FFR-Guided Complete or Culprit-Only PCI in Patients with Myocardial Infarction.

BACKGROUND: The benefit of fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear. METHODS: In this multinational, registry-based, randomized trial, we assigned patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization. RESULTS: A total of 1542 patients underwent randomization, with 764 assigned to receive FFR-guided complete revascularization and 778 assigned to receive culprit-lesion-only PCI. At a median follow-up of 4.8 years (interquartile range, 4.3 to 5.2), a primary-outcome event had occurred in 145 patients (19.0%) in the complete-revascularization group and in 159 patients (20.4%) in the culprit-lesion-only group (hazard ratio, 0.93; 95% confidence interval [CI], 0.74 to 1.17; P = 0.53). With respect to the secondary outcomes, no apparent between-group differences were observed in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularization (hazard ratio, 0.76; 95% CI, 0.56 to 1.04). There were no apparent between-group differences in safety outcomes. CONCLUSIONS: Among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization was not shown to result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI at 4.8 years. (Funded by the Swedish Research Council and others; FULL REVASC ClinicalTrials.gov number, NCT02862119.).

Implementation of an extracorporeal resuscitation (ECPR) program for out-of-hospital cardiac arrest in Stockholm, Sweden: Feasibility, safety, and outcome.

Background: The aim of this study was to evaluate the implementation of a novel extra corporeal cardiopulmonary (ECPR) program in the greater Stockholm area with focus on feasibility, safety aspects and clinical outcomes. Methods: Prospective observational study of ECPR program including patients with OHCA from January 2020 to December 2022, fulfilling ECPR criteria: age 18-65 years, initial shockable rhythm or pulseless electrical activity, witnessed arrest, bystander cardiopulmonary resuscitation and refractory arrest after three cycles of advance cardiac life support. The predefined time threshold from collapse to extracorporeal membrane oxygenation (ECMO) initiation was set at 60 min. Results: We included 95 patients. Of these, 22/95 (23%) had return of spontaneous circulation before ECMO initiation, 39/95 (41%) were excluded for ECMO and 34/95 (36%) had ECMO initiated out of which 23 patients were admitted alive to the ICU. ECMO-initiation within 60 min was met in 9%. In 6 patients vascular access was complicated, 2 patients had severe bleeding at access site requiring intervention. Survival to discharge among all cases was 25% (24/95). Among patients admitted to ICU on ECMO 39% (9/23) survived to discharge, of these 78% had cerebral performance category scale score 1-2 within 12 months. 8 out of 9 survivors had time from OHCA to ECMO-initiation >60 min. Conclusion: The implementation of an ECPR protocol was feasible without any major, unexpected safety aspects but did not meet the intended target time intervals. Despite this, survival rates were similar to previous studies although most survivors had >60 min to ECMO-initiation.

[Value of PET imaging in head and neck cancer]. / Stellenwert der PET-Bildgebung bei Kopf-Hals-Tumoren.

The combination of positron-emission tomography (PET) with cross-sectional imaging in particular is becoming increasingly important in the diagnosis of head and neck tumors because, in addition to pure anatomy, the metabolic activity of tissue can be visualized and assessed. The combination of PET and computed tomography (CT) is already an established procedure in head and neck tumor patients in some indications, e.g., for primary tumor detection in cancer of unknown primary (CUP) syndrome or also after completed primary radio(chemo)therapy for evaluation of response, especially also with regard to nodal status. In some cases, salvage neck dissection can thus be avoided in the case of PET-negative findings. In the context of primary diagnosis, PET/CT imaging can be used primarily to evaluate distant metastasis. According to current guidelines, PET-based imaging is not (yet) of value in determining the local extent at initial diagnosis. A challenge is the still limited reimbursement by health insurance companies, which currently allow only certain indications, and the still lack of nationwide coverage.

[Value of PET imaging in head and neck cancer]. / Stellenwert der PET-Bildgebung bei Kopf-Hals-Tumoren.

