Publications by authors named "Hector M Garcia-Garcia"

550 Publications

A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).

EuroIntervention 2021 Nov 15. Epub 2021 Nov 15.

Cardiology Department, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Background: Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy.

Aims: The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate.

Methods: BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up.

Results: Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%), one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post procedure for restenosis. No stent thrombosis was reported during the 12-month study duration.

Conclusions: The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.
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http://dx.doi.org/10.4244/EIJ-D-21-00537DOI Listing
November 2021

Ultra-Short Term Evaluation of Coronary Vessel Wall Changes in Reference Segments Adjacent to Culprit Lesions in ST-Segment Elevation Myocardial Infarction.

J Invasive Cardiol 2021 Nov 18. Epub 2021 Nov 18.

MedStar Washington Hospital Center, 110 Irving St NW, Washington DC USA.

Background: Culprit lesions of ST-segment elevation myocardial infarction (STEMI) patients are friable, soft, and prone to disruption during primary percutaneous coronary intervention (pPCI). The presence of dissections in reference vessel segments (RVSs), adjacent to stented culprit lesions, and dynamic luminal changes in proximal or distal RVSs have not yet been investigated. We therefore sought to assess the healing patterns of edge dissections and the changes of lumen area at RVSs within 1 week post stent implantation in patients with STEMI.

Methods: In the MATRIX trial (ClinicalTrials.gov NCT01433627), optical coherence tomography (OCT) was performed at the end of pPCI and within 1 week during staged PCI. The RVS dissection was defined as: type 1 = flap; type 2 = cavity; type 3 = double barrel; and type 4 = fissure. We compared separately the fate of residual dissection and luminal area/dimension by OCT in the target vessel between pPCI and staged PCI, including 1-year clinical outcomes.

Results: Out of 151 patients, 46 patients had dissections in 50 RVSs and did not experience worse clinical outcome. Dissections were 44% type 1, 28% type 2, 12% type 3, and 16% type 4. Overall, 18% of the dissections healed. The mean lumen area of the RVS enlarged in 82 patients (59%) from pPCI to staged PCI. Compared with the proximal RVS, there was a significant increase in the lumen diameter at the distal RVS (0.06 ± 0.25 mm vs -0.01 ± 0.21 mm; P=.01).

Conclusion: Dissections occur frequently after pPCI. One-fifth of them heal within 1 week and do not seem to negatively impact clinical outcomes. Distal RVS lumen area increased compared with proximal RVS, likely reflecting a different vasoconstriction pattern over time.
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November 2021

First in-human evaluation of a novel intravascular ultrasound and optical coherence tomography system for intracoronary imaging.

Catheter Cardiovasc Interv 2021 Nov 18. Epub 2021 Nov 18.

Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada.

Aims: We evaluated the first in-human performance of a novel hybrid imaging catheter that permits simultaneous and co-registered acquisition of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) images.

Methods And Results: A total of 17 patients undergoing planned percutaneous coronary intervention (PCI) were imaged between August 2018 and August 2019. Eleven patients with both pre- and post-PCI IVUS and OCT images were included in the offline image analysis. IVUS and OCT images were analyzed separately then together with co-registered images for pre-stent findings, and only separately for post-stent findings. A total of 926 frames were analyzed (218 pre-PCI, 708 post-PCI). There was substantial agreement to detect calcific plaque between co-registered IVUS-OCT and standalone IVUS (Kappa 0.72 [0.65-0.79]) and standalone OCT (Kappa 0.75 [0.68-0.81]) while standalone imaging modalities showed lower agreement to detect lipidic and fibrotic plaques compared with co-registered IVUS-OCT. There were more frames with stent underexpansion on IVUS than OCT [72 (28.7%) vs. 58 (23.1%), respectively, p = 0.039]. Detection rates of incomplete stent apposition (present on 20 OCT frames vs. 2 IVUS frames, p < 0.001) and tissue protrusion (40 vs. 27 frames, p < 0.001) were higher on OCT than IVUS. One stent edge dissection was detected in the image analysis and was seen on OCT but not IVUS. All 177 frames with image artifacts contained at least one co-registered imaging modality with interpretable diagnostic content. There were no study device-related adverse events.

Conclusions: Hybrid image acquisition was safe. The availability of both IVUS and OCT changed image interpretation compared to either modality alone, suggesting a complementary role of these two techniques.
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http://dx.doi.org/10.1002/ccd.30001DOI Listing
November 2021

Transcatheter Aortic Valve Replacement in Mixed Aortic Valve Disease: A Systematic Review and Meta-analysis.

Eur Heart J Qual Care Clin Outcomes 2021 Nov 12. Epub 2021 Nov 12.

Division of Cardiovascular Diseases, Creighton University School of Medicine, Omaha, NE.

Background: Utilization of transcatheter aortic valve replacement (TAVR) has expanded from high-risk patients to intermediate and select low-risk candidates with severe aortic stenosis (AS). TAVR is currently not indicated for patients with aortic insufficiency, and its outcomes in mixed aortic valve disease (MAVD) are unclear.

Methods: A systematic search of PubMed, Medline, CINHAL and Cochrane databases was performed to identify studies comparing TAVR outcomes in patients with AS vs. MAVD. Primary outcomes included 30-day and late all-cause mortality, and paravalvular regurgitation (PVR). Secondary outcomes were major bleeding, vascular complications, device implantation success, permanent pacemaker and stroke. Pooled odds ratios (OR) and 95% confidence intervals (CIs) were calculated using Der Simonian-Laird random-effects model.

