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Rationale and design of the pullback pressure gradient (PPG) global registry

Munhoz D, Collet C, Mizukami T, Yong A, Leone AM, Eftekhari A, et al.

Am Heart J, 2023 Nov;265:170-179.
PMID: 37611857 DOI: 10.1016/j.ahj.2023.07.016

INTRODUCTION: Diffuse disease has been identified as one of the main reasons leading to low post-PCI fractional flow reserve (FFR) and residual angina after PCI. Coronary pressure pullbacks allow for the evaluation of hemodynamic coronary artery disease (CAD) patterns. The pullback pressure gradient (PPG) is a novel metric that quantifies the distribution and magnitude of pressure losses along the coronary artery in a focal-to-diffuse continuum.
AIM: The primary objective is to determine the predictive capacity of the PPG for post-PCI FFR.
METHODS: This prospective, large-scale, controlled, investigator-initiated, multicenter study is enrolling patients with at least 1 lesion in a major epicardial vessel with a distal FFR ≤ 0.80 intended to be treated by PCI. The study will include 982 subjects. A standardized physiological assessment will be performed pre-PCI, including the online calculation of PPG from FFR pullbacks performed manually. PPG quantifies the CAD pattern by combining several parameters from the FFR pullback curve. Post-PCI physiology will be recorded using a standardized protocol with FFR pullbacks. We hypothesize that PPG will predict optimal PCI results (post-PCI FFR ≥ 0.88) with an area under the ROC curve (AUC) ≥ 0.80. Secondary objectives include patient-reported and clinical outcomes in patients with focal vs. diffuse CAD defined by the PPG. Clinical follow-up will be collected for up to 36 months, and an independent clinical event committee will adjudicate events.
RESULTS: Recruitment is ongoing and is expected to be completed in the second half of 2023.
CONCLUSION: This international, large-scale, prospective study with pre-specified powered hypotheses will determine the ability of the preprocedural PPG index to predict optimal revascularization assessed by post-PCI FFR. In addition, it will evaluate the impact of PPG on treatment decisions and the predictive performance of PPG for angina relief and clinical outcomes.

Matched MeSH terms: Coronary Vessels/physiopathology
Fulltext Numerical investigation of the effect of stenosis geometry on the coronary diagnostic parameters

Kamangar S, Kalimuthu G, Badruddin IA, Badarudin A, Ahmed NJ, Khan TM

ScientificWorldJournal, 2014;2014:354946.
PMID: 25258722 DOI: 10.1155/2014/354946

The present study deals with the functional severity of a coronary artery stenosis assessed by the fractional flow reserve (FFR). The effects of different geometrical shapes of lesion on the diagnostic parameters are unknown. In this study, 3D computational simulation of blood flow in three different geometrical shapes of stenosis (triangular, elliptical, and trapezium) is considered in steady and transient conditions for 70% (moderate), 80% (intermediate), and 90% (severe) area stenosis (AS). For a given percentage AS, the variation of diagnostic parameters which are derived from pressure drop across the stenosis was found in three different geometrical shapes of stenosis and it was observed that FFR is higher in triangular shape and lower in trapezium shape. The pressure drop coefficient (CDP) was higher in trapezium shape and lower in triangular model whereas the LFC shows opposite trend. From the clinical perspective, the relationship between percentage AS and FFR is linear and inversely related in all the three models. A cut-off value of 0.75 for FFR was observed at 76.5% AS in trapezium model, 79.5% in elliptical model, and 82.7% AS for the triangular shaped model. The misinterpretation of the functional severity of the stenosis is in the region of 76.5%-82.7 % AS from different shapes of stenosis models.

Matched MeSH terms: Coronary Vessels/physiopathology
Effect of porous media of the stenosed artery wall to the coronary physiological diagnostic parameter: a computational fluid dynamic analysis

Govindaraju K, Kamangar S, Badruddin IA, Viswanathan GN, Badarudin A, Salman Ahmed NJ

Atherosclerosis, 2014 Apr;233(2):630-635.
PMID: 24549189 DOI: 10.1016/j.atherosclerosis.2014.01.043