The combination of positron-emission tomography (PET) with cross-sectional imaging in particular is becoming increasingly important in the diagnosis of head and neck tumors because, in addition to pure anatomy, the metabolic activity of tissue can be visualized and assessed. The combination of PET and computed tomography (CT) is already an established procedure in head and neck tumor patients in some indications, e.g., for primary tumor detection in cancer of unknown primary (CUP) syndrome or also after completed primary radio(chemo)therapy for evaluation of response, especially also with regard to nodal status. In some cases, salvage neck dissection can thus be avoided in the case of PET-negative findings. In the context of primary diagnosis, PET/CT imaging can be used primarily to evaluate distant metastasis. According to current guidelines, PET-based imaging is not (yet) of value in determining the local extent at initial diagnosis. A challenge is the still limited reimbursement by health insurance companies, which currently allow only certain indications, and the still lack of nationwide coverage.

Unlocking New Topologies in Zr-Based Metal-Organic Frameworks by Combining Linker Flexibility and Building Block Disorder.

The outstanding diversity of Zr-based frameworks is inherently linked to the variable coordination geometry of Zr-oxo clusters and the conformational flexibility of the linker, both of which allow for different framework topologies based on the same linker-cluster combination. In addition, intrinsic structural disorder provides a largely unexplored handle to further expand the accessibility of novel metal-organic framework (MOF) structures that can be formed. In this work, we report the concomitant synthesis of three topologically different MOFs based on the same M6O4(OH)4 clusters (M = Zr or Hf) and methane-tetrakis(p-biphenyl-carboxylate) (MTBC) linkers. Two novel structural models are presented based on single-crystal diffraction analysis, namely, cubic c-(4,12)MTBC-M6 and trigonal tr-(4,12)MTBC-M6, which comprise 12-coordinated clusters and 4-coordinated tetrahedral linkers. Notably, the cubic phase features a new architecture based on orientational cluster disorder, which is essential for its formation and has been analyzed by a combination of average structure refinements and diffuse scattering analysis from both powder and single-crystal X-ray diffraction data. The trigonal phase also features structure disorder, although involving both linkers and secondary building units. In both phases, remarkable geometrical distortion of the MTBC linkers illustrates how linker flexibility is also essential for their formation and expands the range of achievable topologies in Zr-based MOFs and its analogues.

A novel 3D-printed laryngoscope with integrated working channels for laryngeal surgery.

Background: For the surgical treatment of early-stage laryngeal cancer, the use of transoral laser microsurgery (TLM) has emerged as the gold standard. However, this procedure requires a straight line of sight to the operating field. Therefore, the patient's neck needs to be brought into a hyperextended position. In a considerable number of patients, this is not possible due to anomalies in the cervical spine anatomy or soft tissue scarring, e.g., after radiation. In these cases, adequate visualization of relevant laryngeal structures cannot be ensured using a conventional rigid operating laryngoscope, which may negatively affect the outcome of these patients. Methods: We present a system based on a 3D-printed prototype of a curved laryngoscope with three integrated working channels (sMAC). The curved profile of the sMAC-laryngoscope is specifically adapted to the nonlinear anatomy of the upper airway structures. The central working channel provides access for flexible video endoscope imaging of the operating field while the two remaining channels provide access for flexible instrumentation. In a user study (n = 11), visualization and reachability of relevant laryngeal landmarks as well as the feasibility of basic surgical procedures with the proposed system were examined in a patient simulator. In a second setup, the system was evaluated for its applicability in a human body donor. Results: All participants of the user study were able to visualize, reach and manipulate the relevant laryngeal landmarks. Reaching those took significantly less time in the second attempt compared to the first one (27.5 s ± 5.2 s vs. 39.7 s ± 16.5 s, p = 0.008) indicating a significant learning curve for handling the system. Instrument changes were performed quickly and reliably by all participants (10.9 s ± 1.7 s). All participants were able to bring the bimanual instruments into position for a vocal fold incision. Relevant laryngeal landmarks could be visualized and reached in the human body donor setup. Conclusion: Possibly, the proposed system may develop into an alternative treatment option for patients with early-stage laryngeal cancer and restricted mobility of the cervical spine in the future. Further improvements of the system could include finer end effectors and a flexible instrument with a laser cutting tool.

