The hemodynamic influence of vessel shape such as bifurcation angle is not fully understood with ... more The hemodynamic influence of vessel shape such as bifurcation angle is not fully understood with clinical and quantitative observations being equivocal. The aim of this study is to use computational modeling to study the hemodynamic effect of shape characteristics, in particular bifurcation angle (BA), for non-stented and stented coronary arteries. Nine bifurcations with angles of 40°, 60° and 80°, representative of ±1 SD of 101 asymptomatic computed tomography angiogram cases (average age 54±8 years; 57 females), were generated for (1) a non-stented idealized, (2) stented idealized, and (3) non-stented patient-specific geometry. Only the bifurcation angle was changed while the geometries were constant to eliminate flow effects induced by other vessel shape characteristics. The commercially available Biomatrix stent was used as a template and virtually inserted into each branch, simulating the T-stenting technique. Three patient-specific geometries with additional shape variation an...
Catheterization and Cardiovascular Interventions, 2011
The Szabo technique has been described as a method to ensure accurate ostial stent placement. We ... more The Szabo technique has been described as a method to ensure accurate ostial stent placement. We sought to investigate this novel technique in detail both in vitro and in vivo. The technique was subjected to bench testing and also undertaken in 26 patients. Each step was recorded with cine angiography and the stents imaged by microcomputed tomography. The ostial LAD was treated in 81% and a DES was implanted in 92%. Angiographic success was 88.5% (one case of stent dislodgement). Repeat angiography was performed in 78% and restenosis observed in two patients. MACE rate at 15.5 ± 5.1 months was 13% (1 TLR, 1 MI, 1 cardiac death). Despite a seemingly excellent immediate angiographic result, we report one case of restenosis at follow up and one case of IVUS examination (performed in four patients) in which significant stent protrusion, into the proximal main vessel, was observed. In vitro bench testing confirmed a significant and asymmetric (carina side) stent protrusion into the main branch, with the last cell of the stent undergoing significant deformation. The Szabo technique is not a precise technique to implant a stent at the level of the ostium. The proximal end of the stent undergoes significant and asymmetric deformation, protruding into main branch. Additional concerns with this complex technique include the potential for stent damage or contamination before implantation and the risk of stent dislodgement. We conclude that there are more disadvantages than benefits to this technique which only partially addresses the difficulties encountered in the treating ostial lesions.
Current generation of drug-eluting stents has significantly improved the outcomes of percutaneous... more Current generation of drug-eluting stents has significantly improved the outcomes of percutaneous coronary intervention by substantially reducing in-stent restenosis and stent thrombosis. However, a potential limitation of these stents is the permanent presence of a metallic foreign body within the artery, which may cause vascular inflammation, restenosis, thrombosis, and neoatherosclerosis. The permanent stents also indefinitely impair the physiological vasomotor function of the vessel and future potential of grafting the stented segment. Bioresorbable scaffolds (BRSs) have the potential to overcome these limitations as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage and restoring pulsatility, cyclical strain, physiological shear stress, andmechanotransduction.While anumberofBRSs are underdevelopment, two devices with substantial clinical data have already received a Conformité Européenne marking. This review article presents the c...
Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adv... more Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adverse clinical outcome. The purpose of this study was to evaluate the impact of stent design on wall shear stress (WSS), time average WSS, and WSS gradient (WSSG), in idealized stent geometries using computational fluid dynamics. Strut spacing, thickness, luminal protrusion, and malapposition were systematically investigated and a comparison made between two commercially available stents (Omega and Biomatrix). Narrower strut spacing led to larger areas of adverse low WSS and high WSSG but these effects were mitigated when strut size was reduced, particularly for WSSG. Local hemodynamics worsened with luminal protrusion of the stent and with stent malapposition, adverse high WSS and WSSG were identified around peak flow and throughout the cardiac cycle respectively. For the Biomatrix stent, the adverse effect of thicker struts was mitigated by greater strut spacing, radial cell offset and ...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 18, 2016
The aim of this study was to define the shape variations, including diameters and angles, of the ... more The aim of this study was to define the shape variations, including diameters and angles, of the major coronary artery bifurcations. Computed tomographic angiograms from 300 adults with a zero calcium score and no stenoses were segmented for centreline and luminal models. A computational atlas was constructed enabling automatic quantification of 3D angles, diameters and lengths of the coronary tree. The diameter (mean±SD) of the left main coronary was 3.5±0.8 mm and the length 10.5±5.3 mm. The left main bifurcation angle (distal angle or angle B) was 89±21° for cases with, and 75±23° for those without an intermediate artery (p<0.001). Analogous measurements of diameter and angle were tabulated for the other major bifurcations (left anterior descending/diagonal, circumflex/obtuse marginal and right coronary crux). Novel 3D angle definitions are proposed and analysed. A computational atlas of normal coronary artery anatomy provides distributions of diameter, lengths and bifurcation...
