Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry.

BACKGROUND: Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the postmarketing evaluation of coronary stents, but their scientific relevance remains debated. METHODS: We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n = 551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n = 35,389). All major events were adjudicated by an independent clinical event committee in both studies. Propensity weighted analysis was used to balance baseline and procedural differences between the 2 populations. RESULTS: Coronary artery disease was more complex in e-UM compared to CII-UM, including more acute coronary syndromes, multivessel disease, left main, arterial, or venous grafts, and chronic total occlusions (P < .005 for all). At one-year follow-up and after excluding periprocedural myocardial infarction (MI) there was no statistically significant difference between CII-UM and e-UM regarding all-cause death (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.26-1.20, P = .14), cardiac death (HR 0.71, 95% CI 0.29-1.72, P = .45), target lesion failure (HR 1.18, 95% CI 0.78-1.78, P = .44), and target vessel MI (HR 0.76, 95% CI 0.24-2.38, P = .63). However, target vessel revascularization rate was significantly higher in CII-UM than in e-UM, HR 1.78, 95% CI 1.23-2.56, P = .002. CONCLUSIONS: A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the postmarket performance of new coronary stents, across a wider range of uses and various geographic areas.

Single trans-septal access technique for left atrial intracardiac echocardiography to guide left atrial appendage closure.

OBJECTIVE: This registry aimed to describe the safety and feasibility of a single trans-septal (TS) access technique for left intracardiac echocardiography (ICE) guidance of left-atrial appendage (LAA) closure procedure. BACKGROUND: LAA closure is currently accepted as an alternative to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (NVAF) who are at high-risk for bleeding. Currently, LAA closure procedure is typically performed under trans-esophageal echocardiogram (TEE) guidance. Although, ICE has the advantage of not requiring profound sedation/anesthesia, ICE-LAA imaging quality is often limited from the right atrium requiring double TS access. METHODS: Twenty-two patients with NVAF underwent LAA closure using the Amplatzer Amulet™ device (St Jude Medical) under ICE guidance from the left atrium. The ICE AcuNav catheter (Biosense Webster) and the Amulet delivery sheath were advanced into the LA through single TS puncture technique. RESULTS: The population was predominately male (59.1%) with a mean age of 74 ± 9.3 years, at high-risk for stroke (mean CHADS2 score of 3.8 ± 1.1) and bleeding (mean HAS BLED score of 3.5 ± 1.3). The Amplatzer AmuletTM device was successfully implanted in all patients. No procedural related complications including device embolization were noted. No major cardiovascular events occurred and all patients were discharged alive. At 30-day follow-up all patients remained alive, free of ischemic stroke and with no residual leak or device thrombus on TEE. CONCLUSIONS: This initial experience suggests that LAA occlusion with the Amplatzer Amulet device using ICE guidance from the left atrium via a single trans-septal technique is feasible and safe.

Relationship of mitral valve annulus plane and circumflex-right coronary artery plane: Implications for Transcatheter Mitral Valve Implantation.

AIM: Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks. We hypothesized that a plane defined by left circumflex-right coronary arteries (LCX-RCA) would have a consistent relationship to MAP. METHODS AND RESULTS: We studied 25 patients with gated cardiac computed tomography. We identified the MAP and the LCX-RCA plane in mid systole and diastole. The distance between the two planes in prespecified four points (anterior, posterior, medial, and lateral) in the apical 2 and 3-chamber views. Alignment of the planes was described by cranial/caudal angulation for both planes in RAO 30° and LAO 90° (lateral) angulation. Mean age was 81 ± 9 years, 56% of patients had ≥2+ mitral regurgitation. In mid systole, the distances between the LCX-RCA plane and the MAP in the four points were < 5 mm in 92% of patients. In mid diastole, distances were < 5 mm in 100% of patients. In mid systole, the correlation between the caudal/cranial orientations of the 2 planes was 0.85 and 0.80 in the LAO 90° and RAO 30°, respectively (P = <0.001). In mid diastole, this was 0.92 and 0.92 in the LAO 90° and RAO 30°, respectively (P = <0.001). CONCLUSION: LCX-RCA plane has a close and consistent relationship to the MAP and can be useful to guide TMVI. Accurate imaging of mitral valve annular plane during TMVI procedure is challenging. MAP guided by fluoroscopy might be crucial to guide successful prosthesis deployment. A plane defined by the left circumflex- right coronary arteries in the atrioventricular grove has a consistent relationship with MAP; this can be used aided by pre-procedural MDCT to guide TMVI procedure. © 2016 Wiley Periodicals, Inc.

