Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry.

BACKGROUND: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR. METHODS: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial. RESULTS: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001). CONCLUSIONS: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.

Clinical Outcomes in Patients Treated With Biodegradable-Polymer Biolimus-Eluting Stents and 6 Months of Dual-Antiplatelet Therapy: The French eBiomatrix 6-Month DAPT Registry.

BACKGROUND: Dual-antiplatelet treatment (DAPT) has conventionally been prescribed for 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Recent evidence suggests that a duration of only 6 months may be equally safe and effective when using contemporary DES options. OBJECTIVE: The aim of this study was to assess clinical outcomes in patients treated with the BioMatrix biodegradable-polymer coated biolimus-eluting stent (BP-BES; Biosensors International) who received only 6 months of DAPT. METHODS: This prospective "all-comers" registry enrolled 2038 patients in France. Following PCI, DAPT was started for a recommended period of 6 months. Patients were followed up at 6 and 24 months. The primary endpoint of major adverse cardiac and cerebrovascular event (MACCE) was a composite of all-cause death, cerebrovascular accidents, non-fatal myocardial infarction, or clinically driven target-vessel revascularization. Secondary endpoints included stent thrombosis (ST) and major bleeding (MB). RESULTS: The mean age of the study population was 67 ± 10.5 years and 77% of patients were male. Follow-up data were available in 96.9% and 95.3% of patients at 6 and 24 months, respectively. At 6 months, the incidences of MACCE, ST, and MB were 3.1%, 0.3%, and 0.4%, respectively. At 24 months, 21.2% of patients were still on DAPT and the cumulative incidences of MACCE, ST, and MB were 9.7%, 0.54%, and 0.79%, respectively. CONCLUSIONS: In this unselected population of patients undergoing PCI with a BP-BES, a 6-month duration of DAPT after implantation is safe and effective.

Predicting the Need For Permanent Pacing After Implantation of the Repositionable Lotus Transcatheter Aortic Valve.

BACKGROUND: The need for permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) is a recognized complication due to compression of the cardiac conduction system. PPI rates vary according to type of TAVI device, implantation technique, and patient-related factors. METHODS: We analyzed the baseline characteristics, and then the preprocedure and daily postprocedure electrocardiograms (ECGs) of 101 consecutive patients who underwent TAVI using the Lotus valve (Boston Scientific) between 2013 and 2015. RESULTS: Mean patient age was 81.7 ± 7.7 years, 56% were male. and 21 patients were excluded because of baseline atrial fibrillation or a pre-existing PPI. Of the remaining 80 patients, a total of 28 (35%) underwent PPI at a mean 2.7 days after TAVI. There were no differences in development of new left bundle-branch block between the two groups (65% PPI group vs 74% no-PPI group; P=.37). The initial PR interval did not differ between groups (183 ms PPI group vs 184 ms no-PPI group). The PR interval increased by day 1 post procedure (232 ms PPI group vs 195 ms no-PPI group; P<.01) and day 2 (267 ms PPI group vs 211 ms no-PPI group; P<.05). CONCLUSIONS: Patients with a PR interval ≤230 ms on day 1 or ≤260 ms on day 2 post TAVI using the Lotus device are at very low risk of requiring PPI, irrespective of the presence of left bundle-branch block, and can be safely discharged without prolonged monitoring.

Automatic segmentation of optical coherence tomography pullbacks of coronary arteries treated with bioresorbable vascular scaffolds: Application to hemodynamics modeling.

