Concordance between vessel-specific and vascular territory coronary functional assessment: A comparison of quantitative flow ratio and myocardial perfusion scintigraphy.

BACKGROUND: Quantitative flow ratio (QFR) and myocardial perfusion scintigraphy (MPS) are utilized for assessing coronary artery disease (CAD) significance. We aimed to analyze their concordance and prognostic impact. AIMS: We aimed to analyze the concordance between QFR and MPS and their risk stratification. METHODS: Patients with invasive coronary angiography and MPS were categorized as concordant if QFR ≤ 0.80 and summed difference score (SDS) ≥ 4 or if QFR > 0.80 and SDS < 4; otherwise, they were discordant. Concordance was classified by coronary territory involvement: total (three territories), partial (two territories), poor (one territory), and total discordance (zero territories). Leaman score assessed coronary atherosclerotic burden. RESULTS: 2010 coronary territories (670 patients) underwent joint QFR and MPS analysis. MPS area under the curve for QFR ≤ 0.80 was 0.637. Concordance rates were total (52.5%), partial (29.1%), poor (15.8%), and total discordance (2.6%). Most concordance occurred in patients without significant CAD or with single-vessel disease (89.5%), particularly without MPS perfusion defects (91.5%). Leaman score (odds ratio [OR]: 0.839, 95% confidence interval [CI]: 0.805-0.875, p < 0.001) and MPS perfusion defect (summed stress score [SSS] ≥ 4) (OR: 0.355, 95% CI: 0.211-0.596, p < 0.001) were independent predictors for discordance. After 1400 days, no significant difference in death/myocardial infarction was observed based on MPS assessment, but Leaman score, functional Leaman score, and average QFR identified higher risk patients. CONCLUSIONS: MPS showed good overall accuracy in assessing QFR significance but substantial discordance existed. Predictors for discordance included higher atherosclerotic burden and MPS perfusion defects (SSS ≥ 4). Leaman score, QFR-based functional Leaman score, and average QFR provided better risk stratification for all-cause death and myocardial infarction than MPS.

Offline Assessment of the Quantitative Flow Ratio: Is it Useful in Clinical Practice?

INTRODUCTION: Fractional flow reserve (FFR) has been established as the gold standard in the physiological assessment of coronary obstructions severity. However, the need to insert an intracoronary pressure guidewire is a factor that limits its use. Quantitative flow ratio (QFR) is a method that infers the value of FFR from 3-dimensional quantitative coronary angiography (3D-QCA), eliminating the use of a pressure wire and coronary hyperemia. The present study aims to evaluate the diagnostic accuracy of QFR and 3D-QCA in comparison with FFR for the identification of significant obstructive coronary lesions (FFR ≤.80) and the feasibility to assess QFR in a cohort of patients without dedicated angiographic acquisition. METHODS: Consecutive patients with coronary angiography with moderate obstructive lesions that had previous FFR measurement were evaluated. Validation of QFR was assessed by the area under the curve (AUC) and other statistical tools, using FFR as the reference method. RESULTS: Seventy-five arteries from 69 patients were evaluated. The accuracy of the QFR to detect FFR ≤.80 was 84.0% (95% confidence interval, 75.6-92.4). The correlation and agreement between FFR and QFR were r=0.54 (P<.01) and mean difference was -0.02 ± 0.09 (P=.09), respectively. The AUC of QFR and 3D-QCA identifying stenosis >50% was 0.854 and 0.755, respectively (P=.09). CONCLUSION: QFR demonstrated good accuracy compared with FFR for the assessment of moderate obstructive coronary lesions in an unselected clinical practice population. However, many patients were excluded from the analysis and there was no statistical difference between the receiver operator characteristic curves of the QFR and percent diameter stenosis.

Seattle Angina Pectoris Questionnaire and Canadian Cardiovascular Society Angina Categories in the Assessment of Total Coronary Atherosclerotic Burden.

