Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial.

BACKGROUND: The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD). AIMS: We sought to determine whether these outcomes remained consistent regardless of geography of enrolment. METHODS: We performed a prespecified subgroup analysis based on regional enrolment. RESULTS: Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (pinteraction=0.02). CONCLUSIONS: In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.

In-hospital stroke after transcatheter aortic valve implantation: A UK observational cohort analysis.

OBJECTIVES: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001). CONCLUSIONS: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve.

Continuous intracoronary versus standard intravenous infusion of adenosine for fractional flow reserve assessment: the HYPEREMIC trial.

AIMS: The aim of this study was to evaluate the accuracy of a continuous intracoronary (IC) adenosine infusion, administered through the novel HYPEREM™IC over-the-wire microcatheter, to measure fractional flow reserve (FFR). METHODS AND RESULTS: The HYPEREMIC trial was a randomised, non-inferiority, crossover study in which patients with intermediate coronary lesions were enrolled for sequential pressure wire studies. FFR was measured using intravenous (IV) (140-180 mcg/kg/min) versus continuous non-weight-adjusted IC (360 mcg/min) adenosine. Patients were randomised and blinded to the order in which they received the adenosine, separated by a washout period. The primary endpoint was the mean hyperaemic FFR. Forty-one patients were enrolled at three UK sites between June and November 2016. The mean (standard deviation) FFR was 0.82 (±0.09) after IC versus 0.84 (±0.09) after IV adenosine. The difference of -0.02 (95% confidence interval [CI]: -0.03 to -0.01) confirmed the non-inferiority (margin <0.05) of IC to IV adenosine. Intracoronary adenosine was associated with a shorter mean time to maximal hyperaemia (difference -44 [95% CI: -59 to -29] seconds; p<0.0001). Chest discomfort was reported in 32/41 (78.0%) patients during IV adenosine versus 12/41 (29.3%) patients during IC adenosine. CONCLUSIONS: Continuous IC adenosine was a reliable, faster and better tolerated method of achieving maximal hyperaemia compared to IV adenosine.

Transcatheter aortic valve-in-valve treatment of degenerative stentless supra-annular Freedom Solo valves: A single centre experience.

BACKGROUND: Redo surgery for degenerative bioprosthetic aortic valves is associated with significant morbidity and mortality. Report results of valve-in-valve therapy (ViV-TAVI) in failed supra-annular stentless Freedom Solo (FS) bioprostheses, which are the highest risk for coronary occlusion. METHODS: Six patients with FS valves (mean age 78.5 years, 50% males). Five had valvular restenosis (peak gradient 87.2 mm Hg, valve area 0.63 cm2 ), one had severe regurgitation (AR). Median time to failure was 7 years. RESULTS: Patients were high risk (mean STS/Logistic EuroScore 10.6 15.8, respectively). FS valves ranged from 21 to 25 mm. Successful ViV-TAVI was achieved in 4/6 patients (67%). Of the unsuccessful cases, (patient 1 and 2 of series) patient 1 underwent BAV with simultaneous aortography which revealed left main stem occlusion. The procedure was stopped and the patient went forward for repeat surgery. Patient 2 underwent successful ViV-TAVI with a 26-mm CoreValve with a guide catheter in the left main, but on removal coronary obstruction occurred, necessitating valve snaring into the aorta. Among the successful cases, (patients 3, 4, 5, 6) the TAVIs used were CoreValve Evolut R 23 mm (n = 3), and Lotus 23 mm (n = 1). In the successful cases the peak gradient fell from 83.0 to 38.3 mm Hg. No patient was left with >1+ AR. One patient had a stroke on Day 2, with full neurological recovery. Two patients underwent semi-elective pacing for LBBB and PR >280 ms. CONCLUSIONS: ViV-TAVI in stentless Freedom Solo valves is high risk. The risk of coronary occlusion is high. The smallest possible prosthesis (1:1 sizing) should be used, and strategies to protect the coronary vessels must be considered. © 2016 Wiley Periodicals, Inc.

