Sex-Specific Disparities in Outcomes of Transcatheter Edge-to-Edge Repair for Mitral Regurgitation: A Multicenter "Real-World" Analysis.

BACKGROUND: mitral regurgitation (mr) is the most common valvular heart disease (vhd) in the elderly and tends to be more prevalent in women. while relevant sex differences in outcomes are evident in surgically treated collectives, there are very limited and conflicting sex-specific data for the growing cohort of patients undergoing transcatheter edge-to-edge repair (teer). OBJECTIVE: to investigate whether sex impacts procedural safety and efficacy, and in-hospital- and long-term outcomes, after teer for mr. METHODS: in a multicenter observational cohort study, patients who underwent teer were stratified by sex and relevant outcome measures, and analyzed using multivariable cox regression and propensity score matching (psm). RESULTS: a total of 821 patients were analyzed, of whom 37.4% (307/821) were female. compared to male patients, females were significantly older (77 ± 8.5 vs. 80.4 ± 6.7 years, p = 0.03), and had less coronary artery disease (cad, 67.7% vs. 53.1%, p < 0.0001) and a higher proportion of preserved left ventricular function (lvef > 50%, 32.5% vs. 50.5%, p > 0.0001). safety and efficacy of the teer procedure and in-hospital mortality did not differ between the sexes. after psm, women showed significantly better survival 3 years after teer compared to men (60.7% vs. 54.2%, p = 0.04) and a lower risk of all-cause death according to multiple cox regression (hr 0.8, 95% ci 0.6-0.9, p = 0.02). after sex-specific stratification for concomitant atrial fibrillation (af), the most common comorbidity in the present collective, women with af experience significantly worse adjusted survival compared to women without af (53.9% vs. 75.1%, p = 0.042) three years after teer and lose the survival advantage over men. CONCLUSIONS: female patients are older and less comorbid than males undergoing TEER. The TEER procedure is equally safe and effective in both sexes. While in-hospital mortality did not differ, female patients experienced a significantly better adjusted long-term survival compared to male patients. Concomitant AF offsets the prognostic advantage of females over males and, in contrast to males, significantly impairs long-term survival in women undergoing TEER. Further research is warranted to elucidate underlying causes for the observed sex disparities and to develop sex-tailored treatment recommendations.

Catheter ablation of concomitant atrial fibrillation improves survival of patients undergoing transcatheter edge-to-edge mitral valve repair.

Background: Atrial fibrillation (AF) is the most common concomitant disease in patients undergoing transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) and detrimentally affects their outcome. While there is increasing evidence for prognostic improvement and safety of catheter ablation (CA) of AF in the overall cohort of heart failure patients, corresponding data in TEER patients are lacking. Objectives: To investigate the impact of treatment regimens for concomitant AF on survival of TEER patients. Methods: In a multicenter observational cohort study consecutive patients successfully undergoing TEER were analyzed and survival of patients receiving CA of concomitant AF was compared with that of patients on pharmacological AF treatment and with that of patients without a history of AF, using propensity score matching (PSM). Results: A total of 821 patients were analyzed. Of these, 608 (74.1%) had concomitant AF, of whom 48 patients received CA. Patients with CA in AF showed significantly higher 3-year-survival after TEER compared to PSM-patients on pharmacological AF treatment (75.5% [36/48] vs. 49.4% [166/336], p = 0.009). The 3-year-survival after TEER of patients with concomitant AF treated with CA was not significantly different from PSM-patients without AF (75.5% [36/48] vs. 68.3% [98/144], p = 0.36). Conclusions: CA of AF is superior to pharmacotherapy as it significantly improves the survival of TEER patients in a PSM analysis. CA even offsets the prognostic disadvantage of coexisting AF in TEER patients. Given the growing evidence of prognostic benefits in the overall cohort of HF patients, our data point out the importance of treating concomitant AF and support CA as an essential part of a holistic management of TEER patients.

Comparative analysis of full-length 16s ribosomal RNA genome sequencing in human fecal samples using primer sets with different degrees of degeneracy.

