Predictors of pacemaker implantation after TAVI in a registry including self, balloon and mechanical expandable valves.

The need for permanent pacemaker implantation (PPMI) is a burdensome complication of transcatheter aortic valve implantation (TAVI). The aim of our study was to evaluate different anatomical, clinical, electrocardiographic, and procedural variables associated with the development of conduction abnormalities after TAVI across the entire device spectrum. Single-center prospective cohort of consecutive patients who underwent TAVI since March 2017. Final cohort was studied to detect areas of calcium within aortic valve characterized by leaflet sector and region. Membranous septum (MS) length was assessed throughout a modified coronal view. Device selection and positioning were performed according to the operator criteria. Device selection and positioning were performed according to the operator criteria. From the 273 patients included, 57 underwent PPMI (20.8%). Univariate analysis determined right bundle branch block (RBBB), QRS duration, MS length and calcium within LVOT of non-coronary cuspid as independent predictors. After multivariable logistic regression, both RBBB (OR 6.138; 95% CI 1.23-30.73, P = 0.027) and MS length (OR 0.259; 95% CI 0.164-0.399, P < 0.005) emerged as statistically significant. As a model, they could predict PPMI in 88.7%, independently of which valve used. Youden index analysis yielded 7.69 mm as the optimal cut-off with a negative and positive predictive value of 94.7 and 71.9%, respectively. In our experience, both RBBB pattern and short membranous septum (< 8 mm) were strongly and independently associated with new permanent pacemaker implantation, regardless of the device type. Our findings suggest that this simple evolved measure of MS length may guide device selection and implantation technique and facilitate early discharge.

Non-pharmacological treatment of refractory angina: The coronary sinus reducer, the new kid on the block.

Refractory angina is defined as persistent angina (≥3 months) despite optimal medical and interventional therapies. It is increasing in frequency, due to the success of current medical and interventional therapies in improving the prognosis of coronary artery disease. Long-term mortality is similar to that of patients with asymptomatic stable disease, but it affects patients' quality of life, and has a significant impact on health care resources. Several therapeutic targets have been investigated, most with disappointing results. Many of the techniques have been abandoned because of lack of efficacy, safety issues, or economic and logistic limitations to wider applicability. The primary focus of this review is the coronary sinus Reducer, supporting evidence for which, although scarce, is promising regarding safety and efficacy in improving anginal symptoms and quality of life. It is also accessible to virtually all interventional cardiology departments.

Non-pharmacological treatment of refractory angina: The coronary sinus reducer, the new kid on the block. / Tratamento não farmacológico da angina refratária. Dispositivo de redução do seio coronário, uma nova alternativa terapêutica.

Refractory angina is defined as persistent angina (≥3 months) despite optimal medical and interventional therapies. It is increasing in frequency, due to the success of current medical and interventional therapies in improving the prognosis of coronary artery disease. Long-term mortality is similar to that of patients with asymptomatic stable disease, but it affects patients' quality of life, and has a significant impact on health care resources. Several therapeutic targets have been investigated, most with disappointing results. Many of the techniques have been abandoned because of lack of efficacy, safety issues, or economic and logistic limitations to wider applicability. The primary focus of this review is the coronary sinus Reducer, supporting evidence for which, although scarce, is promising regarding safety and efficacy in improving anginal symptoms and quality of life. It is also accessible to virtually all interventional cardiology departments.

Unexpected success in early post-transplantation renal vein thrombosis: A case report and literature review.

BACKGROUND: Allograft renal vein thrombosis can cause graft loss during the early postoperative period. This diagnosis is sometimes elusive, requiring a strong suspicion. On the other hand, several authors have recognized risk factors for allograft renal vein thrombosis, but neither a preventive approach nor a treatment have been recommended for this complication. CASE PRESENTATION: We present a case report of early allograft renal vein thrombosis, preceded by femoral common deep vein thrombosis in a recipient of a third kidney transplant. Despite femoral common deep vein thrombosis treatment with low-molecular-weight heparin and progressive improvement of renal function to a nadir serum creatinine of 0.51 mg/dL, the patient experienced a sudden episode of anuria on postoperative day 5. Doppler ultrasonography strongly suggested the diagnosis of allograft renal vein thrombosis. The patient underwent balloon catheter and aspiration venous thrombectomy, followed by unfractionated heparin perfusion. After 4 days of anuria and multiple blood transfusions, when allograft nephrectomy was contemplated, diuresis suddenly resumed. After 1 year of follow-up, the patient still has a normal renal function. CONCLUSION: This case report shows successful treatment of allograft renal vein thrombosis associated with deep vein thrombosis in the first week of transplantation, using balloon catheter and aspiration venous thrombectomy followed by perfusion of unfractionated heparin. The authors suggest this technique as a treatment option for transplant renal vein thrombosis. However, they reinforce the importance of individualized treatment and they remind that a delay may jeopardize the potential benefit of the procedure.