Results: Six observational studies with 58,879 patients were included in the analysis. There was no significant difference in 30-day all-cause mortality (OR 1.03 [95% CI 0.92-1.15]; p = 0.63), however, MAVD group had higher odds of moderate to severe PVR (1.81 [1.41-2.31]; p<0.01). MAVD patients had lower odds of device implantation success (0.60 [0.40-0.91]; p = 0.02) while other secondary outcomes were similar in the two groups.

Conclusions: TAVR in MAVD is associated with increased odds of paravalvular regurgitation and lower odds of device implantation success when compared to severe aortic stenosis.
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http://dx.doi.org/10.1093/ehjqcco/qcab080DOI Listing
November 2021

Fully automated lumen and vessel contour segmentation in intravascular ultrasound datasets.

Med Image Anal 2021 Oct 7;75:102262. Epub 2021 Oct 7.

Interventional Cardiology Department, MedStar Washington Hospital Center, Washington, DC, USA; Georgetown University School of Medicine, Washington, DC, USA. Electronic address:

Segmentation of lumen and vessel contours in intravascular ultrasound (IVUS) pullbacks is an arduous and time-consuming task, which demands adequately trained human resources. In the present study, we propose a machine learning approach to automatically extract lumen and vessel boundaries from IVUS datasets. The proposed approach relies on the concatenation of a deep neural network to deliver a preliminary segmentation, followed by a Gaussian process (GP) regressor to construct the final lumen and vessel contours. A multi-frame convolutional neural network (MFCNN) exploits adjacency information present in longitudinally neighboring IVUS frames, while the GP regression method filters high-dimensional noise, delivering a consistent representation of the contours. Overall, 160 IVUS pullbacks (63 patients) from the IBIS-4 study (Integrated Biomarkers and Imaging Study-4, Trial NCT00962416), were used in the present work. The MFCNN algorithm was trained with 100 IVUS pullbacks (8427 manually segmented frames), was validated with 30 IVUS pullbacks (2583 manually segmented frames) and was blindly tested with 30 IVUS pullbacks (2425 manually segmented frames). Image and contour metrics were used to characterize model performance by comparing ground truth (GT) and machine learning (ML) contours. Median values (interquartile range, IQR) of the Jaccard index for lumen and vessel were 0.913, [0.882,0.935] and 0.940, [0.917,0.957], respectively. Median values (IQR) of the Hausdorff distance for lumen and vessel were 0.196mm, [0.146,0.275]mm and 0.163mm, [0.122,0.234]mm, respectively. Also, the mean value of lumen area predictions, and limits of agreement were -0.19mm, [1.1,-1.5]mm, while the mean value and limits of agreement of plaque burden were 0.0022, [0.082,-0.078]. The results obtained with the model developed in this work allow us to conclude that the proposed machine learning approach delivers accurate segmentations in terms of image metrics, contour metrics and clinically relevant variables, enabling its use in clinical routine by mitigating the costs involved in the manual management of IVUS datasets.
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http://dx.doi.org/10.1016/j.media.2021.102262DOI Listing
October 2021

Coronary Microvascular Dysfunction in Takotsubo Syndrome Assessed by Angiography-Derived Index of Microcirculatory Resistance: A Pressure-Wire-Free Tool.

J Clin Med 2021 Sep 23;10(19). Epub 2021 Sep 23.

Section of Interventional Cardiology, MedStar Washington Hospital Center, EB 521,110 Irving St NW, Washington, DC 20010, USA.

Background: Coronary microvascular dysfunction (CMD) has been proposed as a key mechanism in Takotsubo syndrome (TTS). The non-hyperaemic angiography-derived index of microcirculatory resistance (NH-IMRangio) has been validated as a pressure-wire-free tool for the assessment of coronary microvasculature. We aimed to study the presence of CMD in TTS patients and its association with levels of cardiac biomarkers and systolic dysfunction patterns.

Methods: We recruited 181 consecutive patients admitted for TTS who underwent cardiac angiography at a tertiary center from January 2014 to January 2021. CMD was defined as an NH-IMRangio ≥ 25. Plasma levels of NT-proBNP, high-sensitive cardiac troponin T (hs-cTnT) and the left ventricular ejection fraction (LVEF) by echocardiography were measured at admission.

Results: Mean age was 75.3 years, 83% were women and median LVEF was 45%. All patients presented CMD (NH-IMRangio ≥ 25) in at least one epicardial coronary artery. The left anterior descending artery (LAD) showed higher median NH-IMRangio values than left circumflex (LCx) and right coronary arteries (RCA) (44.6 vs. 31.3 vs. 36.1, respectively; < 0.001). NH-IMRangio values differed among ventricular contractility patterns in the LAD and RCA ( = 0.0152 and 0.0189, respectively) with the highest values in the mid-ventricular + apical and mid-ventricular + basal patterns. NT-proBNP levels, but not high-sensitive cardiac troponin T (hs-cTnT), were correlated with both the degree and the extent of CMD in patients with TTS. Lower LVEF was also associated with higher NH-IMRangio values.

Conclusions: CMD is highly prevalent in patients admitted for TTS and is associated with both a higher degree of systolic dysfunction and higher BNP levels, but not troponin.
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http://dx.doi.org/10.3390/jcm10194331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509411PMC
September 2021

Greater plaque burden and cholesterol content may explain an increased incidence of non-culprit events in diabetic patients: a Lipid-Rich Plaque substudy.

Eur Heart J Cardiovasc Imaging 2021 Sep 26. Epub 2021 Sep 26.

Cardiovascular Department, MedStar Washington Hospital Center, Washington, DC, USA.

