Analysis of complications in transfemoral transcatheter aortic valve implantation: a single-center study.

INTRODUCTION: Transfemoral access is a prevailing approach for transcatheter aortic valve implantation (TAVI) in contemporary practice, with a shift from surgical arteriotomy to a percutaneous arterial approach. OBJECTIVES: This study assessed long- and short­term mortality, along with Valve Academic Research Consortium-2-defined complications in percutaneous transfemoral approach (PTA) TAVI. Furthermore, it explored the impact of a learning curve on procedural outcomes. PATIENTS AND METHODS: The study included 600 patients undergoing PTA TAVI at the National Institute of Cardiology, Warsaw, Poland, from January 2009 to September 2020. Retrospective data comparison involved 2 groups: early experience (first 200 patients) and late experience (next 400 patients). RESULTS: The primary end point (composite of life­threatening bleeding, major vascular complication, or death at 30 days) occurred less often in the late experience group (28% vs 17.5%; P = 0.003). The late experience group also showed fewer cases of vascular complications (19% vs 10.7%; P = 0.005) and major bleeding (17.5% vs 8.5%; P = 0.001). Propensity matching yielded similar trends, including reduced frequency of pacemaker implantation (22.8% vs 10.9%; P = 0.03) and shorter median (interquartile range) hospitalization (11 [8-18] vs 7 [6-12] days; P <0.001) in the late experience group. CONCLUSIONS: The late experience group rated with PTA TAVI exhibited significantly reduced periprocedural complications, indicating a positive impact of accumulated expertise.

Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Prognostic value of computed tomography derived measurements of pulmonary artery diameter for long-term outcomes after transcatheter aortic valve replacement.

BACKGROUND: An increase in pulmonary artery diameter (PAD) on multi-detector computed tomography (MDCT) may indicate pulmonary hypertension. We assessed the prognostic value of MDCT-derived measurements of PAD on outcomes after successful transcatheter aortic valve replacement (TAVR). METHODS: Consecutive patients treated with TAVR from February 2013 to October 2017, with a 68.8% rate of new generation valves, underwent pre-interventional MDCT with measurements of PAD (in the widest short-axis within 3 cm of the bifurcation) and ascending aortic diameter (AoD; at the level of the PAD). The PAD/AoD ratio was calculated. Patients with high-density lipoprotein cholesterol levels ≤46 mg/dl and C-reactive protein levels ≥0.20 mg/dl at baseline were identified as the frail group. One-year mortality was established for all subjects. RESULTS: Among studied 266 patients (median age, 82.0 years; 63.5% women) those who died at 1 year (n = 34; 12.8%) had larger PAD and PAD/AoD (28.9 [5.0] vs. 26.5 [4.6] mm and 0.81 [0.13] vs. 0.76 [0.13] mm vs. the rest of the studied subjects; P = 0.005 and P = 0.02, respectively) but similar AoD. The cutoff value for the PAD to predict 1-year mortality was 29.3 mm (sensitivity, 50%; specificity, 77%; area under the curve, 0.65). Patients with PAD >29.3 mm (n = 72; 27%) had higher 1-year mortality (23.6% vs. 8.8%, log-rank P = 0.001). Baseline characteristics associated with PAD29.3 mm were a bigger body mass index, more frequent diabetes mellitus, more prior stroke/transient ischemic attacks and atrial fibrillation, and lower baseline maximal aortic valve gradient with higher pulmonary artery systolic pressure (PASP). PAD >29.3 mm and frailty, but not baseline PASP, remained predictive of 1-year mortality in the multivariable model (hazard ratio [HR], 2.221; 95%CI, 1.038-4.753; P = 0.04 and HR, 2.801; 95% CI, 1.328-5.910; P = 0.007, respectively). CONCLUSION: PAD >29.3 mm on baseline MDCT is associated with higher 1-year mortality after TAVR, independently of echocardiographic measures of PH and frailty.

Computed tomography assessment of the aortic root morphology in predicting the development of paravalvular leak following transcatheter aortic valve implantation.

