Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence. This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold. The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America.

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence (⨁⨁⨁Ο).This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold.The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

One-Year Follow-Up Results From the Observational, Multicenter, Prospective, and Controlled Registry: The WALTZ All-Comers Study.

The aim of this study was to evaluate 1-year follow-up results in an all "comers" population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival (P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.

Second vs. First generation drug eluting stents in multiple vessel disease and left main stenosis: Two-year follow-up of the observational, prospective, controlled, and multicenter ERACI IV registry.

OBJECTIVE: To compare second generation drug eluting stents (2DES) with first generation (1DES) for the treatment of patients (pts) with multiple coronary vessel disease (MVD). BACKGROUND: Although 2DES improved safety and efficacy compared to 1DES, MVD remains a challenge for percutaneous coronary interventions. METHODS: ERACI IV was a prospective, observational, and controlled study in pts with MVD including left main and treated with 2DES (Firebird 2, Microport). We included 225 pts in 15 sites from Argentina. Primary endpoint was the incidence of major adverse cardiovascular events (MACCE) defined as death, myocardial infarction (MI), cerebrovascular accident (CVA) and unplanned revascularization; and to compare with 225 pts from ERACI III study (1DES). PCI strategy was planned to treat lesions ≥70% in vessels ≥ 2.00 mm, introducing a modified Syntax score (SS) where severe lesions in vessels < 2.0 mm and intermediate lesions were not scored. RESULTS: Baseline characteristics showed that compared to ERACI III, ERACI IV pts had higher number of diabetics (P = 0.02), previous revascularization (P = 0.007), unstable angina IIb/IIIc (P < 0.001) and three vessels/left main disease (P = 0.003). Modified SS was 22.2 ± 11. At 2 years of follow-up ERACI IV group had significantly lower incidence of death+ MI + CVA, (P = 0.01) and MACCE (P = 0.001). MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005). CONCLUSION: This registry showed that 2DES in MVD has a remarkable low incidence of MACCE in unadjusted and adjusted analysis. © 2016 Wiley Periodicals, Inc.

Second vs. first-generation drug-eluting stents in complex lesions subsets: 3 years' follow-up of ERACI IV study.

BACKGROUND: Although percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES-1) did not show a benefit in terms of death rate and myocardial infarction (MI) compared to bypass surgery (coronary artery bypass graft [CABG]), DES platforms have seen a remarkable improvement in the last few years, and a significant increase in their safety and efficacy was observed in randomized controlled trials and observational studies in comparison with DES-1 in patients with coronary artery disease (CAD). One-year results from the ERACI IV registry using a second-generation DES (DES-2) demonstrated significantly greater efficacy and safety in patients with multiple vessel CAD, including diabetics, compared to DES-1. Long-term results are yet unknown. METHODS: The ERACI IV registry was a multicenter, prospective and controlled open-label study conducted in 9 sites in Argentina during 2013 and 2014, which evaluated a DES-2 for the treatment of patients with multiple vessel CAD including unprotected left main disease (ULMD) and diabetes. The primary endpoint was to compare the composite of death of any cause, MI and cerebrovascular accident (CVA) as hard endpoints with ERACI III DES-1 arm. Secondary endpoints included each component of the primary endpoint and target vessel revascularization (TVR) as major adverse cardiovascular events (MACCE) and stent thrombosis. We include a modified Syntax Score (SS) taking in account functional revascularization, treating lesions ≥70% in vessels ≥ 2.00 mm, whereas severe lesions in vessels < 2.0 mm and intermediate lesions were not rated. RESULTS: Baseline characteristics were similar between groups, with higher numbers of diabetics and 3-vessel/ULMD (P=0.02 and P=0.003, respectively) in ERACI IV. At 34.7 months' follow-up, the incidence of the composite of death/MI/CVA between ERACI IV and ERACI III (4.9% vs. 13.7%, P<0.001); unplanned new revascularization (5.3% vs. 14.2%, P<0.001) and MACCE (9.3% vs. 22.7%, P<0.001), were significantly lower in ERACI IV DES-2. MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005). Incidence of stent thrombosis was lower although not significantly between groups, (0.9% vs. 3.1% in ERACI IV and III, respectively; P=0.13). CONCLUSIONS: The use of DES-2 in patients with complex lesions subsets together with a functional PCI strategy were associated with a remarkable low incidence of adverse events at 3 years' follow-up and the benefit was also seen in in diabetic population. Late outcome of this study strongly validated our lesion PCI scoring and assessment.

