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1.
Cardiology ; 2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38527430

ABSTRACT

Introduction The role of balloon aortic valvuloplasty (BAV) amid the era of transcatheter aortic valve replacement (TAVR) remains a topic of debate. We sought to study the safety and feasibility of combined balloon aortic valvuloplasty and percutaneous coronary intervention (BAV-PCI). Methods Between November 2009 and July 2020, all patients undergoing BAV were identified and divided into three groups: combined BAV-PCI (group A), BAV with significant unrevascularised CAD (group B) and BAV without significant CAD (group C). Procedural outcomes, 30-day and one-year mortality were compared. Results A total of 264 patients were studied (n = 84, 93 and 87 patients in group A, B and C, respectively). The STS score was 10.2 ±8, 13.3 ±19 and 8.1 ±7, p = 0.026, in group A, B and C, respectively. VARC-3 adjudicated complications were similar among groups (11%, 13% and 5%, respectively, p = 0.168, respectively). Thirty-day and one-year mortality were 9.8% (n =26) and 32% (n = 86) of the entire cohort. The differences among groups did not reach statistical significance. Using univariate Cox regression analysis, group B were at higher risk of dying compared to group A patients (HR 1.58, 95% CI 1.11 - 2.25, p = 0.010). With multivariate Cox regression analysis, the predictors of mortality were STS score, cardiogenic shock, and mode of presentation and lack of subsequent definitive valve intervention. Conclusion In high-risk patients with aortic valve stenosis, combined BAV-PCI is safe and feasible with comparable outcomes to BAV with and without significant CAD.

2.
Eur Heart J ; 45(21): 1904-1916, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38554125

ABSTRACT

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.


Subject(s)
Aortic Valve Stenosis , Benchmarking , Length of Stay , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Male , Female , Aged, 80 and over , Length of Stay/statistics & numerical data , Aged , Critical Pathways , Europe/epidemiology , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Patient Safety
3.
JAMA ; 327(19): 1875-1887, 2022 05 17.
Article in English | MEDLINE | ID: mdl-35579641

ABSTRACT

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/surgery , Aortic Valve Insufficiency/etiology , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/surgery , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome
4.
JACC Cardiovasc Interv ; 15(6): 590-598, 2022 03 28.
Article in English | MEDLINE | ID: mdl-35331450

ABSTRACT

OBJECTIVES: The aim of this study was to determine the safety and efficacy of same-day discharge (SDD) after transcatheter aortic valve replacement (TAVR) during the COVID-19 pandemic. BACKGROUND: The COVID-19 pandemic has placed significant stress on health care systems worldwide. SDD in highly selected TAVR patients can facilitate the provision of essential cardiovascular care while managing competing COVID-19 resource demands. METHODS: Patient selection for SDD was at the discretion of the local multidisciplinary heart team, across 7 international sites. The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new permanent pacemaker (PPM) implantation. RESULTS: From March 2020 to August 2021, 124 of 2,100 patients who underwent elective transfemoral TAVR were selected for SDD. The average age was 78.9 ± 7.8 years, the median Society of Thoracic Surgeons score was 2.4 (IQR: 1.4-4.2), and 32.3% (n = 40) had preexisting PPMs. There were no major vascular complications, strokes, or deaths during the index admission. One patient (0.8%) required PPM implantation for complete heart block and was discharged the same day. No patient required a PPM between discharge home and 30-day follow-up. The composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new PPM at 30 days occurred in 5.7% patients (n = 6 of 106). CONCLUSIONS: SDD post-TAVR is safe and feasible in selected patients at low risk for adverse clinical events postdischarge. This strategy may have a potential role in highly selected patients even when the COVID-19 pandemic abates.


