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2.
Artigo em Inglês | MEDLINE | ID: mdl-33201611

RESUMO

OBJECTIVES AND BACKGROUND: Iatrogenic aorto-coronary dissection (ICD) is one of the most feared complications of interventional cardiology. Although rare, it is characterized by anterograde coronary ischemia and a concomitant aortic dissection, with potentially fatal consequences. METHODS: We present an example case of IACD and an accurate case-series review of the literature including 125 published cases. RESULTS: There were no significant predisposing factors and the IACD occurred equally in elective and urgent procedures. A significant number of IACDs were associated with CTO procedures. The factors associated with a worse outcome were hemodynamic instability, the presence of anterograde ischemia, and the extent of dissection according to the Dunning classification. Bail-out stenting was the most used strategy and its failure was associated with mortality. CONCLUSION: The main features of IACD are anterograde ischemia, retrograde dissection, and hemodynamic instability, each of them should be addressed with no time delay, possibly with bailout stenting, the most employed exit-strategy. According to our proposed algorithm, a shock team approach is required to coordinate the interdisciplinary skills and enabled patients to receive the best treatment.

3.
Int J Cardiol ; 2020 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-33148461

RESUMO

BACKGROUND: Although bicuspid aortic valve (BAV) is not considered a "sweet spot" to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs). METHODS: patients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium-2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year. RESULTS: Type 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%,p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%;p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%,p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups. CONCLUSIONS: Our study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV.

4.
Artigo em Inglês | MEDLINE | ID: mdl-33189640

RESUMO

OBJECTIVES: The aim of this study was to assess the feasibility, efficacy, and clinical outcomes of transcatheter repair of tricuspid regurgitation (TR) in a pooled analysis of interventional studies. BACKGROUND: New percutaneous devices are available to treat severe TR, but the evidence is sparse and limited to smaller cohorts. METHODS: Several electronic databases were searched for interventional studies involving percutaneous repair of TR. Devices used were the Cardioband, FORMA, MitraClip, PASCAL, and Trialign. Outcomes included in the final analysis were successful implantation, residual severe TR, post-procedural New York Heart Association (NYHA) functional class III or IV, 6-min walk distance, and echocardiographic parameters. Subgroup and meta-regression analysis were performed to further explore residual heterogeneity. RESULTS: Seven studies and 454 patients undergoing transcatheter tricuspid valve repair were included in the pooled analysis; 95% of patients had at least severe TR, and 91% were in NYHA functional class III or IV. Successful implantation was achieved in 86% of patients. At the longest follow-up available (weighted mean 265 days), 9% had died. Compared with baseline, a significantly lower proportion of patients had at least severe TR (relative risk: 0.38; 95% confidence interval: 0.20 to 0.70; p = 0.004) and were in NYHA functional class III or IV (relative risk: 0.23; 95% confidence interval: 0.20 to 0.30; p < 0.001). Patients also experienced increases in 6-min walk distance (mean difference +64.6 m; p < 0.001) and significant reductions in tricuspid valve annular diameter (mean difference -3 mm; p < 0.001), while left and right ventricular function did not change significantly. CONCLUSIONS: A strategy of transcatheter repair for severe TR appears to be feasible, effective, and associated with improved clinical outcomes at mid-term follow-up.

5.
Am J Cardiol ; 2020 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-33058802

RESUMO

The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent (DES) era. We identified 512 consecutive DM patients who underwent PCI for ULMD at New Tokyo Hospital, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus between January 2005 and December 2015. We analyzed according to estimated glomerular filtration rate (eGFR). Each group was defined as follows; no CKD (60 ≤ eGFR), mild CKD (45 ≤ eGFR < 60), moderate CKD (30 ≤ eGFR < 45) and severe CKD (15 ≤ eGFR < 30). The primary endpoint was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). The rate of TLF was significantly higher in the severe CKD group than that in the other groups [Adjusted HR of severe CKD relative to the others 3.64, (1.86-7.11), p < 0.001]. Cardiac mortality was significantly higher in the severe CKD group than that in the other groups [Adjusted HR of severe CKD relative to the others 6.43, (2.19-18.9), p = 0.001]. TLR rate was comparable among 4 groups [Adjusted HR of severe CKD relative to the others 1.71, (0.60-4.82), p = 0.31]. In conclusions, among DM patients, those with severe CKD was extremely associated with worse clinical outcomes.

