Publications by authors named "Peter F Ludman"

68 Publications

Outcomes Following Percutaneous Coronary Intervention in Renal Transplant Recipients: A Binational Collaborative Analysis.

Mayo Clin Proc 2021 02 25;96(2):363-376. Epub 2020 Dec 25.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute of Primary Care and Health Sciences, Keele University, Keele, UK, and Academic Department of Cardiology, Royal Stoke Hospital, University Hospitals of North Midlands, Stoke-on-Trent, UK; Department of Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA. Electronic address:

Objective: To investigate the clinical and procedural characteristics in patients with a history of renal transplant (RT) and compare the outcomes with patients without RT in 2 national cohorts of patients undergoing percutaneous coronary intervention (PCI).

Patients And Methods: Data from the National Inpatient Sample (NIS) and British Cardiovascular Intervention Society (BCIS) were used to compare the clinical and procedural characteristics and outcomes of patients undergoing PCI who had RT with those who did not have RT. The primary outcome of interest was in-hospital mortality.

Results: Of the PCI procedures performed in 2004-2014 (NIS) and 2007-2014 (BCIS), 12,529 of 6,601,526 (0.2%) and 1521 of 512,356 (0.3%), respectively, were undertaken in patients with a history of RT. Patients with RT were younger and had a higher prevalence of congestive cardiac failure, hypertension, and diabetes but similar use of drug-eluting stents, intracoronary imaging, and pressure wire studies compared with patients who did not have RT. In the adjusted analysis, patients with RT had increased odds of in-hospital mortality (NIS: odds ratio [OR], 1.90; 95% CI, 1.41-2.57; BCIS: OR, 1.60; 95% CI, 1.05-2.46) compared with patients who did not have RT but no difference in vascular or bleeding events. Meta-analysis of the 2 data sets suggested an increase in in-hospital mortality (OR, 1.79; 95% CI, 1.40-2.29) but no difference in vascular (OR, 1.24; 95% CI, 0.77-2.00) or bleeding (OR, 1.21; 95% CI, 0.86-1.68) events.

Conclusion: This large collaborative analysis of 2 national databases revealed that patients with RT undergoing PCI are younger, have more comorbidities, and have increased mortality risk compared with the general population undergoing PCI.
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http://dx.doi.org/10.1016/j.mayocp.2020.04.045DOI Listing
February 2021

Macrophage infiltrates in coronary plaque erosion and cardiovascular outcome in patients with acute coronary syndrome.

Atherosclerosis 2020 10 1;311:158-166. Epub 2020 Sep 1.

Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy.

Background And Aims: Plaque erosion (PE) is responsible for at least one-third of acute coronary syndrome (ACS), and inflammation plays a key role in plaque instability. We assessed the presence of optical coherence tomography (OCT)-defined macrophage infiltrates (MØI) at the culprit site in ACS patients with PE, evaluating their clinical and OCT correlates, along with their prognostic value.

Methods: ACS patients undergoing OCT imaging and presenting PE as culprit lesion were retrospectively selected. Presence of MØI at culprit site was assessed. The incidence of major adverse cardiac events (MACEs), defined as the composite of cardiac death, recurrent myocardial infarction and target-vessel revascularization (TVR), was assessed [follow-up median (interquartile range, IQR) time 2.5 (2.03-2.58) years].

Results: We included 153 patients [median age (IQR) 64 (53-75) years, 99 (64.7%) males]. Fifty-one (33.3%) patients presented PE with MØI and 102 (66.7%) PE without MØI. Patients having PE with MØI compared with PE patients without MØI had more vulnerable plaque features both at culprit site and at non-culprit segments. MACEs were significantly more frequent in PE with MØI patients compared with PE without MØI [11 (21.6%) vs. 6 (5.9%), p = 0.008], mainly driven by a higher risk of cardiac death and TVR. At multivariable Cox regression, PE with MØI was an independent predictor of MACEs [HR = 2.95, 95% CI (1.09-8.02), p = 0.034].

Conclusions: Our study demonstrates that among ACS patients with PE the presence of MØI at culprit lesion is associated with more vulnerable plaque features, along with a worse prognosis at a long-term follow-up.
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http://dx.doi.org/10.1016/j.atherosclerosis.2020.08.009DOI Listing
October 2020

Measuring frailty in patients undergoing TAVI: how and why?

Eur Heart J 2019 07;40(27):2240-2242

Institute of Cardiovascular Sciences, University of Birmingham, Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.

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http://dx.doi.org/10.1093/eurheartj/ehz382DOI Listing
July 2019

Comparison of Routine Versus Selective Glycoprotein IIb/IIIa Inhibitors Usage in Primary Percutaneous Coronary Intervention (from the British Cardiovascular Interventional Society).

Am J Cardiol 2019 08 9;124(3):373-380. Epub 2019 May 9.

Department of Cardiology, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK; Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK. Electronic address:

The role of glycoprotein IIb/IIIa inhibitors (GPI) in primary percutaneous coronary intervention (PPCI) remains uncertain. Previous analyses compare PPCI outcomes with clopidogrel plus GPI, versus without GPI. This does not reflect modern contemporary PPCI practice with ticagrelor or prasugrel. Nor does it answer the important question faced daily by PPCI operators: should GPI be used routinely or selectively? We aim to determine whether a strategy of routine use of GPI in contemporary PPCI practice is superior to selective GPI use. A total of 110,327 consecutive PPCIs performed in England were prospectively recorded in the British Cardiovascular Intervention Society Database (2009 to 2015). The cohort was divided into routine and selective GPI usage groups based on the PPCI operator's strategy, defined as GPI used in >75% and <25% PPCIs, respectively. Overall, GPI use declined from 73.1% to 43.3% of PPCIs. Routine compared with selective GPI usage was associated with lower all-cause 1-year mortality: 9.7% versus 11.0%, p < 0.001. There was a consistent survival benefit for routine GPI usage as compared with selective GPI usage: univariable analysis (hazard ratio = 0.88 [95% confidence interval 0.83 to 0.93], p < 0.001), multivariable analysis (hazard ratio = 0.82 [0.77 to 0.88], p < 0.001). For survival, there was no interaction between GPI usage and the type of P2Y12-inhibitor used. In conclusion, a strategy of routine GPI usage in patients who underwent PPCI was associated with lower all-cause mortality as compared with selective GPI usage. This benefit was maintained despite 44.3% of patients receiving prasugrel or ticagrelor.
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http://dx.doi.org/10.1016/j.amjcard.2019.05.010DOI Listing
August 2019

