Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study.

The optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention (PCI) is complex and remains a subject of debate. Current guidelines advise a stepwise provisional approach with optional two-stent strategy. However, a two-stent strategy, both upfront and stepwise provisional, is technically demanding. Therefore, there is increasing interest in the use of drug-eluting balloons (DEB) in bifurcation lesions, mainly after a provisional approach with unsatisfactory result of the side branch. Some small pilot studies already showed that the use of DEB in bifurcation lesions is safe and feasible. However, a randomized comparison of this hybrid DEB strategy with a two-stent strategy is currently lacking. TRIAL DESIGN: The Hybrid DEB study is a prospective, multicenter, randomized controlled trial investigating noninferiority of a hybrid DEB approach, using a combination of a drug-eluting stent (DES) in the main vessel and DEB in the side branch, compared to stepwise provisional two-stent strategy in patients with true bifurcation lesions. A total of 500 patients with de novo true coronary bifurcation lesions, treated with a stepwise provisional approach and an unsatisfactory result of the side branch after main vessel stenting (≥ 70% stenosis and/or < thrombolysis in myocardial infarction III flow), will be randomized in a 1:1 ratio to receive either treatment with a DEB or with a DES in the side branch. The primary endpoint is a composite endpoint of the occurrence of all-cause death, periprocedural or spontaneous myocardial infarction and/or target vessel revascularization at the anticipated median 2-year follow-up. CONCLUSION: The Hybrid DEB study will compare in a multicenter, randomized fashion a hybrid DEB approach with a stepwise provisional two-stent strategy in patients with true bifurcation lesions. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT05731687.

Feasibility of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris and a Cardiac Implanted Electronic Device.

OBJECTIVES: Five to 10% of patients with stable coronary artery disease have refractory angina pectoris (RAP). These patients are restricted in performing daily activities due to angina pectoris. Spinal cord stimulation is a last resort treatment option. A number of this patient population also has an indication for a cardiac implanted electronic device (CIED) (pacemaker or implantable cardiac defibrillator). Manufacturers of spinal cord stimulators have stated a warning that interference can occur between the spinal cord stimulator and the CIED. Consequently, only a limited number of patients with RAP and a CIED have received a spinal cord stimulator. The aim of this retrospective cohort study is to determine whether spinal cord stimulation can be safely used in patients with RAP and a CIED. MATERIALS AND METHODS: All patients with RAP referred to our center were screened and included if 1) the patient received a spinal cord stimulator as treatment for RAP and if 2) the patient received a CIED either prior to or after spinal cord stimulator implantation. A transcutaneous electrical nerve stimulation (TENS) treadmill test was used as a screening tool to determine whether the patient was eligible for implantation of a spinal cord stimulator. Interference between the spinal cord stimulator and CIED was checked 1) after TENS treadmill test, 2) during implantation of spinal cord stimulator or CIED, 3) during mode switches of the SCS, and 4) during regular out patient follow-up. RESULTS: In total, 22 patients had both a spinal cord stimulator and a CIED with an average follow-up duration of 44.5 months. No interference between the spinal cord stimulator and CIED was found. CONCLUSION: Spinal cord stimulation can be safely applied in patients with a CIED provided that the CIED is checked for interference during implantation, if mode switches of the SCS occurred and once yearly after implantation according to routine follow-up.

Single-Center Experience With High-Density Spinal Cord Stimulation in Patients With Refractory Angina Pectoris.