Subject(s)
Aortic Valve Stenosis , COVID-19 , Transcatheter Aortic Valve Replacement , Aftercare , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/etiology , Aortic Valve Stenosis/surgery , Humans , Pandemics , Patient Discharge , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
5.
Clin Cardiol ; 44(10): 1344-1353, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34499383

ABSTRACT

BACKGROUND: The use of transcatheter aortic valve implantation (TAVI) for treating aortic stenosis (AS) has increased exponentially in recent years. Despite the availability of clinical practice guidelines for the management of valvular heart disease, disparities in quality of care (QoC) for TAVI patients remain widespread across Europe. Tailored QoC measures will help to reduce resource utilization and improve patient outcomes without compromising patient safety. Using a clear set of QoC measures, the BENCHMARK registry aims to document the progress that can be achieved if such tailored QoC measures are implemented. METHODS: The BENCHMARK registry (BENCHMARK) is a non-interventional, multicenter registry in patients with severe symptomatic AS undergoing TAVI with a 1- and 12-months follow-up. BENCHMARK will be conducted at 30 centers across Europe and will enroll a total of 2400 consecutive TAVI patients. Patients suffering from severe symptomatic AS who undergo TAVI with a balloon-expandable transcatheter aortic valve will be included. The registry will comprise four phases: (1) a retrospective baseline evaluation phase; (2) an education phase; (3) an implementation phase; and (4) a prospective effect documentation phase (prospective phase). The registry's primary objectives are to reduce the length of hospital stay and accelerate the post-procedural patient recovery pathway, but without compromising safety. The study started in April 2021 and has an estimated completion date of May 2023. DISCUSSION: BENCHMARK will establish QoC measures to reduce resource utilization, intensive care unit bed occupancy, and overall length of hospitalization with uncompromised patient safety post-TAVI (ClinicalTrials.gov Identifier: NCT04579445).


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Benchmarking , Europe , Humans , Prospective Studies , Registries , Retrospective Studies , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
7.
Catheter Cardiovasc Interv ; 98(3): E444-E452, 2021 09.
Article in English | MEDLINE | ID: mdl-33502784

ABSTRACT

OBJECTIVES: To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. BACKGROUND: New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. METHODS: We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. RESULTS: Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. CONCLUSIONS: A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Aftercare , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Humans , Male , Patient Discharge , Postoperative Complications , Retrospective Studies , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
9.
Br J Cardiol ; 28(2): 20, 2021.
Article in English | MEDLINE | ID: mdl-35747458

ABSTRACT

Increased demand for transcatheter aortic valve implantation (TAVI) procedures for patients with severe aortic stenosis has not been matched with a proportional increase in available resources in recent years. This article highlights the importance of developing integrated care pathways for TAVI, which incorporate standardised protocols for permanent pacemaker implantation (PPI) to ensure best practice, increase service efficiency and reduce rates of PPI post-TAVI.

10.
EuroIntervention ; 17(1): 23-31, 2021 May 17.
Article in English | MEDLINE | ID: mdl-32624457

ABSTRACT

The proposed 2020 Core Curriculum for Percutaneous Cardiovascular Interventions aims to provide an updated European consensus that defines the level of experience and knowledge in the field of percutaneous cardiovascular intervention (PCI). It promotes homogenous education and training programmes among countries, and is the cornerstone of the new EAPCI certification, designed to support the recognition of competencies at the European level and the free movement of certified specialists in the European Community. It is based on a thorough review of the ESC guidelines and of the EAPCI textbook on percutaneous interventional cardiovascular medicine. The structure of the current core curriculum evolved from previous EAPCI core curricula and from the "2013 core curriculum of the general cardiologist" to follow the current ESC recommendations for core curricula. In most subject areas, there was a wide - if not unanimous - consensus among the task force members on the training required for the interventional cardiologist of the future. The document recommends that acquisition of competence in interventional cardiology requires at least two years of postgraduate training, in addition to four years devoted to cardiology. The first part of the curriculum covers general aspects of training and is followed by a comprehensive description of the specific components in 54 chapters. Each of the chapters includes statements of the objectives, and is further subdivided into the required knowledge, skills, behaviours, and attitudes.


