Early Outcomes Following Transcatheter Closure With the Amplatzer Vascular Plug and Duct Occluder for Mitral Paravalvular Leak in Japanese Patients

Abstract

Background: Transcatheter closure of paravalvular leak (PVL) has become an established treatment for patients at prohibitive surgical risk. However, few studies have examined the feasibility of transcatheter closure using Amplatzer occluders in Japanese patients with mitral PVL.

Methods and Results: Twelve patients (mean [±SD] age 78±7 years) with heart failure, hemolytic anemia, or both after surgical mitral prosthetic valve replacement (mechanical valve, 75%) underwent transcatheter PVL closure with Amplatzer Vascular Plug II (AVP-II)/Amplatzer Duct Occluder II (ADO-II) between 2014 and 2021 at Toho University Ohashi Medical Center. We examined procedural, in-hospital, 30-day, and 1-year outcomes. All procedures were performed under general anesthesia using an antegrade transseptal approach, and the procedures were successful in all cases. The mean (±SD) number of Amplatzer occluders deployment per patient was 2.9±1.1, and in 2 patients the combined use of ADO-II was required. The mitral PVL grade decreased notably from 3+ to 1+, with residual PVL being mild or absent in 9 patients. There were no all-cause mortalities, major adverse events, or device-related complications at the 30-day follow-up. At 1 year, all-cause mortality was 16.7% and 3 (25%) patients required reintervention because of the recurrence of clinical symptoms.

Conclusions: Our findings suggest that transcatheter PVL closure with AVP-II/ADO-II can be feasible and safe in Japanese patients with mitral PVL, leading to satisfactory early clinical outcomes.

Paravalvular leak (PVL), one of the main causes of valvular dysfunction, develops in approximately 30% of patients after surgical or transcatheter heart valve replacement.^1–3 Mitral PVL after mitral surgical replacement occurs in 7–17% of patients at long-term follow-up over several years and is more common than aortic PVL.^4,5 Although most patients with PVL are asymptomatic, 1–5% of patients with mitral PVL exhibit serious clinical symptoms, such as refractory heart failure, intractable hemolytic anemia, or both. In addition, redo surgery for PVL is associated with significant morbidity and mortality in patients with prohibitive surgical risk.^6–8

Transcatheter PVL closure (PVLC) has been established as an alternative treatment to redo surgery and has proven to be effective in patients with a suitable anatomy.^9,10 As a result, it is a Class 2a recommendation in European Society of Cardiology, American College of Cardiology/American Heart Association, and Japanese Circulation Society guidelines.^11–13

In Japan, the Occlutech PVL device (PLD) occluder (Occlutech Holding AG, Schaffhausen, Switzerland) was approved as a transcatheter PVLC device in 2023; however, there are few reports on the outcomes of transcatheter PVLC in Japanese patients.¹⁴ Thus, in the present study we examined the efficacy and feasibility of transcatheter PVLC using the Amplatzer Vascular Plug II (AVP-II)/Amplatzer Duct Occluder II (ADO-II; both from Abbott Structural Heart, Menlo Park, CA, USA) in Japanese patients with mitral PVL following mitral surgery. Our aim was to gain an insight into short-term clinical outcomes at a tertiary referral center.

Methods

Study Population

We examined all patients who underwent transcatheter PVLC with AVP-II/ADO-II for symptomatic PVL at Toho University Ohashi Medical Center (Tokyo, Japan) between 2014 and 2021. We enrolled 12 patients who underwent a procedure for symptomatic mitral PVL after surgical mitral valve replacement. A multidisciplinary heart team evaluated all patients and recommended transcatheter PVLC.

All patients provided informed consent for the use of their medical records for research purposes. All procedures were performed outside the Japanese public health insurance system. This study was approved by the Ethics Committee of Toho University Ohashi Medical Center (Reference no. H23069_H21012) and was conducted in accordance with the Declaration of Helsinki. Patients were given the opportunity to opt out of the study.

