Transfemoral-only transcatheter aortic valve replacement: A single center experience of 400 consecutive patients.

BACKGROUND: In transcatheter aortic valve replacement (TAVR), transfemoral (TF) access offers several advantages over alternative access routes. Advances in sheaths and valve delivery technology have catalyzed the feasibility of TF-TAVR, even in challenging anatomies. AIMS: Report procedural characteristics and outcomes of a TAVR program aiming for a 100% TF access rate. METHODS: Consecutive patients undergoing TAVR were enrolled in a prospective registry. Equipment used to facilitate TF-access in challenging anatomies included low-profile sheaths, dilatators, peripheral balloons, covered and uncovered self-expanding and balloon-expandable stents, and intravascular lithotripsy (IVL). RESULTS: A total of 400 patients with a mean age of 81 ± 6 years (42% female) were analyzed. Minimal iliofemoral artery diameter (MLD) of the main access side was <5 mm in 42 (10.5%), extreme tortuosity was present in 65 (16.3%), and severe calcification in 59 (14.8%). TF-access was successful in 399 (99.8%) patients. A transaxillary access was used in one patient. In multivariable analysis, an MLD < 5 mm was the strongest predictor for vascular complications (11.9% vs. 3.9%, OR: 3.86, 95% CI: 1.38-10.8, p = 0.01). Such patients also had more major/life-threatening bleeding (14.2% vs. 3.1%, p < 0.001) and required more planned and unplanned peripheral interventions to enable TF access (35.8% vs. 3.4%, p < 0.001). CONCLUSION: Our study shows that utilization of dedicated sheaths, peripheral balloons, stents, and IVL enables TAVR via TF access in >99% of patients. However, rates of vascular and bleeding complications in patients with narrow iliofemoral arteries (MLD < 5 mm) were high.

Mitigating the risk of flow deterioration by deferring stent optimization in STEMI patients with large thrombus burden: Insights from a prospective cohort study.

OBJECTIVES: It is uncertain, if omitting post-dilatation and stent oversizing (stent optimization) is safe and may decrease the risk for distal thrombus embolization (DTE) in STEMI patients with large thrombus burden (LTB). BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) with stenting, (DTE) and flow deterioration are common and increase infarct size leading to worse outcomes. METHODS: From a prospective registry, 74 consecutive STEMI patients with LTB undergoing pPCI with stenting and intentionally deferred stent optimization were analyzed. Imaging data and outcomes up to 2 years follow-up were analyzed. RESULTS: Overall, 74 patients (18% females) underwent deferred stent optimization. Direct stenting was performed in 13 (18%) patients. No major complications occurred during pPCI. Staged stent optimization was performed after a median of 4 (interquartile range (IQR) 3; 7) days. On optical coherence tomography, under-expansion and residual thrombus were present in 59 (80%) and 27 (36%) cases, respectively. During deferred stent optimization, we encountered no case of flow deterioration (slow or no-reflow) or side branch occlusion. Minimal lumen area (mm2) and stent expansion (%) were corrected from 4.87±1.86mm to 6.82±2.36mm (p<0.05) and from 69±18% to 91±12% (p<0.001), respectively. During follow-up, 1 patient (1.4%) required target lesion revascularization and 1 (1.4%) patient succumbed from cardiovascular death. CONCLUSIONS: Among STEMI patients with LTB, deferring stent optimization in the setting of pPCI appears safe and potentially mitigates the risk of DTE. The impact of this approach on infarct size and clinical outcomes warrants further investigation in a dedicated trial.

The relevance of tricuspid regurgitation in patients undergoing percutaneous treatment of mitral regurgitation.

OBJECTIVES: Investigate the impact of concomitant tricuspid regurgitation (TR) on clinical outcomes during long-term follow-up in patients undergoing percutaneous treatment of mitral regurgitation (MR) with the MitraClip system. BACKGROUND: Patients undergoing mitral repair using the MitraClip frequently present with concomitant TR. It is uncertain how the presence of TR impacts the long-term outcomes of such patients. METHODS: We analyzed consecutive patients with MitraClip implantation from the prospective MitraSwiss registry. Endpoints were all-cause mortality, hospitalization for heart failure, and the composite endpoint of the two. RESULTS: We enrolled 177 patients (mean age 76 ± 9 years, 37% female). Acute procedural success was achieved in 149 (84%). Concomitant moderate or severe TR was present in 31% at baseline and 32% before discharge. After a median follow-up of 1103 days (IQR: 555-1766 days), 70 (40%) of patients had died, and 34 (19%) were hospitalized for heart failure. In multivariable analysis, TR at baseline was associated with an increase in all-cause mortality (HR: 2.34, 95% CI: 1.36-4.03, p < 0.01), hospitalization for heart failure (HR: 3.19, 95% CI: 1.37-7.41, p = 0.01), and the composite endpoint (HR: 2.00, 95% CI: 1.19-3.36, p = 0.01). CONCLUSION: Despite treatment of MR, TR did not improve in most patients. The presence of relevant TR at baseline was associated with reduced survival and higher rates of hospitalization for heart failure. More research is needed to understand the causal role of TR in such patients and to investigate if simultaneous treatment of concomitant TR may improve prognosis in patients undergoing percutaneous treatment of MR.

Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms.

OBJECTIVES: Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms. BACKGROUND: The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter <6 mm and clinically established peripheral artery disease (PAD). METHODS: We compared 100 consecutive patients of the initial cohort (first n = 100) with consecutive patients in which the key insights acquired in the initial cohort were implemented (second n = 100). RESULTS: The initial cohort (n = 100 patients) had a MANTA-related vascular complication rate of 11% (7% major and 4% minor), and 14% MANTA-related bleeding complications. In a subsequent cohort of n = 100 patients, we applied the abovementioned findings: we did not use the MANTA device if the CFA was <6 mm and in patients with PAD. In addition, femoral puncture was ultrasound guided. This strategy led to a decline in MANTA-related vascular complication rates: 2% (1% major and 1% minor) p = .03, as well as a reduction in MANTA-related bleeding complications to 5% p = .01. To the best of our knowledge, this is the lowest rate of MANTA-related vascular complication reported thus far. CONCLUSIONS: Our strategy achieves low MANTA-related vascular and bleeding complication rates. Careful and critical examination of complications can lead to rapid identification of complication mechanism and its predictors. In turn, rapid implementation of these insights can lead to a decline in complication rates.

Transcatheter aortic valve-in-valve implantation for failed surgical bioprosthetic valves. A minimalist approach without contrast aortography or echocardiographic guidance.

OBJECTIVES: To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance. BACKGROUND: Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone. METHODS: ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. RESULTS: Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm2 to 1.2 ± 0.4 cm2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II. CONCLUSIONS: Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe.

Mid-term outcome in patients with bicuspid aortic valve stenosis following transcatheter aortic valve replacement with a current generation device: A multicenter study.

OBJECTIVES: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve. BACKGROUND: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce. METHODS: We collected baseline characteristics, procedural data, 30-day and mid-term clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve. RESULTS: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of all-cause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%. CONCLUSIONS: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.

Percutaneous left atrial appendage occlusion: Effect of device positioning on outcome.

OBJECTIVE: The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc. BACKGROUND: The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome. METHODS: Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up. RESULTS: Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA2 DS2 -Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0). CONCLUSIONS: No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of repositioning attempts in case of incomplete coverage does not seem to be warranted. Current findings need further confirmation in a larger scale clinical trial. © 2016 Wiley Periodicals, Inc.

The impact of elevated C-reactive protein levels on long-term outcomes of patients undergoing transcatheter aortic valve replacement.

BACKGROUND: In patients undergoing transcatheter aortic valve replacement (TAVR), elevated pre-procedural C-reactive protein (CRP) levels are frequently observed. Its impact on long-term results of TAVR is unclear. The aim of the study was to investigate the long-term (up to six years) clinical outcomes of TAVR patients with normal compared to elevated CRP levels before TAVR. METHODS: Consecutive patients undergoing TAVR between August 2012 and January 2023 at a tertiary cardiology facility were included. Patients were divided into two cohorts based on the baseline CRP levels: normal CRP (≤ 5 mg/l) and elevated CRP (>5 mg/l). The cohorts were followed clinically for up to six years after TAVR. RESULTS: From a total of 1000 TAVR patients (mean age 81 ± 6 years), 268 patients (27 %) were found to have elevated baseline CRP (>5 mg/l). Such patients had significantly more co-morbidities (e.g. chronic obstructive pulmonary disease, atrial fibrillation, heart failure, concomitant valvopathies). They also developed periprocedural infections more frequently (3 % vs. 1 %, p = 0.007) and required more commonly repeat hospitalizations for infections during follow-up (HR 1.97, CI 1.47-2.64, p < 0.001). All-cause mortality and development of valve dysfunction did not significantly differ between patients with elevated and normal baseline CRP levels. CONCLUSION: Albeit long-term results of TAVR patients with elevated pre-procedural CRP levels seem favorable in terms of survival and development of valve dysfunction, they have an increased risk for periprocedural infections and re-admissions due to infections of any type during the follow-up period.

Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients With Chronic Inflammatory Disease.

BACKGROUND: Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis. METHODS AND RESULTS: From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%, P=0.002) and more often had pulmonary disorders (21% versus 13%, P=0.046) and atrial fibrillation (32% versus 20%, P=0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%, P=0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID. CONCLUSIONS: This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.

The impact of colchicine on patients with acute and chronic coronary artery disease.

Inflammation plays a central role in coronary artery disease (CAD), and recent data have shown that anti-inflammatory drugs have the potential to reduce ischemic events in CAD patients. Colchicine is an ancient anti-inflammatory drug that targets neutrophil and inflammasome activities. It has been prescribed for decades for different rheumatological conditions. Given the important role of inflammation in the development of cardiovascular disease, there has been considerable interest in studying colchicine's potential to limit the progression of atherosclerosis among afflicted patients. In fact, there is a growing body of randomized data suggesting that use of low-dose colchicine reduces the risk of ischemic events in patients with CAD, particularly repeated revascularizations, new myocardial infarctions and strokes. This review article summarizes background information-including possible side effects and contraindications-as well as the current evidence backing up the use of colchicine in patients with established CAD.

Initial experience with a novel stent-based mechanical thrombectomy device for management of acute myocardial infarction cases with large thrombus burden.

BACKGROUND: Patients with acute myocardial infarction (AMI) and large thrombus burden (LTB) still represent a challenge. Afflicted patients have a high morbidity and mortality. Aspiration thrombectomy is often ineffective in those cases. Mechanical thrombectomy devices (MTDs), which are effective for management of ischemic strokes, were recently CE-approved for treatment of thrombotic coronary lesions. Real-world data about their performance in AMI cases with LTB are scarce. This study sought to summarize our early experience with a novel MTD device in this context. METHODS: We analyzed consecutive patients from the prospective OPTIMISER registry (NCT04988672), who have been managed with the NeVa™ MTD (Vesalio, USA) for AMI with LTB at a tertiary cardiology facility. Outcomes of interest included, among others, periprocedural complications, target lesion failure (TLF), target lesion revascularization (TLR) and target vessel myocardial infarction (TV-MI). RESULTS: Overall, 15 patients underwent thrombectomy with the NeVa™ device. Thrombectomy was successfully performed in 14 (93%) patients. Final TIMI 3 flow was achieved in 13 (87%) patients, while 2 (13%) patients had TIMI 2 flow. We encountered no relevant periprocedural complications, especially no stroke, stent thrombosis or vessel closure. After a mean follow-up time of 26 ± 2.9 months, 1 (7%) patient presented with TLR due to stent thrombosis (10 months after treatment with the MTD and stenting). CONCLUSIONS: In AMI patients with LTB, the deployment of the novel NeVa™ MTD seems efficient and safe. Further randomized trials are warranted to assess whether the use of the NeVa™ device in cases with LTB improves procedural and clinical outcomes.

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

Background: There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions. Methods: Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated. Results: From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed. Conclusions: Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons.

OBJECTIVES: Despite the introduction of improved drug eluting stents (DES), the rate of repeat revascularization procedures following percutaneous coronary interventions (PCI) in coronary chronic total occlusions (CTO) remains high. By leaving vessels uncaged and limiting length of stented segments, drug-coated balloons (DCB) represent an appealing alternative to DES for CTO-PCI. Since data supporting the use of DCBs in CTO-PCI is scarce, we compared the outcomes of patients undergoing CTO-PCI involving DCBs vs DES only. METHODS: From 2 prospective registries, outcomes of patients undergoing CTO-PCI involving DCBs and those undergoing PCI with DES only were compared. Outcomes included major adverse cardiac and cerebrovascular events (MACCE) and cardiovascular death (CV-death). RESULTS: Overall, 157 patients were studied; 112 (71%) underwent CTO-PCI involving DCBs and 45 (29%) were treated with DES only. Mean J-CTO score was 1.84 ± 0.7. Most CTO-lesions involved the right coronary artery, 88 (56%), and 26 (17%) cases were in-stent occlusions. In the DCB group, 46 (41%) lesions were treated with DCBs alone. Mean lengths of the stented segments in the DCB vs DES cohorts were 59 ± 28 mm vs 87 ± 37 mm (P less than .001), respectively. After 12 months, the MACCE rate was higher in the DES only vs DCB group (26% vs 11%, P=.03). Length of the stented segment was an independent predictor for MACCE (HR 1.15 [95% CI, 1.05-1.26] per 10-mm stent length). CONCLUSIONS: Revascularization of CTO lesions involving DCBs appears safe and potentially lowers MACCE rates compared to treatment with DES alone. Importantly, using DCBs for CTO treatment may reduce total stent length, which determines PCI outcomes.

