Safety, Efficacy, and Cost-Effectiveness of Same-Day Discharge for Left Atrial Appendage Occlusion.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is FDA approved for stroke prevention in patients with nonvalvular atrial fibrillation who have an appropriate indication. During the COVID-19 pandemic, a same-day discharge protocol (SDDP) was employed to improve resource utilization, relieve hospital occupation, and reduce the possible risk of in-hospital virus transmission. OBJECTIVES: We sought to analyze the safety, feasibility, and cost effectiveness for SDDP in patients receiving LAAO. METHODS: A prospective analysis of 142 consecutive patients, 119 treated prior to SDDP and 23 who underwent SDDP following LAAO with cardiac computed tomography angiography (CTA)-guided pre-procedural planning and intracardiac echocardiogram (ICE). Procedures were performed in a single, large academic hospital in the United States. In-hospital and 45-day procedural success, adverse events, length of procedure, and length-of-stay were evaluated. RESULTS: Baseline patient characteristics including mean CHA2DS2VASc scores and mean HAS-BLED scores were similar in both groups. All procedures were successful. There was no significant difference in rates of procedural complications or in-hospital adverse events. The mean procedure time in the SDDP group was 11 minutes longer than in the conventional group (62.1 ± 5.9 vs 51.1 ± 21; P=.01). Outcomes at 45-day follow-up were similar. SDDP was associated with a reduced length of stay compared with conventional strategy and a 15% reduction in total costs. CONCLUSIONS: Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA pre-procedural planning, ICE-guided deployment and conscious sedation reduces hospital occupation and lowers costs.

Low dose contrast CT for transcatheter aortic valve replacement assessment: Results from the prospective SPECTACULAR study (spectral CT assessment prior to TAVR).

BACKGROUND: Computed tomographic angiography (CTA) based planning for transcatheter aortic valve replacement (TAVR) is essential for reduction of periprocedural complications. Spectral CT based imaging provides several advantages, including better contrast/signal to noise ratio and increased soft tissue contrast, permitting better delineation of contrast filled structures at lower doses of iodinated contrast media. The aim of this prospective study was to assess the initial feasibility of a low dose iodinated contrast protocol, utilizing monoenergetic 40 keV reconstruction, using a dual-layer CT scanner (DLCT) for CTA in patients undergoing TAVR planning. METHODS: 116 consecutive TAVR patients underwent a gated chest and a non-gated CTA of the abdomen and pelvis. 40 keV virtual monoenergetic images (VMI) were reconstructed and compared with conventional polychromatic images (CI). The proximal aorta and access vessels were scored for image quality by independent experienced cardiovascular imagers. RESULTS: Proximal aortic image quality as assessed by signal to noise (SNR) and contrast to noise ratio (CNR), were significantly better with 40 keV VMI relative to CI (SNR 14.65 ±â€¯7.37 vs 44.16 ±â€¯22.39, p < 0.001; CNR 15.84 ±â€¯9.93 vs 59.8 ±â€¯40.83, p < 0.001). Aortic root dimensions were comparable between the two approaches with a bias towards higher measurements at 40 keV (Bland Altman). SNR and CNR in all access vessel segments at 40 keV were substantially better (p < 0.001 for all peripheral access vessel segments) with comparable image quality. CONCLUSION: 40 keV VMI with low dose contrast dose spectral imaging is feasible for comprehensive preprocedural evaluation of access vessels and measurements of aortic root dimensions in patients undergoing TAVR.