Aims : Diabetes mellitus (DM) is associated with increased cardiovascular morbidity and mortality. The multicentre, prospective Lipid-Rich Plaque trial (LRP) examined non-culprit (NC) non-obstructive coronary segments with a combined near-infrared spectroscopy (NIRS)-intravascular ultrasound (IVUS) catheter. This study assessed the differences in NC plaque characteristics and their influence on major adverse cardiac events (MACE) in diabetic and non-diabetic patients.

Methods And Results : Patients with known DM status were divided into no diabetes, diabetes not treated with insulin (non-ITDM), and insulin-treated diabetes (ITDM). The association between presence and type of DM and NC-MACE was assessed at both the patient and coronary segment levels by Cox proportional regression modelling. Out of 1552 patients enrolled, 1266 who had their diabetes status recorded were followed through 24 months. Female sex, hypertension, chronic kidney disease, peripheral vascular disease, and high body mass index were significantly more frequent in diabetic patients. The ITDM group had more diseased vessels, at least one NC segment with a maxLCBI4 mm ≥400 in 46.2% of patients, and maxLCBI4 mm ≥400 in nearly one out of six Ware segments (15.2%, 125/824 segments). The average maxLCBI4 mm significantly increased from non-diabetic patients (NoDM) to non-insulin-treated diabetic patients (non-ITDM) to insulin-treated diabetic patients (ITDM; 137.7 ± 161.9, 154.8 ± 173.6, 182.9 ± 193.2, P < 0.001, respectively). In patients assigned to follow-up (692 ± 129 days), ITDM doubled the incidence of NC-MACE compared with the absence of diabetes (15.7% vs. 6.9%, P = 0.0008). The presence of maxLCBI4 mm>400 further increased the NC-MACE rate to 21.6% (Kaplan-Meier estimate).

Conclusion : Cholesterol-rich NC plaques detected by NIRS-IVUS were significantly more frequent in diabetic patients, especially those who were insulin-treated, and were associated with an increased NC-MACE during follow-up.
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http://dx.doi.org/10.1093/ehjci/jeab161DOI Listing
September 2021

Long-Term Clinical Outcomes in Patients With an Acute ST-Segment-Elevation Myocardial Infarction Stratified by Angiography-Derived Index of Microcirculatory Resistance.

Front Cardiovasc Med 2021 7;8:717114. Epub 2021 Sep 7.

Oxford Heart Centre, NIHR Biomedical Research Centre, Oxford University Hospitals, Oxford, United Kingdom.

Despite the prognostic value of coronary microvascular dysfunction (CMD) in patients with ST-segment-elevation myocardial infarction (STEMI), its assessment with pressure-wire-based methods remains limited due to cost, technical and procedural complexities. The non-hyperaemic angiography-derived index of microcirculatory resistance (NH IMR) has been shown to reliably predict microvascular injury in patients with STEMI. We investigated the prognostic potential of NH IMR as a pressure-wire and adenosine-free tool. NH IMR was retrospectively derived on the infarct-related artery at completion of primary percutaneous coronary intervention (pPCI) in 262 prospectively recruited STEMI patients. Invasive pressure-wire-based assessment of the index of microcirculatory resistance (IMR) was performed. The combination of all-cause mortality, resuscitated cardiac arrest and new heart failure was the primary endpoint. NH IMR showed good diagnostic performance in identifying CMD (IMR > 40U); AUC 0.78 (95%CI: 0.72-0.84, < 0.0001) with an optimal cut-off at 43U. The primary endpoint occurred in 38 (16%) patients at a median follow-up of 4.2 (2.0-6.5) years. On survival analysis, NH IMR > 43U (log-rank test, < 0.001) was equivalent to an IMR > 40U(log-rank test, = 0.02) in predicting the primary endpoint (hazard ratio comparison = 0.91). NH IMRangio > 43U was an independent predictor of the primary endpoint (adjusted HR 2.13, 95% CI: 1.01-4.48, = 0.047). NH IMR is prognostically equivalent to invasively measured IMR and can be a feasible alternative to IMR for risk stratification in patients presenting with STEMI.
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http://dx.doi.org/10.3389/fcvm.2021.717114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452918PMC
September 2021

Comparison of angiographic and intravascular ultrasound vessel measurements in infra-popliteal endovascular interventions: The below-the-knee calibration study.

Cardiovasc Revasc Med 2021 Sep 16. Epub 2021 Sep 16.

Cardiology, NC Heart and Vascular Research, LLC, UNC School of Medicine, Raleigh, NC, USA. Electronic address:

Background: Endovascular revascularization (ER) via percutaneous transluminal angioplasty (PTA) and stenting are viable options for revascularization in below-the-knee (BTK) peripheral arterial disease. Two-dimensional angiography has been the standard of practice for estimating vessel size and selecting treatment devices during ER. However, in other vascular territories, intravascular ultrasound (IVUS) offers better visualization of the lumen dimensions.

Purpose: To compare angiographic and intravascular ultrasound reference vessel (lumen) measurements in below-the-knee peripheral artery interventions.

Methods: 20 consecutive patients were enrolled in the BTK Calibration study from 2 sites in the United States and Australia. Patients with at least one diseased segment in a native infra-popliteal artery (below-the-knee) and a clinical indication for endovascular therapy (EVT) were included with no limitations with regards to vessel diameter or lesion length. Digital subtraction angiography and intravascular ultrasound imaging were collected pre-and post-percutaneous transluminal angioplasty and images were sent to an independent Core lab for standardized quantitative analysis of the normal-looking reference vessel dimensions when available. The results were presented as least square means with 95% confidence intervals and a p-value of <0.05 was considered as significant.

