Tito Kabir

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.

Culprit Vessel Versus Multivessel Intervention at the Time of Primary Percutaneous Coronary Intervention in Patients With ST-Segment–Elevation Myocardial Infarction and Multivessel Disease: Real-World Analysis of 3984 Patients in London

Background—It is estimated that up to two thirds of patients presenting with ST-segment–elevation myocardial infarction have multivessel disease. The optimal strategy for treating nonculprit disease is currently under debate. This study provides a real-world analysis comparing a strategy of culprit-vessel intervention (CVI) versus multivessel intervention at the time of primary percutaneous coronary intervention in patients with ST-segment–elevation myocardial infarction. Methods and Results—We compared CVI versus multivessel intervention in 3984 patients with multivessel disease undergoing primary percutaneous coronary intervention between 2004 and 2011 at all 8 tertiary cardiac centers in London. Multivariable-adjusted models were built to determine independent predictors for in-hospital major adverse cardiovascular events (MACEs) and all-cause mortality at 1 year. To reduce confounding and bias, propensity score methods were used. CVI was associated with reduced in-hospital MACE (4.6% versus 7.2%; P=0.010) and mortality at 1 year (7.4% versus 10.1%; P=0.031). CVI was an independent predictor for reduced in-hospital MACE (odds ratio, 0.49; 95% confidence interval [CI], 0.32–0.75; P<0.001) and survival at 1 year (hazard ratio, 0.65; 95% CI, 0.47–0.91; P=0.011) in the complete cohort; and in 2821 patients in propensity-matched cohort (in-hospital MACE: odds ratio, 0.49; 95% CI, 0.32–0.76; P=0.002; and 1-year survival: hazard ratio, 0.64; 95% CI, 0.45–0.90; P=0.010). Inverse probability treatment weighted analyses also confirmed CVI as an independent predictor for reduced in-hospital MACE (odds ratio, 0.38; 95% CI, 0.15–0.96; P=0.040) and survival at 1 year (hazard ratio, 0.44; 95% CI, 0.21–0.93; P=0.033). Conclusions—In this observational analysis of patients with ST-segment–elevation myocardial infarction undergoing primary percutaneous coronary intervention, CVI was associated with increased survival at 1 year. Acknowledging the limitations with observational analyses, our findings support current recommended practice guidelines.

Delivering thrombectomy for acute stroke using cardiology services.

Why should the location of an acutely occluded artery affect who gets treated?

High incidence of acute coronary occlusion in patients without protocol positive ST segment elevation referred to an open access primary angioplasty programme.

Background Primary percutaneous coronary intervention (PPCI) programmes vary in admission criteria from open referral to acceptance of electrocardiogram (ECG) protocol positive patients only. Rigid criteria may result in some patients with acutely occluded coronary arteries not receiving timely reperfusion therapy. Objective To compare the prevalence of acute coronary occlusion and, in these cases, single time point biomarker estimates of myocardial infarct size between patients presenting with protocol positive ECG changes and those presenting with less diagnostic changes in the primary angioplasty cohort of an open access PPCI programme. Methods We retrospectively performed a single centre cross sectional analysis of consecutive patients receiving PPCI between January and August 2008. Cases were categorised according to presenting ECG—group A: protocol positive (ST segment elevation/left bundle branch block/posterior ST elevation myocardial infarction), group B: ST segment depression or T-wave inversion, or group C: minor ECG changes. Clinical characteristics, coronary flow grades and 12 h postprocedure troponin-I levels were reviewed. Results During the study period there were 513 activations of the PPCI service, of which 390 underwent immediate angiography and 308 underwent PPCI. Of those undergoing PPCI, 221 (72%) were in group A, 41 (13%) in group B and 46 (15%) in group C. Prevalence of coronary occlusion was 75% in group A compared with 73% in group B and 63% in group C. Median 12 h postintervention troponin-I (25th–75th percentile) for those with coronary occlusion was significantly higher in group A patients; 28.9 μg/l (13.2–58.5) versus 18.1 μg/l (6.7–32.4) for group B (p=0.03); and 15.5 μg/l (3.8–22.0) for group C (p<0.001), suggesting greater infarct size in group A. Conclusions A number of patients referred to an open access PPCI programme have protocol negative ECGs but myocardial infarction and acute coronary artery occlusion amenable to angioplasty.

High prevalence of raised lipoprotein(a) in patients with refractory angina.

Background: Angina that is refractory to conventional medical therapy and revascularisation, remains challenging to manage and poses significant burden to patients. Elevated lipoprotein(a) [Lp(a)] has emerged as an important independent cardiovascular risk factor and predictor of adverse outcomes in atherosclerotic disease. The prevalence of raised Lp(a) amongst patients with refractory angina has not yet been defined. Objective: To establish the prevalence of raised [Lp(a)] >500 mg/L in patients with refractory angina. Methods: We conducted an epidemiological screening pilot study in 75 patients with refractory angina from a UK tertiary cardiac centre. We determined the proportion of the cohort with raised Lp(a) >500 mg/L using an isoform-insensitive method. In addition, a full fasting lipid profile (including: LDL cholesterol, HDL cholesterol, total cholesterol to HDL ratio and triglycerides) was obtained. Patients were also asked about the presence of conventional cardiovascular risk factors. Results: Our study demonstrated that 60% of the 75 patients with refractory angina had raised Lp(a) levels of >500 mg/L. The median and inter-quartile range of Lp(a) values were 771 mg/L (162 mg/L,1260 mg/L) respectively. Conclusions: This high prevalence of raised Lp(a) detected in our cohort with refractory angina may suggest a causal role. Further research is necessary to confirm this association and prospective studies are needed to explore the potential therapeutic benefit of Lp(a) reduction in patients with refractory angina.

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

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.

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 cm2) 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/m2 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/m2 (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/m2; 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.

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.

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

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.

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 cusps 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 Youdens 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.