Feasibility and technicality of aortic valve lithotripsy-facilitate balloon valvuloplasty in patients with severe aortic stenosis unsuitable for immediate valvular replacement.

BACKGROUND: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation. AIMS: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement. METHODS: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed. RESULTS: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days. CONCLUSION: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients.

Naloxegol and Postoperative Urinary Retention: A Randomized Trial.

BACKGROUND: Naloxegol antagonizes peripheral opioid-related side effects without preventing opioid-related analgesia. However, the effect of naloxegol on opioid-induced bladder dysfunction remains unknown. HYPOTHESIS: patients given naloxegol have lower residual bladder urine volume than those given placebo. METHODS: 136 patients scheduled for elective hip and knee surgery were randomized to oral naloxegol or placebo given the morning of surgery, and on the first two postoperative mornings. Residual urine volume was measured ultrasonographically within 30 min after voiding once in the morning and once in the afternoon for two postoperative days. Opioid-related Symptom Distress Scale (ORSDS), the need for indwelling urinary catheterization, and quality of recovery (QoR) score were secondary outcomes. RESULTS: 67 were randomized to naloxegol and 64 to placebo. We did not identify a significant effect on urine residual volume, with an estimated ratio of geometric means of 0.9 (0.3, 2.6), p = 0.84. There were no significant differences in ORSDS or QoR. There were 19 (29%) patients assigned to naloxegol who needed indwelling urination catheterization versus 7 (11%) patients in the placebo group, p = 0.012. CONCLUSIONS: Our results do not support use of naloxegol for postoperative urinary retention after hip and knee surgery.

Coronary Intravascular Lithotripsy in a Tight Circumferential Calcified Lesion in the Presence of Haematoma Extending into Left Main Coronary Artery After Rotational Atherectomy.

Calcified disease increases procedural challenges and is associated with worse outcomes in percutaneous coronary intervention. Coronary intravascular lithotripsy is a new balloon-based modality for treating calcified disease with deep circumferential calcification. Its main benefit is simplicity and safety compared to atherectomy. However, atherectomy remains the modality of choice in balloon-uncrossable lesions. More than one modality is often needed for treatment of calcified disease. The authors present a case of a balloon-uncrossable calcified ostial left circumflex lesion which was first treated with rotational atherectomy. However, there was haematoma formation in the ostial circumflex extending into left main coronary artery, together with suboptimal preparation of calcified disease. Intravascular coronary lithotripsy was then used to successfully prepare the calcified lesion for stenting without causing extension of the haematoma.

Association of Pain With Atrial Fibrillation and Delirium After Cardiac Surgery: A DECADE Sub-Study.

OBJECTIVE: The authors aimed to evaluate the effects of postoperative pain on the incidence of atrial fibrillation and delirium in patients having surgery with cardiopulmonary bypass (CPB). DESIGN: Post hoc analysis of the (An investigator-initiated, multicentre, double-blind trial (ClinicalTrials NCT02004613) (DECADE)), a randomized, placebo-controlled trial. SETTING: Tertiary, academic hospital. PARTICIPANTS: Six hundred five adults from the DECADE enrolled at Cleveland Clinic Main Campus, who had had surgery with CPB. INTERVENTIONS: Dexmedetomidine versus placebo started before surgical incision and postoperatively was maintained until 24 hours. MEASUREMENTS: Primary outcomes were atrial fibrillation, diagnosed by clinicians in the intensive care unit (ICU), presence of delirium assessed with the Confusion Assessment Method for the ICU, data on pain scores, and opioid consumption, occurring between ICU admission and the earlier of postoperative day five or hospital discharge. RESULTS: Postoperative pain levels were similar among patients with or without atrial fibrillation. Two hundred six (34%) patients had atrial fibrillation and ninety-two (15%) had delirium before hospital discharge within the first five postoperative days. The risk of atrial fibrillation was not significantly different between groups (hazard ratio: 1.09; 97.5% confidence interval [CI]: 0.99, 1.20, p = 0.039); there were no associations between postoperative pain and the risk of postoperative delirium (hazard ratio: 0.96; 97.5% CI: 0.84-1.11; p = 0.57). Postoperative opioid consumption was neither significantly associated with postoperative atrial fibrillation nor delirium. CONCLUSIONS: Atrial fibrillation and delirium was not associated with pain after cardiac surgery. Opioid use was not associated with atrial fibrillation and delirium. Because both atrial fibrillation and delirium have a multifactorial nature, further studies should be focused on other plausible mechanisms.

Optimal interval and duration of CAM-ICU assessments for delirium detection after cardiac surgery.

