The effect of transcatheter aortic valve implantation approaches on mortality.

OBJECTIVES: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS: This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS: In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches. CONCLUSIONS: The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

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.

Long-Term Durability of Transcatheter Aortic Valve Prostheses.

BACKGROUND: Very little is known about long-term valve durability after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure. METHODS: Demographic, procedural, and in-hospital outcome data on patients who underwent TAVR from 2007 to 2011 were obtained from the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. Patients in whom echocardiographic data were available both at baseline and ≥5 years post-TAVR were included. Hemodynamic SVD was determined according to European task force committee guidelines. RESULTS: A total of 241 patients (79.3 ± 7.5 years of age; 46% female) with paired post-procedure and late echocardiographic follow-up (median 5.8 years, range 5 to 10 years) were included. A total of 149 patients (64%) were treated with a self-expandable valve and 80 (34.7%) with a balloon-expandable valve. Peak aortic valve gradient at follow-up was lower than post-procedure (17.1 vs. 19.1 mm Hg; p = 0.002). More patients had none/trivial aortic regurgitation (AR) (47.5% vs. 33%), and fewer had mild AR (42.5% vs. 57%) at follow-up (p = 0.02). There was 1 case (0.4%) of severe SVD 5.3 years after implantation (new severe AR). There were 21 cases (8.7%) of moderate SVD (mean 6.1 years post-implantation; range 4.9 to 8.6 years). Twelve of these (57%) were due to new AR and 9 (43%) to restenosis. CONCLUSIONS: Long-term transcatheter aortic valve function is excellent. In the authors' study, 91% of patients remained free of SVD between 5 and 10 years post-implantation. The incidence of severe SVD was <1%. Moderate SVD occurred in 1 in 12 patients.

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.

Trans-catheter aortic valve implantation without contrast using the Lotus mechanically-expanded heart valve.

Trans-catheter aortic valve implantation (TAVI) has become an established treatment for inoperable and high-surgical risk patients with severe, symptomatic aortic stenosis (AS). Post-procedural acute kidney injury (AKI) is a frequent complication following TAVI and is associated with increased mortality. Patients with pre-existing chronic renal impairment are at particularly high risk. The etiology of post-TAVI AKI is multi-factorial, but the principal procedural issues are contrast-induced nephropathy, and renal hypoperfusion secondary to intra-procedural hypotension. We report a case of a TAVI in an 80-year-old patient with severe AS and significant chronic kidney disease (CKD), which was carried out without the use of contrast and with minimal procedural hypotension. Pre-procedural imaging was carried out using 3D trans-esophageal echocardiography (TEE) rather than computed tomography (CT) to avoid contrast administration. The Lotus valve (Boston Scientific, Marlborough, MA, USA) was chosen due to a number of design features which minimize both the need for contrast injection and procedural hypotension during valve positioning and deployment. The procedure was carried out successfully and produced an excellent result with no decline in renal function. We believe that the approach of using TEE and the mechanically-expanded Lotus valve illustrates an important therapeutic approach in patients with severe CKD. .

Transcatheter aortic valve implantation via the superficial femoral artery: An underused access route?

Common femoral arterial (CFA) access is the most commonly used access route for transcatheter aortic valve implantation (TAVI). In majority of cases, it is easily accessible percutaneously without requiring surgical cut down. However, in patients with high body mass index (BMI) or central obesity, it can be more than 8-10 cm below the skin making the procedure more technically demanding and satisfactory hemostasis more difficult to achieve. The superficial femoral artery (SFA) lies only a few centimeters distal to the CFA with little compromise on vessel caliber, yet can allow more suitable access in certain patients with a high BMI. We describe three cases in which SFA access was successfully used as the primary delivery route for TAVI.

Use of the Lotus Transcatheter Valve to Treat Severe Native Aortic Regurgitation.

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for aortic stenosis in high-risk patients. TAVI for native valve aortic regurgitation is technically more demanding because of a lack of anchoring calcification, a lower index incidence, heterogeneous causes, and larger anatomy. We present 3 cases in which the Lotus TAV was used to treat severe native aortic regurgitation (AR) successfully.

Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS). OBJECTIVES: This study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry. METHODS: Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria. RESULTS: Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28). CONCLUSIONS: Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.

