Transcatheter aortic valve implantation amid the COVID-19 pandemic: a nationwide analysis of the first COVID-19 wave in the Netherlands.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has put tremendous pressure on healthcare systems. Most transcatheter aortic valve implantation (TAVI) centres have adopted different triage systems and procedural strategies to serve highest-risk patients first and to minimise the burden on hospital logistics and personnel. We therefore assessed the impact of the COVID-19 pandemic on patient selection, type of anaesthesia and outcomes after TAVI. METHODS: We used data from the Netherlands Heart Registration to examine all patients who underwent TAVI between March 2020 and July 2020 (COVID cohort), and between March 2019 and July 2019 (pre-COVID cohort). We compared patient characteristics, procedural characteristics and clinical outcomes. RESULTS: We examined 2131 patients who underwent TAVI (1020 patients in COVID cohort, 1111 patients in pre-COVID cohort). EuroSCORE II was comparable between cohorts (COVID 4.5 ± 4.0 vs pre-COVID 4.6 ± 4.2, p = 0.356). The number of TAVI procedures under general anaesthesia was lower in the COVID cohort (35.2% vs 46.5%, p < 0.001). Incidences of stroke (COVID 2.7% vs pre-COVID 1.7%, p = 0.134), major vascular complications (2.3% vs 3.4%, p = 0.170) and permanent pacemaker implantation (10.0% vs 9.4%, p = 0.634) did not differ between cohorts. Thirty-day and 150-day mortality were comparable (2.8% vs 2.2%, p = 0.359 and 5.2% vs 5.2%, p = 0.993, respectively). CONCLUSIONS: During the COVID-19 pandemic, patient characteristics and outcomes after TAVI were not different than before the pandemic. This highlights the fact that TAVI procedures can be safely performed during the COVID-19 pandemic, without an increased risk of complications or mortality.

Update and, internal and temporal-validation of the FRANCE-2 and ACC-TAVI early-mortality prediction models for Transcatheter Aortic Valve Implantation (TAVI) using data from the Netherlands heart registration (NHR).

BACKGROUND: The predictive performance of the models FRANCE-2 and ACC-TAVI for early-mortality after Transcatheter Aortic Valve Implantation (TAVI) can decline over time and can be enhanced by updating them on new populations. We aim to update and internally and temporally validate these models using a recent TAVI-cohort from the Netherlands Heart Registration (NHR). METHODS: We used data of TAVI-patients treated in 2013-2017. For each original-model, the best update-method (model-intercept, model-recalibration, or model-revision) was selected by a closed-testing procedure. We internally validated both updated models with 1000 bootstrap samples. We also updated the models on the 2013-2016 dataset and temporally validated them on the 2017-dataset. Performance measures were the Area-Under ROC-curve (AU-ROC), Brier-score, and calibration graphs. RESULTS: We included 6177 TAVI-patients, with 4.5% observed early-mortality. The selected update-method for FRANCE-2 was model-intercept-update. Internal validation showed an AU-ROC of 0.63 (95%CI 0.62-0.66) and Brier-score of 0.04 (0.04-0.05). Calibration graphs show that it overestimates early-mortality. In temporal-validation, the AU-ROC was 0.61 (0.53-0.67).The selected update-method for ACC-TAVI was model-revision. In internal-validation, the AU-ROC was 0.63 (0.63-0.66) and Brier-score was 0.04 (0.04-0.05). The updated ACC-TAVI calibrates well up to a probability of 20%, and subsequently underestimates early-mortality. In temporal-validation the AU-ROC was 0.65 (0.58-0.72). CONCLUSION: Internal-validation of the updated models FRANCE-2 and ACC-TAVI with data from the NHR demonstrated improved performance, which was better than in external-validation studies and comparable to the original studies. In temporal-validation, ACC-TAVI outperformed FRANCE-2 because it suffered less from changes over time.

Preoperative frailty parameters as predictors for outcomes after transcatheter aortic valve implantation: a systematic review and meta-analysis.

