Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 100
Filter
1.
Article in English | MEDLINE | ID: mdl-38736246

ABSTRACT

BACKGROUND: Stent implantation has become standard of care in older children and adults for treatment of branch pulmonary artery stenosis (BPAS) and coarctation aorta (CoAo). There are no stents approved or available for infants that have the potential to be dilated to adult diameters. The Minima stent was designed to fulfill this unmet need. METHODS: Multicenter, prospective, nonrandomized early feasibility study evaluating safety and effectiveness of the Minima stent for treatment of BPAS and CoAo. Primary endpoints included: (1) successful deployment across lesion, (2) stenosis relief defined by an increase in angiographic diameter of >50% and (3) freedom from stent explant, embolization or migration at 30 days and 6 months. RESULTS: Between 2/2022 and 5/2022, 10 pts underwent Minima stent implantation with a median age and weight of 9 months (4-43 months) and 7.6 kg (5.1-16.9 kg). Procedural success and predefined stenosis relief was achieved in all cases (CoAo [n = 4], BPAS [n = 6]). Adverse events occurred in 3 pts: transient diminished lower extremity pulse (n = 2), distal stent on-balloon displacement successfully managed in the catheterization suite (n = 1). There were no deaths or major adverse events. All patients were free from stent explant and migration at 30 days and 6 months with no evidence for significant restenosis at latest follow-up. CONCLUSIONS: Implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during early follow-up. Based on these early results, an expanded study with longer follow-up is warranted.

2.
Catheter Cardiovasc Interv ; 103(6): 934-942, 2024 May.
Article in English | MEDLINE | ID: mdl-38584522

ABSTRACT

BACKGROUND: Transcatheter closure of the patent ductus arteriosus (PDA) in premature infants is currently dependent on fluoroscopic guidance and transportation to the catheterization laboratory. AIM: We describe a new echocardiographically guided technique to allow our team to move to the bedside at the neonatal intensive care unit (NICU) of the referring center for percutaneous treatment of PDA in premature infants. METHODS: This is a single-center, retrospective, primarily descriptive analysis. Clinical details about the procedure, its outcomes, and complications were collected. RESULTS: Fifty-eight neonates with a median weight of 1110 g (range 730-2800) and postnatal age of 28 days (range 9-95) underwent percutaneous PDA closure. Five of them were treated in our center with ultrasound guidance only and the other 53 in 18 different neonatology units in 12 towns. The median duration of the procedure was 40 min (range 20-195 min). There were no procedural deaths. There was one residual shunt for 3 weeks, in all other patients the duct closed completely in the first few hours after the intervention. In one patient the procedure had to be interrupted because of a pericardial effusion which had to be drained, the PDA was closed successfully interventionally 5 days later. One device-related aortic coarctation had to be stented. One embolization and one late migration occurred and required treatment. CONCLUSIONS: Echocardiographically guided transcatheter closure of the PDA in prematures was repeatedly possible and allowed that the procedure is performed at the bedside at the NICU with an acceptable rate of complications.


Subject(s)
Cardiac Catheterization , Ductus Arteriosus, Patent , Ultrasonography, Interventional , Humans , Ductus Arteriosus, Patent/therapy , Ductus Arteriosus, Patent/diagnostic imaging , Ductus Arteriosus, Patent/physiopathology , Infant, Newborn , Retrospective Studies , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Treatment Outcome , Gestational Age , Predictive Value of Tests , Male , Female , Time Factors , Severity of Illness Index , Infant, Premature , Infant, Extremely Premature , Intensive Care Units, Neonatal , Point-of-Care Systems , Point-of-Care Testing , Septal Occluder Device , Infant
3.
J Cardiovasc Comput Tomogr ; 18(1): 75-99, 2024.
Article in English | MEDLINE | ID: mdl-37517984

ABSTRACT

This consensus document for the performance of Cardiovascular Computed Tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multi-modality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.


Subject(s)
Cardiac Surgical Procedures , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pulmonary Valve , Surgeons , Adult , Humans , Child , Predictive Value of Tests , Tomography, X-Ray Computed , Angiography , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Pulmonary Valve/diagnostic imaging , Pulmonary Valve/surgery , Treatment Outcome , Cardiac Catheterization/methods
4.
J Perinatol ; 43(10): 1238-1244, 2023 10.
Article in English | MEDLINE | ID: mdl-37587183

ABSTRACT

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.


