Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial.

BACKGROUND: Computed tomography (CT) is recommended for guiding transcatheter aortic valve replacement (TAVR). However, a sizable proportion of TAVR candidates have chronic kidney disease, in whom the use of iodinated contrast media is a limitation. Cardiac magnetic resonance imaging (CMR) is a promising alternative, but randomized data comparing the effectiveness of CMR-guided versus CT-guided TAVR are lacking. METHODS: An investigator-initiated, prospective, randomized, open-label, noninferiority trial was conducted at 2 Austrian heart centers. Patients evaluated for TAVR according to the inclusion criteria (severe symptomatic aortic stenosis) and exclusion criteria (contraindication to CMR, CT, or TAVR, a life expectancy <1 year, or chronic kidney disease level 4 or 5) were randomized (1:1) to undergo CMR or CT guiding. The primary outcome was defined according to the Valve Academic Research Consortium-2 definition of implantation success at discharge, including absence of procedural mortality, correct positioning of a single prosthetic valve, and proper prosthetic valve performance. Noninferiority was assessed using a hybrid modified intention-to-treat/per-protocol approach on the basis of an absolute risk difference margin of 9%. RESULTS: Between September 11, 2017, and December 16, 2022, 380 candidates for TAVR were randomized to CMR-guided (191 patients) or CT-guided (189 patients) TAVR planning. Of these, 138 patients (72.3%) in the CMR-guided group and 129 patients (68.3%) in the CT-guided group eventually underwent TAVR (modified intention-to-treat cohort). Of these 267, 19 patients had protocol deviations, resulting in a per-protocol cohort of 248 patients (121 CMR-guided, 127 CT-guided). In the modified intention-to-treat cohort, implantation success was achieved in 129 patients (93.5%) in the CMR group and in 117 patients (90.7%) in the CT group (between-group difference, 2.8% [90% CI, -2.7% to 8.2%]; P<0.01 for noninferiority). In the per-protocol cohort (n=248), the between-group difference was 2.0% (90% CI, -3.8% to 7.8%; P<0.01 for noninferiority). CONCLUSIONS: CMR-guided TAVR was noninferior to CT-guided TAVR in terms of device implantation success. CMR can therefore be considered as an alternative for TAVR planning. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03831087.

Long-term outcomes after echocardiography versus fluoroscopy-guided left atrial appendage closure: Is there still a role for a simplified approach?

BACKGROUND: Left atrial appendage closure (LAAC) represents an alternative to oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation (AF). While transoesophageal echocardiography is the current standard for guiding LAAC procedures, several centers have employed fluoroscopic guidance alone. However, data on long-term outcomes are lacking. METHODS: A total of 536 patients with AF undergoing LAAC and with available data on long-term follow-up were included in the retrospective, single-center analysis. Outcomes of patients undergoing fluoroscopy-guided LAAC were compared with those undergoing echocardiography guided LAAC. Time-dependent analysis was performed with the Kaplan-Meier method. RESULTS: A total of 234 (44%) and 302 (56%) patients were treated with echocardiography and fluoroscopy guidance, respectively. Baseline characteristics did not differ between the two groups. Procedural success rates were high in both groups (97% of fluoroscopy vs. 98% of echocardiography guided procedures; p = 0.92) and rates of relevant peri-device leaks (p = 0.50) and device-related thrombus formation (p = 0.22) did not differ between groups. Median clinical follow-up time was 48 (IQR 19-73) months. Rates of all-cause mortality (p = 0.15, HR 0.83, CI 0.64-1.07) and stroke (p = 0.076, HR 2.23, CI 0.90-5.54) were comparable among groups. CONCLUSION: LAAC with fluoroscopy guidance alone is equally safe and leads to similar clinical outcome compared to LAAC with additional echocardiography guidance.

Percutaneous closure of a patent foramen ovale causing exercise hypoxemia: Case report and a review of the literature.

Provoked exercise desaturation is a rare presentation of patent foramen ovale (PFO), when vigorous exercise leads to desaturation of arterial blood and subsequent dyspnea. We present a case of provoked exercise desaturation and curative percutaneous closure and review the literature. A 54-year-old male patient presented with shortness of breath during exercise in the pneumology outpatient department. During exercise spirometry, a relevant drop in arterial oxygen saturation and partial pressure of oxygen was observed and a right-left shunt suspected. In a transesophageal echocardiogram, a PFO was observed. Cardiac catheterization documented a right-left-shunt causing desaturation during exercise. Following percutaneous closure of the PFO, exercise induced desaturation was no longer detectable during exercise spirometry and there was considerable improvement in exercise capacity and subjective dyspnea. To sum up, provoked exercise desaturation is a rare but curable presentation of PFO. Percutaneous closure is a safe and effective way to treat this entity.

