Time to TAVI: streamlining the pathway to treatment.

INTRODUCTION: Severe aortic stenosis is a major cause of morbidity and mortality. The existing treatment pathway for transcatheter aortic valve implantation (TAVI) traditionally relies on tertiary Heart Valve Centre workup. However, this has been associated with delays to treatment, in breach of British Cardiovascular Intervention Society targets. A novel pathway with emphasis on comprehensive patient workup at a local centre, alongside close collaboration with a Heart Valve Centre, may help reduce the time to TAVI. METHODS: The centre performing local workup implemented a novel TAVI referral pathway. Data were collected retrospectively for all outpatients referred for consideration of TAVI to a Heart Valve Centre from November 2020 to November 2021. The main outcome of time to TAVI was calculated as the time from Heart Valve Centre referral to TAVI, or alternative intervention, expressed in days. For the centre performing local workup, referral was defined as the date of multidisciplinary team discussion. For this centre, a total pathway time from echocardiographic diagnosis to TAVI was also evaluated. A secondary outcome of the proportion of referrals proceeding to TAVI at the Heart Valve Centre was analysed. RESULTS: Mean±SD time from referral to TAVI was significantly lower at the centre performing local workup, when compared with centres with traditional referral pathways (32.4±64 to 126±257 days, p<0.00001). The total pathway time from echocardiographic diagnosis to TAVI for the centre performing local workup was 89.9±67.6 days, which was also significantly shorter than referral to TAVI time from all other centres (p<0.003). Centres without local workup had a significantly lower percentage of patients accepted for TAVI (49.5% vs 97.8%, p<0.00001). DISCUSSION: A novel TAVI pathway with emphasis on local workup within a non-surgical centre significantly reduced both the time to TAVI and rejection rates from a Heart Valve Centre. If adopted across the other centres, this approach may help improve access to TAVI.

Expedited transfer to a cardiac arrest centre for non-ST-elevation out-of-hospital cardiac arrest (ARREST): a UK prospective, multicentre, parallel, randomised clinical trial.

BACKGROUND: The International Liaison Committee on Resuscitation has called for a randomised trial of delivery to a cardiac arrest centre. We aimed to assess whether expedited delivery to a cardiac arrest centre compared with current standard of care following resuscitated cardiac arrest reduces deaths. METHODS: ARREST is a prospective, parallel, multicentre, open-label, randomised superiority trial. Patients (aged ≥18 years) with return of spontaneous circulation following out-of-hospital cardiac arrest without ST elevation were randomly assigned (1:1) at the scene of their cardiac arrest by London Ambulance Service staff using a secure online randomisation system to expedited delivery to the cardiac catheter laboratory at one of seven cardiac arrest centres or standard of care with delivery to the geographically closest emergency department at one of 32 hospitals in London, UK. Masking of the ambulance staff who delivered the interventions and those reporting treatment outcomes in hospital was not possible. The primary outcome was all-cause mortality at 30 days, analysed in the intention-to-treat (ITT) population excluding those with unknown mortality status. Safety outcomes were analysed in the ITT population. The trial was prospectively registered with the International Standard Randomised Controlled Trials Registry, 96585404. FINDINGS: Between Jan 15, 2018, and Dec 1, 2022, 862 patients were enrolled, of whom 431 (50%) were randomly assigned to a cardiac arrest centre and 431 (50%) to standard care. 20 participants withdrew from the cardiac arrest centre group and 19 from the standard care group, due to lack of consent or unknown mortality status, leaving 411 participants in the cardiac arrest centre group and 412 in the standard care group for the primary analysis. Of 822 participants for whom data were available, 560 (68%) were male and 262 (32%) were female. The primary endpoint of 30-day mortality occurred in 258 (63%) of 411 participants in the cardiac arrest centre group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival 1·00, 95% CI 0·90-1·11; p=0·96). Eight (2%) of 414 patients in the cardiac arrest centre group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention. INTERPRETATION: In adult patients without ST elevation, transfer to a cardiac arrest centre following resuscitated cardiac arrest in the community did not reduce deaths. FUNDING: British Heart Foundation.

Midterm Outcomes in Patients With Aortic Stenosis Treated With Contemporary Balloon-Expandable and Self-Expanding Valves: Does Valve Size Have an Impact on Outcome?

Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (≤26 mm for SE and ≤23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.

Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial.

BACKGROUND: There are a paucity of randomised data on the optimal timing of invasive coronary angiography (ICA) in higher-risk patients with non-ST elevation myocardial infarction (N-STEMI). International guideline recommendations for early ICA are primarily based on retrospective subgroup analyses of neutral trials. AIMS: The RAPID N-STEMI trial aims to determine whether very early percutaneous revascularisation improves clinical outcomes as compared with a standard of care strategy in higher-risk N-STEMI patients. METHODS AND ANALYSIS: RAPID N-STEMI is a prospective, multicentre, open-label, randomised-controlled, pragmatic strategy trial. Higher-risk N-STEMI patients, as defined by Global Registry of Acute Coronary Events 2.0 score ≥118, or >90 with at least one additional high-risk feature, were randomised to either: very early ICA±revascularisation or standard of care timing of ICA±revascularisation. The primary outcome is the proportion of participants with at least one of the following events (all-cause mortality, non-fatal myocardial infarction and hospital admission for heart failure) at 12 months. Key secondary outcomes include major bleeding and stroke. A hypothesis generating cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage and residual ischaemia post percutaneous coronary intervention. On 7 April 2021, the sponsor discontinued enrolment due to the impact of the COVID-19 pandemic and lower than expected event rates. 425 patients were enrolled, and 61 patients underwent CMR. ETHICS AND DISSEMINATION: The trial has been reviewed and approved by the East of England Cambridge East Research Ethics Committee (18/EE/0222). The study results will be submitted for publication within 6 months of completion. TRIAL REGISTRATION NUMBER: NCT03707314; Pre-results.

Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Impact of COVID-19 pandemic on the management of nonculprit lesions in patients presenting with ST-elevation myocardial infarction: Outcomes from the pan-London heart attack centers.

BACKGROUND: The impact of COVID-19 on the diagnosis and management of nonculprit lesions remains unclear. OBJECTIVES: This study sought to evaluate the management and outcomes of patients with nonculprit lesions during the COVID-19 pandemic. METHODS: We conducted a retrospective observational analysis of consecutive primary percutaneous coronary intervention (PPCI) pathway activations across the heart attack center network in London, UK. Data from the study period in 2020 were compared with prepandemic data in 2019. The primary outcome was the rate of nonculprit lesion percutaneous coronary intervention (PCI) and secondary outcomes included major adverse cardiovascular events. RESULTS: A total of 788 patients undergoing PPCI were identified, 209 (60%) in 2020 cohort and 263 (60%) in 2019 cohort had nonculprit lesions (p = .89). There was less functional assessment of the significance of nonculprit lesions in the 2020 cohort compared to 2019 cohort; in 8% 2020 cohort versus 15% 2019 cohort (p = .01). There was no difference in rates of PCI for nonculprit disease in the 2019 and 2020 cohorts (31% vs 30%, p = .11). Patients in 2020 cohort underwent nonculprit lesion PCI sooner than the 2019 cohort (p < .001). At 6 months there was higher rates of unplanned revascularization (4% vs. 2%, p = .05) and repeat myocardial infarction (4% vs. 1%, p = .02) in the 2019 cohort compared to 2020 cohort. CONCLUSION: Changes to clinical practice during the COVID-19 pandemic were associated with reduced rates of unplanned revascularization and myocardial infarction at 6-months follow-up, and despite the pandemic, there was no difference in mortality, suggesting that it is not only safe but maybe more efficacious.

