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Background: Bioprosthetic surgical aortic valve replacement (SAVR) using the Trifecta valve was frequently chosen because of its large opening area and low transvalvular gradient. However, long-term follow-up revealed the potential for early structural valve deterioration. To further assess the long-term clinical outcomes and management considerations for patients implanted with the Trifecta valve, a real-world study using Medicare fee-for-service claims data was conducted with a focus on Trifecta valve reintervention., Methods: De-identified patients undergoing SAVR with the Trifecta™ valve (Abbott) in the U.S. between 1/1/2011-12/31/2021 were selected by ICD-9/10 procedure codes and then linked to a manufacturer device tracking database. All-cause mortality and freedom from Trifecta valve reintervention with repeat SAVR or valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) were evaluated at 10-years using the Kaplan Meier method. Independent predictors for reintervention and clinical outcomes following reintervention were assessed., Results: Among 242,160 Medicare beneficiaries undergoing SAVR during the study period, 23,197 were implanted with the Trifecta valve. Mean age was 75.2 ± 7.4 years. At 10-years survival was 32.3 % (95 % CI, 31.4 %-33.3 %) and the freedom from valve reintervention was 82.4 % (95 % CI, 81.1 %-83.5 %). Independent predictors for reintervention included younger age, female, obesity, and implants with a small valve size (19 mm, 21 mm). Reintervention with ViV-TAVI (N = 796) was associated with better operative survival (3.8 % vs. 12.5 %, p < 0.001) than repeat SAVR (N = 577)., Conclusion: This real-world nationwide study of Medicare beneficiaries receiving the Trifecta valve demonstrates >80 % freedom from all-cause valve reintervention at 10-years post-implant with reintervention using ViV-TAVI having improved operative survival compared to repeat SAVR., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dan Gutfinger reports financial support was provided by Abbott. Dan Gutfinger reports a relationship with Abbott that includes: employment and equity or stocks. Ibrahim Sultan reports institutional research support from Abbott, Atricure, Artivion, Gore, Edwards, Medtronic, and Terumo Aortic. Gorav Ailawadi reports consulting with Abbott, Anteris, Arthrex, Atricure, Avania, Capstan, Edwards, JenaValve, Johnson & Johnson, Medtronic, Nyra, Philips, and WL Gore. Danny Ramzy reports consulting with Abbott. Tsuyoshi Kaneko reports consulting with Abbott. Yang Yu reports a relationship with Abbott that includes: employment and equity or stocks. Geetanjali Meka reports a relationship with Abbott that includes: employment. Julie B. Prillinger reports a relationship with Abbott that includes: employment and equity or stocks. Joseph E. Bavaria reports consulting with Abbott., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Bioprosthetic surgical mitral valve replacement (SMVR) remains an important treatment option in the era of transcatheter valve interventions. We present 10-year clinical outcomes of Medicare beneficiaries undergoing SMVR with a contemporary low-profile mitral porcine valve., Methods: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing SMVR with the Epic™ Mitral valve (Abbott, Minnesota, USA) in the United States between 1/1/2008-12/31/2019 were selected by ICD-9/10 procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure (HF) re-hospitalization, and mitral valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10-years using the Kaplan Meier method., Results: Among 75,739 Medicare beneficiaries undergoing SMVR during the study period, 14,015 were implanted with the Epic™ Mitral valve, of which 76.5% (10,720) had underlying HF. Mean age was 74±8 years. Survival at 10-years in patients without preoperative HF was 40.4% (95% CI 37.4%-43.4%) compared to 25.4% (95% CI 23.8%-27.0%) for patients with HF (p < 0.001). The 10-year freedom from HF rehospitalization was 51.3% (95% CI 49.4%-53.1%). Freedom from mitral valve reintervention was 91.4% (95% CI 89.7%-92.7%) at 10 years., Conclusions: This real-world nationwide study of Medicare beneficiaries receiving the Epic™ Mitral valve demonstrates >90% freedom from all-cause valve reintervention and >50% freedom from HF rehospitalization at 10-years post-implant. Long-term survival and HF rehospitalization in this population with mitral valve disease undergoing SMVR was found to be impacted by underlying HF., (Copyright © 2024. Published by Elsevier Inc.)

