Circadian patterns of heart rate variability in fetal sheep after hypoxia-ischaemia: A biomarker of evolving brain injury.

Hypoxia-ischaemia (HI) before birth is a key risk factor for stillbirth and severe neurodevelopmental disability in survivors, including cerebral palsy, although there are no reliable biomarkers to detect at risk fetuses that may have suffered a transient period of severe HI. We investigated time and frequency domain measures of fetal heart rate variability (FHRV) for 3 weeks after HI in preterm fetal sheep at 0.7 gestation (equivalent to preterm humans) until 0.8 gestation (equivalent to term humans). We have previously shown that this is associated with delayed development of severe white and grey matter injury, including cystic white matter injury (WMI) resembling that observed in human preterm infants. HI was associated with suppression of time and frequency domain measures of FHRV and reduced their circadian rhythmicity during the first 3 days of recovery. By contrast, circadian rhythms of multiple measures of FHRV were exaggerated over the final 2 weeks of recovery, mediated by a greater reduction in FHRV during the morning nadir, but no change in the evening peak. These data suggest that the time of day at which FHRV measurements are taken affects their diagnostic utility. We further propose that circadian changes in FHRV may be a low-cost, easily applied biomarker of antenatal HI and evolving brain injury. KEY POINTS: Hypoxia-ischaemia (HI) before birth is a key risk factor for stillbirth and probably for disability in survivors, although there are no reliable biomarkers for antenatal brain injury. In preterm fetal sheep, acute HI that is known to lead to delayed development of severe white and grey matter injury over 3 weeks, was associated with early suppression of multiple time and frequency domain measures of fetal heart rate variability (FHRV) and loss of their circadian rhythms during the first 3 days after HI. Over the final 2 weeks of recovery after HI, exaggerated circadian rhythms of frequency domain FHRV measures were observed. The morning nadirs were lower with no change in the evening peak of FHRV. Circadian changes in FHRV may be a low-cost, easily applied biomarker of antenatal HI and evolving brain injury.

Dissecting the contributions of the peripheral chemoreflex and myocardial hypoxia to fetal heart rate decelerations in near-term fetal sheep.

Brief repeated fetal hypoxaemia during labour can trigger intrapartum decelerations of the fetal heart rate (FHR) via the peripheral chemoreflex or the direct effects of myocardial hypoxia, but the relative contribution of these two mechanisms and how this balance changes with evolving fetal compromise remain unknown. In the present study, chronically instrumented near-term fetal sheep received surgical vagotomy (n = 8) or sham vagotomy (control, n = 11) to disable the peripheral chemoreflex and unmask myocardial hypoxia. One-minute complete umbilical cord occlusions (UCOs) were performed every 2.5 min for 4 h or until arterial pressure fell below 20 mmHg. Hypotension and severe acidaemia developed progressively after 65.7 ± 7.2 UCOs in control fetuses and 49.5 ± 7.8 UCOs after vagotomy. Vagotomy was associated with faster development of metabolic acidaemia and faster impairment of arterial pressure during UCOs without impairing centralization of blood flow or neurophysiological adaptation to UCOs. During the first half of the UCO series, before severe hypotension developed, vagotomy was associated with a marked increase in FHR during UCOs. After the onset of evolving severe hypotension, FHR fell faster in control fetuses during the first 20 s of UCOs, but FHR during the final 40 s of UCOs became progressively more similar between groups, with no difference in the nadir of decelerations. In conclusion, FHR decelerations were initiated and sustained by the peripheral chemoreflex at a time when fetuses were able to maintain arterial pressure. After the onset of evolving hypotension and acidaemia, the peripheral chemoreflex continued to initiate decelerations, but myocardial hypoxia became progressively more important in sustaining and deepening decelerations. KEY POINTS: Brief repeated hypoxaemia during labour can trigger fetal heart rate decelerations by either the peripheral chemoreflex or myocardial hypoxia, but how this balance changes with fetal compromise is unknown. Reflex control of fetal heart rate was disabled by vagotomy to unmask the effects of myocardial hypoxia in chronically instrumented fetal sheep. Fetuses were then subjected to repeated brief hypoxaemia consistent with the rates of uterine contractions during labour. We show that the peripheral chemoreflex controls brief decelerations in their entirety at a time when fetuses were able to maintain normal or increased arterial pressure. The peripheral chemoreflex still initiated decelerations even after the onset of evolving hypotension and acidaemia, but myocardial hypoxia made an increasing contribution to sustain and deepen decelerations.

