Comparison of intravascular lithotripsy and rotational atherectomy for the treatment of heavily calcified coronary lesions: the STIFF (Stenoses with calcificaTIon treated with angioplasty eFFected with dedicated interventional tools) study.

BACKGROUND: Percutaneous coronary interventions in heavily calcified coronary lesions are associated with technical difficulties and the worse prognosis. Lesion preparation is important to reduce complications and improve outcomes. The aim of this study is to compare the results of rotational atherectomy (RA) and intravascular lithotripsy (IVL) at achieving optimal stent implantation using intravascular ultrasound criteria. METHODS: Retrospective, single-center study comparing patients with heavily calcified coronary lesions that underwent percutaneous coronary interventions using RA or IVL. RESULTS IN TOTAL: 25 patients (13 in the RA group and 12 in the IVL group) were included. Reference vessel diameter was similar between the groups [2.59 (2.51-3.63) mm in the RA group vs. 2.79 (2.59-3.16) mm in the IVL group; P = 0.89], as were minimal lumen area [1.02 (0.80-1.23) mm vs. 1.40 (1.01-1.40) mm; P = 0.43] and diameter stenosis [60.4% (52.3-72.3) vs. 56.1% (47.8-61.3); P = 0.56). The final minimal lumen area was significantly larger in the IVL group [7.6 mm2 (5.8-8.6) vs. 5.4 mm2 (4.5-6.2); P = 0.01] as were lumen area gain [4.1 mm2 (2.6-5.9) vs. 2.3 mm2 (1.4-3.6); P = 0.01] and final stent volume [491.2 mm3 (372.2-729.8) vs. 326.2 mm3 (257.1-435.4); P = 0.03]. In the RA group, 69.2% of the patients achieved the preestablished intravascular ultrasound-based criteria for successful stent implantation, vs. 100% of the patients in the IVL group (P = 0.04). CONCLUSION: Patients in the IVL group achieved the Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation trial criteria of successful stent implantation more frequently than those treated with RA.

P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS.

P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial.

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).

Zero-contrast imaging for the assessment of transcatheter aortic valve implantation in candidates with renal dysfunction.

BACKGROUND: Candidates for transcatheter aortic valve implantation (TAVI) are currently evaluated using computed tomography angiography and invasive cardiac catheterization as an essential part of case selection and pre-procedure interventional planning. However, both imaging methods utilize iodinated agents, which may cause contrast-induced nephropathy, particularly in patients with baseline renal dysfunction. This study aimed to describe a zero-contrast imaging protocol for pre-TAVI evaluation in patients with advanced renal impairment. METHODS: The pre-TAVI zero-contrast scheme consisted of the following multi-modality combinations: (1) gadolinium-free magnetic resonance imaging (three-dimensional navigator-echo with electrocardiogram-gated steady-state free-precession series); (2) iodinated-free multislice computed tomography electrocardiogram-gated; (3) lower limb arterial duplex scan ultrasound; and (4) transesophageal echocardiography. Ultimately, TAVI was performed for those deemed good candidates, and contrast was allowed during the intervention; however, operators were strongly advised to utilize the least volume possible of iodinated agents. This pilot survey included ten patients with symptomatic aortic stenosis and renal dysfunction who underwent zero-contrast multi-modality imaging. RESULTS: All the patients ultimately underwent TAVI. The intervention was successful in all cases, without ≥ moderate residual aortic regurgitation, prosthesis embolization, annulus rupture, major vascular complications, stroke, or death during index hospitalization. The creatinine clearance remained stable throughout the observation period (baseline: 26.85 ± 12.55 mL/min; after multi-modality imaging: 26.76 ± 11.51 mL/min; post-TAVI at discharge: 29.84 ± 13.98 mL/min; p = 0.3 all). CONCLUSION: The proposed contrast-free imaging protocol appears to be a promising clinical tool for pre-TAVI evaluation in patients with severe renal dysfunction.

Quantitative coronary three-dimensional geometry and its association with atherosclerotic disease burden and composition.

