Trends in transcatheter aortic valve implantation practice and clinical outcomes at an Irish tertiary referral centre.

OBJECTIVE: A paucity of data exists on how transcatheter aortic valve implantation (TAVI) practice has evolved in Ireland. This study sought to analyse temporal trends in patient demographics, procedural characteristics, and clinical outcomes at an Irish tertiary referral centre. METHODS: The prospective Mater TAVI database was divided into time tertiles based on when TAVI was performed: Group A, November 2008-April 2013; Group B, April 2013-September 2017; and Group C, September 2017-February 2022. Patient and procedural characteristics and clinical outcomes were compared across groups. RESULTS: A total of 1063 (Group A, 59; Group B, 268; and Group C:, 736) patients were treated with TAVI during the study period (mean age 81.1±7.4, mean Society of Thoracic Surgeons score 5.9±5.1).Conscious sedation (Group A, 0%; Group B, 59.9%; and Group C, 90.2%, p<0.001) and femoral artery access (Group A, 76.3%; Group B, 90.7%; and Group C, 96.6%, p<0.001) were used more frequently over time. The median length of hospital stay reduced from 9 days (IQR 7, 18) in Group A to 2 days (IQR 2, 3) in Group C. In-hospital death was numerically higher in Group A compared with Group C (6.8% vs 1.9%, p=0.078). At 1-year follow-up, the rate of death and/or stroke was similar in Group A and Group C (20.3% vs 12.0%, adjusted HR 1.49, 95% CI (0.59 to 3.74)). CONCLUSION: There was exponential growth in TAVI procedural volume during the study period. A minimalist approach to TAVI emerged, and this was associated with significantly shorter procedure duration and hospital stay. Clinical outcomes at 1-year follow-up did not change significantly over time.

Clinical Frailty Scale as a predictor of adverse outcomes following aortic valve replacement: a systematic review and meta-analysis.

OBJECTIVES: Assessment of frailty prior to aortic valve intervention is recommended in European and North American valvular heart disease guidelines. However, there is a lack of consensus on how it is best measured. The Clinical Frailty Scale (CFS) is a well-validated measure of frailty that is relatively quick to calculate. This meta-analysis sought to examine whether the CFS predicts mortality and morbidity following either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). METHODS: Nine electronic databases were searched systematically for data on clinical outcomes post-TAVI/SAVR, where patients had undergone preoperative frailty assessment using the CFS. The primary endpoint was 12-month mortality. TAVI and SAVR data were assessed and reported separately. For each individual study, the incidence of adverse outcomes was extracted according to a CFS score of 5-9 (ie, frail) versus 1-4 (ie, non-frail), with meta-analysis performed using a random effects model. RESULTS: Of 2612 records screened, nine were included in the review (five TAVI, three SAVR and one which included both interventions). Among 4923 TAVI patients, meta-analysis showed 12-month mortality rates of 19.1% for the frail cohort versus 9.8% for the non-frail cohort (RR 2.53 (1.63 to 3.95), p<0.001, I2=83%). For the smaller cohort of SAVR patients (n=454), mortality rates were 20.3% versus 3.9% for the frail and non-frail cohorts, respectively (RR 5.08 (2.31 to 11.15), p<0.001, I2=5%). CONCLUSIONS: Frailty, as determined by the CFS, was associated with an increased mortality risk in the 12 months following either TAVI or SAVR. These data would support its use in the preoperative assessment of elderly patients undergoing aortic valve interventions.

Transcatheter aortic valve implantation-related infective endocarditis: experience from an Irish tertiary referral centre.