A comparison between surgical risk scores for predicting outcome in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Surgical risk scoring systems are of modest value in predicting outcome following transcatheter aortic valve implantation (TAVI). There is no consensus as to which scoring system is the most useful. We examined the efficacy of all four currently available global scorings systems (Additive EuroScore [aES], Logistic EuroScore [LES], EuroScore II [ES II], Society of Thoracic Surgeons [STS] Score) in predicting outcome, both in the short (30 day) and longer term, in patients undergoing TAVI. METHODS: Additive EuroScore (aES), Logistic EuroScore (LES), EuroScore II (ES II), and Society of Thoracic Surgeons (STS) score were assessed in 312 consecutive TAVI patients. Mortality tracking was obtained from the Office of National Statistics as of May 2014. RESULTS: Mean age was 81.2±7.0 years; 53.2% were male. Mean aES, LES, ESII and STS were 9.7±1.9, 17.4±9.4, 6.1±4.3 and 4.6±2.8, respectively. Thirty-day mortality was 4.8%; long-term mortality (maximum 5.8 years, mean 2.2±1.5 years) was 25.3%. Using both univariate and multivariate modelling all four scoring systems failed to predict outcomes in the short term. In the longer term, univariable analysis demonstrated that higher aES and LES scores were associated with higher mortality (aES P=0.0048, LES P=0.054, respectively). After multivariable analysis, only higher aES remained significant. CONCLUSIONS: Surgical risk scores are poor at predicting outcomes in patients undergoing TAVI, particularly in the short term.

Long-term clinical outcome of elderly patients with acute coronary syndrome treated with early percutaneous coronary intervention: Insights from the BASE ACS randomized controlled trial: Bioactive versus everolimus-eluting stents in elderly patients.

BACKGROUND: The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. METHODS: We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12months and yearly thereafter for up to 7years. Elderly age was defined as ≥65years. RESULTS: Of the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2±1.9years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p=0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p=0.002 and p=0.003, respectively). The rates of ischemia-driven TLR were comparable (p>0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p=0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients. CONCLUSIONS: Elderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate.

4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome.

OBJECTIVES: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. DESIGN: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. RESULTS: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006). CONCLUSIONS: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.

Expert Opinion Percutaneous Coronary Intervention in Older People: Does Age Make a Difference?

As many people are living longer, much older patients are now commonly being seen in clinical practice. The management of coronary disease in this group presents formidable challenges. We review the epidemiology of coronary disease in this population and report on the burden of comorbidity, influence of frailty, problems with polypharmacy, interactions and compliance for the older patient. We discuss the management of stable and acute coronary syndromes, the specific anatomical challenges of the older coronary artery, the outcomes of the limited number of trials involving older patients, and review the guidelines available.

Early gated SPECT adenosine myocardial perfusion imaging may influence the therapeutic management of patients with coronary artery disease.

AIM: The aim of the study was to investigate whether myocardial perfusion imaging at 15 min after injection (T15) is more accurate in detecting coronary artery disease than that at 45 min (T45). PATIENTS AND METHODS: Two-day stress/rest 99mTc-tetrofosmin gated SPECT was performed at T15 and T45 in 50 patients. Coronary angiography was considered when poststress and resting images were discordant. Tracer washout rates were calculated for the myocardium, liver, and subdiaphragmatic region. Perfusion sum difference scores were derived using QPS software. RESULTS: T15 and T45 were discordant in 18/50 (36%) patients. In 16/18 patients (89%) discordant deficits were more apparent at T15. A total of 13/16 patients underwent coronary angiography, of whom 12 had coronary artery disease. Poststress, but not resting, left ventricular ejection fraction was lower at T15 (P=0.02). Sum difference scores were higher at T15 [2.2 (1.9)] than at T45 [1.6 (1.7); P<0.05]. Tracer washout rates from the liver [46 (13.3)%] and subdiaphragmatic region [36 (21.3)%] were significant (P<0.0001), but there was no change in myocardial activity. CONCLUSION: T15 detected more abnormalities than did T45. The reduction in left ventricular ejection fraction after stress may result from adenosine-induced poststunning at T15. Accordingly, the T15 protocol may be useful in the assessment of hibernating myocardium. Contrasting myocardial and hepatic washout rates may be attributable to differential ABC transporter expression.

Acute ischemic complications of PCI and CABG: who should cover whom for coronary revascularization?

