Untreated Mitral Regurgitation Does Not Affect Survival of Elderly Patients Undergoing TAVI.

BACKGROUND: The study aim was to examine the impact of concomitant significant mitral regurgitation (MR) in patients undergoing transcatheter aortic valve implantation (TAVI). TAVI has become an acceptable mode of treatment for high-surgical risk patients with aortic stenosis (AS) requiring valve replacement. A significant number of patients have concomitant MR which cannot be addressed by TAVI alone, and therefore may not be considered candidates for this procedure. A comparison was conducted of results obtained from patients undergoing TAVI with or without MR. METHODS: Between 2008 and 2013, a total of 164 patients (mean age 81 ± 8 years) underwent TAVI at the authors' institution. Of these patients, 87 (53%) had MR of moderate or greater degree. The groups were similar with respect to age, gender, presence of congestive heart failure, left ventricular function and co-morbid conditions. The logistic EuroSCORE was higher in the MR group (p = 0.02). RESULTS: Procedural (30-day) mortality was 12% (n = 19) and similar between groups. Kaplan-Meier estimates showed the overall survival at three years to be 68% and 76% for the MR and non-MR groups, respectively (p = 0.6). By Cox regression, age (p = 0.007) and peripheral vascular disease (p = 0.03) were the only predictors of late survival. Regression of MR was seen in patients with functional MR. Neither the presence of MR nor residual MR emerged as predictors of late mortality. CONCLUSIONS: In elderly patients undergoing TAVI the presence of MR does not impact survival. TAVI should not be withheld from this group of patients because of concomitant MR.

Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial.

BACKGROUND: Activation of systemic innate immunity is critical in the chain of events leading to restenosis. LABR-312 is a novel compound that transiently modulates circulating monocytes, reducing accumulation of these cells at vascular injury sites and around stent struts. The purpose of the study was to examine the safety and efficacy of a single intravenous bolus of LABR-312 in reducing restenosis in patients treated for coronary narrowing. Patient response was examined in light of differential inflammatory states as evidenced by baseline circulating monocyte levels, diabetes mellitus, and acute coronary syndrome. METHODS: BLAST is a Phase II prospective, randomized, multicenter, double-blind, placebo-controlled trial that assessed the safety and efficacy of LABR-312. Patients were randomized to receive LABR-312 at 2 dose levels or placebo as an intravenous infusion during percutaneous coronary intervention and bare metal stent implantation. The primary end point was mean angiographic in-stent late loss at 6 months. RESULTS: Patients (N = 225) were enrolled at 12 centers. There were no safety concerns associated with the study drug. For the overall cohort, there were no differences between the groups in the primary efficacy end point (in-stent late loss of 0.86 ± 0.60 mm, 0.83 ± 0.57 mm, and 0.81 ± 0.68 mm for the placebo, low-dose, and high-dose group, respectively; P = not significant for all comparisons). In the prespecified subgroups of patients with a baseline proinflammatory state, patients with diabetes mellitus, and patients with high baseline monocyte count, there was a significant treatment effect. CONCLUSIONS: Intravenous administration of LABR-312 to patients undergoing percutaneous coronary intervention is safe and effectively modulates monocyte behavior. The average late loss did not differ between the treatment and placebo groups. However, in the inflammatory patient group with baseline monocyte count higher than the median value, there was a significant reduction in late loss with LABR-312.

Buddy balloon for TAVI.

Percutaneous transfemoral aortic valve replacement is a new rapidly evolving technique that has made significant progress in recent years. The technology is however limitted and in some cases has resulted in failure to deliver the prosthetic valve. We describe a new technique using a buddy balloon, from the contralateral femoral artery, to assist in crossing the native aortic valve in those cases where extreme calcification and or tortuosity have caused the delivery system to hang up on the aortic wall. The technique is easily applied and facilitates the success of the procedure in cases which may otherwise have to be converted to open surgical aortic valve replacement.

Comparison between transcatheter and surgical aortic valve replacement: a single-center experience.

