Delayed left main coronary obstruction following transfemoral inovare transcatheter aortic valve replacement: A challenging case.

Coronary obstruction is an uncommon and severe complication after a transcatheter aortic valve replacement (TAVR), that occurs during the procedure in the vast majority of patients. In the present case even in the absence of classic risk factors, an acute coronary syndrome occurred one day after TAVR. Selective angiography revealed a severe left main ostium obstruction by the bulky native leaflet calcification. This is the first case of delayed presentation of coronary obstruction with a transfemoral balloon-expandable valve using the Inovare bioprosthesis (Braile Biomedica, Brazil). In addition, after drug-eluting stent placement in the left main coronary, intravascular ultrasound revealed severe stent underexpansion, so that a second layer of a bare-metal stent and high-pressure balloon post-dilatation was necessary to improve the final result. The patient was discharged after 7 days, and at the 6-month follow-up remained asymptomatic. .

Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Stents farmacológicos no mundo real: impacto de sua disponibilidade no perfil de pacientes tratados por meio de intervenção coronária percutânea em um Hospital Público / Drug-eluting stents in the real world scenario: the impact of their availability in the profile of patients treated percutaneously in a public hospital

Introdução: Pacientes submetidos a intervenção percutânea em hospitais públicos brasileiros não têm acesso aos stents farmacológicos. No início de 2006, participamos de um registro multicêntrico internacional que disponibilizava o uso rotineiro dessas próteses, no cenário do mundo real. Neste artigo, procuramos identificar os perfis clínico, angiográfico e do procedimento de pacientes consecutivamente tratados em períodos subseqüentes de dois meses, de acordo com a disponibilidade desses modelos, visando à identificação de eventuais alterações nesses perfis. Método: Estudo observacional de uma série de 471 pacientes, divididos em dois grupos: A, 229 casos dilatados na vigência da disponibilidade de stents farmacológicos; e B, 242 pacientes subseqüentes tratados da forma usual. Não houve critérios de inclusão/exclusão. Resultados: Stents farmacológicos foram mais implantados no grupo A (44% vs. 2%; p < 0,0001). No que se refere às características de base, observou-se predomínio significante de diabéticos dependentes de insulina em A (8% vs. 3%; p = 0,02), o mesmo ocorrendo com lesões-alvo tipos B2 ou C (73% vs. 57%; p < 0,0001), lesões situadas em bifurcações (15% vs. 9%; p = 0,02) e intervenções multiarteriais (15% vs. 6%; p = 0,003). A angiografia quantitativa identificou os casos de A como portadores de estenoses situadas em vasos de menor calibre (2,4 mm vs. 2,6 mm; p = 0,0004), também exibindo lesões mais longas (14,9 mm vs. 12,7 mm; p = 0,0008). Conclusões: A disponibilidade dos stents farmacológicos gerou alterações no perfil dos casos tratados, que passou a abordar situações mais predispostas à reestenose, como os diabéticos dependentes de insulina, os multiarteriais com lesões de alta complexidade e os portadores de lesões mais longas em vasos de fino calibre.

Introduction: Patients submitted to percutaneous intervention in public hospitals in Brazil have no access to DES. At the beginning of 2006, we participated in an international multicenter registry which made available the routine use of these prosthesis, in a “real world” scenario. In this article, we intend to identify the clinical, angiographical and procedural profiles of the patients, consecutively treated in two-month subsequent periods, according to the availability of these models, with the aim of identifying eventual changes in their profiles. Method: Observational series of 471 patients, divided into two groups: A) 229 cases, treated during a period of availability of DES for routine use; and B) 242 patients subsequently treated as usual (no routine avalilability of DES). There were no inclusion/exclusion criteria. Results: More DES were implanted in group A (44% vs. 2%; p<0.0001). Regarding baseline clinical and angiographic characteristics, a significant predominance of insulin-dependent diabetics was observed in group A (8% vs. 3%; p=0.02), as well as B2 or C lesions (73% vs. 57%; p<0.0001); lesions in bifurcations (15% vs. 9%; p=0.02), and multiarterial interventions (15% vs. 6%; p=0.003). Quantitative angiography identified the A group cases as bearers of stenosis placed in smaller vessels (2.4 mm vs. 2.6 mm; p=0.0004), also exhibiting longer lesions (14.9 mm vs. 12.7 mm; p=0.0008). Conclusions: The availability of DES changed the profile of the patients treated, being more likely situations prone to restenosis, such as insulin dependent diabetics, multiarterial disease, patients presenting complex lesions, longer lesions and smaller target vessels.

Role of probucol in inhibiting intimal hyperplasia after coronary stent implantation: a randomized study.

