Acute iatrogenic aortic coarctation after balloon-expandable prosthesis pop-out during transcatheter aortic valve implantation intervention.

An 80-year-old man was referred to our cath-lab for transcatheter aortic valve implantation (TAVI) due to symptomatic severe aortic valve stenosis. The intervention utilized a balloon-expandable prosthesis (Edwards Sapien 3 Ultra n°26, Edwards Lifesciences).

Última generación de prótesis percutáneas expandibles con balón y autoexpandibles en la estenosis aórtica bicúspide: estudio TRITON / Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

Introducción y objetivos: La última generación de válvulas cardiacas expandibles con balón y autoexpandibles para implante percutáneo no se han comparado en valvulopatía aórtica bicúspide (VAB).Métodos: Registro multicéntrico de pacientes consecutivos con VAB y estenosis grave tratados con las válvulas cardiacas expandibles con balón (Myval y SAPIEN 3 Ultra [S3U]) o autoexpandible Evolut PRO+(EP+). Se realizó un análisis de tripletes mediante el software TriMatch para minimizar el impacto de las diferencias basales. El objetivo primario del estudio fue evaluar la tasa de éxito del dispositivo a 30 días y los objetivos secundarios, el objetivo combinado de seguridad y sus componentes individuales a 30 días.Resultados: Se incluyó a 360 pacientes (media de edad, 76,6±7,6 años; el 71,9% varones); 122 con Myval (33,9%), 129 con S3U (35,8%) y 109 con EP+(30,3%). La media de puntuación STS fue de 3,6±1,9%. No hubo ningún caso de oclusión coronaria, rotura de anillo, disección aórtica o mortalidad periprocedimiento. El evento primario de éxito del dispositivo a 30-días fue significativamente superior en el grupo que recibió Myval (Myval, 100%; S3U, 87,5%, y EP+, 81,3%), fundamentalmente a expensas de mayor gradiente residual con S3U y mayor tasa de insuficiencia aórtica al menos moderada con EP+. La tasa no ajustada de implante de marcapasos no presentó diferencias significativas.Conclusiones: En la VAB con estenosis grave y cirugía contraindicada, Myval, S3U y EP+tuvieron una seguridad comparable, aunque Myval presentó mejor gradiente residual que S3U y ambos dispositivos expandibles con balón resultaron en menos fuga perivalvular residual que EP+. Por lo tanto, ajustándose a los riesgos específicos de cada paciente, se puede seleccionar cualquiera de los 3 dispositivos con resultados óptimos.(AU)

Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis.Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days.Results: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation.Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.(AU)

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.

Neoadjuvant Chemotherapy and Expandable Prosthesis Reconstruction to Treat Osteosarcoma around the Knee in Children.

OBJECTIVE: Survival and reconstruction in osteosarcoma is quite challenging. The study aimed to investigate the prognosis in patients treated with neoadjuvant chemotherapy and determine the clinical outcomes of expandable endoprosthesis reconstruction in children. METHODS: From January 2009 to December 2014, we retrospectively analyzed 29 skeletally immature children (mean age, 10.5 years; range, 6-15 years) with osteosarcoma around the knee. Of the 29 patients who underwent neoadjuvant chemotherapy and limb salvage surgery, an expandable prosthesis was implanted for reconstruction. No patients were missed during follow-up. The evaluation index involved follow-up time, complication, functional results, and lengthening procedures. The survivorship and recurrence were assessed by GraphPad Software, and the function was evaluated by the Musculoskeletal Tumor Society (MSTS) scoring system. RESULTS: A mean follow-up time was 8.9 years (range, 6-12 years), and the overall 5-year survival was 89.1% based on Kaplan-Meier analysis. Three patients suffered a relapse and one underwent amputation. Lung metastasis developed in one patient. At 6 months after the operation, patients had a mean MSTS score of 27 points (range, 24-29). Two patients underwent revision surgery, one for implant infection and one for aseptic loosening. Prognosis is correlated with alkaline phosphatase change after treatment. CONCLUSIONS: Chemotherapy scheme and limb salvage can achieve high survival rates. This expandable prosthesis was associated with good function and low complication rates. The character of expandability could be a method to overcome discrepancies in the growth period.

Comparison of outcomes in patients with severe aortic stenosis treated with small and large Medtronic Evolut R and Evolut PRO self-expandable prosthetic valves.