The influence of biological age and sex on long-term outcome after percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Outcome following ST-segment elevation myocardial infarction (STEMI) is thought to be worse in women than in age-matched men. We assessed whether such differences occur in the UK Pan-London dataset and if age, and particularly menopause, influences upon outcome. METHODS: We undertook an observational cohort study of 26,799 STEMI patients (20,633 men, 6,166 women) between 2005-2015 at 8 centres across London, UK. Patient details were recorded at the time of the procedure into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. Primary outcome was all-cause mortality at a median follow-up of 4.1 years (IQR: 2.2-5.8 years). RESULTS: Kaplan-Meier analysis demonstrated a higher mortality rate in women versus men (15.6% men vs. 25.3% women, P<0.0001). Univariate Cox analysis revealed that female sex was a predictor of all-cause mortality (HR: 1.69 95% CI: 1.59-1.82). However, after multivariate adjustment, this effect of female sex diminished (HR: 1.05 95% CI: 0.90-1.25). In a sub-group analysis, we compared the sexes separated by age into the ≤55 and the >55 year olds. Age-stratified Cox analysis revealed that female sex was a univariate predictor of all-cause mortality (HR: 1.60 95% CI: 1.25-2.05) in the ≤55 group and in the >55 group (HR: 1.38 95% CI: 1.28-1.47). However, after regression adjustment incorporating the propensity score into a proportional hazard model as a covariate, whilst female sex was not a significant predictor of all-cause mortality in the ≤55 group it was a predictor in the >55 group. Moreover, whilst age did not influence outcome in <55 group, this effect in the >55 group was correlated with age. CONCLUSIONS: Overall women have a worse all-cause mortality following primary PCI for STEMI compared to men. However, this effect was driven predominantly by women >55 years of age since after adjusting for co-morbidities the risk in younger women did not differ significantly from that in men. These observations support the view that as women advance past the menopausal years their risk of further events following revascularization increases substantially and we suggest that routine assessment of hormonal status may improve clinical decision-making and ultimately outcome for women post-PCI.

Impact of Early (≤24 h) Versus Delayed (>24 h) Intervention in Patients With Non-ST Segment Elevation Myocardial Infarction: An Observational Study of 20,882 Patients From the London Heart Attack Group.

INTRODUCTION: We aimed to investigate the optimal timing of invasive coronary angiography and subsequent intervention in non-ST-segment elevation acute myocardial infarction (NSTEMI) patients. METHODS: We examined the impact of early (≤24 h) versus delayed (>24 h) intervention in a large observational cohort of 20,882 consecutive NSTEMI patients treated with PCI between 2005 and 2015 at 8 tertiary cardiac centers in London (UK) using Cox-regression analysis and propensity matching. RESULTS: Mean age was 64.5 ± 12.7 years and 26.1% were females. A quarter (27.6%), were treated within 24 h. Patients treated within 24 h were slightly younger (62.8 ± 12.8 vs. 65.2 ± 12.6, p < 0.001), most commonly male (76% vs. 72.9%, p < 0.001) and were more frequently ventilated (2.3% vs. 1.4%, p < 0.001) and in cardiogenic shock (3.6% vs. 1.4%, p < 0.001) with dynamic changes on their ECG (84.5% vs. 76.1% p < 0.001). At a median follow up of 4.2 years (interquartile range 1.8 to 7) 17.7% of patients had died. Estimated 5-year survival in patients treated within 24 h was 84.6% vs. 81% for those treated >24 h following their presentation (p < 0.001). This survival benefit remained following adjustment for confounders; HR(delayed vs. early management) 1.11 (95%CI 1.003 to 1.23, p = 0.046). In the propensity matched cohort of 4356 patients in each group, there remained a trend for higher survival in the early intervention group (p = 0.061). CONCLUSIONS: Notwithstanding the limitations of the retrospective design, this real-world cohort of NSTEMI patients suggests that an early intervention (≤24 h) may improve mid-term survival.

COVID-19 pandemic and STEMI: pathway activation and outcomes from the pan-London heart attack group.

OBJECTIVES: To understand the impact of COVID-19 on delivery and outcomes of primary percutaneous coronary intervention (PPCI). Furthermore, to compare clinical presentation and outcomes of patients with ST-segment elevation myocardial infarction (STEMI) with active COVID-19 against those without COVID-19. METHODS: We systematically analysed 348 STEMI cases presenting to the PPCI programme in London during the peak of the pandemic (1 March to 30 April 2020) and compared with 440 cases from the same period in 2019. Outcomes of interest included ambulance response times, timeliness of revascularisation, angiographic and procedural characteristics, and in-hospital clinical outcomes RESULTS: There was a 21% reduction in STEMI admissions and longer ambulance response times (87 (62-118) min in 2020 vs 75 (57-95) min in 2019, p<0.001), but that this was not associated with a delays in achieving revascularisation once in hospital (48 (34-65) min in 2020 vs 48 (35-70) min in 2019, p=0.35) or increased mortality (10.9% (38) in 2020 vs 8.6% (38) in 2019, p=0.28). 46 patients with active COVID-19 were more thrombotic and more likely to have intensive care unit admissions (32.6% (15) vs 9.3% (28), OR 5.74 (95%CI 2.24 to 9.89), p<0.001). They also had increased length of stay (4 (3-9) days vs 3 (2-4) days, p<0.001) and a higher mortality (21.7% (10) vs 9.3% (28), OR 2.72 (95% CI 1.25 to 5.82), p=0.012) compared with patients having PPCI without COVID-19. CONCLUSION: These findings suggest that PPCI pathways can be maintained during unprecedented healthcare emergencies but confirms the high mortality of STEMI in the context of concomitant COVID-19 infection characterised by a heightened state of thrombogenicity.

