Long-term durability of self-expanding and balloon-expandable transcatheter aortic valve prostheses: UK TAVI registry.

BACKGROUND: With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. AIMS: We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. METHODS: Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry. Patients with paired echocardiograms postprocedure and ≥5-years post-TAVI were included. Severe SVD was determined according to European task force guidelines. RESULTS: 221 patients (79.4 ± 7.3 years; 53% male) were included with median echocardiographic follow-up 7.0 years (range 5-13 years). Follow-up exceeded 10 years in 43 patients (19.5%). Valve types were the supra-annular self-expanding CoreValve (SEV; n = 143, 67%), balloon-expandable SAPIEN/XT (BEV; n = 67, 31%), Portico (n = 4, 5%) and unknown (n = 7, 3%). There was no difference between postprocedure and follow-up peak gradient in the overall cohort (19.3 vs. 18.4 mmHg; p = NS) or in those with ≥10-years follow-up (21.1 vs. 21.1 mmHg; p = NS). Severe SVD occurred in 13 patients (5.9%; median 7.8-years post-TAVI). Three cases (23.1%) were due to regurgitation and 10 (76.9%) to stenosis. Valve-related reintervention/death occurred in 5 patients (2.3%). Severe SVD was more frequent with BEV than SEV (11.9% vs. 3.5%; p = 0.02), driven by a difference in patients treated with small valves (BEV 28.6% vs. SEV 3.0%; p < 0.01). CONCLUSIONS: Hemodynamic function of transcatheter heart valves remains stable up to more than 10 years post-TAVI. Severe SVD occurred in 5.9%, and valve-related death/reintervention in 2.3%. Severe SVD was more common with BEV than SEV.

Quality of Life Assessment in Patients Undergoing Trans-Catheter Aortic Valve Implantation Using MacNew Questionnaire.

The MacNew questionnaire is a disease-specific quality of life measure that has been used in patients with myocardial infarction and heart failure. We aimed to investigate the impact of transcatheter aortic valve implantation (TAVI) on health-related quality of life (HRQoL) using MacNew Questionnaire and identify predictors associated with a change in its score. This was a prospective multi-center study performed across 5 National Health Service hospitals in the United Kingdom performing TAVI between 2016 and 2018. HRQoL was assessed using MacNew Questionnaire, Euro Quality of Life-5D-5L, and Short Form 36 questionnaires collected at baseline, 3-, 6- and 12 months after the procedure. Out of 225 recruited patients, 19 did not have TAVI and 4 withdrew their consent, and hence 202 patients were included. HRQoL was assessed in 181, 161, and 147 patients at 3, 6, and 12 months, respectively. Using MacNew, there was a significant improvement in all domains of HRQoL as early as 3 months after TAVI which was sustained up to 12 months with improved discrimination of change in HRQoL compared with other scales. Poor mobility at baseline and history of myocardial infarction were independent predictors of reduced improvement in HRQoL at 3 months. HRQoL increased in all subgroups of patients including frail ones. In conclusion, the MacNew assessment tool performed well in a representative TAVI cohort and could be used as an alternative disease-specific method for assessing HRQoL change after TAVI.

Ultra-low contrast, complex left main coronary intervention case series using novel intravascular ultrasound technology.

BACKGROUND: Contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) carries a high morbidity and mortality. Ultra-low contrast percutaneous coronary intervention (ULPCI) has previously been described. Complex left main (LM) ULPCI using two-stent strategy guided by novel intravascular ultrasound (IVUS) co-registration software has not been described. We report a series of complex LM ULPCI using IVUS co-registration. CASE SUMMARIES: Five patients with estimated glomerular filtration rate ≤20 mL/min who presented with stable angina or non-ST segment elevation acute coronary syndrome underwent percutaneous coronary intervention (PCI). The patients previously had diagnostic angiography performed as a separate procedure. Successful LM ULPCI was performed in all patients with a provisional and two-stent bifurcation strategies. These were complex procedures, some of which required haemodynamic support and rotational atherectomy. DISCUSSION: This report describes the first ULPCI using a dedicated two-stent LM bifurcation strategy and using rotational atherectomy and IVUS co-registration. This technology facilitated complex PCI in this high-risk patient group with minimal contrast use (≤6 mL) with optimal results and no patients developed acute kidney injury after intervention. The adaptation of ULPCI to daily practice in patients at risk of CIN will improve treatment for this underserved patient group.

