The role of hemoadsorption in cardiac surgery - a systematic review.

BACKGROUND: Extracorporeal blood purification has been widely used in intensive care medicine, nephrology, toxicology, and other fields. During the last decade, with the emergence of new adsorptive blood purification devices, hemoadsorption has been increasingly applied during CPB in cardiac surgery, for patients at different inflammatory risks, or for postoperative complications. Clinical evidence so far has not provided definite answers concerning this adjunctive treatment. The current systematic review aimed to critically assess the role of perioperative hemoadsorption in cardiac surgery, by summarizing the current knowledge in this clinical setting. METHODS: A literature search of PubMed, Cochrane library, and the database provided by CytoSorbents was conducted on June 1st, 2023. The search terms were chosen by applying neutral search keywords to perform a non-biased systematic search, including language variations of terms "cardiac surgery" and "hemoadsorption". The screening and selection process followed scientific principles (PRISMA statement). Abstracts were considered for inclusion if they were written in English and published within the last ten years. Publications were eligible for assessment if reporting on original data from any type of study (excluding case reports) in which a hemoadsorption device was investigated during or after cardiac surgery. Results were summarized according to sub-fields and presented in a tabular view. RESULTS: The search resulted in 29 publications with a total of 1,057 patients who were treated with hemoadsorption and 988 control patients. Articles were grouped and descriptively analyzed due to the remarkable variability in study designs, however, all reported exclusively on CytoSorb® therapy. A total of 62% (18/29) of the included articles reported on safety and no unanticipated adverse events have been observed. The most frequently reported clinical outcome associated with hemoadsorption was reduced vasopressor demand resulting in better hemodynamic stability. CONCLUSIONS: The role of hemoadsorption in cardiac surgery seems to be justified in selected high-risk cases in infective endocarditis, aortic surgery, heart transplantation, and emergency surgery in patients under antithrombotic therapy, as well as in those who develop a dysregulated inflammatory response, vasoplegia, or septic shock postoperatively. Future large randomized controlled trials are needed to better define proper patient selection, dosing, and timing of the therapy.

Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry.

Intraoperative antithrombotic drug removal by haemoadsorption is a novel strategy to reduce perioperative bleeding in patients on antithrombotic drugs undergoing cardiac surgery. The international STAR registry reports real-world clinical outcomes associated with this application. All patients underwent cardiac surgery before completing the recommended washout period. The haemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit. Patients on P2Y12 inhibitors comprised group 1, and patients on direct-acting oral anticoagulants (DOAC) group 2. Outcome measurements included bleeding events according to standardised definitions and 24-hour chest-tube-drainage (CTD). 165 patients were included from 8 institutions in Austria, Germany, Sweden, and the UK. Group 1 included 114 patients (62.9 ± 11.6years, 81% male) operated at a mean time of 33.2 h from the last P2Y12 inhibitor dose with a mean CPB duration of 117.1 ± 62.0 min. Group 2 included 51 patients (68.4 ± 9.4years, 53% male), operated at a mean time of 44.6 h after the last DOAC dose, with a CPB duration of 128.6 ± 48.4 min. In Group 1, 15 patients experienced a BARC-4 bleeding event (13%), including 3 reoperations (2.6%). The mean 24-hour CTD was 651 ± 407mL. In Group 2, 8 patients experienced a BARC-4 bleeding event (16%) including 4 reoperations (7.8%). The mean CTD was 675 ± 363mL. This initial report of the ongoing STAR registry shows that the intraoperative use of a haemoadsorption device is simple and safe, and may potentially mitigate the expected high bleeding risk of patients on antithrombotic drugs undergoing cardiac surgery before completion of the recommended washout period.Clinical registration number: ClinicalTrials.gov identifier: NCT05077124.

Intraoperative ticagrelor removal via hemoadsorption during on-pump coronary artery bypass grafting.

