Outlier identification and monitoring of institutional or clinician performance: an overview of statistical methods and application to national audit data.

BACKGROUND: Institutions or clinicians (units) are often compared according to a performance indicator such as in-hospital mortality. Several approaches have been proposed for the detection of outlying units, whose performance deviates from the overall performance. METHODS: We provide an overview of three approaches commonly used to monitor institutional performances for outlier detection. These are the common-mean model, the 'Normal-Poisson' random effects model and the 'Logistic' random effects model. For the latter we also propose a visualisation technique. The common-mean model assumes that the underlying true performance of all units is equal and that any observed variation between units is due to chance. Even after applying case-mix adjustment, this assumption is often violated due to overdispersion and a post-hoc correction may need to be applied. The random effects models relax this assumption and explicitly allow the true performance to differ between units, thus offering a more flexible approach. We discuss the strengths and weaknesses of each approach and illustrate their application using audit data from England and Wales on Adult Cardiac Surgery (ACS) and Percutaneous Coronary Intervention (PCI). RESULTS: In general, the overdispersion-corrected common-mean model and the random effects approaches produced similar p-values for the detection of outliers. For the ACS dataset (41 hospitals) three outliers were identified in total but only one was identified by all methods above. For the PCI dataset (88 hospitals), seven outliers were identified in total but only two were identified by all methods. The common-mean model uncorrected for overdispersion produced several more outliers. The reason for observing similar p-values for all three approaches could be attributed to the fact that the between-hospital variance was relatively small in both datasets, resulting only in a mild violation of the common-mean assumption; in this situation, the overdispersion correction worked well. CONCLUSION: If the common-mean assumption is likely to hold, all three methods are appropriate to use for outlier detection and their results should be similar. Random effect methods may be the preferred approach when the common-mean assumption is likely to be violated.

Bilateral versus Single Internal-Thoracic-Artery Grafts at 10 Years.

BACKGROUND: Multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. We evaluated the use of bilateral internal-thoracic-artery grafts for CABG. METHODS: We randomly assigned patients scheduled for CABG to undergo bilateral or single internal-thoracic-artery grafting. Additional arterial or vein grafts were used as indicated. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. RESULTS: A total of 1548 patients were randomly assigned to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group) and 1554 to undergo single internal-thoracic-artery grafting (the single-graft group). In the bilateral-graft group, 13.9% of the patients received only a single internal-thoracic-artery graft, and in the single-graft group, 21.8% of the patients also received a radial-artery graft. Vital status was not known for 2.3% of the patients at 10 years. In the intention-to-treat analysis at 10 years, there were 315 deaths (20.3% of the patients) in the bilateral-graft group and 329 deaths (21.2%) in the single-graft group (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.12; P=0.62). Regarding the composite outcome of death, myocardial infarction, or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (hazard ratio, 0.90; 95% CI, 0.79 to 1.03). CONCLUSIONS: Among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Further studies are needed to determine whether multiple arterial grafts provide better outcomes than a single internal-thoracic-artery graft. (Funded by the British Heath Foundation and others; Current Controlled Trials number, ISRCTN46552265 .).

Feasibility of transcaval access TAVI in morbidly obese patients: A single-center experience.

OBJECTIVES: We report a single-center experience in utilizing the transcaval-access transcatheter aortic valve implantation (TAVI) as an alternative approach in morbidly obese patients. BACKGROUND: Morbidly obese patients present frequently for TAVI. Transfemoral arterial access TAVI in these patients is technically challenging due to deep arterial access, resulting in a higher risk of vascular complications. Transcaval access TAVI is increasingly used in patients with prohibitive iliofemoral arterial access. METHODS: We used the transcaval approach for eight morbidly obese patients who had otherwise technically feasible femoral arterial access. This technique provides an alternative arterial access point that potentially circumvents some of the challenges relating to femoral arterial access. RESULTS: We report eight morbidly obese patients with a mean body mass index of 42.3 ± 6.2 kg/m2 who underwent transcaval access TAVI at our center (mean EuroScore II 2.47 ± 1.83%). The patient mean age was 70.3 ± 9.8 years; six were female. All eight patients underwent a successful and uncomplicated procedure. The median time to discharge was 2 days and all patients were alive at 30 days. CONCLUSIONS: Transcaval access TAVI is a feasible alternative for morbidly obese patients and may reduce vascular complications. Further data are required to evaluate the safety of this approach.

Mobility aids predict mortality after transcatheter aortic valve implantation.

