DES. These findings should encourage operators to use IVUS more often.

Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures

ObjectivesThis study sought to determine whether intravascular ultrasound (IVUS) guidance compared with angiographic guidance reduces long-term risk of cardiac death in patients undergoing complex percutaneous coronary intervention (PCI). BackgroundAlthough IVUS is a useful tool for accurate assessment of lesion profiles and optimal stent implantation, there are limited data on long-term clinical outcomes between IVUS-guided and angiography-guided PCI for patients with complex lesions. MethodsFrom March 2003 through December 2015, a total of 6,005 patients undergoing PCI for complex lesions with drug-eluting stents were enrolled from a prospective institutional registry. All enrolled subjects had at least 1 complex lesion (defined as bifurcation, chronic total occlusion, left main disease, long lesion, multivessel PCI, multiple stent implantation, in-stent restenosis, or heavily calcified lesion). Patients were classified according to use of IVUS or not. Multiple sensitivity analyses, including multivariable adjustment, propensity-score matching, and inverse-probability-weighted method, were performed to adjust baseline differences. ResultsAmong the study population, IVUS was used in 1,674 patients (27.9%) during complex PCI. The IVUS-guided PCI group had a significantly larger mean stent diameter (3.2 ± 0.4 vs. 3.0 ± 0.4; p < 0.001), and more frequent use of post-dilatation (49.0% vs. 17.9%; p < 0.001) compared with the angiography-guided PCI group. IVUS-guided PCI was associated with a significantly lower risk of cardiac death during 64 months of median follow-up compared with angiography-guided PCI (10.2% vs. 16.9%; hazard ratio: 0.573; 95% confidence interval: 0.460 to 0.714; p < 0.001). Results were consistent after multivariable regression, propensity-score matching, and inverse-probability-weighted method. The risks of all-cause death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, and major adverse cardiac events were also significantly lower in the IVUS-guided PCI group. ConclusionsAmong patients with complex coronary artery lesion, IVUS-guided PCI was associated with the lower long-term risk of cardiac death and adverse cardiac events compared with angiography-guided PCI. Use of IVUS should be actively considered for complex PCI.

FIRST PILOT BLINDED STUDY COMPARING FEASIBILITY & SAFETY OF THE IMPLANTATION OF THE WATCHMAN DEVICE & ASSESSMENT OF THE PASS CRITERIA AS GUIDED BY STANDARD ANGIOGRAPHY ALONE VERSUS THE GOLD STANDARD OF TEE GUIDANCE

The Watchman implantation procedure is performed using Transesophageal echocardiographic (TEE) and general anesthesia (GA) conditions. We evaluated in a blinded fashion the feasibility and safety of implanting the Watchman device and assessing the (PASS criteria) using angiography guidance alone VS