Diagnostic accuracy of computed tomography angiography for the exclusion of coronary artery disease in candidates for transcatheter aortic valve implantation.

Coronary CT angiography (CTA) is currently considered a reliable method to exclude obstructive coronary artery disease (CAD) before valvular heart surgery in patients with low pretest probability. However, its role in excluding obstructive CAD before transcatheter aortic valve implantation (TAVI) is less well established. Single-center retrospective study where patients with severe symptomatic aortic stenosis underwent both CTA and invasive coronary angiography (ICA) as part of TAVI planning. CTA exams were conducted on a 64-slice dual source scanner, with a median interval of 45 days to ICA (IQR 25-75 [13-82]). In both tests, obstructive CAD was defined as a ≥50% stenosis in an epicardial vessel ≥2 mm diameter. Per-patient, per-vessel and per-proximal segment analyses were conducted, excluding and including non-evaluable segments. The study included 200 patients (120 women, mean age 83 ± 6 years). The prevalence of obstructive CAD on ICA was 35.5% (n = 71). On a per-patient analysis (assuming non-evaluable segments as stenotic), CTA showed sensitivity of 100% (95% CI, 95-100%), specificity of 42% (95% CI, 33-51%), and positive and negative predictive values of 48% (95% CI, 44-51%) and 100% (95% CI, 92-100%), respectively. CTA was able to exclude obstructive CAD in 54 patients (27%), in whom ICA could have been safely withheld. Despite the high rate of inconclusive tests, pre-procedural CTA is able to safely exclude obstructive CAD in a significant proportion of patients undergoing TAVI, possibly avoiding the need for ICA in roughly one quarter of the cases.

Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates.

BACKGROUND: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. METHODS: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. RESULTS: The mean SYNTAX score was 16.3 ±â€¯13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0-8: n = 563; >8-19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44-1.13; tertile 2: HR 0.71, 95% CI 0.46-1.09; tertile 3: HR 0.83, 95% CI 0.61-1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. CONCLUSIONS: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Myocardial Infarction and Left Main or Multivessel Coronary Disease.

Current recommendations on the optimal revascularization strategy in Non-ST-elevation myocardial infarction (NSTEMI) with left main (LM) or multivessel coronary disease (MVD) are based upon randomized clinical trials conducted in stable coronary artery disease. In a real-world contemporary observational registry, we compared the long-term outcome of NSTEMI patients with LM/MVD (n = 1,104) submitted to coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT). The primary end point was 5-year all-cause mortality. Results were assessed in the entire population (CABG 289, PCI 399, and OMT 416) and in a propensity score-matched cohort of CABG (n = 159) and PCI (n = 159). Crude 5-year mortality rates in CABG and PCI were 25.3% versus 29.6%, respectively (unadjusted hazard ratio [HR] 1.2; 95% confidence intervals [CI] 0.9 to 1.6; p = 0.212); OMT, however, was associated with a twofold higher risk of mortality when compared with any revascularization strategy (unadjusted HR 2.0; 95% CI 1.7 to 2.5; p < 0.001). After propensity score-matching and multivariate analysis, there was a trend toward a higher incidence of the primary end point in patients who underwent PCI versus CABG (31% vs 21%; adjusted HR 1.52; 95% CI 0.93 to 2.50; p = 0.094). This was a consistent finding over subgroups deemed clinically relevant, such as in patients with LM or proximal left anterior descending disease, SYNergy between percutaneous coronary intervention with TAXus ≥23 and left ventricle ejection fraction <40%. In conclusion, in a real-world cohort of NSTEMI patients with LM/MVD, those selected for OMT had a dire outcome. Although adjusted 5-year mortality was statistically similar between revascularization strategies, there was a trend favoring CABG, which might be the preferred option in LM, proximal LAD, SYNergy between percutaneous coronary intervention with TAXus ≥23, and left ventricle ejection fraction <40% subgroups.

