Coronary Artery Perforation and Tamponade　- Incidence, Risk Factors, Predictors and Outcomes From 12 Years' Data of the SCAAR Registry.

BACKGROUND: The incidence and short- and long-term outcomes of coronary artery perforation (CAP) are not well described.Methods and Results:We analyzed the characteristics and the short- and long-term outcomes of CAP among 243,149 patients undergoing percutaneous coronary interventions (PCI) from 2005 until 2017 in the national Swedish registry. We identified 1,008 cases of CAP with an incidence of 0.42%. Major adverse event rates were significantly higher in patients with CAP than non-CAP (P<0.001). The 1-year mortality rate was 16% vs. 5.5%, respectively, and the 12-year mortality rate was 52% vs. 34%. The restenosis rate was 5.2% vs. 3.1% and 17% vs. 9%, respectively. The target lesion revascularization rate was 4.2% vs. 2.6% and 10.5% vs. 7%. The stent thrombosis rate was numerically higher, 1.5% vs. 0.8% and 4.5 vs. 2.8%, with no stent thrombosis cases for equine pericardial stent grafts. Among the patients with tamponade a large proportion of cases occurred at the late stage (215/1,008, 21%), and most were not recognized in the cath-lab (167/215, 78%). The mortality rate for late tamponade was similar in patients suffering acute tamponade at 1 year (25.6% vs. 27%) or at 12 years (54% vs. 58%). CONCLUSIONS: CAP is associated with an early high excess in morbidity and mortality but with low risk of additional adverse events in the long term. Late tamponade is as deadly as acute tamponade.

Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement.

BACKGROUND: The mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure. METHODS: We performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry. RESULTS: Mean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm2. There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular complication rate was 2%. The 12-month mortality rate was 14%. At discharge 87% of patients had no/trace PVL, 12% had mild PVL and one patient had a moderate PVL. A total of 13% received a new PPM post valve implantation. Among patients who did not have a PPM before the procedure, the PPM rate was 15.3%. CONCLUSIONS: This single-center evaluation of the Lotus Valve System demonstrated a good clinical outcome with a low mortality, in a high-risk population. Introduction of a new implantation technique resulted in lower PPM rates than previously reported without negatively affecting PVL. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14952278 , retrospectively registered 06/11/2017.

Very long-term outcome of coronary covered stents: a report from the SCAAR registry.

AIMS: Covered stents are mostly used for coronary perforations with a high risk of early adverse events; however, their long-term outcome is unknown. The aim of this study was to elucidate the short- and long-term outcome of patients treated with covered stents compared to all other stented patients. METHODS AND RESULTS: The Swedish national registries from 2005-2017 disclosed 265 patients who had received 366 covered stents. Their outcomes were compared to all other stented patients (197,948) who had received 320,784 stents. Compared to regular stents, covered stents showed significant differences (p<0.001) in the short and long term in relation to in-stent restenosis (ISR), target lesion revascularisation (TLR), re-infarction (MI), re-PCI and mortality, the rates of which were all higher. The higher mortality was concentrated within the first month, as a landmark analysis at that time point, adjusted for age and procedural indication, demonstrated no future difference in mortality (HR 1.02 [0.78-1.33], p=0.877). Stent thrombosis (ST) within one year was reported to be higher in covered stents than in other stents. However, no ST was reported in equine pericardial covered stents. CONCLUSIONS: This observational study including the entire Swedish population shows that patients receiving covered stents have a significantly higher risk of all adverse events. Reassuringly, in the long term, mortality appears to be similar to that in other stented patients.

Intravascular ultrasound assessment of minimum lumen area and intimal hyperplasia in in-stent restenosis after drug-eluting or bare-metal stent implantation. The Nordic Intravascular Ultrasound Study (NIVUS).