Misdiagnosis of aortic dissection: A systematic review of the literature.

BACKGROUND: Aortic dissection is a rare but potentially catastrophic condition. Misdiagnosis of aortic dissection is not uncommon as symptoms can overlap with other diagnoses. OBJECTIVE: We conducted a systematic review to better understand the factors contributing to incorrect diagnosis of this condition. METHODS: We searched MEDLINE and EMBASE for studies that evaluated the misdiagnosis of aortic dissection. The rate of misdiagnosis was pooled and results were narratively synthesized. RESULTS: A total of 12 studies with were included with 1663 patients. The overall rate of misdiagnosis of aortic dissection was 33.8%. The proportion of patients presenting with chest pain, back pain and syncope were 67.5%, 24.8% and 6.8% respectively. The proportion of patients with pre-existing hypertension was 55.4%, 30.5% were smokers while the proportion of patients with coronary artery disease, previous cardiovascular surgery or surgical trauma and Marfan syndrome was 14.7%, 5.8%, and 3.7%, respectively. Factors related to misdiagnosis included the presence of symptoms and features associated with other diseases (such as acute coronary syndrome, stroke and pulmonary embolism), the absence of typical features (such as widened mediastinum on chest X-ray) or concurrent conditions such congestive heart failure. Factors associated with more accurate diagnosis included more comprehensive history taking and increased use of imaging. CONCLUSIONS: Misdiagnosis in patients with an eventual diagnosis of aortic dissection affects 1 in 3 patients. Clinicians should consider aortic dissection as differential diagnosis in patients with chest pain, back pain and syncope. Imaging should be used early to make the diagnosis when aortic dissection is suspected.

Transient effects of forebrain ischemia on fetal heart rate variability in fetal sheep.

Fetal heart rate variability (FHRV) is a key index of antenatal and intrapartum fetal well-being. FHRV is well established to be mediated by both arms of the autonomic nervous system, but it remains unknown whether higher centers in the forebrain contribute to FHRV. We tested the hypothesis that selective forebrain ischemia would impair the generation of FHRV. Sixteen chronically instrumented near-term fetal sheep were subjected to either forebrain ischemia induced by bilateral carotid occlusion or sham-ischemia for 30 min. Time, frequency, and nonlinear measures of FHRV were assessed during and for seven days after ischemia. Ischemia was associated with profound suppression of electroencephalographic (EEG) power, which remained suppressed throughout the recovery period (P < 0.001). During the first 5 min of ischemia, multiple time and frequency domain measures were increased (all P < 0.05) before returning back to sham levels. A delayed increase in sample entropy was observed during ischemia (P < 0.05). For the first 3 h after ischemia, there was moderate suppression of two measures of FHRV (very-low frequency power and the standard deviation of RR-intervals, both P < 0.05) and increased sample entropy (P < 0.05). Thereafter, all measures of FHRV returned to control levels. In conclusion, profound forebrain ischemia sufficient to lead to severe neural injury had only transient effect on multiple measures of FHRV. These findings suggest that the forebrain makes a limited contribution to FHRV. FHRV therefore primarily originates in the hindbrain and is unlikely to provide meaningful information on forebrain neurodevelopment or metabolism.

Outcomes of patients who undergo percutaneous coronary intervention with covered stents for coronary perforation: A systematic review and pooled analysis of data.

