Patent Foramen Ovale and Oxygenation in Patients with Cystic Fibrosis.

INTRODUCTION: Patent foramen ovale (PFO) affects about 25% of the population. We studied outcomes in cystic fibrosis (CF). METHODS: We conducted a case-control study of patients with CF (PwCF) and age and sex-matched controls who underwent agitated saline contrast (bubble) echocardiography, 1998-2020. We assessed PFO impacts using linear, logistic, quasipoisson and proportional hazards models. RESULT: 59 of 64 PwCF and 88 of 93 controls underwent bubble studies to investigate unexplained hypoxemia or dyspnea. PwCF had higher mean pulmonary artery pressure (PAP, 6.9 mm Hg, 95% Confidence Interval [CI] = 2.35-11.4), reduced tricuspid annular plane systolic excursion (TAPSE, -3.78 mm, CI = -5.64 to -1.93) and similar right ventricular diastolic sizes. Absent hypoxemia, PFO incidence was similar between PwCF and controls; with hypoxemia, PFO was more common in CF (Odds Ratio [OR] = 5.00, CI = 1.32-19.0). In CF, oxygen supplementation occurred at a percent predicted forced expiratory volume in 1 s (FEV1%) 22.5 points higher with PFO. Adjusted for FEV1%, PFO was associated with 0.59 more prior year pulmonary exacerbations (CI = 0.20-0.98) and shorter time to next exacerbation (Hazard Ratio = 1.86, CI = 1.06-3.26). Associations between PFO and hypoxemia or exacerbations were insensitive to PAP, TAPSE and CF transmembrane regulator protein modulator treatments. PFO was not associated with CF time to death or lung transplantation (median 1.87 years) adjusted for age, sex, FEV1% and prior year exacerbation counts. CONCLUSION: PFO in CF is associated with hypoxemia at higher FEV1% and more pulmonary exacerbations but not survival.

Transcatheter Aortic Valve Replacement Improves Quality of Life and Ventricular Function With Low-Flow/Low-Gradient Aortic Stenosis.

Background: D2 aortic stenosis (AS) is the highest risk AS subtype with worse operative and mortality outcomes. This study aimed to investigate the quality of life (QoL) and left ventricular ejection fraction (LVEF) in patients with classic (D2 subtype) low-flow/low-gradient AS who underwent transcatheter aortic valve replacement (TAVR). Methods: In total, 634 patients with severe AS underwent TAVR at our institution from 2014 to 2020, of whom 76 met criteria for classic D2 AS with reduced LVEF. Echocardiographic and clinical outcomes including mortality, stroke, pacemaker placement (PPM), and readmission at baseline were compared with those at 30 days and 1 year. QoL data were extracted from the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Results: The average baseline Society of Thoracic Surgeons risk score for patients with D2 AS was 7.66 ± 6.76. Patients with D2 AS reported improved QoL post-TAVR. The average baseline KCCQ-12 score was 39.5 ± 20, with improvement to 68.9 ± 20.6 at 30 days (P < .01) and 74.9 ± 17.5 at 1 year (P < .01). Mortality was 0% at 30 days and 18.4% at 1 year. The average baseline LVEF was 36.1 ± 9.4. Left ventricular function improved to 43.5 ± 12.9 (P <.001) at 30 days and 46.3 ± 11.2 (P = .03) at 1 year. Complications post-TAVR at 30 days included stroke (1.3%) and PPM (11.8%). Patients with D2 AS exhibited higher baseline conduction defects including atrial fibrillation and higher postoperative PPM than those with other subtypes. Conclusions: Patients with D2 AS had significantly improved LVEF and QoL following TAVR at 30 days and 1 year. Postoperative rates of new PPM were higher than other subtypes, while stroke, dialysis, and mortality were lower than expected, supporting the benefit of TAVR in this high-risk group.

Helix-fixed leadless pacemaker implantation through a valve-in-valve tricuspid prosthesis via the femoral approach.

Leadless pacemakers offer the opportunity to avoid transvenous hardware among patients with tricuspid valve prostheses. We present the first case of a helix-based fixation leadless pacemaker implanted through valve-in-valve tricuspid prostheses in a 43-year-old female with extensive prior cardiac history. At the time of presentation, epicardial pacing was no longer a viable option in the setting of pacemaker dependence. Placement of a helix-fixed, leadless right ventricular pacemaker was performed as a bridge to dual-chamber leadless pacing. This was safely and effectively performed and highlighted favorable procedural characteristics that included RV cavity dimensions and prosthesis type.

Predicting mortality in cardiogenic shock secondary to ACS requiring short-term mechanical circulatory support: The ACS-MCS score.

