Real-world long-term survival after non-emergent percutaneous coronary intervention to unprotected left main coronary artery - From the Melbourne Interventional Group (MIG) registry.

BACKGROUND: Current evidence suggests that percutaneous coronary intervention for unprotected left main coronary artery disease (LMPCI) in selected patients is a safe alternative to coronary artery bypass grafting. However, real-world long-term survival data is limited. METHODS: We analyzed 24,644 patients from the MIG (Melbourne Interventional Group) registry between 2005 and 2020. We compared baseline clinical and procedural characteristics, in-hospital and 30-day outcomes, and long-term survival between unprotected LMPCI and non-LMPCI among patients without ST-segment elevation myocardial infarction, cardiogenic shock, or cardiac arrest. RESULTS: Unprotected LMPCI patients (n = 185) were significantly older (mean age 72.0 vs. 64.6 years, p < 0.001), had higher prevalence of impaired ejection fraction (EF <50 %; 27.3 % vs. 14.9 %, p < 0.001) and lower estimated glomerular filtration rate < 60 ml/min/1.73m2 (40.9 % vs. 21.5 %, p < 0.001), and had greater use of intravascular ultrasound (21 % vs. 1 %, p < 0.001) and drug-eluting stents (p < 0.001). LMPCI was associated with longer hospital stay (4 days vs. 2 days, p < 0.001). There was no significant difference in other in-hospital outcomes, 30-day mortality (0.6 % vs. 0.6 %, p = 0.90), and major adverse cardiac events (1.7 % vs. 3 %, p = 0.28). Although the unadjusted Kaplan-Meier survival to 8 years was significantly less with LMPCI compared to non-LMPCI (p < 0.01), LMPCI was not a predictor of long-term survival up to 8 years after Cox regression analysis (HR 0.67, 95 % CI 0.40-1.13, p = 0.13). CONCLUSION: In this study, non-emergent unprotected LMPCI was uncommonly performed, and IVUS was underutilized. Despite greater co-morbidities, LMPCI patients had comparable 30-day outcomes to non-LMPCI, and LMPCI was not an independent predictor of long-term mortality.

Coronary Angiography Complicated by Acute Ischaemic Stroke and the Use of Thrombolysis: a Cardiology Perspective and Narrative Review of Current Literature.

PURPOSE OF REVIEW: Coronary angiography-associated acute ischaemic stroke (CAAIS) is an uncommon event but is associated with significant mortality and morbidity. The incidence of CAAIS has increased with a rise in the volume of coronary angiography (CA) and percutaneous coronary intervention (PCI) performed. Intravenous thrombolysis (IVT) is utilized in the general management of acute ischaemic stroke; however, it is associated with a higher risk of intracranial hemorrhage (ICH). As CA or PCI is performed more often in an aging population or high-risk patients that also carry an increased risk of ICH, it is vital to minimize additional complications from the treatment of CAAIS. This article aims to review the pathophysiological mechanisms for CAAIS, clarify the current evidence regarding IVT use in this setting, and thus assist cardiologists in the management of CAAIS. RECENT FINDINGS: The pathophysiology for CAAIS may be different from acute ischaemic stroke in the general population. Embolic phenomena from dislodgement of calcium or other debris during manipulation of instrumentation during CA or PCI are likely mechanisms. This may contribute to altered thrombus composition, which affects the efficacy of IVT as suggested in recent studies. Furthermore, IVT in the management of CAAIS has not been evaluated specifically. The utilization of IVT should be carefully considered in CAAIS given a paucity of evidence demonstrating safety and efficacy in this setting. A multidisciplinary pathway that emphasizes the involvement of cardiologists in the treatment decision-making process would aid in thoughtful risk-benefit evaluation for IVT use in CAAIS and reduce adverse patient outcomes. Future studies to assess the impact of this pathway on CAAIS outcomes would be beneficial.

Natural History and Clinical Outcomes After ST-Segment Elevation Myocardial Infarction Without Stent Insertion.

