Robert Morley

Primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: changing patterns of vascular access, radial versus femoral artery

Objective: To examine the safety and efficacy of emergency transradial primary percutaneous coronary intervention for ST-elevation myocardial infarction. Design: Single-centre observational study with prospective data collection. Setting: A regional cardiac centre, United Kingdom. Patients: 1051 consecutive patients admitted with ST-elevation myocardial infarction, without cardiogenic shock, between November 2004 and October 2008. Interventions: Percutaneous coronary interventions by radial and femoral access Main outcome measures: The primary outcome measures were procedural success, major vascular complication and failed initial access strategy. Secondary outcomes were in-hospital mortality and major adverse cardiac and cerebrovascular events, needle-to-balloon times, contrast volume used, radiation dose absorbed and time to discharge. Multiple regression analysis was used to adjust for potential differences between the groups. Results: 571 patients underwent radial access and 480 femoral. A variable preference for radial access was observed among the lead operators (between 21% and 90%). Procedural success was similar between the radial and femoral groups, but major vascular complications were more frequent at the site of femoral access (0% radial versus 1.9% femoral, p = 0.001). Failure of the initial access strategy was more frequent in the radial group (7.7% versus 0.6%, p<0.001). Adjustment for other procedural and clinical predictors did not alter these findings. Needle-to-balloon time, as a measure of procedural efficiency, was equal for radial and femoral groups. Conclusions: In the setting of acute ST-elevation myocardial infarction without cardiogenic shock, transradial primary angioplasty is safe, with comparable outcomes to a femoral approach and a lower risk of vascular complications.

Cumulative funnel plots for the early detection of interoperator variation: retrospective database analysis of observed versus predicted results of percutaneous coronary intervention

Objective To use funnel plots and cumulative funnel plots to compare in-hospital outcome data for operators undertaking percutaneous coronary interventions with predicted results derived from a validated risk score to allow for early detection of variation in performance. Design Analysis of prospectively collected data. Setting Tertiary centre NHS hospital in the north east of England. Participants Five cardiologists carrying out percutaneous coronary interventions between January 2003 and December 2006. Main outcome measures In-hospital major adverse cardiovascular and cerebrovascular events (in-hospital death, Q wave myocardial infarction, emergency coronary artery bypass graft surgery, and cerebrovascular accident) analysed against the logistic north west quality improvement programme predicted risk, for each operator. Results are displayed as funnel plots summarising overall performance for each operator and cumulative funnel plots for an individual operator’s performance on a case series basis. Results The funnel plots for 5198 patients undergoing percutaneous coronary interventions showed an average observed rate for major adverse cardiovascular and cerebrovascular events of 1.96% overall. This was below the predicted risk of 2.06% by the logistic north west quality improvement programme risk score. Rates of in-hospital major adverse cardiovascular and cerebrovascular events for all operators were within the 3σ upper control limit of 2.75% and 2σ upper warning limit of 2.49%. Conclusion The overall in-hospital major adverse cardiovascular and cerebrovascular events rates were under the predicted event rate. In-hospital rates after percutaneous coronary intervention procedure can be monitored successfully using funnel and cumulative funnel plots with 3σ control limits to display and publish each operator’s outcomes. The upper warning limit (2σ control limit) could be used for internal monitoring. The main advantage of these charts is their transparency, as they show observed and predicted events separately. By this approach individual operators can monitor their own performance, using the predicted risk for their patients but in a way that is compatible with benchmarking to colleagues, encapsulated by the funnel plot. This methodology is applicable regardless of variations in individual operator case volume and case mix.

Secondary prevention following coronary artery bypass grafting has improved but remains sub-optimal: the need for targeted follow-up

A focused review of secondary preventive medication following revascularisation provides an opportunity to ensure optimal use of these agents. A retrospective analysis of our in-house cardiothoracic surgical database was performed to identify patients undergoing non-emergency, elective surgical revascularisation discharged on four secondary preventive medications: aspirin; beta-blockers; ACE-inhibitors and statins. Of 2749 patients studied, 2302 underwent isolated coronary artery bypass grafting (CABG), mean age 65.5 years (S.D. 9.15). Overall, 2536 (92%) patients were prescribed aspirin. Beta-blockers were prescribed in 2171 (79%) patients overall, in 1096/1360 (81%) of patients with a history of myocardial infarction and in 465/619 (75%) of patients with left ventricular systolic dysfunction (LVSD). Overall, 1518 (55%) patients were prescribed an ACE-inhibitor and 179 (6.5%) an angiotensin receptor blocker (ARB); one of these agents was prescribed in 446/619 (72%) patients with LVSD and 915/1360 (67%) patients with a history of previous myocardial infarction. Overall, 2518 (92%) patients were prescribed a statin. Secondary preventive therapies are prescribed more commonly on discharge after CABG than in previous studies, but there is a continuing under-utilisation of ACE-inhibitors. To maximise the potential benefits of these agents, further study is required to understand why they are not prescribed.

