End-to-End Sepsis Solution Incorporating Expert Telemedicine Consultation.

Introduction: Early detection and optimal resuscitation of critically ill sepsis patients may improve sepsis care delivery. The objective was to assess the feasibility of developing and implementing an end-to-end sepsis solution including early detection, monitoring, and teleconsultation. Methods: Prospective implementation of an end-to-end sepsis solution for potential sepsis patients presenting to a community hospital emergency department (ED) between 11 AM and 5 PM, Monday to Friday, during a 40-day period in 2019. Qualifying patients were compared with patients presenting at other times during the pilot screening period and to historic controls. Results: During the initial period, 203 patients met the screening criteria for potential sepsis; 77 patients (37.9%) had a primary diagnosis of sepsis, present on admission. Mean age was 60 ± 20 years; 50.7% were female; and 24 patients (11.8%) were primary sepsis, SEP-1 bundle eligible. Eighty of 203 (39.4%) had an initial lactate performed, mean, 2.7 ± 1.7 mmol/L. For the 24 primary sepsis, SEP-1 bundle eligible patients, 100% received antibiotics and intravenous fluid. Thirteen consults were performed on 12 patients; mean time from consult decision to beam in to the telemedicine robot was 7.3 ± 5.5 min; mean time from beam in to robot connection with the expert was 23.6 ± 13.2 s; mean consultation call time was 6.3 ± 4.3 min. Conclusions: In a convenience sample of patients with potential sepsis presenting to a community hospital ED, an end-to-end sepsis solution using early detection, tracking, and consultation was feasible and has the potential to improve sepsis detection and treatment.

Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study.

INTRODUCTION: Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design. METHODS AND ANALYSIS: A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients' and carers' experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients' acceptability of the methodology, as well as providing a signal of whether this area should be further investigated. ETHICS AND DISSEMINATION: Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820. TRIAL REGISTRATION NUMBER: ANZCTR ACTRN12617000747325.

Can an End-to-End Telesepsis Solution Improve the Severe Sepsis and Septic Shock Management Bundle-1 Metrics for Sepsis Patients Admitted From the Emergency Department to the Hospital?

Early detection and treatment for sepsis patients are key components to improving sepsis care delivery and increased The Severe Sepsis and Septic Shock Management Bundle (SEP-1) compliance may correlate with improved outcomes. OBJECTIVES: We assessed the impact of implementing a partially automated end-to-end sepsis solution including electronic medical record-linked automated monitoring, early detection, around-the-clock nurse navigators, and teleconsultation, on SEP-1 compliance in patients with primary sepsis, present at admission, admitted through the emergency department (ER). DESIGN SETTING AND PARTICIPANTS: After a "surveillance only" training period between September 3, 2020, and October 5, 2020, the automated end-to-end sepsis solution intervention period occurred from October 6, 2020, to January 1, 2021 in five ERs in an academic health system. Patients who screened positive for greater than or equal to 3 sepsis screening criteria (systemic inflammatory response syndrome, quick Sequential Organ Failure Assessment, pulse oximetry), had evidence of infection and acute organ dysfunction, and were receiving treatment consistent with infection or sepsis were included. MAIN OUTCOMES AND MEASURES: SEP-1 compliance during the "surveillance only" period compared to the intervention period. RESULTS: During the intervention period, 56,713 patients presented to the five ERs; 20,213 (35.6%) met electronic screening criteria for potential sepsis; 1,233 patients had a primary diagnosis of sepsis, present at admission, and were captured by the nurse navigators. Median age of the cohort was 68 years (interquartile range, 57-79 yr); 55.3% were male; 63.5% were White/Caucasian, 26.3% Black/African-American; was 16.7%, and 879 patients (71.3%) were presumed bacterial sepsis, nonviral etiology, and SEP-1 bundle eligible. Nurse navigator real-time classification of this group increased from 51.7% during the "surveillance only" period to 71.8% during the intervention period (p = 0.0002). Five hospital SEP-1 compliance for the period leading into the study period (July 1, 2020-August 31, 2020) was 62% (p < 0.0001), during the "surveillance only" period, it was 68.4% and during the intervention period it was 78.3% (p = 0.002). CONCLUSIONS AND RELEVANCE: During an 11-week period of sepsis screening, monitoring, and teleconsultation in 5 EDs, SEP-1 compliance improved significantly compared with institutional SEP-1 reporting metrics and to a "surveillance only" training period.

