Transcatheter heart valve (THV) embolization is a rare but serious complication of transcatheter aortic valve implantation. Studies, including case reports, case series, and original reports published between 2002 and 2013, with regard to THV embolization were identified with a systemic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A total of 19 publications describing 71 patients were identified. Most patients (64%) were men, with a mean age of 80 ± 6 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 22.4 ± 9.3%. Balloon-expandable valves were used in 72% of the patients. The reported transcatheter aortic valve replacement access site was transfemoral in 80% of patients. Most cases (90%) occurred <1 hour after implantation, whereas 10% had late embolization (range 4 hours to 43 days). The most common site of embolization was the ascending aorta (38%), followed by the left ventricle (31%), descending aorta (23%), and aortic arch (8%). Open-heart surgery was required in 28% for valve retrieval and replacement. The 30-day stroke and mortality rates were 11% and 17%, respectively. Ventricular embolization and urgent conversion to open-heart surgery were significantly associated with death during hospitalization (p = 0.017 and p = 0.029, respectively). Likely causes of embolization were identified in 59 patients, with positioning error as the most commonly reported (47%), followed by pacing error (13%). In conclusion, THV embolization occurred early after transcatheter aortic valve implantation. The ascending aorta was the most common site of embolization. Higher 30-day stroke and mortality rates were associated with THV embolization compared with most published series of transcatheter aortic valve implantation outcomes.
Transcatheter aortic valve implantation (TAVI) is an excellent treatment strategy for patients with severe aortic stenosis who are inoperable or at high risk for conventional surgery. Since the initial implantation in 2002, >150,000 implantations have been reported worldwide. With increasing numbers of cases, various procedural complications have been identified, which differ from complications after surgical aortic valve replacement. Whereas more common complications such as vascular complications, cerebrovascular events, coronary obstruction, and conduction abnormalities are well described, less is known about valve embolization, and most data are derived mainly from small case reports and case series. Device embolization is defined as movement of the device after initial placement leading to complete detachment of the valve from the aortic annulus and movement into either the aorta or the left ventricle. The objective of the present study was to systematically review all reported cases of valve embolization in patients who underwent TAVI and identify the baseline demographic and procedural characteristics, management, and clinical outcomes of these patients.
Methods
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement for reporting systematic reviews recommended by the Cochrane Collaboration was followed in this study ( Figure 1 ). A systematic search of all relevant reports published in English from 2002 to 2013 documenting device embolization after TAVI, including case reports, case series, and original reports, was performed in the PubMed, Embase, and Cumulative Index to Nursing and Allied Health Literature databases. A Boolean search was performed combining the following keywords: “transcatheter aortic valve implantation” OR “transcatheter aortic valve replacement” AND “embolization” OR “dislocation.” No language restriction was applied. Additional manual searching of the bibliographies of included reports, known reviews, and relevant reports was performed to look for additional studies. Only studies reporting data on demographic and procedural characteristics, management, and clinical outcomes were included. To obtain missing data, the primary investigators of the included studies were contacted. Statistical analysis was done using SPSS version 20.0 (IBM Corporation, Armonk, New York). Two authors (SG and OB) screened and retrieved reports and excluded irrelevant studies. A third author (UNI) participated in the review process when uncertainty about eligibility criteria arose. Primary analysis of the data was performed by measuring frequencies and descriptive statistics, including mean and SD. Bivariate analyses of the associations between various clinical and procedural characteristics and 30-day mortality were done using chi-square tests.
Device embolization is defined as movement of the device after initial placement, leading to complete detachment of the valve from the aortic annulus and movement into either the aorta or the left ventricle. This differs from device misplacement, in which the valve remains fixed to the aortic annulus but is not in the right annular plane and is either too high (aortic) or too low (ventricular).
Results
A total of 19 publications describing 71 patients with valve embolization were identified ( Table 1 ). Fifty-five of the 71 cases of valve embolization occurred after TAVI in 3,621 patients (0.02%), and the rest were case reports. The mean age of the study population was 80 ± 6 years, and most patients were men (64.5%) ( Table 2 ). The mean logistic European System for Cardiac Operative Risk Evaluation score was 22.4 ± 9.3%. Balloon-expandable Edwards SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 72% of the cases, and self-expanding Medtronic CoreValve devices (Medtronic, Inc., Minneapolis, Minnesota) were used in 28%. Most cases of embolization (90%) occurred intraoperatively or <1 hour after implantation, whereas 7 patients (10%) had late embolization ranging from 4 hours to 43 days. The most common sites of embolization, in descending order, were the ascending aorta (38%), left ventricle (31%), descending aorta (23%), and aortic arch (8%). Late embolization occurred mostly into the left ventricle (86%) and was associated with worse outcomes (43% mortality). Conversion to open-heart surgery was required in 20 patients (28.2%) for valve retrieval and/or replacement. Occurrence of stroke within 30 days was seen in 8 patients (11.3%). The 30-day mortality rate was 17% (12 of 71). The presence of ventricular embolization and urgent conversion to open-heart surgery were significantly associated with death during hospitalization (p = 0.017 and p = 0.029, respectively). Follow-up clinical data were available for 40 patients, with alleviation of symptoms or improvements in New York Heart Association class reported in 34 patients (85%). Some of the included studies reported follow-up data >1 year. Likely causes of embolization were mentioned in 59 patients. Positioning error was the most commonly reported (n = 28 [47%]), followed by pacing error (n = 8 [13%]) ( Figure 2 ), and 9 cases of embolization (15%) occurred during a snaring maneuver to reposition the valve or as a bailout for coronary ostia obstruction.
