Valvular heart disease: from mechanisms to management.

Valvular heart disease is common and its prevalence is rapidly increasing worldwide. Effective medical therapies are insufficient and treatment was historically limited to the surgical techniques of valve repair or replacement, resulting in systematic underprovision of care to older patients and those with substantial comorbidities, frailty, or left ventricular dysfunction. Advances in imaging and surgical techniques over the past 20 years have transformed the management of valvular heart disease. Better understanding of the mechanisms and causes of disease and an increasingly extensive and robust evidence base provide a platform for the delivery of individualised treatment by multidisciplinary heart teams working within networks of diagnostic facilities and specialist heart valve centres. In this Series paper, we aim to provide an overview of the current and future management of valvular heart disease and propose treatment approaches based on an understanding of the underlying pathophysiology and the application of multidisciplinary treatment strategies to individual patients.

Non-femoral focused transaxillary access in TAVI: GARY data analysis and future trends.

BACKGROUND: In patients not suitable for transfemoral transcatheter aortic valve implantation (TAVI), several access strategies can be chosen. AIM: To evaluate the use and patient outcomes of transaxillary (TAx), transapical (TA), and transaortic (TAo) as alternative access for TAVI in Germany; to further evaluate surgical cutdown vs. percutaneous TAx access. METHODS: All patients entered the German Aortic Valve Registry (GARY) between 2011 and 2019 who underwent non-transfemoral TAVI were included in this analysis. Patients with TA, TAo, or TAx TAVI were compared using a weighted propensity score model. Furthermore, a subgroup analysis was performed for TAx regarding the percutaneous or surgical cutdown approach. RESULTS: Overall, 9686 patients received a non-transfemoral access. A total of 8918 patients (92.1%) underwent TA, 398 (4.1%) TAo, and 370 (3.8%) TAx approaches. Within the TAx subgroup, 141 patients (38.1%) received subclavian cutdown, while 200 (54.1%) underwent a percutaneous approach. The TA patients had a significantly lower 30-day survival than TAx patients (TA 90.92% vs. TAx 95.59%, p = 0.006; TAo 92.22% vs. TAx 95.59%, p = 0.102). Comparing percutaneous and cutdown TAx approaches, no significant differences were seen. However, more vascular complications occurred (TA 1.8%, TAo 2.4%, TAx 12.2%; p < .001), and the hospital length of stay was shorter (TA 12.9 days, TAo 14.1 days, TAx 12 days; p < .001) after TAx access. CONCLUSION: It may be reasonable to consider TAx access first in patients not suitable for TF-TAVI, because the 30-day survival was higher compared with TA access and the 1-year survival was higher compared with TAo access. It remains important for the heart teams to offer alternative access modalities for patients not amenable to the standard TF-TAVI approaches.

Innovation and disruptive science determine the future of cardiothoracic surgery.

One of the currently most asked questions in the field of medicine is how any specialty in the future will evolve to ensure better health for the patients by using current, unparalleled developments in all areas of science. This article will give an overview of new and evolving strategies for cardiothoracic (CT) surgery that are available today and will become available in the future in order to achieve this goal. In the founding era of CT surgery in the 1950s and 1960s, there was tremendous excitement about innovation and disruptive science, which eventually resulted in a completely new medical specialty, i.e. CT surgery. Entirely new treatment strategies were introduced for many cardiovascular diseases that had been considered incurable until then. As expected, alternative techniques have evolved in all fields of science during the last few decades, allowing great improvements in diagnostics and treatment in all medical specialties. The future of CT surgery will be determined by an unrestricted and unconditional investment in innovation, disruptive science and our own transformation using current achievements from many other fields. From the multitude of current and future possibilities, I will highlight 4 in this review: improvements in our current techniques, bringing CT surgery to low- and middle-income countries, revolutionizing the perioperative period and treating as yet untreatable diseases. These developments will allow us a continuation of the previously unheard-of treatment possibilities provided by ingenious innovations based on the fundamentals of CT surgery.

Comparison of contemporary transcatheter heart valve prostheses: data from the German Aortic Valve Registry (GARY).