BACKGROUND / OBJECTIVES: Automatic algorithms for stent struts segmentation in optical coherence tomography (OCT) images of coronary arteries have been developed over the years, particularly with application on metallic stents. The aim of this study is three-fold: (1) to develop and to validate a segmentation algorithm for the detection of both lumen contours and polymeric bioresorbable scaffold struts from 8-bit OCT images, (2) to develop a method for automatic OCT pullback quality assessment, and (3) to demonstrate the applicability of the segmentation algorithm for the creation of patient-specific stented coronary artery for local hemodynamics analysis. METHODS: The proposed OCT segmentation algorithm comprises four steps: (1) image pre-processing, (2) lumen segmentation, (3) stent struts segmentation, (4) strut-based lumen correction. This segmentation process is then followed by an automatic OCT pullback image quality assessment. This method classifies the OCT pullback image quality as 'good' or 'poor' based on the number of regions detected by the stent segmentation. The segmentation algorithm was validated against manual segmentation of 1150 images obtained from 23 in vivo OCT pullbacks. RESULTS: When considering the entire set of OCT pullbacks, lumen segmentation showed results comparable with manual segmentation and with previous studies (sensitivity ~97%, specificity ~99%), while stent segmentation showed poorer results compared to manual segmentation (sensitivity ~63%, precision ~83%). The OCT pullback quality assessment algorithm classified 7 pullbacks as 'poor' quality cases. When considering only the 'good' classified cases, the performance indexes of the scaffold segmentation were higher (sensitivity >76%, precision >86%). CONCLUSIONS: This study proposes a segmentation algorithm for the detection of lumen contours and stent struts in low quality OCT images of patients treated with polymeric bioresorbable scaffolds. The segmentation results were successfully used for the reconstruction of one coronary artery model that included a bioresorbable scaffold geometry for computational fluid dynamics analysis.

Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score.

OBJECTIVES: The aim was to establish a contemporary scoring system to predict the outcome of chronic total occlusion coronary angioplasty. BACKGROUND: Interventional treatment of chronic total coronary occlusions (CTOs) is a developing subspecialty. Predictors of technical success or failure have been derived from datasets of modest size. A robust scoring tool could facilitate case selection and inform decision making. METHODS: The study analyzed data from the EuroCTO registry. This prospective database was set up in 2008 and includes >20,000 cases submitted by CTO expert operators (>50 cases/year). Derivation (n = 14,882) and validation (n = 5,745) datasets were created to develop a risk score for predicting technical failure. RESULTS: There were 14,882 patients in the derivation dataset (with 2,356 [15.5%] failures) and 5,745 in the validation dataset (with 703 [12.2%] failures). A total of 20.2% of cases were done retrogradely, and dissection re-entry was performed in 9.3% of cases. We identified 6 predictors of technical failure, collectively forming the CASTLE score (Coronary artery bypass graft history, Age (≥70 years), Stump anatomy [blunt or invisible], Tortuosity degree [severe or unseen], Length of occlusion [≥20 mm], and Extent of calcification [severe]). When each parameter was assigned a value of 1, technical failure was seen to increase from 8% with a CASTLE score of 0 to 1, to 35% with a score ≥4. The area under the curve (AUC) was similar in both the derivation (AUC: 0.66) and validation (AUC: 0.68) datasets. CONCLUSIONS: The EuroCTO (CASTLE) score is derived from the largest database of CTO cases to date and offers a useful tool for predicting procedural outcome.

Association between inflammatory biomarkers and neointimal response following elective implantation of the ABSORB bioresorbable vascular scaffold.