7.
Eur Heart J ; 41(38): 3762, 2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33026065
8.
J Invasive Cardiol ; 2020 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-33035179

RESUMO

BACKGROUND: Approximately 50% of patients with severe mitral regurgitation (MR) referred for surgery have prohibitive surgical risk. MitraClip (Abbott Vascular) is an alternative therapy option in these patients. The aim of this study is to evaluate mid-term outcome in patients who underwent MitraClip implantation. METHODS: All consecutive patients with ≥2+ MR and high risk for conventional surgical therapy who underwent MitraClip implantation at our unit were included in the analysis. The primary endpoint was all-cause mortality and secondary endpoint was heart failure rehospitalization. RESULTS: From October 2008 to December 2016, a total of 162 patients underwent MitraClip procedure at our unit. The mean follow-up duration was 819.8 ± 671.1 days. Acute procedural success was achieved in 141 of 162 patients (87.0%) and was not significantly different between primary and secondary MR patients (P=.09). Mortality rates were 14.4%, 28.7%, 38.7%, and 49.3% at 1 year, 2 years, 3 years, and 5 years, respectively. Rehospitalization rates for heart failure were 21.7%, 34.3%, 44.2%, and 56.6% at 1 year, 2 years, 3 years, and 5 years, respectively. At follow-up, patients exhibited significant improvement in New York Heart Association functional classification (P<.001). On multivariate analysis, baseline left ventricular ejection fraction (LVEF) <30% (odds ratio, 6.62) and baseline MR severity (odds ratio, 3.40) were the strongest predictors of mortality. Primary MR (odds ratio, 0.20) was associated with lower risk of mortality compared with secondary MR. CONCLUSIONS: Treatment of MR with MitraClip results in significant symptomatic improvement with excellent short-term results. However, 5-year mortality was 49.3%; baseline LVEF <30% and MR severity are the strongest predictors of mortality, while primary MR was a predictor for lower risk of mortality when compared with secondary MR.

9.
Artigo em Inglês | MEDLINE | ID: mdl-33109476

RESUMO

AIMS: The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD). STUDY DESIGN: The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021. CONCLUSIONS: The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD. Clinical Trial Registration URL: https://clinicaltrials.gov. Unique identifier: NCT03913832.

10.
Expert Rev Cardiovasc Ther ; : 1-9, 2020 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-33021849

RESUMO

INTRODUCTION: The widespread use of transcatheter aortic valve implantation (TAVI) is expanding to low-risk patients. Nevertheless, a low clinical risk does not always correspond to a low procedural risk for the percutaneous approach. AREAS COVERED: The initial trials on TAVI in low-risk populations had encouraging results, showing non-inferiority in comparison to surgical aortic valve replacement (SAVR). However, the low-risk definition is based on risk score calculators developed for the surgical setting and not including other specific features that are more relevant to TAVI and can affect procedural outcomes. For example, the presence of bicuspid aortic valves, high calcific burden, low coronary height or conduction disturbances is all potentially associated with suboptimal results or even procedural complications. In addition, the lack of longer follow-up prevents us to draw conclusions about long-term outcomes, including data about valve durability and coronary re-access. EXPERT OPINION: Although current evidence suggest similar results for TAVI and SAVR in low-risk populations, there are some technical and procedural limitations that still need to be addressed in order to close the gap between TAVI and surgery. Optimal, lasting results with a low rate of procedural complications are highly expected in low-risk, otherwise healthy subjects, with potential for longevity.

11.
Artigo em Inglês | MEDLINE | ID: mdl-33008726

RESUMO

BACKGROUND: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. METHODS: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). RESULTS: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. CONCLUSIONS: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.