Guidelines suggest using frailty characteristics in the work-up for a transcatheter aortic valve implantation (TAVI). There are many frailty-screening tools with different components. The prognostic value of the individual parameters in frailty is as yet unclear. The objective of this systematic review and meta-analysis was to find and pool predictors for 1­year mortality after TAVI. We followed a two-step approach. First, we searched for randomised controlled trials on TAVI to identify frailty parameters used in these studies. Second, we searched for publications on these frailty parameters. Articles were included for pooled analysis if the studied frailty parameters were dichotomised with clear cut-off values based on common standards or clinical practice and reported adjusted hazard ratios (HR) of 1­year mortality after TAVI. We calculated pooled effect estimates of 49 studies based on dichotomised frailty scores (HR: 2.16, 95% CI: 1.57-3.00), chronic lung disease (HR: 1.57, 95% CI: 1.45-1.70), estimated glomerular filtration rate <30 ml/min (HR: 1.95, 95% CI: 1.68-2.29), body mass index <20 kg/m2 (HR: 1.49, 95% CI: 1.09-2.03), hypoalbuminaemia (HR: 1.77, 95% CI: 1.38-2.25), anaemia (HR: 2.08, 95% CI: 0.93-4.66), low gait speed (HR: 13.33, 95% CI: 1.75-101.49) and Katz activities of daily living (ADL) score of 1 or more deficits (HR: 5.16, 95% CI: 0.77-34.47). Chronic lung disease, chronic kidney disease, underweight, hypoalbuminaemia, a low frailty score, anaemia, low gait speed and an ADL deficiency were associated with worse 1­year outcomes after TAVI.

Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial.

BACKGROUND: Immobilisation of patients after transfemoral transcatheter aortic valve implantation (TF-TAVI) is the standard of care, mostly to prevent vascular complications. However, immobilisation may increase post-operative complications such as delirium and infections. In this trial, we determine whether it is feasible and safe to implement early ambulation after TF-TAVI. METHODS: We prospectively included TF-TAVI patients from 2016 to 2018. Patients were assessed for eligibility using our strict safety protocol and were allocated (based on the time at which the procedure ended) to the EARLY or REGULAR group. RESULTS: A total of 150 patients (49%) were deemed eligible for early mobilisation, of which 73 were allocated to the EARLY group and 77 to the REGULAR group. The overall population had a mean age of 80 years, 48% were male with a Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of 3.8 ± 1.8. Time to mobilisation was 4 h 49 min ± 31 min in the EARLY group versus 20 h 7 min ± 3 h 6 min in the REGULAR group (p < 0.0001). There were no differences regarding the primary endpoint. No major vascular complications occurred and a similar incidence of minor vascular complications was seen in both groups (4/73 [5.5%] vs 6/77 [7.8%], p = 0.570). The incidence of the combined secondary endpoint was lower in the EARLY group (p = 0.034), with a numerically lower incidence for all individual outcomes (delirium, infections, pain and unplanned urinary catheter use). CONCLUSION: Early mobilisation (ambulation 4-6 h post-procedure) of TF-TAVI patients is feasible and safe. Early ambulation decreases the combined incidence of delirium, infections, pain and unplanned urinary catheter use, and its adoption into contemporary TAVI practice may therefore be beneficial.

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry.

BACKGROUND: Bioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry. METHODS AND RESULTS: In the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013 at the Amsterdam University Medical Centre-Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4­year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy. CONCLUSION: In a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.

[Transcatheter aortic valve implantation: an overview]. / Transkatheter aortaklepvervanging (TAVI).

In recent years, transcatheter aortic valve implantation (TAVI) has evolved from a treatment for patients who are inoperable or at high risk of surgical complications, to an equivalent alternative to surgical valve replacement for almost all patients with symptomatic, severe aortic valve stenosis. In the Netherlands, the number of patients who undergo TAVI gradually increases, while outcomes after TAVI improve and complication rates decrease. Before TAVI can be considered as the preferred treatment for aortic valve stenosis, however, additional insight is needed in valve durability, selection criteria for patients who benefit most from TAVI, and treatment outcomes regarding quality of life.