Results: The overall (N = 19) mean reference vessel diameter for QVA was 2.98 ± 1.24 vs. 3.47 ± 0.72 for IVUS (mean difference was -0.50, (95% CI: -0.80, -0.20; p = 0.14). As expected in the proximal segments (N = 12), the mean reference vessel diameters were larger: for QVA was 3.17 ± 1.34 vs. 3.55 ± 0.76 in IVUS, (mean difference was -0.38, (95% CI:-0.79,0.03; p = 0.40); while in the distal segments (N = 7), mean reference vessel diameters were smaller: for QVA was 2.64 ± 1.06 vs. 3.33 ± 0.67 in IVUS, (mean difference was -0.69, (95% CI:-1.04,-0.34; p = 0.17). We observed a greater degree of acute gain in cases where the treatment balloon size correlated with the IVUS measured reference size.

Conclusion: Angiography underestimates infrapopliteal reference vessel lumen size even when quantitatively assessed. Adjunctive IVUS imaging use in guiding BTK procedures could help ensure adequate sizing and possibly impact immediate post-procedure indices.
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http://dx.doi.org/10.1016/j.carrev.2021.09.004DOI Listing
September 2021

Prosthetic valve endocarditis after transcatheter aortic valve replacement in low-risk patients.

Catheter Cardiovasc Interv 2021 Sep 10. Epub 2021 Sep 10.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA.

Objectives: We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients.

Background: PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking.

Methods: We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee.

Results: We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care.

Conclusions: PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.
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http://dx.doi.org/10.1002/ccd.29943DOI Listing
September 2021

Long-Term Clinical Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents: Final 5-Year Results of the AIDA Randomized Clinical Trial.

EuroIntervention 2021 Aug 31. Epub 2021 Aug 31.

Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands.

Background: Absorb bioresorbable vascular scaffold (BVS) related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of Absorb BVS in daily clinical practice beyond this time point is scarce.

Aims: This report provides the final five-year clinical follow-up of the Absorb BVS in comparison with Xience everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual-antiplatelet therapy (DAPT) administration on events in the scaffold group.

Methods: AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either Absorb BVS (n=924) or Xience EES (n=921). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for effect of prolonged DAPT.

Results: Through 5 years follow-up, there was no difference in TVF between Absorb BVS (17.7%) and Xience EES (16.1%) (hazard ratio 1.31, 95% CI 0.90-1.41, p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) of the scaffold group compared to 13 patients (1.5%) of the stent group (hazard ratio 3.32; 95% CI 1.78-6.17; p<0.001). DT between 3- and 4-years occurred six times in Absorb-arm versus three in Xience-arm. Between 4- and 5-years the incidence was 3 versus 2, respectively. Of those three DT in scaffold group, two occurred in Xience EES treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout 5-year follow-up was 0.36 (95% CI 0.15-0.86).

Conclusions: The excess risk of Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4-years and seems to plateau afterwards.
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http://dx.doi.org/10.4244/EIJ-D-21-00419DOI Listing
August 2021

Frequency of Lipid-Rich Coronary Plaques in Stable Angina Pectoris versus Acute Coronary Syndrome (from the Lipid Rich Plaque Study).

Am J Cardiol 2021 11 28;158:1-5. Epub 2021 Aug 28.

MedStar Washington Hospital Center, Washington, DC. Electronic address:

The multicenter prospective Lipid Rich Plaque (LRP) registry showed that nonculprit (NC) lipid-rich plaques identified by near-infrared spectroscopy (maxLCBI >400) with an intravascular ultrasound plaque burden (PB) >70% and/or minimum lumen area (MLA) <4 mm within the maxLCBI segment were more frequently associated with major adverse cardiac events (MACE) within 2 years. The aim of this sub-study was to report the relationship between initial clinical presentation and subsequent NC-MACE. Patients enrolled in the LRP study were stratified post hoc as having a stable angina pectoris or silent ischemia presentation versus acute coronary syndrome, excluding patients presenting with acute ST-elevation myocardial infarction. Among the 1552 patients, 717 presented with stable angina pectoris or silent ischemia. Patients presenting with acute coronary syndrome were more likely to be younger and Black, current smokers, and have less chronic kidney disease. Of the scanned nonculprit vessels, there was no difference between the 2 clinical presentation groups regarding lipidic content, and the rate of lipid-rich plaques (maxLCBI >400) was 31.9% in both groups. Finally, there was no difference in NC-MACE at 2 years' follow-up, although within each group (stable versus acute coronary syndrome), the NC-MACE rate associated with maxLCBI >400 was significantly higher than maxLCBI ≤400 (stable 13.8% vs 6.5%; acute patients 11.6% vs 6.3%, respectively). In conclusion, in patient groups that present with stable angina pectoris or silent ischemia versus acute coronary syndrome, the NC lipidic content was similar, as was NC-MACE, through 2 years of follow-up.
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http://dx.doi.org/10.1016/j.amjcard.2021.07.033DOI Listing
November 2021

Lipid-rich plaques detected by near-infrared spectroscopy predict coronary events irrespective of age: A Lipid Rich Plaque sub-study.

Atherosclerosis 2021 10 14;334:17-22. Epub 2021 Aug 14.

MedStar Washington Hospital Center, Washington, DC, USA.

Background And Aims: In this Lipid Rich Plaque (LRP) sub-study, 1551 patients undergoing coronary angiography for acute coronary syndromes or stable angina were examined with near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). We aimed to assess the correlation of patient age with the presence of high-risk plaques, defined as maximum 4-mm Lipid Core Burden Index (maxLCBI) >400 and plaque burden >70%, and 2-year incidence of non-culprit major adverse cardiovascular events (NC-MACE).

