Transesophageal Echocardiographic Screening for Structural Heart Interventions.

PURPOSE OF REVIEW: Percutaneous structural interventions have provided patients with an effective therapeutic option, and its growth has been aided by echocardiography. We describe the vital role that transesophageal echocardiography (TEE) plays in screening patients prior to their procedure. RECENT FINDINGS: A multimodality imaging approach is employed by the valve team, but TEE plays a unique role in diagnosis and planning. Utilization of all TEE views and features such as biplane, 3D imaging, and multiplanar reconstruction ensures accurate assessment of the structural lesion of interest. The role of TEE remains essential in the planning of structural interventions, and these studies should be performed in a systematic and comprehensive manner.

Long-term outcomes after transcatheter aortic valve replacement with minimal contrast in chronic kidney disease.

BACKGROUND: Patients with renal insufficiency have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Retrospective chart review identified 575 consecutive patients not on hemodialysis who underwent TAVR between September 2014 and January 2017. Outcomes were defined by VARC-2 criteria. Primary outcome of all-cause mortality was evaluated at a median follow-up of 811 days (interquartile range 125-1,151). RESULTS: Preprocedural glomerular filtration rate (GFR) was ≥60 ml/min in 51.7%, 30-60 ml/min in 42.1%, and < 30 ml/min in 6.3%. Use of transfemoral access (98.8%) and achieved device success (91.0%) did not differ among groups, but less contrast was used with lower GFR (23 ml [15-33], 24 ml [14-33], 13 ml [8-20]; p < .001). Peri-procedural stroke (0.7%, 2.1%, 11.1%; p < .001) was higher with lower GFR. Core lab analysis of preprocedural computed tomography scans of patients who developed a peri-procedural stroke identified potential anatomic substrate for stroke in three out of four patients with GFR 30-60 ml/min and all three with GFR <30 ml/min (severe atheroma was the most common subtype of anatomical substrate present). Compared to GFR ≥60 ml/min, all-cause mortality was higher with GFR 30-60 ml/min (HR 1.61 [1.00-2.59]; aHR 1.61 [0.91-2.83]) and GFR <30 ml/min (HR 2.41 [1.06-5.48]; aHR 2.34 [0.90-6.09]) but not significant after multivariable adjustment. Follow-up echocardiographic data, available in 63%, demonstrated no difference in structural heart valve deterioration over time among groups. CONCLUSIONS: Patients with baseline renal insufficiency remain a challenging population with poor long-term outcomes despite procedural optimization with a transfemoral-first and an extremely low-contrast approach.

Therapeutic blockade of inflammation in severe COVID-19 infection with intravenous N-acetylcysteine.

Glucose 6-phosphate dehydrogenase (G6PD) deficiency facilitates human coronavirus infection due to glutathione depletion. G6PD deficiency may especially predispose to hemolysis upon coronavirus disease-2019 (COVID-19) infection when employing pro-oxidant therapy. However, glutathione depletion is reversible by N-acetylcysteine (NAC) administration. We describe a severe case of COVID-19 infection in a G6PD-deficient patient treated with hydroxychloroquine who benefited from intravenous (IV) NAC beyond reversal of hemolysis. NAC blocked hemolysis and elevation of liver enzymes, C-reactive protein (CRP), and ferritin and allowed removal from respirator and veno-venous extracorporeal membrane oxygenator and full recovery of the G6PD-deficient patient. NAC was also administered to 9 additional respirator-dependent COVID-19-infected patients without G6PD deficiency. NAC elicited clinical improvement and markedly reduced CRP in all patients and ferritin in 9/10 patients. NAC mechanism of action may involve the blockade of viral infection and the ensuing cytokine storm that warrant follow-up confirmatory studies in the setting of controlled clinical trials.

Preprocedural P2Y12 inhibition and decrease in platelet count following transcatheter aortic valve replacement.

