Acute coronary syndrome in an anomalous mid-LAD right coronary artery: Don't forget to look twice before turning left.

A 68-year-old female with past medical history of hypertension, hyperlipidemia, multiple sclerosis, diverticulitis, and tobacco use presented with 1 day of atypical chest pain after a recent diverticulitis flare. Initial workup was notable for a normal electrocardiogram but elevated high sensitivity troponin T (616 ng/L). Due to persistent symptoms, the patient was given antiplatelet therapy and taken urgently to the catheterization lab where she was found to have complete occlusion of an anomalous right coronary artery branching off the mid-left anterior descending artery. Angioplasty was performed with a drug-eluting stent and her symptoms resolved. The patient recovered well and was discharged on appropriate medical therapy. This case demonstrates a case of acute coronary syndrome in an extremely rare coronary congenital abnormality. Further research is needed on when to be suspicious for coronary anomalies on patients presenting with myocardial infarction.

Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices.

BACKGROUND: Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial. METHODS: Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days. RESULTS: Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048). CONCLUSIONS: The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.

Transcatheter heart valve selection in patients with low ejection fraction and aortic stenosis.

OBJECTIVE: The aim of this study was to compare outcomes of transcatheter heart valve (THV) choice in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: The management congestive heart failure with combined LV systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. Head-to-head comparisons among the balloon-expandable (BEV) and self-expandable (SEV) THV remain limited in this subgroup of patients. METHODS: In this retrospective study, we included patients with severe AS with LV systolic dysfunction (LVEF ≤40%) who underwent TAVR at four high volume centers. Two thousand and twenty-eight consecutive patients were analyzed, of which 335 patients met inclusion criteria. One hundred fourty-six patients (43%) received a SEV, and 189 patients (57%) received a BEV. RESULTS: Baseline characteristics were similar except for a higher proportion of females in the SEV group. The primary composite endpoint of in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve reintervention, and/or need for permanent pacemaker (PPM) was no different among THV choice. There was more PVL in the SEV group, but higher transaortic gradients in the BEV group. Clinical outcomes and quality of life measures were similar up to 1 year follow-up. CONCLUSION: The choice of THV in patients with severe AS and systolic dysfunction must be weighed on a case-by-case basis.

Northwell intracoronary brachytherapy for the treatment of recurrent drug eluting stent in-stent restenosis (NITDI study group).

OBJECTIVE: The purpose of this study is to report on safety, short-term and long-term clinical efficacy following intracoronary brachytherapy (ICBT) for restenosis (ISR) in patients with drug eluting stents (DES). BACKGROUND: ICBT is an effective treatment for ISR of bare metal stents (BMS) but its utilization has waned due to the advent of DES. ISR following DES occurs at a frequency of 8% or greater. METHOD: A retrospective analysis was performed on patients treated on an institutional review board (IRB) approved protocol using ICBT for DES ISR between January 2011 and October 2016. All patients were followed for 24 months for procedural complications, mortality, clinical ISR/target lesion revascularization (TLR) and stroke. RESULTS: A total of 290 patients were identified with a mean age of 66.6 years. All of them had high rates of typical coronary artery disease risk factors. Our primary outcome, composite of in-hospital mortality, myocardial infarction (MI), safety outcomes and procedural failure was noted in 1(0.3%) patient who had a MI. No other secondary outcome was noted in-hospital. At 1-year follow up, 12.4% patients had ISR, 1.7% patients died, and 1 (0.3%) had ischemic stroke. At 2-year, 14.7% had ISR, and total 6 (2.1%) patients had MI. CONCLUSION: ICBT demonstrates excellent technical success rates for treatment, safety, and reasonable efficacy over 2-years to be free from recurrent clinical ISR. This study represents the largest ICBT data for DES ISR to date among very complex lesion subsets, however, more prospective data will be needed to determine the optimal patient for treatment.

Impact of COVID-19 pandemic on STEMI care: An expanded analysis from the United States.

OBJECTIVE: To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care. BACKGROUND: We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data. METHODS: Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC. RESULTS: Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05). CONCLUSIONS: The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI.

