ABSTRACT
Even if the Fontan operation is the surgical treatment of choice in patients with univentricular physiology, it remains a palliative strategy. Consequently, when Fontan patients reach adulthood, the majority of them develop late clinical sequelae of a failing cavo-pulmonary circuit (eg, liver failure, protein-losing enteropathy, and arrhythmias). Although heart transplantation represents the gold standard to treat this condition, Fontan patients usually accede to this therapy late, when risk of mortality is significantly increased, and a shortage of donor hearts limits transplantation in this special population. Mechanical circulatory support is an emerging field, but it is still in the experimental stage. Current mechanical circulatory devices have been used in Fontan circulation but are associated with the need for high-risk redo surgery. Percutaneous pumps are an emerging field that is still under investigation, with multiple prototypes developed. This review aims to analyze the hemodynamic profile of the developed intravascular pumps and their application in the preclinical scenario in the Fontan circulation.
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BACKGROUND: Cardiac allograft vasculopathy (CAV) assessment post-heart transplantation (HT) typically relies on invasive coronary angiography (ICA). However, cardiac computed tomography angiography (CCTA) is emerging as a promising alternative due to its potential benefits in economic, safety, and logistical aspects. This study aimed to evaluate the impact of a CCTA program on these aspects in CAV surveillance post-HT. METHODS: A retrospective single-center study was conducted between March 2021 and February 2023, involving HT patients who underwent either CCTA or ICA. RESULTS: Among 260 patients undergoing CAV surveillance, 115 (44.2%) patients underwent CCTA, and 145 (55.8%) patients underwent ICA. The CCTA group showed incurred lower overall costs (p â< â0.0001) and shorter hospitalization times (p â< â0.0001) compared to the ICA group. In terms of safety, CCTA surveillance required significantly lower contrast volumes (p â< â0.0001) and lower effective doses (p â= â0.03). CONCLUSION: CCTA emerges as a safe and cost-effective non-invasive alternative for CAV surveillance post-HT, outperforming ICA in terms of safety, logistical aspects, and economic burden.
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AIMS: Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes. METHODS AND RESULTS: In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035). CONCLUSION: Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.
Subject(s)
Defibrillators, Implantable , Device Removal , Tricuspid Valve Insufficiency , Humans , Tricuspid Valve Insufficiency/etiology , Male , Female , Device Removal/adverse effects , Aged , Middle Aged , Defibrillators, Implantable/adverse effects , Aged, 80 and over , Severity of Illness Index , Risk Factors , Treatment Outcome , Pacemaker, Artificial/adverse effects , Retrospective Studies , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve/physiopathology , Time FactorsABSTRACT
A 45 year old male obese patient with a previous history of repaired congenital heart disease developed worsening heart failure making heart transplantation listing mandatory. Unfortunately, due to his anthropometric measures, the search for a suitable brain-dead donor was unsuccessful. For this reason, he accepted to be enrolled in the controlled donation after circulatory death (cDCD) program. According to the Italian Law regulating death declaration after cardiac arrest (no-touch period of 20 minutes-one of the longest in the world), we faced a 34 minute cardiac asystole, after which the heart was recovered through a thoraco-abdominal normothermic regional perfusion excluding the epiaortic vessels. The heart was then preserved by means of cold static storage. Heart transplantation was performed successfully without any signs of primary graft failure. Postoperative endomyocardial biopsies were negative for acute cellular and antibody-mediated rejection. Furthermore, echocardiographic and cardiac magnetic resonance evaluation of the heart did not show any functional abnormalities. The patient was discharged on post-operative day (POD) #39 in good clinical conditions.
