28 research outputs found
Usefulness of the Hybrid RFR-FFR Approach: Results of a Prospective and Multicenter Analysis of Diagnostic Agreement between RFR and FFRâThe RECOPA (REsting Full-Cycle Ratio Comparation versus Fractional Flow Reserve (A Prospective Validation)) Study
Cardiologia; Estudi fisiolĂČgic; EspanyaCardiologĂa; Estudio fisiolĂłgico; EspañaCardiology; Physiological study; SpainBackground. The resting fullâcycle ratio (RFR) is a novel resting index which in contrast to the gold standard (fractional flow reserve (FFR)) does not require maximum hyperemia induction. The objectives of this study were to evaluate the agreement between RFR and FFR with the currently recommended thresholds and to design a hybrid RFR-FFR ischemia detection strategy, allowing a reduction of coronary vasodilator use. Materials and Methods. Patients subjected to invasive physiological study in 9 Spanish centers were prospectively recruited between April 2019 and March 2020. Sensitivity and specificity studies were made to assess diagnostic accuracy between the recommended levels of RFR â€0.89 and FFR â€0.80 (primary objective) and to determine the RFR âgrey zoneâ in order to define a hybrid strategy with FFR affording 95% global agreement compared with FFR alone (secondary objective). Results. A total of 380 lesions were evaluated in 311 patients. Significant correlation was observed (R2â=â0.81; ) between the two techniques, with 79% agreement between RFRââ€â0.89 and FFRââ€â0.80 (positive predictive value, 68%, and negative predictive value, 80%). The hybrid RFR-FFR strategy, administering only adenosine in the âgrey zoneâ (RFR: 0.86 to 0.92), exhibited an agreement of over 95% with FFR, with high predictive values (positive predictive value, 91%, and negative predictive value, 92%), reducing the need for vasodilators by 58%. Conclusions. Dichotomous agreement between RFR and FFR with the recommended thresholds is significant but limited. The adoption of a hybrid RFR-FFR strategy affords very high agreement, with minimization of vasodilator use
Coronary EndotheliumâDependent Vasomotor Function After DrugâEluting Stent and Bioresorbable Scaffold Implantation
Infarto de miocardio; DisfunciĂłn endotelial; TomografĂa de coherencia ĂłpticaMyocardial infarction; Endothelial dysfunction; Optical coherence tomographyInfart de miocardi; DisfunciĂł endotelial; Tomografia de coherĂšncia ĂČpticaBackground
Early generation drugâeluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endotheliumâdependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the deviceârelated endothelial function of current devices and to correlate neointima healing with endothelial function.
Methods and Results
A total of 206 patients from 4 randomized trials treated with the durableâpolymer everolimusâeluting Xience (n=44), bioresorbableâpolymer sirolimusâeluting Orsiro (n=35), polymerâfree biolimusâeluting Biofreedom (n=24), bioactive endothelialâprogenitor cellâcapturing sirolimusâeluting Combo DES (n=25), polymerâbased everolimusâeluting Absorb (n=44), and Mgâbased sirolimusâeluting Magmaris BRS (n=34) underwent endotheliumâdependent vasomotor tests and optical coherence tomography imaging, as per protocol, at followâup. Crude vasomotor responses of distal segments to lowâdose acetylcholine (10â6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (â8.4%±12.6%) and durableâpolymer DES had the most physiologic (â0.4%±11.8%; P=0.014). Highâdose acetylcholine (10â4 mol/L) showed similar responses between groups (ranging from â10.8%±11.6% to â18.1%±15.4%; P=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbableâpolymer DES) to 2.5%±4.5% (bioactive DES; P=0.056). In multivariate models, endotheliumâdependent vasomotor response was associated with age, bioresorbableâpolymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as â„4% vasoconstriction) was observed in 46.6% of patients with lowâdose and 68.9% with highâdose acetylcholine, without differences between groups.