COVID-19 Vaccination Drive in a Low-Volume Primary Care Clinic: Challenges & Lessons Learned in Using Homegrown Self-Scheduling Web-Based Mobile Platforms.

Background: The whole of humanity has suffered dire consequences related to the novel coronavirus disease 2019 (COVID-19). Vaccination of the world base population is considered the most promising and challenging approach to achieving herd immunity. As healthcare organizations took on the extensive task of vaccinating the entire U.S. population, digital health companies expanded their automated health platforms in order to help ease the administrative burdens of mass inoculation. Although some software companies offer free applications to large organizations, there are prohibitive costs for small clinics such as the Good Health Associates Clinic (GHAC) for integrating and implementing new self-scheduling software into our e-Clinical Works (ECW) Electronic Health Record (EHR). These cost burdens resulted in a search that extended beyond existing technology, and in investing in new solutions to make it easier, more efficient, more cost-effective, and more scalable. Objective: In comparison to commercial entities, primary care clinics (PCCs) have the advantage of engaging the population for vaccination through personalized continuity of clinical care due to good rapport between their patients and the PCC team. In order to support the overall national campaign to prevent COVID-19 infections and restore public health, the GHAC wanted to make COVID-19 vaccination accessible to its patients and to the communities it serves. We aimed to achieve a coordinated COVID-19 vaccination drive in our community through our small primary care clinic by developing and using an easily implementable, cost-effective self-registration and scheduling web-based mobile platform, using the principle of "C.D.S. Five Rights". Results: Overall, the Moderna vaccination drive using our developed self-registration and scheduling web portal and SMS messaging mobile platform improved vaccination uptake (51%) compared to overall vaccination uptake in our town, county (36%), and state (39%) during April-July 2021. Conclusions: Based on our experience during this COVID-19 vaccination drive, we conclude that PCCs have significant leverage as "invaluable warriors", along with government and media education available, to engage patients for vaccination uptake; this leads to national preventive health spread in our population, and reduces expenses related to acute illness and hospitalization. In terms of cost-effectiveness, small PCCs are worthy of government-sponsored funding and incentives, including mandating EHR vendors to provide free (or minimal fee) software for patient self-registration and scheduling, in order to improve vaccination drive access. Hence, improved access to personalized informative continuity of clinical care in the PCC setting is a "critical link" in accelerating similar cost-effective campaigns in patient vaccine uptake.

Optimising curve fitting techniques to look for standardisation of the analysis of defocus curves derived from multifocal intraocular lenses.

INTRODUCTION: To establish the most appropriate curve fitting method to allow accurate comparison of defocus curves derived from intraocular lenses (IOLs). METHODS: Defocus curves were plotted in five IOL groups (monofocal, extended depth of focus, refractive bifocal, diffractive bifocal and trifocal). Polynomial curves from 2nd to 11th order and cubic splines were fitted. Goodness of fit (GOF) was assessed using five methods: least squares, coefficient of determination (R2adj ), Akaike information criteria (AIC), visual inspection and Snedecor and Cochran. Additional defocus steps at -2.25 D and -2.75 D were measured and compared to the calculated visual acuity (VA) values. Area under the defocus curve and range of focus were also compared. RESULTS: Goodness of fit demonstrated variable results, with more lenient methods such as R2adj leading to overfitting and conservative methods such as AIC resulting in underfitting. Furthermore, conservative methods diminished the inflection points resulting in an underestimation of VA. Polynomial of at least 8th order was required for comparison of area methods, but overfitted the EDoF and monofocal groups; the spline curve was consistent for all IOLs and methods. CONCLUSIONS: This study demonstrates the inherent difficulty of selecting a single polynomial function. The R2 method can be used cautiously along with visual inspection to guard against overfitting. Spline curves are suitable for all IOLs, guarding against the issues of overfitting. Therefore, for analysis of the defocus profile of IOLs, the fitting of a spline curves is advocated and should be used wherever possible.

