Evaluation of the safety and efficacy of the Axiostat® dressing device to achieve radial artery access hemostasis: The R3A study.

BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.

The everolimus eluting Synergy MegatronTM drug-eluting stent platform: Early outcomes from the European Synergy MegatronTM Implanters' Registry.

BACKGROUND: The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels. AIMS: To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry. METHODS: This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation. RESULTS: Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%.  At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001). CONCLUSIONS: Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.

Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations.

BACKGROUND: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI). OBJECTIVES: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population. METHODS: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group). RESULTS: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3. CONCLUSIONS: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.

The ability of computed tomography angiography to predict 5-year mortality in the SYNTAX III REVOLUTION trial.

BACKGROUND: The feasibility of using coronary computed tomography angiography (CCTA) for long-term prediction of vital prognosis post-revascularization remains unknown. OBJECTIVES: To compare the prognostic value of the SYNTAX score II 2020 (SS-2020) derived from invasive coronary angiography (ICA) or CCTA in patients with three-vessel disease and/or left main coronary artery disease undergoing percutaneous or surgical revascularization. METHODS: In the SYNTAX III REVOLUTION trial, the probability of death at five years was retrospectively assessed by calculating the SS-2020 using ICA and CCTA. High- and low-risk patients for mortality were categorized according to the median percentages of predicted mortality based on both modalities. The discriminative abilities of the SS-2020 were assessed using Harrell's C statistic. RESULTS: The vital status at five years of the 215 patients revascularized percutaneously (64 patients, 29.8%) or surgically (151 patients, 70.2%) was established through national registries. In patients undergoing revascularization, the SS-2020 was possibly helpful in discriminating vital prognosis at 5 years, with similar results seen with ICA and CCTA (C-index with ICA â€‹= â€‹0.75, intercept â€‹= â€‹-0.19, slope â€‹= â€‹0.92 and C-index with CCTA â€‹= â€‹0.75, intercept â€‹= â€‹-0.22, slope â€‹= â€‹0.99). In high- and low-risk patients, Kaplan-Meier estimates showed significant, and almost identical relative differences in observed mortality, irrespective of imaging modality (ICA: 93.8% vs 78.7%, log-lank P â€‹< â€‹0.001; CCTA: 93.7% vs 78.5%, log-lank P â€‹< â€‹0.001). CONCLUSIONS: The predictive ability of the SS-2020 for five-year all-cause mortality derived from ICA and CCTA was comparable, and could helpfully discriminate vital prognosis in high- and low-risk patients.

Case report: takotsubo cardiomyopathy after transcatheter aortic valve-in-valve replacement.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a first-line therapeutic option in patients with severe, symptomatic aortic stenosis at increased surgical risk. Despite its success, the TAVI procedure has been associated with acute life-threatening complications as myocardial infarction secondary to periprocedural coronary occlusion, annular rupture, or vascular injury. CASE SUMMARY: A 79-year-old woman with a dysfunctional bioprosthetic valve following previous surgical valve replacement was hospitalized in our institution to perform a Valve-in-Valve Transcatheter Aortic Valve Replacement (ViV TAVR). Shortly after the implantation of an Evolut R valve (without complication), left ventricle dysfunction with apical akinesia and basal hyperkinesia was identified during bedside transthoracic echocardiography, in spite of a good prosthesis implantation and function. A concomitant Troponin elevation was noted, and the day-after resting electrocardiogram showed a lateral T-wave inversion. Coronary computed tomography angiography showed no coronary stenosis or occlusion, cardiac magnetic resonance imaging showed no necrosis or fibrosis, and no argument for myocarditis. The patient remained asymptomatic during her hospital stay, and the aforementioned anomalies spontaneously regressed after an in-hospital 2-week surveillance. In the presence of these transient anomalies and after ruling out myocardial infarction and myocarditis, post-procedural stress cardiomyopathy (takotsubo) was diagnosed. DISCUSSION: Post-TAVR stress-related cardiomyopathy seems to be an extremely rare entity. To our knowledge, this is the first case of a takotsubo cardiomyopathy after ViV TAVR. Though the association between the two seems likely to be causal, no clear physiopathological explanation can be formulated.

Home diagnosis of obstructive sleep apnoea in coronary patients: validity of a simplified device automated analysis.