Procedure

Transcatheter PVLC was performed under general anesthesia with slight modifications to previously described techniques guided by transesophageal echocardiography (TEE) and fluoroscopy.^4,15 In all patients, the antegrade transseptal approach using the SL0 sheath (Abbott Cardiovascular, Abbott Park, IL, USA) was initially attempted. Following transseptal puncture, a telescoping system using an 8.5-Fr Agilis sheath (Abbott Cardiovascular) and a 5- or 6-Fr Destination guiding sheath (Terumo, Tokyo, Japan) was inserted into the left atrium. This system was steered towards the PVL defect, which was crossed using a 0.035-inch hydrophilic Radiforcus guidewire (Terumo). After the Radiforcus guidewire was inserted into the left ventricle (LV) through the PVL defect, the first Destination guiding sheath was positioned in the LV. Simultaneously, 2 Amplatz Super Stiff wires (Boston Scientific, St. Paul, MN, USA) were inserted into the LV to support the subsequent insertion of another Destination guiding sheath into the LV.

An Amplatzer occluder could be passed through the Destination guiding sheath, which was compatible with the AVP-II in sizes up to 12 mm, as well as all sizes of the ADO-II. If the Destination guiding sheath could not be passed through the defect using the antegrade transseptal approach, a snare catheter was inserted through the femoral artery to catch the guidewire in the ascending aorta that had passed through the defect and to establish a bidirectional approach to pass through the Destination guiding sheath. The distal retention disc of the AVP-II/ADO-II was pushed from the Destination guiding sheath into LV, followed by straddling the PVL defect with retention discs on both sides. Before AVP-II/ADO-II deployment, leaflet impingement was excluded using both TEE and fluoroscopy, and the mean mitral gradient was assessed using TEE. The key criteria for AVP-II/ADO-II release are a significant reduction in the PVL, the absence of severe mitral stenosis, and adequate device stability.

The choice of the occluder device depended on the location, size, and shape of the PVL defect, and was guided by echocardiographic measurement of the vena contracta, with appropriate oversizing to ensure device stability (Figure 1).

Figure 1.

Transcatheter paravalvular leak (PVL) closure using the Amplatzer Vascular Plug II (AVP-II). (A) Transesophageal echocardiography (TEE) demonstrating moderate to severe mitral PVL (arrow). LA, left atrium. (B) Three-dimensional TEE showing severe mitral PVL from the lateral position of the prosthetic valve (arrow). (C) Fluoroscopy demonstrating crossing of 2 6-Fr Destination guiding sheaths and AVP-II plugs in the PVL defect (arrows). (D) Fluoroscopy demonstrating deployment of 2 8-mm AVP-II plugs (arrows). (E) Postprocedural TEE showing the deployed AVP-II plugs (arrow) and trivial residual regurgitation. (F) Postprocedural 3-dimensional TEE showing the placement of the 2 AVP-II plugs (arrows).

Data Analysis

Total procedure time was defined as the duration from sheath insertion to sheath removal. Clinical outcomes during the procedure, hospitalization, and 30-day and 1-year follow-up were examined. Major adverse clinical events, as defined by the Mitral Valve Academic Research Consortium criteria, were death, rehospitalization for heart failure, myocardial infarction, stroke, major bleeding (Valve Academic Research Consortium-2 criteria), major vascular complications, device-related complications, or subsequent cardiac surgery.^16,17 Data are presented as the mean±SD or median with interquartile range (IQR) where specified. The distributions of continuously skewed data were compared using the non-parametric Wilcoxon rank-sum test. All statistical analyses were performed using SPSS version 25 (SPSS, Chicago, IL, USA).