BACKGROUND AND AIM OF THE STUDY: A comparison was made of the outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) in high-risk patients. METHODS: All patients aged > 75 years that underwent a procedure for severe aortic stenosis with or without coronary revascularization at the authors' institution were included in the study; thus, 64 patients underwent TAVI and 188 underwent AVR. Patients in the TAVI group were older (mean age 84 +/- 5 versus 80 +/- 4 years; p < 0.0001) and had a higher logistic EuroSCORE (p = 0.004). RESULTS: Six patients (9%) died during the procedure in the TAVI group, and 23 (12%) died in the AVR group (p = 0.5). Predictors for mortality were: age (p < 0.0001), female gender (p = 0.02), and surgical valve replacement (p = 0.01). Gradients across the implanted valves at one to three months postoperatively were lower in the TAVI group (p < 0.0001). Actuarial survival at one, two and three years was 78%, 64% and 64%, respectively, for TAVI, and 83%, 78% and 75%, respectively, for AVR (p = 0.4). Age was the only predictor for late mortality (p < 0.0001). CONCLUSION: TAVI patients were older and posed a higher predicted surgical risk. Procedural mortality was lower in the TAVI group, but mid-term survival was similar to that in patients undergoing surgical AVR. Age was the only predictor for late survival. These data support the referral of high-risk patients for TAVI.

Prevalence, Predictors, and Outcomes of Patients With ST-Elevation Myocardial Infarction and Angiographically Significant Coronary Artery Disease of Non-Infarct-Related Artery.

Patients with ST-elevation myocardial infarction (STEMI) can present with angiographically significant coronary artery disease (CAD) of non-infarct-related artery (IRA) or with IRA-only CAD. This study aimed to evaluate the prevalence, predictors, and outcome of patients with STEMI and angiographically significant CAD of non-IRA. All consecutive patients with STEMI who underwent primary percutaneous coronary intervention between 2000 and 2020 were included. Angiographically significant CAD was defined as >50% stenosis of the left main coronary artery and/or >90% stenosis for all other coronary arteries. A total of 2,663 patients had IRA-only CAD (80.2%) and 657 had angiographically significant non-IRA CAD (19.8%). Independent predictors for non-IRA CAD were male gender (odds ratio [OR] 1.34, 95% confidence interval [CI] 1.05 to 1.70, p = 0.021), age >50 years (OR 1.45, 95% CI 1.11 to 1.91, p = 0.007), and diabetes mellitus (OR 1.56, 95% CI 1.29 to 1.9, p <0.001), whereas smoking (OR 0.83, 95% CI 0.68 to 0.99, p = 0.004) and family history of CAD (OR 0.78, 95% CI 0.62 to 0.98, p = 0.032) were found to be negatively associated with non-IRA CAD. In-hospital 30-day and 1- and 5-year all-cause mortality were higher in patients with non-IRA CAD compared with IRA-only CAD (5.8% vs 2.5%, 8.5% vs 3.3%, 18.4% vs 7.6% and 36.3% vs 20.3%, respectively; p for all <0.001). In conclusion, 20% of patients with STEMI had angiographically significant non-IRA CAD. Older age, male gender, and diabetes mellitus were independent predictors for non-IRA CAD, whereas smoking and family history of CAD predicted IRA-only CAD. The presence of non-IRA CAD was associated with higher short- and long-term all-cause mortality rates.

Long-term (>3 Years) outcome and predictors of clinical events after insertion of sirolimus-eluting stent in one or more native coronary arteries (from the Israeli arm of the e-Cypher registry).

The aim of this study was to evaluate long-term (3.4 years) outcomes and predictors of clinical events in patients treated with sirolimus-eluting stents in the Israeli arm of the e-Cypher registry. From July 2002 to October 2003, 488 patients from 8 medical centers in Israel were enrolled in the e-Cypher registry. Nineteen patients with interventions in venous grafts were excluded from the final analysis. Long-term follow-up was completed for 98% of the remaining patients. There were 29 cases (6.3%) of death (3.9% cardiac and 2.4% noncardiac deaths). According to the broad academic research consortium definition of stent thrombosis, there were 19 cases (4%) of stent thrombosis (incidence density 0.9 cases/100 patient-years). There were 46 cases (9.9%) of target lesion revascularization and 76 cases (16.3%) of major adverse cardiac events (combination of death, myocardial infarction, and target lesion revascularization). Independent predictors of stent thrombosis were renal failure (hazard ratio 9.6, 95% confidence interval 1.9 to 47), stent length (hazard ratio 1.1, 95% confidence interval 1 to 1.2), and the off-label use of sirolimus-eluting stents (hazard ratio 5.3, 95% confidence interval 1.2 to 24). In conclusion, during >3 years of follow-up, stent thrombosis, major adverse cardiac events, and target lesion revascularization continued at constant rates over time. Clinical parameters such as renal failure and procedural parameters such as off-label use and stent length were independent predictors of stent thrombosis.

