Introduction: Migration of a transcatheter aortic valve replacement (TAVR) is a rare, life-threatening complication that typically occurs during or shortly after the procedure. We present a unique case of an exceptionally rare, delayed migration of a valve-in-valve TAVR three years post-procedure that was subsequently treated with surgical explantation of the TAVR prosthesis and surgical aortic valve replacement (SAVR). Clinical Case: A 64-year-old male presented to an outpatient cardiology visit with one month of exertional dyspnea and near-syncopal episodes with a new diastolic murmur. Notable history included aortic regurgitation due to bicuspid aortic valve resulting in subcoronary implantation of a 27 mm Medtronic Freestyle stentless porcine bioprosthesis 20 years prior to presentation. Following the development of severe bioprosthetic regurgitation, a valve-in-valve TAVR with a 26 mm Edwards SAPIEN 3 Ultra was implanted 3 years prior to presentation with no evidence of stenosis or regurgitation on transthoracic echocardiograms completed 1 month and 1 year after implantation. Transesophageal echocardiogram now demonstrated migration of the TAVR valve into the left ventricular outflow tract 2 cm proximal to the surgical bioprosthesis. Severe eccentric transvalvular regurgitant flow through the surgical bioprosthesis and severe paravalvular regurgitation around the TAVR valve was seen with an unstable “rocking appearance”. No evidence of abscess or endocarditis was appreciated and blood cultures showed no growth. Following a short hospitalization, the patient underwent TAVR explantation and implantation of a 25 mm Edwards Inspiris Resilia stented bovine bioprosthesis with subsequent resolution of his symptoms. Discussion: Recognizing atypical presentations of TAVR complications such as delayed valve migration is facilitated by understanding key risk factors. This case highlights notable risk factors for TAVR migration including a valve-in-valve TAVR over a degenerative regurgitant bioprosthesis, decreased aortic annulus calcification resulting in suboptimal anchoring, the patient’s younger age, and the lack of a radiopaque marker on the stentless bioprosthesis which increases the potential for malpositioning.
Objectives. The Wolverine cutting balloon (CB) (Boston Scientific) is a specialized balloon catheter with microsurgical blades that is used for balloon-resistant lesions. The Manufacturer and User Facility Device Experience (MAUDE) database serves as a repository for reports of medical device complications. The aim of this study was to analyze complications associated with CB use during percutaneous coronary intervention in real-world contemporary practice. Methods. The MAUDE database was searched from January 1, 2020, through December 31, 2023 for reports of complications associated with CB use. Data from individual reports were extracted for analysis. Results. The final analysis included 2278 complications, of which 97.3% (n = 2216) were associated with device malfunction, 2.4% (n = 55) were associated with patient injury, and 0.3% (n = 7) were associated with patient death. The most common complication overall was balloon rupture (n = 1847), while the most common complication associated with patient injury or death was device entrapment (n = 33). The median number of inflations was significantly higher for complications associated with patient injury or death (3 [IQR 1-8]) compared with complications associated with device malfunction (1[IQR 1-2]) (P = .0035). The median maximum inflation pressure was significantly higher for complications associated with patient injury or death (12 [IQR 11-15] atm) compared with complications associated with device malfunction (8 [IQR 6-10] atm) (P = .0001). Conclusions. Overall, 2.7% of reported complications were associated with patient injury or death. The most common complication overall was balloon rupture. Device entrapment was the most common complication among reports associated with patient injury or death. Higher inflation pressures and greater number of inflations may be associated with adverse outcomes.
Platypnea-orthodeoxia syndrome is a rare entity seen in patients with patent foramen ovale, characterized by dyspnea and arterial desaturation in the upright position. We describe a case of a patient who presented with cryptogenic stroke, evidence of right-to-left interatrial shunting, and refractory hypoxemia necessitating closure of his patent foramen ovale.
