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Comparison of device-specific adverse event profiles between Impella platforms

Chen, Stacey; Paone, Darien; Spellman, Lilly; Ranganath, Neel K; Carillo, Julius A; Gidea, Claudia G; Reyentovich, Alex; Thompson, Craig A; Razzouk, Louai; Kon, Zachary N; Moazami, Nader; Smith, Deane E
BACKGROUND:The Impella (Abiomed) ventricular support system is a family of temporary mechanical circulatory support (MCS) devices used to treat patients with cardiogenic shock, acute cardiogenic decompensation, and for high-risk percutaneous or surgical revascularization. These devices include the percutaneously implanted 2.5/cardiac power (CP) and the surgically implanted 5.0/left direct (LD). Despite the beneficial effects and increased usage of these devices, data to assess adverse outcomes and guide clinician decision-making between the Impella CP and 5.0/LD are limited. METHODS:This is a retrospective analysis of 91 consecutive patients who required at least 24 h of Impella support, from January 1, 2015 to December 31, 2019. Groups were stratified based on either initial Impella CP or 5.0/LD placement. Clinical outcomes and in-hospital complications were compared. RESULTS:Impella CP was implanted in 66 patients (mean age: 61 ± 15 years, male 71.2%) and Impella 5.0/LD was implanted in 25 patients (mean age: 62 ± 9 years, male 84.0%). There was greater stability of device position (p = .033), less incidence of hemolysis (p < .001), and less frequent need for additional MCS (p = .001) in patients implanted with the Impella 5.0/LD compared with Impella CP in this study cohort. Patients with Impella 5.0/LD were more likely to survive from Impella and survive to discharge. CONCLUSIONS:This study suggests that for patients who require temporary MCS for more than 24 h, the Impella 5.0/LD may have a more favorable device-specific adverse profile compared with the Impella CP.
PMID: 32939839
ISSN: 1540-8191
CID: 4593232

Differential radiation exposure to interventional cardiologists in the contemporary era [Meeting Abstract]

Koshy, L M; Iqbal, S; Xia, Y; Serrano, C; Feit, F; Smilowitz, N R; Bangalore, S; Thompson, C A; Razzouk, L; Attubato, M; Shah, B
Background: Exposure to low-dose ionizing radiation is associated with malignancies. Lead garment specifications in the cardiac catheterization laboratory are not currently regulated, potentially resulting in unprotected areas.
Method(s): Interventional cardiology attendings and fellows wore 7 dosimeters, one externally on the thyroid shield and six inside the lead apron: bilateral axilla, chest wall, and pelvis. Radiation protection included a lower table-mounted lead drape, upper ceiling-mounted lead shield, and use of 7.5 frames per second during fluoroscopy. All procedures were performed with operators standing to the right of the patient. The primary endpoint was operator radiation exposure to the left versus right axilla. Radiation exposures in millirem (mrem) per participant over the study period are shown as median [interquartile range] and compared between left- and right-sided measures using paired Wilcoxon tests.
Result(s): Nine participants (66% female) wore dosimeters during 231 cases. Transradial coronary angiography was selected in 81.1% of cases and PCI was performed in 32.1%. A sterile radiation drape placed on the patient abdomen was used in 18.6% of cases. Median dose area product and fluoroscopy time for the participants ranged from 29.0-60.5 Gy cm2 and 6.2-13.5 minutes, respectively. Radiation exposure at the left axilla was higher than the right axilla (5 vs. 0.9 mrem, p=0.018) but did not differ between left or right chest wall and left or right pelvis (Figure).
Conclusion(s): This analysis demonstrates insufficient protection in the left axillary area. The use of additional left axillary protection should be evaluated. (Figure Presented)
ISSN: 1522-726x
CID: 4558522

Cardiac Allograft Vasculopathy in Heart Transplant Recipients from Hepatitis C Viremic Donors

