Pre-procedural pacing bias among transcatheter aortic valves with higher post-procedure pacing rates: evidence from the UK TAVI Registry.

Rates of permanent pacemaker (PPM) implantation following transcatheter aortic valve implantation (TAVI) are higher than following surgery and are dependent on patient factors and valve type. There is an increasing trend towards pre-emptive PPM insertion in patients with significant conduction disease prior to TAVI. We report results from the British Cardiovascular Intervention Society (BCIS) on pre- and post-procedural PPM implantation in the TAVI population. All centres in the United Kingdom performing TAVI are required to submit data on all TAVI procedures to the National database which are then reported annually. During 2015, there were 2373 TAVI procedures in the UK. 22.4% of TAVI patients had a PPM implanted either pre-procedure (including the distant past), or during the in-hospital procedural episode. Of these, 7.9% were pre-procedure and 14.5% post-procedure. Overall PPM rates were Edwards Sapien (13.5%), Medtronic CoreValve (28.2%) and Boston Lotus (42.1%; p < 0.01). Pre-procedure pacing rates were Edwards Sapien (6.0%), Medtronic CoreValve (9.1%) and Boston Lotus (12.3%; p < 0.01). Pre-procedural pacing rates for the Boston Lotus valve have risen year-on-year from 5.8% (2013) to 8.6% (2014) to 12.3% (2015). The UK TAVI Registry demonstrates a pre-procedural permanent pacing bias amongst patients receiving transcatheter valves with higher post-procedure pacing rates. Pre-emptive permanent pacing is likely to be responsible for this difference.

Sex-based differences in outcomes with bivalirudin or unfractionated heparin for transcatheter aortic valve replacement: Results from the BRAVO-3 randomized trial.

BACKGROUND: Women comprise almost 50% of patients undergoing transcatheter aortic valve replacement (TAVR) and previous studies have indicated higher rates of procedural complications and bleeding in women compared to men. It is unknown whether men and women demonstrate a differential response to bivalirudin versus unfractionated heparin (UFH) in TAVR. We sought to evaluate outcomes by sex and type of anticoagulant from the Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement (BRAVO-3) trial of transfemoral TAVR. METHODS: BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). The primary endpoint was 48 h major bleeding defined as Bleeding Academic Research Consortium (BARC) type ≥3b. Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or stroke. Net adverse cardiovascular events (NACE) were a composite of BARC ≥3b bleeding or 30-day MACE. We examined the outcomes in men and women. RESULTS: The total cohort included 49% women (n = 391, 195 received bivalirudin and 196 UFH) and 51% men (n = 411, 209 received bivalirudin and 202 UFH). Women were older than men with fewer comorbidities including coronary artery disease, atrial fibrillation, diabetes but similar EuroSCORE I. Women received smaller sheath and device sizes compared with men without differences in the use of vascular closure devices. At 48-hr post-TAVR there was no difference in bleeding or vascular complications in women compared to men. The use of bivalirudin did not result in significantly lower bleeding at 48 hr or 30-days compared to UFH. CONCLUSIONS: There was no difference in early outcomes with bivalirudin versus UFH in men or women undergoing contemporary TAVR. © 2016 Wiley Periodicals, Inc.

Percutaneous paravalvular leak closure for symptomatic aortic regurgitation after CoreValve transcatheter aortic valve implantation.

OBJECTIVES: We present a case series of five patients in whom percutaneous paravalvular leak closure with the AVP4 device has been undertaken for symptomatic aortic regurgitation after CoreValve TAVI. BACKGROUND: Significant post-procedure aortic regurgitation (AR) is often difficult to assess, and is an important predictor of adverse outcome following TAVI. Paravalvular leak closure is an established procedure for surgical aortic prostheses, and has been undertaken for Edwards TAVIs, but has not been described for closure of CoreValve paravalvular leaks. METHODS AND RESULTS: Five patients were treated (mean age 81 ± 4 years) with residual grade 3-4 AR following placement of a single CoreValve (n = 2), double CoreValve (n = 2) or CoreValve within a bioprosthetic AVR (n = 1). The mean time post TAVI implantation was 308 ± 269 days. All patients were symptomatic with persistent NYHA Grade III dyspnoea. 6 devices were deployed successfully, with mean procedure time of 109 ± 23 min. There were no procedural complications and all patients were discharged home by Day 2. Residual AR after treatment was grade 0 (n = 2), grade 1 (n = 1), grade 2 (n = 1) and grade 3 (n = 1). Symptomatic improvement was noted in all 4 patients who have been reviewed in clinic since. CONCLUSIONS: This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038' lumen and can therefore be delivered down standard diagnostic catheters.

Procedural and follow-up outcomes among patients undergoing successful recanalisation of coronary chronic total occlusions using biolimus drug-eluting stents.