OBJECTIVES: Spinal cord stimulation (SCS) is a treatment option for patients with refractory angina pectoris (RAP) which was first used in 1987 and led to a reduction in the number of angina pectoris episodes, less consumption of short-acting nitrates, and an improvement in the quality of life. The conventional mode of stimulation leads to paresthesia felt at the target area. In recent years novel modes of stimulation have been developed that are paresthesia free, such as "burst," "high-density (HD)," or "high-frequency/10 kHz" stimulation. To date, these new modes of stimulation have not been used in patients with RAP and a spinal cord stimulator. This retrospective, single-center, observational study gives a description of the experience of using HD stimulation in selected patients with RAP being treated with SCS. MATERIALS AND METHODS: All patients with RAP who received a spinal cord stimulator as treatment at our center from September 2009 to February 2021 were screened. Patients were eligible for inclusion into this retrospective, observational study if 1) patients had used HD stimulation, or 2) were currently using HD stimulation. RESULTS: Fifty-three patients out of a total of 157 patients who had a spinal cord stimulator due to RAP use or have used HD stimulation. In most patients (79.2%), the reason for switching from conventional to HD stimulation was due to progression of symptoms under conventional stimulation. The average duration of conventional stimulation use prior to switching to HD stimulation was 40.3 (± 29.6) months. In total, 26 patients (of 53 patients; 49.1%) were using HD stimulation at the end of the follow-up period or until lost to follow-up, and two patients used both forms of stimulation interchangeably. Five patients (9.4%) had stopped using SCS, and 20 patients (37.7%) switched back to conventional stimulation due to a variety of reasons. CONCLUSIONS: This retrospective study shows that the use of HD stimulation in patients with RAP being treated with SCS could be an alternative option for conventional stimulation. Due to the nature of this study, additional research is essential to confirm these initial findings.

Intra-aortic balloon pump counterpulsation in extensive myocardial infarction with persistent ischemia: The SEMPER FI pilot study.

OBJECTIVES: This study aimed to prospectively investigate intra-aortic balloon pump counterpulsation (IABP) support in large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI). BACKGROUND: Use of IABP is suggested to be effective by increasing diastolic aortic pressure, thereby improving coronary blood flow. This can only be expected with exhausted coronary autoregulation, typical in acute myocardial infarction complicated by persistent ischemia. In this situation, augmented diastolic pressure is expected to increase myocardial oxygenation. METHODS: One hundred patients with large STEMI complicated by persistent ischemia after primary PCI were randomized to treatment with or without IABP therapy on top of standard care. IABP support was initiated following primary PCI, immediately after inclusion. Primary end point was all-cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months. RESULTS: Mean age was 63 ± 10 years, 76% were male. Mean systolic and diastolic blood pressure were 120 ± 25 mmHg and 73 ± 17 mmHg. Mean heart rate was 75 ± 18 mmHg. Before PCI, mean summed ST-deviation was 21 ± 8 mm with only minimal ST-resolution after PCI. One patient in the IABP group reached the primary end point versus four patients in the control group (2% vs. 8%; p = 0.16). After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01). CONCLUSIONS: In this pilot study, in patients with large STEMI and persistent ischemia after primary PCI, use of IABP showed a nonsignificant decrease in mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure at 6 months, and resulted in more rapid ST-resolution.

Thermodilution-Based Invasive Assessment of Absolute Coronary Blood Flow and Microvascular Resistance: Quantification of Microvascular (Dys)Function?

During the last two decades, there has been a sharp increase in both interest and knowledge about the coronary microcirculation. Since these small vessels are not visible by the human eye, physiologic measurements should be used to characterize their function. The invasive methods presently used (coronary flow reserve (CFR) and index of microvascular resistance (IMR)) are operator-dependent and mandate the use of adenosine to induce hyperemia. In recent years, a new thermodilution-based method for measurement of absolute coronary blood flow and microvascular resistance has been proposed and initial procedural problems have been overcome. Presently, the technique is easy to perform using the Rayflow infusion catheter and the Coroventis software. The method is accurate, reproducible, and completely operator-independent. This method has been validated noninvasively against the current golden standard for flow assessment: Positron Emission Tomography-Computed Tomography (PET-CT). In addition, absolute flow and resistance measurements have proved to be safe, both periprocedurally and at long-term follow-up. With an increasing number of studies being performed, this method has great potential for better understanding and quantification of microvascular disease.