Kadosh, B; Gidea, C; Reyentovich, A; Razzouk, L; Smith, D; Katz, S; Saraon, T; Rao, S; Goldberg, R; Moazami, N
PURPOSE: Heart transplantation from Hepatitis C (HCV) viremic donors is becoming increasingly used due to advent of direct acting antiviral drugs with almost 100% cure. There are limited data about its impact on cardiac allograft vasculopathy (CAV). We report the incidence of CAV in heart transplant recipients from HCV viremic donors (nucleic amplification test positive; NAT+) compared to non-HCV infected donors (NAT-).
METHOD(S): We retrospectively reviewed coronary angiograms with intravascular ultrasound (IVUS) of heart transplant recipients at our institution from January 5, 2018 to September 17, 2019. The presence of CAV was graded according to ISHLT guidelines. IVUS was performed as per our lab protocol on the left main and left anterior descending arteries. Maximal intimal thickness (MIT) was measured with advanced quantification software as per protocol. MIT >= 5mm was considered significant for future adverse outcomes.
RESULT(S): LHC and IVUS was performed on 24 heart transplant recipients (mean age 56; 70% male) at 1- year post transplant. Eleven of these patients were transplanted from NAT+ donors. Thirteen patients received a NAT- donor heart. Two recipients (18.7%) of NAT+ donors had CAV grade >= 1 compared to 2 (16.7%) from NAT- donors (p=1). MIT >= 5mm was seen in 88.9% of NAT+ vs 50% of NAT- recipients (p=0.14) (Figure). The mean MIT was 76mm and 65mm for NAT+ and NAT- group, respectively. Both NAT+ and NAT- donor recipients exhibit mostly eccentric (84.2%) and few (15.7%) demonstrated concentric plaques. There was no heterogeneity in the data after adjusting for risk factors for CAD and donor LHC.
CONCLUSION(S): Our data show no difference in the presence of (CAV >= grade 1) or subclinical atherosclerosis at 1 year among NAT+ donor recipients. HCV viremia is a known risk factor for accelerated atherosclerosis and the consequence of prolonged donor viremia on the recipient is not known. A larger cohort and further longitudinal follow-up is needed to assess the validity of this trend and its prognostic implications.
ISSN: 1557-3117
CID: 4471822

Coronary OCT and Cardiac MRI to Determine Underlying Causes of Minoca in Women [Meeting Abstract]

Reynolds, Harmony; Maehara, Akiko; Kwong, Raymond; Sedlak, Tara; Saw, Jacqueline; Smilowitz, Nathaniel; Mahmud, Ehtisham; Wei, Janet; Marzo, Kevin; Matsumura, Mitsuaki; Seno, Ayako; Hausvater, Anais; Giesler, Caitlin; Jhalani, Nisha; Toma, Catalin; Har, Bryan; Thomas, Dwithiya; Mehta, Laxmi S.; Trost, Jeffrey; Mehta, Puja; Ahmed, Bina; Bainey, Kevin R.; Xia, Yuhe; Shah, Binita; Attubato, Michael; Bangalore, Sripal; Razzouk, Louai; Ali, Ziad; Merz, Noel Bairey; Park, Ki; Hada, Ellen; Zhong, Hua; Hochman, Judith S.
ISSN: 0009-7322
CID: 5285732

Letter by Sherrid et al Regarding Article, "Bail-Out Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy in a Patient With Takotsubo Cardiomyopathy-Induced Cardiogenic Shock" [Letter]

Sherrid, Mark V; Razzouk, Louai; Massera, Daniele
PMID: 30998394
ISSN: 1941-7632
CID: 3810592


Shah, Tina; Razzouk, Louai; Saric, Muhamed; Skolnick, Adam; Loulmet, Didier; Halpern, Dan
ISSN: 0735-1097
CID: 4136022

Impact and trends of intravascular imaging in diagnostic coronary angiography and percutaneous coronary intervention in inpatients in the United States