BACKGROUND: Thrombocytopenia after transcatheter aortic valve replacement (TAVR) is associated with adverse clinical outcomes. Whether preprocedural P2Y12 inhibition prevents postprocedural thrombocytopenia is uncertain. METHODS: This retrospective analysis identified consecutive patients (n = 266) undergoing TAVR between November 2016 and July 2017. Preprocedure clopidogrel load ≥300 mg or maintenance P2Y12 inhibitor therapy defined preprocedural P2Y12 inhibition. Patients who did not consent for the registry (n = 8), with baseline severe thrombocytopenia (<90 × 103 platelets/µL; n = 14), or without baseline platelet count (n = 4) were excluded. The primary outcome was proportion of patients who developed >20% decrease in platelet count from baseline to day 1 post-TAVR. RESULTS: Patients with (n = 134) versus without (n = 106) preprocedural P2Y12 inhibition had no differences in platelet count at baseline. Patients with preprocedural P2Y12 inhibition had a significantly lower proportion of the primary outcome (34.3% vs. 57.5%, p = .001) and a lower absolute decrease in platelet count (32.8 × 103 vs. 45.8 × 103 platelet/µL, p = .01). Of patients without baseline thrombocytopenia (n = 198), a numerically lower rate of patients with versus without preprocedural P2Y12 inhibition developed thrombocytopenia on day 1 post-TAVR (25.5% vs. 36.4%, p = .1). CONCLUSION: Patients who received preprocedural P2Y12 inhibition prior to TAVR were less likely to demonstrate a decrease in platelet count after TAVR. Prospective studies to further understand the clinical implication of these findings are warranted.

Factors predicting persistence of AV nodal block in post-TAVR patients following permanent pacemaker implantation.

INTRODUCTION: A common complication of transcatheter aortic valve repair (TAVR) is development of conduction defects requiring pacemaker (PPM) implantation. These defects are not universally permanent. OBJECTIVE: To determine the incidence and predictors of persistent device dependency in patients with PPM implantation following TAVR with a self-expanding prosthesis. METHODS: Records of patients who underwent post-TAVR PPM implantation were reviewed. Patients with persistent complete AV block (AVBIII) one month post-TAVR were compared to those regaining conduction. RESULTS: Between September 2014 and March 2017, 485 patients underwent TAVR with a self-expanding prosthesis; 77 (15.9%) underwent PPM implantation for AVBIII. Device interrogation at one month was available for 61 patients (79%): 22 (36.1%) had resolution of AVBIII while 39 (63.9%) remained pacemaker-dependent. Pre-TAVR right bundle branch block was more frequent in device-dependent patients (19 of 38, 50% vs 4 of 22, 18%; RR 2.75; P = .01). Device-dependence was associated with AVBIII as the first postprocedural rhythm (37 of 39, 95% vs 12 of 22, 55%; RR 1.74; P < .0001), earlier implantation (median 1d, IQR: 0-1.5d vs 2d, IQR: 1.0-4.0d, P = .0004), and a shorter duration of hospitalization (median 3d, IQR: 2-3.5d vs 4d, IQR: 2-5.75d, P = .03). Pacemaker dependence was also associated with a higher prosthesis-to left ventricular outflow tract (LVOT) diameter (1.45 ± 0.11 vs 1.39 ± 0.07; P = .02) and the lack of prior aortic valvuloplasty (5 of 39, 13% vs 8 of 22, 36%; RR 0.35; P = .03). CONCLUSIONS: In patients receiving a PPM following self-expanding TAVR, a long-term pacing requirement can be predicted from the timing of AV block, existing conduction-system disease, larger prosthesis-to-LVOT diameter, and the lack of aortic valvuloplasty.

Outcomes after transcatheter aortic valve replacement in patients with low versus high gradient severe aortic stenosis in the setting of preserved left ventricular ejection fraction.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for low gradient (LG) severe aortic stenosis (AS) with preserved left ventricular ejection fraction (LVEF) remains an area of clinical uncertainty. METHODS: Retrospective review identified 422 patients who underwent TAVR between September 4, 2014 and July 1, 2016. Procedural indication other than severe AS (n = 22) or LVEF <50% (n = 98) were excluded. Outcomes were defined by valve academic research consortium two criteria when applicable and compared between LG (peak velocity <4.0 m/s and mean gradient <40 mmHg; n = 73) and high gradient (HG) (n = 229) groups. The LG group was further categorized as low stroke volume index (SVI) (n = 41) or normal SVI (n = 32). Median follow-up was 747 days [interquartile range 220-1013]. RESULTS: Baseline thirty-day mortality risk (LG 6.2% [3.8-8.1] vs HG 5.7% [4.1-7.4], P = 0.43) did not differ between groups. Short-term outcomes, including procedural success rate (86.1% vs 88.8%, P = 0.53), peri-procedural complications (intra-procedural heart block: 6.8% vs 7.9%, P = 0.99; permanent pacemaker placement: 11.0% vs 13.6%, P = 0.69; moderate paravalvular regurgitation: 2.7% vs 1.3%, P = 0.60), and all-cause in-hospital mortality (2.7% vs 0.9%, P = 0.25) did not differ between LG and HG groups. On long-term follow-up, all-cause mortality also did not differ between LG and HG groups (6.8% vs 10.0%, plog-rank = 0.33) or between the LG low SVI (9.8%), LG normal SVI (3.1%), and HG (10.0%) groups (plog-rank = 0.39). CONCLUSION: Patients with preserved LVEF undergoing TAVR for severe AS with LG, including LG with low SVI, have no significant difference in adverse outcomes when compared to patients with HG.