Prior Coronary Artery Bypass Graft Surgery and Outcome After Percutaneous Coronary Intervention: An Observational Study From the Pan-London Percutaneous Coronary Intervention Registry.

Background Limited information exists regarding procedural success and clinical outcomes in patients with previous coronary artery bypass grafting (CABG) undergoing percutaneous coronary intervention (PCI). We sought to compare outcomes in patients undergoing PCI with or without CABG. Methods and Results This was an observational cohort study of 123 780 consecutive PCI procedures from the Pan-London (UK) PCI registry from 2005 to 2015. The primary end point was all-cause mortality at a median follow-up of 3.0 years (interquartile range, 1.2-4.6 years). A total of 12 641(10.2%) patients had a history of previous CABG, of whom 29.3% (n=3703) underwent PCI to native vessels and 70.7% (n=8938) to bypass grafts. There were significant differences in the demographic, clinical, and procedural characteristics of these groups. The risk of mortality during follow-up was significantly higher in patients with prior CABG (23.2%; P=0.0005) compared with patients with no prior CABG (12.1%) and was seen for patients who underwent either native vessel (20.1%) or bypass graft PCI (24.2%; P<0.0001). However, after adjustment for baseline characteristics, there was no significant difference in outcomes seen between the groups when PCI was performed in native vessels in patients with previous CABG (hazard ratio [HR],1.02; 95%CI, 0.77-1.34; P=0.89), but a significantly higher mortality was seen among patients with PCI to bypass grafts (HR,1.33; 95% CI, 1.03-1.71; P=0.026). This was seen after multivariate adjustment and propensity matching. Conclusions Patients with prior CABG were older with greater comorbidities and more complex procedural characteristics, but after adjustment for these differences, the clinical outcomes were similar to the patients undergoing PCI without prior CABG. In these patients, native-vessel PCI was associated with better outcomes compared with the treatment of vein grafts.

Comparison of the self-expanding Evolut-PRO transcatheter aortic valve to its predecessor Evolut-R in the real world multicenter ATLAS registry.

BACKGROUND: The Evolut PRO self-expanding transcatheter aortic valve has been designed to feature an outer pericardial wrap that aims to reduce paravalvular regurgitation (PVR) rates. Medium-term clinical outcomes, compared to its predecessor Evolut R, in a real-world setting, have not been investigated. The aim of the present study was to compare the two valves with regards to peri-procedural complications, early outcomes and mid-term survival. METHODS: Consecutive patients, undergoing TAVI with either the Evolut PRO or Evolut R device, from the multicenter ATLAS registry were retrospectively studied. Outcomes studied included periprocedural complications, PVR at discharge, need for new pacemaker implantation and Kaplan-Meier estimated 1-year all-cause mortality. RESULTS: Analysis included 673 patients (498 treated with Evolut R and 175 treated with Evolut PRO). At least moderate PVR was numerically lower amongst patients treated with Evolut PRO (7.4% vs 3.8% for Evolut R and Evolut PRO respectively, p = .108). Rates of new permanent pacemaker (PPM) implantation (21.1% vs. 11.9%, p = .023), and bail-out valve-in-valve (2.4% vs. 0%, p = .049) were significantly lower amongst the Evolut PRO group. No differences were demonstrated regarding bleeding, stroke or acute kidney injury. One-year Kaplan-Meier estimated survival was similar between groups (93% for Evolut R vs. 91.2% for Evolut PRO, plog-rank = 0.806). CONCLUSIONS: The Evolut PRO self-expanding valve demonstrates similar mid-term survival rates and numerically, yet not significant, lower incidence of PVR compared to its predecessor. Interestingly this new generation valve is associated with a significantly reduced rate for new PPM implantation. Future studies are required to confirm this finding.