Pressure gradient vs. flow relationships to characterize the physiology of a severely stenotic aortic valve before and after transcatheter valve implantation.

Aims: Echocardiography and tomographic imaging have documented dynamic changes in aortic stenosis (AS) geometry and severity during both the cardiac cycle and stress-induced increases in cardiac output. However, corresponding pressure gradient vs. flow relationships have not been described. Methods and results: We recruited 16 routine transcatheter aortic valve implantations (TAVI's) for graded dobutamine infusions both before and after implantation; 0.014″ pressure wires in the aorta and left ventricle (LV) continuously measured the transvalvular pressure gradient (ΔP) while a pulmonary artery catheter regularly assessed cardiac output by thermodilution. Before TAVI, ΔP did not display a consistent relationship with transvalvular flow (Q). Neither linear resistor (median R2 0.16) nor quadratic orifice (median R2 < 0.01) models at rest predicted stress observations; the severely stenotic valve behaved like a combination. The unitless ratio of aortic to left ventricular pressures during systolic ejection under stress conditions correlated best with post-TAVI flow improvement. After TAVI, a highly linear relationship (median R2 0.96) indicated a valid valve resistance. Conclusion: Pressure loss vs. flow curves offer a fundamental fluid dynamic synthesis for describing aortic valve pathophysiology. Severe AS does not consistently behave like an orifice (as suggested by Gorlin) or a resistor, whereas TAVI devices behave like a pure resistor. During peak dobutamine, the ratio of aortic to left ventricular pressures during systolic ejection provides a 'fractional flow reserve' of the aortic valve that closely approximates the complex, changing fluid dynamics. Because resting assessment cannot reliably predict stress haemodynamics, 'valvular fractional flow' warrants study to explain exertional symptoms in patients with only moderate AS at rest.

Safety and feasibility of local myocardial hypothermia.

BACKGROUND: In ST-elevation myocardial infarction (STEMI), reduction in time to reperfusion of the occluded coronary artery reduces infarct size. In animal models, an additional reduction of infarct size was observed when hypothermia was induced before reperfusion, despite a longer ischemic time. However, several human studies did not corroborate this positive effect, which is believed to be in part due to the inability of systemic induced hypothermia to induce sufficient decrease of local myocardial temperature before reperfusion. Providing rapid local myocardial hypothermia by intracoronary infusion of saline before reperfusion in patients with STEMI may overcome this problem. In this study, we evaluate the safety and feasibility of providing rapid intracoronary myocardial hypothermia in patients undergoing intracoronary blood flow measurements based on thermodilution with continuous infusion of saline at room temperature. METHODS AND RESULTS: In 53 patients with stable angina (SA) and 20 patients with STEMI, a total of 215 measurements were performed. The measurements consisted of continuous selective intracoronary infusion of saline at room temperature with rates between 10 ml/min and 30 ml/min. Temperature changes compared to initial blood temperature (Tb ) were measured at the tip of the infusion catheter (Ti ) and distally in the coronary artery (Td ). In patients with SA, Ti was -5.65 ± 1.41°C (range -9.27 to -2.28) and Td was -0.78 ± 0.51°C (range -3.27 to -0.23°C). In patients with STEMI, Ti was -7.45 ± 0.51°C (range -8.21 to -6.56) and Td was -1.37 ± 0.82°C (range -4.62 to -0.74°C). In all patients, steady-state intracoronary hypothermia was achieved within 15 sec and could be maintained without noticeable complications. CONCLUSION: This study demonstrates the safety and feasibility of inducing intracoronary hypothermia by selective infusion of saline at room temperature in patients with SA and STEMI. Steady-state hypothermia could be achieved and maintained quickly, easily, and safely using common PCI techniques. Therefore, our findings warrant further studies to the use of intracoronary hypothermia to enhance myocardial salvage in acute myocardial infarction.

Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial.