Background: A postinfarct ventricular septal defect (PIVSD) is associated with high mortality and morbidity, particularly in patients with hemodynamic instability who are not suitable candidates for surgical repair. The Amplatzer PIVSD Occluder (Abbott) is indicated for transcatheter PIVSD closure in patients who are not satisfactory candidates for surgical repair. The objective of this study was to evaluate associated clinical outcomes., Methods: A total of 131 patients underwent transcatheter PIVSD closure using the Amplatzer PIVSD Occluder between 2011 and 2021 as part of a postapproval, multicenter, retrospective, observational study. The patients were analyzed in 2 cohorts. Cohort 1 included 99 patients (age 68.6 ± 11.9 years) implanted from 2011 to 2016 and evaluated technical success, procedure survival, and 6-month survival. Cohort 2 included 32 patients (age 66.4 ± 10.9 years) implanted from 2012 to 2021 with postprocedure echocardiograms and evaluated 24-hour closure, 6-month closure, and 6-month survival., Results: Technical success was achieved in 76.8% (76/99), procedure survival in 84.3% (75/89), and 6-month survival was observed in 37.2% of cohort 1 patients. Twenty-four-hour closure and 6-month closure were achieved in 53.1% (17/32) and 66.7% (4/6) of cohort 2 patients, respectively. Six-month survival was 46.4% of cohort 2 patients. Of the 16 deaths in cohort 2, 11 were cardiac-related, 4 were noncardiac-related, and 1 was of unknown etiology., Conclusions: This study demonstrates high morbidity of patients undergoing PIVSD closure using the Amplatzer PIVSD Occluder and that the device continues to be a safe alternative to medical therapy in patients who are not satisfactory candidates for surgical repair of a PIVSD., (© 2024 The Author(s).)

Objective: This study describes 3-year follow-up of 200 infants weighing ≥ 700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder., Study Design: Between June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study., Results: The implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and tricuspid regurgitation (5), for which no interventions were required., Conclusions: This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants., Clinicaltrials: gov identifier: NCT0305585., (© 2023. The Author(s).)

Transcatheter closure of patent ductus arteriosus (PDA) in premature infants is a feasible, safe, and an effective alternative to surgical ligation and may be performed with an implant success rate of 97%. Major procedural complications related to transcatheter PDA closure in extremely low birth weight (ELBW) infants are relatively infrequent (< 3%) ,but may be associated with a fatality if not optimally managed. Operators performing transcatheter PDA closures should be knowledgeable about these potential complications and management options. Prompt recognition and treatment are often necessary to avoid serious consequences. With strict guidelines on operator training, proctoring requirements, and technical refinements, transcatheter PDA closure in ELBW infants can be performed safely with low complication rates. This article summarizes the consensus guidelines put forward by a panel of physicians for the prevention and management of periprocedural complications of transcatheter PDA closure with the Amplatzer Piccolo Occluder in ELBW infants., (© 2021. The Author(s).)

Objective: Bioprosthetic surgical aortic valve replacement remains an important treatment option in the era of transcatheter interventions. Real-world outcomes are not well characterized because of limited prospective follow-up studies. We present the 10-year clinical outcomes of Medicare beneficiaries undergoing surgical aortic valve replacement with a contemporary supra-annular porcine valve., Methods: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing surgical aortic valve replacement with the Epic Supra valve (Abbott) in the United States between January 1, 2008, and December 31, 2019, were selected by International Classification of Diseases 9 th and 10 th Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure rehospitalization, and aortic valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years using the Kaplan-Meier method., Results: Among 272,591 Medicare beneficiaries undergoing surgical aortic valve replacement during the study period, 11,685 received the Epic Supra valve, of whom 51.6% (6029) had underlying heart failure. Mean age was 76 ± 7 years. Survival at 10 years in patients without preoperative heart failure was 43.5% (95% confidence interval, 41.8-45.2) compared with 24.1% (95% confidence interval, 22.6-25.5) for patients with heart failure ( P  < .001). The 10-year freedom from heart failure rehospitalization was 64.0% (95% confidence interval, 62.6-65.3). Freedom from aortic valve reintervention was 94.6% (95% confidence interval, 93.8-95.3) at 10 years., Conclusions: This real-world nationwide study of US Medicare beneficiaries receiving the Epic Supra valve demonstrates more than 94% freedom from all-cause valve reintervention and 64% freedom from heart failure rehospitalization at 10 years postimplant. Long-term survival and heart failure rehospitalization in this population with aortic valve disease undergoing surgical aortic valve replacement were found to be impacted by underlying heart failure., (© 2022 The Author(s).)

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward., (© 2021 Wiley Periodicals LLC.)

