Short-term outcome after transcatheter aortic valve replacement with a novel balloon-expandable valve.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) has been expanding rapidly with numerous transcatheter heart valve (THV) systems currently available. The Myval balloon-expandable (BE) valve (Meril Life Sciences Pvt. Ltd., India) is a novel THV system indicated for the treatment of patients with severe aortic stenosis. The primary objective of this study is to assess the safety and performance of the Myval BE valve. METHODS: In this prospective single-centre study, 120 consecutive patients who underwent TAVR with the Myval BE valve were included. Clinical outcomes were evaluated at 30 days and 6 months using Valve Academic Research Consortium­2 criteria. All-cause mortality, stroke, acute kidney injury, major vascular complications, moderate or severe paravalvular leakage (PVL) and need for a permanent pacemaker implantation (PPI) were investigated. RESULTS: At 6­month follow-up, all-cause death and cardiac death were seen in 5.8% and 0.8% of the patients respectively. Periprocedural stroke and need for PPI were both seen in 3.3% of the patients. Access-site-related vascular and bleeding complications were absent. Improved valve haemodynamics and no moderate to severe PVL could be seen at 30 days. An intermediate valve size was selected in 51% of the patients. CONCLUSIONS: The Myval BE valve demonstrates improved valve haemodynamics, absence of moderate to severe PVL and good safety outcomes at 6­month follow-up with low cardiac death rate and acceptable rates of permanent pacemaker implantation and periprocedural stroke. Future randomised controlled trials will further establish the clinical utility of the Myval BE valve.

Transcatheter aortic valve implantation amid the COVID-19 pandemic: a nationwide analysis of the first COVID-19 wave in the Netherlands.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has put tremendous pressure on healthcare systems. Most transcatheter aortic valve implantation (TAVI) centres have adopted different triage systems and procedural strategies to serve highest-risk patients first and to minimise the burden on hospital logistics and personnel. We therefore assessed the impact of the COVID-19 pandemic on patient selection, type of anaesthesia and outcomes after TAVI. METHODS: We used data from the Netherlands Heart Registration to examine all patients who underwent TAVI between March 2020 and July 2020 (COVID cohort), and between March 2019 and July 2019 (pre-COVID cohort). We compared patient characteristics, procedural characteristics and clinical outcomes. RESULTS: We examined 2131 patients who underwent TAVI (1020 patients in COVID cohort, 1111 patients in pre-COVID cohort). EuroSCORE II was comparable between cohorts (COVID 4.5 ± 4.0 vs pre-COVID 4.6 ± 4.2, p = 0.356). The number of TAVI procedures under general anaesthesia was lower in the COVID cohort (35.2% vs 46.5%, p < 0.001). Incidences of stroke (COVID 2.7% vs pre-COVID 1.7%, p = 0.134), major vascular complications (2.3% vs 3.4%, p = 0.170) and permanent pacemaker implantation (10.0% vs 9.4%, p = 0.634) did not differ between cohorts. Thirty-day and 150-day mortality were comparable (2.8% vs 2.2%, p = 0.359 and 5.2% vs 5.2%, p = 0.993, respectively). CONCLUSIONS: During the COVID-19 pandemic, patient characteristics and outcomes after TAVI were not different than before the pandemic. This highlights the fact that TAVI procedures can be safely performed during the COVID-19 pandemic, without an increased risk of complications or mortality.

The history of transcatheter aortic valve implantation: The role and contribution of an early believer and adopter, the Netherlands.

This paper describes the history of transcatheter aortic valve implantation (TAVI) from its preclinical phase during which visionary pioneers developed its concept and prototype valves against strong head wind to first application in clinical practice (2002) and the clinical and scientific role of an early believer and adopter, the Netherlands (2005).

The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation.

Aortic valve stenosis is one of the most common valvular abnormalities, which can manifest as angina, syncope, dyspnoea and sudden cardiac death. Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to surgical valve replacement in patients with severe aortic valve stenosis, resulting in less morbidity, shorter time to recovery and similar mortality rates. Progress in this field has reduced complication rates. However, the incidence of peri-procedural stroke remains relatively high (around 4%). To fully utilise the potential of TAVI, cerebral embolic protection devices (CEPD) have been developed and introduced. In this position paper, we aim to summarise the available data on several CEPD.