Outcome of inter-hospital transfer versus direct admission for primary percutaneous coronary intervention: An observational study of 25,315 patients with ST-elevation myocardial infarction from the London Heart Attack Group.

BACKGROUND AND AIMS: In patients with ST-segment elevation myocardial infarction (STEMI), mortality is directly related to time to reperfusion with guidelines recommending patients be delivered directly to centres for primary percutaneous coronary intervention (PCI). The aim of this study was to describe the impact of inter-hospital transfer on reperfusion time and to assess whether or not treatment delays influenced clinical outcomes in comparison with direct admission to a primary PCI centre in a large regional network. METHOD AND RESULTS: We undertook an observational cohort study of patients with STEMI treated with primary PCI between 2005 and 2015 in London, UK. Patient details were recorded at the time of the procedure in databases using the British Cardiovascular Intervention Society PCI dataset. The primary end-point was all-cause mortality at a median of 4.1 years (interquartile range: 2.2-5.8 years). Secondary outcomes were in-hospital major adverse cardiac events. Of 25,315 patients, 17,560 (69.4%) were admitted directly to a primary PCI centre and 7755 (31.6%) were transferred from a non-primary PCI centre. Patients in the direct admission group were older and more likely to have left ventricular impairment compared with the inter-hospital transfer group. Median time from call for help to reperfusion in transferred patients was 52 minutes longer compared with patients admitted directly (p <0.001). However, call to first hospital admission was similar. Kaplan-Meier analysis demonstrated significantly lower mortality rates in patients who were transferred directed to a primary PCI centre compared with patients who were transferred from a non-PCI centre (17.4% direct vs. 18.7% transfer, p=0.017). Furthermore, after propensity matching, direct admission for primary PCI was still a predictor of all-cause mortality (hazard ratio: 0.89, 95% confidence interval: 0.64-0.95). CONCLUSIONS: In this large registry of over 25,000 STEMI patients treated by primary PCI survival was better in patients admitted directly to a cardiac centre versus patients transferred for primary PCI, most likely due to longer call to balloon times in patient transferred from other hospitals.

Clinical Indications of IMPELLA Short-Term Mechanical Circulatory Support in a Tertiary Centre.

INTRODUCTION: The Impella family of devices are short-term mechanical circulatory support (MCS) pumps that hold promise in treating patients with acute cardiogenic shock, acting as bridge to recovery, transplant or durable left ventricular assist device. We assessed the clinical utility, indications and outcomes of the Impella family of devices in a tertiary centre. METHODS: In the current study we present our initial 2-year experience with different Impella types. We explored the indications for device implantation, initial hemodynamic and biochemical response and mid-term survival. RESULTS: A total of 57 patients underwent Impella implantation; 36 Impella CP, 14 Impella 5.0 and 7 Impella RP. Mean age was 54.2 ±â€¯15.2 whereas 78.9% were males. The main indications for left sided MCS included cardiogenic shock secondary to ACS, decompensated dilated or ischemic end stage cardiomyopathy and myocarditis. Mean LVEF pre-Impella implantation was 23 ±â€¯13.7%. PCI was performed in 24 (54.5%) patients. Main indication for Impella RP was RV failure following LVAD implantation. The median duration of support was 5 days (IQR 1 to 10.5 days). 24 h following Impella implantation, there was significant improvement in all hemodynamic parameters as well as renal and liver function. Patients presenting with INTERMACS I had a 30-day survival of 40% whereas patients with INTEMACS 2 or above had a 30-day survival of 82.4%. CONCLUSIONS: The Impella short-term mechanical assist device provides immediate improvement in hemodynamic parameters and end organ function recovery. Patient outcomes are heavily influenced by the stage of shock and the timely insertion of MCS.

Initial experience of a self-expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry.

OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Complete Versus Culprit only Revascularisation in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction: Incidence and Outcomes from the London Heart Attack Group.