Conclusions
At followâup, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.The source funding of the 4 randomized trials included in this study is the following. The BVSâFLOW trial (Coronary vasomotor function and myocardial flow with bioresorbable vascular scaffolds or everolimusâeluting metallic stents: a randomised trial) was funded by a grant of âLa Maratoâ Foundation. The Spanish Heart Foundation funded the REâTROFI2 (LongâTerm Coronary Functional Assessment of the InfarctâRelated Artery Treated With EverolimusâEluting Bioresorbable Scaffolds or EverolimusâEluting Metallic Stents: Insights of the TROFI II Trial) and MAGSTEMI (MagnesiumâBased Resorbable Scaffold Versus Permanent Metallic SirolimusâEluting Stent in Patients With STâSegment Elevation Myocardial Infarction) trials. The FUNCOMBO (Coronary endothelial and microvascular function distal to polymerâfree and endothelial cellâcapturing drugâeluting stents) trial was funded by OrbusNeich and was promoted by the Spanish Heart Foundation
Ajustando RFR por Preditores de DiscordĂąncia, âThe Adjusted RFRâ: Uma Metodologia Alternativa para Melhorar a Capacidade DiagnĂłstica de Ăndices Coronarianos
Background: Cutoff thresholds for the "resting full-cycle ratio" (RFR) oscillate in different series, suggesting that population characteristics may influence them. Likewise, predictors of discordance between the RFR and fractional flow reserve (FFR) have been documented. The RECOPA Study showed that diagnostic capacity is reduced in the RFR "grey zone", requiring the performance of FFR to rule out or confirm ischemia.
Objectives: To determine predictors of discordance, integrate the information they provide in a clinical-physiological index, the "Adjusted RFR", and compare its agreement with the FFR.
Methods: Using data from the RECOPA Study, predictors of discordance with respect to FFR were determined in the RFR "grey zone" (0.86 to 0.92) to construct an index ("Adjusted RFR") that would weigh RFR together with predictors of discordance and evaluate its agreement with FFR.
Results: A total of 156 lesions were evaluated in 141 patients. Predictors of discordance were: chronic kidney disease, previous ischemic heart disease, lesions not involving the anterior descending artery, and acute coronary syndrome. Though limited, the "Adjusted RFR" improved the diagnostic capacity compared to the RFR in the "grey zone" (AUC-RFR = 0.651 versus AUC-"Adjusted RFR" = 0.749), also showing an improvement in all diagnostic indices when optimal cutoff thresholds were established (sensitivity: 59% to 68%; specificity: 62% to 75%; diagnostic accuracy: 60% to 71%; positive likelihood ratio: 1.51 to 2.34; negative likelihood ratio: 0.64 to 0.37).
Conclusions: Adjusting the RFR by integrating the information provided by predictors of discordance to obtain the "Adjusted RFR" improved the diagnostic capacity in our population. Further studies are required to evaluate whether clinical-physiological indices improve the diagnostic capacity of RFR or other coronary indices.Fundamento: Os limiares de corte para a ârelação do ciclo completo de repousoâ (RFR) oscilam em diferentes sĂ©ries, sugerindo que as caracterĂsticas da população podem influenciĂĄ-los. Da mesma forma, foram documentados preditores de discordĂąncia entre a RFR e a reserva de fluxo fracionado (FFR). O Estudo RECOPA, mostrou que a capacidade diagnĂłstica estĂĄ reduzida na âzona cinzentaâ da RFR, tornando necessĂĄria a realização de FFR para descartar ou confirmar isquemia.
Objetivos: Determinar os preditores de discordĂąncia, integrar as informaçÔes que eles fornecem em um Ăndice clĂnico-fisiolĂłgico: a âRFR Ajustadaâ, e comparar sua concordĂąncia com o FFR.
MĂ©todos: Usando dados do Estudo RECOPA, os preditores de discordĂąncia em relação Ă FFR foram determinados na âzona cinzentaâ da RFR (0,86 a 0,92) para construir um Ăndice (âRFR Ajustadaâ) que pesaria a RFR juntamente com os preditores de discordĂąncia e avaliar sua concordĂąncia com a FFR.