Objectives: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure., Background: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature., Methods: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up., Results: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g., Conclusions: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

To evaluate the association, if any, between closure modality (surgical ligation SL vs. catheter CC) of a hemodynamically significant patent ductus arteriosus (PDA), after failure of or contraindication to medical therapy, and immediate procedural complications, and post-procedure physiologic status in preterm (gestational age < 32 weeks) infants. In this single-center retrospective cohort study, data were accessed on infants < 32 weeks gestation, who underwent SL or CC of PDA, born from 2019-2021. The choice of modality was determined by parents, after they were provided information on both procedures. Our cohort (n = 112) included 36 (32.1%) infants who underwent SL while 76 (67.9%) underwent CC. The SL group of infants were significantly more immature at birth, younger on admission to the level IV NICU and received more mean (SD) surfactant doses than the CC group. Higher proportions of infants in the SL group had 5-min Apgar scores ≤ 5, seizures, severe intracranial hemorrhage and had received medical therapy for PDA. Both procedures were highly efficacious, with 1 unsuccessful device placement attempt and had low associated adverse events. Two (2.6%) infants had device migration 24 h after CC. SL was associated with a higher rate of immediate postoperative hypothermia whereas, in the CC group, mean airway pressure was significantly lower 48 h after, compared to before the procedure. SL and CC are comparable in short-term efficacy and safety for PDA closure. Long-term outcomes data are needed following both procedures., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Outline a quality initiative establishing an institutional service line for neonatal transcatheter device closure of the patent ductus arteriosus (TDC-PDA). A retrospective descriptive observational study surrounds programmatic approach to TDC-PDA in premature neonates with process measure spanning education, implementation, referral, and post-procedural care. Metrics tracked pre- and post-program creation with statistical analyses performed. Neonatal TDC-PDA referrals increased exponentially since program inception (n = 13 in year prior; n = 42 year 1; n = 74 year 2), especially in patients weighing less than 1.3 kg (12.5%; 55%; 50%), and were associated with an increased procedural success rate (81%; 95%; 99%). Procedural checklist creation decreased procedural "out of isolette" time (median 93 min; 59; 52), and procedural-related complication or clinical sequelae (19%; 12%; 4%). A multidisciplinary service line and program dedicated to neonatal TDC-PDA can result in a significant increase in referrals as well as procedural efficacy and safety for this medically fragile population., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Transcatheter patent ductus arteriosus (PDA) closure (TCPC) utilizing transthoracic echocardiogram (TTE) as the sole imaging guide could simplify care. This single-center study compares PDA dimensions obtained from the TTE and angiogram images of patients who underwent attempted TCPC at Stead Family Children's Hospital from 10/01/2019 to 10/31/2020. Blinded investigators measured these dimensions solely for this study and had no impact on clinical care. Also, a hypothetical Piccolo device size was chosen based on the TTE dimensions and another on the angiographic dimensions, and then the correlation was analyzed. Sixty-two patients underwent TCPC attempts. TTE tends to overestimate the PDA narrowest dimension and underestimate the PDA length and aortic end dimension. Linear regression analysis revealed a weak correlation between the length and aortic diameter (R = 0.37 and 0.21, respectively). A modest correlation was observed for the smallest dimension without color Doppler (R = 0.57) and with color Doppler, which was utilized when needed (R = 0.6). Bland-Altman analysis revealed a smaller mean difference between the TTE and angiogram measurements of the narrowest diameter without color Doppler (0.4 mm) and with color Doppler (used as needed) (0.4 mm). However, the mean difference is larger for the aortic end (- 1.64 mm) and the length (- 1.73 mm). TTE accurately predicted the Piccolo device size in 43 (72%) patients and overestimated the size in 17 (28%) patients to the next size. Our findings should be verified with further studies, and additional development of protocols is needed to use TTE to guide TCPC without fluoroscopy., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Aim: Transcatheter closure of the patent ductus arteriosus (TCPDA) is increasingly used in preterm infants as an alternative to surgical ligation. However, clinically ill preterm infants are at risk of contrast nephropathy due to the angiography contrast agents used during the procedure., Methods: We performed a single-centre before-and-after comparative study in VLBW infants to compare the kinetics of serum creatinine during the first 4 days after TCPDA with or without angiography., Results: 69 patients were included and divided into two groups: TCPDA with (contrast+; n = 37) and without (contrast-, n = 32) use of contrast agent. The median dose [range] of contrast agent was 1.0 mL/kg [0.6-2.4 mL/kg]. The change in serum creatinine level between day 2 to 4 after TCPCA and baseline decreased in the contrast- group (-17% [-46%; 18%]), while it increased in the contrast+ group (7% [-24%; 202%] p = 0.002). Comparison of blood urea levels between groups showed similar significant differences. The change in serum creatinine between day 2 to 4 and baseline was significantly correlated with the dose of contrast agent (r 2  = 0.682; p < 0.001)., Conclusion: The use of contrast agents during TCPDA can potentially harm the renal function of very preterm infants. Therefore, we advise minimising or avoiding the use of contrast agents., (© 2024 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.)

