ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial.

BACKGROUND: The percutaneous treatment of calcified coronary lesions remains challenging and is associated with worse clinical outcomes. In addition, coronary artery calcification is associated with more frequent peri-procedural myocardial infarction. STUDY DESIGN AND OBJECTIVES: The ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions (SONAR) study is an investigator-initiated, prospective, randomized, international, multicenter, open label trial (NCT05208749) comparing a lesion preparation strategy with either shockwave intravascular lithotripsy (IVL) or rotational atherectomy (RA) before drug-eluting stent implantation in 170 patients with moderate to severe calcified coronary lesions. The primary endpoint is difference in the rate of peri-procedural myocardial infarction. Key secondary endpoints include rate of peri-procedural microvascular dysfunction, peri-procedural myocardial injury, descriptive study of IMR measurements in calcified lesions, technical and procedural success, interaction between OCT calcium score and primary endpoint, 30-day and 1-year major adverse clinical events. CONCLUSIONS: The SONAR trial is the first randomized controlled trial comparing the incidence of peri-procedural myocardial infarction between 2 contemporary calcium modification strategies (Shockwave IVL and RA) in patients with calcified coronary artery lesions. Furthermore, for the first time, the incidence of peri-procedural microvascular dysfunction after Shockwave IVL and RA will be evaluated and compared.

The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials.

BACKGROUND: We aimed to study the incidence of acute kidney injury (AKI) in out-of-hospital cardiac arrest (OHCA) patients treated according to low-normal or high-normal mean arterial pressure (MAP) targets. METHODS: A post hoc analysis of the COMACARE (NCT02698917) and Neuroprotect (NCT02541591) trials that randomized patients to lower or higher targets for the first 36 h of intensive care. Kidney function was defined using the Kidney Disease Improving Global Outcome (KDIGO) classification. We used Cox regression analysis to identify factors associated with AKI after OHCA. RESULTS: A total of 227 patients were included: 115 in the high-normal MAP group and 112 in the low-normal MAP group. Eighty-six (38%) patients developed AKI during the first five days; 40 in the high-normal MAP group and 46 in the low-normal MAP group (p = 0.51). The median creatinine and daily urine output were 85 µmol/l and 1730 mL/day in the high-normal MAP group and 87 µmol/l and 1560 mL/day in the low-normal MAP group. In a Cox regression model, independent AKI predictors were no bystander cardiopulmonary resuscitation (p < 0.01), non-shockable rhythm (p < 0.01), chronic hypertension (p = 0.03), and time to the return of spontaneous circulation (p < 0.01), whereas MAP target was not an independent predictor (p = 0.29). CONCLUSION: Any AKI occurred in four out of ten OHCA patients. We found no difference in the incidence of AKI between the patients treated with lower and those treated with higher MAP after CA. Higher age, non-shockable initial rhythm, and longer time to ROSC were associated with shorter time to AKI. CLINICAL TRIAL REGISTRATION: COMACARE (NCT02698917), NEUROPROTECT (NCT02541591).

Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI.

OBJECTIVES: The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Selective intracoronary hypothermia is a novel treatment designed to reduce myocardial reperfusion injury and is currently being investigated in the ongoing randomized controlled EURO-ICE (European Intracoronary Cooling Evaluation in Patients With ST-Elevation Myocardial Infarction) trial (NCT03447834). Data on the safety of such a procedure during PPCI are still limited. METHODS: The first 50 patients with anterior STEMI treated with selective intracoronary hypothermia during PPCI were included in this analysis and compared for safety with the first 50 patients randomized to the control group undergoing standard PPCI. In-hospital mortality, occurrence of rhythm or conduction disturbances, stent thrombosis, onset of heart failure during the procedure, and subsequent hospital admission were assessed. RESULTS: In-hospital mortality was 0%. One patient in both groups developed cardiogenic shock. Atrial fibrillation occurred in 0 and 3 patients (P = 0.24), and ventricular fibrillation occurred in 5 and 3 patients (P = 0.72) in the intracoronary hypothermia group and control group, respectively. Stent thrombosis occurred in 2 patients in the intracoronary hypothermia group; 1 instance was intraprocedural, and the other occurred following interruption of dual-antiplatelet therapy consequent to an intracranial hemorrhage 6 days after enrollment. No stent thrombosis was observed in the control group (P = 0.50). CONCLUSIONS: Selective intracoronary hypothermia during PPCI in patients with anterior STEMI can be implemented within the routine of PPCI and seems to be safe. The final safety results will be reported at the end of the trial.

Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest.

BACKGROUND: In patients with shock after acute myocardial infarction (AMI), the optimal level of pharmacologic support is unknown. Whereas higher doses may increase myocardial oxygen consumption and induce arrhythmias, diastolic hypotension may reduce coronary perfusion and increase infarct size. OBJECTIVES: This study aimed to determine the optimal mean arterial pressure (MAP) in patients with AMI and shock after cardiac arrest. METHODS: This study used patient-level pooled analysis of post-cardiac arrest patients with shock after AMI randomized in the Neuroprotect (Neuroprotective Goal Directed Hemodynamic Optimization in Post-cardiac Arrest Patients; NCT02541591) and COMACARE (Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation; NCT02698917) trials who were randomized to MAP 65 mm Hg or MAP 80/85 to 100 mm Hg targets during the first 36 h after admission. The primary endpoint was the area under the 72-h high-sensitivity troponin-T curve. RESULTS: Of 235 patients originally randomized, 120 patients had AMI with shock. Patients assigned to the higher MAP target (n = 58) received higher doses of norepinephrine (p = 0.004) and dobutamine (p = 0.01) and reached higher MAPs (86 ± 9 mm Hg vs. 72 ± 10 mm Hg, p < 0.001). Whereas admission hemodynamics and angiographic findings were all well-balanced and revascularization was performed equally effective, the area under the 72-h high-sensitivity troponin-T curve was lower in patients assigned to the higher MAP target (median: 1.14 µg.72 h/l [interquartile range: 0.35 to 2.31 µg.72 h/l] vs. median: 1.56 µg.72 h/l [interquartile range: 0.61 to 4.72 µg. 72 h/l]; p = 0.04). Additional pharmacologic support did not increase the risk of a new cardiac arrest (p = 0.88) or atrial fibrillation (p = 0.94). Survival with good neurologic outcome at 180 days was not different between both groups (64% vs. 53%, odds ratio: 1.55; 95% confidence interval: 0.74 to 3.22). CONCLUSIONS: In post-cardiac arrest patients with shock after AMI, targeting MAP between 80/85 and 100 mm Hg with additional use of inotropes and vasopressors was associated with smaller myocardial injury.

Early goal-directed haemodynamic optimization of cerebral oxygenation in comatose survivors after cardiac arrest: the Neuroprotect post-cardiac arrest trial.

AIMS: During the first 6-12 h of intensive care unit (ICU) stay, post-cardiac arrest (CA) patients treated with a mean arterial pressure (MAP) 65 mmHg target experience a drop of the cerebral oxygenation that may cause additional cerebral damage. Therefore, we investigated whether an early goal directed haemodynamic optimization strategy (EGDHO) (MAP 85-100 mmHg, SVO2 65-75%) is safe and could improve cerebral oxygenation, reduce anoxic brain damage, and improve outcome when compared with a MAP 65 mmHg strategy. METHODS AND RESULTS: A total of 112 out-of-hospital CA patients were randomly assigned to EGDHO or MAP 65 mmHg strategies during the first 36 h of ICU stay. The primary outcome was the extent of anoxic brain damage as quantified by the percentage of voxels below an apparent diffusion coefficient (ADC) score of 650.10-6 mm2/s on diffusion weighted magnetic resonance imaging (at day 5 ± 2 post-CA). Main secondary outcome was favourable neurological outcome (CPC score 1-2) at 180 days. In patients assigned to EGDHO, MAP (P < 0.001), and cerebral oxygenation during the first 12 h of ICU stay (P = 0.04) were higher. However, the percentage of voxels below an ADC score of 650.10-6 mm2/s did not differ between both groups [16% vs. 12%, odds ratio 1.37, 95% confidence interval (CI) 0.95-0.98; P = 0.09]. Also, the number of patients with favourable neurological outcome at 180 days was similar (40% vs. 38%, odds ratio 0.98, 95% CI 0.41-2.33; P = 0.96). The number of serious adverse events was lower in patients assigned to EGDHO (P = 0.02). CONCLUSION: Targeting a higher MAP in post-CA patients was safe and improved cerebral oxygenation but did not improve the extent of anoxic brain damage or neurological outcome.