Next-generation sequencing has revolutionized the field of microbiology research and greatly expanded our knowledge of complex bacterial communities. Nanopore sequencing provides distinct advantages, combining cost-effectiveness, ease of use, high throughput, and high taxonomic resolution through its ability to process long amplicons, such as the entire 16s rRNA genome. We examine the performance of the conventional 27F primer (27F-I) included in the 16S Barcoding Kit distributed by Oxford Nanopore Technologies (ONT) and that of a more degenerate 27F primer (27F-II) in the context of highly complex bacterial communities in 73 human fecal samples. The results show striking differences in both taxonomic diversity and relative abundance of a substantial number of taxa between the two primer sets. Primer 27F-I reveals a significantly lower biodiversity and, for example, at the taxonomic level of the phyla, a dominance of Firmicutes and Proteobacteria as determined by relative abundances, as well as an unusually high ratio of Firmicutes/Bacteriodetes when compared to the more degenerate primer set (27F-II). Considering the findings in the context of the gut microbiomes common in Western industrial societies, as reported in the American Gut Project, the more degenerate primer set (27F-II) reflects the composition and diversity of the fecal microbiome significantly better than the 27F-I primer. This study provides a fundamentally relevant comparative analysis of the in situ performance of two primer sets designed for sequencing of the entire 16s rRNA genome and suggests that the more degenerate primer set (27F-II) should be preferred for nanopore sequencing-based analyses of the human fecal microbiome.

Delayed perforation of an atrial pacemaker electrode: Lifelong risk for a rare but serious complication.

Key Clinical Message: Nonspecific symptoms such as pleuritic or pericardial chest pain in cardiovascular implantable electronic devices patients, even with unremarkable ECG or device parameters, should always raise suspicion of electrode perforation, regardless of how long ago the implantation was performed. Abstract: We report the successful percutaneous management of a 77-year-old woman who had a dual-chamber pacemaker implanted more than 1 year ago and presented with pericarditis pain and compensated pericardial hemorrhagic tamponade. The symptoms were due to very late acute perforation of the atrial lead. This report is intended to raise awareness of procedure-related complications in the large group of cardiovascular implantable electronic device patients. Pleuritic or pericardial pain in these patients should raise suspicion of electrode perforation, as the risk of perforation is not restricted to the period immediately after implantation and a lifelong risk cannot apparently be excluded.

Incidence of ablation-induced esophageal lesions and gastroparesis in patients undergoing ablation index guided high power short duration atrial fibrillation ablation.

INTRODUCTION: Aim of this study was to evaluate the incidence of ablation-induced endoscopically detected esophageal lesions (EDEL) and gastroparesis in patients undergoing high-power short-duration (HPSD) atrial fibrillation (AF) ablation using different target ablation index (AI) values. METHODS AND RESULTS: Consecutive patients undergoing AF ablation were included. Radiofrequency (RF) ablation was performed using HPSD ablation (50 W, target AI of 320 and 350 (group 1) and 380 (group 2) at posterior wall). Postablation endoscopy was performed in all patients. In total, 233 patients (66.8 ± 10 years; 52% male) were included consecutively (n = 137 patients in group 1 and n = 96 patients in group 2). Mean AI values und RF time at posterior wall was significantly higher and longer in group 2 compared to group 1 patients (413 ± 9 vs. 392 ± 19 AI, p < 0.01; 9.0 ± 0.8 s vs. 7.8 ± 0.7 s, p < 0.01). Esophageal endoscopy revealed esophageal lesions or gastroparesis in 43 of 233 patients (18.5%) in the total cohort (13.1% in group 1 and 26.0% in group 2; p = 0.02). Incidence of EDEL was 8.0% and 13.5% in group 1 and group 2, respectively. According to logistic analysis incidence of EDEL and/or gastroparesis was significantly lower in patients with a higher body mass index and higher in group 2 patients compared to group 1 patients. CONCLUSION: The incidence of EDEL or gastroparesis in patients undergoing HPSD AF ablation was 18.5% in the total cohort. The risk of EDEL and gastroparesis was associated with a higher AI target value of 380 compared to 320 and 350 at posterior wall and was reversely associated with body mass index.