Innovative use of self-expanded polytetrafluoroethylene endoprosthesis for percutaneous endovascular interventions.

VIABAHN® endoprosthesis (Gore & Associates, Flagstaff, AZ), a nitinol self-expanding polytetrafluoroethylene (PTFE) lined stent, has demonstrated utility for percutaneous treatment of chronic occlusive disease involving the superficial femoral artery. In a case series communication we aimed to describe the feasibility of a PTFE-lined stent for percutaneous treatment of conditions other than chronic occlusive disease. We report the successful use of PTFE-endoprosthesis to percutaneously treat several vascular conditions, including arterio-venous fistula closure, reconstruction of a distal limb of an aorto-femoral endoprosthesis aneurysm, femoral artery perforation repair, and an exclusion of large saphenous vein graft aorto-coronary bypass aneurysm. This case series illustrates the feasibility of the "off-label" use of self-expanded PTFE endoprosthesis to percutaneously treat several conditions, which would otherwise require "open" surgical reconstructions.

Successful transfemoral aortic valve replacement in a bicuspid aortic stenotic valve: requirements for a safe implant.

Although transcatheter aortic valve replacement (TAVR) has been accepted as an attractive alternative for high-risk patients with severe symptomatic aortic stenosis (AS), patients with congenital bicuspid AS has been typically disqualified for this indication due to an implied risk of device dislocation, distortion, or device malfunctioning. Nonetheless, bicuspid AS is not uncommon and frequently missed by transthoracic echocardiography. We reported an interesting case of a high-risk patient with severe symptomatic bicuspid AS who underwent successful TAVR and discussed the anatomic requirements for a safe implant in patients with bicuspid AS considered candidates for TAVR.

Outcomes of concomitant percutaneous coronary intervention and balloon aortic valvuloplasty.

BACKGROUND: Coronary artery disease often coexists with severe aortic stenosis. The feasibility and safety of combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) are unknown. AIM: To compare outcomes and complications of combined BAV and PCI with BAV alone. METHODS: The study cohort consisted of 409 patients with severe aortic stenosis undergoing BAV from 1/2007 to 12/2010. Overall, 329 patients underwent BAV alone and 80 underwent concomitant PCI. Clinical and hemodynamic data, as well as acute and intermediate-term outcomes, were collected. RESULTS: At the operator's discretion PCI was done before BAV in 66 (82.5%) and after in 14 (17.5%). Patients who underwent concomitant procedures had a higher incidence of prior stroke and a lower incidence of atrial fibrillation. Procedure time and fluoroscopic time were significantly greater in the BAV/PCI group, (90.0 ± 36.6 vs. 72.8 ± 39.8, P = 0.002 and 20.5 ± 10.9 vs. 12.9 ± 7.0, P < 0.001). Significantly more radiographic contrast was used in the BAV/PCI group (95.1 ± 45.5 vs. 36.7 ± 38.4 cm(3) , P < 0.001. Serious adverse events occurred with equal frequency 13.7 and 17.3%, P = 0.44). Transfusion requirement was also similar (21.2% vs. 20.0%, P = 0.81). The frequency of a periprocedural increase in troponin or creatinine was also similar. In the BAV alone group the mortality rate was 48.6% (n = 160) during a mean follow-up of 191 days, and in the BAV/PCI group the mortality rate was 40% (n = 32) during mean follow-up of 175.5 day, P = 0.34. CONCLUSION: Combined BAV and PCI are safe and are associated with similar complications as BAV alone and may offer protection against myocardial ischemia during BAV.

Balloon aortic valvuloplasty for severe aortic stenosis as a bridge to transcatheter/surgical aortic valve replacement.