Eurointervention Journal of Europcr in Collaboration With the Working Group on Interventional Cardiology of the European Society of Cardiology, Nov 1, 2010
We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first... more We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 15, 2015
Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES... more Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoint...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 2, 2018
This is a consensus document from the European Bifurcation Club concerning bench testing in coron... more This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 8, 2017
To confirm clinically that coronary balloon catheter tips may be damaged during bifurcation treat... more To confirm clinically that coronary balloon catheter tips may be damaged during bifurcation treatment with side-branch access through the side of a stent. On the bench, we aimed to assess the susceptibility of different balloon designs to damage. We compared catheter tip widths. We tested whether balloon tip flaring can cause stent distortion. We had observed that balloon catheters that failed to cross to a side-branch frequently exhibited tip damage. We examined microscopically for damage 82 balloon tips after clinical side-branch access. In a bench study, the forces required to compress catheter tips 0.5 mm were compared to assess susceptibility to damage. We compared tip widths of balloons of different nominal inflation diameters. We examined stents after side-branch access for distortion. In 42 of 48 (88%) of balloon tips from patients with resistance to or failure to cross through the side of a stent there was tip damage. Even when the balloon crossed without perceptible resist...
The ideal stent must fulfil a broad range of technical requirements. Stents must be securely crim... more The ideal stent must fulfil a broad range of technical requirements. Stents must be securely crimped onto the delivery balloon and, in this form, must have a low profile and be sufficiently flexible to facilitate deliverability to the lesion site without distortion or displacement. Following expansion, stents must exert sufficient radial force on the vessel wall to overcome lesion resistance and elastic recoil. To achieve an optimal lumen diameter, the lesion must be uniformly and adequately scaffolded, with minimal tissue prolapse between struts but without compromising side-branch access. Furthermore, the deployed stent must conform to the vessel curvature to minimise vessel distortion, particularly at the stent edges. Radio-opacity is also important to guide safe positioning, adequate deployment and postdilataion and to permit assessment of optimal stent expansion. Equally though, the stent lumen must also be sufficiently visible to allow radiographic assessment of flow dynamics ...
The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure ... more The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure (BP)-lowering efficacy of externally delivered focused ultrasound for renal denervation (RDN). Nonrandomized, first proof-of-concept study and experimental evidence suggested that noninvasive techniques of RDN emerged as an alternative approach of RDN to invasive technologies. WAVE IV, an international, randomized (1 : 1) sham-controlled, double-blind prospective clinical study, was prematurely stopped. Patients were enrolled if office BP was at least 160 mmHg and 24-h ambulatory BP was at least 135 mmHg, while taking three or more antihypertensive medications. The treatment consisted of bilateral RDN using therapeutic levels of ultrasound energy and the sham consisted of bilateral application of diagnostic levels of ultrasound energy. In the 81 treated patients neither changes in office BP at 12 and 24 weeks, nor changes in 24-h ambulatory BP at 24-week follow-up visit differed between ...
Journal of the American College of Cardiology, Jan 12, 2017
Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) imp... more Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes. This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters). TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and ...
As the indications for transcatheter aortic valve implantation (TAVI) have expanded, so to have t... more As the indications for transcatheter aortic valve implantation (TAVI) have expanded, so to have the demands on interventionists to allow as many patients to access this technology as possible. We retrospectively reviewed our TAVI database for patients who had received a 29mm SAPIEN 3 valve despite having an annular area greater than the manufacturer-recommended upper limit of 683mm2, as determined by multi-detector computed tomography (MDCT). Procedural and inpatient outcome data were collected. The study population was 5 of 121 patients receiving a SAPIEN 3 valve since it became available in March 2015. Their annular area ranged from 691 to 800mm2. Valve deployment was successful in all patients. The deployment balloon volume was nominal, except for an additional 1ml in one patient. No patient had a new indication for permanent pacing, and no significant valvular or paravalvular regurgitation (PVR) was identified on post-procedure transthoracic echocardiography. All patients surviv...