Mean arterial pressure of 65 mm Hg versus 85-100 mm Hg in comatose survivors after cardiac arrest: Rationale and study design of the Neuroprotect post-cardiac arrest trial.

BACKGROUND: Post-cardiac arrest (CA) patients admitted to the intensive care unit (ICU) have a poor prognosis, with estimated survival rates of around 30%-50%. On admission, these patients have a large cerebral penumbra at risk for additional damage in case of suboptimal brain oxygenation during their stay in the ICU. The aim of the Neuroprotect post-CA trial is to investigate whether forcing mean arterial blood pressure (MAP) and mixed venous oxygen saturation (SVO2) in a specific range (MAP 85-100 mm Hg, SVO2 65%-75%) with additional pharmacological support (goal-directed hemodynamic optimization) may better salvage the penumbra, reduce cerebral ischemia, and improve functional outcome when compared with current standard of care (MAP 65 mm Hg). DESIGN: The Neuroprotect post-CA trial (NCT02541591) is a multicenter, randomized, parallel-group, open-label, assessor-blinded, monitored, and investigator-driven clinical trial. The trial will be conducted in 2 tertiary care hospitals in Belgium (UZ Leuven and ZOL-Genk). A total of 112 eligible patients will be randomly assigned in a 1:1 ratio to goal-directed hemodynamic optimization or standard care strategy by an interactive voice response system. Patients will be stratified according to the presence of an initial shockable rhythm. Adult patients (≥18 years) resuscitated from out-of-hospital CA of a presumed cardiac cause who are unconscious upon hospital admission are eligible for inclusion. Patients can be included irrespective of their presenting heart rhythm but need to have a sustained return of spontaneous circulation. Trial interventions will take 36 hours starting from ICU admission. The primary outcome is the extent of cerebral ischemia as quantified by the apparent diffusion coefficient on diffusion-weighted magnetic resonance imaging to be performed at day 4-5 post-CA. Secondary outcomes include surrogate biomarkers of brain injury (neuron specific enolase) at day 1-5, neuropsychological and functional testing at hospital discharge, a Short Form-36 health questionnaire at 180 days, and outcome as assessed with cerebral performance category scores at ICU discharge and at 180 days. CONCLUSIONS: The Neuroprotect post-CA trial will investigate whether a more aggressive hemodynamic strategy to obtain a MAP 85-100 mm Hg and SVO2 65%-75% reduces brain ischemia and improves outcome when compared with standard treatment (MAP 65 mm Hg) in comatose post-CA survivors.

Telescopic Corsair in 5F Guidion for Retrograde Recanalization of Complex Chronic Total Occlusions (CTOs).

BACKGROUND Retrograde advancement of microcatheters through septal/epicardial connectors can be challenging. Although several tricks might help to do so (e.g., balloon trap of retro wire in second guiding, balloon trap of retro wire in native coronary artery, and use of antegrade extension to approximate the antegrade conduit to the retrograde gear), these tricks cannot always be applied, especially in patients with poor access. Also, puncturing, knuckling, and crossing of the distal CTO cap (or the aorta as described in 1 of the cases) sometimes needs a lot of backup of the microcatheter. CASE REPORT We describe 3 cases in which we used a novel telescopic technique with 5F Guidion (IMDS®) supported retrograde Corsair (Asahi®) advancement in complex CTO lesions. CONCLUSIONS The telescopic Corsair in 5F Guidion may offer the support needed to end successfully in these situations.

Initial Experience and Feasibility of the New Low-Profile Stingray Catheter as Part of the Antegrade Dissection and Re-Entry Revascularization Strategy for Coronary Chronic Total Occlusions.

