Renal denervation for the treatment of ventricular arrhythmias: A systematic review and meta-analysis.

INTRODUCTION: Ventricular arrhythmias (VAs) are a major cause of morbidity and mortality in patients with heart disease. Recent studies evaluated the effect of renal denervation (RDN) on the occurrence of VAs. We conducted a systematic review and meta-analysis to determine the efficacy and safety of this procedure. METHODS AND RESULTS: A systematic search of the literature was performed to identify studies that evaluated the use of RDN for the management of VAs. Primary outcomes were reduction in the number of VAs and implantable cardioverter-defibrillator (ICD) therapies. Secondary outcomes were changes in blood pressure and renal function. Ten studies (152 patients) were included in the meta-analysis. RDN was associated with a reduction in the number of VAs, antitachycardia pacing, ICD shocks, and overall ICD therapies of 3.53 events/patient/month (95% confidence interval [CI] = -5.48 to -1.57), 2.86 events/patient/month (95% CI = -4.09 to -1.63), 2.04 events/patient/month (95% CI = -2.12 to -1.97), and 2.68 events/patient/month (95% CI = -3.58 to -1.78), respectively. Periprocedural adverse events occurred in 1.23% of patients and no significant changes were seen in blood pressure or renal function. CONCLUSIONS: In patients with refractory VAs, RDN was associated with a reduction in the number of VAs and ICD therapies, and was shown to be a safe procedure.

Serial intravascular ultrasound evaluation of the DESolve™ novolimus-eluting bioresorbable coronary scaffold system.

INTRODUCTION: Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. METHODS: Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS: Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm2 vs. 7.35 ± 1.53 mm2 , P < 0.002; and 101.19 ± 20.9 mm3 vs. 118.51 ± 26.6 mm3 , P = 0.001). Late lumen loss was 0.22 ± 0.30 mm at 6 months and 0.33 ± 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow-up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. CONCLUSIONS: IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.

A Randomized Trial of Creatine-kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR-PCI).

OBJECTIVES: To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI). BACKGROUND: Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI. METHODS: From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK-MB) greater than three times the upper limit of normal. RESULTS: The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK-MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial.

IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.

Coronary embolism and calcified aortic valve: is there a correlation?

Coronary artery embolism is an uncommon cause of myocardial infarction. We report a case of acute ST-segment elevation myocardial infarction due to a coronary embolism that originated from a calcified aortic valve. Coronary angiography demonstrated complete occlusion of the left anterior descending coronary artery. Primary percutaneous coronary intervention was successfully performed, with aspiration of the valve tissue and complete restoration of the coronary artery blood flow. This was followed by aortic valve replacement a few days later.

One-year results of the INSPIRE trial with the novel MGuard stent: serial analysis with QCA and IVUS.

BACKGROUND: The newly developed balloon-expandable Mguard stent system, a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS, was conceived to provide embolic protection during PCI of SVG and thrombus-containing lesions. Although the acute results (<30 days) have pointed to the efficacy of this novel device, few is known about its long-term performance. METHODS: The present article address the 1-year clinical results of a cohort of 30 patients enrolled in the INSPIRE trial. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. The primary endpoint (incidence of MACE-composite of cardiac death, nonfatal MI, and TLR) up to 30 days of the procedure has already been published. Secondary endpoints here presented included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined MACE at 1 year. QCA and IVUS were performed by independent corelabs. RESULTS: Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesions had complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0 ± 4.5 mm and 3.0 ± 0.5 mm. The MGuard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with no MACE up to 30 days. At 6 months, in-stent late loss and % of stent obstruction were 1.0 ± 0.4 mm and 28.5 ± 15.6%. Up to 1 year there was no case of cardiac death, two MI (one Q-wave and one non-Q-wave) and six cases of ischemia-driven TLR. Of note, there was no case of definite/probable stent thorombosis. CONCLUSIONS: In this series of patients treated with MGuard stent, the novel device showed no midterm efficacy and safety concerns.

Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions: The iSIGHT Randomized Trial.

[Figure: see text].

Preliminary results of the INSPIRE trial with the novel MGuard stent system containing a protection net to prevent distal embolization.