INTRODUCTION: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients presenting with a DES or bare-metal stent (BMS) in-stent restenosis. METHODS: The "Nordic Intravascular Ultrasound Study (NIVUS)" study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n=121 and BMS n=88) with in-stent restenosis were enrolled. RESULTS: At the minimum lumen area site in the stented segment, the stent area (5.8±2.2mm2 vs. 7.6±2.4mm2, p<0.001) and intimal hyperplasia area (2.6±2.0mm2 vs. 5.0±2.2mm2, p<0.001) were significantly lower in patients treated with DES compared to BMS. The percentage of stents that did not have a minimum stent area of at least 5.0mm2 (under expansion) was higher in DES (58.7% vs. 37.7%, p=0.008) compared to BMS. Intimal hyperplasia covered 55.4±33.3% of the stent length in the DES compared to 90.7±17.4% in the BMS group, p<0.001. Focal in-stent restenosis was more often seen in DES treated patients compared to BMS treated patients (DES n=84 (59.9%) vs. BMS n=15 (17.0%), p<0.001). CONCLUSION: Stent underexpansion was more often seen in DES than BMS in-stent restenosis. DES more often had focal in-stent restenosis with less intimal hyperplasia.

Repositionable percutaneous aortic valve implantation with the LOTUS valve: 30-day and 1-year outcomes in 250 high-risk surgical patients.

AIMS: The REPRISE IIE trial aimed to evaluate outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable LOTUS valve with a unique seal designed to minimise paravalvular leak (PVL). METHODS AND RESULTS: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent clinical events committee adjudicated events per Valve Academic Research Consortium criteria. Mean age was 84 years; 77% were in NYHA Class III/IV. LOTUS valve implantation produced significant haemodynamic improvements at one year without valve embolisation, ectopic valve deployment, or additional valve implantation. Primary endpoints were met as the 30-day mortality rate in the extended cohort (4.4%, N=250), and mean valve gradient in the main cohort (11.5±5.2 mmHg, N=120) were below (p<0.001) their predefined performance objectives. At 30 days, disabling stroke was 2.8% and new pacemaker implantation was 28.9% in all patients and 32.0% in pacemaker-naïve patients. By one year, all-cause mortality was 11.6%, disabling stroke was 3.6%, 95% of patients alive were in NYHA Class I/II, and there was no core laboratory-adjudicated moderate/severe PVL. CONCLUSIONS: LOTUS valve implantation produced good valve haemodynamics, minimal PVL, sustained significant improvement in functional status, and good clinical outcomes one year post implant.

Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort).

Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.

Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients: results from the REPRISE II trial with extended cohort.

AIMS: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. METHODS AND RESULTS: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06). CONCLUSIONS: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.

Assessment of increasing intravenous adenosine dose in fractional flow reserve.

BACKGROUND: Effects of increased adenosine dose in the assessment of fractional flow reserve (FFR) were studied in relation to FFR results, hemodynamic effects and patient discomfort. FFR require maximal hyperemia mediated by adenosine. Standard dose is 140 µg/kg/min administrated intravenously. Higher doses are commonly used in clinical practice, but an extensive comparison between standard intravenous dose and a high dose (220 µg/kg/min) has previously not been performed. METHODS: Seventy-five patients undergoing FFR received standard dose adenosine, followed by high dose adenosine. FFR, mean arterial pressure (MAP) and heart rate (HR) were analyzed. Patient discomfort measured by Visual Analogue Scale (VAS) was assessed. RESULTS: No significant difference was found between the doses in FFR value (0.85 [0.79-0.90] vs 0.85 [0.79-0.89], p = 0.24). The two doses correlated well irrespective of lesion severity (r = 0.86, slope = 0.89, p = <0.001). There were no differences in MAP or HR. Patient discomfort was more pronounced using high dose adenosine (8.0 [5.0-9.0]) versus standard dose (5.0 [2.0-7.0]), p = <0.001. CONCLUSIONS: Increased dose adenosine does not improve hyperemia and is associated with increased patient discomfort. Our findings do not support the use of high dose adenosine. TRIAL REGISTRATION: Retrospective Trial registration: Current Controlled Trials ISRCTN14618196 . Registered 15 December 2016.

The safety of introducing a new generation TAVR device: one departments experience from introducing a second generation repositionable TAVR.

BACKGROUND: In the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department. METHODS: In a retrospective study, 53 patients receiving the Lotus system, and 47 patients receiving the Sapien system over a period of three years were compared for short-term outcome according to VARC-2 definitions and 1-year survival. RESULTS: Outcome in terms VARC-2 criteria for early safety and clinical efficacy, stroke rate, and survival at 30 days and at 1 year were similar. The Lotus valve had less paravalvular leakage, where 90% had none or trace aortic insufficiency as compared to only 48% for the Sapien system. CONCLUSIONS: Introduction of a new generation valve can be done with early device success and safety, and without jeopardizing the outcome for patients up to one year. We found no adverse effects by changing valve type and observed improved outcome in terms of lower PVL-rates. Both existing and new centers starting a TAVR program can benefit from the use of a new generation device.

