Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation.

BACKGROUND: The development of the PASCAL transcatheter valve repair system for treating mitral regurgitation (MR) greatly extends therapeutic options. AIMS: To assess the safety, efficacy, and time efficiency of the PASCAL system in transcatheter edge-to-edge repair (TEER) under conscious sedation (CS). METHODS: This is a retrospective, two-center, German registry study consisting of 211 patients who underwent TEER using the PASCAL system under CS. The endpoints were to assess (1) technical, device, and procedural success as per Mitral Valve Academic Research Consortium (MVARC), (2) conversion rate to general anesthesia (GA), (3) hospital length of stay (LoS), (4) New York Heart Association (NYHA) class, and (5) MR compared to baseline at 30-day. RESULTS: A total of 211 patients with a mean age of 78.4 ± 8.9 years, with 51.4% being female and 86.7% belonging to NYHA functional class III/IV and EuroSCORE II 6.3 ± 4.9%, were enrolled. Procedural success attained was 96.9%, and six patients (2.8%) required conversion from CS to GA. At 30 days follow-up, a significant improvement in MR was found in 96 patients (54.2%) patients with 0/1 grade MR and 45 patients (29.5%) were in NYHA functional class III + IV. Moreover, TEER under CS has a short hospital LoS (6.71 ± 5.29 days) and intensive care unit LoS (1.34 ± 3.49 days) with a 2.8% mortality rate. CONCLUSIONS: Performing TEER with the PASCAL system under CS resulted in appreciable (96.9%) procedural success with low mortality and is a safe and promising alternative to GA with positive clinical outcomes.

Outcome of Patients Managed by Percutaneous Left Ventricular Assist Device Implantation During On-Hours and Off-Hours.

Percutaneous left ventricular assist devices (pVADs) may be used in patients with cardiogenic shock (CS) to stabilize hemodynamics and maintain sufficient end-organ perfusion. Vascular complications are commonly observed in patients with pVAD support. We aimed to assess the relationship between pVAD implantation time and access-site complication rates. This retrospective observational study included all patients who underwent pVAD insertion for the treatment of CS at our university hospital between 2014 and 2021 (n = 224). Depending on the pVAD insertion time, the patients were assigned to the on-hours (n = 120) or off-hours group (n = 104). Both groups had comparable baseline characteristics and comorbidities. The rate of access-site-related complications was higher in the off-hours group than in the on-hours group (26% vs. 10%, p = 0.002). Premature discontinuation of pVAD support to prevent limb ischemia or manage access-site bleeding was required more often in the off-hours group than in the on-hours group (14% vs. 5%, p = 0.016). Pre-existing peripheral artery disease and implantation time off-hours were independent predictors for access-siterelated vascular complications. In conclusion, patients with CS in whom pVAD was inserted during off-hours had higher rates of access-site-related complications and premature discontinuation of pVAD support than those in whom pVAD was inserted during on-hours.

Comparison of costs associated with transcatheter mitral valve repair: PASCAL vs MitraClip in a real-world setting.

AIMS: We aimed to conduct a clinical process cost analysis to evaluate all upcoming costs of mitral valve transcatheter edge-to-edge repair (M-TEER) treatment using the MitraClip and the PASCAL repair system. METHODS: First, we prospectively enrolled 107 M-TEER patients treated with either the PASCAL or MitraClip system and compared all upcoming costs during the M-TEER procedure and the associated in-hospital stay. Second, we retrospectively analysed 716 M-TEER procedures with regard to the occurrence of complications and their associated costs. All materials used in the catheterization laboratory for the procedures were evaluated. The cost analysis considered various expenses, such as general in-hospital costs, device costs, catheter laboratory and material costs. RESULTS: In the prospective study, 51 patients were treated using the PASCAL system, and 56 were treated using the MitraClip system. The two groups had comparable baseline characteristics and comorbidities. The total in-hospital costs were 25 414 (Interquartile range (IQR) 24 631, 27 697) € in the PASCAL group and 25 633 (IQR 24 752, 28 256) € in the MitraClip group (p = 0.515). The major cost driver was initial material expenditure, mostly triggered by device costs, which were similar to the PASCAL and MitraClip systems. Overall intensive care unit and general ward costs did not differ between the PASCAL and MitraClip groups. In the retrospective analysis, M-TEER-related complications were rare but were associated with higher costs, mainly due to prolonged hospitalisation. CONCLUSION: The major cost driver of M-TEER was the material expenditure, which was mostly triggered by high device costs. The costs of treating patients were similar for the PASCAL and MitraClip systems. M-TEER-related complications are associated with higher costs, mainly due to prolonged hospitalisation. This analysis provides valuable insights into reducing expenses by modifying the process of M-TEER.

