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1.
JACC Cardiovasc Interv ; 17(5): 666-677, 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38479966

RESUMO

BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.


Assuntos
Estenose da Valva Aórtica , Dispositivos de Proteção Embólica , AVC Isquêmico , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , AVC Isquêmico/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de Risco , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia
2.
EuroIntervention ; 20(6): e376-e388, 2024 03 18.
Artigo em Inglês | MEDLINE | ID: mdl-38506739

RESUMO

BACKGROUND: There are limited data regarding treatment for failed balloon-expandable transcatheter heart valves (THVs) in redo-transcatheter aortic valve implantation (TAVI). AIMS: We aimed to assess THV performance, neoskirt height and expansion when performing redo-TAVI with the ACURATE platform inside a SAPIEN 3 (S3) compared to redo-TAVI with an S3 in an S3. METHODS: Redo-TAVI was performed on the bench using each available size of the S3, the ACURATE neo2 (ACn2) and the next-generation ACURATE Prime XL (AC XL) implanted at 2 different depths within 20 mm/23 mm/26 mm/29 mm S3s serving as the "failed" index THV. Hydrodynamic testing was performed to assess THV function. Multimodality assessment was performed using photography, X-ray, microcomputed tomography (micro-CT), and high-speed videos. RESULTS: The ACURATE in S3 combinations had favourable hydrodynamic performance compared to the S3 in S3 for all size combinations. In the 20 mm S3, redo-TAVI with the ACn2 had lower gradients compared to the S3 (mean gradient 16.3 mmHg for the ACn2 vs 24.7 mmHg for the 20 mm S3 in 20 mm S3). Pinwheeling was less marked for the ACURATE THVs than for the S3s. On micro-CT, the S3s used for redo-TAVI were underexpanded across all sizes. This was also observed for the ACURATE platform, but to a lesser extent. CONCLUSIONS: Redo-TAVI with an ACn2/AC XL within an S3 has favourable hydrodynamic performance and less pinwheeling compared to an S3 in S3. This comes at the price of a taller neoskirt.


Assuntos
Insuficiência Cardíaca , Substituição da Valva Aórtica Transcateter , Humanos , Microtomografia por Raio-X , Cateteres , Valvas Cardíacas
3.
Am J Cardiol ; 219: 60-70, 2024 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-38401656

RESUMO

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

5.
JACC Cardiovasc Interv ; 17(3): 374-387, 2024 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-38180419

RESUMO

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.


Assuntos
Estenose da Valva Aórtica , COVID-19 , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Pandemias , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/epidemiologia , Resultado do Tratamento , COVID-19/epidemiologia , Sistema de Registros , Fatores de Risco
6.
EuroIntervention ; 20(1): 95-103, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37982161

RESUMO

BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Sistema de Registros , Acidente Vascular Cerebral/etiologia , Desenho de Prótese
9.
Front Cardiovasc Med ; 10: 1288278, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38028444

RESUMO

Late balloon valvuloplasty can be used to treat under-expansion-related transcatheter heart valve (THV) dysfunction. Whether this can be performed following redo-THV implantation is unknown. Herein, we report a case of a 72-year-old male presenting with symptomatic gradient elevation following redo mitral valve-in-valve implantation. The patient was successfully treated with late balloon valvuloplasty with gradient improvement. In conclusion, late valvuloplasty is effective even with several layers of valves. However, larger studies are required to clarify the role of this approach further.

10.
Eur Heart J ; 44(46): 4862-4873, 2023 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-37930776

RESUMO

BACKGROUND AND AIMS: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. METHODS: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. RESULTS: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. CONCLUSIONS: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Feminino , Idoso , Masculino , Insuficiência da Valva Tricúspide/epidemiologia , Insuficiência da Valva Tricúspide/cirurgia , Valva Tricúspide/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Cateterismo Cardíaco/métodos , Índice de Gravidade de Doença
11.
JACC Cardiovasc Interv ; 16(23): 2820-2832, 2023 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-37905772

RESUMO

BACKGROUND: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. OBJECTIVES: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. METHODS: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. RESULTS: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). CONCLUSIONS: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.