BACKGROUND: Various second-generation transcatheter heart valve (THV) prostheses with high clinical efficacy and safety are available, but there is limited large-scale data available comparing their hemodynamic performance and clinical implications. OBJECTIVE: To compare the hemodynamic performance and short-term clinical outcome of four second-generation THV prostheses. METHODS: 24,124 patients out of the German Aortic Valve Registry who underwent transfemoral transcatheter aortic valve implantation (TAVI) (Evolut™ R n = 7028, Acurate neo™ n = 2922, Portico n = 878 and Sapien 3 n = 13,296) were included in this analysis. Propensity-score weighted analysis was performed to control for differences in age, left ventricular function, STS score and sex. Primary endpoint was survival at one-year, secondary endpoints were 30 days survival, pre-discharge transvalvular gradients, paravalvular leakage and peri-procedural complications. RESULTS: Thirty-day and one-year survival were not significantly different between the four patient groups. Transvalvular gradients in Evolut™ R and Acurate neo™ were significantly lower as compared to Portico and Sapien 3 at hospital discharge. This difference exists across all annulus sizes. Paravalvular leakage ≥ II occurred significantly less often in the Sapien 3 group (1.2%, p < 0.0001). Rate of severe procedural complications was low and comparable in all groups. Permanent pacemaker implantation rate at one year was lowest in the ACUARATE neo group (13.0%) and highest in the Evolut™ R group (21.9%). CONCLUSION: Albeit comparable short-term clinical outcomes there are certain differences regarding hemodynamic performance and permanent pacemaker implantation rate between currently available THV prostheses which should be considered for individual prosthesis selection.

The Impact of Head Position on Neurological and Histopathological Outcome Following Controlled Automated Reperfusion of the Whole Body (CARL) in a Pig Model.

Introduction: Based on extracorporeal circulation, targeted reperfusion strategies have been developed to improve survival and neurologic recovery in refractory cardiac arrest: Controlled Automated Reperfusion of the whoLe Body (CARL). Furthermore, animal and human cadaver studies have shown beneficial effects on cerebral pressure due to head elevation during conventional cardiopulmonary resuscitation. Our aim was to evaluate the impact of head elevation on survival, neurologic recovery and histopathologic outcome in addition to CARL in an animal model. Methods: After 20 min of ventricular fibrillation, 46 domestic pigs underwent CARL, including high, pulsatile extracorporeal blood flow, pH-stat acid-base management, priming with a colloid, mannitol and citrate, targeted oxygen, carbon dioxide and blood pressure management, rapid cooling and slow rewarming. N = 25 were head-up (HUP) during CARL, and N = 21 were supine (SUP). After weaning from ECC, the pigs were extubated and followed up in the animal care facility for up to seven days. Neuronal density was evaluated in neurohistopathology. Results: More animals in the HUP group survived and achieved a favorable neurological recovery, 21/25 (84%) versus 6/21 (29%) in the SUP group. Head positioning was an independent factor in neurologically favorable survival (p < 0.00012). Neurohistopathology showed no significant structural differences between HUP and SUP. Distinct, partly transient clinical neurologic deficits were blindness and ataxia. Conclusions: Head elevation during CARL after 20 min of cardiac arrest independently improved survival and neurologic outcome in pigs. Clinical follow-up revealed transient neurologic deficits potentially attributable to functions localized in the posterior perfusion area, whereas histopathologic findings did not show corresponding differences between the groups. A possible explanation of our findings may be venous congestion and edema as modifiable contributing factors of neurologic injury following prolonged cardiac arrest.

Role of ECLS in Managing Post-Myocardial Infarction Ventricular Septal Rupture.