Consensus priority research questions in gastrointestinal and endoscopic surgery in the year 2020: results of a SAGES Delphi study.

INTRODUCTION: The objectives of this study were to identify consensus priority research questions according to members of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and to explore differences in priorities according to specific membership subgroups. METHODS: A modified Delphi study was conducted including active members of SAGES. An initial list of research questions was compiled by members of 26 SAGES Committees and Task Forces, and was further refined by the SAGES Delphi Task Force. The questions were divided into five research categories: (1) Surgical Outcomes; (2) Education, Training, and Simulation; (3) Health Services Research; (4) New Technology; and (5) Artificial Intelligence. Delphi respondents were asked to rank each question with regards to its importance in the field of gastrointestinal and endoscopic surgery (1-low; 5-high). "Priority" was defined as a single-round mean score of ≥ 3.5, and "consensus" as a single-round standard deviation < 1.0. Subgroup analyses were performed according to a priori selected respondent characteristics. RESULTS: The total number of respondents for each round was: Round 1 (n = 407); Round 2 (n = 569); Round 3 (n = 273). In each round, the majority of respondents were male (Round 1: 77.4%; Round 2: 77.1%; Round 3: 76.7%), self-identified as academic (vs. community) surgeons (Round 1: 57.1%; Round 2: 61.1%; Round 3: 60.2%), and practiced in North America (Round 1: 71.8%; Round 2: 70.8%; Round 3: 75.9%). A total of 29 out of 122 research questions met criteria for both "priority" and "consensus"-Surgical Outcomes, n = 6; Education, Training, and Simulation, n = 9; Health Services Research, n = 5; New Technology, n = 5; and Artificial Intelligence, n = 4. CONCLUSIONS: Consensus priority research questions in gastrointestinal and endoscopic surgery were identified across five different research categories. These results can provide direction and areas of interest for funding and investigation for future studies.

Feasibility of early waking cardiac arrest patients whilst receiving therapeutic hypothermia: The therapeutic hypothermia and early waking (THAW) trial.

AIM: To determine the safety and feasibility of an early (12 h) waking and extubation protocol for out-of-hospital cardiac arrest (OHCA) patients receiving targeted temperature management (TTM). METHODS: This was a single-centre, prospective, non-randomised, observational, safety and feasibility pilot study which included successfully resuscitated OHCA patients, of presumed cardiac cause. Inclusion criteria were: OHCA patients aged over 18 years with a return of spontaneous circulation, who were going to receive TTM33 (TTM at 33 °C for 24 h and prevention of hyperthermia for 72 h) as part of their post cardiac arrest care. Clinical stability was measured against physiological and neurological parameters as well as clinical assessment. RESULTS: 50 consecutive patients were included (median age 65.5 years, 82% male) in the study. Four (8%) patients died within the first twelve hours and were excluded from the final cohort (n = 46). Twenty-three patients (46%) were considered clinically stable and suitable for early waking based on the intention to treat analysis; 12 patients were extubated early based on a variety of clinical factors (21.4 ± 8.6 h) whilst continuing to receive TTM33 with a mean core temperature of 34.2 °C when extubated. Of these, five patients were discharged from the intensive care unit (ICU) <48 h after admission with a mean ICU length of stay 1.8 ± 0.4 days. Twenty-eight patients (56%) were discharged from the ICU with a modified Rankin Score of 0-2. The overall intra-hospital mortality was 50% (n = 25). CONCLUSIONS: It is safe and feasible to wake selected comatose OHCA patients at 12 h, allowing for earlier positive neuro-prognostication and reduced ICU stay.

Referrals from community optometrists to the hospital eye service in Scotland and England.