Methods: The study population was divided into four groups according to age: <50 years (122), 50-64 years (700), 65-74 years (502), and ≥75 years (227). The primary outcome was NC-MACE from index procedure to event or the end of the study. Cox regression and mixed-effects Cox regression models were used to assess the effect of age on the association between LCBI and NC-MACE at the patient and plaque levels.

Results: Average maxLCBI and percentage of patients with at least one segment with maxLCBI > 400 were similar across the four age groups at both the patient and coronary segment levels. Having at least one segment with maxLCBI > 400 was strongly associated with NC-MACE, and that association did not differ significantly across age subgroups. Although less common (prevalence of 0.8%-1.3%), a similar trend toward greater NC-MACE rates was seen in patients with plaque burden >70% at the maximum LCBI site across age subgroups.

Conclusions: Lipid-rich plaques were as frequent in older as in younger patients and predicted a higher incidence of NC-MACE over 2-year follow-up irrespective of age.
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http://dx.doi.org/10.1016/j.atherosclerosis.2021.08.022DOI Listing
October 2021

Predicting future left anterior descending artery events from non-culprit lesions: insights from the Lipid-Rich Plaque study.

Eur Heart J Cardiovasc Imaging 2021 Aug 19. Epub 2021 Aug 19.

Section of Interventional Cardiology, Department of Cardiology, MedStar Washington Hospital Center, 110 Irving St NW, Suite 4B1, Washington, DC 20010, USA.

Aims: The left anterior descending (LAD) artery is the most frequently affected site by coronary artery disease. The prospective Lipid Rich Plaque (LRP) study, which enrolled patients undergoing imaging of non-culprits followed over 2 years, reported the successful identification of coronary segments at risk of future events based on near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS) lipid signals. We aimed to characterize the plaque events involving the LAD vs. non-LAD segments.

Methods And Results: LRP enrolled 1563 patients from 2014 to 2016. All adjudicated plaque events defined by the composite of cardiac death, cardiac arrest, non-fatal myocardial infarction, acute coronary syndrome, revascularization by coronary bypass or percutaneous coronary intervention, and rehospitalization for angina with >20% stenosis progression and reported as non-culprit lesion-related major adverse cardiac events (NC-MACE) were classified by NIRS-IVUS maxLCBI4 mm (maximum 4-mm Lipid Core Burden Index) ≤400 or >400 and association with high-risk-plaque characteristics, plaque burden ≥70%, and minimum lumen area (MLA) ≤4 mm2. Fifty-seven events were recorded with more lipid-rich plaques in the LAD vs. left circumflex and right coronary artery; 12.5% vs. 10.4% vs. 11.3%, P = 0.097. Unequivocally, a maxLCBI4 mm >400 in the LAD was more predictive of NC-MACE [hazard ratio (HR) 4.32, 95% confidence interval (CI) (1.93-9.69); P = 0.0004] vs. [HR 2.56, 95% CI (1.06-6.17); P = 0.0354] in non-LAD segments. MLA ≤4 mm2 within the maxLCBI4 mm was significantly higher in the LAD (34.1% vs. 25.9% vs. 13.7%, P < 0.001).

Conclusion: Non-culprit lipid-rich segments in the LAD were more frequently associated with plaque-level events. LAD NIRS-IVUS screening may help identify patients requiring intensive surveillance and medical treatment.
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http://dx.doi.org/10.1093/ehjci/jeab160DOI Listing
August 2021

End-diastolic segmentation of intravascular ultrasound images enables more reproducible volumetric analysis of atheroma burden.

Catheter Cardiovasc Interv 2021 Aug 17. Epub 2021 Aug 17.

Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.

Background: Volumetric intravascular ultrasound (IVUS) analysis is currently performed at a fixed frame interval, neglecting the cyclic changes in vessel dimensions occurring during the cardiac cycle that can affect the reproducibility of the results. Analysis of end-diastolic (ED) IVUS frames has been proposed to overcome this limitation. However, at present, there is lack of data to support its superiority over conventional IVUS.

Objectives: The present study aims to compare the reproducibility of IVUS volumetric analysis performed at a fixed frame interval and at the ED frames, identified retrospectively using a novel deep-learning methodology.

Methods: IVUS data acquired from 97 vessels were included in the present study; each vessel was segmented at 1 mm interval (conventional approach) and at ED frame twice by an expert analyst. Reproducibility was tested for the following metrics; normalized lumen, vessel and total atheroma volume (TAV), and percent atheroma volume (PAV).

Results: The mean length of the analyzed segments was 50.0 ± 24.1 mm. ED analysis was more reproducible than the conventional analysis for the normalized lumen (mean difference: 0.76 ± 4.03 mm vs. 1.72 ± 11.37 mm ; p for the variance of differences ratio < 0.001), vessel (0.30 ± 1.79 mm vs. -0.47 ± 10.26 mm ; p < 0.001), TAV (-0.46 ± 4.03 mm vs. -2.19 ± 14.39 mm ; p < 0.001) and PAV (-0.12 ± 0.59% vs. -0.34 ± 1.34%; p < 0.001). Results were similar when the analysis focused on the 10 mm most diseased segment. The superiority of the ED approach was due to a more reproducible detection of the segment of interest and to the fact that it was not susceptible to the longitudinal motion of the IVUS probe and the cyclic changes in vessel dimensions during the cardiac cycle.