OBJECTIVES: The aim of this study was to analyze outcomes in patients undergoing surgery for ventricular septal rupture (VSR) after myocardial infarction (MI) and the preoperative use of extracorporeal life support (ECLS) as a bridge to surgery. METHODS: We included patients undergoing surgery for VSR from January 2009 until June 2021 from two centers in Germany. Patients were separated into two groups, those with and without ECLS, before surgery. Pre- and intraoperative data, outcome, and survival during follow-up were evaluated. RESULTS: A total of 47 consecutive patients were included. Twenty-five patients were in the ECLS group, and 22 were in the group without ECLS. All the ECLS-group patients were in cardiogenic shock preoperatively. Most patients in the ECLS group were transferred from another hospital [n = 21 (84%) vs. no-ECLS (n = 12 (57.1%), p = 0.05]. We observed a higher number of postoperative bleeding complications favoring the group without ECLS [n = 6 (28.6%) vs. n = 16 (64%), p < 0.05]. There was no significant difference in the persistence of residual ventricular septal defect (VSD) between groups [ECLS n = 4 (16.7%) and no-ECLS n = 3 (13.6%)], p = 1.0. Total in-hospital mortality was 38.3%. There was no significant difference in in-hospital mortality [n = 6 (27.3%) vs. n = 12 (48%), p = 0.11] and survival at last follow-up between the groups (p = 0.50). CONCLUSION: We detected no statistical difference in the in-hospital and long-term mortality in patients who received ECLS as supportive therapy after MI-induced VSR compared to those without ECLS. ECLS could be an effective procedure applied as a bridge to surgery in patients with VSR and cardiogenic shock.

Effects of Prolonged Serum Calcium Suppression during Extracorporeal Cardiopulmonary Resuscitation in Pigs.

Controlled reperfusion by monitoring the blood pressure, blood flow, and specific blood parameters during extracorporeal reperfusion after cardiac arrest has the potential to limit ischemia-reperfusion injury. The intracellular calcium overload as part of the ischemia-reperfusion injury provides the possibility for the injury to be counteracted by the early suppression of serum calcium with the aim of improving survival and the neurological outcome. We investigated the effects of prolonged serum calcium suppression via sodium citrate during extracorporeal resuscitation using the CARL protocol (CARL-controlled automated reperfusion of the whole body) compared to a single-dose approach in a porcine model after prolonged cardiac arrest. A control group (N = 10) was resuscitated after a 20 min cardiac arrest, initially lowering the intravascular calcium with the help of a single dose of sodium citrate as part of the priming solution. Animals in the intervention group (N = 13) received additional sodium citrate for the first 15 min of reperfusion. In the control group, 9/10 (90.0%) animals survived until day 7 and 7/13 (53.8%) survived in the intervention group (p = 0.09). A favorable neurological outcome on day 7 after the cardiac arrest was observed in all the surviving animals using a species-specific neurological deficit score. The coronary perfusion pressure was significantly lower with a tendency towards more cardiac arrhythmias in the intervention group. In conclusion, a prolonged reduction in serum calcium levels over the first 15 min of reperfusion after prolonged cardiac arrest tended to be unfavorable regarding survival and hemodynamic variables compared to a single-dose approach in this animal model.

Development of an in-vitro model for extracorporeal blood pumps to study the effects of artificial pulsatility on human blood.

Introduction: The application of extracorporeal circulation (ECC) systems is known to be associated with several implications regarding hemolysis, inflammation, and coagulation. In the last years, systems with pulsatile blood flow are increasingly used with the intention to improve hemodynamics in reperfusion. However, their implications on the aforementioned aspects remain largely unknown. To investigate the effects of pulsatility, this ex-vivo study was initiated. Methods: Test circuits (primed with human whole blood) were set up in accordance with the recommendations of international standards for in-vitro evaluation of new components and systems of ECC. Diagonal pumps were either set up with non-pulsatile (n = 5, NPG) or pulsatile (n = 5, PG) pump settings and evaluated for 6 h. All analyses were conducted with human whole blood. Blood samples were repeatedly drawn from the test circuits and analyzed regarding free hemoglobin, interleukin 8 (IL-8), platelet aggregation and acquired von Willebrand syndrome (AVWS). Results: After 1 h of circulation, a significant coagulation impairment (impaired platelet function and AVWS) was observed in both groups. After 6 h of circulation, increased IL-8 concentrations were measured in both groups (NPG: 0.05 ± 0.03 pg./mL, PG: 0.03 ± 0.01 pg./mL, p = 0.48). Pulsatile pump flow resulted in significantly increased hemolysis after 6 h of circulation (NPG: 37.3 ± 12.4 mg/100 L; PG: 59.6 ± 14.5 mg/100 L; p < 0.05). Conclusion: Our results indicate that the coagulative impairment takes place in the early phase of ECC. Pulsatility did not affect the occurrence of AVWS ex-vivo. Prolonged durations of pulsatile pump flow led to increased hemolysis and therefore, its prolonged use should be employed cautiously in clinical practice with appropriate monitoring.