BACKGROUND: Isolate features of the coronary anatomy have been associated with the pathophysiology of atherosclerotic disease. Computational methods have been described to allow precise quantification of the complex three-dimensional (3D) coronary geometry. The present study tested whether quantitative parameters that describe the spatial 3D coronary geometry is associated with the extension and composition of the underlying coronary artery disease (CAD). METHODS: Patients with CAD scheduled for percutaneous intervention were investigated with coronary computed tomography angiography (CCTA), and invasive coronary angiography, and virtual histology intravascular ultrasound (IVUS-VH). For all target vessels, 3D centerlines were extracted from CCTA images and processed to quantify 23 geometric indexes, grouped into 3 main categories as follows: (i) length-based; (ii) curvature-based, torsion-based, and curvature/torsion-combined; (iii) vessel path-based. The geometric variables were compared with IVUS-VH parameters assessing the extent and composition of coronary atherosclerosis. RESULTS: A total of 36 coronary patients (99 vessels) comprised the study population. From the 23 geometric indexes, 18 parameters were significantly (p < 0.05) associated with at least 1 IVUS-VH parameter at a univariate analysis. All three main geometric categories provided parameters significantly related with atherosclerosis variables. The 3D geometric indexes were associated with the degree of atherosclerotic extension, as well as with plaque composition. Geometric features remained significantly associated with all IVUS-VH parameters even after multivariate adjustment for clinical characteristics. CONCLUSIONS: Quantitative 3D vessel morphology emerges as a relevant factor associated with atherosclerosis in patients with established CAD.

Inflammatory Phenotype by OCT Coronary Imaging: Specific Features Among De Novo Lesions, In-Stent Neointima, and In-Stent Neo-Atherosclerosis. / Fenótipo Inflamatório por Imagem de OCT Coronária: Características Específicas Entre Lesões De Novo, Hiperplasia Intimal e Neoaterosclerose Intra-Stent.

BACKGROUND: Coronary stenosis can be caused de novo atherosclerosis, in-stent restenosis, and in-stent neoatherosclerosis, three entities that develop from a diverse pathophysiological milieu. OBJECTIVE: This study aims to investigate, using optical coherence tomography (OCT), whether or not coronary lesions related to these processes differ in their local inflammatory profile. METHODS: Retrospective analysis of patients with diagnosed or suspected coronary lesions who had undergone OCT imaging for clinical reasons. Macrophage and intra-plaque neovascularization were assessed by OCT and used as surrogates of local inflammation. A significance level of < 0.05 was adopted as statistically significant. RESULTS: From the 121 lesions, 74 were de novo, 29 were restenosis, and 18 were neoatherosclerosis. Neovascularization was found in 65.8% of de novo, 10.3% in restenosis, and 94.4% in neoatherosclerosis (p<0.01 for all). The volume of neovascularization was different among lesion types (950 vs. 0 vs. 6220, respectively [median values in 1000 x µm3/mm]; p<0.01 for all), which were significantly higher in neoatherosclerosis and lower in restenosis. The presence of macrophages differed among the lesions (95.9% in de novo vs. 6.9% in restenosis vs. 100% in neoatherosclerosis [p<0.01 for all]). Moreover, the intensity of macrophagic infiltration was different among lesion types (2.5 vs. 0.0 vs. 4.5, respectively [median values of macrophage score]; p<0.01 for all), significantly higher in neoatheroscleosis and lower in restenosis. CONCLUSION: When compared using coronary OCT, de novo atherosclerosis, in-stent restenosis, and neoatherosclerosis presented markedly different inflammatory phenotypes.

FUNDAMENTO: A estenose coronária pode ser causada por de novo aterosclerose, reestenose intra-stent e neoaterosclerose intra-stent, três entidades que se desenvolvem a partir de diversos meios fisiopatológicos. OBJETIVOS: Este estudo tem como objetivo investigar, por meio da tomografia de coerência óptica (OCT), se as lesões coronarianas relacionadas a esses processos diferem em seu perfil inflamatório local. MÉTODOS: Análise retrospectiva de pacientes com lesões coronárias diagnosticadas ou suspeitas que realizaram exames de OCT por motivos clínicos. Macrófagos e neovascularização intraplaca foram avaliados por OCT e utilizados como marcadores de inflamação local. O nível de significância < 0,05 foi adotado como estatisticamente significante. RESULTADOS: Das 121 lesões, 74 eram de novo , 29 eram reestenose e 18 eram neoaterosclerose. Neovascularização foi encontrada em 65,8% das de novo , 10,3% na reestenose e 94,4% na neoaterosclerose (p<0,01 para todos). O volume de neovascularização foi diferente entre os tipos de lesão (950 vs. 0 vs. 6.220, respectivamente [valores medianos em 1000 x µm 3 /mm]; p<0,01 para todos), sendo significativamente maior na neoaterosclerose e menor na reestenose. A presença de macrófagos diferiu entre as lesões (95,9% em de novo vs. 6,9% em reestenose vs. 100% em neoaterosclerose [p<0,01 para todos]). Além disso, a intensidade da infiltração macrofágica foi diferente entre os tipos de lesão (2,5 vs. 0,0 vs. 4,5, respectivamente [valores medianos do escore de macrófagos]; p<0,01 para todos), significativamente maior na neoaterosclerose e menor na reestenose. CONCLUSÕES: Quando comparados pela OCT coronariana, de novo , reestenose intra-stent e neoaterosclerose apresentaram fenótipos inflamatórios marcadamente diferentes.