Conclusions: ED IVUS segmentation enables more reproducible volumetric analysis and quantification of TAV and PAV that are established end points in longitudinal studies assessing the efficacy of novel pharmacotherapies. Therefore, it should be preferred over conventional IVUS analysis as its higher reproducibility is expected to have an impact on the sample size calculation for the primary end point.
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http://dx.doi.org/10.1002/ccd.29917DOI Listing
August 2021

Impact of intravascular ultrasound on Outcomes following PErcutaneous coronary interventioN for In-stent Restenosis (iOPEN-ISR study).

Int J Cardiol 2021 Oct 8;340:17-21. Epub 2021 Aug 8.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address:

Background: Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) remains common. Intravascular imaging allows for the determination of the mechanism of ISR, potentially guiding appropriate therapy. Intravascular ultrasound (IVUS)-guided stent implantation is associated with a reduction in adverse events after PCI, but its impact on treatment of ISR is not clear.

Methods: All patients with 1-year follow-up after ISR treatment from 2003 through 2016 were included and stratified by IVUS use. The primary endpoint was the rate of major adverse cardiac events (MACE) at 1 year, defined as the composite of all-cause mortality, Q-wave myocardial infarction, and target vessel revascularization (TVR).

Results: The final analysis included 1522 ISR patients, 65.9% of whom were treated with IVUS guidance. The primary endpoint occurred in 18.0% of patients treated with IVUS guidance vs. 24.5% of patients treated with angiography guidance (p = 0.0014). Post-dilatation was used more often with IVUS (18.6% vs. 14.1%, p < 0.001), with a larger diameter of new stents (3.04 ± 0.35 mm vs. 2.94 ± 0.47 mm, p = 0.001). At 1 year, TVR occurred in 14.5% with IVUS guidance and 19.2% with angiography guidance (p = 0.021).

Conclusions: The use of IVUS is associated with decreased MACE at 1 year following PCI for ISR. These results support routine IVUS for the treatment of ISR lesions.
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http://dx.doi.org/10.1016/j.ijcard.2021.08.003DOI Listing
October 2021

Sustained safety and performance of a second-generation sirolimus-eluting absorbable metal scaffold: Long-term data of the BIOSOLVE-II first-in-man trial at 5 years.

Cardiovasc Revasc Med 2021 Jul 22. Epub 2021 Jul 22.

Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.

Background: Permanent drug-eluting stents are associated with a steady increase of late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years.

Methods: BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints target lesion failure and rate of definite or probable stent thrombosis.

Results: 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischemia. Target lesion failure rate was 8.0% [95% CI:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarction, and 6 clinically-driven target lesion revascularizations. Only one target lesion failure occurred beyond 3 years; a target-vessel myocardial infarction with clinically-driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed.

Conclusion: The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years.

Annotated Table Of Contents: BIOSOLVE-II is a prospective, multi-centre, first-in-man trial enrolling 123 patients with de novo coronary artery lesions. Target lesion failure rate at 5 years was low (8.0%), including 2 cardiac deaths, 2 target-vessel myocardial infarction and 6 clinically-driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.
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http://dx.doi.org/10.1016/j.carrev.2021.07.017DOI Listing
July 2021

Peri-interventional Triple Therapy With Dabigatran Improves Vasomotion and Promotes Endothelialization in Porcine Coronary Stenting Model.

Front Cardiovasc Med 2021 2;8:690476. Epub 2021 Jul 2.

Department of Cardiology, Medical University of Vienna, Vienna, Austria.

We evaluated the short and long-term effect of peri-interventional dabigatran therapy on vasomotion, endothelialization, and neointimal formation in a porcine coronary artery stenting model. Stenting of coronary arteries induces local inflammation, impairs vasomotion and delays endothelialization. Twenty-eight animals underwent percutaneous coronary intervention (PCI) with drug eluting stents. Sixteen pigs started dabigatran therapy 4 days prior to PCI and continued for 4 days post-stenting, while 12 animals served as controls. Post-stenting dual antiplatelet therapy (75 mg clopidogrel and 100 mg aspirin) was continued in both groups until termination. Immediately post-stenting and at day 3 optical coherence tomography (OCT) was performed in all animals, followed by euthanasia of 8 dabigatran and 4 control animals. The remaining pigs (8 of each group) were followed up for 1 month, with control angiography and OCT. Tissue burden (degree of peri-strut structure-thrombus and/or fibrin) was evaluated. After euthanasia coronary arteries were harvested for myometry and histology. Thrombin generation was lower ( < 0.001) and tissue burden (0.83 ± 0.98 vs. 3.0 ± 2.45; = 0.031) was significantly decreased in dabigatran treated animals. After 3 days post-PCI endothelium-dependent vasodilation was significantly improved (77 ± 40% vs. 41 ± 31%, = 0.02) in dabigatran animals. Neither quantitative angiography nor histomorphometry showed differences between the groups. Endothelialization was faster in the dabigatran group as compared with controls ( = 0.045). Short-term peri-interventional triple therapy with dabigatran, aspirin, and clopidogrel led to an enhanced endothelium dependent vasodilation and faster endothelialization. However, neointimal formation 1-month after stent implantation was comparable between groups.
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http://dx.doi.org/10.3389/fcvm.2021.690476DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8300015PMC
July 2021

Non-culprit MACE-rate in LRP: The influence of optimal medical therapy using DAPT and statins.

Cardiovasc Revasc Med 2021 Jul 17. Epub 2021 Jul 17.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.

Background/purpose: The Lipid Rich Plaque (LRP) study demonstrated the association between coronary plaque lipid content and outcomes. In this LRP substudy, we assessed the impact of optimal medical therapy (OMT) on the occurrence of non-culprit major adverse cardiac events (NC-MACE). Advanced intracoronary imaging modalities are able to identify patients with vulnerable coronary lesion morphology associated with future events.