Antithrombotic Treatment and Its Association with Outcome in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients.

Transcatheter edge-to-edge mitral valve repair (TEER) has become established as a safe and efficacious therapy for severe mitral regurgitation (MR) in high-risk patients. Despite its widespread use, postprocedural antithrombotic therapy (ATT) still to date is based on local expertise rather than evidence. In a multicenter, observational cohort study, 646 consecutive patients undergoing TEER were enrolled; 609 patients were successfully treated and antithrombotic therapy analyzed; 449 patients (73.7%) were previously treated with oral anticoagulants (OAC) due to the high prevalence of atrial fibrillation (459/609, 75.4%). Postprocedural ATT in patients previously treated with OAC consisted of no additional, additional single (SAPT) or dual antiplatelet therapy (DAPT) in 146/449 (33.6%), 248/449 (55.2%) and 55/449 (12.2%), respectively. There were 234/449 (52.1%) patients treated with vitamin-k antagonists (VKA) and 215/449 (47.9%) with nonvitamin-k antagonist oral anticoagulants (NOAC). One hundred sixty patients (26.3%) had no prior indication for OAC and were predominantly treated with DAPT (132/160, 82.5%). Use of SAPT (17/160, 10.6%) and no APT (11/160, 6.9%) was marginal. No statistically significant differences in terms of in-hospital mortality or the rate of major adverse cardiac and cerebrovascular events (MACCE) between the different antithrombotic therapy regimens were observed. Multiple Cox regression analysis showed a statistically significant decreased risk for all-cause mortality after a median follow-up of 419 days for OAC monotherapy (HR 0.6, 95%-CI 0.5-0.9, p = 0.04). This study provides evidence for a more favorable long-term outcome of OAC monotherapy in patients with an indication for OAC and reiterates the urgent need for randomized controlled trials on the optimal antithrombotic treatment of TEER patients.

Impact of Rhythm vs. Rate Control in Atrial Fibrillation on the Long-Term Outcome of Patients Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair.

Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR) undergoing transcatheter mitral valve repair (TMVR) and has been shown to significantly worsen their outcome. However, data on the impact of AF treatment strategy in this rapidly growing cohort of patients is unknown. In a multicenter, observational cohort study, 542 consecutive patients undergoing TMVR were enrolled, and subsequently, comprehensive survival analyses according to AF status and therapy were performed using propensity score matching and Cox regression. In the analyzed cohort, 373 (73.3%) of the TMVR patients had concomitant AF. Of these patients, 212 (59%) were on rate control therapy and 161 (41%) were on rhythm control therapy. At 3 years, significantly reduced cumulative survival was observed for patients on rhythm compared to patients on rate control (46.7% (75/161) vs. 56.5% (91/161), p = 0.032). Amiodarone was used to a substantial extent for rhythm control and found to be an independent mortality predictor (Hazard Ratio 1.5, 95%CI 1.1-2.1, p = 0.04). The adverse outcome of concomitant AF in TMVR patients was confirmed (AF: 47.3% (126/266) vs. non-AF: 58.3% (78/133), p = 0.047). Rhythm control achieved almost exclusively pharmacologically is associated with an adverse outcome compared to the rate control of AF in TMVR. This raises awareness of the importance of AF and its treatment, as this seems to be a promising key point for improving the prognosis of TMVR patients.

Comparison of Mechanical Support with Impella or Extracorporeal Life Support in Post-Cardiac Arrest Cardiogenic Shock: A Propensity Scoring Matching Analysis.