Cardiac resynchronization therapy in patients with a coronary sinus reducer: a case series.

Background: Reducing venous drainage of the coronary sinus is a promising intervention for refractory angina. Coronary Sinus Reducer (CSR) System™ effectively treats patients with refractory angina, possibly by increasing coronary collateral circulation, and leads to an improvement in their symptoms and quality of life. In patients with impaired left ventricular function and electrocardiographic dyssynchrony, cardiac resynchronization therapy (CRT) is an established treatment. However, there is only one published case report of CRT in a patient implanted with a CSR system. We present the first case series of CRT in patients implanted with the CSR system. Case summary: This case series describes three patients. The first case demonstrated that CRT is feasible in patients implanted with a CSR system. The second case is the first report of a left ventricular lead extraction after CSR, and the third case was complicated due to the patient's medical history; however, CSR system implantation was feasible without major complications. Discussion: Our results suggest that CRT is feasible in patients implanted with a CSR system, and lead extraction after CSR system implantation is possible. However, lead extraction in cases of severe adhesions around the CSR system and the coronary sinus may be associated with a high risk of complications; alternative options should be discussed at an early stage.

Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon.

BACKGROUND: Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population. METHODS: From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE). RESULTS: Totally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died. CONCLUSIONS: For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.

Relevance of Motion Artifacts in Planning Computed Tomography on Outcomes After Transcatheter Aortic Valve Implantation.

Background: Motion artifacts in planning computed tomography (CT) for transcatheter aortic valve implantation (TAVI) can potentially skew measurements required for procedural planning. Whether such artifacts may affect safety or efficacy has not been studied. Methods: We conducted a retrospective analysis of 852 consecutive patients (mean age, 82 years; 47% women) undergoing TAVI-planning CT at a tertiary care center. Two independent observers divided CTs according to the presence of motion artifacts at the annulus level (Motion vs. Normal group). Endpoints included surrogate markers for inappropriate valve selection: annular rupture, valve embolization or misplacement, need for a new permanent pacemaker, paravalvular leak (PVL), postprocedural transvalvular gradient, all-cause death. Results: Forty-six (5.4%) patients presented motion artifacts on TAVI-planning CT (Motion group). These patients had more preexisting heart failure, moderate-severe mitral regurgitation, and atrial fibrillation. Interobserver variability of annular measurement (Normal vs. Motion group) did not differ for mean annular diameter but was significantly different for perimeter and area. Presence of motion artifacts on planning CT did not affect the prevalence of PVL (≥moderate PVL 0% vs. 2.5% p = 0.5), mean transvalvular gradient (6±3 mmHg vs 7±5 mmHg, p = 0.1), or the need for additional valve implantation (0% vs. 2.8%, p = 0.6). One annular rupture occurred (Normal group). Pacemaker implantation, procedural duration, hospital stay, 30-day outcomes, and all-cause mortality did not differ between the groups. Conclusions: Motion artifacts on planning CT were found in about 5% of patients. Measurements for valve selection were possible without the need for repeat CT, with mean diameter-derived annulus measurement being the most accurate. Motion artifacts were not associated with worse outcomes.

Hypoattenuated Leaflet Thickening After Implantation of the ACURATE neo or the ACURATE neo2 Transcatheter Heart Valve.

Subclinical leaflet thrombosis, identified as hypoattenuated leaflet thickening (HALT) on cardiac computed tomography scan, has been observed after transcatheter aortic valve replacement (TAVR). However, data on HALT after the implant of the supra-annular ACURATE neo/neo2 prosthesis are limited. This study aimed to determine the prevalence and risk factors for the development of HALT after TAVR with the ACURATE neo/neo2. A total of 50 patients who received the ACURATE neo/neo2 prosthesis were prospectively enrolled. Patients underwent a contrast-enhanced multidetector row cardiac computed tomography scan at before, after, and 6 months after TAVR. At the 6-month follow-up, HALT was detected in 16% (8 of 50 patients). These patients had a lower implant depth of the transcatheter heart valve (8 ± 2 mm vs 5 ± 2 mm, p = 0.001), less calcified native valve leaflets, a better expansion of the frame at the level of the left ventricular outflow tract, and were less often hypertensive. Thrombosis of the sinus of Valsalva occurred in 18% (9/50). There was no difference in the anticoagulation regimen between patients with and without thrombotic findings. In conclusion, HALT was present in 16% of patients at 6 months follow-up, patients presenting with HALT had a lower implant depth of the transcatheter heart valve, and HALT was detected in patients on oral anticoagulation therapy.