Subject(s)
Heart Transplantation , Warm Ischemia , Humans , Male , Heart Transplantation/adverse effects , Heart Transplantation/methods , Middle Aged , Warm Ischemia/adverse effects , Warm Ischemia/methods , Italy , Tissue Donors , Tissue and Organ Procurement/methods , Organ Preservation/methodsABSTRACT
BACKGROUND: Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure (HF). Subcutaneous implantable cardioverter defibrillator (S-ICD) might be a viable alternative to conventional ICDs with a lower risk of short- and long-term of device-related complications and infections.The aim of this multicenter study was to evaluate the outcomes and management of S-ICD recipients who underwent LVAD implantation. METHODS: The study population included patients with a preexisting S-ICD who underwent LVAD implantation for advanced HF despite optimal medical therapy. RESULTS: The study population included 30 patients (25 male; median age 45 [38-52] years).The HeartMate III was the most common LVAD type. Median follow-up in the setting of concomitant use of S-ICDs and LVADs was 7 months (1-20).There were no reports of inability to interrogate S-ICD systems in this population. Electromagnetic interference (EMI) occurred in 21 (70%) patients. The primary sensing vector was the one most significantly involved in determining EMI. Twenty-seven patients (90%) remained eligible for S-ICD implantation with at least one optimal sensing vector. The remaining 3 patients (10%) were ineligible for S-ICD after attempts of reprogramming of sensing vectors. Six patients (20%) experienced inappropriate shocks (IS) due to EMI. Six patients (20%) experienced appropriate shocks. No S-ICD extraction because of need for antitachycardia pacing, ineffective therapy or infection was reported. CONCLUSIONS: Concomitant use of LVAD and S-ICD is feasible in most patients. However, the potential risk of EMI oversensing, IS and undersensing in the post-operative period following LVAD implantation should be considered. Careful screening for EMI should be performed in all sensing vectors after LVAD implantation.
Subject(s)
Defibrillators, Implantable , Heart Failure , Heart-Assist Devices , Pacemaker, Artificial , Adult , Female , Humans , Male , Middle Aged , Defibrillators, Implantable/adverse effects , Electric Countershock/adverse effects , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/complications , Heart-Assist Devices/adverse effects , Pacemaker, Artificial/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: The Medtronic SelectSecure Model 3830 lumenless lead (Medtronic, Inc., Minneapolis, MN) is commonly used for conduction system pacing (CSP). However, with this increased use, the potential need for transvenous lead extraction (TLE) also will increase. While extraction of endocardial 3830 leads is rather well described especially in pediatric and adult congenital heart disease population, there is very limited data on extraction of CSP leads. In the present study, we reported our preliminary experience on TLE of CSP leads and provided technical considerations. METHODS: The study population comprised 6 consecutive patients (67% male; mean age 70 ± 22 years) with CSP leads (3830 leads), including left bundle branch pacing (LBBP) lead (n = 3) and His pacing lead (n = 3) undergoing TLE. Overall target leads were 17. The mean implant duration time of CSP leads was 97 ± 90 months [range 8-193). RESULTS: Manual traction was successful in 2 cases and mechanical extraction tools were required in the remaining cases. Sixteen leads (94%) were completely extracted, whereas incomplete removal was observed in one lead (6%) among 1 patient. Of note, in the only lead incompletely removed, we observed retention of < 1-cm remnant of lead material consisting of the screw of 3830 LBBP lead into the interventricular septum. No failure of lead extraction was reported and no major complications occurred. CONCLUSIONS: Our findings demonstrated that at an experienced center the success of TLE of chronically implanted CSP leads is high in the absence of major complications also when mechanical extraction tools are needed.
Subject(s)
Heart Defects, Congenital , Pacemaker, Artificial , Humans , Male , Adult , Child , Middle Aged , Aged , Aged, 80 and over , Female , Retrospective Studies , Device Removal , Heart Defects, Congenital/surgery , Cardiac Pacing, Artificial , Cardiac Conduction System DiseaseABSTRACT
Transfusions are extremely frequent after cardiac surgery, and they have a considerable economic burden and impact on outcomes. Optimal patient blood management could play a fundamental role in reducing the rate of transfusion and Jehovah's Witnesses (JW) represent the ideal surrogate study population. This meta-analysis compares outcomes of JWs and non-JWs' patients undergoing cardiac surgery, assessing the safety of a bloodless cardiac surgery. A scoping review was conducted using a search strategy for studies assessing outcomes of JW undergoing cardiac surgery. The primary outcome was perioperative mortality, and a random-effects meta-analysis was performed. Ten studies were included in our meta-analysis, involving 780 JW patients refusing any type of transfusion ("JW") and 1182 patients accepting transfusion if needed ("non-JW"). 86% of non-JW patients received at least 1 transfusion. There was no significant difference in terms of perioperative mortality (OR 0.91; 95% CI 0.55-1.52; pâ¯=â¯0.72). The volume blood loss was significantly less in the JW (pâ¯=â¯0.001), while the rate of reoperation for bleeding was also lower, but not statistically significative, in the JW (pâ¯=â¯0.16). Both preoperative and postoperative hemoglobin and hematocrit were significantly higher in the JW. Therefore, we concluded that bloodless cardiac surgery is safe and early outcomes are similar between JW and non-JW patients: optimal patient blood management is fundamental in guarantying these results. Further studies are needed to assess if a limitation of transfusion could have a positive long-term impact on outcomes.
