Key Findings.
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The Double Perclose ProGlide (DPP) approach showed reduced overall in-room, ambulation, and procedural times, indicating earlier eligibility for same-day discharge and possible advantages for shorter hospital stay.
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Despite DPP and figure-of-eight methods having the same safety performance, the DPP system is a mechanical device that reduces operator-dependent variability and procedural times.
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There were no statistically significant variations in the time to discharge or postoperative pain management dosages between the 2 treatment arms.
Background
Leadless pacemakers (LPs) represent groundbreaking advancement in cardiac pacing, mitigating common complications associated with conventional transvenous pacemakers, including lead dislodgement/malfunction, pocket hematoma, and infection.1 However, the use of large venous transcatheter delivery systems with outer diameters up to 27-F is necessary for delivering LP systems, raising concerns about access site complications and prolonged bed rest.1,2
Currently, 2 primary techniques are commonly employed for vascular closure following LP implantation: the use of two suture-mediated closure devices prepared at the time of vascular access (Double Perclose ProGlide [DPP] technique), and the manual creation of a figure-of-eight (FOE) using nonabsorbable polypropylene suture at the time of sheath removal.3,4 A previous small single-center randomized study with 40 patients demonstrated that device-mediated DPP suture is equally effective and safe as the traditional FOE suture in the setting of left atrial appendage occlusion and transcatheter edge-to-edge mitral valvular repair, but so far, the safety and efficacy following LP implantation has not been studied.5
The objective of our study was to compare the efficacy, efficiency, and safety of the DPP technique vs the FOE suture for achieving hemostasis during LP implantation in a multicenter study involving multiple operators.
Methods
This retrospective multicenter, observational study included 394 consecutive patients who underwent LP implantation between March 2016 and October 2023 at Brigham and Women’s Hospital and Montefiore Medical Center. To preserve patient confidentiality, we did not require an informed consent form for this patient population as per research agreement approved for our Institutional Review Board (IRB). Hemostasis was achieved using either the DPP technique or FOE suture. Propensity score matching (PSM) was conducted for nine variables in which age, sex, and comorbidities (hypertension, diabetes, heart failure, chronic kidney disease, atrial fibrillation, chronic obstructive pulmonary disease, and need for hemodialysis) were part of the statistical matching method.
The efficacy outcome assessed was successful access site hemostasis at the conclusion of the procedure. Efficiency outcomes included procedural time (from incision to suture placement), total in-room time (admission to transfer out of procedural room) and time to ambulation, while safety outcomes comprised vascular access complications. The decision of vascular closure method was based on the operator’s preference.
Statistical analysis involved the use of the Shapiro-Wilk to assess the normality of distribution. The Mann-Whitney U test was employed for univariate analysis, while the chi-square test was utilized for the analysis of categorical variables. This study received the approval from the IRB at both participating institutions and adhered to the principles outlined in the Helsinki Declaration.
Results
A total of 394 patients were included, with 76 in the DPP group and 318 in the FOE group. Following PSM, 75 matched pairs were obtained, and there were no statistically significant differences in baseline characteristics between the groups (Figures 1A and 1B). The median age was 77 ± 15 years in both cohorts, with a majority of patients being male (67.3%) and admitted as inpatients (54%).
Figure 1.
(A) Baseline characteristics before and after propensity score matching (PSM). (B) Patient population flowchart. (C) Procedural outcomes. CHF = congestive heart failure; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; DPP = Double Perclose ProGlide; FOE = figure-of-eight; IQR = interquartile range.
Both closure techniques demonstrated 100% success rate in achieving hemostasis. In terms of efficiency outcomes, the DPP group exhibited shorter total in-room time (91 ± 31 minutes vs 109 ± 45 minutes; P < .001), time to ambulation (275 ± 121 minutes vs 392 ± 187 minutes; P = .015), and procedural time (DPP: 40 ± 21 minutes vs FOE: 53 ± 32 minutes; P < .001). Safety outcomes between groups were comparable, with rates of vascular complications of 0% for the DPP group and 2 (2.67%) complications for the FOE group (P = .50). Specifically, 1 patient had an access site infection and 1 patient had a local groin hematoma (Figure 1C).
The mean daily oral morphine milligram equivalents (MME) did not significantly differ between the 2 groups (3.4 mg/d for DPP vs 4.01 mg/d for FOE; P = .748). There was a nonsignificant trend toward a faster time to discharge with DPP (4.6 days vs 7.01 days in the FOE group; P = .154).
Discussion
Our study demonstrates comparable safety profiles between both techniques, while highlighting the superior efficiency of the DPP technique compared with the FOE method for LP implantation. The DPP technique demonstrated shorter total in-room time, time to ambulation, and procedural time, suggesting potential benefits for reducing hospital stay. Nevertheless, further studies are warranted to validate these findings.
The DPP system, being a mechanical device that is predeployed at the beginning of the case, minimizes the operator-dependent variability and eliminates the risks of leaving sutures exposed at access site, which can lead to patient discomfort and potential complications. Furthermore, the reduced procedural time suggests faster hemostasis with the DPP device.
In summary, while both the DPP and FOE techniques yield similar safety outcomes, the DPP technique may be preferred for optimizing time efficiency in the lab and facilitating eligibility for same-day discharge. Notably, there was no statistically significant differences in postoperative pain management doses or time to discharge between the 2 treatment arms. This work represents the first attempt, to our knowledge, to compare outcomes between the 2 vascular closure techniques in LP patients. Further research is essential to generalize and corroborate our findings across different patient populations and clinical settings.
Disclosures
The authors have no conflicts to disclose.
Acknowledgments
Funding Sources
In the interest of transparency, we declare that our author group has no conflicting relationships/activities/interests between the content of our manuscript and third parties whose interests may affect our results. This research received no funding from any agency in the public, commercial, for-profit, or not-for-profit sectors.
Authorship
All authors attest they meet the current ICMJE criteria for authorship.
Patient Consent
Only de-identified data were gathered. To preserve patient confidentiality, we did not require an informed consent form for this patient population as per the research agreement approved for our institutional IRB.
Ethics Statement
This study received the approval from the institutional review board at both participating institutions and adhered to the principles outlined in the Helsinki Declaration.
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