OBJECTIVES: This study aimed to determine success- and complication rates after balloon aortic valvuloplasty (BAV) and the outcome of BAV as a standalone therapy versus BAV as a bridge to transcatheter/surgical aortic valve replacement (T/SAVR). BACKGROUND: The introduction of transcatheter aortic valve replacement (TAVR) has led to a revival in BAV as treatment for patients with severe aortic stenosis. METHODS: A cohort of 472 patients underwent 538 BAV procedures. The cohort was divided into two groups: BAV alone 387 (81.9%) and BAV as a bridge 85 (18.1%) to (n = 65, TAVR; n = 20, surgery). Clinical, hemodynamic, and follow-up mortality data were collected. RESULTS: There was no significant difference between the two groups in mean age (81.7 ± 8.3 vs. 83.2 ± 10.9 years, P = 0.18), society of thoracic surgeons score (13.1 ± 6.2 and 12.4 ± 6.4, P = 0.4), logistic EuroSCORE (45.4 ± 22.3 vs. 46.9 ± 21.8, P = 0.43), and other comorbidities. The mean increase in aortic valve area was 0.39 ± 0.25 in the BAV alone group and 0.42 ± 0.26 in the BAV as a bridge group, P = 0.33. The decrease in mean gradient was 24.1 ± 13.1 in the BAV alone group vs. 27.1 ± 13.8 in the BAV as a bridge group, P = 0.06. During a median follow up of 183 days [54-409], the mortality rate was 55.2% (n = 214) in the BAV alone group vs. 22.3% (n = 19) in the BAV as a bridge group during a median follow-up of 378 days [177-690], P < 0.001. CONCLUSION: In high-risk patients with aortic stenosis and temporary contraindications to SAVR/TAVR, BAV may be used as a bridge to intervention with good mid-term outcomes.

Incidence and predictors of acute kidney injury after transcatheter aortic valve replacement.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) are at increased risk for acute kidney injury (AKI). The Valve Academic Research Consortium (VARC) recently published criteria for AKI after TAVR. We aimed to identify predictors, assess the prognostic impact of AKI after TAVR, and compare various criteria for AKI. METHODS: Patients with aortic stenosis undergoing TAVR were retrospectively analyzed for periprocedural AKI (<72 hours) according to the VARC definition (increase in serum creatinine ≥0.3 mg/dL or ≥1.5× baseline) or according to the modified Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria (decrease of >25% in estimated glomerular filtration rate at 48 hours). RESULTS: Acute kidney injury, according to the VARC definition, occurred in 24 (14.6%) of 165 patients after TAVR. Acute kidney injury, according to RIFLE criteria, occurred in 19 patients (11.5%). Men (63% vs 38%, P = .03) and patients receiving blood transfusion (63% vs 39%, P = .04) were more likely to develop AKI. In multivariable analysis, only blood transfusion emerged as a predictor for AKI (odds ratio 3.74, 95% CI 1.36-10.3). Patients who developed AKI had higher in-hospital (21% vs 4%, P = .007) and 30-day mortality (29% vs 7%, P = .004) as compared with patients without AKI. CONCLUSION: Acute kidney injury is a frequent complication of TAVR. Even a small increase (0.3 mg/dL) in baseline creatinine post-TAVR is associated with worse outcome. The poor prognosis of these patients should encourage improvement in patient selection and careful management for prevention of this complication.

Accepted TCT challenging case: common femoral artery perforation after primary percutaneous coronary intervention successfully treated with a novel transcatheter "thrombin-blood patch" injection technique.

Severe vascular access complications are infrequent, yet potentially life-threatening, conditions related to percutaneous procedures approached via the femoral artery. Surgical vascular repair of such complications are associated with high rates of morbimortality due to advanced cardiovascular disease. Endovascular repair of the injured vessel appears to be the treatment of choice for patients who cannot tolerate vascular reconstruction and bleeding due to severe cardiovascular disease. We report a case that illustrates the feasibility of a novel technique: transcatheter "thrombin-blood patch" injection to access perforated arteries.

Transcatheter "thrombin-blood patch" injection: a novel and effective approach to treat catheterization-related arterial perforation.