Transradial access for peripheral vascular interventions.

Transradial access for coronary interventions has grown substantially in the last few years. Currently, there is an increased interest in applying this approach to peripheral vascular interventions. This report reviews the current status of transradial peripheral interventions, and offers advice in terms of feasibility, equipment use, and technical challenges.

Very Late Sinus of Valsalva Sequestration After Transcatheter Aortic Valve Implantation in Native Aortic Annuli.

Coronary artery obstruction caused by sinus sequestration is well described after transcatheter aortic valve implantation in failed bioprosthetic valves, which usually occurs during or shortly after the transcatheter aortic valve implantation procedure. We report the presentation, management, and outcomes of 2 cases of very late sinus sequestration in native aortic annuli, which has not been described before to our knowledge. (Level of Difficulty: Advanced.).

Study to determine the clinical significance of HEmolysis During Orbital AtheRectomy (CLEAR study).

PURPOSE: To evaluate the incidence of clinically evident hemolysis associated with orbital atherectomy used to treat severe peripheral artery disease. METHODS: The observational CLEAR study enrolled 31 subjects (16 men; mean age 71 ± 10 years, range 44-92) with claudication (58.1%) or critical limb ischemia (38.7%) who underwent orbital atherectomy with the Diamondback 360 system at 4 US centers. The 42 lesions in 31 limbs were located in the superficial femoral (n = 19, 45.2%), popliteal (n = 8, 19.0%), and tibial arteries (n = 15, 35.8%). The majority of lesions (34, 81.0%) were de novo; moderate or severe calcification was identified in 90.5% of cases. Lesion and procedural parameters were analyzed at a core laboratory. Blood samples were collected during and post procedure and analyzed for markers of hemolysis. The primary endpoint was the occurrence of clinically significant hemolysis. The secondary endpoints included the occurrence of any clinical symptoms/signs potentially related to hemolysis. Statistical analysis was performed to identify predictors for hemolysis. RESULTS: Laboratory evidence of hemolysis was seen in 11 (35.5%) subjects. No one met the clinical event criteria, and so the primary endpoint of the study was not reached. The secondary endpoints were hypertensive crisis (1, 3.2%) and transient hemoglobinuria (3, 9.7%). Lower glomerular filtration rates, calcified plaque, long atherectomy runs, and solid crown selection were independent predictors of hemolysis. CONCLUSION: There was no clinically significant hemolysis after orbital atherectomy. The results of this study will enable users to predict conditions that predispose to high levels of red cell hemolysis following orbital atherectomy and to take appropriate measures to limit its occurrence.

Acquired pulmonary vein stenosis resulting in haemoptysis: a case series.

BACKGROUND: Acquired pulmonary vein stenosis (PVS) is an infrequent complication of atrial fibrillation ablation that is often misdiagnosed due to predominant respiratory symptoms. It can result in pulmonary venous hypertension, with varying presentations, ranging from shortness of breath to haemoptysis. CASE SUMMARY: We report two patients with a history of paroxysmal atrial fibrillation treated with radiofrequency ablation and pulmonary vein (PV) isolation, who subsequently developed PVS. Case 1 initially presented with indolent symptoms of shortness of breath and cough. He was initially diagnosed with and treated for pneumonia. In contrast, Case 2 presented with massive haemoptysis, requiring intubation and intensive care unit admission. Both patients were eventually diagnosed with PVS by computed tomography. They were treated with PV angioplasty and stenting. DISCUSSION: While previously limited to the congenital heart disease population, PVS is occurring more frequently now in adult patients as a complication of ablation procedures. It is most effectively treated with angioplasty and stent implantation but has a high rate of recurrence.