Prognostic Impact of Chronic Total Occlusions: A Report From SCAAR (Swedish Coronary Angiography and Angioplasty Registry).

OBJECTIVES: The aim of this study was to determine the prognostic impact of chronic total occlusion (CTO) on long-term mortality in a large prospective cohort. BACKGROUND: CTO is present in many patients with coronary artery disease and is difficult to treat with percutaneous coronary intervention. METHODS: The study population consisted of all consecutive patients who underwent coronary angiography in Sweden between January 1, 2005 and January 1, 2012, who were registered in SCAAR (Swedish Coronary Angiography and Angioplasty Registry). The patient population was heterogeneous with regard to indication for angiography (stable angina, ST-segment elevation myocardial infarction [STEMI], unstable angina or non-STEMI, and other) and treatment options. The long-term mortality rates of patients with and without CTO were compared by using shared frailty Cox proportional hazards regression adjusted for confounders. Tests were conducted for interactions between CTO and several pre-specified characteristics: indication for angiography and percutaneous coronary intervention (stable angina, STEMI, unstable angina or non-STEMI, and other), severity of coronary artery disease (1-, 2-, and 3-vessel and/or left main coronary artery disease), age, sex, and diabetes. RESULTS: During the study period, 14,441 patients with CTO and 75,431 patients without CTO were registered in SCAAR. CTO was associated with higher mortality (hazard ratio: 1.29; 95% confidence interval: 1.22 to 1.37; p < 0.001). In subgroup analyses, the risk attributable to CTO was lowest in patients with stable angina and highest in those with STEMI. In addition, CTO was associated with highest risk in patients under 60 years of age and with lowest risk in octogenarians. There was no interaction between CTO and either diabetes or sex, suggesting an equally adverse effect in both groups. CONCLUSIONS: In this large prospective observational study of patients with coronary artery disease, CTO was associated with increased mortality. This association was most prominent in younger patients and in those with acute coronary syndromes.

First-in-Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions.

OBJECTIVES: To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI. BACKGROUND: Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal. METHODS: Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria-TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution >70% at 90 minutes after vessel reperfusion-was also evaluated. RESULTS: Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration. CONCLUSIONS: This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI.

Confirmation of the Intracoronary Near-Infrared Spectroscopy Threshold of Lipid-Rich Plaques That Underlie ST-Segment-Elevation Myocardial Infarction.

OBJECTIVE: In a previous exploratory analysis, intracoronary near-infrared spectroscopy (NIRS) found the majority of culprit lesions in ST-segment-elevation myocardial infarction (STEMI) to contain a maximum lipid core burden index in 4 mm (maxLCBI4mm) of >400. This initial study was limited by a small sample size, enrollment at a single center, and post hoc selection of the maxLCBI4mm ≥400 threshold. This study was designed a priori to substantiate the ability of NIRS to discriminate STEMI culprit from nonculprit segments and to confirm the performance of the maxLCBI4mm ≥400 threshold. APPROACH AND RESULTS: At 2 centers in the United States and Sweden, 75 STEMI patients underwent intracoronary NIRS imaging after establishing thrombolysis in myocardial infarction 3 flow, but before stenting. Blinded core laboratory analysis defined the culprit segment as the 10-mm segment distal to the proximal angiographic culprit margin. The remaining vessel was divided into contiguous 10-mm nonculprit segments. The maxLCBI4mm of culprit segments (median [interquartile range]: 543 [273-756]) was 4.4-fold greater than nonculprit segments (median [interquartile range]: 123 [0-307]; P<0.001). Receiver-operating characteristic analysis demonstrated that maxLCBI4mm differentiated culprit from nonculprit segments with high accuracy (c-statistic=0.83; P<0.001). A threshold maxLCBI4mm ≥400 identified STEMI culprit segments with a sensitivity of 64% and specificity of 85%. CONCLUSIONS: This study substantiates the ability of NIRS to accurately differentiate STEMI culprit from nonculprit segments and confirms that a threshold maxLCBI4mm ≥400 is detected by NIRS in the majority of STEMI culprits.

Mechanical chest compressions in the coronary catheterization laboratory to facilitate coronary intervention and survival in patients requiring prolonged resuscitation efforts.