Introduction: Transcatheter aortic valve implantation (TAVI) is an effective treatment of significant aortic stenosis. Paravalvular leaks (PVLs) are one of the most common complications after the procedure. Objectives: The aim of this study was to assess whether the aortic root morphology affects the occurrence of PVL after TAVI. Patients and methods: We enrolled 50 patients with bicuspid and 50 patients with tricuspid aortic valve who underwent multislice computed tomography (MSCT) and transthoracic echocardiography prior to TAVI. The dimensions of the aortic root were assessed by MSCT. PVL after TAVI was assessed by transthoracic echocardiography. Patients were divided in 2 groups according to the PVL severity: less than moderate PVL (n = 80) and moderate or worse PVL (n = 20), and comparisons between the groups were performed. Results: Patients with at least moderate PVL, compared with those with less than moderate PVL, had greater mean (SD) area (5.2 [1.1] cm2 vs 4.7 [0.8] cm2; P = 0.02), perimeter (8.4 [0.9] cm vs 7.9 [0.7] cm; P = 0.01), and long axis (29.5 [2.7] mm vs 28 [2.7] mm; P = 0.04) of the aortic annulus and greater mean (SD) area (5.3 [1.3] cm2 vs 4.7 [1.1] cm2; P = 0.04) and perimeter (8.6 [1.1] cm vs 8.1 [0.9] cm; P = 0.02) of the left ventricular outflow tract. In multivariable analysis, bicuspid aortic valve disease, interventricular septum hypertrophy, greater left ventricular outflow tract, and postdilatation were significant predictors of moderate PVL following TAVI. Conclusions: The assessment of the aortic root morphology with MSCT can be helpful in predicting PVL after TAVI.

Association between calcifications of mitro-aortic continuity and mitral regurgitation in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: The presence of mitral annular calcification (MAC) affects prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). MAC frequently coexists with calcifications of mitro-aortic continuity (CMAC). AIMS: We aimed at qualitative and semi-quantitative analysis of calcifications of the mitral complex - MAC and CMAC in multi-slice computed tomography, in order to assess their impact on the occurrence and dynamics of mitral regurgitation (MR) following TAVI. METHODS: The study group consisted of 94 patients (mean [SD] age was 79.9 [8.02] years; 67.1% female). Agatston scale - Calcium Score was used for quantitative analysis. MAC and CMAC were also assessed semi-quantitatively as either non-severe or severe. MR following TAVI was defined as unchanged, improved or worsened by at least one degree. RESULTS: Patients with MAC (59.6%) had higher mean aortic gradients (P = 0.02) and smaller left ventricular diastolic diameter (P = 0.002). Patients with CMAC (48.9%) had higher Calcium Score aortic valve (P = 0.006). After TAVI MR improved in 17 (18.1%) patients and worsened in 7 (7.5%) patients. In multivariable logistic regression analysis MR worsening was associated with higher CMAC (OR, 1.092; 95% CI, 1.006-1.185; P = 0.03), as well as bicuspid aortic valve (OR, 6.348; 95% CI, 1.048-38.436; P = 0.04). CONCLUSIONS: CMAC was associated with MR worsening following TAVI. This is of relevance in procedural planning in patients with severe aortic stenosis (AS) and coexisting MR in whom arguments for and against surgical repair of concomitant mitral insufficiency are considered.

The role of cardiac computed tomography in the diagnosis of prosthetic valve endocarditis - A comparison with transthoracic and transesophageal echocardiography and intra-operative findings.

