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.

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.

Valvular complications following the Impella device implantation.

BACKGROUND: Despite clear clinical benefits, there is limited evidence regarding possible complications of the novel mechanical support device Impella. Aortic and mitral valve regurgitation or injury are rare but potential complications following implantation of the Impella device. METHODS: To evaluate valvular complications after the Impella device implantation, we have performed a comprehensive search of literature on multiple sites on this topic. RESULTS AND CONCLUSION: Ten case reports and one observational retrospective study were identified, with a total number of 19 patients identified. This article aims to draw attention to potential periprocedural complications relating to the Impella, in particular iatrogenic aortic and mitral valve injuries. Moreover, we have summarized our recommendations emphasizing the need for careful management and meticulous follow-up of these patients to avoid such potentially devastating complications.

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.

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.

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.

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.

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.

Coronary artery bypass confers intermediate-term survival benefit over percutaneous coronary intervention with new-generation stents in real-world patients with multivessel coronary artery disease, including left main disease: a retrospective analysis of 6383 patients.

OBJECTIVES: The intermediate-term all-cause mortality rate of real-world patients with multivessel disease (MVD) treated with percutaneous coronary intervention (PCI) with new-generation drug-eluting stents or coronary artery bypass grafting (CABG) remains unknown. We sought to compare the intermediate-term all-cause mortality rates of real-world patients with MVD including left main stem disease, treated with CABG or PCI. METHODS: All consecutive all-comer patients with MVD undergoing CABG or PCI with second/third generation drug-eluting stents from 2007 to 2015 in Harefield Hospital, UK were included in this study. The revascularization modality was based on heart team discussions. Primary outcome was all-cause mortality. Mean follow-up of the study was 3.3 years. Cox regression analysis and propensity matching were used. RESULTS: Of 6383 patients with MVD, 4230 underwent CABG, whereas 2153 had PCI with new-generation stents. In the CABG group, the mean age was 66.4 ± 10 years, whereas in the PCI group it was 65.3 ± 12.1 years (P < 0.001). Fewer female patients with MVD were treated with CABG than were treated with PCI (18.5% vs 20.5%; P = 0.026). There was a higher 5-year estimated survival rate among patients having CABG (88% vs 78.3%; Plog-rank < 0.001). The adjusted hazard ratio (HR) for PCI over CABG was 1.74 [95% confidence interval (CI) 1.41-2.16; P < 0.001]. A total of 653 patients having CABG and 653 having PCI were included in the propensity-matched groups. At mean follow-up, PCI was associated with a higher adjusted HR for all-cause mortality (2.18, 95% CI 1.54-3.1; P < 0.001). CONCLUSIONS: In this contemporary cohort of real-world patients with MVD, CABG was associated with increased intermediate-term survival compared to PCI with new-generation drug-eluting stents.

Real-world comparison of the new 34 mm self-expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor.

OBJECTIVES: The aim of the present study was to compare the incidence of periprocedural complications and short-term outcomes between the second-generation recapturable 34 mm Evolut-R and its first-generation 31 mm predecessor. BACKGROUND: Although already in extensive clinical use in real world patients, the periprocedural complications and clinical outcomes of the new 34 mm device have not been investigated yet. METHODS: Consecutive patients who had undergone transcatheter aortic valve implantation in two centers with either a 31 mm CoreValve or a 34 mm Evolut-R device were retrospectively studied. Periprocedural complications of malpositioning, valve-in-valve implantation, conversion to full sternotomy or percutaneous coronary intervention and vascular complications were compared between the two groups. Short-term outcomes at discharge were compared using Valve Academic Research Consortium (VARC-2) criteria. RESULTS: The study group included 106 patients (35 Evolut-R 34 mm; 71 CoreValve 31 mm). Significantly lower rates of valve-in-valve implantation were demonstrated for the 34 mm group compared to the first-generation device (0% vs. 11.9%, respectively, P = 0.036). All other periprocedural complications were similar between groups. At discharge, the rates of new pacemaker implantation (5.7% vs. 26.8%, P = 0.037) and bleeding complications (2.9% vs. 19.6%, P = 0.025) were statistically significantly lower among the 34 mm group. With regards to VARC-2 defined combined endpoints, rates of early safety were significantly improved among the 34 mm group compared to 31 mm group (0% vs. 27.9%, respectively, P = 0.004). CONCLUSIONS: The recently introduced 34 mm Evolut-R seems to demonstrate an improved safety profile, as evidenced by the reduced bleeding rates, lower rates of valve-in-valve implantation and lower PPM rates compared to its 31 mm predecessor.

Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.

OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 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 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study: RECOVER-TAVI Pilot, ORCA 4, For the Optimal Restoration of Cardiac Activity Group.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population. DESIGN: We undertook a pilot randomised trial of CR following TAVI to inform the feasibility and design of a future randomised clinical trial (RCT). PARTICIPANTS: We screened patients undergoing TAVI at a single institution between June 2016 and February 2017. INTERVENTIONS: Participants were randomised post-TAVI to standard of care (control group) or standard of care plus exercise-based CR (intervention group). OUTCOMES: We assessed recruitment and attrition rates, uptake of CR, and explored changes in 6-min walk test, Nottingham Activities of Daily Living, Fried and Edmonton Frailty scores and Hospital Anxiety and Depression Score, from baseline (30 days post TAVI) to 3 and 6 months post randomisation. We also undertook a parallel study to assess the use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the post-TAVI population. RESULTS: Of 82 patients screened, 52 met the inclusion criteria and 27 were recruited (3 patients/month). In the intervention group, 10/13 (77%) completed the prescribed course of 6 sessions of CR (mean number of sessions attended 7.5, SD 4.25) over 6 weeks. At 6 months, all participants were retained for follow-up. There was apparent improvement in outcome scores at 3 and 6 months in control and CR groups. There were no recorded adverse events associated with the intervention of CR. The KCCQ was well accepted in 38 post-TAVI patients: mean summary score 72.6 (SD 22.6). CONCLUSIONS: We have demonstrated the feasibility of recruiting post-TAVI patients into a randomised trial of CR. We will use the findings of this pilot trial to design a fully powered multicentre RCT to inform the provision of CR and support guideline development to optimise health-related quality of life outcomes in this vulnerable population. Retrospectively registered 3rd October 2016 clinicaltrials.gov NCT02921880. TRIAL REGISTRATION: Clinicaltrials.Gov identifier NCT02921880.

Effect of Aortic Valve Calcium Quantity on Outcome After Balloon Aortic Valvuloplasty for Severe Aortic Stenosis.

Balloon aortic valvuloplasty has a role in a select group of patients with severe aortic stenosis. Identifying those appropriate patients who will benefit most is key. Given previous evidence demonstrating that histologically the intervention involves a physical disrupting of the cusp's calcium we hypothesized that the quantity of calcium seen at CT will influence outcome. We examined our cohort of patients who had undergone balloon aortic valvuloplasty and CT-quantified aortic valve calcium (AVC) between July 2011 and April 2014. All patients underwent echocardiography pre- and post-procedure and for those patients managed medically, again at 6 months. A potential predictive AVC value for mortality was calculated using Youden's index. A total of 240 aortic valvuloplasties were performed in 206 patients (male = 124). Valvuloplasty caused a significant (pre 0.63 ± 0.21 vs post 0.77 ± 0.27 cm2, p <0.01, n = 240), but temporary (post 0.80 ± 0.27 vs 6 months: 0.64 ± 0.18 cm2, p <0.01, n = 88) increase in valve area. Those patients with a non-severe AVC (<1853.5 AU) had a larger increase in valve area after valvuloplasty compared with those with more calcium (0.10 [95% confidence interval {CI} 0.05 to 0.10] vs 0.15 [95%CI 0.10 to 0.22] cm2, p = 0.049). Multivariate analysis revealed severe AVC (Hazard ratio 2.79, 95% CI 1.18 to 6.63, p = 0.02) along with pulmonary artery pressure post-valvuloplasty (Hazard ratio 1.02, 95% CI 1.00 to 1.03, p = 0.03) to be predictive of survival. In conclusion, in patients with severe aortic stenosis the degree of AVC impacts on the success of valvuloplasty.

Mid-to-long term mortality following surgical versus percutaneous coronary revascularization stratified according to stent subtype: An analysis of 6,682 patients with multivessel disease.

