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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical cut-down and arterial puncture under direct vision |
| ||
| Percutaneous arteriotomy closed with closure device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous arteriotomy closed using a plug-based arteriotomy closure device | Procedure | Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). |
| Measure | Description | Time Frame |
|---|---|---|
| Major vascular groin-related complication according to the VARC-2 definition criteria | During the first 8 weeks after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patientes 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31794742 | Derived | Kastengren M, Svenarud P, Kallner G, Settergren M, Franco-Cereceda A, Dalen M. Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery. Ann Thorac Surg. 2020 Jul;110(1):85-91. doi: 10.1016/j.athoracsur.2019.10.038. Epub 2019 Nov 30. |
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Individual participant data not planned to be shared.
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| Surgical cut-down and arterial puncture under direct vision | Procedure | Surgical cut-down and arterial puncture under direct vision. |
|
| Access-site related groin infection | During the first 8 weeks after surgery |