In-hospital outcomes of transcatheter versus surgical aortic valve replacement in end stage renal disease.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at intermediate and high risk for surgery. Commercial use of TAVR has expanded to patients with end stage renal disease (ESRD). OBJECTIVES: Compare in-hospital outcomes of TAVR versus SAVR in ESRD patients requiring hemodialysis (HD). METHODS: ESRD patients on HD undergoing TAVR (n = 328) or SAVR (n = 697) between 2012 and 2014 were identified in the National Inpatient Sample (NIS). Propensity-score matching method was used to minimize selection bias. Baseline characteristics and in-hospital outcomes were compared. RESULTS: TAVR patients were older (75.3 vs. 61.6 years, P < 0.001) and had more comorbidities, including congestive heart failure (16.2% vs. 7.5%), diabetes mellitus (28.4% vs. 22.5%), chronic lung disease (27.7% vs. 20.4%), and peripheral vascular disease (35.1% vs. 21.2%). Propensity-score matching yielded 175 pairs of patients matched on 30 baseline covariates. Overall in-hospital mortality was high (9.9%) and similar between TAVR and SAVR (8% vs. 10.3%, P = 0.58). TAVR was associated with shorter length of stay (LOS) (8 vs. 14 days, P < 0.001), lower hospitalization cost ($276,448 vs. $364,280, P = 0.01), lower in-hospital complications (60.6% vs. 76%, P = 0.003), and higher rate of home discharge (31.4% vs. 17.7%, P = 0.004) compared with SAVR. CONCLUSIONS: Regardless of treatment modality, patients with AS on HD have high in-hospital mortality. TAVR and SAVR have comparable in-hospital mortality in this population. However, TAVR is associated with shorter LOS, lower hospitalization costs, lower in-hospital complications, and higher rates of home discharge.

Transcatheter Replacement of Failed Bioprosthetic Valves: Large Multicenter Assessment of the Effect of Implantation Depth on Hemodynamics After Aortic Valve-in-Valve.

BACKGROUND: Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV. METHODS AND RESULTS: Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P=0.03 and Sapien XT, 18.5% versus 43.5%; P=0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0-10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1-0.52; P=0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28-0.88; P=0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002). CONCLUSIONS: High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV.

Optical coherence tomography assessment of in-stent restenosis after percutaneous coronary intervention with two-stent technique in unprotected left main.

BACKGROUND: Optical coherence tomography (OCT) has contributed to a better understanding of in-stent restenosis (ISR); however, studies evaluating ISR pattern after two-stent technique in unprotected left main (ULM) are lacking. We aim to evaluate the ISR pattern of proximal LAD and LCX after two-stent technique in ULM. METHODS: We performed OCT in 26 patients with isolated or combined ISR (identified by angiography as >50%) after two stent implantation in the proximal LCX and LAD. Finally, 13 LAD and 22 LCX ISR lesions underwent OCT assessments. OCT analyses were undertaken in the proximal segments of the LAD and LCX. In addition, we compared OCT findings in the flow divider (FD) and lateral wall (LW). RESULTS: In both the LAD and LCX, the distance from the ostium to the minimum lumen area (MLA; LAD, 2.00mm [1.00, 3.00]; LCX, 1.00mm [0.00, 1.80] distal to ostium) was short. Uncovered struts were more common on the FD side compared with the LW in the LAD (6.25% [0.00, 20.00] vs 0.00% [0.00, 0.00], respectively, p=0.016) and LCX (11.32% [0.00, 19.44] vs 0.00% [0.00, 4.55], respectively, p<0.001). Conversely, neointimal hyperplasia (NIH) was significantly thicker on the FD side compared with the LW in the LCX (0.31mm [0.19, 0.47] vs 0.15mm [0.09, 0.31], p<0.001). CONCLUSIONS: While uncovered struts were more commonly found on the FD side of both arteries, NIH was significantly thicker on the FD side compared with the LW in the LCX. These unique findings might indicate inferior outcomes after two-stent techniques in ULM bifurcation lesions.

Cardiac computed tomography assessment of the near term impact of percutaneous ventricular restoration therapy (parachute(®) ) on mitral valve geometry.