OBJECTIVE: To identify predictors of 30-day all-cause mortality for patients with cardiogenic shock secondary to acute coronary syndrome (ACS-CS) who require short-term mechanical circulatory support (ST-MCS). BACKGROUND: ACS-CS mortality is high. ST-MCS is an attractive treatment option for hemodynamic support and stabilization of deteriorating patients. Mortality prediction modeling for ACS-CS patients requiring ST-MCS has not been well-defined. METHODS: The Utah Cardiac Recovery (UCAR) Shock database was used to identify patients admitted with ACS-CS requiring ST-MCS devices between May 2008 and August 2018. Pre-ST-MCS clinical, laboratory, echocardiographic, and angiographic data were collected. The primary endpoint was 30-day all-cause mortality. A weighted score comprising of pre-ST-MCS variables independently associated with 30-day all-cause mortality was derived and internally validated. RESULTS: A total of 159 patients (mean age, 61 years; 78% male) were included. Thirty-day all-cause mortality was 49%. Multivariable analysis resulted in four independent predictors of 30-day all-cause mortality: age, lactate, SCAI CS classification, and acute kidney injury. The model had good calibration and discrimination (area under the receiver operating characteristics curve 0.80). A predictive score (ranging 0-4) comprised of age ≥ 60 years, pre-ST-MCS lactate ≥2.5 mmol/L, AKI at time of ST-MCS implementation, and SCAI CS stage E effectively risk stratified our patient population. CONCLUSION: The ACS-MCS score is a simple and practical predictive score to risk-stratify CS secondary to ACS patients based on their mortality risk. Effective mortality risk assessment for ACS-CS patients could have implications on patient selection for available therapeutic strategy options.

Preventing or Minimizing Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is now routinely performed in patients with aortic stenosis with low mortality and complication rates. Although periprocedural risks have been substantially minimized, procedure- and contrast-induced acute kidney injury (AKI) remains a major concern. AKI remains a frequent complication of contrast-guided interventional procedures and is associated with a significantly adverse prognosis. We review the currently available clinical data related to AKI, with emphasis on contrast-induced nephropathy (CIN), and discuss a novel, integrated approach aiming to minimize AKI risk in high-risk patients. A stepwise algorithm is also proposed for the management of these complex patients.

Trans-Septal Puncture Through Gore® Cardioform Septal Occluder Device - Step by Step Approach.

We describe the patient selection, intraprocedural imaging, and procedural technique for transseptal puncture through the Gore® Cardioform interatrial septal occluder. Due to new indications for PFO closure and increasing need for access to the left atrium via percutaneous approach, we expect an increasing need for utilization of a trans-septal puncture technique through these devices.

Is timing everything? Bioprosthetic valve fracture in valve-in-valve TAVR.

We present a challenging case of early bioprosthetic valve degeneration following valve-in-valve transcatheter aortic valve replacement and bioprosthetic valve fracture.

Strong Relationship Between Vascular Function in the Coronary and Brachial Arteries.

Early detection of coronary artery dysfunction is of paramount cardiovascular clinical importance, but a noninvasive assessment is lacking. Indeed, the brachial artery flow-mediated dilation test only weakly correlated with acetylcholine-induced coronary artery function ( r=0.36). However, brachial artery flow-mediated dilation methodologies have, over time, substantially improved. This study sought to determine if updates to this technique have improved the relationship with coronary artery function and the noninvasive indication of coronary artery dysfunction. Coronary artery and brachial artery function were assessed in 28 patients referred for cardiac catheterization (61±11 years). Coronary artery function was determined by the change in artery diameter with a 1.82 µg/min intracoronary acetylcholine infusion. Based on the change in vessel diameter, patients were characterized as having dysfunctional coronary arteries (>5% vasoconstriction) or relatively functional coronary arteries (<5% vasoconstriction). Brachial artery function was determined by flow-mediated dilation, adhering to current guidelines. The acetylcholine-induced change in vessel diameter was smaller in patients with dysfunctional compared with relatively functional coronary arteries (-11.8±4.6% versus 5.8±9.8%, P<0.001). Consistent with this, brachial artery flow-mediated dilation was attenuated in patients with dysfunctional compared with relatively functional coronaries (2.9±1.9% versus 6.2±4.2%, P=0.007). Brachial artery flow-mediated dilation was strongly correlated with the acetylcholine-induced change in coronary artery diameter ( r=0.77, P<0.0001) and was a strong indicator of coronary artery dysfunction (receiver operator characteristic=78%). The current data support that updates to the brachial artery flow-mediated dilation technique have strengthened the relationship with coronary artery function, which may now provide a clinically meaningful indication of coronary artery dysfunction.

Managing Stenotic Septal Perforator Branches.

