Leaflet Morphology and its Implications for Direct Transcatheter Annuloplasty of Tricuspid Regurgitation.

BACKGROUND: Leaflet morphology has been associated with treatment success in edge-to-edge repair of tricuspid regurgitation (TR), but the impact on annuloplasty is unclear. OBJECTIVES: The authors sought to examine the association of leaflet morphology with efficacy and safety of direct annuloplasty in TR. METHODS: The authors analyzed patients who underwent catheter-based direct annuloplasty with the Cardioband at 3 centers. Leaflet morphology was assessed according to number and location of leaflets by echocardiography. Patients with simple morphology (2 or 3 leaflets) were compared with complex morphology (>3 leaflets). RESULTS: The study included 120 patients (median age 80 years) with ≥severe TR. A total of 48.3% of patients had a 3-leaflet morphology, 5% a 2-leaflet morphology, and 46.7% had >3 tricuspid leaflets. Baseline characteristics did not differ relevantly between groups except for a higher incidence of torrential TR grade (50 vs 26.6%) in complex morphologies. Postprocedural improvement of 1 (90.6% vs 92.9%) and 2 (71.9% vs 67.9%) TR grades was not significantly different between groups, but patients with complex morphology had more often residual TR ≥3 at discharge (48.2 vs 26.6%; P = 0.014). This difference did not remain significant (P = 0.112) after adjusting for baseline TR severity, coaptation gap, and nonanterior jet localization. Safety endpoints including complications of the right coronary artery, and technical success did not show significant differences. CONCLUSIONS: Efficacy and safety of transcatheter direct annuloplasty using Cardioband are not affected by leaflet morphology. Assessment of leaflet morphology should be part of procedural planning in patients with TR and might help to individually tailor repair techniques to patient anatomy.

Multi-parametric speckle tracking analyses to characterize cardiac amyloidosis: a comparative study of systolic left ventricular longitudinal myocardial mechanics.

Cardiac amyloidosis (CAM), the most common cardiac storage disease is associated with significant changes in left-ventricular (LV) morphology and function. To gain particular insights into LV systolic longitudinal myocardial mechanics we investigated seven parameters derived by speckle-tracking-echocardiography (STE) in patients with confirmed CAM (n = 59). The results were compared with those of individuals with healthy heart (n = 150) and another primary myocardial disease with also thickened myocardium and severe diastolic and systolic LV-dysfunction (symptomatic LV-non-compaction-cardiomyopathy, LV-NC, n = 30). In addition to standard echocardiographical measures, the STE-derived data were evaluated and documented utilizing polar-diagrams to obtain overviews of longitudinal myocardial mechanics of the entire LV. Compared with healthy individuals, patients with CAM and LV-NC showed significantly reduced LV-ejection-fraction (EF), global longitudinal systolic peak-strain, strain-rate, and displacement. Pre-systolic stretch-index, post-systolic index, and the EF/global peak-longitudinal-strain-ratio (EF/S) were increased. In contrast to healthy-hearts and the LV-NC group only patients with CAM demonstrated significantly reduced time-to-peak systolic longitudinal strain and time-to-peak strain-rate. Although the level of the segmental values in longitudinal mechanics was significantly different between the groups, comparable intraventricular baso-apical parameter-gradients were found for systolic longitudinal peak-strain and strain-rate, pre-systolic-stretch-index, post-systolic-index, and peak systolic displacement. Compared to ATTR-amyloidosis (ATTR-CAM), patients with AL-amyloidosis (AL-CAM) demonstrated significantly lower end-diastolic and end-systolic LV-volumes, LV-mass-indices, relative apical strain, time-to-peak systolic longitudinal strain, and time-to-peak longitudinal strain-rate. CAM and LV-NC demonstrated altered myocardial mechanics with significantly different STE-derived echocardiographical parameters. ATTR-amyloidosis and AL-amyloidosis had at least significantly different time-to-peak strain, time-to-peak strain-rate and relative apical sparing values.

