First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery

2020 ◽  
Author(s):  
Ali El-Sayed Ahmad ◽  
Saad Salamate ◽  
Mohamed Amer ◽  
Sami Sirat ◽  
Nadejda Monsefi ◽  
...  
Keyword(s):  
Cardiopulmonary Bypass ◽  
Minimally Invasive ◽  
Femoral Artery ◽  
Academic Research ◽  
Vascular Complications ◽  
Valve Surgery ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Surgical Closure ◽  
Minimally Invasive Valve Surgery

Abstract Background To more minimize the minimally invasive valve surgeries, percutaneous vascular access and closure has been used for the establishment of extracorporeal circulation. This study investigates early clinical outcomes of patients who received MANTA for femoral artery closure as first experiences in minimally invasive valve surgery. Methods Between January 2019 and July 2019, 103 consecutive patients (mean age: 58 ± 11 years) underwent video-assisted minimally invasive valve surgery through right anterior minithoracotomy at two cardiac surgery referral centers in Germany. Percutaneous cannulation for cardiopulmonary bypass and femoral artery closure with MANTA were performed in all patients: 18-F and 14-F MANTA were used in 88 (85.4%) and 15 (14.6%) patient, respectively. Mitral, aortic, tricuspid, and double valve surgeries were performed in 51 (49.5%), 39 (37.9%), 7 (6.8%), and 6 (5.8%), patients, respectively. Clinical data were prospectively entered into our institutional database. Results Cardiopulmonary bypass time and cross-clamping time were 69 ± 23 and 38 ± 14 minutes, respectively. Except for two patients with late pseudoaneurysm on 15th and 23th postoperative day, neither major nor minor vascular complications nor vascular closure device failure according to the Valve Academic Research Consortium-2 definition criteria was observed. Additionally, no wound healing disorders or conversion to surgical closure was observed. Conclusions MANTA as percutaneous femoral artery closure after decannulation of cardiopulmonary bypass is a safe, feasible, and effective approach and yields excellent early outcomes. Larger size studies are needed to evaluate more the efficacy and safety of MANTA.

scholarly journals A Novel Plug-Based Vascular Closure Device for Percutaneous Femoral Artery Closure in Patients Undergoing Minimally-Invasive Valve Surgery

2021 ◽  
Vol 8 ◽  
Author(s):  
Andreas Schaefer ◽  
Harun Sarwari ◽  
Hermann Reichenspurner ◽  
Lenard Conradi
Keyword(s):  
Cardiopulmonary Bypass ◽  
Minimally Invasive ◽  
Valve Surgery ◽  
Ease Of Use ◽  
Bleeding Complications ◽  
Closure Device ◽  
Tricuspid Valve Repair ◽  
Vascular Closure Device ◽  
Aortic Cross Clamp Time ◽  
Minimally Invasive Valve Surgery

Objectives: Surgical exposure of groin vessels to establish cardiopulmonary bypass (CPB) for minimally-invasive valve surgery (MIS) is standard of care but may result in postoperative wound healing disorders or seroma formation. Therefore, adaption of transcatheter techniques for fully percutaneous insertion of CPB cannulae may improve clinical results. We herein analyze a single center experience with a novel plug-based vascular closure device for MIS.Methods: Between 03/2020 and 02/2021 MIS using the MANTA™ (Teleflex Medical Inc., Wayne, PA, USA) vascular closure device was performed in 28 consecutive patients (58.8 ± 10.6 years, 60.3% male, logEuroSCORE II 1.1 ± 0.8%) receiving mitral and/or tricuspid valve repair/replacement. Concomitant procedures were left atrial appendage occlusion and cryoablation for atrial fibrillation in 21.4% (6/28) and 10.7% (3/28) of patients, respectively. Data were retrospectively analyzed in accordance with standardized M-VARC definitions. MANTA™ device success and early safety was defined as absence of any access site or access related vascular injury and major and life-threatening bleeding complications.Results: MANTA™ device success with immediate hemostasis and early safety were 96.4% (27/28). In one case, device failure necessitated surgical cut down without further complications. Mean aortic cross clamp time and cardiopulmonary bypass were 96.5 ± 24.2 min and 150.2 ± 33.6 min. Stroke, renal failure or myocardial infarction were not observed. Intensive care unit and total hospital stay were 1.7 ± 0.8 days and 10.1 ± 5.7 days. Overall 30-day mortality was 0%. Post-procedure echocardiography presented one case of residual moderate tricuspid regurgitation and competent valves in all other cases.Conclusions: The MANTA™ device is safe and effective in MIS. Its ease of use and effectiveness to achieve immediate hemostasis have further simplified MIS.