Value of machine learning in predicting TAVI outcomes.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a commonly applied procedure for high-risk aortic valve stenosis patients. However, for some patients, this procedure does not result in the expected benefits. Previous studies indicated that it is difficult to predict the beneficial effects for specific patients. We aim to study the accuracy of various traditional machine learning (ML) algorithms in the prediction of TAVI outcomes. METHODS AND RESULTS: Clinical and laboratory data from 1,478 TAVI patients from a single centre were collected. The outcome measures were improvement of dyspnoea and mortality. Three experiments were performed using (1) screening data, (2) laboratory data, and (3) the combination of both. Five well-established ML techniques were implemented, and the models were evaluated based on the area under the curve (AUC). Random forest classifier achieved the highest AUC (0.70) for predicting mortality. Logistic regression had the highest AUC (0.56) in predicting improvement of dyspnoea. CONCLUSIONS: In our single-centre TAVI population, the tree-based models were slightly more accurate than others in predicting mortality. However, ML models performed poorly in predicting improvement of dyspnoea.

Cardiology fellows-in-training are exposed to relatively high levels of radiation in the cath lab compared with staff interventional cardiologists-insights from the RECAP trial.

BACKGROUND: Interventional cardiologists are inevitably exposed to low-dose radiation, and consequently are at risk for radiation induced diseases like cataract and left-sided brain tumours. Operator behaviour may possibly be the largest influencer on radiation exposure. We hypothesised that awareness regarding radiation exposure grows as skill and the general experience in the catheterization laboratory increase. OBJECTIVES: In this study we determined the difference in the relative radiation exposure of staff interventional cardiologists compared with cardiology fellows-in-training. METHODS: During this prospective trial the operator's radiation exposure (E in µSv) was measured at chest height during 766 diagnostic catheterisations and percutaneous coronary interventions. Also, the patient exposure (DAP in mGy·cm2), representing the amount of radiation administered by the operator per procedure, was collected. The primary outcome of this study was the difference in relative exposure between staff interventional cardiologists versus cardiology fellows-in-training (E/DAP). RESULTS: From January to May 2017, staff interventional cardiologists performed 637 procedures and cardiology fellows-in-training 129 procedures. The performance of relatively complex procedures by staff interventional cardiologists resulted in a 74% higher use of radiation compared with fellows-in-training. Consequently, staff interventional cardiologists were exposed to 50% higher levels of actual radiation exposure. However, when correcting for the complexity of the procedure, by comparing the relative operator exposure (E/DAP), fellows-in-training were exposed to a 34% higher relative exposure compared with staff interventional cardiologists (p = 0.025). CONCLUSIONS: In the current study, when corrected for complexity, cardiology fellows-in-training were exposed to significantly higher radiation levels than staff interventional cardiologists during catheterisation procedures.

Can stress echocardiography identify patients who will benefit from percutaneous mitral valve repair?

The aim of the current study was to investigate whether stress echocardiography improves selection of patients who might have clinical benefit from percutaneous mitral valve repair with the MitraClip. In total, 39 patients selected for MitraClip implantation underwent preprocedural low-dose stress (dobutamine or handgrip) echocardiography from which stroke volume, ejection fraction and MR grade were measured. Outcome after MitraClip implantation was determined by New York Heart Association classification and Quality of Life questionnaires. Clinical benefit from MitraClip treatment was defined as survival and NYHA class I-II at 6 months follow-up. In total, 36 patients with a technically successful procedure were included in the analysis (mean age 79 ± 8 years, 47% male, 50% functional MR). Clinical benefit was achieved in 18 patients. All seven patients with MR decreasing during stress remained in NYHA III-IV or died within 6 months, while 62% (18 out of 29) of the patients with stable or increased MR during stress had clinical benefit (p = 0.008). Significant increase in Quality of Life on 4/8 subscales of the RAND Short Form-36 questionnaire was observed: Physical Functioning (p < 0.001), Social Functioning (p < 0.001), Mental Health (p = 0.022) and Vitality (p = 0.026) was seen in patients with an increase in stroke volume during stress echocardiography. Patients with a decreased MR during preprocedural stress echocardiography remained more symptomatic than patients with a stable or increased MR during stress. Stress echocardiography may support patient selection for percutaneous mitral valve repair.

