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.

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.

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.

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.

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.

Transient ST-segment changes associated with mitral valvuloplasty using the Inoue balloon.

We describe unexplained transient inferior ST-segment elevation on the electrocardiogram during Inoue mitral valvuloplasty in 8 patients from a series of 108. Electrocardiographic changes were associated with chest pain in 7 patients, and although the clinical features were suggestive of myocardial ischemia, no cause for this could be found.

Pulmonary capillary wedge pressure in mitral stenosis accurately reflects mean left atrial pressure but overestimates transmitral gradient.

Current opinion varies as to whether pulmonary capillary wedge pressure assessment of transmitral gradient in mitral stenosis is accurate; we therefore compared transmitral gradient in 36 patients awaiting balloon valvuloplasty using both pulmonary capillary wedge pressure and direct left atrial pressure. Mean pulmonary capillary wedge pressure correlated well with mean left atrial pressure (limits of agreement -1.5 to +3.7 mm Hg), but mean diastolic mitral gradient calculated using pulmonary capillary wedge pressure differed significantly from that calculated using left atrial pressure (limits of agreement -1.2 to +9.8 mm Hg): wedge pressure-assessed transmitral gradient is therefore misleading, routinely overestimating stenosis severity.

Comparison of central venous and inferior vena caval pressures.

Inferior vena caval pressures were measured in 60 patients undergoing cardiac catheterization and compared with central venous pressure from within the right atrium. Mean pressures within the abdominal inferior vena cava were essentially the same as mean right atrial pressure, suggesting that the inferior vena cava provides a useful safe alternative for measuring central venous pressure.

Comparison of radial versus brachial approaches for diagnostic coronary angiography when the femoral approach is contraindicated.

One hundred patients with contraindications to the femoral approach were randomized to undergo diagnostic coronary angiography via percutaneous radial puncture or brachial artery cutdown. Procedure duration, fluoroscopy time, and total radiation dose were significantly less via the radial route, whereas procedural success, complication rates, and pain scores were comparable; we conclude that the radial technique should be the arm approach of choice for new trainees, although there will be occasions when radial access fails and a brachial approach is required.

Ventricular pacemaker upgrade: experience, complications and recommendations.

OBJECTIVE: To assess outcomes of pacemaker upgrade from single chamber ventricular to dual chamber. DESIGN: Retrospective analysis of patients undergoing the procedure. SETTING: Specialist cardiothoracic unit. PATIENTS: 44 patients (15 female, 29 male), mean (SD) age at upgrade 68.2 (12.9) years. INTERVENTIONS: Upgrade of single chamber ventricular to dual chamber pacemaker. MAIN OUTCOME MEASURES: Procedure duration and complications. RESULTS: Principal indications for upgrade were pacemaker syndrome (17), "opportunistic"--that is, at elective generator replacement (8), heart failure (7), non-specific breathlessness/fatigue (7), and neurally mediated syncope (3). Mean (SD) upgrade procedure duration (82.9 (32.6) minutes) significantly exceeded mean VVI implantation duration (42.9 (13.3) minutes) and mean DDD implantation duration (56.6 (22.7) minutes) (both p < 0.01). Complications included pneumothorax (1), ventricular arrhythmia requiring cardioversion (2), protracted procedure (10), atrial lead repositioning within six weeks (8), haematoma evacuation (1), superficial infection (1), and admission to hospital with chest pain (1); 20 patients (45%) suffered one or more complications including four of the eight who underwent opportunistic upgrade. CONCLUSIONS: Pacemaker upgrade takes longer and has a higher complication rate than either single or dual chamber pacemaker implantation. This suggests that the procedure should be performed by an experienced operator, and should be undertaken only if a firm indication exists. Patients with atrial activity should not be offered single chamber ventricular systems in the belief that the unit can be upgraded later if necessary at minimal risk.

Transthoracic echocardiographic measurement of coronary artery diameter: validation against quantitative coronary angiography.