British Cardiovascular Intervention Society registry framework: a quality improvement initiative on behalf of the National Institute of Cardiovascular Outcomes Research (NICOR).

Eur Heart J Qual Care Clin Outcomes 2019 10;5(4):292-297

Keele Cardiovascular Research Group, Centre of Prognosis Research, Institute of Primary Care Sciences, Keele University, Stoke-on-Trent, UK.

The British Cardiovascular Intervention Society (BCIS) percutaneous coronary intervention (PCI) registry is hosted by the National Institute of Cardiovascular Outcomes Research (NICOR) at Bart's Heart Centre and collects clinical characteristics, indications, procedural details, and outcomes of all patients undergoing PCI in the UK. The data are used for audit and research to monitor and improve PCI practices and patient outcomes. Bespoke live data analysis and structured monthly reports are used to provide real-time feedback to all participating hospitals about the provision of care. Risk-adjusted analyses are used as a quality metric and benchmarking PCI practices. The consecutive patients undergoing PCI in all PCI performing hospitals in the UK from 1994 to present. One hundred and thirteen variables encompassing patient demographics, indication, procedural details, complications, and in-hospital outcomes are recorded. Prospective data are collected electronically and encrypted before transfer to central database servers. Data are validated locally and further range checks, sense checks, and assessments of internal consistency are applied during data uploads. Analyses of uploaded data including an assessment of data completeness are provided to all hospitals for validation, with repeat validation rounds prior to public reporting. Endpoints are in-hospital PCI complications, bleeding and mortality. All-cause mortality is obtained via linkage to the Office of National Statistics. No other linkages are available at present. Available for research by application to NICOR at http://www.nicor.org.uk/ using a data sharing agreement.
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http://dx.doi.org/10.1093/ehjqcco/qcz023DOI Listing
October 2019

UK TAVI registry.

Authors:
Peter F Ludman

Heart 2019 03;105(Suppl 2):s2-s5

Cardiology Department, Queen Elizabeth Hospital, Birmingham B15 2TH, UK.

The UK Transcatheter Aortic Valve Implantation (TAVI) registry has collected data about every TAVI procedure performed in the UK. The latest data are from 2016 when 3250 procedures (49.5 pmp) were performed. There has been no change in the mean age of patients but there has been a shift to lower risk with fall in mean Logistic Euroscore since 2012. The switch from general anaesthetic to conscious sedation has been rapid, and propensity-adjusted analysis has not shown a difference in outcomes. In-hospital mortality has fallen to 1.8% in 2016, and relative survival analysis has shown outcome the same as the matched general population to 3 years. The UK TAVI registry has provided valuable benchmarks, and a risk adjustment model that includes frailty measures has been successfully developed and is available online.
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http://dx.doi.org/10.1136/heartjnl-2018-313510DOI Listing
March 2019

Long-Term Durability of Transcatheter Aortic Valve Prostheses.

J Am Coll Cardiol 2019 02;73(5):537-545

Department of Cardiology, Royal Sussex County Hospital, Brighton, United Kingdom.

Background: Very little is known about long-term valve durability after transcatheter aortic valve replacement (TAVR).

Objectives: This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure.

Methods: Demographic, procedural, and in-hospital outcome data on patients who underwent TAVR from 2007 to 2011 were obtained from the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. Patients in whom echocardiographic data were available both at baseline and ≥5 years post-TAVR were included. Hemodynamic SVD was determined according to European task force committee guidelines.

Results: A total of 241 patients (79.3 ± 7.5 years of age; 46% female) with paired post-procedure and late echocardiographic follow-up (median 5.8 years, range 5 to 10 years) were included. A total of 149 patients (64%) were treated with a self-expandable valve and 80 (34.7%) with a balloon-expandable valve. Peak aortic valve gradient at follow-up was lower than post-procedure (17.1 vs. 19.1 mm Hg; p = 0.002). More patients had none/trivial aortic regurgitation (AR) (47.5% vs. 33%), and fewer had mild AR (42.5% vs. 57%) at follow-up (p = 0.02). There was 1 case (0.4%) of severe SVD 5.3 years after implantation (new severe AR). There were 21 cases (8.7%) of moderate SVD (mean 6.1 years post-implantation; range 4.9 to 8.6 years). Twelve of these (57%) were due to new AR and 9 (43%) to restenosis.

Conclusions: Long-term transcatheter aortic valve function is excellent. In the authors' study, 91% of patients remained free of SVD between 5 and 10 years post-implantation. The incidence of severe SVD was <1%. Moderate SVD occurred in 1 in 12 patients.
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http://dx.doi.org/10.1016/j.jacc.2018.10.078DOI Listing
February 2019

Cardiac Marker Release During Transcatheter Aortic Valve Implantation.

Authors:
Peter F Ludman

Circ Cardiovasc Interv 2018 11;11(11):e007454

Department of Cardiology, Queen Elizabeth Hospital, Birmingham University Hospitals NHS Foundation Trust, United Kingdom.

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007454DOI Listing
November 2018

Association of comorbid burden with clinical outcomes after transcatheter aortic valve implantation.

