The clinical impact of invasive hemodynamic support with Impella in patients with cardiogenic shock (CS) remains to be defined.
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.
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.
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.
•Cardiogenic shock 30 day mortality is high despite the use of Impella.•A correct patient selection is a fundamental step.•Some technical issues such as the use of a CP device or the initiation prior to PCI are correlated with a better outcomes.
The aim of this multicentre study was to investigate the in-hospital and midterm outcomes of rotational atherectomy (RA) followed by metallic stent implantation.
Between 2002 and 2013, 1,176 de novo ...lesions with calcified coronary lesions treated by RA and metallic stent implantation at nine institutions were assessed. Patients with ST-segment elevation myocardial infarction (STEMI) within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis were excluded from the current analysis. In-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16.0% at one-year and 24.9% at two-year follow-up, both driven by target vessel revascularisation (13.5% at one year and 19.8% at two years). Multivariable analysis revealed that dialysis was an independent predictor for both in-hospital MACE (OR 2.33, 95% CI: 1.11-4.87, p=0.03) and follow-up MACE (HR 4.14, 95% CI: 2.87-5.96, p<0.001), whilst drug-eluting stent (DES) use was associated with a reduction in follow-up MACE (HR 0.42, 95% CI: 0.26-0.67, p<0.001).
RA appears to be safe and effective with acceptable in-hospital and follow-up MACE considering the severity of patient and lesion characteristics. DES implantation following RA was associated with a reduction in MACE during the follow-up period.
Background
Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. ...Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue.
Aim
To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real‐world patient with persistent LAA thrombus.
Methods and results
The study retrospectively enrolled consecutive patients with non‐valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high‐volume centres. Twenty‐seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2DS2‐VASc and HAS‐BLEED scores 3 2–5 and 3 2.75–4, respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra‐aortic trunks dissection was recorded.
Conclusions
In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
Heavily calcified unprotected left main (ULM) disease continues to be a challenging situation and represent a high-risk subset for interventional cardiologist. To date, there are limited data ...investigating the results after rotational atherectomy (RA) in this setting. The aim of this study was to investigate the in-hospital and 1-year outcomes after RA of heavily calcified ULM lesions. A retrospective cohort analysis was performed on all calcified patients with ULM (n = 86) enrolled in the multicenter international ROTATE registry (overall patients, n = 962). End points of the study were the in-hospital and 1-year incidence of major adverse cardiovascular events (MACE): a composite of death, myocardial infarction, and target-vessel revascularization in the ULM versus non-ULM group. Patients in the ULM group were older (p = 0.01) and more frequently with diabetes (p = 0.001) compared with the non-ULM group, whereas intravascular ultrasound guidance was higher, even if not systematic, in the ULM group (p <0.001). No difference was reported between ULM versus non-ULM groups in terms of in-hospital MACE (5.8% vs 8%). At 1 year, MACE rate was higher in ULM versus non-ULM (26.4% vs 14.9%, p = 0.002) mostly driven by target-vessel revascularization (20.3% vs 12.7%, p = 0.05). Even definite/probable stent thrombosis rate was higher in the ULM group (3.9% vs 0.8%). All these events were subacute and 2/3 (75%) were fatal. In conclusion, our multicenter experience shows that RA followed by stent implantation in patients with heavily calcified ULM narrowing is feasible and associated with good in-hospital results. Patient (age and diabetes) and procedural aspects (relatively low intravascular ultrasound guidance) may affect the worse subacute mid-term prognosis in the more complex ULM group.
The safety and efficacy of rotational atherectomy (RA) in patients presenting with non-ST-elevation myocardial infarction (NSTE-ACS) remain to be defined. The aim of our study was to assess the ...safety and efficacy of RA in NSTE-ACS patients with reference to both short- and long-term follow-up.
This was an observational retrospective registry which enrolled all consecutive patients undergoing RA, comparing patients with stable angina (SA) and NSTE-ACS. In addition, ACS patients were matched with those not undergoing RA. The primary endpoint was angiographic success. Procedural complications and in-hospital MACE were secondary endpoints along with MACE during follow-up. One thousand three hundred and eight patients were included: 37% (484) with an NSTE-ACS diagnosis and 63% (824) in the SA group. Angiographic success did not differ between the groups (98.8% vs. 99.2%, p=0.57). By univariate analysis procedural complications were more frequent in the NSTE-ACS group (11.3% vs. 8.0%, p=0.04). In-hospital MACE rates were comparable (5.7% vs. 5.8%, p=0.93); by multivariate analysis NSTE-ACS patients showed a non-significant trend towards a higher risk of adverse events (HR 2.39, CI: 0.96-5.96, p=0.061). MACE after a median of 27.9 months was significantly higher in the NSTE-ACS group compared with the SA group (32.4% vs. 24.2%, log-rank p<0.001), results confirmed by multivariate analysis. After propensity score matching, NSTE-ACS patients undergoing RA had similar outcomes to ACS patients who did not undergo RA (16% vs. 13%, log-rank p=0.14).
Rotational atherectomy has similar safety and angiographic outcome in patients with NSTE-ACS or SA. The higher rate of adverse cardiac events at follow-up in NSTE-ACS patients undergoing RA is comparable with a matched population of NSTE-ACS patients not undergoing RA.
Background
Aim of this study was to evaluate the clinical impact of the culprit plaque features assessed by optical coherence tomography (OCT) in patients with acute coronary syndrome (ACS).
Methods
...The OCT‐FORMIDABLE register enrolled retrospectively all consecutive patients who perform OCT on culprit plaque in patients with ACS in nine European centres. The primary endpoint was the prevalence of culprit plaque rupture (CPR) in patients experiencing major adverse cardiovascular events (MACEs). Secondary endpoint was the prevalence necrotic core with macrophage infiltrations (NCMI) in the patients experiencing MACEs.
Results
Two‐hundred and nine patients were included in the study. Mean age was 60.1 ± 12.9 years old, 19.1% were females. Main clinical presentation was ST‐elevation myocardial infarction (55%). At OCT analysis, CPR was observed in 71.8% patients, while 31.6% presented NCMI. During follow‐up (12.6 ± 14.5 months), 11% of the patients experienced MACEs. The presence of CPR (HR 3.7,1.4‐9.8, P < .01) and NCMI (HR 3.3,1.6‐6.6, P < .01) were independent predictors for MACEs, while dual antiplatelet therapy with prasugrel/ticagrelor at discharge (HR 0.2,0.1‐0.6, P < .01) were protective. The protective impact of new antiplatelet drugs was reported only in patients with CPR while in patients without any of the baseline clinical or procedural features impacted on MACEs.
Conclusions
CPR and the presence of NCMI are independent predictors of worse outcome. Patients with CPR seem to benefit more of an intensive therapy, both from a pharmacological and interventional point of view. (NCT02486861)
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