Transcatheter patent ductus arteriosus (PDA) closure is a safe and effective alternative to surgical ligation in low-body-weight infants. Post-ligation cardiac syndrome (PLCS) is defined as severe hemodynamic and respiratory collapse within 24 h of PDA closure, requiring initiation or an increase of an inotropic agent by > 20% of preligation dosing and an absolute increase of at least 20% in ventilation parameters compared with the preoperative value. Whilst PLCS is routinely observed after surgery, its incidence remains poorly described following transcatheter closure. This study aimed to compare the incidence of PLCS after surgical versus transcatheter closure of PDA in low-body-weight premature infants. Propensity scores were used to compare surgical (N = 78) and transcatheter (N = 76) groups of preterm infants who underwent PDA closure at a procedural weight less than 2000 g in two tertiary institutions between 2009 and 2021. The primary outcome was the incidence of PLCS. Secondary outcomes included overall mortality before discharge, risk factors for PLCS, and post-procedural complications. Procedural success was 100% in both groups. After matching, transcatheter group experienced no PLCS vs 15% in the surgical group (p = 0.012). Furthermore, overall mortality (2% vs 17%; p = 0.03) and major complications (2% vs 23%; p = 0.002) were higher in the surgical group. Surgery (100% vs 47%; p < 0.01), gestation age (25 ± 1 vs 26 ± 2 weeks, p < 0.05) and inotropic support before closure (90% vs 29%; p < 0.001) were associated with PLCS occurrence.          Conclusion: Transcatheter PDA closure may be equally effective but safer than surgical PDA closure in low-body-weight premature infants. What is Known: • Post-ligation cardiac syndrome is a serious and common complication of surgical closure of the ductus arteriosus in preterm infants. • Transcatheter closure of preterm ductus arteriosus is a safe and effective technique that is becoming more and more common worldwide. What is New: • Device closure is safer than surgical ligation for patent ductus arteriosus closure in preterm infants and may be the first-line non-pharmacological therapeutic option in this indication in experienced teams. • Our findings should encourage neonatologists and pediatric cardiologists to start and/or strengthen a durable interventional program for transcatheter PDA closure in premature infants., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Aim: To describe our initial experience with the indications and results of the 5/7 Occlutech® duct Occluder (ODO, Occlutech International AB, Helsingborg, Sweden). A small incremental increase in occluder sizes is of utmost importance for successful outcomes, especially in smaller patients in whom protrusion of the distal disk towards the aorta should be minimised., Methods: Retrospective study of all patients undergoing PDA closure with the 5/7 ODO in three institutions since 2018., Results: The 5/7 ODO was used in 18 patients with median age and weight at the time of the procedure of 17.5 months (interquartile range 25th to 75th percentile 8 months- 4.4 years) and 13.6 kg (interquartile range 25th to 75th percentile 6.4-22.5 kg) respectively. All cases were successful. There were no cases of device embolisation, haemolysis, or flow disturbance of the LPA or the aorta., Conclusions: This small retrospective study demonstrated an excellent outcome of transcatheter PDA closure with the 5/7 ODO. The device is a beneficial complement to the existing sizes of PDA devices, filling the gap between the 4/6 and 6/8 ODO and avoiding protrusion of a larger disk in the aortic isthmus., (© 2023 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.)

The rationale for intrathoracic impedance (Z) detection of worsening heart failure (HF) presupposes that changes in Z reflect changes in pulmonary congestion, but is confounded by poor specificity in clinical trials. We therefore tested the hypothesis that Z is primarily affected by tissue/water content in proximity to electrodes rather than by lung water distribution between electrodes through the use of a new computational model for deriving the near-field impedance contributions from the various electrodes. Six sheep were implanted with a left atrial pressure (LAP) monitor and a cardiac resynchronization therapy device which measured Z from six vectors comprising of five electrodes. The vector-based Z was modelled as the summation of the near-field impedances of the two electrodes forming the vector. During volume expansion an acute increase in LAP resulted in simultaneous reductions in the near-field impedances of the intra-cardiac electrodes, while the subcutaneous electrode showed several hours of lag (all p<0.001). In contrast, during the simulated formation of device-pocket edema (induced by fluid injection) the near-field impedance of the subcutaneous electrode had an instantaneous response, while the intra-cardiac electrodes had a minimal inconsistent response. This study suggests that the primary contribution to the vector based Z is from the tissue/water in proximity to the individual electrodes. This novel finding may help explain the limited utility of Z for detecting worsening HF.

