Feasibility of Same-Day Discharge Approach After Transcatheter Mitral Valve Repair Procedures

Abstract

Introduction. Early discharge strategies are increasingly adopted after percutaneous cardiac interventions. However, there is a paucity of data on early discharge after transcatheter mitral valve repair (TMVRep) procedures. In this report, we aimed to present our data on same-day discharge after MitraClip (Abbott Structural) procedures. Methods. A total of 82 patients who underwent TMVRep and were discharged the same day were included in the study. Patients who underwent the procedure with moderate conscious anesthesia, and without periprocedural complications and a stable early course post procedure, were considered candidates for same-day discharge. A next-day follow-up exam at the cardiology clinic was scheduled for all patients for removal of the groin access figure-of-eight subcutaneous sutures and for echocardiographic examination. Results. Thirty-nine patients had primary mitral regurgitation (MR), while 43 patients had secondary MR. A mean of 1.4 ± 0.4 clips were implanted per patient (range, 1 to 2 clips). Postprocedural MR grade was 1+ or lower in 64 patients (63.6%) and 2+ in 38 patients (36.4%). All patients were evaluated in the office clinic the next day, and had no major complications. Conclusion. Same-day discharge approach can be safely performed in selected patients after TMVRep procedures. However, further studies with larger sample sizes are needed.

J INVASIVE CARDIOL 2021;33(2):E123-E126. Epub 2021 January 14. doi:10.25270/jic/20.00417

Key words: MitraClip, mitral valve repair, safety, same-day discharge, transcatheter

The traditional standard of care after percutaneous cardiovascular interventions in the United States is in-hospital observation to detect and manage periprocedural or early postprocedural complications in a timely manner.¹ However, with advances in device technology and increased institutional and operator experience, early complications have reduced, making a shorter period of postprocedural observation reasonable.^2-4 In fact, the safety and feasibility of same-day discharge (SDD) after percutaneous coronary interventions (PCI) have been shown in a number of studies.^1,5 Similarly, early discharge can be safely performed after transcatheter aortic valve replacement (TAVR) in selected patients.^2,3,6 Shorter hospital stays after percutaneous interventions may potentially enhance patient satisfaction and decrease hospital-related complications and healthcare costs.⁴

Mitral regurgitation (MR) is one of the most frequent valvular diseases in the industrialized countries and its prevalence continues to rise.⁷ Surgery is the treatment of choice for patients with severe MR; however,  a significant number of patients are turned down for surgery due to old age, low ejection fraction, or other comorbidities.⁸ Therefore, transcatheter treatment modalities have been introduced as an alternative to surgery.⁹ MitraClip (Abbott Structural) is a transcatheter mitral valve repair (TMVRep) system that reduces MR by edge-to-edge approximation of the mitral valve leaflets via delivery of mitral clips.^10,11 Although TMVRep is a complex procedure, requiring a unique skill set, it can be safely performed with low periprocedural complication rates by experienced operators.¹² There are no previous data on SDD after TMVRep. In this study, we present our results regarding SDD of patients after TMVRep with MitraClip.

Methods

Study population and preprocedural evaluation. A total of 95 patients underwent TMVRep procedures between February 2019 and April 2020. Of these, 82 patients (86%) with severe MR (39 primary MRs and 43 secondary MRs) who underwent TMVRep and were discharged on the same day during this period were included in the study. Clinical and procedural outcomes were evaluated using hospital medical records. Before the TMVRep procedure, every patient was assessed and judged unsuitable for a surgical approach by an interdisciplinary heart team of cardiologists, cardiothoracic surgeons, and cardiac-anesthesiologists. Decisions were based on Society of Thoracic Surgeons (STS) score. MV surgery was deemed unsuitable if STS score for the risk of death within 30 days after mitral-valve replacement was 8% or higher or in the presence of poor prognostic features that were not included in the STS score (frailty, cancer, autoimmune conditions, etc). All patients gave informed consent to undergo the procedure, and the authors have conformed to institutional guidelines for the study.

Preprocedural evaluation standards consisted of transthoracic echocardiography and transesophageal echocardiography (TEE) to determine the grade and etiology of the MR, the left ventricular ejection fraction (LVEF), effective regurgitant orifice area (EROA), and the anatomy of the MV and MR jet location. LVEF was measured using the modified Simpson’s method. Primary MR was defined as the pathology of ≥1 of the components of the valve (leaflets, chordae tendineae, papillary muscles, annulus) causing valve incompetence with systolic regurgitation of blood from the left ventricle to the left atrium. Secondary MR was defined as MR due to primary left ventricular dysfunction with normal mitral valve leaflets and chordae.

TMVRep procedure. All procedures were performed under moderate conscious sedation (MCS) or monitored anesthesia care (MAC) with fluoroscopy and TEE guidance. We have previously published our MCS protocol in detail.¹³ Femoral vein access was obtained with ultrasonography guidance in all patients to minimize access-site complications. Left atrial pressure was invasively measured and recorded before and following the MitraClip implantation in all patients. The selection of the type (NTR or XTR) and number of clips was left to the discretion of the interventionist upon preprocedural review of the MV morphology as well as the width of the MR jet. Procedural time, clip implant time, and fluoroscopy time were calculated. Procedural time was defined as the time from the insertion to the removal of the steerable guiding catheter. Clip implant time was defined as the time from transseptal puncture to the clip delivery. Procedural success was defined as at least 2 grade reductions in MR jet.