This study aimed at evaluating the outcome of Biolimus eluting stent (BES) implantation in the treatment of chronic total coronary occlusions (CTO). We identified patients who underwent successful angioplasty for a CTO lesion with ≥1 BES between June 2008 and March 2012. All patients were followed up for major adverse cardiac events (MACE), which comprised death, non-fatal myocardial infarction (MI), cerebrovascular accident, target vessel revascularization (TVR), target lesion revascularization (TLR) and stent thrombosis. 125 patients underwent successful CTO angioplasty with ≥1 Biolimus-eluting stents. Mean age was 63.8 ± 12.0 years, and 82.4 % were males. Lesion location was right coronary artery (n = 80, 64 %), left anterior descending artery (n = 35, 28 %) and left circumflex artery (n = 10, 8 %). During follow-up of 579 ± 293 days, all cause mortality was n = 8 (6.4 %) patients, non-fatal MI was n = 3 (2.4 %), TVR was n = 3 (2.4 %) and TLR was n = 1 (0.8 %). Overall MACE was, therefore, n = 15 (12 %). BES is safe and effective in treatment of CTO lesions, with a low rate of major adverse cardiovascular events during follow-up.

Antegrade rewiring of the retrograde Corsair catheter during revascularization of chronic total coronary occlusions: a simple alternative to guidewire exteriorization.

Chronic total occlusions prevent a significant challenge to interventional cardiologists. Successful opening of chronically occluded vessels has been shown to be associated with decreased mortality and morbidity. Recently, the retrograde approach to chronic total occlusion intervention has been developed. In this case series, we present a novel technique to assist with this procedure involving antegrade wiring of a retrograde microcatheter.

Mid-term prognostic value of coronary artery disease in patients undergoing transcatheter aortic valve implantation: a meta-analysis of adjusted observational results.

AIMS: Coronary artery disease (CAD) negatively affects prognosis in patients undergoing surgical aortic valve replacement, being currently evaluated in the most common used risk score. Our meta-analysis aims to clarify the prognostic role of CAD on mid-term survival in patients undergoing TAVI. METHODS AND RESULTS: Studies reporting multivariate predictors of adverse outcomes in patients undergoing TAVI were systematically searched for and pooled, when appropriate, using a random-effect method. 960 citations were first screened and finally 7 studies (2472 patients) were included. Diagnosis of CAD was reported in 52%(42-65) of patients and 1169 Edwards SAPIEN and 1303 CoreValve prostheses were implanted. After a median follow up of 452 days (357-585) 24% of patients (19-33) died, and 23 (14-32) for cardiovascular death. At pooled analysis of multivariate approach, diagnosis of coronary artery disease did not increase risk of death (OR 1.0, 95% CI, confidence interval, 0.67-1.50 I(2) 0%). CONCLUSION: CAD does not affect mid-term TAVI outcome: this finding should be weighted to accurately evaluate risk and strategies for patients with severe aortic stenosis.

Changing the coronary bifurcation angles after stenting procedures: the relevance to the technique and unfavorable outcome (Three-dimensional analysis).

AIM: Percutaneous transluminal balloon co-ronary angioplasty (PTCA) of coronary bifurcations is associated with a low success rate, higher rate of complications and need for revascularazation. We sought to analyze: 1) the change in 3D measurement of angles following stenting of coronary bifurcations; and 2) if changes in these angles might predict unfavourable outcomes. METHODS: Coronary angiograms of 102 patients with bifurcation lesions were analyzed with 3D software (CardiOp-B) before and after stenting. The change in angle between the proximal main artery and side branch (BA), and between the distal main artery and side branch (BS) were measured. A change of ≥ 5° after stenting was considered significant. The results were compared with clinical follow-up. RESULTS: Bifurcation lesions included 66 left anterior descending/first diagonal (LAD/D1) lesions, 15 left main stem (LMS) lesions, 19 atrioventricular circumflex/obtuse marginal (AVCx/OM) lesions, and 2 coronary artery (RCA) crux lesions. BA and BS measured 138.3° ± 17.2° and 64.3° ± 20.6° respectively. Stent deployment altered BA and BS significantly in 80-90% of cases. Furthermore, BS correlated positively with the magnitude of change in BS after stenting. BA was unaffected by the complexity of the stenting procedure, whereas BS increased significantly in complex versus simple stenting strategies (P<0.05). Procedure related complications occurred in 15.6% of patients. The incidence of in-hospital complications was lower when BA was increased (P<0.05). The one year incidence of the composite of in-hospital complications and late complications was also significantly lower when BA was increased by ≥ 5° (P=0.027). A decrease of BA was associated with 80% more complications compared to cases where BA was increased. No correlation was found between the change of BS and procedural or late complications. CONCLUSION: 3D measurements of coronary bifurcation angles prior to stenting can predict changes in bifurcation geometry after stenting. A decrease in BA after stenting is a strong predictor for less favourable outcomes of coronary bifurcation stenting procedures.

Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative).

BACKGROUND: Permanent pacemaker (PPM) requirement is a recognized complication of transcatheter aortic valve implantation. We assessed the UK incidence of permanent pacing within 30 days of CoreValve implantation and formulated an anatomic and electrophysiological model. METHODS AND RESULTS: Data from 270 patients at 10 centers in the United Kingdom were examined. Twenty-five patients (8%) had preexisting PPMs; 2 patients had incomplete data. The remaining 243 were 81.3±6.7 years of age; 50.6% were male. QRS duration increased from 105±23 to 135±29 milliseconds (P<0.01). Left bundle-branch block incidence was 13% at baseline and 61% after the procedure (P<0.001). Eighty-one patients (33.3%) required a PPM within 30 days. Rates of pacing according to preexisting ECG abnormalities were as follows: right bundle-branch block, 65.2%; left bundle-branch block, 43.75%; normal QRS, 27.6%. Among patients who required PPM implantation, the median time to insertion was 4.0 days (interquartile range, 2.0 to 7.75 days). Multivariable analysis revealed that periprocedural atrioventricular block (odds ratio, 6.29; 95% confidence interval, 3.55 to 11.15), balloon predilatation (odds ratio, 2.68; 95% confidence interval, 2.00 to 3.47), use of the larger (29 mm) CoreValve prosthesis (odds ratio, 2.50; 95% confidence interval, 1.22 to 5.11), interventricular septum diameter (odds ratio, 1.18; 95% confidence interval, 1.10 to 3.06), and prolonged QRS duration (odds ratio, 3.45; 95% confidence interval, 1.61 to 7.40) were independently associated with the need for PPM. CONCLUSION: One third of patients undergoing a CoreValve transcatheter aortic valve implantation procedure require a PPM within 30 days. Periprocedural atrioventricular block, balloon predilatation, use of the larger CoreValve prosthesis, increased interventricular septum diameter and prolonged QRS duration were associated with the need for PPM.

Radial artery anomaly and its influence on transradial coronary procedural outcome.

BACKGROUND: The transradial approach for percutaneous coronary procedures has the advantage of reduced access site complications but is associated with specific technical challenges in comparison with the transfemoral approach. Transradial procedure failures can sometimes be due to variation in radial artery anatomy. However, data describing such variations are limited. OBJECTIVE: To evaluate the incidence and impact of radial artery anomalies in patients undergoing transradial coronary procedures. METHODS: Retrograde radial arteriography was performed in all patients presenting for a first-time radial procedure. Patient characteristics, radial artery anatomy and procedural outcome were assessed. RESULTS: 1540 consecutive patients were studied, 70.6% male, mean (SD) age 63.6 (11.1) years. The overall incidence of radial artery anomaly was 13.8% (n = 212). 108 (7.0%) patients had a high-bifurcating radial origin, 35 (2.3%) had a full radial loop, 30 (2.0%) had extreme radial artery tortuosity and 39 (2.5%) had miscellaneous anomalies such as radial atherosclerosis and accessory branches. Overall transradial procedural success was 96.8%. Procedural failure was more common in patients with anomalous anatomy than in patients with normal anatomy (14.2% vs 0.9%, p<0.001). Procedural failure in patients with high radial bifurcation, radial loop, severe radial tortuosity and other anomalies was 4.6%, 37.1%, 23.3% and 12.9%, respectively. 15 (1%) vascular complications occurred, all of which were treated conservatively without ischaemic sequelae. CONCLUSION: Anomalous radial artery anatomy is relatively common and is a significant cause of procedural failure. Within each specific anomalous pattern there is a differential procedural failure rate. This has implications for clinical practice and suggests a need for imaging of the radial artery after sheath insertion.

Percutaneous closure of an aortic paravalvular leak via the transradial approach.

Percutaneous closure of aortic and mitral paraprosthetic leaks using the Amplatzer occluders (muscular ventricular septal defect occluder) is now a well recognized procedure although as "off label" use. Aortic paravalvular leak closure is usually carried out via transfemoral puncture, but problems with this approach include the need to stop warfarin and the inadequate length of standard delivery sheaths. We report the first case of percutaneous aortic paravalvular leak closure through the radial artery route.

Transradial coronary intervention without pre-screening for a dual palmar blood supply.

It is usual practice to determine the presence of collateral blood supply to the hand prior to radial artery cannulation. We propose that pre-screening for a dual palmar vascular supply is not necessary and the presence of a palpable radial pulse is sufficient to allow successful radial artery cannulation. We retrospectively analysed our interventional PTCA registry, including only patients who had a transradial procedure without being pre-screened with an Allen's test or plethysmography. We report our data including complications the day after the procedure and at 30 days, and provide an up to date discussion on the need to assess patients for a dual palmar blood supply prior to transradial intervention.