Solving the Pulmonary Hypertension Paradox in Patients With Severe Tricuspid Regurgitation by Employing Artificial Intelligence.

OBJECTIVES: This study aimed to improve echocardiographic assessment of pulmonary hypertension (PH) in patients presenting with severe tricuspid regurgitation (TR). BACKGROUND: Echocardiographic assessment of PH in patients with severe TR carries several pitfalls for underestimation, hence concealing the true severity of PH in very sick patients in particular, and ultimately obscuring the impact of PH on survival after transcatheter tricuspid valve intervention (TTVI). METHODS: All patients in this study underwent TTVI for severe TR between 2016 and 2020. To predict the mean pulmonary artery pressure (mPAP) solely based on echocardiographic parameters, we trained an extreme gradient boosting (XGB) algorithm. The derivation cohort was constituted by 116 out of 162 patients with both echocardiography and right heart catheterization data, preprocedurally obtained, from a bicentric registry. Moreover, 142 patients from an independent institution served for external validation. RESULTS: Systolic pulmonary artery pressure was consistently underestimated by echocardiography in comparison to right heart catheterization (40.3 ± 15.9 mm Hg vs 44.1 ± 12.9 mm Hg; P = 0.0066), and the assessment was most discrepant among patients with severe defects of the tricuspid valve and impaired right ventricular systolic function. Using 9 echocardiographic parameters as input variables, an XGB algorithm could reliably predict mPAP levels (R = 0.96, P < 2.2 × 10-16). Moreover, patients with elevations in predicted mPAP levels ≥29.9 mm Hg showed significantly reduced 2-year survival after TTVI (58.3% [95% CI: 41.7%-81.6%] vs 78.8% [95% CI: 68.7%-90.5%]; P = 0.026). Importantly, the poor prognosis associated with elevation in predicted mPAP levels was externally confirmed (HR for 2-year mortality: 2.9 [95% CI: 1.5-5.7]; P = 0.002). CONCLUSIONS: PH in patients with severe TR can be reliably assessed based on echocardiographic parameters in conjunction with an XGB algorithm, and elevations in predicted mPAP levels translate into increased mortality after TTVI.

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.

BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). CONCLUSIONS: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation.

BACKGROUND: The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow's disease. METHODS: 38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint. RESULTS: Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5-85.3] years (PASCAL) and 82.5 [76.5-86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68-0.83] cm2 (PASCAL) and 0.70 [0.50-0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured. CONCLUSION: In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.

Systolic longitudinal global and segmental myocardial mechanics in symptomatic isolated left ventricular non-compaction cardiomyopathy.

BACKGROUND: Left ventricular (LV) non-compaction cardiomyopathy (LV-NC) is rare, and data of segmental myocardial mechanics are largely lacking. We investigated myocardial longitudinal mechanics in adults with symptomatic LV-NC (n = 30) versus individuals with healthy hearts (n = 150). The contribution of compacted and non-compacted myocardial layer to systolic LV function has to be determined. METHODS: Seven parameters derived from speckle tracking echocardiography were evaluated and documented utilizing polar-diagrams to obtain overviews of myocardial mechanics of the entire LV. RESULTS: According to embryonal myocardial development, non-compacted myocardium was mostly located in mid-ventricular and apical segments of the free LV wall. LV ejection fraction was reduced in LV-NC (34 ± 15%, healthy 63 ± 5%, P < .0001). The compact wall layer in LV-NC demonstrated increasing systolic radial thickness (diastolic 5.6 ± 1.4, systolic 6.5 ± 1.4mm, P = .016), whereas the non-compacted layer remained unchanged or tended to decrease in thickness (diastolic 17.6 ± 5.3, systolic 16.0 ± 4.6mm, P = .22). Compared with heart-healthy individuals in LV-NC peak systolic longitudinal strain (healthy -21.1% vs. LV-NC -8.8, P < .0001), peak systolic longitudinal strain-rate (-1.23%/s vs. -0.64, P < .0001), and peak longitudinal displacement (12.1 vs. 5.6 mm, P < .0001) were reduced, while pre-systolic stretch index (1.31% vs. 3.2%, P < .0001) and post-systolic index (2.5% vs. 15.9%, P < .0001) increased. Time-to-peak longitudinal strain (371 vs. 389 ms, P = .065) and time-to-peak longitudinal strain rate (181 vs. 200 ms, P = .0677) did not differ significantly. In LV-NC, there were no significant differences between analyses using an interpolated endocardial border along the edges of the recesses and the endocardial edge of the compact wall layer. Hence, LV function appeared to depend only on the thin compact wall layer. CONCLUSION: In LV-NC, myocardial efficiency is severely diminished compared with healthy controls and LV function seemed to depend mainly on the compact myocardial wall layer.