Branched endovascular iliac artery repair using the Zenith® Branch Endovascular Iliac Bifurcation graft: outcomes and reinterventions in our retrospective cohort.

Background: The aim of this retrospective cohort study was to analyze the outcomes and the need for reinterventions following branched iliac artery repair using the Zenith® Branch Endovascular Iliac Bifurcation (ZBIS; Cook Medical Europe LTD, Limerick, Ireland) graft. Methods: Patient characteristics and follow-up data on 63 patients following branched iliac artery repair using the ZBIS device were evaluated and compared between patients with and without iliac reinterventions. A competing risk regression model was analyzed to identify independent predictors of reinterventions, and to predict the reintervention risk. Results: ZBIS implantation's technical success rate was 100%, and we observed no in-hospital mortality. Internal iliac artery patency was 93% during a median [first quartile, third quartile] follow-up of 19 [5, 39] months. Thirty-two iliac reinterventions were performed in 23 patients (37%) after a mean time of 3.0 months (IQR: 0.4-6.8) (time to first reintervention). Endoleaks type I and II were the most common indication for reinterventions (n=14, 61%). The internal iliac artery's diameter [subdistribution hazard ratio (sHR): 1.046; P=0.0015] and a prior abdominal aortic intervention (sHR: 0.3331; P=0.0370) were identified as significant variables in the competing risk regression model for a reintervention. The risk for reintervention was 33% (95% CI: 20-46%), and 46% (95% CI: 28-63%) after 12 and 36 months, respectively. Conclusions: Endovascular repair of degenerative iliac artery aneurysms with Zenith Branch Iliac Bifurcation device is a feasible and safe option. Perioperative morbidity and mortality are low with good graft patency rates. The risk for secondary iliac artery interventions is considerable and highlights the need for patients with iliac disease to undergo continuous follow-up in a dedicated vascular center.

Direct oral anticoagulants versus vitamin K antagonist after transcatheter aortic valve implantation.

OBJECTIVE: After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population. METHODS: The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint 'cardiac and cerebrovascular events' containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen. RESULTS: Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups. CONCLUSIONS: This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation.

Development and validation of explainable machine learning models for risk of mortality in transcatheter aortic valve implantation: TAVI risk machine scores.

Aims: Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. Methods and results: Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). Conclusion: TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI.

The endogenous thrombin potential in patients with left ventricular assist device or heart transplant.

Background: The Heartmate 3 (HM 3) is a left ventricular assist device featuring less shear stress, milder acquired von Willebrand syndrome, and fewer bleeding incidences than its predecessor the Heartmate II (HM II). The novel surface coating of the HM 3 suggests less contact activation of plasmatic coagulation. We hypothesized that patients with HM 3 exhibit fewer aberrations in their thrombin potential than patients with HM II. We compared these results with the thrombin potential of patients with heart transplantation (HTX). Methods: Thrombin generation in plasma samples of patients with HM II (n = 16), HM 3 (n = 20), and HTX (n = 13) was analyzed 3 days after implantation/transplantation and after long-term support (3-24 months) with HM II (n = 16) or HM 3 (n = 12) using calibrated automated thrombography. Heparin in postoperative samples was antagonized with polybrene. Results: Three days postoperatively HM II patients exhibited a lower endogenous thrombin potential (ETP) than HM 3 and HTX patients (HM II: 947 ± 291 nM*min; HM 3: 1231 ± 176 nM*min; HTX: 1376 ± 162 nM*min, p < 0.001) and a lower velocity index of thrombin generation (HM II: 18.74 ± 10.90 nM/min; HM 3: 32.41 ± 9.51 nM/min; HTX: 37.65 ± 9.41 nM/min, p < 0.01). Subtle differences in the thrombin generation profiles remained in HM II and HM 3 patients under long-term support (Velocity Index: HM II: 38.70 ± 28.46 nM/min; HM 3: 73.32 ± 32.83 nM/min, p < 0.05). Prothrombin fragments 1 + 2 were higher in HM II than in HM 3 patients (HM II: 377.7 ± 208.4 pM; HM 3: 202.1 ± 87.7 pM, p < 0.05) and correlated inversely with the ETP (r = -0.584, p < 0.05). Conclusion: We observed a more aberrant thrombin generation in HM II than in HM 3 despite comparable anticoagulation and routine parameters. A trend toward lower values was still observable in HM 3 compared to HTX patients. Calibrated automated thrombography may be a good tool to monitor the coagulation state of these patients and guide anticoagulation in the future.