First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery

2020 ◽  
Author(s):  
A. El-Sayed Ahmad ◽  
S. Salamate ◽  
M. Amer ◽  
S. Sirat ◽  
Ö. Akhavuz ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Valve Surgery ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Minimally Invasive Valve Surgery

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI

2021 ◽  
Author(s):  
Lukasz Kmiec ◽  
Matthaeus Zerdzitzki ◽  
Christof Schmid ◽  
Kurt Debl ◽  
Samuel Sossalla ◽  
...  
Keyword(s):  
Academic Research ◽  
Case Series ◽  
Vascular Complications ◽  
Female Gender ◽  
Closure Device ◽  
Complication Rates ◽  
Imaging Data ◽  
Patient Death ◽  
Vascular Closure Device ◽  
Puncture Site

Abstract Background The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. Methods This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. Results A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. Conclusions The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

Femoral cannulation for cardiopulmonary bypass with a novel bidirectional perfusion cannula

2021 ◽  
Keyword(s):  
Cardiopulmonary Bypass ◽  
Mitral Valve ◽  
Minimally Invasive ◽  
Femoral Artery ◽  
Mitral Valve Surgery ◽  
Valve Surgery ◽  
The Novel ◽  
Postoperative Course ◽  
Video Tutorial ◽  
Percutaneous Cannulation

The use of the novel bidirectional femoral cannula is described in this video tutorial. We demonstrate the percutaneous cannulation and decannulation of the femoral artery for cardiopulmonary bypass in a patient undergoing minimally invasive mitral valve surgery. The procedure itself is presented step by step for each important phase. Finally, we report the postoperative course following the successful use of a peripheral bidirectional cannula.

scholarly journals Peripheral vascular complications following totally endoscopic cardiac surgery

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ling-chen Huang ◽  
Qi-chen Xu ◽  
Dao-zhong Chen ◽  
Xiao-fu Dai ◽  
Liang-wan Chen
Keyword(s):  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Minimally Invasive ◽  
Femoral Artery ◽  
Femoral Vein ◽  
Vascular Complications ◽  
Minimally Invasive Cardiac Surgery ◽  
Venous Cannulation ◽  
Artery Cannulation ◽  
Short Period

Abstract Background Clinical application of minimally invasive cardiac surgery has increased annually. Cardiopulmonary bypass is established by peripheral cannulation during minimally invasive cardiac surgery. The methodology of peripheral cannulation has unique characteristics, which have associated risks and complications. Few studies have been conducted on this topic. In this study, we focused on complications of peripheral cannulation in totally endoscopic cardiac surgery. Methods Patients who underwent totally endoscopic cardiac surgery with cardiopulmonary bypass established by peripheral cannulation at our institution between January 2019 and June 2020 were reviewed. Specific cannulation strategies and related cannulation complications were noted. Results One hundred forty-eight patients underwent totally endoscopic cardiac surgery. One hundred forty-eight cannulations were performed in the femoral artery and vein, and eleven were performed in the internal jugular vein (combined with the femoral vein). The median size of the femoral artery cannula was 22Fr, and that of the venous canula was 24Fr. One patient died of retroperitoneal haematoma due to femoral artery injury. Three patients had postoperative lower limb oedema. One patient had a postoperative diagnosis of femoral vein thrombosis. Conclusions Different from cannulation in patients with aortic dissection and aneurysms, femoral artery cannulation is safe in totally endoscopic cardiac surgery. Venous cannulation is characterized by a large-bore venous cannula and a short period of use. There are few reports about complications of venous cannulation. The main complication in this study was mechanical injury, and the key to preventing this injury is meticulous manipulation during surgery.

Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery

2020 ◽  
Vol 110 (1) ◽  
pp. 85-91 ◽  
Author(s):  
Mikael Kastengren ◽  
Peter Svenarud ◽  
Göran Källner ◽  
Magnus Settergren ◽  
Anders Franco-Cereceda ◽  
...  
Keyword(s):  
Mitral Valve ◽  
Minimally Invasive ◽  
Mitral Valve Surgery ◽  
Valve Surgery ◽  
Closure Device ◽  
Vascular Closure Device

scholarly journals Long-term results of endoclamping in patients undergoing minimally invasive mitral valve surgery where external aortic clamping cannot be used – a propensity matched analysis

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Ayse Cetinkaya ◽  
Emad Ebraheem ◽  
Karin Bramlage ◽  
Stefan Hein ◽  
Peter Bramlage ◽  
...  
Keyword(s):  
Cardiopulmonary Bypass ◽  
Mitral Valve ◽  
Minimally Invasive ◽  
Hospital Stay ◽  
Statistical Significance ◽  
Vascular Complications ◽  
Mitral Valve Surgery ◽  
Valve Surgery ◽  
Long Term Results ◽  
Aortic Clamping