Heart 2018 12 20;104(24):2058-2066. Epub 2018 Jul 20.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, Stoke-on-Trent, UK.

Objectives: To investigate the association of the CharlsonComorbidity Index (CCI) with clinical outcomes after transcatheter aortic valve implantation (TAVI).

Background: Patients undergoing TAVI have high comorbid burden; however, there is limited evidence of its impact on clinical outcomes.

Methods: Data from 1887 patients from the UK, Canada, Spain, Switzerland and Italy were collected between 2007 and 2016. The association of CCI with 30-day mortality, Valve Academic Research Consortium-2 (VARC-2) composite early safety, long-term survival and length of stay (LoS) was calculated using logistic regression and Cox proportional hazard models, as a whole cohort and at a country level, through a two-stage individual participant data (IPD) random effect meta-analysis.

Results: Most (60%) of patients had a CCI ≥3. A weak correlation was found between the total CCI and four different preoperative risks scores (=0.16 to 0.29), and approximately 50% of patients classed as low risk from four risk prediction models still presented with a CCI ≥3. Per-unit increases in total CCI were not associated with increased odds of 30-day mortality (OR 1.09, 95% CI 0.96 to 1.24) or VARC-2 early safety (OR 1.04, 95% CI 0.96 to 1.14) but were associated with increased hazard of long-term mortality (HR 1.10, 95% CI 1.05 to 1.16). The two-stage IPD meta-analysis indicated that CCI was not associated with LoS (HR 0.97, 95% CI 0.93 to 1.02).

Conclusion: In this multicentre international study, patients undergoing TAVI had significant comorbid burden. We found a weak correlation between the CCI and well-established preoperative risks scores. The CCI had a moderate association with long-term mortality up to 5 years post-TAVI.
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http://dx.doi.org/10.1136/heartjnl-2018-313356DOI Listing
December 2018

Do frailty measures improve prediction of mortality and morbidity following transcatheter aortic valve implantation? An analysis of the UK TAVI registry.

BMJ Open 2018 06 30;8(6):e022543. Epub 2018 Jun 30.

Farr Institute, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

Objectives: Previous studies indicate frailty to be associated with poor outcomes following transcatheter aortic valve implantation (TAVI), but there is limited evidence from multicentre registries. The aim was to investigate the independent association of frailty with TAVI outcomes, and the prognostic utility of adding frailty into existing clinical prediction models (CPMs).

Design: The UK TAVI registry incorporated three frailty measures since 2013: Canadian Study of Health and Ageing, KATZ and poor mobility. We investigated the associations between these frailty measures with short-term and long-term outcomes, using logistic regression to estimate multivariable adjusted ORs, and Cox proportional hazards models to explore long-term survival. We compared the predictive performance of existing TAVI CPMs before and after updating them to include each frailty measure.

Setting: All patients who underwent a TAVI procedure in England or Wales between 2013 and 2014.

Participants: 2624 TAVI procedures were analysed in this study.

Primary And Secondary Outcomes: The primary endpoints in this study were 30-day mortality and long-term survival. The Valve Academic Research Consortium (VARC)-2 composite early safety endpoint was considered as a secondary outcome.

Results: KATZ <6 (OR 2.10, 95% CI 1.39 to 3.15) and poor mobility (OR 2.15, 95% CI 1.41 to 3.28) predicted 30-day mortality after multivariable adjustment. All frailty measures were associated with increased odds of the VARC-2 composite early safety endpoint. We observed a significant increase in the area under the receiver operating characteristic curves by approximately 5% after adding KATZ <6 or poor mobility into the TAVI CPMs. Risk stratification agreement was significantly improved by the addition of each frailty measure, with an increase in intraclass correlation coefficient of between 0.15 and 0.31.

Conclusion: Frailty was associated with worse outcomes following TAVI, and incorporating frailty metrics significantly improved the predictive performance of existing CPMs. Physician-estimated frailty measures could aid TAVI risk stratification, until more objective scales are routinely collected.
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http://dx.doi.org/10.1136/bmjopen-2018-022543DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042628PMC
June 2018

Comparison of general anaesthesia and non-general anaesthesia approach in transfemoral transcatheter aortic valve implantation.

Heart 2018 10 29;104(19):1621-1628. Epub 2018 Mar 29.

Department of Cardiology, King's College Hospital, London, UK.

Objective: Performing transfemoral transcatheter aortic valve implantation (TAVI) without general anaesthesia (GA) has been increasingly adopted. We sought to study the impact of GA and non-GA approaches on procedural outcome and 30-day and 1-year mortality in transfemoral TAVI.

Methods: The UK TAVI registry holds information for every TAVI procedure in the UK. We analysed the data for patients implanted during 2013-2014 using either an Edwards Sapien or a Medtronic CoreValve prosthesis. Propensity score-matching analysis was performed to adjust for confounding factors.

Results: 2243 patients were studied (aged 81.4±7.5 years, 1195 males). 1816 (81%) underwent TAVI with GA and 427 (19%) without GA. Transoesophageal echocardiography (TOE) was used in 92.3% of GA and 12.4% of non-GA cases (p<0.001). There was no significant difference in the rate of successful valve deployment (GA 97.2% vs non-GA 95.7%, p=0.104) and in the incidence of more than mild aortic regurgitation (AR) at the end of the procedure (GA 5.6% vs non-GA 7.0%, p=0.295). However, procedure time was longer (131±60 vs 121±60mins, p=0.002) and length of stay was greater (8.0±13.5 vs 5.7±5.5 days, p<0.001) for GA cases. 30-day and 1-year mortality rates did not differ between the GA and non-GA cases. After propensity matching, these results remained unchanged. A second propensity analysis (adjusted for mode of anaesthesia) did not show an association between use of TOE and rate of successful valve deployment or frequency of significant AR. Neither was TOE associated with a longer procedural time or greater length of stay.