Short term outcomes of rotational atherectomy versus orbital atherectomy in patients undergoing complex percutaneous coronary intervention: a systematic review and meta-analysis.

OBJECTIVE: Coronary artery calcification (CAC) is one of the paramount hurdles for percutaneous coronary intervention (PCI) since it impedes stent delivery and complete expansion. This study intended to evaluate the short-term clinical and procedural outcomes comparing rotational atherectomy (RA) and orbital atherectomy (OA) in patients with heavily calcified coronary lesions undergoing PCI. Design: This systematic review and meta-analysis included all head-to-head published comparisons of coronary RA versus OA. Procedural endpoints and post-procedural clinical outcomes (30 days/in-hospital), were compared. RevMan 5.3 software was used for data analysis. Results: Seven retrospective observational investigations with a total of 4623 patients, including 3203 patients in the RA group and 1420 patients in the OA group, were incorporated. Compared with OA, the RA group was associated with a higher incidence of myocardial infarction at short-term follow-up (OR: 1.56, 95% CI: 1.07-2.29, p = .02, I2 = 0%). No difference was noted among other short-term post-procedural clinical outcomes including all-cause mortality, target vessel revascularization, or major adverse cardiac events. Among procedural complications, RA was associated with reduced coronary artery dissection and arterial perforation. Increased fluoroscopy time was observed in the RA cohort as compared with OA (MD: 4.78, 95% CI: 2.25-7.30, p = .0002, I2 = 80%). Conclusion: RA was associated with fewer vascular complications, but at a cost of higher incidence of myocardial infarction and higher fluoroscopy time compared with OA, at short term follow-up. OA is a safe and effective alternative for the management of CAC.

Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

North American COVID-19 ST-Segment-Elevation Myocardial Infarction (NACMI) registry: Rationale, design, and implications.

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. Patients with cardiovascular risk factors or established cardiovascular disease are more likely to experience severe or critical COVID-19 illness and myocardial injury is a key extra-pulmonary manifestation. These patients frequently present with ST-elevation on an electrocardiogram (ECG) due to multiple etiologies including obstructive, non-obstructive, and/or angiographically normal coronary arteries. The incidence of ST-elevation myocardial infarction (STEMI) mimics in COVID-19-positive hospitalized patients, and the association with morbidity and mortality is unknown. Understanding the natural history and appropriate management of COVID-19 patients presenting with ST elevation is essential to inform patient management decisions and protect healthcare workers. Methods: The Society for Cardiovascular Angiography and Interventions (SCAI) and The Canadian Association of Interventional Cardiology (CAIC) in conjunction with the American College of Cardiology Interventional Council have collaborated to create a multi-center observational registry, NACMI. This registry will enroll confirmed COVID-19 patients and persons under investigation (PUI) with new ST-segment elevation or new onset left bundle branch block (LBBB) on the ECG with clinical suspicion of myocardial ischemia. We will compare demographics, clinical findings, outcomes and management of these patients with a historical control group of over 15,000 consecutive STEMI activation patients from the Midwest STEMI Consortium using propensity matching. The primary clinical outcome will be in- hospital major adverse cardiovascular events (MACE) defined as composite of all-cause mortality, stroke, recurrent MI, and repeat unplanned revascularization in COVID-19 confirmed or PUI. Secondary outcomes will include the following: reporting of etiologies of ST Elevation; cardiovascular mortality due to myocardial infarction, cardiac arrest and /or shock; individual components of the primary outcome; composite primary outcome at 1 year; as well as ECG and angiographic characteristics. Conclusion: The multicenter NACMI registry will collect data regarding ST elevation on ECG in COVID-19 patients to determine the etiology and associated clinical outcomes. The collaboration and speed with which this registry has been created, refined, and promoted serves as a template for future research endeavors.

Differences in risk factors and resource utilization for women undergoing percutaneous coronary intervention and lower extremity peripheral vascular intervention.