The hemodynamic influence of vessel shape such as bifurcation angle is not fully understood with ... more The hemodynamic influence of vessel shape such as bifurcation angle is not fully understood with clinical and quantitative observations being equivocal. The aim of this study is to use computational modeling to study the hemodynamic effect of shape characteristics, in particular bifurcation angle (BA), for non-stented and stented coronary arteries. Nine bifurcations with angles of 40°, 60° and 80°, representative of ±1 SD of 101 asymptomatic computed tomography angiogram cases (average age 54±8 years; 57 females), were generated for (1) a non-stented idealized, (2) stented idealized, and (3) non-stented patient-specific geometry. Only the bifurcation angle was changed while the geometries were constant to eliminate flow effects induced by other vessel shape characteristics. The commercially available Biomatrix stent was used as a template and virtually inserted into each branch, simulating the T-stenting technique. Three patient-specific geometries with additional shape variation an...
Catheterization and Cardiovascular Interventions, 2011
The Szabo technique has been described as a method to ensure accurate ostial stent placement. We ... more The Szabo technique has been described as a method to ensure accurate ostial stent placement. We sought to investigate this novel technique in detail both in vitro and in vivo. The technique was subjected to bench testing and also undertaken in 26 patients. Each step was recorded with cine angiography and the stents imaged by microcomputed tomography. The ostial LAD was treated in 81% and a DES was implanted in 92%. Angiographic success was 88.5% (one case of stent dislodgement). Repeat angiography was performed in 78% and restenosis observed in two patients. MACE rate at 15.5 ± 5.1 months was 13% (1 TLR, 1 MI, 1 cardiac death). Despite a seemingly excellent immediate angiographic result, we report one case of restenosis at follow up and one case of IVUS examination (performed in four patients) in which significant stent protrusion, into the proximal main vessel, was observed. In vitro bench testing confirmed a significant and asymmetric (carina side) stent protrusion into the main branch, with the last cell of the stent undergoing significant deformation. The Szabo technique is not a precise technique to implant a stent at the level of the ostium. The proximal end of the stent undergoes significant and asymmetric deformation, protruding into main branch. Additional concerns with this complex technique include the potential for stent damage or contamination before implantation and the risk of stent dislodgement. We conclude that there are more disadvantages than benefits to this technique which only partially addresses the difficulties encountered in the treating ostial lesions.
Current generation of drug-eluting stents has significantly improved the outcomes of percutaneous... more Current generation of drug-eluting stents has significantly improved the outcomes of percutaneous coronary intervention by substantially reducing in-stent restenosis and stent thrombosis. However, a potential limitation of these stents is the permanent presence of a metallic foreign body within the artery, which may cause vascular inflammation, restenosis, thrombosis, and neoatherosclerosis. The permanent stents also indefinitely impair the physiological vasomotor function of the vessel and future potential of grafting the stented segment. Bioresorbable scaffolds (BRSs) have the potential to overcome these limitations as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage and restoring pulsatility, cyclical strain, physiological shear stress, andmechanotransduction.While anumberofBRSs are underdevelopment, two devices with substantial clinical data have already received a Conformité Européenne marking. This review article presents the c...
Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adv... more Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adverse clinical outcome. The purpose of this study was to evaluate the impact of stent design on wall shear stress (WSS), time average WSS, and WSS gradient (WSSG), in idealized stent geometries using computational fluid dynamics. Strut spacing, thickness, luminal protrusion, and malapposition were systematically investigated and a comparison made between two commercially available stents (Omega and Biomatrix). Narrower strut spacing led to larger areas of adverse low WSS and high WSSG but these effects were mitigated when strut size was reduced, particularly for WSSG. Local hemodynamics worsened with luminal protrusion of the stent and with stent malapposition, adverse high WSS and WSSG were identified around peak flow and throughout the cardiac cycle respectively. For the Biomatrix stent, the adverse effect of thicker struts was mitigated by greater strut spacing, radial cell offset and ...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 18, 2016
The aim of this study was to define the shape variations, including diameters and angles, of the ... more The aim of this study was to define the shape variations, including diameters and angles, of the major coronary artery bifurcations. Computed tomographic angiograms from 300 adults with a zero calcium score and no stenoses were segmented for centreline and luminal models. A computational atlas was constructed enabling automatic quantification of 3D angles, diameters and lengths of the coronary tree. The diameter (mean±SD) of the left main coronary was 3.5±0.8 mm and the length 10.5±5.3 mm. The left main bifurcation angle (distal angle or angle B) was 89±21° for cases with, and 75±23° for those without an intermediate artery (p<0.001). Analogous measurements of diameter and angle were tabulated for the other major bifurcations (left anterior descending/diagonal, circumflex/obtuse marginal and right coronary crux). Novel 3D angle definitions are proposed and analysed. A computational atlas of normal coronary artery anatomy provides distributions of diameter, lengths and bifurcation...