Conclusion: Procedure outcome, and 30-day and 1-year mortality are not influenced by mode of anaesthesia. However, GA is associated with longer procedure duration and greater length of stay.
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http://dx.doi.org/10.1136/heartjnl-2017-312559DOI Listing
October 2018

Novel United Kingdom prognostic model for 30-day mortality following transcatheter aortic valve implantation.

Heart 2018 07 7;104(13):1109-1116. Epub 2017 Dec 7.

Faculty of Biology, Medicine and Health, Farr Institute, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

Objective: Existing clinical prediction models (CPM) for short-term mortality after transcatheter aortic valve implantation (TAVI) have limited applicability in the UK due to moderate predictive performance and inconsistent recording practices across registries. The aim of this study was to derive a UK-TAVI CPM to predict 30-day mortality risk for benchmarking purposes.

Methods: A two-step modelling strategy was undertaken: first, data from the UK-TAVI Registry between 2009 and 2014 were used to develop a multivariable logistic regression CPM using backwards stepwise regression. Second, model-updating techniques were applied using the 2013-2014 data, thereby leveraging new approaches to include frailty and to ensure the model was reflective of contemporary practice. Internal validation was performed by bootstrapping to estimate in-sample optimism-corrected performance.

Results: Between 2009 and 2014, up to 6339 patients were included across 34 centres in the UK-TAVI Registry (mean age, 81.3; 2927 female (46.2%)). The observed 30-day mortality rate was 5.14%. The final UK-TAVI CPM included 15 risk factors, which included two variables associated with frailty. After correction for in-sample optimism, the model was well calibrated, with a calibration intercept of 0.02 (95% CI -0.17 to 0.20) and calibration slope of 0.79 (95% CI 0.55 to 1.03). The area under the receiver operating characteristic curve, after adjustment for in-sample optimism, was 0.66.

Conclusion: The UK-TAVI CPM demonstrated strong calibration and moderate discrimination in UK-TAVI patients. This model shows potential for benchmarking, but even the inclusion of frailty did not overcome the need for more wide-ranging data and other outcomes might usefully be explored.
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http://dx.doi.org/10.1136/heartjnl-2017-312489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6031259PMC
July 2018

A feasibility study of transaxillary TAVI with the lotus valve.

Catheter Cardiovasc Interv 2018 09 11;92(3):542-549. Epub 2017 Nov 11.

Queen Elizabeth Hospital, Birmingham, United Kingdom.

Objectives: To assess the feasibility of axillary transcatheter aortic valve implantation (TAVI) using the Lotus valve.

Background: TAVI is used to treat patients with severe aortic stenosis, with transfemoral (TF) access being the safest and most widely used route. In patients unsuitable for this, there are reports that the axillary artery may be safest alternative access route. The Lotus device is a fully retrievable 2nd generation transcatheter heart valve which is licensed for femoral and transaortic access. There are limited data on the suitability of this valve for axillary access.

Methods: We assessed the feasibility of transaxillary TAVI with the Lotus valve in patients unsuitable for TF TAVI. Between January and October 2016, we identified 10 patients who underwent transaxillary TAVI with the Lotus valve. This cohort was compared with 347 (85%) patients who underwent TF TAVI, 45 (11%) patients who underwent and trans-apical or direct-aortic TAVI and the total group of 16 (4%) patients who underwent axillary TAVI.

Results: Ten patients aged 75 years (69-83) underwent attempted TAVI with the Lotus via axillary access. Device success was 100%. In-hospital and 30-day mortality was zero. There were no neurological events, no major vascular complications and no myocardial infarctions. Four of 10 patients required a pacemaker post-TAVI. No patient was left with moderate or greater aortic regurgitation. Median length of stay was 3 days CONCLUSIONS: TAVI with the Lotus valve is feasible via the axillary artery and appears safe in our small cohort of patients.
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http://dx.doi.org/10.1002/ccd.27409DOI Listing
September 2018

Relative Survival After Transcatheter Aortic Valve Implantation: How Do Patients Undergoing Transcatheter Aortic Valve Implantation Fare Relative to the General Population?

J Am Heart Assoc 2017 Oct 17;6(10). Epub 2017 Oct 17.

Farr Institute, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, United Kingdom

Background: Transcatheter aortic valve implantation (TAVI) is indicated for patients with aortic stenosis who are intermediate-high surgical risk. Although all-cause mortality rates after TAVI are established, survival attributable to the procedure is unclear because of competing causes of mortality. The aim was to report relative survival (RS) after TAVI, which accounts for background mortality risks in a matched general population.

Methods And Results: National cohort data (n=6420) from the 2007 to 2014 UK TAVI registry were matched by age, sex, and year to mortality rates for England and Wales (population, 57.9 million). The Ederer II method related observed patient survival to that expected from the matched general population. We modelled RS using a flexible parametric approach that modelled the log cumulative hazard using restricted cubic splines. RS of the TAVI cohort was 95.4%, 90.2%, and 83.8% at 30 days, 1 year, and 3 years, respectively. By 1-year follow-up, mortality hazards in the >85 years age group were not significantly different from those of the matched general population; by 3 years, survival rates were comparable. The flexible parametric RS model indicated that increasing age was associated with significantly lower excess hazards after the procedure; for example, by 2 years, a 5-year increase in age was associated with 20% lower excess mortality over the general population.

Conclusions: RS after TAVI was high, and survival rates in those aged >85 years approximated those of a matched general population within 3 years. High rates of RS indicate that patients selected for TAVI tolerate the risks of the procedure well.
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http://dx.doi.org/10.1161/JAHA.117.007229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5721896PMC
October 2017

Relative survival and excess mortality following primary percutaneous coronary intervention for ST-elevation myocardial infarction.

