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.

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.

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.

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.

Coronary artery bypass surgery in the UK, trends in activity and outcomes from a 15-year complete national series.

OBJECTIVES: The aim of this study was to review the UK national trends in activity and outcome in coronary artery bypass graft (CABG) over a 15-year period (2002-2016). METHODS: Validated data collected (2002-2016) and uploaded to National Institute for Cardiovascular Outcomes Research were used to generate summary data from the National Adult Cardiac Surgery Audit Database for the analysis. Logistic European System of Cardiac Operative Risk Evaluation was used for risk stratification with recalibration applied for governance. Data were analysed by financial year and presented as numerical, categorical, %, mean and standard deviation where appropriate. Mortality was recorded as death in hospital at any time after index CABG operation. RESULTS: A total of 347 626 CABG procedures (282 883 isolated CABG, 61 109 CABG and valve and 4132 redo CABG) were recorded. Over this period annual activity reduced from 66.6% of workload to 41.7%. The mean age for isolated CABG was 65.7 years. The mean log European System of Cardiac Operative Risk Evaluation was 3.1, 5.9 and 23.2 for elective, urgent and emergency isolated CABG, respectively. There was a decline in the observed mortality for all procedures. Overall mortality for isolated CABG surgery is now 1.0% and only 0.6% for elective operations. CONCLUSIONS: Quality of care and risk-adjusted mortality rates have consistently improved over the last 15 years despite the increasing risk profile of patients. There have been a consistent decline in overall case volumes and a three-fold increase in elderly cases.

Balloon Seal Separation Leading to SAPIEN 3 Transcatheter Heart Valve Deployment Failure: Complications and Management.

We present two cases of failure of balloon inflation secondary to balloon separation from the delivery catheter when implanting the SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA). Although very uncommon, this is a potentially disastrous complication of transcatheter intervention. Case 1 highlights the complexity of the problem when it occurs and subsequent complications. Case 2 highlights how to manage this issue successfully.

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.

Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial.

BACKGROUND: The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD). AIMS: We sought to determine whether these outcomes remained consistent regardless of geography of enrolment. METHODS: We performed a prespecified subgroup analysis based on regional enrolment. RESULTS: Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (pinteraction=0.02). CONCLUSIONS: In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.

Cardiac surgery in older patients: hospital outcomes during a 15-year period from a complete national series.

OBJECTIVES: The objective was to review national trends in activity and hospital outcomes in older patients having cardiac surgery over a 15-year time period. METHODS: Data were collected prospectively and uploaded to the National Institute for Cardiovascular Outcomes Research electronically. Data were validated, cleaned and processed using reproducible algorithms. Mortality was death in hospital after index operation. RESULTS: A total of 227 442 cardiac procedures were recorded in patients aged ≥70 years of which 46 354 were in those aged ≥80 years. Overall patients aged ≥70 years represented 43% of all adult cardiac surgery in the most recent study year. The annual proportion of surgery in patients ≥80 years increased from 4.1% to 10.8% between the first and last study years. There has been a significant linear increase in octogenarian valve [ß 67.44, 95% confidence interval (CI) 55.04 to 79.83, P < 0.001] and coronary artery bypass graft surgery (ß 32.53, 95% CI 6.16 to 58.90, P = 0.020) patients. In-hospital mortality reduced significantly for patients aged 70-79 years (ß -0.17, 95% CI -0.20 to -0.13, P < 0.001) and all patients aged ≥80 (ß -0.37, 95% CI -0.45 to -0.30, P < 0.001). The median length of hospital stay was 7 days for 70-79 and 9 days for ≥80 group, compared with 7 days for the whole cohort <70 years. CONCLUSIONS: This study represents the largest complete validated national dataset of cardiac surgery in the entire population of older patients. Octogenarians represent 11% of adult patients having cardiac surgery by the end of the study period, a three-fold increase from the start. In-hospital mortality in patients aged ≥80 years halved during study period to only 4% despite high logistic EuroSCORE of 15%. Cardiac surgery in octogenarians places a higher demand on resources, however, with an increased postoperative length of stay.

Surgical aortic valve replacement in the era of transcatheter aortic valve implantation: a review of the UK national database.