BACKGROUND: Studies comparing coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) have largely been performed in the bare-metal stent (BMS) and first-generation drug eluting stent (F-DES) era. Second-generation DES (S-DES) have shown improved outcomes when compared to F-DES, but data comparing CABG with PCI using S-DES is limited. We compared mortality following CABG versus PCI for patients with multivessel disease and analyzed different stent types. METHODS: A total of 6,682 patients underwent multivessel revascularization at Harefield Hospital, UK. We stratified CABG patients into single arterial graft (SAG) or multiple arterial grafts (MAG); and PCI patients into BMS, F-DES or S-DES groups. We analyzed all-cause mortality at 5 years. RESULTS: 4,388 patients had CABG (n[SAG] = 3,358; n[MAG] = 1,030) and 2,294 patients had PCI (n[BMS] = 416; n[F-DES] = 752; n[S-DES] = 1,126). PCI had higher 5-year mortality with BMS (HR = 2.27, 95% CI:1.70-3.05, p<0.001); F-DES (HR = 1.52, 95% CI:1.14-2.01, p = 0.003); and S-DES (HR = 1.84, 95% CI:1.42-2.38, p<0.001). This was confirmed in inverse probability treatment weighted analyses. When adjusting for both measured and unmeasured factors using instrumental variable analyses, PCI had higher 5-year mortality with BMS (Δ = 15.5, 95% CI:3.6,27.5, p = 0.011) and FDES (Δ = 16.5, 95% CI:6.6,26.4, p<0.001), but had comparable mortality with CABG for PCI with SDES (Δ = 0.9, 95% CI: -9.6,7.9, p = 0.844), and when exclusively compared to CABG patients with SAG (Δ = 0.4, 95% CI: -8.0,8.7, p = 0.931) or MAG (Δ = 4.6, 95% CI: -0.4,9.6, p = 0.931). CONCLUSIONS: In this real-world analysis, when adjusting for measured and unmeasured confounding, PCI with SDES had comparable 5-year mortality when compared to CABG. This warrants evaluation in adequately-powered randomized controlled trials.

The prognostic significance of incomplete revascularization and untreated coronary anatomy following percutaneous coronary intervention: An analysis of 6,755 patients with multivessel disease.

BACKGROUND: More than half of the patients undergoing percutaneous coronary intervention (PCI) have multivessel disease. Whether complete revascularization impacts long-term mortality or whether selected patients or those with specific coronary anatomy benefit from complete revascularization is unclear. METHODS: A total of 14,452 patients underwent PCI between 2004 and 2015 at Harefield Hospital, UK. Of these, 7,076 patients had multivessel disease. We excluded 321 patients with left main-stem stenosis ≥50%, with 6,755 patients included in the analysis (936 patients had complete revascularization). RESULTS: The unadjusted 3-year mortality rates were lower with complete revascularization (10.8% vs 13.1%, P = 0.047). However, multivariable-adjusted analyses indicated that complete revascularization was not independently associated with mortality (HR = 1.01, 95% CI: 0.78-1.31, P = 0.939). These findings were unchanged when addressing measured confounding using propensity-matched analyses (HR = 1.16, 95% CI: 0.81-1.65, P = 0.417) and inverse probability treatment weighted analyses (HR = 1.01, 95% CI: 0.77-1.33, P = 0.950); and unmeasured confounding using instrumental variable analyses (Δ = 0.9%, 95% CI: -2.5%, 4.3%, P = 0.958). There was no association with mortality and untreated LAD disease (HR = 0.92, 95% CI: 0.72-1.17, P = 0.482) and LCx disease (HR = 0.90, 95% CI: 0.74-1.10, P = 0.999). However, untreated proximal LAD disease (HR = 1.23, 95% CI: 1.06-1.51, P = 0.045) and RCA disease (HR = 1.36, 95% CI: 1.08-1.65, P = 0.007) was associated with increased mortality, particularly in patients with ST-elevation acute coronary syndrome (STEACS). CONCLUSIONS: In this study of unselected patients undergoing PCI, complete revascularization did not confer a mortality benefit. However, the presence of untreated proximal LAD and RCA disease was prognostic in patients with STEACS. Thus, complete revascularization may be considered in select patient groups with anatomical subsets of coronary disease.

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.

OBJECTIVES: The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BACKGROUND: The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. METHODS: Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. RESULTS: A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. CONCLUSIONS: This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

Comparison of Outcomes of Coronary Artery Bypass Grafting Using Internal Mammary Graft Versus Percutaneous Coronary Intervention for Isolated Proximal Left Anterior Descending Narrowing.