Funnel plots for comparing performance of PCI performing hospitals and cardiologists: demonstration of utility using the New York hospital mortality data.

The New York State Department of Health collects and reports outcome data on the hospitals and cardiologists who perform percutaneous coronary intervention (PCI) to allow them to examine their quality of care. Results are provided in tabular form. However funnel plots are the display method of choice for comparison of institutions and operators, using the principles of statistical process control (SPC). We aimed to demonstrate that funnel plots, which aid a meaningful interpretation of the results, can be derived from the New York PCI dataset.

External Validation of Established Risk Adjustment Models for Procedural Complications after Percutaneous Coronary Intervention

Background: Workable risk models for patients undergoing percutaneous coronary intervention (PCI) are needed urgently. Objective: To validate two proposed risk adjustment models (Mayo Clinic Risk Score (MC), USA and North West Quality Improvement Programme (NWQIP), UK models) for in-hospital PCI complications on an independent dataset of relatively high risk patients undergoing PCI. Setting: Tertiary centre in northern England. Methods: Between September 2002 and August 2006, 5034 consecutive PCI procedures (validation set) were performed on a patient group characterised by a high incidence of acute myocardial infarction (MI; 16.1%) and cardiogenic shock (1.7%). Two external models—the NWQIP model and the MC model—were externally validated. Main outcome measure: Major adverse cardiovascular and cerebrovascular events: in-hospital mortality, Q-wave MI, emergency coronary artery bypass grafting and cerebrovascular accidents. Results: An overall in-hospital complication rate of 2% was observed. Multivariate regression analysis identified risk factors for in-hospital complications that were similar to the risk factors identified by the two external models. When fitted to the dataset, both external models had an area under the receiver operating characteristic curve ⩾0.85 (c index (95% CI), NWQIP 0.86 (0.82 to 0.9); MC 0.87(0.84 to 0.9)), indicating overall excellent model discrimination and calibration (Hosmer–Lemeshow test, p>0.05). The NWQIP model was accurate in predicting in-hospital complications in different patient subgroups. Conclusions: Both models were externally validated. Both predictive models yield comparable results that provide excellent model discrimination and calibration when applied to patient groups in a different geographic population other than that in which the original model was developed.

The SSTARS (STeroids and Stents Against Re-Stenosis) Trial: Different stent alloys and the use of peri-procedural oral corticosteroids to prevent in-segment restenosis after percutaneous coronary intervention

BACKGROUND Stent design and technological modifications to allow for anti-proliferative drug elution influence restenosis rates following percutaneous coronary intervention (PCI). We aimed to investigate whether peri-procedural administration of corticosteroids or the use of thinner strut cobalt alloy stents would reduce rates of binary angiographic restenosis (BAR) after PCI. METHODS This was a two centre, mixed single and double blinded, randomised controlled trial using a factorial design. We compared (a) the use of prednisolone to placebo, starting at least six hours pre-PCI and continued for 28days post-PCI, and (b) cobalt chromium (CoCr) to stainless steel (SS) alloy stents, in patients admitted for PCI. The primary end-point was BAR at six months. RESULTS 315 patients (359 lesions) were randomly assigned to either placebo (n=145) or prednisolone (n=170) and SS (n=160) or CoCr (n=160). The majority (58%) presented with an ACS, 11% had diabetes and 287 (91%) completed angiographic follow up. BAR occurred in 26 cases in the placebo group (19.7%) versus 31 cases in the prednisolone group (20.0%) respectively, p=1.00. For the comparison between SS and CoCr stents, BAR occurred in 32 patients (21.6%) versus 25 patients (18.0%) respectively, p=0.46. CONCLUSION Our study showed that treating patients with a moderately high dose of prednisolone for 28days following PCI with BMS did not reduce the incidence of BAR. In addition, we showed no significant reduction in 6month restenosis rates with stents composed of CoCr alloy compared to SS (http://www.isrctn.com/ISRCTN05886349).

27 Use of rotational atherectomy in primary pci for st-elevation myocardial infarction- a single centre 10-year experience