INTRODUCTION: Our aim was to evaluate a type 3 portable simplified device as a screening tool for obstructive sleep apnoea (OSA) in coronary patients. MATERIALS AND METHODS: In 50 patients selected independently from sleep complaints, we compared the number of respiratory events per hour of valid recording time counted automatically by the device and the number counted manually per hour of sleep on polysomnography performed at home during the same night. RESULTS: Five patients were excluded because of technical failures. Estimated OSA prevalences (95% confidence interval) for apnoea/hypopnoea index (AHI) cut-offs > or = 5, > or = 15, and > or = 30 by polysomnography were 0.93 (0.81-0.98), 0.69 (0.53-0.81), and 0.27 (0.15-0.42), respectively. The device would have correctly diagnosed 75% of patients with severe OSA (AHI > or = 30 by polysomnography) and would have classified the remaining 25% as having moderate OSA. DISCUSSION: This ambulatory device may prove valuable in reducing the costs of diagnosing and managing OSA in coronary patients.

Treatment with a dedicated bifurcation sirolimus-eluting cobalt-chromium stent for distal left main coronary artery disease: rationale and design of the POLBOS LM study.

AIMS: The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA). METHODS AND RESULTS: The POLBOS LM study is a single-arm, prospective, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months. CONCLUSIONS: The POLBOS LM study will indicate the efficacy of the BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

Chimney Stenting for Coronary Occlusion During TAVR: Insights From the Chimney Registry.

OBJECTIVES: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO). BACKGROUND: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication. METHODS: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR. RESULTS: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days. CONCLUSIONS: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.

Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry.

BACKGROUND: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND RESULTS: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010). CONCLUSIONS: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.

Prevalence and characteristics of left ventricular outflow tract obstruction in Tako-Tsubo syndrome.

BACKGROUND AND OBJECTIVE: Tako-Tsubo syndrome is a clinical entity mimicking acute coronary syndrome (ACS). Left ventricular outflow tract (LVOT) obstruction may occur in Tako-Tsubo syndrome. The aim of this study was to determine the prevalence and features of LVOT obstruction in Tako-Tsubo syndrome in a population presenting with ACS. METHODS: This study included consecutive patients admitted to 2 catheterization laboratories for suspected ACS. All patients underwent echocardiography, coronary arteriography, and left ventricular angiography if no significant coronary lesions were found. RESULTS: Among 10,366 patients referred for coronary angiography, the study population consisted of 3,909 patients with suspected ACS. Thirty-two patients (mean age 71 +/- 13 years old) presented with Tako-Tsubo syndrome, resulting in a prevalence of 0.8% in our population of ACS and 5% of patients without significant coronary lesions. Eight women (mean age 81 +/- 4 years old, P = .01) exhibited LVOT obstruction, a prevalence of 25% among Tako-Tsubo syndrome cases. All patients with intraventricular pressure gradient had systolic anterior motion of the mitral valve and septal bulge. Prevalence of septal bulge was 100% in patients with Tako-Tsubo syndrome and LVOT obstruction versus 29% in patients without LVOT obstruction (P = .002). Mean degree of mitral regurgitation was 2.1 +/- 0.7 in cases of LVOT obstruction versus 0.9 +/- 0.7 in patients without LVOT (P = .0003) and significantly decreased during follow-up (1 +/- 0.8, P = .002). Recovery of left ventricular ejection fraction was similar in patients with and without LVOT obstruction (P = .58). CONCLUSIONS: The present study demonstrates that the prevalence of LVOT obstruction in Tako-Tsubo syndrome is high, with specific characteristics as compared with patients without LVOT obstruction. Echocardiography should be systematically performed for all patients presenting with Tako-Tsubo syndrome for the detection of LVOT obstruction.

Reliability of echocardiography for hemodynamic assessment of end-stage heart failure.

The management of patients with end-stage heart failure is difficult and may require the monitoring of intracardiac pressures. The aim of this prospective study was to assess the reliability of echocardiography in patients with end-stage HF. Twenty consecutive patients presenting with severe left ventricular dysfunction in end-stage heart failure were prospectively studied. All patients underwent right-sided cardiac catheterization and transthoracic echocardiography. Right atrial pressure, estimated using a new echocardiographic parameter, was significantly improved. There was good agreement between systemic and pulmonary vascular resistance, determined by catheterization and echocardiography. All patients with echocardiographic pulmonary vascular resistance<6 Wood units also had invasive pulmonary vascular resistance<6 Wood units. Only echocardiographic mean right atrial pressure was related to the use of saline infusion or bolus infusion of furosemide. All patients requiring intravenous furosemide had pulmonary capillary wedge pressures persistently>or=15 mm Hg despite adequate medication. In conclusion, this study indicates that echocardiography may be a reliable tool for the management of patients with end-stage heart failure.

Comparative assessment of "plaque/media" change on three modalities of IVUS immediately after implantation of either everolimus-eluting bioresorbable vascular scaffold or everolimus-eluting metallic stent in Absorb II study.