Treatment decision for transcatheter aortic valve implantation: the role of the heart team : Position statement paper of the Dutch Working Group of Transcatheter Heart Interventions.

The current paper presents a position statement of the Dutch Working Group of Transcatheter Heart Valve Interventions that describes which patients with aortic stenosis should be considered for transcatheter aortic valve implantation and how this treatment proposal/decision should be made. Given the complexity of the disease and the assessment of its severity, in particular in combination with the continuous emergence of new clinical insights and evidence from physiological and randomised clinical studies plus the introduction of novel innovative treatment modalities, the gatekeeper of the treatment proposal/decision and, thus, of qualification for cost reimbursement is the heart team, which consists of dedicated professionals working in specialised centres.

Incidence and outcome of prosthetic valve endocarditis after transcatheter aortic valve replacement in the Netherlands.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used as an alternative to conventional surgical valve replacement. Prosthetic valve endocarditis (PVE) is a rare but feared complication after TAVR, with reported first-year incidences varying from 0.57 to 3.1%. This study was performed to gain insight into the incidence and outcome of PVE after TAVR in the Netherlands. METHODS: A multicentre retrospective registry study was performed. All patients who underwent TAVR in the period 2010-2017 were screened for the diagnosis of infective endocarditis in the insurance database and checked for the presence of PVE before analysis of general characteristics, PVE parameters and outcome. RESULTS: A total of 3968 patients who underwent TAVR were screened for PVE. During a median follow-up of 33.5 months (interquartile range (IQR) 22.8-45.8), 16 patients suffered from PVE (0.4%), with a median time to onset of 177 days (IQR 67.8-721.3). First-year incidence was 0.24%, and the overall incidence rate was 0.14 events per 1000 person-years. Overall mortality during follow-up in our study was 31%, of which 25% occurred in hospital. All patients were treated conservatively with intravenous antibiotics alone, and none underwent a re-intervention. Other complications of PVE occurred in 5 patients (31%) and included aortic abscess (2), decompensated heart failure (2) and cerebral embolisation (1). CONCLUSION: PVE in patients receiving TAVR is a relatively rare complication and has a high mortality rate.

Recommendations for the use of bioresorbable vascular scaffolds in percutaneous coronary interventions : 2017 revision.

BACKGROUND: To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or 'bioresorbable vascular scaffolds' (BVS) have been developed. METHODS: We reviewed all currently available clinical data on BVS implantation. RESULTS: Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implantation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individualised approach for patients treated with current generation BVS. CONCLUSION: The new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place.

Antithrombotic therapy in patients undergoing TAVI: an overview of Dutch hospitals.

PURPOSE: To assess current antithrombotic treatment strategies in the Netherlands in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: For every Dutch hospital performing TAVI (n = 14) an interventional cardiologist experienced in performing TAVI was interviewed concerning heparin, aspirin, thienopyridine and oral anticoagulation treatment in patients undergoing TAVI. RESULTS: The response rate was 100 %. In every centre, a protocol for antithrombotic treatment after TAVI was available. Aspirin was prescribed in all centres, concomitant clopidogrel was prescribed 13 of the 14 centres. Duration of concomitant clopidogrel was 3 months in over two-thirds of cases. In 2 centres, duration of concomitant clopidogrel was based upon type of prosthesis: 6 months versus 3 months for supra-annular and intra-annular prostheses, respectively. CONCLUSIONS: Leaning on a small basis of evidence and recommendations, the antithrombotic policy for patients undergoing TAVI is highly variable in the Netherlands. As a standardised regimen might further reduce haemorrhagic complications, large randomised clinical trials may help to establish the most appropriate approach.

Antiplatelet therapy in patients undergoing coronary stenting: The risk of late stent thrombosis.

BACKGROUND: Anticoagulation after coronary stenting is essential to prevent stent thrombosis. Drug-eluting stents, which are the preferred therapy, may be associated with a higher tendency for stent thrombosis. METHODS: Patients who underwent coronary stent placement and presented with late stent thrombosis are described. RESULTS: Eight patients with stent thrombosis are presented. Early discontinuation of the antithrombotic medication is associated with the occurrence of these complications. CONCLUSION: Long-term antithrombotic therapy seems essential to prevent stent thrombosis, especially for patients treated with drug-eluting stents.

Angioscopic versus angiographic detection of intimal dissection and intracoronary thrombus.