[Telemedicine in Otorhinolaryngology and Head and Neck Surgery - An universal remedy?] / Telemedizin in der HNO-Heilkunde ­ wirklich ein Allheilmittel?

Digitalization in healthcare has gained considerable importance in recent years and especially during the Covid19 pandemic. The pandemic has undeniably severely limited human interactions. In light of the risk of infection, and also in light of the decreasing number of physician consultations by patients due to fear of infection, the medical community has had to seek new platforms for physician-patient interaction and -communication and achieved these goals predominantly by accelerating the development of digitization processes and telemedicine. In otolaryngology, the term telemedicine usually refers to video consultation (VS) or teleconsultations. In principle, ENT physicians belong to the group of specialists who are allowed to perform and invoice video consultations. Data protection and legal aspects pose challenges with regard to offering telemedical services. From an ethical point of view, any telemedical consultation would also have to be preceded by a mandatory explanation of the risks and disadvantages of using these procedures, and the basis for liability would also have to be clarified here in principle. Telemedicine will also have to assert itself in view of the evidence. Thus, at least from the medical university side, accompanying studies should be initiated when new telemedical procedures are offered, in order to evaluate the corresponding advantages and disadvantages on the basis of evidence. In terms of professional policy, care should always be taken to ensure that telemedicine is only offered by players in the healthcare sector who can also guarantee personal treatment of the patient assessed by telemedicine.

Erythrocytes from patients with ST-elevation myocardial infarction induce cardioprotection through the purinergic P2Y13 receptor and nitric oxide signaling.

Red blood cells (RBCs) are suggested to play a role in cardiovascular regulation by exporting nitric oxide (NO) bioactivity and ATP under hypoxia. It remains unknown whether such beneficial effects of RBCs are protective in patients with acute myocardial infarction. We investigated whether RBCs from patients with ST-elevation myocardial infarction (STEMI) protect against myocardial ischemia-reperfusion injury and whether such effect involves NO and purinergic signaling in the RBCs. RBCs from patients with STEMI undergoing primary coronary intervention and healthy controls were administered to isolated rat hearts subjected to global ischemia and reperfusion. Compared to RBCs from healthy controls, RBCs from STEMI patients reduced myocardial infarct size (30 ± 12% RBC healthy vs. 11 ± 5% RBC STEMI patients, P < 0.001), improved recovery of left-ventricular developed pressure and dP/dt and reduced left-ventricular end-diastolic pressure in hearts subjected to ischemia-reperfusion. Inhibition of RBC NO synthase with L-NAME or soluble guanylyl cyclase (sGC) with ODQ, and inhibition of cardiac protein kinase G (PKG) abolished the cardioprotective effect. Furthermore, the non-selective purinergic P2 receptor antagonist PPADS but not the P1 receptor antagonist 8PT attenuated the cardioprotection induced by RBCs from STEMI patients. The P2Y13 receptor was expressed in RBCs and the cardioprotection was abolished by the P2Y13 receptor antagonist MRS2211. By contrast, perfusion with PPADS, L-NAME, or ODQ prior to RBCs administration failed to block the cardioprotection induced by RBCs from STEMI patients. Administration of RBCs from healthy subjects following pre-incubation with an ATP analog reduced infarct size from 20 ± 6 to 7 ± 2% (P < 0.001), and this effect was abolished by ODQ and MRS2211. This study demonstrates a novel function of RBCs in STEMI patients providing protection against myocardial ischemia-reperfusion injury through the P2Y13 receptor and the NO-sGC-PKG pathway.

[PSMA-PET-MRI and radio-guided surgery in cervical lymphadenectomy]. / PSMA-PET und "radio-guided surgery" bei zervikaler Lymphadenektomie.