Subject(s)
Bloodless Medical and Surgical Procedures , Cardiac Surgical Procedures , Jehovah's Witnesses , Humans , Retrospective Studies , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Blood TransfusionABSTRACT
BACKGROUND: When heart transplantation and myocardial recovery are unlikely, patients presenting with biventricular cardiogenic shock initially treated with extracorporeal membrane oxygenation (ECMO) may benefit from a mechanical support upgrade. In this scenario, a micro-invasive approach is proposed: the combination of the double-lumen ProtekDuo cannula (Livanova, London, UK) and the Impella 5.5 (Abiomed, Danvers, MA) trans-aortic pump that translates into a hybrid BiVAD. METHODS: All consecutive ECMO patients presenting with biventricular cardiogenic shock and ineligibility to heart transplantation from August 2022 were prospectively enrolled. The clinical course, procedural details, and in-hospital events were collected via electronic medical records. RESULTS: A total of three patients, who were temporarily not eligible for heart transplantation or durable LVAD due to severe acute pneumonia and right ventricular (RV) dysfunction, were implanted with a hybrid BiVAD. This strategy provided high-flow biventricular support while pulmonary function ameliorated. Moreover, by differentially sustaining the systemic and pulmonary circulation, it allowed for a more adequate reassessment of RV function. All the patients were considered eligible for isolated durable LVAD and underwent less invasive LVAD implantation paired with a planned postoperative RVAD. In all cases, RV function gradually recovered and the RVAD was successfully removed. CONCLUSIONS: The Hybrid BiVAD represents an up-to-date micro-invasive mechanical treatment of acute biventricular failure beyond ECMO. Its rationale relies on more physiological circulation across the lungs, the complete biventricular unloading, and the possibility of including an oxygenator in the circuit. Finally, the independent and differential control of pulmonary and systemic flows allows for more accurate RV function evaluation for isolated durable LVAD eligibility reassessment.
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The use of left ventricular assist devices (LVADs) is intended to treat patients with end-stage heart failure. Owing to technological advances, these devices are becoming more durable. However, LVADs may need to be exchanged when complications arise and heart transplantation is not possible. Indications for LVAD exchange (LVADE) include device thrombosis, device infections, and pump component failure. LVADE has historically been associated with a high risk of morbidity and mortality. In this review, we discuss the indications of LVADE, the decisional and technical aspects during surgery, and outcomes.
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Intravascular and intracardiac clots, thrombi, and vegetative material can be safely and effectively treated with the AngioVac System (AngioDynamics, Latham, NY) as an alternative to open surgery. However, this technology is still not performed in children or adolescents as a rule. We aimed to present our experience with two cases (a 10 year old girl and a 17 year old male adolescent) with concurrent hypoxemia in whom this device was successfully used in combination with venovenous extracorporeal membrane oxygenation to remove caval thrombi and cavoatrial septic material, respectively. This extracorporeal circuit configuration allowed adequate respiratory support during the procedure. No endovascular recurrence of the pathologic material was found at 2 and 1 year of follow-up, respectively.
Subject(s)
Extracorporeal Membrane Oxygenation , Heart Diseases , Thrombosis , Male , Child , Female , Humans , Adolescent , Extracorporeal Membrane Oxygenation/methods , Thrombosis/therapy , Heart Diseases/therapy , Hypoxia , Retrospective StudiesABSTRACT
Heart transplantation is considered the gold standard for the treatment of advanced end-stage heart failure. However, standard donors after brain death are decreasing, whereas patients on the heart transplant waitlist are constantly rising. The introduction of the ex vivo machine perfusion device has been a turning point; in fact, these systems are able to significantly reduce ischemic times and have a potential effect on ischemia-related damage reduction. From a clinical standpoint, these machines show emerging results in terms of heart donor pool expansion, making marginal donors and donor grafts after circulatory death suitable for donation. This article aims to review mechanisms and preclinical and clinical outcomes of currently available ex vivo perfusion systems, and to explore the future fields of application of these technologies.