OBJECTIVES: This audit assesses communication between community optometrists (COs) and hospital eye service (HES) in Scotland and England. METHODS: Optometric referrals and replies were extracted from six practices in Scotland and England. If no reply was found, replies/records were copied from HES records. De-identified referrals, replies and records were audited against established standards, evaluating whether referrals were necessary, accurate and directed to the appropriate professional. The referral rate (RR) and referral reply rate (RRR) were calculated. RESULTS: From 905 de-identified referrals, RR ranged from 2.6 to 8.7%. From COs' perspective, the proportion of referrals for which they received replies ranged from 37 to 84% (Scotland) and 26 to 49% (England). A total of 88-96% of referrals (Scotland) and 63-76% (England) were seen in the HES. Adjusting for cases when it is reasonable to expect replies, RRR becomes 45-92% (Scotland) and 38-62% (England) with RRR significantly greater in Scotland (P = 0.015). Replies were copied to patients in 0-21% of cases. Referrals were to the appropriate service and judged necessary in ≥90% of cases in both jurisdictions. Accuracy of referral ranged from 89 to 97% (Scotland) and 81 to 98% (England). The reply addressed the reason for referral in 94-100% of cases (Scotland) and 93-97% (England) and was meaningful in 95-100% (Scotland) and 94-99% (England). CONCLUSIONS: Despite the interdisciplinary joint statement on sharing patient information, this audit highlights variable standard of referrals and deficits in replies to the referring COs, with one exception in Scotland. Replies from HES to COs are important for patient care, benefitting patients and clinicians and minimising unnecessary HES appointments.

One-year post-operative comparison of visual function and patient satisfaction with trifocal and extended depth of focus intraocular lenses.

PURPOSE: To evaluate visual performance with trifocal and extended depth of focus IOL at 1 year post-operatively. SETTING: BMI Southend Hospital. DESIGN: Cohort study. METHODS: An age-matched cohort of forty subjects bilaterally implanted with the AT LISA 839MP trifocal IOL (20 patients, 40 eyes) and the Tecnis Symfony extended depth of focus IOL (20 patients, 40 eyes) were assessed at 3-6 months and 12-18 months post-operatively. Primary outcome measures were distance (6 m), intermediate (70 cm), near visual acuity (40 cm), and analysis of defocus profiles. Secondary outcomes included contrast sensitivity, Radner reading performance, quality of vision and assessment of halos. RESULTS: Distance visual acuity (VA) and defocus areas were similar (p = 0.07). No significant difference in intermediate VA was noted but the intermediate area of focus was greater in the EDoF (0.31 ± 0.12 LogMAR*m-1) compared to the trifocal (0.22 ± 0.08LogMAR*m-1) (p = 0.02). However, all near metrics were significantly better in the trifocal group. 80% of trifocal subjects were spectacle independent compared to 50% EDoF subjects. Quality of vision questionnaire found no significant differences between groups, however halo scores were greater at 3-6 months in the trifocal group (p < 0.01) but no differences were noted at 12-18 months. CONCLUSIONS: Near vision is significantly better for the trifocal, thus greater levels of spectacle independence. The range of intermediate vision was greater for the EDoF but no difference in intermediate VA. In the early period, differences in contrast sensitivity and halo size/intensity were noted, however, by one-year these measures were not significantly different.

Defining Global Benchmarks in Elective Secondary Bariatric Surgery Comprising Conversional, Revisional, and Reversal Procedures.

OBJECTIVE: To define "best possible" outcomes for secondary bariatric surgery (BS). BACKGROUND: Management of poor response and of long-term complications after BS is complex and under-investigated. Indications and types of reoperations vary widely and postoperative complication rates are higher compared to primary BS. METHODS: Out of 44,884 BS performed in 18 high-volume centers from 4 continents between 06/2013-05/2019, 5,349 (12%) secondary BS cases were identified. Twenty-one outcome benchmarks were established in low-risk patients, defined as the 75th percentile of the median outcome values of centers. Benchmark cases had no previous laparotomy, diabetes, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, thromboembolic events, BMI> 50 kg/m2 or age> 65 years. RESULTS: The benchmark cohort included 3143 cases, mainly females (85%), aged 43.8 ±â€Š10 years, 8.4 ±â€Š5.3 years after primary BS, with a BMI 35.2 ±â€Š7 kg/m2. Main indications were insufficient weight loss (43%) and gastro-esophageal reflux disease/dysphagia (25%). 90-days postoperatively, 14.6% of benchmark patients presented ≥1 complication, mortality was 0.06% (n = 2). Significantly higher morbidity was observed in non-benchmark cases (OR 1.37) and after conversional/reversal or revisional procedures with gastrointestinal suture/stapling (OR 1.84). Benchmark cutoffs for conversional BS were ≤4.5% re-intervention, ≤8.3% re-operation 90-days postoperatively. At 2-years (IQR 1-3) 15.6% of benchmark patients required a reoperation. CONCLUSION: Secondary BS is safe, although postoperative morbidity exceeds the established benchmarks for primary BS. The excess morbidity is due to an increased risk of gastrointestinal leakage and higher need for intensive care. The considerable rate of tertiary BS warrants expertise and future research to optimize the management of non-success after BS.