BACKGROUND: Resuscitation after cardiac arrest (CA) in the catheterization laboratory (cath-lab) using mechanical chest compressions (CC) during simultaneous percutaneous coronary intervention (PCI) is a strong recommendation in the 2015 European Resuscitation Council (ERC) guidelines. This study aimed at re-evaluating survival to hospital discharge and assess long term outcome in this patient population. METHODS: Patients presenting at the cath lab with spontaneous circulation, suffering CA and requiring prolonged mechanical CC during cath lab procedures between 2009 and 2013 were included. Circumstances leading to CA, resuscitation parameters and outcomes were evaluated within this cohort. For comparison, patients needing prolonged manual CC in the cath lab in the pre-mechanical CC era were evaluated. Six-month and one year survival with a mechanical CC treatment strategy from 2004 to 2013 was also evaluated. RESULTS: Thirty-two patients were included between 2009 and 2013 (24 ST-elevation myocardial infarction (STEMI), 4 non-STEMI, 2 planned PCI, 1 angiogram and 1 intra-aortic counter pulsation balloon pump insertion). Twenty were in cardiogenic shock prior to inclusion. Twenty-five were successfully treated with PCI. Median mechanical CC duration for the total cohort (n = 32) was 34 min (range 5-90), for the 15 patients with circulation discharged from the cath-lab, 15 min (range 5-90), and for the eight discharged alive from hospital, 10 min (range 5-52). Twenty-five percent survived with good neurological outcome at hospital discharge. Ten patients treated with manual CC were included with one survivor. DISCUSSION: Eighty-seven percent of the patients included in the mechanical CC cohort had their coronary or cardiac intervention performed during mechanical CC with an 80 % success rate. This shows that the use of mechanical CC during an intervention does not seem to impair the interventional result substantially. The survival rate after one year was 87 %. CONCLUSIONS: Among patients suffering CA treated with mechanical CC in the cath-lab, 25% had a good neurological outcome at hospital discharge compared to 10% treated with manual CC. Long term survival in patients discharged from hospital is good.

Safety, Feasibility, and Hemodynamic Effects of Mild Hypothermia in Transcatheter Aortic Valve Replacement: The TAVR-CHILL Trial.

The safety, feasibility, and hemodynamic effects of mild hypothermia (MH) induced by transnasal cooling were studied in transcatheter aortic valve replacement (TAVR). MH is a common therapy following cardiac arrest and seems to have favorable effects in myocardial infarction and on hemodynamic stability. In TAVR, hemodynamic instability is common during rapid pacing. Twenty subjects undergoing TAVR were randomized 1:1 to hypothermia or normothermia. Hemodynamic endpoints were mean arterial blood pressure and required dosage of vasoactive and inotropic drugs. Patients were followed up at 6 months. All patients in the MH group (n=10) reached the target temperature of 34°C before first rapid pacing. Tympanic and urinary bladder temperature remained significantly lower in the MH group during the procedure. No adverse effects of cooling were observed. Mean arterial pressure was higher in the MH group (90±20 mm Hg) than in the control group (71±13 mm Hg) at the start of the procedure, at first rapid pacing (94±19 vs. 80±16 mm Hg), and at balloon aortic valvuloplasty (90±17 vs. 73±14 mm Hg). Less norepinephrine was administered to the hypothermia group. Transnasal cooling during TAVR was safe and well tolerated. We observed a more stable hemodynamic profile in the MH group, indicated by higher blood pressure and lower levels of vasoactive drugs required. A larger study of patients with severe ventricular dysfunction is required to more comprehensively investigate the hemodynamic effects of transnasal cooling in TAVR.

Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials.