BACKGROUND: Transcatheter aortic valve implantation-related infective endocarditis (TAVI-IE) is a well-recognised and serious complication following TAVI. The purpose of this study was to describe the clinical characteristics, microorganism spectrum, and outcomes of TAVI-IE in an Irish context. METHODS: A prospective registry was used to assess the baseline demographics, procedural variables, and clinical outcomes of patients undergoing TAVI between 2009 and 2020 at two tertiary referral Irish Hospitals. RESULTS: A total of 733 patients underwent TAVI during the study period. During a follow-up duration of 1,949 person-years (median 28 months), TAVI-IE occurred in 17 (2.3%) patients. The overall incidence was 0.87 per 100 person-years and the median time from TAVI to presentation with IE was 7 months [IQR: 5-13 months]. In those who developed TAVI-IE, the mean age was 78.7 years, 70.5% were male, and there was a trend towards more permanent pacemaker implantations post-TAVI (17.6% vs. 5.86%; p = 0.08). The dominant culprit microorganisms were streptococci (41.1%) and four (23.5%) cases were attributed to dental seeding. Major complications of TAVI-IE included one (5.8%) stroke, one (5.8%) in-hospital death, and two (11.7%) urgent surgical aortic valve replacements. The Kaplan-Meier estimate of survival at 1-year was 82% (95% CI = 55-95). CONCLUSIONS: This Irish cohort of TAVI-IE exhibited a similar incidence and time to presentation compared to prior international registries; however, the 1-year mortality rate was comparatively lower. The need for rigorous dental clearance pre-TAVI and maintenance of dental health post-TAVI is underscored by the high prevalence of oral streptococcus species in this cohort.

Correlation of aortic valve annular plane assessment by on-table three-dimensional rotational angiography and preprocedural computed tomography.

OBJECTIVES: To assess the correlation between the aortic valve annular plane (AVAP) obtained by preprocedural computed tomography (CT) with on-table three-dimensional rotational angiography (3DRA), in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Accurate assessment of the AVAP is critical during TAVR procedures to enable optimal positioning and minimize complications. Most commonly, preprocedural CT has been used to determine the AVAP. However, this can differ from the actual AVAP obtained during the TAVR procedure. METHODS: Consecutive TAVR patients at a single center undergoing both preprocedural CT and 3DRA were included in the study. The AVAP assessment by CT was performed using 3mensio software (Pie Medical Imaging). 3DRA assessment was performed using DynaCT (Siemens). RESULTS: A total of 100 patients were included in the analysis. A difference of ≥5° and ≥10° in both the LAO/RAO and cranial/caudal components of the AVAP projection angle as assessed by CT and 3DRA was recorded in 39% and 10% of patients, respectively. The concordance correlation coefficient for the LAO/RAO and cranial/caudal implantation angles was 0.519 (95% CI: 0.377-0.661) and 0.558 (95% CI: 0.432-0.684), respectively. CONCLUSION: Correlation between preprocedural CT and on-table 3DRA in the prediction of the actual AVAP at the time of TAVR implantation is moderate.

Intravascular lithotripsy-assisted balloon angioplasty to facilitate transfemoral transcatheter aortic valve implantation in a patient with coral reef aorta.

This case describes the management of a woman in her 70s with severe symptomatic aortic stenosis and concomitant severe stenosis of the suprarenal abdominal aorta due to 'coral reef' calcification of the aortic wall and lumen (CRA). Due to her religious beliefs as a Jehovah's Witness regarding the use of blood products, she rejected the option of surgical aortic valve replacement. Transfemoral (TF) delivery of a transcatheter aortic valve was challenged by the presence of CRA. A successful TF transcatheter aortic valve implantation (TAVI) was achieved by the treatment of the CRA with intravascular lithotripsy-assisted angioplasty, followed by delivery and deployment of a self-expanding TAVI valve.

Safety of Conscious Sedation for Transcatheter Aortic Valve Replacement Without an Anesthetist.

