The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.

Feasibility of a Porcine Arteriovenous Shunt Model for Assessment of Acute Thrombogenicity in Bifurcation Stenting Technique By Optical Coherence Tomography.

BACKGROUND: Double kissing (DK) crush stenting has been reported as a superior bifurcation stenting strategy compared to culotte stenting. However, the mechanism associated with the reduction of clinical events by DK crush stenting remains unclear. We therefore investigated the thrombogenicity of DK crush stenting and culotte stenting with both bare-metal stents (BMS) and drug-eluting stents (DES) and the feasibility of a novel porcine arteriovenous shunt model. METHODS: High-resolution intracoronary imaging with optical coherence tomography (OCT) evaluated the bifurcation stenting models for thrombogenicity. RESULTS: All porcine models retained continuous circulation without blood leakage. Thrombus was macroscopically demonstrated around the bifurcation in all settings. The volume of thrombus (mm3) with BMS using DK crush/culotte and DES using DK crush/culotte were 1.38/1.19 and 0.09/0.15, respectively. Culotte stenting had more thrombus in the proximal main branch, and DK crush stenting had more at the bifurcation. Unlike DK crush stenting, culotte stenting showed malapposition in the proximal main branch and bifurcation segments. CONCLUSION: The feasibility of a porcine arteriovenous shunt model to assess thrombogenicity by OCT in bifurcation stenting technique was confirmed. OCT detected less thrombogenicity in DES when used in the bifurcation model when compared to BMS.

Racial Disparities in Clinical Characteristics and Outcomes of Women Undergoing Percutaneous Coronary Intervention.

BACKGROUND/PURPOSE: Women are underrepresented in cardiovascular clinical studies. Black women have a higher ischemic heart disease mortality risk than their white counterparts. However, there exist limited outcome data comparing black women and white women after percutaneous coronary intervention (PCI). The aim of this retrospective analysis was to evaluate for racial disparities in 1-year major adverse cardiovascular events (MACE) in women undergoing PCI. METHODS/MATERIALS: Within our PCI database, we identified 4776 female patients who underwent PCI between 2003 and 2016. Of those, 1916 were black and 2860 were white. Endpoints included MACE, death, myocardial infarction, target vessel revascularization (TVR) and stent thrombosis (ST) at 30 days and 1 year. A proportional Cox hazard model analysis was performed to assess outcomes after adjustment for confounding factors. RESULTS: Black women presented at a younger age and had a significantly higher prevalence of risk factors. Periprocedural and in-hospital outcomes were similar in the 2 groups. At 30 days and 1 year, the rates of myocardial infarction, TVR and ST were significantly higher in black women. After adjustment for baseline differences, only ST appears to be more likely to occur in black women than in white women. CONCLUSIONS: In this large cohort of women with coronary artery disease undergoing PCI, we observed racial disparities primarily in baseline characteristics indicative of need for interventions to achieve early diagnosis and better prevention in black women. Future directions should include efforts to identify and better characterize the factors underlying and contributing to cardiovascular outcomes in women after PCI. SUMMARY: In this real-world analysis from a large cohort of women with coronary artery disease undergoing percutaneous coronary intervention at a US tertiary-care center, racial disparities were observed, especially in baseline characteristics, indicating late presentation.

Clinical Outcomes of Atherectomy Prior to Percutaneous Coronary Intervention: A Comparative Assessment of Atherectomy in Patients With Obesity (COAP-PCI Subanalysis).

OBJECTIVES: The aim of this study was to investigate the safety and efficacy of atherectomy devices in obese patients with coronary artery calcification (CAC). BACKGROUND: Atherectomy is an important tool for lesion preparation in patients with CAC undergoing percutaneous coronary intervention (PCI). There have been no studies that compared the outcomes of orbital atherectomy (OA) and rotational atherectomy (RA) in obese patients. METHODS: A total of 35,590 patients from five tertiary-care hospitals who underwent PCI between January 2011 to April 2016 were identified. All adult patients with body mass index ≥30 kg/ m2 who had OA or RA prior to PCI were included in this analysis. A total of 91 patients were included in the OA arm and 131 patients in the RA arm prior to the matching. To remove potential selection bias, a propensity-score matched analysis was performed, and 69 patients were included in each group. RESULTS: The primary endpoint, composite of safety outcomes, did not occur in any patient of either group. The secondary endpoints - death on discharge (0.0% vs 1.5%; P=.48) and myocardial infarction (2.9% vs 6.4%; P=.42) - were similar between groups, as were individual outcomes including cardiogenic shock, bleeding complications, and congestive heart failure. Stroke, vascular complications, and the requirement for dialysis initiation did not occur in any of the patients. CONCLUSION: In this study assessing atherectomy in obese patients, OA and RA demonstrated comparable outcomes with complication rates within an acceptable range. It demonstrates that OA and RA can be safely performed in this high-risk patient subset with CAC.

