Background
A clinical study comparing the hemodynamic outcomes of transcatheter mitral valve replacement (TMVR) with vs. without Laceration of the Anterior Mitral leaflet to Prevent Outflow ...Obstruction (LAMPOON) has never been designed nor conducted.
Aims
To quantify the hemodynamic impact of LAMPOON in TMVR using patient-specific computational (
in silico
) models.
Materials
Eight subjects from the LAMPOON investigational device exemption trial were included who had acceptable computed tomography (CT) data for analysis. All subjects were anticipated to be at prohibitive risk of left ventricular outflow tract (LVOT) obstruction from TMVR, and underwent successful LAMPOON immediately followed by TMVR. Using post-procedure CT scans, two 3D anatomical models were created for each subject: (1) TMVR with LAMPOON (performed procedure), and (2) TMVR without LAMPOON (virtual control). A validated computational fluid dynamics (CFD) paradigm was then used to simulate the hemodynamic outcomes for each condition.
Results
LAMPOON exposed on average 2 ± 0.6 transcatheter valve cells (70 ± 20 mm
2
total increase in outflow area) which provided an additional pathway for flow into the LVOT. As compared to TMVR without LAMPOON, TMVR with LAMPOON resulted in lower peak LVOT velocity, lower peak LVOT gradient, and higher peak LVOT effective orifice area by 0.4 ± 0.3 m/s (14 ± 7% improvement,
p
= 0.006), 7.6 ± 10.9 mmHg (31 ± 17% improvement,
p
= 0.01), and 0.2 ± 0.1 cm
2
(17 ± 9% improvement,
p
= 0.002), respectively.
Conclusion
This was the first study to permit a quantitative, patient-specific comparison of LVOT hemodynamics following TMVR with and without LAMPOON. The LAMPOON procedure achieved a critical increment in outflow area which was effective for improving LVOT hemodynamics, particularly for subjects with a small neo-left ventricular outflow tract (neo-LVOT).
Despite advances in the diagnosis and treatment of coronary artery disease (CAD), gender-related disparities continue to exist, and ischemic heart disease mortality in women remains higher than in ...men. This review will highlight gender-specific differences in the treatment of CAD that may impact outcomes for women. Further studies are needed to clarify the unique pathophysiology of CAD in women and, in turn, create more specific guidelines for its diagnosis, management, and treatment in this patient population.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Commentary: Not all meta-analyses can be trusted Tom, Stephanie K.; Perdoncin, Emily; Grubb, Kendra J.
The Journal of thoracic and cardiovascular surgery,
July 2021, 2021-07-00, 20210701, Volume:
162, Issue:
1
Journal Article
Peer reviewed
Open access
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Aortic insufficiency (AI) is common after left ventricular assist device (LVAD), and results from decreased aortic valve opening. Progressive AI can be associated with hemodynamic and clinical ...deterioration. We report two patients with HeartMate3 LVAD who had transcatheter aortic valve implantation (TAVI) for severe AI.
Our first patient is a 28-year-old woman with postpartum coronary artery dissection 15 months prior. Despite attempted surgical revascularization, she required HeartMate3 LVAD during the same admission. She developed progressive aortic regurgitation and presented in cardiogenic shock with acute respiratory failure, acute kidney injury, shock liver, and lactic acidosis. She was intubated and stabilized with high dose dobutamine and increased pump speed. Her surgical risks were prohibitive, and TAVI was recommended after multidisciplinary team discussion and planning. Due to small femoral artery size, she underwent trans-caval TAVI with a 26mm Sapien 3 valve inflated to nominal size with immediate hemodynamic improvement. She was extubated and inotropes weaned within 2 days and continues to do well in follow-up.
Our second patient is a 39-year-old-woman with peripartum cardiomyopathy who had HeartMate-3 LVAD as destination therapy that was complicated by right ventricle failure and was inotrope dependent on home milrinone infusion at 0.5 mcg/mg/kg. She developed progressive AI and was admitted for worsening cardiogenic shock and acute kidney injury, which required continuous renal replacement therapy (CRRT). After multidisciplinary team discussion and planning, she underwent successful TAVI with a 26mm Sapien 3 valve inflated to nominal size while providing mechanical right ventricle support with a RP Impella, which allowed her kidneys to recover. She was discharged from hospital on home milrinone 6 days later.