A 75-year-old male patient with suspicious cervical lymph nodes in level IV on the left side is presented. The cervical mass was detected in PSMA-PET-MRI as part of a restaging examination conducted due to an increase of PSA levels in the context of the patient's known prostate cancer. We conducted a selective cervical level IV lymphadenectomy with the aid of a gamma probe subsequent to radiolabelling with 99mTc-PSMA. Two visibly enlarged lymph nodes with high gamma probe signals could be extracted. Histopathological examination revealed lymph node metastases of the known prostate cancer. Using an adequate tracer radio-guided surgery helps to detect pathological lymph nodes in the head and neck region allowing for supraselective resection.

[Centralization, Specialization, and Outpatient Care for Head and Neck Tumor Patients]. / Zentralisierung, Spezialisierung und Ambulantisierung der Versorgung von Kopf-Hals-Tumorpatienten.

Demographically, the German population is aging and becoming more morbid. At the same time, urbanization trends, medical overcapacities, and increasing care costs are being observed in association with a tight healthcare budget. Centralization, specialization, and outpatient care are intended to provide a remedy and can be controlled by modifications to remuneration. This upheaval poses new challenges for patients and physicians, which were analyzed exemplarily at the Head and Neck Tumor (HNC) Center of the University Hospital Ulm. This is a retrospective, monocentric cohort study on the development of patient volume, catchment area, treatment modality, and demographics including 2070 HNC patients at the ENT clinic between the years 2011 and 2020. It was observed that the number (new diagnoses 2011: 134 vs. 2020: 204) and the average age (2011: 61.5 years vs. 2020: 65.8 years; p < 0.0001) of HNC patients increased over time. In addition, patients tended to travel longer distances (2011: 54.4 km vs. 2020: 64.4 km; p = 0.05). At the same time, the mean number of consultations and treatments per patient per 5-year follow-up interval grew (at initial diagnosis in 2011: 7.8 vs. 2016: 10.4; p = 0.0003), with the proportion of outpatient contacts increasing from 58.9 % to 62.4 % (p = 0.09) from 2011 to 2020. Accordingly, clinical centers are expected to become more important in the care of HNC patients as the healthcare system becomes more specialized, and centralized with a growing outpatient setting. The following consequences for patient care should be considered in restructuring strategies.

Association of coronary angiographic lesions and mortality in patients over 80 years with NSTEMI.

OBJECTIVE: Coronary angiography (CA) and percutaneous coronary intervention (PCI) is of great importance during non-ST-segment elevation myocardial infarction (NSTEMI) management. Coronary artery lesions and their association to mortality in elderly patients with NSTEMI was investigated. METHODS: Patients >80 years of age who underwent CA at index NSTEMI during 2011-2014 were included. Data were collected from the Swedish Coronary Angiography and Angioplasty Registry and Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registries. Coronary lesions were categorised into; one vessel disease (1VD), multi-vessel disease (MVD) and left main disease (LMD) and 0%-49% stenosis grade were considered as controls.Cox regression was used to estimate HRs for all-cause mortality associated with coronary lesions. Survival benefit was determined after PCI and in relation to if revascularisation was complete or incomplete and any complications in the Cath lab was assessed. RESULTS: Five thousand seven hundred and seventy patients with history of CA and PCI were included, 10% had normal coronary arteries, 26% had 1VD, 50% MVD and 14% LMD. Mortality was higher in patients with 1VD, MVD and LMD: HR 1.8 (1.3-2.5), HR 2.2 (1.6-3.0) and HR 2.8 (2.1-3.9), respectively. PCI were treated in 84% of 1VD, 73% MVD, and 54% in LMD. Survival was higher with PCI HR 0.85 (0.73-0.99). MVD had lower adjusted mortality HR 0.71 (0.58-0.87) compared with patients with MVD who did not undergo PCI. Complications and mortality were higher in patients with LMD both during CA and PCI, HR 2.9 (1.1-7.6) and HR 4.5 (1.6-12.5). CONCLUSION: Coronary lesions (>50% stenosis) are strong predictors of mortality in elderly patients with NSTEMI. MVD is common and PCI treatment is associated with increased survival.