INTRODUCTION: The ABSORB bioresorbable vascular scaffold (BVS) is associated with greater neointimal proliferation and thrombotic rate than metal stent. The role of inflammatory biomarkers on neointimal proliferation has not been studied in the setting of BVS implantation. PATIENTS AND METHODS: Thirty patients had arterial blood sampling before elective percutaneous coronary intervention with the ABSORB BVS and at 9-months follow-up. Plasma levels of interleukin-6, soluble CD40 ligand, monocyte chemotactic protein-1 and C-reactive protein were measured using enzyme-linked immunosorbent assay. Baseline and follow-up levels were compared for each biomarker. Optical frequency domain imaging was performed at follow-up and the neointimal burden was calculated as the ratio of neointimal area to scaffold area. The levels of inflammatory mediators were correlated with the neointimal burden. RESULTS: There was no significant increase in the levels of biomarkers from baseline to follow-up. Median C-reactive protein levels changed from 1.1 [interquartile range (IQR): 0.5-2.5] to 2.2 (IQR: 0.5-3.5) µg/ml, interleukin-6 from 1.0 (IQR: 0.6-1.4) to 1.0 (IQR: 0.6-1.4) pg/ml, monocyte chemotactic protein-1 from 120.4 (IQR: 86.0-153.4) to 102.0 (IQR: 70.3-148.1) pg/ml and soluble CD40 ligand from 108.3 (IQR: 74.1-173.7) to 112.0 (IQR: 71.0-225.9) pg/ml. The average neointimal burden in the cohort was 18±6%. Baseline, follow-up and change in plasma levels of inflammatory markers between these two time points did not correlate with the neointimal burden. CONCLUSION: Elective percutaneous coronary intervention with the ABSORB BVS does not provoke a chronic inflammatory response. The degree of neointimal proliferation after elective implantation of the ABSORB BVS is independent of the pre-existing inflammatory environment.

Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement.

OBJECTIVES: The aim of this study was to evaluate the predictors of left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a major concern with TMVR, but limited data exist regarding its predictors and impact on outcomes. METHODS: Patients with pre-procedural multidetector row computed tomography (MDCT) undergoing TMVR for failed mitral bioprosthetic valves (valve-in-valve), annuloplasty rings (valve-in-ring), and mitral annular calcification (valve-in-MAC) were included in this study. Echocardiographic and procedural characteristics were recorded, and comprehensive assessment with MDCT was performed to identify the predictors of LVOT obstruction (defined as an increment of mean LVOT gradient ≥10 mm Hg from baseline). The new LVOT (neo-LVOT) area left after TMVR was estimated by embedding a virtual valve into the mitral annulus on MDCT, simulating the procedure. RESULTS: Among 194 patients with pre-procedural MDCT undergoing TMVR (valve-in-valve, 107 patients; valve-in-ring, 50 patients; valve-in-MAC, 37 patients), LVOT obstruction was observed in 26 patients (13.4%), with a higher rate after valve-in-MAC than valve-in-ring and valve-in-valve (54.1% vs. 8.0% vs. 1.9%; p < 0.001). Patients with LVOT obstruction had significantly higher procedural mortality compared with those without LVOT obstruction (34.6% vs. 2.4%; p < 0.001). Receiver-operating characteristic curve analysis showed that an estimated neo-LVOT area ≤1.7 cm2 predicted LVOT obstruction with sensitivity of 96.2% and specificity of 92.3%. CONCLUSIONS: LVOT obstruction after TMVR was associated with higher procedural mortality. A small estimated neo-LVOT area was significantly associated with LVOT obstruction after TMVR and may help identify patients at high risk for LVOT obstruction.

A randomized trial comparing two stent sizing strategies in coronary bifurcation treatment with bioresorbable vascular scaffolds - The Absorb Bifurcation Coronary (ABC) trial.