New worldwide lipid guidelines.

PURPOSE OF REVIEW: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in most countries. Modification of common risk factors such as dyslipidaemia can result in significant reduction of ASCVD incidence in the population and improve clinical outcomes. The purpose of this review is to discuss and compare the latest worldwide lipid guidelines, and to demonstrate the variation in practice in different parts of the world. RECENT FINDINGS: The lipid guidelines have recently been updated in different countries. The National Institute for Health and Care Excellence (NICE) guidelines in the United Kingdom were issued in July 2014, are risk based and are broadly similar to the American College of Cardiology/American Heart Association task force guidelines that were published in November 2013. Both these guidelines are in variance with both the Canadian Guidelines and the European Society of Cardiology/European Atherosclerosis Society guidelines 2011, which are target based and have different risk scoring systems, which results in significant variation in practice and increased healthcare costs in certain countries. SUMMARY: The difference in guidelines in different countries makes it difficult for the clinician to standardize the treatment provided to individuals. The variance in risk scoring systems makes it difficult to compare risk prediction tools across countries and hence the optimum treatment available for a given population. Standardization of guidelines based on randomized controlled trial data and validation and calibration of various risk scoring systems could help improve clinical outcomes in this high-risk group of individuals at risk of ASCVD within individual countries.

Guidelines in the USA, a viewpoint contrary to those guidelines in Europe, Canada, Britain and the International Atherosclerosis Society.

PURPOSE OF REVIEW: Management of dyslipidaemia is crucial for the reduction in the risk of atherosclerotic cardiovascular disease in the population. Optimum control of this risk factor in both primary and secondary care will not only help reduce cardiovascular disease, but also help reduce long-term healthcare costs for hospital stays, clinic visits and morbidity due to a chronic disease. The purpose of this review is to compare the recent American College of Cardiology/American Heart Association 2013 guidelines with those in Europe, Britain, Canada and the International Atherosclerosis Society position paper. RECENT FINDINGS: The American College of Cardiology/American Heart Association Task Force have published new guidelines on the management of LDL cholesterol for the reduction in atherosclerotic cardiovascular disease risk, which are in variance with the European Society of Cardiology/European Atherosclerosis Society and other country guidelines and have significant repercussions in different populations. SUMMARY: Significant variance between the guidelines can make it difficult for healthcare providers to provide standardized care in different countries, and their long-term implications are uncertain.

Clinical outcomes with 6 months dual antiplatelet therapy after implantation of biolimus-A9 drug eluting coronary stents.

INTRODUCTION: Duration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate. AIMS: We evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation. METHODS: 692 patients (77.2% male), aged 65.6 ± 12.5 years received biolimus-eluting DES (March 2008 -November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres). RESULTS: Presentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0-6 months, 1.0% at 6-12 months and 0.9% at >12 months. Of the 7 deaths between 6 and 12 months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months. CONCLUSIONS: After implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective.

Temporary transvenous pacing: endangered skill.

BACKGROUND: Temporary cardiac pacing although is an essential requirement for core medical training (CMT) in UK, there are no defined training measures and guidelines available as to who should perform this. METHODS: We conducted an anonymous survey of 300 non-cardiology medical registrars regarding their individual ability, experience and training received in temporary pacing wire (TPW) insertion. RESULTS: A total of 202 (67%) responses were received. 61% (123) had not performed any TPW insertion before becoming a registrar. Only 18% (38) felt confident in inserting a TPW unsupervised and only 14 (7%) had ever received any formal training. The majority, 169 (84%), did not feel that their on-call consultant general physician would be able to perform the procedure. CONCLUSION: This survey shows that general medical registrars lack a major life-saving skill that is required as part of CMT. Thus, there is now an urgent clinical governance need to either formally train physicians or abandon the concept and practice of general internal medicine-led temporary pacing, and devolve this to cardiologists.

First direct comparison of platelet reactivity and thrombolytic status between Japanese and Western volunteers: possible relationship to the "Japanese paradox".