Short versus conventional hydration for prevention of kidney injury during pre-TAVI computed tomography angiography.

BACKGROUND: Computed tomography angiography (CTA) is required in the work-up for transcatheter aortic valve implantation (TAVI). However, CTA may cause contrast-induced acute kidney injury (CI-AKI). We hypothesised that a short (1 h, 3 ml/kg/h sodium bicarbonate) hydration protocol is not inferior to conventional (24 h, 1 ml/kg/h saline) hydration in avoiding a decline in renal function in patients with impaired renal function. METHODS AND RESULTS: Single-centre randomised non-inferiority trial in patients with impaired renal function who underwent pre-TAVI CTA. Patients were randomised on a 1:1 ratio to short hydration (SHORT; 1 h sodium bicarbonate, 3 ml/kg/h) or conventional hydration (CONV; 24 h saline, 1 ml/kg/h). Outcomes included percentage change in serum creatinine until 2-6 days after CTA with a non-inferiority margin of 10% and an increase on the Borg dyspnoea scale ≥1 point. Seventy-four patients were included. Increase in creatinine was 6 µmol/l (95% CI 2.5-9.3) in the SHORT versus 2 µmol/l (95% CI-1.4 to 6.3) in the CONV arm (p = 0.167). The percentage change was 4.6% (95% CI 2.0-7.3%) in the SHORT arm versus 2.5% (95% CI: 0.8 to 5.8%) in the CONV arm. The difference in percentage increase in creatinine between the two arms was 2.1% (95% CI: 2.0-6.2%; p-value non-inferiority: <0.001). CI-AKI and a need for dialysis were not observed. An increase of ≥1 point on the Borg scale (dyspnoea scale ranging from 1 (lowest) to 10 (highest)) was seen in 1 patient in the SHORT arm versus 5 patients in the CONV arm (2.9% vs 16.1%, p = 0.091). CONCLUSION: For patients with impaired renal function undergoing pre-TAVI CTA, a short 1­h, low-volume hydration protocol with sodium bicarbonate is not inferior to conventional 24-h, high-volume saline hydration.

Trends in patient characteristics and clinical outcome over 8 years of transcatheter aortic valve implantation.

AIM: In the evolving field of transcatheter aortic valve implantations (TAVI) we aimed to gain insight into trends in patient and procedural characteristics as well as clinical outcome over an 8­year period in a real-world TAVI population. METHODS: We performed a single-centre retrospective analysis of 1,011 consecutive patients in a prospectively acquired database. We divided the cohort into tertiles of 337 patients; first interval: January 2009-March 2013, second interval: March 2013-March 2015, third interval: March 2015-October 2016. RESULTS: Over time, a clear shift in patient selection was noticeable towards lower surgical risks including Society of Thoracic Surgeons predicted risk of mortality score and comorbidity. The frequency of transfemoral TAVI increased (from 66.5 to 77.4%, p = 0.0015). Device success improved (from 62.0 to 91.5%, p < 0.0001) as did the frequency of symptomatic relief (≥1 New York Heart Association class difference) (from 73.8 to 87.1%, p = 0.00025). Complication rates decreased, including in-hospital stroke (from 5.0 to 2.1%, p = 0.033) and pacemaker implantations (from 10.1 to 5.9%, p = 0.033). Thirty-day mortality decreased (from 11.0 to 2.4%, p < 0.0001); after adjustment for patient characteristics, a mortality-risk reduction of 72% was observed (adjusted hazard ratio [HR]: 0.28, 95% confidence interval [CI]: 0.13-0.62). One-year mortality rates decreased (from 23.4 to 11.4%), but this was no longer significant after a landmark point was set at 30 days (mortality from 31 days until 1 year) (adjusted HR: 0.69, 95% CI: 0.41-1.16, p = 0.16). CONCLUSION: A clear shift towards a lower-risk TAVI population and improved clinical outcome was observed over an 8­year period. Survival after TAVI improved impressively, mainly as a consequence of decreased 30-day mortality.