OBJECTIVES: This review aims to evaluate the adverse outcomes for patients after treatment with covered stents. BACKGROUND: Coronary perforation is a potentially fatal complication of percutaneous coronary revascularization which may be treated using covered stents. Studies have evaluated long-term outcomes among patients who received these devices, but hitherto no literature review has taken place. METHODS: We conducted a systematic review of adverse outcomes for patients after treatment with covered stents. Data from studies were pooled and outcomes were compared according to stent type. RESULTS: A total of 29 studies were analyzed with data from 725 patients who received covered stents. The proportion of patients with chronic total occlusions, vein graft percutaneous coronary intervention (PCI), intracoronary imaging and rotational atherectomy were 16.9, 11.5, 9.2, and 6.6%, respectively. The stents used were primarily polytetrafluoroethylene (PTFE) (70%) and Papyrus (20.6%). Mortality, major adverse cardiovascular events, pericardiocentesis/tamponade and emergency surgery were 17.2, 35.3, 27.1, and 5.3%, respectively. Stratified analysis by use of PTFE, Papyrus and pericardial stents, suggested no difference in mortality (p = .323), or target lesion revascularization (p = .484). Stent thrombosis, pericardiocentesis/tamponade and emergency coronary artery bypass surgery (CABG) occurred more frequently in patients with PTFE stent use (p = .011, p = .005, p = .012, respectively). In-stent restenosis was more common with pericardial stent use (<.001, pooled analysis for first- and second-generation pericardial stents). CONCLUSIONS: Cases of coronary perforation which require implantation of a covered stent are associated with a high rate of adverse outcomes. The use of PTFE covered stents appears to be associated with more stent thrombosis, pericardiocentesis/tamponade, and emergency CABG when compared to Papyrus or pericardial stents.

The Influence of the Charlson Comorbidity Index on Procedural Characteristics, VARC-2 Endpoints and 30-Day Mortality Among Patients Who Undergo Transcatheter Aortic Valve Implantation.

BACKGROUND: Aortic stenosis (AS) is a common valvular abnormality and transcatheter aortic valve implantation (TAVI) is being increasingly used to treat patients considered too high risk for conventional surgery. We aimed to assess the prevalence of comorbid conditions in patients undergoing TAVI using the Charlson Comorbidity Index (CCI) and to assess their impact on clinical and procedural outcomes. METHODS: We analysed 158 patients who underwent a TAVI at our institution between June 2009 and September 2015 to define their co-morbid burden as measured with CCI, and study its impact on procedural characteristics and mortality at 30 days. RESULTS: One hundred fifty-eight (158) patients with a mean age of 82±8years and a mean CCI score of 2.67 underwent a TAVI. Only 12/158 patients had a CCI of 0. The commonest cardiovascular comorbidities were previous myocardial infarction (24%), congestive heart failure (15%) and diabetes mellitus (23%) whilst the commonest non-cardiovascular comorbidities were renal disease (46%) and chronic obstructive pulmonary disease (COPD) (29%). After multivariable adjustment, CCI was not independently associated with adverse clinical outcomes. The addition of CCI to scoring systems such as Logistic EuroScore (LES) and Society of Thoracic Surgeons (STS) risk models improved the area under the curve from 0.75 (95%CI: 0.44-1.00) and 0.83 (95%CI: 0.64-1.00) to 0.78 (95%CI: 0.53-1.00) and 0.89 (95%CI: 0.78-1.00) respectively. CONCLUSIONS: The burden of comorbid conditions in patients undergoing TAVI is significant. The CCI score was not independently associated with a higher risk of death but can be useful in addition to LES and STS risk models in informing decision making on the selection of patients for TAVI.

Balloon aortic valvuloplasty in contemporary practice.