Our aim was to compare the outcomes of Impella with extracorporeal life support (ECLS) in patients with post-cardiac arrest cardiogenic shock (CS) complicating acute myocardial infarction (AMI). This was a retrospective study of patients resuscitated from out of hospital cardiac arrest (OHCA) with post-cardiac arrest CS following AMI (May 2015 to May 2020). Patients were supported either with Impella 2.5/CP or ECLS. Outcomes were compared using propensity score-matched analysis to account for differences in baseline characteristics between groups. 159 patients were included (Impella, n = 105; ECLS, n = 54). Hospital and 12-month survival rates were comparable in the Impella and the ECLS groups (p = 0.16 and p = 0.3, respectively). After adjustment for baseline differences, both groups demonstrated comparable hospital and 12-month survival (p = 0.36 and p = 0.64, respectively). Impella patients had a significantly greater left ventricle ejection-fraction (LVEF) improvement at 96 h (p < 0.01 vs. p = 0.44 in ECLS) and significantly fewer device-associated complications than ECLS patients (15.2% versus 35.2%, p < 0.01 for relevant access site bleeding, 7.6% versus 20.4%, p = 0.04 for limb ischemia needing intervention). In subgroup analyses, Impella was associated with better survival in patients with lower-risk features (lactate < 8.6 mmol/L, time from collapse to return of spontaneous circulation < 28 min, vasoactive score < 46 and Horowitz index > 182). In conclusion, the use of Impella 2.5/CP or ECLS in post-cardiac arrest CS after AMI was associated with comparable adjusted hospital and 12-month survival. Impella patients had a greater LVEF improvement than ECLS patients. Device-related access-site complications occurred more frequently in patients with ECLS than Impella support.

Left Ventricle Architecture and Valvular Integrity Following Microaxial Mechanical Support: A Two-Year Follow-Up Study.

Although the use of microaxilar mechanical circulatory support systems may improve the outcome of patients with cardiogenic shock (CS), little is known about its effect on the long-term structural integrity of left ventricular (LV) valves as well as on the development of LV-architecture. Therefore, we aimed to study the integrity of the LV valves and architecture and function after Impella support. Thus, 84 consecutive patients were monitored over two years having received ImpellaTM CP (n = 24) or 2.5 (n = 60) for refractory CS (n = 62) or for high-risk percutaneous coronary interventions (n = 22) followed by optimal medical treatment. Beside a significant increase in LV ejection fraction after two years (p ≤ 0.03 vs. pre-implantation), we observed a statistically significant decrease in LV dilation (p < 0.001) and severity of mitral valve regurgitation (p = 0.007) in the two-year follow-up period, suggesting an improved LV architecture. Neither the duration of support, nor the size of the Impella device or the indication for its use revealed any devastating impact on aortic or mitral valve integrity. These findings indicate that Impella device is a safe means of support of LV-function without detrimental long-term effects on the structural integrity of LV valves regardless of the size of the device or the indication of support.

Biventricular Unloading with Impella and Venoarterial Extracorporeal Membrane Oxygenation in Severe Refractory Cardiogenic Shock: Implications from the Combined Use of the Devices and Prognostic Risk Factors of Survival.

Since mechanical circulatory support (MCS) devices have become integral component in the therapy of refractory cardiogenic shock (RCS), we identified 67 patients in biventricular support with Impella and venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO) for RCS between February 2013 and December 2019 and evaluated the risk factors of mortality in this setting. Mean age was 61.07 ± 10.7 and 54 (80.6%) patients were male. Main cause of RCS was acute myocardial infarction (AMI) (74.6%), while 44 (65.7%) were resuscitated prior to admission. The mean Simplified Acute Physiology Score II (SAPS II) and Sequential Organ Failure Assessment Score (SOFA) score on admission was 73.54 ± 16.03 and 12.25 ± 2.71, respectively, corresponding to an expected mortality of higher than 80%. Vasopressor doses and lactate levels were significantly decreased within 72 h on biventricular support (p < 0.05 for both). Overall, 17 (25.4%) patients were discharged to cardiac rehabilitation and 5 patients (7.5%) were bridged successfully to ventricular assist device implantation, leading to a total of 32.8% survival on hospital discharge. The 6-month survival was 31.3%. Lactate > 6 mmol/L, vasoactive score > 100 and pH < 7.26 on initiation of biventricular support, as well as Charlson comorbity index > 3 and prior resuscitation were independent predictors of survival. In conclusion, biventricular support with Impella and VA-ECMO in patients with RCS is feasible and efficient leading to a better survival than predicted through traditional risk scores, mainly via significant hemodynamic improvement and reduction in lactate levels.

