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.

Cerebral embolic protection during transcatheter aortic valve replacement: Insights from a consecutive series with the Sentinel cerebral protection device.

BACKGROUND: Growing interest in neuroprotection in transcatheter aortic valve replacement (TAVR) has catalyzed the development of cerebral protection systems (CPS). OBJECTIVES: Report insights from consecutive real-world patients undergoing TAVR with the Sentinel-CPS. METHODS: Patients with severe aortic stenosis undergoing TAVR from April 2019 to May 2022 were enrolled in a prospective registry. The reason for unsuccessful Sentinel-CPS deployment and the amount of debris captured by the filters were prospectively recorded. RESULTS: The Sentinal CPS was successfully deployed in 330 patients (85%, Group 1). Deployment was not attempted, unsuccessful or only partially successful in 59 patients (15%, Group 2), caused by anatomical factors such as tortuosity, heavy calcification or small dimensions of radial or brachial artery in 46, technical aspects such as puncture failure or dissection in 5 or use of right radial access for the pigtail in 6. Debris was captured in 98% of patients in Group 1. In 40%, the amount of debris was graded moderate or extensive. Predictors for moderate/extensive debris were moderate/severe aortic calcification (OR 1.50, CI 1.05-2.15, p = 0.03), pre- and postdilatation (OR 1.97, CI 1.02-3.79, p = 0.04 and OR 1.71, CI 1.01-2.89, p = 0.048). The risk of stroke was numerically lower in patients who underwent TAVR with the Sentinel CPS (2.1 vs. 5.1%, respectively, p = 0.15). There was no stroke during CPS deployment, but one patient had a stroke immediately after device retrieval. CONCLUSIONS: The Sentinel-CPS was successfully deployed in 85% of patients. Predictors for moderate/extensive debris captured were moderate/severe aortic calcification, pre- and postdilatation.

Cerebral embolic protection during transcatheter aortic valve replacement: a systematic review and meta-analysis of propensity score matched and randomized controlled trials using the Sentinel cerebral embolic protection device.

BACKGROUND: The Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR. METHODS: Eligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD). RESULTS: A total of 4066 patients from 4 RCTs (3'506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48-0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 - -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17-0.65. ARD: -0.9%, 95% CI: -1.5 - -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16-0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62-1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35-1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33-1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37-1.50, p = 0.40) were similar. CONCLUSIONS: The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.

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.

The Allegra transcatheter heart valve: Short term results from a multicenter registry.

OBJECTIVES: We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. BACKGROUND: The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. METHODS: Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. RESULTS: This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. CONCLUSIONS: Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.

Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter.

OBJECTIVES: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. BACKGROUND: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. METHODS: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. RESULTS: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. CONCLUSION: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Hyper-acute cardiovascular magnetic resonance T1 mapping predicts infarct characteristics in patients with ST elevation myocardial infarction.

BACKGROUND: Myocardial recovery after primary percutaneous coronary intervention in acute myocardial infarction is variable and the extent and severity of injury are difficult to predict. We sought to investigate the role of cardiovascular magnetic resonance T1 mapping in the determination of myocardial injury very early after treatment of ST-segment elevation myocardial infarction (STEMI). METHODS: STEMI patients underwent 3 T cardiovascular magnetic resonance (CMR), within 3 h of primary percutaneous intervention (PPCI). T1 mapping determined the extent (area-at-risk as %left ventricle, AAR) and severity (average T1 values of AAR) of acute myocardial injury, and related these to late gadolinium enhancement (LGE), and microvascular obstruction (MVO). The characteristics of myocardial injury within 3 h was compared with changes at 24-h to predict final infarct size. RESULTS: Forty patients were included in this study. Patients with average T1 values of AAR ≥1400 ms within 3 h of PPCI had larger LGE at 24-h (33% ±14 vs. 18% ±10, P = 0.003) and at 6-months (27% ±9 vs. 12% ±9; P < 0.001), higher incidence and larger extent of MVO (85% vs. 40%, P = 0.016) & [4.0 (0.5-9.5)% vs. 0 (0-3.0)%, P = 0.025]. The average T1 value was an independent predictor of acute LGE (ß 0.61, 95%CI 0.13 to 1.09; P = 0.015), extent of MVO (ß 0.22, 95%CI 0.03 to 0.41, P = 0.028) and final infarct size (ß 0.63, 95%CI 0.21 to 1.05; P = 0.005). Receiver-operating-characteristic analysis showed that T1 value of AAR obtained within 3-h, but not at 24-h, predicted large infarct size (LGE > 9.5%) with 100% positive predictive value at the optimal cut-off of 1400 ms (area-under-the-curve, AUC 0.88, P = 0.006). CONCLUSION: Hyper-acute T1 values of the AAR (within 3 h post PPCI, but not 24 h) predict a larger extent of MVO and infarct size at both 24 h and 6 months follow-up. Delayed CMR scanning for 24 h could not substitute the significant value of hyper-acute average T1 in determining infarct characteristics.