Functional assessment of a coronary artery stenosis severity is generally assessed by fractional flow reserve (FFR), which is calculated from pressure measurements across the stenosis. The purpose of this study is to investigate the effect of porous media of the stenosed arterial wall on this diagnostic parameter. To understand the role of porous media on the diagnostic parameter FFR, a 3D computational simulations of the blood flow in rigid and porous stenotic artery wall models are carried out under steady state and transient conditions for three different percentage area stenoses (AS) corresponding to 70% (moderate), 80% (intermediate), and 90% (severe). Blood was modeled as a non Newtonian fluid. The variations of pressure drop across the stenosis and diagnostic parameter were studied in both models. The FFR decreased in proportion to the increase in the severity of the stenosis. The relationship between the percentage AS and the FFR was non linear and inversely related in both the models. The cut-off value of 0.75 for FFR was observed at 81.89% AS for the rigid artery model whereas 83.61% AS for the porous artery wall model. This study demonstrates that the porous media consideration on the stenotic arterial wall plays a substantial role in defining the cut-off value of FFR. We conclude that the effect of porous media on FFR, could lead to misinterpretation of the functional severity of the stenosis in the region of 81.89 %-83.61% AS.

Matched MeSH terms: Coronary Vessels/physiopathology
The influence of artery wall curvature on the anatomical assessment of stenosis severity derived from fractional flow reserve: a computational fluid dynamics study

Govindaraju K, Viswanathan GN, Badruddin IA, Kamangar S, Salman Ahmed NJ, Al-Rashed AA

Comput Methods Biomech Biomed Engin, 2016 Nov;19(14):1541-9.
PMID: 27052093 DOI: 10.1080/10255842.2016.1170119

This study aims to investigate the influence of artery wall curvature on the anatomical assessment of stenosis severity and to identify a region of misinterpretation in the assessment of per cent area stenosis (AS) for functionally significant stenosis using fractional flow reserve (FFR) as standard. Five artery models of different per cent AS severity (70, 75, 80, 85 and 90%) were considered. For each per cent AS severity, the angle of curvature of the arterial wall varied from straight to an increasingly curved model (0°, 30°, 60°, 90° and 120°). Computational fluid dynamics was performed under transient physiologic hyperemic flow conditions to investigate the influence of artery wall curvature on the pressure drop and the FFR. The findings in this study may be useful in in vitro anatomical assessment of functionally significant stenosis. The FFR decreased with increasing stenosis severity for a given curvature of the artery wall. Moreover, a significant decrease in FFR was found between straight and curved models discussed for a given severity condition. These findings indicate that the curvature effect was included in the FFR assessment in contrast to minimum lumen area (MLA) or per cent AS assessment. The MLA or per cent AS assessment may lead to underestimation of stenosis severity. From this numerical study, an uncertainty region could be evaluated using the clinical FFR cutoff value of 0.8. This value was observed at 81.98 and 79.10% AS for arteries with curvature angles of 0° and 120° respectively. In conclusion, the curvature of the artery should not be neglected in in vitro anatomical assessment.

Matched MeSH terms: Coronary Vessels/physiopathology*
The influence of curvature wall on the blood flow in stenosed artery: A computational study

Ahamad NA, Kamangar S, Badruddin IA

Biomed Mater Eng, 2018;29(3):319-332.
PMID: 29578467 DOI: 10.3233/BME-181734

The current study investigates the curvature effect due to various angles of curvature on the blood flow in human artery. The stenosis is considered to have three sizes 70%, 80% and 90% blockage before the curve section of artery. Numerical study of four different angle of curvature was considered to understand the flow behavior of artery having various curvatures, on the hemodynamics factors that includes drop in arterial pressure, flow velocity as well as wall shear stress. It was found that, the augmentation of the flow resistance due to the curvature increases in presence of stenosis. It was also noted that the wall shear is higher at the outer wall as compared to the inside wall in four models considered. Results showed that both the curvature of artery and size of the stenosis have significant impact. These two factors should be considered by cardiologist to assess the complexity of stenosis.

Matched MeSH terms: Coronary Vessels/physiopathology*
Influence of stenosis on hemodynamic parameters in the realistic left coronary artery under hyperemic conditions

Kamangar S, Badruddin IA, Badarudin A, Nik-Ghazali N, Govindaraju K, Salman Ahmed NJ, et al.