Advanced Modular Manikin and Surgical Team Experience During a Trauma Simulation: Results of a Single-Blinded Randomized Trial.

BACKGROUND: Our aim was assess whether an integrated Advanced Modular Manikin (AMM) provides improved participant experience compared with use of peripheral simulators alone during a standardized trauma team scenario. Simulation-based team training has been shown to improve team performance. To address limitations of existing manikin simulators, the AMM platform was created that enables interconnectedness, interoperability, and integration of multiple simulators ("peripherals") into an adaptable, comprehensive training system. METHODS: A randomized single-blinded, crossover study with 2 conditions was used to assess learner experience differences when using the integrated AMM platform vs peripheral simulators. First responders, anesthesiologists, and surgeons rated their experience and workload with the conditions in a 3-scene standardized trauma scenario. Participant ratings were compared and focus groups conducted to obtain insight into participant experience. RESULTS: Fourteen teams (n = 42) participated. Team experience ratings were higher for the integrated AMM condition compared with peripherals (Cohen's d = .25, p = 0.016). Participant experience varied by background with surgeons and first responders rating their experience significantly higher compared with anesthesiologists (p < 0.001). Higher workload ratings were observed with the integrated AMM condition (Cohen's d = .35, p = 0.014) driven primarily by anesthesiologist ratings. Focus groups revealed that participants preferred the integrated AMM condition based on its increased realism, physiologic responsiveness, and feedback provided on their interventions. CONCLUSIONS: This first comprehensive evaluation suggests that integration with the AMM platform provides benefits over individual peripheral simulators and has the potential to expand simulation-based learning opportunities and enhance learner experience, especially for surgeons.

Predicting the Postoperative Addition Power of a Multifocal Intraocular Lens at the Spectacle Plane.

PURPOSE: To establish a simple clinical method of predicting addition power achieved with a multifocal intraocular lens (IOL). METHODS: In this prospective cohort study, 41 patients were bilaterally implanted with the Bi-Flex MY multifocal IOL (Medicontur) with +3.50 diopters (D) near addition power. Monocular defocus curves were plotted for each patient and effective addition power was calculated as the dioptric difference between the distance and near inflection points of the defocus curve. Six biometry formulas (Haigis, Holladay, SRK/T, Hill RBF, Barrett Universal II, and Holladay 2) were used to predict the addition power at the spectacle plane. RESULTS: Mean effective addition power was 2.60 ± 0.29 D, with significant (P < .01) differences between the prediction methods. Significant differences were found between predicted and effective addition when the Holladay, SRK/T, Hill RBF, and Holladay 2 formulas were used. A moderate but significant correlation (r = 0.342, P = .033) was found with the Barrett formula, and this was also the method to show the least proportional bias with Bland-Altman analysis. CONCLUSIONS: The study demonstrates that the effective addition power can be predicted using the proposed simple clinical method derived using the Barrett Universal II formula. The proposed technique may have significant clinical value in screening for patients where ocular biometry may lead to aberrant addition power. [J Refract Surg. 2021;37(5):318-323.].

Renal supportive care programs: An observational study assessing impact on hospitalization and survival outcomes.