Subject(s)
Ductus Arteriosus, Patent , Septal Occluder Device , Infant , Humans , Child , Follow-Up Studies , Ductus Arteriosus, Patent/surgery , Prospective Studies , Cardiac Catheterization/adverse effects , Septal Occluder Device/adverse effects , Treatment Outcome
5.
World J Pediatr Congenit Heart Surg ; 14(6): 761-791, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37647270

ABSTRACT

This consensus document for the performance of cardiovascular computed tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital heart disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons, and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multimodality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.


Subject(s)
Heart Defects, Congenital , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pulmonary Valve Insufficiency , Pulmonary Valve , Ventricular Outflow Obstruction , Adult , Humans , Child , Pulmonary Valve/surgery , Heart Valve Prosthesis Implantation/methods , Treatment Outcome , Prosthesis Design , Cardiac Catheterization/methods , Heart Defects, Congenital/surgery , Tomography, X-Ray Computed , Pulmonary Valve Insufficiency/surgery , Ventricular Outflow Obstruction/surgery
6.
J Subst Use Addict Treat ; 155: 209058, 2023 12.
Article in English | MEDLINE | ID: mdl-37149149

ABSTRACT

INTRODUCTION: Clinical pharmacists are well positioned to enhance efforts to promote emergency department (ED)-initiated buprenorphine to treat opioid use disorder (OUD). Among clinical pharmacists in urban EDs, we sought to characterize barriers and facilitators for ED-initiated buprenorphine to inform future implementation efforts and enhance access to this highly effective OUD treatment. METHODS: This study was conducted as a part of Project ED Health (CTN-0069, NCT03023930), a multisite effectiveness-implementation study aimed at promoting ED-initiated buprenorphine that was conducted between April 2017 and July 2020. Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) framework to assess perspectives on the relationship between 3 elements: evidence for buprenorphine, the ED context, and facilitation needs to promote ED-initiated buprenorphine. The study used an iterative coding process to identify overlapping themes within these 3 domains. RESULTS: The study conducted eight focus groups/interviews across four geographically disparate EDs with 15 pharmacist participants. We identified six themes. Themes related to evidence included (1) varied levels of comfort and experience among pharmacists with ED-initiated buprenorphine that increased over time and (2) a perception that patients with OUD have unique challenges that require guidance to optimize ED care. With regards to context, clinical pharmacists identified: (3) their ability to clarify scope of ED care in the context of unique pharmacology, formulations, and regulations of buprenorphine to ED staff, and that (4) their presence promotes successful program implementation and quality improvement. Participants identified facilitation needs including: (5) training to promote practice change and (6) ways to leverage already existing pharmacy resources outside of the ED. CONCLUSION: Clinical pharmacists play a unique and critical role in the efforts to promote ED-initiated buprenorphine. We identified 6 themes that can inform pharmacist-specific interventions that could aid in the successful implementation of this practice.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Humans , Buprenorphine/therapeutic use , Pharmacists , Opiate Substitution Treatment , Opioid-Related Disorders/drug therapy , Emergency Service, Hospital
7.
Eur J Orthop Surg Traumatol ; 33(4): 955-960, 2023 May.
Article in English | MEDLINE | ID: mdl-35230543

ABSTRACT

PURPOSE: The objectives of this study were to assess the incidence of vitamin D deficiency in orthopaedic trauma patients, evaluate the safety and efficacy of a vitamin D supplementation protocol, and investigate the utility of vitamin D supplementation in reducing nonunions. METHODS: Three hundred seventy patients with operative tibia and/or fibula fractures were retrospectively reviewed. Both overall and matched cohorts were analysed. RESULTS: Ninety-eight per cent (n = 210) were found to have vitamin D insufficiency (serum 25(OH)D level < 30 ng/ml). There were no cases of vitamin D toxicity following vitamin D replacement. Median follow-up vitamin D level was 22.7 ng/mL. No statistical difference between union rates was found between either the two consecutive cohorts or matched cohorts. CONCLUSION: This vitamin D replacement protocol was a safe treatment for hypovitaminosis D, but post hoc analysis shows there would need to be over 1200 matched patients to achieve adequate power.