BACKGROUND: Oxygen-free radicals can stimulate smooth muscle cell proliferation and may therefore be involved in the genesis of in-stent restenosis. Thus, treatment with probucol, a potent antioxidant agent that has been shown to reduce restenosis after balloon angioplasty, may be an effective strategy to prevent intimal hyperplasia after stenting. METHODS: In a prospective double-blind study, 59 patients submitted to coronary stent implantation were randomly assigned to treatment with either probucol (1 g/d) or placebo, starting two weeks before the procedure and continued for 6 months. The primary end point was the intimal hyperplasia volume at 6 months measured by intravascular ultrasound (IVUS) imaging. RESULTS: Of the 59 randomized patients, 54 underwent successful stent implantation, completed the follow-up period, and underwent repeat angiography, 6.1 +/- 1.1 months after the procedure. Volumetric IVUS analysis revealed similar intimal hyperplasia volumes (403 +/- 26.7 mm3 for probucol vs 44.8 +/- 28.3 mm3 for placebo) and percent volume obstruction of the lumen (30.4% +/- 14.5% for probucol versus 30.7% +/- 17.2% for placebo) in both groups. In addition, quantitative coronary angiography showed no differences in late loss (1.0 +/- 0.8 mm vs 1.1 +/- 0.8 mm), loss index (0.5 +/- 0.4 for both groups), or angiographic restenosis rates (19.4% vs 18.5%) between the probucol and placebo groups, despite the observation of significant changes in the lipid profile and in the plasma antioxidant defenses in patients receiving probucol. CONCLUSIONS: Treatment with the antioxidant probucol failed to reduce neointimal formation after coronary stent implantation as assessed by IVUS volumetric analysis.

Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis for plaque composition in event-free patients.

OBJECTIVES: This study sought to evaluate the long-term arterial response after sirolimus-eluting stent implantation. BACKGROUND: Sirolimus-eluting stents are effective in inhibiting neointimal hyperplasia without affecting plaque volume behind the stent struts at six months. METHODS: Serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis over four years were performed in 23 event-free patients treated with sirolimus-eluting stents. RESULTS: In the first two years, the mean plaque volume (155.5 +/- 42.8 mm3 post-procedure and 156.8 +/- 57.7 mm3 at two years, p = 0.86) and plaque compositional change expressed as mean percent hypoechogenic tissue of the plaque behind the stent struts (78.9 +/- 8.6% post-procedure and 78.2 +/- 8.9% at two years, p = 0.67) did not significantly change. However, significant plaque shrinking (change in plaque volume = -18.4 mm3, p = 0.02) with an increase in plaque echogenicity (change in percent hypoechogenic tissue = -7.8%, p < 0.0001) was observed between two and four years. The mean neointimal volume increased over four years from 0 to 8.4 +/- 5.8 mm3 (p < 0.0001). However, no further statistically significant change occurred between two and four years (7.0 +/- 6.7 mm3 vs. 8.4 +/- 5.8 mm3, p = 0.25). CONCLUSIONS: Between two and four years after sirolimus-eluting stent implantation, peri-stent tissue shrank with a concomitant increase in echogenicity. These intravascular ultrasound findings suggest that late chronic artery responses may evolve for up to four years after sirolimus-eluting stent implantation. In addition, the fact that the neointima does not significantly change from two to four years may suggest that the biological phenomenon of a delayed healing response has begun to subside.

Nonrandomized registries for de novo lesions (FIM) and in-stent restenosis

Takind advantage of the knowledge accumulated over decades of unsuccessful attempts to prevent restenosis, novel devices for local drug-eluting stents, have been developed in the recent years. Sirolimus eluting Bx Velocity stents is certainly one of these novel technologies that may finnally represent the "magic bullet" we have been searching for in our war against the restenosis. The first clinical evaluation of this new technology was initiated in December 1999. This endeavor was conducted at Institute Dante Pazzanese of Cardiology in São Paulo, Braziland at Thoraxcenter, Rotterdam, The Netherlands. The unparalleled 1-year out-come of this first series of patients treated with sirulimus-eluting stents (SES) paved the way to launch a more challenging pilot study involving only patients with in-stent restenosis, which was started in 2000...

Serial assessment of tissue growth inside and outsidethe stent after implantation of drug-eluting stentin clinical trials. – Does delayed neointimal growth exist?

Although long term follow-up after drug-eluting stent (DES)implantation shows a sustained clinical benefit in several randomizedtrials, delayed neointimal growth beyond the first 6 to 9 monthshas been reported in serial intravascular ultrasound (IVUS) analysesin some trials. The issue of a delayed restenosis which wasobserved after brachytherapy has not been thoroughly evaluatedwith DES.

Intracoronary brachytherapy. Treatment of in-stent restenosis with the Beta-Cath system. Initial experience in Latin America.