BACKGROUND: Limited information is available on the use of Bioresorbable Vascular Scaffold (BVS) in bifurcations involving significant side branches. When treating bifurcation disease with metal stents, the recommendation is to choose a stent diameter based on the distal main vessel diameter. Whether this sizing strategy is applicable to BVS is currently unknown. METHODS: We randomised 37 patients undergoing elective PCI for 'false' bifurcation disease (Medina 0,1,0; 1,0,0; 1,1,0) to receive BVS based either on proximal or distal reference diameters. Optical Frequency Domain Imaging (OFDI) measurements were performed pre BVS insertion to obtain proximal and distal reference diameters and post implantation. BVS size was chosen according to the proximal or distal reference diameter as per randomisation. Implantation was performed using the PSP technique tailored to bifurcation stenting. OFDI was repeated post implantation to confirm satisfactory expansion and apposition. RESULTS: Baseline demographics between the two groups were similar. Patients were aged 62.8 ±â€¯3.3 years; 76% were male. Mean side branch diameter was 2.24 ±â€¯0.13 mm. TIMI III flow in the main vessel was achieved in all cases. Side branch occlusion occurred in 1 case (2.7%). In the distal-sizing arm, there was a greater incidence of significant malapposition (>300 µm) at the proximal end of the scaffold on OCT (2.3% versus 0.8%, p 0.023). The incidence of distal edge dissections was numerically greater in the proximal-sizing group but this was not statistically significant (31.3% vs 11.8%, p 0.17). CONCLUSION: Both proximal and distal sizing strategies have similar procedural complication rates when using the ABSORB BVS to treat coronary bifurcations. However a proximal sizing strategy is associated with less malapposition and may be preferable.

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.

The effect of elective implantation of the ABSORB bioresorbable vascular scaffold on coronary microcirculation: Serial assessment using the index of microcirculatory resistance.

INTRODUCTION: Stenting with metal stents can affect microcirculatory function. The impact of BVS on the microvascular network has not been studied. METHODS: A total of 30 patients with bifurcation disease of Medina (X,X,0) scheduled for elective PCI with the ABSORB BVS were studied. Pressure wire studies were performed before and after scaffold implantation and at a mean follow-up of 9 months. At each time point, FFR, IMR, and CFR were calculated using the thermodilution method. RESULTS: Following scaffold implantation, FFR change from pre-PCI, post-PCI and follow-up was 0.76, 0.92 and 0.91, respectively (P < 0.001 from pre to post-PCI and P = 0.91 from post-PCI to follow-up). There was a statistically significant improvement between pre- and post-procedural IMR (median 27.7 to 17.9, P = 0.02) and CFR (median 2.2 to 2.9, P = 0.02). Median IMR at follow-up (23.6) remained numerically lower than pre-procedure but this was not statistically significant (P = 0.05). Similarly, while median CFR at follow-up remained at post-procedural level (2.9), this effect did not reach statistical significance (P = 0.06). CONCLUSION: There is an immediate reduction in microvascular resistance after elective BVS implantation but this effect is not sustained long term.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings.

BACKGROUND: Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. OBJECTIVES: This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). METHODS: From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. RESULTS: A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). CONCLUSIONS: The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

OBJECTIVES: The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. METHODS: Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. RESULTS: Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of aortic valve calcification was also associated with a higher pacing rate (OR: 0.55; p = 0.031). Multivariate regression analysis did not show an independent association between depth of implant, valve oversizing, balloon post-dilatation, and the need for pacing post-procedure. CONCLUSIONS: Following implantation of the repositionable LOTUS valve, 55% of patients developed LBBB and 32% of patients required a pacemaker during their index hospital admission. Patients with pre-procedural conduction disturbance and non-calcified aortic valves were more likely to need pacing. No other anatomic features were identified with increased pacing requirement with the LOTUS device.

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.

Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Valve: United Kingdom Experience.

OBJECTIVES: This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts). BACKGROUND: First-generation transcatheter aortic valves have limitations. Second-generation repositionable valves may improve on some of those limitations. METHODS: Prospectively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom. RESULTS: Implants in 228 patients age 81.4 ± 7.6 years were studied; 53.5% were male. Mean logistic EuroScore was 17.5 ± 12.4. One hundred eighty-seven (82.0%) were undertaken for aortic stenosis, 7 (3.1%) for aortic regurgitation, and 34 (14.9%) for mixed aortic valve disease. A total of 67.1% of cases were done under local anesthetic and/or sedation with transfemoral access in 94.7% and transaortic in 5.3%. Three device sizes were used: 23 mm (n = 66, 28.9%), 25 mm (n = 39, 17.1%), and 27 mm (n = 123, 53.9%). The valve was successfully deployed in 99.1% of procedures. After implantation, the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2). In-hospital mortality was 1.8% (n = 4). Complications included cardiac tamponade (1.8%), conversion to sternotomy (1.3%), stroke (3.9%), vascular access-related (7.0%), and acute kidney injury (7.9%). The incidence of moderate/severe aortic regurgitation was 0.8% (n = 2). A total of 31.8% of patients required new permanent pacemaker implantation. CONCLUSIONS: This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation.