After restoration of coronary perfusion in patients presenting with ST-segment elevation myocardial infarction (STEMI), discrete severe stenotic coronary lesions are not always apparent. There remains ambiguity whether drug-eluting stent (DES) insertion or initial medical management is best practice. We sought to assess short-term clinical outcomes in patients presenting with STEMI without initial stent insertion. Patients who underwent percutaneous coronary intervention for STEMI between 2014 and 2020 were prospectively enrolled and assessed for inclusion. Patients presenting with in-stent restenosis or stent thrombosis, or who did not survive to hospital discharge were excluded. Of 13,871 patients presenting, 456 (3.3%) were treated without initial stenting. These patients were older than those treated with DES (66.1 ± 13.6 vs 62.3 ± 12.4 years, p <0.001), had higher rates of diabetes (23.5% vs 16.0%, p <0.001) and previous revascularization with either percutaneous coronary intervention (14.0% vs 7.3%, p <0.001) or coronary artery bypass graft (3.5% vs 1.8%, p = 0.008). Thirty-day mortality was elevated in patients treated without stenting compared to those receiving DES (4.2% vs 0.9%, p <0.001), as were rates of myocardial infarction (1.3% vs 0.5%, p = 0.026) and major adverse cardiac events (10.5% vs 2.4%, p <0.001). After propensity matching, a trend toward increased mortality remained (4.2% vs 2.0%, p = 0.055). In conclusion, a no-stenting initial strategy, compared with DES insertion, is associated with increased 30-day mortality in those presenting with STEMI without severe stenosis. These data suggest when appropriate, current-generation DES insertion should be undertaken.

Characteristics of Radial Artery Coronary Bypass Graft Failure and Outcomes Following Subsequent Percutaneous Coronary Intervention.

BACKGROUND: When patients with prior coronary artery bypass grafting (CABG) undergo percutaneous coronary intervention (PCI), targeting the native vessel is preferred. Studies informing such recommendations are based predominantly on saphenous vein graft (SVG) PCI. There are few data regarding arterial graft intervention, particularly to a radial artery (RA) graft. OBJECTIVES: The aim of this study was to report the characteristics of arterial graft stenoses and evaluate the feasibility of RA PCI. METHODS: This study included 2,780 consecutive patients with prior CABG undergoing PCI between 2005 and 2018 who were prospectively enrolled in the MIG (Melbourne Interventional Group) registry. Data were stratified by PCI target vessel. RA graft PCI was compared with both native vessel (native PCI) and SVG PCI. Internal mammary graft PCI data were reported. The primary outcome was 3-year mortality. RESULTS: Overall, 1,928 patients (69.4%) underwent native PCI, 716 (25.6%) SVG PCI, 86 (3.1%) RA PCI, and 50 (1.8%) internal mammary graft PCI. Compared with SVG PCI, the RA PCI cohort presented earlier after CABG, less frequently had acute coronary syndrome, and more commonly had ostial or distal anastomosis intervention (P < 0.005 for all). Compared with patients who underwent native PCI, those who underwent RA PCI were more likely to have diabetes and peripheral vascular disease (P < 0.001 for both) and to present with non-ST-segment elevation myocardial infarction (P = 0.010). The RA PCI group had no perforations or in-hospital myocardial infarctions, though no significant difference was found in periprocedural outcomes compared with either native or SVG PCI. No differences were found between RA PCI and either native or SVG PCI in 30-day outcomes or 3-year mortality. CONCLUSIONS: Presenting and lesion characteristics differed between patients undergoing arterial compared with SVG PCI, implying a varied pathogenesis of graft stenosis. RA PCI appears feasible, safe, and where anatomically suitable, may be a viable alternative to native PCI.

Contemporary percutaneous management of coronary calcification: current status and future directions.

Severe coronary artery calcification is one of the greatest challenges in attaining success in percutaneous coronary intervention, limiting acute and long-term results. In many cases, plaque preparation is a critical prerequisite for delivery of devices across calcific stenoses and also to achieve adequate luminal dimensions. Recent advances in intracoronary imaging and adjunctive technologies now allow the operator to select the most appropriate strategy in each individual case. In this review, we will revisit the distinct advantages of a complete assessment of coronary artery calcification with imaging and application of appropriate and contemporary plaque modification technologies in achieving durable results in this complex lesion subset.

Intravascular lithotripsy in the treatment of coronary artery calcification in a high-risk real world population.