Resultados: Foram avaliadas 156 lesĂ”es em 141 pacientes. Os preditores de discordĂąncia foram: doença renal crĂŽnica, cardiopatia isquĂȘmica prĂ©via, lesĂ”es nĂŁo envolvendo a artĂ©ria descendente anterior esquerda e sĂndrome coronariana aguda. Embora limitada, a âRFR Ajustadaâ melhorou a capacidade diagnĂłstica em comparação com a RFR na âzona cinzentaâ (AUC-RFR = 0,651 versus AUC-âRFR Ajustadaâ = 0,749), mostrando tambĂ©m uma melhora em todos os Ăndices diagnĂłsticos quando foram estabelecidos limiares de corte otimizados (sensibilidade: 59% a 68%; especificidade: 62% a 75%; acurĂĄcia diagnĂłstica: 60% a 71%; razĂŁo de verossimilhança positiva: 1,51 a 2,34; razĂŁo de verossimilhança negativa: 0,64 a 0,37).
ConclusĂ”es: Ajustar a RFR integrando as informaçÔes fornecidas pelos preditores de discordĂąncia para obter a âRFR Ajustadaâ melhorou a capacidade diagnĂłstica em nossa população. Mais estudos sĂŁo necessĂĄrios para avaliar se os Ăndices clĂnico-fisiolĂłgicos melhoram a capacidade diagnĂłstica da RFR ou de outros Ăndices coronarianos
Clinical follow-up of long nontapered sirolimus-eluting coronary stent in real-world patients with de novo lesions. The Billar registry
Introduction and objectives: Coronary lesions with stent overlapping are associated with higher neointimal proliferation that leads to more restenosis. Furthermore, the tapering of coronary arteries is a major challenge when treating long coronary lesions. This study attempted to assess the safety and clinical level of performance of long nontapered sirolimus-eluting coronary stent systems (> 36 mm) to treat long and diffused de novo coronary lesions in real-world scenarios. Methods: This was a prospective, non-randomized, multicentre study that included 696 consecutive patients treated with the long nontapered BioMime sirolimus-eluting coronary stent system in long and diffused de novo coronary lesions. The safety endpoint was major adverse cardiovascular events defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, and major bleeding at the 12-month follow-up. Results: Of a total of 696 patients, 38.79% were diabetic. The mean age of all the patients was 64.6 +/- 14 years, and 80% were males. The indication for revascularization was acute coronary syndrome in 63.1%. A total of 899 lesions were identified out of which 742 were successfully treated with long BioMime stents (37 mm, 40 mm, 44 mm, and 48 mm). The cumulative incidence of major adverse cardiovascular events was 8.1% at the 12-month follow-up including cardiac death (2.09%), myocardial infarction (1.34%), and total stent thrombosis (0.5%). Conclusions: This study confirms the safety and good performance of long nontapered BioMime coronary stents to treat de novo coronary stenosis. Therefore, it can be considered a safe and effective treatment for long and diffused de novo coronary lesions in the routine clinical practice
Predictive Value of Cardiac Magnetic Resonance Feature Tracking after Acute Myocardial Infarction: A Comparison with Dobutamine Stress Echocardiography
[EN] In acute ST-segment elevation myocardial infarction (STEMI) late gadolinium enhancement (LGE) may underestimate segmental functional recovery. We evaluated the predictive value of cardiac magnetic resonance (CMR) feature-tracking (FT) for functional recovery and whether it incremented the value of LGE compared to low-dose dobutamine stress echocardiography (LDDSE) and speckle-tracking echocardiography (STE). Eighty patients underwent LDDSE and CMR within 5-7 days after STEMI and segmental functional recovery was defined as improvement in wall-motion at 6-months CMR. Optimal conventional and FT parameters were analyzed and then also applied to an external validation cohort of 222 STEMI patients. Circumferential strain (CS) was the strongest CMR-FT predictor and addition to LGE increased the overall accuracy to 74% and was especially relevant in segments with 50-74% LGE (AUC 0.60 vs. 0.75, p = 0.001). LDDSE increased the overall accuracy to 71%, and in the 50-74% LGE subgroup improved the AUC from 0.60 to 0.69 (p = 0.039). LGE + CS showed similar value as LGE + LDDSE. In the validation cohort, CS was also the strongest CMR-FT predictor of recovery and addition of CS to LGE improved overall accuracy to 73% although this difference was not significant (AUC 0.69, p = 0.44). Conclusion: CS is the strongest CMR-FT predictor of segmental functional recovery after STEMI. Its incremental value to LGE is comparable to that of LDDSE whilst avoiding an inotropic stress agent. CS is especially relevant in segments with 50-74% LGE where accuracy is lower and further testing is frequently required to clarify the potential for recovery.This research was supported by the Instituto de Salud Carlos III and co-funded by Fondo Europeo de Desarrollo Regional (FEDER) (grant numbers PI17/01836 and CIBERCV16/11/00486). JG and DM acknowledge financial support from the "Agencia Valenciana de la Innovacion, Generalitat Valenciana" (grant) and from the "Conselleria d'Educacio, Investigacio, Cultura i Esport, Generalitat Valenciana" (grant number AEST/2019/037).Valente, FX.; Gavara-Doñate, J.; Gutiérrez, L.; Rios-Navarro, C.; Rello, P.; Maymi, M.; Fernandez-Galera, R.... (2021). Predictive Value of Cardiac Magnetic Resonance Feature Tracking after Acute Myocardial Infarction: A Comparison with Dobutamine Stress Echocardiography. Journal of Clinical Medicine. 10(22):1-12. https://doi.org/10.3390/jcm10225261S112102
Predictive Value of Cardiac Magnetic Resonance Feature Tracking after Acute Myocardial Infarction: A Comparison with Dobutamine Stress Echocardiography
EcocardiografĂa de seguimiento de manchas; DeformaciĂłn del miocardio; Seguimiento de caracterĂsticas de resonancia magnĂ©tica cardĂacaSpeckle-tracking echocardiography; Myocardial deformation; Cardiac magnetic resonance feature-trackingEcocardiografia de seguiment de taques; DeformaciĂł del miocardi; Seguiment de caracterĂstiques de ressonĂ ncia magnĂštica cardĂacaIn acute ST-segment elevation myocardial infarction (STEMI) late gadolinium enhancement (LGE) may underestimate segmental functional recovery. We evaluated the predictive value of cardiac magnetic resonance (CMR) feature-tracking (FT) for functional recovery and whether it incremented the value of LGE compared to low-dose dobutamine stress echocardiography (LDDSE) and speckle-tracking echocardiography (STE). Eighty patients underwent LDDSE and CMR within 5â7 days after STEMI and segmental functional recovery was defined as improvement in wall-motion at 6-months CMR. Optimal conventional and FT parameters were analyzed and then also applied to an external validation cohort of 222 STEMI patients. Circumferential strain (CS) was the strongest CMR-FT predictor and addition to LGE increased the overall accuracy to 74% and was especially relevant in segments with 50â74% LGE (AUC 0.60 vs. 0.75, p = 0.001). LDDSE increased the overall accuracy to 71%, and in the 50â74% LGE subgroup improved the AUC from 0.60 to 0.69 (p = 0.039). LGE + CS showed similar value as LGE + LDDSE. In the validation cohort, CS was also the strongest CMR-FT predictor of recovery and addition of CS to LGE improved overall accuracy to 73% although this difference was not significant (AUC 0.69, p = 0.44). Conclusion: CS is the strongest CMR-FT predictor of segmental functional recovery after STEMI. Its incremental value to LGE is comparable to that of LDDSE whilst avoiding an inotropic stress agent. CS is especially relevant in segments with 50â74% LGE where accuracy is lower and further testing is frequently required to clarify the potential for recovery.This research was supported by the Instituto de Salud Carlos III and co-funded by Fondo Europeo de Desarrollo Regional (FEDER) (grant numbers PI17/01836 and CIBERCV16/11/00486). JG and DM acknowledge financial support from the âAgencia Valenciana de la InnovaciĂłn, Generalitat Valencianaâ (grant) and from the âConselleria dâEducaciĂł, InvestigaciĂł, Cultura i Esport, Generalitat Valencianaâ (grant number AEST/2019/037)
Spontaneous reperfusion enhances succinate concentration in peripheral blood from stemi patients but its levels does not correlate with myocardial infarct size or area at risk