The patient reported angina measurement with the Seattle Angina Questionnaire (SAQ) has shown to have prognostic implications and became an endpoint in clinical trials. Our objective was to study physician-reported and SAQ severity with the total coronary atherosclerotic burden as assessed by 4 angiographic scores. We prospectively analyzed data of consecutive patients scheduled for coronary angiography or percutaneous coronary intervention. The Canadian Cardiovascular Society (CCS) angina categories was used as physician-reported angina. SAQ domains were categorized as severe (0 to 24), moderate 25 to 75 and mild angina (>75). All angina assessments were done before coronary angiography. Gensini, Syntax, Friesinger, and Sullivan angiographic scores were used for total atherosclerotic burden quantification: 261 patients were included in the present analysis. The median age was 66.0 (59.0 to 71.8) years, 53.6% were male and 43.7% had diabetes. The median SYNTAX score was 6.0 (0 to 18.0). The worse the symptoms of CCS categories, the more severe was the atherosclerotic burden in all angiographic scores: SYNTAX (p = 0.01); Gensini (p <0.01); Friesinger (p = 0.02) and Sullivan (p = 0.03). Conversely, SAQ domains were not able to discriminate the severity of CAD in any of the scores. The only exception was the severe SAQ quality of life that had worse Gensini score than the mild SAQ quality of life (p = 0.04). In conclusion, CCS angina categories are related to the total atherosclerotic burden in coronary angiography, by all angiographic scores. SAQ domains should be used as a measure of patient functionality and quality of life but not as a measure of CAD severity.

Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial).

Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is used for treating coronary lesions. However, the natural history of the jailed side-branch (SB) after DREAMS 2G implantation remains to be elucidated. The aim of this study is to investigate the effect of scaffold struts on jailed SBs as assessed by 3-dimensional (3D) optical coherence tomography (OCT) after implantation of DREAMS 2G. We enrolled the patients who received a DREAMS 2G implantation and where OCT was performed at postprocedure and 12-month follow-up in the BIOSOLVE-II trial. The area of the ostium of jailed SBs and number of compartments divided by scaffold struts were assessed by cut-plane analysis using 3D OCT. A total of 24 patients with 61 jailed SBs were analyzed in this study. The number of compartments was significantly decreased (postprocedure; 1.98 ± 0.84 vs 12 months; 1.10 ± 0.30, p <0.001) during the 12 months. Since most of the struts disappeared, the ostium area was increased in 62% of jailed SBs at 12 months, however, not significantly different from postprocedure (postprocedure; 0.74 [0.34 to 1.46] mm2 vs 12 months; 0.78 [0.41 to 1.68] mm2, p = 0.055). The number of compartments created by scaffold struts and branching angle at postprocedure had no effect on the changes of SB ostium area. DREAMS 2G has a favorable absorption process in the jailed SBs up to 12 months and may be considered as an optional therapy for treating lesions that involve SBs.

The Role of Quantitative Aortographic Assessment of Aortic Regurgitation by Videodensitometry in the Guidance of Transcatheter Aortic Valve Implantation.

BACKGROUND: Balloon post-dilatation (BPD) is often needed for optimizing transcatheter heart valve (THV) implantation, since paravalvular leak (PVL) after transcatheter aortic valve implantation is associated with poor outcome and mortality. Quantitative assessment of PVL severity before and after BPD is mandatory to properly assess PVL, thus improving implantation results and outcomes. OBJECTIVE: To investigate a quantitative angiographic assessment of aortic regurgitation (AR) by videodensitometry before and after BPD. METHODS: Videodensitometric-AR assessments (VD-AR) before and after BPD were analysed in 61 cases. RESULTS: VD-AR decreased significantly from 24.0[18.0-30.5]% to 12.0[5.5-19.0]% (p < 0.001, a two-tailed p < 0.05 defined the statistical significance). The relative delta of VD-AR after BPD ranged from -100% (improvement) to +40% (deterioration) and its median value was -46.2%. The frequency of improvement, no change, and deterioration were 70% (n = 43), 25% (n = 15) and 5% (n = 3), respectively. Significant AR (VD-AR > 17%) was observed in 47 patients (77%) before and in 19 patients (31%) after BPD. CONCLUSIONS: VD-AR after THV implantation provides a quantitative assessment of post-TAVI regurgitation and can help in the decision-making process on performing BPD and in determining its efficacy.

The Role of Quantitative Aortographic Assessment of Aortic Regurgitation by Videodensitometry in the Guidance of Transcatheter Aortic Valve Implantation / Papel da Avaliação Aortográfica Quantitativa da Regurgitação Aórtica por Videodensitometria na Orientação do Implante da Valva Aórtica Transcateter

Abstract Background: Balloon post-dilatation (BPD) is often needed for optimizing transcatheter heart valve (THV) implantation, since paravalvular leak (PVL) after transcatheter aortic valve implantation is associated with poor outcome and mortality. Quantitative assessment of PVL severity before and after BPD is mandatory to properly assess PVL, thus improving implantation results and outcomes. Objective: To investigate a quantitative angiographic assessment of aortic regurgitation (AR) by videodensitometry before and after BPD. Methods: Videodensitometric-AR assessments (VD-AR) before and after BPD were analysed in 61 cases. Results: VD-AR decreased significantly from 24.0[18.0-30.5]% to 12.0[5.5-19.0]% (p < 0.001, a two-tailed p < 0.05 defined the statistical significance). The relative delta of VD-AR after BPD ranged from -100% (improvement) to +40% (deterioration) and its median value was -46.2%. The frequency of improvement, no change, and deterioration were 70% (n = 43), 25% (n = 15) and 5% (n = 3), respectively. Significant AR (VD-AR > 17%) was observed in 47 patients (77%) before and in 19 patients (31%) after BPD. Conclusions: VD-AR after THV implantation provides a quantitative assessment of post-TAVI regurgitation and can help in the decision-making process on performing BPD and in determining its efficacy.

Resumo Fundamento: A pós-dilatação com balão (PDB) é normalmente necessária para otimização do implante da válvula cardíaca transcateter (THV), uma vez que o "escape" ou leak paravalvar (PVL) após implante de valva aórtica transcateter está associada com desfecho ruim e mortalidade. A avaliação quantitativa da gravidade do PVL antes e após a PDB é mandatória para se avaliar adequadamente o PVL e, assim, melhorar os resultados e os desfechos do implante. Objetivo: Investigar uma avalição angiográfica quantitativa da regurgitação aórtica (RA) por videodensitometria (VD-RA) antes e após a PDB. Métodos: Resultados da VD-RA antes e após a PDB foram analisados em 61 casos. Resultados Houve diminuição significativa da VD-RA de 24,0(18,0-30,5)% para 12,0(5,5-19,0)% (p < 0,001; p < 0,05 bilateral foi definido como significância estatística). O delta relativo de VD-RA após a PDB variou de -100% (melhora) a +40% (piora) e o valor mediano foi -46,2%. As frequências de melhora, ausência de mudança, e piora foram 70% (n = 43), 25% (n = 15) e 5% (n = 3), respectivamente. Observou-se RA significativo (VD-RA > 17%) em 47 pacientes (77%) antes e em 19 pacientes (31%) após a PDB. Conclusões: A VD-RA após o implante de THV possibilita a avaliação quantitativa da regurgitação pós-TAVI, e pode auxiliar na tomada de decisão quanto à realização ou não da PDB, bem como na avaliação de sua eficácia.

Assessment of long-term mortality in patients with complex coronary artery disease undergoing percutaneous intervention: comparison of multiple anatomical and clinical prognostic risk scores.

AIMS: Three-vessel and left main coronary artery disease (CAD) have important prognostic implications. Consequently, numerous risk scores have been developed to stratify patients with complex CAD. The aim of the present study was to compare the predictive performance of six risk scores for occurrence of fouryear all-cause mortality. METHODS AND RESULTS: From March 2008 to December 2012, 348 consecutive patients with complex CAD undergoing percutaneous coronary intervention (PCI) in a tertiary centre in São Paulo, Brazil, were analysed. Four-year mortality was assessed. The scores compared were: baseline SYNTAX score (SS), residual SYNTAX score (rSS), ACEF score, clinical SYNTAX score (cSS), SYNTAX revascularisation index (SRI) and SYNTAX score II (SSII). SSII had the best predictive performance, AUC 0.82, Brier score 0.10, surpassing all the other scores for long-term mortality prediction. Moreover, SSII discriminated well PCI patients in risk groups with p<0.01 for four-year all-cause mortality. The ACEF score (AUC 0.77) and the cSS (AUC 0.78) were significantly better than the SS (AUC 0.65), SRI (AUC 0.60) or the rSS (AUC 0.55). CONCLUSIONS: For patients with complex CAD treated by PCI, the combination of baseline clinical and angiographic factors provided better risk assessment. The SSII demonstrated the most precise predictive performance for long-term mortality.

Angiographic assessment of aortic regurgitation by video-densitometry in the setting of TAVI: Echocardiographic and clinical correlates.

OBJECTIVES: We sought to investigate a new angiographic method for aortic regurgitation (AR) severity assessment in the setting of transcatheter aortic valve implantation (TAVI). BACKGROUND: AR after TAVI is common but challenging to quantitate, especially in the cath-lab. METHODS: In 228 patients, AR was quantitated before and after TAVI by echocardiography and by video-densitometric analysis of aortograms. Contrast time-density curves for the aortic root (the reference region) and the left ventricular outflow tract, LVOT were generated. LVOT-AR was calculated as the area under the curve of the LVOT as a fraction of the area under the curve of the reference region. RESULTS: LVOT-AR was 0.10 ± 0.08, 0.13 ± 0.10 and 0.28 ± 0.14 in none-trace, mild and moderate-severe post-TAVI AR as defined by echocardiography (P < 0.001) and a cutpoint of >0.17 corresponded to moderate-severe AR on echocardiography (area under the curve = 0.84). At follow-up (median, 496 days), patients with LVOT-AR ≤ 0.17 showed a significant reduction of LV mass index (LVMi; 121 [95-148] vs. 140 [112-169] g/m2 , P = 0.009) and the prevalence of LV hypertrophy (LVH; 64 vs. 88%, P = 0.001) compared to baseline. In patients with LVOT-AR > 0.17, LVMi (149 [121-178] vs. 166 [144-188] g/m2 , P = 0.14) and the prevalence of LVH (74 vs. 87%, P = 0.23) did not show a significant change. Compared to patients with LVOT-AR ≤ 0.17, those with LVOT-AR > 0.17 had an increased 30-day (16.4% vs. 7.1%, P = 0.035) and one year mortality (32.9 vs. 14.2%, log rank P value = 0.001; HR: 2.690 [1.461-4.953], P = 0.001). CONCLUSIONS: LVOT-AR > 0.17 corresponds to greater than mild AR as defined by echocardiography and predicts impaired LV reverse remodeling and increased early and midterm mortality after TAVI. © 2017 Wiley Periodicals, Inc.

Gender-related differences on short- and long-term outcomes of patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to compare gender-related differences in outcomes of patients undergoing TAVI over a long-term follow-up period. BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been considered the standard therapy for patients with inoperable or high-risk symptomatic aortic stenosis. The influence of gender-related differences in outcomes of patients undergoing TAVI is currently on debate. METHODS: From January 2008 to January 2015, 819 patients (49% men) underwent TAVI and were included in a multicenter Brazilian registry. Patients were followed-up and clinical outcomes were evaluated according to the updated Valve Academic Research Consortium-2 criteria. RESULTS: Mean follow-up was 497 ± 478 days. Compared with women, men had a lower rate of major or life-threatening bleeding (12.0% vs. 20.6%; HR = 0.57 [95CI% 0.40-0.81]; P = 0.001), and major vascular complications (6% vs. 11.7%; HR = 0.50 [95CI% 0.31-0.82]; P = 0.004). At 30 days, all-cause mortality was lower in men than in women (6.5% vs. 11.5%; P = 0.013), however, cumulative all-cause mortality was similar between groups (25.9% vs. 29.7%, men and women, respectively, HR = 0.92 [95CI% 0.71-1.19]; P = 0.52) over the entire follow-up period. By adjusted Cox regression model, renal function, diabetes, peripheral artery disease, and chronic obstructive pulmonary disease (COPD) remained independently predictors of all-cause mortality. CONCLUSIONS: In this large-scale study evaluating patients undergoing TAVI, 30-day mortality was higher among women than men driven by significant higher rates of major or life-threatening bleeding and major vascular complications. However, all-cause mortality on long-term follow-up was similar between groups. © 2016 Wiley Periodicals, Inc.

Role of invasive imaging in acute and long-term assessment of bioresorbable scaffold technology.

Fully bioresorbable scaffolds (BRS) represent a novel approach for the percutaneous treatment of coronary artery stenosis, providing temporary vessel scaffolding with drug-eluting capability during the restenosis-prone phase of the vascular healing. Beyond this initial critical period, when mechanical scaffolding support is no longer necessary, the device is bioresorbed, restoring the normal vascular physiology with the aim to eliminate the long-term safety concerns related to permanent metallic implants. Nonetheless, current BRS technology suffers from limited mechanical properties as compared to available metallic platforms, requiring careful attention to lesion preparation, accurate vessel sizing, and implantation technique. Intravascular imaging has played an important role in providing knowledge on the acute effects after BRS deployment, and it helped refine the current technique of BRS implantation. In addition, extensive work with multiple intravascular imaging modalities have also contributed to the understanding of the unique dynamic vascular changes that are experienced in the treated segment from post-implantation up to complete device bioresorption. In this manuscript, we review the role of invasive imaging modalities-from angiography to sound- and light-based techniques-to guide BRS implantation procedures, to assess its acute results postimplantation, and the changes experienced in the long-term until complete bioresorption has ensued. © 2016 Wiley Periodicals, Inc.

First-in-man assessment of the InSeal VCD, a novel closure device for large puncture accesses.

AIMS: To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large puncture holes following percutaneous structural interventions. METHODS AND RESULTS: Prospective, non-randomised, single-arm, single-centre study with a series of patients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheter aortic valve implantation in whom the InSeal VCD was used to close the access site. These patients were followed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primary endpoint was the occurrence of major vascular complications at the puncture site. From a total of nine patients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes were achieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascular complications were observed during the follow-up period. Average ankle-brachial index pre-intervention and at one-month follow-up were 0.85 and 0.82, respectively. CONCLUSIONS: The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis after usage of higher profile endovascular devices in this study. These results translated into no clinical complications up to one-year clinical follow-up.

Intervenção coronária percutânea pelas vias radial e femoral: comparação entre desconfortos relacionados ao procedimento e custos / Percutaneous coronary intervention using the radial and femoral approaches: comparison between procedure-related discomforts and costs

INTRODUÇÃO: Escassos são os estudos a respeito da Qualidade de Vida pós-intervenção coronária percutânea (ICP), pelas vias radial e femoral, e dos gastos comparando as duas vias de acesso. Comparamos os desconfortos relacionados ao procedimento e os custos da ICP pelos acessos radial e femoral na fase hospitalar. MÉTODOS: Registro prospectivo, unicêntrico, que incluiu pacientes submetidos à ICP eletiva. As queixas relacionadas ao procedimento foram avaliadas ao final do período de repouso no leito, por meio de um questionário específico. Foram computados os custos por unidade de todo o material utilizado na ICP. RESULTADOS: Os pacientes tratados por via radial eram mais jovens, do sexo masculino e a angina estável foi o quadro clínico mais frequentemente tratado nos dois grupos. O tempo de exame, o número de vasos tratados e stents por paciente foram semelhantes entre os grupos. Não ocorreram complicações vasculares maiores após a ICP. Observamos maior desconforto geral associado ao procedimento (60,3% vs. 81,0%; P = 0,01), dor nas costas (1,7% vs. 17,2%; P < 0,01), dificuldade para urinar (1,7% vs. 12,1%; P = 0,03) e dependência do paciente para desempenhar atividades básicas (70,7% vs. 98,3%; P < 0,01) durante o período de observação no grupo femoral. Na comparação dos gastos, não foram notadas diferenças significantes entre os grupos, com ou sem a inclusão dos custos dos stents. CONCLUSÕES: A ICP por via radial demonstrou trazer maior conforto para o paciente comparada à via femoral, durante a fase hospitalar. Os custos dos procedimentos pelas duas vias de acesso foram semelhantes.

BACKGROUND: There are few studies on quality of life and costs after percutaneous coronary intervention (PCI) using different vascular accesses. We have compared procedure-related discomforts and costs of PCI using the radial or femoral approaches during hospital stay. METHODS: Prospective, single center registry, including patients undergoing elective PCI. Procedure related complaints were assessed at the end of bed rest using a specific questionnaire. Costs per unit of all the materials used in PCI were taken into account. RESULTS: Patients treated by the radial approach were younger, male, and stable angina was the most common clinical presentation in both groups. Procedural duration, number of vessels treated and stents per patient were similar in both groups. There were no major vascular complications after PCI. We observed greater overall discomfort associated with the procedure (60.3% vs. 81.0%; P = 0.01), back pain (1.7% vs. 17.2%; P < 0.01), difficult urination (1.7% vs. 12.1%; P = 0.03) and patient's dependence to carry on basic activities (70.7% vs. 98.3%; P < 0.01) during the post-procedural observation period in the femoral group. No significant differences were observed between groups when costs were compared, with or without taking into account stent-related costs. CONCLUSIONS: PCI using the radial approach demonstrated to provide greater comfort for patients when compared to the femoral approach during hospitalization. Costs of the procedure using the two accesses were similar.