In the randomized rapid intravascular cooling in myocardial infarction as adjunctive to percutaneous coronary intervention (RAPID MI-ICE) and rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction CHILL-MI studies, hypothermia was rapidly induced in conscious patients with ST-elevation myocardial infarction (STEMI) by a combination of cold saline and endovascular cooling. Twenty patients in RAPID MI-ICE and 120 in CHILL-MI with large STEMIs, scheduled for primary percutaneous coronary intervention (PCI) within <6 hours after symptom onset were randomized to hypothermia induced by rapid infusion of 600-2000 mL cold saline combined with endovascular cooling or standard of care. Hypothermia was initiated before PCI and continued for 1-3 hours after reperfusion aiming at a target temperature of 33°C. The primary endpoint was myocardial infarct size (IS) as a percentage of myocardium at risk (IS/MaR) assessed by cardiac magnetic resonance imaging at 4±2 days. Patients randomized to hypothermia treatment achieved a mean core body temperature of 34.7°C before reperfusion. Although significance was not achieved in CHILL-MI, in the pooled analysis IS/MaR was reduced in the hypothermia group, relative reduction (RR) 15% (40.5, 28.0-57.6 vs. 46.6, 36.8-63.8, p=0.046, median, interquartile range [IQR]). IS/MaR was predominantly reduced in early anterior STEMI (0-4h) in the hypothermia group, RR=31% (40.5, 28.8-51.9 vs. 59.0, 45.0-67.8, p=0.01, median, IQR). There was no mortality in either group. The incidence of heart failure was reduced in the hypothermia group (2 vs. 11, p=0.009). Patients with large MaR (>30% of the left ventricle) exhibited significantly reduced IS/MaR in the hypothermia group (40.5, 27.0-57.6 vs. 55.1, 41.1-64.4, median, IQR; hypothermia n=42 vs. control n=37, p=0.03), while patients with MaR<30% did not show effect of hypothermia (35.8, 28.3-57.5 vs. 38.4, 27.4-59.7, median, IQR; hypothermia n=15 vs. control n=19, p=0.50). The prespecified pooled analysis of RAPID MI-ICE and CHILL-MI indicates a reduction of myocardial IS and reduction in heart failure by 1-3 hours with endovascular cooling in association with primary PCI of acute STEMI predominantly in patients with large area of myocardium at risk. (ClinicalTrials.gov id NCT00417638 and NCT01379261).

Coronary liposuction during percutaneous coronary intervention: evidence by near-infrared spectroscopy that aspiration reduces culprit lesion lipid content prior to stent placement.

AIMS: Intracoronary near-infrared spectroscopy (NIRS) in ST-segment elevation myocardial infarction (STEMI) has demonstrated substantial lipid in STEMI culprit plaques. Thrombus aspiration during primary PCI reduces distal embolization and improves reperfusion. This study was performed to examine if aspiration thrombectomy reduces the lipid content of acute coronary syndrome (ACS) culprit plaques. METHODS AND RESULTS: NIRS-IVUS imaging was performed in patients with an ACS at two hospitals in the US and Sweden. After establishment of TIMI 3 flow with an undersized balloon, NIRS was performed, followed by aspiration thrombectomy, followed by repeated NIRS. The same culprit segment was identified on the post-aspiration chemogram. The culprit lipid content was quantified before and after thrombectomy as the lipid core burden index (LCBI). Aspirates were examined by histological staining for lipids, calcium, and macrophages. In 18 ACS patients (age 65 ± 11, 61% male), culprit lesions were characterized by high lipid content prior to aspiration thrombectomy. Thrombectomy resulted in a 28% reduction in culprit lesion lipid content (pre-aspiration LCBI 466 ± 141 vs. post-aspiration 335 ± 117, P = 0.0001). In addition to thrombus, histological analysis of aspirates demonstrated the presence of lipids, calcium, and macrophages, indicating that fragments of atherosclerotic plaques had been aspirated. CONCLUSION: Thrombectomy aspirates both thrombus and lipid-rich fragments of the culprit atherosclerotic plaques, thereby reducing material that may embolize during stenting. Reduction of lipid content before stenting might contribute to the beneficial effects of thrombectomy and may be particularly useful if a large lipid core is present at the culprit site.

Detection by near-infrared spectroscopy of large lipid cores at culprit sites in patients with non-ST-segment elevation myocardial infarction and unstable angina.

