Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Independent Clinical and Echocardiographic Predictors of Restenosis After Percutaneous Mitral Balloon Commissurotomy in a Large, Consecutive Cohort Followed for 24 Years.

OBJECTIVE: To enlighten preprocedural risk factors of mitral valve restenosis in a large, single-center cohort of patients submitted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral stenosis (MS) secondary to rheumatic heart disease. METHODS: This is a database analysis of a single-center, high-volume tertiary institution involving all consecutive PMBC procedures performed in the mitral valve (MV). Restenosis was diagnosed when MV area was <1.5 cm² and/or loss of 50% or more of the immediate procedural result aligned with the return/worsened symptoms of heart failure. The primary endpoint was to determine the preprocedural independent predictors of restenosis after PMBC. RESULTS: Among a total of 1921 PMBC procedures, 1794 consecutive patients without previous intervention were treated between 1987 and 2010. Throughout 24 years of follow-up, MV restenosis was observed in 483 cases (26%). Mean age was 36 years and most (87%) were female. Median follow-up duration was 9.03 years (interquartile range, 0.33-23.38). Restenosis population, however, presented a significantly lower age at the procedure time as well as a higher Wilkins-Block score. At multivariate analysis, independent preprocedure predictors of restenosis were left atrium diameter (hazard risk [HR], 1.03; 95% confidence interval [CI], 1.02-1.05; P<.04), preprocedure maximum gradient (HR, 1.02; 95% CI, 1.00-1.03; P=.04), and higher Wilkins-Block score (>8) (HR, 1.38; 95% CI, 1.14-1.67; P<.01). CONCLUSIONS: At long-term follow-up, MV restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum MV gradient, and Wilkins-Block score were found to be the only independent predictors.

Serial assessment of coronary artery healing of a biodegradable polymer drug-eluting stent at 1, 2, and 3 months by optical coherence tomography (OCT)­the REPAIR trial

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. Aims. We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS. This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Independent clinical and echocardiographic predictors of restenosis after percutaneous mitral balloon commissurotomy in a large, consecutive cohort followed for 24 years

OBJECTIVES: to enlighten preprocedural risk factors of mitral valve restenosis in a large, single-center cohort of patients submitted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral stenosis (MS) secondary to rheumatic heart disease. METHODS: this is a database analysis of a single-center, high-volume tertiary institution involving all consecutive PMBC procedures performed in the mitral valve (MV). Restenosis was diagnosed when MV area was <1.5 cm2 and/or loss of 50% or more of the immediate procedural result aligned with the return/worsened symptoms of heart failure. The primary endpoint was to determine the preprocedural independent predictors of restenosis after PMBC. Results: among a total of 1921 PMBC procedures, 1794 consecutive patients without previous intervention were treated between 1987 and 2010. Throughout 24 years of follow-up, MV restenosis was observed in 483 cases (26%). Mean age was 36 years and most (87%) were female. Median follow-up duration was 9.03 years (interquartile range, 0.33-23.38). Restenosis population, however, presented a significantly lower age at the procedure time as well as a higher Wilkins-Block score. At multivariate analysis, independent preprocedure predictors of restenosis were left atrium diameter (hazard risk [HR], 1.03; 95% confidence interval [CI], 1.02-1.05; P<.04), preprocedure maximum gradient (HR, 1.02; 95% CI, 1.00-1.03; P=.04), and higher Wilkins-Block score (>8) (HR, 1.38; 95% CI, 1.14-1.67; P<.01). CONCLUSIONS: at long-term follow-up, MV restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum MV gradient, and Wilkins-Block score were found to be the only independent predictors.

Novel prognostic score for immediate and late success after percutaneous mitral balloon commissurotomy in patients with mitral stenosis