OBJECTIVE: This study aimed to describe the safety and feasibility of transcatheter "thrombin-blood patch" (TBP) injection to treat catheterization-related arterial vascular access perforation. BACKGROUND: Vascular access complications are infrequent but potentially life threatening conditions related to percutaneous procedures. Surgical vascular repair are associated with high rates of morbidity and mortality due to advanced cardiovascular disease. METHODS: From October 2007 to July 2010 we studied 23 patients who presented active access arterial bleeding after percutaneous procedures and underwent transcatheter angiographic guided TBP injection across the entry site of the arterial perforation as a primary approach. RESULTS: The mean age of the population was 67 years, predominantly female (78.3%) with high rate of comorbidities including diabetes (30.4%), prior coronary revascularization (50.0%), chronic renal failure (43.5%), and heart failure (56.5%). Thirteen patients (56.5%) developed severe hypotension after the index procedure. The repair procedure had a mean duration of 82 ± 57 minutes. TBP was injected in all patients. One case additionally required covered-stent to obtain hemostasis. Angiographic success was achieved in the 23 patients; however, one case required a second intervention due to recurrent bleeding, which was effectively treated using covered-stent. All patients were discharged alive and no major cardiovascular events, including myocardial infarction/stroke, were observed. CONCLUSIONS: Transcatheter "thrombin-blood patch" injection is a safe, novel technique that allows prompt percutaneous approach to treat catheterization-related arterial perforation. This strategy appears particularly attractive to treat patients who cannot tolerate "open" vascular reconstruction and repair.

A novel, minimally invasive access technique versus standard 18-gauge needle set for femoral access.

OBJECTIVE: To compare access site complications with the Micropuncture 21 gauge (G) needle set to the standard 18G needle in patients undergoing percutaneous coronary intervention (PCI) using the femoral approach. BACKGROUND: Vascular access site complications are the most common problems after PCI. The Micropuncture 21G needle set was recently introduced to minimize such complications. METHODS: A cohort of 3,243 consecutive patients was studied. Patients receiving thrombolytics, IIb/IIIa antagonist, coumadin, or intra-aortic balloon pump were excluded. Micropuncture access was used in 544 patients and standard 18G needle in 2,699. All access sites were managed with a vascular closure device. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, and groin hematoma (>4 cm). RESULTS: Patients undergoing PCI with Micropuncture were at higher risk: they were older (65.9 ± 9 vs. 64.7 ± 11.8, P = 0.03); had lower body surface area (1.9 ± 0.2 vs. 2.0 ± 0.3, P = 0.02); more prevalent peripheral vascular disease [119 (21.9%) vs. 380 (14.1%), P < 0.001] and renal failure [106 (19.6%) vs. 318 (11.8%), P < 0.001]. Overall, there was no significant difference in the access site complications rate using Micropuncture vs. standard needle, 7 (1.3%) vs. 27 (1.0%), respectively, P = 0.54. The Micropuncture group had significantly higher retroperitoneal bleeding, 0.7% vs. 0.18%, P = 0.04. After multivariable adjustment, only age remained significantly associated with vascular complications (OR 1.03, P = 0.04). CONCLUSIONS: Femoral access using the Micropuncture technique did not reduce the incidence of vascular complications and the marginally higher than expected retroperitoneal bleeding is based on very small numbers. The routine use of the Micropuncture set and its technique should be revisited.

Retroperitoneal hemorrhage after percutaneous coronary intervention in the current practice era: clinical outcomes and prognostic value of abdominal/pelvic computed tomography.

BACKGROUND: Retroperitoneal hemorrhage (RPH) is a serious but infrequent complication of percutaneous coronary intervention (PCI). This study aimed to describe the clinical outcomes of patients who developed RPH following PCI in the current practice era, with particular focus on treatment strategies and the related prognostic value of abdominal/pelvic computed tomography (CT). METHODS: Among 20,904 patients undergoing PCI, we identified 93 RPH (0.45%) confirmed by CT or by unequivocal surgical findings. We identified three groups with RPH for comparison: patients who developed refractory shock (systolic blood pressure <80 mm Hg for ≥30 min despite fluids and vasopressors, n = 16 [17.2%]); patients with transient hypotension (<30 min, n = 34 [36.6%]); and patients without hypotension (n = 43 [46.2%]). The primary endpoint was a composite of in-hospital mortality, myocardial infarction, and cerebral vascular accident (CVA). RESULTS: Baseline clinical, angiographic, and procedural characteristics were similar among the three groups. Patients who developed refractory shock had significantly more bleeding quantified by abdominal/pelvic CT (P < 0.001), had a higher rate and amount of red blood cell transfusion (P < 0.001), and were managed invasively more frequently (68.7%) than the rest of the population. The primary endpoint trended higher in patients presenting with refractory shock; however, this difference was not statistically significant. The volume of bleeding quantified by CT and the timing of imaging diagnosis did not correlate with the primary endpoint. Red blood cell transfusion, but not clopidogrel discontinuation, was associated with the primary endpoint. CONCLUSIONS: RPH remains as a serious complication of PCI and is associated with high rates of mortality and morbidity independently of the therapeutic strategy. In patients who were hemodynamically stable, RPH volume as quantified by non-contrast abdominal/pelvic CT did not contribute to prognosis.