OBJECTIVES: The aim of current study is to assess the near term impact of percutaneous ventricular restoration therapy (PVR), Parachute(®) on mitral valve (MV) geometry by cardiac computed tomography (CCT). BACKGROUND: Recent data demonstrates the feasibility of PVR for treatment of post anterior myocardial infarction (MI) heart failure. Little is known, however, about the interaction of the device and left ventricular structures, particularly the MV apparatus. METHODS: This is a retrospective Core Laboratory analysis of Parachute Trials' CCT data. Patients with paired (before and after Parachute implant) CCT acquisitions were included into analysis. MV geometric parameters were measured. RESULTS: Thirty-three patients were included in the analysis. The mean time of follow-up CCT post procedure was 188 ± 52 days. There were significant reduction in tenting height (A1P1: -1.70 ± 1.89 mm, -17.40 ± 20.20%; A2P2: -1.43 ± 1.89 mm, -12.10 ± 15.00%; A3P3: -1.54 ± 1.58 mm, -15.50 ± 15.20%, P < 0.001), tenting volume (-0.93 ± 0.60 mm3, -22.00 ± 11.40%, P < 0.001), systolic interpapillary muscle distance (-2.22 ± 2.11 mm, -7.51 ± 7.23%, P < 0.001) and diastolic interpapillary muscle distance (-3.14 ± 2.20 mm, -8.46 ± 5.73%, P < 0.001) post PVR. CONCLUSIONS: In post anterior MI heart failure patients, PVR has favorable near term impact on MV geometry as assessed by CCT. © 2015 Wiley Periodicals, Inc.

Comparison of Outcomes of Transfemoral Transcatheter Aortic Valve Implantation Using a Minimally Invasive Versus Conventional Strategy.

Some centers, mostly in Europe, have demonstrated the feasibility of a minimally invasive strategy (MIS; i.e., local anesthesia and conscious sedation, performed in the cath laboratory without transesophageal echocardiography guidance). Nonetheless, the experience of MIS for TAVI using both commercially available valves is lacking in the United States. We, therefore, retrospectively studied all transfemoral TAVI cases performed at our institution between March 2011 and November 2014 to assess the safety and efficacy of MIS. Patients were dichotomized according to the strategy (MIS vs conventional strategy [CS]) used for the procedure. One hundred sixteen patients were included in the MIS group and 91 patients were included in the CS group. Baseline characteristics were similar, and procedural success was comparable (99.1% in MIS and 98.9% in CS, p = 1). One intraprocedural death occurred in each group, whereas conversion rates to general anesthesia were low (3.4%). Comparable device success was obtained. Rates of complications and >mild paravalvular leak before discharge were low and comparable. Length of hospital stay was significantly reduced in the MIS (median, 3.0 [2.0 to 5.0] days) compared with than that in CS group (median 6.0 days [3.5, 8.0]). At a median follow-up of 230 days, no significant difference in survival rate was detected (89% vs 88%, p = 0.9). On average, MIS was associated with remarkable cost saving compared with CS ($16,000/case). In conclusion, TAVI through MIS was associated with a shorter postprocedural hospital stay, lower costs, and similar safety profile while keeping procedural efficacy compared with CS.

Intravascular frequency-domain optical coherence tomography assessment of carotid artery disease in symptomatic and asymptomatic patients.

OBJECTIVES: The goal of this study was to investigate carotid plaque characteristics in symptomatic versus asymptomatic patients with the use of nonocclusive optical coherence tomography (OCT). BACKGROUND: The identification of asymptomatic patients with carotid disease who are at risk of stroke remains a challenge. There is an increasing awareness that plaque characteristics may best risk-stratify this population. We hypothesized that OCT, a new high-resolution (∼ 10 µm) imaging modality, might be useful for the identification of low-risk versus high-risk carotid plaque features and help us to understand the relationship between carotid diameter stenosis and plaque morphology to ischemic stroke. METHODS: Fifty-three patients undergoing diagnostic carotid angiography were studied with OCT. Data analysis was carried out by imaging experts who were unaware of the clinical characteristics of the study population. RESULTS: Plaque with American Heart Association type VI complicated features was more common in symptomatic than asymptomatic patients (74.1% vs. 36.4%, p = 0.02). This was largely driven by differences in the incidence of thin-cap fibroatheroma with rupture (40.7% vs. 13.6%, p = 0.056) and thrombus (67.7% vs. 36.4%, p = 0.034). Conversely, non-type VI plaques were more common in asymptomatic than symptomatic patients (63.6% vs. 25.9%, p = 0.02). No association between the degree of stenosis and plaque morphology was identified. CONCLUSIONS: This retrospective analysis of carotid OCT data supports the hypothesis that the evaluation of carotid plaque characteristics with this high-resolution imaging technique has the potential to alter the understanding and treatment of carotid artery disease.