OBJECTIVES: This study was undertaken to compare coronary angioscopy with angiography for the detection of intimal dissection and intracoronary thrombus. BACKGROUND: It has been demonstrated previously that coronary angioscopy provides more intravascular detail than cineangiography. Both imaging methods have to be compared directly to assess the additional diagnostic value of angioscopy. METHODS: The angiograms and videotapes of 52 patients who had undergone angioscopy were reviewed independently by two observers unaware of other findings. Classic angiographic definitions were used for dissection and thrombus. Angioscopic dissection was defined as visible cracks or fissures on the lumen surface or mobile protruding structures that are contiguous with the vessel wall. Angioscopic thrombus was defined as a red, white or mixed red and white intraluminal mass. RESULTS: Angiography and angioscopy were in agreement in 40.4% of cases in the absence of thrombus and in 11.5% in the presence of thrombus. No fewer than 25 (48.1%) angioscopically observed thrombi remained undetected at angiography. With angioscopy as the standard, although the specificity of angiography for thrombus was 100%, sensitivity was very low at 19%. Angioscopic dissection was present in 40 patients (76.9%) versus angiographic dissection in 15 patients (28.8%). With regard to dissection, there was no correlation between the two imaging methods (r phi = 0.15, p = 0.29). CONCLUSIONS: Coronary angiography underestimates the presence of intracoronary thrombus. Angioscopy and angiography are complementary techniques for detecting and grading intimal dissections.

Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group.

OBJECTIVES: This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. BACKGROUND: The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. METHODS: To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. RESULTS: After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. CONCLUSIONS: These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.

Percutaneous coronary angioscopic comparison of thrombus formation during percutaneous coronary angioplasty with ionic and nonionic low osmolality contrast media in unstable angina.

Patients with unstable coronary syndromes are more likely to have a lesion containing thrombus and have a higher procedural complication and restenosis rate. The aim of this study was to evaluate the effect of an ionic (ioxaglate) and a nonionic (iohexol) low osmolality contrast media on thrombus generation using percutaneous intracoronary angioscopy in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Thirty patients with unstable angina pectoris randomized to either ioxaglate or iohexol (15 patients in each group), underwent percutaneous intracoronary angioscopy before and after PTCA and 15 minutes after PTCA. Angioscopically visible thrombus was defined using the Ermenonville classification and the lesion divided into 3 zones-proximal, mid, and distal. Angiographic filling defects were seen in 3 patients before PTCA, and in 10 after PTCA. Angioscopically visible thrombus was seen in 10 patients before PTCA in the ioxaglate group and 8 in the iohexol group. After PTCA 5 patients (33.3%) in the ioxaglate and 11 (73.6%) in the iohexol group developed new thrombus, p = 0.028. Total thrombi before PTCA were 16 versus 13, after PTCA 25 versus 27, and at 15 minutes after PTCA 23 versus 25, ioxaglate versus iohexol respectively, p = NS. There was no correlation between type or extent of intimal dissection and angioscopically visible new thrombus formation. Angiography underestimated the incidence of intracoronary thrombus before and after PTCA. Nonionic low osmolality contrast medium was associated with significantly more patients developing angioscopically visible new thrombus. This has clinical implications in the choice of contrast medium used in PTCA, particularly in the setting of unstable angina.

Reocclusion three months after successful thrombolytic treatment of acute myocardial infarction with anisoylated plasminogen streptokinase activating complex.

Thirty consecutive patients with acute myocardial infarction (AMI) were treated with anisoylated plasminogen streptokinase activating complex (APSAC) within 4 hours after onset of symptoms. After 1.5 and 48 hours, patency of the infarct-related vessel and the quantitative degree of residual diameter stenosis were studied by selective coronary angiography. Ventriculograms were made to determine the global left ventricular ejection fraction. Patients showing patency at 48 hours were reevaluated angiographically after 3 months. At 1.5 and 48 hours after APSAC administration patent vessels were demonstrated in 65 and 69% of patients, respectively. Mean residual stenosis decreased significantly from 56 +/- 11% at 1.5 hours to 46 +/- 13% at 48 hours (p less than 0.01). Patients not responding to thrombolytic therapy showed significant deterioration of the left ventricular function during the first 48 hours after AMI. Side effects were minor and mainly associated with invasive procedures. Despite adequate oral anticoagulation, angiographically documented reocclusion at 3 months amounted to 28%. Reocclusion, however, was neither associated with clinically documented reinfarction, nor with a decrease in the left ventricular ejection fraction. Our study shows that APSAC is an effective thrombolytic agent in AMI but that late reocclusion may occur. Oral anticoagulants appear to be less effective in the prevention of reocclusion in the treatment regimen after thrombolysis.