Contemporary Management of Patent Foramen Ovale: A Multinational Survey on Cardiologists' Perspective.

OBJECTIVES: The purpose of our survey is to analyze the clinical approach used by interventional and imaging cardiologists to diagnose, treat, and follow-up patients with PFO-related left circulation thromboembolism in different parts of the world with particular emphasis on adherence to current guidelines. BACKGROUND: Firm guidelines do not cover many aspects of PFO-related patient care. Consequently, very disparate approaches exist among clinicians in the real-world. METHODS: A 24-item electronic questionnaire was sent directly to experienced cardiology specialists practicing at consultant/attending positions directly involved in PFO closure management in the United States, United Kingdom, Gulf countries, and other countries. There were no unanswered questions. Responses were recorded between October 2019 and July 2020. RESULTS: Seventy-one responses were obtained: 31 from the UK, 19 from the US, 16 from Gulf countries, 2 from Poland, and 1 response from Australia, Italy, and Switzerland. The overall response rate was 76%. Significant differences between regions were noted in the duration of ECG monitoring during the diagnostic process, PFO closure for left circulation thromboembolism other than stroke/transient ischemic attack, and intraoperative use of intracardiac echocardiography. A similar pattern was noted in the lack of routine screening for thrombophilia and the use of the long-term single antiplatelet therapy. CONCLUSIONS: The study shows a vast spectrum of opinions on the optimal approach to PFO closure with significant differences between the US, UK, and Gulf countries. The results stress the need for systematic, high-quality data on the diagnostic work-up and follow-up strategies to inform the standardized approach.

Mental Health Outcomes Among British Healthcare Workers-Lessons From the First Wave of the Covid-19 Pandemic.

OBJECTIVE: To ascertain the level of psychological distress, using validated psychology tools, among British National healthcare workers (HCW) during the first wave of the Covid-19 crisis. METHODS: A multi-centre, anonymized, all-comer staff survey across 3 hospitals in Lancashire, England during the Covid-19 first wave (April to June 2020), consisting of Patient Health Questionnaire (PHQ-9), Perceived Stress Scale-10 (PSS-10), Generalized Anxiety Disorder-7 (GAD-7), and Impact of Events Scale (IES-6). RESULTS: Among 1113 HCW, median (IQR) PHQ-9, GAD-7, PSS-10, and IES-6 score was 7 (3 to 11), 6 (3 to 11), 19 (13 to 24), and 9 (5 to 14), respectively. Potential predictors of higher levels of psychological distress included living alone, disabled dependents, history of depression/anxiety, and being female. CONCLUSIONS: The study indicates a high prevalence of psychological distress during the acute Covid-19 period among HCW, identifies groups at risk and areas of future research.

Meta-Analysis Comparing Percutaneous to Surgical Access in Trans-Femoral Transcatheter Aortic Valve Implantation.