Orbital Atherectomy of the Iliofemoral Arteries Facilitates Large-Bore Access Prior to Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVES: To describe the use of orbital atherectomy to prepare iliofemoral vessels for large-bore access prior to transcatheter aortic valve replacement (TAVR). BACKGROUND: Transfemoral (TF)-TAVR has been shown to be at least equivalent to surgery. Nevertheless, many patients do not qualify for the TF approach due to severe iliofemoral occlusive disease. The use of an atherectomy device in order to facilitate TF-TAVR has only been reported in case reports. METHODS: We performed 1000 TAVR procedures from June 2017 to October 2019. Patient demographics, procedural characteristics, computed tomography characteristics, and short-term outcomes were recorded. Hostile access was defined as luminal size <5 mm, or <5.5 mm along with the presence of >270° calcification. The primary endpoint was the ability to successfully deliver a transcatheter valve via the intended pretreated access site. RESULTS: During the study period, 6 subjects (0.6%) required alternative access and 68 patients (6.8%) were considered to have a hostile iliofemoral anatomy that required vessel preparation prior to TAVR. Forty-eight patients (70.6%) had angioplasty only and 20 patients (29.4%) required atherectomy and angioplasty. Out of 20 patients treated with atherectomy, successful TF delivery of the valve was achieved in 19 patients (95%). There was no in-hospital mortality or stroke. There were no perforations. One subject required placement of a self-expandable stent due to severe dissection. CONCLUSION: Orbital atherectomy used for vessel preparation is a safe and very effective technique to facilitate TF-TAVR in patients with hostile peripheral anatomy.

Three-Dimensional Imaging and Dynamic Modeling of Systolic Anterior Motion of the Mitral Valve.

Left ventricular outflow tract (LVOT) obstruction in hypertrophic cardiomyopathy (HCM) is often caused by systolic anterior motion (SAM) of the mitral valve caused by the interplay between increased left ventricular (LV) wall thickness and an abnormal mitral valve anatomy and geometry. Three-dimensional (3D) echocardiographic imaging of the mitral valve has revolutionized the practice of cardiology, paving the way for new methods to see and treat valvular heart disease. Here we present the novel and incremental value of 3D transesophageal echocardiography (TEE) of SAM visualization. This review first provides step-by-step instructions on acquiring and optimizing 3D TEE imaging of SAM. It then describes the unique and novel findings using standard 3D TEE rendering as well as dynamic mitral valve modeling of SAM from 3D data sets, which can provide a more detailed visualization of SAM features. The findings include double-orifice LVOT caused by the residual leaflet, the dolphin smile phenomenon, and delineation of SAM width. Finally, the review discusses the essential role of 3D TEE imaging for preprocedural assessment and intraprocedural guidance of surgical and novel percutaneous treatments of SAM.

Multiphase Assessment of Mitral Annular Dynamics in Consecutive Patients With Significant Mitral Valve Disease.

OBJECTIVES: The aim of this study was to clarify the dynamics of the mitral annulus throughout the cardiac cycle and its relevance to transcatheter mitral valve replacement (TMVR) sizing and case selection. BACKGROUND: Limited data are available regarding the relevance of mitral annular (MA) and neo-left ventricular outflow tract (LVOT) dynamics in the overall population presenting with significant mitral valve disease. METHODS: Patients attending a combined surgical-transcatheter heart valve clinic for severe symptomatic mitral valve disease were assessed using multiphase computed tomography. The relative influence of MA and neo-LVOT dynamics to TMVR case selection was studied. RESULTS: A total of 476 patients with significant mitral valve disease were evaluated. In 99 consecutive patients with severe mitral regurgitation, a 10-phase assessment showed that the mitral annulus was on average largest in late systole. On comparing maximal MA dimension with late systolic dimension, TMVR size assignment changed in 24.2% of patients. If the average MA perimeter was used to determine sizing, 48.5% were excluded because of MA dimension being too large; in a multiphase assessment of the neo-LVOT, an additional 16.2% were excluded on the basis of neo-LVOT dimension. In an expanded series of 312 consecutive patients, selection protocol influenced anatomical exclusion: a manufacturer-proposed early systolic approach excluded 69.2% of patients, whereas a late systolic approach excluded 82.7% of patients, the vast majority because of large mitral annuli. CONCLUSIONS: Contemporary TMVR can treat only a minority of patients with severe mitral regurgitation, principally because of limitations of large MA dimension.

Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.

BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Safety and efficacy of transradial aortoiliac interventions.

BACKGROUND: This study compares transradial approach (TRA) aortoiliac angioplasty/stenting to the transfemoral approach (TFA). METHODS: We reviewed our peripheral database for aortoiliac interventions performed between 2007 and 2009. Demographics, clinical characteristics, procedural, and lesion details were collected. The efficacy endpoints included procedural success, ankle-brachial index (ABI) improvement, and time to discharge. The safety endpoints were as follows: occurrence of intra-/periprocedural complications, 30-day MACE, and access-site complications (minor/major). The subjects were divided into two groups, TRA and TFA, and compared using appropriate statistics. RESULTS: Twenty-seven patients had 33 lesions treated via TRA, and 41 patients had 47 lesions treated via TFA access. Baseline demographic differences between the TRA and TFA groups were similar, including mean Rutherford category (2.9 vs. 2.6, P = 0.31) and preintervention ABI (0.64 vs. 0.67, P = 0.80). There was a significantly higher percentage of total occlusions in the TRA group (27.3 vs. 8.5%, P = 0.03). Dye use (238 vs. 213 mL, P = 0.35) and fluoroscopy time (30 vs. 27 min, P = 0.60) were similar. Procedural success rate was similar (87.9 vs. 97.8%, P = 0.15), as well as the improvement in mean ABI (TRA: 0.64-0.77 and TFA: 0.67-0.85, P = 0.77). The time to discharge was significantly shorter for the TRA group (14.4 vs. 20.9 hr, P = 0.003). There were no 30-day MACE or major access-site complications, but minor access-site complications were lower in the TRA group (0.0 vs. 7.3%, P = 0.28), although nonsignificant. CONCLUSIONS: The TRA to aortoiliac interventions is as safe and effective as the TFA with the advantage of a lower rate of access-site complications and shorter hospitalization time.

Orbital atherectomy for symptomatic lower extremity disease.

BACKGROUND: Plaque-debulking technologies have been proposed as alternative treatment options for peripheral arterial disease. Orbital atherectomy (OA), using the DiamondBack360 device, has emerged as one promising modality. METHODS: We evaluated the safety and efficacy of OA in the first 200 lesions treated at our institution. Patient demographics, clinical characteristics, and lesion and procedural variables were collected and analyzed. The primary safety endpoint was the 30-day major adverse events (MAE), including death, myocardial infarction, stroke, unplanned amputation, or target lesion revascularization. Other safety endpoints included access-site complications, occurrence of dissections, perforations, distal embolization, spasm, and hemolysis. The efficacy endpoints were procedural success, need for adjunctive therapy, and improvement in ankle-brachial index. Multivariate analysis was performed to find independent predictors of the safety endpoints. RESULTS: One hundred seventeen (58.5%) lesions were femoral, 31 (15.5%) were popliteal, and 52 (26.0%) were tibial. The procedural success (residual stenosis ≤30%) was comparable between the femoral and tibial lesions (86.3% vs. 92.5%, P = 0.18), but significantly lower for the popliteal lesions when compared with femoral and tibial (64.7% vs. 86.3%, P = 0.058, and 64.7% vs. 92.5%, P = 0.007 respectively). MAE at 30-days occurred in 3 (2.2%) procedures, and major access-site complications also occurred in 3 (2.2%). There were 31 (15.5%) dissections; independent predictors were diabetes mellitus (OR: 7.3, P = 0.008), crown-to-RVD ratio <0.6 (OR: 11.6, P = 0.005), and atherectomy time >360 sec (OR: 11.8, P = 0.001). There were 2 (1.0%) distal embolizations, 6 (3.0%) arterial spasms, and no perforations. Laboratory evidence of hemolysis was noted in 33.8% of cases. CONCLUSION: Orbital atherectomy allows for a significant procedural success, limited need for stenting, and favorable safety profile.