Background. Tricuspid regurgitation (TR) is a high-prevalence disease associated with poor quality of life and mortality. This quantitative patient preference study aims to identify TR patients’ perspectives on risk-benefit tradeoffs. Methods. A discrete-choice experiment was developed to explore TR treatment risk-benefit tradeoffs. Attributes (levels) tested were treatment (procedure, medical management), reintervention risk (0%, 1%, 5%, 10%), medications over 2 y (none, reduce, same, increase), shortness of breath (none/mild, moderate, severe), and swelling (never, 3× per week, daily). A mixed logit regression model estimated preferences and calculated predicted probabilities. Relative attribute importance was calculated. Subgroup analyses were performed. Results. An online survey was completed by 150 TR patients. Shortness of breath was the most important attribute and accounted for 65.8% of treatment decision making. The average patients’ predicted probability of preferring a “procedure-like” profile over a “medical management-like” profile was 99.7%. This decreased to 78.9% for a level change from severe to moderate in shortness of breath in the “medical management-like” profile. Subgroup analysis confirmed that patients older than 64 y had a stronger preference to avoid severe shortness of breath compared with younger patients ( P < 0.02), as did severe or worse TR patients relative to moderate. New York Heart Association class I/II patients more strongly preferred to avoid procedural reintervention risk relative to class III/IV patients ( P < 0.03). Conclusion. TR patients are willing to accept higher procedural reintervention risk if shortness of breath is alleviated. This risk tolerance is higher for older and more symptomatic patients. These results emphasize the appropriateness of developing TR therapies and the importance of addressing symptom burden. Highlights This study provides quantitative patient preference data from clinically confirmed tricuspid regurgitation (TR) patients to understand their treatment preferences. Using a targeted literature search and patient, physician, and Food and Drug Administration feedback, a cross-sectional survey with a discrete-choice experiment that focused on 5 of the most important attributes to TR patients was developed and administered online. TR patients are willing to accept higher procedural reintervention risk if shortness of breath is alleviated, and this risk tolerance is higher for older and more symptomatic patients.
An 88-year-old woman with an extensive medical history presented to the hospital with altered mental status, vague abdominal pain, and dysuria. A previous transcatheter aortic valve replacement (TAVR) prosthesis was known to be failing and was suspected to have acquired a vegetation. No other infective endocarditis (IE) stigmata were present. Fortunately, the work-up for replacement was allowed to proceed with a broader cardiac examination from which a mitral vegetation was identified and IE then treated.
A 73-year-old male patient presented with shortness of breath at rest resulting from new-onset severe primary mitral regurgitation with a flail posterior leaflet, left ventricular dysfunction, and cardiogenic shock. After initial stabilization in the intensive care unit, multiple treatment options were considered for this patient, all associated with significant mortality. Ultimately, operative mitral valve repair with Impella 5.5 placement was performed for postoperative hemodynamic support. Surgical repair provided elimination of mitral regurgitation. Impella support was maintained for 7 days to provide unloading of the left ventricle. After device removal, the patient had sustained left ventricular recovery with significantly improved ejection fraction. Full left ventricular support and unloading may decrease operative risk and promote left ventricular recovery in patients with severe mitral regurgitation and left ventricular dysfunction. This case emphasizes the value of ventricular unloading to facilitate the recovery of left ventricular function as a treatment option for patients with challenging cases of severe mitral regurgitation and left ventricular dysfunction.
Background: Transcatheter aortic valve replacement [TAVR] for severe pure aortic insufficiency [AI] in the presence of a durable left ventricular assist device [LVAD] is fraught with challenges. We report an interesting case of TAVR valve dislodgement by the LVAD that was treated with redeployment of another TAVR valve, and redo surgery for extraction of the intraventricular TAVR valve. Methods and Results: A 46-year-old man presented to our unit in cardiogenic shock [CS] and severe pulmonary hypertension [PH] of 72/45mmHg. He underwent placement of an Impella 5.5 [Abiomed, Danvers, MA] as a bridging strategy to treat his CS and PH while transplant candidacy was being assessed. However, he remained pulmonary hypertensive with a trans-pulmonary gradient 26mmHg and pulmonary vascular resistance 5.3 wood units, despite 14 days of impella 5.5 therapy combined with aggressive management with milrinone 0.25 mcg/kg/min and bumetanide infusion 1mg/hr. He therefore underwent implantation of heart mate 3 [HM3] LVAD [Abbott Laboratories, Chicago, IL] by a limited left thoracotomy in the 5th intercostal space and upper ‘inverse-T’ hemi-sternotomy into the fourth intercostal space. His postoperative course was complicated by requirement for 31mm percutaneous Protek Duo [LivaNova, London, UK] Right VAD [RVAD] for 32 days, and gastrointestinal bleeding requiring cessation of heparin therapy, which prompted formation of thrombus in the left coronary cusp of the aortic valve. Organization of this thrombus and consequent retraction of the left coronary leaflet led to severe AI and consequent CS, requiring inotropic support and discussion on optimal management strategy. He underwent TAVR with a 29mm Edwards Sapien 3 valve [Edwards Lifesciences, Irvine, CA] with 20% over-sizing, which got dislodged