Lactate to Albumin Ratio for Predicting Clinical Outcomes after In-Hospital Cardiac Arrest.

In-hospital cardiac arrest (IHCA) is associated with high mortality and poor neurological outcomes. Our objective was to assess whether the lactate-to-albumin ratio (LAR) can predict the outcomes in patients after IHCA. We retrospectively screened 75,987 hospitalised patients at a university hospital between 2015 and 2019. The primary endpoint was survival at 30-days. Neurological outcomes were assessed at 30 days using the cerebral performance category scale. 244 patients with IHCA and return of spontaneous circulation (ROSC) were included in this study and divided into quartiles of LAR. Overall, there were no differences in key baseline characteristics or rates of pre-existing comorbidities among the LAR quartiles. Patients with higher LAR had poorer survival after IHCA compared to patients with lower LAR: Q1, 70.4% of the patients; Q2, 50.8% of the patients; Q3, 26.2% of the patients; Q4, 6.6% of the patients (p = 0.001). Across increasing quartiles, the probability of a favourable neurological outcome in patients with ROSC after IHCA decreased: Q1: 49.2% of the patients; Q2: 32.8% of the patients; Q3: 14.7% of the patients; Q4: 3.2% of the patients (p = 0.001). The AUCs for predicting 30-days survival using the LAR were higher as compared to using a single measurement of lactate or albumin. The prognostic performance of LAR was superior to that of a single measurement of lactate or albumin for predicting survival after IHCA.

Deep sedation vs. general anesthesia for transcatheter tricuspid valve repair.

Background: Transcatheter tricuspid valve repair (TTVr) is routinely performed under general anesthesia (GA). This study aimed to investigate whether TTVr procedures can be performed effectively and safely without GA but using deep sedation (DS). Methods: We performed a retrospective analysis of 104 patients from three centers who underwent TTVr between 2020 and 2021. The primary performance endpoints were technical success and severity of TR assessed at the time of discharge. The safety outcome was a composite of in-hospital complications, including occurrence of death, conversion to surgery, major adverse cardiac and cerebrovascular events, major vascular complications, or occurrence of pneumonia. Results: Sixty-four procedures were performed in GA and 40 procedures were performed in DS. The groups did not differ in age, EuroScore II, TR severity, ventricular function, or hemodynamic parameters. Technical success was achieved in 92.5% of the patients in the DS group and in 93.6% of the patients in the GA group (p = 0.805). In none of the patients intraprocedural conversion from DS to GA was required. There was no difference in total duration of the procedure, and number of devices implanted. The degree of TR was ≤2+ in 77.5% of the patients in the DS group and in 74.2% of the patients in the GA group (p = 0.705). The composite safety endpoint did not differ between the groups (2.5 vs. 6.3%, p = 0.384). The total duration of hospital stay was shorter in patients who underwent TTVr in DS compared to those who underwent TTVr in GA (6 [5, 9] days vs. 8 [6, 11] days; p = 0.011). Conclusion: Performing TTVr in DS was effective with similar procedural results, and was safe with similar low complication rates compared to GA.

Acute Kidney Injury Following Tricuspid Transcatheter Edge-to-Edge Repair.

BACKGROUND: Little is known about the incidence and clinical relevance of postprocedural acute kidney injury (AKI) in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR). OBJECTIVES: The aim of this study was to investigate the prognostic impact of postprocedural AKI following TEER for TR. METHODS: Two hundred sixty-eight patients who underwent TEER for TR at 2 centers were retrospectively analyzed. Postprocedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days after the procedure compared with baseline. The association between AKI and the composite outcome, consisting of all-cause mortality and rehospitalization for heart failure within 1 year after the procedure, was determined. RESULTS: The mean age of the patients was 79.0 ± 6.8 years, and 43.3% were men. Postprocedural AKI occurred in 42 patients (15.7%). Age, male sex, an estimated glomerular filtration rate of <60 mL/min/1.73 m2, and absence of procedural success were associated with the occurrence of AKI. Patients with AKI had a higher incidence of in-hospital mortality than those without AKI (9.5% vs 0.9%; P = 0.006). Moreover, AKI was associated with the incidence of the composite outcome within 1 year after TEER for TR (adjusted HR: 2.39; 95% CI: 1.45-3.94; P = 0.001). CONCLUSIONS: Postprocedural AKI occurred in 15.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. These findings highlight the clinical impact of AKI following TEER for TR and should help in identifying patients at high risk for AKI.