Introduction: Indications for transcatheter aortic valve implantation (TAVI) continue to expand. Very often TAVI must be done in large annuli. Implantation of the bigger prostheses is often associated with more procedural problems, which may affect the outcomes. Aim: To compare the outcomes of TAVI procedures using the self-expandable Medtronic Evolut R 34 with the smaller Evolut R or Evolut Pro 23, 26 or 29. Material and methods: We analysed 87 patients who received self-expandable Medtronic Evolut R and Pro valves. Group I consisted of 59 (67.81%) patients with Evolut 23, 26 or 29, and group II consisted of 28 (32.18%) patients who received an Evolut 34 valve. Results: EuroSCORE II was 5.59 in group I vs 7.87 in group II (p = 0.02). The oversizing rate was higher in group II: 24.1% vs. 18.5% (p < 0.001). The procedure and fluoroscopy times were longer in group II: 209 vs. 187 min (p = 0.03), 44 vs. 27 min (p = 0.01). Moderate paravalvular leak was found more frequently in group II: 5 v 1 (p = 0.04). There was less device success in group II: 22 (78.57%) vs. 57 (96.6%) (p = 0.05). Early safety criteria were similar in both groups: 52 (88.1%) and 24 (92.3%) (p = 0.56). 30-day mortality was similar: 4 (6.7%) vs. 0 in group I and II respectively (p = 0.16). Conclusions: TAVI procedures in patients requiring an Evolut R 34 prosthesis are more challenging than in those who need smaller valves. Paravalvular leaks are more frequently observed after TAVI with Evolut R 34, which results in lower device success.

Tibia Multiplanar Deformities and Growth Disturbance Following Expandable Endoprosthetic Distal Femur Replacement.

Background: Expandable distal femur endoprosthesis (EDFE) is commonly used to compensate for the loss of the distal femoral epiphyseal plate in skeletally immature children who have undergone surgical resection of bone malignancies. However, the effect of the passive tibial component of the EDFE on tibial growth has not been extensively studied in the literature. This study aims to delineate the type, frequency, and associated risk factors of multiplanar proximal tibial deformities in skeletally immature children following the use of the expandable distal femur endoprosthesis (EDFE). Moreover, we plan to detect how these deformities influence the long-term functionality of the endoprosthesis in defining the need for subsequent implant revision or further surgical management. Patients and Methods: A total of 20 patients aged (7−12) years underwent expandable distal femur replacement. Two types of implants were used: Juvenile Tumor System (JTS) non-invasive prosthesis in 14 patients, and Modular Universal Tumor and Revision System (MUTARS)® Xpand Growing Prostheses in six patients. A scanogram and CT scan documented the measurements of longitudinal and multiplanar growth as leg length discrepancy (LLD), femur length discrepancy (FLD), tibia length discrepancy (TLD), and the yield values of rotational, sagittal, and coronal deformities of the tibia. The patients were followed up to assess the need for further management. Sex, age, size of tibial plate perforation, and type of implant used were studied for possible correlation with deformities or growth disturbance. Results: The patients were followed up for a mean of 3 (2−7) years. A total of 14 patients, (10 JTS, 4 implant cast) had a tibial deformity and/or growth disturbance. A single patient was found to have all deformities (growth, rotational, coronal, and sagittal). Fourteen patients were found to have an LLD ranging from 5.3 to 59 mm (median 21 mm), 12 had a TLD from 3 to 30 mm, (median 10 mm), and 11 patients showed evidence of malrotation from 6 to 32 degrees (median 11 degrees). TLD was found to contribute entirely to LLD in three patients, and >50% of LLDs in seven patients. All LLDs were treated conservatively, except in three patients; two received contralateral tibia epiphysiodesis and one received revision with a new implant. A single patient had a posterior tibia slope angle (PTSA) of −2.8 degrees, and three patients had a coronal deformity with a mean medial proximal tibia angle (MPTA) of 80.3 (77−83 degrees). Conclusions: Tibial growth disturbance and multiplanar deformities occur in the majority of patients following EDFE replacement, exacerbating LLD. Yet, these disturbances may be well tolerated, managed conservatively, and rarely mandate endoprosthetic revision or subsequent corrective surgery. Age at the time of surgery was found to be the only significant contributor to the development of tibia growth disturbance.