Results

Twelve patients with prior mitral valve replacement underwent transcatheter PVLC using AVP-II/ADO-II. Baseline characteristics of the study population and procedural details are presented in Tables 1 and 2. Overall, mean age was 78±7 years, the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) was 11.6% (IQR 8.3–18.7%) for mitral valve replacement, and LV function was preserved in 10 (83%) patients (mean ejection fraction 57.7±10.9%). Nine (75%) patients had undergone previous mechanical mitral valve replacement. Symptomatic heart failure, hemolytic anemia, or both were evident in all patients. The median duration between mitral surgery and transcatheter PVLC was 14 years (IQR 9–20 years). Overall, 75% of patients had greater than Grade 3 mitral PVL. Mean lactate dehydrogenase (LDH) was 4,049±2,464 U/dL. Sixty-seven per cent of PVL defects were single, with 37% located anteriorly and 26% located laterally.

Table 1.

Baseline Characteristics and Echocardiography Findings (n=12)

Age (years)	78±7
Male sex	5 (42)
BMI (kg/m2)	20.5±2.0
Presenting symptoms
Heart failure	10 (83)
Hemolytic anemia	11 (92)
NYHA functional class
III	2 (17)
IV	1 (8)
Coronary artery disease	1 (8)
Peripheral arterial disease	1 (8)
Hypertension	4 (33)
Diabetes	0
Atrial fibrillation	10 (83)
COPD	0
Prior MI	1 (8)
Prior stroke	2 (17)
PCI	1 (8)
CABG	0
Permanent pacemaker	4 (33)
Hemoglobin (mg/dL)	10.0±1.2
Total bilirubin (mg/dL)	2.7±1.1
LDH (U/dL)	4,049±2,464
Creatinine (mg/dL)	1.3±0.4
NT-pro BNP (pg/mL)	3,051±2,774
STS-PROM for replacement (%)	11.6 [8.3–18.7]
Type of surgical mitral prosthetic valve
Mechanical valve	9 (75)
Carbomedics	4 (33)
St. Jude Medical	2 (17)
Bioprosthetic valve	3 (25)
Epic	2 (17)
No. previous valve surgeries	2.3±1.0
Time from last mitral surgery to transcatheter closure (years)	14 [9–20]
Mitral PVL grade
2	3 (25)
3	8 (67)
4	1 (8)
Mean mitral gradient (mmHg)	6.2±2.2
LVEF (%)	57.7±10.9
LVEDd (cm)	5.0±0.7
LVESd (cm)	3.4±0.6
Right ventricular systolic pressure (mmHg)	43.0±13.9
Moderate or severe aortic regurgitation	1 (8)
Moderate or severe tricuspid regurgitation	2 (17)

Data are expressed as the mean±SD, median [interquartile range], or n (%). BMI, body mass index; CABG, coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease; LDH, lactate dehydrogenase; LVEDd, left ventricular end-diastolic diameter; LVEF, left ventricular ejection fraction; LVESd, left ventricular end-systolic diameter; MI, myocardial infarction; NT-proBNP, N-terminal pro B-type natriuretic peptide; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PVL, paravalvular leak; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality.

Table 2.

Procedural Characteristics (n=12)

	All (n=12)	Mechanical valve (n=9)	Bioprosthetic valve (n=3)
General anesthesia	12 (100)	9 (100)	3 (100)
Imaging during procedure
Intracardiac echocardiography	1 (8)	0	1 (33)
Transthoracic echocardiography	0	0	0
TEE	12 (100)	9 (100)	3 (100)
Preprocedural right heart catheterization
Mean PCWP (mmHg)	18±6	17±6	22±7
Mean PAP (mmHg)	27±8	24±8	34±2
Cardiac index (L/min/m2)	2.9±0.6	2.9±0.3	2.9±1.0
Approach
Antegrade transseptal	7 (58)	6 (67)	1 (33)
Retrograde aortic approach	0	0	0
Bidirectional approach	5 (42)	3 (33)	2 (67)
No. defects
1	8 (67)	5 (56)	3 (100)
2	2 (17)	2 (22)	0
≥3	2 (17)	2 (22)	0
PVL position as defined as on TEE
Anterior	4 (21)	3 (75)	1 (25)
Posterior	7 (37)	6 (86)	1 (14)
Septal	3 (16)	2 (67)	1 (33)
Lateral	5 (26)	5 (100)	0
No. devices implanted	2.9±1.1	3.1±1.2	2.3±0.5
Type of devices implanted
AVP-II	10 (83)	7 (78)	3 (100)
ADO-II	0	0	0
AVP-II and ADO-II	2 (17)	2 (22)	0
Residual mitral PVL grade
0	3 (25)	2 (22)	1 (33)
1	9 (75)	7 (78)	2 (67)
Procedure time (min)	332±121	371±113	214±47