BACKGROUND: There has been a revival of balloon aortic valvuloplasty (BAV) for severe aortic stenosis, as a result of an increasing number of patients undergoing trans-catheter aortic valve implantation (TAVI). However, there has not been universal adoption of BAV as a standalone, nor bridging therapy. METHODS: A retrospective analysis of the practice at our institution between June 2009 and May 2016 was performed. Demographic, clinical, procedural, and follow-up data on all patients were collected. RESULTS: A total of 200 patients with a median age of 82 years and severe symptomatic aortic stenosis underwent BAV from June 2009 to May 2016. All patients had appreciable comorbidity with a mean logistic Euro SCORE of 48 ± 11 and mean standard Euro SCORE 15 ± 4. BAV was performed for palliation in 118 (59%), as a bridging therapy for TAVI in 55 (27.5%) and bridging to surgical AVR in 27 patients (13.5%), respectively. Major complications occurred in 14 patients (7%) including 2 in-patient deaths (1%). A statistically significant improvement in symptoms and a decrease in trans-valvular gradient were observed. CONCLUSION: BAV is an effective treatment strategy, either as a bridge to definitive therapy or as a palliative procedure, with an acceptable mortality. BAV is associated with a significant improvement in symptoms and is valuable as a palliative treatment in high-risk patients, where no other invasive option is available.

Cardiovascular Outcomes Following Rotational Atherectomy: A UK Multicentre Experience.

OBJECTIVES: To identify factors associated with outcomes following rotational atherectomy (RA). BACKGROUND: RA is an effective way to mechanically modify heavily calcified lesions before stenting; however its outcomes are not well defined. METHODS AND RESULTS: Retrospective evaluation of all patients who underwent RA in three large UK centers (Leeds General Infirmary (LGI), Royal Infirmary of Edinburgh (RIE) and University Hospital of North Staffordshire (UHNS)) from March 2005 to January 2013. Five hundred and eighteen patients had RA with median follow-up period of 22 months. About 68.3% were male, 28.7% had DM and 34.6% were treated because of ACS. Stents were deployed in 97.3% of the patients while 30.7% of the procedures were performed transradially. Maximum burr was ≤1.75 mm in 85.5% and the mean SYNTAX score was 19.5 ± 11.6. Peri-procedural complications occurred in 6.4% and vascular access complications in 1.9%. Outcomes in the follow-up period were: MACE 17.8%, cardiac death 7.1%, MI 11.7%, TVR 7.5%, all-cause death 13.7%, definite stent thrombosis (ST) 1.4% and stroke 2.9%. Patients with intermediate and high SYNTAX scores were more likely to suffer MACE, cardiac death, MI, all-cause death and ST. Patients with a SYNTAX score >32 were also more likely to have a peri-procedural complication. Multiple logistic regression analysis showed that the presence of PVD (P = 0.026, OR = 2.0), DM (P = 0.008, OR = 2.1), ACS presentation (P = 0.011, OR = 2.1) and SYNTAX score ≥23 (P = 0.02, OR = 1.9) had a significant association with MACE. CONCLUSIONS: RA is safe and effective, with high rate of procedural success and relatively low incidence of MACE. PVD, DM, ACS presentation and SYNTAX score were significant predictors for MACE. © 2016 Wiley Periodicals, Inc.

Standalone balloon aortic valvuloplasty: indications and outcomes from the UK in the transcatheter valve era.

OBJECTIVES: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. BACKGROUND: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). METHODS: Data from 423 patients at 14 centers across the UK were analyzed. RESULTS: Patients were aged 80.9 ± 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% ± 16.8%. Mean peak transaortic gradient fell from 62.0 ± 26.3 to 28.3 ± 16.2 mm Hg. Aortic valve area increased from 0.58 ± 0.19 to 0.80 ± 0.25 cm(2) echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion ≥ 2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08-2.17, P = 0.018), poor LV function (HR 1.54, 95%CI 1.09-2.16, P = 0.014), and either urgent (HR 1.70, 95%CI 1.18-2.45; P = 0.004) or emergent presentation (HR 3.72, 95%CI 2.27-6.08; P < 0.0001). CONCLUSION: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy.

What Are the Causes of Death among Patients Admitted to a Contemporary Tertiary-Level Cardiology Department? An Analysis of 10 Years of Morbidity and Mortality Meetings.