OBJECTIVE: To investigate the differences in risk factors and in-hospital outcomes for women undergoing percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). BACKGROUND: The clinical impact of coronary artery disease (CAD) and peripheral artery disease (PAD) is well characterized and is associated with high morbidity and mortality. There is lack of data comparing risk factors and in-hospital outcomes for PCI and PVI, particularly in women. METHODS: Only female hospitalizations (age ≥ 18 years) who underwent PCI or PVI from 2005 to 2014 were identified using appropriate International Classification of Diseases-Ninth Revision, Clinical Modification codes from the National Inpatient Sample database. Charlson's Comorbidity Index (CCI) was selected as the primary endpoint of the study. Coprimary endpoint was the cost of hospitalizations associated with PCI or PVI. RESULTS: Of the 2,461,328 female hospitalizations that were included, 85.6% (N = 2,105,236) underwent PCI and 14.4% (N = 356,092) received PVI. Compared to PCI, PVI hospitalizations were 3.2 years older (p < .001) and consisted of significantly more hospitalizations above 80 years of age (26.5% vs. 18.6%; p < .001). Hospitalizations with CCI ≥3 were significantly higher in the PVI cohort (29.1% vs. 24%; p < .001). CCI in women increased during the study period for both groups. PVI hospitalizations had a significantly longer length of stay (3 days vs. 2 days; p < .001) and cost of hospitalization ($23,610 vs. $20,571; p < .001), compared to PCI. Finally, the mean cost of hospitalizations increased during the study period for PCI and PVI. CONCLUSION: Women hospitalized for PVI had a greater risk-profile and resource utilization as demonstrated by the longer length of stay and higher cost compared to PCI.

Management of acute myocardial infarction during the COVID-19 pandemic: A Consensus Statement from the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the American College of Emergency Physicians (ACEP).

The worldwide pandemic caused by the novel acute respiratory syndrome coronavirus 2 has resulted in a new and lethal disease termed coronavirus disease 2019 (COVID-19). Although there is an association between cardiovascular disease and COVID-19, the majority of patients who need cardiovascular care for the management of ischemic heart disease may not be infected with this novel coronavirus. The objective of this document is to provide recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic. There is a recognition of two major challenges in providing recommendations for AMI care in the COVID-19 era. Cardiovascular manifestations of COVID-19 are complex with patients presenting with AMI, myocarditis simulating an ST-elevation myocardial infarction (STEMI) presentation, stress cardiomyopathy, non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury, and the prevalence of COVID-19 disease in the US population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on (a) varied clinical presentations; (b) appropriate personal protection equipment (PPE) for health care workers; (c) the roles of the emergency department, emergency medical system, and the cardiac catheterization laboratory (CCL); and (4) regional STEMI systems of care. During the COVID-19 pandemic, primary percutaneous coronary intervention (PCI) remains the standard of care for STEMI patients at PCI-capable hospitals when it can be provided in a timely manner, with an expert team outfitted with PPE in a dedicated CCL room. A fibrinolysis-based strategy may be entertained at non-PCI-capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option.

Considerations for cardiac catheterization laboratory procedures during the COVID-19 pandemic perspectives from the Society for Cardiovascular Angiography and Interventions Emerging Leader Mentorship (SCAI ELM) Members and Graduates.

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is highly infectious, carries significant morbidity and mortality, and has rapidly resulted in strained health care system and hospital resources. In addition to patient-related care concerns in infected individuals, focus must also relate to diminishing community spread, protection of staff, case selection, and concentration of resources. The current document based on available data and consensus opinion addresses appropriate catheterization laboratory preparedness for treating these patients, including procedure-room readiness to minimize external contamination, safe donning and doffing of personal protective equipment (PPE) to eliminate risk to staff, and staffing algorithms to minimize exposure and maximize team availability. Case selection and management of both emergent and urgent procedures are discussed in detail, including procedures that may be safely deferred or performed bedside.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Nonemergent Percutaneous Coronary Intervention on an Unprotected Left Main Coronary Artery Supported with Impella® Heart Pump in Patients Ineligible for Surgical Revascularization.