Objectives: Patients on ticagrelor undergoing urgent cardiac surgery are at high risk for perioperative bleeding complications. We sought to determine whether intraoperative hemoadsorption could remove ticagrelor and lower circulating drug concentrations. Methods: The hemoadsorption device was incorporated in the cardiopulmonary bypass (CPB) circuit and remained active for the duration of the pump run. Blood samples were collected before and after CPB. The main objective of the current analysis was to compare mean total plasma ticagrelor levels (ng/mL) at baseline with ticagrelor levels obtained at the end of CPB. Plasma ticagrelor levels were measured at a certified outside laboratory (LabConnect). Data are presented as mean ± standard deviation. Results: A total of 11 patients undergoing urgent coronary artery bypass grafting at 3 institutions were included (mean age, 67.9 ± 9.9 years; 91% male; mean European System for Cardiac Operative Risk Evaluation II of 3.0 ± 3.3%; range, 0.7%-12.4%). Mean intraoperative hemoadsorption duration was 97.1 ± 43.4 minutes with a mean flow rate through the device of 422.9 ± 40.3 mL/min. Mean ticagrelor levels pre-CPB were 103.5 ± 63.8 ng/mL compared with mean post-CPB levels of 34.0 ± 17.5 ng/mL, representing a significant 67.1% reduction (P < .001). Intraoperative integration of the device was simple and safe without any device-related adverse events reported. Conclusions: This is the first in vivo report demonstrating that intraoperative hemoadsorption can efficiently remove ticagrelor and significantly reduce circulating drug levels. Whether active ticagrelor removal can reduce serious perioperative bleeding in patients undergoing urgent cardiac surgery is currently being evaluated in the double-blinded, randomized Safe and Timely Antithrombotic Removal-Ticagrelor (STAR-T) trial.

Impact of Graft Strategies on the Outcome of Octogenarians Undergoing Coronary Artery Bypass Grafting.

PURPOSE: To analyse the outcome of coronary artery bypass grafting (CABG) in octogenarians with coronary multivessel disease and the impact of different graft strategies and other factors. METHODS: Out of 1654 patients with multivessel disease who underwent CABG at our institution between January 2014 and March 2020, we investigated 225 consecutive patients with a median age of 82.1 years for survival prediction and need for coronary reintervention; a detailed outcome analysis was performed. RESULTS: At mean follow-up of 3.3 years, the overall survival was 76.4%. An indication for emergency operation (p = 0.002), age (p <0.001), chronic pulmonary disease (p = 0.024), and reduced renal or ventricular function (p <0.001) had the highest impact on limited survival. The combination outcome of survival and coronary reintervention was 1.7-fold improved (p = 0.024) after use of the bilateral internal thoracic artery (BITA) (66.2%). Off-pump CABG (12%) revealed no impact on survival. Smokers showed a poorer outcome (p = 0.004). The logistic European System for Cardiac Operative Risk Evaluation was highly effective for evaluating long-term outcomes (p <0.001). CONCLUSIONS: BITA grafting normalizes survival and reveals a better outcome in octogenarians with multivessel disease. However, patients at risk of poorer survival were operated under emergency conditions and those with pulmonary disease and reduced ventricular or renal function.

Removal of Apixaban during Emergency Cardiac Surgery Using Hemoadsorption with a Porous Polymer Bead Sorbent.

Background: Patients on direct oral anticoagulants are at high risk of perioperative bleeding complications. We analyzed the results of intraoperative hemoadsorption (HA) in patients undergoing cardiac surgery who were also on concurrent therapy with apixaban. Methods: we included 25 consecutive patients on apixaban who underwent cardiac surgery with the use of cardio-pulmonary bypass (CPB) at three sites. The first 12 patients underwent surgery without hemoadsorption (controls), while the next 13 consecutive patients were operated with the Cytosorb® (Princeton, NJ, USA) device integrated into the CPB circuit (HA group). The primary outcome was perioperative bleeding assessed by the Bleeding Academic Research Consortium (BARC) definition and secondary outcomes included 24 h chest-tube-drainage (CTD) and need for 1-deamino-8-d-arginine-vasopressin (desmopressin (DDAVP)) administration to achieve hemostasis. Results: Preoperative mean daily dose of apixaban was higher in the HA group (8.5 ± 2.4 vs. 5.6 ± 2.2 mg, p = 0.005), while time since last apixaban dose was longer in the controls (1.3 ± 0.9 vs. 0.6 ± 1.2 days, p < 0.001). No BARC-4 bleeding events and no repeat-thoracotomies occurred in the HA group compared with 3 and 1, respectively, in the controls. Postoperative 24 h CTD volume was significantly lower in the HA group (510 ± 152 vs. 893 ± 579 mL, p = 0.03) and there was no need for DDAVP compared to controls, who received an average of 10 ± 13.6 mg (p = 0.01). Conclusions: In patients on apixaban undergoing emergent cardiac surgery, the intraoperative use of hemoadsorption was feasible and safe. Compared to patients operated on without hemoadsorption, BARC-4 bleeding complications did not occur and the need for 24 h CTD and DDAVP was significantly lower.