OBJECTIVES: To date the reported outcomes of surgical aortic valve replacement (SAVR) are mainly in the settings of trials comparing it with evolving transcatheter aortic valve implantation. We set out to examine characteristics and outcomes in people who underwent SAVR reflecting a national cohort and therefore 'real-world' practice. DESIGN: Retrospective analysis of prospectively collected data of consecutive people who underwent SAVR with or without coronary artery bypass graft (CABG) surgery between April 2013 and March 2018 in the UK. This included elective, urgent and emergency operations. Participants' demographics, preoperative risk factors, operative data, in-hospital mortality, postoperative complications and effect of the addition of CABG to SAVR were analysed. SETTING: 27 (90%) tertiary cardiac surgical centres in the UK submitted their data for analysis. PARTICIPANTS: 31 277 people with AVR were identified. 19 670 (62.9%) had only SAVR and 11 607 (37.1%) had AVR+CABG. RESULTS: In-hospital mortality for isolated SAVR was 1.9% (95% CI 1.6% to 2.1%) and was 2.4% for AVR+CABG. Mortality by age category for SAVR only were: <60 years=2.0%, 60-75 years=1.5%, >75 years=2.2%. For SAVR+CABG these were; 2.2%, 1.8% and 3.1%. For different categories of EuroSCORE, mortality for SAVR in low risk people was 1.3%, in intermediate risk 1% and for high risk 3.9%. 74.3% of the operations were elective, 24% urgent and 1.7% emergency/salvage. The incidences of resternotomy for bleeding and stroke were 3.9% and 1.1%, respectively. Multivariable analyses provided no evidence that concomitant CABG influenced outcome. However, urgency of the operation, poor ventricular function, higher EuroSCORE and longer cross clamp and cardiopulmonary bypass times adversely affected outcomes. CONCLUSIONS: Surgical SAVR±CABG has low mortality risk and a low level of complications in the UK in people of all ages and risk factors. These results should inform consideration of treatment options in people with aortic valve disease.

Decade-long trends in surgery for acute Type A aortic dissection in England: A retrospective cohort study.

BACKGROUND: Little is known about variations in care and outcomes of patients undergoing surgical repair for type A aortic dissection(TAAD). We aim to investigate decade-long trends in TAAD surgical repair in England. METHODS: Retrospective review of the National Adult Cardiac Surgery Audit, which prospectively collects demographic and peri­operative information for all major adult cardiac surgery procedures performed in the UK. We identified patients undergoing surgery for TAAD from January 2009-December 2018, reviewed trends in operative frequency, patient demographics, and mortality. FINDINGS: Over the 10-year period,3,680 TAAD patients underwent surgical repair in England. A doubling in the overall number of operations conducted in England was observed (235 cases in 2009 to 510 in 2018). Number of procedures per hospital per year also doubled(9 in 2009 to 23 in 2018). Overall, in-hospital mortality was 17.4% with a trend toward lower mortality in recent years(23% in 2009 to 14.7% in 2018). There was a significant variation in operative mortality between hospitals and surgeons. We also found that most patients presented towards the middle of the week and during winter. INTERPRETATION: Surgery is the only treatment for acute TAAD but is associated with high mortality. Prompt diagnosis and referral to a specialist center is paramount. The number of operations conducted in England has doubled in 10 years and the associated survival has improved. Variations exist in service provision with a trend towards better survival in high volume centers. FUNDING: British Heart Foundation and NIHR Biomedical Research center(University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol).

Neuroprotective strategies in acute aortic dissection: an analysis of the UK National Adult Cardiac Surgical Audit.

OBJECTIVES: The risk of brain injury following surgery for type A aortic dissection (TAAD) remains substantial and no consensus has still been reached on which neuroprotective technique should be preferred. We aimed to investigate the association between neuroprotective strategies and clinical outcomes following TAAD repair. METHODS: Using the UK National Adult Cardiac Surgical Audit, we identified 1929 patients undergoing surgery for TAAD (2011-2018). Deep hypothermic circulatory arrest (DHCA) only, unilateral (uACP), bilateral antegrade cerebral perfusion (bACP) and retrograde cerebral perfusion were used in 830, 117, 760 and 222 patients, respectively. The primary end point was a composite of death and/or cerebrovascular accident (CVA). Generalized linear mixed model was used to adjust the effect of neuroprotective strategies for other confounders. RESULTS: The use of bACP was associated with longer circulatory arrest (CA) compared to other strategies. There was a trend towards lower incidence of death and/or CVA using uACP only for shorter CA. In particular, primary end point rate was 27.7% overall and 26.5%, 12.5%, 28.0% and 22.9% for CA <30 min and 28.6%, 30.4%, 33.3% and 33.0% for CA ≥30 min with DHCA only, uACP, bACP and retrograde cerebral perfusion, respectively. The use of DHCA only was associated with five-fold [odds ratio (OR) 5.35, 95% confidence interval (CI) 1.36-21.02] and two-fold (OR 1.77, 95% CI 1.01-3.09) increased risk of death and/or CVA compared to uACP and bACP, respectively, but the effect of uACP was significantly associated with CA duration (hazard ratio 0.97, 95% CI 0.94-0.99; P = 0.04). CONCLUSIONS: In TAAD repair, the use of uACP and bACP was associated with a lower adjusted risk of death and/or CVA when compared to DHCA. uACP can offer some advantage but only for a shorter CA duration.

