Abstract
Background
Cardiac tamponade is a rare but potentially lethal complication of transcatheter aortic valve replacement (TAVR). There is paucity of evidence assessing the incidence and outcomes of patients with cardiac tamponade after TAVR.
Methods
A retrospective review was performed of all patients who underwent TAVR at our institution from January 2013 to January 2019. The clinical characteristics of patients who developed cardiac tamponade in the periprocedural period were compared to the patients who did not develop tamponade. Qualitative and quantitative assessment of aortic annular calcium distribution on cardiac computerized tomography was analyzed.
Results
Twenty out of 2030 patients (0.9%) developed cardiac tamponade post-TAVR. The mean age of the cohort developing cardiac tamponade was 81.7 years, and 50% of them were men. Most of these were intraprocedural (70%) while the remaining were identified in the postprocedural period. The site of injury resulting in pericardial tamponade was thought to be from the injury to aortic annulus (50%), right ventricle (40%), and left ventricle (10%). Tamponade due to annular or left ventricular trauma was mostly identified intraprocedurally (91%; n = 10 of 11), while patients with tamponade due to presumed right ventricular injury were mostly identified in the postprocedural period (62.5%; n = 5 of 8) ( p = 0.009). Conservative management with supportive therapies was employed in 90% of patients with cardiac tamponade, while two patients had cardiac surgery. There was one in-hospital mortality, and another patient died within 30 days of the TAVR procedure.
Conclusion
The incidence of cardiac tamponade after TAVR (0.9%) was low, and this serious complication can be managed successfully in the majority of patients with streamlined processes in high-volume centers.
Highlights
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Cardiac tamponade post-transcatheter aortic valve replacement is a rare complication with low rates noted in our cohort.
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Majority of the cases were identified in the intraprocedural period and occurred as a result of trauma to the aortic annulus. Postprocedural cardiac tamponade occurred most often due to injury to right ventricle.
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Favorable outcomes were seen in patients suffering from cardiac tamponade post-transcatheter aortic valve replacement. This signals the need for careful patient selection in heart team consortium and appropriate preprocedural planning using multimodality imaging.
Introduction
Transcatheter aortic valve replacement (TAVR) has revolutionized the way patients with severe aortic stenosis are managed at all surgical risk levels. While significant complications like aortic dissection, access site injury, valve embolization, and aortic annular rupture are rare, they present significant risk for morbidity and/or mortality. In this regard, cardiac tamponade is uncommon but carries a high mortality rate, especially when it is due to annular trauma. , Management of cardiac tamponade often requires pericardiocentesis or surgical intervention, which may be challenging due to the high surgical risk of patients undergoing TAVR. There is a paucity of literature regarding the incidence and management of cardiac tamponade after TAVR. , The aim of this study was to provide a temporal trend of cardiac tamponade post-TAVR and report its incidence and management in the contemporary era.
Study Design
This was a single-center retrospective observational study performed to evaluate the incidence of tamponade post-TAVR and its management in a tertiary care center. We also aim to provide a procedural case description that may shed some light on this complication and help to identify the etiology of tamponade in these cases. The study was approved by the Cleveland Clinic Institutional Review Board (IRB-181500). The data were deidentified and informed consent was waived. All patients who underwent TAVR from January 2013 to January 2019 after the routine heart team evaluation were identified in the Cleveland Clinic Aortic Valve Center TAVR database. A total of 2030 cases of TAVR were identified. Cardiac tamponade was defined as a life-threatening event that involved slow or rapid compression of the cardiac chambers as a result of pericardial fluid.