Subject(s)
Fractures, Bone , Orthopedics , Vitamin D Deficiency , Humans , Fractures, Bone/epidemiology , Retrospective Studies , Vitamin D Deficiency/epidemiology , Vitamin D Deficiency/therapy , Vitamin D , Vitamins , Dietary Supplements
8.
J Vasc Access ; 23(3): 348-352, 2022 May.
Article in English | MEDLINE | ID: mdl-33541202

ABSTRACT

BACKGROUND: Pandemics create challenges for medical centers, which call for innovative adaptations to care for patients during the unusually high census, to distribute stress and work hours among providers, to reduce the likelihood of transmission to health care workers, and to maximize resource utilization. METHODS: We describe a multidisciplinary vascular access team's development to improve frontline providers' workflow by placing central venous and arterial catheters. Herein we describe the development, organization, and processes resulting in the rapid formation and deployment of this team, reporting on notable clinical issues encountered, which might serve as a basis for future quality improvement and investigation. We describe a retrospective, single-center descriptive study in a large, quaternary academic medical center in a major city. The COVID-19 vascular access team included physicians with specialized experience in placing invasive catheters and whose usual clinical schedule had been lessened through deferment of elective cases. The target population included patients with confirmed or suspected COVID-19 in the medical ICU (MICU) needing invasive catheter placement. The line team placed all invasive catheters on patients in the MICU with suspected or confirmed COVID-19. RESULTS AND CONCLUSIONS: Primary data collected were the number and type of catheters placed, time of team member exposure to potentially infected patients, and any complications over the first three weeks. Secondary outcomes pertained to workflow enhancement and quality improvement. 145 invasive catheters were placed on 67 patients. Of these 67 patients, 90% received arterial catheters, 64% central venous catheters, and 25% hemodialysis catheters. None of the central venous catheterizations or hemodialysis catheters were associated with early complications. Arterial line malfunction due to thrombosis was the most frequent complication. Division of labor through specialized expert procedural teams is feasible during a pandemic and offloads frontline providers while potentially conferring safety benefits.


Subject(s)
COVID-19 , Catheterization, Central Venous , Central Venous Catheters , Catheterization, Central Venous/adverse effects , Catheterization, Central Venous/methods , Critical Illness , Humans , Pandemics , Retrospective Studies
9.
Circ Cardiovasc Interv ; 15(1): e010852, 2022 01.
Article in English | MEDLINE | ID: mdl-34930015

ABSTRACT

BACKGROUND: The Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease. METHODS: Enrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death. RESULTS: One hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1-Q3: 15-26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1-Q3: 12-22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1-Q3: 5.4-10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%-89%), with an annualized rate of 2.0% per patient-year. CONCLUSIONS: Ten-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00740870.


Subject(s)
Heart Valve Prosthesis Implantation , Pulmonary Valve Insufficiency , Pulmonary Valve , Adolescent , Adult , Humans , Prosthesis Design , Pulmonary Valve/diagnostic imaging , Pulmonary Valve/surgery , Pulmonary Valve Insufficiency/diagnostic imaging , Pulmonary Valve Insufficiency/surgery , Retrospective Studies , Treatment Outcome , Young Adult
10.
Case Rep Anesthesiol ; 2021: 4716997, 2021.
Article in English | MEDLINE | ID: mdl-34745665

ABSTRACT

Extremely low birth weight (ELBW) infants weighing less than 1 kilogram are at a high-risk for delayed patent ductus arteriosus (PDA) closure. Percutaneous PDA closure offers a less invasive approach when compared with surgical PDA closure, which may provide faster recovery times and less transfusion requirements. However, this procedure involves transporting tenuous, unstable patients from the neonatal intensive care unit (NICU) to the catheterization laboratory which introduces many potential risks for the neonate. Performing percutaneous PDA closure at the bedside offers a successful alternative to performing the procedure in the catheterization laboratory and avoiding risk associated with transporting ELBW neonates.

11.
Pediatr Cardiol ; 42(6): 1258-1274, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34195869

ABSTRACT

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.


Subject(s)
Consensus , Ductus Arteriosus, Patent/surgery , Postoperative Complications/prevention & control , Practice Guidelines as Topic , Septal Occluder Device/adverse effects , Humans , Infant , Infant, Extremely Low Birth Weight
13.
Pediatr Cardiol ; 42(7): 1640-1646, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34050375