Antiatherogenicity of extra virgin olive oil and its enrichment with green tea polyphenols in the atherosclerotic apolipoprotein-E-deficient mice: enhanced macrophage cholesterol efflux.

The antiatherogenic properties of extra virgin olive oil (EVOO) enriched with green tea polyphenols (GTPPs; hereafter called EVOO-GTPP), in comparison to EVOO, were studied in the atherosclerotic apolipoprotein-E-deficient (E0) mice. E0 mice (eight mice in each group) consumed EVOO or EVOO-GTPP (7 microl/mouse/day, for 2 months) by gavage feeding. The placebo group received only water. At the end of the study, blood samples, peritoneal macrophages and aortas were collected. Consumption of EVOO or EVOO-GTPP resulted in a minimal increase in serum total and high-density lipoprotein (HDL) cholesterol levels (by 12%) and in serum paraoxonase 1 activity (by 6% and 10%). EVOO-GTPP (but not EVOO) decreased the susceptibility of the mouse serum to AAPH-induced lipid peroxidation (by 18%), as compared to the placebo-treated mice. The major effect of both EVOO and EVOO-GTPP consumption was on HDL-mediated macrophage cholesterol efflux. Consumption of EVOO stimulated cholesterol efflux rate from mouse peritoneal macrophages (MPMs) by 42%, while EVOO-GTPP increased it by as much as 139%, as compared to MPMs from placebo-treated mice. Finally, the atherosclerotic lesion size of mice was significantly reduced by 11% or 20%, after consumption of EVOO or EVOO-GTPP, respectively. We thus conclude that EVOO possesses beneficial antiatherogenic effects, and its enrichment with GTPPs further improved these effects, leading to the attenuation of atherosclerosis development.

Transfemoral Implantation of the Acurate neo for the Treatment of Aortic Regurgitation.

OBJECTIVES: We report an international experience of transfemoral transcatheter aortic valve replacement (TAVR) using the self-expanding Acurate neo valve (Boston Scientific) in aortic regurgitation. METHODS: This series comprises 20 patients with pure aortic regurgitation undergoing transfemoral TAVR with the Acurate neo prosthesis at nine centers in Europe and Israel. RESULTS: Mean age was 79 ± 8 years and mean STS score was 8.3 ± 9.3%. Leaflet calcification was none/minimal in 19 patients (95%). Prosthesis size selection was based on perimeter-derived annular diameter, with a tendency to over-size in cases of borderline annuli. One patient required implantation of a second valve. Device success rate was 18/20 (90%). At discharge, aortic regurgitation was none in 14 patients (70%), mild in 5 patients (25%), and moderate in 1 patient (5%). Left ventricular end-diastolic diameter decreased from 58 ± 7 mm at baseline to 53 ± 7 mm before discharge (P<.001). At 30-day follow-up, there was no mortality, no stroke, and 3 patients (15%) had received a permanent pacemaker. New York Heart Association class had improved significantly compared to baseline (85% in class I/II compared to 15% at baseline; P<.001). CONCLUSIONS: In a selected patient population, transfemoral TAVR using the Acurate neo transcatheter heart valve was successful in treating aortic regurgitation, significantly reduced left ventricular dimensions, and improved clinical symptoms.

Safety and efficacy of the FilterWire EZ in acute ST-segment elevation myocardial infarction.

Primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) achieves a high epicardial reperfusion rate; however, it is often suboptimal in achieving myocardial reperfusion due to distal embolization of atherothrombotic particles. The present study assessed whether the capture of embolic particles during PCI would improve myocardial reperfusion outcome. In a multicenter, prospective, randomized, controlled study, 100 patients with STEMI and coronary angiographic evidence of thrombotic occlusion were randomly assigned to PCI using the FilterWire EZ (n=51) or a control group (n=49) using regular guidewires. The FilterWire EZ was successfully delivered across the lesion in 84% of patients in the FilterWire EZ group. Primary efficacy end points, including markers of epicardial (Thrombolysis In Myocardial Infarction grade flow) and myocardial reperfusion (myocardial blush score and percent early resolution of ST-segment elevation), did not differ between the 2 study groups. Further, 60- and 90-minute percent ST-segment resolutions were identical in the 2 groups. In a subgroup analysis, a blush score of 3 was achieved in 94% of patients in whom the filter's landing zone was in a vessel diameter>2.5 mm compared with only 55% in those with smaller vessel diameter (p=0.04). This corresponds to a better debris capture in filters located in large versus small vessels (p=0.08). In conclusion, in patients with STEMI, use of the FilterWire EZ as an adjunct to primary PCI did not improve angiographic or electrocardiographic measurements of reperfusion compared with conventional PCI only.

Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography.

BACKGROUND: Fractional flow reserve (FFR), an index of the hemodynamic severity of coronary stenoses, is derived from invasive measurements and requires a pressure-monitoring guidewire and hyperemic stimulus. Angiography-derived FFR measurements (FFRangio) may have several advantages. The aim of this study is to assess the diagnostic performance and interobserver reproducibility of FFRangio in patients with stable coronary artery disease. METHODS AND RESULTS: FFRangio is a computational method based on rapid flow analysis for the assessment of FFR. FFRangio uses the patient's hemodynamic data and routine angiograms to generate a complete 3-dimensional coronary tree with color-coded FFR values at any epicardial location. Hyperemic flow ratio is derived from an automatic resistance-based lumped model of the entire coronary tree. A total of 203 lesions were analyzed in 184 patients from 4 centers. Values derived using FFRangio ranged from 0.5 to 0.97 (median 0.85) and correlated closely (Spearman ρ=0.90; P<0.001) with the invasive FFR measurements, which ranged from 0.5 to 1 (median 0.84). In Bland-Altman analyses, the 95% limits of agreement between these methods ranged from -0.096 to 0.112. Using an FFR cutoff value of 0.80, the sensitivity, specificity, and diagnostic accuracy of FFRangio were 88%, 95%, and 93%, respectively. The intraclass coefficient between 2 blinded operators was 0.962 with a 95% confidence interval from 0.950 to 0.971, P<0.001. CONCLUSIONS: There is a high concordance between FFRangio and invasive FFR. The color-coded display of FFR values during coronary angiography facilitates the integration of physiology and anatomy for decision making on revascularization in patients with stable coronary artery disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03005028.

Results of coronary artery stenting in women versus men: a single center experience.

BACKGROUND: Prior studies have suggested that women are at higher risk for morbidity and mortality during coronary angioplasty, although long-term prognosis is similar after successful procedures. OBJECTIVES: To examine the role of gender in coronary stenting, including immediate procedural success as well as early and late outcomes. METHODS: The study group comprised 560 consecutive patients (119 women and 441 men) who had undergone stenting over a 3 year period. RESULTS: The indications for coronary stenting were similar among women and men, and stents were successfully deployed at similar rates without complications (92 vs. 90% respectively). Cardiac death or myocardial infarction within 30 days of the procedure was observed in 5% of women and men, whereas none of the women, compared to 1.4% of men, had early revascularization. Bleeding complications occurred in 4% of women and 2% of men. During 10 +/- 2.8 months of follow-up, 58% of women and men underwent repeat cardiac catheterization, revealing similar rates of restenosis, 36 vs. 32% respectively. During the study period, 3.3% of women as compared to 0.9% of men had a cardiac death (not significant). Cardiac death or myocardial infarction was observed in 7% of women and 8% of men, and the combined endpoint of death, myocardial infarction or revascularization, was noted in 24% and 26% respectively. Multivariate Cox analyses of the clinical, angiographic and procedural characteristics revealed that multiple stent deployment was the only predictor of major adverse cardiac event among men, whereas none of these characteristics predicted outcome in women. CONCLUSION: Coronary stenting is performed with similar success rates among women and men, with similar restenosis rates as well as early and late major adverse cardiac events.