BACKGROUND: Bioabsorbable vascular scaffolds were developed to overcome limitations of permanent bare-metal or drug-eluting coronary stents­ie, stent thrombosis (despite prolonged dual antiplatelet therapy), the life-long presence of a caged vessel segment that does not allow vasomotion or remodelling, and chronic vessel wall inflammation. We assessed the safety and performance of a new magnesium-based paclitaxel-eluting absorbable metal scaffold in symptomatic patients with de-novo coronary lesions. METHODS: We did a prospective, multicentre, first-in-man trial (BIOSOLVE-1) of the drug-eluting absorbable metal scaffold (DREAMS). 46 patients with 47 lesions were enrolled at five European centres. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation, at 6 and 12 months. Clinical follow-up was scheduled at 1, 6, 12, 24, and 36 months. Patients were consecutively assigned to angiographic and intravascular ultrasonographic follow-up at 6 months or 12 months. Optical coherence tomography was done in some patients. All patients were recommended to take dual antiplatelet therapy for at least 12 months. This trial is registered with ClinicalTrials.gov, number NCT01168830. FINDINGS: Overall device and procedural success was 100%. Two of 46 (4%) patients had target lesion failure at 6 months (both clinically driven target lesion revascularisations), which rose to three of 43 (7%) at 12 months (one periprocedural target vessel myocardial infarction occurred during angiography at the 12 month follow-up visit). We noted no cardiac death or scaffold thrombosis. INTERPRETATION: Our results show feasibility, a good safety profile, and promising clinical and angiographic performance results up to 12 months for DREAMS. Our promising clinical results show that absorbable metal scaffolds might be an alternative to polymeric absorbable scaffolds. FUNDING: Biotronik.

Is the Corrected Carotid Flow Time a Clinically Acceptable Surrogate Hemodynamic Parameter for the Left Ventricular Ejection Time?

OBJECTIVE: The corrected left ventricular ejection time (cLVET) comprises the phase from aortic valve opening to aortic valve closure corrected for heart rate. As a surrogate measure for cLVET, the corrected carotid flow time (ccFT) has been proposed in previous research. The aim of this study was to assess the clinical agreement between cLVET and ccFT in a dynamic clinical setting. METHODS: Twenty-five patients with severe aortic valve stenosis (AS) were selected for transcatheter aortic valve replacement (TAVR). The cLVET and ccFT were derived from the left ventricular outflow tract (LVOT) and the common carotid artery (CCA), respectively, using pulsed wave Doppler ultrasound. Bazett's (B) and Wodey's (W) equations were used to calculate cLVET and ccFT. Measurements were performed directly before (T1) and after (T2) TAVR. Correlation, Bland-Altman and concordance analyses were performed. RESULTS: Corrected LVET decreased from T1 to T2 (p < 0.001), with relative reductions of 11% (B) and 9% (W). Corrected carotid flow time decreased (p < 0.001), with relative reductions of 12% (B) and 10% (W). The correlation between cLVET and ccFT was strong for B (ρ = 0.74, p < 0.001) and W (ρ = 0.81, p < 0.001). The bias was -39 ms (B) and -37 ms (W), and the upper and lower levels of agreement were 19 and -98 ms (B) and 5 and -78 ms (W), respectively. Trending ability between cLVET and ccFT was good (concordance 96%) for both B and W. CONCLUSION: In TAVR patients, the clinical agreement between cLVET and ccFT was acceptable, indicating that ccFT could serve as a surrogate measure for cLVET.

Cardiac Health Assessment Using a Wearable Device Before and After Transcatheter Aortic Valve Implantation: Prospective Study.