Management of perioperative bleeding risk in patients on antithrombotic medications undergoing cardiac surgery-a systematic review.

Background: Antithrombotic drugs increase the risk of bleeding, especially in patients who need urgent surgery without an adequate wash-out period. This review aims to evaluate perioperative bleeding complications in patients on dual antiplatelet therapy (DAPT) or direct-acting oral anticoagulants (DOACs) undergoing high-bleeding risk cardiovascular surgery and to present currently available potential solutions to mitigate antithrombotic therapy-related bleeding complications. Methods: As a first step, we searched for relevant articles, over the last 10 years, in Medline (PubMed) and abstracted clinical information based on pre-defined criteria for bleeding complications. In the next step, an additional search evaluating potential solutions to mitigate bleeding complications was performed. The literature screening and selection process followed the principles derived from the PRISMA statement. Results: From all reviewed studies, a total of 19 articles could be included evaluating the risk for bleeding in cardiac surgery related to DAPT or DOACs and 10 papers evaluating antithrombotic drug reversal or removal in the setting of cardiovascular surgery. Reported bleeding rates ranged between 18% and 41%. The variability of the reported data is remarkable. Idarucizumab is reported to provide optimal perioperative hemostasis in up to 93% of patients. It has been observed that andexanet alfa causes unresponsiveness to the anticoagulant effects of heparin. Antithrombotic removal by intraoperative hemoadsorption is found to be associated with a significant decrease in re-thoracotomy rate, overall procedure duration, administered transfusion volumes, chest-tube drainage, and length of hospitalization. Discussion: Bleeding complications in patients treated with DAPT or DOACs in cardiac surgery are high. New costly reversal agents are available but have not been sufficiently tested in the cardio-surgical setting so far. Interestingly, bleeding-related complications seem to be effectively reduced by applying innovative intraoperative hemoadsorption techniques. Expected results from the ongoing trials should provide better insights concerning the efficacy and safety of several potential solutions. Currently, the variability of reports and the deficit of high-quality studies in this specific setting represent the major limitation for the unbiased conclusion of this review.

Hemoadsorption of Rivaroxaban and Ticagrelor during Acute Type A Aortic Dissection Operations.

OBJECTIVE: To analyze the results of hemoadsorption in patients with cardiac surgery to thoracic aortic surgery, who had been loaded beforehand with either Factor Xa inhibitor rivaroxaban or P2Y12 receptor antagonist ticagrelor. METHODS: We investigated 21 of 171 consecutive patients (median age 71 [interquartile range 62, 76] years) who underwent emergency cardiac operations for acute type A aortic dissection between 2014 and 2020. These patients were pretreated with rivaroxaban (n = 9) or ticagrelor (n = 12). In ten of 21 cases (since 2017), we installed a hemoadsorber into the heart-lung machine and compared the results to eleven patients done without hemoadsorber before that time. RESULTS: The operation time was significantly shorter in the adsorber group (286 ± 40 min vs. 348 ± 79 min; p = 0.045). The postoperative 24-hour drainage volume was significantly lower after adsorption (p <0.001; 482 ± 122 ml vs. 907 ± 427 ml) and no rethoracotomy had to be performed (compared to two rethoracotomies [18.9%] among patients without adsorber use). Also, patients without hemoadsorption required significantly more platelet transfusions (p = 0.049). CONCLUSIONS: In patients with acute type A aortic dissection who were pretreated with rivaroxaban and ticagrelor, the intraoperative use of CytoSorb hemoadsorption during cardiopulmonary bypass is reported for the first time. The method was found to be effective to prevent from bleeding and to improve the outcome in aortic dissection.

Clinical impact of intervention strategies after failed transcatheter mitral valve repair.