Data are expressed as the mean±SD or n (%). ADO-II, Amplatzer Duct Occluder II; AVP-II, Amplatzer Vascular Plug II; PAP, pulmonary artery pressure; PCWP, pulmonary capillary wedge pressure; PVL, paravalvular leak; TEE, transesophageal echocardiography.

Procedural Outcomes

The procedural details in each case are presented in Table 3. All patients underwent the procedure under general anesthesia and TEE; 1 (8%) patient underwent combined TEE and intracardiac echocardiography guidance. Seven (58%) patients underwent the antegrade transseptal approach, whereas the bidirectional approach was used in remaining 5 patients. Device implantation was successful in all patients. On average, 2.9±1.1 occluder devices were deployed per patients, with 2 (17%) patients requiring the combined use of AVP-II and ADO-II. These 2 patients had prior prosthetic valves, either mechanical (Carbomedics; LivaNova, London, UK) or MIRA (Edwards Lifesciences, Irvine, CA, USA).

Table 3.

Procedural and Follow-up Details for All Patients

	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6
Procedural details
Type of mitral prosthetic valve	Mechanical	Bioprosthetic	Mechanical	Mechanical	Bioprosthetic	Mechanical
Detail of prosthetic valve	NA	Epic 27 mm	SJM 27 mm	SJM 27 mm	Epic 25 mm	Carbomedics 27 mm
Time since prior mitral surgery (years)	24.9	1.7	10.4	9.8	2.5	24.1
Approach	Antegrade	Bidirectional	Bidirectional	Bidirectional	Bidirectional	Bidirectional
PVL position	Lateral	Septal	Anterior, septal and posterior	Lateral	Anterior	Posterior
No. defects	1	1	3	2	1	1
AVP-II size (mm)	8/10	10	6/8	6	10	8
No. AVP-II	3	2	3	2	3	2
ADO-II size (mm)	NA	NA	NA	NA	NA	NA
No. ADO-II	NA	AN	NA	NA	NA	NA
Total procedure time (min)	401	253	310	466	240	281
Hemodynamic and laboratory details
Mitral PVL grade
PreA	3+	3+	3+	3+	2+	3+
PostB	1+	1+	1+	Trivial	Trivial	1+
Lactate dehydrogenase (U/dL)
At admission	7,136	696	7,202	2,473	1,375	7,349
At discharge	3,127	697	5,261	2,861	1,089	4,291
NYHA functional class
At admission	1	3	2	3	4	2
At discharge	1	2	2	2	3	2
At 30-day follow-up	2	2	2	2	2	2
	Patient 7	Patient 8	Patient 9	Patient 10	Patient 11	Patient 12
Procedural details
Type of mitral prosthetic valve	Mechanical	Mechanical	Bioprosthetic	Mechanical	Mechanical	Mechanical
Detail of prosthetic valve	Bjork-Shiley 27 mm	Carbomedics 29 mm	Magna 27 mm	Carbomedics 29 mm	Carbomedics 25 mm	MIRA 29 mm
Period from prior mitral surgery (years)	45.1	18.8	5.4	15.8	14.2	12.9
Approach	Antegrade	Antegrade	Antegrade	Antegrade	Antegrade	Antegrade
PVL position	Anterior, septal and posterior	Lateral and posterior	Posterior	Lateral	Posterior	Anterior, lateral and posterior
No. defects	1	2	1	1	1	4
AVP-II size (mm)	8	8/10/12	8	8	8	10
No. AVP-II	5	3	2	2	2	1
ADO-II size (mm)	NA	6	NA	NA	NA	4/6
No. ADO-II	NA	2	NA	NA	NA	3
Total procedure time (min)	480	369	148	472	115	444
Hemodynamic and laboratory details
Mitral PVL grade
PreA	3+	2+	3+	3+	2+	4+
PostB	1+	1+	1+	1+	Trivial	1+
Lactate dehydrogenase (U/dL)
At admission	7,631	2,805	2,233	4,340	2,824	2,519
At discharge	2,357	1,892	1,215	2,232	1,492	1,360
NYHA functional class
At admission	2	1	2	2	2	2
At discharge	2	1	1	1	1	1
At 30-day follow-up	2	1	1	1	1	1