| Author/ Publication year | Age (years) | Sex | Valve type | Approach | Timing of embolization | Dislocation position |
|---|---|---|---|---|---|---|
| Fairbairn 2013 | 86 | f | CoreValve | Transfemoral | Intraop | Ascending aorta |
| 82 | f | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| Soutenyard 2013 | 79 | m | CoreValve | Transfemoral | Intraop | Ascending aorta |
| 85 | m | CoreValve | Left subclavian | Intraop | Ascending aorta | |
| Ussia 2012 | 81 | f | CoreValve | Transfemoral | Intraop | Ascending aorta |
| 84 | f | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 82 | m | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 82 | m | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 87 | m | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 81 | f | CoreValve | Transfemoral | Intraop | Descending aorta | |
| 85 | f | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| Tay 2011 | 84 | f | Edwards Sapien | Transfemoral | Intraop | Transverse aorta |
| 85 | f | Edwards Sapien | Transfemoral | Intraop | Descending aorta | |
| 71 | m | Edwards Sapien | Transfemoral | Intraop | Abdominal aorta | |
| 82 | f | Edwards Sapien | Transfemoral | Intraop | Abdominal aorta | |
| 86 | m | Edwards Sapien | Transfemoral | Intraop | Transverse aorta | |
| 76 | m | Edwards Sapien | Transfemoral | Intraop | Descending aorta | |
| 82 | m | Edwards Sapien | Transfemoral | Intraop | Abdominal aorta | |
| Gul 2012 | 76 | m | Edwards Sapien | Transfemoral | 4 hours postop | Left ventricle |
| Guerios 2012 | 86 | f | CoreValve | Transfemoral | Intraop | Ascending aorta |
| 78 | f | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 85 | f | CoreValve | Transfemoral | Intraop | LVOT | |
| 82 | f | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 77 | f | CoreValve | Transfemoral | Intraop | Ascending aorta | |
| 81 | m | CoreValve | Transfemoral | Intraop | LVOT | |
| Al Ali 2008 | 83 | Edwards Sapien | Tranfemoral 7. Transapical 2 | Immediate | Ascending aorta 8, LVOT 1 | |
| Mwipatayi 2013 | 83 | m | Edwards Sapien | Transfemoral | Intraop | Transverse aorta |
| Naganuma 2013 | 67 | m | Edwards sapien | Transfemoral | 21 days postop | LVOT |
| Sarkar 2011 | 81 | m | CoreValve | Transfemoral | Intraop | Ascending aorta |
| Bagur 2012 | 78 | m | Edwards Sapien | Transapical | Intraop | Left ventricule |
| Astarci 2011 | 85 | f | Edwards Sapien | Transapical | Immediate | Left ventricule |
| Delhaye 2012 | 87 | m | CoreValve | Subclavian access | Immediate | Ascending aorta |
| Makkar 2013 PARTNER 1 trial | 81 | 20 m, 6 f | Edwards Sapien | Transfemoral 20, transapical 6 | 20 early postop, 1 late postop | Descending aorta 10, transverse aorta 3, left ventricle 10, LVOT 2 |
| Clavel 2009 | 79 | m | Edwards Sapien | Transapical | 2 days postop | LVOT |
| Radu 2012 | 85 | m | Edwards Sapien | Transfemoral | 5 days postop | LVOT |
| Maroto 2009 | 75 | f | Edwards Sapien | Transapical | 3 weeks postop | Ascending aorta |
| Pang 2011 | 75 | m | Edwards Sapien | Transfemoral | 43 days postop | LVOT |
| Piazza 2012 | 40 | m | CoreValve | Transfemoral | Immediate | Ascending aorta |
| Characteristic | Value |
|---|---|
| Mean Age (mean ± SD) (Years) | 80.28 (6.3) |
| Gender (n=62) | |
| Male | 40 (65%) |
| Female | 22 (36%) |
| Aortic Valve Area (mean ± SD in cm 2 ) | 0.5 (0.3) |
| Aortic Valve gradient (mean ± SD in mm Hg) | 48 (18) |
| Mean Logistic Euroscore (mean ± SD) | 22 (9) |
| Access (n=71) | |
| Transfemoral | 57 (80%) |
| Transapical | 12 (17%) |
| Subclavian | 2 (3%) |
| Type of valve (n=71 ) | |
| Corevalve | 20 (28%) |
| Edward Sapiens | 51 (72%) |
| Timing of Embolization (n=71) | |
| Immediate (intraoperative or within 1 hour) | 64 (90%) |
| Late (after 1 hour) | 7 (10%) |
| Site of Embolization (n=71) | |
| Ascending Aorta | 27 (38%) |
| Left Ventricle | 22 (31%) |
| Descending Aorta | 16 (23%) |
| Aortic Arch | 6 (8%) |
| Complications | |
| All-cause mortality in 30 days | 12 (17%) |
| Stroke within 30 days | 8 (11%) |
| Conversion to open surgery | 20 (28%) |
| Arrhythmia | 5 (7%) |
| Minor Vascular | 8 (11%) |
| Factors associated with Embolization (n=59) | |
| Positioning Error | 28 (48%) |
| Pacing Error | 12 (17%) |
| Anatomic reasons (asymmetric calcification, valve asymmetry, aortic angulation) | 11 (16%) |
| Accidental dislocation during snaring Maneuver | 9 (15%) |
| Malpositioned prosthesis coaxially to valve plane | 4 (6%) |
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