Early Impella Support in Postcardiac Arrest Cardiogenic Shock Complicating Acute Myocardial Infarction Improves Short- and Long-Term Survival.

OBJECTIVES: Early mechanical circulatory support with Impella may improve survival outcomes in the setting of postcardiac arrest cardiogenic shock after out-of-hospital cardiac arrest complicating acute myocardial infarction. However, the optimal timing to initiate mechanical circulatory support in this particular setting remains unclear. Therefore, we aimed to compare survival outcomes of patients supported with Impella 2.5 before percutaneous coronary intervention (pre-PCI) with those supported after percutaneous coronary intervention (post-PCI). DESIGN: Retrospective single-center study between September 2014 and December 2019 admitted to the Cardiac Arrest Center in Marburg, Germany. PATIENTS: Out of 2,105 patients resuscitated from out-of-hospital cardiac arrest due to acute myocardial infarction with postcardiac arrest cardiogenic shock between September 2014 and December 2019 and admitted to our regional cardiac arrest center, 81 consecutive patients receiving Impella 2.5 during admission coronary angiogram were identified. OUTCOMES/MEASUREMENTS: Survival outcomes were compared between those with Impella support pre-PCI to those with support post-PCI. MAIN RESULTS: A total of 81 consecutive patients with infarct-related postcardiac arrest shock supported with Impella 2.5 during admission coronary angiogram were included. All patients were in profound cardiogenic shock requiring catecholamines at admission. Overall survival to discharge and at 6 months was 40.7% and 38.3%, respectively. Patients in the pre-PCI group had a higher survival to discharge and at 6 months as compared to patients of the post-PCI group (54.3% vs 30.4%; p = 0.04 and 51.4% vs 28.2%; p = 0.04, respectively). Furthermore, the patients in the early support group demonstrated a greater functional recovery of the left ventricle and a better restoration of the end-organ function when Impella support was initiated prior to percutaneous coronary intervention. CONCLUSIONS: Our results suggest that the early initiation of mechanical circulatory support with Impella 2.5 prior to percutaneous coronary intervention is associated with improved hospital and 6-month survival in patients with postcardiac arrest cardiogenic shock complicating acute myocardial infarction.

Comparison of Mortality Risk Models in Patients with Postcardiac Arrest Cardiogenic Shock and Percutaneous Mechanical Circulatory Support.

BACKGROUND: Although scoring systems are widely used to predict outcomes in postcardiac arrest cardiogenic shock (CS) after out-of-hospital cardiac arrest (OHCA) complicating acute myocardial infarction (AMI), data concerning the accuracy of these scores to predict mortality of patients treated with Impella in this setting are lacking. Thus, we aimed to evaluate as well as to compare the prognostic accuracy of acute physiology and chronic health II (APACHE II), simplified acute physiology score II (SAPS II), sepsis-related organ failure assessment (SOFA), the intra-aortic balloon pump (IABP), CardShock, the prediction of cardiogenic shock outcome for AMI patients salvaged by VA-ECMO (ENCOURAGE), and the survival after venoarterial extracorporeal membrane oxygenation (SAVE) score in patients with OHCA refractory CS due to an AMI treated with Impella 2.5 or CP. METHODS: Retrospective study of 65 consecutive Impella 2.5 and 32 CP patients treated in our cardiac arrest center from September 2015 until June 2020. RESULTS: Overall survival to discharge was 44.3%. The expected mortality according to scores was SOFA 70%, SAPS II 90%, IABP shock 55%, CardShock 80%, APACHE II 85%, ENCOURAGE 50%, and SAVE score 70% in the 2.5 group; SOFA 70%, SAPS II 85%, IABP shock 55%, CardShock 80%, APACHE II 85%, ENCOURAGE 75%, and SAVE score 70% in the CP group. The ENCOURAGE score was the most effective predictive model of mortality outcome presenting a moderate area under the curve (AUC) of 0.79, followed by the CardShock, APACHE II, IABP, and SAPS score. These derived an AUC between 0.71 and 0.78. The SOFA and the SAVE scores failed to predict the outcome in this particular setting of refractory CS after OHCA due to an AMI. CONCLUSION: The available intensive care and newly developed CS scores offered only a moderate prognostic accuracy for outcomes in OHCA patients with refractory CS due to an AMI treated with Impella. A new score is needed in order to guide the therapy in these patients.