^AOn intraprocedural TEE. ^BOn TTE at discharge. MR, mitral regurgitation; NA, not available; SJM, St. Jude Medical. Other abbreviations as in Table 2.

Overall, the mean procedure time was 332±121 min. Device implantation led to reductions in mitral PVL grade (from 2.8±0.6 to 0.8±0.5; P<0.001), a significant decrease in LDH levels (from 4,049±2,573 U/dL at baseline to 2,323±1,370U/dL after the procedure; P=0.004), and a significant improvement of New York Heart Association (NYHA) class (from 2.2±0.8 to 1.6±0.7; P<0.002; Figures 2–4).

Figure 2.

Changes in the severity of the mitral paravalvular leak (PVL) following transcatheter PVL closure in 12 patients.

Figure 3.

Change in lactate dehydrogenase (LDH) concentrations following transcatheter paravalvular leak closure in 12 patients. Data are the mean±SD.

Figure 4.

Changes in New York Heart Association (NYHA) functional class following transcatheter paravalvular leak closure in 12 patients.

There were no major adverse events, including procedural death, myocardial infarction, stroke, device-related complications (i.e., prosthetic leaflet impingement and embolization), or urgent cardiovascular surgery during the procedure or hospitalization (Table 4). All 12 patients were successfully discharged, with a mean hospital stay of 5.3±2.3 days.

Table 4.

Clinical Outcomes

	All (n=12)	Mechanical valve (n=9)	Bioprosthetic valve (n=3)
Procedural and in-hospital outcomes
Procedure success	12 (100)	9 (100)	3 (100)
All-cause mortality	0	0	0
Cardiac death	0	0	0
Myocardial infarction	0	0	0
Stroke	0	0	0
Cardiac perforation	0	0	0
Conversion to emergency cardiac surgery	0	0	0
Vascular complication	1 (8)	0	1 (33)
Prosthetic leaflet impingement	0	0	0
Device embolization	0	0	0
Device thrombosis	0	0	0
30-day outcomes
All-cause mortality	0	0	0
Cardiac death	0	0	0
Rehospitalization for heart failure	0	0	0
Death or rehospitalization for heart failure	0	0	0
Myocardial infarction	0	0	0
Stroke	0	0	0
Major bleeding (VARC-2 criteria)	0	0	0
Persistent hemolytic anemia	1 (8)	1 (11)	0
Prosthetic leaflet impingement	0	0	0
Device embolization	0	0	0
Device thrombosis	0	0	0
Subsequent cardiac surgery	1 (8)	1 (11)	0
1-year outcomes
All-cause mortality	2 (17)	2 (22)	0
Cardiac death	1 (8)	1 (11)	0
Rehospitalization for heart failure	3 (25)	3 (33)	0
Death or rehospitalization for heart failure	4 (33)	3 (33)	0
Prosthetic leaflet impingement	1 (8)	1 (11)	0
Device embolization	0	0	0
Device thrombosis	0	0	0
Reintervention	3 (25)	3 (33)	0

Data are expressed as n (%). VARC, Valve Academic Research Consortium.