Fatal outcome of isolated patients who suffered an in-hospital cardiac arrest.

AIM: Isolation of patients in single-patient rooms for infection control precautions leads to less contact with medical staff. Our objective was to assess whether isolated patients who suffer an in-hospital cardiac arrest (IHCA) have lower survival as non-isolated IHCA patients. METHODS: We screened for IHCA occurrence and the isolation state in 75.987 patients that had been hospitalized from 2016 to 2019 at the university hospital. Primary endpoint was survival to discharge. Neurological outcome was assessed using the cerebral performance category scale. RESULTS: In five consecutive years, 4,249 out of 75,987 patients (5.6%) had to be isolated for infection control precautions. In-hospital cardiac arrest occurred in 32 (0.8%) of these isolated patients and in 410 out of 71,738 non-isolated patients (0.6%) (p = 0.130). Propensity score matching yielded 30 isolated and 30 non-isolated patients who suffered an IHCA, without a difference in baseline characteristics and characteristics of cardiac arrests between the groups. Only one out of 30 isolated patients (3.3%) survived to discharge after IHCA compared to 11 non-isolated patients (36.6%) (risk difference, 33.3% [95% CI, 14.9%-51.7%]. None of the 30 isolated patients were discharged with good neurological outcomes compared to nine out of 30 non-isolated IHCA patients (30%) (risk difference, 30% [95% CI, 13.6%-46.4%]). In the multivariate analysis, patient isolation was an independent predictor of poor survival after IHCA (OR, 18.99; 95% CI, 2.467-133.743). CONCLUSIONS: Isolation of patients for infection control precautions is associated with considerable poorer survival and neurological outcome in case these patients are suffering an IHCA.

Impella Mechanical Circulatory Support for Takotsubo Syndrome With Shock: A Retrospective Multicenter Analysis.

OBJECTIVES: To analyze the characteristics and outcome of Impella mechanical circulatory support (MCS) for Takotsubo syndrome (TS) with cardiogenic shock. BACKGROUND: TS is an acute heart failure syndrome characterized by transient severe reduction of left ventricular (LV) systolic function, with cardiogenic shock occurring in around 10% of patients. Since inotropes should be avoided due to their role in TS pathogenesis and aggravation of LV outflow tract obstruction, the use of MCS as treatment is a viable treatment option, however, studies are lacking. METHODS: The catheter-based ventricular assist device (cVAD) registry and local MCS databases were screened for TS patients with cardiogenic shock (TS-CS) supported with an Impella percutaneous ventricular assist device (pVAD). Patient and treatment characteristics and in-hospital outcomes were retrospectively analyzed. RESULTS: At 10 US and European centers, 16 TS-CS patients supported with an Impella pVAD were identified between December 2013 and May 2018 (mean age, 61.8 ± 15.5 years; 87.5% women). LV ejection fraction (LVEF) at presentation was severely reduced (mean, 19.4 ± 8.3%). Prior to MCS, 13 patients (81.3%) were mechanically ventilated, 4 patients (25.0%) had been resuscitated, and mean serum lactate was 4.7 ± 3.5 mmol/L. Mean duration of Impella support was 1.9 ± 1.0 days (range, 1-4 days). Thirteen patients (81.3%) survived to discharge, and all survivors experienced cardiac recovery with significant improvement of LVEF at discharge compared to baseline (20.4 ± 8.8 vs. 52.9 ± 12.0, P < 0.001). CONCLUSIONS: This is the first series of TS-CS patients supported with an Impella pVAD. Mortality was low, and LV systolic function recovered in all survivors. Prospective studies of Impella support in this special condition are warranted.