Comparison of mechanical circulatory support with venoarterial extracorporeal membrane oxygenation or Impella for patients with cardiogenic shock: a propensity-matched analysis.

BACKGROUND: Percutaneous mechanical circulatory devices are increasingly used in patients with cardiogenic shock (CS). As evidence from randomized studies comparing these devices are lacking, optimal choice of the device type is unclear. Here we aim to compare outcomes of patients with CS supported with either Impella or vaECMO. METHODS: Retrospective single-center analysis of patients with CS, from September 2014 to September 2019. Patients were assisted with either Impella 2.5/CP or vaECMO. Patients supported ultimately with both devices were analyzed according to the first device implanted. Primary outcomes were hospital and 6-month survival. Secondary endpoints were complications. Survival outcomes were compared using propensity-matched analysis to account for differences in baseline characteristics between both groups. RESULTS: A total of 423 patients were included (Impella, n = 300 and vaECMO, n = 123). Survival rates were similar in both groups (hospital survival: Impella 47.7% and vaECMO 37.3%, p = 0.07; 6-month survival Impella 45.7% and vaECMO 35.8%, p = 0.07). There was no significant difference in survival rates, even after adjustment for baseline differences (hospital survival: Impella 50.6% and vaECMO 38.6%, p = 0.16; 6-month survival Impella 45.8% and vaECMO 38.6%, p = 0.43). Access-site bleeding and leg ischemia occurred more frequently in patients with vaECMO (17% versus 7.3%, p = 0.004; 17% versus 7.7%, p = 0.008). CONCLUSIONS: In this retrospective analysis of patients with CS, treatment with Impella 2.5/CP or vaECMO was associated with similar hospital and 6-month survival rates. Device-related access-site vascular complications occurred more frequently in the vaECMO group. A randomized trial is warranted to examine the effects of these devices on outcomes and to determine the optimal device choice in patients with CS.

Analysis of Atrial Fibrillation Treatment Regimes in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients.

BACKGROUND: Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR). Recent studies show a deleterious outcome of patients with concomitant AF after transcatheter mitral valve repair (TMVR). This underlines the essential need for additional strategies that ameliorate the prognosis of these patients. Fundamental data on AF characteristics and treatment regimes in this special cohort of patients are lacking. METHODS: We retrospectively analyzed the data of 542 consecutive patients with severe MR undergoing TMVR in three tertiary heart centers with special focus on AF type and underlying treatment strategies. RESULTS: The prevalence of concomitant AF was 73.3%, and AF did not affect the procedural success or the incidence of major adverse cardiac and cerebrovascular events. The patients with AF were more frequently >75 years, had more tricuspid regurgitation, and less coronary artery disease than non-AF patients. The distribution of AF types was 32% paroxysmal AF, 27% persistent AF, and 41% permanent AF. Except for a higher degree in severe tricuspid regurgitation and a higher likelihood of male sex, no substantial differences were observed while comparing permanent and nonpermanent AF patients. The predominant treatment regime was rate control (57%), with only beta blockers (BB) in the majority of persistent and permanent AF patients, while additional digitalis or a pacemaker was used infrequently. Rhythm control was mainly achieved with BB alone in paroxysmal AF patients and with additional antiarrhythmic drugs in the majority of persistent AF patients. Interventional rhythm control therapy was performed in 2.5% and 30.9% of paroxysmal and persistent AF patients, respectively. The guideline-adherent use of oral anticoagulants was comparable and high in both groups (91.9% in nonpermanent vs. 90.1% in permanent AF). CONCLUSION: This is the first study to provide necessary information for the understanding of the current clinical practice in dealing with TMVR patients. Since evidence suggests that AF is not a benign concomitant disease, further investigations are needed to assess the prognostic impact of these different AF treatment strategies.