Gated SPECT myocardial perfusion imaging with cadmium-zinc-telluride detectors allows real-time assessment of dobutamine-stress-induced wall motion abnormalities.

BACKGROUND: Left ventricular (LV) ejection fraction (EF) during high dobutamine stress (HD) by real-time gated-SPECT myocardial perfusion imaging (MPI) on a cadmium-zinc-telluride (CZT) gamma camera was validated versus cardiac magnetic resonance imaging (CMR). METHODS AND RESULTS: After injecting 99mTc-tetrofosmin (320 MBq) in 50 patients (mean age 64 +/- 11 years), EF at rest and post-stress as well as relevant changes in EF at HD (ΔEF ≥ 5%) were assessed. CZT and CMR rest EF values yielded an excellent correlation and agreement (r = 0.96; P < 0.001; Bland-Altman limits of agreement (BA): + 0 to 14.8%). HD EF acquisition was feasible using CZT and correlated better to HD CMR EF than did post-stress CZT EF (r = 0.85 vs 0.76, respectively, all P < 0.001). Agreement in ΔEF detection between HD CMR and immediate post-stress CZT (reflecting standard acquisition using conventional SPECT camera unable to scan during stress) was 45%, while this increased to 85% with real-time HD CZT scan. CONCLUSION: Real-time ultrafast dobutamine gated-SPECT MPI with a CZT device is feasible and provides accurate measurements of HD LV performance.

Role of deferred stenting in patients with ST elevation myocardial infarction treated with primary percutaneous coronary intervention: A systematic review and meta-analysis.

OBJECTIVES: We conducted a meta-analysis of studies comparing deferred stenting strategy versus the conventional approach with immediate stenting in patients with ST elevation myocardial infarction. BACKGROUND: Deferring stent after mechanical flow restoration has been proposed as a strategy to reduce the risk of "no reflow" in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI). Conflicting evidence is available currently, especially after the recent publication of three randomized clinical trials. METHODS: Searches in electronic databases were performed. Comparisons between the two strategies were performed for both hard clinical endpoints (all cause-mortality, cardiovascular mortality, unplanned revascularization, myocardial infarction and readmission for heart failure) and surrogate angiographic endpoints (TIMI flow < 3 and myocardial blush grade (MBG) < 2). RESULTS: Eight studies (three randomized and five non-randomized) were deemed eligible, accounting for a total of 2101 patients. No difference in terms of hard clinical endpoints was observed between deferred and immediate stenting (OR [95% CI]: 0.79 [0.54-1.15], for all-cause mortality; odds ratio (OR) [95% CI]: 0.79 [0.47-1.31] for cardiovascular mortality; OR [95% CI]: 0.95 [0.64-1.41] for myocardial infarction; OR [95% CI]: 1.37 [0.87-2.16], for unplanned revascularization and OR [95% CI]: 0.50 [0.21-1.17] for readmission for heart failure). Notably, the deferred stenting approach was associated with improved outcome of the surrogate angiographic endpoints (OR [95% CI]: 0.43 [0.18-0.99] of TIMI flow < 3 and OR [95% CI]: 0.25 [0.11-0.57] for MBG < 2. CONCLUSIONS: A deferred stenting strategy could be a feasible alternative to the conventional approach with immediate stenting in "selected" STEMI patients undergoing pPCI.