Background: Due to aging of the population, the prevalence of aortic valve stenosis will increase drastically in upcoming years. Consequently, transcatheter aortic valve implantation (TAVI) procedures will also expand worldwide. Optimal selection of patients who benefit with improved symptoms and prognoses is key, since TAVI is not without its risks. Currently, we are not able to adequately predict functional outcomes after TAVI. Quality of life measurement tools and traditional functional assessment tests do not always agree and can depend on factors unrelated to heart disease. Activity tracking using wearable devices might provide a more comprehensive assessment. Objective: This study aimed to identify objective parameters (eg, change in heart rate) associated with improvement after TAVI for severe aortic stenosis from a wearable device. Methods: In total, 100 patients undergoing routine TAVI wore a Philips Health Watch device for 1 week before and after the procedure. Watch data were analyzed offline-before TAVI for 97 patients and after TAVI for 75 patients. Results: Parameters such as the total number of steps and activity time did not change, in contrast to improvements in the 6-minute walking test (6MWT) and physical limitation domain of the transformed WHOQOL-BREF questionnaire. Conclusions: These findings, in an older TAVI population, show that watch-based parameters, such as the number of steps, do not change after TAVI, unlike traditional 6MWT and QoL assessments. Basic wearable device parameters might be less appropriate for measuring treatment effects from TAVI.

Prehospital risk assessment and direct transfer to a percutaneous coronary intervention centre in suspected acute coronary syndrome.

OBJECTIVE: Prehospital risk stratification and triage are currently not performed in patients suspected of non-ST-segment elevation acute coronary syndrome (NSTE-ACS). This may lead to prolonged time to revascularisation, increased duration of hospital admission and higher healthcare costs. The preHEART score (prehospital history, ECG, age, risk factors and point-of-care troponin score) can be used by emergency medical services (EMS) personnel for prehospital risk stratification and triage decisions in patients with NSTE-ACS. The aim of the current study was to evaluate the effect of prehospital risk stratification and direct transfer to a percutaneous coronary intervention (PCI) centre, based on the preHEART score, on time to final invasive diagnostics or culprit revascularisation. METHODS: Prospective, multicentre, two-cohort study in patients with suspected NSTE-ACS. The first cohort is observational (standard care), while the second (interventional) cohort includes patients who are stratified for direct transfer to either a PCI or a non-PCI centre based on their preHEART score. Risk stratification and triage are performed by EMS personnel. The primary endpoint of the study is time from first medical contact until final invasive diagnostics or revascularisation. Secondary endpoints are time from first medical contact until intracoronary angiography (ICA), duration of hospital admission, number of invasive diagnostics, number of inter-hospital transfers and major adverse cardiac events at 7 and 30 days. RESULTS: A total of 1069 patients were included. In the interventional cohort (n=577), time between final invasive diagnostics or revascularisation (42 (17-101) hours vs 20 (5-44) hours, p<0.001) and length of hospital admission (3 (2-5) days vs 2 (1-4) days, p=0.007) were shorter than in the observational cohort (n=492). In patients with NSTE-ACS in need for ICA or revascularisation, healthcare costs were reduced in the interventional cohort (€5599 (2978-9625) vs €4899 (2278-5947), p=0.02). CONCLUSION: Prehospital risk stratification and direct transfer to a PCI centre, based on the preHEART score, reduces time from first medical contact to final invasive diagnostics and revascularisation, reduces duration of hospital admission and decreases healthcare costs in patients with NSTE-ACS in need for ICA or revascularisation. TRIAL REGISTRATION: NCT05243485.

A randomised trial of selective intracoronary hypothermia during primary PCI.

BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking. AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI. METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months. RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53). CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).

Gender differences in long-term outcome after primary percutaneous intervention for ST-segment elevation myocardial infarction.