Eur Heart J Acute Cardiovasc Care 2019 Feb 10;8(1):68-77. Epub 2017 Jul 10.

1 MRC Medical Bioinformatics Centre, University of Leeds, UK.

Background:: High survival rates are commonly reported following primary percutaneous coronary intervention for ST-elevation myocardial infarction, with most contemporary studies reporting overall survival.

Aims:: The aim of this study was to describe survival following primary percutaneous coronary intervention for ST-elevation myocardial infarction corrected for non-cardiovascular deaths by reporting relative survival and investigate clinically significant factors associated with poor long-term outcomes.

Methods And Results:: Using the prospective UK Percutaneous Coronary Intervention registry, primary percutaneous coronary intervention cases ( n=88,188; 2005-2013) were matched to mortality data for the UK populace. Crude five-year relative survival was 87.1% for the patients undergoing primary percutaneous coronary intervention and 94.7% for patients <55 years. Increasing age was associated with excess mortality up to four years following primary percutaneous coronary intervention (56-65 years: excess mortality rate ratio 1.61, 95% confidence interval 1.46-1.79; 66-75 years: 2.49, 2.26-2.75; >75 years: 4.69, 4.27-5.16). After four years, there was no excess mortality for ages 56-65 years (excess mortality rate ratio 1.27, 0.95-1.70), but persisting excess mortality for older groups (66-75 years: excess mortality rate ratio 1.72, 1.30-2.27; >75 years: 1.66, 1.15-2.41). Excess mortality was associated with cardiogenic shock (excess mortality rate ratio 6.10, 5.72-6.50), renal failure (2.52, 2.27-2.81), left main stem stenosis (1.67, 1.54-1.81), diabetes (1.58, 1.47-1.69), previous myocardial infarction (1.52, 1.40-1.65) and female sex (1.33, 1.26-1.41); whereas stent deployment (0.46, 0.42-0.50) especially drug eluting stents (0.27, 0.45-0.55), radial access (0.70, 0.63-0.71) and previous percutaneous coronary intervention (0.67, 0.60-0.75) were protective.

Conclusions:: Following primary percutaneous coronary intervention for ST-elevation myocardial infarction, long-term cardiovascular survival is excellent. Failure to account for non-cardiovascular death may result in an underestimation of the efficacy of primary percutaneous coronary intervention.
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http://dx.doi.org/10.1177/2048872617710790DOI Listing
February 2019

The Relationship of Body Mass Index to Percutaneous Coronary Intervention Outcomes: Does the Obesity Paradox Exist in Contemporary Percutaneous Coronary Intervention Cohorts? Insights From the British Cardiovascular Intervention Society Registry.

JACC Cardiovasc Interv 2017 07;10(13):1283-1292

Academic Department of Cardiology, Royal Stoke Hospital, University Hospital of North Midlands, Stoke-on-Trent, United Kingdom; Keele Cardiovascular Research Group, Institute of Applied Clinical Science, Keele University, Stoke-on-Trent, United Kingdom. Electronic address:

Objectives: The aims of this study were to examine the relationship between body mass index (BMI) and clinical outcomes following percutaneous coronary intervention (PCI) and to determine the relevance of different clinical presentations requiring PCI to this relationship.

Background: Obesity is a growing problem, and studies have reported a protective effect from obesity compared with normal BMI for adverse outcomes after PCI.

Methods: Between 2005 and 2013, 345,192 participants were included. Data were obtained from the British Cardiovascular Intervention Society registry, and mortality data were obtained through the U.K. Office of National Statistics. Multiple logistic regression was performed to determine the association between BMI group (<18.5, 18.5 to 24.9, 25 to 30 and >30 kg/m) and adverse in-hospital outcomes and mortality.

Results: At 30 days post-PCI, significantly lower mortality was seen in patients with elevated BMIs (odds ratio [OR]: 0.86 [95% confidence interval (CI): 0.80 to 0.93] 0.90 [95% CI: 0.82 to 0.98] for BMI 25 to 30 and >30 kg/m, respectively). At 1 year post-PCI, and up to 5 years post-PCI, elevated BMI (either overweight or obese) was an independent predictor of greater survival compared with normal weight (OR: 0.70 [95% CI: 0.67 to 0.73] and 0.73 [95% CI: 0.69 to 0.77], respectively, for 1 year; OR: 0.78 [95% CI: 0.75 to 0.81] and 0.88 [95% CI: 0.84 to 0.92], respectively, for 5 years). Similar reductions in mortality were observed for the analysis according to clinical presentation (stable angina, unstable angina or non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction).

Conclusions: A paradox regarding the independent association of elevated BMI with reduced mortality after PCI is still evident in contemporary U.K. practice. This is seen in both stable and more acute clinical settings.
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http://dx.doi.org/10.1016/j.jcin.2017.03.013DOI Listing
July 2017

Transcatheter Aortic Valve Implantation With or Without Percutaneous Coronary Artery Revascularization Strategy: A Systematic Review and Meta-Analysis.

J Am Heart Assoc 2017 Jun 27;6(6). Epub 2017 Jun 27.

Keele Cardiovascular Research Group, Institute for Applied Clinical Science and Centre for Prognosis Research, Institute of Primary Care and Health Sciences, University of Keele, Stoke-on-Trent, United Kingdom

Background: Recent recommendations suggest that in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and coexistent significant coronary artery disease, the latter should be treated before the index procedure; however, the evidence basis for such an approach remains limited. We performed a systematic review and meta-analysis to study the clinical outcomes of patients with coronary artery disease who did or did not undergo revascularization prior to transcatheter aortic valve implantation.