ABSTRACT

Transcatheter pulmonary valve replacement (TPVR) is a staple in the pediatric cardiac catheterization lab. Despite the ubiquitous use of this procedure, guidelines for antithrombosis post pulmonary valve replacement are non-existent. A survey was sent out via email to the members of the Congenital Cardiovascular Interventional Study Consortium (CCISC) and the Pediatric and Adult Interventional Cardiac Symposium (PICS-AICS). Responses were received from 109 cardiologists who perform this procedure. Following TPVR 76.5% of respondents use only Aspirin, while the remainder prescribe a second antithrombotic agent at discharge. The majority (78%) of respondents do not educate patients about avoiding enteric formulations of aspirin, and another 86% do not educate patients about the need to avoid proton pump inhibitors (PPI). In addition, 67% do not advise against concomitant use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Lastly, the survey showed a wide discrepancy in prescribed dose with 56% choosing to always prescribe 70-100 mg regardless of weight, 28% choosing to do weight-based dosing, and 7.5% choosing 325 mg regardless of weight. In a survey sent out to pediatric cardiac interventionalists worldwide, a significant discrepancy was noted in antithrombotic regimens used following TPVR. We hypothesize that these discrepancies may contribute to early valve failure and suggest the need for further study and the development of unified antithrombosis guidelines following TPVR.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pulmonary Valve , Adult , Aspirin , Cardiac Catheterization , Child , Humans , Pulmonary Valve/surgery , Retrospective Studies , Treatment Outcome
14.
Catheter Cardiovasc Interv ; 98(1): 117-127, 2021 07 01.
Article in English | MEDLINE | ID: mdl-33942962

ABSTRACT

OBJECTIVES: This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions. BACKGROUND: There are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs. METHODS: This study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5). RESULTS: Successful deployment occurred in 21/22 attempts. Two instances of post-deployment migration occurred. Stents were re-expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re-dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/- 1.2 mm; final diameter 16.1 mm +/- 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time. CONCLUSIONS: In this in vivo study of the Minima stent, there was high implant success, predictable re-dilatability to adult diameters and favorable histopathology. Further study is warranted.


Subject(s)
Pulmonary Artery , Stents , Adult , Animals , Aorta , Humans , Infant , Neointima , Pulmonary Artery/diagnostic imaging , Pulmonary Artery/surgery , Swine , Treatment Outcome
15.
Catheter Cardiovasc Interv ; 98(1): 128-136, 2021 07 01.
Article in English | MEDLINE | ID: mdl-33909945

ABSTRACT

BACKGROUND: Covered stent correction of sinus venosus ASDs (SVASD) is a relatively new technique. Challenges include anchoring a sufficiently long stent in a nonstenotic superior vena cava (SVC) and expanding the stent at the wider SVC-RA junction without obstructing the anomalous right upper pulmonary vein (RUPV). The 10-zig covered Cheatham-platinum (CCP) stent has the advantage of being available in lengths of 5-11 cm and dilatable to 34 mm in diameter. METHODS: An international registry reviewed the outcomes of 10-zig CCP stents in 75 patients aged 11.4-75.9 years (median 45.4) from March 2016. Additional stents were used to anchor the stent in the SVC or close residual shunts in 33/75. An additional stent was placed in 4/5 (80%) with 5/5.5 cm CCPs, 18/29 (62%) with 6 cm CCPs, 5/18 (28%) with 7 cm CCPs, 5/22 (23%) with 7.5/8 cm CCPs and 0/1 with an 11 cm CCP. A "protective" balloon catheter was inflated in the RUPV in 17. RESULTS: Early stent embolization in two patients required surgical removal and defect repair and tamponade was drained in one patient. The CT at 3 months showed occlusion of the RUPV in one patient. Follow up is from 2 months to 5.1 years (median 1.8 years). QP:QS has reduced from 2.5 ± 0.5 to 1.2 ± 0.36 (p < .001) and RVEDVi from 149.1 ± 35.4 to 95.6 ± 21.43 ml/m2 (p < .001). CONCLUSIONS: Ten-zig CCPs of 7-8 cm appear to provide reliable SVASD closure with a low requirement for additional stents. Careful selection of patients and meticulous attention to detail is required to avoid complications.


Subject(s)
Heart Septal Defects, Atrial , Platinum , Humans , Registries , Stents , Treatment Outcome , Vena Cava, Superior
16.
Pediatr Cardiol ; 42(3): 628-636, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33394112