Cardiovascular biology; Diagnostic markers; Prognostic markersBiologĂa cardiovascular; Marcadores de diagnĂłstico; Marcadores pronĂłsticosBiologia cardiovascular; Marcadors diagnĂČstics; Marcadors pronĂČsticsSuccinate is enhanced during initial reperfusion in blood from the coronary sinus in ST-segment elevation myocardial infarction (STEMI) patients and in pigs submitted to transient coronary occlusion. Succinate levels might have a prognostic value, as they may correlate with edema volume or myocardial infarct size. However, blood from the coronary sinus is not routinely obtained in the CathLab. As succinate might be also increased in peripheral blood, we aimed to investigate whether peripheral plasma concentrations of succinate and other metabolites obtained during coronary revascularization correlate with edema volume or infarct size in STEMI patients. Plasma samples were obtained from peripheral blood within the first 10 min of revascularization in 102 STEMI patients included in the COMBAT-MI trial (initial TIMI 1) and from 9 additional patients with restituted coronary blood flow (TIMI 2). Metabolite concentrations were analyzed by 1H-NMR. Succinate concentration averaged 0.069â±â0.0073 mmol/L in patients with TIMI flowââ€â1 and was significantly increased in those with TIMI 2 at admission (0.141â±â0.058 mmol/L, pâ<â0.05). However, regression analysis did not detect any significant correlation between most metabolite concentrations and infarct size, extent of edema or other cardiac magnetic resonance (CMR) variables. In conclusion, spontaneous reperfusion in TIMI 2 patients associates with enhanced succinate levels in peripheral blood, suggesting that succinate release increases overtime following reperfusion. However, early plasma levels of succinate and other metabolites obtained from peripheral blood does not correlate with the degree of irreversible injury or area at risk in STEMI patients, and cannot be considered as predictors of CMR variables.
Trial registration: Registered at www.clinicaltrials.gov (NCT02404376) on 31/03/2015. EudraCT number: 2015-001000-58.This work was supported by the Spanish Ministry of Economy and Competitiveness, Instituto de Salud Carlos III (Grants PI17/01397 and CIBERCV) and the Spanish Society of Cardiology (Proyectos de la FEC para InvestigaciĂłn BĂĄsica en CardiologĂa 2018, Sociedad Española de CardiologĂa), and was cofinanced by the European Regional Development Fund (ERDF-FEDER, a way to build Europe). Antonio RodrĂguez-Sinovas has a consolidated Miguel Servet contract
Genetic association study of coronary collateral circulation in patients with coronary artery disease using 22 single nucleotide polymorphisms corresponding to 10 genes involved in postischemic neovascularization
Background: collateral growth in patients with coronary artery disease (CAD) is highly heterogeneous. Although multiple factors are thought to play a role in collateral development, the contribution of genetic factors to coronary collateral circulation (CCC) is largely unknown. The goal of this study was to assess whether functional single nucleotide polymorphisms (SNPs) in genes involved in vascular growth are associated with CCC. Methods: 677 consecutive CAD patients were enrolled in the study and their CCC was assessed by the Rentrop method. 22 SNPs corresponding to 10 genes involved in postischemic neovascularization were genotyped and multivariate logistic regression models were adjusted using clinically relevant variables to estimate odds ratios and used to examine associations of allelic variants, genotypes and haplotypes with CCC. Results: statistical analysis showed that the HIF1A rs11549465 and rs2057482; VEGFA rs2010963, rs1570360, rs699947, rs3025039 and rs833061; KDR rs1870377, rs2305948 and rs2071559; CCL2 rs1024611, rs1024610, rs2857657 and rs2857654; NOS3 rs1799983; ICAM1 rs5498 and rs3093030; TGFB1 rs1800469; CD53 rs6679497; POSTN rs3829365 and rs1028728; and LGALS2 rs7291467 polymorphisms, as well as their haplotype combinations, were not associated with CCC (pâ<â0.05). Conclusions: we could not validate in our cohort the association of the NOS3 rs1799983, HIF1A rs11549465, VEGFA rs2010963 and rs699947, and LGALS2 rs7291467 variants with CCC reported by other authors. A validated SNP-based genome-wide association study is required to identify polymorphisms influencing CCC