There are limited contemporary studies comparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for isolated proximal left anterior descending (LAD) disease. Increasing stent length and decreasing stent diameters are associated with increased risk of restenosis and adverse outcomes after PCI. Whether these parameters influence outcomes when comparing CABG and PCI is unclear. We compared CABG and PCI in 3,473 patients who underwent revascularization for isolated proximal LAD disease from 2004 to 2015 at Harefield Hospital, UK; 3,078 patients (89%) had PCI and 384 patients had CABG (11%). We analyzed all-cause mortality at 3 years. The unadjusted mortality rates were similar (PCI vs CABG: 9.5% vs 7.0%, p = 0.109). PCI was associated with comparable mortality (hazard ratio [HR] 1.15, 95% confidence interval [CI] 0.70 to 1.89, p = 0.593), even when stratified to bare-metal stents (HR 1.58, 95% CI 0.89 to 2.80, p = 0.121); first-generation drug-eluting stents (FDES; HR 1.16, 95% CI 0.67 to 2.02, p = 0.597); and second-generation DES (SDES; HR 0.98, 95% CI 0.53 to 1.82, p = 0.946). Stent diameters did not influence outcomes, but PCI was associated with higher mortality when stent length ≥30 mm (HR 2.12, 95% CI 1.12 to 4.03, p = 0.022). There was a linear association between stent length and mortality, and for every 1-mm increase in stent length, the 3-year mortality increased by 0.32%. In conclusion, for patients with isolated proximal LAD disease, PCI and CABG were associated with similar mortality. Increasing stent length was progressively associated with worse outcomes with PCI. For longer segments of disease requiring stent lengths ≥30 mm, CABG may be associated with better outcomes.

Imaging diagnoses and outcome in patients presenting for primary angioplasty but no obstructive coronary artery disease.

OBJECTIVE: A proportion of patients with suspected ST-elevation myocardial infarction (STEMI) presenting for primary percutaneous coronary intervention (PPCI) do not have obstructive coronary disease and other conditions may be responsible for their symptoms and ECG changes. In this study, we set out to determine the prevalence and aetiology of alternative diagnoses in a large PPCI cohort as determined with multimodality imaging and their outcome. METHODS: From 2009 to 2012, 5238 patients with suspected STEMI were referred for consideration of PPCI. Patients who underwent angiography but had no culprit artery for revascularisation and no previous history of coronary artery disease were included in the study. Troponin values, imaging findings and all-cause mortality were obtained from hospital and national databases. RESULTS: A total of 575 (13.0%) patients with a mean age of 58±15 years (69% men) fulfilled the inclusion criteria. A specific diagnosis based on imaging was made in 237 patients (41.2%) including cardiomyopathies (n=104, 18%), myopericarditis (n=48, 8.4%), myocardial infarction/other coronary abnormality (n=27, 4.9%) and severe valve disease (n=23, 4%). Pulmonary embolism and type A aortic dissection were identified in seven (1.2%) and four (0.7%) cases respectively. A total of 40 (7.0%) patients died over a mean follow-up of 42.6 months. CONCLUSIONS: A variety of cardiac and non-cardiac conditions are prevalent in patients presenting with suspected STEMI but culprit-free angiogram, some of which may have adverse outcomes. Further imaging of such patients could thus be useful to help in appropriate management and follow-up.

Classification of Aortic Stenosis by Flow and Gradient Patterns Provides Insights into the Pathophysiology of Disease.

Different patterns of flow and valve gradients can lead to diagnostic uncertainty about the severity of aortic stenosis (AS). Consecutive patients with severe AS (valve area <1 cm(2)) underwent echocardiography and computed tomography. Patients were classified into 4 groups (high-gradient/normal flow [HGNF], high-gradient/low flow [HGLF], low-gradient/normal flow [LGNF], and low-gradient/low flow [LGLF]). Low flow was defined as stroke volume index <35 mL/m(2) and low gradient as a mean aortic gradient <40 mm Hg. Aortic valve calcification (AVC) was calculated using the Agatston score. Of 181 patients, 56, 30, 46, and 49 had HGNF, HGLF, LGNF and LGLF with median AVC of 2048, 2015, 1366, and 1178 AU/m(2) (P < .0001) and valvuloarterial impedance of 4.5, 6.4, 4.2, and 5.9, respectively (P < .0001). Among those with LGLF, AVC was lower in patients with preserved compared to reduced left ventricular ejection fraction (1018 vs 2550 AU/m(2); P < .0001), but valvuloarterial impedance was similar (P = .33). The LGLF AS with preserved ejection fraction is associated with lower AVC and may identify patients with less severe AS in association with an adaptive ventricular response to high afterload.