12.
Echocardiography ; 2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33026122

RESUMO

AIMS: Aortic stenosis (AS) grading by 2D-transthoracic echocardiography (2D-TTE) aortic valve area (AVA) calculation is limited by left ventricular outflow tract (LVOT) area underestimation. The combination of Doppler parameters with 3D LVOT area obtained by multidetector computed tomography (MDCT) can improve AS grading, reconciling discordant 2D-TTE findings. This study aimed to systematically evaluate the role of 3D-transesophageal echocardiography (3D-TEE) in AS grading using MDCT as reference standard. METHODS AND RESULTS: 288 patients (81 ± 6.3 years, 52.4% female) with symptomatic AS underwent 2D-TTE, 3D-TEE, and MDCT for transcatheter aortic valve implantation. Doppler parameters were combined with 3D LVOT areas measured by manual and semi-automated software 3D-TEE and by MDCT to calculate AVA, reassessing AS severity. Both 3D-TEE modalities demonstrated good correlation with MDCT, with excellent intra-observer and inter-observer variability. Compared to MDCT, 3D-TEE measurements significantly underestimated AVA (PANOVA  < .0001), although the difference was clinically acceptable. Compared to 2D-TTE, 3D-TEE manual and semi-automated software reclassified severe AS in 21.9% and 25.2% of cases, respectively (P < .0001), overcame grading parameters discordance in more than 40% of cases in patients with low-gradient AS (P < .0001) and reduced the proportion of low-flow states in nearly 75% of cases when combined to stroke volume index assessment (P < .0001). 3D-TEE imaging modalities showed a reduction in the proportion of patients with low-gradient and pathological AVA as defined by 2D-TTE, and improved AVA and mean pressure gradient agreement with current guidelines cutoff values. CONCLUSION: 3D-TEE AVA calculation is a reliable tool for AS grading with excellent reproducibility and good correlation with MDCT measurements.

13.
Artigo em Inglês | MEDLINE | ID: mdl-33077393

RESUMO

AIM: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. METHODS AND RESULTS: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

14.
EuroIntervention ; 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32928715

RESUMO

AIMS: To investigate the risk of impaired coronary access and coronary obstruction after REDO-TAVI. METHODS AND RESULTS: Post-procedure multi-detector computed tomography (MDCT) scans of 221 TAVI recipients were analyzed. Increased risk of impaired coronary access was defined as coronary ostium below TAVI commissures with valve-to-aorta distance <2mm at this level. Increased risk was found in 123 (55.6%) cases, the left main involved in 109 (49.3%), the right coronary in 79 (35.7%), both in 65 (29.4%) patients. Small sino-tubular junction (STJ width OR 0.68, CI 0.56-0.81, P<0.001; STJ height OR 0.81, CI 0.69-0.95, P<0.011) and supra-annular devices (OR 19.8, CI 6.6-58.8, P<0.001) predicted increased risk. Increased risk of coronary obstruction defined as coronary ostium below TAVI commissures with valve-to-coronary distance <2mm was observed in 14.9% of patients, and in 17.2% of cases complete sealing of STJ would occur. CONCLUSIONS: Post-TAVI MDCT suggested an increased potential risk of impaired coronary access in more than half of patients should REDO-TAVI be required, predicted by small STJ and supra-annular device design. Furthermore, 10-20% of patients presented an increased risk of coronary obstruction. While this theoretical study is hypothesis-generating, it raises concerns that need to be further investigated and addressed before TAVI is extended to patients with longer life expectancy.

15.
EuroIntervention ; 2020 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-32894231

RESUMO

AIMS: We assessed the safety and efficacy of the DynamX™ Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements. METHODS AND RESULTS: This multi-center study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Through 12 months, two target lesion failures occurred, both were cardiac deaths (day 255 and 267 post-procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility with an approximate lumen area variance of 11% between systole and diastole. CONCLUSIONS: The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy through one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomized trials are required to assess the benefit of this device on events beyond one year.