AIMS: Failure of transcatheter mitral valve repair (fTMVR) therapy has a decisive prognostic influence, and complex retreatment is of higher risk. The aim of this analysis was to evaluate the survival outcome following percutaneous procedures and surgery after unsuccessful TMVR interventions for different aetiologies. METHODS AND RESULTS: Of 824 consecutive patients who had been treated with the MitraClip device at our institution, between September 2009 and May 2019, 63 (7.6%) symptomatic patients with therapy failure and persistent or recurrent mitral regurgitation (MR) underwent reinterventions. An outcome analysis for primary (PMR) and secondary mitral regurgitation (SMR) and subsequent percutaneous versus surgical treatment was carried out. MitraClip reinterventions were performed in 36 patients (57.1%; n=26 SMR, n=10 PMR), while 27 (42.9%; n=13 SMR, n=14 PMR) underwent open heart surgery. Surgical patients with PMR showed lower mortality than patients with SMR (p<0.0001) and ReClip patients with PMR (p=0.073). Atrial fibrillation (HR 2.915, 95% CI: [1.311, 6.480]), prior open heart surgery (2.820 [1.215, 6.544]) and chronic obstructive pulmonary disease (2.506 [1.099, 5.714]) increased the risk of death. The level of post-interventional MR had no relevant impact on survival. CONCLUSIONS: We conclude that, after SMR and failed TMVR, reclipping is an appropriate treatment option for symptomatic patients. For PMR patients, surgery must be favoured over a reclipping procedure. However, patients with atrial fibrillation, prior open heart surgery and chronic obstructive pulmonary disease are at risk of reduced survival after reinterventions.

Cytosorb Adsorption During Emergency Cardiac Operations in Patients at High Risk of Bleeding.

BACKGROUND: The purpose of this study was to analyze the results of Cytosorb (CytoSorbents, Monmouth Junction, NJ) adsorption during emergency open heart operations in patients at high risk of bleeding due to treatment with coagulation-active substances. METHODS: We investigated 55 consecutive patients (median age 70 years; interquartile range: 60 to 77) who underwent emergency cardiac surgery at our institution between June 2016 and June 2018. All patients were receiving therapy with either ticagrelor (n = 43) or rivaroxaban (n = 12). In 39 of 55 cases, we routinely installed standardized Cytosorb adsorption into the heart-lung machine. Bleeding complications during and after surgery were analyzed in detail and compared with 16 patients without adsorption. RESULTS: In the Cytosorb adsorption group, no rethoracotomies had to be performed. Drainage volumes in 24 hours were only 350 mL (interquartile range: 300 to 450 mL) after ticagrelor administration and 390 mL (interquartile range: 310 to 430 mL) after rivaroxaban therapy. In the majority of patients, transfusions of blood products were not needed. Compared with that group, among the group of patients without adsorption, multiple bleeding complications occurred. These were associated with longer total operation (p = 0.0042), higher drainage volumes (p = 0.0037), more transfusions of red blood cells (p = 0.0119) and platelets (p = 0.0475), a significantly higher rethoracotomy rate (p = 0.0003), significantly prolonged stay in the intensive care unit (p = 0.0141), and a longer hospital stay (p = 0.0244). CONCLUSIONS: The intraoperative use of Cytosorb adsorption of ticagrelor and rivaroxaban in emergency open heart operations is reported for the first time. The data show that the strategy is safe and is an effective method to reduce bleeding complications. We recommend the use for safety in patients with ticagrelor or rivaroxaban undergoing emergency cardiac surgery.

A case report of a late left atrial appendage perforation 4 months after occluder implant: reason for or caused by a resuscitation?

BACKGROUND: Atrial fibrillation (AF) is a common disease and can lead to cardioembolic stroke. Stroke prevention according to the CHA2DS2VASc score is achieved via oral anticoagulation. In recent years, interventional occlusion of the left atrial appendage (LAA) has become a common alternative. Besides showing non-inferiority in large trials compared with warfarin interventional LAA occlusion can lead to serious adverse events with most of them occurring peri-interventionally. CASE SUMMARY: A 75-year-old man with AF and recurrent gastrointestinal bleedings was referred for an interventional closure of the LAA. The intervention was successful with an ABBOTT® Amulet device. Four months later, the patient had to be resuscitated. Return of spontaneous circulation occurred after 10 min. On hospital arrival, echocardiography revealed a pericardial tamponade and 2 L of blood were drained. A coronary angiogram revealed a lesion with active leakage of contrast agent in the proximal circumflex artery. The patient was transferred to the cardiac surgery department immediately. Intra-operatively a perforation of the tissue at the basis of the LAA close to the left main coronary artery was discovered. The occluder was excised and the LAA was closed by endocardial sutures. DISCUSSION: In this report, we review the literature concerning interventional LAA occlusion and the reported cases of LAA perforation. Retrospectively, it remains unclear whether the perforation caused the resuscitation or was induced by it. To our knowledge, this is the first reported case of a laceration of a coronary artery by an occlusion device.