Comparison of multiparametric risk scores for predicting early mortality after transcatheter aortic valve implantation.

INTRODUCTION: Surgical risk scores are widely used to identify patients at high surgical risk who may benefit from transcatheter aortic valve implantation (TAVI). A multiparametric TAVI mortality risk score based on a French registry (FRANCE-2) has recently been developed. The aim of our study was to compare the 30-day mortality prediction performance of the FRANCE-2, EuroSCORE II and STS scores. METHODS: We retrospectively studied 240 patients from a single-center prospective registry who underwent TAVI between January 2008 and December 2015. All scores were assessed for calibration and discrimination using calibration-in-the-large and ROC curve analysis, respectively. RESULTS: The observed mortality was 5.8% (n=14). The median EuroSCORE II, STS and FRANCE-2 scores were 5.0 (IQR 3.2-8.3), 5.1 (IQR 3.6-7.1) and 2.0 (IQR 1.0-3.0), respectively. Discriminative power was greater for EuroSCORE II (C-statistic 0.67) and STS (C-statistic 0.67) than for FRANCE-2 (C-statistic 0.53), but this was not statistically significant (p=0.26). All scores showed adequate calibration. CONCLUSIONS: All scores showed modest performance in early mortality prediction after TAVI. Despite being derived from a TAVI population, FRANCE-2 was no better than surgical risk scores in our population.

Advantages of a prospective multidisciplinary approach in transcatheter aortic valve implantation: Eight years of experience.

INTRODUCTION: Aortic stenosis is the most prevalent type of valvular disease in Europe. Surgical aortic valve replacement (SAVR) is the standard therapy, while transcatheter aortic valve implantation (TAVI) is an alternative in patients at unacceptably high surgical risk. Assessment by a heart team is recommended by the guidelines but there is little published evidence on this subject. The purpose of this paper is to describe the experience of a multidisciplinary TAVI program that began in 2008. METHODS: The heart team prospectively assessed 473 patients using a standardized approach. A total of 214 patients were selected for TAVI and 80 for SAVR. Demographic, clinical and procedural characteristics and long-term success rates were compared between the groups. RESULTS: TAVI patients were older than the SAVR group (median 83 vs. 81 years), and had higher surgical risk scores (median EuroSCORE II 5.3 vs. 3.6% and Society of Thoracic Surgeons score 5.1 vs. 3.1%), as did the patients under medical treatment only. These scores were unable to assess multiple comorbidities. Patients' outcomes were different between the three groups (mortality with SAVR 25% vs. TAVI 37.6% vs. conservative therapy 57.6%, p=0.001). CONCLUSIONS: The heart team program was able to select candidates appropriately for TAVI, SAVR and conservative treatment, taking into account the risk of both invasive treatments. The use of a prospective standardized heart team approach is recommended, but requires continuous monitoring to ensure effectiveness in a timely manner.

Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.

OBJECTIVES: This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. BACKGROUND: DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. METHODS: The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. RESULTS: Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups. CONCLUSIONS: Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Predictors of Conversion from Radial Into Femoral Access in Cardiac Catheterization / Fatores Preditivos da Conversão de Acesso Radial em Femoral no Cateterismo Cardíaco

Background: Fewer bleeding complications and early ambulation make radial access a privileged route for cardiac catheterization. However, transradial (TR) approach is not always successful, requiring its conversion into femoral access. Objectives: To evaluate the rate of conversion from radial into femoral access in cardiac catheterization and to identify its predictors. Methods: Prospective dual-center registry, including 7632 consecutive patients undergoing catheterization via the radial access between Jan/2009 and Oct/2012. We evaluated the incidence of conversion into femoral access and its predictors by logistic regression analysis. Results: The patients’ mean age was 66 ± 11 years, and 32% were women. A total of 2969 procedures (38.4%) were percutaneous coronary interventions (PCI), and the most used first intention arterial access was the right radial artery (97.6%). Radial access failure rate was 5.8%. Independent predictors of conversion from radial into femoral access were the use of short introducer sheaths (OR 3.047, CI: 2.380-3.902; p < 0.001), PCI (OR 1.729, CI: 1.375-2.173; p < 0.001), female sex (OR 1.569, CI: 1.234-1.996; p < 0.001), multivessel disease (OR 1.457, CI: 1.167-1.819; p = 0.001), body surface area (BSA) ≤ 1.938 (OR 1.448, CI: 1.120-1.871; p = 0.005) and age > 66 years (OR 1.354, CI: 1.088-1.684; p = 0.007). Conclusion: Transradial approach for cardiac catheterization has a high success rate and the need for its conversion into femoral access in this cohort was low. Female sex, older age, smaller BSA, the use of short introducer sheaths, multivessel disease and PCI were independent predictors of conversion into femoral access. .