BACKGROUND: The DISRUPT-CAD study series demonstrated feasibility and safety of intravascular lithotripsy (IVL) in selected patients, but applicability across a broad range of clinical scenarios remains unclear. AIMS: This study aims to evaluate the procedural and clinical outcomes of IVL in a high-risk real-world cohort, compared to a regulatory approval cohort. METHODS: Consecutive patients treated with IVL and percutaneous coronary intervention at our center from May 2016 to April 2020 were included. Comparison was made between those enrolled in the DISRUPT-CAD series of studies to those with calcified lesions but an exclusion criteria. RESULTS: Among 177 patients treated with IVL, 142 were excluded from regulatory trials due to acute coronary syndrome presentation (47.2%), left ventricular ejection fraction <40% (22.5%), chronic renal failure (12.0%), or use of mechanical circulatory support (8.5%). This clinical cohort had a higher SYNTAX score (22.6 ± 12.1 vs. 17.4 ± 9.9, p = 0.019), and more treated ACC/AHA C lesions (56.3% vs. 37.1%, p = 0.042). Rates of device success (93.7% vs. 100.0%, p = 0.208), procedural success (96.5% vs. 100.0%, p = 0.585), and minimal lumen area gain (221.2 ± 93.7% vs. 198.6 ± 152.0%, p = 0.807) were similar in both groups. The DISRUPT-CAD cohort had no in-hospital mortality, 30-day major adverse cardiac events (MACE), or 30-day target vessel revascularization (TVR). The clinical cohort had an in-hospital mortality of 4.2%, 30-day MACE of 7.8%, and 30-day TVR of 1.5%. There was no difference in 12-month TVR (2.9% vs. 2.2%; p = 0.825). Twelve-month MACE was higher in the clinical cohort (21.1% vs. 8.6%, p = 0.03). CONCLUSION: IVL use remains associated with high clinical efficacy, procedural success, and low complication rates in a real-world population previously excluded from regulatory approving trials.

Reperfusion Times and Outcomes in Patients With ST-Elevation Myocardial Infarction Presenting Without Pre-Hospital Notification.

BACKGROUND: Primary percutaneous coronary intervention (PCI) for patients with ST-elevation myocardial infarction (STEMI) is recommended within 90 min of first medical contact. Those without pre-hospital notification (PN) are less likely to meet reperfusion targets and are an understudied subset of the STEMI population. METHODS: An observational cohort study from a multicentre PCI registry of consecutive patients undergoing primary PCI for STEMI between 2012 and 2017. Exclusion criteria included out-of-hospital cardiac arrest, prior thrombolysis, symptom onset >12 h prior, and cardiogenic shock. RESULTS: 2519 patients were included: 1392 (55.3%) without PN (no-PN group) and 1127 (44.7%) with PN (PN group). Those without PN had longer median DTBT (78 min vs 51 min, p < 0.001) and STBT (206 min vs 161 min, p < 0.001), with only 55% meeting DTBT targets out-of-hours in the no-PN group. No-PN patients had lower rates of AHA/ACC type B2/C lesions, GP IIb/IIIa use, aspiration thrombectomy and had smaller stent diameter (all p ≤ 0.003), suggesting smaller areas of ischemic myocardium. There were no significant differences in 30-day MACE (no-PN 5.6% vs PN 6.5%, p = 0.36) or long-term National Death Index linked mortality (no-PN 6.2% vs PN 7.9%, p = 0.09). Lack of PN did not independently predict long-term mortality. CONCLUSION: Despite comparably excellent outcomes overall, those without PN had longer ischemic times and were less likely to meet DTBT targets, especially after hours. Ischemic times may be a better evaluation of PN networks than hard clinical outcomes, and efficient systems of care tailored to the individual health service are essential to ensure timely reperfusion of patients with STEMI.

Intravascular lithotripsy for treatment of calcific coronary lesions in ST elevation myocardial infarction.

AIMS: To describe the utility and safety of intravascular lithotripsy (IVL) in the setting of primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). METHODS AND RESULTS: We performed a retrospective analysis, across six UK sites of all patients in whom IVL was used for coronary calcium modification of the culprit lesion during primary PCI for STEMI. The 72 patients were included. IVL was used in de-novo culprit lesions in 57 (79%) of cases and culprit in-stent restenoses in 11 (15%) of cases. In four cases (6%) it was used in a newly deployed stent when this was under-expanded due to inadequate calcium modification. Of the 30 cases in which intracoronary imaging was available for stent analysis, the average stent expansion was 104%. Intra-procedural stent thrombosis occurred in one case (1%), and no-reflow in three cases (4%). The 30 day MACE rates were 18%. CONCLUSION: IVL appears to be feasible and safe for use in the treatment of calcific coronary artery disease in the setting of STEMI.

Trends and Real-World Safety of Patients Undergoing Percutaneous Coronary Intervention for Symptomatic Stable Ischaemic Heart Disease in Australia.