Serial assessment of vessel interactions after drug-eluting stent implantation in unprotected distal left main coronary artery disease using frequency-domain optical coherence tomography.

OBJECTIVES: This study sought to assess stent-vessel interactions after drug-eluting stent (DES) implantation in unprotected left main coronary artery (ULM) by frequency-domain optical coherence tomography (FD-OCT). BACKGROUND: Percutaneous coronary intervention using DES in ULM has been increasingly performed in routine practice. Recently, FD-OCT assessments of DES-vessel interactions have been used as surrogates for DES safety; however, there are no FD-OCT studies in ULM. METHODS: We prospectively enrolled 33 consecutive patients with ULM disease treated with sirolimus- (n = 11) and everolimus-eluting stents (n = 22). FD-OCT assessments were performed post-percutaneous coronary intervention and at 9-month follow-up. Three different segments of ULM were compared: distal (DIS), bifurcation (BIF), and ostial-body (BODY). The primary endpoints were percentages of uncovered and malapposed struts at 9-month follow-up, and the secondary endpoint was neointimal hyperplasia area. RESULTS: We analyzed 25,873 stent struts. Significant differences were demonstrated for percentage of uncovered struts (3.4%, 11.7%, and 18.7%, respectively for DIS, BIF, and BODY; p < 0.05 for all the comparisons). Malapposition was also more common in BODY (5.3%) than in DIS (0.6%) and BIF (2.0%) segments (p < 0.05 for BODY vs. DIS, and BODY vs. BIF). Equivalent neointimal hyperplasia areas were demonstrated in all segments. Acute malapposition rates led to different patterns of DES-vessel interactions at 9-month follow-up. CONCLUSIONS: Distinct patterns of DES-vessel interactions were demonstrated in different segments of ULM. Acute stent strut malapposition affects these findings.

Serial assessment by optical coherence tomography of early and late vascular responses after implantation of an absorbable-coating Sirolimus-Eluting stent (from the first-in-human DESSOLVE I trial).

The initial enthusiasm caused by the potent antirestenotic effect of early generation drug-eluting stents was recently plagued by concerns regarding their safety profile. Investigators worldwide were stimulated, therefore, to seek for improvement in drug-eluting stent technology, such as eliminating their permanent polymer blamed for vascular inflammation and delayed healing. Optical coherence tomography (OCT) assessments of stent-vessel interactions are used as a surrogate for vessel healing after DES implantation. Herewith, we report serial OCT assessments of vascular reactions to the implantation of a novel absorbable polymer sirolimus-eluting stent (MiStent). In total, 30 patients were included. At 4-, 6-, and 8-month follow-up, different groups of 10 patients underwent OCT imaging, whereas all the patients had OCT assessments scheduled at 18-month follow-up. A total of 13,569 stent struts were analyzed. Low rates of uncovered (14.34 ± 15.35%, 6.62 ± 10.93%, 3.51 ± 2.87%, and 0.84 ± 1.15%, respectively, p <0.05 for 8- vs 18-month follow-up) and malapposed (3.74 ± 7.35%, 3.15 ± 6.13%, 0.48 ± 0.56%, and 0.09 ± 0.28%, respectively, p = NS) stent struts coupled with thin and increasingly homogenous neointimal proliferation were demonstrated. Neointimal area increased from 4- to 8-month follow-up (0.46 ± 0.29 and 1.12 ± 0.73 mm(2), respectively, p <0.05), whereas no "late catch up" was demonstrated at 18-month follow-up (1.28 ± 0.66 mm(2), p = NS vs 8-month follow-up). Early tissue maturation and reduction of low signal intensity tissue covering stent struts (8.8%, 3.1%, 0.3%, and 0%, respectively, p <0.05 for 4- vs 8-month follow-up comparison) were revealed by optical density analysis. In addition, high rates of strut coverage overlying the ostia of side branches without proliferative pattern were demonstrated. In conclusion, this comprehensive OCT analysis depicted favorable absorbable polymer sirolimus-eluting stent-vessel interactions up to 18-month follow-up.

Frequency-domain optical coherence tomography assessment of unprotected left main coronary artery disease-a comparison with intravascular ultrasound.