Fundamento: Menos complicações hemorrágicas e deambulação precoce fazem do acesso radial uma via privilegiada para cateterismo cardíaco. Entretanto, a abordagem transradial (TR) nem sempre é bem-sucedida, sendo necessária a sua conversão em acesso femoral. Objetivo: Avaliar a taxa de conversão do acesso radial em femoral no cateterismo cardíaco e identificar seus fatores preditivos. Métodos: Registro prospectivo de dois centros, incluindo 7.632 pacientes consecutivos submetidos a cateterização via acesso radial entre janeiro de 2009 e outubro de 2012. Avaliou-se a incidência de conversão em acesso femoral e seus fatores preditivos através de análise de regressão logística. Resultados: A idade média dos pacientes foi de 66 ± 11 anos, sendo 32% deles mulheres. Houve 2.969 (38.4%) intervenções coronarianas percutâneas (ICP),sendo a artéria radial direita a primeira escolha mais usada (97,6%). A taxa de insucesso do acesso radial foi de 5,8%. Fatores preditivos independentes da conversão do acesso radial em femoral foram o uso de bainhas introdutoras curtas (OR 3,047; IC: 2,380-3,902; p < 0,001), ICP (OR 1,729; IC: 1,375-2,173; p < 0,001), sexo feminino (OR 1,569;IC: 1,234-1,996; p < 0,001), doença multiarterial (OR 1,457; IC: 1,167-1,819; p = 0,001), área de superfície corporal(ASC) ≤ 1,938 (OR 1,448; IC: 1,120-1,871; p = 0,005) e idade > 66 anos (OR 1,354; IC: 1,088-1,684; p = 0,007). Conclusão: A abordagem transradial para cateterismo cardíaco tem alta taxa de sucesso e a necessidade de sua conversão em acesso femoral nesta coorte foi baixa. Os fatores preditivos independentes de sua conversão em acesso femoral foram: sexo feminino; idade mais avançada; menor ASC; uso de bainhas introdutoras curtas; doença multiarterial; e ICP. .

Predictors of Conversion from Radial Into Femoral Access in Cardiac Catheterization.

BACKGROUND: Fewer bleeding complications and early ambulation make radial access a privileged route for cardiac catheterization. However, transradial (TR) approach is not always successful, requiring its conversion into femoral access. OBJECTIVES: To evaluate the rate of conversion from radial into femoral access in cardiac catheterization and to identify its predictors. METHODS: Prospective dual-center registry, including 7632 consecutive patients undergoing catheterization via the radial access between Jan/2009 and Oct/2012. We evaluated the incidence of conversion into femoral access and its predictors by logistic regression analysis. RESULTS: The patients' mean age was 66 ± 11 years, and 32% were women. A total of 2969 procedures (38.4%) were percutaneous coronary interventions (PCI), and the most used first intention arterial access was the right radial artery (97.6%). Radial access failure rate was 5.8%. Independent predictors of conversion from radial into femoral access were the use of short introducer sheaths (OR 3.047, CI: 2.380-3.902; p < 0.001), PCI (OR 1.729, CI: 1.375-2.173; p < 0.001), female sex (OR 1.569, CI: 1.234-1.996; p < 0.001), multivessel disease (OR 1.457, CI: 1.167-1.819; p = 0.001), body surface area (BSA) ≤ 1.938 (OR 1.448, CI: 1.120-1.871; p = 0.005) and age > 66 years (OR 1.354, CI: 1.088-1.684; p = 0.007). CONCLUSION: Transradial approach for cardiac catheterization has a high success rate and the need for its conversion into femoral access in this cohort was low. Female sex, older age, smaller BSA, the use of short introducer sheaths, multivessel disease and PCI were independent predictors of conversion into femoral access.

Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates.

BACKGROUND: The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. OBJECTIVES: This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). METHODS: We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS: Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). CONCLUSIONS: Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319).

Neurologic complications after transradial or transfemoral approach for diagnostic and interventional cardiac catheterization: A propensity score analysis of 16,710 cases from a single centre prospective registry.