Impact of microaxillar mechanical left ventricular support on renal resistive index in patients with cardiogenic shock after myocardial infarction: a pilot trial to predict renal organ dysfunction in cardiogenic shock.

OBJECTIVES: To evaluate the effects of left ventricular support with the microaxial left ventricular pump using the Impella device on the renal resistive index assessed by Doppler ultrasonography in haemodynamically stable patients with cardiogenic shock following myocardial infarction. METHODS: A non-randomised interventional single-centre study. Consecutive patients with cardiogenic shock supported with an Impella were included during May 2018 and October 2018. The renal resistive index determined as a quotient of (peak systolic velocity - end diastolic velocity)/ peak systolic velocity was obtained using Doppler ultrasound; invasive blood pressure was determined in radial artery simultaneously for safety reasons. RESULTS: A total of 15 patients were measured. The renal resistive index was determined in both kidneys in 13 patients and for one kidney in two patients, respectively. The mean difference between right and left renal resistive index was 0.026 ± 0.023 (P=0.72). When increasing the Impella microaxillar mechanical support by a mean of 0.44 L/min (±0.2 L/min), the renal resistive index decreased significantly from 0.66 ± 0.08 to 0.62 ± 0.06 (P<0.001) consistently in all patients, whereas systolic or diastolic blood pressure remained unchanged. CONCLUSIONS: Microaxillar mechanical support by the Impella device in haemodynamically stable patients with cardiogenic shock led to a significant reduction of the renal resistive index without affecting systolic or diastolic blood pressure. This observation is consistent with the notion that Impella support may promote renal organ protection by enhancing renal perfusion.

Impella support following emergency percutaneous balloon aortic valvuloplasty in patients with severe aortic valve stenosis and cardiogenic shock.

BACKGROUND: To investigate the feasibility and outcomes of Impella 2.5 support in patients with severe aortic valve stenosis (AS) and cardiogenic shock (CS), who underwent emergency percutaneous balloon aortic valvuloplasty (BAV) with or without percutaneous coronary intervention (PCI). METHODS AND RESULTS: We retrospectively analyzed a consecutive series of patients with severe AS and CS who underwent Impella 2.5 support following emergency BAV with or without subsequent PCI. Outcome data included 30-day outcomes, periprocedural as well as throughout the circulatory support period complications. Eight patients with severe AS and CS were identified. Impella 2.5 implantation was successful following emergency BAV in all patients attempted. Additional PCI was performed in four patients. No periprocedural deaths or periprocedural neurologic events occurred. Mean procedure time was 125.9 min (range 64-210 min). Mortality at 30 days was 50%. CONCLUSIONS: Impella 2.5 can be used as hemodynamic support in patients with severe AS and CS following emergency percutaneous BAV and may help to improve tolerability of PCI in these high-risk patients.

Impella support compared to medical treatment for post-cardiac arrest shock after out of hospital cardiac arrest.