Despite the efforts to deliver the best evidence-based care, in-hospital death is an inevitable event among some patients hospitalized in cardiology departments. We conducted a retrospective evaluation of mortality events from inpatient admissions to the cardiology department between 2010 and 2019. Data were collected from morbidity and mortality meeting presentations that evaluated comorbidities, medical history, treatments, and causes of death for the overall cohort and according to age group and sex. There were 1182 registered deaths. The most common causes of death among patients were acute myocardial infarction (AMI, 53.0%), heart failure (HF, 11.7%), cardiac arrest (CA, 6.6%), HF with complication/defined cardiomyopathy (6.3%), and sepsis (4.4%). We observed a decline in deaths from AMI from 61.9% in 2010 to 46.7% in 2019, while there was a clear increase in deaths from HF (11.1% in 2010 to 25.9% in 2019). Compared to patients ≥65 years, younger patients were more likely to have died from CA (15.7% vs. 4.3%, p < 0.001) and other cardiac reasons (3.0% vs. 0.4%, p < 0.001). The majority of deaths were due to AMI, HF, and CA. We observed a significant declining trend in the proportion of deaths due to AMI in recent years, with an increase in deaths due to HF.

Impact of access site selection and operator expertise on radiation exposure; a controlled prospective study.

BACKGROUND: Published data relating to arterial access site selection and radiation exposure during coronary procedures suggest radial access may lead to increased radiation exposure, but this is based on poorly controlled studies. We sought to measure radiation exposure to patients and operators during elective coronary angiography (CA) according to access site, with other procedure related variables controlled for. We also investigated the specific effect of operator expertise in relation to radiation exposure. METHODS: 100 consecutive patients undergoing first time elective CA were recruited prospectively. An expert transradial (TR) and an expert transfemoral (TF) operator performed 25 cases each via their default route. A trainee cardiologist with intermediate experience in both access sites performed 25 cases via each route. Angiographic projections were standardised and optimised radiation protection was utilised for all procedures. The primary endpoints were operator and patient exposure, quantified by effective dose (ED) and dose area product (DAP) respectively. Secondary endpoints included fluoroscopy time (FT) and time to patient ambulation. RESULTS: The trainee operator recorded higher values for radiation exposure in radial and femoral cases when compared to the expert operators. There were no significant differences in radiation exposure during CA to operator or patient according to access site when standardised by operator experience. For the trainee, ED for TR and TF procedures was 8.8 ± 4.3 µSv and 8.5 ± 6.5 µSv (P = .86) and DAP was 25.4 ± 4.8 Gycm(2) vs 25.2 ± 8.3 Gycm(2) (P = .9). For the expert TR and TF operators, ED was 6.4 ± 4.7 µSv vs 6.1 ± 5.6 µSv (P = .85) and DAP was 21.7 ± 6.5 Gycm(2) vs 22.4 ± 8.0 Gycm(2), (P = .74). There was no significant difference in FT in relation to access site. Time to ambulation was significantly longer with TF access. CONCLUSION: The use of TR access has no adverse effect on radiation exposure or FT for diagnostic CA, but does allow for quicker ambulation compared to TF access. The magnitude of radiation exposure is related to operator expertise for both access sites. The results of previous studies reflect the effect of uncontrolled patient and operator variables and not access site selection.

Patient, Clinician, and Healthcare Perspectives in Evaluating Care Pathways for Stable Chest Pain.

Chest pain is one of the most common reasons for patients to present to healthcare professionals. One of the main challenges with the management of chest pain is the wide differential diagnosis, ranging from minor chest trauma to potentially life-threatening acute myocardial infarction. In a patient-centered health service pathway, the aim is to assess, investigate, diagnose, and treat patients in the safest and most accurate, time, and cost-efficient manner. This report describes the concept of clinical pathways and their importance. It iterates different perspectives of the investigation of chest pain and the barriers to understanding the clinical sequence of events. By considering the patient, clinician, and healthcare service perspective, it is possible to critically evaluate the current stable chest pain pathway. This exercise gives consideration into the way in which patient care could be improved.

Edwards SAPIEN 3 Transcatheter Heart Valve Implantation in a Native Bicuspid Aortic Regurgitation.