Aortic valve surgery in the UK, trends in activity and outcomes from a 15-year complete national series.

OBJECTIVES: Since the turn of the century, cardiac surgery has evolved quite notably. This study sought to investigate the trends in aortic valve surgery activity and subsequent outcomes in the UK by using a mandatory national cardiac surgical clinical database within the context of a comprehensive public healthcare system (National Health Service). METHODS: The UK National Adult Cardiac Surgery Audit database provided data for aortic valve surgery procedures performed between 2002 and 2016, and the data were validated and cleaned using reproducible algorithms. The findings and trends in in activity and outcomes were then analysed by financial year. RESULTS: During the study period, a total of 148 862 procedures were performed, with the number of cases per year peaking in 2014/2015 at 12 483. The mean in-hospital mortality rate for all aortic valve surgery has fallen from 5.6% to 3.4%, despite an increase in patient age and mean logistic EuroSCORE. While the number of isolated aortic valve replacements has remained stable at around 5000 per year, aortic valve replacement and coronary artery bypass graft have increased to over 3200 with transcatheter aortic valve implantation activity continuing to increase. CONCLUSIONS: This study demonstrates that despite an increase in patient risk profile, there has been a consistent reduction in in-hospital mortality within all aortic valve surgery procedures performed in the UK over a 15-year period. Increasing catheter-based interventions have not yet resulted in a significant decrease in surgical aortic valve replacements in the UK.

'Valve for Life': tackling the deficit in transcatheter treatment of heart valve disease in the UK.

Transcatheter aortic valve implantation (TAVI) is a proven treatment for life-threatening aortic valve disease, predominantly severe aortic stenosis. However, even among developed nations, access to TAVI is not uniform. The Valve for Life initiative was launched by the European Association of Percutaneous Cardiovascular Interventions in 2015 with the objective of improving access to transcatheter valve interventions across Europe. The UK has been identified as a country with low penetration of these procedures and has been selected as the fourth nation to be included in the initiative. Specifically, the number of TAVI procedures carried out in the UK is significantly lower than almost all other European nations. Furthermore, there is substantial geographical inequity in access to TAVI within the UK. As a consequence of this underprovision, waiting times for TAVI are long, and mortality among those waiting intervention is significant. This article reviews these issues, reports new data on access to TAVI in the UK and presents the proposals of the UK Valve for Life team to address the current problems in association with the British Cardiovascular Intervention Society.

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.

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.

Trends and outcomes for cardiac surgery in the United Kingdom from 2002 to 2016.

Objectives: Cardiac surgery has evolved significantly since the turn of the century. The objective of this study was to investigate trends in cardiac surgery activity and outcomes in the United Kingdom utilizing a mandatory national cardiac surgical clinical database in the context of a comprehensive public health care system (ie, the UK National Health Service). Methods: Data for all cardiac surgery procedures performed between 2002 and 2016 were extracted from the UK National Adult Cardiac Surgery Audit database. Data are validated and cleaned using reproducible algorithms. Trends in activity and outcomes were analyzed by fiscal year using linear regression. Results: A total of 534,067 procedures were performed during the study period with the number of cases per year peaking in 2008/2009 at 41,426. Despite an increase in patient age and mean logistic European System for Cardiac Operative Risk Evaluation score, the in-hospital mortality rate for all cardiac surgery has fallen from 4.0% to 2.8% (P < .001). The number of isolated coronary artery bypass graft procedures has steadily declined but the total number of valve procedures has steadily increased (both P values < .001). The number of thoracic aortic procedures performed each year has doubled (P < .001), but the incidence of redo procedures has steadily declined. The proportion of emergency and salvage procedures has remained stable. Conclusions: This study, which covers all cardiac surgery procedures performed in the United Kingdom for fiscal years between 2002 and 2016, demonstrates that despite an increase in patient risk profile, there has been a consistent reduction in in-hospital mortality. A number of other markers associated with quality have also improved.

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.

Thrombosis of a Percutaneous Transcatheter Mitral Valve Implant and Its Treatment.

Bioprosthetic heart valves do not usually require formal anticoagulation as they are less thrombogenic than their mechanical counterparts. However, valve thrombosis has been reported after both transcatheter and surgical aortic bioprosthesis implantation. Short-term anticoagulation after surgical bioprosthesis implantation is often recommended while endothelialisation of the prosthesis takes place, particularly for mitral valve implants. There have been no reports of tissue heart valve thrombosis in transcatheter mitral valve replacement. We describe our experience and successful treatment of such a case.