Transradial peripheral vascular interventions.

Recently the importance of post procedure bleeding contributing to both short-term and long-term mortality has lead to a renewed interest in transradial coronary interventions in the United States. It has been long known that the incidence of access site bleeding is dramatically decreased by transradial access but the procedure is only used in 1% of coronary interventions in the United States, far below the rest of the world. In India, Japan and some European centers 50% of interventions are transradial. To extend this benefit of lower incidence of access site complications, we started using a transradial approach for peripheral interventions for the lower extremities, renal and subclavian arteries. By experience, we realized that in many cases the radial approach makes the procedure actually simpler. Also, in many instances, the transradial approach allows discharge of the patient on the same day. In this paper, we describe our approach to lower extremity, renal and subclavian interventional procedures.

Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study.

INTRODUCTION: Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies. PATIENTS AND METHODS: Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up. RESULTS: A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9±117.3mm and 127.4±113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09-5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up. DISCUSSION: Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.

N-Acetylcysteine added to volume expansion with sodium bicarbonate does not further prevent contrast-induced nephropathy: results from the cardiac angiography in renally impaired patients study.

We reviewed data from the multicenter CARE (Cardiac Angiography in Renally Impaired Patients) study to see if benefit could be shown for N-acetylcysteine (NAC) in patients undergoing cardiac angiography who all received intravenous bicarbonate fluid expansion. Four hundred fourteen patients with moderate-to-severe chronic kidney disease were randomized to receive intra-arterial administration of iopamidol-370 or iodixanol-320. All patients were prehydrated with isotonic sodium bicarbonate solution. Each site chose whether or not to administer NAC 1,200 mg twice daily to all patients. Serum creatinine (SCr) levels and estimated glomerular filtration rate were assessed at baseline and 2-5 days after receiving contrast. The primary outcome was a postdose SCr increase 0.5 mg/dL (44.2 mumol/L) over baseline. Secondary outcomes were a postdose SCr increase 25% and the mean peak change in SCr. The NAC group received significantly less hydration (892 +/- 236 mL vs. 1016 +/- 328 mL; P < 0.001) and more contrast volume (146 +/- 74 mL vs. 127 +/- 71 mL; P = 0.009) compared with no-NAC group. SCr increases 0.5 mg/dL occurred in 4.2% (7 of 168 patients) in NAC group and 6.5% (16 of 246 patients) in no-NAC group (P = 0.38); rates of SCr increases 25% were 11.9% and 10.6%, respectively (P = 0.75); mean post-SCr increases were 0.07 mg/dL in NAC group versus 0.11 mg/dL in no-NAC group (P = 0.14). In conclusion, addition of NAC to fluid expansion with sodium bicarbonate failed to reduce the rate of contrast-induced nephropathy (CIN) after the intra-arterial administration of iopamidol or iodixanol to high-risk patients with chronic kidney disease.

Outcomes After Transcatheter Mitral Valve Repair in Patients With Renal Disease.

BACKGROUND: Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. METHODS AND RESULTS: Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services-linked data were available in 63% of patients (n=3300). CrCl was <60 mL/min in 77% (n=4010) and <30 mL/min in 23% (n=1183) of the cohort. Rates of primary outcome were higher with lower CrCl (>60 mL/min, 1.4%; 30-<60 mL/min, 2.7%; <30 mL/min, 5.2%; dialysis, 7.8%; P<0.001), and all low CrCl groups were independently associated with the primary outcome (30-<60 mL/min: adjusted odds ratio, 2.32; 95% CI, 1.38-3.91; <30 mL/min: adjusted odds ratio, 4.44; 95% CI, 2.63-7.49; dialysis: adjusted hazards ratio, 4.52; 95% CI, 2.08-9.82) when compared with CrCl >60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30-<60 mL/min, 18.8%; <30 mL/min, 29.9%; dialysis, 32.3%; P<0.001), and all low CrCl groups were independently associated with 1-year mortality (30-<60 mL/min: adjusted hazards ratio, 1.50; 95% CI, 1.13-1.99; <30 mL/min: adjusted hazards ratio, 2.38; 95% CI, 1.78-3.20; adjusted hazards ratio: dialysis, 2.44; 95% CI, 1.66-3.57) when compared with CrCl >60 mL/min. CONCLUSIONS: The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.