BACKGROUND During antegrade dissection re-entry (ADR) of chronic total occlusions (CTO), the first-generation Stingray catheter requires the use of large-bore guides (sheathless 7.5 Fr or 8 Fr), which increases the risk for access site-related complications and compromises radial approaches. Smaller guiding sizes necessitate long guidewires (e.g., 300 cm) or guidewire extensions for catheter advancement or removal. However, friction between guides and the Stingray catheter can result in unstable guidewire position or unintentional removal. Furthermore, failure to deliver the catheter at the distal re-entry zone is a common problem. To overcome issues of deliverability and reduce the need for pre-dilatations, with its inherent risk of creating subintimal hematomas, the Stingray low-profile (LP) balloon catheter was developed. CASE REPORT We describe 3 cases of successful application of the novel Stingray LP catheter during ADR. In all cases, 7 Fr guiding catheters were successfully used in combination with the device. The lower profile facilitated a good exchange and delivery of the device, without the need for balloon pre-dilatations in 2 cases. This resulted in a limited subintimal plane, enabling a smooth puncture into the true lumen. One case presented with extreme levels of calcification and tortuosity, resulting in a high degree of friction, despite the lower catheter profile. No in-hospital coronary or access site-related complications occurred. CONCLUSIONS This case report illustrates the feasibility of the Stingray LP catheter for the treatment of CTOs via the ADR technique. The lower profile of the catheter potentially increases the deliverability, safety, and exchangeability of the device.

Hemosuccus pancreaticus caused by rupture of a splenic artery pseudoaneurysm complicating chronic alcoholic pancreatitis: an uncommon cause of gastrointestinal bleeding.

We present a case of a 52-year old female patient with intermittent gastrointestinal bleeding and iron deficiency anaemia. Repeated endoscopic investigation revealed no diagnosis, but contrast-enhanced computed tomography showed a splenic artery pseudo-aneurysm secondary to chronic alcoholic pancreatitis. A distal pancreatectomy and splenectomy was performed. Hemosuccus pancreaticus is an uncommon cause of gastrointestinal bleeding, most frequently associated with chronic pancreatitis. Erosion of a peripancreatic artery by a pseudocyst can cause a pseudoaneurysm and rupture occurs in up to 10% of the cases. Bleeding from a pseudocyst wall or rupture of an atherosclerotic or traumatic aneurysm is rare. Angiography, contrast-enhanced computed tomography and endoscopic findings can be diagnostic in the majority of cases. Angiographic embolization or surgery are both therapeutic options depending on underlying nonvascular pancreas related indications requiring surgery. We discuss diagnostic pitfalls and current therapeutic strategies in the management of this disease.

The accuracy of noninvasive cardiac output and pressure measurements with finger cuff: a concise review.

PURPOSE OF REVIEW: The present review aims to summarize literature on the accuracy of the finger cuff method to measure cardiac output (CO) and blood pressure, its ability to track hemodynamic changes, and to predict fluid responsiveness. RECENT FINDINGS: Finger cuff is an easy-to-use hemodynamic monitoring technique. Different devices are currently available, which provide continuous arterial blood pressure (Finapress), whereas only ClearSight (previously known as Nexfin; BMEYE) provides an estimate of CO. In most studies, the criteria for clinical interchangeability (for CO) were not met, when compared with the currently used invasive monitoring systems such as uncalibrated CO via a radial artery line, and calibrated CO either via a pulmonary artery catheter or a femoral artery catheter connected to the PiCCO (Pulsion Medical Systems) or VolumeView (Edwards Lifesciences) devices. In particular, ClearSight obtained CO seems to be less accurate in patients with a low CO. However, in most patients, ClearSight is able to track hemodynamic changes induced by a fluid challenge or passive leg raising test. We will discuss in this review the relevant literature with regard to validation of the finger cuff technique for both arterial blood pressure and CO. SUMMARY: The finger cuff method provides a reasonable estimate of CO and blood pressure, which does not meet the criteria for clinical interchangeability with the currently used invasive devices.

From therapeutic hypothermia towards targeted temperature management: a decade of evolution.

More than a decade after the first randomised controlled trials with targeted temperature management (TTM), it remains the only treatment with proven favourable effect on postanoxemic brain damage after out-of-hospital cardiac arrest. Other well-known indications include neurotrauma, subarachnoidal haemorrhage, and intracranial hypertension. When possible pitfalls are taken into consideration when implementing TTM, the side effects are manageable. After the recent TTM trials, it seems that classic TTM (32-34°C) is as effective and safe as TTM at 36°C. This supports the belief that fever prevention is one of the pivotal mechanisms that account for the success of TTM. Uncertainty remains concerning cooling method, timing, speed of cooling and rewarming. New data indicates that TTM is safe and feasible in cardiogenic shock, one of its classic contra-indications. Moreover, there are limited indications that TTM might be considered as a therapy for cardiogenic shock per se.