OBJECTIVES: To compare the safety of performing transfemoral transcatheter aortic valve replacement (TAVR) under conscious sedation without an anesthetist present (TAVR-NA) vs TAVR performed with an anesthetist supervising sedation (TAVR-A). BACKGROUND: In almost all United States and European centers, TAVR-A represents the standard of care. There are limited data on the safety of TAVR-NA. METHODS: The prospective Mater TAVR database was analyzed. Patients undergoing transfemoral TAVR under conscious sedation were identified and divided into 2 groups, ie, TAVR-NA and TAVR-A. Demographics, procedural characteristics, and clinical outcomes for each group were assessed and compared. RESULTS: From a cohort of 300 patients who underwent transfemoral TAVR under conscious sedation, TAVR-NA and TAVR-A were performed in 85 patients and 215 patients, respectively. Baseline variables were similar except for a higher median Society of Thoracic Surgeons score in the TAVR-NA group vs the TAVR-A group (5.1% vs 4.4% in the TAVR-A group; P=.05). TAVR-A patients had a higher rate of conversion to general anesthesia (4.2% vs 1.2% in the TAVR-NA group; P=.29), with 1 patient in each group requiring conversion to emergency surgery. In-lab and in-hospital complication rates were similar in the TAVR-NA and TAVR-A groups (7.1% vs 6.5% [P=.86] and 8.2% vs 12.1% [P=.34], respectively). The Kaplan-Meier estimate of freedom from mortality and/or stroke at 1 month was comparable between both groups (96.5% vs 97.7%; P=.57). CONCLUSIONS: In this modest-sized transfemoral TAVR cohort with a low conversion rate to emergency surgery, TAVR-NA was associated with safety outcomes that were equivalent to TAVR-A. In healthcare systems where access to TAVR may be limited by anesthetic resources, TAVR-NA appears to be a reasonable option to enable the application of this therapy.

Clinical experience with trans-catheter aortic valve implantation at a tertiary hospital in the Republic of Ireland.

INTRODUCTION: There is a paucity of published data on the clinical experience with trans-catheter aortic valve implantation (TAVI) in the Republic of Ireland. We sought to examine the clinical outcomes of patients with medium-term follow-up treated with TAVI at our institution. METHODS: A prospective TAVI registry was used to assess the baseline demographics, procedural variables and clinical outcomes of patients treated with TAVI between the inception of the programme in 2008 and November 2017. RESULTS: A total of 354 patients (mean age 80.9 ± 8.1 years, 58% male, mean STS score 6.1 ± 4.3%) were treated during the study period. Major in-hospital outcomes included in-lab death (n = 2, 0.6%), stroke (n = 8, 2.2%), device embolisation (n = 4, 1.2%), permanent pacemaker implantation (n = 22, 6.2%) and major vascular complication (n = 2, 0.6%). The median length of hospital stay was 4 days (IQR 2-8 days). The Kaplan-Meier estimate of freedom from death at 30 days and 1 year for the entire cohort was 97 ± 1% and 85.4 ± 2.3%, respectively. Trans-femoral access was associated with a significantly lower rate of death and/or stroke at 1 year compared to trans-apical access (84.9 ± 2.4% versus 60 ± 8.9%, p = 0.0005). There was no significant difference in freedom from death and/or stroke at 1 year between balloon-expandable and self-expanding valves (81.6 ± 2.6% versus 84.4 ± 7.4%, p = 0.63). CONCLUSION: This study documents low complication rates and favourable rates of survival following TAVI in a consecutive series of patients undergoing TAVI at a tertiary referral centre in the Republic of Ireland. These data support the application of this therapy in the Irish context.

Trans-catheter paravalvular leak closure: a single-centre experience.

INTRODUCTION: A significant paravalvular leak (PVL) is estimated in at least 1-3% of patients undergoing surgical aortic and/or mitral valve replacement. Surgical repair of a PVL is associated with a 30-day mortality of approximately 10%. Percutaneous closure of PVL has emerged as an alternative to surgical repair. AIM: We sought to examine the clinical outcomes of patients treated with percutaneous closure of PVL at an Irish tertiary referral centre. METHODS: A prospective registry was used to record patient and procedural characteristics at the time of the PVL procedure. Medical records were retrospectively reviewed to assess clinical outcomes during the index hospitalisation and at follow-up. RESULTS: A total of 26 PVL procedures were performed in 21 patients (mean age 68 ± 13 years, 76% male). Heart failure (HF), haemolysis (HL) or a combination of both was the presenting symptoms in 62%, 24% and 14% of patients, respectively. In the entire cohort, clinical success was achieved in 18 patients (86%). Clinical success was achieved more frequently when HF was the clinical indication compared to HL (100% versus 66%). Among patients presenting with isolated HF (n = 13), the mean NYHA class at baseline and follow-up was 2.5± 0.7 and 1.4± 0.7, respectively. Thirty-day mortality was 0%. There was one (3.8%) major adverse procedural complication (stroke). A total of six deaths (28%) occurred during follow-up (22 ± 13.4 months). CONCLUSIONS: Patients with PVL represent a high-risk patient cohort. Percutaneous PVL offers a safe alternative to surgical PVL repair and appears particularly effective in those patients who present primarily with HF.