Modifying angiographic syntax score according to PCI strategy: lessons learnt from ERACI IV Study.

In recent years an angiographic score was introduced in clinical practice to stratified different levels of risk after percutaneous coronary interventions (PCI) with drug eluting stents. The SYNTAX score (SS) classified patients in three different risk levels and was included in revascularization guidelines that patients allocated with low SS could be equally treated with either PCI or CABG, whereas those with intermediate or high SS were better off with CABG. However, using original SS each coronary lesion with a diameter stenosis ≥50% in vessels ≥1.5 mm was scored. In ERACI IV registry we used a revascularization strategy during PCI where operators were advised to only treat lesions≥than 70% in a≥2.0 mm reference vessel; therefore, no intermediate lesions should be treated, and severe stenosis in vessels<2.0 mm was discouraged as well. If we recalculated SS using the above-mentioned operators' advices all intermediate lesions were not scored, and severe stenosis in vessels<2.0 mm were excluded for the analysis, including bifurcations, trifurcations and chronic total occlusions; after this new scoring, the original SS dropped significantly which is in accordance with the goal of complete functional revascularization strategy of the ERACI IV study and the low one year adverse events of such study. In conclusion, if we performed an SS scoring, only severe stenosis in vessels with a reference diameter ≥2.0 mm would allow a more rational assessment of coronary anatomy, and the use of a more conservative PCI strategy.

[Vena cava filters in cancer patients]. / Filtros de vena cava en pacientes con cáncer.

Cancer patients with venous thromboembolism (VTE) have more complications related to the anticoagulation treatment than the general population. Vena cava filters are a useful tool in cancer patients, but their use in advanced disease is controversial. In this paper, we reviewed the indications, complications and frequency of retrieval of vena cava filters in cancer patients with VTE. Twenty seven patients with vena cava filter placements were analyzed. Twenty five had solid tumors and two non Hodgkin lymphomas. Twenty five were under active treatment (surgery and/or chemotherapy). Nineteen were classified as stage IV of disease. Indications for filter placement were perioperative prophylaxis in 14 cases (51.9%), hemorrhage (n = 5), thrombocytopenia (n = 4), central nervous system metastases (n = 2), stroke (n = 1) and previous neurosurgery (n = 1). Eight (29.6%) filters were retrieved. The median time to retrieval was 21 days (range: 6-75). There was no statistically significant difference in the frequency of retrieval between perioperative prophylaxis placement (6/14) and other contraindications for anticoagulation treatment (2/13; p = 0.2087). There were no adverse events related to the placement or retrieval procedures.

Filtros de vena cava en pacientes con cáncer / Vena cava filters in cancer patients

Los pacientes con tromboembolismo venoso (TEV) y cáncer tienen más complicaciones vinculadas al tratamiento anticoagulante que la población general. Los filtros de vena cava constituyen una herramienta útil para el tratamiento del TEV y su utilización es controvertida en estadios avanzados de la enfermedad. En este trabajo se revisaron las indicaciones, complicaciones y frecuencia de retiro de los filtros de vena cava en una población de pacientes oncológicos con TEV. Se analizaron 27 pacientes a quienes se les había colocado filtros de vena cava. Veinticinco tenían tumores sólidos y dos linfomas no Hodgkin. Veinticinco estaban bajo tratamiento activo (cirugía y/o quimioterapia). Diecinueve se hallaban en estadio IV de su enfermedad. El motivo de su indicación fue profilaxis en el período perioperatorio en 14 casos (51.9%), hemorragia (n = 5), trombocitopenia (n = 4), metástasis en sistema nervioso central (n = 2), accidente cerebrovascular (n = 1) y neurocirugía previa no reciente (n = 1). Se retiraron 8 (29.6%) filtros. La mediana del tiempo de permanencia fue 21 días (6-75). No hubo diferencias estadísticamente significativas en la frecuencia de retiro entre los filtros colocados en el perioperatorio (6/14) y los colocados por otras contraindicaciones para la anticoagulación (2/13; p = 0.2087). No hubo fracasos ni complicaciones en los procedimientos de colocación y retiro.