Is Surgical or Catheter-based Interventions an Option After an Unsuccessful Mitral Clip?

The objective of this study was to assess the results of catheter-based and surgical reinterventions in primary mitral regurgitation after failed MitraClip therapy. We report on 21 consecutive symptomatic patients with primary mitral regurgitation (median age 78 years) who underwent either repeat MitraClip therapy (n = 7) or mitral valve surgery (n = 14) after failure of the index procedure with 1-2 MitraClip implantations. At the time of reinterventions, 193 (interquartile range [IQR]: 32-622) days after the index procedure, patients had recurrent or persistent grade 3 mitral regurgitation. Early mortality at 30 days was 4.8%. Cardiac-related survival at 2 years was 85.4% (4 cardiac and 4 noncardiac deaths). Three of 7 patients with percutaneous reintervention were converted to surgery at 34, 52, and 56 days because repeat MitraClip therapy was ineffective because of pre-existing clip detachment or leaflet tear. Final therapy was biological mitral valve replacement in 14 of 21 patients (66.7%); 4 were treated with percutaneous repeat MitraClip repair (19%), and in 3 patients, surgical repairs were performed (14.3%). At follow-up with a median of 708 days, New York Heart Association class had improved significantly to class 2 (IQR: 1.0-2.5) (P = 0.0004), and the left ventricular end-diastolic diameter had decreased from 56 (IQR: 52-59) mm to 51 (48-58) mm (P = 0.0378), respectively. Recurrence of significant mitral regurgitation was absent in all but 1 patient with unsuccessful repeat MitraClip therapy who was deemed inoperable. Our data show that both repeat MitraClip and also mitral valve surgery are feasible and safe alternatives in patients without an excessively increased perioperative risk. We conclude that whenever leaflet insertion is not compromised, repeat catheter-based repair is a reasonable redo concept; in the remaining cases, surgery should be offered to the patient.

Bleeding Complications After Use of Novel Oral Anticoagulants in Patients Undergoing Cardiac Surgery.

BACKGROUND: The study was performed to analyze the results of open-heart surgery and bleeding complications after administration of novel oral anticoagulants (NOAC). METHODS: We investigated 81 consecutive patients (median age 74 years, interquartile range [IQR]: 68 to 78) who underwent open-heart operations at our institution between July 2014 and June 2016. All patients presented for surgery while on NOAC therapy: 37 received rivaroxaban (45.7%), 35 apixaban (43.2%), and 9 dabigatran (11.1%). The calculated risk using the European System for Cardiac Operative Risk Evaluation II was 3.5% (IQR: 2.0% to 8.1%). RESULTS: Surgery was performed at a median 4 days (IQR: 3 to 6) after NOAC withdrawal. Reduced renal function was predictive for length of intensive care unit stay and administration of red blood cells (p < 0.0001 and p = 0.0291, respectively). The NOAC withdrawal interval significantly influenced postoperative drainage volume (p = 0.0056). Five patients needed rethoracotomy because of relevant bleeding (6.2%), 4 after apixaban (11.4%) and 1 after rivaroxaban therapy (2.7%). Apixaban showed a borderline influence on prolonged intensive care unit stay (p = 0.0736). Prolonged cardiopulmonary bypass time was predictive for thrombocyte administration (p = 0.0249). Intensive care unit stay was 2 days after NOAC withdrawal of 10 days, compared with 4.2 days without termination. Thirty-day mortality was 3.7%. CONCLUSIONS: A lengthy NOAC withdrawal period, particularly for patients with reduced renal function, is essential for safe open-heart surgery. We conclude that despite official recommendations, patients should whenever possible not be considered for elective cardiac surgery within 10 days of terminating NOAC treatment.

Antegrade-transseptal approach for left ventricular tachyarrhythmia in patients with previous Mitraclip implantation.