Intracardiac versus transesophageal echocardiography for left atrial appendage occlusion with watchman.

BACKGROUND: Left atrial appendage occlusion (LAAO) is mostly performed by transesophageal echocardiography (TEE) guidance. Intracardiac echocardiography (ICE) may be an alternative imaging modality for LAAO that precludes the need for general anesthesia or sedation. METHODS AND RESULTS: All consecutive single center, single operator LAAO candidates were analyzed. Baseline clinical and procedural characteristics and in-hospital outcomes were compared between patients in whom a Watchman was implanted with ICE vs. TEE guidance. In 76 consecutive patients the Watchman device was deployed under ICE in 32 patients (42%) and under TEE guidance in 44 patients (58%). Baseline characteristics were comparable between groups, except that patients in the TEE group were older (81 [75-85] years vs. 75 [68-80] years, P = 0.007). Total injected contrast media as well as fluoroscopy time were comparable between groups (90 ml [54-140] vs. 85 ml [80-110], P = 0.86 and 7.9 min [6.4-15.5] vs. 9.8 min [7.0-13.2], P = 0.51, for TEE vs. ICE, respectively). However, time from femoral venous puncture to transseptal puncture and to closure was longer in the ICE group (14 min [7.3-20] vs. 6 min [3.3-11], P = 0.007 and 48 min [40-60] vs. 34.5 min [27-44], P = 0.003, respectively). In the TEE group one patient suffered esophageal erosion with bleeding, which was managed conservatively and one non-LAAO related in-hospital mortality occurred in an 88-year-old patient. Device implantation success rate was 100% in both groups. No device embolization, no significant peri-device leak, no tamponade, no stroke, and no access site bleeding occurred in any patient. Total hospital stay for stand-alone LAAO was comparable between groups (2 days [2-2] vs. 2 days [2-3.3], P = 0.17, in ICE vs. TEE, respectively). CONCLUSIONS: ICE guidance for LAAO with the Watchman device is feasible and comparable to TEE and may become the preferred imaging modality for LAAO. © 2016 Wiley Periodicals, Inc.

Multi-vessel revascularization in ST-segment elevation myocardial infarction: where do we stand?

In summary, current evidence suggests that it appears to be better to do something rather than nothing. However, the question of single vs. staged complete revascularization, the best timing of the staged PCI (during the index admission or within weeks) and the question of stratification for evidence of ischaemia remain to be answered in upcoming trials. Meanwhile, complete revascularization should not be routinely performed ad-hoc, but based on individual and careful patient and lesion assessments

Transcatheter aortic-valve implantation with one single minimal contrast media injection.

OBJECTIVES: Performing transcatheter aortic valve implantation (TAVI) with the use of minimal contrast in patients at high-risk for acute kidney injury (AKI). BACKGROUND: Contrast-induced nephropathy (CIN) is a major cause of AKI following TAVI and is associated with increased morbidity and mortality. The amount of contrast media used increases the risk for CIN. METHODS: Computed tomography was omitted during the screening process. For the procedure transfemoral access was default. The self-expanding CoreValve prosthesis was chosen in all patients to minimize the risk of annular rupture in case of oversizing. Valve sizing was based on echocardiography, aortography, calcification on fluoroscopy, as well as weight and height of the patient. A single contrast injection was performed to confirm correct position of the pigtail catheter at the level of the annulus. The pigtail then served as the marker for the device landing zone. Intraprocedural assessment of the implantation result relied on echocardiography and hemodynamics. RESULTS: Five patients with severe aortic stenosis and at high risk for developing CIN were included. Device success was achieved in all patients and no major complications occurred. The median dose of injected contrast media was 8 ml (4-9). All but one patient had improved renal function after the intervention compared to baseline. CONCLUSIONS: Our study shows feasibility of performing TAVI with a single minimal contrast media injection, using a self-expandable valve. This technique has the potential to reduce the incidence of CIN.

N-terminal pro-B-type natriuretic peptide-ratio predicts mortality after transcatheter aortic valve replacement.