Abstract: Objectives. Percutaneous mitral balloon commissurotomy (PMBC) remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis (MS) and suitable anatomy. The objective of this study was to propose a new score for the prediction of immediate and late success. Methods. This is a single-center, retrospective analysis of all 1582 patients with severe mitral stenosis who underwent PMBC from August 1987 to July 2010. The composite outcome was cardiovascular death, new PMBC, or mitral valve repair surgery up to 24 years of follow-up. Results. Mean patient age was 36.8 ± 12.9 years, most (86.4%) were female, and Wilkins score was between 9-11 in 49.1% of patients. In the multivariate analysis, the predictors of immediate success were age (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.96-0.99; P=.01), left atrium size (OR, 0.96; 95% CI, 0.93-0.99; P=.01), mean preprocedure mitral gradient (OR, 0.93; 95% CI, 0.89-0.96; P<.001), intermediate Wilkins score 9-11 (OR, 0.62; 95% CI, 0.40-0.94; P=.02), and high Wilkins score ≥12 (OR, 0.35; 95% CI, 0.16-0.76; P<.01). For prediction of late events, age (hazard ratio [HR], 0.98; 95% CI, 0.97-0.98; P<.001), New York Heart Association class III-IV (HR, 1.50; 95% CI, 1.18-1.92; P<.001), left atrium size (HR, 1.02; 95% CI, 1.02-0.04; P<.01), and high Wilkins score ≥12 (HR, 2.02; 95% CI, 1.30-3.15; P<.01) were significant. Two nomograms were developed using significant predictors from the model. Conclusions. In this large population, not only the Wilkins score, but also clinical and hemodynamic features, seem to be relevant in predicting immediate and late success for patients with rheumatic MS who underwent PMBC.

Novel Prognostic Score for Immediate and Late Success After Percutaneous Mitral Balloon Commissurotomy in Patients With Mitral Stenosis.

OBJECTIVES: Percutaneous mitral balloon commissurotomy (PMBC) remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis (MS) and suitable anatomy. The objective of this study was to propose a new score for the prediction of immediate and late success. METHODS: This is a single-center, retrospective analysis of all 1582 patients with severe mitral stenosis who underwent PMBC from August 1987 to July 2010. The composite outcome was cardiovascular death, new PMBC, or mitral valve repair surgery up to 24 years of follow-up. RESULTS: Mean patient age was 36.8 ± 12.9 years, most (86.4%) were female, and Wilkins score was between 9-11 in 49.1% of patients. In the multivariate analysis, the predictors of immediate success were age (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.96-0.99; P=.01), left atrium size (OR, 0.96; 95% CI, 0.93-0.99; P=.01), mean preprocedure mitral gradient (OR, 0.93; 95% CI, 0.89-0.96; P<.001), intermediate Wilkins score 9-11 (OR, 0.62; 95% CI, 0.40-0.94; P=.02), and high Wilkins score ≥12 (OR, 0.35; 95% CI, 0.16-0.76; P<.01). For prediction of late events, age (hazard ratio [HR], 0.98; 95% CI, 0.97-0.98; P<.001), New York Heart Association class III-IV (HR, 1.50; 95% CI, 1.18-1.92; P<.001), left atrium size (HR, 1.02; 95% CI, 1.02-0.04; P<.01), and high Wilkins score ≥12 (HR, 2.02; 95% CI, 1.30-3.15; P<.01) were significant. Two nomograms were developed using significant predictors from the model. CONCLUSIONS: In this large population, not only the Wilkins score, but also clinical and hemodynamic features, seem to be relevant in predicting immediate and late success for patients with rheumatic MS who underwent PMBC.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV).BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy.METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years.RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n»1,438).Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to0.99; p»0.045), Wilkins score#8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p»0.02) and age (odds ratio: 0.97; 95% CI:0.96 to 0.99; p»0.006). Very long-term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall lmortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p<0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to0.98; p»0.028), and mitral valve area#1.75 cm2after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11;p»0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.(J Am Coll Cardiol Intv 2018;11:1945­52) © 2018 by the American College of Cardiology Foundation.

Drug-Coated Balloons: Hope or Hot Air: Update on the Role of Coronary DCB.

PURPOSE OF REVIEW: The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices. RECENT FINDINGS: DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty.

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV). BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy. METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years. RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p < 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cm2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.

Drug-Coated Balloons: Hope or Hot Air: Update on the Role of Coronary DCB

Purpose of review: The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices. Recent findings: DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results.

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.

