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Published in: Clinical Research in Cardiology 4/2016

01-04-2016 | Original Paper

Transcatheter mitral valve repair with the MitraClip® can be performed without general anesthesia and without conscious sedation

Authors: Jakob Ledwoch, Predrag Matić, Jennifer Franke, Sameer Gafoor, Stefan Bertog, Markus Reinartz, Laura Vaskelyte, Ilona Hofmann, Horst Sievert

Published in: Clinical Research in Cardiology | Issue 4/2016

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Abstract

Background

General anesthesia is known to be associated with an increased risk for complications, especially in elderly and multi-morbid patients, the primary target population of the MitraClip® technique. The aim is to assess whether general anesthesia and even conscious sedation can be avoided during the MitraClip® procedure.

Methods

A total of 91 consecutive patients who underwent MitraClip® implantation [median 77 years, (IQR 72–83), 40 % female] were retrospectively analyzed. The first 26 patients were treated in general anesthesia. Afterwards, local anesthesia was chosen as primary anesthetic approach. Altogether, 28 (31 %) patients received general anesthesia, local anesthesia was performed in 35 (38 %) patients with sedation and in 28 (31 %) patients without sedation.

Results

The respective patient groups were similar regarding their baseline characteristics. Procedural success (successful implantation of at least one clip and post-procedure MR grade ≤2) was achieved in 89 % with no difference between the groups (93 % in general anesthesia, 89 % in local anesthesia with sedation, 86 % in local anesthesia without sedation, p = ns). No difference regarding hospital complications was noted. Local anesthesia with and without sedation was associated with less necessity for ICU/IMC stay (100 % in general anesthesia, 14 % in local anesthesia with sedation, 14 % in local anesthesia without sedation; p < 0.0001). One-year estimated survival was not significantly different among the groups (63, 82 and 75 %; p = ns).

Conclusions

Transcatheter mitral valve repair with the MitraClip® can be performed without general anesthesia and even without conscious sedation with similar procedural success and complication rates.
Literature
1.
go back to reference Conradi L, Treede H, Rudolph V et al (2013) Surgical or percutaneous mitral valve repair for secondary mitral regurgitation: comparison of patient characteristics and clinical outcomes. Eur J Cardiothorac Surg 44:490–496CrossRefPubMed Conradi L, Treede H, Rudolph V et al (2013) Surgical or percutaneous mitral valve repair for secondary mitral regurgitation: comparison of patient characteristics and clinical outcomes. Eur J Cardiothorac Surg 44:490–496CrossRefPubMed
2.
go back to reference Schillinger W, Hunlich M, Baldus S et al (2013) Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry. EuroIntervention 9:84–90CrossRefPubMed Schillinger W, Hunlich M, Baldus S et al (2013) Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry. EuroIntervention 9:84–90CrossRefPubMed
3.
go back to reference Boekstegers P, Hausleiter J, Baldus S et al (2014) Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system. Clin Res Cardiol 103:85–96CrossRefPubMed Boekstegers P, Hausleiter J, Baldus S et al (2014) Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system. Clin Res Cardiol 103:85–96CrossRefPubMed
4.
go back to reference Jin F, Chung F (2001) Minimizing perioperative adverse events in the elderly. Br J Anaesth 87:608–624CrossRefPubMed Jin F, Chung F (2001) Minimizing perioperative adverse events in the elderly. Br J Anaesth 87:608–624CrossRefPubMed
5.
go back to reference Oguri A, Yamamoto M, Mouillet G et al (2014) Clinical outcomes and safety of transfemoral aortic valve implantation under general versus local anesthesia: subanalysis of the French Aortic National CoreValve and Edwards 2 registry. Circ Cardiovasc Interv 7:602–610CrossRefPubMed Oguri A, Yamamoto M, Mouillet G et al (2014) Clinical outcomes and safety of transfemoral aortic valve implantation under general versus local anesthesia: subanalysis of the French Aortic National CoreValve and Edwards 2 registry. Circ Cardiovasc Interv 7:602–610CrossRefPubMed
6.
go back to reference Yamamoto M, Meguro K, Mouillet G et al (2013) Effect of local anesthetic management with conscious sedation in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 111:94–99CrossRefPubMed Yamamoto M, Meguro K, Mouillet G et al (2013) Effect of local anesthetic management with conscious sedation in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 111:94–99CrossRefPubMed
7.
go back to reference Rassaf T, Balzer J, Zeus T, et al (2014) Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system. Catheter Cardiovasc Interv 84:E38–42CrossRefPubMed Rassaf T, Balzer J, Zeus T, et al (2014) Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system. Catheter Cardiovasc Interv 84:E38–42CrossRefPubMed
8.
go back to reference Ussia GP, Barbanti M, Tamburino C (2010) Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv 75:1137–1140PubMed Ussia GP, Barbanti M, Tamburino C (2010) Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv 75:1137–1140PubMed
9.
go back to reference Feldman T, Wasserman HS, Herrmann HC et al (2005) Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 46:2134–2140CrossRefPubMed Feldman T, Wasserman HS, Herrmann HC et al (2005) Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 46:2134–2140CrossRefPubMed
10.
go back to reference Kappetein AP, Head SJ, Genereux P et al (2013) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 145:6–23CrossRefPubMed Kappetein AP, Head SJ, Genereux P et al (2013) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 145:6–23CrossRefPubMed
11.
go back to reference Teufel T, Steinberg DH, Wunderlich N et al (2012) Percutaneous mitral valve repair with the MitraClip(R) system under deep sedation and local anaesthesia. EuroIntervention 8:587–590CrossRefPubMed Teufel T, Steinberg DH, Wunderlich N et al (2012) Percutaneous mitral valve repair with the MitraClip(R) system under deep sedation and local anaesthesia. EuroIntervention 8:587–590CrossRefPubMed
12.
go back to reference Ely EW, Truman B, Shintani A et al (2003) Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA 289:2983–2991CrossRefPubMed Ely EW, Truman B, Shintani A et al (2003) Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA 289:2983–2991CrossRefPubMed
13.
go back to reference Baldus S, Schillinger W, Franzen O et al (2012) MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail 14:1050–1055CrossRefPubMed Baldus S, Schillinger W, Franzen O et al (2012) MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail 14:1050–1055CrossRefPubMed
14.
go back to reference Surder D, Pedrazzini G, Gaemperli O, et al (2013) Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart 99:1034–1040CrossRefPubMed Surder D, Pedrazzini G, Gaemperli O, et al (2013) Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart 99:1034–1040CrossRefPubMed
15.
go back to reference Armoiry X, Brochet E, Lefevre T et al (2013) Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry. Arch Cardiovasc Dis 106:287–294CrossRefPubMed Armoiry X, Brochet E, Lefevre T et al (2013) Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry. Arch Cardiovasc Dis 106:287–294CrossRefPubMed
16.
go back to reference Grasso C, Capodanno D, Scandura S et al (2013) One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry). Am J Cardiol 111:1482–1487CrossRefPubMed Grasso C, Capodanno D, Scandura S et al (2013) One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry). Am J Cardiol 111:1482–1487CrossRefPubMed
17.
go back to reference Braun D, Lesevic H, Orban M et al (2014) Percutaneous edge-to-edge repair of the mitral valve in patients with degenerative versus functional mitral regurgitation. Catheter Cardiovasc Interv 84:137–146CrossRefPubMed Braun D, Lesevic H, Orban M et al (2014) Percutaneous edge-to-edge repair of the mitral valve in patients with degenerative versus functional mitral regurgitation. Catheter Cardiovasc Interv 84:137–146CrossRefPubMed
18.