Mechanical circulatory support with the Impella 5.0 device for postcardiotomy cardiogenic shock: a three-center experience.

AIM: Postcardiotomy cardiogenic shock (PCCS) is associated with high mortality rates, despite full conventional treatment. Although the results of treatment with surgically implantable ventricular assist devices have been encouraging, the invasiveness of this treatment limits its applicability. Several less invasive devices have been developed, including the Impella system. The objective of this study was to describe our three-center experience with the Impella 5.0 device in the setting of PCCS. METHODS: From January 2004 through December 2010, a total of 46 patients were diagnosed with treatment-refractory PCCS and treated with the Impella 5.0 percutaneous left ventricular assist device at three european heart centers. Baseline and follow-up characteristics were collected retrospectively and entered into a dedicated database. RESULTS: Within the study cohort of 46 patients, mean logistic and additive EuroSCORES were 24 ± 19 and 10 ± 4. The majority of patients underwent coronary artery bypass grafting (48%) or combined surgery (33%). Half of all patients had been treated with an intra-aortic balloon pump before 5.0-implantation, 1 patient had been treated with an Impella 2.5 device. All patients were on mechanical ventilation and intravenous inotropes. The Kaplan-Meier estimate of overall 30-day survival was 39.5%. CONCLUSION: Thirty-day survival rates for patients with PCCS, refractory to aggressive conventional treatment and treated with the Impella 5.0 device, are comparable to those reported in studies evaluating surgically implantable VADs, whereas the Impella system is much less invasive. Therefore, mechanical circulatory support with the Impella 5.0 device is a suitable treatment modality for patients with severe PCCS.

Coronary microcirculatory dysfunction is associated with left ventricular dysfunction during follow-up after STEMI.

BACKGROUND: Coronary microvascular resistance is increased after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), which may be related in part to changed left ventricular (LV) dynamics. Therefore we studied the coronary microcirculation in relation to systolic and diastolic LV function after STEMI. METHODS: The study cohort consisted of 12 consecutive patients, all treated with primary PCI for a first anterior wall STEMI. At 4 months, we assessed pressure-volume loops. Subsequently, we measured intracoronary pressure and flow velocity and calculated coronary microvascular resistance. Infarct size and LV mass were assessed using magnetic resonance imaging. RESULTS: Patients with an impaired systolic LV function due to a larger myocardial infarction showed a higher baseline average peak flow velocity (APV) than the other patients (26 ± 7 versus 17 ± 5 cm/s, p = 0.003, respectively), and showed an impaired variable microvascular resistance index (2.1 ± 1.0 versus 4.1 ± 1.3 mmHg cm(-1)∙s(-1), p = 0.003, respectively). Impaired diastolic relaxation time was inversely correlated with hyperaemic APV (r = -0.56, p = 0.003) and positively correlated with hyperaemic microvascular resistance (r = 0.48, p = 0.01). LV dilatation was associated with a reduced variable microvascular resistance index (r = 0.78, p = 0.006). CONCLUSION: A larger anterior myocardial infarction results in impaired LV performance associated with reduced coronary microvascular resistance variability, in particular due to higher coronary blood flow at baseline in these compromised left ventricles.