16.
Cardiorenal Med ; : 1-10, 2020 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-32894836

RESUMO

BACKGROUND: The impact of diabetes mellitus (DM) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) distal bifurcation lesions in patients with chronic kidney disease (CKD) is poorly understood in the era of drug-eluting stents (DESs). OBJECTIVE: We assessed the impact of DM on clinical outcomes after PCI for ULM distal bifurcation lesions in CKD patients compared to patients without DM. METHODS: We identified 1,832 consecutive patients who underwent PCI for ULM lesions at New Tokyo Hospital, Matsudo, Japan, San Raffaele Scientific Institute, Milan, Italy, and EMO-GVM, Centro Cuore Columbus, Milan, Italy between January 2005 and August 2015. Of the 1,832 patients, 1,391 were treated with DESs. We excluded 750 patients without CKD and 89 hemodialysis patients. Finally, 552 patients with CKD were included: 219 with DM (DM group) and 333 without DM (no DM group). The primary endpoint was target lesion failure (TLF) at 5 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. RESULTS: Patients in the DM group were more likely to have hypertension, dyslipidemia, peripheral artery disease, and lower ejection fraction and were more frequently using insulin for DM. The TLF rate during the follow-up period was significantly higher in the DM than in the no DM group (adjusted hazard ratio [HR] 1.50; 95% confidence interval [CI] 1.06-2.13; p = 0.023). Cardiac mortality was comparable between both groups (adjusted HR 1.11; 95% CI 0.63-1.95; p = 0.71). The TLR rate was significantly higher in the DM group than in the no DM group (adjusted HR 1.69; 95% CI 1.12-2.54; p = 0.012). CONCLUSION: DM is strongly associated with adverse event after PCI for ULM distal bifurcation lesions in CKD patients compared to those without DM.

17.
Egypt Heart J ; 72(1): 61, 2020 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-32955624

RESUMO

BACKGROUND: To present a case of anomalous origin of the left coronary artery evaluated with invasive coronary angiography (ICA) and ECG-gated coronary computed tomography (CCT). CASE PRESENTATION: A patient (55 years old, male) with a past medical history of respiratory failure and atrial fibrillation underwent ICA to rule out coronary artery disease. Subsequently, the patient underwent ECG-gated CCT to evaluate a suspected anomalous aortic origin of the left coronary artery, since the interventional cardiologist was not able to properly identify the left coronary artery and its distal branches. CCT showed left coronary artery originating from the right coronary Valsalva sinus, coursing within the interventricular septum and emerging at the middle segment of the interventricular sulcus, where the left anterior descending and circumflex arteries originated. CONCLUSION: The case we presented highlights the value of ECG-gated CCT in the evaluation of coronary anomaly anatomy and thus risk stratification derived by proper coronary anatomy assessment. Although ICA was not helpful in the diagnosis, it also has a pivotal role regarding the therapeutic management of this condition.

18.
Artigo em Inglês | MEDLINE | ID: mdl-32964556

RESUMO

BACKGROUND: Chronic kidney disease (CKD) patients undergoing percutaneous coronary intervention (PCI) experience greater ischemic events including clinically driven target lesion revascularization (CD-TLR). Whether the COMBO biodegradable-polymer sirolimus-eluting stent promotes better outcomes in these patients by virtue of endothelial progenitor cell capture technology is unknown. OBJECTIVE: We examined one-year outcomes by CKD status from the COMBO collaboration. METHODS: The COMBO collaboration was a patient-level pooled dataset from the REMEDEE and MASCOT registries (3,614 patients) of all-comers undergoing attempted COMBO stent PCI. The primary endpoint was one-year target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or CD-TLR. Secondary endpoints included stent thrombosis (ST). RESULTS: The study included 6.4% (n = 231) CKD and 93.6% (n = 3,361) non-CKD patients. CKD patients were older and included more women with greater prevalence of several comorbidities but similar rate of acute coronary syndrome (50.6% vs. 54.5%, p = .26). CKD patients underwent radial PCI less often (56.1% vs. 70.3%, p < .001) and received clopidogrel (78.6% vs. 68.3%) more often (p = .004). One-year TLF occurred in 7.9% CKD vs. 3.7% non-CKD patients, p = .001. CKD patients also demonstrated greater incidence of cardiac death (6.2% vs. 1.2%, p < .0001), TV-MI (2.7% vs. 1.1%, p = .04) but similar CD-TLR (2.7% vs 2.2%, p = .61) and definite/probable ST (1.4% vs. 0.8%, p = .42), compared to non-CKD patients. CONCLUSIONS: CKD patients treated with COMBO stents had significantly greater incidence of one-year TLF compared to non-CKD patients driven by cardiac death and to a lesser extent TV-MI but not CD-TLR. They had similar rates of definite/probable ST.