Incidence and risk factors of cerebrovascular events following cardiac catheterization.

BACKGROUND: One of the most daunting complications of cardiac catheterization is a cerebrovascular event (CVE). We aimed to assess the real-life incidence, etiology, and risk factors of cardiac catheterization-related acute CVEs in a large cohort of patients treated in a single center. METHODS AND RESULTS: We undertook a retrospective analysis of 43,350 coronary procedures performed on 30,907 procedure days over the period 1992-2011 and compared patient and procedural characteristics of procedures complicated by CVEs with the remaining cohort. CVEs occurred in 47 cases: 43 were ischemic, 3 intracerebral hemorrhages, and 1 undetermined. The overall CVE rate was 0.15%, with percutaneous coronary intervention (PCI) and diagnostic coronary angiography rates 0.23% and 0.09%, respectively. Using a forward stepwise multivariate logistic regression model including patient demographic and procedural characteristics, a total of 5 significant predictors were defined: prior stroke (OR=15.09, 95% CI [8.11 to 28.08], P<0.0001), presence of coronary arterial thrombus (OR=2.79, 95% CI [1.25 to 6.22], P=0.012), age >75 years (OR=3.33, 95% CI [1.79 to 6.19], P<0.0001), triple vessel disease (OR=2.24, 95% CI [1.20 to 4.18], P=0.011), and performance of intervention (OR=2.21, 95% CI [1.12 to 4.33], P=0.021). An additional analysis excluded any temporal change of CVE rates but demonstrated a significant increase of all high-risk patient features. CONCLUSION: In a single-center, retrospective assessment over nearly 20 years, cardiac catheterization-related CVEs were very rare and nearly exclusively ischemic. The independent predictors for these events were found to be the performance of an intervention and those associated with increased atherosclerotic burden, specifically older age, triple vessel disease, and prior stroke. The presence of intracoronary thrombus appears also to raise the risk of procedure-related CVE.

Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.

OBJECTIVES: This study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment. BACKGROUND: Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results. METHODS: This multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel). RESULTS: The location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 ± 16.3% of device height below the plane of the lower sinus border versus 32.6 ± 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 ± 1.43 mm, range: -1.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 ± 1.4 mm vs. 0.75 ± 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49% higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = -0.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width. CONCLUSIONS: The final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment.

Impact of vessel size, lesion length and diabetes mellitus on angiographic restenosis outcomes: insights from the NIRTOP study.

BACKGROUND: The primary objective of the current analysis was to define the impact of vessel size, lesion length, and diabetes on clinical and angiographic restenosis following implantation of the NIRFLEX stent. METHODS AND RESULTS: Clinical and angiographic restenosis outcomes and multivariate predictors were compared between patients treated in 'small' (<3 mm, n=113 pts/133 lesions) versus 'large' (> or =3 mm, n=41 pts/53 lesions) vessels; between 'tubular' (10-20 mm lesion length n=49 pts/51 lesions) versus 'discrete' (<10 mm lesion length n=103 pts/133 lesions) lesions; and between 'diabetic' (n=30/35 lesions) versus 'non-diabetic' (n=128/156 lesions) patients using the flexible closed-cell design 'bare-metal' NIRFLEX stent in patients with native coronary artery disease. At six month follow-up, target vessel revascularization (TVR) and target lesion revascularization (TLR) rates were significantly less frequent in the 'large' versus 'small' vessel group (2.4% versus 16.8% for TVR, P=0.016, 0% versus 12.4% for TLR, P=0.022). Likewise, angiographic late loss was lower in 'large' versus 'small' vessels (0.54 versus 0.70 mm, P=0.05). Lesion length affected MACE rates but not angiographic restenosis. Angiographic late loss was greater in diabetics compared to the non-diabetic group (0.89 versus 0.60 mm, P=0.003). Using a multivariate model, diabetes mellitus (odds ratio=2.65, P=0.047) and post-procedure in-stent MLD (mm) (odds ratio=0.178, P=0.0019) were major determinants of restenosis. CONCLUSION: Clinical and angiographic restenosis outcomes following NIRFLEX stent implantation were dependent upon vessel size, lesions length, post-procedural stent lumen dimensions, and the diabetic status.