BACKGROUND: Despite advances in technology, patients with Cardiogenic Shock (CS) presenting with ST-segment myocardial infarction (STEMI) still have a poor prognosis with high mortality rates. A large proportion of these patients have multi-vessel coronary artery disease, the treatment of which is still unclear. We aimed to assess the trends in management of CS patients with multi-vessel disease (MVD), particularly looking at the incidence and outcomes of complete revascularisation compared to culprit vessel only. METHODS AND RESULTS: We undertook an observational cohort study of 21,210 STEMI patients treated between 2005 and 2015 at the 8 Heart Attack Centres in London, UK. Patients' details were recorded prospectively into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. 1058 patients presented with CS and MVD. Primary outcome was all-cause mortality. Patients were followed-up for a median of 4.1 years (IQR range: 2.2-5.8 years). 497 (47.0%) patients underwent complete revascularisation during primary PCI for CS with stable rates seen over time. These patients were more likely to be male, hypertensive and more likely to have poor LV function compared to the culprit vessel intervention group. Although crude, in hospital major adverse cardiac events (MACE) rates were similar (40.8% vs. 36.0%, p = 0.558) between the two groups. Kaplan-Meier analysis demonstrated no significant differences in mortality rates between the two groups (53.8% complete revascularisation vs. 46.8% culprit vessel intervention, p = 0.252) during the follow-up period. After multivariate cox analysis (HR 0.69 95% CI (0.44-0.98)) and the use of propensity matching (HR: 0.81 95% CI: 0.62-0.97) complete revascularisation was associated with reduced mortality. A number of co-variates were included in the model, including age, gender, diabetes, hypertension, hypercholesterolaemia, previous PCI, previous MI, chronic renal failure, Anterior infarct, number of treated vessels, pre-procedure TIMI flow, procedural success and GP IIb/IIIA use. CONCLUSION: In a contemporary observational series of CS patients with MVD, complete revascularisation appears to be associated with better outcomes compared to culprit vessel only intervention. This supports on-going clinical trials in this area and provides further evidence of the association of complete revascularisation in STEMI with good outcomes.

Comparison of warfarin versus DOACs in patients with concomitant indication for oral anticoagulation undergoing TAVI; results from the ATLAS registry.

The optimal antithrombotic therapy for patients undergoing TAVI with concomitant indication for oral anticoagulation remains unclear. In this high-risk population group, there is a paucity of data with regards to the use of DOACs. In the present study we compared long-term clinical outcomes of TAVI patients requiring anticoagulation, treated with warfarin versus DOACs. Consecutive patients, who underwent TAVI with indication for oral anticoagulation from the multicenter ATLAS registry were studied and divided in two groups depending on the chosen anticoagulation regimen, warfarin vs. DOACs. 30-day survival, as well as estimated 1 and 2-year all-cause mortality were compared between groups. The secondary endpoint included in-hospital major or life-threatening bleeding. The study group included 217 patients (102 treated with warfarin; 115 treated with DOACs). Kaplan-Meier estimated survival was found to be statistically similar in the warfarin and DOAC groups (90.6% vs. 93.7% for 1-year and 84.5% vs. 88.5%, for 2-year survival, respectively, Plog-rank = 0.984). Adjusted hazard ratio for all cause mortality was similar between the two groups (HRwarfarin vs. DOAC = 1.15; 95% CI 0.33 to 4.04, p = 0.829). Propensity matching revealed similar results. At 30-days, all-cause mortality was found to be comparable between the two groups. With regards to BARC defined bleeding complications, major and life-threatening complications did not differ between the two anticoagulation groups (6% vs. 8% for warfarin and DOACs respectively, p = 0.857). DOACs seem to demonstrate a similar safety and efficacy profile compared to warfarin in TAVI patients with a concomitant indication for oral anticoagulation.

Long-Term Follow-Up of Complete Versus Lesion-Only Revascularization in STEMI and Multivessel Disease: The CvLPRIT Trial.