Subject(s)
Cardiology , Percutaneous Coronary Intervention , Cardiology/education , Consensus , Curriculum , Europe , Humans
11.
Heart Views ; 22(4): 297-299, 2021.
Article in English | MEDLINE | ID: mdl-35330651

ABSTRACT

Transcatheter aortic valve implantation (TAVI) for bicuspid aortic valve stenosis can pose several technical challenges including difficult valve crossing. We report the case of a 77-year-old woman undergoing transfemoral TAVI for symptomatic severe bicuspid aortic stenosis. It proved impossible to cross the bicuspid aortic valve retrogradely despite the use of multiple catheters and wires and attempts by two interventional cardiologists. We describe a novel approach to antegrade crossing, through a transseptal access, to permit retrograde implant of prosthesis.

12.
J Am Heart Assoc ; 9(15): e016990, 2020 08 04.
Article in English | MEDLINE | ID: mdl-32715844

ABSTRACT

Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization. Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST-TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1-year after discharge. The end point-a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding-was reached in 27.0% of patients (95% CI, 23.3-31.2) within 1 year after intervention; 7.5% (95% CI, 5.5-10.2) had in-hospital complications before discharge and 19.6% (95% CI, 16.3-23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular-access-related complications 0.7%, life-threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days. Conclusions The FAST-TAVI risk assessment provides a tool for appropriate, risk-based discharge that was validated with the 1-year event rate after transfemoral TAVI. Registration URL: https://www.ClinicalTrials.gov; Unique identifier: NCT02404467.


Subject(s)
Patient Discharge , Postoperative Complications/epidemiology , Registries , Transcatheter Aortic Valve Replacement/statistics & numerical data , Europe/epidemiology , Humans , Prospective Studies
13.
Eur J Cardiovasc Nurs ; 19(6): 537-544, 2020 08.
Article in English | MEDLINE | ID: mdl-32498556

ABSTRACT

The COVID-19 pandemic continues to significantly impact the treatment of people living with aortic stenosis, and access to transcatheter aortic valve implantation. Transcatheter aortic valve implantation (TAVI) programmes require unique coordinated processes that are currently experiencing multiple disruptions and are guided by rapidly evolving protocols. We present a series of recommendations for TAVI programmes to adapt to the new demands, based on recent evidence and the international expertise of nurse leaders and collaborators in this field. Although recommended in most guidelines, the uptake of the role of the TAVI programme nurse is uneven across international regions. COVID-19 is further highlighting why a nurse-led central point of coordination and communication is a vital asset for patients and programmes. We propose an alternative streamlined evaluation pathway to minimize patients' pre-procedure exposure to the hospital environment while ensuring appropriate treatment decision and shared decision-making. The competing demands created by COVID-19 require vigilant wait list management, with risk stratification, telephone surveillance and optimized triage and prioritization. A minimalist approach with close scrutiny of all parts of the procedure has become an imperative to avoid any complications and ensure patients' accelerated recovery. Lastly, we outline a nurse-led protocol of rapid mobilization and reconditioning as an effective strategy to facilitate safe next-day discharge home. As the pandemic abates, TAVI programmes must facilitate access to care without compromising patient safety, enable hospitals to manage the competing demands created by COVID-19 and establish new processes to support patients living with valvular heart disease.


Subject(s)
Aortic Valve Insufficiency/surgery , Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , Transcatheter Aortic Valve Replacement , Aortic Valve Stenosis/surgery , COVID-19 , Humans , Patient Discharge , Patient Safety , Practice Guidelines as Topic , SARS-CoV-2 , Treatment Outcome
14.
Int J Cardiol ; 308: 67-72, 2020 06 01.
Article in English | MEDLINE | ID: mdl-32247575