BACKGROUND: Selection of appropriate patients for transcatheter aortic valve implantation (TAVI) can be challenging. Many factors can influence post-procedure outcomes. Traditional surgical scoring systems do not discriminate effectively. Medical parameters and functional indices can characterize mortality risk. Mobility is an important predictive functional index but is largely defined using subjective criteria. AIM: To describe the relationship between mobility, objectively defined by the requirement for gait aids to ambulate, and all-cause 30-day and long-term mortality in patients undergoing TAVI. METHODS: Mobility aid use was assessed in 1444 consecutive patients undergoing TAVI in a single center. Patients were categorized into "unaided," "1-stick," and "higher aid" groups based on the Brighton Mobility Index. Mortality tracking was obtained via the NHS Spine Portal in February 2021. RESULTS: Patients were aged 82 (IQR 78-86). 66% of patients walked unaided, 26% walked with 1 stick, and 8% required more assistance (e.g., 2 sticks, a Rollator, a Zimmer frame, or a wheelchair). Overall 30-day mortality for the whole cohort was 3.5%; 1-year mortality was 12.2%. Mobility was a significant predictor of 30-day mortality (p = 0.025). Use of a higher aid was associated with a mortality odds ratio of 2.83 (95% CI: 1.39-5.74). Mobility was also a significant predictor of long-term mortality (p < 0.001). Odds ratios for 1-stick and higher aid groups were 1.45 (95% CI: 1.21-1.72) and 2.01 (95% CI: 1.55-2.60), respectively. CONCLUSION: Objective assessment of mobility by gait aid use predicts both short and long-term survival in patients undergoing TAVI. Increased dependence on mobility aids is associated with a worse prognosis.

Apical versus subclavian transcatheter aortic valve implantation: An 8-year United Kingdom analysis.

OBJECTIVES: Subclavian (SC) and transapical (TA) approaches are the main alternatives to the default femoral delivery for transcatheter aortic valve implantation (TAVI). The aim of this study was to compare complications and morbidity/mortality associated with SC and TA in a long-term time frame. METHODS: From January 2007 to July 2015, 1506 patients underwent TAVI surgery in 36 United Kingdom TAVI centers. Primary outcomes were complications according to VARC-2 criteria. The secondary outcome was long-term survival. RESULTS: The enrolled patients were distributed as follows: 1216 in the TA group and 290 in the SC group. There were no differences in the rates of acute myocardial infarction, emergency valve-in-valve, paravalvular leak, balloon post dilatation, cardiac tamponade, stroke, renal replacement therapy, vascular injuries, and 30-day mortality among the groups. Conversely, the rate of permanent pacemaker implantation (p = .02), the procedural time duration (p = .04), and the 12-month mortality (p = .03) was higher in SC than in TA, while in-hospital length of stay was reduced in SC than in TA (p = .01). Up to 8 years, the long-term mortality was not different among groups (p = .77), and no difference in long-term survival between self- versus balloon-expandable devices was found (p = .26). CONCLUSIONS: According to our results, TA provided the best 12-month survival compared to SC, while the long-term survival up to 2900 days is not significantly different between groups, so SC and TA may both represent a safe non-femoral access if femoral is precluded.

Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. METHODS: The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009). INTERPRETATION: In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. FUNDING: Biosensors.

Elective versus urgent in-hospital transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is maturing as a treatment option and is now often undertaken during an unscheduled index hospital admission. The aim of this study was to look at procedural and mid-term outcomes of patients undergoing elective versus urgent in-hospital transcatheter aortic valve implantation. METHODS: We identified a total of 1,157 patients who underwent TAVI between November 2007 and November 2019 at the Sussex Cardiac Centre in the UK. We compared the demographics, procedural outcomes, 30-day and 1-year mortality between elective and urgent patients. Emergency and salvage TAVI cases were excluded. RESULTS: Of the 1,157 patients who underwent the procedure, 975 (84.3%) had elective while 182 (15.7%) had urgent TAVI. Predominant aortic stenosis was more frequent in elective patients (91.7% vs. 77.4%); p < .01), while predominant aortic regurgitation was seen more commonly in the urgent group (11.5% vs. 4.2%; p < .01). Implantation success was similar between the elective (99.1%) and urgent group (99.4%). In-hospital (1.65% vs. 1.3%: p .11), 30 day (3.5% vs. 3.3%: p .81) and 1 year (10.9% vs. 11%; p .81) mortality rates were similar in the elective and urgent groups, respectively. CONCLUSIONS: In contemporary practice, urgent TAVI undertaken on the index admission can be performed at similar risk to elective outpatient TAVI.

In-hospital stroke after transcatheter aortic valve implantation: A UK observational cohort analysis.

OBJECTIVES: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001). CONCLUSIONS: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve.

Survival relative to pacemaker status after transcatheter aortic valve implantation.

OBJECTIVES: To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. BACKGROUND: New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. METHODS: We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. RESULTS: Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. CONCLUSIONS: A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.