Safety and effectiveness of introducing a robotic-assisted percutaneous coronary intervention program in a tertiary center: a prospective study.

Background: Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty. Methods: Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion. Results: A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold). Conclusions: Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

Improvement of renal function after transcatheter aortic valve replacement in patients with chronic kidney disease.

BACKGROUND: Chronic kidney disease is commonly found in patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) and has marked impact in their prognosis. It has been shown however that TAVR may improve renal function by alleviating the hemodynamic barrier imposed by AS. Nevertheless, the predictors of and clinical consequences of renal function improvement are not well established. Our aim was to assess the predictors of improvement of renal function after TAVR. METHODS: The present work is an analysis of the Brazilian Registry of TAVR, a national non-randomized prospective study with 22 Brazilian centers. Patients with baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) were stratified according to renal function after TAVR: increase >10% in eGFR were classified as TAVR induced renal function improvement (TIRFI); decrease > 10% in eGFR were classified as acute kidney injury (AKI) and stable renal function (neither criteria). RESULTS: A total of 819 consecutive patients with symptomatic severe AS were included. Of these, baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) was present in 577 (70%) patients. Considering variance in renal function between baseline and at discharge after TAVR procedure, TIRFI was seen in 197 (34.1%) patients, AKI in 203 (35.2%), and stable renal function in 177 (30.7%). The independent predictors of TIRFI were: absence of coronary artery disease (OR: 0.69; 95% CI 0.48-0.98; P = 0.039) and lower baseline eGFR (OR: 0.98; 95% CI 0.97-1.00; P = 0.039). There was no significant difference in 30-day and 1-year all-cause mortality between patients with stable renal function or TIRFI. Nonetheless, individuals that had AKI after TAVR presented higher mortality compared with TIRFI and stable renal function groups (29.3% vs. 15.4% vs. 9.5%, respectively; p < 0.001). CONCLUSIONS: TIRFI was frequently found among baseline impaired renal function individuals but was not associated with improved 1-year outcomes.

Use of robotic assistance to reduce proximity and air-sharing during percutaneous cardiovascular intervention.

Aim: Traditional percutaneous cardiovascular interventions require close physical proximity between the patients and the healthcare team, posing occupational hazards that range from radiation exposure to interpersonal air contamination. Materials & methods: Prospective single-arm pilot study (n = 10) to investigate robotic-assisted intervention as a strategy to reduce proximity during the procedure. Primary end point: composite of angiographic success, intervention performed with the team positioned >2 meters from the patient for ≥50% procedure duration, and absence of in-hospital death or acute target lesion occlusion. Results: The composite primary end point was achieved in 100% of cases. Conclusion: Robotic-assisted percutaneous intervention provided successful invasive treatment while reducing proximity and shared air space between the care-delivery team and the patient during the procedure. Trial registration number: NCT04379453 (Clinicaltrials.gov).

Lay abstract Minimally invasive therapies for cardiovascular diseases are techniques that limit the size of incisions needed and so lessen wound healing time, but traditionally require close contact between the patients and the healthcare team. This fact poses hazards that range from radiation exposure to the spread of airborne diseases. We developed a small study of ten patients to investigate whether a new method of robotic-assisted stent implantation for the treatment of a heart attack would reduce proximity between the patient and medical staff during the procedure. To evaluate the effectiveness of that strategy, we assessed the success of the procedure (by analyzing the images of the operation), the amount of time the team was positioned more than 2 meters from the patient and the occurrence of complications during the hospitalization. We concluded that this method of robotic-assisted stent implantation after a heart attack provided successful treatment while reducing proximity and shared air space between the care-delivery team and the patient.

Late clinical outcomes of myocardial hybrid revascularization versus coronary artery bypass grafting for complex triple-vessel disease: Long-term follow-up of the randomized MERGING clinical trial.

