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Vol. 76. Issue 4.
Pages 276-278 (April 2023)
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Vol. 76. Issue 4.
Pages 276-278 (April 2023)
Scientific letter
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Impact on early patient mobilization of the use of a single vascular closure device in patients undergoing leadless pacemaker implantation
Impacto en la movilización precoz con el uso de un único dispositivo de cierre vascular en pacientes tratados con implante de marcapasos sin cable
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Bieito Campos-Garcíaa,b,
Corresponding author
bieitocampos@gmail.com

Corresponding author:
, Concepción Alonso-Martína,b, Zoraida Moreno-Weidmanna,b, Enrique Rodríguez-Fonta,b, Francisco J. Méndez-Zuritaa,b, Xavier Viñolasa,b
a Unidad de Arritmias, Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Instituto de Investigación Biomédica Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain
b Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
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To the Editor,

Leadless pacing has become a safe alternative to conventional pacing. This has led to an increase in its use in clinical practice, particularly in elderly individuals.1 The only leadless pacing device currently available is the Micra transcatheter pacing system (TPS, models MC1VR01 and MC1AVR1; Medtronic plc, United States), which is implanted via the femoral vein using a large-bore introducer (27 Fr). Despite the caliber of the system, the clinical experience indicates a low risk of vascular complications. Nonetheless, the standard manual compression-mediated hemostasis necessitates 24-hour postimplantation resting of the lower limbs, which delays patient mobilization.

Vascular closure devices represent an alternative to manual compression-mediated hemostasis and permit early patient mobilization. However, their use with the Micra device is infrequent. The reported experience is based on a technique involving 2 such devices for the closure of a single vascular access site.2 In this scientific letter, we report our experience with the use of a single vascular closure device for hemostasis of the puncture site after Micra implantation.

In June 2021, we began to systematically use the Perclose system (ProGlide/ProStyle, Abbott, United States) in our center for femoral hemostasis during Micra implantation. The Perclose device comprises a percutaneous vascular closure system involving a pretied polypropylene monofilament suture.

All procedures were performed according to the guidelines of the institutional research ethics board of Sant Pau Hospital, and all patients provided written informed consent. Direct oral anticoagulant therapy was withdrawn 24hours before the procedure, as well as vitamin K antagonists until an INR ≤ 2 was achieved. Implants were performed according to the standard technique and with conscious sedation.3 Femoral venous access was achieved using ultrasound-guided puncture. The access site was predilated with an 8-Fr introducer and the Perclose device was deployed while the polypropylene filaments were retained. Through the Perclose, a conventional metal guidewire was introduced to once again advance the 8-Fr introducer and this wire was then exchanged for an extra-stiff guidewire. Serial dilatation was performed with a single 18-Fr dilator, followed by a 27-Fr introducer for the implantation. If considerable tortuosity was encountered while the implant material was being advanced toward the heart, iliofemoral venous angiography was performed, although this was rare. The 27-Fr introducer and the release system were constantly perfused with heparinized serum, without the administration of additional anticoagulant. After removal of the 27-Fr introducer, the vascular closure was finalized by advancing the propylene filament knot. Once hemostasis was confirmed, the access site was covered with a dressing, without compression. Patient mobilization was recommended 6hours after implantation.

The objective of the current study was to evaluate the hemostatic effectiveness of the closure device, patient mobilization 6hours after the procedure, and vascular access complications in the first postimplantation month.

Percutaneous vascular closure was performed using a single Perclose device in 62 patients implanted with the Micra device. Patients’ clinical characteristics are shown in table 1. The mean patient age was 85.6±6.5 years and 16 of the patients (25.8%) were ≥ 90 years old; 28 patients (45.1%) were receiving chronic anticoagulation.

Table 1.

Baseline characteristics of the study population

Patients, No.  62 
Age, y  85.6 ± 6.5 
Male sex  27 (43.5) 
Hypertension  53 (85.5) 
Diabetes mellitus  16 (25.8) 
Chronic kidney disease  18 (29.0) 
Heart disease  33 (53.2) 
LVEF, %  0.54 ± 0.09 
Heart failure  22 (35.5) 
Atrial fibrillation  33 (53.2) 
Atrial fibrillation at implantation  28 (45.2) 
Stroke  12 (19.4) 
Peripheral vascular disease  3 (4.8) 
Oral anticoagulation  28 (45.2) 
Direct anticoagulation  18 (29.0) 
Vitamin K antagonists  10 (16.1) 
Preimplant INR if administered vitamin K antagonist  1.50 ± 0.29 
Pacing indication
Atrioventricular block  46 (74.2) 
AF with a slow ventricular response  13 (21.0) 
Sinus node dysfunction  5 (8.1) 
Pacemaker model
Micra VR  37 (60.0) 
Micra AV  25 (40.0) 

AF, atrial fibrillation; AV, pacemaker with atrioventricular synchrony; INR, international normalized ratio; LVEF, left ventricular ejection fraction; VR, single-chamber pacemaker.

