Twelve patients (75% male; median age, 53 years; interquartile range [IQR], 45-60 years,) underwent percutaneous TA approach for PVLs closure during the study period (Table 1). All the 12 patients got 17 prosthetic mechanical valves in mitral and/or aortic position. A total of 13 artificial valves developed PVLs in which 10 of them had a single leak while 3 had double leaks. Characterization of the patients showed that, before the procedure, 8 patients (66.7%) had atrial fibrillation, while 5 patients (41.7%) had trivial to moderate tricuspid regurgitation. Besides, 1 patient had previous coronary artery bypass graft surgery. Four patients had hemolysis before operation, while 3 patients were referred from the cardiology department. The characteristics of these patients are shown in Table 1.
Percutaneous Perventricular Device Closure
All the TA punctures were conducted successfully. Total median procedure time was 82 minutes (IQR, 65-85 minutes). The delivery sheath sizes ranged from 5-7 Fr. All the PVL occluders were muscle ventricular septal defect occluder, with a waist height of 5mm or 6mm (Beijing Starway Medical Technology Inc, Beijing, China). All the apical puncture points were closed with muscle ventricular septal defect occluder with a waist height of 5mm or 6mm (Beijing Starway Medical Technology Inc, Beijing, China). The size of the PVL occluder ranged from 6mm - 12mm, and the device size for apical access point ranged from 5mm - 8mm. No patient needed sternotomy incision. 10 of the 13 valves (76.9%) with a single leak were closed by a single occlude while 2 (15.3%) valves with double leaks were closed by a single bigger device. The last valve with double leaks was corrected by two devices (Table 2).
There was no valve dysfunction, device migration or embolization after deployment of the occluder. 1 patients (10%) experienced hemodynamically insignificant pericardial effusion after the procedure and there was no new post-operation hemolysis. Compared to pre-procedure, 2 patients had less severe hemolysis while 1 patient had more severe hemolysis. Three patients had residual shunt that led to reoperation in one patient. The patient had significant comorbidity such as viral hepatitis C and decompensated hepatic cirrhosis, permanent atrial fibrillation and prosthetic valve stenosis in aortic position before surgery. In addition, the patient had two leaks (8mm/10mm) in mitral position with severe regurgitation, NYHA IV and serious anemia. There was mild residual regurgitation after deployment of two devices (10mm/12mm). Our TTE analysis demonstrated an increase in the residual regurgitation, one week after the procedure. The patient had a concurrent secondary serious hemolytic anemia which couldn’t be improved by blood transfusion, and an acute renal failure (ARF) which depended on hemodialysis therapy. Successful re-closure to deploy the device decreased the residual regurgitation. However, the patient died due to congestive heart failure, hemolytic anemia, ARF, and multiple organ dysfunction syndrome. The remaining 11 patients were discharged uneventfully.
The mean postoperative ICU stay and mean time from procedure to hospital discharge was 4 days (IQR, 1 - 2 days) and 7 days (IQR, 4 - 7 days) respectively. Only 1 ICU patient stayed for 30 days and died prior to discharge (Table 3).
The median follow-up was 31 (IQR, 16 - 47) months. A total of 11 patients (100%) and 4 patients (36.3%) successfully completed the one-year and three-year follow-up respectively. THE patients took warfarin regularly, and examined international normalized ratio (INR) in order to avoid stroke and bleeding. Our standard TTE analysis showed that one patient had mild residual regurgitation, while another had hemolysis and disappeared at 1 year follow-up. Functional status was NYHA class I in six (66.7%) and II in three (33.3%) at final follow-up. No patient presented with significant congestive heart failure, cardiovascular events or neurological morbidities (Table 4).
Comment
Paravalvular leak is defined as peri-prosthetic regurgitation via a defect between sewing ring and the annulus of the native valve (7). Factors such as annular calcification, endocarditis, tissue friability, chronic inflammatory disease, and surgical techniques lead to the occurrence of PVL (8). With the development of medical technology, surgical techniques have become less invasive or even non-invasive. Hourihan M, et al, 1992, first showed the application of TA approach in PVL closure (6, 7, 9-11).
Compared with the use of femoral vessel, TA approach has excellent technical advantages. TA uses a more direct manipulation of guide-wires and sheaths which results into easier accessibility of defects and a stable implantation of the device. In addition, patients are free from contrast agent examination. Richard Tanner et al. reported a median procedure time of 140 minutes [90–210] (12). Joseph et al. reports were completed successfully via the TA approach with relatively low median fluoroscopy time (26.5 minutes; IQR, 8.3-43.8 minutes) and median procedure time (106 minutes; IQR, 39-117 minutes) (7). In our study, we showed that there was no patient who needed screening, and the median procedure time was (81 minutes; IQR, 65-84 minutes).