Efficacy and Safety of Percutaneous Access Via Large-Bore Sheaths (22-26F Diameter) in Endovascular Therapy.

PURPOSE: To evaluate the closure success rate's outcomes with suture-mediated vascular closure device Perclose ProGlide in patients undergoing aortic or iliac artery endovascular repair using large delivery systems (>21F). MATERIALS AND METHODS: We screened all the patient records in aortic databases at 2 centers who had undergone vascular interventions via ProGlide for percutaneous femoral access >21F between 2016 and 2020. Patients were divided into 2 groups according to the delivery system size: large (L) (22F-23F) and extra-large (XL) (24F-26F). Demographics, anatomical details, and outcome of percutaneous access were evaluated. RESULTS: Included were 239 patients: 121 in the L group and 118 the XL group. Intraprocedural conversion to open surgery because of bleeding was necessary in 2% L and 6% XL patients (p=0.253). Severe femoral artery calcification was the sole risk factor for converting to open surgery (odds ratio=23.44, 95% confidence interval=1.49-368.17, p=0.025). In all, 2% of L and 3% of XL (p=0.631) did require late percutaneous intervention due to stenosis (all treated with balloon angioplasty). Overall, 3% developed pseudoaneurysm treated conservatively in all except one patient requiring surgical repair. Hematoma and groin infection were observed in 9% and 1%, respectively; none required surgical therapy. CONCLUSION: A femoral arterial defect after accessing the artery via a large bore sheath (22F-26F) can be closed successfully with ProGlide in more than 90% of patients. Severe femoral artery calcification is a risk factor for conversion to open surgery caused by bleeding. CLINICAL IMPACT: This study adds evidence on efficacy of accessing the artery via a large bore sheath (22-26F) secured by ProGlide. In more than 200 patients conversion to open surgery was necessary in only 4%. Severe femoral artery calcification was the sole risk factor for converting to open surgery. Our findings encourage physicians to choose the percutaneous access even in patients requiring the use of large bore sheath.

Extracorporeal Membrane Oxygenation in Intoxication and Overdoses: A Systematic Review.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been increasingly applied over recent decades to treat severe cardiogenic shock and acute lung failure and cardiac arrest of various causes. Acute intoxication with therapeutic substances or other chemical substances can cause severe cardiogenic shock or even cardiac arrest. The purpose of this study was to conduct a qualitative systematic review of ECMO use in intoxication and poisoning. METHODS: We searched the PubMed, Medline, and Web of Science databases from January 1971 to December 2021 and selected appropriate studies according to our inclusion and exclusion criteria to evaluate the role of ECMO in intoxication and poisoning systematically. Survival at hospital discharge was examined to describe the outcome. RESULTS: The search resulted in 365 publications after removing duplicates. In total, 190 full-text articles were assessed for eligibility. A total of 145 articles from 1985 to 2021 were examined in our final qualitative analysis. A total of 539 (100%) patients were included (mean age: 30.9 ± 16.6 years), with a distribution of n = 64 (11.9%) cases with venovenous (vv) ECMO, n = 218 (40.4%) cases with venoarterial (va) ECMO, and n = 257 (47.7%) cases with cardiac arrest and extracorporeal cardiopulmonary resuscitation. Survival at hospital discharge was 61.0% for all patients, 68.8% for vaECMO, 75% for vvECMO, and 50.9% for extracorporeal cardiopulmonary resuscitation. CONCLUSION: When used and reported, ECMO seems to be a valid tool for adult and pediatric patients suffering intoxication from various pharmaceutical and nonpharmaceutical substances due to a high survival rate at hospital discharge.

Routine versus selective near-infrared spectroscopy-guided shunting during carotid eversion endarterectomy.