Autoperfusion balloon versus stent for acute or threatened closure during percutaneous transluminal coronary angioplasty.

Efficacy and major clinical end points were compared in 61 patients treated with a Stack autoperfusion balloon versus 36 patients who received a Palmaz-Schatz stent for acute or threatened closure during coronary angioplasty. The groups were comparable regarding baseline clinical characteristics. Procedural success was achieved in 43 patients (70%) treated with an autoperfusion balloon versus 34 patients (94%) who received a stent (p < 0.02). Emergency bypass surgery was performed in 13 patients (21%) with the autoperfusion balloon versus none of the patients with a stent (p < 0.001). In the stent group, 3 patients (8%) died (p < 0.05); 2 deaths were caused by thrombotic reclosure, and 1 patient died after unsuccessful stent delivery. Subacute reclosure during hospitalization occurred in none of the patients with autoperfusion versus 8 patients with the stent (22%) (p < 0.0002). Therefore, the number of patients with successful stent implantation at discharge decreased to 26 (72%). At 3-month follow-up in all patients with a successful intervention, reclosure or angiographic restenosis (> 50%) occurred in 13 patients with autoperfusion (30%) versus 3 patients with stents (12%) (p = NS). There was no difference in event-free survival during follow-up. Thus, both interventions were equally successful in the treatment of acute and threatened closure. More emergency surgery was performed in the autoperfusion balloon group, whereas a higher subacute reclosure rate was seen in the stent group. At 3-month follow-up, there were no significant differences regarding reclosure, restenosis, and event-free survival.

Coronary blood flow dynamics during transcutaneous electrical nerve stimulation for stable angina pectoris associated with severe narrowing of one major coronary artery.

To study the effect of transcutaneous electrical nerve stimulation (TENS) on coronary vasomotion, patients with New York Heart Association class III angina pectoris and significant single-vessel left coronary artery disease and who were also scheduled for elective percutaneous transluminal coronary angioplasty, were allocated to a study group (precordial actual TENS, n = 10) and a control group (precordial simulated TENS, n = 5, and TENS on the back, n = 3). Coronary volumetric flow was assessed in the stenotic and nonstenotic coronary artery before and after neurostimulation. The diameter (in millimeters) of the stenotic coronary artery was reduced in the study group after actual TENS (from 2.73 +/- 0.55 by 0.12 +/- 0.11; p = 0.008). In the nonstenotic coronary artery, the diameter increased in the study group (from 2.64 +/- 0.43 by 0.24 +/- 0.15; p = 0.01). In both the stenotic and nonstenotic coronary arteries, no effect was shown on the average peak velocity (centimeters per second) in the study group. The coronary volumetric flow (milliliters per minute) was reduced in the stenotic artery of the study group (from 62 +/- 18 by 8 +/- 7; p = 0.007). In the nonstenotic coronary artery, volumetric flow increased in the study group (from 57 +/- 18 by 11 +/- 10; p = 0.007). In the control group, simulated TENS and TENS on the back had no effect on the diameter of the artery, average peak velocity, or volumetric flow. In addition, in all patients, TENS had no effect on the total volumetric flow of the left coronary artery and hemodynamic variables during the study period. This observation suggests that TENS modulates regional coronary vasomotion in patients with coronary artery disease.

Minimally invasive coronary artery bypass grafting versus coronary angioplasty for isolated type C stenosis of the left anterior descending artery.