Values are reported as mean±standard deviation or No. (%).

Table 2 shows the implant characteristics. Complete hemostasis was achieved in 59 of the 62 patients (95.2%). Early mobilization 6hours after implantation was accomplished in 45 of the 59 patients (76%) successfully managed with the Perclose system. In the 14 remaining patients, early mobilization failure was considered to be due to nonimplantation-related factors: 3 patients with implantation immediately after transcatheter aortic valve implantation, 1 in the subacute phase of stroke, 1 with intense back pain due to vertebral fracture, and 9 with cognitive decline/drowsiness. The 3 patients with partial device effectiveness were at the start of the series. In these 3 patients, hemostasis was effectively achieved by adding an external “figure-of-8 suture” with a 3-way stopcock. No vascular access-associated complications were seen in the peri-implantation period or in the first 30 postimplantation days.

Table 2.

Implantation characteristics

Patients, No.  62 
Successful implantation  62 (100) 
Procedure time, min  32.7 ± 10.2 
Percutaneous closure device effectiveness  59 (95.2) 
Early mobilization (6 h, if percutaneous closure device was effective)  45 (76.3) 
Complications (peri-implantation and 30 d after implant)   
Major complications 
Vascular access complications 

Values are reported as mean±standard deviation or No. (%).

Based on our outcomes, we conclude that the use of a single Perclose vascular closure device during implantation of the Micra leadless pacemaker is highly safe and effective and permits the early mobilization of the vast majority of patients.

Early mobilization is a particularly relevant aspect for the profile of patients receiving pacemakers, who are typically elderly and with comorbidity. Our research group had previously proven the safety and effectiveness of the Micra device in elderly patients.1 Nonetheless, the need for a prolonged postimplantation recovery period related to the vascular access had limited the early mobilization of these patients. This restriction additionally represented a clear disadvantage vs conventional transvenous pacemakers, which allow safe same-day discharge.4 Kiani et al. has proposed the same-day discharge of patients receiving a leadless pacemaker, using femoral hemostasis with a “figure-of-8 suture”. However, the restriction of the early discharge to highly selected patients and the nonnegligible risk of vascular complications limited the standardized use of the figure-of-8 suture for systematic early discharge strategies.5 The use of a vascular closure device overcomes this limitation classically associated with leadless pacemakers and permits consideration of a safer same-day discharge after implantation. The ability of the device to reduce the length of hospital stay remains to be assessed, although it is a real possibility with an undoubted potential impact at both clinical and economic levels.

The closure device was also safe and effective in chronically anticoagulated patients with the standard temporary peri-implantation adjustment/interruption protocol. The use of a device with a strategy that maintains full peri-implantation anticoagulation has not yet been evaluated.

The good safety and effectiveness profile of the Perclose system has already been reported for Micra implantation in younger patients and using the dual-device preclosure technique.2 However, the use of a single device simplifies the vascular closure technique and shows a similar safety and effectiveness profile, even in elderly patients.

FUNDING

This work has not received any specific funding.

AUTHORS’ CONTRIBUTIONS

All authors contributed significantly to the current work. All authors participated in the data collection and drafting of the scientific letter, made critical revisions, and approved the final submitted document.

CONFLICTS OF INTEREST

X. Viñolas is a member of the Medtronic Micra advisory board. F.J. Méndez-Zurita has received honoraria from Medtronic. None of the other authors have conflicts of interest.

References
[1]
A. El Amrani, B. Campos, C. Alonso-Martín, et al.
Performance of the Micra cardiac pacemaker in nonagenarians.
Rev Esp Cardiol., 73 (2020), pp. 307-312
[2]
A. Deshmukh, M. Ghannam, R. Cunnane, J.J. Liang.
Double ProGlide preclose technique for vascular access closure after leadless pacemaker implantation.
J Interv Card Electrophysiol., 63 (2022), pp. 341-343
[3]
P. Ritter, G.Z. Duray, C. Steinwender, et al.
Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.
Eur Heart J., 36 (2015), pp. 2510-2519
[4]
A. Trongtorsak, J. Kewcharoen, S. Thangjui, P. Worapongsatitaya, R. Yodsuwan, L. Navaravong.
Same-day discharge after implantation of cardiac implantable electronic devices: A systematic review and meta-analysis.
Pacing Clin Electrophysiol., 44 (2021), pp. 1925-1933
[5]
S. Kiani, G.B. Black, B. Rao, et al.
The Safety and Feasibility of Same-Day Discharge After Implantation of MICRA Transcatheter Leadless Pacemaker System.
J Atr Fibrillation., 12 (2019), pp. 2153
Copyright © 2022. Sociedad Española de Cardiología
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