Ostial left anterior descending coronary artery stent positioning: partial preinflation prevents stent oscillation and facilitates accurate deployment.

Ostial intracoronary stent deployment is complicated by the influence of cardiac motion, which causes the stent to oscillate back and forth during the cardiac cycle. Accurate deployment can be facilitated by initial low pressure inflation of the balloon on which the stent is mounted. This stabilizes the stent within the stenosis, while still allowing adjustment of the exact stent location prior to deployment.

Coronary flow reserve improves after aortic valve replacement for aortic stenosis: an adenosine transthoracic echocardiography study.

OBJECTIVES: The goal of this study was to assess coronary flow reserve (CFR) before and after aortic valve replacement (AVR). BACKGROUND: Coronary flow reserve is impaired under conditions of left ventricular (LV) hypertrophy. It is not known whether CFR improves with regression of LV hypertrophy in humans. METHODS: We investigated 35 patients with pure aortic stenosis, LV hypertrophy and normal coronary arteriograms. Patients underwent adenosine transthoracic echocardiography on two occasions--immediately before AVR and six months postoperatively. Left ventricular mass, distal left anterior descending coronary artery (LAD) diameter, flow and CFR were assessed on each occasion. RESULTS: Distal LAD diameter was successfully imaged in 30 patients (86%), and blood flow was successfully imaged in 27 (77%). Paired data were subsequently available in 24 patients, of whom 14 were men, mean age 68.1+/-12.5 years, body mass index 24.5+/-2.0 kg/m2, aortic valve gradient 93+/-32 mm Hg. Pre- to post-AVR a significant decrease was seen in LV mass (271+/-38 vs. 236+/-32g, p<0.01) and LV mass index (154+/-21 vs. 134+/-21 g/m2, p< 0.01). Distal LAD diameter fell from 2.27+/-0.37 to 2.23+/-0.35 mm, p = 0.08). Pre- to post-AVR there was no significant change in resting parameters of peak diastolic velocity (0.43+/-0.16 vs. 0.41+/-0.11 m/s), distal LAD flow 23.3+/-10.1 vs. 20.9+/-5.2 ml/min or distal LAD flow scaled for LV mass (8.7+/-3.8 vs. 9.0+/-2.5 ml/min/100 g LV mass), but there was significant increase in hyperemic peak diastolic velocity (0.71+/-0.26 vs. 1.08+/-0.24 m/s; p<0.01), distal LAD flow (37.8+/-11.3 vs. 53.5+/-16.1 ml/min; p<0.01) and distal LAD flow scaled for LV mass (14.3+/-5.0 vs. 23.3+/-8.5 ml/min/100 g LV mass; p<0.01). Coronary flow reserve, therefore, increased from 1.76+/-0.5 to 2.61+/-0.7. CONCLUSIONS: Coronary flow reserve increases after AVR for aortic stenosis. This increase occurs in tandem with regression of LV hypertrophy.

Inoue balloon mitral valvuloplasty: long-term clinical and echocardiographic follow-up of a predominantly unfavourable population.

AIMS: To assess long-term outcome in a typical Western population of predominantly unfavourable patients undergoing Inoue balloon mitral valvuloplasty. Outcome amongst patients has only been undertaken in the medium term. Long-term echocardiographic data in particular are scarce. METHODS: Inoue mitral valvuloplasty was attempted in 106 patients. There were six technical failures; the procedure was therefore completed in 100 patients, who underwent annual clinical and echocardiographic follow-up. RESULTS: Patients were aged 63.5+/-10. 3 years. 82% were female. Unfavourable characteristics included age >65 (52%), NYHA class III or IV (87%), >/=1 significant co-morbidity (63%), atrial fibrillation (82%), previous surgical commissurotomy (25%) and echocardiographic score >8 (59%, mean 8.9+/-2.1). Mitral valve area increased from 0.98+/-0.23 to 1.54+/-0.31 cm(2). There were three major complications. Post-procedure, symptoms improved in 88% of patients. Haemodynamic success (mitral valve area increase >50%, final mitral valve area >1.5 cm(2), mitral regurgitation 50% gain in mitral valve area, mitral valve area <1.5cm (2)) was 98%, 92% and 75% at 1, 3 and 6 years. Pre-procedural predictors of event-free survival were male sex, absence of co-morbidities, lower echocardiographic score and smaller left atrial diameter. CONCLUSIONS: In a Western population with predominantly unfavourable characteristics for mitral valvuloplasty, long-term outcome post-procedure is reasonable. A moderate increase in mitral valve area can be achieved at low procedural risk, and the subsequent rate of restenosis is low. Nonetheless, 6 years after the procedure, half of the patients will have required further intervention or died. For fitter patients willing to accept significant operative risk, mitral valve replacement remains a valuable alternative.