BACKGROUND: Previous studies on gender differences in outcome in patients with ST segment elevation myocardial infarction (STEMI) have been performed, but most of those are from before the current era of PCI technique and medical therapy and have a short duration of follow-up. The objective of our study is to assess the influence of gender on long-term outcome in patients with STEMI who underwent primary percutaneous intervention (PCI) between January 2006 and May 2008. METHODS: Two-year follow-up data from 202 female and 668 male patients undergoing primary PCI for STEMI were available from the DEBATER (A Comparison of Drug Eluting and Bare Metal Stents for Primary Percutaneous Coronary Intervention with or without Abciximab in ST-segment elevation Myocardial Infarction: The Eindhoven Reperfusion Study) trial database. The primary endpoint was major adverse cardiac events (MACE), defined as the composite of death, myocardial infarction, and target vessel revascularization. RESULTS: Women were older (64.7 ± 11.7 vs. 59.0 ± 10.7; P < 0.001), and had more often diabetes mellitus (15% vs. 9%; P = 0.01) and hypertension (44% vs. 25%; P < 0.001). At two years, the rate of MACE was significantly higher in women (21% vs. 14%; P = 0.02). The mortality rate in women was 8% versus 2.6% in men (P < 0.001). However, multivariate analysis after adjustment for age and the baseline characteristics hypertension, smoking, diabetes mellitus, stent diameter, and time between onset of symptoms and arrival of the ambulance showed similar MACE and mortality rates in men and women. CONCLUSION: Women have higher rates of both MACE and mortality after primary PCI for STEMI compared to men because of higher age with higher baseline risk profiles.

Neuromodulation in patients with refractory angina pectoris: a review.

The number of patients with coronary artery disease (CAD) who have persisting angina pectoris despite optimal medical treatment known as refractory angina pectoris (RAP) is growing. Current estimates indicate that 5-10% of patients with stable CAD have RAP. In absolute numbers, there are 50 000-100 000 new cases of RAP each year in the USA and 30 000-50 000 new cases each year in Europe. The term RAP was formulated in 2002. RAP is defined as a chronic disease (more than 3 months) characterized by diffuse CAD in the presence of proven ischaemia which is not amendable to a combination of medical therapy, angioplasty, or coronary bypass surgery. There are currently few treatment options for patients with RAP. One such last-resort treatment option is spinal cord stimulation (SCS) with a Class of recommendation IIB, level of evidence B in the 2019 European Society of Cardiology guidelines for the diagnosis and management of chronic coronary syndromes. The aim of this review is to give an overview of neuromodulation as treatment modality for patients with RAP. A comprehensive overview is given on the history, proposed mechanism of action, safety, efficacy, and current use of SCS.

Direct admission versus interhospital transfer for revascularisation in non-ST-segment elevation myocardial infarction.

BACKGROUND: The differences in outcomes and process parameters for NSTEMI patients who are directly admitted to an intervention centre and patients who are first admitted to a general centre are largely unknown. HYPOTHESIS: There are differences in process indicators, but not for clinical outcomes, for NSTEMI who are directly admitted to an intervention centre and patients who are first admitted to a general centre. METHODS: We aim to compare process indicators, costs and clinical outcomes of non-ST-segment elevation myocardial infarction (NSTEMI) patients stratified by center of first presentation and revascularisation strategy. Hospital claim data from patients admitted with a NSTEMI between 2017 and 2019 were used for this study. Included patients were stratified by center of admission (intervention vs. general center) and subdivided by revascularisation strategy (PCI, CABG, or no revascularisation [noRevasc]). The primary outcome was length of hospital stay. Secondary outcomes included: duration between admission and diagnostic angiography and revascularisation, number of intracoronary procedures, clinical outcomes at 30 days (MACE: all-cause mortality, recurrent myocardial infarction and cardiac readmission) and total costs (accumulation of costs for hospital claims and interhospital ambulance rides). RESULTS: A total of 9641 NSTEMI events (9167 unique patients) were analyzed of which 5399 patients (56%) were admitted at an intervention center and 4242 patients to a general center. Duration of hospitalization was significantly shorter at direct presentation at an intervention centre for all study groups (5 days [2-11] vs. 7 days [4-12], p < 0.001). For PCI, direct presentation at an intervention center yielded shorter time to diagnostic angiography (1 day [0-2] vs. 1 day [1-2], p < 0.01) and revascularisation (1 day [0-3] vs. 4 days [1-7], p < 0.001) and less intracoronary procedures per patient (2 [1-2] vs. 2 [2-2], p < 0.001). For CABG, time to revascularisation was shorter (8 days [5-12] vs. 10 days [7-14], p < 0.001). Total costs were significantly lower in case of direct presentation in an intervention center for all treatment groups €10.211 (8750-18.192) versus €13.741 (11.588-19.381), p < 0.001) while MACE was similar 11.8% versus 12.4%, p = 0.344). CONCLUSION: NSTEMI patients who were directly presented to an intervention center account for shorter duration of hospitalization, less time to revascularisation, less interhospital transfers, less intracoronary procedures and lower costs compared to patients who present at a general center.