Efficacy and timing of intra-aortic counterpulsation in patients with ST-elevation myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Guidelines strongly recommend additional intra-aortic balloon pump (IABP) therapy in STEMI patients with cardiogenic shock (CS) treated by primary percutaneous coronary intervention (PCI). However, there is no randomised evidence suggesting survival benefit of IABP treatment in CS. It is suggested that timing of initiation of IABP therapy could be of great importance. Therefore, we compared mortality rates of IABP therapy versus no IABP therapy in the setting of STEMI complicated by CS. In addition, we investigated the effect of initiation of IABP therapy on mortality. METHODS: From a cohort of 292 STEMI patients with CS treated by primary PCI, 199 patients received IABP therapy (IABP group) and 93 patients received no support (no IABP group). The IABP group was divided into two subgroups based on timing of initiation of support, i.e. 'IABP pre PCI' (n = 59) and 'IABP post PCI' (n = 140). Outcomes were assessed by propensity stratification and multivariate logistic regression. RESULTS: All-cause 30-day mortality for the IABP versus the no IABP group was 47 % vs. 28 %, respectively, in univariate analysis resulting in an odds ratio (OR) of 1.67 (95%CI, 1.16 to 2.39). However, analyses adjusting outcomes by propensity stratification and logistic regression, respectively, neutralised this OR. In the IABP pre-PCI group vs. the post-PCI group 30-day mortality was 64 % vs. 40 %, resulting in an OR of 1.56 (95 % CI, 1.18 to 2.08). However, after propensity stratification analysis and multivariate logistic regression analysis, there were no significant differences in odds of 30-day mortality. CONCLUSION: In our cohort of patients with STEMI complicated by CS treated with primary PCI we observed a difference in mortality between those treated with IABP and those treated without IABP in favour of the 'no IABP' group. The mortality difference was eliminated after adjustment for differences in case mix by propensity stratification or by logistic regression analysis. Neither did we observe any difference in mortality between patients whose IABP treatment was initiated before or immediately after PCI.

Six-month clinical outcomes of the Tryton Side Branch Stent for the treatment of bifurcation lesions.

AIMS: Percutaneous coronary intervention (PCI) of a bifurcation lesion (BL) is still associated with poorer clinical outcomes when compared with PCI of a non-BL. Therefore, several dedicated coronary bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA), were developed to improve clinical outcomes. We investigated 6-month clinical outcomes after placement of a Tryton stent in 91 patients treated for 93 BLs in our centre. METHODS AND RESULTS: All consecutive patients who have undergone PCI of a BL treated with the Tryton stent in our centre were included. Outcomes were defined as any death, cardiac death, myocardial infarction (MI), any revascularisation, ischaemia-driven target vessel revascularisation (TVR), ischaemia-driven target lesion revascularisation (TLR), stent thrombosis, and target vessel failure (TVF; composite of cardiac death, MI, and ischaemia-driven TVR). Event rates were estimated using the Kaplan-Meier method. Thirty-eight (42 %) patients with acute coronary syndrome (ACS) were included (16 % ST-segment elevation MI (STEMI)). The 6-month event rates were 5.4 % (death), 4.3 % (cardiac death), 2.2 % (MI), 4.5 % (any revascularisation), 4.5 % (TVR), 4.5 % (TLR) and 9.7 % (TVF). CONCLUSION: In a real-world all-comers single-centre registry, the use of the Tryton Side Branch Stent was associated with acceptable procedural and promising clinical outcomes at 6 months, including ACS and STEMI patients.

Cardiogenic shock: role of revascularization.