To compare the outcomes in trans-femoral transcatheter aortic valve implantation (TF-TAVI) performed with percutaneous approach (PC) versus surgical cut-down (SC). In 13 trials including 5,859 patients (PC = 3447, SC = 2412), the outcomes based on Valve Academic Research Consortium criteria were compared between PC and SC in TF-TAVI. Compared with SC, PC was associated with similar major vascular complications (VCs) (8.7% vs 8.5%; odds ratio [OR] = 0.93, 95% confidence interval [CI] = 0.76 to 1.15, p = 0.53), major bleeding (OR = 1.09, 95% CI = 0.66 to 1.8, p = 0.73), perioperative mortality (5.7% vs 5.2%; OR = 1.13, 95% CI = 0.85 to 1.49, p = 0.4), urgent surgical repair (OR = 1.27, 95% CI = 0.81 to 2.02, p = 0.3), stroke (3.3% vs 3.9%; OR = 0.85, 95% CI = 0.53 to 1.36, p = 0.5), myocardial infarction (1.3% vs 1.1%; OR = 1.06, 95% CI = 0.53 to 2.12, p = 0.86), and renal failure (5.2% vs 5.9%; OR = 0.68, 95% CI = 0.38 to 1.22, p = 0.2), but shorter hospital stay (9.1 ± 8.5 vs 9.6 ± 9.5 days; mean difference = -1.07 day, 95% CI = -2.0 to -0.15, p = 0.02) and less blood transfusion (18.5% vs 25.7%; OR = 0.61, 95% CI = 0.43-0.86, p = 0.005). Minor VCs occurred more frequently in PC compared to SC (11.9% vs 6.9%; OR = 1.67, 95% CI = 1.04-2.67, p = 0.03). In conclusion, in TF-TAVI, PC is a safe and feasible alternative to SC, and adopting either approach depends on operator experience after ensuring that vascular access could be safely achieved with that specific technique.

Complex regional pain syndrome: A rare but potentially disabling complication of transradial cardiac catheterization.

BACKGROUND: Chronic Regional Pain Syndrome (CRPS) is a rare complication following transradial cardiac catheterization. AIMS: To discuss the clinical features, pathophysiology, diagnosis and management of CRPS. METHODS: Literature review performed. RESULTS: CRPS is seen rarely in the literature following upper limb arterial access for coronary procedures, which may be due to a low incidence of the syndrome as well as limited recognition and underreporting. DISCUSSION: The diagnosis and management of CRPS are discussed in detail. CONCLUSION: If CRPS is a potential diagnosis then prompt early referral to a center with a specialist interest in CRPS is recommended. Prompt diagnosis and early commencement on the correct patient treatment pathway are essential, to avoid potentially life changing disability and the psychological consequences of living with intractable chronic undiagnosed pain.

Initial experience of a self-expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry.

OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Balloon-assisted tracking technique as 'a way forward' for transradial intervention.

BACKGROUND: In percutaneous coronary interventions, use of the radial artery may be limited by vascular anatomy or vascular complications, such as radial artery spasm, dissection or perforation. The balloon-assisted tracking (BAT) technique is a novel and innovative method to successfully perform transradial procedures in patients with difficult vascular anatomy, severe tortuosity or radial artery spasm. In addition, the BAT technique can serve as a bail-out technique when vascular complications such as artery dissection or perforation occur. OBJECTIVE: We analysed data of all percutaneous coronary intervention patients in whom the BAT technique was undertaken in daily practice and report acute and long-term outcomes. RESULTS: A total of 62 patients were included and, in most patients, the BAT technique was performed for radial spasm. Most patients were administered benzodiazepines or nitrates before the BAT technique was performed. The primary end point, defined as successful passage of the catheter through the artery of the arm using the BAT technique, was 98%. 11% of patients developed a complication within 24 h (haematoma, prolonged pain or visible vascular damage at the end of procedure); all completely recovered at follow-up. No complications occurred during long-term follow-up. CONCLUSION: BAT is a low-risk and easy-to-use technique that increases the success rate of radial artery access and may prevent vascular complications.

Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.

OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Successful Transcatheter Aortic Valve Replacement Using Balloon-Expandable Valve for Pure Native Aortic Valve Regurgitation in the Presence of Ascending Aortic Dissection.

The use of balloon-expandable prosthesis in the treatment of native aortic valve regurgitation in the presence of ascending aortic dissection is described.

Balloon assisted retraction of a migrated CoreValve Evolut R bioprosthesis during cardiac arrest.

We describe a case of balloon assisted retraction of a migrated CoreValve Evolut R bioprosthesis during trans-femoral TAVI.