BACKGROUND: Infective endocarditis is one of the most severe complications after prosthetic valve implantation and an accurate diagnosis is a clinical challenge. The purpose was to assess the diagnostic usefulness of cardiac computed tomography (CT) in valvular and perivalvular complications in patients with prosthetic valve endocarditis (PVE) and to compare CT results with transthoracic echocardiography (TTE), transesophageal echocardiography (TEE) and intraoperative findings. METHODS: The retrospective study included 44 consecutive patients with PVE who underwent cardiac surgery. The mean age was 59.6 ±â€¯12.9 years, 33 (75 %) were males. The presence of vegetations, abscess/pseudoaneurysm, paravalvular leakage (PVL) and inflammatory infiltration were evaluated by TTE, TEE and CT prior to surgery and the results were compared with intraoperative findings. RESULTS: Endocarditis affected 47 valves (26 mechanical, 21 biological) in 44 patients. PVE most often affected the aortic valve (n = 36), followed by the mitral valve (n = 9) and the pulmonary valve (n = 2). In the per-valve analysis, the sensitivity of TTE, TEE and CT in diagnosing vegetations was 65 %, 91 % and 96 %; abscess 44 %, 77 % and 89 %; paravalvular leakage 90 %, 100 % and 70 %; inflammatory infiltration 39 %, 56 % and 78 %, respectively. The combination of CT and echocardiography allowed the detection of abscesses/pseudoaneurysms and inflammatory infiltration in all cases except one. CONCLUSION: CT was superior to echocardiography in the diagnosis of paravalvular abscesses, vegetations and inflammatory infiltration. Echocardiography had a higher diagnostic value to CT in the evaluation of paravalvular leakage. Cardiac CT combined with echocardiography improves the diagnostic accuracy of PVE and both modalities should be performed.

Pulmonary artery aneurysm as a result of group 2 pulmonary artery hypertension in a patient with significant mitral and aortic valve disease - review and case report.

Aneurysms are uncommon, but potentially life-threatening abnormalities of the pulmonary arteries. Aneurysm of the main pulmonary artery (MPA) defined as MPA diameter over 40 mm was reported in 1 : 14 000 autopsies. The most frequent location is the main pulmonary artery (89% of cases), whereas the maximum described diameter is 106-170 mm. Clinical manifestations are usually nonspecific or asymptomatic. Right heart failure symptoms, pulmonary regurgitation, trachea or bronchi compression or pulmonary emboli caused by enlarged MPA are the most commonly described clinical manifestations. Pulmonary artery aneurysm dissection is an uncommon complication but associated with a high mortality rate. Unfortunately, guidelines regulating the optimal time for the surgical intervention still have not been developed. We present the history of 76-year-old patient suffering from an aneurysm of the pulmonary artery (74 × 61 mm), as well as mitral and aortic valve disease, who was successfully operated on in our hospital.

Clinical application of stress echocardiography in valvular heart disease: an expert consensus of the Working Group on Valvular Heart Disease of the Polish Cardiac Society.

Valvular heart diseases (VHDs) constitute an increasing problem both as a consequence of population aging and as the sequelae of other heart diseases. Accurate diagnosis is essential for correct clinical decision­making; however, in many patients, transthoracic and transesophageal echocardiography is insufficient. Stress echocardiography (SE) proved to be a useful tool allowing for simultaneous assessment of left ventricular contractile reserve and HVD hemodynamics under conditions of physiological or pharmacological stress. It is recommended for assessing the severity of VHD, guiding the choice of treatment, as well as for surgical risk stratification. It can be applied both in asymptomatic patients with severe VHD and in symptomatic individuals with moderate disease. In patients with VHD, SE can be performed either as exercise stress echocardiography (ESE) or dobutamine stress echocardiography (DSE). The first modality is recommended to unmask symptoms or abnormal blood pressure response in patients with aortic stenosis (AS) who report to be asymptomatic or in those with mitral stenosis with discordance between clinical symptoms and the severity of valve disease on transthoracic echocardiography. In asymptomatic patients with paradoxical low­flow, low­gradient (LFLG) AS, ESE can be used to assess the severity of stenosis. On the other hand, low­dose DSE can be a useful diagnostic tool in classical LFLG AS, providing information on stenosis severity and contractile reserve. Moreover, SE is indicated in patients with prosthetic valve when there is discordance between symptoms and echocardiographic findings. It is also recommended in high­risk surgical patients with VHD with poor functional capacity and more than 2 clinical risk factors. The present paper discusses in detail the use of SE in VHD.

Elective versus rescue balloon aortic valvuloplasty for critical aortic stenosis.