Clinical value of echocardiographic Doppler-derived right ventricular dp/dt in patients with pulmonary arterial hypertension.

AIMS: Right ventricular (RV) dp/dt is the instantaneous rate of RV pressure rise during early systole and is a surrogate marker of RV contractility. The main objective of this study was to evaluate the ability of echocardiographic Doppler obtained RV dp/dt to predict long-term survival in patients with pulmonary arterial hypertension (PAH) and chronic thrombo-embolic pulmonary hypertension (CTEPH). METHODS AND RESULTS: Seventy-eight consecutive newly diagnosed untreated patients (64 ± 15 years, 71% female, 57% PAH, 43% inoperable CTEPH) were included in the study. At baseline, patients were assessed clinically [New York Heart Association (NYHA) and 6 minutes walking distance (6MWD)], by transthoracic cardiac ultrasound and by right heart catherization. RV dp/dt was assessed using spectral Doppler recordings from the tricuspid regurgitation signal at a sweep speed of 200 mm/s by measuring the time interval in which the regurgitant velocity increased from 0.5 to 2 m/s. During a mean follow-up period of 3.5 ± 1.7 years, 31 patients died and 3 received a lung transplant [study endpoint reached in 34/78 (44%) patients]. The optimal RV dp/dt cut-off was determined by receiver operating characteristic analysis at 3 years to be 410 mmHg/s (specificity 84%, positive-predictive value 55%, and negative-predictive value 83%). In univariate analysis, RV dp/dt <410 mmHg/s (hazard ratio 2.67, 95% CI 1.30-5.47, P = 0.007), tricuspid annulus plane systolic excursion (TAPSE) <15 mm, NYHA, 6MWD, and right atrial pressure were predictors of mortality. In a multivariate model with TAPSE, RV dp/dt remained an independent predictor of mortality (P = 0.01). CONCLUSION: A reduced baseline RV dp/dt is a clear indicator of poor outcome independent of TAPSE in patients with PAH/CTEPH.

[Therapeutic hypothermia: effects beyond neuroprotection]. / Therapeutische hypothermie: meer dan neuroprotectief.

In the past 10 years there have been major advances in the treatment of cardiac arrest by the application of therapeutic hypothermia (TH). TH is a safe treatment option, providing the physiological effects are taken into consideration and providing the potential pitfalls of application of hypothermia are avoided. TH (32-34°C) is just as safe and effective as cooling to 36°C ('near-normal temperature'). The benefit of TH is thus probably derived from the effective suppression of fever. The broad spectrum of pathophysiological mechanisms by which therapeutic hypothermia exerts its effect on organism in a hypoxic situation suggests a potential wider role for this therapy than in current daily clinical practice. Cardiogenic shock is no longer regarded as a contraindication for TH; in the past few years the safety and effectiveness of this treatment have been proven in patients with cardiogenic shock. In fact, the anti-ischaemic and positive inotropic effects of TH suggest that this treatment could be a potential treatment specifically for patients with cardiogenic shock.

Assessment of three minimally invasive continuous cardiac output measurement methods in critically ill patients and a review of the literature.

BACKGROUND: In this study we compared the accuracy of three continuous cardiac output (CCO) measurement methods, with intermittent transcardiopulmonary thermodilution (TPTD-CO) as the gold standard. The three studied CCO measurement methods were: uncalibrated peripheral pulse contour measurement (FCCO), calibrated central pulse contour measurement (PCCO), and CCO obtained by indirect Fick principle (NCCO). METHODS: We performed an observational study in 23 critically ill patients. Statistical analysis was done using Pearson's correlation and Bland-Altman analysis. A review of the relevant medical literature was performed. RESULTS: Only PCCO showed good correlation (R = 0.9) and agreement with a bias of 0.0 ± 0.8 L min⁻¹ and percentage error of 24.5% when compared to TPTD-CO. In patients with normal systemic vascular resistance index (SVRI > 1,700 dyne sec cm⁻5 m⁻²), NCCO (R = 0.8 and bias 0.4 ± 1.3 L min⁻¹) and FCCO (R = 0.8 and bias 0.1 ± 1 L min⁻¹) also produced reliable results. CONCLUSIONS: These results indicate that in our patient population, CCO can be most reliably monitored by calibrated central pulse contour measurements. All other methods appeared less accurate, especially in situations of low SVRI.