Comparison of trans-catheter closure of paravalvular leak versus surgical approach-outcomes and cost analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Pu ◽  
W.H Wu ◽  
Y.T Ke ◽  
X.H Ma ◽  
L.J Huang

Abstract Background The outcomes and costs of trans-catheter closure (TC) of paravalvular leak (PVL) compared with surgical closure (SC) are rarely described. Purpose The aim of the study was to assess the outcomes and hospital costs of patients who underwent TC or SC of PVL in our center. Methods Patients who underwent TC and SC of PVL between Jan. 2016 and Dec. 2019 were enrolled. Baseline characteristics, procedural, in-hospital and mid-term outcomes and hospital costs were compared. Results A total of 141 patients were studied (TC, n=65 and SC, n=76). The patients were elder in TC group (56.8±12.8 years vs. 50.1±12.8 years, p=0.002). Technical success was higher in SC group (83.1% vs. 98.7%, p<0.001). Procedure room time (93±38 min vs. 395±132 min, p<0.001), intensive care unit time (0 h vs. 25 h, p<0.001), length of stay from hospitalization to discharge (7 days vs. 21 days, p<0.001) and costs (¥45090±19343 vs. ¥164165±94300, p<0.001) were significantly less in TC group. After risk adjustment, there was no significant differences between in 30 days survival between TC group and SC group. However, the residual PVLs were less in SC group (43.1% vs. 12.0%, p=0.012). At a median follow-up of 21 months, there was a trend towards reduce all-cause death following TC versus SC (OR=0.054, 95% CI: 0.070 to 0.445, p=0.007). Conclusions SC for PVL is associated with higher technical rates and less residual shunt. But, the shorter length of stay and lower resources use with TC group significantly reduce hospital costs. In addition, TC achieve a better mid-term results in survival. Funding Acknowledgement Type of funding source: None

Author(s):  
M. Bergmann ◽  
C. P. Germann ◽  
J. Nordmeyer ◽  
B. Peters ◽  
F. Berger ◽  
...  

Abstract Interventional closure of congenital ventricular septal defects (VSD) is recording a continuous rise in acceptance. Complete atrioventricular block (cAVB) and residual shunting are major concerns during follow-up, but long-term data for both are still limited. We retrospectively evaluated the outcome of patients with interventional VSD closure and focused on long-term results (> 1 year follow-up). Transcatheter VSD closures were performed between 1993 and 2015, in 149 patients requiring 155 procedures (104 perimembranous, 29 muscular, 19 residual post-surgical VSDs, and 3 with multiple defects). The following devices were used: 65 × Amplatzer™ Membranous VSD Occluder, 33 × Duct Occluder II, 27 × Muscular VSD Occluder, 3 × Duct Occluder I, 24 × PFM-Nit-Occlud®, and 3 × Rashkind-Occluder. The median age at time of implantation was 6.2 (0.01–66.1) years, median height 117 (49–188) cm, and median weight 20.9 (3.2–117) kg. Median follow-up time was 6.2 (1.1–21.3) years and closure rate was 86.2% at last follow-up. Complications resulting in device explantation include one case of cAVB with a Membranous VSD occluder 7 days after implantation and four cases due to residual shunt/malposition. Six (4%) deaths occurred during follow-up with only one procedural related death from a hybrid VSD closure. Overall, our reported results of interventional VSD closure show favorable outcomes with only one (0.7%) episode of cAVB. Interventional closure offers a good alternative to surgical closure and shows improved performance by using softer devices. However, prospective long-term data in the current era with different devices are still mandatory to assess the effectiveness and safety of this procedure.