Coronary artery disease of the septal perforator branches can lead to clinical ischemia and conduction abnormalities. Performing interventional procedures in these vessels is frequently impossible because they are small, which makes it difficult to approach them and to select appropriate equipment. Larger septal perforator branches have been treated percutaneously in a few patients; however, the clinical effectiveness and long-term outcomes are not known. We present our experience in managing obstructive septal perforator branch stenosis in 4 patients.

Effect of reduced cardiac output on blood stasis on transcatheter aortic valve leaflets: implications for valve thrombosis.

AIMS: There is an increasing awareness of leaflet thrombosis following transcatheter aortic valve implantation (TAVI) and valve-in-valve (ViV) procedures. Nevertheless, the predisposing factors affecting transcatheter aortic valve (TAV) thrombosis have remained unclear. This study aimed to quantify the effects of reduced cardiac output (CO) on blood stasis on the TAV leaflets as a permissive factor for valve thrombosis. METHODS AND RESULTS: An idealised computational model representing a TAV was developed in a patient-specific geometry. Three-dimensional flow fields were obtained via a fluid-solid interaction modelling approach at different COs: 5.0, 3.5, 2.0 L/min. Blood residence time (BRT) was subsequently calculated on the leaflets. An association between reduced CO and increased blood stasis on the TAV leaflets was observed. At the end of diastole, larger areas of high BRT (>1.2 s) were observed at the leaflet's fixed edge at low COs. Such areas were calculated to be 2, 8, and 11% of the total surface area of leaflets at CO=5.0, 3.5, and 2.0 L/min, respectively, indicating a ~sixfold increase of BRT on the leaflets from the highest to the lowest CO. CONCLUSIONS: This study indicates an association between reduced CO and increased blood stasis on the TAV leaflets which can be regarded as a precursor of valve thrombosis.

Blood Stasis on Transcatheter Valve Leaflets and Implications for Valve-in-Valve Leaflet Thrombosis.

BACKGROUND: Leaflet thrombosis after valve-in-valve (ViV) procedure has been increasingly recognized. This study aimed to investigate the flow dynamics aspect of leaflet thrombosis by quantifying the blood stasis on the noncoronary and coronary leaflets of a surgical aortic valve (SAV) and a transcatheter aortic valve (TAV) in a ViV setting. METHODS: Two computational models, representing a SAV and a TAV in ViV setting, were developed in a patient-specific geometry. Three-dimensional flow fields were obtained through a fluid-solid interaction modeling approach to study the difference in blood residence time (BRT) on the coronary and noncoronary leaflets. RESULTS: Longer BRT was observed on the TAV leaflets compared with the SAV, specifically near the leaflet fixed boundary. Particularly, at the end of diastole, the areas of high BRT (≥1.2 seconds) on the surface of the TAV model leaflets were four times larger than those of the SAV model. The distribution of BRT on the three leaflets exhibited a similar pattern in the model for the TAV in ViV setting. That was in contrast to the SAV model where large areas of high BRT were observed on the noncoronary leaflet. CONCLUSIONS: Geometric confinement of the TAV by the leaflets and the frame of the degenerated bioprosthesis that circumferentially surround the TAV stent increases the BRT on the leaflets, which may act as a permissive factor in the TAV leaflet thrombosis after ViV procedure. A similar distribution pattern of BRT observed on the TAV leaflets may explain the similar rate of occurrence of thrombosis on the three leaflets.

Valve thrombosis following transcatheter aortic valve replacement: significance of blood stasis on the leaflets.

OBJECTIVES: Leaflet thrombosis following transcatheter aortic valve replacement (TAVR) and valve-in-valve (ViV) procedures has been increasingly recognized. However, the factors affecting the post-TAVR/ViV thrombosis are not fully understood. This study aimed to investigate the effect of the geometric confinement of transcatheter aortic valve (TAV) on blood residence time (BRT) on the TAV leaflets and in turn on the post-TAVR valve thrombosis. METHODS: Two computational models, representing a surgical bioprosthesis and a TAV, were developed to study the effect of the geometric confinement on BRT on the leaflets in ViV setting/TAVR Intra-annular positioning. 3D flow fields were obtained via a one-way fluid-solid interaction modelling approach validated by experimental testing. BRT was compared between the two models by quantification and statistical analysis of the residence time of randomly distributed particles in close proximity of the leaflets. RESULTS: Significantly longer BRT on the leaflets was observed in the TAV compared to the surgical valve during different stages of the cardiac cycle. During forward flow, the mean value of BRT was found to be 39% higher in the TAV compared to the surgical bioprosthesis ( P < 0.0001). During diastole, specifically from end-systole to mid-diastole and from mid-diastole to the beginning of systole, the amount by which the mean BRT was higher for TAV compared to the surgical valve was 150% and 40%, respectively ( P < 0.0005). CONCLUSIONS: The geometric confinement of TAV by the failed bioprosthesis or the calcified native valve increases the BRT on the TAV leaflets. This may act as a permissive factor in valve thrombosis.