Methods And Results: We conducted a search of Medline and Embase to identify studies evaluating patients who underwent transcatheter aortic valve implantation with or without percutaneous coronary intervention. Random-effects meta-analyses with the inverse variance method were used to estimate the rate and risk of adverse outcomes. Nine studies involving 3858 participants were included in the meta-analysis. Patients who underwent revascularization with percutaneous coronary intervention had a higher rate of major vascular complications (odd ratio [OR]: 1.86; 95% confidence interval [CI], 1.33-2.60; =0.0003) and higher 30-day mortality (OR: 1.42; 95% CI, 1.08-1.87; =0.01). There were no differences in effect estimates for 30-day cardiovascular mortality (OR: 1.03; 95% CI, 0.35-2.99), myocardial infarction (OR: 0.86; 95% CI, 0.14-5.28), acute kidney injury (OR: 0.89; 95% CI, 0.42-1.88), stroke (OR: 1.07; 95% CI, 0.38-2.97), or 1-year mortality (OR: 1.05; 95% CI, 0.71-1.56). The timing of percutaneous coronary intervention (same setting versus a priori) did not negatively influence outcomes.

Conclusions: Our analysis suggests that revascularization before transcatheter aortic valve implantation confers no clinical advantage with respect to several patient-important clinical outcomes and may be associated with an increased risk of major vascular complications and 30-day mortality. In the absence of definitive evidence, careful evaluation of patients on an individual basis is of paramount importance to identify patients who might benefit from elective revascularization.
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http://dx.doi.org/10.1161/JAHA.117.005960DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5669191PMC
June 2017

United Kingdom: coronary and structural heart interventions from 2010 to 2015.

EuroIntervention 2017 05;13(Z):Z83-Z88

Queen Elizabeth Hospital, University Hospital Birmingham NHS Foundation Trust, Edgbaston, Birmingham, United Kingdom.

In the United Kingdom, a clinical data set is completed for every patient undergoing coronary intervention and certain structural interventions, and sent to central servers in the National Institute for Cardiovascular Outcomes Research (NICOR) on behalf of the British Cardiovascular Intervention Society (BCIS). These data are linked to the national mortality register. In addition, data are obtained about the structure of healthcare provision using an annual survey. Analyses of these data are provided for different audiences in several formats. Public reports of individual consultant operator activity and risk-adjusted outcomes from percutaneous coronary intervention (PCI) have also been produced annually since 2012. Transcatheter aortic valve implantation (TAVI) has been performed since 2007. Over 2,000 cases were performed in 2015, giving a rate of 30 per million population. Complications to discharge have fallen as case mix has changed and technologies improved. While the mean age has remained about 81 years, the logistic EuroSCORE of patients treated by TAVI has fallen from about 22 in 2010 to 18 in 2015. Tracked 30-day mortality was 3.7% in 2014. Left atrial appendage occlusion and patent foramen ovale (PFO) closure for stroke, and the use of the MitraClip® system (Abbott Vascular, Santa Clara, CA, USA) for mitral regurgitation have been funded through a process called "commissioning through evaluation".
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http://dx.doi.org/10.4244/EIJ-D-16-00833DOI Listing
May 2017

Choice of Stent for Percutaneous Coronary Intervention of Saphenous Vein Grafts.

Circ Cardiovasc Interv 2017 Apr;10(4)

From the South Yorkshire Cardiothoracic Centre, Northern General Hospital, Sheffield, United Kingdom (J.I.); Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, United Kingdom (C.S.K., M.A.M.); University Hospital North Staffordshire, United Kingdom (C.S.K., A.L., R.B., M.A.M.); Institute of Population Health (E.K.) and Farr Institute (M.A.M.), University of Manchester, United Kingdom; The James Cook University Hospital, Middlesbrough, United Kingdom (M.A.d.B.); Department of Cardiology, Queen Elizabeth Hospital, Birmingham, United Kingdom (P.F.L.); Freeman Hospital, Newcastle upon Tyne, United Kingdom (A.G., A.Z.); and Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom (T.K.).

Background: There are limited data on comparison of contemporary drug-eluting stent (DES) platforms, previous generation DES, and bare-metal stents (BMS) for percutaneous coronary intervention in saphenous vein grafts (SVG). We aimed to assess clinical outcomes following percutaneous coronary intervention to SVG in patients receiving bare-metal stents (BMS), first-generation DES, and newer generation DES in a large unselected national data set from the BCIS (British Cardiovascular Intervention Society).

Methods And Results: Patients undergoing percutaneous coronary intervention to SVG in the United Kingdom from January 2006 to December 2013 were divided into 3 groups according to stent use: BMS, first-generation DES, and newer generation DES group. Study outcomes included in-hospital major adverse cardiovascular events, 30-day mortality, and 1-year mortality. Patients (n=15 003) underwent percutaneous coronary intervention to SVG in England and Wales during the study period. Of these, 38% received BMS, 15% received first-generation DES, and 47% received second-generation DES. The rates of in-hospital major adverse cardiovascular events were significantly lower in patients treated with second-generation DES (odds ratio, 0.51; 95% confidence interval, 0.38-0.68; <0.001), but not with first-generation DES, compared with BMS-treated patients. Similarly, 30-day mortality (odds ratio, 0.43; 95% confidence interval, 0.32-0.59; <0.001) and 1-year mortality (odds ratio, 0.60; 95% confidence interval, 0.51-0.71; <0.001) were lower in patients treated with second-generation DES, but not with first-generation DES, compared with the patients treated with BMS.

Conclusions: Patients receiving second-generation DES for the treatment SVG disease have lower rates of in-hospital major adverse cardiovascular events, 30-day mortality, and 1-year mortality, compared with those receiving BMS.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.004457DOI Listing
April 2017

Variation in emergency percutaneous coronary intervention in ventilated patients in the UK: Insights from a national database.

Cardiovasc Revasc Med 2017 Jun 13;18(4):250-254. Epub 2017 Feb 13.