The most common cause of cardiogenic shock is myocardial ischemia developing early or late in the course of acute myocardial infarction. The incidence of cardiogenic shock (CS) is around 7% in ST-segment elevation myocardial infarction (STEMI) patients and has remained constant over the last 20 years. Therapy should be chain based by increased patient's awareness. Early and prehospital diagnosis and treatment, with prompt transfer to a catheterization laboratory. Early revascularization is the cornerstone treatment of acute myocardial infarction complicated by cardiogenic shock. According to the guidelines, revascularization is effective up to 36 hours after the onset of CS and performed within 18 hours after the diagnosis of CS. Primary percutaneous coronary intervention (PCI) is the most efficient and easily available therapy to restore coronary flow in the infarct related artery. Although recommended, there is little evidence that immediate multivessel PCI is beneficial for CS. The growing numbers of reports suggest staged PCI procedures or CABG is preferred in CS patients with significant LM disease or 3-vessel disease. The use of hemodynamic support with newly available percutaneous left ventricular unloading devices may herald a new era enabling preservation of adequate perfusion to other vital organs such as the brain, kidney and bowel. Despite all current efforts, in-hospital mortality for CS remains around 50%. However, long-term outcome and quality of life in hospital survivors is similar to patients with ST-segment elevation myocardial infarction patients presenting without CS.

Proximal embolic protection in patients undergoing primary angioplasty for acute myocardial infarction (PREPARE): core lab adjudicated angiographic outcomes of a randomised controlled trial.

BACKGROUND: Patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) with the Proxis system (St. Jude Medical, St. Paul, MN, USA) achieved significantly better microvascular flow as measured by ST-segment resolution. However, no differences were observed in left ventricular ejection fraction or infarct size as obtained by cardiovascular magnetic resonance imaging. The goal of the present study was to evaluate the effect of combined proximal embolic protection and thrombus aspiration on core-lab adjudicated angiographic outcomes. METHODS: In the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation (PREPARE) study, patients were randomised to primary PCI with the Proxis system (n=141) or primary PCI alone (n=143). An independent core laboratory re-evaluated all angiograms and adjudicated the angiographic outcomes and computerised quantitative blush evaluation (QuBE) value. RESULTS: There were no significant differences in Thrombolysis In Myocardial Infarction (TIMI) flow grade, myocardial blush grade, or angiographic signs of distal embolisation among the two arms. QuBE values did not significantly differ between the Proxis-treated patients and control patients (15.1±5.4 vs. 15.8±5.5, respectively, p=0.34). CONCLUSION: Primary PCI with combined proximal embolic protection and thrombus aspiration in STEMI patients more frequently resulted in complete immediate ST resolution compared with control patients. However, there were no significant differences in core laboratory adjudicated angiographic outcomes. (Neth Heart J 2010;18:531-6.).

Infarct size and left ventricular function in the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-segment Elevation (PREPARE) trial: ancillary cardiovascular magnetic resonance study.

OBJECTIVES: The aim of the study was to evaluate whether primary percutaneous coronary intervention (PCI) with combined proximal embolic protection and thrombus aspiration results in smaller final infarct size and improved left ventricular function assessed by cardiovascular magnetic resonance (CMR) in ST-segment elevation myocardial infarction (STEMI) patients compared with primary PCI alone. Background Primary PCI with the Proxis system improves immediate microvascular flow post-procedure as measured by ST-segment resolution, which could result in better outcomes. METHODS: The ancillary CMR study included 206 STEMI patients who were enrolled in the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation (PREPARE) trial. CMR imaging was assessed between 4 and 6 months after the index procedure. RESULTS: There were no significant differences in final infarct size (6.1 g/m(2) vs 6.3 g/m(2), p = 0.78) and left ventricular ejection fraction (50% vs 50%, p = 0.46) between both groups. Also, systolic wall thickening in the infarct area (44% vs 45%, p = 0.93) or the extent of transmural segments (8.3% of segments vs 8.3% of segments, p = 0.60) showed no significant differences. The incidence of major adverse cardiac and cerebral events at 6 months was similar in the Proxis and control group (8% vs 10%, respectively, p = 0.43). Conclusions Primary PCI with combined proximal embolic protection and thrombus aspiration in STEMI patients did not result in significant differences in final infarct size or left ventricular function at follow-up CMR. In addition, there was no difference in the incidence of major adverse cardiac and cerebral events at 6 months. TRIAL REGISTRATION: number ISRCTN71104460.