Artificial enveloping reverberation for binaural auralization using reciprocal maximum-length sequences.

Binaural auralization through proper room-acoustic simulation can produce a realistic listening experience as if the listener were sitting in a room with spatial perception, including enveloping reverberance. Based on analysis of experimentally measured binaural room-acoustic data, this paper discusses an approach to creating artificial but natural-sounding reverberation for binaural rendering that can be employed in simulating such an environment in an efficient way. Approaches to adjusting the spaciousness of enveloping reverberance within the context of artificially generated reverberation are investigated via hearing tests. This paper exploits the excellent pseudorandom properties of maximum-length sequences to generate deterministic and controllable decorrelations between binaural channels for artificial reverberation for room-acoustic simulations with high computational efficiency. To achieve natural-sounding enveloping reverberance in an enclosed space, and thereby an immersive environment, the shapes of both the reverberation energy decays and the spatial characteristics are found to be decisive. This paper discusses systematic hearing test results that support the mentioned finding.

Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial.

BACKGROUND: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke. INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. FUNDING: Biosensors, Aarhus University Hospital, and participating sites.

Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation.

BACKGROUND: The performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry. METHODS: The calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level. RESULTS: The observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50. CONCLUSIONS: Although the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries.

Transcatheter aortic valve-in-valve treatment of degenerative stentless supra-annular Freedom Solo valves: A single centre experience.

BACKGROUND: Redo surgery for degenerative bioprosthetic aortic valves is associated with significant morbidity and mortality. Report results of valve-in-valve therapy (ViV-TAVI) in failed supra-annular stentless Freedom Solo (FS) bioprostheses, which are the highest risk for coronary occlusion. METHODS: Six patients with FS valves (mean age 78.5 years, 50% males). Five had valvular restenosis (peak gradient 87.2 mm Hg, valve area 0.63 cm2 ), one had severe regurgitation (AR). Median time to failure was 7 years. RESULTS: Patients were high risk (mean STS/Logistic EuroScore 10.6 15.8, respectively). FS valves ranged from 21 to 25 mm. Successful ViV-TAVI was achieved in 4/6 patients (67%). Of the unsuccessful cases, (patient 1 and 2 of series) patient 1 underwent BAV with simultaneous aortography which revealed left main stem occlusion. The procedure was stopped and the patient went forward for repeat surgery. Patient 2 underwent successful ViV-TAVI with a 26-mm CoreValve with a guide catheter in the left main, but on removal coronary obstruction occurred, necessitating valve snaring into the aorta. Among the successful cases, (patients 3, 4, 5, 6) the TAVIs used were CoreValve Evolut R 23 mm (n = 3), and Lotus 23 mm (n = 1). In the successful cases the peak gradient fell from 83.0 to 38.3 mm Hg. No patient was left with >1+ AR. One patient had a stroke on Day 2, with full neurological recovery. Two patients underwent semi-elective pacing for LBBB and PR >280 ms. CONCLUSIONS: ViV-TAVI in stentless Freedom Solo valves is high risk. The risk of coronary occlusion is high. The smallest possible prosthesis (1:1 sizing) should be used, and strategies to protect the coronary vessels must be considered. © 2016 Wiley Periodicals, Inc.

Rapid pacing using the 0.035-in. Retrograde left ventricular support wire in 208 cases of transcatheter aortic valve implantation and balloon aortic valvuloplasty.

INTRODUCTION AND METHOD: Transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) are now well established percutaneous procedures. These procedures almost always require bursts of rapid ventricular pacing to temporarily reduce cardiac output to facilitate the procedure, usually done via a temporary pacing wire inserted into the right ventricle. We describe a case series of 132 cases of TAVI and 76 BAV done using ventricular pacing via the left ventricular lead by simply connecting one electrode to the patient's skin and one electrode through the left ventricular (LV) wire. RESULTS: All of the 132 TAVI cases (a mixture of Edwards Sapien, Medtronic CoreValve and Boston Scientific Lotus) and 76 BAV were successfully performed using pacing through the LV wire. No BAV patients required temporary pacing wire (TPW) or permanent pacemaker (PPM) insertion. Of the TAVI patients, 6 (4.5%) required TPW during the procedure due to complete heart block to facilitate removal of the LV wire. 1 patient (0.8%) required a PPM urgently due to complete heart block and haemodynamic instability. Twenty eight Patients (21.2%) required PPM following TAVI, 9 of which were within the first 24 hr. Average time to pacemaker implantation was 3.7 days. CONCLUSION: Rapid ventricular pacing via the LV wire is a simple, safe and effective strategy for percutaneous aortic valve intervention and balloon aortic valvuloplasty. It eliminates the need for a temporary pacing wire with its attendant risks in the vast majority of cases. Furthermore, most pacemakers following TAVI are required late, after the first 24 hr period, by which time the TPW has already usually been removed. © 2016 Wiley Periodicals, Inc.

Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012.

BACKGROUND: We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. METHODS AND RESULTS: Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007-2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 µmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P<0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. CONCLUSIONS: We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.

Poor mobility predicts adverse outcome better than other frailty indices in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Surgical risk scoring systems are poor at predicting outcome in patients undergoing transcatheter aortic valve implantation (TAVI). Frailty indices might more accurately predict outcome. AIMS: To examine multiple frailty indices as markers of performance to see whether they predict outcomes both in the shorter (30 days) and longer terms (5 years) in patients who have undergone TAVI. METHODS: Frailty indices (Mobility; Brighton Mobility Index, New York Heart Association (NYHA), Karnofsky Performance Index, Canadian Study Health Association (CSHA) clinical frailty scale, and Katz Index of Dependence) were assessed in 312 consecutive TAVI patients. Mortality tracking was obtained from the Office of National Statistics as of May 2014. RESULTS: Mean age was 81.2 ± 7.0 years; 53.2% were male. Mean Logistic EuroSCORE and STS were 17.4 ± 9.4 and 4.6 ± 2.8, respectively. Mean peak aortic valve gradient and aortic valve area were 79.1 ± 28.0 mm Hg and 0.72 ± 0.25 cm(2) , respectively. 30-day mortality was 4.8%; long-term mortality (maximum 5.8 years, mean 2.2 ± 1.5 years) was 25.3%. Both univariate and multivariate analyses confirmed poor mobility (defined as severe impairment of mobility secondary to musculoskeletal or neurological dysfunction (Euroscore II risk)), as the best predictor of adverse outcome over both the short-term (OR 4.03, 95% CI (1.36-11.96), P = 0.012 (30 days)) and longer term (OR 2.15, 95% CI (1.33-3.48), P = 0.002, (2.2 ± 1.5 years.)). CONCLUSION: Poor mobility predicts worse survival among patients undergoing TAVI, both in the shorter and longer terms. Our data suggest that mobility impairment, of either neurological or musculoskeletal etiology, is an appropriate screening measure when considering patients for TAVI.

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.

Do outcomes from transcatheter aortic valve implantation vary according to access route and valve type? The UK TAVI Registry.

OBJECTIVES: To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real-world population. BACKGROUND: Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type. METHODS: Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality. RESULTS: Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P = 0.01), and 2 years (56.0% vs. 43.5%, P = 0.01). Logistic EuroSCORE was higher in TA patients (22.5 ± 12.9% vs. 17.7 ± 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46-4.48, P < 0.01) and 2 years (OR 1.75, 1.08-2.74, P = 0.02). There was no significant difference in mortality at any time-point between patients treated with SAPIEN (n = 812) and CoreValve (n = 808) prostheses. CoreValve-treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade ≥2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01). CONCLUSIONS: Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type.

Acute ischemic complications of PCI and CABG: who should cover whom for coronary revascularization?

INTRODUCTION: Percutaneous coronary intervention (PCI) has historically required cardiothoracic backup in the event of ischemic complications. However, many complications occurring during PCI can now be effectively treated at the time of the indexed procedure. Equally, ischemic complications, which occur following coronary artery bypass grafting (CABG), which were previously treated medically or with reoperation, may now also be effectively treated by acute PCI. AIMS AND METHODS: To identify the rate, cause, treatment, and outcomes of ischemic complications from PCI or isolated CABG procedures undertaken from January 2004 to January 2011 where there was immediate crossover from PCI to CABG or vice versa, and to determine from the indexed revascularization procedure, whether or not the ischemic complications were rectified by either CABG with respect to PCI or PCI with respect to CABG. RESULTS: Three hundred fifty-six PCI major ischemic complications were identified. Three hundred forty-seven (97.5%) were rectified percutaneously and 9 (2.5%) required emergency CABG. The commonest reason for emergency CABG was occlusive dissection (n=7). Of the 9 patients that underwent emergency CABG, 3 patients (33.3%) died. Forty CABG major ischemic complications were identified. Twenty-seven (67.5%) were treated medically. Thirteen (32.5%) underwent diagnostic angiography. The etiology of the ischemia was found in all cases. Consequently, 2 underwent reoperation, one was treated medically, and 10 underwent acute PCI. CONCLUSION: Acute coronary ischemia remains a small but significant complication of both PCI and CABG. Resolution of ischemia requires prompt diagnosis and early discussion between cardiothoracic surgeon and cardiac interventionalist to determine the safest and therefore most appropriate way to resolve the problem.