Abstract
This medical record review assesses the safety and feasibility of using nonpledgeted sutures for patients undergoing heart valve replacement.
One of the major complications of heart valve replacement is paravalvular leak (PVL). Large PVLs result in the progression of heart failure and endocarditis.1,2 Clinically significant PVL requiring reoperation occurs in fewer than 2% of cases.3 Traditionally, pledgeted, nonabsorbable sutures are used to secure prosthetic valves. The aim of this study was to assess the safety and feasibility of using nonpledgeted sutures for heart valve replacements.
Methods
This medical record review was approved by the institutional review board of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, which also granted a waiver of patient informed consent. We retrospectively reviewed the medical records of all patients operated on by one of us (D.C.) from November 1, 2014, through October 31, 2017. All 133 patients who underwent aortic valve replacement (AVR), including those who had concomitant procedures, were included in this study. Prosthetic aortic valves were placed by using an interrupted, circumferential mattress, supra-annular technique with nonpledgeted 2-0 nonabsorbable braided sutures (Ethibond; Ethicon) that were hand tied by the attending surgeon (D.C.). The primary end points were PVL and freedom from reoperation due to PVL. Immediate intraoperative PVL was evaluated with the use of transesophageal echocardiography; transthoracic echocardiography was used during the follow-up period. Patients without appropriate follow-up were excluded.
Results
Among 133 patients whose medical records were reviewed, 21 were either lost to follow-up or excluded because of nonadherence to recommended follow-up clinic appointments and tests. A total of 112 patients were included in the final analysis. Of these patients, 106 (94.6%) were men, and patients had a mean (SD) age of 68.1 (9.5) years. The procedures included 45 isolated AVRs and 67 AVRs with concomitant procedures (Table 1). Of the patients undergoing AVR, 94 (83.9%) received bioprosthetic valves and 18 (16.1%) received mechanical valves.
Table 1. Number of Patients Receiving Heart Valve Replacement Surgery With Breakdown by Valve Type.
| Operation | Patients, No. (%) (N = 112) | Pump Time, Mean (SD), min | Cross-Clamp Time, Mean (SD), min |
|---|---|---|---|
| Type of valve | |||
| Bioprosthetic | 94 (83.9) | ||
| Mechanical | 18 (16.1) | ||
| AVR only | 45 (40.2) | 115.6 (30.6) | 85.6 (25.3) |
| AVR + CABG | 50 (44.6) | 155.9 (45.7) | 127.5 (34.2) |
| AVR + MVR or MV repair | 6 (5.4) | 278.0 (64.3) | 232.2 (70.9) |
| AVR + TVR or TV repair | 2 (1.8) | 200.0 (49.5) | 135.5 (30.4) |
| AVR + MVR + TV repair | 1 (.89) | 274.0 (NA) | 204.0 (NA) |
| AVR + ascending aortic aneurysmal repair | 8 (7.1) | 144.4 (39.2) | 108.6 (30.7) |
| Cardiogenic shock at time of operation | 7 (6.3) | NA | NA |
Abbreviations: AVR, aortic valve replacement; CABG, coronary artery bypass graft; MV, mitral valve; MVR, MV replacement; NA, not applicable; TV, tricuspid valve; TVR, TV replacement.
No patients had PVL immediately following implant, and no conversions to a pledgeted technique were noted. The median time to follow-up transthoracic echocardiography was 2 months (range, 2 days to 35 months). Freedom from PVL was noted in 107 patients (95.5%), 4 (3.6%) had insignificant PVL on results of follow-up transthoracic echocardiography, and 1 (0.9%) had clinically significant PVL that required reoperation because of recurrent endocarditis from continued intravenous drug abuse (Table 2).
Table 2. Characteristics and Outcomes of 112 Patients Undergoing Heart Valve Replacement.
| Variable | Data (N = 112) |
|---|---|
| Preoperative characteristic | |
| Age, mean (SD), y | 68.1 (9.5) |
| Comorbidities, No. (%) | |
| Hypertension | 85 (75.9) |
| Diabetes | 42 (37.5) |
| Chronic obstructive pulmonary disease | 34 (30.4) |
| Hyperlipidemia | 80 (71.4) |
| Obesity | 29 (25.9) |
| Postoperative outcome, No. (%) | |
| Return to operating room | 11 (9.8) |
| Stroke | 1 (0.9) |
| Sternal wound infection | 4 (3.6) |
| Postoperative renal failure | 1 (0.9) |
| Extracorporeal membrane oxygenation support | 3 (2.7) |
| Pacemaker placement | 2 (1.8) |
| Mortality | 3 (2.6) |
| Paravalvular leak characteristic | |
| Time to follow-up TTE, median (range) | 2 (2 d to 35 mo) |
| Intraoperative PVL, No. | 0 |
| Conversion to pledgeted technique, No. | 0 |
| Freedom from PVL, No. (%) | 107 (95.5) |
| Clinically significant PVL, No. (%) | 1 (0.9) |
| Reoperation due to PVL, No. (%) | 1 (0.9) |
Abbreviations: PVL, paravalvular leak; TTE, transthoracic echocardiography.
Discussion
The use of pledgeted sutures was shown to confer a protective effect on PVL in the Artificial Valve Endocarditis Reduction Trial (AVERT); however, the mechanical valve of interest in that trial was eventually recalled because of increased rates of PVL.4 LaPar et al5 showed that a nonpledgeted suture technique offers an equivalent alternative to the use of pledgets for AVR, with no increase in PVL and significantly decreased cross-clamp time.
Our study results showed that significant PVL requiring reoperation occurred in just 0.9% of the patients. This rate of reoperation for PVL is similar to the 1% to 2% cited in the literature3 and comparable to the rate in the pledgeted cohort seen in LaPar et al5 and Tabata et al,6 which resulted in a 1.2% and 2% PVL rate, respectively. This technique eliminates the need to adjust the orientation of pledgets and has been shown to decrease cross-clamp and cardiopulmonary bypass times.5 Although pledgets are inexpensive, potential reduction of costs may be incurred owing to these decreased times. Also, multiple studies have shown that pledgets can decrease the effective orifice area, especially in smaller aortic roots, owing to tissue gathering. This tissue gathering on the ventricular side may result in tissue exposure into the valvular orifice, disturbing leaflet movement, or reducing effective orifice area.6 Furthermore, while there are no current studies to suggest this, we speculate that implanting less foreign and thrombogenic material may decrease the incidence of future pannus formation. Although this study was limited by the number of patients, its retrospective nature, and the need for long-term follow-up data, the findings suggest that this technique can potentially be used in lieu of the classic pledgeted technique, with similar results.
References
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