The Index of Microcirculatory Resistance After Primary PCI: A Pooled Analysis of Individual Patient Data.

BACKGROUND: Despite treatment with primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), the risk of heart failure and late death remains high. Microvascular dysfunction, as assessed by the index of microcirculatory resistance (IMR), after primary PCI for STEMI has been associated with worse outcomes. It is unclear whether IMR after primary PCI predicts cardiac death. OBJECTIVES: The aims of this analysis were: 1) to determine if IMR is an independent predictor of cardiac death; 2) to assess the optimal cutoff value of IMR after STEMI; and 3) to compare IMR with several cardiac magnetic resonance parameters, including infarct size. METHODS: In a collaborative, pooled analysis of individual patient data from 6 cohorts that measured IMR directly after primary PCI, cardiac mortality up to 5 years was estimated using Kaplan-Meier analyses. The primary endpoint was cardiac death using the predefined IMR cutoff value of 40. RESULTS: In total, 1,265 patients were included in this study with a median follow-up of 2.8 years (IQR: 1.2-5.0 years). Cardiac death at 5 years occurred in 2.2% and 4.9% of patients (HR: 2.81; 95% CI: 1.34-5.88; P = 0.006) in the IMR ≤40 and IMR >40 groups, respectively. The composite of cardiac death or hospitalization for heart failure occurred in 4.9% and 8.9% (HR: 1.98; 95% CI: 1.20-3.29; P = 0.008) in the IMR ≤40 and IMR >40 groups, respectively. IMR was an independent predictor of cardiac death, whereas coronary flow reserve was not. The optimal cutoff value of IMR for the prediction of cardiac death in this cohort was 70 (HR: 4.73; 95% CI: 2.27-9.83; P < 0.001). Infarct size was 17.6% ± 13.3% and 23.9% ± 14.6% of the left ventricular mass in the IMR ≤40 and IMR >40 groups, respectively (P < 0.001). Microvascular obstruction and intramyocardial hemorrhage occurred more frequently in the IMR >40 group than in the IMR ≤40 group. CONCLUSIONS: In this large, pooled analysis of individual patient data, IMR measured directly after primary PCI in STEMI was an independent predictor of cardiac death. IMR may be used as a tool to identify patients at the time of primary PCI who are at highest risk for late cardiac mortality and who might benefit most from additional cardioprotective therapies and monitoring.

Single center experience in the treatment of hemodynamically significant diffuse coronary artery disease of the left anterior descending.