Trajectories of Cardiac Function Following Treatment With an Impella Device in Patients With Acute Anterior ST-Elevation Myocardial Infarction.

Background: Left ventricular (LV) unloading via the percutaneous micro-axial Impella pump is increasingly used in patients with anterior ST-segment elevation myocardial infarction (STEMI) and overt cardiogenic shock. In this context, the evolution of cardiac function and dimensions beyond hospital discharge remains uncertain. We aimed to characterize echocardiographic changes over time in patients with acute anterior STEMI treated with an Impella device. Methods: From an ongoing prospective registry, consecutive patients with acute anterior STEMI managed with an Impella device were extracted. Transthoracic echocardiography was performed at index hospitalization and at first outpatient follow-up. Predictors of response, defined as a ≥ 10% absolute increase in left ventricular ejection fraction (LVEF) at follow-up, were sought. Results: A total of 66 patients (89.4% male, aged 64.3 ± 11.6 years) with anterior STEMI were treated with an Impella device in the first 24 hours of hospitalization, from 2014 to 2022. In-hospital mortality was 24%. Major bleeding and vascular complications requiring surgery occurred in 24% and 11% of patients, respectively. At baseline, mean LVEF was 34% ±12%. At follow-up, survivors showed a significant increase in LVEF (P < 0.0001), whereas LV dimensions, diastolic parameters, and measures of right ventricular dimension and function remained stable. Overall, 28 patients had a ≥ 10% absolute increase in LVEF at follow-up. Baseline creatinine was the only significant predictor of response at univariate analysis. Conclusions: Among patients with anterior STEMI requiring mechanical hemodynamic support with an Impella device, the majority of survivors showed a sustained increase in LV function, without evidence of adverse remodelling. This signal warrants further investigation in dedicated trials.

Contexte: La décharge du ventricule gauche (VG) à l'aide de la pompe microaxiale percutanée Impella est de plus en plus employée chez les patients qui présentent un infarctus du myocarde avec élévation du segment ST (STEMI) et un choc cardiogénique manifeste. Dans ce contexte, l'évolution de la fonction et des dimensions cardiaques après le congé de l'hôpital demeure incertaine. Nous avons cherché à caractériser les variations des paramètres échocardiographiques au fil du temps chez les patients ayant subi un STEMI antérieur aigu traités au moyen d'un dispositif Impella. Méthodologie: À partir d'un registre prospectif actif, nous avons extrait les dossiers de patients consécutifs ayant subi un STEMI antérieur aigu et pris en charge au moyen d'un dispositif Impella. Une échocardiographie transthoracique a été effectuée durant l'hospitalisation de référence puis à la première visite de suivi ambulatoire. Les facteurs prédictifs de la réponse, définis comme une augmentation absolue ≥ 10 % de la fraction d'éjection ventriculaire gauche (FEVG) au moment du suivi, ont été recherchés. Résultats: Au total, 66 patients (89,4 % d'hommes, âgés de 64,3 ± 11,6 ans) ayant subi un STEMI antérieur ont été traités au moyen d'un dispositif Impella pendant les 24 premières heures de l'hospitalisation, entre 2014 et 2022. Le taux de mortalité hospitalière était de 24 %. Des hémorragies majeures et des complications vasculaires ayant nécessité une intervention chirurgicale sont survenues chez 24 % et 11 % des patients, respectivement. Au début de l'étude, la FEVG moyenne était de 34 % ± 12 %. Lors du suivi, les survivants affichaient une augmentation significative de la FEVG (p < 0,0001), alors que les dimensions du VG, les paramètres diastoliques et les mesures de la taille et de la fonction du ventricule droit étaient demeurés stables. Globalement, 28 patients affichaient une augmentation absolue de la FEVG ≥ 10 % lors du suivi. D'après l'analyse univariée, la créatininémie initiale était le seul facteur prédictif important de la réponse. Conclusions: Parmi les patients ayant subi un STEMI antérieur nécessitant un support mécanique hémodynamique au moyen d'un dispositif Impella, une augmentation durable de la fonction ventriculaire gauche, sans signe de remodelage indésirable, a été observée chez la majorité des survivants. Ce signal justifie une évaluation plus approfondie dans le cadre d'essais cliniques conçus à cet effet.