Sleep duration and architecture during ASV for central sleep apnoea in systolic heart failure.

BACKGROUND: Adaptive servoventilation (ASV) effectively treats nocturnal respiratory events in patients with heart failure and reduced ejection fraction (HFrEF) and central sleep apnoea (CSA), but increased mortality has been reported. This study investigated changes in sleep architecture during ASV treatment in HFrEF patients. METHODS: A retrospective analysis of polysomnographic datasets for 30 ASV-treated patients with stable HFrEF and moderate-to-severe CSA was performed, including blinded analyses of total sleep time (TST), and percentage of REM and non-REM sleep (stages N1-N3). RESULTS: Follow-up was 109 ±â€¯32 days; mean device usage was 6.0 ±â€¯1.1 h/day. During ASV there was reduction of N1 (34 ±â€¯20%/TST to 13 ±â€¯5%/TST, p < 0.001) and N3 sleep (4 ±â€¯6%/TST to 1 ±â€¯4%/TST, p = 0.020), and increase of N2 (44 ±â€¯14%/TST to 62 ±â€¯7%/TST, p < 0.001) and REM-sleep (18 ±â€¯8%/TST to 24 ±â€¯6%/TST, p = 0.002). CONCLUSIONS: Disturbances of sympatho-vagal balance during ASV might help explain increased mortality during ASV. Since sympathetic tone is highest in REM-sleep and vagal predominance occurs during N3 sleep, these findings generate new hypotheses for the increased mortality seen in SERVE-HF.

When to operate on the bicuspid valve patient with a modestly dilated ascending aorta.

BACKGROUND: Bicuspid aortic valves (BAV) are frequently associated with root/ascending aorta dilatation, but there is controversy regarding when to operate to prevent dissection of a dilated aorta associated with a well-functioning BAV. METHODS: From 1988 through 2008, 158 patients (mean age: 56 ± 13.5 years) with a dilated ascending aorta (AA) and a well-functioning BAV were referred to our institution. All patients underwent computed tomographic (CT) scanning and digitization to calculate mean AA diameter. Forty-two patients underwent operation a median of 52 days after initial CT scan with a mean AA diameter of 5.6 ± 0.5 cm. One hundred sixteen patients (mean diameter 4.6 ± 0.5 cm) were enrolled in annual or semiannual surveillance. Seventy-one patients, 45 with 2 or more CT scans, are still under surveillance. RESULTS: Average follow-up was 6.5 ± 4.1 years. Overall survival after the first encounter was 93% at 5 years and 85% at 10 years. A total of 87 of 158 patients had a Bentall or Yacoub procedure, with two hospital deaths (2.3%). Mean duration of surveillance in the 116 patients without immediate operation was 4.2 ± 2.9 years (481 patient-years). Average growth rate of the AA in patients with 2 scans or greater was 0.77 mm/year (p < 0.0001 versus normal population) with no significant impact of hypertension, sex, smoking or age. Forty-five of the 116 surveillance patients underwent operation after a mean of 3.4 ± 2.9 years (mean age 55 ± 14.7 years; mean AA diameter 4.9 ± 0.6 cm). Six patients died without surgery, median age 82 (range, 44 to 87) years, but none within one year of the last CT scan. CONCLUSIONS: A consistent approach to patients with a well-functioning BAV and AA dilatation, recommending operation to those with an AA diameter greater than 5 cm and deferring operation in patients under surveillance in the absence of significant enlargement (>0.5 cm/year), resulted in overall survival equivalent to a normal age-matched and sex-matched population. Operation was necessary in approximately 10% of patients under surveillance each year.