Ajustando a RFR por Preditores de DiscordĂąncia, âA RFR Ajustadaâ: Uma Metodologia Alternativa para Melhorar a Capacidade DiagnĂłstica dos Ăndices Coronarianos
Angina de pecho; Reserva de flujo fraccional; SensibilidadAngina de pit; Reserva de flux fraccionari; SensibilitatAngina; Fractional flow reserve; SensitivityBackground
Cutoff thresholds for the âresting full-cycle ratioâ (RFR) oscillate in different series, suggesting that population characteristics may influence them. Likewise, predictors of discordance between the RFR and fractional flow reserve (FFR) have been documented. The RECOPA Study showed that diagnostic capacity is reduced in the RFR âgrey zoneâ, requiring the performance of FFR to rule out or confirm ischemia.
Objectives
To determine predictors of discordance, integrate the information they provide in a clinical-physiological index, the âAdjusted RFRâ, and compare its agreement with the FFR.
Methods
Using data from the RECOPA Study, predictors of discordance with respect to FFR were determined in the RFR âgrey zoneâ (0.86 to 0.92) to construct an index (âAdjusted RFRâ) that would weigh RFR together with predictors of discordance and evaluate its agreement with FFR.
Results
A total of 156 lesions were evaluated in 141 patients. Predictors of discordance were: chronic kidney disease, previous ischemic heart disease, lesions not involving the anterior descending artery, and acute coronary syndrome. Though limited, the âAdjusted RFRâ improved the diagnostic capacity compared to the RFR in the âgrey zoneâ (AUC-RFR = 0.651 versus AUC-âAdjusted RFRâ = 0.749), also showing an improvement in all diagnostic indices when optimal cutoff thresholds were established (sensitivity: 59% to 68%; specificity: 62% to 75%; diagnostic accuracy: 60% to 71%; positive likelihood ratio: 1.51 to 2.34; negative likelihood ratio: 0.64 to 0.37).
Conclusions
Adjusting the RFR by integrating the information provided by predictors of discordance to obtain the âAdjusted RFRâ improved the diagnostic capacity in our population. Further studies are required to evaluate whether clinical-physiological indices improve the diagnostic capacity of RFR or other coronary indices
Coronary EndotheliumâDependent Vasomotor Function After DrugâEluting Stent and Bioresorbable Scaffold Implantation
Background Early generation drug-eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium-dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device-related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable-polymer everolimus-eluting Xience (n=44), bioresorbable-polymer sirolimus-eluting Orsiro (n=35), polymer-free biolimus-eluting Biofreedom (n=24), bioactive endothelial-progenitor cell-capturing sirolimus-eluting Combo DES (n=25), polymer-based everolimus-eluting Absorb (n=44), and Mg-based sirolimus-eluting Magmaris BRS (n=34) underwent endothelium-dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow-up. Crude vasomotor responses of distal segments to low-dose acetylcholine (10-6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (-8.4%±12.6%) and durable-polymer DES had the most physiologic (-0.4%±11.8%; P=0.014). High-dose acetylcholine (10-4 mol/L) showed similar responses between groups (ranging from -10.8%±11.6% to -18.1%±15.4%; P=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable-polymer DES) to 2.5%±4.5% (bioactive DES; P=0.056). In multivariate models, endothelium-dependent vasomotor response was associated with age, bioresorbable-polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as â„4% vasoconstriction) was observed in 46.6% of patients with low-dose and 68.9% with high-dose acetylcholine, without differences between groups. Conclusions At follow-up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction