Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip<sup>®</sup> system

Horn, Patrick; Hellhammer, Katharina; Minier, Michael; Stenzel, Monika A.; Veulemans, Verena; Rassaf, Tienush; Luedike, Peter; Pohl, Julia; Balzer, Jan C.; Zeus, Tobias; Kelm, Malte; Westenfeld, Ralf

doi:10.1002/ccd.26884

Cited by 30 publications

(23 citation statements)

References 22 publications

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“…Our study confirms the results of previous studies that demonstrated the safety and efficacy of MitraClip ® procedures using DS [ 2 ; 3 ; 10 ]. Only one patient (1.5%) had to be converted to GA due to respiratory depression, which is a low conversion rate and consistent with previous reports [ 2 ; 5 ]. Procedural success was achieved in 100% of the patients irrespective the difficulty of DS.…”

Section: Discussionsupporting

confidence: 91%

“…No in-hospital deaths occurred. We previously reported in a larger study that mortality did not differ between MitraClip ® procedures using DS and procedures using GA [ 2 ]. These mortality rates are comparable to those reported for MitraClip ® procedures using GA, which have been reported as 2.5% in the TRAMI registry [ 11 ] and 4.8% in the EVEREST II high-risk study [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…Adverse event rates of pneumonia, renal failure, stroke or vascular complications were low and have been described in equal numbers in MitraClip ® procedures performed under GA or DS [ 2 ; 4 ]. In a previous report, the rate of pneumonia in patients undergoing DS for MitraClip ® procedures was 6.7% [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

“…With the advent of minimally invasive therapeutic options for the treatment of valvular heart disease for most of these severely morbid patients, the concept of the use of deep sedation (DS) as opposed to GA has emerged. Previous studies have shown that the MitraClip ® procedure can be performed safely and efficiently using DS [ 2 – 5 ]. Furthermore, we have shown that MitraClip ® procedures using DS require less preparation time in the catheter laboratory than procedures performed using GA [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

“…Previous studies have shown that the MitraClip ® procedure can be performed safely and efficiently using DS [ 2 – 5 ]. Furthermore, we have shown that MitraClip ® procedures using DS require less preparation time in the catheter laboratory than procedures performed using GA [ 2 ]. Another study demonstrated a significantly shorter stay in the intensive care unit (ICU) for patients in which MitraClip ® procedures were performed with DS [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

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High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

et al. 2018

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BackgroundThe safety and efficacy of deep sedation (DS) in MitraClip® procedures have been shown previously. However, clinical experience demonstrates that in some patients DS is difficult to achieve. We hypothesize that some patient characteristics can predict difficult DS.MethodsWe prospectively analysed 69 patients undergoing MitraClip® procedures using DS. Application of DS was graded as simple (group 1) or difficult (group 2) depending on a cumulative score based on one point for each of the following criteria: decrease in oxygen saturation, retention of carbon dioxide, disruptive body movements, and the need for catecholamines. Patients with one point or less were classified as group 1, and patients with two or more points were classified as group 2.ResultsIn 58 of 69 patients (84.1%), the performance of DS was simple, while in 11 patients (15.9%), DS was difficult to achieve. Patients with difficult DS were characterized by a higher body mass index (33.7 ± 6.0 kg/m2 vs. 26.1 ± 4.1; p = 0.001), younger age (67 ± 13 years vs. 75 ± 13 years; p = 0.044), and reduced left ventricular ejection fraction (36% ± 10 vs. 45% ± 14; p = 0.051) and presented more often with an obstructive sleep apnoea syndrome (6.9% vs. 45.5%; p = 0.003). In the multivariate analysis, body mass index was an independent predictor of difficult DS. Using a body mass index of 31 kg/m2 as a cut-off value, the sensitivity of predicting difficult DS was 73%, and the specificity was 88%. Using a body mass index of 35 kg/m2 as a cut-off value, the specificity increased to 97%, with a sensitivity of 36%.ConclusionIn patients with a higher body mass index who undergo MitraClip® procedures, DS might be difficult to perform.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

et al. 2018

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Effectiveness and safety of same day discharge after left atrial appendage closure under moderate conscious sedation