The Bentall procedure: is it the gold standard? A series of 597 consecutive cases.

OBJECTIVES: We compared aortic root reconstructions using conduits with biological valves and mechanical valves. METHODS: Of 597 patients (1995-2008), 307 (mean age 71 years [23-89 years]) had biological valves and 290 (mean age 51 years [21-82 years]) had mechanical valves. The subgroup of 242 patients aged 50 to 70 years included 133 with biological and 109 with mechanical valves. RESULTS: Overall hospital mortality was 3.9% with biological valves (n = 15; elective: 3.7% [n = 10]) versus 2.8% with mechanical valves (n = 8; elective: 1.4% [n = 3]). In patients 50 to 70 years, age greater than 65 years (relative risk: 3.3 [P = .0001]), clot (relative risk: 2.5 [P = .05]), coronary artery disease (relative risk:3.5 [P < .0001]), and degenerative etiology (relative risk: 0.4 [P = .006]) were independent risk factors for long-term survival (after postoperative day 30); there was no difference in long-term survival between biological and mechanical valves (relative risk: 0.9 [P = .74]). The linearized rate for valve/ascending aorta reoperation was 0.86%/pt-y (2 in 2310 pt-y) after mechanical valves and 2.5%/pt-y (4 in 1586 pt-y) after Bentall procedures with the biological valve. CONCLUSIONS: The choice of valve for aortic root reconstruction seems to have no influence on long-term outcome. Emergency operation and the presence of clot/atheroma have a significant impact on short-term outcome. Reoperation for either ascending aorta and/or aortic valve is low.

Predicting the risk of paraplegia after thoracic and thoracoabdominal aneurysm repair.

BACKGROUND: Endovascular repair of descending thoracic and thoracoabdominal aortic aneurysms is an appealing alternative to the standard surgical approach, but precludes revascularization of segmental arteries (SAs). For safer surgical and endovascular repairs, an accurate prediction of the risk of paraplegia in relation to the extent of SA sacrifice is needed. METHODS: From January 1994 to October 2008, 609 patients (mean age, 63 ± 14 years) underwent surgical descending thoracic or thoracoabdominal aortic aneurysm repair without SA reimplantation. Three hundred seventy-six patients (62%) were male; 159 (26%) had urgent or emergent operation; 199 (33%) had previous aortic surgery. Somatosensory- or motor-evoked potential monitoring and cerebrospinal fluid drainage were routinely performed. RESULTS: Hospital mortality was 10.7% (65 patients). Spinal cord injury (SCI) occurred in 3.4% (21 patients). The extent of resection-expressed as the number of SAs sacrificed (p = 0.007)-and the need for visceral artery reimplantation (p = 0.03) were independent risk factors for paraplegia. Further analysis identified four risk groups (p < 0.0001): fewer than 8 SAs sacrificed (group A, SCI = 1.2%); sacrifice of 8 to 12 SAs with proximal origin in the upper thorax (group B, SCI = 3.7%); 8 to 12 SAs sacrificed beginning in the lower thorax (group C, SCI = 15.4%); and 13 or more SAs sacrificed (group D, SCI = 12.5%). This four-group model more accurately predicts SCI risk than the Crawford classification (goodness of fit c statistic: 0.748 versus 0.640). CONCLUSIONS: The extent of SA sacrifice is the most powerful predictor of paraplegia risk. For aneurysms of moderate extent, a more distal location involving the abdominal aorta increases the risk of spinal cord injury. Sacrifice of fewer than 8 SAs is associated with a very low paraplegia risk regardless of location.

Experimental two-stage simulated repair of extensive thoracoabdominal aneurysms reduces paraplegia risk.

BACKGROUND: In a pig model, we compared spinal cord injury after extensive segmental artery (SA) sacrifice in a single stage with recovery after a two-stage procedure: lumbar artery followed by thoracic SA sacrifice. METHODS: Twenty juvenile Yorkshire pigs were randomly assigned to undergo extensive SA sacrifice at 32 degrees C in a single operation (group 1, n = 10), or thoracic SA ligation 7 days after lumbar artery sacrifice (group 2, n = 10). Spinal cord perfusion pressure (SCPP) was monitored using a catheter placed in the distal stump of L1. Hind limb function was evaluated intraoperatively using motor-evoked potentials and for 5 days postoperatively using a modified Tarlov score. RESULTS: Motor-evoked potentials were intact in all pigs until 1 hour after surgery. All pigs in group 2 fully recovered hind limb function, whereas 40% in group 1 experienced paraplegia (median Tarlov scores 9 versus 7; p = 0.004). Group 1 SCPP fell to 28 +/- 6 mm Hg after SA sacrifice, compared with 44 +/- 8 mm Hg in group 2 (p < 0.0001). After sacrifice of all residual SAs, SCPP in group 2 remained consistently greater than 85% of baseline, significantly higher than group 1 SCPP from end clamping until 72 hours (p = 0.0002). Histopathologic analysis showed more severe ischemic damage to the lower thoracic (p < 0.001) and lumbar spinal cord (p = 0.01) in group 1. CONCLUSIONS: In contrast with the single-stage approach, a two-stage procedure, starting with ligation of six or fewer lumbar SAs, leads to only a mild drop in SCPP and stimulates vascular remodeling, minimizing the impact of subsequent SA sacrifice on spinal cord function. The greater safety of extensive SA sacrifice when undertaken in two stages has important implications for endovascular and hybrid aneurysm repair.

Long-term survival after open repair of chronic distal aortic dissection.

BACKGROUND: The optimal treatment of chronic distal aortic dissection remains controversial, with endovascular stent-graft techniques challenging traditional surgery. METHODS: From January 1994 to April 2007, 104 patients (82 male, median age 60.5 years) with chronic distal aortic dissection underwent surgical repair, 0 to 21 years after initial diagnosis of acute type A or B dissection (median 2.1 years). Twenty-three (22%) patients underwent urgent-emergent surgery. Mean aortic diameter was 6.9 +/- 1.4 cm. Indications for surgery, other than aortic expansion, were pain in 6 (6%) patients, malperfusion in 6 (6%), and rupture in 11 (11%). Forty-nine (47%) had previous cardioaortic surgery (29% dissection-related), 21 (20%) had coronary artery disease, 12 (12%) had Marfan syndrome, and 4 (4%) were on chronic dialysis. Twenty-six (25%) had a thrombosed false lumen. Thirty (29%) patients required reimplantation of visceral arteries; 8.3 +/- 2.7 segmental artery pairs were sacrificed. RESULTS: Hospital mortality was 9.6% (10 patients). Paraplegia occurred in 5 (4.8%). Twenty-seven patients (26%) experienced adverse outcome (death within one year, paraplegia, stroke, or dialysis). Adverse outcome was associated with atheroma (p = 0.04, odds ratio = 4.3). Survival was 78% at 1, 68% at 5, and 59% at 10 years (average follow-up, 7.7 +/- 4.1 years). Freedom from distal aortic reoperation was 99% at 1, 93% at 5, and 83% at 10 years. After one year, patients enjoyed longevity equivalent to a normal age-sex matched population (standardized mortality ratio = 1.38, p = 0.23). By multivariate analysis, atheroma (p = 0.0005, relative risk = 9.32) and age (p = 0.0003, relative risk = 1.15/year) were risk factors for long-term survival. CONCLUSIONS: The efficacy of open repair for distal chronic dissection is highlighted by normal survival after the first year, and a low reoperation-reintervention rate.