BACKGROUND: Percutaneous coronary intervention (PCI) in stable ischaemic heart disease (SIHD) has not been shown to improve prognosis but can alleviate symptoms and improve quality of life. Appropriately selected patients with symptoms refractory to medical therapy therefore stand to benefit, provided safety is proven. METHODS: Consecutive patients undergoing PCI for SIHD between 2005-2018 in a prospective registry were included. Yearly comparisons evaluated trends, and a sub-analysis was performed comparing proximal left anterior descending artery (prox-LAD) to other-than-proximal LAD (non-pLAD) PCI. Outcomes included peri-procedural characteristics, in-hospital and 30-day event rates including MACE, and 5-year National Death Index (NDI) linked mortality. RESULTS: There were 9,421 procedures included. Over time, patients were increasingly co-morbid and had higher rates of AHA/ACC class B2/C lesions, ostial stenoses, bifurcation lesions, and chronic total occlusions (all p-for-trend ≤0.001). Over 14 years, major bleeding reduced (1.05% in 2005/06 vs 0.29% in 2017/18, p-for-trend <0.001), while other in-hospital and 30-day event rates were stably low. There were only seven (0.07%) in hospital deaths and 5-year mortality was 10.3%. No differences were found in outcomes between patients who underwent prox-LAD compared to non-pLAD PCI. Major independent predictors of NDI linked all-cause mortality included an eGFR <30 mL/min/1.73 m2 (HR 4.06, 95% CI 3.26-5.06), chronic obstructive pulmonary disease (COPD) (HR 2.25, 95% CI 1.89-2.67) and LVEF <30% (HR 2.13, 95% CI 1.57-2.89). CONCLUSIONS: Although patient and procedural complexity increased over time, a high degree of procedural success and safety was maintained, including in those undergoing prox-LAD PCI. These real-world data can enhance shared decision making discussions regarding whether PCI should be pursued in patients with symptomatic SIHD refractory to medical therapy.

Safety and Long-Term Clinical Outcomes of Fractional Flow Reserve Guided Coronary Revascularisation.

BACKGROUND: Increasingly, fractional flow reserve (FFR) is employed to assess coronary artery stenoses although there is limited real world long-term outcome data with a recent report questioning its safety. This study aimed to assess the in-hospital complications and clinical outcomes up to 10 years after FFR-guided revascularisation at a tertiary Australian hospital. METHODS: The cohort comprised 274 consecutive patients undergoing FFR from 2010 to 2015 with follow-up to 2020. In-hospital complications and long-term outcomes were compared between patients with FFR≤0.80 and FFR>0.80. Major adverse cardiac events (MACE) comprised cardiac death, myocardial infarction (MI) and target vessel revascularisation (TVR). RESULTS: The FFR was ≤0.80 in 166 and >0.80 in 108 patients. Stable coronary disease was present in 95%. Revascularisation was undertaken in 86.7% of the FFR≤0.80 group and in 2.8% of the group with an FFR>0.80. In-hospital adverse events were 3.3% with no pressure wire-related coronary dissection, stroke or death. At median follow-up of 5 years, patients with FFR≤0.80 and FFR>0.80 had a similar rate of cardiac death (2.6% versus 5.0%, p=0.335) and MI (2.6% versus 6.9%, p=0.154). In the FFR>0.80 group, MACE (17.8% v 7.9%; p=0.018) and TVR (12.9% v 5.3%; p=0.033) were significantly higher. CONCLUSION: This observational study highlights the safety and long-term effectiveness of FFR-guided coronary revascularisation in patients with predominantly stable disease.

Management of stent underexpansion using intravascular lithotripsy-Defining the utility of a novel device.

OBJECTIVES: This study aimed to present a case series of patient treated for stent underexpansion resistant to conventional treatment with intravascular lithotripsy (IVL). BACKGROUND: Stent underexpansion is a powerful predictor of long-term stent patency and correlates with unfavorable clinical outcomes. This case series demonstrates the utility of IVL in managing stent underexpansion resistant to conventional treatment. METHODS: We describe a case series of patients with stent underexpansion due to calcific coronary artery disease treated with IVL. Stent underexpansion was identified as an inability to adequately expand stents with conventional treatment. Only cases that failed to achieve adequate expansion with high-pressure noncompliant balloon inflation were included. RESULTS: Thirteen patients from six institutions have been included in this case series. The average age was 70.25 years with 76.9% of male patients. The average pre-IVL minimal stent area (MSA) was 2.71 mm2 , which improved to 6.44 mm2 post-IVL treatment, representing an average MSA gain of 238%. There were no procedural, peri-procedural, or 30-day major adverse cardiac and cerebrovascular event. CONCLUSION: This case series demonstrates that IVL is a feasible, safe alternative for the management of stent underexpansion due to calcific coronary disease.