Marmagkiolis

Ateş

Kose

et al. 2020

Cathet Cardio Intervent

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Background Left atrial appendage occlusion (LAAO) using Watchman device has become a world‐wide, well‐established therapeutic alternative to chronic systemic oral anticoagulation in patient who are at high‐risk of bleeding with paroxysmal (PAF) or chronic atrial fibrillation (Afib). Currently, LAAO procedures are performed under general anesthesia (GA) and patients stay overnight post procedure in the United States. We aimed to present the effectiveness and safety of same day discharge following LAAO under moderate conscious sedation (MCS) in patients without procedural complications. Methods A total of 112 patients between August 2019 and May 2020 with elevated CHA2DS2VASc (median score of 3) underwent transesophageal echocardiography (TEE)‐guided LAAO with FDA approved Watchman (Boston Scientific, MN) under MCS and discharged home on the same day 6 hr following their post procedural transthoracic echocardiogram (TTE) evaluations. All patients had next day TTE and follow up at the cardiology clinic. We prospectively evaluated clinical and procedural outcomes using medical records of these patients. Results Among all the patients, the mean age was 83.5 ± 8.5 years, 45 (40%) were women. Procedural duration, device implant time and fluoroscopic times were 45 ± 8.6, 14.5 ± 7.8 and 10.2 ± 1.2 min, respectively. The median required dosage of propofol was 105 ± 2.8 mg. No complications arose from MCS. There was no need for conversion to GA in any of the patients during the procedure. All patients were able to be discharged 6 hr following their TTE evaluation post procedure. There were no procedural complications. Conclusions Same day discharge following LAAO closure seems to be safe and effective in patients without procedural complications. LAAO can also be performed safely and effectively under moderate conscious sedation. Applying moderate conscious sedation may simplify the LAAO procedure, reduce procedural time, procedural costs and hospital stay while increasing overall patient satisfaction.

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Outcomes of patients undergoing edge‐to‐edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation

Geisler,

Schreieck,

Euper

et al. 2023

Cathet Cardio Intervent

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BackgroundThe development of the PASCAL transcatheter valve repair system for treating mitral regurgitation (MR) greatly extends therapeutic options.AimsTo assess the safety, efficacy, and time efficiency of the PASCAL system in transcatheter edge‐to‐edge repair (TEER) under conscious sedation (CS).MethodsThis is a retrospective, two‐center, German registry study consisting of 211 patients who underwent TEER using the PASCAL system under CS. The endpoints were to assess (1) technical, device, and procedural success as per Mitral Valve Academic Research Consortium (MVARC), (2) conversion rate to general anesthesia (GA), (3) hospital length of stay (LoS), (4) New York Heart Association (NYHA) class, and (5) MR compared to baseline at 30‐day.ResultsA total of 211 patients with a mean age of 78.4 ± 8.9 years, with 51.4% being female and 86.7% belonging to NYHA functional class III/IV and EuroSCORE II 6.3 ± 4.9%, were enrolled. Procedural success attained was 96.9%, and six patients (2.8%) required conversion from CS to GA. At 30 days follow‐up, a significant improvement in MR was found in 96 patients (54.2%) patients with 0/1 grade MR and 45 patients (29.5%) were in NYHA functional class III + IV. Moreover, TEER under CS has a short hospital LoS (6.71 ± 5.29 days) and intensive care unit LoS (1.34 ± 3.49 days) with a 2.8% mortality rate.ConclusionsPerforming TEER with the PASCAL system under CS resulted in appreciable (96.9%) procedural success with low mortality and is a safe and promising alternative to GA with positive clinical outcomes.

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Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip^® system

Abstract: The MitraClip implantation performed using DS is as safe and effective as MitraClip implantation performed using GA. © 2017 Wiley Periodicals, Inc.

Cited by 30 publications

References 22 publications

High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

Effectiveness and safety of same day discharge after left atrial appendage closure under moderate conscious sedation

Outcomes of patients undergoing edge‐to‐edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation

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Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip® system

Abstract: The MitraClip implantation performed using DS is as safe and effective as MitraClip implantation performed using GA. © 2017 Wiley Periodicals, Inc.

Cited by 30 publications

References 22 publications

High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

Effectiveness and safety of same day discharge after left atrial appendage closure under moderate conscious sedation

Outcomes of patients undergoing edge‐to‐edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation

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Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip^® system