OBJECTIVES: This article aimed to compare the outcomes after hybrid revascularization with conventional coronary artery bypass grafting (CABG) surgery. BACKGROUND: The concept of hybrid coronary revascularization combines the advantages of CABG and percutaneous coronary intervention to improve the treatment of patients with complex multivessel disease. METHODS: The Myocardial hybrid revascularization versus coronary artERy bypass GraftING for complex triple-vessel disease-MERGING study is a pilot randomized trial that allocated 60 patients with complex triple-vessel disease to treatment with hybrid revascularization or conventional CABG (2:1 ratio). The primary outcome was the composite of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization at 2 years. RESULTS: Clinical and anatomical characteristics were similar between groups. After a mean follow-up of 802 ± 500 days, the primary endpoint rate was 19.3% in the hybrid arm and 5.9% in the CABG arm (p = NS). The incidence of unplanned revascularization increased over time in both groups, reaching 14.5 versus 5.9% in the hybrid and in the CABG groups, respectively (p = .4). Of note, in the hybrid group, there were no reinterventions driven by the occurrence of stent restenosis. CONCLUSIONS: Hybrid myocardial was feasible but associated with increasing rates of major adverse cardiovascular events during 2 years of clinical follow-up, while the control group treated with conventional surgery presented with low rates of complications during the same period. In conclusion, before more definitive data arise, hybrid revascularization should be applied with careful attention in practice, following a selective case-by-case indication.

Robotic-assisted intervention strategy to minimize air exposure during the procedure: a case report of myocardial infarction and COVID-19.

Percutaneous coronary interventions (PCI) is traditionally a manual procedure executed by one or more operators positioned at a close distance from the patient. The ongoing pandemic of coronavirus disease 2019 (COVID-19) has imposed severe restrictions to such an interventional environment. The novel SARS-CoV-2 virus that causes COVID-19 is transmitted mainly through expelled respiratory particles, which are known to travel approximately 3-6 feet away from infected persons. During PCI, that contamination range obligatorily poses the team and the patient to direct air exposure. We herein present a case report with the description of a minimum-contact strategy to reduce interpersonal air exposure during PCI. The approach designed to minimize proximity between the patient and the healthcare team included the performance of robotic-assisted PCI, operated by unscrubbed cardiac interventionalists from a control cockpit located outside the catheterization suite. Also included, was the delineation of the potential zone of respiratory particle spread; a circle measuring 4 meters (13.1 feet) in diameter was traced on the floor of the cath lab with red tape, centered on the patient's mouth and nose. The team was rigorously trained and advised to minimize time spent within the 4-meter perimeter as much as possible during the procedure. Following this strategy, a 60-year-old male with non-ST-elevation myocardial infarction and COVID-19 was treated with successful coronary implantation of two stents in the obtuse marginal branch and one stent in the circumflex artery. The total duration of the procedure was 103 minutes and 22 seconds. During most of the procedure, the 4-meter spread zone was not entered by any personnel. For each individual team member, the proposed strategy was effective in ensuring that they stayed outside of the 4-meter area for the majority of their work time, ranging from 96.9% to 59.7% of their respective participation. This case report illustrates the potential of robotic-assisted percutaneous coronary intervention in reducing physical proximity between the team and the patient during the procedure.

Procedural Strategies to Reduce the Incidence of Contrast-Induced Acute Kidney Injury During Percutaneous Coronary Intervention.

Contrast-induced acute kidney injury (CI-AKI) is a potentially serious complication following coronary angiography and percutaneous coronary intervention (PCI). The incidence of CI-AKI is particularly high in patients with advanced chronic kidney disease (defined as an estimated glomerular filtration rate <30 ml/min/1.73 m2). Although much effort has been dedicated to the identification and implementation of preventive measures for this complication at the pre-intervention stage, much less has been investigated on the procedural strategies and techniques to decrease the risk of CI-AKI during PCI. The mainstay of such approaches relies on the minimization of contrast volume by means of specific strategies or dedicated devices. Invasive imaging, such as intravascular ultrasound or non-contrast-based optical coherence tomography, is another pillar of any ultra-low-contrast-volume PCI protocol. Finally, an array of miscellaneous ancillary measures can be implemented to decrease the risk of CI-AKI, which includes the use of radial access, remote ischemic conditioning, and hemodynamic support in high-risk patients. The present review analyzes the technical aspects as well as the scientific evidence supporting these novel techniques, with the goal to improve the outcomes of patients at high risk for CI-AKI undergoing PCI.

Renal denervation in patients with heart failure secondary to Chagas' disease: A pilot randomized controlled trial.