Patients who underwent a successful TMVRep with MCS, and who had no periprocedural complications and a stable early course after the procedure were considered candidates for SDD after walking and confirmation of no access-site bleeding. A next-day follow-up at the cardiology clinic was scheduled for all patients for removal of the groin access figure-of-eight subcutaneous sutures and for echocardiographic examination.

Results

All patients (39 primary severe MRs and 43 secondary severe MRs) underwent TMVRep under MCS with an acute procedural success rate of 100%. Mean age was 80.2 ± 2.5 years, 42 (52%) were women, and 70.5% had coronary artery disease. The mean LVEF was 45.2 ± 10.3%. MR grade was 3+ in 20.5% and 4+ in 79.5% of patients. Baseline clinical and demographic features of the study population are presented in Table 1.

A mean of 1.4 ± 0.6 clips were implanted per patient (range, 1 to 2 clips). Postprocedural MR grade was 1+ or lower in 57 patients (70.3%) and 2+ in 25 patients (29.7%). Mean procedural duration, clip implant time, and fluoroscopic time were 60 ± 10.2 minutes, 19.5 ± 6.5 minutes, and 10.3 ± 3.1 minutes, respectively. None of the procedures were converted to general anesthesia, and all patients included in the study had SDD. Procedural data, outcomes, and complications are shown in Table 2.

Discussion

The findings of the current study suggest that SDD after TMVRep with MitraClip is safe and feasible. All patients in this study were discharged home at an average of 6-8 hours post procedure. A next-day follow-up exam at the cardiology office clinic was scheduled for removal of the figure-of-eight subcutaneous sutures and for echocardiographic examination.

A number of prospective randomized trials demonstrated that SDD after elective PCI can be performed safely in the majority of patients, and this approach does not increase complications compared with overnight stay.^14,15 Consequently, there has been an increased rate of SDD after PCI over the last years, although a substantial variation exists between institutions.⁵ Two recent, large, population‐based cohorts of elective PCI patients from Canada and the United Kingdom confirmed the safety of this approach.^1,5 Feasibility and safety of SDD/next-day discharge have also been shown in selected patients after atrial septal defect/patent foramen ovale closure and even after TAVI procedures, despite the use of large-bore arterial access.^2,3,6,16-18 In our experience, the SDD concept can be safely extended to selected MitraClip procedures.

The main reason for overnight observation following an uncomplicated percutaneous procedure is to detect and manage potential complications that may not be apparent immediately after the procedure.¹⁹ Access-site complications remain the most common cause of morbidity, and therefore are a major consideration for the discharge decision after percutaneous interventions. TMVRep using the MitraClip device requires a 24 Fr sheath introduced into the femoral vein. Vascular complications following large-bore venous puncture are less frequent compared with arterial access.²⁰ Hemostasis after TMVRep can be achieved by manual compression, compression and vascular closure devices, or the figure-of-eight suturing technique.^21,22 In a study by Steppich et al, access‐site related major and minor complications were comparable between figure-of-eight sutures and closure devices, suggesting that both techniques are safe.²³ In the current study, we exclusively used the figure-of-eight suturing technique for hemostasis and achieved a very low rate of access-site bleeding complications. Our study results are not singular; complication data from the GRASP registry demonstrated low rates of bleeding requiring ≥2 units of transfusion.²⁴ On the other hand, Körber et al reported that unlike TAVR and PCI, the majority of bleeding complications after MitraClip procedures were unrelated to vascular access, and were either remote from the access site or had no identifiable source.²⁵ Other potential complications include cardiac tamponade, ischemic events, dislocation of pre-existing pacemaker leads, mitral stenosis, and clip embolism.^20,26 These complications are rare, especially when performed by experienced operators,¹² and can typically be detected early after the procedure. Moreover, whether a longer hospital stay can prevent these complications is questionable.

The anesthesia method used is also a key factor for determining the discharge timing after interventional procedures. While general anesthesia offers a number of advantages during the procedure, such as easier and prolonged use of TEE, it carries several risks.²⁷ Those risks are especially important during transcatheter valvular interventions, considering that most patients are frail and have multiple comorbidities. In fact, evidence from recent reports suggest that TAVR with conscious sedation may be associated with shorter length of stay and better outcomes in comparison with TAVR under general anesthesia.^28,29 At present, the majority of TMVRep procedures are performed with general anesthesia. Several groups, including ours, recently demonstrated that TMVRep can be performed without general anesthesia and even without conscious sedation, with comparable procedural success and complication rates.^13,27,30 The avoidance of general anesthesia allows early discharge/SDD after those procedures. Consequently, the use of MCS made SDD possible in our patient group.

Study limitations. There are certain limitations to the current study. First, this is a single-center, observational study without a comparison group. The sample size is relatively small, without information about long-term outcomes. Ideally, the feasibility and safety of this approach should be confirmed in larger-sized multicenter, randomized trials. Medical management to optimize patients before the procedure could play a role, and its impact was not evaluated in the current study.

Conclusion

SDD after TMVRep is possible without apparent increase in risk. While further randomized data are needed, our initial data suggest SDD is an attractive alternative in a selected group of patients.

From the ¹UT Houston, MD Anderson Cancer Center, Houston, Texas; ²HCA Northside Hospital, St. Petersburg, Florida; ³Department of Cardiology, Pamukkale University Hospitals, Kinikli, Denizli; and ⁴Bahcesehir University, School of Medicine, Istanbul, Turkey.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript accepted July 1, 2020.

Address for correspondence: Mehmet Cilingiroglu, MD, UT Houston MD Anderson Cancer Center, Houston, TX and University of Hawaii John Burns Medical School, Honolulu, Hawaii. Email: cilingiroglumehmet@gmail.com

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