Long-Term Outcomes of Patients with Self-Expandable Transcatheter Heart Valve Embolized in the Aorta.

This study assesses the long-term outcomes of patients who suffered from self-expandable transcatheter heart valve (THV) embolized in the aorta in transcatheter aortic valve implantation (TAVI).We retrospectively reviewed the patients with self-expandable THV embolized in the aorta. Follow-up computed tomography was performed to assess the THV migration, struct fractures, and device-related aortic complications.Of the 539 TAVI patients, 11 suffered from self-expandable THV embolized in the aorta. Two patients underwent open-heart surgery to remove the embolized THVs in the ascending aorta. Embolized THVs were repositioned in the aortic arch distal to the left subclavian artery (n = 3) and the thoracic descending aorta (n = 6). Three patients died during a median follow-up time of 40 months. The remaining eight survivors presented with New York Heart Association functional class I or II at the last follow-up. Degeneration of embolized prostheses with thick leaflets and rolled cusp edges was observed in three patients. There was no evidence of valve migration, strut fracture, prosthesis-associated aortic complication, and thrombosis attached on embolized valve for all patients with THVs repositioned in the aorta.Self-expandable THV embolization can be effectively managed in TAVI. Although some embolized valves exhibited leaflet degeneration, the long-term safety of repositioning embolized self-expandable THV in the aorta is assured.

Frequency and reason for reoperation following non-invasive expandable endoprostheses: A systematic review.

BACKGROUND: Non-invasive expandable endoprostheses (NIEPR) utilize an external electromagnetic field to drive an innate mechanical gearbox. This lengthens the extremity following oncological resections in children with a predicted limb length discrepancy (LLD), facilitating limb-salvage. This review was conducted to assess NIEPR implant survival rates and identify modes of implant failure unique to these prostheses. METHODS: Medline, EMBASE and the Cochrane Library databases were searched for all manuscripts evaluating implant survival of NIEPRs implanted into skeletally immature patients following resection of extremity sarcomas. Minimum follow-up of 12 months or implant failure was required for inclusion. Failures were classified using the latest ISOLS classification and exact implant-specific failure modality was also identified. RESULTS: 19 studies met inclusion criteria. Mean age was 10.0 years (7.7 - 11.4 years). The most common locations for NIEPR implantation were the distal femur (343, 76.7%) and proximal tibia (53, 119%). Mean follow-up was 65.3 months (19.4 - 163 months). The overall implant revision rate was 46.2% (0 - 100%); implant specific revisions included maximal prosthesis lengthening with persistent LLD (10.4%), failed extension mechanism (6.1%), implant fracture (7.7%), hinge fracture (1.4%) and bushing wear (0.9%). Persistent clinically significant (>20 mm) LLD at final follow-up was present in 19.2% (0 - 50%) of patients. The mean MSTS score was 85.1% (66.7-96.3%) at final follow-up. CONCLUSION: Implant-related failures are the most common reason for NIEPR revision. Implant reliability appears to be improved with current designs. A sub-classification to the current classification system based on implant-specific failures for NIEPRs is proposed.

The Transaxillary Approach via Prosthetic Conduit for Transcatheter Aortic Valve Replacement With the New-Generation Balloon-Expandable Valves in Patients With Severe Peripheral Artery Disease.

Background: The left subclavian artery (LSA) is an infrequently used alternative access route for patients with severe peripheral artery disease (PAD) in patients who underwent transcatheter aortic valve replacement (TAVR). We report a new endovascular approach for TAVR combining an axillary prosthetic conduit-based access technique with new-generation balloon-expandable TAVR prostheses. Methods and Results: Between January 2020 and December 2020, 251 patients underwent TAVR at the West German Heart and Vascular Center. Of these, 10 patients (3.9%) were deemed to be treated optimally by direct surgical exposure of the left or right axillary artery via a surgically adapted prosthetic conduit. All procedures were performed under general anesthesia. One procedural stroke occurred due to severe calcification of the aortic arch. No specific complications of the subclavian access site (vessel rupture, vertebral, or internal mammary ischemia) were reported. Two minor bleedings from the access site could be treated conservatively. No surgical revision was necessary. Conclusion: The axillary prosthetic conduit-based access technique using new-generation balloon-expandable valves allows safe and successful TAVR in a subgroup of patients with a high risk of procedural complications due to severe peripheral vascular disease. Considering the increasing number of patients referred for TAVR, this approach could represent an alternative for patients with limited access sites.