Methods/materials: A total of 1270 patients who underwent cardiac catheterization for suspected coronary artery disease (CAD) with evaluable maxLCBI in non-culprit vessels and known medical therapy after discharge were followed for 2 years. OMT was defined as the use of a statin and dual antiplatelet therapy (DAPT).

Results: Among the 1270 patients included in this substudy, 1110 (87.7%) had PCI for an index event, and 1014 (80%) patients received OMT. Estimated cumulative incidence functions of NC-MACE did not differ significantly between patients treated with or without OMT (log-rank p-value = 0.876). In patients labeled high risk (maxLCBI > 400), cumulative incidence function also did not differ between patients treated with vs without OMT (log-rank p-value = 0.19).

Conclusions: In the current LRP analysis, we could not identify a beneficial effect of OMT in the reduction of NC-MACE rate, even in patients with high-risk plaques during 24-month follow-up.
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http://dx.doi.org/10.1016/j.carrev.2021.07.015DOI Listing
July 2021

Waksman In-Stent Restenosis Classification: A Mechanism-Based Approach to the Treatment of Restenosis.

Cardiovasc Revasc Med 2021 Dec 5;33:62-67. Epub 2021 Jun 5.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America. Electronic address:

Despite contemporary advances in stent technology, in-stent restenosis (ISR) remains a common issue following percutaneous coronary intervention. A novel classification system based on the underlying mechanism of action of restenosis was recently introduced. The Waksman In-Stent Restenosis Classification characterizes different patterns of ISR to best delineate the type of restenosis and help guide treatment. Intravascular imaging with either intravascular ultrasound or optical coherence tomography allows for real-time evaluation of ISR. We herein provide an illustrative review of the Waksman In-Stent Restenosis Classification.
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http://dx.doi.org/10.1016/j.carrev.2021.06.004DOI Listing
December 2021

Discordance in the diagnostic assessment of vulnerable plaques between radiofrequency intravascular ultrasound versus optical coherence tomography among patients with acute myocardial infarction: insights from the IBIS-4 study.

Int J Cardiovasc Imaging 2021 Oct 8;37(10):2839-2847. Epub 2021 Jul 8.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.

We aimed to evaluate the diagnostic agreement between radiofrequency (RF) intravascular ultrasound (IVUS) and optical coherence tomography (OCT) for thin-cap fibroatheroma (TCFA) in non-infarct-related coronary arteries (non-IRA) in patients with ST-segment elevation myocardial infarction (STEMI). In the Integrated Biomarker Imaging Study (IBIS-4), 103 STEMI patients underwent OCT and RF-IVUS imaging of non-IRA after successful primary percutaneous coronary intervention and at 13-month follow-up. A coronary lesion was defined as a segment with ≥ 3 consecutive frames (≈1.2 mm) with plaque burden ≥ 40% as assessed by grayscale IVUS. RF-IVUS-derived TCFA was defined as a lesion with > 10% confluent necrotic core abutting to the lumen in > 10% of the circumference. OCT-TCFA was defined by a minimum cap thickness < 65 μm. The two modalities were matched based on anatomical landmarks using a dedicated matching software. Using grayscale IVUS, we identified 276 lesions at baseline (N = 146) and follow-up (N = 130). Using RF-IVUS, 208 lesions (75.4%) were classified as TCFA. Among them, OCT identified 14 (6.7%) TCFA, 60 (28.8%) thick-cap fibroatheroma (ThCFA), and 134 (64.4%) non-fibroatheroma. All OCT-TCFA (n = 14) were confirmed as RF-TCFA. The concordance rate between RF-IVUS and OCT for TCFA diagnosis was 29.7%. The reasons for discordance were: OCT-ThCFA (25.8%); OCT-fibrous plaque (34.0%); attenuation due to calcium (23.2%); attenuation due to macrophage (10.3%); no significant attenuation (6.7%). There was a notable discordance in the diagnostic assessment of TCFA between RF-IVUS and OCT. The majority of RF-derived TCFA were not categorized as fibroatheroma using OCT, while all OCT-TCFA were classified as TCFA by RF-IVUS.ClinicalTrials.gov Identifier NCT00962416.
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http://dx.doi.org/10.1007/s10554-021-02272-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8494667PMC
October 2021

Comparison of Quantitative Flow Ratio and Invasive Physiology Indices in a Diverse Population at a Tertiary United States Hospital.

Cardiovasc Revasc Med 2021 11 25;32:1-4. Epub 2021 Jun 25.

Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address:

Background: Quantitative flow ratio (QFR) is a technology to evaluate the coronary stenosis significance on 3-dimensional quantitative coronary angiography. The aim of this study is to evaluate and compare the QFR versus fractional flow reserve (FFR) and/or instantaneous free-wave ratio (iFR) in a US population with a fair African American population representation.

Methods And Results: This was a retrospective, observational and single-center study that enrolled 100 patients who underwent coronary angiography. The diagnostic performance of QFR in terms of sensitivity was 0.80 (95%CI 0.64-0.97) and specificity was 0.95 (95% CI 0.90-1.00), the positive predictive value (PPV) was 0.83 (0.68-0.98), while the negative predictive value (NPV) was 0.94 (0.88-0.99). The overall accuracy was 0.91 and area under the curve (AUC) was 0.92 (95% CI 0.87-0.97). The R-squared was 0.54 and the Bland-Altman plot showed a bias of 0.0016 (SD 0.063) and limits of agreement (LOA): Upper LOA 0.13 and Lower LOA -0.12. In African Americans (n = 33), accuracy, AUC, sensitivity, specificity (94%; 0.90 [0.80-1.00]; 0.90 [0.71-1.00]; 0.96 [0.87-1.00], respectively) were better than those for the overall population.