OBJECTIVE: To assess the efficacy of the MGuard(TM) stent combining a polymer-mesh sleeve attached to the external surface of a bare-metal stent in preventing distal embolization during percutaneous coronary intervention (PCI). BACKGROUND: Distal embolization of thrombus/platelet aggregates is associated with worse immediate and long-term prognosis after PCI. Treatment of saphenous vein graft (SVG) and PCI in the setting of acute coronary syndromes (ACS) is often related to this complication. Although protection and aspiration devices have been shown to reduce distal embolization, they add time and cost to PCI. METHODS: A total of 30 patients were included. Inclusion criteria were de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. Primary endpoint included the incidence of major adverse cardiac events (MACE) (composite of cardiac death, non-fatal myocardial infarction and TLR) up to 30 days of the procedure and TIMI flow right after the PCI. RESULTS: Mean population age was 60.8 years with 36.7% of diabetes. Overall, 53.3% presented with ACS, and most lesions were located in SVG (16 of 30). The majority of lesions had complex morphology including the presence of thrombus (30%) and ulcer (33.3%). The MGuard stent was successfully deployed in all cases with no angiographic/clinical complications including distal embolization. Final TIMI-3/blush-3 were achieved in all cases with no MACE up to 30 days of the procedure. CONCLUSIONS: In this preliminary evaluation, the MGuard device demonstrated excellent performance in a highly complex lesion subset, including absence of angiographic/procedural complications, and no adverse events up to 30-day FU.

The revascular active percutaneous interventional device for coronary total occlusions study.

BACKGROUND: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. METHODS: The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. RESULTS: A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. CONCLUSIONS: The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.

Long-term clinical outcomes of the Drug-Eluting Stents in the Real World (DESIRE) Registry.

BACKGROUND: Recently, cardiologists have treated more complex patients and lesions with drug-eluting stents (DES). However, long-term efficacy and safety of the off-label use of these new devices is yet to be demonstrated. METHODS: The Drug-Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end-point was long-term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years. RESULTS: A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 +/- 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cyphertrade mark was the predominant DES in this registry (83.5%). Mean follow-up time was 2.6 +/- 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6-12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2-5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1-16.7, P < 0.001), and in-stent residual stenosis (HR 14.5; 95% CI, 10.2-17.6, P < 0.001). CONCLUSION: The use of DES in unselected population is associated with long-term safety and effectiveness with acceptable low rates of adverse clinical events.

Anatomical and physiologic assessments in patients with small coronary artery disease: final results of the Physiologic and Anatomical Evaluation Prior to and After Stent Implantation in Small Coronary Vessels (PHANTOM) trial.

BACKGROUND: Patients with small coronary arteries are at high risk for complications after percutaneous coronary intervention (PCI). The objective of our study was to investigate the correlation between angiography, intravascular ultrasound (IVUS), and fractional flow reserve (FFR) in patients with moderate stenoses in small (<2.8 mm) coronary arteries. METHODS AND RESULTS: Sixty consecutive patients, of 800 scheduled for PCI during the study period, were prospectively enrolled in the study. The FFR was measured after a 2-minute infusion of adenosine. For the preprocedural assessments, 60 patients underwent an FFR measurement, 56 underwent an IVUS, and 60 underwent an angiography; for the postprocedural assessments, 22 patients underwent an FFR measurement, 18 underwent an IVUS, and 22 underwent an angiography. The jeopardy score for the target vessel was calculated. Data were analyzed by an independent core laboratory. Patients with an FFR >0.75 were deferred from PCI. Patients were stratified in 2 groups according to their FFR values (< or =0.75 vs >0.75) and were followed for 1 year. Significant (FFR < or =0.75) coronary stenosis was observed in only 35% of the patients. The mean preprocedural FFR values were 0.79 +/- 0.13 for the overall population, 0.64 +/- 0.08 for the patients with an FFR < or =0.75, and 0.87 +/- 0.06 for the patients with an FFR >0.75. There was no correlation between angiography, IVUS, and FFR. The jeopardy score was inversely correlated with FFR (R = -0.32). Only a third of the patients with optimal stenting defined by IVUS achieved an FFR >0.90. After 1 year, 24% of the patients with an FFR < or =0.75 required a repeat PCI. There was no occurrence of myocardial infarction or death, and only 2.6% of the patients deferred from PCI required revascularization. CONCLUSION: Anatomical parameters are limited in determining the hemodynamic significance of small coronary disease. Most moderate stenoses in small coronaries could be safely deferred from PCI based on FFR.

Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels.

BACKGROUND: Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established. OBJECTIVE: We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. METHODS: This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. RESULTS: Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). CONCLUSION: Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Randomized Angiographic and Intravascular Ultrasound Comparison of Dual-Antiplatelet Therapy vs Triple-Antiplatelet Therapy to Reduce Neointimal Tissue Proliferation in Diabetic Patients.