ABSTRACT

BACKGROUND: Surgical subclavian (SC) and direct aortic (DA) access are established alternatives to the default transfemoral route for transcatheter aortic valve implantation (TAVI). We sought to find differences in survival and procedure-related outcomes after SC- versus DA-TAVI. METHODS: We performed an observational cohort analysis of cases prospectively uploaded to the UK TAVI registry. To ensure the most contemporaneous comparison, the analysis focused on SC and DA procedures performed from 2013 to 2015. RESULTS: Between January 2013 and July 2015, 82 (37%) SC and 142 (63%) DA cases were performed that had validated 1-year life status. Multivariable regression analysis showed procedure duration was longer for SC cases (SC 193.5 ± 65.8 vs. DA 138.4 ± 57.7 min; p < .01) but length of hospital stay was shorter (SC 8.6 ± 9.5 vs. DA 11.9 ± 10.8 days; p = .03). Acute kidney injury was observed less frequently after SC cases (odds ratio [OR] 0.35, 95% confidence interval [CI 0.12-0.96]; p = .042) but vascular access site-related complications were more common (OR 9.75 [3.07-30.93]; p < .01). Procedure-related bleeding (OR 0.54 [0.24-1.25]; p = .15) and in-hospital stroke rate (SC 3.7% vs. DA 2.1%; p = .67) were similar. There were no significant differences in in-hospital (SC 2.4% vs. DA 4.9%; p = .49), 30-day (SC 2.4% vs. DA 4.2%; p = .71) or 1-year (SC 14.5% vs. DA 21.9%; p = .344) mortality. CONCLUSIONS: Surgical subclavian and direct aortic approaches can offer favourable outcomes in appropriate patients. Neither access modality conferred a survival advantage but there were significant differences in procedural metrics that might influence which approach is selected.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , United Kingdom/epidemiology
15.
Circ Cardiovasc Interv ; 13(2): e008855, 2020 02.
Article in English | MEDLINE | ID: mdl-32069113
16.
Case Rep Cardiol ; 2019: 6707690, 2019.
Article in English | MEDLINE | ID: mdl-31110822

ABSTRACT

Intramyocardial calcification is a rare phenomenon often only discovered on postmortem. We describe the case of a healthy 69-year-old lady diagnosed with idiopathic caseous intracardiac calcification extending from the mitral valve annulus. We present high-quality images and propose an investigatory template for future cases.

17.
EuroIntervention ; 15(2): 147-154, 2019 06 20.
Article in English | MEDLINE | ID: mdl-30777842

ABSTRACT

AIMS: Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set of risk criteria that allows a safe and timely discharge, to validate their appropriateness prospectively in different centres and multiple European countries, and to assess post-discharge outcomes. METHODS AND RESULTS: We defined and validated the adequacy of a set of discharge criteria and its ability to predict timely and safe discharge properly after the intervention in a prospective, European, multicentre registry. A total of 502 unselected patients were enrolled at 10 sites in three countries. The primary endpoint, defined as a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding at 30 days, was reached in 12.9% of patients (95% CI: 11.3-16.5). The overall 30-day mortality was 1.1% (95% CI: 0.2-2.0), and the rates of stroke/TIA 1.7% (95% CI: -0.6 to 4.0), PPI 7.3% (95% CI: 5.8-8.9), major vascular complications 1.9% (95% CI: 0.7-3.1), major/life-threatening bleeding 2.4% (95% CI: 1.0-3.8) and cardiac re-hospitalisation 3.7% (95% CI: 1.4-6.0). Patients appropriately discharged early had a significantly lower risk of the primary endpoint (7.0 vs. 26.4%; p<0.001) which was reflected in some of its relevant components: stroke (0.0 vs. 2.8%; p=0.015), PPI (4.3 vs. 15.9%; p<0.001), major vascular complications (0.3 vs. 4.7%; p=0.004) and major/life-threatening bleeding (0.3 vs. 6.5%; p<0.001). CONCLUSIONS: We validated the appropriateness of a pre-specified set of risk criteria that allows a safe and timely discharge. The rate of 30-day complications did not reveal any risk increase with this strategy compared with the reported outcomes in major TAVI trials and registries. ClinicalTrials.gov Identifier: NCT02404467.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aortic Valve , Europe , Humans , Patient Discharge , Prospective Studies , Registries , Risk Factors , Treatment Outcome
18.
JAMA ; 321(1): 56-68, 2019 01 01.
Article in English | MEDLINE | ID: mdl-30620371