Conclusions: In a US-based representative population, vessel QFR accuracy and agreement with FFR as reference is high. Diagnostic performance of QFR in African Americans is also excellent.
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http://dx.doi.org/10.1016/j.carrev.2021.06.115DOI Listing
November 2021

Optical coherence tomography and vulnerable plaque detection: how far are we willing to stray from true histology?

Eur Heart J Cardiovasc Imaging 2021 Jul 1. Epub 2021 Jul 1.

Georgetown University, School of Medicine, Washington, DC, USA.

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http://dx.doi.org/10.1093/ehjci/jeab118DOI Listing
July 2021

Seattle Angina Pectoris Questionnaire and Canadian Cardiovascular Society Angina Categories in the Assessment of Total Coronary Atherosclerotic Burden.

Am J Cardiol 2021 08 24;152:43-48. Epub 2021 Jun 24.

Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil; Insituto Prevent Senior, Sao Paulo, Brazil. Electronic address:

The patient reported angina measurement with the Seattle Angina Questionnaire (SAQ) has shown to have prognostic implications and became an endpoint in clinical trials. Our objective was to study physician-reported and SAQ severity with the total coronary atherosclerotic burden as assessed by 4 angiographic scores. We prospectively analyzed data of consecutive patients scheduled for coronary angiography or percutaneous coronary intervention. The Canadian Cardiovascular Society (CCS) angina categories was used as physician-reported angina. SAQ domains were categorized as severe (0 to 24), moderate 25 to 75 and mild angina (>75). All angina assessments were done before coronary angiography. Gensini, Syntax, Friesinger, and Sullivan angiographic scores were used for total atherosclerotic burden quantification: 261 patients were included in the present analysis. The median age was 66.0 (59.0 to 71.8) years, 53.6% were male and 43.7% had diabetes. The median SYNTAX score was 6.0 (0 to 18.0). The worse the symptoms of CCS categories, the more severe was the atherosclerotic burden in all angiographic scores: SYNTAX (p = 0.01); Gensini (p <0.01); Friesinger (p = 0.02) and Sullivan (p = 0.03). Conversely, SAQ domains were not able to discriminate the severity of CAD in any of the scores. The only exception was the severe SAQ quality of life that had worse Gensini score than the mild SAQ quality of life (p = 0.04). In conclusion, CCS angina categories are related to the total atherosclerotic burden in coronary angiography, by all angiographic scores. SAQ domains should be used as a measure of patient functionality and quality of life but not as a measure of CAD severity.
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http://dx.doi.org/10.1016/j.amjcard.2021.04.029DOI Listing
August 2021

Can Cocaine Use Cause Myocardial Infarction?

JACC Cardiovasc Interv 2021 06;14(12):1383

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http://dx.doi.org/10.1016/j.jcin.2021.04.029DOI Listing
June 2021

Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-Risk Patients With Severe Aortic Stenosis.

JACC Cardiovasc Interv 2021 06;14(11):1169-1180

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address:

Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (<65 years), low-risk patients. Unanswered questions remain, including the safety and effectiveness of TAVR in patients with bicuspid aortic valves; future coronary access; durability of transcatheter heart valves; technical considerations for surgical transcatheter heart valve explantation; management of concomitant conditions such as aortopathy, mitral valve disease, and coronary artery disease; and the safety and feasibility of future TAVR-in-TAVR. The authors predict that balancing these questions with patients' clear preference for less invasive treatment will become common. In this paper, the authors consider each of these questions and discuss risks and benefits of theoretical treatment strategies in the lifetime management of young patients with severe aortic stenosis.
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http://dx.doi.org/10.1016/j.jcin.2021.03.058DOI Listing
June 2021

PRospective Observational registry evaluating the Safety and Effectiveness of Orsiro Stent in Chilean patients - ROSES registry.

Cardiovasc Revasc Med 2021 May 27. Epub 2021 May 27.

San Borja Arriarán Hospital & University of Chile, Santiago, Chile. Electronic address:

Background: There is little information of the performance of the new generation of stents with bioabsorbable polymers in the Latin-American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers.

Methods: We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers. The primary endpoint was defined as the composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization at 1-year follow-up.

Results: From April 2017 to February 2019, n = 520 patients were enrolled in the registry, more frequently male (74.6%), with a mean age of 62.7 ± 10.8 years-old and a high prevalence of diabetes (40.2%). The clinical presentation was stable angina in 41.1% (n = 214), acute MI in 52.5% (n = 167 [32.1%] ST-elevation MI and n = 106 [20.4%] non-ST-elevation MI) and unstable angina in 6.3% (n = 33). Of 610 treated lesions, 425 (69.7%) were ACC/AHA type B or C lesions. Device and procedural success were achieved in 99.4% and 98.7% of the patients, respectively. The primary endpoint of the study occurred in 4%, primary driven by cardiac death.

Conclusions: The results of the ROSES multicenter registry indicated good clinical outcomes of BPSES Orsiro in all-comers Latin-American patients undergoing PCI, despite the high-risk patients and treated lesions.
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http://dx.doi.org/10.1016/j.carrev.2021.05.022DOI Listing
May 2021

Drug-Coated Balloons for Coronary Artery Disease: First New-Generation Comparison of a Non-Widespread Technology.

Cardiovasc Revasc Med 2021 07 3;28:7-8. Epub 2021 Jun 3.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, D.C., USA. Electronic address:

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http://dx.doi.org/10.1016/j.carrev.2021.05.024DOI Listing
July 2021
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