Successful transcarotid transcatheter aortic valve replacement in a 34-kg patient with Schimke immuno-osseous dysplasia and severe biscuspid aortic stenosis.

We present the case of transcatheter aortic valve replacement in a 20-year-old woman with severe bicuspid aortic stenosis and Schmike immuno-osseous dysplasia who was unfit for surgical aortic valve replacement. Meticulous pre-procedural planning and a multidisciplinary team approach can enable successful transcatheter aortic valve replacement in complex patients with genetic syndromes.

Longitudinal Risk of Adverse Events in Patients With Acute Kidney Injury After Percutaneous Coronary Intervention: Insights From the National Cardiovascular Data Registry.

BACKGROUND: Acute kidney injury (AKI) remains a common complication after percutaneous coronary intervention (PCI) and is associated with adverse in-hospital patient outcomes. The incidence of adverse events after hospital discharge in patients having post-PCI AKI is poorly defined, and the relationship between AKI and outcomes after hospital discharge remains understudied. METHODS AND RESULTS: Using the National Cardiovascular Data Registry CathPCI registry, we assessed the incidence of AKI among Medicare beneficiaries after PCI from 2004 to 2009 and subsequent post-discharge adverse events at 1 year. AKI was defined using Acute Kidney Injury Network (AKIN) criteria. Adverse events included death, myocardial infarction, bleeding, and recurrent kidney injury. Using Cox methods, we determined the relationship between in-hospital AKI and risk of post-discharge adverse events by AKIN stage. In a cohort of 453 475 elderly patients undergoing PCI, 39 850 developed AKI (8.8% overall; AKIN stage 1, 85.8%; AKIN 2/3, 14.2%). Compared with no AKI, in-hospital AKI was associated with higher post-discharge hazard of death, myocardial infarction, or bleeding (AKIN 1: hazard ratio [HR], 1.53; confidence interval [CI], 1.49-1.56 and AKIN 2/3: HR, 2.13; CI, 2.01-2.26), recurrent AKI (AKIN 1: HR, 1.70; CI, 1.64-1.76; AKIN 2/3: HR, 2.22; CI, 2.04-2.41), and AKI requiring dialysis (AKIN 1: HR, 2.59; CI, 2.29-2.92; AKIN 2/3: HR, 4.73; CI, 3.73-5.99). For each outcome, the highest incidence was within 30 days. CONCLUSIONS: Post-PCI AKI is associated with increased risk of death, myocardial infarction, bleeding, and recurrent renal injury after discharge. Post-PCI AKI should be recognized as a significant risk factor not only for in-hospital adverse events but also after hospital discharge.

Vascular plug closure of a complex coronary artery fistula.

This case report describes the percutaneous closure of a complex coronary artery fistula through the successful deployment of a vascular plug. It particularly highlights the technical challenges of percutaneously treating complex distal-type fistulae. © 2016 Wiley Periodicals, Inc.

Community-based walking exercise for peripheral artery disease: An exploratory pilot study.