Comparison of two strategies for managing in-hospital cardiac arrest.

In-hospital cardiac arrest (IHCA) is associated with poor outcomes. There are currently no standards for cardiac arrest teams in terms of member composition and task allocation. Here we aimed to compare two different cardiac arrest team concepts to cover IHCA management in terms of survival and neurological outcomes. This prospective study enrolled 412 patients with IHCA from general medical wards. From May 2014 to April 2016, 228 patients were directly transferred to the intensive care unit (ICU) for ongoing resuscitation. In the ICU, resuscitation was extended to advanced cardiac life support (ACLS) (Load-and-Go [LaG] group). By May 2016, a dedicated cardiac arrest team provided by the ICU provided ACLS in the ward. After return of spontaneous circulation (ROSC), the patients (n = 184) were transferred to the ICU (Stay-and-Treat [SaT] group). Overall, baseline characteristics, aetiologies, and characteristics of cardiac arrest were similar between groups. The time to endotracheal intubation was longer in the LaG group than in the SaT group (6 [5, 8] min versus 4 [2, 5] min, p = 0.001). In the LaG group, 96% of the patients were transferred to the ICU regardless of ROSC achievement. In the SaT group, 83% of patients were transferred to the ICU (p = 0.001). Survival to discharge did not differ between the LaG (33%) and the SaT (35%) groups (p = 0.758). Ultimately, 22% of patients in the LaG group versus 21% in the SaT group were discharged with good neurological outcomes (p = 0.857). In conclusion, we demonstrated that the cardiac arrest team concepts for the management of IHCA did not differ in terms of survival and neurological outcomes. However, a dedicated (intensive care) cardiac arrest team could take some load off the ICU.

Outcome of patients with non-ischaemic cardiogenic shock supported by percutaneous left ventricular assist device.

AIMS: Percutaneous left ventricular assist devices (pVADs) are used to haemodynamically stabilize patients with cardiogenic shock (CS) caused by acute myocardial infarction (AMI). One out of every two patients has a non-ischaemic cause of CS, and these patients differ profoundly from patients with AMI-related CS. We assessed the usefulness of pVAD support for patients with non-ischaemic CS. METHODS AND RESULTS: We analysed 106 patients with CS and Impella® support between 2015 and 2018. CS was non-ischaemic in 36 patients and AMI-related in 70 patients. Compared with the AMI group, those in the non-ischaemic group were significantly younger [median age 62 (50.8, 70.8) years vs. 68 (58.0, 75.5) years, P = 0.007] and had more patients with severely reduced left ventricular function (94% vs. 79%, P = 0.035) and worse glomerular filtration rate [45 (27, 57) mL/min vs. 60 (44, 78) mL/min]. Propensity score matching yielded 31 patients with non-ischaemic CS and 31 patients with AMI-related CS, without a difference in baseline laboratory values or comorbidities. In both groups, pVAD support was performed along with haemodynamic stabilization, reduction of catecholamines and normalization of lactate levels. In 7 days, systolic blood pressure increased from 91 (80, 101) mmHg at baseline to 100 (100, 120) mmHg in the non-ischaemic CS group (P = 0.001) and 89 (80, 100) mmHg at baseline to 112 (100, 128) mmHg in the AMI-related CS group (P = 0.001). Moreover, in 7 days, the need of catecholamines (calculated as vasoactive-inotropic score) decreased from 32.0 (11.1, 47.0) at baseline to 5.3 (0, 16.1) in the non-ischaemic group (P = 0.001) and from 35.2 (18.11, 67.0) to zero (0, 0) in the AMI-related CS group (P = 0.001). Lactate level decreased from 3.8 (2.8, 5.9) mmol/L at baseline to 1.0 (0.8, 2.1) mmol/L (P = 0.001) in the non-ischaemic CS group and from 3.8 (2.6, 6.5) mmol/L to 1.2 (1.0, 2.0) mmol/L in the AMI-related group (P = 0.001). In the non-ischaemic CS group, eight patients (25.8%) were upgraded to veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or long-term mechanical circulatory support. Two of these upgraded patients received heart transplantation. In the AMI group, eight patients (25.8%) were upgraded to VA-ECMO or long-term mechanical circulatory support. Ninety-day survival did not significantly differ between the groups (non-ischaemic CS group 48.4%, AMI-related CS group 45.2%, P = 0.799). CONCLUSIONS: pVAD support is useful for haemodynamic stabilization of patients with non-ischaemic CS and is valuable as a bridge to patients' recovery or long-term left ventricular support and heart transplantation.