OBJECTIVE: To assess the safety and efficacy of intracoronary brachytherapy using the Beta-Cath system for preventing recurrence of in-stent restenosis (ISR), by analyzing clinical, angiographic, and intracoronary ultrasound (ICUS) results. METHODS: This study assessed 30 patients with ISR in native coronary arteries who underwent balloon catheter angioplasty followed by intracoronary beta radiation with the Beta-Cath system (90Sr/Y). RESULTS: The study comprised complex, extensive (18.66 +/- 4.15 mm) restenotic lesions, 77% of which were of the diffuse-proliferative type. Brachytherapy was successful in 100% of the cases. The mean radiation dose used was 20.7 +/- 2.3 Gy, released for a mean period of 3.8 +/- 2.1 minutes. On late follow-up, the in-stent minimum luminal diameter (MLD) slightly decreased (from 1.98 +/- 0.30 mm to 1.84 +/- 0.39 mm at 6 months; P=0.13), with a late loss of 0.14 +/- 0.18 mm. The intrasegmentary MLD was significantly smaller than the in-stent diameter (1.55 +/- 0.40 mm vs 1.84 +/- 0.39 mm; P=0.008), and was associated with a more significant late loss (0.40 +/- 0.29 mm vs 0.14 +/- 0.18 mm; P=0.0001). On ICUS, a mild increase of 6.8 +/- 14.3 mm3 in the neointimal tissue was observed at 6 months (P=0.19), and the percentage of volumetric obstruction increased by 4.7 +/- 7.5%. Binary restenosis and revascularization of the target vessel recurred in 17% of the cases; late occlusion associated with myocardial infarction occurred in 1 case (3%). Event-free survival was 80%. CONCLUSION: The management of in-stent restenosis with intracoronary beta radiation proved to be a safe and effective procedure, with a high rate of immediate success, representing a therapeutic option for inhibiting neointimal hyperplasia.

Braquiterapia intracoronariana. Tratamento da reestenose intra-stent com o sistema Beta-Cath: experiência inicial na América Latina / Intracoronary brachytherapy. Treatment of in-stent restenosis with the Beta-Cath system: initial experience in Latin America

OBJETIVO: Avaliar a segurança e eficácia da braquiterapia intracoronariana usando o sistema Beta-CathTM na prevenção da recorrência de restenose intra-stent (RIS), por meio da análise dos resultados clínicos, angiográficos e pelo ultra-som intracoronariano (USIC). MÉTODO: Foram submetidos à angioplastia com cateter-balão, seguida de beta-radiação intracoronariana com o sistema Beta-CathTM (90Sr/Y) 30 pacientes com RIS em artérias coronárias nativas e, posteriormente, avaliados. RESULTADOS: Incluíram-se lesões reestenóticas complexas (77 por cento do tipo difuso-proliferativo) com extensão elevada (18,66±4,15 mm). O sucesso da braquiterapia foi de 100 por cento. A dose média utilizada foi de 20,7±2,3 Gy, liberada em um período médio de 3,8±2,1 min. No seguimento tardio, o diâmetro luminal mínimo (DLM) intra-stent diminuiu discretamente (1,98±0,30mm para 1,84±0,39 aos 6 meses, p=0,13), com uma perda tardia de 0,14±0,18 mm. O DLM intra-segmentar foi significativamente menor do que o intra-stent (1,55±0,40mm vs.1,84±0,39mm, p=0,008), associando-se à perda tardia (0,40±0,29mm vs. 0,14±0,18mm; p=0,0001). No USIC, observou-se discreto incremento do tecido neointimal em 6,8±14,3 mm aos 6 meses (p=0,19) e a percentagem de obstrução volumétrica aumentou em 4,7±7,5 por cento. A reestenose binária e a revascularização do vaso-alvo recorreram em 17 por cento dos casos; houve 1 caso (3 por cento) de oclusão tardia, associada a infarto do miocárdio. A sobrevida livre de eventos foi de 80 por cento. CONCLUSAO: O manejo da reestenose intra-stent com a beta-radiação intracoronariana mostrou-se procedimento seguro e eficaz, com alta taxa de sucesso imediato, representando uma opção terapêutica para a inibição da hiperplasia neointimal.

Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries.

BACKGROUND: The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation. METHODS AND RESULTS: This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], n=15, and fast release [FR], n=15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28+/-0.4 mm) than in the SR group (-0.09+/-0.23 mm, P=0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had < or =35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33+/-0.42 mm [FR] and 0.13+/-0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FR= 9.90+/-9 mm3 and SR=10.35+/-9.3 mm3). CONCLUSIONS: This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis "catch-up" was not found in our patient population.

Two-year angiographic and intravascular ultrasound follow-up after / implantation of sirolimus-eluting stents in human coronary arteries

BACKGROUND: The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of ients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation. METHODS AND RESULTS: This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], n=15, and fast release [FR], n=15) in Sao Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28+/-0.4 mm) than in the SR group (-0.09+/-0.23 mm, P=0.007).No patient had in-stent restenosis. At 2-year follow-up, 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had < or =35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33+/-0.42 mm [FR] and 0.13+/-0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FR= 9.90+/-9 mm3 and SR=10.35+/-9.3 mm3). CONCLUSIONS: This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans...

Sustained suppression of neointimal proliferation by sirolimus-eluting stents

Background—We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year. Methods and Results—Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n530, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular

ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the $50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis

was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (265% obstruction volume, GIII) and at 12 months (GI5265% and GII5263%). Conclusions—This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.