Smilowitz, Nathaniel R; Mohananey, Divyanshu; Razzouk, Louai; Weisz, Giora; Slater, James N
BACKGROUND:Intravascular imaging with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) is an important adjunct to invasive coronary angiography. OBJECTIVES/OBJECTIVE:The primary objective was to examine the frequency of intravascular coronary imaging, trends in imaging use, and outcomes of patients undergoing angiography and/or percutaneous coronary intervention (PCI) in the United States. METHODS:Adult patients ≥18 years of age undergoing in-hospital cardiac catheterization from January 2004 to December 2014 were identified from the National Inpatient Sample (NIS). International Classification of Diseases, Ninth Revision (ICD-9) diagnosis and procedure codes were used to identify IVUS and OCT use during diagnostic angiography and PCI. RESULTS:Among 3,211,872 hospitalizations with coronary angiography, intracoronary imaging was performed in 88,775 cases (4.8% of PCI and 1.0% of diagnostic procedures), with IVUS in 98.9% and OCT in 1.1% of cases. Among patients undergoing PCI, the rate of intravascular coronary imaging increased from 2.1% in 2004-2005 to 6.6% in 2013-2014 (P < 0.001 for trend). Use of intravascular coronary imaging was associated with lower in-hospital mortality in patients undergoing PCI (adjusted OR 0.77; 95% CI 0.71-0.83). There was marked variability in intravascular imaging by hospital, with 63% and 13% of facilities using intravascular imaging in <5% and >15% of PCIs, respectively. CONCLUSIONS:In a large administrative database from the United States, intravascular imaging use was low, increased over time, and imaging was associated with reduced in-hospital mortality. Substantial variation in the frequency of intravascular imaging by hospital was observed. Additional investigation to determine clinical benefits of IVUS and OCT are warranted.
PMID: 30019831
ISSN: 1522-726x
CID: 3202192

Revascularization for Advanced Coronary Artery Disease in Type 2 Diabetic Patients: Choosing Wisely Between PCI and Surgery

Razzouk, Louai; Feit, Frederick; Farkouh, Michael E
PURPOSE OF REVIEW: Patients with type 2 diabetes mellitus (T2DM) are at an increased risk of systemic atherosclerosis and advanced coronary artery disease (CAD). Herein, we review clinical trials comparing surgical to percutaneous revascularization in the context of the unique pathophysiology in this patient population, and seek to answer the question of optimal strategy of revascularization. RECENT FINDINGS: Early studies showed a signal towards benefit of surgical revascularization over percutaneous revascularization in this group, but there was a paucity of randomized clinical trials (RCT) to directly support this finding. The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM), a large-scale international RCT, was then undertaken and established the benefit of coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI) in terms of mortality, myocardial infarction and repeat revascularization; CABG was inferior to PCI with regards to stroke. The quality of life and cost effectiveness also demonstrated a long-term benefit for surgery. The decision as to choice of mode of revascularization in patients with T2DM and advanced CAD depends upon a multitude of factors, including the coronary anatomy, co-morbidities and the patient's surgical risk. These factors influence the recommendation of the cardiovascular team, which should result in a balanced presentation of the short and long-term risks and benefits of either mode of revascularization to the patient and his/her family.
PMID: 28374179
ISSN: 1534-3170
CID: 2519412

Posterior Descending Coronary Artery Arising From a Septal Branch of the Left Anterior Descending Coronary Artery

Smilowitz, Nathaniel R; Razzouk, Louai; Slater, James N
A 48-year-old man with hypertension presented with heart failure and reduced left ventricular systolic function. Coronary angiography revealed a non-dominant right coronary artery and a long anomalous branch of the proximal left anterior descending coronary artery that coursed inferiorly to give rise to the posterior descending artery. No epicardial coronary artery disease was visualized. The highly unusual anomalous branch was considered to be an incidental finding, with no pathological contribution to the clinical presentation.
PMID: 28145878
ISSN: 1557-2501
CID: 2424292

Optimal approaches to diabetic patients with multivessel disease

Razzouk, Louai; Farkouh, Michael E
The pathophysiology of diabetes and systemic insulin resistance contributes to the nature of diffuse atherosclerosis and a high prevalence of multivessel coronary artery disease (CAD) in diabetic patients. The optimal approach to this patient population remains a subject of an ongoing discussion. In this review, we give an overview of the unique pathophysiology of CAD in patients with diabetes, summarize the current state of therapies available, and compare modalities of revascularization that have been investigated in recent clinical trials. We conclude by highlighting the importance of a comprehensive heart team approach to every patient while accommodating both patient preference and quality-of-life decisions.
PMID: 26398271
ISSN: 1873-2615
CID: 1786542