Aims: Antegrade-transseptal approach to treat left ventricular tachyarrhythmia (LVT) is useful and widespread. Meanwhile, Mitraclip has been recently introduced as an alternative to mitral valve surgery for severe mitral regurgitation, usually coexisting with ventricular arrhythmias. However, data on the antegrade approach for mapping and ablating LVT in these patients are insufficient. We evaluated the feasibility and clinical impact of the antegrade approach for LVT after Mitraclip implantation. Methods and results: We included five patients (all men; age 72.6 ± 10.5 years) with Mitraclip implantation who underwent catheter ablation for LVT and employed the antegrade approach. Post-ablation mitral valve function was systematically evaluated by transthoracic echocardiography. Six procedures with the antegrade approach were performed on the five patients; three of these patients developed electrical storm. The number of implanted Mitraclip was 1 in two patients, 2 in two patients, and 3 in one patient, for a mean duration of 417 ± 324 days before ablation. After 117-day median follow-up, there was no recurrence of electrical storm, but ventricular tachyarrhythmia recurred and required implantable cardioverter defibrillator therapy in one patient (only sporadic anti-tachycardia pacing); two patients died because of reasons other than ventricular arrhythmia. There was no procedure-related injury on the mitral valve immediately and 3 months after ablation. Conclusions: Antegrade ablation of LVT after Mitraclip implantation may be feasible. Non-arrhythmic death during follow-up suggested the need for comprehensive evaluation before and after ablation.

Oral Anticoagulation After Successful Atrial Fibrillation Ablation Operations: Is It Necessary?

BACKGROUND: This study analyzed the results of atrial fibrillation (AF) ablation concomitant to open heart operations using continuous monitoring. METHODS: We investigated 70 consecutive patients (mean age, 72.1 ± 6 years; European System for Cardiac Operative Risk Evaluation II: 9.7% ± 8.2%) who underwent AF ablation concomitant to cardiac operations in our institution between February 2012 and February 2013. For precise rhythm analysis we implanted Reveal XT devices (Medtronic Inc, Minneapolis, MN) in all patients at the end of operations. Twenty-two patients had paroxysmal (31.4%), 20 persistent (28.6%) and 28 longstanding-persistent AF (40%). AF duration time was at a median 18 months. Cardiac rhythm data were obtained by telemonitoring at 1-month intervals, and the AF burden was calculated at 3, 6, and 9 months and at 1 year postoperatively (ablation procedure success was defined as a burden of ≤ 0.5%). Further, a neurologic follow-up was performed at 1 year postoperatively. RESULTS: Overall survival was 95.7% at 30 days and 84.3% at 1 year. At 1 year, 66.7% of patients were in stable sinus rhythm, and AF burden was significantly reduced even in nonresponders: 88.2% of patients were off antiarrhythmic drugs, and oral anticoagulation had been stopped in 92.1%. No late neurologic events had occurred. Sinus rhythm at discharge and paroxysmal type of AF were predictive for later sinus rhythm (p = 0.04 and p = 0.048, respectively). CONCLUSIONS: Considering the long AF duration and the high proportion of longstanding-persistent AF, the overall success of ablation procedures was satisfactory. Even though oral anticoagulation was stopped in most patients, no neurologic events were detected.

Survival Prediction in Patients Undergoing Open-Heart Mitral Valve Operation After Previous Failed MitraClip Procedures.

BACKGROUND: The objective of this study was to analyze the results of open heart mitral valve operations for survival prediction in patients with previously unsuccessful MitraClip procedures. METHODS: Thirty-three consecutive patients who underwent mitral valve surgery in our institution were studied. At a median of 41 days, they had previously undergone one to five futile MitraClip implantations. At the time of their operations, patients were 72.6 ± 10.3 years old, and the calculated risk, using the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II, was a median of 26.5%. Individual outcomes were recorded, and all patients were monitored postoperatively. RESULTS: Thirty-day mortality was 9.1%, and the overall survival at 2.2 years was 60.6%. Seven cardiac-related and six noncardiac deaths occurred. Univariate survival regression models demonstrated a significant influence of the following variables on survival: EuroSCORE II (p = 0.0022), preoperative left ventricular end-diastolic dimension (p = 0.0052), left ventricular ejection fraction (p = 0.0249), coronary artery disease (p = 0.0385), and severe pulmonary hypertension (p = 0.0431). Survivors showed considerable improvements in their New York Heart Association class (p < 0.0001), left ventricular ejection fraction (p = 0.0080), grade of mitral regurgitation (p = 0.0350), and mitral valve area (p = 0.0486). Survival after mitral repair was not superior to survival after replacement. CONCLUSIONS: Indications for surgery after failed MitraClip procedures must be considered with the greatest of care. Variables predicting postoperative survival should be taken into account regarding the difficult decision as to whether to operate or not. Our data suggest that replacement of the pretreated mitral valve is probably the more reasonable concept rather than complex repairs. When the EuroSCORE II at the time of surgery exceeds 30%, conservative therapy is advisable.