BACKGROUND: Randomized trials have shown that complete revascularization in patients with ST-segment elevation myocardial infarction (MI) with multivessel disease results in lower major adverse cardiovascular events (MACE) (all-cause death, MI, ischemia-driven revascularization, heart failure). OBJECTIVES: The goal of this study was to determine whether the benefits of complete revascularization are sustained long-term and their impact on hard endpoints. METHODS: CvLPRIT (Complete versus Lesion-only Primary PCI Trial) was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission. Randomized patients have been followed longer-term. The components of the original primary endpoint were collected from physical and electronic patient records, and from local databases for all readmissions. RESULTS: The median follow-up (achieved in >90% patients) from randomization to first event or last follow-up was 5.6 years (0.0 to 7.3 years). The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079). The composite endpoint of all-cause death/MI was 10.0% in the complete revascularization group versus 18.5% in the infarct-related artery-only group (hazard ratio: 0.47; 95% confidence interval: 0.25 to 0.89; p = 0.0175). In a landmark analysis (from 12 months to final follow-up), there was no significant difference between MACE, death/MI, and individual components of the primary endpoint. CONCLUSIONS: Long-term follow-up of the CvLPRIT trial shows that the significantly lower rate of MACE in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed. (Complete versus Lesion-only Primary PCI Trial; ISRCTN70913605).

Inconsistency in aortic stenosis severity between CT and echocardiography: prevalence and insights into mechanistic differences using computational fluid dynamics.

Objectives: The aims of this study were to evaluate the inconsistency of aortic stenosis (AS) severity between CT aortic valve area (CT-AVA) and echocardiographic Doppler parameters, and to investigate potential underlying mechanisms using computational fluid dynamics (CFD). Methods: A total of 450 consecutive eligible patients undergoing transcatheter AV implantation assessment underwent CT cardiac angiography (CTCA) following echocardiography. CT-AVA derived by direct planimetry and echocardiographic parameters were used to assess severity. CFD simulation was performed in 46 CTCA cases to evaluate velocity profiles. Results: A CT-AVA>1 cm2 was present in 23% of patients with echocardiographic peak velocity≥4 m/s (r=-0.33) and in 15% patients with mean Doppler gradient≥40 mm Hg (r=-0.39). Patients with inconsistent severity grading between CT and echocardiography had higher stroke volume index (43 vs 38 mL/m2, p<0.003) and left ventricular outflow tract (LVOT) flow rate (235 vs 192 cm3/s, p<0.001). CFD simulation revealed high flow, either in isolation (p=0.01), or when associated with a skewed velocity profile (p=0.007), as the main cause for inconsistency between CT and echocardiography. Conclusion: Severe AS by Doppler criteria may be associated with a CT-AVA>1 cm2 in up to a quarter of patients. CFD demonstrates that haemodynamic severity may be exaggerated on Doppler analysis due to high LVOT flow rates, with or without skewed velocity profiles, across the valve orifice. These factors should be considered before making a firm diagnosis of severe AS and evaluation with CT can be helpful.

Exercise-based cardiac rehabilitation for patients following open surgical aortic valve replacement and transcatheter aortic valve implant: a systematic review and meta-analysis.

Objectives: Exercise-based cardiac rehabilitation (CR) may be beneficial to patients following transcatheter aortic valve implantation (TAVI) and open surgical aortic valve replacement (SAVR). We aimed to undertake a systematic review and meta-analysis to evaluate the efficacy, safety and costs of exercise-based CR post-TAVI and post-SAVR. Methods: We searched numerous databases, including Embase, CENTRAL and MEDLINE, up to October 2017. We included randomised controlled trials (RCTs) and non-randomised controlled trials (non-RCTs) of exercise-based CR compared with no exercise control in TAVI or SAVR patients ≥18 years. Data extraction and risk of bias assessments were performed independently by two reviewers. Narrative synthesis and meta-analysis (where appropriate) were carried out for all relevant outcomes, and a Grading of Recommendations Assessment, Development and Evaluation (GRADE) analysis was also performed. Results: Six studies, all at low risk of bias, were included: three RCTs and three non-RCTs (total of 27 TAVI, 99 SAVR and 129 mixed patients), with follow-up of 2-12 months. There was an increase in pooled exercise capacity (standardised mean difference: 0.41, 95% CI 0.11 to 0.70; moderate certainty evidence as assessed by GRADE), with exercise-based rehabilitation compared with control. Data on other outcomes including quality of life and clinical events were limited. Conclusions: Exercise-based CR probably improves exercise capacity of post-TAVI and post-SAVR patients in the short term. Well conducted multicentre fully powered RCTs of ≥12 months follow-up are needed to fully assess the clinical and cost-effectiveness of exercise-based CR in this patient population. PROSPERO Protocol Registration Number: CRD42017084716.