Incidence and mechanisms of longitudinal stent deformation associated with Biomatrix, Resolute, Element, and Xience stents: Angiographic and case-by-case review of 1,800 PCIs.

BACKGROUND: There is conflicting evidence regarding the incidence of longitudinal stent deformation (LSD) in contemporary practice. METHODS AND RESULTS: To assess the incidence and mechanism of LSD across commonly used DES platforms, we performed a case-by-case review of 1,800 PCI cases involving 450 consecutive procedures using Biomatrix Flex, Resolute Integrity, Promus Element, and Xience V stents, respectively, between January 2009 and December 2011. LSD was detected in a higher proportion with Promus Element [15 (3.1%)] compared with other platforms (Xience V [4 (0.9%)], Biomatrix [3 (0.7%)], Resolute [3 (0.7%)]; P = 0.002). LSD was characterized as guide catheter/guide extension induced, or as impact from secondary devices such as postdilatation balloons or IVUS catheters. The incidence of guide catheter/guide extension LSD was similar across platforms; (Promus Element [5 (1.1%)], Xience V [4 (0.9%)], Biomatrix [3 (0.7%)], Resolute [3 (0.7%)]; P = 0.85). Secondary device LSD occurred exclusively with Promus Element (9/450 cases [2%] (P < 0.0001). Re-entering the deformed stent was more difficult in cases of secondary device LSD (6/9 compared with 0/12 treated cases; P < 0.001). Univariate predictors of LSD were previous CABG, culprit vessel, ostial involvement, and lesion tortuosity. Multivariate predictors of LSD were the Promus Element stent (OR 5.53 CI[1.54-19.85]), Guideliner use (OR 22.09 CI[4.73-103]), postdilation balloons (OR 5.47 CI[1.31-22.81]) and number of stents deployed (OR 2.06 CI[1.45-2.9]. CONCLUSION: LSD is more common than previously reported. LSD by a guide catheter/guide extension occurred equally with all platforms, however, LSD associated with secondary devices only occurred with the Element stent. These findings have important implications regarding current and future stent designs.

Use of the Sideguard (Cappella) stent in bifurcation lesions: a real-world experience.

AIMS: The Sideguard® stent (Cappella Medical Devices Ltd, Galway, Ireland), is a novel nitinol self-expanding dedicated bifurcation stent that flares proximally at the ostium of the side branch (SB) into a trumpet shape thereby achieving full ostial coverage. The aim of this study is to report the utility and limitations of this stent in patients undergoing treatment to bifurcation coronary lesions in a real-world setting. METHODS AND RESULTS: We prospectively identified 20 successive patients admitted over a 6-month period in whom there was significant SB disease and who were suitable for a bifurcation procedure. The Sideguard® stent was successfully used in all 20 cases including several that would have been technically difficult using conventional bifurcation techniques. We highlight use of this system using five illustrative cases that illustrate its utility and limitations in the treatment of bifurcation lesions. CONCLUSIONS: The Sideguard® stent can be used to treat complex bifurcation lesions in a straight forward manner and is not subject to the limitations associated with conventional bifurcation PCI techniques including jailing of the SB ostium and inability to fully cover/scaffold the ostium of the SB.

Gross aortic root dilation in a young woman with acromegaly.

Mild aortic root dilation is relatively common in patients with acromegaly and does not usually require surgical intervention. A case involving a 27-year-old acromegalic woman who presented with heart failure and gross aortic root dilation that was successfully treated with a composite aortic graft prosthesis is described.

A comparison of drug-eluting stents versus bare metal stents in saphenous vein graft PCI outcomes: a meta-analysis.

AIMS: Studies demonstrate that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta-analysis to compare outcomes between BMS and DES in SVG PCI. METHODS AND RESULTS: A search (2004-2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta-analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta-analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53-0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51-0.82; P < 0.001), total lesion revascularization (OR 0.60; 95% CI 0.43-0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41-0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies. CONCLUSIONS: Our meta-analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed.