José Mariani

Intravascular Ultrasound Guidance to Minimize the Use of Iodine Contrast in Percutaneous Coronary Intervention: The MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) Randomized Controlled Trial

Objective To evaluate the impact of IVUS guidance on the final volume of contrast agent utilized in patients undergoing PCI.

Transcatheter aortic valve implantation with a self-expanding nitinol bioprosthesis: prediction of the need for permanent pacemaker using simple baseline and procedural characteristics.

Objective: To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self‐expanding aortic bioprosthesis. Background: TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post‐procedural conduction abnormalities and frequent need for PPM. Methods: Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12‐lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. Results: Patients exhibited high‐risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32–0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03–1.83). Conclusions: Conduction abnormalities are frequently observed after TAVI with self‐expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness.

Residual aortic regurgitation is a major determinant of late mortality after transcatheter aortic valve implantation.

aortic valve implantation Pedro A. Lemos ⁎, Francesco Saia , Jose Mariani Jr., Cinzia Marrozzini , Antonio Esteves Filho , Luiz J. Kajita , Cristina Ciuca , Nevio Taglieri , Barbara Bordoni , Carolina Moretti , Tullio Palmerini , Marianna D.A. Dracoulakis , Fabio B. Jatene , Roberto Kalil-Filho , Antonio Marzocchi c a Sirio-Libanes Hospital, Sao Paulo, Brazil b Heart Institute, University of Sao Paulo Medical School, Sao Paulo, Brazil c Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy d Irmandade da Santa Casa de Misericordia, Sao Paulo, Brazil

Implante transcateter de prótese valvular aórtica: perfil clínico e evolução de uma série consecutiva de 75 casos do registro conjunto Universidade de Bolonha/Hospital Sírio-Libanês

INTRODUCAO: O implante transcateter de protese valvular aortica (ITVA) tem sido utilizado em nosso meio e em diversos paises do mundo como alternativa ao tratamento conservador em pacientes com estenose aortica grave e elevado risco cirurgico. Objetivou-se descrever o perfil clinico basal e a mortalidade a curto e medio prazos de uma serie consecutiva de casos tratados com ITVA em dois centros localizados, respectivamente, na Italia e no Brasil. METODOS: A populacao de estudo foi composta pelos primeiros 75 pacientes consecutivos com estenose valvar aortica grave tratados com a protese Medtronic CoreValveTM Revalving System (MCV - Medtronic, Minneapolis, Estados Unidos). Tipicamente, a indicacao para o ITVA foi motivada pelo alto risco cirurgico. A media de idade era de 82 anos, 55% eram mulheres, um terco apresentava doenca pulmonar grave e 95% apresentavam insuficiencia cardiaca sintomatica. RESULTADOS: Apos o ITVA, houve reducao significativa do gradiente transvalvar aortico maximo (basal: 95,8 ± 32,3 mmHg; pos-procedimento: 18,5 ± 6,1 mmHg) e medio (basal: 45,9 ± 16,9 mmHg; pos-procedimento: 10,4 ± 5,2 mmHg) (P < 0,01 para ambos). Insuficiencia aortica moderada ou acentuada foi evidenciada em 7% dos casos apos ITVA. A taxa de sobrevida global aos 30 dias foi de 91,6% e aos 12 meses, de 79%. CONCLUSOES: O ITVA surge como um metodo terapeutico de grande relevância para portadores de estenose aortica de alto risco cirurgico. As taxas de sobrevida precoce e a medio prazo indicam o beneficio potencial do novo procedimento tambem para pacientes tratados no chamado mundo real.

Validation of coronary computed tomography angiography scores for non-invasive assessment of atherosclerotic burden through a comparison with multivessel intravascular ultrasound

AIMS While the atherosclerotic plaque volume can be manually quantified in coronary computed tomography angiography (CTA) it is impractical for clinical routine use. Several anatomical scores have been developed as surrogates for overall atherosclerotic burden in coronary CTA and even proven to be highly predictive for future adverse events. However, they have not been validated against the gold standard for atherosclerotic burden, intra-vascular ultrasound (IVUS). In the present study we have compared several coronary CTA scores with the coronary IVUS. METHODS AND RESULTS A total of 62 patients with diagnosed coronary disease scheduled for percutaneous intervention were prospectively enrolled. For all patients, coronary CTA and multivessel IVUS were obtained. Calcium score and 6 previously reported scores were calculated from coronary CTA imaging and compared to average IVUS-derived percent atheroma volume (PAV). On average, 3.8 ± 0.7 vessels, comprising 123.8 ± 31.3 mm in length, were imaged with IVUS per patient. All but one previously described scoring systems showed a significant association with IVUS-derived PAV. Among them, the SSS score demonstrated the strongest correlation with IVUS-PAV (r = 0.61, p < 0.001) and the greatest area under the ROC curve (C-statistic = 0.87), to predict a high PAV. CONCLUSIONS Most frequently used coronary CTA scores have a good correlation with global coronary atherosclerotic burden measured by multivessel IVUS derived atheroma volume. Among them, the SSS score shows the best performance being a good non-invasive alternative to IVUS for global coronary atherosclerotic burden assessment.

Implante transcateter de valva aórtica sem a necessidade de marca-passo definitivo em uma série de casos consecutivos: é possível predizer o risco de bloqueio atrioventricular?

INTRODUCAO: O implante transcateter de protese valvar aortica (ITVA) tem sido relatado, de forma crescente, como uma opcao terapeutica para pacientes com estenose aortica de elevado risco cirurgico. Embora eficaz e relativamente segura, o ITVA e atualmente associado a taxa de necessidade de marca-passo definitivo de 20% a 30%, com alguns preditores do risco dessa complicacao ja descritos na literatura METODO: Relatamos uma serie de 8 casos consecutivos de pacientes com estenose aortica tratados com ITVA (Corevalve Revalving, Medtronic Inc., Estados Unidos) RESULTADOS: Foram incluidos pacientes de alto risco cirurgico (na media, Escore STS = 22,9% e EuroSCORE = 27,2%). Todos os pacientes apresentavam pelo menos uma caracteristica preditora de bloqueio atrioventricular de alto grau apos o procedimento. A intervencao foi bem-sucedida em todos os pacientes, exceto em um caso que apresentou tamponamento e obito intra-hospitalar. O gradiente transaortico maximo reduziu-se de 91,3 ± 26,9 mmHg para 19,4 ± 6,3 mmHg. Apos a alta, o tempo de seguimento clinico variou de quatro semanas a doze meses. Durante o seguimento, nao houve obitos e nenhum paciente apresentou bloqueio atrioventricular de 2o ou 3o graus novo, com taxa zero de marca-passo definitivo CONCLUSAO: Embora o acaso possa explicar a ausencia de marca-passo definitivo na populacao do estudo, nossa experiencia inicial sugere que a necessidade de marca-passo apos ITVA nao e prontamente previsivel por meio dos preditores de risco atualmente descritos.

Clinical performance of a novel ultrathin strut, low-dose, sirolimus-eluting stent with abluminal-only biodegradable polymeric coating for patients undergoing percutaneous coronary intervention in the daily practice

BACKGROUND The present study aimed to evaluate the clinical performance, in the daily practice of a busy catheterization laboratory, of a novel drug-eluting stent (DES) built with an ultra-thin-strut metallic platform, eluting sirolimus at low doses, abluminal coated with biodegradable polymers, and mounted in a low-compliant delivery system. METHODS Prospective, single-arm study, comprising all consecutive patients undergoing percutaneous coronary intervention (PCI) with the Inspiron™ sirolimus-eluting stent (SES) (Scitech, Aparecida de Goiania, Brazil). The primary endpoint was the occurrence of major adverse cardiac events (MACE) [cardiac death, non-PCI related myocardial infarction (MI), or target vessel revascularization (TVR)]. RESULTS A total of 470 patients were included, from which 51.3% were diabetics, 33.8% had triple-vessel disease, 15.3% had heart failure, 38.9% had at least one bifurcation treated, 19.8% were treated for a bare metal stent restenosis, and 61.9% had at least one type C lesion; one or more of these features were found in 96.0%. At 300 days, the rate target lesion revascularization was 5.4% and the rate of MACE was 8.1%. The incidence of definite or probable stent thrombosis was 0.4%, with no cases between 30 and 300 days. CONCLUSIONS The novel stent is associated with excellent short and mid-term clinical outcomes in patients treated with PCI in the daily practice.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial

AIMS To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

A Novel Algorithm to Quantify Coronary Remodeling Using Inferred Normal Dimensions

Background Vascular remodeling, the dynamic dimensional change in face of stress, can assume different directions as well as magnitudes in atherosclerotic disease. Classical measurements rely on reference to segments at a distance, risking inappropriate comparison between dislike vessel portions. Objective to explore a new method for quantifying vessel remodeling, based on the comparison between a given target segment and its inferred normal dimensions. Methods Geometric parameters and plaque composition were determined in 67 patients using three-vessel intravascular ultrasound with virtual histology (IVUS-VH). Coronary vessel remodeling at cross-section (n = 27.639) and lesion (n = 618) levels was assessed using classical metrics and a novel analytic algorithm based on the fractional vessel remodeling index (FVRI), which quantifies the total change in arterial wall dimensions related to the estimated normal dimension of the vessel. A prediction model was built to estimate the normal dimension of the vessel for calculation of FVRI. Results According to the new algorithm, “Ectatic” remodeling pattern was least common, “Complete compensatory” remodeling was present in approximately half of the instances, and “Negative” and “Incomplete compensatory” remodeling types were detected in the remaining. Compared to a traditional diagnostic scheme, FVRI-based classification seemed to better discriminate plaque composition by IVUS-VH. Conclusion Quantitative assessment of coronary remodeling using target segment dimensions offers a promising approach to evaluate the vessel response to plaque growth/regression.

Early Removal of the Arterial Sheath After Percutaneous Coronary Intervention Using the Femoral Approach: Safety and Efficacy Study

ABSTRACT Introduction We evaluated the safety and efficacy of protamine administration, guided by activated clotting time, for the immediate femoral arterial sheath removal in patients undergoing percutaneous coronary intervention with unfractionated heparin in order to propose an algorithm for clinical practice. Methods Prospective study with consecutive patients with stable angina or low-to-moderate risk acute coronary syndrome. We compared patients with an early removal of the arterial sheath to those whose sheath removal was based on a standard protocol. Results The early removal group (n = 149) had lower access manipulation time than the conventional group (58.3 ± 21.4 minutes vs. 355.0 ± 62.9 minutes; p p p = 0.49). There was no stent thrombosis during hospitalization and no significant differences in the incidence of major vascular or bleeding events. The incidence of other bleeding events leading to a prolonged in-hospital length of stay was lower in the early removal group (1.3% vs. 5.1%; p = 0.05). Conclusions: The selective use of an approach for immediate femoral sheath removal, based on activated clotting time guidance and protamine administration, is a safe and effective option in patients undergoing percutaneous coronary intervention by femoral access.