ABSTRACT

Importance: Microvascular obstruction commonly affects patients with acute ST-segment elevation myocardial infarction (STEMI) and is associated with adverse outcomes. Objective: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with alteplase infused early after coronary reperfusion will reduce microvascular obstruction. Design, Setting, and Participants: Between March 17, 2016, and December 21, 2017, 440 patients presenting at 11 hospitals in the United Kingdom within 6 hours of STEMI due to a proximal-mid-vessel occlusion of a major coronary artery were randomized in a 1:1:1 dose-ranging trial design. Patient follow-up to 3 months was completed on April 12, 2018. Interventions: Participants were randomly assigned to treatment with placebo (n = 151), alteplase 10 mg (n = 144), or alteplase 20 mg (n = 145) by manual infusion over 5 to 10 minutes. The intervention was scheduled to occur early during the primary PCI procedure, after reperfusion of the infarct-related coronary artery and before stent implant. Main Outcomes and Measures: The primary outcome was the amount of microvascular obstruction (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment. The primary comparison was the alteplase 20-mg group vs the placebo group; if not significant, the alteplase 10-mg group vs the placebo group was considered a secondary analysis. Results: Recruitment stopped on December 21, 2017, because conditional power for the primary outcome based on a prespecified analysis of the first 267 randomized participants was less than 30% in both treatment groups (futility criterion). Among the 440 patients randomized (mean age, 60.5 years; 15% women), the primary end point was achieved in 396 patients (90%), 17 (3.9%) withdrew, and all others were followed up to 3 months. In the primary analysis, the mean microvascular obstruction did not differ between the 20-mg alteplase and placebo groups (3.5% vs 2.3%; estimated difference, 1.16%; 95% CI, -0.08% to 2.41%; P = .32) nor in the analysis of 10-mg alteplase vs placebo groups (2.6% vs 2.3%; estimated difference, 0.29%; 95% CI, -0.76% to 1.35%; P = .74). Major adverse cardiac events (cardiac death, nonfatal MI, unplanned hospitalization for heart failure) occurred in 15 patients (10.1%) in the placebo group, 18 (12.9%) in the 10-mg alteplase group, and 12 (8.2%) in the 20-mg alteplase group. Conclusions and Relevance: Among patients with acute STEMI presenting within 6 hours of symptoms, adjunctive low-dose intracoronary alteplase given during the primary percutaneous intervention did not reduce microvascular obstruction. The study findings do not support this treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT02257294.


Subject(s)
Coronary Occlusion/drug therapy , ST Elevation Myocardial Infarction/drug therapy , Tissue Plasminogen Activator/administration & dosage , Aged , Area Under Curve , Cardiac Catheters , Combined Modality Therapy , Coronary Angiography , Coronary Occlusion/surgery , Coronary Vessels , Dose-Response Relationship, Drug , Female , Humans , Infusions, Intra-Arterial , Magnetic Resonance Imaging , Male , Middle Aged , Percutaneous Coronary Intervention , Quality of Life , ST Elevation Myocardial Infarction/surgery , Tissue Plasminogen Activator/adverse effects , Treatment Failure , Troponin T/blood
19.
J Cardiovasc Pharmacol Ther ; 24(4): 359-364, 2019 07.
Article in English | MEDLINE | ID: mdl-30614246