BACKGROUND: Balloon aortic valvuloplasty (BAV) may be considered a bridge to further intervention in hemodynamically unstable patients or patients with symptomatic severe aortic stenosis (AS). AIMS: This study aimed to retrospectively compare periprocedural and in­hospital outcomes of AS patients treated with elective BAV (group 1) and rescue BAV (group 2). METHODS: We identified 35 patients in whom BAV was performed between 2010 and 2018. Among them, 16 were treated electively (group 1) and 19 urgently (group 2). RESULTS: Overall, BAV resulted in a significant decrease in the mean transaortic gradient by a median (interquartile range [IQR]) value of 5 (1-10) mm Hg (P <0.01) and the maximal transaortic gradient by a median (IQR) value of 13.5 (2.5-23.2) mm Hg (P <0.01). Postprocedural grade II aortic regurgitation rates increased from 8.6% to 17.1% (P = 0.48). Periprocedural death occurred in 4 patients (11.4%)-all from group 2 (21%) (P = 0.1). In­hospital death occurred in 15 patients (42.8%)-3 patients (18.7%) from group 1 and 12 patients (63.1%) from group 2 (P <0.01). During follow­up, a single patient underwent surgical aortic valve replacement, and transcatheter aortic valve implantation was performed in 4 individuals. A single patient died 22 months after BAV. CONCLUSIONS: Periprocedural and in­hospital mortality in patients with critical AS treated with BAV remains very high, especially in patients treated urgently.

Incidence, clinical correlates, timing, and consequences of acute thrombus formation in patients undergoing the MitraClip procedure.

BACKGROUND: Despite adequate heparinization, formation of fresh intracardiac thrombi during the MitraClip procedure was reported. AIMS: We aimed to evaluate the incidence and clinical consequences of intracardiac thrombus formation during the MitraClip device implantation. METHODS: Clinical data and transesophageal echocardiography findings obtained during MitraClip procedures in 100 consecutive patients (81 men; mean [SD] age, 67.8 [8.3] years) were reviewed. In all patients, a heparin bolus was given immediately after a successful transseptal puncture, and the activated clotting time above 250 seconds was maintained throughout the procedure. RESULTS: Thrombus formation was documented in 9 patients (9%). In 6 patients, thrombi formed on a transseptal needle/sheath (2 attached to the sheath in the right atrium and 4 on the sheath immediately after the puncture in the left atrium), and in 3 patients, on the MitraClip device in the left atrium (2 on a steerable guiding catheter and 1 on the clip delivery system). Overall, 6 thrombi (67%) formed prior to and 3 (33%) after heparin administration. All thrombi were transient and disappeared within minutes. No periprocedural ischemic stroke, transient ischemic attack, or other embolic complications were reported. Clinical characteristics were similar in patients with and without thrombi, except for lower left ventricular ejection fraction (LVEF; mean [SD], 23% [10%] and 30% [10%], respectively; P = 0.03). In-hospital death was reported in 6 patients: 2 with a visible thrombus and 4 without (P = 0.09). CONCLUSIONS: Transient thrombus formation is relatively common during the MitraClip procedure, especially in patients with low LVEF; however, acute clinical consequences are benign.

Comparison of the geometry of the left ventricle outflow tract, the aortic root and the ascending aorta in patients with severe tricuspid aortic stenosis versus healthy controls.

The purpose of this study was to assess by multislice computed tomography (MSCT) imaging geometry of the ascending aorta, the aortic root, the aortic annulus and the left ventricle outflow tract (LVOT) in aortic stenosis (AS) patients, to compare aortic root morphology in patients with AS with healthy controls and to evaluate sex differences. Fifty patients with severe AS and 50 age- and gender-matched controls who underwent MSCT were included in the study. The dimensions of the LVOT, the aortic annulus, the aortic root, the ascending aorta, and the volume of the aortic root were retrospectively assessed and a comparison was made between patients with severe tricuspid AS and controls. Patients with tricuspid AS in comparison with controls had smaller dimensions of the sinus of Valsalva resulting in reduction of the aortic root volume, whereas the dimensions of the other structures were comparable. MSCT revealed larger annular, LVOT and the sinus of Valsalva dimensions and the aortic root volume in men than women. Men with AS differed from healthy men only in regard to the dimensions of the sinus of Valsalva, while women showed significant differences also in the LVOT, and the aortic annulus. MSCT showed accurately aortic root remodeling in tricuspid AS patients and indentified sex-dependent differences. Women with tricuspid AS differ from healthy women more than men did. A high degree of the variability in the aortic root dimensions requires further careful research.