Follow-up Evaluation

At the 30-day follow-up, symptom improvement occurred and persisted in 7 of 10 patients with heart failure, with 4 patients exhibiting only mild or no symptoms (i.e., NYHA class 2.2±0.8 to 1.6±0.5; P<0.027 vs. baseline; Figure 4). One (8%) of the 12 implanted patients underwent subsequent surgery for mitral valve replacement within 30 days after the transcatheter procedure because of persistent hemolytic anemia. None of the patients experienced adverse clinical events or device-related complications at the 30-day follow-up (Table 4). Furthermore, during the 1-year follow-up, the all-cause mortality rate was 16.7% and the freedom from heart failure rehospitalization rate was 75%. One (8%) patient was rehospitalized for heart failure due to prosthetic leaflet impingement 8 months after transcatheter PVLC. Reintervention was required in 3 (24%) patients because of the recurrence of clinical symptoms. One of these patients subsequent underwent surgical mitral valve replacement, another underwent redo surgical mitral replacement after 8 months, and the remaining patient underwent additional transcatheter PVLC 5 months after the first procedure.

Discussion

This study examined the efficacy and feasibility of transcatheter PVLC with AVP-II/ADO-II in Japanese patients with mitral PVL after surgical mitral valve replacement. We achieved procedural success with the deployment of several Amplatzer occluders in all patients. No major adverse events were noted in any patient during hospitalization. Postoperative mitral PVL severity, LDH levels, and NYHA functional class improved significantly. At the 30-day follow-up, only 1 patient required subsequent repeat surgery, but improvement in heart failure symptoms was maintained. At the 1-year follow-up, the all-cause mortality rate was 16.7%, and the freedom from heart failure rehospitalization rate was 75%. Three patients underwent reintervention because of worsening clinical symptoms. Together, these findings suggest that mitral PVL after mitral valve replacement can be successfully treated with transcatheter PVLC using AVP-II/ADO-II, which may lead to satisfactory 30-day outcomes. Conversely, the 1-year outcomes may be less satisfactory. This study, involving more than 10 Japanese patients, is the first report of transcatheter PVLC in Japan.

Amplatzer vascular plugs are widely used as occluder devices for transcatheter PVLC, with AVP-II plugs being preferred. Their 3-segment design offers robust stability and effectively seals the PVL defects. Retention discs help prevent device dislocation and embolization. In addition, the risk of hemolysis, compared with other devices, is relatively low because of the small caliber of the nitinol mesh.¹⁸ AVP-II plugs are available in various sizes and are relatively less expensive, which is important for off-label use. In contrast, the ADO-II has a central waist and 2 symmetrical retention discs (both 6 mm larger than the central waist). A central waist was designed to fill the defect, and 2 retention discs were deployed on the left atrial and LV sides of the defect. In situations where the deployment of a large AVP-II may cause prosthetic valve dysfunction, such as leaflet impingement, or where the width of the defect is narrow and the wide waist of the AVP-II could potentially enlarge and worsen the defect, ADO-II may be a useful alternative option. However, although AVP-II/ADO-II may be highly effective, the long-term durability of all occluder devices remains uncertain and requires further follow-up. It is also important to note that the optimal antithrombotic therapeutic regimens for antiplatelet and anticoagulant therapies in these patients have not been established.

In our study, the procedure was successful in all patients regardless of the type of prosthetic valve used. Multiple plug devices (mean 2.9±1.1) were deployed, and a bidirectional approach was required in 5 (42%) patients. PVL occurs in multiple forms and locations, depending on factors such as the type of prosthetic valve, calcification, and inflammation of the mitral annulus and surrounding valve tissues.¹⁹ Therefore, transcatheter PVLC procedures often require multiple device deployments and complicated access to the PVL defect, such as a bidirectional or transapical approach. Previous reports have indicated that the transapical approach is effective in certain cases when transcatheter PVLC is used for mitral PVL.^5,8,20 However, in our study, the patient group was elderly (mean age 78 years) with prohibitive surgical risks (median STS-PROM 11.6%); therefore, the transapical approach was avoided because it is a relatively invasive option. This may have caused difficulty in passing the guidewire to the PVL defect, thereby prolonging the procedure time. Moreover, Sorajja et al. reported that transcatheter PVLC is a complex procedure with a learning curve that improves procedural techniques and imaging.²¹ The findings of the present study provide the initial results of transcatheter PVLC for mitral PVL in Japan. Procedure strategies, the selection of appropriate devices, and discussion of procedural endpoints during the procedures may have contributed to the prolonged procedure time.