OBJECTIVES: We studied the prognostic value of plasma N-terminal pro-brain natriuretic peptide (NT-proBNP)-ratio, which is independent of individual cutoff levels, in predicting mortality in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Elevated levels of natriuretic peptides are associated with adverse outcomes across a wide spectrum of cardiovascular diseases. However, cutoff values differ according to age, gender, and body weight. METHODS: 244 TAVR patients with preprocedural NT-proBNP levels were analyzed, and the predictive value of NT-proBNP-ratio (measured NT-proBNP/maximal normal NT-proBNP values specific for age and gender) on all-cause-mortality was assessed in a multivariate model. RESULTS: Median NT-proBNP-ratio was 4.2 [IQR 1.8-9.7]. All-cause mortality at 30 days was 3.4% in patients with less than median NT-proBNP-ratio, and 14.0% in patients with more than median NT-proBNP-ratio (P=0.02). All-cause mortality at 1 year was 8.5% in patients with less than median NT-proBNP-ratio, and 32.1% in those with more than median NT-proBNP-ratio (P=0.001). Cumulative survival declined with increasing quartiles of NT-proBNP-ratio (log rank P=0.001). All patients with a NT-proBNP-ratio below 1.5 survived at 1-year follow-up. In ROC analysis, NT-proBNP-ratio significantly predicted 30-day (AUC=0.72; P=0.002) and 1-year all-cause mortality (AUC=0.72; P<0.001). By multivariate Cox regression analysis, NT-proBNP-ratio, chronic obstructive pulmonary disease, and serum creatinine were the only independent predictors of all-cause mortality. CONCLUSIONS: Elevated NT-proBNP-ratio was associated with increased short- and long-term mortality after TAVR, and independently predicted all-cause mortality. NT-proBNP-ratio should be considered in the risk stratification of patients undergoing TAVR.

Prevalence and impact of preoperative moderate/severe tricuspid regurgitation on patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: Significant tricuspid regurgitation (TR) is a marker for late-stage myocardial and valvular heart disease. Whether preoperative TR affects clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) has never been investigated. This study sought to identify the impact of moderate and severe TR on outcomes after TAVR. METHODS: All patients undergoing TAVR from January 2007 to August 2012 at St. Paul's Hospital, Vancouver, Canada, (n = 518) were dichotomized according to the severity of preoperative TR (moderate/severe vs. none/mild). All clinical outcomes were defined according to the valve academic research consortium-2 definitions. RESULTS: At baseline, moderate or severe TR was reported in 79 patients (15.2%). At 30 days, moderate/severe TR had improved in 12 patients (15.2%), was unchanged in 46 patients (58.3%), and worsened in 7 patients (8.9%). Of those with none/mild TR at baseline, 35 (7.9%) patients had moderate TR at 30-day follow-up. Two-year all-cause (38.4% vs. 20.0%, Log-rank test, P = 0.001) and cardiac mortality (12.9% vs. 4.6%, Log-rank test, P = 0.004) as estimated by Kaplan-Meier analysis were considerably higher in patients with significant TR. However, significant TR did not emerge as independent risk factor for 2-year all-cause mortality (adjusted OR: 1.55, 95% confidence interval (CI): 0.91-2.64, P = 0.105). Pre-specified subgroups showed an interaction between TR and left ventricular systolic function (Pinteraction = 0.047). Indeed, moderate/severe TR was significantly related to mortality only in patients with left ventricular ejection fraction (LVEF) > 40% (adjusted OR: 2.01, CI: 1.05-3.84, P = 0.036). In patients with LVEF ≤ 40%, TR had no significant impact on all-cause mortality (adjusted OR: 1.04, CI: 0.34-3.16, P = 0.946). No significant interactions were identified regarding patients with perioperative moderate/severe mitral regurgitation (Pinteraction = 0.829) and patients with baseline systolic pulmonary artery pressure ≥ 60 mm Hg (Pinteraction = 0.669). CONCLUSIONS: In patients undergoing TAVR, significant preoperative TR was present in 15% of patients and associated with more comorbidities. Despite being associated with a doubling of mortality rate, after a robust adjustment, significant TR was not an independent predictor of 2-year mortality. However, a significant interaction between TR and left ventricular systolic function was found. The response of TR to TAVR was extremely variable.