Introduction: Delivery systems are crucially important for the implantation of medical devices in patients with congenital heart disease. However, very little data is available comparing the advantages and disadvantages of the various delivery systems. Areas covered: This article describes the delivery systems and methods used for delivery of atrial septal occluder devices, ventricular septal occluder devices, devices to occlude patent arterial ducts, and transcatheter pulmonary valves. Delivery systems are compared relating to prepping and loading, positioning of the delivery sheath/catheter, deployment, ability to recapture and reposition, as well as device release. Expert opinion: For most ASD/VSD/PDA occluder devices, the basic delivery mechanism has changed very little over the preceding 20 years. Future modifications may focus on meaningful modifications to the cable systems that reduce stiffness and improve angulation at the connection to the device. Over the next 5–10 years, it is expected to see significant changes to delivery systems used for transcatheter pulmonary valve implantation, that result in improvements in the ability to recapture and reposition self-expandable transcatheter valves during the deployment process, combined with kink resistant sheaths that facilitate easy tracking across often complex right ventricular outflow tracts. [ABSTRACT FROM AUTHOR]

Background: We hypothesized that left atrial pressure (LAP) obtained by a permanent implantable sensor is sensitive to changes in cardiac resynchronization therapy (CRT) settings and could guide CRT optimization to improve the response rate. We investigated the effect of CRT optimization on LAP and its waveform parameters in ambulant heart failure (HF) patients., Methods: CRT optimization was performed in eight ambulant HF patients, using echocardiography as reference. LAP waveform was acquired at each of eight atrioventricular (AV) intervals and five inter-ventricular (VV) intervals. Selected waveform parameters were also evaluated for their sensitivity to CRT changes and agreement with echocardiography-guided optimal settings., Results: Optimal AV and VV intervals varied considerably between patients. All patients exhibited significant changes in waveform morphology with AV optimization. Optimal AV delay determined from echocardiography ranged between 140 ms and 225 ms. Mean LAP tended to be lower at optimal setting 14 ± 3 mmHg compared to shorter (<100 ms) or longer (>160 ms) AV settings (P = 0.16). There were clear trends to smaller peak a-wave (P = 0.11) and gentler positive a-slope (P = 0.15) and positive v-slope (P = 0.09) with longer AV delays. Mean LAP and negative v-wave slope correlated well with echo-guided optimal setting, r = 0.91 (P = 0.001) and 0.79 (P = 0.03), respectively. No significant effects on LAP or waveform were seen during VV optimization., Conclusions: LAP and its waveform changes considerably with AV optimization. There is good agreement between echo-guided optimal setting and LAP. LAP could provide an objective guide to CRT optimization. (Clinical Trial Registry information: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT00632372)., (©2014 Wiley Periodicals, Inc.)

Monitoring of HF (heart failure) with intracardiac pressure, intrathoracic impedance and/or natriuretic peptide levels has been advocated. We aimed to investigate possible differences in the response patterns of each of these monitoring modalities during HF decompensation that may have an impact on the potential for early therapeutic intervention. Six sheep were implanted with a LAP (left atrial pressure) sensor and a CRT-D (cardiac resynchronization therapy defibrillator) capable of monitoring impedance along six lead configuration vectors. An estimate of ALAP (LAP from admittance) was determined by linear regression. HF was induced by rapid ventricular pacing at 180 and 220 bpm (beats/min) for a week each, followed by a third week with daily pacing suspensions for increasing durations (1-5 h). Incremental pacing induced progressively severe HF reflected in increases in LAP (5.9 ± 0.4 to 24.5 ± 1.6 mmHg) and plasma atrial (20 ± 3 to 197 ± 36 pmol/l) and B-type natriuretic peptide (3.7 ± 0.7 to 32.7 ± 5.4 pmol/l) (all P<0.001) levels. All impedance vectors decreased in proportion to HF severity (all P<0.001), with the LVring (left ventricular)-case vector correlating best with LAP (r2=0.63, P<0.001). Natriuretic peptides closely paralleled rapid acute changes in LAP during alterations in pacing (P<0.001), whereas impedance changes were delayed relative to LAP. ALAP exhibited good agreement with LAP. In summary, impedance measured with an LV lead correlates significantly with changes in LAP, but exhibits a delayed response to acute alterations. Natriuretic peptides respond rapidly to acute LAP changes. Direct LAP, impedance and natriuretic peptide measurements all show promise as early indicators of worsening HF. ALAP provides an estimate of LAP that may be clinically useful.