These cases illustrate the importance of multidisciplinary team-based approach and planning that allows the use of established therapies, including TAVI and right ventricle mechanical support in novel ways that provide new life saving options.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Propensity matching was used within cohorts defined by access site and the impact of bivalirudin use on in-hospital outcomes evaluated with Fisher's exact tests.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Leaflet thrombosis after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) may be caused by blood flow stagnation in the native and neosinus regions. To date, ...aortic leaflet laceration has been used to mitigate coronary obstruction following TAVR; however, its influence on the fluid mechanics of the native and neosinus regions is poorly understood. This in vitro study compared the flow velocities and flow patterns in the setting of SAVR vs TAVR with and without aortic leaflet lacerations.
Two valves, (23-mm Perimount and 26-mm SAPIEN 3; Edwards Lifesciences) were studied in a validated mock flow loop under physiologic conditions. Neosinus and native sinus fluid mechanics were quantified using particle image velocimetry in the left and noncoronary cusp, with an increasing number of aortic leaflets lacerated or removed.
Across all conditions, SAVR had the highest average sinus and neosinus velocities, and this value was used as a reference to compare against the TAVR conditions. With an increasing number of leaflets lacerated or removed with TAVR, the average sinus and neosinus velocities increased from 25% to 70% of SAVR flow (100%). Diastolic velocities were substantially augmented by leaflet laceration. Also, the shorter frame of the SAVR led to higher flow velocities compared with the longer frame of the TAVR, even after complete leaflet removal.
Leaflet laceration augmented TAVR native and neosinus flow fields, approaching that of SAVR. These findings may have potential clinical implications for the use of single or multiple leaflet lacerations to reduce leaflet thrombosis and thus potentially improve TAVR durability.
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While redo surgical aortic valve replacement has traditionally been the gold standard for the treatment of failed surgical valves, valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) ...has arisen as a viable, less invasive option with the potential for improved short-term morbidity and mortality. Retrospective registry data regarding ViV TAVR outcomes have been encouraging, with excellent 1-year mortality, and sustained valve performance and quality of life improvement out to 3 years. Operators must be comfortable with CT analysis for procedural planning, and be able to identify and troubleshoot patients who are at risk for coronary obstruction and patient prosthesis mismatch. The authors provide a review of clinical outcomes associated with ViV TAVR, procedural planning recommendations, and strategies to overcome technical challenges that can occur during ViV TAVR.
Abstract only
Introduction:
The purpose of this study was to investigate the hemodynamic impact of LAMPOON (Laceration of the Anterior Mitral leaflet to Prevent Outflow ObstructioN) in transcatheter ...mitral valve replacement (TMVR) using patient-specific
in silico
modeling.
Methods:
Eight subjects from the LAMPOON investigational device exemption trial were included. All subjects were at prohibitive risk of outflow tract obstruction from TMVR based on computed tomography (CT), and underwent successful LAMPOON immediately followed by TMVR. A validated computational fluid dynamics (CFD) model was used to compare simulated hemodynamics and 3D flow patterns between two modeled conditions: 1) TMVR with LAMPOON and 2) TMVR without LAMPOON. Using the post-procedure CT scans, anatomical models of TMVR with LAMPOON were created for each subject. The open transcatheter valve cells were then
virtually closed
to model TMVR without LAMPOON for each subject. Finally, CFD was performed for each condition to simulate the systolic flow fields.
Results:
As compared to TMVR without LAMPOON, TMVR with LAMPOON resulted in lower peak velocity, lower peak LVOT gradient, and higher peak LVOT effective orifice area by 13
±
6% (p=0.004), 28
±
14% (p=0.008), and 15
±
8% (p=0.002), respectively. LAMPOON provided flow communication through exposed cells of the transcatheter valve, thereby decreasing the flow constriction and reducing flow stasis in the vicinity of the neo-LVOT (Figure). The hemodynamic benefit of LAMPOON was observed to be greater in subjects with a smaller neo-LVOT area measured post-implant (p<0.001).
Conclusions:
In silico
modeling allowed for a quantitative patient-specific comparison of TMVR with and without LAMPOON, which is impossible to study clinically. The LAMPOON procedure improved simulated hemodynamics in all subjects, with a greater hemodynamic impact observed in subjects with a smaller post-implant neo-LVOT area.
This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure.
Transcatheter ...aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking.
The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events.
Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection.
BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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