OBJECTIVES: We sought to assess if ineligibility to coronary artery bypass grafting (CABG) constitutes a risk factor in patients who underwent a nonemergent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with prophylactic Impella® heart pump support. BACKGROUND: ULMCA PCI in patients not deemed eligible for CABG is associated with significantly worse outcomes compared to ULMCA PCI in eligible patients. METHODS: Patients from the cVAD Registry and the PROTECT II trial who underwent a nonemergent ULMCA PCI were identified. We compared in-hospital mortality and major adverse cardiac and cerebrovascular event (MACCE) rates as well as 30-day survival and MACCE rates between CABG ineligible and CABG eligible patients. RESULTS: A total of 331 patients were included (293 Impella 2.5®, 38 Impella CP®); 227 were ineligible for CABG and 104 were eligible. Baseline characteristics were remarkable for a trend toward higher rate of chronic obstructive pulmonary disease in the ineligible patients. In-hospital mortality (3.52% vs. 5.77%; p=0.383) and MACCE (6.61% vs. 7.69%; p=0.816) rates as well as 30-day survival (92.0% vs. 93.4%; Log-Rank p-value =0.781) and MACCE (88.1% vs. 90.1%; Log-Rank p-value=0.648) rates were not different between the two groups. CONCLUSIONS: The results of our study suggest that prophylactic Impella support appears to mitigate the risks inherent to surgical ineligibility in patients undergoing a nonemergent ULMCA PCI. Our results require further investigation.

Trends in the Utilisation and In-Hospital Mortality Associated With Short-Term Mechanical Circulatory Support for Heart Failure With Reduced Ejection Fraction.

Heart failure with reduced ejection fraction (HFrEF) is a systolic dysfunction with an ejection fraction below 40% and the prevalence of it is substantially increasing in the United States. Mechanical circulatory support (MCS) devices have increasingly been used for the management of HFrEF and are associated with improved outcomes. The National Inpatient Sample database was used to identify hospitalisations with mechanical circulatory support for HFrEF from 2005 to 2014. This study observed a reduction in the utilisation of intra-aortic balloon pump (IABP), which is partially replaced by percutaneous left ventricular assist device (pLVAD) and extracorporeal membrane oxygenation (ECMO) for the management of HFrEF. In-hospital mortality in IABP and ECMO recipients decreased during the study period while mortality with pLVAD did not change. Finally, technology for the short-term MCS in HFrEF hospitalisations continues to improve, however, there is still some space for updated technology in future.

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study).

BACKGROUND: Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. METHODS: A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. RESULTS: After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. CONCLUSION: In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

Utilization and in-hospital outcomes associated with atherectomy in the treatment of peripheral vascular disease: An observational analysis from the National Inpatient Sample.

Objective Percutaneous revascularization for patients with peripheral arterial disease has become a treatment of choice for many symptomatic patients. The presence of severe arterial calcification presents many challenges for successful revascularization. Atherectomy is an adjunctive treatment option for patients with severe calcification undergoing percutaneous intervention. We sought to analyze the impact of atherectomy on in-hospital outcomes, length of stay, and cost in the percutaneous treatment of peripheral arterial disease. Methods Patients with lower extremity peripheral arterial disease undergoing percutaneous revascularization were assessed, utilizing the National Inpatient Sample (2012-2014) and appropriate International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedural codes. Patients who were not treated with atherectomy ( n = 51,037) were compared to those treated with atherectomy ( n = 11,408). Propensity score-matched analysis was performed to address baseline differences. Results After performing propensity score-matched analysis, 11,037 patients were included in each group. Utilization of atherectomy was associated with lower in-hospital mortality (2% vs. 1.4% p = 0.0006). All secondary outcomes were lower when using atherectomy except acute renal failure. Length of stay was slightly lower when using atherectomy (7.2 vs. 7.0 days, p = 0.0494). However, median cost was higher in patients treated with atherectomy ($21,589 vs. $24,060, p = <0.0001). Conclusion The use of atherectomy was associated with significantly decreased in-hospital mortality, adverse events, and length of stay. Though, cost associated with atherectomy use is increased, this is offset by decreased in-hospital adverse outcomes. Appropriate use of atherectomy devices is an important tool in revascularization of peripheral arterial disease in select patients.

Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial.

BACKGROUND: Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. METHODS: In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm2), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586. FINDINGS: Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm2 (IQR 4·54-7·34) with OCT guidance, 5·89 mm2 (4·67-7·80) with IVUS guidance, and 5·49 mm2 (4·39-6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI -0·70 mm2; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). INTERPRETATION: OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. FUNDING: St Jude Medical.

Gender disparities among patients with peripheral arterial disease treated via endovascular approach: A propensity score matched analysis.

BACKGROUND: Remarkable improvement in the treatment of Peripheral Arterial Disease (PAD) has led to changes in revascularization strategies from traditional open surgery to less invasive endovascular management. However, few studies are available on gender disparities in patients with PAD treated via an endovascular approach. This study was designed to analyze gender related differences with respect to in-hospital outcomes in PAD patients. METHODS: Our data was obtained from National Inpatient Sample (NIS) 2012 through 2014. We used International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedural codes appropriate for PAD and endovascular treatment. Endovascular treatment included drug eluting stent, bare metal stent, atherectomy or angioplasty of lower extremity arteries. A propensity score matching was performed to adjust for imbalances between variables. RESULTS: Females presented late with more comorbidities and underwent more emergent/urgent procedures. After performing propensity score matched analysis, 25 758 patients were included in each group. There was no difference in in-hospital mortality between males and females in matched cohorts (2.3% vs 2.4%, P = 0.25). Acute renal failure, gangrene, infection, and composite of all complications were higher in males. Only blood transfusion was noted higher in females. CONCLUSION: This study revealed no difference in in-hospital mortality between males and females undergoing endovascular peripheral intervention. Males have a higher rate of complications compared to females which explains the higher cost of care in males. Further research with long-term follow up is needed to see if there is any difference with regards to long-term outcomes and re-admission.

Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival.

OBJECTIVES: To assess post-procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention (PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS). BACKGROUND: Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized. METHODS: Thirty-six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study. RESULTS: The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre-PCI group (n = 20) and Post-PCI group (n = 16). Non-ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre-PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan-Meier 30-day survival analysis showed very poor survival in Post-PCI group (48.1% vs 12.5%, Log-Rank P = 0.004). CONCLUSIONS: Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days.

Safety of orbital atherectomy in patients with left ventricular systolic dysfunction.

OBJECTIVES: We evaluated the angiographic and clinical outcomes in patients with severely calcified lesions and systolic dysfunction who underwent orbital atherectomy (OA). We hypothesized that OA would provide similar outcomes in patients with systolic dysfunction compared with patients with preserved systolic function. BACKGROUND: Systolic dysfunction is associated with an increased risk of adverse clinical events after percutaneous coronary intervention (PCI). The effects of OA in patients with systolic dysfunction are unknown. METHODS: Our analysis retrospectively analyzed 438 patients (n = 69 with EF ≤ 40%) who underwent OA. The primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days. RESULTS: There were no significant differences between patients with preserved versus reduced systolic function in terms of dissections (0.9% vs. 1.6%, P = 0.51), perforation (0.3% vs. 3.2%, P = 0.07), or no reflow (0.3% vs. 3.2%, P = 0.07). Patients with systolic dysfunction had higher rates of the composite of 30-day MACCE (1.1% vs. 8.7%, P = 0.002) and the individual end points of death (0.3% vs. 7.2%, P < 0.001), and myocardial infarction (0.5% vs. 4.3%, P = 0.03). The rates of target vessel revascularization (0% vs. 0%, P = 1), stroke (0.3% vs. 0%, P > 0.9), and stent thrombosis (0.8% vs. 1.4%, P = 0.5) were low in both groups and did not differ. CONCLUSION: Plaque modification with OA was safe and well tolerated in patients with systolic dysfunction. In this high-risk cohort, adverse clinical outcomes occurred more frequently than in a lower risk population.