2009 ◽  
Vol 5 (1) ◽  
pp. 71
Author(s):  
Bernhard Meier ◽  

The relative risk of a thromboembolic event is four-fold higher in the 25–35% of adults with a patent foramen ovale (PFO) and 33-fold higher in patients who also have an atrial septal aneurysm. The American PICSS trial showed a yearly incidence of stroke or death after an initial event of 5% with warfarin and 9% with acetylsalicylic acid. The presence of a PFO more than doubles the mortality rate in patients with clinically relevant pulmonary embolism. The risk of a PFO increases with age. Proof of effectiveness in migraine alleviation is likely to be achievable in a couple of years – much quicker than in prevention of paradoxical embolism. Percutaneous closure of PFO has been performed with various devices at the University Hospital Bern in Switzerland since April 1994, with over 1,000 patients treated. At the last available transoesophageal echocardiogram, a significant residual shunt persisted in 4% with Amplatzer devices and 17% with other devices. During follow-up, a recurrent embolic event was observed in 1.6% of patients per year – less than would be expected under medical treatment. Several randomised multicentre trials comparing catheter closure with medical treatment have been started. The PC and CLOSURE trials are in the follow-up phase; results cannot be expected before 2010, and they may well be ‘falsely’ neutral because the follow-up is rather short for the low-risk patients randomised. In a matched control study on patients with cryptogenic stroke and a PFO, 158 patients were treated medically and 150 concomitant patients underwent percutaneous PFO closure. At four years, PFO closure resulted in a trend towards risk reduction of death, stroke or transient ischaemic attack (TIA) (9 versus 24%; p=0.08) compared with medical treatment. The calculated occurrence of patients with cryptogenic strokes associated with a PFO amounts to somewhere between 100 and 300 per year and per million population, corresponding to more than 10% of yearly coronary angioplasty cases. Coronary and peripheral paradoxical emboli without prior exclusion of competing causes plus the presumed associations between PFO and migraine or decompression illness in divers open additional vast fields of potential indications for catheter closure. Finally, the linearly decreasing prevalence of a PFO with age suggests a weeding out of PFO carriers (unless spontaneous closure is assumed). A PFO represents a lethal threat that increases with age. It can be closed percutaneously in 15 minutes virtually free of complications. The patient can resume unrestricted physical activities a few hours after the intervention.


Author(s):  
Mattia Glauber ◽  
Lorenzo Di Bacco ◽  
Jose Cuenca ◽  
Roberto Di Bartolomeo ◽  
Max Baghai ◽  
...  

Objective To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. Methods Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( n = 266) or ministernotomy ( n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. Results Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. Conclusions In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.


2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Yang Liu ◽  
Chennian Xu ◽  
Peng Ding ◽  
Jiayou Tang ◽  
Ping Jin ◽  
...  

Objectives. The purpose of this study was to review the experiences with transcatheter closure of mitral PVL after surgical valve replacement. Background. Transcatheter closure of paravalvular leak (PVL) is an intricate alternative to surgical closure. But it represents one of the most intricate procedures in the field of structural heart interventions, especially for patients with mitral PVL. Methods. From January 2015 through January 2019, 35 patients with mitral PVL after valve replacement underwent transcatheter closure. We reviewed the catheter techniques, perioperative characteristics, and prognosis. The median follow-up was 26 (3–48) months. Results. Acute procedural success was achieved in 33/35 (94.3%) patients. Twenty-five patients had single mitral prosthetic valve replacements; 10 had combined aortic and mitral prosthetic valve replacements previously; 28 had mechanical valves; and 7 had bioprosthetic valves. All percutaneous procedures were performed with local anesthesia except for seven transapical cases with general anesthesia. Multiple approaches were used: transfemoral, transapical, and transseptal via an arteriovenous loop. Multiple devices were deployed. There were no hospital deaths. The procedural time was 67–300 (124 ± 62) minutes. Fluoroscopic time was 17–50 (23.6 ± 12.1) minutes. The hospital stay was 5–17 (8.3 ± 3.2) days. Complications included recurrent hemolysis, residual regurgitation, acute renal insufficiency, and anemia. Twenty-seven (77.1%) patients improved by ≥1 New York Heart Association functional class at the 1-year follow-up. Conclusions. Transcatheter mitral PVL closure requires complex catheter techniques. However, this minimally invasive treatment could provide reliable outcomes and shorter hospital stays in selected patients. This trial is registered with NCT02917980.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jelani Grant ◽  
Bertrand Ebner ◽  
Jennifer Maning ◽  
Louis Vincent ◽  
Amanda Fernandes ◽  
...  

Introduction: TAVR is widely accepted for the management of symptomatic severe aortic stenosis (AS), but its use in rheumatic heart disease has been limited. We sought to investigate the in-hospital outcomes of patients undergoing TAVR for symptomatic severe rheumatic AS. Methods: This is a retrospective NIS Database search from 2012 to 2017 to identify patients with ICD-9 and10 procedure codes for TAVR and for rheumatic AS. We compared baseline characteristics, procedure characteristics, in-hospital mortality and length of hospitalization based on the presence or absence of rheumatic AS. Results: From a total of 32,273 patients who underwent TAVR, the incidence of non-rheumatic severe AS was 6.54%. Baseline characteristics are displayed in Table 1. All-cause mortality was similar between both groups (2.3% vs. 2.4%, p=0.780) but length of stay (days) was significantly higher in the rheumatic AS group (6.1 ± 7 vs. 5.8 ± 6.4, p<0.001). Rates of Paravalvular Leak (1.1% vs. 0.7%, p<0.05) and post-procedure ischemic stroke (5.3 vs. 2.0%, p<0.001) were higher in patients with non-rheumatic AS. Using a multivariate logistic regression model, this cohort did not reveal increased odds of in hospital mortality based on the presence of severe rheumatic AS after adjusting for confounders (OR-0.97, 95% CI 0.69 to 1.37, p=0.867). Conclusions: This retrospective cohort demonstrated that TAVR may be feasible for rheumatic severe AS. Despite an older population than reported in the literature, mortality rates, complications and hospital length of stay was comparable to patients undergoing TAVR for calcific aortic disease. Further randomized studies are needed to support these findings.