The purpose of the study to assess the comparability of immediate changes in plaque/media volume (PV) on three modalities of intravascular ultrasound (IVUS) after implantation of either bioresorbable vascular scaffold (BVS) or everolimus-eluting metallic stent (EES) in Absorb II Study. The two devices have different device volume and ultrasound backscattering that may interfere with the "plaque/media" assessed by three modalities on IVUS: grayscale, backscattering of radiofrequency and brightness function. In a multicenter randomized controlled trial, 501 patients with stable or unstable angina underwent documentary IVUS pre- and post- implantation. The change in plaque/media volume (PV) was categorized into three groups according to the relative PV change in device segment: PV "increased" >+5% (PVI), PV unchanged ±5% (PVU), and PV decreased <-5% (PVD). The change in PV was re-evaluated three times: after subtraction of theoretical device volume, after analysis of echogenicity based on brightness function. In 449 patients, 483 lesions were analyzed pre- and post-implantation. "PVI" was more frequently observed in BVS (53.8%) than EES group (39.4%), p = 0.006. After subtraction of the theoretical device volume, the frequency of "PVI" decreased in both BVS (36.2%) and EES (32.1%) groups and became comparable (p = 0.581). In addition, the percentage of "PVI" was further reduced in both device groups after correction for either radiofrequency backscattering (BVS 34.4% vs. EES 22.6%) or echogenicity (BVS 25.2% vs. EES 9.7%). PV change in device segment was differently affected by BVS and EES devices implantation due to their differences in device volume and ultrasound backscattering. It implies that the lumen volume was also artifactually affected by the type of device implanted. Comparative IVUS assessment of lumen and plaque/media volume changes following implantation of BVS and EES requires specific methodological adjustment.

Prevalence of tako-tsubo syndrome in a large urban agglomeration.

Among 4,551 patients referred to the investigators' catheterization laboratory, 1,613 presented with acute coronary syndrome, and 12 had confirmed Tako-Tsubo syndrome (prevalence 0.7%). In conclusion, the present study emphasizes the underestimation of this new heart disease.

Echocardiographic automated cardiac output measurement of pulmonary output and quantification of intracardiac shunt.

BACKGROUND: The quantification of intracardiac shunt (ICS) with echocardiographic pulsed-wave Doppler (PWD) method using pulmonary-to-systemic flow ratio (QP/QS ratio) remains difficult and may induce false quantification of pulmonary output. We sought to validate the recent echocardiographic automated cardiac output measurement (ACM) for the calculation of pulmonary output and the quantification of ICS in adults. METHODS: One hundred and twenty consecutive patients were divided in 1) 40 patients who underwent echocardiographic and invasive explorations (group I) with groups IA (quantification of ICS using ACM, PWD and invasive oximetric methods in 20 patients) and IB (calculation of pulmonary output with ACM, PWD and thermodilution methods in 20 patients); 2) 80 patients underwent calculation of aortic and pulmonary outputs using echocardiographic ACM and PWD methods (group II). RESULTS: The feasibility of ACM and conventional PWD methods for the calculation of pulmonary output was respectively 93.3% and 90%. Correlations between ACM and invasive pulmonary output were strong (r2=0.92 vs. r2=0.80 for PWD). The best correlation and agreement between invasive and echocardiographic QP/QS ratio were observed with ACM (r=0.96 vs. r=0.82 for PWD). Intracardiac shunts were best-classified with ACM, as compared to PWD (respectively 94% and 72%); sensitivities and specificities for evaluation of significant ICS were 92.3% and 100% with ACM (85% and 40% with PWD). CONCLUSIONS: This study shows that ACM is a reliable and accurate echocardiographic method for calculating pulmonary output and quantifying ICS in adults and may be routinely performed in clinical practice.

Prevalence, clinical characteristics and outcomes of high-risk patients treated for severe aortic stenosis prior to and after transcatheter aortic valve implantation availability.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has emerged as an effective treatment for high-risk patients with severe aortic stenosis (AS). The aim of our study was to compare the prevalence, characteristics and outcomes of high-risk patients treated prior to and after the availability of TAVI in our high-volume surgical institution. METHODS: Among 879 consecutive patients treated 2 years before ('pre-TAVI era') and after ('modern era') the availability of TAVI in our institution, 83 patients were at high risk [defined by logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) >20%]. RESULTS: Among all patients treated for severe AS, the prevalence of high-risk patients was higher in the modern era (12.7 vs 4.9%, P < 0.0001). In the modern era, high-risk patients were treated by TAVI in 89% of cases. Despite similar logistic EuroSCORE (34.9 vs 34%, P = 0.96), the clinical characteristics of these patients have evolved: high-risk patients in the modern era were older (85.3 ± 5.9 vs 78.5 ± 6.5 years, P = 0.0005) and presented more frequently with New York Heart Association class III-IV (92.3 vs 61.1%, P = 0.003), while high-risk patients treated by surgical aortic valve replacement in the pre-TAVI era presented more frequently with a critical preoperative status (33.3 vs 7.7%, P = 0.01), lower left ventricular ejection fraction (41 ± 14 vs 49 ± 15%, P = 0.05) and a history of recent myocardial infarction (27.8 vs 6.1%, P = 0.02). The overall 1-year survival was not different for high-risk patients treated in the pre-TAVI era or in the modern era (61 ± 11 vs 68 ± 6%, P = 0.52). CONCLUSIONS: The availability of TAVI has increased the prevalence of high-risk patients treated for severe AS and changed the clinical features of this kind of patients who were rarely surgically treated before. The 1-year survival was similar between pre-TAVI and modern eras.