There has been no in vivo validation of the use of transthoracic echocardiography to measure distal left anterior descending coronary artery (LAD) diameter. We therefore undertook transthoracic echocardiography on 65 male patients immediately before cardiac catheterization to compare echocardiographic and angiographic findings. The distal LAD was successfully imaged in 41 (63%) patients; 29 of these had an angiographically normal distal LAD as assessed by an independent cardiologist and formed the study group. Transthoracic echocardiographic and quantitative coronary angiographic measurements of distal LAD diameter were made. Echocardiographic measurements ranged from 0.14 to 0.28 cm (mean 0.20 cm). Angiographic results ranged from 0.12 to 0.28 cm (mean 0.195 cm). Correlation between techniques was good (r=.925). The maximum discrepancy between transthoracic echocardiography and quantitative coronary angiography was 0.03 cm. Limits of agreement were +0.032 to -0.024 cm. We conclude that transthoracic echocardiography is a valid technique for measurement of distal LAD diameter.

Potential use of transthoracic echocardiography in the assessment of coronary flow reserve.

Coronary flow reserve provides a gold standard assessment of the epicardial and microvascular coronary circulation. However, measurement of coronary flow reserve is limited by the invasiveness or complexity of the methods hitherto available. We investigated whether transthoracic echocardiography could be used to assess coronary flow reserve. We imaged distal left anterior descending coronary artery diameter and flow in 14 healthy volunteers, both at rest and during intravenous infusion of adenosine (140 microg/kg per minute). Volunteers were men, with an average (+/-SD) age of 28.4 +/- 6.3 years. Complete data were acquired in 11 cases. Average distal left anterior descending coronary artery diameter was 0.213 +/- 0.03 cm. Velocity time integral rose from 8.6 +/- 2.1 cm to 27.7 +/- 5.6 cm with adenosine infusion. Heart rate rose from 64.7 +/- 9. 8 to 75.3 +/- 11.7 bpm. The Doppler angle of incidence to flow was 42.4 +/- 8.7 degrees. Resting distal left anterior descending coronary artery flow was therefore calculated as 13.4 +/- 3.2 mL/min and hyperemic flow as 51.2 +/- 16.2 mL/min, yielding a coronary flow reserve of 3.81 +/- 0.6. We conclude that coronary flow reserve can be assessed in a selected population with the use of transthoracic echocardiography and an intravenous infusion of adenosine. The simplicity of this noninvasive technique suggests that it could become a useful tool for measurement of coronary flow reserve if imaging success rates can be optimized.

Coronary angiography from the radial artery--experience, complications and limitations.

AIMS: to assess the outcomes, complications and limitations of coronary angiography performed via percutaneous radial artery puncture. METHODS AND RESULTS: two hundred and fifty patients underwent diagnostic coronary angiography from the radial artery, 182 (72.8%) of whom had contraindications to the femoral approach, for example due to peripheral vascular disease (n=85), therapeutic anticoagulation (29), or failed femoral approach (17). Procedural success in this high-risk population was achieved in 231 patients (92.4%). Principle reasons for failure were unsuccessful radial access (5) and arterial spasm (5). Procedure duration (SD) for an operator's first 20 cases compared with cases thereafter (min) was 47.7 (16.7) vs. 41.5 (14.6), P=0.0004; fluoroscopy time (min) 9.7 (7.1) vs. 6.6 (5.1), P=0.0001 and procedural success 89.6% vs. 94.1%, P=ns. Complications included two deaths associated temporally with catheterisation, three cases of arterial dissection without ischaemic sequelae and one transient ischaemic attack. CONCLUSIONS: coronary angiography can be performed successfully from the radial artery, but this approach has limitations, which include the need to demonstrate dual palmar vascular supply, the prolonged learning phase, the procedural failure rate, patient discomfort and a demonstrable incidence of vascular and haemodynamic complications. We believe that radial coronary angiography should only be undertaken when there is a contraindication to the femoral approach.

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.

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.

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.