1998 ◽  
Vol 8 (4) ◽  
pp. 462-471 ◽  
Author(s):  
Gerd Hausdorf ◽  
Martin Schneider ◽  
Christoph Fink ◽  
Ulrich Neudorf ◽  
Gunther Fischer ◽  
...  

AbstractObjectivesThe purpose of this study was to evaluate the safety and efficacy of the ASDOS-tech-nique (Sulzer-Osypka GmbH, Germany) for transcatheter closure of atrial septal defects within the oval fossa.BackgroundAlthough several attempts have been made to occlude defects within the oval fossa by transcatheter techniques, none of these has gained general acceptance.MethodsPatients with a defect in the oval fossa measuring equal to or less than 20 mm diameter, with a residual septal rim of 5mm or greater, body weight greater than 10 kg, with clinical indications for surgical closure were considered for transcatheter closure. Follow-up investigations were performed at discharge, after 1, 3, 6 and 9 months, as well as after 1 and 2 years.ResultsOf 78 patients considered for closure, a device was inserted in 41 patients (53%), with success being achieved in 40 patients (98%). The ages ranged from 1.1 to 15 years (7.8 ± 1.92 years), the ’stretched’ diameter of the defect from 10 to 20 mm (14.7 ± 2.60 mm), and the diameters of the inserted devices from 25 to 45 mm (33.2 ± 5.43 mm). Transient impairment of atrioventricular conduction occured in 4 patients. During the follow-up of 23.0 ± 5.6 months elective surgical closure of a residual shunt was performed 26 months after insertion of the devcie in one patient. None of the other patients required surgery, hospitalisation or medical treatment, and none is requiring further treatment of the defect within the oval fossa. Fracture of one arm of the device occurred in 4 patients, but the fractured arms are in an unchanged and stable position after a period of at least 19 months.ConclusionsOur medium-term data show that transcatheter closure in children of defects within the oval fossa can be performed with a high efficacy and safety using the ASDOS-device.


2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Magdalena Cuman ◽  
Giuseppe Santoro ◽  
Katia Capellini ◽  
Emanuele Gasparotti ◽  
Alessandra Pizzuto ◽  
...  

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Faizus Sazzad ◽  
Ong Zhi Xian ◽  
Ashlynn Ler ◽  
Chang Guohao ◽  
Kang Giap Swee ◽  
...  

Abstract Background CORKNOT® facilitates a reduction in cardiopulmonary bypass (CPB) time, aortic cross clamp (ACC) time and operative time, but reported to be associated with other complications. We aim to quantify the incidence of valvular complications related to CORKNOT® and determine the feasibility of its use between different valvular surgeries. Methods Patients who underwent heart valve repair or replacement surgery via the use of automated titanium suture fasteners (CORKNOT®) in a tertiary care hospital were included in the study. This single-centre retrospective study was conducted on 132 patients between January 2016 and June 2018. Results In our study, the overall mean operative time was 320.0 ± 97.0 min, mean CPB time was 171.4 ± 76.0 min and the calculated mean ACC time was 105.9 ± 54.0 min. Fifty-eight patients (43.9%) underwent minimally invasive valve replacement or repair surgery and 66 patients (50.0%) underwent concomitant procedures. A total of 157 valves were operated on, with 112 (84.8%) single valve surgeries, 15 (11.4%) double valve surgeries and 5 (3.8%) triple valve surgeries. After reviewed by the cardiologist blinded towards the study, we report trivial and/or mild paravalvular leak (PVL) in immediate post-operative echocardiography was found in 1 (1.01%) patients. There were no reported cases of valvular thrombosis, leaflet perforation, device dislodgement or embolization, moderate and/or severe PVL during hospitalization and follow-up echocardiography within 1 year. Single mitral valve and aortic surgeries had comparable incidences of post surgical complications. Conclusion We conclude the feasibility of CORKNOT® utilisation in mitral and aortic valve surgeries. Additionally, incidence of CORKNOT® related complications in heart valve repair or replacement surgery is less usual in our setting than previously reported. These results motivate the use of CORKNOT® as a valid alternative with complete commitment.


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