OBJECTIVE: To determine and compare thrombotic and endogenous thrombolytic status in Japanese and Western populations. BACKGROUND: Incidence of coronary heart disease (CHD) and AMI in Japan remains lower than in Western countries. Primary genetic effects are unlikely, given the increased CHD in Japanese migrants. For men, cholesterol and blood pressure have been similar in Japan and the U.S. Dietary factors are implicated, but how these effect CHD is unclear. We postulated that differences in thrombotic and/or thrombolytic status may contribute. METHODS: We measured thrombotic and thrombolytic status in 100 healthy Japanese (J) from Japan and 100 healthy Westerners (W) from the U.K. using the Global Thrombosis Test (GTT). The GTT employs non-anticoagulated blood to create platelet-rich thrombi under high shear (occlusion time OT; seconds), and then measures the restart of blood flow, due to spontaneous thrombolysis (lysis time LT; seconds). RESULTS: OT was longer in (J) compared to (W) (545 vs. 364, p<0.0001). LT was longer in (J) than in (W) (1753 vs. 1052, p<0.0001). Distribution of LT in (J) did not conform to a normal population, with markedly impaired thrombolytic status (LT>3,000 s) in 18%, compared to none of the Westerners (p<0.0001). CONCLUSIONS: There are marked differences in thrombotic and thrombolytic status, with (J) having less prothrombotic (longer OT) but less favourable endogenous thrombolytic profile (longer LT). This may be important in the aetiology of thrombotic events. Since platelets and thrombolysis were both inhibited in (J) and yet incidence of AMI is lower, OT would seem more important than LT as a determinant of overall thrombotic risk in this population.

Impaired endogenous thrombolysis in acute coronary syndrome patients predicts cardiovascular death and nonfatal myocardial infarction.

OBJECTIVES: Our objective was to assess endogenous thrombolytic activity in acute coronary syndrome (ACS) patients and relate this to their likelihood of future adverse cardiovascular events. BACKGROUND: Spontaneous lysis of platelet-rich thrombi is an important defense mechanism against lasting occlusion. Despite convincing evidence for the role of endogenous fibrinolysis in ACS, the prognostic value of plasma fibrinolytic markers in assessing risk is limited. We employed a novel global test which, in addition to platelet reactivity, allows assessment of endogenous thrombolytic activity to identify ACS patients who remain at risk of cardiovascular events. METHODS: We used the global thrombosis test (GTT) to assess thrombotic and thrombolytic status in 300 ACS patients receiving dual-antiplatelet therapy. The test assesses the time required to form an occlusive thrombus, the occlusion time (OT), and the time to lyse this, the lysis time (LT). The end point of the study at 12 months' follow-up was the composite of death, nonfatal myocardial infarction, or stroke. RESULTS: The OT and LT were both prolonged in ACS patients compared with normal volunteers (p < 0.001). LT > or =3,000 s occurred in 23% of ACS patients versus none of the normal subjects and was a significant and independent predictor of cardiovascular death and nonfatal myocardial infarction in a multivariate model adjusted for cardiovascular risk factors. LT > or =3,000 s was the optimal cutoff value for predicting 12-month major adverse cardiovascular events (hazard ratio [HR]: 2.52, 95% confidence interval: 1.34 to 4.71, p = 0.004) and cardiovascular death (HR: 4.2, 95% confidence interval: 1.13 to 15.62, p = 0.033). HR increased further as LT increased. No association was found between OT and the risk of major adverse cardiovascular events. CONCLUSIONS: Assessment of endogenous thrombolytic status based on the lysis of platelet-rich thrombi from native blood using the point-of-care GTT can identify ACS patients at risk of future cardiac events.

Coronary thrombosis: In vivo, ex vivo and in vitro.

Acute stent thrombosis remains one of the most important concerns in clinical cardiology. The mechanism is not fully understood but a prothrombotic state is a key component. We describe a case of acute stent thrombosis, within an hour of rescue angioplasty, despite use of full dose fibrinolytic (reteplase) and antiplatelet therapy (aspirin and clopidogrel). Risk of acute stent thrombosis was predicted an hour earlier, when the patient was clinically well, by a novel near-patient test of thrombotic and thrombolytic status (in vitro). Subsequent stent thrombosis was visualised angiographically (in vivo) and confirmed by extraction of the thrombus (ex vivo). The near-patient test sensitively detected reversal of the prothrombotic state after abciximab treatment. We believe this is the first description of the clinical use of a near-patient test within the cardiac catheterisation laboratory to predict risk of imminent stent thrombosis.