BACKGROUND: Previous studies have suggested a benefit of cilostazol in addition to standard dual-antiplatelet therapy (DAPT), reducing in-stent late luminal loss and restenosis after percutaneous coronary intervention (PCI) with bare-metal and drug-eluting stent (DES) implantation. However, there is a paucity of intravascular ultrasound (IVUS) assessment of neointimal tissue hyperplasia (NIH) after triple-antiplatelet therapy (TAPT), especially in diabetic patients treated with DES. METHODS: This prospective, placebo-controlled trial was conducted in diabetic patients randomized (1:1) to receive either standard DAPT (aspirin and clopidogrel) vs TAPT with cilostazol for a minimum of 12 months after PCI with Endeavor zotarolimus-eluting stent (E-ZES). The primary endpoint was the 9-month comparison of percentage of NIH in both groups. Additionally, we compared in-stent late lumen loss, binary restenosis, major adverse cardiac event (MACE; cardiac death, non-fatal myocardial infarction, and restenosis) rates, and the incidence of vascular/bleeding complications. RESULTS: In total, 133 diabetic patients were enrolled (cilostazol cohort = 65 patients) with 56.4% male and mean age of 60.8 years. Overall, the two cohorts were comparable in terms of baseline clinical and angiographic characteristics, except for the reference vessel diameter, which was smaller among patients randomized to cilostazol (2.48 ± 0.46 mm vs 2.69 ± 0.48 mm; P=.01). At 9 months, there was a non-significant trend toward less percentage of NIH obstruction in the TAPT cohort (33.2 ± 8.29% vs 35.1 ± 8.45%; P=.07). However, this finding did not impact angiographic late-lumen loss (0.60 ± 0.46 mm cilostazol group vs 0.64 ± 0.48 mm control group; P=.30) and binary restenosis (9.8% vs 6.8%; P=.99). MACE rate also did not significantly differ between the cohorts (13.8% cilostazol group vs 8.8% control group; P=.81). Of note, the addition of a third antiplatelet agent did not increase vascular and bleeding complications. CONCLUSION: In diabetic patients treated with E-ZES, TAPT with cilostazol did not add any significant benefit in terms of NIH suppression or MACE reduction.

Impact of the Occlusion Duration on the Performance of J-CTO Score in Predicting Failure of Percutaneous Coronary Intervention for Chronic Total Occlusion.

OBJECTIVES: The present study examined the association between Multicenter CTO Registry in Japan (J-CTO) score in predicting failure of percutaneous coronary intervention (PCI) correlating with the estimated duration of chronic total occlusion (CTO). BACKGROUND: The J-CTO score does not incorporate estimated duration of the occlusion. METHODS: This was an observational retrospective study that involved all consecutive procedures performed at a single tertiary-care cardiology center between January 2009 and December 2014. RESULTS: A total of 174 patients, median age 59.5 years (interquartile range [IQR], 53-65 years), undergoing CTO-PCI were included. The median estimated occlusion duration was 7.5 months (IQR, 4.0-12.0 months). The lesions were classified as easy (score = 0), intermediate (score = 1), difficult (score = 2), and very difficult (score ≥3) in 51.1%, 33.9%, 9.2%, and 5.7% of the patients, respectively. Failure rate significantly increased with higher J-CTO score (7.9%, 20.3%, 50.0%, and 70.0% in groups with J-CTO scores of 0, 1, 2, and ≥3, respectively; P<.001). There was no significant difference in success rate according to estimated duration of occlusion (P=.63). Indeed, J-CTO score predicted failure of CTO-PCI independently of the estimated occlusion duration (P=.24). Areas under receiver-operating characteristic curves were computed and it was observed that for each occlusion time period, the discriminatory capacity of the J-CTO score in predicting CTO-PCI failure was good, with a C-statistic >0.70. CONCLUSION: The estimated duration of occlusion had no influence on the J-CTO score performance in predicting failure of PCI in CTO lesions. The probability of failure was mainly determined by grade of lesion complexity.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

BACKGROUND:: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. OBJECTIVES:: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. METHODS:: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). RESULTS:: All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). CONCLUSIONS:: In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. FUNDAMENTO:: Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. OBJETIVOS:: Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. MÉTODOS:: Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). RESULTADOS:: Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos. A média de idade foi 56,8 ± 7,6 anos, sendo 71,4% da população estudada do sexo masculino e 26,5% composta por diabéticos. Considerando a apresentação clínica, a grande maioria (94%) tinha angina estável ou isquemia silenciosa. Obteve-se sucesso do dispositivo em 100% dos casos e do procedimento, em 96%. A taxa de eventos cardiovasculares maiores foi de 4% aos 30 dias, de 8,2% em 1 ano, e de 12,2% em 2 anos, sem mais eventos até 4,6 anos. Houve 2 casos de trombose (1 subaguda e 1 tardia) até o último seguimento. CONCLUSÕES:: Nesta análise preliminar, o uso do SVB Absorb® mostrou-se seguro e eficaz no seguimento bastante tardio. Faz-se necessário estabelecer o perfil de eficácia e segurança destes dispositivos em cenários de maior complexidade.

Intracoronary ultrasound assessment late after the arterial switch operation for transposition of the great arteries.