AIM: Renal supportive care (RSC) programs are used to manage non-dialysis end-stage kidney disease (ESKD) patients. The aim of this study was to analyse the impact of RSC programs on hospitalization and survival outcomes in these patients. METHODS: A retrospective, single-centre observational cohort study of non-dialysis ESKD patients was undertaken. Hospitalizations and survival from eGFR≤15 ml/min was compared between patients managed in an RSC program (RSC group) and patients receiving standard conservative therapy (non-RSC group). Local databases, physician letters and electronic medical records were used for data collection. Prevalent patients from 2013 to 2017 with eGFR ≤15 ml/min were included. Cox proportion hazard testing and generalized linear modelling was undertaken to adjust for confounders. RESULTS: A total of 172 patients were included (95 RSC; 75 non-RSC). The median age was 82 years [IQR 78-85], 46% were male, the median Charlson-comorbidity Index was 5 [IQR 4-7]. The RSC group had significantly lowered haemoglobin level (102 g/L vs. 111 g/L) and fewer English-speakers (34% vs. 44%). RSC was associated with the decreased number of days in hospital per year (estimated means 46.6 days [95% CI 21-67] vs. 83.2 days [95%CI 60.5-105.8]; p = .01) and decreased number of hospital admissions per year (estimated means 5.4 [95%CI 2.1-8.8] vs. 12.3 [95%CI 8.2-16.4]; p = .01) compared with non-RSC. Median overall survival from eGFR≤15 in the entire cohort was 735 days, with no significant difference between RSC and non-RSC groups (p = .9), both unadjusted and adjusted for confounders. CONCLUSION: RSC programs can significantly decrease the number and length of hospitalizations in conservatively managed ESKD patients.

Referrals from community optometrists to the hospital eye service in England.

PURPOSE: In the UK, most referrals to the hospital eye service (HES) originate from community optometrists (CO). This audit investigates the quality of referrals, replies, and communication between CO and the HES. METHODS: Optometric referrals and replies were extracted from three practices in England. If no reply letter was found, the records were searched at each local HES unit, and additional replies or records copied. De-identified referrals, replies and records were audited by a panel against established standards to evaluate whether the referrals were necessary, accurate and directed to the appropriate professional. The referral rate (RR) and referral reply rate (RRR) were calculated. RESULTS: A total of 459 de-identified referrals were extracted. The RR ranged from 3.6%-8.7%. The proportion of referred patients who were seen in the HES unit was 63%-76%. From the CO perspective, the proportion of referrals for which they received replies ranged from 26%-49%. Adjusting the number of referrals for cases when it would be reasonable to expect an HES reply, RRR becomes 38%-62%. Patients received a copy of the reply in 3%-21% of cases. Referrals were made to the appropriate service in over 95% of cases, were judged necessary in 93%-97% and were accurate in 81%-98% of cases. The referral reply addressed the reason for the referral in 93%-97% and was meaningful in 94%-99% of cases. The most common conditions referred were glaucoma, cataract, anterior segment lesions, and neurological/ocular motor anomalies. The CO/HES dyad (pairing) in the area with the lowest average household income had the highest RR. CONCLUSIONS: In contrast with the Royal College of Ophthalmologists/College of Optometrists joint statement on sharing patient information, CO referrals often do not elicit a reply to the referring CO. Replies from the HES to COs are important for patient care, benefitting patients and clinicians, and minimising unnecessary HES appointments.

Coronary artery height differences and their effect on fractional flow reserve.

BACKGROUND: Fractional flow reserve (FFR) uses pressure-based measurements to assess the severity of a coronary stenosis. Distal pressure (Pd) is often at a different vertical height to that of the proximal aortic pressure (Pa). The difference in pressure between Pd and Pa due to hydrostatic pressure, may impact FFR calculation. METHODS: One hundred computed tomography coronary angiographies were used to measure height differences between the coronary ostia and points in the coronary tree. Mean heights were used to calculate the hydrostatic pressure effect in each artery, using a correction factor of 0.8 mmHg/cm. This was tested in a simulation of intermediate coronary stenosis to give the "corrected FFR" (cFFR) and percentage of values, which crossed a threshold of 0.8. RESULTS: The mean height from coronary ostium to distal left anterior descending (LAD) was +5.26 cm, distal circumflex (Cx) -3.35 cm, distal right coronary artery-posterior left ventricular artery (RCA-PLV) -5.74 cm and distal RCA-posterior descending artery (PDA) +1.83 cm. For LAD, correction resulted in a mean change in FFR of +0.042, -0.027 in the Cx, -0.046 in the PLV and +0.015 in the PDA. Using 200 random FFR values between 0.75 and 0.85, the resulting cFFR crossed the clinical treatment threshold of 0.8 in 43% of LAD, 27% of Cx, 47% of PLV and 15% of PDA cases. CONCLUSIONS: There are significant vertical height differences between the distal artery (Pd) and its point of normalization (Pa). This is likely to have a modest effect on FFR, and correcting for this results in a proportion of values crossing treatment thresholds. Operators should be mindful of this phenomenon when interpreting FFR values.