Assuntos
Cateterismo Cardíaco , Insuficiência da Valva Mitral , Humanos , Cateterismo Cardíaco/efeitos adversos , Ecocardiografia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Resultado do Tratamento , Ensaios Clínicos como Assunto
12.
N Engl J Med ; 389(21): 1949-1960, 2023 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-37874020

RESUMO

BACKGROUND: A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS: We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. RESULTS: A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. CONCLUSIONS: Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Seguimentos , Readmissão do Paciente , Insuficiência Cardíaca/etiologia
13.
Curr Cardiol Rep ; 25(11): 1425-1431, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37815660

RESUMO

PURPOSE OF REVIEW: As TAVR is increasingly performed on younger patients with a longer life expectancy, the number of redo-TAVR procedures is likely to increase in the coming years. Limited data is currently available on this sometimes challenging procedure. We provide a summary of currently published literature on management of patients with a failed transcatheter aortic valve. RECENT FINDINGS: Recent registry data have increased the clinical knowledge on redo-TAVR. Additionally, numerous bench studies have provided valuable insights into the technical aspects of redo-TAVR with various combinations of valve types. Redo-TAVR can be performed safely in selected cases with a high procedural success and good short-term outcomes. However, at present, the procedure remains relatively infrequent and many patients are not eligible. Bench testing can be useful to understand important concepts such as valve expansion, neoskirt, leaflet overhang, and leaflet deflection as well as their potential clinical implications.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Resultado do Tratamento , Valva Aórtica/cirurgia , Fatores de Risco , Desenho de Prótese
14.
Ann Thorac Surg ; 2023 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-37717882

RESUMO

BACKGROUND: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. METHODS: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. RESULTS: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). CONCLUSIONS: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

16.
Curr Cardiol Rep ; 25(10): 1361-1371, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37698820

RESUMO

PURPOSE OF REVIEW: Mitral and tricuspid regurgitation represents a clinical challenge. They are associated with a poor prognosis, and many patients are not eligible for conventional surgery. Transcatheter therapies have been the focus of numerous studies and devices over the past decade. Here, we provide a summary of current options for transcatheter treatment of these 2 entities. RECENT FINDINGS: Recent studies have demonstrated the benefits of edge-to-edge repair for increasing numbers of patients. Encouraging early results with transcatheter valve replacement are also becoming available. To date, transcatheter edge-to-edge repair is currently the first-line transcatheter treatment for both mitral and tricuspid regurgitation for many patients who are not candidates for surgery. A number of transcatheter replacement devices are under development and clinical investigation but, for the most part, their current use is limited to compassionate cases or clinical trials.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Cateterismo Cardíaco/métodos , Resultado do Tratamento , Insuficiência da Valva Mitral/cirurgia
18.
Artigo em Inglês | MEDLINE | ID: mdl-37610363

RESUMO

AIM: Early mobilisation is associated with improved outcomes in hospitalised older patients. We sought to determine the effect of a nurse-led protocol on mobilisation 4 hours after transfemoral transcatheter aortic valve implantation (TAVI) across different units of care. METHODS AND RESULTS: We conducted a prospective observational cohort single centre study of consecutive patients. We implemented a standardised protocol for safe early recovery and progressive mobilisation in the critical care and cardiac telemetry units. We measured time to first mobilisation and conducted descriptive statistics to identify patient and systems barriers to timely ambulation.We recruited 139 patients (82.5 years, SD = 6.7; 46% women). At baseline, patients who mobilized early (≤4 hours) and late (>4 hours) did not differ, except for higher rates of diabetes (25.5% vs. 43.9%, p = 0.032) and peripheral arterial disease (8.2% vs. 26.8%, p = 0.003) in the late mobilisation group. Median time to mobilisation was 4 hours (IQR 3.25, 4); 98 patients (70.5%) were mobilized successfully after 4 hours of bedrest; 118 (84.9%) were walking by the evening of the procedure (< 8 hours bedrest), and 21 (15.1%) were on bedrest overnight and mobilised the following day. Primary reasons for overnight bedrest were arrhythmia monitoring (n = 10, 7.2%) and hemodynamic and/or neurological instability (n = 6, 4.3%); 6 patients (4.3%) experienced delayed ambulation due to systems issues. Procedure location in the hybrid operating room and transfer to critical care were associated with longer bedrest times. CONCLUSION: Standardised nurse-led mobilisation 4 hours after TF TAVI is feasible in the absence of clinical complications and system barriers.