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.

Comparison of Transcatheter Mitral Valve Repair Versus Surgical Mitral Valve Repair in Patients With Advanced Kidney Disease (from the National Inpatient Sample).

Transcatheter mitral valve repair (TMVR) is an emerging treatment modality that has been reserved for high-risk patients with multiple co-morbidities. We hypothesize that TMVR is a safe and effective procedure for patients with moderate to severe mitral regurgitation who are not surgical candidates. The National Inpatient Sample (2012 to 2014) using the International Classification of Diseases, 9th Revision, Clinical Modification procedure codes 35.97 for TMVR and 35.12 for surgical mitral valve repair (SMVR) were used. Patients with chronic kidney disease stage IV, Stage V, and end-stage renal disease (ESRD) were considered as patients with advanced kidney disease. A total of 2,123 patients were treated with SMVR and 74 patients were treated with TMVR. There were notably fewer patients treated with TMVR compared with patients treated with SMVR. The mean age was higher with the TMVR group (72.4 vs 61.7 years, p = <0.001). After performing multivariate regression analysis, the primary outcome of in-hospital mortality (13.8% vs 1.3%, adjusted p = 0.003) and all secondary outcomes, excluding dialysis requirement, cardiogenic shock, and cardiac arrest, were significantly lower with the TMVR approach. The average length of stay was lower with TMVR compared with SMVR (22.8 vs 12.6 days, adjusted p = <0.001), with reduced in-hospital costs ($98,165 vs $52,646, adjusted p = <0.001). This large, national study suggests TMVR is associated with significantly lower in-patient morbidity and mortality, with significant cost savings in patients with advanced kidney disease compared with SMVR. Hence, TMVR could be a safe and effective alternative for patients with advanced kidney disease who are not surgical candidates.

Impact of sex on short term in-hospital outcomes with transcatheter edge-to-edge mitral valve repair.

BACKGROUND AND AIM OF THE STUDY: Transcatheter edge-to-edge mitral valve repair with the mitraclip device for treatment of severe mitral regurgitation has been shown to be an effective treatment. However, the impact of sex on in-hospital outcomes has not been studied on a large scale with "real-world" patients. The aim of this study was to assess for disparities of sex in patients treated with mitraclip. MATERIALS AND METHODS: Data from the National Inpatient Sample (NIS) (2012 through 2014) using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) procedure code 35.97 for transcatheter mitral valve repair was analyzed for this study. SAS 9.4 (SAS institute, Cary, NC) was used for univariate and multivariate analysis. Multivariate analysis was used to adjust for various confounders. RESULTS: A total of 521 patients were identified that were treated with MitraClip, with 57.97% males (n=302) and 42.03% females (n=219). There was no significant difference in the primary outcome, in-hospital mortality between two sex [2.6% vs. 3.6%, p=0.43, Odds Ratio 1.62 (95% Confidence Interval, 0.50-5.28)]. After performing multivariate analysis, no difference in any secondary outcomes existed. Additionally, length of stay and median hospitalization cost was similar regardless of sex. CONCLUSIONS: Analysis of this large database of patients undergoing treatment with MitraClip suggests that MitraClip in females is not associated with increased in-hospital mortality, morbidity, length of stay or cost. A prospective registry with excluded patients from the clinical trials needed to be fully access if sex disparities in patients being treated with MitraClip exist.

Coronary resting gradients for hemodynamic lesion assessment - The future of coronary physiology?

Coronary resting gradient measurements with cut-off values of ≤0.87 and ≥0.93 portend a high degree of certainty with respect to appropriateness of coronary revascularization Less agreement exists in patients in the so called indeterminate "gray zone" Pressure-bounded coronary flow reserve may aid in our understanding of the underlying physiologic principles and facilitate the clinical assessment of these lesions.