Effects of stent postdilatation during primary PCI for STEMI: Insights from coronary physiology and optical coherence tomography.

OBJECTIVES: This study aimed to assess the impact of stent optimization by NC-balloon postdilatation (PD) during primary-PCI for STEMI with the use of coronary physiology and intracoronary imaging. METHODS: This was a prospective observational study (ClinicalTrials.gov:NCT02788396). Optical coherence tomography (OCT) and physiological measurements were performed immediately before and after PD with the operators blinded to all measurements. The index of microcirculatory resistance (IMR), coronary flow reserve (CFR) and fractional flow reserve (FFR) were measured. OCT analysis was performed for assessment of stent expansion, malapposition, in-stent plaque-thrombus prolapse (PTP) and stent-edge dissections (SED). The change in IMR before and after PD as a measure of microvascular injury was the primary objective of the study. RESULTS: Thirty-two STEMI patients undergoing primary-PCI had physiological measurements before and after PD. All patients received second-generation DES (diameter 3.1 ± 0.5 mm, length 29.9 ± 10.7 mm) and postdilatation with NC-balloons (diameter 3.6 ± 0.6 mm, inflation pressure 19.3 ± 2.0 atm). IMR (44.9 ± 25.6 vs. 48.8 ± 34.2, p = 0.26) and CFR (1.60 ± 0.89 vs. 1.58 ± 0.71, p = 0.87) did not change, while FFR increased after PD (0.91 ± 0.08 vs. 0.93 ± 0.06, p = 0.037). At an individual patient level, IMR increased in half of the cases. PD improved significantly absolute and relative stent expansion, reduced malapposition, and increased PTP. There was no difference in clinically relevant SED. CONCLUSION: In this exploratory, hypothesis-generating study, postdilatation during primary-PCI for STEMI improved stent expansion, apposition and post-PCI FFR, without a significant effect on coronary microcirculation overall. Nevertheless, IMR increased in a group of patients and larger studies are warranted to explore predictors of microcirculatory response to postdilatation.

Revascularisation or medical therapy in elderly patients with acute anginal syndromes: the RINCAL randomised trial.

BACKGROUND: Historically the elderly have been under-represented in non-ST-elevation myocardial infarction (NSTEMI) management trials. AIMS: The aim of this trial was to demonstrate that an intervention-guided strategy is superior to optimal medical therapy (OMT) alone for treating NSTEMI in elderly individuals. METHODS: Patients (≥80 years, chest pain, ischaemic ECG, and elevated troponin) were randomised 1:1 to an intervention-guided strategy plus OMT versus OMT alone. The primary endpoint was a composite of all-cause mortality and non-fatal myocardial reinfarction at 1 year. Ethics approval was obtained by the institutional review board of every recruiting centre. RESULTS: From May 2014 to September 2018, 251 patients (n=125 invasive vs n=126 conservative) were enrolled. Almost 50% of participants were female. The trial was terminated prematurely due to slow recruitment. A Kaplan-Meier estimate of event-free survival revealed no difference in the primary endpoint at 1 year (invasive 18.5% [23/124] vs conservative 22.2% [28/126]; p=0.39). No significant difference persisted after Cox proportional hazards regression analysis (hazard ratio 0.79, 95% confidence interval 0.45-1.35; p=0.39). There was greater freedom from angina at 3 months (p<0.001) after early intervention but this was similar at 1 year. Both non-fatal reinfarction (invasive 9.7% [12/124] vs conservative 14.3% [18/126]; p=0.22) and unplanned revascularisation (invasive 1.6% [2/124] vs conservative 6.4% [8/126]; p=0.10) occurred more frequently in the OMT alone cohort. CONCLUSIONS: An intervention-guided strategy was not superior to OMT alone to treat very elderly NSTEMI patients. The trial was underpowered to demonstrate this definitively. Early intervention resulted in fewer cases of reinfarction and unplanned revascularisation but did not improve survival.