University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine, University of Southampton, Southampton, UK. Electronic address:

Aims: Pre-procedural ventilation is a marker of high risk in PCI patients. Causes include out-of-hospital cardiac arrest (OHCA) and cardiogenic shock. OHCA occurs in approximately 60,000 patients in the UK per annum. No consensus exists regarding the need/timing of coronary angiography ± revascularization without ST elevation. The aim was to describe the national variation in the rate of emergency PCI in ventilated patients.

Methods And Results: Using the UK national database for PCI in 2013, we identified all procedures performed as 'emergency' or 'salvage' for whom ventilation had been initiated before the PCI. Of the 92,589 patients who underwent PCI, 1342 (5.5%) fulfilled those criteria. There was wide variation in practice. There was no demonstrable relationship between the number of emergency PCI patients with pre-procedure ventilation per annum and (i) total number of PPCIs in a unit (r=-0.186), and (ii) availability of 24h PCI, (iii) on-site surgical cover.

Conclusion: We demonstrated a wide variation in practice across the UK in rates of pre-procedural ventilation in emergency PCI. The majority of individuals will have suffered an OHCA. In the absence of a plausible explanation for this discrepant practice, it is possible that (a) some patients presenting with OHCA that may benefit from revascularization are being denied treatment and (b) procedures may be being undertaken that are futile. Further prospective data are needed to aid in production of guidelines aiming at standardized care in OHCA.
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http://dx.doi.org/10.1016/j.carrev.2017.02.005DOI Listing
June 2017

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

Am Heart J 2017 02 3;184:97-105. Epub 2016 Nov 3.

Health e-Research Centre, University of Manchester, Manchester, United Kingdom; Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, UK, Royal Stoke Hospital, University Hospitals North Midlands, Stoke-on-Trent, United Kingdom. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ahj.2016.10.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333927PMC
February 2017

Pre-Implantation Balloon Aortic Valvuloplasty and Clinical Outcomes Following Transcatheter Aortic Valve Implantation: A Propensity Score Analysis of the UK Registry.

J Am Heart Assoc 2017 02 18;6(2). Epub 2017 Feb 18.

Health e-Research Centre, University of Manchester, Manchester, United Kingdom

Background: Aortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short-term outcomes in the UK TAVI registry.

Methods And Results: Eleven clinical endpoints were investigated, including 30-day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety. All endpoints were defined as per the VARC-2 definitions. Odd ratios of each endpoint were estimated using logistic regression, with data analyzed in balloon- and self-expandable valve subgroups. Propensity scores were calculated using patient demographics and procedural variables, which were included in the models of each endpoint to adjust for measured confounding. Between 2007 and 2014, 5887 patients met the study inclusion criteria, 1421 (24.1%) of whom had no BAV before TAVI valve deployment. We observed heterogeneity in the use of BAV nationally, both temporally and by center experience; rates of BAV in pre-TAVI workup varied between 30% and 97% across TAVI centers. All endpoints were similar between treatment groups in SAPIEN (Edwards Lifesciences Inc., Irvine, CA) valve patients. After correction for multiple testing, none of the endpoints in CoreValve (Medtronic, Minneapolis, MN) patients were significantly different between patients with or without predilation.

Conclusions: Performing TAVI without predilation was not associated with adverse short-term outcomes post procedure, especially when using a balloon-expandable prosthesis. Randomized trials including different valve types are required to provide conclusive evidence regarding the utility of predilation before-TAVI.
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http://dx.doi.org/10.1161/JAHA.116.004695DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5523768PMC
February 2017

Assessing flow limitation in patients with stable coronary artery disease.

BMJ 2016 Oct 20;355:i5534. Epub 2016 Oct 20.

Department of Cardiology, Papworth Hospital, Cambridge, UK.

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http://dx.doi.org/10.1136/bmj.i5534DOI Listing
October 2016

The scientific value of TAVI surveys: insights and perspectives from European centres and European patients.

EuroIntervention 2016 Sep;12(7):823-6

Department of Cardiology, Queen Elizabeth Hospital, Birmingham, United Kingdom.

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http://dx.doi.org/10.4244/EIJV12I7A136DOI Listing
September 2016

Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta-Analysis.

J Am Heart Assoc 2016 06 13;5(6). Epub 2016 Jun 13.

Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, United Kingdom Keele Cardiovascular Research Group, Institute of Science and Technology in Medicine and Primary Care, Keele University, Stoke-on-Trent, Staffordshire, United Kingdom.

Background: Preimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV.

Methods And Results: We conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random-effects meta-analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30-day all-cause mortality occurred in 6% (72 of 1282) of patients. Meta-analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32-1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62-1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23-1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66-1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30-1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49-1.30, P=0.37).

Conclusions: Our analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.
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http://dx.doi.org/10.1161/JAHA.115.003191DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4937264PMC
June 2016

Impact of call-to-balloon time on 30-day mortality in contemporary practice.

Heart 2017 01 13;103(2):117-124. Epub 2016 Jul 13.

Trent Cardiac Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.

Objective: Studies reporting an association between treatment delay and outcome for patients with ST segment elevation myocardial infarction (STEMI) have generally not included patients treated by a primary percutaneous coronary intervention (PPCI) service that systematically delivers reperfusion therapy to all eligible patients. We set out to determine the association of call-to-balloon (CTB) time with 30-day mortality after PPCI in a contemporary series of patients treated within a national reperfusion service.

Methods: We analysed data on 16 907 consecutive patients with STEMI treated by PPCI in England and Wales in 2011 with CTB time of ≤6 hours.