Introduction: We investigated trends in intrathoracic impedance measured between multiple implanted electrodes for monitoring pulmonary edema secondary to congestive heart failure (CHF) in an experimental model., Methods: Biventricular ICDs were implanted in 16 dogs and 5 sheep. Continuous RV pacing (230- 250 bpm) was applied over several weeks. Meanwhile, impedance was measured every hour along 4 intrathoracic and 2 intracardiac vectors. Four cardiogenic impedance vectors were also monitored. Cardiac function was assessed biweekly by catheterization and echocardiography. Left atrial (LA) pressure was measured daily by an implanted LA pressure sensor., Results: All animals developed CHF after 2-4 weeks of pacing as evidenced by changes in function (EF, 52 vs. 34%; LV end-diastolic volume, 65 vs. 97 ml; LV end-diastolic pressure, 7 vs. 16 mmHg; LA volume, 17 vs. 33 ml; LA pressure, 7 vs. 26 mmHg), clinical symptoms, or autopsy. Steady state impedance decreased during CHF: LV-Can, 17+/-9%; LV-RV, 15+/-8%; LV-RA, 13+/-6%; RV-Can, 13+/-8%; RVcoil-Can, 8+/-6%; RA-Can, 6+/-6%. Change in LV-Can impedance was greater than that of RA-Can, RV-Can, and RVcoil-Can (P0.05). LV-Can impedance correlated well with LA pressure (r(2)=0.73), while RV-Can and RVcoil-Can were weakly correlated (r(2)=0.43 and r(2)=0.52, respectively). Changes in LV-RV and LV-RA impedances were also larger than those of RVcoil-Can and RA-Can (P0.05). Meanwhile, all impedances were associated with circadian variability at baseline (5+/-2%) which diminished during CHF (2+/-1%); P=0.02. Furthermore, significant variations were observed in cardiogenic impedances during progression into CHF as evidenced by reduced peak-to-peak amplitude and increased fractionation of the signals., Conclusions: All impedance vectors decreased during CHF. Impedance measurement employing left heart sensors correlated well wit- - h LA pressure, and may improve detection of CHF onset compared to sensing by RA or RV leads alone. This approach has important clinical implications for managing heart failure patients in the ambulatory setting.

Aim: The Amplatzer Piccolo Occluder (APO) is approved for patent ductus arteriosus (PDA) occlusion in infants weighing >700 g but could offer versatility to treat other lesions. Methods: Retrospective review of children in whom APO was utilized for defects other than PDA between January 2022 and June 2023. Results: The APO was used in nine patients; three for ventricular septal defects, four with coronary fistulas, one for a ventricular pseudoaneurysm and one where APO deployed within a fenestration of a previously placed Amplatzer Septal Occluder. All nine patients had successful occlusions without complications. Conclusion: The APO is a versatile device that can be used to treat various small diameter lesions in children besides the PDA for which it is currently approved for. Article highlights The Amplatzer Piccolo Occluder (APO) is currently used for closure of patent ductus arteriosus in infants and children. Its utility to treat other small lesions in children has not been previously described. In this series, the APO was used to treat small lesions such as coronary artery fistulas, residual ventricular septal defects, etc. All lesions were successfully treated using the APO, and there were no procedural complications. The APO can be used to successfully occlude small defects of many varieties in infants and children. The advantage of delivering a disc device through a relatively small catheter may prove valuable while treating certain vascular lesions in infants and small children. The 4-French delivery system allows this device to be used in small patients that cannot tolerate the large delivery systems of other devices. The symmetric design of the APO also allows for both antegrade and retrograde deployment. [ABSTRACT FROM AUTHOR]