Arginase 1 is upregulated at admission in patients with ST-elevation myocardial infarction.

BACKGROUND: The mechanisms underlying rupture of a coronary atherosclerotic plaque and development of myocardial ischemia-reperfusion injury in ST-elevation myocardial infarction (STEMI) remain unresolved. Increased arginase 1 activity leads to reduced nitric oxide (NO) production and increased formation of reactive oxygen species due to uncoupling of the NO-producing enzyme endothelial NO synthase (eNOS). This contributes to endothelial dysfunction, plaque instability and increased susceptibility to ischemia-reperfusion injury in acute myocardial infarction. OBJECTIVE: The purpose of this study was to test the hypothesis that arginase gene and protein expression are upregulated in patients with STEMI. METHODS: Two cohorts of patients with STEMI were included. In the first cohort (n = 51), expression of arginase and NO-synthases as well as arginase 1 protein levels were determined and compared to a healthy control group (n = 45). In a second cohort (n = 68), plasma arginase 1 levels and infarct size were determined using cardiac magnetic resonance imaging. RESULTS: Expression of the gene encoding arginase 1 was significantly elevated at admission and 24-48 h after STEMI but not 3 months post STEMI, in comparison with the control group. Expression of the genes encoding arginase 2 and endothelial NO synthase (NOS3) were unaltered. Arginase 1 protein levels were elevated at admission, 24 h post STEMI and remained elevated for up to 6 months. No significant correlation between plasma arginase 1 protein levels and infarct size was observed. CONCLUSION: The markedly increased gene and protein expression of arginase 1 already at admission indicates a role of arginase 1 in the development of STEMI.

The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial.

BACKGROUND: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. METHODS AND RESULTS: The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) - is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint. CONCLUSION: This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing.

Application of a new computer-assisted robotic visualization system in cochlear implantation-Proof of concept.

BACKGROUND: Over the last decades conventional cochlear implant (CI) surgery has remained essentially unchanged. Nevertheless, alternative implantation techniques to further improve patient outcomes such as endaural implantation or robot-assisted surgery have been proposed in recent years. However, none of these have gained acceptance in clinical routine, thus confirming a demand for new developments. METHODS: Cochlear implant surgery was performed in two mastoid bones obtained from body donors using a novel hands-free exoscope. Advantages and disadvantages of the system were evaluated. RESULTS: In all cases, implantation of the electrode was feasible. The system allowed for hands-free movement and adjustment of the exoscope by the head-mounted display. Network connectivity of the system leaves room for improvement. CONCLUSION: The RoboticScope is an innovative tool and can be used supportively in conventional CI surgery in the experimental setting. Although operating the device requires a certain learning curve, the usability is intuitive for every ear surgeon.

Uninterrupted Oral Anticoagulant Therapy in Patients Undergoing Unplanned Percutaneous Coronary Intervention.

OBJECTIVES: This study sought to compare interrupted and uninterrupted oral anticoagulant therapy (I-OAC vs. U-OAC) in patients on OAC undergoing percutaneous coronary intervention. BACKGROUND: There is a paucity of data regarding the optimal peri-procedural management of OAC-treated patients. METHODS: In the SWEDEHEART registry, all patients on OAC who were admitted acutely and underwent percutaneous coronary intervention or coronary angiography with a diagnostic procedure, from 2005 to 2017, were included. Outcomes were major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, or stroke) and bleeds at 120 days. Propensity score was used to adjust for the nonrandomized treatment selection. RESULTS: The study included 6,485 patients: 3,322 in the I-OAC group and 3,163 in the U-OAC group. The cumulative incidence of MACCE was 8.2% (269 events) versus 8.2% (254 events) in the I-OAC and the U-OAC groups, respectively. The adjusted risk for MACCE did not differ between the groups (I-OAC vs. U-OAC hazard ratio: 0.89; 95% confidence interval: 0.71 to 1.12). Similarly, no difference was found in the risk for MACCE or bleeds (12.6% vs. 12.9%, adjusted hazard ratio: 0.87; 95% confidence interval: 0.70 to 1.07). The risk for major or minor in-hospital bleeds did not differ between the groups. However, U-OAC was associated with a significantly shorter duration of hospitalization: 4 (3 to 7) days versus 5 (3 to 8) days; p < 0.01. CONCLUSIONS: I-OAC and U-OAC were associated with equivalent risk for MACCE and bleeding complications. An U-OAC strategy was associated with shorter length of hospitalization. These data support U-OAC as the preferable strategy in patients on OAC undergoing coronary intervention.