STUDY OBJECTIVE: Our goal was to determine when postoperative delirium first occurs, and to assess evaluation strategies that reliably detect delirium with lowest frequency of testing'. DESIGN: This was a retrospective study that used a database from a five-center randomized trial. SETTING: Postoperative cardiothoracic ICU and surgical wards. PARTICIPANT: Adults scheduled for elective coronary artery bypass and/or valve surgery. INTERVENTION AND MEASUREMENTS: Postoperative delirium was assessed using CAM-ICU questionnaires twice daily for 5 days or until hospital discharge. Data were analyzed using frequency tables and Kaplan-Meier time-to-event estimators, the latter being used to summarize time to first positive CAM-ICU over POD1-5 for all patients for various evaluation strategies, including all assessments, only morning assessment, and only afternoon assessments. Sensitivity for various strategies were compared using McNemar's test for paired proportions. MAIN RESULTS: A total of 95 of 788 patients (12% [95% CI, 10% to 15%]) had at least 1 episode of delirium within the first 5 postoperative days. Among all patients with delirium, 65% were identified by the end of the first postoperative day. Delirium was detected more often in the mornings (10% of patients) than evenings (7% of patients). Compared to delirium assessments twice daily for five days, we found that twice daily assessments for 4 days detected an estimated 97% (95% CI 91%, 99%) of delirium. Measurements twice daily for three days detected 90% (82%, 95%) of delirium. CONCLUSIONS: Postoperative delirium is common, and CAM-ICU assessments twice daily for 4 days, versus 5 days, detects nearly all delirium with 20% fewer assessments. Four days of assessment may usually be sufficient for clinical and research purposes.

Impact of coronavirus disease 2019 (COVID-19) outbreak on outcome of myocardial infarction in Hong Kong, China.

OBJECTIVE: To determine whether COVID-19 may adversely affect outcome of myocardial infarction (MI) patients in Hong Kong, China. BACKGROUND: The COVID-19 pandemic has infected thousands of people and placed enormous stress on healthcare system. Apart from being an infectious disease, it may affect human behavior and healthcare resource allocation which potentially cause treatment delay in MI. METHODS: This was a single center cross-sectional observational study. From November 1, 2019 to March 31, 2020, we compared outcome of patients admitted for acute ST-elevation MI (STEMI) and non-ST elevation MI (NSTEMI) before (group 1) and after (group 2) January 25, 2020 which was the date when Hong Kong hospitals launched emergency response measures to combat COVID-19. RESULTS: There was a reduction in daily emergency room attendance since January 25, 2020 (group 1,327/day vs. group 2,231/day) and 149 patients with diagnosis of MI were included into analysis (group 1 N = 85 vs. group 2 N = 64). For STEMI, patients in group 2 tended to have longer symptom-to-first medical contact time and more presented out of revascularization window (group 1 27.8 vs. group 2 33%). The primary composite outcome of in-hospital death, cardiogenic shock, sustained ventricular tachycardia or fibrillation (VT/VF) and use of mechanical circulatory support (MCS) was significantly worse in group 2 (14.1 vs. 29.7%, p = .02). CONCLUSIONS: More MI patients during COVID-19 outbreak had complicated in-hospital course and worse outcomes. Besides direct infectious complications, cardiology community has to acknowledge the indirect effect of communicable disease on our patients and system of care.

Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial.

BACKGROUND: Atrial fibrillation and delirium are common consequences of cardiac surgery. Dexmedetomidine has unique properties as sedative agent and might reduce the risk of each complication. This study coprimarily aimed to establish whether dexmedetomidine reduces the incidence of new-onset atrial fibrillation and the incidence of delirium. METHODS: A randomised, placebo-controlled trial was done at six academic hospitals in the USA. Patients who had had cardiac surgery with cardiopulmonary bypass were enrolled. Patients were randomly assigned 1:1, stratified by site, to dexmedetomidine or normal saline placebo. Randomisation was computer generated with random permuted block size 2 and 4, and allocation was concealed by a web-based system. Patients, caregivers, and evaluators were all masked to treatment. The study drug was prepared by the pharmacy or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation. Participants were given either dexmedetomidine infusion or saline placebo started before the surgical incision at a rate of 0·1 µg/kg per h then increased to 0·2 µg/kg per h at the end of bypass, and postoperatively increased to 0·4 µg/kg per h, which was maintained until 24 h. The coprimary outcomes were atrial fibrillation and delirium occurring between intensive care unit admission and the earlier of postoperative day 5 or hospital discharge. All analyses were intention-to-treat. The trial is registered with ClinicalTrials.gov, NCT02004613 and is closed. FINDINGS: 798 patients of 3357 screened were enrolled from April 17, 2013, to Dec 6, 2018. The trial was stopped per protocol after the last designated interim analysis. Among 798 patients randomly assigned, 794 were analysed, with 400 assigned to dexmedetomidine and 398 assigned to placebo. The incidence of atrial fibrillation was 121 (30%) in 397 patients given dexmedetomidine and 134 (34%) in 395 patients given placebo, a difference that was not significant: relative risk 0·90 (97·8% CI 0·72, 1·15; p=0·34). The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99-2·23). Safety outcomes were clinically important bradycardia (requiring treatment) and hypotension, myocardial infarction, stroke, surgical site infection, pulmonary embolism, deep venous thrombosis, and death. 21 (5%) of 394 patients given dexmedetomidine and 8 (2%) of 396 patients given placebo, had a serious adverse event as determined by clinicians. 1 (<1%) of 391 patients given dexmedetomidine and 1 (<1%) of 387 patients given placebo died. INTERPRETATION: Dexmedetomidine infusion, initiated at anaesthetic induction and continued for 24 h, did not decrease postoperative atrial arrhythmias or delirium in patients recovering from cardiac surgery. Dexmedetomidine should not be infused to reduce atrial fibrillation or delirium in patients having cardiac surgery. FUNDING: Hospira Pharmaceuticals.