Predicting blood pressure improvement in hypertensive patients after renal artery stent placement: renal fractional flow reserve.

BACKGROUND: Renal stent placement improves or cures hypertension in only 60-70% of patients with renal artery stenosis (RAS) and uncontrolled hypertension. There is a need to better identify patients who are likely to respond to percutaneous renal revascularization. We investigated whether an abnormal renal fractional flow reserve (FFR) would predict blood pressure improvement in patients undergoing renal artery stent placement. METHODS: We prospectively enrolled 17 patients with unilateral RAS and medically refractory hypertension (BP > 140/90 mm Hg). Renal FFR was measured at maximal hyperemia induced by papaverine followed by renal stent placement. Blood pressure improvement was defined as a blood pressure of

'Fused-Gold' vs. 'Bare' stainless steel NIRflex stents of the same geometric design in diseased native coronary arteries. Long-term results from the NIR TOP Study.

OBJECTIVES: We evaluated the long-term clinical and angiographic results of 'fused-gold' (NIRFlex Royal) and 'bare' (NIRFlex) stainless steel stents in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Recent studies have shown high clinical and angiographic restenosis rates following the intracoronary implantation of 'gold-coated' stainless steel stents. The new 'fused-gold' stent, with improved surface characteristics and flexibility, was developed to improve procedural and long-term results, while maintaining enhanced radiopacity. METHODS: A total of 305 patients (358 lesions) with symptomatic native coronary artery disease (CAD) undergoing native vessel PCI were randomised to receive a 'fused-gold' (n=147) or 'bare' (n=158) stent. Primary endpoint was minimal luminal diameter (MLD) at 6 months angiographic follow-up. Secondary endpoints included technical and procedural success, major adverse cardiac events (MACE), target vessel failure (TVF), angiographic binary restenosis rates, and additional angiographic comparisons. RESULTS: There were no major differences in the baseline angiographic variables or patient characteristics between the two groups, however there was a trend towards a higher risk in the 'fused-gold' stent group. Clinical and angiographic follow-up was 100% and 87% respectively. MLD at 6 months follow-up was smaller in the 'fused-gold' stent group compared to the 'bare' stent group (1.61+/-0.65 vs. 1.81+/-0.60 mm, respectively); Therefore, the null hypothesis of non-inferiority cannot be rejected (p=0.49); equivalency cannot be claimed for the two stent types. The 'fused-gold' stents were also associated with a higher angiographic binary and clinical restenosis rates (33 vs. 18%; p=0.002 & 26.9 vs. 20.3%; p<0.001, respectively). CONCLUSION: The 'bare' NIRflex stent was associated with excellent long-term clinical and angiographic results. Taking into account the equivalence margin, the null hypothesis of non-equivalence between the 'fused-gold' NIRflex Royal stent and the 'bare' NIRflex stent cannot be rejected (p=0.49), so equivalence cannot be claimed for the two stent types.

Remote-control percutaneous coronary interventions: concept, validation, and first-in-humans pilot clinical trial.

OBJECTIVES: This study was designed to assess the feasibility and safety of a Remote Navigation System (RNS, NaviCath, Haifa, Israel) in which the angioplasty guidewire, the balloon, and the stent are navigated via a computerized system. BACKGROUND: Percutaneous coronary interventions (PCIs) are manually performed under fluoroscopic guidance, requiring lead protection for the operators. A system in which the operator can remotely, safely, and precisely navigate the procedure during PCI would have clear advantages. METHODS: The RNS involves a computer-controlled wire and delivery system navigator. Following preclinical validation, the system was assessed in patients undergoing single-vessel PCI. RESULTS: The study involved 18 patients (age 55.9 years, 16% women). The RNS successfully crossed lesions with the guidewire in 17 patients. The stent was then advanced by the advance/rotate mode and adequately positioned in 15 of 17 cases. Technical malfunction was encountered in three patients in whom the procedure was successfully completed manually. Direct stenting was employed in 10 of 18 patients, pre-dilation in 7 patients, and after-stent balloon dilation in 5 patients. The total fluoroscopy time for 17 RNS patients was compared with the corresponding time of 20 consecutive patients who underwent standard single-lesion PCI. Fluoroscopy time was similar for both procedures, with 8.8 +/- 4.8 min with the RNS versus 9.1 +/- 3.5 min with the standard techniques (p = NS). Clinical success was 100% and technical success 94% for the guidewire and 83% for the overall procedure. CONCLUSIONS: The use of the RNS for guidewire, balloon, and stent manipulation during PCI appears safe and feasible for the treatment of patients with coronary stenosis. The system offers operator radiation safety and may enhance precision of stent placement and balloon dilation strategies.