ABSTRACT

Transcatheter patent ductus arteriosus closure (TCPC) is an emerging treatment for low birth weight extremely premature neonates (EPNs). Left pulmonary artery (LPA) and descending aorta (DAO) obstruction are described device-related complications, however, data on mid- and long-term vascular outcomes are lacking. A retrospective analysis of EPNs who underwent successful TCPC at our institution from 03/2013 to 12/2018 was performed. Two-dimensional echocardiography and spectral Doppler velocities from various time points before and after TCPC were used to identify LPA and DAO flow disturbances. A total of 44 EPNs underwent successful TCPC at a median (range) procedural weight of 1150 g (755-2500 g). Thirty-two (73%) patients were closed with the AVP II and 12 (27%) with the Amplatzer Piccolo device. LPA and DAO velocities on average remained within normal limits and improved spontaneously in long-term follow up (26.1 months, range 1-75 months). One patient, who had concerning LPA flow characteristics immediately after device implant (peak velocity 2.6 m/s) developed progressive LPA stenosis requiring stent placement 3 months post-procedure. In the remaining infants, including 7 (16%) who developed LPA and 3 (7%) who developed DAO flow disturbances (range 2-2.4 m/s), all had progressive normalization of flow velocities over time. TCPC can be performed safely in EPNs with a low incidence of LPA and DAO obstruction. In the absence of significant progressive vascular obstruction in the early post-procedure period, mild increases in LPA and DAO flow velocities tend to improve spontaneously and normalize in long-term follow-up.


Subject(s)
Cardiac Catheterization/methods , Ductus Arteriosus, Patent/surgery , Aorta, Thoracic/physiopathology , Cardiac Catheterization/adverse effects , Female , Humans , Infant , Infant, Low Birth Weight , Infant, Newborn , Infant, Premature , Male , Pulmonary Artery/physiopathology , Retrospective Studies , Risk Factors , Stenosis, Pulmonary Artery/etiology , Treatment Outcome
17.
J Am Coll Cardiol ; 76(24): 2847-2858, 2020 12 15.
Article in English | MEDLINE | ID: mdl-33303074

ABSTRACT

BACKGROUND: There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve. OBJECTIVES: This study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve. METHODS: Data were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy. RESULTS: Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR. CONCLUSIONS: Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.


Subject(s)
Endovascular Procedures/statistics & numerical data , Heart Valve Prosthesis Implantation/statistics & numerical data , Heart Valve Prosthesis , Pulmonary Valve , Registries , Adolescent , Adult , Bioprosthesis , Child , Endovascular Procedures/instrumentation , Endovascular Procedures/methods , Female , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Humans , Male , Middle Aged , Retrospective Studies , Young Adult
18.
JACC Cardiovasc Interv ; 13(21): 2510-2524, 2020 11 09.
Article in English | MEDLINE | ID: mdl-33069657

ABSTRACT

OBJECTIVES: The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR). BACKGROUND: Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV. METHODS: Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular-to-pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported. RESULTS: Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported. CONCLUSIONS: This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pulmonary Valve Insufficiency , Pulmonary Valve , Cardiac Catheterization , Feasibility Studies , Humans , Prosthesis Design , Pulmonary Valve/surgery , Pulmonary Valve Insufficiency/surgery , Treatment Outcome
19.
Catheter Cardiovasc Interv ; 96(6): 1258-1265, 2020 11.
Article in English | MEDLINE | ID: mdl-32840956

ABSTRACT

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 for high-level field-wide discussions. The 2020 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 (CHD). 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 dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.


Subject(s)
Cardiac Catheterization/trends , Cardiology/trends , Coronary Angiography/trends , Heart Diseases/diagnostic imaging , Heart Diseases/therapy , Percutaneous Coronary Intervention/trends , Diffusion of Innovation , Heart Diseases/physiopathology , Humans
20.
Curr Cardiol Rep ; 22(10): 125, 2020 08 13.
Article in English | MEDLINE | ID: mdl-32789652

ABSTRACT

PURPOSE OF REVIEW: Advanced imaging has played a vital role in the contemporary, rapid rise of structural heart interventions. 3D modeling and printing has emerged as one of the most recent imaging tools and the implementation of 3D modeling is expected to increase with further advances in imaging, print hardware, and materials. RECENT FINDINGS: 3D modeling can be used to educate patients and clinical teams, provide ex vivo procedural simulation, and improve outcomes. Intra-procedural success rates may be improved, and post-procedural complications can be predicted more robustly with appropriate application of 3D modeling. Recent advances in technology have increased the availability of this tool, such that there can be more ready adoption into a routine clinical workflow. Familiarity with 3D modeling and its current utilization and role in structural interventions will help inform how to approach and adapt this exciting new technology.


Subject(s)
Cardiac Surgical Procedures , Heart Valve Diseases , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/surgery , Humans
SELECTION OF CITATIONS
SEARCH DETAIL
...