OBJECTIVE: This study was performed to assess the lipid burden of culprit lesions in non-ST-segment elevation myocardial infarction (non-STEMI) and unstable angina (UA). BACKGROUND: A recent intracoronary near-infrared spectroscopy (NIRS) study showed 85% of STEMI culprit lesions have a maximum lipid core burden index in 4-mm (maxLCBI(4mm)) ≥ 400. Whether culprit lesions in non-STEMI and UA are characterized by a similarly large lipid burden is unknown. METHODS: We studied 81 non-STEMI and UA patients undergoing culprit vessel NIRS imaging before stenting. Culprit segments were compared to all nonoverlapping 10-mm nonculprit segments for maxLCBI(4mm). Culprit segments in non-STEMI and UA were compared for the frequency of maxLCBI(4mm) ≥ 400. RESULTS: Among 81 patients (53.1% non-STEMI, 46.9% UA), non-STEMI culprit segments had a 3.4-fold greater maxLCBI(4mm) than nonculprits (448 ± 229 vs 132 ± 154, P < 0.001) and UA culprit segments had a 2.6-fold higher maxLCBI(4mm) than nonculprits (381 ± 239 vs 146 ± 175, P < 0.001). NIRS detected a maxLCBI(4mm) ≥ 400 in 63.6% of culprit segments in NSTEMI and in 38.5% of culprit segments in UA (P = 0.02). Against a background of nonculprit segments, maxLCBI(4mm) ≥ 400 had a sensitivity of 63.6% and specificity of 94.0% for culprit segments in NSTEMI and a sensitivity of 38.5% and specificity of 89.8% for culprit segments in UA. CONCLUSIONS: Large lipid cores similar to those recently detected by NIRS at STEMI culprit sites were frequently observed at culprit sites in patients with non-STEMI and UA. These findings support ongoing prospective trials designed to determine if NIRS can provide site-specific prediction of future acute coronary events.

A pharmacodynamic comparison of 5 anti-platelet protocols in patients with ST-elevation myocardial infarction undergoing primary PCI.

BACKGROUND: Despite advances in anti-platelet treatments, there still exists an early increase in both ischemic as well as bleeding events following primary PCI in patients with ST-elevation myocardial infarction (STEMI). Platelet inhibition data of different anti-platelet treatments in the acute phase of a myocardial infarction might offer some insight into these problems. The aim of this study was to evaluate the pharmacodynamic profile of 5 different anti-platelet treatments in the acute phase of STEMI in patients undergoing primary PCI. METHODS: A total of 223 STEMI patients undergoing primary PCI were prospectively included. Patients received either pre-hospital clopidogrel only, pre-hospital clopidogrel followed by prasugrel switch in the cath lab, prasugrel treatment only, pre-hospital clopidogrel followed by ticagrelor switch in the cath lab or pre-hospital ticagrelor only. Platelet reactivity was measured serially using vasodilator-stimulated phosphoprotein (VASP). RESULTS: Patients receiving pre-hospital clopidogrel followed by prasugrel switch showed similar platelet inhibition data as patients receiving prasugrel only, with more than 90% being good responders the day after PCI. Average time from prasugrel administration to a VASP value of <50% was 1.5 hours. In patients receiving pre-hospital ticagrelor, 50% were good responders at completion of PCI and average time to a VASP-value of <50% was 2.3 hours. Only 32% of patients receiving clopidogrel only were responders the day after PCI. CONCLUSIONS: Switching from an upstream bolus dose of clopidogrel to prasugrel at the time of PCI, appeared as a safe and feasible option with no tendency for overshoot or attenuation of platelet inhibition. Pre-hospital administration of ticagrelor was associated with a 50% good responder rate at completion of PCI.

A review of the role of nurses and technicians in ST-elevation myocardial infarction (STEMI).

The role of nurses and technicians in the treatment of ST-elevation myocardial infarction (STEMI) by primary percutaneous coronary intervention (PPCI) is vital for the success of the multidisciplinary Heart Team. Several editorials have emphasised the importance of a holistic treatment which links each step of care to the next, a chain that is essential for quality and efficacy in the management of STEMI patients. In pre-hospital acute coronary care, the first medical contact is most commonly a nurse and/or a paramedic. The time from symptom onset to reperfusion is crucial for the long-term outcome. On arrival at the hospital, it is important for the nurse or paramedic to share an overview of what has been done to the patient so far, in a structured and evidence-based way, with the receiving nurse and physician. During PPCI, the role of nurses and technicians includes puncture site assessment, administration of pharmaceuticals and the ability to anticipate and prevent complications. In patients with cardiogenic shock and cardiac arrest, advanced knowledge of haemodynamic support systems is required. In the future, this knowledge must be extended from a limited number of individuals in a small number of centres to a standard of care which is available for all citizens throughout Europe. This review demonstrates the necessity for a multidisciplinary team approach where every person plays an equal, important role in every element of PPCI. The future role of nurses and technicians is intriguing and demands education and experience from an advanced medical and nursing point of view, where the multidisciplinary Heart Team and the knowledge of the different key players are vital.