INTRODUCTION: Chagas disease is one of the most relevant endemic parasitic diseases in Latin America, affecting approximately 6 million people. Overt Chagas heart disease is an ominous condition, occurring in 20-30% of infected individuals, which has besides the persistent myocarditis a peculiar intracardiac ganglionic neuronal depletion and dysautonomy. This study aims to evaluate the safety and feasibility of renal denervation for patients with advanced symptomatic Chagas cardiomyopathy. METHODS: Open-label prospective pilot study that randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio). The primary endpoint was the incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function. RESULTS: A total of 17 patients were allocated for renal denervation (n = 11) or conservative treatment (n = 6). Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7 ± 4.9%). For patients randomized to renal denervation, the procedure was performed successfully and uneventfully. After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6). After 9 months, clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups. CONCLUSIONS: This pilot study suggests that renal denervation is safe and feasible in patients with Chagas cardiomyopathy, warranting future studies to better evaluate the clinical efficacy of the interventional strategy in improving the prognosis of this high-risk population.

Coronary fractional flow reserve derived from intravascular ultrasound imaging: Validation of a new computational method of fusion between anatomy and physiology.

OBJECTIVES: To evaluate the diagnostic performance of a novel computational algorithm based on three-dimensional intravascular ultrasound (IVUS) imaging in estimating fractional flow reserve (IVUSFR ), compared to gold-standard invasive measurements (FFRINVAS ). BACKGROUND: IVUS provides accurate anatomical evaluation of the lumen and vessel wall and has been validated as a useful tool to guide percutaneous coronary intervention. However, IVUS poorly represents the functional status (i.e., flow-related information) of the imaged vessel. METHODS: Patients with known or suspected stable coronary disease scheduled for elective cardiac catheterization underwent FFRINVAS measurement and IVUS imaging in the same procedure to evaluate intermediate lesions. A processing methodology was applied on IVUS to generate a computational mesh condensing the geometric characteristics of the vessel. Computation of IVUSFR was obtained from patient-level morphological definition of arterial districts and from territory-specific boundary conditions. FFRINVAS measurements were dichotomized at the 0.80 threshold to define hemodynamically significant lesions. RESULTS: A total of 24 patients with 34 vessels were analyzed. IVUSFR significantly correlated (r = 0.79; P < 0.001) and showed good agreement with FFRINVAS , with a mean difference of -0.008 ± 0.067 (P = 0.47). IVUSFR presented an overall accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 91%, 89%, 92%, 80%, and 96%, respectively, to detect significant stenosis. CONCLUSION: The computational processing of IVUSFR is a new method that allows the evaluation of the functional significance of coronary stenosis in an accurate way, enriching the anatomical information of grayscale IVUS.

Potential of transcatheter aortic valve replacement to improve post-procedure renal function.

BACKGROUND: Baseline comorbidities including renal dysfunction are frequently found in patients treated with transcatheter aortic valve replacement (TAVR) and may increase the risks of acute kidney injury (AKI), although some of them may actually improve renal function. We aimed to evaluate the potential of TAVR to acutely improve post-procedure renal function. METHODS: This is a prospective single-center registry of consecutive patients with severe symptomatic aortic stenosis treated by transfemoral TAVR. Creatinine levels were determined at baseline and daily until hospital discharge. AKI was defined according to VARC-2 criteria. Patients who had improvement of creatinine levels >25% were classified as having TAVR induced renal function improvement (TIRFI). RESULTS: A total of 69 patients undergoing TAVR were included, with a mean age of 83.0±7.4 years, being 24.6% diabetics, with a median STS score of 9.2 (5.1-21.6). Using the VARC-2 criteria, the majority of patients (64.6%) did not have renal impairment, while AKI was detected in 35.4% of the patients. Importantly, in those with prior severe renal dysfunction (clearance <30mL/min/1.73m2) or diabetes, AKI reached up to 50% and 56.3% of the patients, respectively. Conversely, acute kidney recovery (TIRFI) occurred in 12 patients (18.5%) being >50% in 1 patient (1.5%), and at hospital discharge the majority of the patients (88.6%) left the hospital in their original or better renal function categories. CONCLUSION: Despite multiple comorbidities in a selected TAVR-population and the use of contrast media, TAVR did not impair renal function in a majority of patients, with a significant proportion of them rather having acute renal function improvement.

Validation of coronary computed tomography angiography scores for non-invasive assessment of atherosclerotic burden through a comparison with multivessel intravascular ultrasound.