Sirolimus-eluting stent in chronic total occlusion: the SICTO study.

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.

FX MiniRAIL catheter usage for treatment of de novo complex coronary lesions: results from the "OFFAR".

INTRODUCTION: Gradual prolonged balloon angioplasty may cause less arterial trauma, higher success rates, and fewer complications than conventional angioplasty (POBA). The OFFAR aimed to determine the safety and effectiveness of the FX MiniRAIL (FX) catheter, used with a slow, stepwise inflation protocol. METHODS AND RESULTS: From June to December 2003, 181 consecutive patients (age 61.9 +/- 10.6 years) with de novo coronary artery lesions (n = 217) were treated by FX and stent implantation in 11 European centers. Fifty-one patients (28.2%) had diabetes, and 70 (38.7%) had prior MI; 73 patients (40.3%) presented with stable angina and 85 (47.0%) with unstable angina. Fifty-five lesions (25.3%) were in small vessels (<2.5 mm), 40 (18.6%) were highly calcific, and 133 (62%) were long lesions (>18 mm). Stenosis resolution pressure was 7.17 +/- 4.2 atm; inflation time was 116.5 +/- 54.6 seconds. FX technical success (residual stenosis <50% post-FX) was obtained in 191 lesions (88.0%), and FX optimal success (residual stenosis <20% post-FX) in 117 (54.9%). Dissection was observed in 34 lesions (15.9%), 27 (79.3%) of which were type A or B. No coronary ruptures occurred. Nine (5.0%) in-hospital events occurred, all non-Q-wave MI. During 6-month follow-up, major adverse clinical events occurred in 14.4% of cases (n = 26; 3 cardiac deaths, 1 Q-wave MI, 2 non-Q-wave MI, 3 CABG, and 17 re-PTCA). CONCLUSION: The results of the OFFAR suggest that FX utilization for treatment of de novo complex coronary lesions is safe and effective.

Renal fractional flow reserve: a hemodynamic evaluation of moderate renal artery stenoses.

The objective of this study was to perform a hemodynamic evaluation of moderate (50-90%) renal artery stenosis (RAS) under conditions of rest and maximum hyperemia. Identifying patients with RAS who have hemodynamically significant stenoses and are most likely to benefit from revascularization is clinically important. Current methods used to evaluate RAS, including angiography, have limitations. Physiologic evaluation of RAS may have a role in identifying patients with hemodynamically significant stenosis. Patients with suspected renovascular hypertension due to aorto-ostial RAS were included in the study. Hyperemia was induced by administration of intrarenal papavarine. Translesional pressure gradients were measured and renal fractional flow reserve (FFR) was calculated using a 0.014'' pressure guidewire. Thirteen patients and 14 arteries with moderately severe (50-90%) RAS were studied. The mean translesional pressure gradient rose from a baseline of 6.3 +/- 3.9 to 17.5 +/- 10.8 mm Hg with maximal hyperemia. The renal FFR ranged from 0.58 to 0.95. There was a poor correlation between angiographic stenosis measurement and the renal FFR (r = -0.18; P = 0.54) and the hyperemic translesional mean pressure gradient (r = 0.22; P = 0.44). There was an excellent correlation between renal FFR and the resting mean translesional pressure gradient (r = -0.76; P = 0.0016) and the hyperemic mean translesional pressure gradient (r = -0.94; P < 0.0001). Selective renal arterial papavarine administration induces maximum hyperemia, permitting the calculation of renal FFR in renal arteries with aorto-ostial stenoses. The renal FFR correlates well with other hemodynamic parameters of lesion severity, but poorly with angiographic measures of lesion severity.