Eurointervention Journal of Europcr in Collaboration With the Working Group on Interventional Cardiology of the European Society of Cardiology, Nov 1, 2010
We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first... more We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 15, 2015
Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES... more Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoint...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 2, 2018
This is a consensus document from the European Bifurcation Club concerning bench testing in coron... more This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 8, 2017
To confirm clinically that coronary balloon catheter tips may be damaged during bifurcation treat... more To confirm clinically that coronary balloon catheter tips may be damaged during bifurcation treatment with side-branch access through the side of a stent. On the bench, we aimed to assess the susceptibility of different balloon designs to damage. We compared catheter tip widths. We tested whether balloon tip flaring can cause stent distortion. We had observed that balloon catheters that failed to cross to a side-branch frequently exhibited tip damage. We examined microscopically for damage 82 balloon tips after clinical side-branch access. In a bench study, the forces required to compress catheter tips 0.5 mm were compared to assess susceptibility to damage. We compared tip widths of balloons of different nominal inflation diameters. We examined stents after side-branch access for distortion. In 42 of 48 (88%) of balloon tips from patients with resistance to or failure to cross through the side of a stent there was tip damage. Even when the balloon crossed without perceptible resist...
The ideal stent must fulfil a broad range of technical requirements. Stents must be securely crim... more The ideal stent must fulfil a broad range of technical requirements. Stents must be securely crimped onto the delivery balloon and, in this form, must have a low profile and be sufficiently flexible to facilitate deliverability to the lesion site without distortion or displacement. Following expansion, stents must exert sufficient radial force on the vessel wall to overcome lesion resistance and elastic recoil. To achieve an optimal lumen diameter, the lesion must be uniformly and adequately scaffolded, with minimal tissue prolapse between struts but without compromising side-branch access. Furthermore, the deployed stent must conform to the vessel curvature to minimise vessel distortion, particularly at the stent edges. Radio-opacity is also important to guide safe positioning, adequate deployment and postdilataion and to permit assessment of optimal stent expansion. Equally though, the stent lumen must also be sufficiently visible to allow radiographic assessment of flow dynamics ...
The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure ... more The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure (BP)-lowering efficacy of externally delivered focused ultrasound for renal denervation (RDN). Nonrandomized, first proof-of-concept study and experimental evidence suggested that noninvasive techniques of RDN emerged as an alternative approach of RDN to invasive technologies. WAVE IV, an international, randomized (1 : 1) sham-controlled, double-blind prospective clinical study, was prematurely stopped. Patients were enrolled if office BP was at least 160 mmHg and 24-h ambulatory BP was at least 135 mmHg, while taking three or more antihypertensive medications. The treatment consisted of bilateral RDN using therapeutic levels of ultrasound energy and the sham consisted of bilateral application of diagnostic levels of ultrasound energy. In the 81 treated patients neither changes in office BP at 12 and 24 weeks, nor changes in 24-h ambulatory BP at 24-week follow-up visit differed between ...
Journal of the American College of Cardiology, Jan 12, 2017
Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) imp... more Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes. This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters). TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and ...
As the indications for transcatheter aortic valve implantation (TAVI) have expanded, so to have t... more As the indications for transcatheter aortic valve implantation (TAVI) have expanded, so to have the demands on interventionists to allow as many patients to access this technology as possible. We retrospectively reviewed our TAVI database for patients who had received a 29mm SAPIEN 3 valve despite having an annular area greater than the manufacturer-recommended upper limit of 683mm2, as determined by multi-detector computed tomography (MDCT). Procedural and inpatient outcome data were collected. The study population was 5 of 121 patients receiving a SAPIEN 3 valve since it became available in March 2015. Their annular area ranged from 691 to 800mm2. Valve deployment was successful in all patients. The deployment balloon volume was nominal, except for an additional 1ml in one patient. No patient had a new indication for permanent pacing, and no significant valvular or paravalvular regurgitation (PVR) was identified on post-procedure transthoracic echocardiography. All patients surviv...
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