BACKGROUND AND AIM: Transradial approach (TRA) is being used increasingly as the preferential vascular access site for both diagnostic and interventional procedures. However, concerns have risen about the risk of clinically meaningful neurologic complications. We aimed to assess the association between the risk of stroke/transient ischemic attack (TIA) and the transradial (vs. transfemoral) approach. METHODS AND RESULTS: Data from 16,710 cases included in a single centre prospective registry between January 2006 and November 2012 was analyzed. Radial procedures were considered as those in which the radial access was used either primarily (n = 4,195) or after conversion (n = 36). Potential cases with neurologic events were targeted by cross-referencing patients who underwent both cardiac catheterization and cranial-computed tomography (cranial-CT) during the same admission episode (n = 67). Procedure-related events were defined as a definitive non-CABG related stroke/TIA occurring within 48 hr of the procedure. TRA increased from 0.7% in 2006 to 75% in 2012. Total incidence of stroke/TIA was 0.16% and did not change over the study period (P = 0.26). There was no significant difference in stroke/TIA rates between groups (0.165% vs. 0.160%; P = 1.0). After correction for baseline differences and propensity score matching, TRA was not an independent predictor of stroke/TIA (OR 1.21; 95% CI 0.49-2.98 and 1.3; 95% CI 0.55-3.54, respectively). Results were consistent in pre-specified sub-groups according to age (≥65 y.o. vs. younger), gender, interventional vs. diagnostic and ACS vs. stable. CONCLUSION: Rates of documented stroke/TIA were low. Our observational study suggests that widening the use of the TRA is not associated with an increased risk of clinically relevant procedure-related neurologic complications.

[Transapical aortic valve replacement: a 5-years experience]. / VÁLVULA AÓRTICA PERCUTÂNEA TRANSAPICAL: 5 ANOS DE EXPERIÊNCIA.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) by transapical approach is accepted for severe aortic stenosis in patients with high risk for conventional surgical therapy. Herein is reported the initial clinical results of this technique in a reference center METHODS: We conducted a longitudinal prospective single center study including 54 consecutive patients (mean age 79 ± 7.5 years, 59% male) who underwent, between November 2008 and October 2013, TAVR with Edwards Sapien valves throught transapical approach. The etiology was native aortic stenosis in 83% (mean gradient = 49 ± 18.3 mmHg and area = 0,7 cm2), 11% aortic disease and 3 patients had degenerated biological valvular prostheses, being 65% in class III/IV NYHA. The major comorbidities were coronary heart disease in 56% (status post-coronary surgery 37%), diabetes (37%), peripheral artery disease (31%) and chronic renal failure (24%). The logistic EuroSCORE was 19.8 ± 11.2 and EuroSCORE II 5.5 ± 3.5%, with STS mortality score 5.1 ± 3.7 and 23.7 ± 7.6 STS morbidity. RESULTS: Analysis following the VARC-2 criteria (Valve Academic Research Consortium), showed 30-day mortality of 5.6%; peri-procedural myocardial infarction 7.4%; disabling cerebral vascular accident 1.9%; severe haemorrhage 14.8%; major vascular complications 5.6%; pacemaker implantation 11%. Unplanned extracorporeal circulation was used in 5 cases and prosthetic dysfunction occurred in 4 patients (shift valve in 2 cases). The median hospital stay was 8.0 days, with re-hospitalization in 12.2% of cases. The composite VARC-2 endpoints were: device success = 90.7%; early safety at 30 days = 75.9% and clinical efficacy after 30 days= 83.7%. CONCLUSION: The transapical approach was found as an effective therapy for patients at high risk for conventional surgery.

Percutaneous coronary intervention of unprotected left main disease: five-year outcome of a single-center registry.