Supervised walking exercise is an effective treatment to improve walking ability of patients with peripheral artery disease (PAD), but few exercise programs in community settings have been effective. The aim of this study was to determine the efficacy of a community-based walking exercise program with training, monitoring and coaching (TMC) components to improve exercise performance and patient-reported outcomes in PAD patients. This was a randomized, controlled trial including PAD patients (n=25) who previously received peripheral endovascular therapy or presented with stable claudication. Patients randomized to the intervention group received a comprehensive community-based walking exercise program with elements of TMC over 14 weeks. Patients in the control group did not receive treatment beyond standard advice to walk. The primary outcome in the intent-to-treat (ITT) analyses was peak walking time (PWT) on a graded treadmill. Secondary outcomes included claudication onset time (COT) and patient-reported outcomes assessed via the Walking Impairment Questionnaire (WIQ). Intervention group patients (n=10) did not significantly improve PWT when compared with the control group patients (n=10) (mean ± standard error: +2.1 ± 0.7 versus 0.0 ± 0.7 min, p=0.052). Changes in COT and WIQ scores were greater for intervention patients compared with control patients (COT: +1.6 ± 0.8 versus -0.6 ± 0.7 min, p=0.045; WIQ: +18.3 ± 4.2 versus -4.6 ± 4.2%, p=0.001). This pilot using a walking program with TMC and an ITT analysis did not improve the primary outcome in PAD patients. Other walking performance and patient self-reported outcomes were improved following exercise in community settings. Further study is needed to determine whether this intervention improves outcomes in a trial employing a larger sample size.

The ROX coupler: creation of a fixed iliac arteriovenous anastomosis for the treatment of uncontrolled systemic arterial hypertension, exploiting the physical properties of the arterial vasculature.

OBJECTIVES: Uncontrolled hypertension, whether due to drug resistance or poor adherence and persistence, remains a problem in many patients. The ROX coupler is a novel technology designed to reduce arterial blood pressure consequent to the predicted physical effects of reducing vascular resistance and improving arterial compliance. This article describes the technical aspects of the device and implantation procedure, results from a preclinical study, patient selection criteria, and potential complications of this therapy for uncontrolled hypertension. BACKGROUND: The coupler is a self-expanding, stent-like device that exploits the mechanical effects of the creation of a low-resistance, high-compliance venous segment to the central arterial tree, and can be implanted in a standard catheterization laboratory under fluoroscopic guidance. METHODS: Preclinical studies were conducted in sheep with acute or chronic hypertension. The devices were implanted in the aorta for up to 12 months. The anastomoses were evaluated for patency, healing, conformation into the artery and vein, and complications. RESULTS: Deployment of the anastomotic device in ovine aortas for up to 12 months showed optimal anastomotic patency in all animals with proper healing and conformation of the device into the artery and the vein. There was no significant residual mural thrombus and minimal to moderate intimal thickening at the vein outflow, consistent with expected arterialization. CONCLUSIONS: A novel arteriovenous coupler for percutaneous placement in the iliac vasculature is under clinical investigation as a potential treatment modality for selected patients with uncontrolled hypertension. Initial results from patients with uncontrolled hypertension are expected in Autumn 2014.

Safety and effectiveness of drug-eluting versus bare-metal stents in saphenous vein bypass graft percutaneous coronary interventions: insights from the Veterans Affairs CART program.

BACKGROUND: Stenosis of saphenous vein grafts (SVGs) after coronary artery bypass grafting (CABG) is common and often requires percutaneous coronary interventions (PCI) for treatment. However, data for the effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) in SVG-PCI are unclear. OBJECTIVES: This study sought to examine the association between DES versus BMS used during SVG PCI and clinical outcomes in the national Veterans Affairs integrated healthcare system. METHODS: We studied a national cohort of 2,471 post-CABG veterans undergoing SVG-PCI between 2008 and 2011 at all Veterans Affairs hospitals and compared clinical outcomes of between those receiving DES and BMS. Clinical outcomes included procedural complications, myocardial infarction (MI), and all-cause mortality. Comparisons were made in a propensity-matched cohort using Cox proportional hazards regression models. RESULTS: DES were used in 1,549 SVG-PCI patients (63%) and the use of DES increased progressively with each calendar year (50% in 2008 to 69% in 2011). Incidence of procedural complications was low and comparable in both groups (2.8% among BMS vs. 2.3% among DES patients; p = 0.54). During long-term (>2 years) follow-up, use of DES was associated with lower mortality than BMS (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.57 to 0.89) and similar rates of MI (HR: 0.94; 95% CI: 0.71 to 1.24) in the propensity-matched cohort. CONCLUSIONS: In a national cohort of veterans, we observed widespread and increasing use of DES during SVG-PCI. In long-term follow-up, compared with BMS, DES use was safe and effective in SVG-PCI patients.

