Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery

Study Overview
=================
Brief Summary
-----------------
A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.

Official Title
-----------------
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery

Conditions
-----------------
Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device
* Procedure: Surgical cut-down and arterial puncture under direct vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical cut-down and arterial puncture under direct vision<br> | Procedure: Surgical cut-down and arterial puncture under direct vision<br>* Surgical cut-down and arterial puncture under direct vision.<br>|
| Percutaneous arteriotomy closed with closure device<br> | Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device<br>* Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major vascular groin-related complication according to the VARC-2 definition criteria |  | During the first 8 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor vascular groin-related complication according to the VARC-2 definition criteria |  | During the first 8 weeks after surgery | 
| Access-site related groin seroma |  | During the first 8 weeks after surgery | 
| Access-site related groin infection |  | During the first 8 weeks after surgery |