Subject(s)
Heart Transplantation , Humans , Heart Transplantation/methods , Tissue Donors , Organ Preservation/methods , Heart , Extracorporeal Circulation/methods , Ischemia , Perfusion/methodsABSTRACT
In patients with a prohibitive surgical risk, the AngioVac cannula can be used to remove left-sided cardiac masses, as an off-label adaptation of the device. We herein describe a novel micro-invasive approach to gain access to the left atrium for the aspiration of a mitral valve mass in a patient affected by severe coronavirus disease 2019. Through a right anterior mini-thoracotomy, the right superior pulmonary vein was accessed and used to insert the aspiration cannula. A parallel venous-arterial extracorporeal membrane oxygenation (ECMO)-like circuit provided circulatory and respiratory support to ensure proper intra- and postoperative hemodynamic stabilization.
Subject(s)
Atrial Fibrillation , COVID-19 , Thrombosis , Humans , Mitral Valve/surgery , COVID-19/complications , Heart Atria/surgery , Thrombosis/etiology , Thrombosis/surgeryABSTRACT
BACKGROUND: Outcomes of transvenous lead extraction (TLE) are well reported in the general population, However, data on safety, efficacy of TLE in octogenarians with a long lead dwell time, using powered extraction tools are limited. The aim of this multicenter study was to evaluate the safety, effectiveness of TLE in octogenarians using the bidirectional rotational mechanical sheaths and mid-term outcome after TLE. METHODS: The study population comprised 83 patients (78.3% male; mean age 85 ± 3 years; [range 80-94 years]) with 181 target leads. All the leads (mean implant duration 112 ± 77 months [range 12-377]) were extracted exclusively using the Evolution RL sheaths (Cook Medical, Bloomington, IN, USA). RESULTS: The main indication for TLE was infection in 84.3% of cases. Complete procedural success rate, clinical success rate, per lead were 93.9% and 98.3%, respectively. Failure of lead extraction was seen in 1.7% of leads. The additional use of a snare was required in 8.4% of patients. Major complications occurred in one patient (1.2%). Thirty-day mortality after TLE was 6%. During a mean time follow-up of 22 ± 21 months, 24 patients (29%) died. No procedure-related mortality occurred. Predictors of mortality included ischemic cardiomyopathy (HR 4.35; 95% CI 1.87-10.13; p = .001), left ventricularejection fraction ≤35% (HR 7.89; 95% CI 3.20-19.48; p < .001), and TLE for systemic infection (HR 4.24; 95% CI 1.69-10.66; p = .002). CONCLUSIONS: At experienced centers bidirectional rotational mechanical sheaths combined with different mechanical tools and femoral approach allowreasonable success and safety in octogenarian with long lead dwell time. Patient's age should not influence the decision to extract or not the leads, although the 30-day and mid-term mortality are significant, especially in the present of specific comorbidities.
Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Aged, 80 and over , Humans , Male , Female , Defibrillators, Implantable/adverse effects , Octogenarians , Treatment Outcome , Comorbidity , Device Removal/adverse effects , Pacemaker, Artificial/adverse effects , Retrospective StudiesABSTRACT
We investigated the efficacy, safety, and versatility of the AngioVac (AngioDynamics, Latham, NY) system for the treatment of intravascular and intracardiac masses of different origins. We prospectively enrolled all consecutive patients treated with the AngioVac system between July-2016 and November-2021 at our institution. Three configurations of the device were adopted in 44 patients: a venous-venous circuit in 21 cases (47.7%), a venous-arterial ECMO-like configuration in 20 (45.5%), and a venous-arterial-arterial circuit with 2 centrifugal pumps for left-sided cardiac masses in 3 (6.8%). Successful removal of the mass was achieved in 41 patients (93.2%), while in the other cases conversion to full sternotomy was necessary. Intraoperative complications occurred in 3 cases (6.8%), including 1 death, 1 pulmonary embolization, and 1 cardiac perforation. The AngioVac system is a valid, safe, and versatile option for the treatment of intravascular masses also in patients with prohibitive surgical risk.