Besides, data concerning the safety and utility of percutaneous TA access remains very scant. Here, we demonstrate our experiences with this technique, and review the efficacy and safety of the TA approach to PVL closure. Our analysis only showed a single death(8.3%)within 30 days. This rate is slightly higher than other larger trials that have reported 30-day mortality rates of 1.7 – 4.5% with percutaneous PVL closure. Surgical series have reported a 30-day mortality rate of 6.9 – 10.7% for surgical PVL closure. Percutaneous PVL closure is emerging as the primary strategy for patients with PVL, with surgical PVL closure being reserved for those who fail or have unfavorable anatomy for percutaneous PVL closure.
Our study reported no death during follow-up, and the residual regurgitation and NYHA function class remained stable. Whereas there is limited literature on TA approach to PVL closure, it is reported to be suitable for high risk patients and achieves acceptable periprocedural rate of adverse events. A study by Ruiz et al. reported long-term survival of percutaneous PVL closure at 6, 12 and 18 months as 91.9, 89.2 and 86.5%, respectively (5). In addition, Sorajja et al. showed a 1–2 year survival of 70–75 % after percutaneous PVL closure, with an estimated 3-year survival rate of 64.5% (13). The direct, in-line access to the valve and valve annulus from TA access is therefore attractive in terms of success rate and procedure duration.
To date, there are no specialized devices for transcatheter PVL closure (14, 15). We use a VSD occluder in all patients. For different PVLs, occluder waist or height might differ. For the mitral valve leakage, we choose an occluder with waist height of 4mm for the CarboMedics mechanical valve and a waist height of 5mm for the St. Jude Medical mechanical valve. For the aortic valve leakage, we choose an occluder with waist height of 6mm for the CarboMedics supra-annular Top Hat valve and a waist height of 5mm for the standard St. Jude mechanical valve. All the puncture site devices have a waist height of 5mm.
There was residual regurgitation in 3 patients. 2 cases had 2 leaks on the same valve, and the maximal diameter for the larger leak was ≥ 8 mm, with residual regurgitation. The other patient had a single leak, with a maximal diameter ≥ 10mm, and a mild or trace residual regurgitation after procedure.
All cases had 2 PVLs of > = 10 mm, and residual shunt as well as hemolysis were found after the closure. Despite PVL reduction to a mild degree in one patient, the hemolysis lasted for 1 year of follow up. We observed that, multiple leaks with diameters of ≥ 10 mm may be the risk factors for residual defect after PVL closure.
Hemothorax is the most common complication of Percutaneous TA access. Pitta et al. reported occurrence of hemothorax in 6 of 32 (19%) patients of Percutaneous TA access (16). On the other hand, Zorinas et al. published outcomes of 19 patients who underwent surgical TA catheter-based mitral PVL closure. 1 (5.2%) patient with hemothorax due to surgical retractor blade injury to the rib with subsequent severe bleeding required surgical revision (17). In our study, 1(8.3%) patients had hemodynamically insignificant pericardial effusion, after the procedure. Our data demonstrates low procedure-related complications associated with routine closure of TA puncture sites with a device.
In the past decade, there has been a huge application of percutaneous PVL closure. However, the use of the percutaneous PVL closure remains relatively novel, and remains technically challenging especially due to the need for precise size, number and location of PVL and puncture point locations. Cautious evaluation of the coronary artery before “blind” puncture is essential. To ensure the puncture site does not compromise the coronary vasculature, all the patients in our study underwent CTA to precisely define the puncture site and angle before surgery. In addition, the use of CTA is beneficial in cases with unclear anatomy or in patients with poor echocardiography windows. We also routinely ask the anesthesiologist for solitary right-lung ventilation in order to deflate the left lung. Joseph’s team (7) innovatively combined CTA with fluoroscopy technology, and then guided by TEE and achieved accurate positioning of the device in hybrid operation room. Compared with this technology, our study only used 3D-CTA imaging before operation, and completed positioning with software post-processing, which does not depend on intraoperative fluoroscopy or hybrid operation room. The whole procedure can performed only under TEE. We therefore observe that hospitals can carry out such operations without hybridized operating rooms.