Serial greyscale and radiofrequency intravascular ultrasound assessment of plaque modification and vessel geometry at proximal and distal edges of bare metal and first-generation drug-eluting stents.

BACKGROUND: Little is known about the correlation between modifications in plaque composition at stent edges and the changes in vessel geometry. This study sought to evaluate, by serial greyscale intravascular ultrasound (IVUS) and Virtual Histology intravascular ultrasound (VH-IVUS), the modifications in plaque composition at the edges of drug-eluting and bare metal stents and the correlation of these findings with changes in the measurements of vessel, lumen and plaque area at those segments. METHODS AND RESULTS: Single-centre, prospective and randomised (1:1) evaluation of 40 patients with acute coronary syndrome treated with bare metal (Driver; Medtronic, Santa Clara, CA, USA; n=20 patients) or drug-eluting stents (Cypher; Cordis, Miami Lakes, FL, USA; n=20 patients). IVUS and VH-IVUS assessments were done post-procedure and at nine months. Primary endpoint included the modification in vessel, lumen and plaque area and in the composition of the plaque in the mean time between the baseline and follow-up procedure. At the proximal edge of the vessel treated with the Cypher stent, a trend toward positive vessel remodelling (D=+0.6 mm², p=0.06) was observed while at the distal edge, less plaque growth (D=+0.2 mm² vs. D=+1.1 mm², p<0.001), resulted in a larger lumen area at follow-up. By VH, there was a marked reduction in the percentage of fibrotic tissue and necrotic core at the edges of both stents and a positive correlation was seen between increase in percentage of fibro-fatty component and increase in plaque area (r=0.78, p=0.01). CONCLUSION: Patients treated with drug-eluting stents (DES) experienced less plaque growth, especially at the distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty tissue component, may partially explain these findings.

Incidência, manejo e prognóstico de perfurações coronárias / Incidence, management and prognosis of coronary perforations

INTRODUÇÃO: A perfuração coronária na atualidade é complicação rara, mas potencialmente catastrófica. Nosso objetivo foi avaliar a incidência, os preditores, o manejo e o prognóstico das perfurações coronárias na experiência de um serviço de cardiologia intervencionista com grande volume de intervenções coronárias percutâneas (ICPs). MÉTODOS: Comparamos as características clínicas, angiográficas e do procedimento e a evolução intra-hospitalar de pacientes que apresentaram ou não perfuração coronária. Análise univariada foi realizada para determinar os preditores dessa complicação. RESULTADOS: No período de dezembro de 2007 a janeiro de 2012, 5.585 pacientes consecutivos foram submetidos a ICP e 18 apresentaram perfuração coronária (0,32%), dos quais 55,5% eram do sexo feminino e 38,9% eram diabéticos. Nesse grupo, a artéria descendente anterior foi o vaso mais frequentemente tratado (61,1%), assim como a lesão do tipo C (61,1%), e as oclusões crônicas foram abordadas em 27,8% desses casos. A maioria das perfurações coronárias (11/18) apresentou menor complexidade de acordo com a classificação de Ellis modificada, enquanto as demais foram qualificadas como graus III (6/18) ou IV (1/18). O cateter-balão foi o dispositivo responsável pela perfuração em 61,1% dos casos. Realizou-se insuflação prolongada com cateter-balão e inativação da heparina com protamina em 72,2% e 88,9% dos casos, respectivamente. Apenas 1 paciente (5,6%) necessitou de abordagem cirúrgica de emergência em decorrência de tamponamento cardíaco. Não houve óbito associado à perfuração coronária. Na análise univariada, os preditores de perfuração coronária foram: sexo feminino (P = 0,03), doença pulmonar obstrutiva crônica (P = 0,006) e oclusão crônica (P < 0,01). CONCLUSÕES: Em nossa experiência, a perfuração coronária foi evento raro, controlada conservadoramente na maioria dos casos e com evolução hospitalar satisfatória.