Comparison of a safety strategy using transradial access and dual-axis rotational coronary angiography with transfemoral access and standard coronary angiography.

OBJECTIVES: We sought to investigate the radiation exposure and contrast utilization associated with using a strategy of transradial access and rotational angiography (radial-DARCA) compared to the traditional approach of transfemoral access and standard angiography (femoral-SA). BACKGROUND: There is an increased focus on optimizing patient safety during cardiac catheterization procedures. Professional guidelines have highlighted physician responsibility to minimize radiation doses and contrast volume. Dual axis rotational coronary angiography (DARCA) is the most recently investigated type of rotational angiography. This new technique permits complete visualization of the left or right coronary tree with a single injection, and is felt to reduce contrast and radiation exposure. METHODS: A total of 56 consecutive patients who underwent radial-DARCA were identified. From the same time period, an age- and gender-matched group of 61 patients who had femoral-SA were selected for comparison. Total volume of contrast agent used, fluoroscopy time, and 2 measures of radiation dose (dose area product and air kerma) were recorded for each group. RESULTS: Mean contrast agent use and patient radiation exposure of the radial-DARCA group were significantly less than that of the femoral-SA group. There was no significant difference in fluoroscopy time between the 2 groups. CONCLUSIONS: Physicians can successfully employ an innovative safety strategy of transradial access combined with DARCA that is feasible and is associated with lower radiation doses and contrast volume than femoral artery access and traditional coronary angiography approach.

Acute and medium-term outcomes of endovascular therapy of obstructive disease of diverse etiology of the common femoral artery.

BACKGROUND: Common femoral endarterectomy is regarded as the standard revascularization strategy for the treatment of common femoral artery (CFA) disease. The availability of a variety of endovascular tools has resulted in an increased number of patients with CFA disease being treated using an endovascular strategy. We sought to evaluate clinical outcomes in a contemporary series of patients who were treated for CFA disease using an endovascular-first approach. METHODS: All patients with obstructive CFA disease who were treated using endovascular therapy were retrospectively identified from a peripheral interventional database. Baseline patient characteristics, anatomic details, procedural data, and clinical outcomes were assessed. Kaplan-Meier (KM) curves for mortality, amputation-free survival, and primary and secondary patency were generated. RESULTS: Between 2006 and 2011, a total of 30 patients underwent 31 CFA procedures. The primary etiologies of CFA obstruction were atherosclerosis (58%), access-site-related complication (32%), and thromboembolism (10%). Patients presented with severe claudication (60%), critical limb ischemia (13%), or acute limb ischemia (27%). The procedure was technically successful in 90% of cases with major complications in two (7%) patients. There was no procedure-related mortality. The KM estimate of survival and amputation-free survival at 1 year was 96% (± 4%) and 96% (± 4%), respectively. In those patients who had a successful revascularization, the overall 1-year estimate for primary and secondary patency was 88% (± 6) and 92% (± 5%), respectively. There was a nonsignificant trend toward lower patency in patients treated for atherosclerotic disease compared to those with access-site-related complications and thromboembolic disease at 2-year follow-up (76 vs. 100%, P = 0.08). CONCLUSIONS: Endovascular therapy for treatment of obstructive disease of the CFA is associated with a high rate of acute technical success. Primary patency rates in the cohort treated for access-site-related complications and thromboembolic disease are excellent and support an endovascular-first approach for this patient subset. Based on lower patency rates, surgical endarterectomy for the treatment of atherosclerotic disease in the CFA remains the gold standard in patients with normal surgical risk.

Embolization of radiopaque tip component of clip delivery system of MitraClip device: a rare complication with successful percutaneous retrieval.

This case report describes a rare complication that occurred during the performance of a MitraClip procedure. Following deployment of the clip, the portion of the device that attaches the clip to the clip delivery system (CDS), referred to as the radiopaque tip, embolized to the left atrium during removal of the CDS through the guide catheter. The percutaneous strategy that was used to successfully retrieve the radiopaque tip is described and discussed.