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Precipitates of calcium phosphate in coronary arteries always indicate the presence of atherosclerosis. The mass of these precipitates is related to the severity of atherosclerosis. To determine the accuracy of electron beam computed tomographic (CT) mass estimates, we imaged 21 human hearts inside an anthropomorphic chest phantom using an Imatron C-100 electron beam CT scanner (Imatron, San Francisco, CA). We then incinerated the 63 imaged coronary arteries and weighed the mineral ash. We calculated the mass estimates from the images using an algorithm derived from a model that assumes simple radiographic properties of the coronary arteries. We also calculated the currently used coronary calcium score for each artery. Although both the mass estimates and the scores correlated with the actual mass of the incinerated specimens (r = .97 and r = .93), the correlation with the mass estimates was better (P = .02; William's test). The regression equation relating the actual mass to the mass estimates was y = 1.37 x + 14, indicating that the CT mass estimates consistently underestimate actual coronary calcium phosphate mass. We conclude that relative mass estimates using electron beam CT scanning are accurate and that both these and the currently employed calcium scores reflect the actual mass of precipitated calcium phosphate in diseased coronary arteries.

Background: Transcatheter interventions are increasingly used in children with congenital heart disease. However, these interventions can affect cardiac output and cerebral circulation. In this pilot study, we aimed to investigate the use of NeoDoppler, a continuous transfontanellar cerebral Doppler monitoring system, to evaluate the impact of transcatheter interventions on cerebral circulation. Methods: Nineteen participants under one year of age (mean age 3.5 months) undergoing transcatheter cardiac interventions were prospectively included. Transfontanellar cerebral Doppler monitoring with the NeoDoppler system was initiated after intubation and continued until the end of the procedure. Results: Instant detection of changes in cerebral blood flow were observed across a spectrum of transcatheter interventions. Balloon aortic valvuloplasty demonstrated temporary cessation of cerebral blood flow during balloon inflation. Increase in cerebral diastolic blood flow velocity and decreased pulsatility were observed during patent ductus arteriosus occlusion. Changes in cerebral blood flow patterns were detected in two patients who encountered complications during their transcatheter interventions. There was no significant change in Doppler parameters before and after the interventions for the entire patient group. High quality recordings were achieved in 87.3% of the monitoring period. Conclusions: Continuous transfontanellar cerebral Doppler is feasible in monitoring cerebral hemodynamic trends and shows instantaneous changes associated with interventions and complications. It could become a useful monitoring tool during transcatheter interventions in infants. [ABSTRACT FROM AUTHOR]

We present the case of a 3-year-old female, who had an ostium secundum type atrial septal defect and who had been scheduled for interventional closure with an amplatzer occluder device. Pediatric hemodynamics service notified us of the device migration and her hemodynamic instability due to the failed attempt to recapture the device with an umbrella technique and its consequent migration to the aortic arch. Urgent surgery is performed through conventional medial (median full) sternotomy, dissection by planes, opening and marsupialization (opening) of anterior pericardium with 0 silk, placement of reins with 1-0 silk, purse-string like suture on aorta with 3-0 ethibond, and in the right atrium and the inferior vena cava 3-0 prolene suture. Administration of 200 units of heparin, placement of arterial cannula and venous cannula in both superior and inferior vena cava, partial occlusion of cavas, dissection of the transverse aorta up to aortic arch until visualization of left subclavian artery and ductus arteriosus occupied with stent. Reins are placed with 1-0 silk in the brachiocephalic trunk, carotid artery and left subclavian artery in an individualized manner, and an amplatzer type device is evidenced and palpated in the zone between the left subclavian artery and the ductus arteriosus, a purse-string like suture is made with 4-0 prolene, a 5 mm incision is made with a scalpel, and with 3 mosquito clamps and a traction- countertraction maneuver complete removal of the amplatzer device is obtained. Posterior closure of the purse-string like suture is performed without complications and without evidence of active bleeding in the incision area. Aortic clamping is performed, cardiopulmonary bypass, and the administration of 300cc of custodiol solution until the visualization of the heart´s electromechanical stop, temperature drop to 28 degrees, right atrium opening, inspection of ostium secundum type of interatrial communication of approximately 5-6 mm in diameter, placement of reins in right atrium with closure of interatrial communication. A bovine pericardium patch is made and placed with 5-0 prolene continuous suture, the absence of leaks is verified, closure of right atrium, increase of temperature to normothermia and partial occlusion of cavas removed, the right atrium is purged, hemostasis is verified without complications. Extracorporeal circulation is stopped on the first attempt with output to sinus rhythm, pacemaker cables are placed with exteriorization by counter opening, removal of inferior venous cannula first and then superior venous cannula, purging of the root and removal of arterial cannula, administration of 300 IU of protamine is started, complete textile count is verified and a 19 Fr mediastinal tube is placed, verification of hemostasis, sternal closure with one no 5 wire in manubrium in an x style knot and two in the middle and lower third with 2-0 ethibond suture, hemostasis is verified and subcutaneous cellular tissue is closed with 1-0 vycril suture, skin is closed with 3-0 monocryl suture, and the surgical event is concluded. [ABSTRACT FROM AUTHOR]