and migrated into the LV. Another 29mm Edwards Sapien 3 TAVR valve was successfully deployed. The patient was then placed on cardiopulmonary bypass via the femoral vessels, and the left thoracotomy was reopened. The LVAD was temporarily stopped, and the latch mechanism on the HM3 was opened. The HM3 was removed from the sewing cuff, and the TAVR valve was ‘fished-out’ from the cavity of the LV. The HM3 was reinserted and restarted after thorough de-airing through the outflow graft. The incisions were closed in a standard manner and the patient was discharged home on the 20th postoperative day. Conclusions: TAVR for severe AI in the presence of a durable LVAD is fraught with challenges due to the constant suction action of the LVAD, and the absence of calcium in the native annulus to anchor the prosthesis. Our case highlights the feasibility of extricating a dislodged TAVR valve through simple redo-surgery. With this approach, we managed to avoid a more conventional redo procedure involving administration of cardioplegia for a surgical AVR or for extricating the prosthesis, with its inherent risk of right ventricular failure requiring RVAD. Figure showing dislodged TAVR on the left and redeployment on the right
Background: A quantitative patient preference study aims to understand tricuspid regurgitation (TR) patients’ priorities for symptom relief and treatment risk-benefit tradeoffs. Methods: 150 clinically confirmed moderate or greater TR patients completed a discrete choice experiment survey online to elicit their preferences. Attributes (levels) tested were treatment (procedure, medical management), re-intervention risk (0%, 1%, 5%, 10%), medications in 2 yrs (none, reduce, same, more), shortness of breath (none/mild, moderate, severe) and swelling (never, 3x a week, daily). A mixed logit regression (MXL) model estimated preferences. MXL choice model calculated predicted probabilities. Results: Shortness of breath contributed 66% to patients’ treatment decision making over other attributes. Patients’ predicted probability of preferring a procedure-like profile over a medical management-like profile was 99.7% and it was 78.9% for a medical management shortness of breath level change (Table 1). Subgroup analysis showed that patients over 64 yrs old preferred to more strongly avoid severe shortness of breath compared to under 65 (p<0.02), as did severe or worse TR patients over moderate. NYHA Class I/II patients more strongly preferred to avoid procedural re-intervention risk of 10% over Class III/IV (p<0.03). Conclusion: TR patients prioritize improving shortness of breath and are willing to accept higher procedural re-intervention risk if it is alleviated, even to a small degree.
BACKGROUND:Bedside manipulation of an Impella CP is often necessary as subtle changes in device position after initial placement can dramatically affect proper function. CASE PRESENTATION:A 59 year old man in cardiogenic shock on V-A ECMO support underwent Impella CP placement to function as an LV vent. Bedside manipulation led to the Impella dislodging into the ascending aorta and kinking in half. Percutaneous rescue was performed in the cardiac catheterization laboratory by snaring the device, and guiding it back into the LV in a controlled fashion restoring normal function. CONCLUSIONS:Bedside manipulation of an Impella is often necessary, but may cause device dislodgement. Re-entry into the LV is challenging and replacement of the device carries significant cost and clinical implications. Radial approach, snare guided repositioning offers an alternative solution to an increasingly encountered challenge.
Contemporary direct ("fully percutaneous") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a "fully upper extremity" (FUE) bailout approach, as a refinement to previously described direct TAx technique.
BACKGROUND:Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device.METHODS AND RESULTS:A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%).CONCLUSIONS:In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices.CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.
Background Hospitalization for acute myocardial infarction (MI) in the United States is both common and expensive, but those features alone provide little insight into cost‐saving opportunities. Methods and Results To understand the cost drivers during hospitalization for acute MI and in the following year, we prospectively studied 11 969 patients with acute MI undergoing percutaneous coronary intervention at 233 US hospitals (2010–2013) from the TRANSLATE‐ACS (Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) registry. Baseline costs were collected in a random subset (n=4619 patients, 54% ST‐segment–elevation MI [STEMI]), while follow‐up costs out to 1 year were collected for all patients. The mean index length of stay was 3.1 days (for both STEMI and non‐STEMI) and mean intensive care unit length of stay was 1.2 days (1.4 days for STEMI and 1.0 days for non‐STEMI). Index hospital costs averaged $18 931 ($19 327 for STEMI, $18 465 for non‐STEMI), with 45% catheterization laboratory–related and 20% attributable to postprocedure hospital stay. Patient factors, including severity of illness and extent of coronary disease, and hospital characteristics, including for profit status and geographic region, identified significant variations in cost. Intensive care was used for 53% of non‐STEMI and increased costs by $3282. Postdischarge 1‐year costs averaged $8037, and 48% of patients were rehospitalized (half within 2 months and 57% with a cardiovascular diagnosis). Conclusions While much of the cost of patients with acute MI treated with percutaneous coronary intervention is probably not modifiable by the care team, cost reductions are still possible through quality‐preserving practice efficiencies, such as need‐based use rather than routine use of intensive care unit for patients with stable non‐STEMI. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00097591.