Results: The median CTB and door-to-balloon times were 111 and 41 min, respectively, with 80.9% of patients treated within 150 min of the call for help. An out-of-hours call time (58.2% of patients) was associated with a 10 min increase in CTB time, whereas inter-hospital transfer for PPCI (18.5% of patients) was associated with a 49 min increase in CTB time. CTB time was independently associated with 30-day mortality (p<0.0001) with a HR of 1.95 (95% CI 1.54 to 2.47) for a CTB time of >180-240 min compared with ≤90 min. The relationship between CTB time and 30-day mortality was influenced by patient risk profile with a greater absolute impact of increasing CTB time on mortality in high-risk patients.

Conclusion: CTB time is a useful metric to assess the overall performance of a PPCI service. Delays to reperfusion remain important even in the era of organised national PPCI services with rapid treatment times and efforts should continue to minimise treatment delays.
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http://dx.doi.org/10.1136/heartjnl-2016-309658DOI Listing
January 2017

Determinants and Outcomes of Stroke Following Percutaneous Coronary Intervention by Indication.

Stroke 2016 06 10;47(6):1500-7. Epub 2016 May 10.

From the Epidemiology Group, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK (P.K.M.); Keele Cardiovascular Research Group, Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK (C.S.K., C.R., M.A.M.); Farr Institute, University of Manchester, Manchester, UK (E.K., M.A.M.); Department of Cardiology, Freeman Hospital and Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, UK (A.Z.); Department of Cardiology, Royal Jubilee Hospital, Glasgow, UK (C.B.); Department of Cardiology, Queen Elizabeth Hospital, Edgbaston, Birmingham, UK (P.F.L.); and Department of Cardiology, The James Cook University Hospital, Middlesbrough, UK (M.A.d.B.).

Background And Purpose: Stroke after percutaneous coronary intervention (PCI) is a serious complication, but its determinants and outcomes after PCI in different clinical settings are poorly documented.

Methods: The British Cardiovascular Intervention Society (BCIS) database was used to study 560 439 patients who underwent PCI in England and Wales between 2006 and 2013. We examined procedural-type specific determinants of ischemic and hemorrhagic stroke and the likelihood of subsequent 30-day mortality and in-hospital major adverse cardiovascular events (a composite of in-hospital mortality, myocardial infarction or reinfarction, and repeat revascularization).

Results: A total of 705 stroke cases were recorded (80% ischemic). Stroke after an elective PCI or PCI for acute coronary syndrome indications was associated with a higher risk of adverse outcomes compared with those without stroke; 30-day mortality and major adverse cardiovascular events outcomes in fully adjusted model were odds ratios 37.90 (21.43-67.05) and 21.05 (13.25-33.44) for elective and 5.00 (3.96-6.31) and 6.25 (5.03-7.77) for acute coronary syndrome, respectively. Comparison of odds of these outcomes between these 2 settings showed no differences; corresponding odds ratios were 1.24 (0.64-2.43) and 0.63 (0.35-1.15), respectively.

Conclusions: Hemorrhagic and ischemic stroke complications are uncommon, but serious complications can occur after PCI and are independently associated with worse mortality and major adverse cardiovascular events outcomes in both the elective and acute coronary syndrome setting irrespective of stroke type. Our study provides a better understanding of the risk factors and prognosis of stroke after PCI by procedure type, allowing physicians to provide more informed advice around stroke risk after PCI and counsel patients and their families around outcomes if such neurological complications occur.
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http://dx.doi.org/10.1161/STROKEAHA.116.012700DOI Listing
June 2016

Is There a Relationship of Operator and Center Volume With Access Site-Related Outcomes? An Analysis From the British Cardiovascular Intervention Society.

Circ Cardiovasc Interv 2016 May;9(5):e003333

From the Farr Institute, Institute of Population Health, University of Manchester, Manchester, United Kingdom (W.H., M.S., H.R., I.B., M.A.M.); Department of Cardiology, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom (P.F.L.); Department of Cardiology, The James Cook University Hospital, Middlesbrough, United Kingdom (M.D.B.); Department of Cardiology, Faculty of Medicine, University of Southampton, Southampton, United Kingdom (N.C.); Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom (T.K.); Keele Cardiovascular Research Group, Institutes of Science and Technology in Medicine and Primary Care and Health Sciences, Stoke-on-Trent, United Kingdom (C.S.K., J.N., M.A.M.); and Department of Cardiology, Royal Stoke Hospital, University Hospital North Midlands Trust, Stoke-on-Trent, United Kingdom (C.S.K., J.N., M.A.M.).

Background: Transradial access is associated with reduced access site-related bleeding complications and mortality post percutaneous coronary intervention. The objective of this study is to examine the relationship between access site practice and clinical outcomes and how this may be influenced by operator and center experience/expertise.

Methods And Results: The influence of operator and center experience/expertise was studied on 30-day mortality, in-hospital major adverse cardiovascular events (a composite of in-hospital mortality and in-hospital myocardial infarction and target vessel revascularization) and in-hospital major bleeding based on access site adopted (radial versus femoral). Operator/center experience/expertise were defined by both total volume and transradial access proportion. A total of 164 395 procedures between 2012 and 2013 in the National Health Service in England and Wales were analyzed. After case-mix adjustment, transradial access was associated with an average odds reduction of 39% for 30-day mortality compared with transfemoral access (odds ratio, 0.61; 95% confidence interval, 0.55-0.68; P<0.001). The magnitude of this risk reduction was modified by increases in total procedural volume and radial proportion at the operator level (odds ratio reduction of 11% per 100 extra procedures, 95% confidence interval, 3%-19%; odds ratio reduction of 6% per 10%-point increase in radial proportion, 95% confidence interval, 1%-11%) with no significant impact of operator radial volume, center total volume, center radial volume, and center radial proportion.

Conclusions: The lower mortality associated with transradial access adoption relates to both the total procedural volume and the proportion of procedures undertaken radially by operator, with operators undertaking the greatest proportion of their procedures radially having the largest relative reduction in mortality risk.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003333DOI Listing
May 2016