Clinical predictors for failure of percutaneous coronary intervention in ST-elevation myocardial infarction.

BACKGROUND: Failed percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with adverse outcome. With recent improvements in PCI techniques, the incidence and predictors for failed primary PCI are unclear. METHODS: A clinical database of consecutive patients who underwent primary or rescue PCI from 1993 to 2011 was used to compare patients with successful versus failed PCI. Clinical follow-up was obtained in-hospital, at 30 days and at 1 year. RESULTS: Of 2900 patients fulfilling our inclusion criteria, 111 (3.98%) had failed PCI. Patients who had failed PCI were older (65 vs. 61 years), were more likely to be women (46% vs. 32%), were more likely to have previous peripheral vascular disease (19% vs. 11%), previous PCI (29% vs. 20%), and were more likely to present with cardiogenic shock (25% vs. 11%) (all P < 0.05). Multivariable logistic regression analysis identified female gender (OR 1.54; 95% CI 1.01-2.38), cardiogenic shock (2.07; 1.22-3.49), previous PCI (1.71; 1.08-2.70), and type C lesion (2.47; 1.60-3.82) as independent predictors of PCI failure. The in-hospital (18% vs. 4%) and long-term mortality (48% vs. 14%) were worse in the failed PCI group compared to the successful group (P < 0.05). CONCLUSION: In patients with STEMI, primary PCI failure is uncommon. It is associated with worse short- and long-term clinical outcome compared with a successful procedure. Special care should be taken when PCI is performed in women at higher risk for failure when presenting with STEMI.

Impact of diabetes mellitus on long-term clinical outcomes of patients on chronic hemodialysis after percutaneous coronary intervention.

BACKGROUND: End-stage renal disease (ESRD) is known to correlate with poor outcome in patients undergoing percutaneous coronary intervention (PCI). This study examines the impact of diabetes mellitus (DM) on the long-term outcome of patients with ESRD on chronic hemodialysis. METHODS: A cohort of patients with ESRD on chronic hemodialysis, who underwent PCI with drug-eluting stents, was followed for 1 year. The clinical outcome in this population was compared retrospectively based on the presence of DM. Major adverse cardiac events (MACE) as the composite of all-cause death, Q-wave myocardial infarction and target lesion revascularization (TLR), as well as TLR as an individual outcome, were the main end points of the study. RESULTS: In the study cohort (n = 198), 48.5% had DM. Diabetic patients were more commonly female. The lesion characteristics were similar between groups except for more frequent saphenous vein graft intervention in nondiabetics. At 1-year follow-up there was no difference in the rate of MACE between diabetic and nondiabetic patients (40.4% vs. 39.3%, respectively, p = 0.89), driven primarily by a very high mortality rate (1-year overall mortality of 33.5%). After adjustment for the relevant clinical co-variables, DM was not associated with the composite end point. However, diabetic patients had a significantly higher incidence of 1-year TLR compared to nondiabetics (13.8% vs. 3.6%, respectively, p = 0.04). CONCLUSION: The prognosis of patients with ESRD after PCI is dismal with a very high overall mortality rate regardless of the presence of DM. Patients with ESRD appear to be at higher risk for the need of revascularization.

The impact of balloon aortic valvuloplasty on aortic regurgitation in patients with severe aortic stenosis.