Perspectivas futuras e novos dispositivos transcateter no tratamento da estenose aórtica / Future perspectives and new transcatheter devices in the treatment of aortic tenosis

O implante de prótese valvar aórtica por cateter (TAVI, do inglês transcatheter aortic valve implantation) constitui o tratamento de escolha para pacientes com estenose aórtica considerada inoperável e surge como opção terapêutica à cirurgia em indivíduos com alto e moderado risco operatório. Embora excelentes resultados clínicos sejam obtidos com as próteses primeiramente disponibilizadas para uso clínico, a ocorrência de complicações ­ como acidente vascular cerebral (AVC), regurgitação (leak) paraprotética, distúrbios de condução com implante de marca-passo (MP) e complicações vasculares ­ deve ser prevenida. As novas próteses têm como características primordiais: menor calibre dos instrumentais, implante valvar mais seguro e previsível e a incorporação de características no arcabouço das próteses que reduzam a ocorrência de refluxo paravalva

Transcatheter aortic valve implantation (TAVI) is the treatment of choice for patients with aortic stenosis that is considered inoperable, and has emerged as a treatment option to surgery in individuals with high to moderate surgical risk. Although excellent clinical results have been obtained with the prostheses primarily provided for clinical use, the occurrence of complications ­ such as cerebral stroke, paraprosthetic regurgitation (leak), pacemaker (MP) implant conduction disorders, and vascular complications ­ should be prevented. The main characteristics of the new prostheses are: narrower instruments, a safer, more predictable valve implant, and the incorporation of characteristics in the framework of the prostheses that reduce the occurrence of paravalvular leaks

Thrombus aspiration in STEMI patients: an updated systematic review and meta-analysis.

INTRODUCTION: Clinical efficacy and safety of adjunctive thrombus aspiration (TA) in patients with ST-segment elevation myocardial infarction (STEMI) during percutaneous coronary intervention (PCI) remain controversial. EVIDENCE ACQUISITION: Twenty-five eligible randomized controlled trials were included to compare the use of TA with PCI and PCI-only for STEMI. The primary endpoint was major adverse cardiac events (MACE) according to study definitions. The secondary endpoints were all-cause mortality, recurrent myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST) and stroke. EVIDENCE SYNTHESIS: In comparison with conventional PCI, TA followed by PCI was associated with a lower risk for MACE with statistical significance [relative risk (RR): 0.91; 95% confidence interval (CI): 0.83-0.99; P=0.04). Regarding secondary endpoints, there was a significant increase in the risk for stroke (RR: 1.56; 95% CI: 1.09-2.24; P=0.015); there were no differences in the risk of all-cause mortality (RR: 0.88; 95% CI: 0.78-1.01; P=0.06), myocardial infarction (RR: 0.94; 95% CI: 0.79-1.13; P=0.537), target vessel revascularization (RR: 0.92; 95% CI: 0.82-1.04; P=0.177), and definite or probable stent thrombosis (RR: 0.84; 95% CI: 0.66-1.07; P=0.151). CONCLUSIONS: Updated data about routine TA-assisted PCI in STEMI showed reduced risk of subsequent MACE in comparison with conventional primary PCI, but get limited benefits related to the clinical endpoints, and may be associated with an increase in the risk of stroke. As a routine strategy, TA in patients with STEMI cannot be supported.

Prognostic value of renal function in patients with aortic stenosis treated with transcatheter aortic valve replacement.

OBJECTIVES: The objectives of the present study were to analyze the variation of renal function after transcatheter aortic valve replacement (TAVR) focused on acute kidney injury (AKI) and its impact on short- and mid-term mortality. BACKGROUND: Changes on renal function after TAVR and their impact on clinical outcomes are incompletely understood until now. METHODS: At two tertiary centers 221 consecutive patients were submitted to TAVR. Kidney injury was defined according to VARC-2 criteria. Patients were classified according to the presence (group 1) or absence (group 2) of AKI. Creatinine values were collected daily until seventh day after procedure, 1 month, 6 months, and then 1 year after TAVR. RESULTS: At baseline, groups were similar, except for EuroSCORE II (8.66% vs. 7.34%, P = 0.02) and glomerular filtration rate (GFR) (39.59 vs. 48.49 mL/min.1.73 m2 , P = 0.002). Overall 30 day-mortality and 1-year mortality were 6.3% and 14.0%, respectively. Both 30-day mortality (23.1% vs. 1.2%, P < 0.001) and 1-year mortality (44.2% vs. 4.7%, P < 0.001) were higher in group 1. After multivariable-adjusted models, the only independent predictor for AKI after TAVR was baseline GFR (HR: 1.37, 95% CI: 1.08-1.77, P = 0.01). The independent risk factors for 1-year mortality were AKI (HR: 15.66, 95% CI: 6.07-44.63, P < 0.001), COPD (HR: 3.14, 95% CI: 1.05-9.40, P = 0.04) and aortic regurgitation grade postprocedure ≥ 2 (P = 0.05) also after multivariate analysis. CONCLUSIONS: In this TAVR cohort, baseline GFR was the only independent predictor of AKI, which negatively impacted on 30-day and 1-year mortality. © 2016 Wiley Periodicals, Inc.

Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis.

OBJECTIVE: We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS). BACKGROUND: Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT. METHODS: We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria. RESULTS: A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups. CONCLUSIONS: In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc.

Prognostic value of renal function in patients with aortic stenosis treated with transcatheter aortic valve replacement

OBJECTIVES: The objectives of the present study were to analyze the variation of renal function after transcatheter aortic valve replacement (TAVR) focused on acute kidney injury (AKI) and its impact on short- and mid-term mortality. BACKGROUND: Changes on renal function after TAVR and their impact on clinical outcomes are incompletely understood until now. METHODS: At two tertiary centers 221 consecutive patients were submitted to TAVR. Kidney injury was defined according to VARC-2 criteria. Patients were classified according to the presence (group 1) or absence (group 2) of AKI. Creatinine values were collected daily until seventh day after procedure, 1 month, 6 months, and then 1 year after TAVR.RESULTS:At baseline, groups were similar, except for EuroSCORE II (8.66% vs. 7.34%, P = 0.02) and glomerular filtration rate (GFR) (39.59 vs. 48.49 mL/min.1.73 m2 , P = 0.002). Overall 30 day-mortality and 1-year mortality were 6.3% and 14.0%, respectively. Both 30-day mortality (23.1% vs. 1.2%, P < 0.001) and 1-year mortality (44.2% vs. 4.7%, P < 0.001) were higher in group 1. After multivariable-adjusted models, the only independent predictor for AKI after TAVR was baseline GFR (HR: 1.37, 95% CI: 1.08-1.77, P = 0.01). The independent risk factors for 1-year mortality were AKI (HR: 15.66, 95% CI: 6.07-44.63, P < 0.001), COPD (HR: 3.14, 95% CI: 1.05-9.40, P = 0.04) and aortic regurgitation grade postprocedure ≥ 2 (P = 0.05) also after multivariate analysis...

Impact of the occlusion duration on the performance of j-cto score in predicting failure of percutaneous coronary intervention for chronic total occlusion

Abstract: 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; P0.70...

Embolic protection devices in percutaneous coronary intervention.

Clinical benefit of percutaneous coronary intervention (PCI) depends on both angiographic success at lesion site as well as the restoration of adequate macro and microvascular perfusion. The pathophysiology of embolization from coronary lesions during PCI is multifactorial, being more frequently observed in patients with acute coronary syndrome and in those with lesions at saphenous vein graft (SVG). In this population, despite successful epicardial intervention, distal tissue perfusion may still be absent in up to a quarter of all PCI. Multiple devices and pharmacologic regimens have been developed and refined in an attempt to protect the microvascular circulation during PCI. Among them, embolic protection devices have raised as an attractive adjunctive toll due to their ability to retain debris and potentially prevent distal embolization, reducing major adverse cardiac events. Currently, their use has been validated for the treatment of SVG lesions but failed to show effectiveness in the percutaneous approach of acute coronary syndrome patients, including those with ST elevation myocardial infarction.

Embolic protection devices in percutaneous coronary intervention

Clinical benefit of percutaneous coronary intervention (PCI) depends on both angiographic success at lesion site as well as the restoration of adequate macro and microvascular perfusion. The pathophysiology of embolization from coronary lesions during PCI is multifactorial, being more frequently observed in patients with acute coronary syndrome and in those with lesions at saphenous vein graft (SVG). In this population, despite successful epicardial intervention, distal tissue perfusion may still be absent in up to a quarter of all PCI. Multiple devices and pharmacologic regimens have been developed and refined in an attempt to protect the microvascular circulation during PCI. Among them, embolic protection devices have raised as an attractive adjunctive toll due to their ability to retain debris and potentially prevent distal embolization, reducing major adverse cardiac events. Currently, their use has been validated for the treatment of SVG lesions but failed to show effectiveness in the percutaneous approach of acute coronary syndrome patients, including those with ST elevation myocardial infarction.