OBJECTIVES: The aim of this study was to compare outcomes of routine shunting to near-infrared spectroscopy (NIRS)-guided shunting in patients undergoing eversion endarterectomy (EEA) under general anaesthesia. METHODS: We retrospectively evaluated data of all patients undergoing EEA of the internal carotid artery (ICA) in our department from January 2011 until January 2019. Included were patients with EEA of the ICA and the patients were divided into 2 groups: selective-shunting group and routine-shunting group. Patients (i) with patch angioplasty during the surgery, (ii) undergoing surgery for restenosis and (ii) stenosis after radiation therapy, (iii) without recorded regional cerebral oxygen saturation trends, (iv) presenting with an emergency treatment indication and (v) operated upon by residents were excluded. In all patients, EEA was performed in general anaesthesia and under NIRS monitoring. One-to-one propensity score matching was used to compare EEA outcomes after routine shunting to NIRS-guided shunting. Primary end points were defined as perioperative stroke and in-hospital mortality after EEA. RESULTS: Routine and NIRS-guided selective shunting were applied in 340 (34.0%) and 661 (66.0%) patients, respectively. A total of 277 pairs were generated via propensity score matching. Fifty-eight (20.1%) from the selective-shunting group were intraoperatively shunted. Concomitant procedures were more frequently performed in the routine-shunting group [170 (61.4%) vs 47 (17.0%), 180 (65%) vs 101 (36.5%), and 60 (21.7%) vs 6 (2.2%), P < 0.001]. The perioperative stroke rate in the routine-shunting group was higher as well [11 (4.0%) vs 3 (1.1%), P = 0.022]. In-hospital death was overall 0.2% (n = 1). Multivariable logistic regression in the matched patient indicated age (odds ratio 1.050, 95% confidence interval 1.002-1.104, P = 0.046) and routine shunting (odds ratio 2.788, confidence interval 1.119-7.428, P = 0.032) as risk factors for perioperative stroke during EEA of the ICA. CONCLUSIONS: We found that, during EEA of the ICA, under general anaesthesia, NIRS-guided selective shunting was associated with a lower incidence of perioperative stroke than routine shunting.

Benefit From a Humanitarian Pediatric Congenital Heart Surgery Program Over a 10-Year Period.

Background: The charity organization Kinderherzen retten e.V. (KHR) enables humanitarian congenital heart surgery for pediatric patients from low- and middle-income countries at the University Heart Center Freiburg, Germany. The aim of this study was to assess periprocedural and mid-term outcomes of these patients for evaluation of KHR sustainability. Methods: Part one of the study comprised retrospective medical chart analyses of the periprocedural course of all KHR-treated children from 2008 to 2017, and part two a prospective evaluation of their mid-term outcome, assessed by questionnaires concerning survival, medical history, mental and physical development, and socioeconomic situation. Results: Of the 100 consecutively presented children from 20 countries (median age 3.25 years), 3 patients were not invasively treatable, 89 underwent cardiovascular surgery, and 8 received a catheter intervention only. There were no periprocedural deaths. Median postoperative duration of mechanical ventilation, intensive care stay, and total hospital stay was 7 (interquartile range [IQR] 4-21) hours, 2 (IQR 1-3) days, and 12 (IQR 10-16) days, respectively. Mid-term postoperative follow-up demonstrated a 5-year survival probability of 94.4%. The majority of patients received continued medical care in their home country (86.2% of patients), were in good mental and physical condition (96.5% and 94.7% of patients, respectively), and able to engage in age-appropriate education/employment (98.3% of patients). Conclusions: Cardiac, neurodevelopmental, and socioeconomic outcomes of patients treated via KHR was satisfactory. Thorough pre-visit evaluation and close contact with local physicians are crucial when providing this high-quality, sustainable, and viable therapeutic option for these patients.

Clinical Outcomes after Mitral Valve Surgery in Failed MitraClip Procedures.