BACKGROUND AND AIM OF THE STUDY: Severe aortic regurgitation (AR) is a contraindication for balloon aortic valvuloplasty (BAV). As the effects of mild and moderate AR are unknown, the study aim was to determine the effects of BAV in patients with mild and moderate AR. METHODS: A total of 263 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent BAV was included in the study. The patients were stratified into three groups according to their pre-procedural degree of AR, as assessed echocardiographically. RESULTS: The study groups included pre-BAV with no AR (n = 76; 28.9%), mild AR (n = 180; 68.4%), and moderate AR (n = 7; 2.7%). There were no differences in the baseline characteristics of the groups, with a mean age of 81.9 +/- 9.0 years and a Society of Thoracic Surgeons score of 12.9 +/- 6.0. Among patients with no AR pre-BAV, 48.7% developed mild AR post-BAV, while 4.5% of those with mild AR pre-BAV developed moderate AR (p < 0.001). The majority of patients (93%) had mild AR both pre- and post-BAV. Only two patients developed severe AR post-BAV. A good agreement existed between the categories of AR pre- and post-BAV (weighted kappa = 0.54, 95% CI, 0.43-0.65). The degree of AR post-BAV did not impact on the mortality rates of mild AR (41.1%), moderate AR (46.9%), or severe AR (63.6%) (p = 0.31). CONCLUSION: It is safe to perform BAV in patients with mild and moderate AR. About half of all patients with no AR may develop mild AR, the majority will remain in mild AR, and a small percentage will develop moderate or severe AR.

PRospective Observational Registry Evaluating the Safety and Effectivenessof Orsiro Stent in Chilean Patients - ROSES Registry.

BACKGROUND: There is little information on the performance of the new generation of stents with bioabsorbable polymers in the Latin American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable-polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers. METHODS: We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers. The primary endpoint was defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization at 1-year follow-up. RESULTS: From April 2017 to February 2019, 520 patients were enrolled in the registry, more frequently male (74.6%), with a mean age of 62.7 ± 10.8 years and a high prevalence of diabetes (40.2%). The clinical presentation was stable angina in 41.1% (n = 214), acute MI in 52.5% (n = 167 [32.1%] ST-elevation MI and n = 106 [20.4%] non-ST-elevation MI), and unstable angina in 6.3% (n = 33). Of 610 treated lesions, 425 (69.7%) were American College of Cardiology/American Heart Association type B or C lesions. Device and procedural success were achieved in 99.4% and 98.7% of the patients, respectively. The primary endpoint of the study occurred in 4%, primarily driven by cardiac death. CONCLUSIONS: The results of the ROSES multicenter registry indicated good clinical outcomes of BPSES Orsiro in all-comers Latin Americann patients undergoing PCI, despite the high-risk patients and treated lesions.

Outcomes and regional differences in practice in a worldwide coronary stent registry.

OBJECTIVE: The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide. METHODS: e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions. RESULTS: A total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y12 inhibitors were prescribed in 48% of patients at discharge, while at 1 year 72% were on any dual antiplatelet therapy. Lipid-lowering treatment was administered in 80.9% and 75.5% of patients at discharge and 1 year, respectively. Regional differences in the profile of the treated patients as well as in PCI practice were reported. CONCLUSIONS: In this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.

Recent Developments and Current Status of Transcatheter Aortic Valve Replacement Practice in Latin America - the WRITTEN LATAM Study. / Evolução e Estado Atual das Práticas de Implante Transcateter de Válvula Aórtica na América Latina ­ Estudo WRITTEN LATAM.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found. OBJECTIVE: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020. METHODS: A survey was applied to global TAVR centers between March and September 2015, and again to Latin-American centers between July 2019 and January 2020. The survey consisted of questions addressing: i) center's general information; ii) pre-TAVR evaluation; iii) procedural techniques; iv) post-TAVR management; v) follow-up. Answers from the 2015 survey of Latin-American centers (LATAM15) were compared with those of other centers around the world (WORLD15) and with the 2020 updated Latin-American survey (LATAM20). A 5% level of significance was adopted for statistical analysis. RESULTS: 250 centers participated in the 2015 survey (LATAM15=29; WORLD15=221) and 46 in the LATAM20. Combined centers experience accounted for 73 707 procedures, with WORLD15 centers performing, on average, 6- and 3-times more procedures than LATAM15 and LATAM20 centers, respectively. LATAM centers performed less minimalistic TAVR than WORLD15 centers, but there was a significant increase in less invasive procedures after 5 years in Latin-American centers. For postprocedural care, a lower period of telemetry and maintenance of temporary pacing wire, along with less utilization of dual antiplatelet therapy was observed in LATAM20 centers. CONCLUSION: Despite still having a much lower number of procedures, many aspects of TAVR practice in Latin-American centers have evolved in recent years, followingthe trend observed in developed country centers.