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.

Impact of impaired fractional flow reserve after coronary interventions on outcomes: a systematic review and meta-analysis.

BACKGROUND: FFR is routinely used to guide percutaneous coronary interventions (PCI). Visual assessment of the angiographic result after PCI has limited efficacy. Even when the angiographic result seems satisfactory FFR after a PCI might be useful for identifying patients with a suboptimal interventional result and higher risk for poor clinical outcome who might benefit from additional procedures. The aim of this meta-analysis was to investigate available data of studies that examined clinical outcomes of patients with impaired vs. satisfactory fractional flow reserve (FFR) after percutaneous coronary interventions (PCI). METHODS: This meta-analysis was carried out according to the Cochrane Handbook for Systematic Reviews. The Mantel-Haenszel method using the fixed-effect meta-analysis model was used for combining the results. Studies were identified by searching the literature through mid-January, 2016, using the following search terms: fractional flow reserve, coronary circulation, after, percutaneous coronary intervention, balloon angioplasty, stent implantation, and stenting. Primary endpoint was the rate of major adverse cardiac events (MACE). Secondary endpoints included rates of death, myocardial infarction (MI), repeated revascularisation. RESULTS: Eight relevant studies were found including a total of 1337 patients. Of those, 492 (36.8 %) had an impaired FFR after PCI, and 853 (63.2 %) had a satisfactory FFR after PCI. Odds ratios indicated that a low FFR following PCI was associated with an impaired outcome: major adverse cardiac events (MACE, OR: 4.95, 95 % confidence interval [CI]: 3.39-7.22, p <0.001); death (OR: 3.23, 95 % CI: 1.19-8.76, p = 0.022); myocardial infarction (OR: 13.83, 95 % CI: 4.75-40.24, p <0.0001) and repeated revascularisation (OR: 4.42, 95 % CI: 2.73-7.15, p <0.0001). CONCLUSIONS: Compared to a satisfactory FFR, a persistently low FFR following PCI is associated with a worse clinical outcome. Prospective studies are needed to identify underlying causes, determine an optimal threshold for post-PCI FFR, and clarify whether simple additional procedures can influence the post-PCI FFR and clinical outcome.

The impact of modern noninvasive cardiac imaging on coronary intervention rates.

OBJECTIVES: It remains still unclear whether the use of modern noninvasive diagnostic modalities for evaluation of coronary artery disease (computed tomography coronary angiography (CTCA), nuclear myocardial perfusion imaging (MPI)) were able to change the "diagnostic yield" of invasive coronary angiography (ICA). METHODS: The total number of ICA in the years 2000-2009 was related to the number of percutaneous interventions (PCIs) and we assessed whether there was a significant trend over time using time series analyses. We compared these data with the number of patients undergoing CTCA and nuclear MPI in the same time period. RESULTS: During the 10-year observational period, 23,397 ICA were performed. The proportion of purely diagnostic ICA (without PCI) remained stable over the whole study period (tau = -0.111, P = 0.721). A CTCA program was initiated in 2005 and 1,407 examinations were performed until 2009. Similarly, the number of nuclear MPI increased from 2,284 in the years 2000-2004 to 5,260 in the years 2005-2009 (P = 0.009). CONCLUSION: Despite increasing availability, noninvasive testing modalities did not significantly alter the rate of purely diagnostic ICA, and still are underused as gatekeeper to ICA. Further effort is needed to optimize the use of noninvasive imaging modalities in the work-up process for coronary artery disease.

Haemodynamically irrelevant pericardial effusion is associated with increased mortality in patients with chronic heart failure.