Intravascular haemolysis after transcatheter aortic valve implantation with self-expandable prosthesis: incidence, severity, and impact on long-term mortality.

We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6 years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P = 0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm2/m2, P = 0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6 years with log-rank test P = 0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9-28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. METHODS: We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA). RESULTS: Among 628 patients (mean age 82.4 ±â€¯5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4-8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93-1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01-1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18-60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention. CONCLUSIONS: While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases.

Growing Without Pain: The Noninvasive Expandable Prosthesis is Boon for Children with Bone Cancer, as well as Their Surgeons!

BACKGROUND: Orthopedic oncology has evolved over the past few decades to favor limb salvage over amputations. The noninvasive expandable prosthesis can be lengthened with an externally applied magnetic field eliminating the pain, stiffness, as well as the risk of infection. We present the largest series in Indian experience with this implant over the last 8 years while analyzing its benefit to the surgeons and the patients, but are we able to justify the cost effectiveness? MATERIALS AND METHODS: Eighteen implants were used in 16 patients with nonmetastatic primary bone sarcoma from May 2006 to June 2015. All implants were manufactured by Stanmore implants worldwide based in London, UK. Lengthening was done in the outpatient department during the followup visits using an external electromagnetic coil. The function was assessed using the musculoskeletal tumor society (MSTS) score. RESULTS: The patients had a mean age of 10.25 years at the time of surgery. The mean followup was 49.56 months. Twelve patients are alive at a followup after surgery. The prostheses were lengthened by a mean of 31.64 mm and average lengthening per session was 4.18 mm. The mean MSTS score was 28.83. Two revisions for jammed mechanism and two patients had a successful two-stage revision for delayed infection. CONCLUSION: The noninvasive expandable prosthesis is an ideal implant for children undergoing limb salvage surgery for bone sarcoma who are expected to have more than 3 cm of limb length discrepancy at maturity. The initial high cost compared to a minimally invasive expandable implant can be recovered as there is no additional cost of lengthening. The small amounts of lengthening at more frequent intervals is more physiological as compared with the minimally invasive type where more lengthening is done to minimize the number of procedures. While the functional and oncological outcomes are comparable, this implant allows limb lengths to be maintained without pain, functional compromise or risk of infection.

Comparison of minimally invasive and non-invasive systems in lengthening total femoral prostheses.

AIMS: The aim of this study was to describe, analyze, and compare the survival, functional outcome, and complications of minimally invasive (MI) and non-invasive (NI) lengthening total femoral prostheses. PATIENTS AND METHODS: A total of 24 lengthening total femoral prostheses, 11 MI and 13 NI, were implanted between 1991 and 2016. The characteristics, complications, and functional results were recorded. There were ten female patients and ten male patients. Their mean age at the time of surgery was 11 years (2 to 41). The mean follow-up was 13.2 years (seven months to 29.25 years). A survival analysis was performed, and the failures were classified according to the Modified Henderson System. RESULTS: The overall implant survival was 79% at five, ten, and 20 years for MI prostheses, and 84% at five years and 70% at ten years for NI prostheses. At the final follow-up, 13 prostheses did not require further surgery. The overall complication rate was 46%. The mean revision-free implant survival for MI and NI prostheses was 59 months and 49 months, respectively. There were no statistically significant differences in the overall implant survival, revision-free survival, or the distribution of complications between the two types of prosthesis. Infection rates were also comparable in the groups (9% vs 7%; p = 0.902). The rate of leg-length discrepancy was 54% in MI prostheses and 23% in NI prostheses. In those with a MI prosthesis, there was a smaller mean range of movement of the knee (0° to 62° vs 0° to 83°; p = 0.047), the flexion contracture took a longer mean time to resolve after lengthening (3.3 months vs 1.07 months; p < 0.001) and there was a lower mean Musculoskeletal Tumor Society (MSTS) score (24.7 vs 27; p = 0.295). CONCLUSION: The survival and complications of MI and NI lengthening total femoral prostheses are comparable. However, patients with NI prosthesis have more accurate correction of leg-length discrepancy, a better range of movement of the knee and an improved overall function.