Adjunctive Rotational Atherectomy and Intravascular Lithotripsy for Heavily Calcified Left Main Disease Via Radial Access.

Coronary angiography demonstrated severe distal left main disease in a patient with heavy concentric calcification extending into the left anterior descending and left circumflex arteries. Rotational atherectomy and lithotripsy were used to debulk plaque so that stenting could be performed.

Long-term outcomes following percutaneous coronary intervention to an unprotected left main coronary artery in cardiogenic shock.

BACKGROUND: In cardiogenic shock with severe left main coronary artery stenosis (LM), limited information exists on short and longer-term outcomes. We sought to determine the outcomes of unprotected LM PCI in cardiogenic shock. METHODS: Excluding patients with previous CABG, consecutive patients undergoing PCI in cardiogenic shock from the Melbourne Intervention Group registry between 2005 and 2013 were analysed. Those post LM PCI were compared to those post non-LM PCI. Patient and procedural data were collected with 30-day and 12-month follow-up. Australian National Death Index linkage was performed for long-term mortality analysis. RESULTS: After excluding previous CABG, 18,069 procedures were performed during 1st January 2005 to 30th November 2013, 601 procedures in the setting of cardiogenic shock. Of these, 45 were performed to an isolated LM and 556 to a non-LM. Those with LM PCI were older and more likely to have a baseline left ventricular ejection fraction (LVEF) of <45%. The in-hospital, 30-day, 12-month and long-term mortality to 9 years in cardiogenic shock after LM PCI was 64.4%, 66.7%, 73.3% and 80.0% compared to 36.5%, 36.9%, 40.5% and 46.0%, after non-LM PCI (p < 0.001). On multivariate analysis, LM PCI was a significant independent predictor of long-term mortality (HR1.59, 95%CI 1.00-2.53, p = 0.048). Landmark analysis of survivors to discharge found the long-term mortality of LM PCI approaches 60% compared to 27% for those with non-LM PCI (p = 0.003). CONCLUSION: Long-term outcomes after PCI to LM in cardiogenic shock are poor, with much of the excess in mortality occurring early. However, reasonable long-term survival was found beyond the initial high-risk period.

Angiography-derived functional assessment of non-culprit coronary stenoses in primary percutaneous coronary intervention.

AIMS: Functional assessment of non-culprit lesions (NCL) in patients presenting with ST-elevation myocardial infarction (STEMI) and multivessel disease constitutes an unmet need. This study aimed to evaluate the diagnostic accuracy of quantitative flow ratio (QFR) in the functional assessment of NCL during the acute phase of STEMI. METHODS AND RESULTS: This was a retrospective, observational, multicentre study including patients with STEMI and staged fractional flow reserve (FFR) assessment of NCL. QFR in NCL was calculated from the coronary angiogram acquired during primary PCI in a blinded fashion with respect to FFR. The diagnostic value of QFR in the STEMI population was compared with a propensity score-matched population of stable angina patients. Eighty-two patients (91 NCL) were included. Target lesions were of both angiographic and functional (mean FFR 0.82±0.09) intermediate severity. The diagnostic performance of QFR was high (AUC 0.91 [95% CI: 0.85-0.97]) and similar to that observed in the matched control population (AUC 0.91 vs 0.94, p=0.5). The diagnostic accuracy of QFR was very high (>95%) in those vessels (61.5%) with QFR values out of a ROC-defined "grey zone" (0.75-0.85). A hybrid FFR/QFR approach (FFR only when QFR is in the grey zone) would adequately classify 96.7% of NCL, avoiding 58.5% of repeat diagnostic procedures. CONCLUSIONS: QFR has a good diagnostic accuracy in assessing the functional relevance of NCL during primary PCI, similar to the accuracy observed in stable patients.

A contemporary and complete treatment solution for a high-risk patient with critical aortic stenosis, left ventricular thrombus, severe left ventricular dysfunction, and calcified left main stem disease.

The combination of severe coronary disease, significant valvular dysfunction and impaired ventricular function pose patients at a very high procedural risk. In addition, the presence of left ventricular thrombus can complicate ventricular instrumentation increasing embolic risk. Contemporary techniques and devices have now become available to overcome these challenges to reduce risk and allow safer, more efficient procedures. We describe the feasibility of using Impella CP™ with cerebral protection to facilitate complete revascularisation and percutaneous valve replacement in a patient with critical aortic stenosis, severe left ventricular (LV) impairment, LV thrombus and a calcified left main stem disease.