AIMS: Pericardial effusion (PE) is a common finding in cardiac patients with chronic heart failure. The prognostic relevance of a small, haemodynamically non-compromising PE in such patients, however, remains to be determined. METHODS AND RESULTS: All patients referred to our heart failure clinic and having a baseline echocardiography and follow-up clinical visits were included. Patients with a haemodynamically relevant PE, acute myo-/pericarditis, systemic sclerosis, rheumatoid arthritis, heart transplantation, heart surgery within the last 6 months or malignancies within the last 3 years were excluded. Patients with or without a haemodynamically irrelevant PE were compared regarding all-cause mortality as the primary and cardiovascular death or need for heart transplantation as secondary outcomes. A total of 897 patients (824 patients in the control vs. 73 patients in the PE group) were included. In the PE group, left ventricular ejection fraction (LVEF) was lower [31%, interquartile range (IQR): 18.0-45.0] than in controls (34%, IQR: 25.0-47.0; P = 0.04), while the end-systolic diameters of the left ventricle and the left atrium were larger (P = 0.01 and P = 0.001, respectively). Similarly, in patients with PE, the right ventricle (RV) systolic function was lower (P < 0.005 for both the fractional area change and the tricuspid annulus movement), the dimensions of RV and right atrium (RA) were larger (P < 0.05 for RV and P < 0.01 for RA), and the degree of tricuspid regurgitation was higher (P < 0.0001). Furthermore, in the PE group, the heart rate was higher (P < 0.001) and the leukocyte count as well as CRP values were increased (P = 0.004 and P < 0.0001, respectively); beta-blocker use was less frequent (P = 0.04), while spironolactone use was more frequent (P = 0.03). The overall survival was reduced in the PE group compared with controls (P = 0.02). Patients with PE were more likely to suffer cardiovascular death (1-year estimated event-free survival: 86 ± 5 vs. 95 ± 1%; P = 0.01) and to require heart transplantation (1-year estimated event-free survival: 88 ± 4 vs. 95 ± 1%; P = 0.009). A multivariate Cox proportional hazard model revealed the following independent predictors of mortality: (a) PE (P = 0.04, hazard ratio (HR): 1.95, 95% confidence interval (CI): 1.0-3.7), (b) age (P = 0.04, HR: 1.02, 95% CI: 1.0-1.04) and (c) LVEF <35% (P = 0.03, HR: 1.7, 95% CI: 1.1-2.8). CONCLUSION: In chronic heart failure, even minor PEs are associated with an increased risk of all-cause mortality, cardiac death, and need for transplantation.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

OBJECTIVES: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. METHODS: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. RESULTS: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. CONCLUSIONS: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

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 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.

A fully automated artificial intelligence-driven software for planning of transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly performed for the treatment of aortic stenosis. Computed tomography (CT) analysis is essential for pre-procedural planning. Currently available software packages for TAVR planning require substantial human interaction. We describe development and validation of an artificial intelligence (AI) powered software to automatically rend anatomical measurements and other information required for TAVR planning and implantation. METHODS: Automated measurements from 100 CTs were compared to measurements from three expert clinicians and TAVR operators using commercially available software packages. Correlation coefficients and mean differences were calculated to assess precision and accuracy. RESULTS: AI-generated annular measurements had excellent agreements with manual measurements by expert operators yielding correlation coefficients of 0.97 for both perimeter and area. There was no relevant bias with a mean difference of -0.07 mm and - 1.4 mm2 for perimeter and area, respectively. For the ascending aorta measured 5 cm above the annular plane, correlation coefficient was 0.95 and mean difference was 1.4 mm. Instruction for use-based sizing yielded agreement with the effective implant size in 87-88 % of patients for self-expanding valves (perimeter-based sizing) and in 88 % for balloon-expandable valves (area-based sizing). CONCLUSIONS: A fully automated software enables accurate and precise anatomical segmentation and measurements required for TAVR planning without human interaction and with high reliability.