AIMS: While the atherosclerotic plaque volume can be manually quantified in coronary computed tomography angiography (CTA) it is impractical for clinical routine use. Several anatomical scores have been developed as surrogates for overall atherosclerotic burden in coronary CTA and even proven to be highly predictive for future adverse events. However, they have not been validated against the gold standard for atherosclerotic burden, intra-vascular ultrasound (IVUS). In the present study we have compared several coronary CTA scores with the coronary IVUS. METHODS AND RESULTS: A total of 62 patients with diagnosed coronary disease scheduled for percutaneous intervention were prospectively enrolled. For all patients, coronary CTA and multivessel IVUS were obtained. Calcium score and 6 previously reported scores were calculated from coronary CTA imaging and compared to average IVUS-derived percent atheroma volume (PAV). On average, 3.8 ± 0.7 vessels, comprising 123.8 ± 31.3 mm in length, were imaged with IVUS per patient. All but one previously described scoring systems showed a significant association with IVUS-derived PAV. Among them, the SSS score demonstrated the strongest correlation with IVUS-PAV (r = 0.61, p < 0.001) and the greatest area under the ROC curve (C-statistic = 0.87), to predict a high PAV. CONCLUSIONS: Most frequently used coronary CTA scores have a good correlation with global coronary atherosclerotic burden measured by multivessel IVUS derived atheroma volume. Among them, the SSS score shows the best performance being a good non-invasive alternative to IVUS for global coronary atherosclerotic burden assessment.

Clinical performance of a novel ultrathin strut, low-dose, sirolimus-eluting stent with abluminal-only biodegradable polymeric coating for patients undergoing percutaneous coronary intervention in the daily practice.

BACKGROUND: The present study aimed to evaluate the clinical performance, in the daily practice of a busy catheterization laboratory, of a novel drug-eluting stent (DES) built with an ultra-thin-strut metallic platform, eluting sirolimus at low doses, abluminal coated with biodegradable polymers, and mounted in a low-compliant delivery system. METHODS: Prospective, single-arm study, comprising all consecutive patients undergoing percutaneous coronary intervention (PCI) with the Inspiron™ sirolimus-eluting stent (SES) (Scitech, Aparecida de Goiania, Brazil). The primary endpoint was the occurrence of major adverse cardiac events (MACE) [cardiac death, non-PCI related myocardial infarction (MI), or target vessel revascularization (TVR)]. RESULTS: A total of 470 patients were included, from which 51.3% were diabetics, 33.8% had triple-vessel disease, 15.3% had heart failure, 38.9% had at least one bifurcation treated, 19.8% were treated for a bare metal stent restenosis, and 61.9% had at least one type C lesion; one or more of these features were found in 96.0%. At 300 days, the rate target lesion revascularization was 5.4% and the rate of MACE was 8.1%. The incidence of definite or probable stent thrombosis was 0.4%, with no cases between 30 and 300 days. CONCLUSIONS: The novel stent is associated with excellent short and mid-term clinical outcomes in patients treated with PCI in the daily practice.

A Novel Algorithm to Quantify Coronary Remodeling Using Inferred Normal Dimensions.

BACKGROUND: Vascular remodeling, the dynamic dimensional change in face of stress, can assume different directions as well as magnitudes in atherosclerotic disease. Classical measurements rely on reference to segments at a distance, risking inappropriate comparison between dislike vessel portions. OBJECTIVE: to explore a new method for quantifying vessel remodeling, based on the comparison between a given target segment and its inferred normal dimensions. METHODS: Geometric parameters and plaque composition were determined in 67 patients using three-vessel intravascular ultrasound with virtual histology (IVUS-VH). Coronary vessel remodeling at cross-section (n = 27.639) and lesion (n = 618) levels was assessed using classical metrics and a novel analytic algorithm based on the fractional vessel remodeling index (FVRI), which quantifies the total change in arterial wall dimensions related to the estimated normal dimension of the vessel. A prediction model was built to estimate the normal dimension of the vessel for calculation of FVRI. RESULTS: According to the new algorithm, "Ectatic" remodeling pattern was least common, "Complete compensatory" remodeling was present in approximately half of the instances, and "Negative" and "Incomplete compensatory" remodeling types were detected in the remaining. Compared to a traditional diagnostic scheme, FVRI-based classification seemed to better discriminate plaque composition by IVUS-VH. CONCLUSION: Quantitative assessment of coronary remodeling using target segment dimensions offers a promising approach to evaluate the vessel response to plaque growth/regression.