OBJECTIVES: This research was undertaken to assess the status of the coronary wall morphology late after the arterial switch operation (ASO) for transposition of the great arteries employing intravascular ultrasound (IVUS). BACKGROUND: Long-term patency of the reimplanted coronary arteries is a key issue after ASO. Follow-up studies have demonstrated coronary obstruction in up to 8% of patients that may be related to progressive fibrocellular intimal thickening. METHODS: Twenty-two asymptomatic children were enrolled at a median age of 9.5 years (range 5 to 22 years); IVUS images were obtained in 20 children at cardiac catheterization 5.0 to 21.6 years after the operation (in two cases IVUS study was not feasible due to technical constraints). Quantitative analysis was performed in 37 coronary arteries involving segments with a mean length of 28.4 +/- 1.8 mm. RESULTS: Thirty-three arteries (89%) displayed variable degrees of proximal eccentric intimal proliferation, with the maximal intimal thickening being 0.26 +/- 0.14 mm (range 0.06 to 0.71 mm) at the most thickened site. According to the Stanford classification, all children had coronary artery involvement with 50% having moderate-to-severe lesions (>0.3 mm). No risk factors for such abnormalities were encountered, including age, origin of the coronary arteries, hemodynamics, and follow-up duration after surgery. CONCLUSIONS: Intravascular ultrasound assessment late after the ASO revealed proximal eccentric intimal thickening in most of the studied vessels. This observation suggests the development of early atherosclerosis in the reimplanted coronary arteries, which may have a role in the genesis of late coronary events.

[Comparative analysis of intimal hyperplasia after sirolimus-eluting stent and thin-strut bare-metal stent implantation in small coronary arteries]. / Análise comparativa da hiperplasia intimal após o implante de stents com e sem sirolimus em artérias coronárias de pequeno calibre.

OBJECTIVE: This study aimed at evaluating reduction in intimal hyperplasia volume following angioplasty using sirolimus-eluting stents (Cypher) compared with thin-strut bare-metal stents (Pixel) in patients with small vessels. METHODS: Eighty patients with coronary artery disease were prospectively included in two consecutive series, the first using sirolimus-eluting stents (50) and the second using bare-metal stents (30). RESULTS: The use of sirolimus-eluting stents reduced: in-stent net volume obstruction [5.0% (SE = 0.77) x 39.0% (SE = 4.72), p < 0.001], in-stent late loss [0.25 mm (SE = 0.03) x 1,11 mm (SE = 0.13), p < 0.001], in-segment late loss [0.30 mm (SE = 0.04) x 0.83 mm (SE = 0.11), p < 0.001], in-stent restenosis (0% x 33.3%, p < 0.001) and in-segment restenosis (4% x 36.7%, p < 0.001). The event-free survival rate was 96% in the sirolimus-eluting stent group versus 86.7% in the bare-metal stent group (BMS) (p = 0.190). CONCLUSION: Sirolimus-eluting stents are superior to thin-strut bare-metal stents in reducing intimal hyperplasia (less in-stent obstruction and less late lumen loss) in patients with small vessels. The use of these stents significantly reduced angiographic restenosis at eight months.

[Adenosine myocardial perfusion SPECT with Tc-99m-MIBI in patients with obstructive coronary artery disease: correlation between quantitative coronary angiography and intravascular ultrasound measurements]. / Cintilografia do miocárdio com tecnécio 99m-MIBI e administração de adenosina em portadores de doença arterial coronária: correlação dos resultados com a angiografia coronária e o ultra-som intracoronário.

OBJECTIVE: To correlate myocardial perfusion scintigraphy (MPS) with Tc-99m-MIBI and adenosine infusion using quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). METHODS: Seventy patients with coronary artery disease (CAD) referred for myocardial perfusion scintigraphy (MPS) with MIBI and adenosine were studied. Clinical, electrocardiographic (ECG), and scintigraphic findings were correlated with variables of visual and quantitative angiographic analysis, as well as to those of IVUS. RESULTS: The mean age of patients was 60.6 years, and 39 were male. Coronary angiography showed percentage of diameter stenosis (% DS) of 49.94% in 105 arteries, 83 of which were re-evaluated by QCA (79%), mean of 44.20%, p<0.05. ST-segment depression during adenosine infusion was associated with higher degrees of % DS (55.0% vs. 47.8%), p<0.05). Scintigraphic ischemia was correlated with greater cross-sectional area of lumen obstruction by IVUS (% CSA). Clinical, ECG, and IVUS findings were considered together and expressed as global ischemic versus non-ischemic responses. Ischemia was associated with lower values of minimal lumen diameter (MLD) and minimal lumen area (MLA) determined by QCA and IVUS. CONCLUSION: Tc-99m-MIBI and adenosine myocardial SPECT is correlated with % CSA on IVUS, perfusion images considered. Global results assessment showed association between lumen diameter and area at obstructed sites as determined by QCA and IVUS.