Comput Methods Biomech Biomed Engin, 2017 Mar;20(4):365-372.
PMID: 27612619 DOI: 10.1080/10255842.2016.1233402

The current study investigates the hyperemic flow effects on heamodynamics parameters such as velocity, wall shear stress in 3D coronary artery models with and without stenosis. The hyperemic flow is used to evaluate the functional significance of stenosis in the current era. Patients CT scan data of having healthy and coronary artery disease was chosen for the reconstruction of 3D coronary artery models. The diseased 3D models of coronary artery shows a narrowing of >50% lumen area. Computational fluid dynamics was performed to simulate the hyperemic flow condition. The results showed that the recirculation zone was observed immediate to the stenosis and highest wall shear stress was observed across the stenosis. The decrease in pressure was found downstream to the stenosis as compared to the coronary artery without stenosis. Our analysis provides an insight into the distribution of wall shear stress and pressure drop, thus improving our understanding of hyperemic flow effect under both conditions.

Matched MeSH terms: Coronary Vessels/physiopathology*
Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study

Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, et al.

Heart Rhythm, 2014 Jul;11(7):1150-5.
PMID: 24801899 DOI: 10.1016/j.hrthm.2014.04.020

Left ventricular (LV) lead implantation for cardiac resynchronization therapy (CRT) is associated with lead dislodgement rates ranging from 3% to 10%, and some implant approaches to prevent dislodgement may contribute to suboptimal CRT response. We report our early human experience with an LV lead with a side helix for active fixation to the coronary vein wall.

Matched MeSH terms: Coronary Vessels/physiopathology
Evaluation of functional severity of coronary artery disease and fluid dynamics' influence on hemodynamic parameters: A review

Govindaraju K, Badruddin IA, Viswanathan GN, Ramesh SV, Badarudin A

Phys Med, 2013 May;29(3):225-32.
PMID: 22704601 DOI: 10.1016/j.ejmp.2012.03.008

Coronary Artery Disease (CAD) is responsible for most of the deaths in patients with cardiovascular diseases. Diagnostic coronary angiography analysis offers an anatomical knowledge of the severity of the stenosis. The functional or physiological significance is more valuable than the anatomical significance of CAD. Clinicians assess the functional severity of the stenosis by resorting to an invasive measurement of the pressure drop and flow. Hemodynamic parameters, such as pressure wire assessment fractional flow reserve (FFR) or Doppler wire assessment coronary flow reserve (CFR) are well-proven techniques to evaluate the physiological significance of the coronary artery stenosis in the cardiac catheterization laboratory. Between the two techniques mentioned above, the FFR is seen as a very useful index. The presence of guide wire reduces the coronary flow which causes the underestimation of pressure drop across the stenosis which leads to dilemma for the clinicians in the assessment of moderate stenosis. In such condition, the fundamental fluid mechanics is useful in the development of new functional severity parameters such as pressure drop coefficient and lesion flow coefficient. Since the flow takes place in a narrowed artery, the blood behaves as a non-Newtonian fluid. Computational fluid dynamics (CFD) allows a complete coronary flow simulation to study the relationship between the pressure and flow. This paper aims at explaining (i) diagnostic modalities for the evaluation of the CAD and valuable insights regarding FFR in the evaluation of the functional severity of the CAD (ii) the role of fluid dynamics in measuring the severity of CAD.

Matched MeSH terms: Coronary Vessels/physiopathology*
Effect of bradykinin and its antagonist on survival time after coronary artery occlusion in rats

Atif Abbas S, Sharma JN, Pauzi A, Yusof M

Gen. Pharmacol., 1999 Sep;33(3):243-7.
PMID: 10480657

The present study was conducted to examine the effect of bradykinin and bradykinin 2 receptor antagonist on survival time in rats with coronary artery ligation for 15 min and continuously. We also evaluated the heart rate and blood pressure responses in the presence and absence of bradykinin and its antagonist. Bradykinin treatment (4 microg and 8 microg/kg IV) significantly (p < 0.05) increased the survival time of rats compared with saline-treated rats with coronary artery ligation for 15 min and continuously. The heart rate and blood pressure responses were significantly (p < 0.001) altered in the presence of coronary artery ligation. Bradykinin antagonist treatment (4 microg/kg IV) abolished the effect of bradykinin and thus reduced the survival time of rats with coronary artery ligation. The mean value of survival time between saline-treated and bradykinin antagonist- plus bradykinin-treated rats did not differ significantly (p > 0.05).

Matched MeSH terms: Coronary Vessels/physiopathology*
Endothelium-dependent vascular relaxation is abnormal in the coronary microcirculation of atherosclerotic primates

Sellke FW, Armstrong ML, Harrison DG

Circulation, 1990 May;81(5):1586-93.
PMID: 2110036

Atherosclerosis impairs endothelium-dependent relaxation of large conduit arteries. Because coronary resistance vessels are spared from the development of overt atherosclerosis, endothelium-dependent responses were examined in these vascular segments. Malaysian cynomolgus monkeys (n = 6) were made atherosclerotic by being fed a 0.7% cholesterol diet for 18 months. Control monkeys (n = 6) were fed a standard diet. Coronary microvessels (122-220 microns) were studied in a pressurized (20 mm Hg), no-flow state using a video-imaging apparatus. Relaxations of microvessels, preconstricted with the thromboxane analogue U46619, were determined in response to acetylcholine, bradykinin, the calcium ionophore A23187, adenosine, and sodium nitroprusside. Microvascular relaxations to bradykinin and A23187 were reduced in atherosclerotic monkeys compared with controls, whereas acetylcholine produced additional contraction in atherosclerotic monkeys. Responses of preconstricted microvessels to adenosine and sodium nitroprusside were identical in atherosclerotic and control animals. Indomethacin did not alter responses in control or atherosclerotic animals. Histologic examination revealed neither intimal thickening nor plaque formation in microvessels of this size class despite marked changes in conduit arteries. Electron microscopy showed minor alterations of endothelial cell morphology in microvessels of atherosclerotic animals. In conclusion, long-term hypercholesterolemia markedly impairs endothelium-dependent vascular relaxation in the coronary microcirculation where overt atherosclerosis does not develop. These changes in endothelial cell function may significantly alter regulation of myocardial perfusion by neurohumoral stimuli.

Matched MeSH terms: Coronary Vessels/physiopathology*
Coronary artery bypass graft surgery in a young female with systemic lupus erythematosus and its operative challenges: A case report

Gurpreet S, Vendargon SJ, Syed Rasul SH

Med J Malaysia, 2019 12;74(6):549-550.
PMID: 31929487

We understand that autoimmune disorders such as Systemic Lupus Erythematosus increases the likelihood of developing coronary heart disease. However, its implications on patients undergoing cardiac surgery is not well understood. Here we present a female patient with SLE who developed coronary artery disease at a young age and underwent coronary artery bypass graft surgery. As SLE is associated with vasculitis, we wanted to understand regarding the choice of conduit as well as its long term patency. Also whether percutaneous angioplasty has a role to play in patients with SLE.

Matched MeSH terms: Coronary Vessels/physiopathology*
Fulltext Impaired coronary metabolic dilation in the metabolic syndrome is linked to mitochondrial dysfunction and mitochondrial DNA damage

Guarini G, Kiyooka T, Ohanyan V, Pung YF, Marzilli M, Chen YR, et al.

Basic Res Cardiol, 2016 May;111(3):29.
PMID: 27040114 DOI: 10.1007/s00395-016-0547-4

Mitochondrial dysfunction in obesity and diabetes can be caused by excessive production of free radicals, which can damage mitochondrial DNA. Because mitochondrial DNA plays a key role in the production of ATP necessary for cardiac work, we hypothesized that mitochondrial dysfunction, induced by mitochondrial DNA damage, uncouples coronary blood flow from cardiac work. Myocardial blood flow (contrast echocardiography) was measured in Zucker lean (ZLN) and obese fatty (ZOF) rats during increased cardiac metabolism (product of heart rate and arterial pressure, i.v. norepinephrine). In ZLN increased metabolism augmented coronary blood flow, but in ZOF metabolic hyperemia was attenuated. Mitochondrial respiration was impaired and ROS production was greater in ZOF than ZLN. These were associated with mitochondrial DNA (mtDNA) damage in ZOF. To determine if coronary metabolic dilation, the hyperemic response induced by heightened cardiac metabolism, is linked to mitochondrial function we introduced recombinant proteins (intravenously or intraperitoneally) in ZLN and ZOF to fragment or repair mtDNA, respectively. Repair of mtDNA damage restored mitochondrial function and metabolic dilation, and reduced ROS production in ZOF; whereas induction of mtDNA damage in ZLN reduced mitochondrial function, increased ROS production, and attenuated metabolic dilation. Adequate metabolic dilation was also associated with the extracellular release of ADP, ATP, and H2O2 by cardiac myocytes; whereas myocytes from rats with impaired dilation released only H2O2. In conclusion, our results suggest that mitochondrial function plays a seminal role in connecting myocardial blood flow to metabolism, and integrity of mtDNA is central to this process.

Matched MeSH terms: Coronary Vessels/physiopathology*

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