ABSTRACT

AIMS: There are limited data on aspirin (ASA) desensitization for patients with coronary disease. We present our experience with a rapid nurse-led oral desensitization regimen in patients with aspirin sensitivity undergoing coronary angiography. METHODS: This single-center retrospective observational study includes patients with a history of ASA sensitivity undergoing coronary angiography with intent to perform percutaneous coronary intervention (PCI). RESULTS: Between January 2012 and January 2017, 24 patients undergoing coronary angiography for stable coronary disease (7 cases) or acute coronary syndromes (non-ST-segment myocardial infarction [NSTEMI; 8 cases], STEMI [9 cases]) underwent aspirin desensitization having reported previous reactions to aspirin. At initial presentation, previous sensitivity reactions were reported as: mucocutaneous reactions in 17 patients (urticaria in 3 [13%], nonurticarial rash in 6 [25%], angio-oedema in 8 [33%]), respiratory sensitivity in 4 (17%), and systemic anaphylactoid reactions in 3 (13%). Seventeen (71%) patients underwent PCI. Desensitization was acutely successful in 22 (92%) patients and unsuccessful in 2 (8%) patients who both had a single short-lived episode of acute bronchospasm treated successfully with nebulized salbutamol. Fifteen successfully desensitized patients completed 12 months of aspirin; no patient had recurrent hypersensitivity reaction. Aspirin was stopped prior to 12 months in 7 patients (replaced by warfarin [1 case], no antiplatelet or single antiplatelet clinically indicated and clopidogrel chosen [4 cases], patient choice without evidence of recurrent hypersensitivity [1 case], and death due to cardiogenic shock following STEMI [1 case]). CONCLUSION: A rapid aspirin desensitization protocol is safe and effective across a broad spectrum of hypersensitivity reactions and clinical presentations.


Subject(s)
Acute Coronary Syndrome/therapy , Aspirin/administration & dosage , Desensitization, Immunologic , Drug Hypersensitivity/prevention & control , Non-ST Elevated Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/administration & dosage , ST Elevation Myocardial Infarction/therapy , Acute Coronary Syndrome/diagnostic imaging , Aged , Aged, 80 and over , Aspirin/adverse effects , Aspirin/immunology , Desensitization, Immunologic/adverse effects , Desensitization, Immunologic/nursing , Drug Hypersensitivity/diagnosis , Drug Hypersensitivity/immunology , Female , Humans , Male , Middle Aged , Non-ST Elevated Myocardial Infarction/diagnostic imaging , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/immunology , Retrospective Studies , ST Elevation Myocardial Infarction/diagnostic imaging , Time Factors , Treatment Outcome
20.
Heart Lung Circ ; 28(4): 637-646, 2019 Apr.
Article in English | MEDLINE | ID: mdl-29685717

ABSTRACT

BACKGROUND: Vascular complications from transfemoral (TF) secondary access during transcatheter aortic valve implantation (TAVI) are common. We compare our experience of transradial (TR) versus transfemoral secondary access during TAVI and describe techniques for performing iliofemoral arterial intervention from the transradial approach. METHODS: All TAVI procedures with a single secondary access were included. Demographics, procedural details and 30-day outcomes were recorded. VARC-2 criteria were used for procedural complications. Procedures with TF primary access were stratified by the site of secondary arterial access. RESULTS: Single secondary access was used in 199 cases, of which 20 were performed via non-TF access. Of the 179 TF primary access cases, 115 (64%) used TR secondary access and 64 (36%) used TF secondary access. In the TR cohort percutaneous vascular intervention was performed from the transradial approach in 19 cases (17%). Emergent TF secondary access was not required in any case. There were no differences in procedural time, radiation dose, contrast use, bleeding complications, stroke or mortality between the groups. There was one secondary access complication in the TF cohort and none in the TR cohort. CONCLUSIONS: Transradial (TR) secondary access during TAVI is safe and feasible and may reduce the secondary access site vascular complication rate. With appropriate equipment, most peripheral vascular complications can be managed entirely via TR access avoiding unplanned femoral arterial access. TR secondary access should be considered the default approach for non-TF TAVI cases and can be considered for all TF cases as long as dedicated equipment is available.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Catheterization, Peripheral/methods , Intraoperative Complications/prevention & control , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Angiography , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/diagnosis , Female , Follow-Up Studies , Humans , Intraoperative Complications/diagnosis , Male , Middle Aged , Radial Artery , Retrospective Studies , Treatment Outcome
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