BACKGROUND: We retrospectively evaluated in-hospital and overall outcome of patients who received mitral valve replacement (MVR) after failed MitraClip procedure. METHODS: A total of 26 out of 740 patients received MVR after treatment with MitraClip between June 2010 and December 2020. We analyzed in-hospital mortality and overall mortality during the median follow-up period of 72 days after MVR. RESULTS: The median age in the entire cohort was 77.5 years. In-hospital mortality was 15.4% (n = 4) and the overall mortality during the follow-up period was 27% (n = 7). The median time between the MitraClip procedure and surgery was 34.5 days. The main reasons for surgery were mitral stenosis (23.1%), persistent prolapse of the mitral valve leaflets (42.3%), and persistent tethering of the mitral valve leaflets (34.6%). At the time of surgery all of the patients presented with New York Heart Association 3 and above. The underlying mitral valve pathology was mainly secondary 61.5% (n = 16). Median left ventricular end-diastolic diameter was 60 mm. Preoperative ejection fraction was 40% and above in 73% of the cohort. In addition to the mitral valve procedure, 57.7% of patients received either concomitant tricuspid annuloplasty, aortic valve surgery, ascending aortic replacement, or coronary artery bypass grafting. CONCLUSION: The need for MVR for failed MitraClip repair is low and the results are acceptable. However, remaining options for reconstruction are usually limited and MVR is often needed. Anticipating success or failure according to the underlying pathology more than according to concomitant risk factors should form the basis in decision making for the treatment modality of first choice.

Limiting calcium overload after cardiac arrest: The role of human albumin in controlled automated reperfusion of the whole body.

BACKGROUND: Regarding the overall inadequate results after cardiopulmonary resuscitation, the development of new treatment concepts is urgently needed. Controlled Automated Reperfusion of the whoLe body (CARL) represents a therapy bundle to control the conditions of reperfusion and the composition of the reperfusate after cardiac arrest (CA). The aim of this study was to investigate the plasma expander's role in the CARL priming solution and examine its mechanism of action. METHODS: Viscosity, osmolality, colloid osmotic pressure (COP), pH and calcium binding of different priming solutions were measured in vitro and compared to in vivo data. N = 16 pigs were allocated to receive CARL following 20 min of untreated CA with either human albumin 20% (HA, N = 8) or gelatin polysuccinate 4% (GP, N = 8). Blood gas analyses were performed during the first hour of reperfusion and catecholamine and fluid requirements were recorded. Neurological outcome was assessed by neurological deficit scoring (NDS) on the seventh day. RESULTS: In vitro, addition of HA to the CARL priming solution resulted in higher COP and higher calcium-binding than GP. In vivo, treatment with HA led to greater reduction of ionized calcium and higher extracorporeal flows within the first 30 min of reperfusion with no difference in catecholamine support and fluid requirement. Seven-day survival of 75% with no difference in NDS was observed in both groups. CONCLUSIONS: Our data show that the plasma expander in the CARL priming solution has a significant effect on the initial reperfusate and can potentially influence the course of resuscitation. However, seven-day survival and NDS did not differ between groups.

Intervention rates and outcomes in medically managed uncomplicated descending thoracic aortic dissections.

OBJECTIVE: To evaluate the long-term incidence and outcome of aortic interventions for medically managed uncomplicated thoracic aortic dissections. METHODS: Between January 2012 and December 2018, 91 patients were discharged home with an uncomplicated, medically treated aortic dissection (involving the descending aorta with or without aortic arch involvement, no ascending involvement). After a median period of 4 (first quartile: 2, third quartile: 11) months, 30 patients (33%) required an aortic intervention. Patient characteristics, radiographic, treatment, and follow-up data were compared for patients with and without aortic interventions. A competing risk regression model was analyzed to identify independent predictors of aortic intervention and to predict the risk for intervention. RESULTS: Patients who underwent aortic interventions had significantly larger thoracic (P = .041) and abdominal (P = .015) aortic diameters, the dissection was significantly longer (P = .035), there were more communications between both lumina (P = .040), and the first communication was significantly closer to the left subclavian artery (P = .049). A descending thoracic aortic diameter exceeding 45 mm was predictive for an aortic intervention (P = .001; subdistribution hazard ratio: 3.51). The risk for aortic intervention was 27% ± 10% and 36% ± 11% after 1 and 3 years, respectively. Fourteen patients (47%) underwent thoracic endovascular aortic repair, 11 patients (37%) thoracic endovascular aortic repair and left carotid to subclavian bypass, 3 patients (10%) total arch replacement with the frozen elephant trunk technique, and 2 patients (7%) thoracoabdominal aortic replacement. We observed no in-hospital mortality. CONCLUSIONS: The need for secondary aortic interventions in patients with initially medically managed, uncomplicated descending aortic dissections is substantial. The full spectrum of aortic treatment options (endovascular, hybrid, conventional open surgical) is required in these patients.