Prevalence of coronary artery spasm during dobutamine stress echocardiography.

The aim of this study was to assess the prevalence of coronary artery spasm during dobutamine stress echocardiography (DSE). Over a 9-year period (from November 2001 to October 2010) we reviewed all patients (n = 2,224) referred for DSE. Criteria for selection included patients > 18 years old who underwent DSE. We systematically analyzed all electrocardiograms obtained during DSE to detect ST-segment elevation during the examination. All patients with ST-segment elevation underwent coronary angiography. DSE was performed in 2,179 patients. ST-segment elevation was observed in 21 patients, all of whom underwent emergency coronary angiography. In 13 of these 21 patients (62%) significant coronary stenosis was observed: 6 patients with critical coronary stenosis and 7 patients with chronic coronary occlusion. The remaining 8 patients (38% of patients presenting with ST-segment elevation during DSE, 7 men, mean age 67 ± 11 years) had no significant coronary stenosis. Prevalence of coronary artery spasm during DSE was 0.4%. In conclusion, physicians should be aware that, although rare, coronary artery spasm may occur during DSE.

Acute hyperkalemia and failure of pacemaker stimulus.

Acute hyperkalemia may induce well-known serious cardiac arrhythmia. However, ventricular aberration including concealed conduction may also occur. We report the case of a 35-year-old woman who had a previous history of late-operated ventricular septal defect communication and DDD pacemaker was admitted for dyspnea. During hospitalization, an acute hyperkalemia induced sinoatrial block despite correct pacemaker programming. Sodium bicarbonate allowed to restore sinus rhythm. Our report highlights that acute hyperkalemia may increase thresholds of pacemaker stimulus and physicians should be aware that complete block of conduction may occur despite correct pacemaker programming.

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias De Novo: resultados do Estudo PAX-B / Late clinical and angiographic follow-up of the new non-polymeric paclitaxel-eluting stent for the treatment of De Novo coronary lesions: outcomes of the PAX-B Study

Introdução: O stent farmacológico eluidor de paclitaxel, não-polimérico, Amazonia® PAX não mostrou diferença na reestenose coronária ou eventos clínicos aos 4 meses de evolução quando comparado com o stent Taxus®. Entretanto, o desempenho do stent Amazonia® PAX em cenários de maior complexidade e com seguimento angiográfico mais longo ainda não foi demonstrado. Métodos: O Estudo PAX-Bfoi um estudo prospectivo, não-randomizado, multicêntrico, que avaliou os resultados tardios de pacientes tratados com o stent Amazonia® PAX. O desfecho primário foi a perda tardiado lúmen intrastent. Resultados: Foram incluídos 103 pacientes com média de idade de 61,3 ± 11,4 anos, 26,2% eramdiabéticos, 24,3% apresentaram-se com síndrome coronária aguda e 71,6% tinham lesões tipo B2/C. Implante de múltiplos stents ocorreu em 4,7% dos casos e o sucesso angiográfico foi de 100%. Na fase hospitalar, a taxa de infarto agudo do miocárdio periprocedimento foi de 3,9%, e um desses eventos levou à revascularização da lesão-alvo (RLA). No seguimento angiográfico de 9 meses, a mediana da perda tardia do lúmen intrastent foi de 0,91 [0,50; 1,21] mm. As taxas cumulativas de eventos cardíacos adversos maiores nos seguimentos de 6meses, 9 meses e 12 meses foram, respectivamente, de 7,8%, 18,5% e 21,3%, principalmente em decorrência de RLA. Não se observou morte ou trombose de stent em 12 meses.Conclusões: O stent Amazonia® PAX demonstrou excelentes resultados imediatos e alto perfil de segurança. Entretanto, as taxas de recorrência angiográfica foram relativamente altas,em razão da pouca eficácia na inibição da formação de hiperplasia neointimal.