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial.

BACKGROUND: Hypotension is associated with serious complications, including myocardial infarction, acute kidney injury, and mortality. Consequently, predicting and preventing hypotension may improve outcomes. We will therefore determine if use of a novel hypotension prediction tool reduces the duration and severity of hypotension in patients having non-cardiac surgery. METHODS/DESIGN: We will conduct a two-center, pragmatic, randomized controlled trial (N = 213) in noncardiac surgical patients > 45 years old who require intra-arterial blood pressure monitoring. All participating patients will be connected to a Flortrac IQ sensor and EV1000 platform (Edwards Lifesciences, Irvine). They will be randomly assigned to blinded or unblinded arms. The Hypotension Prediction Index (HPI) and advanced hemodynamic information will be universally recorded, but will only be available to clinicians when patients are assigned to unblinded monitoring. The primary outcome will be the effect of HPI software guidance on intraoperative time-weighted average mean arterial pressure under a threshold of 65 mmHg, which will be assessed with a Wilcoxon-Mann-Whitney 2-sample, two-tailed test. DISCUSSION: Our trial will determine whether the Hypotension Prediction Index and associated hemodynamic information substantively reduces hypotension during non-cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03610165 . Registered on 1 August 2018.

Safety and feasibility of a midseptal implantation technique of a leadless pacemaker.

BACKGROUND: The major risk of implanting a leadless pacemaker at the right ventricular (RV) apex is cardiac perforation. OBJECTIVE: The purpose of this study was to describe and prospectively evaluate the safety and feasibility of a technique for midseptal implantation of the Micra leadless pacemaker. METHODS: We positioned the device at the center of the cardiac silhouette in the right anterior oblique (RAO) view, toward the left in the left anterior oblique (LAO) view, and away from the sternum in the left lateral view. RESULTS: Among the 51 patients (mean age 81.3 ± 9.3 years; 47% men) included in the study, 29 (57%) were >80 years old, 7 (14%) had body mass index <20 kg/m2, 48 (94%) had renal dysfunction, and 33 (65%) had valvular heart disease. The implantation sites were mid and apical septum in 46 (90%) and 5 (10%) patients, respectively. Although RAO and LAO views suggested a septal location, 9 (17.6%) devices were found to be directing at the free wall in the left lateral view and required repositioning. One patient (2%) developed cardiac perforation due to contrast injection against the RV anterior wall before verification of sheath location by lateral view. Mean R-wave sensing and pacing threshold at implantation were 9.7 ± 4.0 mV and 0.61 ± 0.31 V/0.24 ms, respectively. After median follow-up of 218.7 days, the pacing threshold remained stable. CONCLUSION: In this high-risk patient cohort, midseptal implantation of a leadless pacemaker as guided by RAO, LAO, and left lateral views was achieved in 90% of patients, with a low risk of complications.

Extrinsic pulmonary artery compression mimicking acute pulmonary embolism.

Right ventricular strain patterns on electrocardiogram such as right axis derivation and S1Q3T3 are well known for their diagnostic value in cases of acute pulmonary embolism. Nonetheless, these changes are not pathognomonic. We report a patient with electrocardiographic evidence of right ventricular strain secondary to an unusual etiology.

Nanomaterials for photohyperthermia: a review.

The unique properties of nanomaterials have propelled the field of nanomedicine. Nanomaterials have been used as drug delivery, imaging, and photothermal agents for diagnosis and therapy of diseases. Recently, photohyperthermia has attracted great interest from researchers and is actively being investigated as an alternative method of therapy for cancer and even bacteria. Photohyperthermia, or photothermal therapy, is the process of a photothermal agent absorbing light and converting it into heat for the destruction of malignant cells, which is due to elevated temperatures. This technique is non-invasive, can target specific diseased cells for minimal adverse side effects, and can be used in conjunction with other cancer treatments, such as chemotherapy. In this review, we will discuss different nanomaterials that have been implemented as photothermal agents for the treatment of various cancer and bacterial cells. The review will mainly focus on gold nanoparticles, magnetic nanoparticles, and carbon nanotubes. However, other nanomaterials, such as semiconductor nanoparticles and polymer composites, will be briefly discussed. In addition, the photothermal mechanism, current developments, dual imaging and therapy, and future perspectives of nanoparticle-based photohyperthermia will be presented.