[Primary small cell neuroendocrine carcinoma of the larynx: a review of literature and case series]. / Kleinzelliges neuroendokrines Karzinom des Kopf-Hals-Bereichs: eine Übersichtsarbeit und Fallserie.

INTRODUCTION: Small cell neuroendocrine carcinoma (SCNC) of the larynx is a rare tumor entity with a 5-year overall survival (OS) of only 5 % after treatment with chemoradiotherapy. METHODS: A systematic review of the literature was performed for "SCNC" and "SCNC in head and neck". Our hospital's own electronic patient file database was investigated for patients diagnosed with a SCNC over the last 12 years. RESULTS: The effectiveness of chemoradiotherapy in SCNC is still unclear since randomized clinical trials are missing for the evaluation of standard of care treatment. Common therapy approaches are based on experiences with small cell lung cancer. 0.5 % of all SCNC occur in the head and neck region. In the last 12 years, we diagnosed 9 patients with SCNC, two of which were located in the larynx. Exemplarily, we report the case of a 29-year-old male with the initial diagnosis of a SCNC of the larynx with concurrent lymph node metastasis. This case is particularly interesting due to the young age at disease onset and the lack of major risk factors. Treatment was modified to nivolumab due to progressive disease after treatment with chemoradiotherapy. After an OS of 22 months, the patient deceased due to a tumor-associated major bleeding with airway obstruction. CONCLUSION: So far there are no clinical reports evaluating the use of nivolumab in third-line-therapy of SCNC. NTRK fusion (neurotrophic tyrosine receptor kinase gene fusion) or the folate receptor expression analysis should be considered to evaluate the potential use of a tropomyosin receptor kinase inhibitor or a folate receptor targeting therapy.

Long-term effect of remote ischemic conditioning on infarct size and clinical outcomes in patients with anterior ST-elevation myocardial infarction.

BACKGROUND: Conflicting evidence exists concerning the cardioprotective efficacy of remote ischemic conditioning as an adjunct to primary percutaneous intervention (PCI) in ST-elevation myocardial infarction (STEMI) and data on long-term outcomes are scarce. We evaluated final infarct size by cardiac magnetic resonance (CMR) performed 6 months after anterior STEMI treated with remote ischemic conditioning and clinical outcomes up to 3 years after the event. METHODS: One hundred and fifteen patients with anterior STEMI were randomized to remote ischemic per-postconditioning (RIperpostC) or sham procedure as adjunct to primary PCI. The primary outcome was myocardial salvage index (MSI) on CMR 6 months after the event. Secondary outcomes were absolute infarct size, left ventricular function, cardiac mortality, major adverse cardiac and cerebrovascular events (MACCE-composite of all-cause mortality, myocardial infarction, readmission for heart failure, ischemic stroke, and target lesion revascularization) and all the individual components of MACCE. RESULTS: There was no difference in MSI or left ventricular function between the RIperpostC and the control group after 6 months. Nor did clinical outcomes at 6 months or 3 years differ between the groups. CONCLUSIONS: RIperpostC as an adjunct to PCI in anterior STEMI did not result in better MSI or left ventricular function 6 months after the event. Furthermore, clinical outcomes at 6 months and 3 years were not altered.