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides mechanical circulatory support for patients with advanced cardiogenic shock, facilitating myocardial recovery and limiting multi-organ failure. In patients with severely limited left ventricular ejection, peripheral VA-ECMO can further increase left ventricular and left atrial pressures (LAP). Failure to decompress the left heart under these circumstances can result in pulmonary edema and upper body hypoxemia, that is, myocardial and cerebral ischemia. Atrial septostomy can decrease LAP in these situations. However, the effects of atrial septostomy on upper body oxygenation remain unknown. After IRB approval, we identified 9 out of 242 adult VA-ECMO patients between January 2011 and June 2016 who also underwent atrial septostomy for refractory pulmonary edema/upper body hypoxemia. We analyzed LAP/pulmonary capillary wedge pressure (PCWP), right atrial pressures (RAPs), Pa O2 /Fi O2 ratios (blood samples from right radial artery), intrathoracic volume status, and resolution of pulmonary edema before and up to 48 h after septostomy. There were no procedure-related complications. Thirty-day survival was 44%. LAP/PCWP decreased by approximately 40% immediately following septostomy and remained so for at least 24 h. Pa O2 /Fi O2 ratios significantly increased from 0.49 (0.38-2.12) before to 5.35 (3.01-7.69) immediately after septostomy and continued so for 24 h, 6.6 (4.49-10.93). Radiographic measurements also indicated a significant improvement in thoracic intravascular volume status after atrial septostomy. Atrial septostomy reduces LAP and improves upper body oxygenation and intrathoracic vascular volume status in patients developing severe refractory pulmonary edema while undergoing peripheral VA-ECMO. Atrial septostomy therefore appears safe and suitable to reduce the risk of upper body ischemia under these circumstances.
Background: Rapid activation of the cardiac catheterization laboratory for primary percutaneous coronary intervention (PCI) improves outcomes for ST-segment elevation myocardial infarction (STEMI), but selected emphasis on minimizing time to reperfusion may lead to an increased frequency of false -positive STEMI activations (FPSA). While delays in reperfusion therapy are associated with worse outcomes, inaccurate diagnosis also has potential clinical as well as cost related repercussions. According to prior reports, FPSA rates vary between 15-52 percent. Method: We analyzed consecutive patients referred for primary PCI for a possible STEMI at a single center from November 2013 to February 2017. False-positive STEMI activation was defined as lack of electrocardiographic criteria consistent with American College of Cardiology/American Heart Association guidelines for diagnosis of STEMI, and clinical assessments. Overall differences amongst various STEMI activators were evaluated using Chi-square test. Differences between working-hours (0700-1600) versus off-hours (1601-0659) were evaluated using Cochran-Mantel-Haenszel test. Results: Of 355 STEMI activations, 194 (55%) were called by emergency physicians (ED), 81 (23%) by emergency medical services (EMS) and 80 (22%) by other (inpatient services & out of hospital transfers). A total of 120 (34%) cases occurred during working-hours and 235 (66%) cases occurred during off-hours. The average age of the study population was 62 (13) years, with 245(68%) males and average BMI of 30 (6) kg/m2. The prevalence of FPSA initiated by the ED, EMS, and others was 32 (16.5%), 9 (11%), and 14 (18%), respectively (p=0.06). Of FSPA, 40% were anterior, 25% inferior, 21% lateral, and 14% inferolateral wall infarctions. Out of 55 total FPSA, 37 (67%) occurred during the off-hours. Comparing activators based on hours, the prevalence of FPSA during off-hours initiated by the ED, EMS, and others were 69%, 66%, and 66%, respectively (p=0.6). Conclusion: In this study, approximately 1 out of 6.5 STEMI activations was a false-positive. This trend is the same during working as well as off-hours and does not differ between various STEMI activators. Improved and structured communication between cardiology, emergency medicine, and paramedic teams may promote lower false positive rates and positively impact overall delivery of care.
Mitral valve repair is becoming an increasingly frequent surgery for patients with mitral valve regurgitation. Iatrogenic coronary artery injury and ischemic myocardial compromise have been previously reported in the literature as a rare but serious complication of surgical mitral valve repair. This potentially life-threatening complication should be considered and quickly recognized during perioperative mitral valve repair or replacement to prevent morbidity and mortality. To increase awareness and to prevent this complication from being missed in the future, we present a case report of iatrogenic left circumflex artery dynamic occlusion and subsequent myocardial infarction from mitral valve annuloplasty resulting in severe peri-operative heart failure and death.
Background: The ability of interventional cardiologists to reproducibly identify the culprit vessel in patients with multivessel coronary artery disease and non- ST elevation myocardial infarction (NSTEMI) is unknown. Inconsistency in this regard could indicate a mechanism for improved outcomes with
Background: Progression to renal replacement therapy (RRT) is a common concern for chronic kidney disease patients undergoing TAVR. Shared decision making requires accurate estimates on the need for RRT following TAVR; however, this information is unknown. We sought to quantify the need for RRT