FUNDAMENTO: Implante transcateter de valva aórtica (TAVI) é um procedimento adotado em todo o mundo e suas práticas evoluem rapidamente. Variações regionais e temporais são esperadas. OBJETIVO: Comparar a prática de TAVI na América Latina com aquela no resto do mundo e avaliar suas mudanças na América Latina de 2015 a 2020. MÉTODO: A pesquisa foi realizada em centros de TAVI em todo o mundo entre março e setembro de 2015, e novamente nos centros latino-americanos entre julho de 2019 e janeiro de 2020. As seguintes questões foram abordadas: i) informação geral sobre os centros; ii) avaliação pré-TAVI; iii) técnicas do procedimento; iv) conduta pós-TAVI; v) seguimento. As respostas da pesquisa dos centros latino-americanos em 2015 (LATAM15) foram comparadas àquelas dos centros no resto do mundo (WORLD15) e ainda àquelas da pesquisa dos centros latino-americanos de 2020 (LATAM20). Adotou-se o nível de significância de 5% na análise estatística. RESULTADOS: 250 centros participaram da pesquisa em 2015 (LATAM15=29; WORLD15=221) e 46 na avaliação LATAM20. No total, foram 73.707 procedimentos, sendo que os centros WORLD15 realizaram, em média, 6 e 3 vezes mais procedimentos do que os centros LATAM15 e LATAM20, respectivamente. Os centros latino-americanos realizaram menor número de TAVI minimalista do que os do restante do mundo, mas aumentaram significativamente os procedimentos menos invasivos após 5 anos. Quanto à assistência pós-procedimento, observaram-se menor tempo de telemetria e de manutenção do marca-passo temporário, além de menor uso de terapia dupla antiplaquetária nos centros LATAM20. CONCLUSÃO: A despeito do volume de procedimentos ainda significativamente menor, muitos aspectos da prática de TAVI nos centros latino-americanos evoluíram recentemente, acompanhando a tendência dos centros dos países desenvolvidos.

Does black ethnicity influence the development of stent thrombosis in the drug-eluting stent era?

BACKGROUND: It has been suggested that black race predicts stent thrombosis (ST) after drug-eluting stent implantation. Whether socioeconomic status or comorbid conditions confound the contribution of black race to the development of ST is unclear. METHODS AND RESULTS: We compared 1594 black patients who underwent drug-eluting stent implantation with 5642 nonblack patients. Overall, 108 definite STs were reported. Multivariable Cox regression analysis was performed with adjustment for comorbidities, including median household income as a marker of socioeconomic status, to assess the impact that black race may have on the development of ST. On univariable analysis, black patients were younger (63.43±12.42 versus 65.15±12.59 years; P<0.001) and more likely to have a history of hypertension (89.8% versus 81.7%; P<0.001), diabetes mellitus (45.5% versus 30.8%; P<0.001), chronic renal insufficiency (19.2% versus 10.7%; P<0.001), and congestive heart failure (18.7% versus 13.1%; P<0.001). Clopidogrel compliance at the time of the ST event was higher in the black than in the nonblack population (87.5% versus 77.8%; P=0.068). After multivariable analysis, including adjustment for median income and clopidogrel compliance, black race emerged as a strong predictor of definite late ST. CONCLUSIONS: Black race is an independent predictor of definite drug-eluting stent ST. Because clopidogrel compliance was higher in black patients and socioeconomic status was not associated with ST, further investigation into the potential mechanisms of this influence of race on ST must be pursued.

Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. METHODS AND RESULTS: From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. CONCLUSIONS: Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.