Adding Flexible Instrumentation to a Curved Videolaryngoscope: A Novel Tool for Laryngeal Surgery.

OBJECTIVES: Transoral surgery of the larynx with rigid instruments is not always possible. This may result in insufficient therapy or in an increased need for open surgery. For these patients, alternative surgical systems are needed. Here, we demonstrate a curved prototype for laryngeal surgery equipped with flexible instruments. STUDY DESIGN: Pre-clinical user study in an ex vivo porcine laryngeal model. METHODS: The prototype was built from established medical devices, namely a hyperangulated videolaryngoscope and modified flexible instruments as well as three-dimensional printed parts. Feasibility of laryngeal manipulation was evaluated in a user study (n = 19) with a porcine ex vivo laryngeal model. Using three different visualization technologies, the participants performed various fine motor skills tasks and rated the usability of the system on a 5-point Likert scale. RESULTS: Exposure, accessibility, and manipulation of important laryngeal structures were always possible using the new prototype. The participants needed considerably less time (mean, 96.4 seconds ± 6.4 seconds vs. 111.5 seconds ± 4.5 seconds, P = .18), reported significantly better general impression (mean score 3.0 vs. 3.8, P = .041) and significantly lower user head and neck strain (2.6 vs. 1.7, P = .022) using a 40-inch television screen as compared to a standard videolaryngoscope monitor. CONCLUSION: The results indicate that our curved prototype and large monitor visualization may provide a cost-effective minimally invasive alternative for difficult laryngeal exposure. Its special advantages include avoiding the need for a straight line of sight and a simple and cost-effective construction. The system could be further improved through advances in camera chip technology and smaller instruments. Laryngoscope, 131:E561-E568, 2021.

Impact of real-time angiographic co-registered optical coherence tomography on percutaneous coronary intervention: the OPTICO-integration II trial.

AIMS: Longitudinal geographic mismatch (LGM) as well as edge dissections are associated with an increased risk of adverse events after percutaneous coronary intervention (PCI). Recently, a novel system of real-time optical coherence tomography (OCT) with angiographic co-registration (ACR) became available and allows matched integration of cross-sectional OCT images to angiography. The OPTICO-integration II trial sought to assess the impact of ACR for PCI planning on the risk of LGM and edge dissections. METHODS: A total of 84 patients were prospectively randomized to ACR-guided PCI, OCT-guided PCI (without co-registration), and angiography-guided PCI. Primary endpoint was a composite of major edge dissection and/or LGM as assessed by post-PCI OCT. RESULTS: The primary endpoint was significantly reduced in ACR-guided PCI (4.2%) as compared to OCT-guided PCI (19.1%; p = 0.03) and angiography-guided PCI (25.5%; p < 0.01). Rates of LGM were 4.2%, 17.0%, and 22.9% in the ACR-guided PCI, in the OCT-guided PCI, and the angiography-guided PCI groups, respectively (ACR vs. OCT p = 0.04; ACR vs. angiography p = 0.04). The number of major edge dissections was low and without significant differences among the study groups (0% vs. 2.1% vs. 4.3%). CONCLUSION: This study for the first time demonstrates superiority of ACR-guided PCI over OCT- and angiography-guided PCI in reducing the composite endpoint of major edge dissection and LGM, which was meanly driven by a reduction of LGM.

Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

AIMS: The aim of this study was to assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) (Orsiro) in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: From the Swedish Coronary Angiography and Angioplasty Registry, the two-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer-generation DES (n-DES group) were analysed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI]: 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% vs 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI: 0.63-1.03, p-value=0.09). The risk of target lesion revascularisation by PCI was lower in the Orsiro group (1.6% vs 2.3%, adjusted HR 0.75, 95% CI: 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI: 0.72-1.35, p-value=0.94; 6.0% vs 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI: 1.00-1.43, p-value=0.06). CONCLUSIONS: In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favourable clinical outcomes.