AIMS: To compare survival outcomes of Impella support and medical treatment in patients with post-cardiac arrest cardiogenic shock related to acute myocardial infarction (AMI). METHODS: Retrospective single center study of patients resuscitated from out of hospital cardiac arrest (OHCA) due to AMI with post-cardiac arrest cardiogenic shock between September 2014 and September 2016. Patients were either assisted with Impella or received medical treatment only. Survival outcomes were compared using propensity score-matched analysis to account for differences in baseline characteristics between both groups. RESULTS: A total of 90 consecutive patients with post-cardiac arrest shock due to AMI were included; 27 patients in the Impella group and 63 patients in the medical treatment group. Patients with Impella support had a longer duration of low-flow time (29.54 ±â€¯10.21 versus 17.57 ±â€¯8.3 min, p < 0.001), higher lactate levels on admission (4.75 [IQR 3.8-11] versus 3.6 [IQR 2.6-3.9] mmol/L, p = 0.03) and lower baseline systolic LVEF (25% [IQR 25-35] versus 45% [IQR 35-51.25], p < 0.001) as compared to patients without circulatory support. After propensity score matching, patients with Impella support had a significantly higher survival to hospital discharge (65% versus 20%, p = 0.01) and 6-months survival (60% versus 20%, p = 0.02). CONCLUSION: The results from our study suggest that Impella support is associated with significantly better survival to hospital discharge and at 6 months compared to medical treatment in OHCA patients admitted with post-cardiac arrest cardiogenic shock and AMI.

Biventricular unloading in patients with refractory cardiogenic shock.

BACKGROUND: Cardiogenic shock remains a clinical challenge with high mortality rate. Mechanical circulatory support (MCS) devices have become an integral component of the therapeutic armamentarium expanding the treatment options for refractory cardiogenic shock (RCS). METHODS: We included all consecutive patients with biventricular unloading with Impella-2.5 and VA-ECMO admitted for RCS between October 2013 and March 2015. Outcome data included survival to discharge, bridging to VAD and 28-day mortality. RESULTS: A total of 17 patients were included. Mean age was 63.3±10.5 and 15 (88%) patients were male. RCS resulted from acute myocardial infarction in 14 (82%), acute myocarditis in 1 (6%) dilated cardiomyopathy in 2 (12%) patients. Mean SAPS II and SOFA score on admission was 74.7±16.86 and 11.16±1.79, respectively. Vasopressor doses and lactate levels were significantly decreased within 72h on biventricular support (p=0.025 for norepinephrine and p=0.005 for lactate). Nine (53%) patients died while on support. Of the remaining 8 patients, 5 (29%) patients were weaned successfully and discharged in cardiac rehabilitation and 3 (18%) patients were successfully bridged to VAD. All 5 patients who were discharged to rehabilitation survived at day 28 after discharge, while 1 of 3 VAD patients died after VAD implantation, corresponding to an overall 28-day survival rate of 41%. CONCLUSIONS: Biventricular support with Impella-2.5 and VA-ECMO in patients with RCS is feasible and led to significant hemodynamic improvement and reduction of lactate levels. Despite high severity scores, ICU- and 28-day mortality rates were better than predicted.

Ablation of typical right atrial flutter in patients with pulmonary hypertension.

BACKGROUND: RF ablation for cavotricuspid isthmus (CTI) dependent flutter is an established therapy. Right atrial hypertrophy and enlargement are associated with the occurrence of cavotricuspid isthmus dependent flutter. Therefore, patients with pulmonary hypertension (PAH) are prone to atrial arrhythmias like cavotricuspid isthmus dependent flutter. However, the influence of PAH on typical atrial flutter ablation procedure has not been systematically examined. METHODS: In a retrospective single-centre analysis data of patients undergoing an ablation procedure for cavotricuspid isthmus dependent flutter between January 2007 and October 2009 at Hannover Medical School, Germany were analysed. Only procedures performed by experienced electrophysiologists with an 8mm RF-ablation catheter were included. Data for 196 patients were analysed. Thirty-eight patients were identified with PAH and were compared to 158 patients without PAH for procedural ablation parameters, procedure time, ablation time, ablation points and fluoroscopy time. RESULTS: A bidirectional block of the CTI was achieved in all patients. Patients with severe PAH had a significantly longer procedure time (78±40 min vs. 62±29 min; p=0.033), total ablation time (20±11 min vs. 15±9 min; p=0.02) and more ablation lesions (26±16 vs. 19±12; p=0.018) as compared to patients without PAH. CONCLUSION: Cavotricuspid isthmus dependent flutter ablation in patients with PAH is associated with longer procedure duration and a greater amount of cumulative tissue ablation needed to achieve bidirectional block of the CTI compared to patients without pulmonary hypertension.