BACKGROUND: Isolated stenosis of the left anterior descending coronary artery can be treated with medication, percutaneous transluminal coronary angioplasty, or coronary artery bypass grafting. Recently a new treatment has been developed, which is called minimally invasive direct coronary artery bypass grafting. This new treatment is a modification of the conventional bypass operation and is performed through a small anterolateral thoracotomy without cardiopulmonary bypass. METHODS: To compare minimally invasive bypass with angioplasty, we evaluated in-hospital results and 1-year follow-up in 181 consecutive patients with isolated type C stenosis of the left anterior descending coronary artery between January 1995 and July 1996. Of these patients, 71 underwent minimally invasive bypass and 110 angioplasty. Preoperative characteristics were not significantly different between the two groups. RESULTS: In-hospital death, periprocedural myocardial infarction, emergency reoperation by means of conventional coronary bypass grafting, use of an intraaortic balloon pump, and cerebrovascular accidents were not significantly different between the two groups. At 1-year follow-up, survival was not significantly different in the two groups (minimally invasive bypass 95.7% +/- 0.2% vs angioplasty 95.3% +/- 0.2%; p = 0.89), whereas freedom from repeated revascularization was significantly more common in the group undergoing minimally invasive bypass (bypass 96.9% +/- 0.2% vs angioplasty 67.6% +/- 0.5%; p < 0.001). This study shows that the need for repeated revascularization, and therefore the use of health care resources, is significantly less with minimally invasive bypass than with angioplasty in patients with isolated type C stenosis of the left anterior descending coronary artery.

Histopathologic validation of in-vivo angioscopic observation of coronary thrombus after angioplasty in a porcine model.

BACKGROUND: Coronary angioscopy has been reported to be superior to angiography and intravascular ultrasound for detecting intracoronary thrombus. However, in-vivo histopathologic validation of angioscopic detection of intracoronary thrombus had not been performed. OBJECTIVE: To perform histopathologic validation of in-vivo angioscopic detection of coronary thrombus. DESIGN: An experimental, blinded comparison of angioscopy and histopathology. METHODS: Coronary angioscopy was performed from 0 to 14 days after angioplasty in 39 porcine coronary arteries. When thrombus was detected by angioscopy, it was subclassified into white, mixed red-white, or red thrombus according to color. By histopathology the presence of thrombus was determined and subclassified into platelet-rich, mixed platelet-erythrocyte, or erythrocyte-rich thrombus. RESULTS: Angioscopy correctly classified 19 of 21 coronary thrombi (sensitivity 90%) but incorrectly classified nine of 18 arteries without formation of thrombus as having a thrombus (specificity 50%). Positive and negative predictive values were 68 and 82%, respectively. The angioscopic subclassification of thrombus into white, mixed red-white, or red thrombi was not correlated to the corresponding histopathologic morphology (platelet-rich, mixed platelet-erythrocyte, or erythrocyte-rich) of the observed thrombi (chi2 test: P = 0.5). CONCLUSIONS: Angioscopic detection of thrombus in vivo had high sensitivity and negative predictive value but low-to-moderate specificity and positive predictive value. Visual assessment of color of angioscopically detected thrombi seemed not to reflect histopathologic morphology of thrombus according to the definitions used in the present study.

Autoperfusion balloon catheter for complicated coronary angioplasty: a prospective study with retrospective controls.

Prolonged angioplasty balloon inflation with an autoperfusion balloon for failed conventional coronary angioplasty, was compared with emergency surgery for this condition. Restenosis was assessed 6 weeks after successful intervention with the autoperfusion balloon. Forty consecutive patients with persistent acute occlusion and/or severe intimal dissection during conventional angioplasty, were treated with the autoperfusion balloon. They were candidates for emergency surgery if it failed. Total inflation time was significantly longer (p < 0.001) with the autoperfusion balloon (27.5; 10-180 min) than with the standard balloon (10; 1-20 min) (median; range). The number of inflations was significantly lower (p < 0.001) with the autoperfusion balloon (2; 1-5 times) than with the standard balloon (5; 2-14 times) (median; range). Two patients died, one before surgery could be performed. The autoperfusion balloon was successful in 26 patients (65%). After 6 weeks, 16 (62%) were asymptomatic without anti-anginal medication, 24 underwent repeat angiography, 10 (42%) had restenosis, 7 (27%) underwent elective bypass surgery. Emergency surgery remained necessary in 13 patients (33%), 9 received arterial grafts. In 31 retrospective controls, who had undergone immediate surgery for the same indication, only venous grafts could be used. Thus, prolonged autoperfusion balloon inflation was successful in 65% of the cases of failed, conventional angioplasty. The angiographic restenosis rate after 6 weeks was 42%. If emergency surgery remained necessary, the autoperfusion balloon facilitated the use of arterial bypass grafts.