19.
Int J Cardiol ; 2020 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-32971148

RESUMO

INTRODUCTION: The clinical impact of invasive hemodynamic support with Impella in patients with cardiogenic shock (CS) remains to be defined. METHOD: Only studies including patients treated with Impella in CS were selected. The primary endpoint was short term mortality, while secondary endpoints were major vascular complications and major bleeding. RESULTS: 17 studies and 3933 patients were included in the analysis. Median age was 61.9 (IQR 59.2-63.5) years, CS was mainly related to acute coronary syndrome (ACS): 79.6% (IQR 75.1-79.6). Thirty-day mortality was 47.8% (CI 43.7-52%). Based on metaregression analysis, the Impella 5.0 (point estimate -0.006, 95% CI -0.01 - - 0.02, p < 0.01) and the Impella CP (point estimate -0.007, 95% CI -0.01 - - 0.03, p < 0.01) devices were related to a higher survival rate, whereas the Impella 2.5 was not. Furthermore, a correlation with reduced mortality was found when Impella was initiated in CS not complicated by cardiac arrest (CA), and before revascularization, (point estimate 0.01, 95% CI 0.002-0.02, p < 0.01 and point estimate -0.02, 95% CI 0.023-0.01, p < 0.001 respectively). The vascular complication and major bleeding rate were 7.4% (95% CI 5.6-9.6%) and 15.2% (95% CI 10.7-21%) respectively, and were associated with older age and comorbidities, while the implantation of an Impella CP/2.5 L was associated with fewer complications. CONCLUSIONS: Despite the use of Impella the 30 day mortality of CS still remains high. Our data suggest that the use of an Impella CP, initiation of Impella prior to PCI and in patients without cardiac arrest was correlated with outcome improvements.

20.
Am J Cardiol ; 134: 83-90, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32892987

RESUMO

The optimal antiplatelet strategy after left atrial appendage (LAA) occlusion able to protect from device-related thrombosis, paying the lowest price in terms of bleeding increase, is unclear. In a real-world, observational study we performed a head-to-head comparison of single versus dual antiplatelet therapy (SAPT vs DAPT) in patients who underwent LAA occlusion. We included 610 consecutive patients, stratified according to the type of post-procedural antiplatelet therapy (280 on SAPT and 330 on DAPT). Primary outcome measure was the incidence of the net composite end point including Bleeding Academic Research Consortium classification 3-5 bleeding, major adverse cardiovascular events or device-related thrombosis at 1-year follow-up. The use of SAPT compared with DAPT was associated with similar incidence of the primary net composite end point (9.3% vs 12.7% p = 0.22), with an adjusted hazard ratio (HR) of 0.69, 95% confidence interval 0.41 to 1.15; p = 0.15) at multivariate analysis. However, SAPT significantly reduced Bleeding Academic Research Consortium classification 3-5 bleeding (2.9% vs 6.7%, p = 0.038; adjusted HR 0.37, 0.16 to 0.88; p = 0.024). The occurrence of ischemic events (major adverse cardiovascular events or device-related thrombosis) was not significantly different between the 2treatment strategies (7.8% vs 7.4%; adjusted HR 1.34, 0.70 to 2.55; p = 0.38). In patients who underwent LAA occlusion, post-procedural use of SAPT instead of DAPT was associated with reduction of bleeding complications, with no significant increase in the risk of thrombotic events. These hypothesis-generating findings should be confirmed in a specific, randomized study.

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