Repeat MitraClip Therapy for Significant Recurrent Mitral Regurgitation in High Surgical Risk Patients: Impact of Loss of Leaflet Insertion.

OBJECTIVES: The goal of this study was to assess procedural details and outcomes of repeat MitraClip therapy. BACKGROUND: MitraClip implantation is a safe and efficacious percutaneous approach to treat significant mitral regurgitation (MR). METHODS: Of 410 inoperable or high surgical risk patients treated with the MitraClip at our institution, 17 (4.1%) patients, as well as 4 patients initially treated at external institutions, underwent repeat MitraClip procedures. Mean age of the 21 patients (14 men [67%]) was 77 years; 15 patients (71%) had functional MR. RESULTS: Repeat procedures performed at a median of 6.3 months (range 0.7 to 34 months) after the index intervention were successful (discharge MR grade ≤2+) in 13 patients (62%), with a pronounced difference in success rate observed between the 13 patients with adequate leaflet insertion at the time of the repeat intervention and the 8 patients in whom loss of leaflet insertion (LLI) (leaflet tear/perforation or partial clip detachment) was present (11 of 13 [85%] vs. 2 of 8 [25%], respectively). The 21 patients were followed for a median of 8.5 (interquartile range: 2.3 to 18.6) months; 13 patients (62%), 8 with adequate leaflet insertion and 5 with LLI, died during follow-up. CONCLUSIONS: Repeat MitraClip intervention for significant recurrent MR appears to be a viable therapeutic approach in patients in whom leaflet insertion into the MitraClip is not compromised. LLI is strongly associated with repeat procedural failure.

Severe infective endocarditis after MitraClip implantation treated by cardiac surgery.

AIMS: To report the first described case of a mitral valve infective endocarditis (IE) post MitraClip®. METHODS AND RESULTS: An 88-year-old patient at high surgical risk (log. EuroSCORE 30.4%) underwent a MitraClip procedure for severe eccentric organic mitral regurgitation (MR) due to prolapse with a flail leaflet of the P2 segment (flail gap 6 mm). After one month, the patient was readmitted to our department for fever and recurrence of shortness of breath. An echocardiogram demonstrated severe MR recurrence due to ulceration in the region of the posterior leaflet despite good insertion of both clips, and a large vegetation of 1513 mm within the clip region. Blood cultures were positive for staphylococcus aureus. The patient was treated by cardiac surgery with mitral valve replacement due to IE despite a very high logistic EuroSCORE of 56.8%. Histological and bacteriological analysis of the clip devices confirmed active IE. After cardiac surgery, transthoracic echocardiography showed no mitral regurgitation and a mean gradient across the mitral valve bioprosthesis of about 5 mmHg. The patient was discharged to a rehabilitation department 15 days after cardiac surgery. CONCLUSIONS: Surgical treatment as bail-out therapy for MR recurrence secondary to IE after MitraClip can be successfully carried out despite a high surgical risk.

Impact of failed mitral clipping on subsequent mitral valve operations.

BACKGROUND: This study analyzed the effect of failed percutaneous mitral intervention with the MitraClip device (Abbott Laboratories, Abbott Park, IL) on subsequent mitral valve (MV) operations. METHODS: Nineteen patients (74 ± 9 years) with treatment failure after implantation of 37 MitraClips (mean, 1.9 ± 0.8; range, 1 to 4) for functional or degenerative MV disease underwent operations a median of 12 days later (range, 0 to 546 days). All patients were studied before and after the operation by clinical investigation and echocardiographic analysis. Intraoperative findings and the effect on the operation were analyzed and are described in detail. Data before clipping and at the time of operation were compared, and the surgical outcome was recorded. RESULTS: There was a significant increase in risk between that at the time of clipping and that at subsequent operations, noted as a rise of the European System for Cardiac Operative Risk Evaluation II from a median 12.74% to 26.87%, respectively (p < 0.0001, Wilcoxon signed rank test). Severe clip implantation-induced tissue damage was found in most patients. Surgical MV repair could be performed in 5 of 6 patients (83%) with a 1-clip implant and in only 3 of 13 patients (23%) when 2 or more clips had been inserted (p = 0.0188, Wilcoxon-Mann-Whitney test). All patients required other associated procedures: closure of an artificial atrial septal defect that was caused by the clipping procedure (100%), tricuspid valve repair (37%), atrial fibrillation ablation operations (37%), coronary artery bypass grafting (16%), and aortic valve replacement (11%). Two early cardiac deaths (< 30 days) occurred. Survival at 1 year was 68%. CONCLUSIONS: There is a remarkable impact of failed clipping procedures on MV operations. We observed a severely aggravated cardiac pathology in parallel with a reduced preoperative clinical state compared with the original condition. Moreover, the likelihood of an optimal surgical solution with valve reconstruction was reduced thereafter. However, operations in the critical situation of an unsuccessful mitral clipping procedure should be discussed immediately, because it still seems to be an option compared with conservative therapy.