INTRODUCTION: To date there are no recommendations on how to treat patients with an FFR positive but diffusely diseased left anterior descending coronary artery (LAD). Benefit of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) is not so evident due to doubts regarding longevity and patency. METHODS: This retrospective single-center study assessed clinical outcomes in patients presenting with symptomatic single vessel coronary artery disease of a diffusely diseased, hemodynamically significant LAD treated by coronary artery bypass grafting (CABG) or optimal medical therapy (OMT) between 2015 and 2020. Primary outcome of this study was the composite endpoint of all-cause mortality, myocardial infarction and repeat revascularization during 2-year follow-up. Secondary endpoints consisted of the individual components of the primary endpoint. Change in angina severity grade based on the Canadian Cardiovascular Society (CCS) class between baseline and 2-year follow-up was assessed. RESULTS: Fifty-nine patients were included of which 25 patients underwent CABG and 34 patients were treated by OMT. There was a statistically significant difference in FFR value at baseline between the treatment groups (CABG 0.70 ± 0.04; OMT 0.75 ± 0.04; p < 0.001). After 2-year follow-up, there were no statistically significant differences with regard to the primary endpoint (CABG 16% (n = 4); OMT 17.6% (n = 6); p = 1.00) and secondary endpoints between the groups over 2-year follow-up. CONCLUSION: In patients with hemodynamically significant diffuse single vessel coronary artery disease of the left anterior descending, there was no difference between OMT and CABG in terms of mortality, myocardial infarction, revascularization and symptom reduction after two years of follow-up.

Transient midventricular ballooning syndrome. an atypical presentation of takotsubo cardiomyopathy.

A 72-year-old woman without cardiovascular history presented with acute substernal chest pain and dyspnoea. The electrocardiogram was normal, but the blood test analyses showed an elevated troponin T level. Emergency coronary angiography revealed normal epicardial coronary arteries, but the left ventriculogram demonstrated midventricular dilatation and akinesis with well-preserved contractility of the apex and base. The patient was diagnosed as having an atypical presentation of takotsubo cardiomyopathy. She was treated with a beta blocker and an ACE inhibitor and recovered well. A follow-up echocardiogram at 2 months showed normalization of the wall motion abnormality.

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.

Efficacy and Safety of Stents in ST-Segment Elevation Myocardial Infarction.

BACKGROUND: To date, no specific drug-eluting stent (DES) has fully proven its superiority over others in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention. OBJECTIVES: The purpose of this study was to compare the safety and efficacy of coronary artery stents in STEMI patients in a patient-level network meta-analysis. METHODS: Eligible studies were dedicated randomized controlled trials comparing different stents in STEMI patients undergoing percutaneous coronary intervention with at least 12 months of clinical follow-up. Of 19 studies identified from the published data, individual patient data were collected in 15 studies with 10,979 patients representing 87.7% of patients in the overall network of evidence. The primary endpoint was the composite of cardiac death, reinfarction, or target lesion revascularization. RESULTS: Overall, 8,487 (77.3%) of 10,979 STEMI patients were male and the mean age was 60.7 years. At a median follow-up of 3 years, compared with bare-metal stents (BMS), patients treated with paclitaxel-, sirolimus-, everolimus-, or biolimus-eluting stents had a significantly lower risk of the primary endpoint (adjusted hazard ratios [HRs]: 0.74 [95% confidence interval (CI): 0.63 to 0.88], 0.65 [95% CI: 0.49 to 0.85], 0.70 [95% CI: 0.53 to 0.91], and 0.66 [95% CI: 0.49 to 0.88], respectively). The risk of primary endpoint was not different between patients treated with BMS and zotarolimus-eluting stents (adjusted HR: 0.83 [95% CI: 0.51 to 1.38]). Among patients treated with DES, no significant difference in the risk of the primary outcome was demonstrated. Treatment with second-generation DES was associated with significantly lower risk of definite or probable stent thrombosis compared with BMS (adjusted HR: 0.61 [95% CI: 0.42 to 0.89]) and first-generation DES (adjusted HR: 0.56 [95% CI: 0.36 to 0.88]). CONCLUSIONS: In STEMI patients, DES were superior to BMS with respect to long-term efficacy. No difference in long-term efficacy and safety was observed among specific DES. Second-generation were superior to first-generation DES in reducing stent thrombosis. (Clinical Outcomes After Primary Percutaneous Coronary Intervention [PCI] Using Contemporary Drug-Eluting Stent [DES]: Evidence From the Individual Patient Data Network Meta-Analysis; CRD42018104053).