INTRODUCTION: Percutaneous coronary intervention (PCI) has historically required cardiothoracic backup in the event of ischemic complications. However, many complications occurring during PCI can now be effectively treated at the time of the indexed procedure. Equally, ischemic complications, which occur following coronary artery bypass grafting (CABG), which were previously treated medically or with reoperation, may now also be effectively treated by acute PCI. AIMS AND METHODS: To identify the rate, cause, treatment, and outcomes of ischemic complications from PCI or isolated CABG procedures undertaken from January 2004 to January 2011 where there was immediate crossover from PCI to CABG or vice versa, and to determine from the indexed revascularization procedure, whether or not the ischemic complications were rectified by either CABG with respect to PCI or PCI with respect to CABG. RESULTS: Three hundred fifty-six PCI major ischemic complications were identified. Three hundred forty-seven (97.5%) were rectified percutaneously and 9 (2.5%) required emergency CABG. The commonest reason for emergency CABG was occlusive dissection (n=7). Of the 9 patients that underwent emergency CABG, 3 patients (33.3%) died. Forty CABG major ischemic complications were identified. Twenty-seven (67.5%) were treated medically. Thirteen (32.5%) underwent diagnostic angiography. The etiology of the ischemia was found in all cases. Consequently, 2 underwent reoperation, one was treated medically, and 10 underwent acute PCI. CONCLUSION: Acute coronary ischemia remains a small but significant complication of both PCI and CABG. Resolution of ischemia requires prompt diagnosis and early discussion between cardiothoracic surgeon and cardiac interventionalist to determine the safest and therefore most appropriate way to resolve the problem.

Standalone balloon aortic valvuloplasty: indications and outcomes from the UK in the transcatheter valve era.

OBJECTIVES: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. BACKGROUND: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). METHODS: Data from 423 patients at 14 centers across the UK were analyzed. RESULTS: Patients were aged 80.9 ± 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% ± 16.8%. Mean peak transaortic gradient fell from 62.0 ± 26.3 to 28.3 ± 16.2 mm Hg. Aortic valve area increased from 0.58 ± 0.19 to 0.80 ± 0.25 cm(2) echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion ≥ 2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08-2.17, P = 0.018), poor LV function (HR 1.54, 95%CI 1.09-2.16, P = 0.014), and either urgent (HR 1.70, 95%CI 1.18-2.45; P = 0.004) or emergent presentation (HR 3.72, 95%CI 2.27-6.08; P < 0.0001). CONCLUSION: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy.

Transcatheter aortic valve implantation for stenosed and regurgitant aortic valve bioprostheses CoreValve for failed bioprosthetic aortic valve replacements.

Transcatheter aortic valve implantation is increasingly being used to treat severe aortic stenosis in patients with high operative risk. In an aging population the incidence of aortic stenosis is rising, and increasing numbers of elderly patients are undergoing aortic valve replacement with bioprosthetic valves. Therefore, there is a corresponding increase in prosthetic degeneration. This presents cardiologists with a cohort of patients for whom the risk of re-do aortic valve surgery is prohibitive. We present the first series of such patients with degenerative bioprosthetic stenosis or regurgitation successfully treated with CoreValve (Medtronic, Luxembourg) implantation.

Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial.

OBJECTIVES: The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease. BACKGROUND: CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization. METHODS: The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available. RESULTS: At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p=0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p=0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p=0.82), respectively. CONCLUSIONS: The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154).

Prognostic benefit of transcatheter aortic valve implantation compared with medical therapy in patients with inoperable aortic stenosis.

OBJECTIVES: To compare survival in patients with inoperable aortic stenosis who undergo transcatheter aortic valve implantation against those managed medically. BACKGROUND: Without surgical correction, survival of patients with severe symptomatic aortic stenosis is poor. It is unknown whether patients undergoing transcatheter aortic valve implantation (TAVI) have a better prognosis than similar patients who are treated with medical management. METHODS: Survival rates were compared in consecutive patients with severe symptomatic aortic stenosis who either underwent TAVI or continued on medical management following multidisciplinary team assessment. All patients had been turned down, or considered at unacceptably high risk, for conventional aortic valve surgery. Patients were reviewed in clinic or by telephone six monthly. Mortality data was obtained from the United Kingdom Office of National Statistics. RESULTS: The study group included 85 patients aged 81 +/- 7 years (range 62-94), of whom 48 were male. Thirty eight patients underwent TAVI while 47 patients were deemed unsuitable based on echocardiographic, angiographic, or clinical criteria and remained on medical therapy. The calculated EuroSCORE for the TAVI group was 11 +/- 2 and for the medical group 9 +/- 2 (P < 0.001). TAVI-related procedural mortality was 2.6%, and 30-day mortality was 5.2%. Among the medically-treated patients, 14 (30%) underwent palliative balloon aortic valvuloplasty, with a trend toward improved survival (P = 0.06). During overall follow-up of 215 +/- 115 days there were a total of 18 deaths; TAVI N = 5 (13%); Medical N = 13 (28%) (P = 0.04). CONCLUSIONS: Patients with severe aortic valve disease who are not suitable for surgical aortic valve replacement have an improved prognosis if treated with transcatheter aortic valve implantation rather than continuing on medical management alone.