Implantable loop recorders after atrial ablation: patient compliance and data surveillance in clinical practice.

OBJECTIVE: Recent data suggest continuous monitoring by implanted loop recorder (ILR) to be the criterion standard for rhythm surveillance after atrial ablation. Studies describing patient compliance and pitfalls in the perioperative period are lacking. It was the aim of this study to evaluate patient compliance and time invested by physicians for obtaining data during the follow-up period after implanting an ILR. METHODS: We prospectively collected data of 70 consecutive patients undergoing concomitant cardiac surgery, atrial ablation, and implantation of an ILR. Patient compliance was calculated as the ratio of incoming/expected data transmission. We documented total time spent by physicians with preoperative and postoperative supervision. RESULTS: Between February 2012 and February 2013, a total of 70 patients had an ILR implanted; 49 of 70 patients were eligible for evaluation of data at 3-month follow-up. The ratio of incoming/expected data transmission was 12/49 (24%). The mean ± SD time spent with ILR-related issues during hospital stay was 88 ± 19 minutes. Assessment of incoming data and information of the patient and the general practitioner took 132 ± 13 minutes per patient. Overall, a mean ± SD of 220 ± 16 minutes per patient was needed for appropriate data acquisition, from implantation to first data transmission. CONCLUSIONS: In the patients having an ILR after surgical atrial ablation, initial compliance regarding data transmission was low. A substantial time effort was necessary to obtain sufficient data on cardiac rhythm. Device-related complications were observed. Patient selection should therefore be handled with care. Beneficial therapeutic decisions can be expected only when reliable data are obtained by efficient management.

Ablation surgery in patients with persistent atrial fibrillation: an 8-year clinical experience.

OBJECTIVE: This analysis was undertaken to evaluate the results of persistent atrial fibrillation ablation procedures concomitant to open surgery and to identify risk factors for persistent atrial fibrillation recurrence. METHODS: Since 2001, a total of 325 consecutive patients with persistent atrial fibrillation (duration, 0.5-33 years) have undergone persistent atrial fibrillation ablation concomitant to open surgery by creating 2 encircling isolation lesions around the left and right pulmonary veins and a connecting lesion between both with the use of radiofrequency ablation procedures. Patients were restudied at discharge, 3 months, and 3 years after surgery. RESULTS: Survivals at the time of reexamination at discharge, 3 months, and 3 years were 97.8%, 96.2%, and 94.4%, respectively. Stable sinus rhythm could be documented in 72.1%, 73.9%, and 75.6% of surviving patients, respectively. Long-term persistent atrial fibrillation before surgery and a larger left atrium were predictive of postoperative persistent atrial fibrillation return (P<.001). Statistical analysis demonstrated cutoff points of 5 years for persistent atrial fibrillation and 55 mm for left atrium diameter; 89.7% of patients with persistent atrial fibrillation duration of less than 5 years and 84.5% of patients with left atrium size of 55 mm or less were in stable sinus rhythm at late follow-up. Cardiac rhythm at discharge and at 3 months was predictive of long-term rhythm prognosis (P<.001). Age, gender, concomitant diseases (eg, arterial hypertension, diabetes, renal insufficiency, or pulmonary disease), and the underlying cause of heart disease did not significantly influence the postoperative cardiac rhythm. CONCLUSIONS: The duration of persistent atrial fibrillation and the size of the left atrium are the most reliable preoperative variables to predict the success rate of ablation concomitant to open surgery. The probability of reestablishing stable sinus rhythm is excellent when persistent atrial fibrillation duration is short and left atrium size is small.