Clinical, imaging, procedural features, and follow-up data were collected through review of the electronic medical records. The clinical features collected included age, gender, race, clinical symptoms (angina and syncope), body mass index, diabetes mellitus, smoking, porcelain aorta, hypertension, end-stage renal disease, peripheral vascular disease, stroke, or transient ischemic attack, right/left ventricular size (RV/LV) and function, prior coronary artery bypass graft/percutaneous coronary intervention, and intracardiac devices. Procedural features included type of anesthesia, access site and sheath size, type of temporary pacemaker wire, valve type (balloon-expandable or self-expanding valve), bioprosthetic valve type for valve-in-valve TAVR, guide wires, and pre-/post-dilation. Given the potentially lethal complication, primary endpoint was all-cause death within 30 days of the TAVR procedure. Secondary endpoints included need for cardiac surgery, shock, acute kidney injury, requirement for permanent pacemaker implantation, and in-hospital death. The etiology of tamponade was retrospectively confirmed by A.K. and S.R.K. via review of procedural imaging, the medical chart, and blood gases drawn from the drain when available.
In cases of cardiac tamponade, the preoperative cardiac computed tomography was reviewed again for calcification and its extent. Annular and aortic root measurements were typically performed in systolic (20-30%) phases. Quantitative and qualitative measures were used to assess calcium burden. A volumetric technique was used to assess the extent of calcium, and the mean calcium score was determined using the Agatston method.
Statistical Analysis
Continuous variables were expressed as mean (standard deviation), and categorical variables were expressed as frequency (percentages). Continuous variables were compared using the Student’s t test, while categorical variables were compared using chi-square tests or Fisher exact tests as deemed suitable. The statistical analysis was accomplished using STATA (version 15.1; Statacorp, College Station, Texas).
Results
Baseline Characteristics
We identified 20 patients (0.9%) with cardiac tamponade from a total cohort of 2030 patients who underwent TAVR for severe aortic stenosis. Baseline characteristics are summarized in Table 1 . As expected, patients undergoing TAVR were elderly and had a mean Society of Thoracic Surgeons score of 6.8 ± 3.5. Almost half of the patients had a history of smoking, with more than 80% suffering from hypertension, and diabetes was present in two-third of the cohort.
| Characteristics | TAVR complicated by cardiac tamponade (20) | TAVR without cardiac tamponade (2030) | P value |
|---|---|---|---|
| Age | 81.7 ± 10.1 | 80.6 ± 9.2 | NS |
| Male | 10 (50) | 1167 (57.4) | NS |
| BMI | 25.8 ± 5.06 | 29.4 ± 13.6 | NS |
| Former smoker | 9 (45) | 1112 (54.7) | NS |
| Hypertension | 16 (80) | 1729 (85.1) | NS |
| Diabetes mellitus | 4 (20) | 729 (35.5) | NS |
| Chronic kidney disease | 10 (50) | 841 (41.4) | NS |
| History of stroke | 4 (20) | 748 (41.9) | NS |
| Percutaneous coronary intervention | 7 (35) | 1379 (67.9) | 0.001 |
| Coronary artery bypass grafting | 1 (5) | 156 (7.6) | NS |
| TAVR | Subclavian/axillary-1 (5%) Transcaval-1 (5%) Transfemoral-18 (90%) | Subclavian/axillary-50 (2.5%) Transaortic-83 (4.1%) Transapical-67 (3.3%), Transfemoral-1830 (90.1%) |
The average age of the patients suffering from cardiac tamponade was 81.7 years with high rates of comorbidities. Twenty percent (n = 4) of patients suffering from cardiac tamponade were on chronic suppressant steroids. Peripheral arterial disease was present in 20% (n = 4) patients, of whom two had anatomy unsuitable for transfemoral transcatheter aortic valve replacement; one patient underwent subclavian access, and another had transcaval TAVR. Details of anesthesia and equipment including valve type and size and guidewire are provided in Table 2 .