INTRODUCTION AND AIMS: Percutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main coronary artery (ULMCA) lesions. We aimed to evaluate the long-term outcome of patients undergoing ULMCA PCI. METHODS AND RESULTS: We retrospectively analyzed 95 consecutive patients (median EuroSCORE I 2.9 [IQR 1.4;6.1]) who underwent ULMCA PCI between 1999 and 2006, included in a single-center prospective registry. The primary outcome was major adverse cardiovascular events (MACE) defined as all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR) at five years. Forty patients (42.1%) were treated in the setting of acute coronary syndrome and 81 patients (85%) had at least one additional significant lesion (SYNTAX score 24.2±11.8). Single ULMCA PCI was performed in 33% (81.1% with drug-eluting stents) and complete functional revascularization was achieved in 79% of the patients. During the observation period, 20 patients died (21.1%), 6 (6.3%) had MI and 11 (11.6%) had TLR (total combined MACE 28.4%). Independent predictors of MACE were previous MI (HR 2.9 95% CI 1.23-6.92; p=0.015), hypertension (HR 5.7 95% CI 1.86-17.47; p=0.002) and the EuroSCORE I (HR 1.1 95% CI 1.03-1.12; p=0.001). Drug-eluting stent implantation was associated with a significantly lower MACE rate, even after propensity score adjustment (AUC=0.84; HR [corrected] 0.1; 95% CI 0.04-0.26; p<0.001). CONCLUSIONS: Unprotected left main percutaneous coronary intervention, particularly using drug-eluting stents, can be considered a valid alternative to coronary artery bypass grafting, especially in high-risk surgical patients and with favorable anatomic features.

Intervenção coronária percutânea utilizando Full Metal Jacket com stents farmacológicos: eventos cardíacos adversos maiores em um ano / Percutaneous coronary intervention using a full metal jacket with drug-eluting stents: major adverse cardiac events at one year

FUNDAMENTO: O benefício clínico de intervenção coronária percutânea (ICP) para lesões coronárias longas é incerto; além disso, foram levantadas dúvidas questões sobre a sua segurança. OBJETIVO: Avaliar os preditores de eventos cardíacos adversos maiores (ECAM) associados à ICP utilizando Full Metal Jacket (FMJ), definido como a sobreposição de stents farmacológicos (SF) medindo >60 mm de comprimento, para lesões muito longas. MÉTODOS: Foram incluídos 136 pacientes consecutivos com lesões coronárias longas, requerendo FMJ em nosso cadastro de centro único. O desfecho primário incluiu a ocorrência combinada de todas as causas de morte, infarto do miocárdio (IM) e revascularização do vaso alvo (RVA). Variáveis demográficas, clínicas, angiográficas e de procedimento foram avaliadas por meio de análise de regressão de Cox para determinar os preditores independentes de desfecho. RESULTADOS: O comprimento médio do stent por lesão foi de 73,2 ± 12,3 mm e o diâmetro médio do vaso de referência foi de 2,9 ± 0,6 mm. O sucesso angiográfico foi de 96,3%. A ausência de ECAM foi de 94,9% em 30 dias e 85,3% em um ano. No acompanhamento de um ano, a taxa de mortalidade por todas as causas foi de 3,7% (1,5% por mortes cardíacas), a taxa de IM foi de 3,7%, e a incidência de trombose de stent (TS) definitiva ou provável foi de 2,9%. O gênero feminino [risco relativo (RR), 4,40; intervalo de confiança de 95% (IC), 1,81-10,66, p = 0,001) e ICP de artéria coronária não direita (RR, 3,49; p = 0,006; IC 95%, 1,42-8,59) foram preditores independentes de ECAM em um ano. A ausência de eventos adversos em um ano foi maior em pacientes com angina estável submetidos à ICP (RR, 0,33; IC 95% 0,13-0,80, p = 0,014). CONCLUSÕES: A ICP utilizando FMJ com SF para lesões muito longas foi eficaz, mas associada a uma alta taxa de TS em acompanhamento de um ano. No entanto, a taxa de mortalidade cardíaca, IM não relacionado a procedimento, e ECAM foi relativamente baixa. ICP de vaso coronário alvo, apresentação clínica, e gênero feminino são novos fatores clínicos contemporâneos que parecem apresentar efeitos adversos sobre o resultado da ICP utilizando FMJ para lesões longas.