go back to reference Blazek S, Lurz P, Mangner N, et al (2014) Incidence, characteristics and functional implications of cerebral embolic lesions after the MitraClip procedure. EuroIntervention 10:1195–1203CrossRef Blazek S, Lurz P, Mangner N, et al (2014) Incidence, characteristics and functional implications of cerebral embolic lesions after the MitraClip procedure. EuroIntervention 10:1195–1203CrossRef
19.
go back to reference Whitlow PL, Feldman T, Pedersen WR et al (2012) Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol 59:130–139CrossRefPubMed Whitlow PL, Feldman T, Pedersen WR et al (2012) Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol 59:130–139CrossRefPubMed
20.
go back to reference Tadie JM, Behm E, Lecuyer L et al (2010) Post-intubation laryngeal injuries and extubation failure: a fiberoptic endoscopic study. Intensive Care Med 36:991–998CrossRefPubMed Tadie JM, Behm E, Lecuyer L et al (2010) Post-intubation laryngeal injuries and extubation failure: a fiberoptic endoscopic study. Intensive Care Med 36:991–998CrossRefPubMed
21.
go back to reference Jaber S, Jung B, Corne P et al (2010) An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med 36:248–255CrossRefPubMed Jaber S, Jung B, Corne P et al (2010) An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med 36:248–255CrossRefPubMed
22.
go back to reference Motloch LJ, Rottlaender D, Reda S et al (2012) Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol 101:45–53CrossRefPubMed Motloch LJ, Rottlaender D, Reda S et al (2012) Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol 101:45–53CrossRefPubMed
23.
go back to reference Babaliaros V, Devireddy C, Lerakis S et al (2014) Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv 7:898–904CrossRefPubMed Babaliaros V, Devireddy C, Lerakis S et al (2014) Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv 7:898–904CrossRefPubMed
24.
go back to reference Reddy VY, Doshi SK, Sievert H et al (2013) Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation 127:720–729CrossRefPubMed Reddy VY, Doshi SK, Sievert H et al (2013) Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation 127:720–729CrossRefPubMed
25.
go back to reference Wutzler A, Mueller A, Loehr L et al (2014) Minimal and deep sedation during ablation of ventricular tachycardia. Int J Cardiol 172:161–164CrossRefPubMed Wutzler A, Mueller A, Loehr L et al (2014) Minimal and deep sedation during ablation of ventricular tachycardia. Int J Cardiol 172:161–164CrossRefPubMed
26.
go back to reference Maisano F, Franzen O, Baldus S, et al (2013) Percutaneous mitral valve interventions in the real world: early and 1 year results from the ACCESS-EU, a prospective, multicenter, non-randomized post-approval study of the MitraClip(R) therapy in Europe. J Am Coll Cardiol 62:1052–1061CrossRefPubMed Maisano F, Franzen O, Baldus S, et al (2013) Percutaneous mitral valve interventions in the real world: early and 1 year results from the ACCESS-EU, a prospective, multicenter, non-randomized post-approval study of the MitraClip(R) therapy in Europe. J Am Coll Cardiol 62:1052–1061CrossRefPubMed
27.
go back to reference Grewal KS, Malkowski MJ, Piracha AR et al (2000) Effect of general anesthesia on the severity of mitral regurgitation by transesophageal echocardiography. Am J Cardiol 85:199–203CrossRefPubMed Grewal KS, Malkowski MJ, Piracha AR et al (2000) Effect of general anesthesia on the severity of mitral regurgitation by transesophageal echocardiography. Am J Cardiol 85:199–203CrossRefPubMed
28.
go back to reference Di Prima AL, Covello DR, Franco A, et al (2014) Do patients undergoing mitraclip implantation require routine ICU admission?. J Cardiothorac Vasc Anesth 28:1479–1483CrossRefPubMed Di Prima AL, Covello DR, Franco A, et al (2014) Do patients undergoing mitraclip implantation require routine ICU admission?. J Cardiothorac Vasc Anesth 28:1479–1483CrossRefPubMed
29.
go back to reference Nickenig G, Estevez-Loureiro R, Franzen O et al (2014) Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. J Am Coll Cardiol 64:875–884CrossRefPubMed Nickenig G, Estevez-Loureiro R, Franzen O et al (2014) Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. J Am Coll Cardiol 64:875–884CrossRefPubMed
30.
go back to reference Orban M, Braun D, Sonne C et al (2014) Dangerous liaison: successful percutaneous edge-to-edge mitral valve repair in patients with end-stage systolic heart failure can cause left ventricular thrombus formation. EuroIntervention. 10:253–259CrossRefPubMed Orban M, Braun D, Sonne C et al (2014) Dangerous liaison: successful percutaneous edge-to-edge mitral valve repair in patients with end-stage systolic heart failure can cause left ventricular thrombus formation. EuroIntervention. 10:253–259CrossRefPubMed
31.
go back to reference Huntgeburth M, Muller-Ehmsen J, Brase C, Baldus S, Rudolph V (2014) Thrombus formation at the MitraClip system during percutaneous mitral valve repair. JACC Cardiovasc Interv. 7:e111–e112CrossRefPubMed Huntgeburth M, Muller-Ehmsen J, Brase C, Baldus S, Rudolph V (2014) Thrombus formation at the MitraClip system during percutaneous mitral valve repair. JACC Cardiovasc Interv. 7:e111–e112CrossRefPubMed
32.
go back to reference Hamm K, Barth S, Diegeler A, Kerber S (2013) Stroke and thrombus formation appending to the MitraClip: what is the appropriate anticoagulation regimen? J Heart Valve Dis 22:713–715PubMed Hamm K, Barth S, Diegeler A, Kerber S (2013) Stroke and thrombus formation appending to the MitraClip: what is the appropriate anticoagulation regimen? J Heart Valve Dis 22:713–715PubMed
Metadata
Title
Transcatheter mitral valve repair with the MitraClip® can be performed without general anesthesia and without conscious sedation
Authors
Jakob Ledwoch
Predrag Matić
Jennifer Franke
Sameer Gafoor
Stefan Bertog
Markus Reinartz
Laura Vaskelyte
Ilona Hofmann
Horst Sievert
Publication date
01-04-2016
Publisher
Springer Berlin Heidelberg
Published in
Clinical Research in Cardiology / Issue 4/2016
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-015-0918-0

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