Cancer patients with venous thromboembolism (VTE) have more complications related to the anticoagulation treatment than the general population. Vena cava filters are a useful tool in cancer patients, but their use in advanced disease is controversial. In this paper, we reviewed the indications, complications and frequency of retrieval of vena cava filters in cancer patients with VTE. Twenty seven patients with vena cava filter placements were analyzed. Twenty five had solid tumors and two non Hodgkin lymphomas. Twenty five were under active treatment (surgery and/or chemotherapy). Nineteen were classified as stage IV of disease. Indications for filter placement were perioperative prophylaxis in 14 cases (51.9%), hemorrhage (n = 5), thrombocytopenia (n = 4), central nervous system metastases (n = 2), stroke (n = 1) and previous neurosurgery (n = 1). Eight (29.6%) filters were retrieved. The median time to retrieval was 21 days (range: 6-75). There was no statistically significant difference in the frequency of retrieval between perioperative prophylaxis placement (6/14) and other contraindications for anticoagulation treatment (2/13; p = 0.2087). There were no adverse events related to the placement or retrieval procedures.

Filtros de vena cava en pacientes con cáncer / Vena cava filters in cancer patients

Los pacientes con tromboembolismo venoso (TEV) y cáncer tienen más complicaciones vinculadas al tratamiento anticoagulante que la población general. Los filtros de vena cava constituyen una herramienta útil para el tratamiento del TEV y su utilización es controvertida en estadios avanzados de la enfermedad. En este trabajo se revisaron las indicaciones, complicaciones y frecuencia de retiro de los filtros de vena cava en una población de pacientes oncológicos con TEV. Se analizaron 27 pacientes a quienes se les había colocado filtros de vena cava. Veinticinco tenían tumores sólidos y dos linfomas no Hodgkin. Veinticinco estaban bajo tratamiento activo (cirugía y/o quimioterapia). Diecinueve se hallaban en estadio IV de su enfermedad. El motivo de su indicación fue profilaxis en el período perioperatorio en 14 casos (51.9%), hemorragia (n = 5), trombocitopenia (n = 4), metástasis en sistema nervioso central (n = 2), accidente cerebrovascular (n = 1) y neurocirugía previa no reciente (n = 1). Se retiraron 8 (29.6%) filtros. La mediana del tiempo de permanencia fue 21 días (6-75). No hubo diferencias estadísticamente significativas en la frecuencia de retiro entre los filtros colocados en el perioperatorio (6/14) y los colocados por otras contraindicaciones para la anticoagulación (2/13; p = 0.2087). No hubo fracasos ni complicaciones en los procedimientos de colocación y retiro.(AU)

Cancer patients with venous thromboembolism (VTE) have more complications related to the anticoagulation treatment than the general population. Vena cava filters are a useful tool in cancer patients, but their use in advanced disease is controversial. In this paper, we reviewed the indications, complications and frequency of retrieval of vena cava filters in cancer patients with VTE. Twenty seven patients with vena cava filter placements were analyzed. Twenty five had solid tumors and two non Hodgkin lymphomas. Twenty five were under active treatment (surgery and/or chemotherapy). Nineteen were classified as stage IV of disease. Indications for filter placement were perioperative prophylaxis in 14 cases (51.9%), hemorrhage (n = 5), thrombocytopenia (n = 4), central nervous system metastases (n = 2), stroke (n = 1) and previous neurosurgery (n = 1). Eight (29.6%) filters were retrieved. The median time to retrieval was 21 days (range: 6-75). There was no statistically significant difference in the frequency of retrieval between perioperative prophylaxis placement (6/14) and other contraindications for anticoagulation treatment (2/13; p = 0.2087). There were no adverse events related to the placement or retrieval procedures.(AU)

Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.

OBJECTIVES: The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy. BACKGROUND: OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown. METHODS: In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR. RESULTS: Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test. CONCLUSIONS: At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.