BACKGROUND: The clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety. OBJECTIVES: To evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring >60 mm in length, for very long lesions. METHODS: We enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our single-center registry. The primary endpoint included the combined occurrence of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR). Demographic, clinical, angiographic, and procedural variables were evaluated using stepwise Cox regression analysis to determine independent predictors of outcome. RESULTS: The mean length of stent per lesion was 73.2 ± 12.3 mm and the mean reference vessel diameter was 2.9 ± 0.6 mm. Angiographic success was 96.3%. Freedom from MACE was 94.9% at 30 days and 85.3% at one year. At the one-year follow-up, the all-cause mortality rate was 3.7% (1.5% cardiac deaths), the MI rate was 3.7%, and the incidence of definite or probable stent thrombosis (ST) was 2.9%. Female gender [hazard ratio (HR), 4.40; 95% confidence interval (CI), 1.81-10.66; p = 0.001) and non-right coronary artery PCI (HR, 3.49; 95%CI, 1.42-8.59; p = 0,006) were independent predictors of MACE at one year. Freedom from adverse events at one year was higher in patients with stable angina who underwent PCI (HR, 0.33; 95%CI, 0.13-0.80; p = 0.014). CONCLUSIONS: PCI using FMJ with DES for very long lesions was efficacious but associated with a high rate of ST at the one-year follow-up. However, the rate of cardiac mortality, nonprocedure-related MI, and MACE was relatively low. Target coronary vessel PCI, clinical presentation, and female gender are new contemporary clinical factors that appear to have adverse effects on the outcome of PCI using FMJ for long lesions.

Percutaneous coronary intervention using a full metal jacket with drug-eluting stents: major adverse cardiac events at one year.

BACKGROUND: The clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety. OBJECTIVES: To evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring >60 mm in length, for very long lesions. METHODS: We enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our single-center registry. The primary endpoint included the combined occurrence of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR). Demographic, clinical, angiographic, and procedural variables were evaluated using stepwise Cox regression analysis to determine independent predictors of outcome. RESULTS: The mean length of stent per lesion was 73.2 ± 12.3 mm and the mean reference vessel diameter was 2.9 ± 0.6 mm. Angiographic success was 96.3%. Freedom from MACE was 94.9% at 30 days and 85.3% at one year. At the one-year follow-up, the all-cause mortality rate was 3.7% (1.5% cardiac deaths), the MI rate was 3.7%, and the incidence of definite or probable stent thrombosis (ST) was 2.9%. Female gender [hazard ratio (HR), 4.40; 95% confidence interval (CI), 1.81-10.66; p = 0.001) and non-right coronary artery PCI (HR, 3.49; 95%CI, 1.42-8.59; p = 0,006) were independent predictors of MACE at one year. Freedom from adverse events at one year was higher in patients with stable angina who underwent PCI (HR, 0.33; 95%CI, 0.13-0.80; p = 0.014). CONCLUSIONS: PCI using FMJ with DES for very long lesions was efficacious but associated with a high rate of ST at the one-year follow-up. However, the rate of cardiac mortality, nonprocedure-related MI, and MACE was relatively low. Target coronary vessel PCI, clinical presentation, and female gender are new contemporary clinical factors that appear to have adverse effects on the outcome of PCI using FMJ for long lesions.

Nonobstructive coronary disease leading to STEMI: assessment of residual stenosis after thrombus aspiration.

AIMS: Nonobstructive coronary atherosclerotic lesions can lead to ST-elevation myocardial infarction (STEMI). Thrombus aspiration during a primary percutaneous coronary intervention provides a setting to evaluate the degree of stenosis of culprit lesions leading to STEMI. The aim of this study was to assess the degree of culprit lesion residual stenosis after thrombus aspiration and to compare the demographic, clinical, and angiographic characteristics between patients with obstructive versus nonobstructive residual stenosis. METHODS AND RESULTS: From a single-center registry of 483 consecutive patients with STEMI undergoing a primary percutaneous coronary intervention, 172 patients underwent thrombus aspiration and were eligible for our study. We defined two groups according to the residual stenosis after thrombus aspiration: group A (n=119, 69%) with residual stenosis greater than or equal to 50%, and group B (n=53, 31%) with residual stenosis less than 50%.In terms of the baseline angiographic characteristics, patients with residual stenosis less than 50% had significantly lower prevalence of multivessel disease (15.1 vs. 46.2%, P<0.001). On multivariable analysis of the preprocedural variables, absence of vascular disease (odds ratio 4.99, 95% confidence interval 1.08-23.12, P=0.040) and age less than 59 years (odds ratio 2.67, 95% confidence interval 1.25-5.73, P=0.011) were independent predictors of culprit residual stenosis less than 50%. CONCLUSION: In this population, a significant proportion of patients with STEMI had nonobstructive residual stenosis after thrombus aspiration. These patients were younger, had a lower prevalence of vascular disease in other vascular territories, and less multivessel disease, suggesting an earlier stage of atherosclerosis.