| Timing of cardiac tamponade | Anesthesia | Type of valve | Prosthesis size | Guidewire | Annular area (cm 2 ) | Annular perimeter (cm) | Aortic valve calcification | Landing zone calcium | Landing zone calcium extent | Sinotubular junction calcium | Type of rupture | Pericardial drain | Open heart surgery | Shock | Stroke | AKI | Permanent pacemaker |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intraprocedure | MAC | ES3 | 23 mm | Amplatz extrastiff J | 3.6 | 6.8 | Leaflets | NA | 0% | Flat | LV | + | + | ||||
| MAC converted to GA | ES3 | 29 mm | Amplatz extrastiff J | 3.5 | 8.7 | Leaflet tips | Nodular; left cusp | 25% | Flat | Annular | + | ||||||
| GA | ES-XT + second valve | 23 mm | Amplatz extrastiff J | 3.4 | 6.8 | Leaflet tips | Nodular; left cusp and noncusp | 50% | Nodular | Annular | + | + | |||||
| MAC | ES3 | 29 mm | Amplatz extrastiff J | 6.2 | 9 | Leaflets | Nodular; left cusp | 50% | Nodular | Annular | + | + | + | ||||
| GA | ES3 | 29 mm | Confida wire | na | na | Leaflets | Bulky; left cusp | 50% | NA | Annular | + | + | |||||
| GA | Evolute Pro | 29 mm | Amplatz extrastiff J | 4.1 | 7.1 | Leaflets | Bulky; left and noncusp | 75% | Flat | Annular | + | + | |||||
| MAC | ES3 | 26 mm | Amplatz extrastiff J | 4.6 | 7.7 | Leaflet tips | Nodular; left cusp | 25% | NA | RV | + | + | + | ||||
| MAC converted to GA | ES3 | 26 mm | Amplatz extrastiff J | 4.7 | 8 | Leaflet tips | Nodular; left cusp | 25% | Flat | Annular | + | ||||||
| Postprocedure | MAC | ES-XT | 23 mm | Amplatz extrastiff J | 3.2 | 6.4 | Leaflets | NA | 0% | Flat | Annular | + | + | + | |||
| GA | ES-S3 | 26 mm | Amplatz extrastiff J | 4.9 | 7.9 | Leaflets | NA | 0% | Flat | RV | + | + | |||||
| MAC | ES-S3 | 23 mm | Amplatz extrastiff J | 4 | 7.6 | Leaflets | Bulky; NA | 0% | Flat | RV | + | ||||||
| GA | ES-S3 | 23 mm | Amplatz extrastiff J | 4.2 | 8 | Leaflets | NA | 0% | Flat | LV | + | + | |||||
| GA | Medtronic Evolut | 29 | Amplatz extrastiff J | 4.4 | 7.6 | Leaflets | Nodular: NA | 25% | Nodular | Annular | + | ||||||
| MAC converted into GA | ES-S3 | 26 | Amplatz extrastiff J | 4.4 | 7.3 | Leaflets | NA; | 25% | Flat | Annular | + | ||||||
| GA | ES3 | 23 mm | Amplatz extrastiff J | 3.4 | 6.8 | Leaflets | Bulky; left and noncusp | 25% | Flat | Annular | + | + | + | + | |||
| MAC | ES3 | 23 mm | Amplatz extrastiff J | 4.2 | 7.3 | Leaflet tips | Nodular; left cusp | 25% | Nodular | RV | + | + | |||||
| MAC | Evolut Core | 29 mm | Amplatz extrastiff J | 4.5 | 7.5 | Leaflet tips | Nodular; left cusp | 25% | Nodular | RV | + | + | |||||
| MAC | ES3 | 29 mm | Amplatz extrastiff J | 5 | 8.1 | Leaflets | NA | 0% | Bulky | RV | + | ||||||
| GA | ES3 | 23 mm | Amplatz extrastiff J | 4.2 | 7.5 | Leaflets | NA | 0% | Nodular | RV | + | + | + | ||||
| MAC | ES3 | 26 mm | Amplatz extrastiff J | 4.6 | 7.8 | Leaflets | NA | 0% | Nodular | RV | + |
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