Predictors of aortic stenosis severity reclassification using an imaging data fusion method in patients referred for transcatheter aortic valve implantation.

BACKGROUND: The use of imaging data fusion method (IDFM) with multislice computed tomography (MSCT) and two-dimensional transthoracic echocardiography (2D-TTE) in patients with aortic stenosis (AS) may result in reclassification of AS severity from severe to non-severe. AIM: We sought to establish potential predictors of AS severity reclassification using the IDFM method. METHODS: A total of 54 high-risk patients (mean age 79 ± 7.9 years; 40.7% male) with severe AS by 2D-TTE (indexed aortic valve area [AVAi] < 0.6 cm2/m2), referred for transcatheter aortic valve implantation, were included in the analysis. AVAi was subsequently recalculated using IDFM by replacing 2D-TTE left ventricular outflow tract (LVOT) measurements with MSCT LVOT parameters. RESULTS: Imaging data fusion method reclassified 20.4% patients into the potentially non-severe AS group. In a multivariable model including clinical variables, reclassification to non-severe AS by IDFM was independently associated with younger age and diabetes mellitus (DM), (odds ratio [OR] 0.864; 95% confidence interval [CI] 0.76-0.99; p < 0.035 and OR 19.259; 95% CI 2.28-162.41; p < 0.007, respectively). In a multivariable analysis of echocardiographic variables, reclassification was associ-ated with higher LVOT velocity time integral and lower aortic mean gradient (OR 1.402; 95% CI 1.07-1.84; p < 0.014 and OR 0.858; 95%: CI 0.760-0.968; p < 0.013, respectively). In addition, 24.1% of patients were reallocated from low-flow (< 35 mL/m2) to normal-flow AS. CONCLUSIONS: Imaging data fusion method reclassified a substantial proportion of patients with severe AS into a potentially moderate AS group and from a low-flow to a normal-flow AS group. Such regrouping calls for increased diagnostic prudence in AS patients, especially those with specific clinical and echocardiographic predictors of reclassification, such as DM or low aortic mean gradient.

Quantitative estimation of aortic valve calcification in multislice computed tomography in predicting the development of paravalvular leaks following transcatheter aortic valve replacement.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) improves prognosis in patients disqualified from surgical valve replacement. Calcifications of the aortic complex can lead to deformation of the prosthesis, resulting in paravalvular leaks (PVL). AIM: To evaluate the predictive value of quantitative estimation of volume/weight and geometric distribution of calcifications in multislice computed tomography, for the development of PVL. MATERIAL AND METHODS: This was a retrospective, case-control study on patients with a CoreValve aortic prosthesis. The study group consisted of 20 patients with confirmed significant PVL after TAVI. The control group consisted of 20 patients without significant PVL, matched according to valve type and clinical characteristics. The size spatial distribution and shape of calcifications were measured. RESULTS: The average age of patients was 79.9 years (60% women). Cases and controls did not differ in their clinical characteristics. The size of the aortic annulus was significantly larger in cases vs. controls (23.4 ±1.6 vs. 22 ±1.4 mm, p = 0.01). Volume, area and curvature of calcifications were greater in cases vs controls (1.09 ±0.56 vs. 0.59 ±0.41 cm3, p = 0.011; 15.26 ±5.46 vs. 9.50 ±5.29 cm2, p = 0.008; 1.76 ±0.07 vs. 1.68 ±0.13 cm3, p = 0.037). In multivariate analysis, adjusted for aortic annulus size, the area of aortic valve calcifications independently predicted paravalvular regurgitation (OR = 1.41, 95% CI: 0.09-1.92, p < 0.009). CONCLUSIONS: Morphometric analysis of aortic valve calcifications predicted the risk of paravalvular leak following TAVI irrespectively of patients' clinical characteristics.