Transradial Secondary Arterial Access for Transcatheter Aortic Valve Implantation: Experience and Limitations.

OBJECTIVES: The transradial approach limits vascular complications in coronary interventions. The same may be true for transcatheter aortic valve implantation (TAVI). We present our experience using secondary transradial arterial access. METHODS: Secondary transradial arterial access has been our default strategy for TAVI since 2007. Procedural data is collected prospectively. We assessed procedural success and complications. RESULTS: Data from 282 patients aged 81±5.2 yrs was examined. Secondary arterial access was transradial (74%), femoral (24%) and none (2%). Secondary femoral access was reserved for failed radial access (3%), anatomical anomalies (4%), operator preference (7%), trial requirements (6%) or proctor preference (4%). The principal pathology was aortic stenosis (90.8%), aortic regurgitation (6.7%) or a combination (2.5%). CoreValve (91.4%), Edwards (7%) or Lotus valves (1.7%) were delivered via transfemoral (88.6%), direct aortic (5.3%), subclavian (3.9%) or transapical approaches (1.8%). Significant vascular complications occurred in 25 cases (9.4%), including surgical repair of a failed percutaneous closure device (n=16), ilio-femoral dissection (n=3), iliac perforations (n=3), plaque disruption (n=1) and false aneurysm (n=2), one of which was from the secondary femoral access site. There was no local vascular complication from the secondary radial site. CONCLUSIONS: The transradial secondary access route for TAVI is safe and effective. The transradial route may limit vascular access complications from secondary transfemoral access.

Left Main Stem Percutaneous Coronary Intervention - Data and Ongoing Trials.

Left main stem (LMS) disease is associated with significant morbidity and mortality. Traditionally coronary artery bypass grafting (CABG) has been the gold standard for treatment of these lesions. However over the past decade, percutaneous coronary intervention (PCI) has assumed a more prominent role in the treatment of LMS disease. With the advent of newer drug-eluting stents (DES) with an improved risk factor profile, better intravascular imaging modalities and careful patient selection, the use of PCI in this cohort is expanding. We review the current data to support this and discuss the on-going trials that will hopefully shed more light into the management of this complex disease.

An unusual cause of ST elevation myocardial infarction (STEMI).

A 67-year-old Caucasian woman presented to clinic with a 2-month history of worsening shortness of breath on exertion and a single episode of chest pain 1 week before. Her ECG in clinic showed ST elevation inferiorly and she was admitted from clinic for further investigations as inpatient. She was initiated on the acute coronary syndrome protocol and underwent emergency left heart catheterisation on the day of admission. The coronary angiogram revealed large aneurysmal dilations in the right coronary artery and left main stem. A ventriculogram showed poor left ventricular (LV) systolic function in line with subsequent transthoracic echocardiogram, which revealed her to have an left ventricular ejection-fraction (LVEF) of approximately 20%. It was agreed with the cardiothoracic surgeons to treat the aneurysms non-operatively and start low-molecular weight heparin. Furthermore the underlying biventricular impairment was treated with ACE-inhibitors, ß-blockers and diuretic therapy (loop and potassium-sparing). The strategy was to prevent further thrombus formation with the aneurysmal vessels and to achieve this the patient was initiated on lifelong warfarin. Other medical risk factors were optimised and patient started on statin medication. The aneurysm was monitored with serial CTs with a view to reconsider surgical intervention if any evidence of dilation. This case highlights an unusual cause of ST elevation myocardial infarction.