Prosthesis-Specific Predictors of Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Impact of Calcification and Sizing on Balloon-Expandable versus Self-Expandable Transcatheter Heart Valves.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate prosthesis-specific predictors for paravalvular aortic regurgitation (PAR) in self-expandable versus balloon-expandable transcatheter heart valves (THVs). PAR is frequently observed after transcatheter aortic valve replacement (TAVR). As self-expandable and balloon-expandable THVs engage differently with the native aortic valve structures, factors that impact PAR may differ between the prosthesis types. METHODS: A total of 137 TAVR patients who underwent pre-procedural multidetector computed tomography and post-procedural transthoracic echocardiography were studied. Predictors for PAR, including annulus area oversizing and aortic valve calcification mass and volume, were analyzed in a multivariate model. RESULTS: The Medtronic CoreValve (MCV) prosthesis was utilized in 68 patients (50%), and the Edwards SAPIEN (ES) prosthesis in 69 (50%). More than mild PAR was observed in 43 patients (32%). Among MCV patients, aortic valve calcification volume and mass were higher in those with more than mild PAR than in those with none or mild PAR (p = 0.04, p = 0.03, respectively). Among ES patients, the annulus area and perimeter oversizing were lower in those with more than mild PAR compared to those with no or mild PAR (p = 0.001). By univariate and multivariate logistic regression analysis, aortic valve calcification mass was the only independent predictor for PAR in MCV patients (p = 0.02), whereas in ES patients it was THV undersizing (p = 0.002), irrespective of the calcific burden. CONCLUSION: For self-expandable THVs, aortic valve calcification mass was the strongest predictor of PAR, whereas for balloon-expandable THVs it was prosthesis undersizing. Hence, in patients evaluated for TAVR these parameters should guide the selection of prosthesis type.

Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Aortic root rupture is a major concern with balloon-expandable transcatheter aortic valve replacement (TAVR). We sought to identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography. METHODS AND RESULTS: Thirty-one consecutive patients who experienced left ventricular outflow tract (LVOT)/annular/aortic contained/noncontained rupture during TAVR were collected from 16 centers. A caliper-matched sample of 31 consecutive patients without annular rupture, who underwent pre-TAVR multidetector computed tomography served as a control group. Multidetector computed tomography assessment included short- and long-axis diameters and cross-sectional area of the sinotubular junction, annulus, and LVOT, and the presence, location, and extent of calcification of the LVOT, as well. There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of ≥20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23-36.91; P<0.001) and prosthesis oversizing ≥20% (odds ratio, 8.38; 95% confidence interval, 2.67-26.33; P<0.001) were associated with aortic root contained/noncontained rupture. CONCLUSIONS: This study demonstrates that LVOT calcification and aggressive annular area oversizing are associated with an increased risk of aortic root rupture during TAVR with balloon-expandable prostheses. Larger studies are warranted to confirm these findings.

Left main dissection conservatively managed with optical coherence tomography guidance.

Left main dissection (LMD) is a rare but feared complication of cardiac catheterization. It is usually managed by bailout stent implantation or coronary artery bypass surgery. We describe a case of iatrogenic, retrograde LMD during percutaneous coronary intervention. After covering the retrograde entry of the dissection in the ostial left anterior descending artery (LAD), optical coherence tomography (OCT) showed, that there was no antegrade entry in the left main and that the minimal true lumen area in the left main was 7.2 mm(2) . It was therefore decided to treat the LMD conservatively and reassess the results by angiography 6 months later. At follow-up angiography, no stenosis or residual dissection in the left main were noted. The patient was doing fine at 1-year follow-up. OCT is a valuable tool for assessing coronary artery dissections and may guide the decision, whether to stent or not to stent a dissection. In selected cases LMD may be managed conservatively.

Blood loss and transfusion rates associated with transcatheter aortic valve replacement: recommendations for patients who refuse blood transfusion.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is less invasive than surgical aortic valve replacement and may be preferred for patients who refuse blood transfusions. OBJECTIVES: Our study sought to define transfusion rates in TAVR, identify predictors and develop recommendations for patients who refuse transfusions. METHODS: A large cohort of consecutive patients undergoing TAVR was prospectively studied. Blood loss and transfusion rates were observed in patients undergoing transfemoral (TF-TAVR) and transapical TAVR (TA-TAVR). Predictors for transfusion were investigated in a multivariate model. RESULTS: Of 373 consecutive patients, 270 underwent TF-TAVR and 103 TA-TAVR. Transfusion rates were significantly lower in TF-TAVR than TA-TAVR (11.1 vs 41.7%; P < 0.001). In patients who did not receive transfusions, blood loss was significantly lower in TF-TAVR than TA-TAVR (23.6 ± 12.2 g/l vs 28.9 ± 13.7 g/l; P = 0.004), but did not differ in transfused patients (36.9 ± 12.9 g/l vs 33.4 ± 21.2 g/l; P = 0.428). Predictors for transfusions were low baseline hemoglobin, female sex, low body weight and decreased renal function. In seven Jehovah's Witness patients, who refused transfusions, no vascular complications occurred and clinical outcome was excellent. CONCLUSION: In patients, who refuse transfusions, TAVR may be performed with good clinical outcomes provided a high baseline hemoglobin level, careful management of the access site and strict measurements to reduce blood loss. TF-TAVR is associated with less blood loss and a lower rate of transfusions than TA-TAVR, and may be the preferred option for patients, who refuse transfusions.