Abstract Background Minimally invasive mitral valve surgery is standard of care in many centres and it is commonly associated with the need for cardiopulmonary bypass. Conventional external aortic clamping (exoclamping) is not always feasible, so endoaortic clamping (endoclamping) has evolved as a viable alternative. The aim of this study is to compare endoclamping (Intraclude™, Edwards Lifesciences) with exoclamping (Chitwood) during minimally invasive mitral valve procedures. Methods This single-centre study included 822 consecutive patients undergoing minimally invasive mitral valve procedures. The endoclamp was used in 64 patients and the exoclamp in 758. Propensity-score (PS) matching was performed resulting in 63 patients per group. Outcome measures included procedural variables, length of intensive care unit (ICU) and hospital stay, major adverse cardiac and cerebrovascular events (MACCE) and repeat surgery. Results The mean age was similar in the two group (62.2 [endoclamp] vs. 63.5 [exoclamp] years; p = 0.554), as were the cardiopulmonary bypass (145 vs. 156 min; p = 0.707) and the procedure time (203 vs. 211 min; p = 0.648). The X-clamp time was significantly shorter in the endoclamp group (88 vs. 99 min; p = 0.042). Length of ICU stay (25.0 vs. 23.0 h) and length of hospital stay (10.0 vs. 9.0 days) were slightly longer in the endoclamp group, but without statistical significance. There were nominal but no statistically significant differences between the groups in the rates of stroke, vascular complications, myocardial infarction or repeat mitral valve surgery. The conversion rate to open sternotomy approach was 2.4% without difference between groups. The estimated 7-year survival rate was similar for both groups (89.9% [endoclamp]; 84.0% [exoclamp]) with a hazard ratio of 1.291 (95% CI 0.453–3.680). Conclusions Endoaortic clamping is an appropriate and reasonably safe alternative to the conventional Chitwood exoclamp for patients in which the exoclamp cannot be used because the ascending aorta cannot be safely mobilised.

Symptomatic vascular complications after vascular closure device use following diagnostic and interventional catheterisation

VASA ◽  
2004 ◽  
Vol 33 (2) ◽  
pp. 78-81 ◽  
Author(s):  
Thalhammer ◽  
Aschwanden ◽  
Jeanneret ◽  
Labs ◽  
Jäger
Keyword(s):  
Current Literature ◽  
Vascular Complications ◽  
University Hospital ◽  
Closure Device ◽  
Ultrasound Guided ◽  
Vascular Closure Device ◽  
Device Use ◽  
Arterial Stenoses ◽  
The University ◽  
Stenotic Lesions

Background: Haemostatic puncture closure devices for rapid and effective hemostasis after arterial catheterisation are a comfortable alternative to manual compression. Implanting a collagen plug against the vessel wall may become responsible for other kind of vascular injuries i.e. thrombotic or stenotic lesions and peripheral embolisation. The aim of this paper is to report our clinically relevant vascular complications after Angio-Seal® and to discuss the results in the light of the current literature. Patients and methods: We report the symptomatic vascular complications in 17 of 7376 patients undergoing diagnostic or therapeutic catheterisation between May 2000 and March 2003 at the University Hospital Basel. Results: Most patients presented with ischaemic symptoms, arterial stenoses or occlusions and thrombotic lesions (n = 14), whereas pseudoaneurysms were extremely rare (n = 3). Most patients with ischaemic lesions underwent vascular surgery and all patients with a pseudoaneurysm were successfully treated by ultrasound-guided compression. Conclusions: Severe vascular complications after Angio-Seal® are rare, consistent with the current literature. There may be a shift from pseudoaneurysms to ischaemic lesions.

A New Access Site Management Tool: The Angio-Seal™ Hemostatic Puncture Closure Device

1995 ◽  
Vol 2 (3) ◽  
pp. 289-296 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Mohamed Allaoui ◽  
Olivier Tricoche
Keyword(s):  
Arterial Wall ◽  
Bypass Graft ◽  
Vascular Complications ◽  
Common Femoral Artery ◽  
Management Tool ◽  
Closure Device ◽  
Manual Compression ◽  
Vascular Closure Device ◽  
Arterial Lumen ◽  
Manual Pressure

Purpose: Given the increasing number of percutaneously applied endovascular therapies, the incidence of access-related vascular complications can be expected to rise, particularly in association with those techniques requiring large sheaths or anticoagulation. The need exists for a safe, easy to use, and effective hemostatic technique to replace the labor-intensive method of manual compression. Methods: A bioabsorbable, sheath-delivered vascular closure device (Angio-Seal™) has been developed that deposits a small collagen plug within the arterial wall to mechanically seal the puncture defect. An anchor connected by suture to the plug is first deployed in the arterial lumen and pulled flush against the interior arterial wall to guard against intraluminal deposition of the collagen. Results: The Angio-Seal device was deployed successfully in 80 (96%) of 83 attempts involving common femoral arteries accessed for peripheral angioplasty (n = 30), coronary angiography (n = 30), and coronary angioplasty (n = 16). Three popliteal artery access sites and one femoropopliteal bypass graft were also treated. Hemostasis was immediate in 78 cases (98%); 2 sites required a 5-minute manual compression to effect a secure seal. Three devices failed to deploy, and manual pressure was used to close the puncture. Nondeployment did not cause any sequelae, and no complications were encountered with the technique. Conclusions: This novel vascular closure device is quick (< 1 minute application time) and simple to use, providing a positive seal of common femoral artery puncture sites for both peripheral and coronary interventions. It appears to be a reliable alternative to standard manual hemostasis.

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