Objective: Compare the use of nonsteroidal anti-inflammatory drugs (NSAIDs) with placebo/expectant management in preterm infants at 28 weeks or less gestational age with a large Patent Ductus (PDA)., Study Design: A meta-analysis of RCTs following PRISMA guidelines comparing the use of NSAIDs with placebo/expectant management in extremely preterm infants with a large PDA., Results: There were no significant differences between the NSAIDs and placebo/expectant groups for all-cause mortality (RR 1.27; 95% CI 0.97-1.65; p = 0.081). However, the ibuprofen subgroup showed a significant difference in all-cause mortality (RR 1.36; 95% CI 1.03-1.80; p = 0.03) favoring the placebo/expectant group., Conclusion: In extremely preterm infants with a large PDA on ultrasound, early treatment with NSAIDs provides no additional clinical benefit compared to placebo/expectant treatment. Ibuprofen was associated with an increased risk ratio for all-cause mortality in the subgroup analysis., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Objective: Review a cohort of preterm infants ≤29 weeks of gestation at birth and compare morbidities and neurodevelopmental outcomes based on PDA status and type of PDA closure., Study Design: Single center observational retrospective-prospective case control study of premature infants who had no hsPDA, underwent surgical ligation or percutaneous transcatheter closure of the PDA. Neurodevelopmental testing was done using the Bayley Scales of Infant Development 3rd ed., Results: The percutaneous transcatheter closure group had an older post menstrual age and greater weight at the time of procedure, and started enteral feeds and achieved room air status at an earlier post procedure day. Infants in the surgical ligation group were more likely to experience vocal cord paralysis. There was no difference in neurodevelopmental outcomes between groups., Conclusion: Waiting for infants to achieve the appropriate size for percutaneous transcatheter closure of the PDA may lead to reduced short-term complications without increasing the risk of neurodevelopmental impairment., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Importance: Transcatheter closure of the patent ductus arteriosus (PDA) is being increasingly adopted as an alternative to surgical PDA closure in preterm infants., Objective: To develop rigorous clinical practice guideline recommendations on procedural PDA closure in preterm infants., Methods: The principles of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence-to-Decision (EtD) framework were used to develop the guideline recommendations. An e-Delphi survey of 45 experts was conducted and recommendations that reached ≥75% agreement were accepted as consensus., Main Recommendations: Procedural PDA closure may be considered in extremely preterm infants (<28 weeks gestational age) requiring invasive mechanical ventilation >10 postnatal days and confirmed to have a large hemodynamically significant PDA, at centers with high local rates of death and/or bronchopulmonary dysplasia (conditional recommendation). If sufficient institutional expertise is available and patient characteristics are suitable, transcatheter PDA closure may be considered as the preferred approach over PDA ligation (conditional recommendation)., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Ductal patency of preterm infants is potentially associated with long term morbidities related to either pulmonary overflow or systemic steal. When an interventional closure is needed, it can be achieved with either surgical ligation or a catheter-based approach. Transcatheter PDA closure is among the safest of interventional cardiac procedures and it is the first choice for ductal closure in adults, children, and infants weighing more than 6 kg. In preterm and very low birth weight infants, it is increasingly becoming a valid and safe alternative to ligation, especially for the high success rate and the minor invasiveness and side effects. Nevertheless, being it performed at increasingly lower weights and gestational ages, hemodynamic complications are possible events to be foreseen. Procedural steps, timing, results, possible complications and available monitoring systems, as well as future outlooks are here discussed. [ABSTRACT FROM AUTHOR]

Newborns with congenital heart disease often require interventions linked to high morbidity and mortality rates. In the last few decades, many transcatheter interventions have become the first-line treatments for some critical conditions in the neonatal period. A catheter-based approach provides several advantages in terms of procedural time, length of hospitalization, repeatability and neurodevelopmental issues (usually related to cardiopulmonary bypass). The main transcatheter procedures will be reviewed, as they are now valid alternatives to conventional surgical management. [ABSTRACT FROM AUTHOR]