Subject(s)
Heart Diseases , Thrombosis , Venous Thrombosis , Humans , Thrombosis/etiology , Thrombectomy , Treatment Outcome , Heart Diseases/etiologyABSTRACT
We aimed to identify prognostic laboratory markers during extracorporeal life support (ECLS) in patients with primary refractory cardiogenic shock (RCS) and to create a preliminary specific mortality score. All 208 consecutive subjects admitted for primary RCS and treated with ECLS between January-2009 and December-2018 were retrospectively analyzed. Multivariate regression analysis on laboratory markers during the first nine days of ECLS was used to develop a "Refractory End-stage Shock CUred with Ecls" (RESCUE) score. Serum creatinine (ORâ¯=â¯3.72, 95%CI: 2.01-6.88), direct bilirubin (ORâ¯=â¯1.40, 95%CI: 1.05-1.8), and platelet count (ORâ¯=â¯0.62, 95%CI: 0.42-0.94) were independent predictors of in-hospital mortality and were included in the score. The mean AUC was 0.763 (95%CI: 0.698-0.828) in the development cohort and 0.729 (95%CI: 0.664-0.794) in the bootstrap internal validation cohort. The RESCUE score represents a novel promising instrument to predict early mortality during the first critical days of ECLS and to help in properly guiding the therapeutic decision-making process.
Subject(s)
Extracorporeal Membrane Oxygenation , Shock, Cardiogenic , Humans , Shock, Cardiogenic/therapy , Retrospective Studies , Treatment Outcome , BiomarkersABSTRACT
INTRODUCTION: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years. METHODS: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures. RESULTS: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up. CONCLUSION: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.
Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Humans , Device Removal/methods , Electrodes, Implanted , Retrospective Studies , Treatment OutcomeABSTRACT
To evaluate the safety and effectiveness of anticoagulation alone in HeartMate3 patients. According to antithrombotic regimen, patients were divided into 2 groups: Group-1(warfarin+aspirin) and Group-2(warfarin). A comparison of hemocompatibility-related adverse events (HRAEs), hemocompatibility score (HCS), and hemocoagulative laboratory markers, both qualitative and quantitative, between the 2 groups were performed. Fifty patients were enrolled, 28 (56%) in Group-1 and 22 in Group-2 (44%), without statistical differences at baseline. Median time of follow-up was 590 days (IQR: 410.25-1007.50). Eighteen HRAEs (36.0%) occurred: 17 in Group-1 (34%) and 1 in Group-2 (2%) (P < 0.001). The net HCS for Group-1 versus Group-2 was 24 points and 1 point (OR 12.116[2.034-233.226], Pâ¯=â¯0.023), respectively. Hemocoagulative values turned into the normality and remained stable during follow-up, without differences between groups, except for ASPI-test (Pâ¯=â¯0.003). HeartMate3 showed a high hemocompatibility independently from antithrombotic therapy. Aspirin avoidance resulted a safe and effective strategy since it reduced hemorrhagic events, without increasing thrombotic risk.
Subject(s)
Fibrinolytic Agents , Warfarin , Humans , Warfarin/adverse effects , Fibrinolytic Agents/adverse effects , Anticoagulants/adverse effects , Hemorrhage/chemically induced , Hemorrhage/drug therapy , Aspirin/adverse effectsABSTRACT
We propose a patient-tailored strategy that considers the risk for postoperative right heart failure, utilizing the percutaneous ProtekDuo cannula (Livanova, London, UK) in an innovative way to perform cardiopulmonary bypass during LVAD implantation in ECMO patients. Our novel protocol is based on the early intra-operative use of the ProtekDuo cannula, adopting the distal lumen as the pulmonary vent and the proximal lumen as the venous inflow cannula during cardiopulmonary bypass. This configuration is rapidly switched to the standard fashion to provide planned postoperative temporary right ventricular support, in selected patients at high risk of right ventricular failure. From September 2020 to June 2022, six patients were supported with the ProtekDuo cannula during and after an intracorporeal LVAD implantation (five of which were minimally invasive): four HeartMate III (Abbott, U.S.A.) and two HVAD (Medtronic Inc, MN). In all cases, the ProtekDuo cannula was correctly positioned and removed without complications after a median period of 8 days. Non-fatal bleeding (bronchial hemorrhage) occurred in one patient (17%) during biventricular support. Thirty-day mortality was 0%. From this preliminary work, our novel strategy demonstrated to be a feasible solution for planned minimally invasive right ventricular support in ECMO patients scheduled for a durable LVAD implantation.