In this study, although the patient group was older and had a higher surgical risk than in previous studies,^5,8,9,20 the in-hospital and 30-day mortality rates were favorable. Furthermore, there were no major adverse events or device-related complications (e.g., device embolization or prosthetic leaflet impingement). Postoperative residual mitral PVL is an important factor affecting symptom severity and clinical outcomes.^4,9 In the present study, transcatheter PVLC procedures were able to significantly decrease the mitral PVL grade from 2.8±0.6 to 0.8±0.5, resulting in significant improvements in LDH and NYHA functional class. Conversely, subsequent repeat surgery due to recurrence of hemolytic anemia was required in 1 (8.3%) patient. Gurner et al. recently reported that transcatheter PVLC is associated with lower in-hospital mortality than surgical PVLC.²⁰ Previous studies have demonstrated improvements in heart failure symptoms and hemolytic anemia after transcatheter PVLC using an Occlutech PLD device. However, approximately 1–10% of patients exhibited device-related complications and persistent hemolytic anemia, and required reintervention.^5,20 The results of the present study are consistent with those of previous studies. In addition, the efficacy of the transcatheter procedure persisted at the 1-year follow-up, and the mortality and device-related complications were equivalent to those reported previously.^5,20

Although redo surgery for severe symptomatic PVL is the gold standard strategy under current guidelines, it is associated with high perioperative complications, mortality, and recurrence of PVL due to fragility, inflammation, and calcified tissues around the valve.²² Alternative strategies, such as transcatheter PVLC and transcatheter valve-in-valve therapy for prosthetic valve dysfunction, including PVL, have been increasingly useful in these patients.^5,20 Moreover, with the increase in the number of transcatheter heart valve implantations in recent years, the number of patients with PVL is also expected to increase. Thus, there is an ongoing need for transcatheter PVLC, as demonstrated in the present study. However, transcatheter PVLC is effective for a limited number of mitral PVL patients who are at prohibitive risk of repeat surgery and have suitable locations and shapes of the PVL defect for the transcatheter procedure. Therefore, this procedure is uncommon but can be performed in limited cases of mitral PVL with careful patient selection and consideration through multidisciplinary evaluation.

Together, our results provide new insights into transcatheter PVLC using AVP-II/ADO-II in Japanese patients with mitral PVL. Our findings also suggest that transcatheter PVLC using AVP-II/ADO-II may be an effective alternative strategy to avoid repeat mitral surgery in Japanese patients with mitral PVL after surgical mitral replacement.

Study Limitations

The present study has several limitations. First, this was a single-center retrospective observational study with a small case series of selected patients. Therefore, our findings may be institution-specific and not generalizable. Second, because this study demonstrated the early experience of transcatheter PVLC in Japanese patients with mitral PVL, our results (i.e., procedure time) may have been affected by learning curves for the operator and with the procedure.

Further validation with a larger series and more long-term data are required to support the use of the device in this patient population.

Conclusions

Transcatheter PVLC is feasible and safe for most Japanese patients with mitral PVL who have undergone surgical prosthetic mitral valve replacement. Clinical success with durable relief from severe clinical symptoms and avoidance of the need for mitral repeat surgery were possible in most patients with procedural success. Our results suggest that transcatheter PVLC using AVP-II/ADO-II may help avoid the need for subsequent valve replacements in this population.

Acknowledgments

The authors thank the staff of Toho University Ohashi Medical Center and acknowledge the medical institutions and physicians who referred these patients to our hospital.

Sources of Funding

This study did not receive any specific funding.

Disclosures

The authors declare that there are no conflicts of interest.

IRB Information

The study protocol was approved by the Ethics Committee of Toho University Ohashi Medical Center (Reference no. H23069_H21012).

Data Availability

The deidentified participant data will not be shared.

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