Bioprosthetic Aortic Paravalvular Leak: Is Valve-in-Valve Another Solution?

Paravalvular leak (PVL) following aortic valve implantation is a rare complication but may cause potentially serious consequences. It occurs in 2%-10% of surgical aortic valve replacements and 7%-17% of surgical mitral valve replacements. Transcatheter valve replacement data show that significant PVL occurs in 6%-8% of cases. The management of significant PVL has traditionally involved repeat surgical repair. However, many of these patients are considered too high risk to undergo a repeat surgical procedure; hence, a percutaneous transcatheter approach has often been utilized to treat these patients. Vascular plugs have been used to close PVLs, with variable results; the procedure is complex and technically demanding. Transcatheter aortic valve replacement, using a valve-in-valve approach, may provide an alternative approach for bioprosthetic PVL in the aortic position.

Transradial access mitigates bleeding benefit offered by bivalirudin over heparin in patients undergoing percutaneous coronary intervention: Insights from meta-analysis of randomized and observational studies.

OBJECTIVE: Recent randomized control trials (RCTs) showed conflicting efficacy and safety between bivalirudin and heparin during percutaneous coronary intervention (PCI). We aimed to perform an updated meta-analysis, including real-world and trial data to examine the factors affecting their risk-benefit ratio. METHODS: We searched Medline, the Cochrane library, and meeting abstracts for studies comparing bivalirudin versus heparin during PCI. Random-effect meta-analyses for MACE (major adverse cardiovascular events), stent thrombosis (ST) and major bleeding were performed. p-Value <0.05 was considered statistically significant. RESULTS: Meta-analysis of 20 RCTs and 31 observation studies (n=165,835) showed that bivalirudin and heparin were similar in the risk of MACE in RCTs (OR 1.05, 95% CI 0.97-1.13) and observational studies (OR 0.94, 95% 0.81-1.10). Major bleeding was lower with bivalirudin in both RCTs (OR 0.60, 95% CI 0.51-0.70) and observational studies (OR 0.56, 95% CI 0.47-0.68). However, in the metaregression analysis, every 10% increase of transradial access decreased the bleeding benefit of bivalirudin by 4.9% (p=0.046, adjusted for GPI and heparin loading dose). ST with bivalirudin was higher with ST-segment elevation myocardial infarction (STEMI) in RCTs (OR 1.51, 95% CI 1.15-1.99) but not in observational studies (p=0.65). CONCLUSIONS: In this large meta-analysis, bivalirudin is associated with a lower risk of bleeding compared to heparin in both RCTs and observational studies, however, transradial PCI mitigated most of this bleeding benefit. Heparin should be the preferred agent in transradial PCI given its lower cost and comparable outcomes.

Carotid Artery Stenosis in the Setting of Transcatheter Aortic Valve Replacement: Clinical and Technical Considerations of Carotid Stenting.

OBJECTIVE: No consensus exists regarding the safety and efficacy of treatment of carotid stenosis before transcatheter aortic valve replacement (TAVR). Our objective was to review our series of patients treated for carotid stenosis with stenting in the setting of severe aortic valve disease and TAVR to evaluate its safety and efficacy. METHODS: We reviewed patients who underwent carotid stenting in the setting of preoperative work-up or after TAVR from August 2012 through January 2015. Perioperative patient outcomes were collected to assess the safety and efficacy of carotid stenting. RESULTS: Five patients (4 men, 1 woman; median age, 83 years; range, 72-88 years) underwent successful carotid stenting before (median, 30 days before; range, 2 days-3 months) TAVR. The median extent of carotid stenosis was 80% (range, 75%-90%), but the diagnoses were incidental and all patients were asymptomatic. One patient suffered acute systolic heart failure during stenting requiring emergent balloon aortic valvuloplasty and vasopressor therapy. Median intensive care unit stay was 1 day (range, 1-16 days) for all patients, and 1 day for patients treated electively. The median hospital stay was 1 day (range, 1-16 days) for all patients, and 1 day for patients treated electively. All patients were discharged home. None suffered immediate or delayed neurological complications. CONCLUSIONS: We successfully performed carotid stenting in 5 patients before TAVR for severe aortic pathology. These patients require intensive care and careful monitoring. Larger prospective studies are needed to determine whether carotid stenting in the setting of TAVR can provide long-term neurological benefits.