OBJECTIVES: To investigate safety and feasibility of imaging unprotected left main (ULM) using frequency-domain optical coherence tomography (FD-OCT) compared with intravascular ultrasound (IVUS). BACKGROUND: IVUS has been used to assess and guide percutaneous coronary intervention (PCI) of ULM disease. FD-OCT offers 10-fold higher axial resolution than IVUS and its high-speed image acquisition obviates the need for proximal balloon occlusion. METHODS: We prospectively enrolled 35 consecutive patients with ULM disease. FD-OCT and IVUS assessments were attempted pre- and post-PCI and compared in regards to safety, ability to image the region of interest (ROI), number of pullbacks, volume of contrast and ability to detect malapposition, dissection, and thrombus. RESULTS: Patients were followed for 1 year when FD-OCT imaging was repeated. FD-OCT required more repeated pullbacks to image the ROI compared to IVUS. Mean lumen and stent areas were similar between FD-OCT and IVUS (11.24 ± 2.66 vs. 10.85 ± 2.47 mm(2) , P = 0.13 and 10.44 ± 2.33 vs. 10.49 ± 2.32 mm(2) , P = 0.82, respectively), whereas imaged stent length was shorter with FD-OCT. Malapposition areas and volumes were larger and more edge dissections were detected by FD-OCT. There were no clinical adverse events and no complications associated with FD-OCT at baseline and 1-year follow-up. All dissections were healed, whereas stent malapposition was still detected at follow-up. CONCLUSIONS: FD-OCT assessment of ULM is feasible and safe. Direct comparisons with IVUS reveal that FD-OCT achieved imaging completeness less often, whereas it was more sensitive in detecting malapposition and edge dissections, and similar to IVUS in the assessment of lumen and stent dimensions.

Frequency-domain optical coherence tomography assessment of very late vascular response after carotid stent implantation.

Intravascular optical coherence tomography is a high-resolution invasive imaging modality that allows the evaluation of vascular responses after stent implantation in a micron-scale level. We describe for the first time two patients with very late vascular response after carotid artery stenting that exhibit two different patterns of low-signal intensity (LSI), "ill-appearing" neointima: the first patient shows layered LSI neointima leading to stent restenosis, coupled with the presence of intraluminal thrombus, whereas the second patient demonstrates another pattern of non-restenotic LSI stent strut coverage, suggestive of lipid laden neointima (ie, "neoatherosclerosis"), recently associated with stent failure in coronary arteries.

Optical coherence tomography assessment of calcified plaque modification after rotational atherectomy.

Rotational atherectomy (RA) facilitates stent delivery in highly calcified coronary plaques (CCP). However, lesion ablation by RA in angulated segments may be affected by guidewire bias, leading to a non-uniform plaque modification. Intravascular optical coherence tomography (iOCT) is the highest resolution (∼10 µm axial) intravascular imaging modality available for clinical use; furthermore, near infrared light easily penetrates calcium, with significantly fewer artifacts, including no "blooming effect" as seen by intravascular ultrasound. Therefore, it may pose as a unique tool for serial calcium quantification, as related in this article with pre- and post-RA assessment, allowing accurate characterization of plaque modification, as well as quality of stent deployment. The effects of guidewire bias in the debulking process have not been well documented by iOCT. We present a case of lesion preparation by RA affected by guidewire bias in which iOCT revealed unique insights into CCP modification.

Automatic stent detection in intravascular OCT images using bagged decision trees.

Intravascular optical coherence tomography (iOCT) is being used to assess viability of new coronary artery stent designs. We developed a highly automated method for detecting stent struts and measuring tissue coverage. We trained a bagged decision trees classifier to classify candidate struts using features extracted from the images. With 12 best features identified by forward selection, recall (precision) were 90%-94% (85%-90%). Including struts deemed insufficiently bright for manual analysis, precision improved to 94%. Strut detection statistics approached variability of manual analysis. Differences between manual and automatic area measurements were 0.12 ± 0.20 mm(2) and 0.11 ± 0.20 mm(2) for stent and tissue areas, respectively. With proposed algorithms, analyst time per stent should significantly reduce from the 6-16 hours now required.