Predictors of functional mitral regurgitation recurrence after percutaneous mitral valve repair.

We aimed to identify predictors of mitral regurgitation recurrence (MR) after percutaneous mitral valve repair (PMVR) in patients with functional mitral regurgitation (FMR). Patients with FMR were enrolled who underwent PMVR using the MitraClip® device. Procedural success was defined as reduction of MR of at least one grade to MR grade ≤ 2 + assessed at discharge. Recurrence of MR was defined as MR grade 3 + or worse at one year after initially successful PMVR. A total of 306 patients with FMR underwent PMVR procedure. In 279 out of 306 patients (91.2%), PMVR was successfully performed with MR grade ≤ 2 + at discharge. In 11.4% of these patients, MR recurrence of initial successful PMVR after 1 year was observed. Recurrence of MR was associated with a higher rate of heart failure rehospitalization during the 12 months follow-up (52.0% vs. 30.3%; p = 0.029), and less improvement in New York Heart Association (NYHA) functional class [68% vs. 19% of the patients presenting with NYHA functional class III or IV one year after PMVR when compared to patients without recurrence (p = 0.001)]. Patients with MR recurrence were characterized by a higher left ventricular sphericity index {0.69 [Interquartile range (IQR) 0.64, 0.74] vs. 0.65 (IQR 0.58, 0.70), p = 0.003}, a larger left atrium volume [118 (IQR 96, 143) ml vs. 102 (IQR 84, 123) ml, p = 0.019], a larger tenting height 10 (IQR 9, 13) mm vs. 8 (IQR 7, 11) mm (p = 0.047), and a larger mitral valve annulus [41 (IQR 38, 43) mm vs. 39 (IQR 36, 40) mm, p = 0.015] when compared to patients with durable optimal long-term results. In a multivariate regression model, the left ventricular sphericity index [Odds Ratio (OR) 1.120, 95% Confidence Interval (CI) 1.039-1.413, p = 0.003)], tenting height (OR 1.207, 95% CI 1.031-1.413, p = 0.019), and left atrium enlargement (OR 1.018, 95% CI 1.000-1.038, p = 0.047) were predictors for MR recurrence after 1 year. In patients with FMR, baseline parameters of advanced heart failure such as spherical ventricle, tenting height and a large left atrium might indicate risk of recurrent MR one year after PMVR.

Percutaneous left ventricular assist support is associated with less pulmonary congestion and lower rate of pneumonia in patients with cardiogenic shock.

OBJECTIVES: The aim of this study was to investigate the impact of acute left ventricular unloading by percutaneous left ventricular assist device on pulmonary congestion and pneumonia in patients with cardiogenic shock (CS). METHODS: In this retrospective study, we analysed patients with CS who received the Impella percutaneous left ventricular assist device (n=50) compared with those who received intra-aortic balloon pump (IABP) support (n=50). Pulmonary congestion was longitudinally assessed while on support by calculating characteristic findings on the chest X-ray using the Halperin score. The rate of pneumonia and early mortality were assessed as a secondary endpoint. RESULTS: The groups (Impella vs IABP) did not differ in terms of age, Sequential Organ Failure Assessment (SOFA) score, Acute Physiology, Chronic Health Evaluation (APACHE) II score or serum lactate levels. Pulmonary congestion decreased in patient treated with Impella at each time point postimplantation. No change in congestion status was observed in patients supported with IABP. Multivariate analysis indicated Impella support as an independent predictor for pulmonary decongestion (OR 4.06, 95% CI 1.15 to 14.35, p=0.030). The rate of early pneumonia was lower in the Impella group compared with the IABP group (54% vs 74%, p=0.037). Failure of pulmonary decongestion during mechanical circulatory support independently predicted early pneumonia (OR 0.28, 95% CI 0.12 to 0.70, p=0.006). CONCLUSION: Pulmonary decongestion may facilitate treatment of pneumonia in patients with CS. Left ventricular unloading by Impella device might support pulmonary decongestion, although a larger prospective trial in this patient population is required.