BACKGROUND: Coronary perforation is currently a rare, but potentially catastrophic complication. The aim of the study was to evaluate the incidence, predictors, management and prognosis of coronary perforations at a hospital with a large number of percutaneous coronary interventions (PCIs). METHODS: Clinical, angiographic, procedural and in-hospital outcomes of patients with or without coronary perforations were compared. Univariate analysis was performed to determine the predictors of this complication. RESULTS: From December 2007 to January 2012, 5,585 consecutive patients were submitted to PCI and 18 had coronary perforation (0.32%), of whom 55.5% were female and 38.9% were diabetic. In this group, the left anterior descending artery was the most frequently treated vessel (61.1%) as well as type C lesion (61.1%) and chronic occlusions were approached in 27.8% of these cases. Most of the coronary perforations (11/18) had a lower complexity according to the modified Ellis classification, whereas the remaining perforations were classified as grades III (6/18) or IV (1/18). The balloon-catheter device was responsible for perforation in 61.1% of the cases. Prolonged inflation with a balloon-catheter and heparin reversal with protamine was performed in 72.2% and 88.9% of the cases, respectively. Only 1 patient (5.6%) required an emergency surgery due to cardiac tamponade. There were no deaths associated with coronary perforation. According to the univariate analysis, coronary perforation predictors were: female gender (P = 0.03), chronic obstructive pulmonary disease (P = 0.006) and chronic occlusion (P < 0.01). CONCLUSIONS: In our experience, coronary perforation was a rare event, which was managed conservatively in most of the cases and was associated with a good in-hospital outcome.

First nine-month complete invasive assessment (angiography, IVUS, and OCT) of the novel NEVO sirolimus-eluting stent with biodegradable polymer.

At present, percutaneous coronary intervention with drug-eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long-term safety of first-generation DES have prompted the development of novel DES systems such as the NEVO (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus-eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res-Elution I study.

Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions.

BACKGROUND: Despite the advances in interventional cardiology, stent expansion remains an important predictor of success, impacting restenosis and thrombosis rates after either bare-metal (BMS) or drug-eluting stent implantation. Especially for the treatment of complex lesions (e.g., calcified lesions, in-stent restenosis, etc.), adequate lesion preparation might help improve procedural results as well as clinical outcomes. We sought to investigate the safety, feasibility and mechanism of action of a new scoring-balloon catheter, the AngioSculpt, comprised of a semicompliant balloon and a nitinol spiral cage designed to address complex lesions. METHODS: A total of 60 consecutive patients at two centers were prospectively enrolled in this first-in-man coronary study and divided into two groups according to the type of lesion treated: Group I: patients with de novo coronary lesions (n = 47) as a pretreatment strategy before BMS implantation, and Group II: patients with BMS restenosis (n = 17) as a standalone therapy. A subgroup of patients in each cohort was assigned to intravascular (IVUS) analysis. Patients in Group II were submitted to routine 6-month follow-up angiography. In Group I, angiographic restudy was contingent upon the presence of ischemia. Lesions longer than 20 mm in very tortuous vessels, in arterial or vein grafts, in the setting of acute myocardial infarction or with visible thrombus were excluded from this study. RESULTS: Success was achieved in all cases. The mean age of the study populations was 62 +/- 11.6 years (Group I) and 53 +/- 9.4 years (Group II), with 26% and 18% diabetics, respectively. In Group I, 73% of lesions were diffuse and fibrocalcified, while in Group II, 72% were classified as diffuse. No serious complications were observed in either group. Balloon slippage (or the "watermelon seed" phenomenon) was not observed. Significant acute gain was achieved in both groups (0.7 mm in Group I and 1.64 mm in Group II). A minimum final area (in-stent) 6.5 mm2 was achieved in 85% of the cases in Group I and in 82% of the cases in Group II. CONCLUSIONS: In this preliminary in vivo study, the use AngioSculpt(R) proved to be feasible and safe for the treatment of complex coronary lesions. Six-month results suggest the use of this novel device as an attractive option for the percutaneous approach of restenotic coronary lesions and should be assessed in a larger, more complex cohort of patients.

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.