Introduction Rotational atherectomy (RA) during primary PCI (PPCI) for STEMI is relatively contraindicated because of the perceived increased risk of no-reflow. However, RA PPCI may sometimes be required to restore flow in heavily calcified coronary arteries. Previously only very limited observational data has described the use of RA in PPCI. Aim We report the clinical and procedural characteristics, and in hospital outcomes, of 21 patients who underwent RA PPCI at our centre between 2006 and 2016, Methods A retrospective review of the PCI database and medical records. Results 21 patients (age 78(10) years (mean (SD)), 12 men) underwent RA during PPCI (0.4% of all PPCI). 3 patients had cardiogenic shock at presentation and 2 had out of hospital cardiac arrest. Hypertension (n=19), smoking history (n=18), hypercholesterolemia (n=16), diabetes (n=6) and chronic kidney disease (n=6 with eGFR<60) were frequently present. Aspirin was given to 20/21 patients and clopidogrel, ticagrelor and prasugrel to 10, 9 and 3 patients respectively. Heparin was used in all patients, glycoprotein (GP) IIBIIIA inhibitor in 10 and bivalirudin in 2. Radial access was used in 14 and femoral in 7. Initial TIMI flow grade was 0, 1, 2 and 3 in 11, 2, 1 and 7 patients respectively. The target vessel was the RCA in 14, Cx in 4, LMS in 2 and LAD in 1. All were severely calcified with visible thrombus in 13/21. The lesion length was 36(19) mm (range 12–72 mm). The vessel diameter was 2.5–2.99 mm in 5, 3–3.49 mm in 10 and 3.5–4.0 mm in 6. RA was used because of anticipated difficulty with conventional PCI in 7/21 and uncrossable/unexpandable lesions in 14/21. The number of burrs used was 1.33 (0.48) and the final burr was 1.25, 1.5, 1.75 and 2 mm in 4, 11, 4 and 1 patient respectively. The burr-to-artery ratio was <0.4 in 5 and 0.4–0.6 in 16. The final procedure was DES in 17, BMS in 3 and POBA followed by CABG in 1. A temporary pacemaker was used in 3 cases and intra-aortic balloon pump in 3 cases. There were no perforations, no tamponade and no vascular complications. The median(range) pain-to-PCI time was 180 min (114–544); door-to-PCI time 49 min (21–186, 14 patients <60 min) and procedure time was 119 min (66-175). Procedural difficulty caused door-to-PCI>60 min in 5/7 patients while medical/logistic reasons contributed in the other 2. 1 patient underwent CT scanning prior to PCI; 1 underwent an urgent MDT discussion before PCI. Final flow was TIMI 3 in 19/21 and TIMI 2 in 2/21 cases. The procedure was complicated by 1 event of distal embolization. There was 1 event of peri-procedural cerebral infarction. 20/21 patients survived to hospital discharge. Conclusions Our study suggests that RA PPCI can be performed safely in a small group of predominantly elderly, complex patients in whom conventional techniques are inadequate or unsuccessful. It is associated with a relatively long procedure time but we did not experience a marked increase in no-reflow.

65 Proximal Lad PCI - Single Centre Long Term Outcomes 2003–2013

The 2010 ESC guidelines on myocardial revascularisation state that for patients with significant disease in the proximal LAD (pLAD), CABG is the preferred revascularisation strategy (class I, evidence Level A) and that PCI is less strongly supported (class IIa, evidence level B). The 2011 ACC/AHA guideline for PCI does not differentiate between modes of revascularisation for pLAD disease. We have analysed all PCI procedures performed at this institution between January 2003 and January 2013 with reference to involvement of the pLAD and long term outcome. In total 14,935 PCI procedures were undertaken. We excluded 4,080 emergency PCIs for STEMI. We present data for 10,855 PCIs, 6,859 for ACS patients and 3,996 for patients with stable angina. Of these, 2,723 (25%) involved the pLAD and 8,132 (75%) non-pLAD disease (non-pLAD). Median follow up was 5.9 years, with 5 year follow up available for 6,387. Patients with pLAD versus non-pLAD PCI were of similar age (median age 62 (IQR 54–72) vs 63 (IQR 56–71)) but more likely to be male (73% vs 71%, p = 0.04). pLAD patients were less likely to have had previous MI (22.5% vs 29.3%, p < 0.001), previous PCI (13.3% vs 18.6%, p < 0.001) or previous CABG (1.5% vs 11.2%, p < 0.001). Patients with pLAD disease were more likely to undergo multi vessel PCI (30.6% vs 16.1%, p < 0.001) or present with shock (0.8% vs 0.5%, p = 0.03). Use of DES was greater in the pLAD PCI group (77.8% vs. 66.8%, p < 0.001). Mortality rates at 1 and 5 years are shown in Table 1. The data for repeat revascularisation are shown in Table 2 and are derived from data on patients returning to this hospital and do not include patients who may have attended a different cardiothoracic centre. Local geography means that this should be a small number. Abstract 65 Table 1 Mortality 1 year 5 years pLAD 2.6% 9.9% non-pLAD 2.2% 12.0% p value 0.26 0.02 Abstract 65 Table 2 Repeat revascularisation at any time PCI (any) PCI (target lesion) CABG pLAD (n = 2723) 10.9% 5.1% 2.3% non-pLAD (n = 8132) 14.2% 6.9% 2.7% p value <0.001 0.001 0.24 Conclusion Our data suggest that the long term results for PCI to the pLAD are at least as good as the results for non-pLAD PCI. The rates of repeat revascularisation by PCI or CABG are markedly lower than in studies cited in the 2010 ESC revascularisation guideline which were mainly based on PCI by balloon angioplasty. The ESC guidelines are not based on contemporary outcomes of PCI for pLAD disease.