Transcatheter aortic valve replacement over the last few years has revolutionized the way severe aortic stenosis patients are being managed [1-4]. Randomized clinical trials commonly excluded bicuspid aortic valves and pure native severe aortic regurgitation [2,4]. We present a case with severe acute aortic regurgitation complicated by refractory pulmonary oedema successfully managed by transfemoral transcatheter aortic valve replacement using a Sapien 3 valve.

Relation of Length of Stay to Unplanned Readmissions for Patients Who Undergo Elective Percutaneous Coronary Intervention.

The cost of inpatient percutaneous coronary interventions (PCI) procedure is related to length of stay (LOS). It is unknown, how LOS may be associated with readmission rates and costs of index PCI and readmissions in elective PCI. This study aims to evaluate rates, predictors, causes, and costs associated with 30-day unplanned readmissions according to lLOS in patients, who underwent elective PCI. We included patients in the Nationwide Readmission Database, who were admitted to hospital from 2010 to 2014, who underwent uncomplicated elective PCI. LOS was defined as 0, 1, 2, and ≥3 days. A total of 324,345 patients were included in the analysis and the 30-day unplanned readmission was 4.75%, 4.67%, 6.44%, and 9.42% in the LOS groups 0, 1, 2, and ≥3 days, respectively. Prolonged LOS was associated with increased average total 30-day cost (index and readmission cost, 0 days $15,063, 1 day $14,693, 2 days $18,136, and ≥3 days $24,336). Compared with 0 days, the odds of readmissions were greater for 2 days (odds ratio 1.41, 95% confidence interval 1.07 to 1.87, p = 0.016) and ≥3 days (odds ratio 1.70, 95% confidence interval 1.28 to 2.24, p <0.001). Comorbidities were strong predictors of LOS and noncardiac causes, account for more than half of all causes for readmission. Longer LOS was associated with reduced incidence of readmissions for noncardiac causes such as noncardiac chest pain, but a greater rate of readmissions for heart failure. In conclusion, shorter length of stay was associated with reduced healthcare costs in elective PCI.

Giant Circumflex Artery Aneurysm With a Coronary Sinus Fistula.

Giant coronary artery aneurysms are extremely rare entities, and the authors are aware of only 13 case reports of such aneurysms of the circumflex artery. This case report is provided to add evidence of the natural history and pathophysiology and describe the successful surgical treatment of this condition.

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

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.

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

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.

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

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.

Quantitative electroencephalographic patterns in normal preterm infants over the first week after birth.

BACKGROUND: Currently available tools to assist clinicians with prediction of neurodevelopmental outcome of preterm infants are inadequate. Modified cotside electroencephalography (EEG) has the ability to produce quantitative electrophysiologic measures. These measures may be useful in future prediction of outcome. AIM: To determine patterns of change in quantitative EEG measures in preterm infants during their first week after birth. DESIGN: Observational. SUBJECTS: Preterm infants born at less than 32 weeks completed gestation surviving to discharge with unremarkable serial ultrasound scans. OUTCOME MEASURES: Changes in continuity, amplitude and spectral edge frequency measures of EEGs obtained over the first week after birth. RESULTS: Results of EEGs performed using a novel EEG device on 63 infants are reported here. Their median (range) gestation was 29 (24-31) weeks and birthweight was 1,235 (540-1,980) g. Quantitative measures of EEG continuity increased over the first week after birth from 72 (25-99)% to 92 (54-100)% at the 25 microV threshold, and from 39 (10-87)% to 64 (34-75)% at the 50 microV threshold, both p<0.0001. There was a related 32% increase in median amplitude from 5.8 (2.6-10.6) microV on day 1 to 7.6 (4.3-9.4) microV on day 4, p=0.005. There was a trend for average spectral edge frequency to fall from 10.7 (9.3-12.9) Hz on day 1 to 9.9 (8.1-12.3) Hz on day 3, p=0.06. Each gestational tertile showed similar patterns. CONCLUSIONS: There are consistent changes in quantitative neurophysiologic measures over the first week after birth, and particularly measures of continuity over the first 4 days, in normal preterm infants.