19.
Can J Cardiol ; 39(12): 1959-1970, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37625668

RESUMO

BACKGROUND: Favourable early outcomes have been reported following valve-in-valve transcatheter mitral valve replacement (TMVR). However, reports of long-term outcomes are lacking. We aimed to evaluate early and late outcomes in a large first-in-human valve-in-valve TMVR 13-year experience. METHODS: All patients undergoing valve-in-valve TMVR in our centre from 2008 to 2021 were included. Clinical and echocardiographic outcomes, defined according to the Mitral Valve Academic Research Consortium, were reported. RESULTS: A total of 119 patients were analysed: mean age 76.8 ± 10.2 years, mean Society of Thoracic Surgeons score 10.7 ± 6.8%, 55.4% female, 63.9% transapical access. Thirty-day mortality was 2.5% for the total population and 0.0% after transseptal TMVR. Maximum follow-up was 13.1 years. During a median follow-up of 3.4 years (interquartile range 1.8-5.3 years), 55 patients (46.2%) died, mainly from noncardiovascular causes. Valve hemodynamics were acceptable at 5 years, with 2.5% structural dysfunction. Patients treated from 2016 on (n = 68; 57.1%), following the advent of routine use of the Sapien 3 valve, CT screening, and transseptal access, were compared with those treated before 2016 (n = 51; 42.9%). Patients from 2016 on had a higher technical success rate (100.0% vs 94.1%; P = 0.04), shorter hospitalisation (P < 0.001), trending lower 30-day mortality (1.5% vs 3.9%; P = 0.4) and better 5-year survival (74.7% vs 41.1%; P = 0.03). CONCLUSIONS: Valve-in-valve TMVR can be performed with little morbidity and low mortality. Mid- to long-term survival remains limited owing to advanced age and comorbidities. Structural bioprosthetic valve dysfunction was rare and redo TMVR feasible in selected patients. Outcomes continue to improve, but the role for valve-in-valve TMVR in lower surgical risk patients remains unclear.


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia
20.
CJC Open ; 5(7): 508-521, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37496781

RESUMO

Background: Historically, quality-of-care monitoring was performed separately for transcatheter and surgical aortic valve replacement (TAVR, SAVR). Using consensus indicators, we provide a global report on the quality of care for treatment of aortic stenosis across the highest-volume treatments: transfemoral (TF) TAVR, isolated SAVR, and SAVR combined with coronary artery bypass graft. Methods: Retrospective observational cohort study of consecutive patients in a regional system of care. Primary endpoint was 30-day and 1-year mortality (2015-2019). Secondary endpoints included rate of new pacemaker, rate of readmission, and length of stay (2012-2019). Following multivariable logistic regressions, we developed mortality case-mix adjustment models to report risk estimates. Results: The proportion of patients receiving TAVR grew from 32% to 53% (2015-2019). Those receiving TF TAVR were significantly older, with higher rates of comorbidities. Observed 30-day and 1-year all-cause mortality after TF TAVR decreased from 3.1% to 0.6% (P = 0.03), and 13.6% to 6.6% (P = 0.09), respectively; surgical mortality rates for isolated SAVR and SAVR combined with coronary artery bypass graft were low and did not change significantly over time, ranging from 0.3% to 1.4% and from 0.9% to 3.4%, respectively at 30 days, and from 0.9% to 3.4% and from 4.7% to 6.7 at 1 year. In the TF TAVR cohort, the observed vs expected ratio for 30-day and 1-year mortality decreased significantly from 1.9 (95% confidence interval [CI] 0.9, 3.5) to 0.3 (95% CI 0.1, 0.8), and from 1.3 (95% CI 0.9, 1.7) to 0.7 (95% CI 0.5, 0.99), respectively; no change occurred in risk-adjusted surgical mortality. Conclusions: Consensus quality indicators provide unique insights on the quality of care for patients receiving treatment for aortic stenosis.


Contexte: Par le passé, la surveillance de la qualité des soins était réalisée séparément pour l'implantation valvulaire aortique par cathéter (IVAC) et la chirurgie de remplacement valvulaire aortique (CRVA). À l'aide d'indicateurs consensuels, nous dressons un rapport général de la qualité des soins dans les traitements les plus courants de la sténose aortique : IVAC fémorale, CRVA seule et CRVA combinée à un pontage coronarien. Méthodologie: Une étude de cohorte observationnelle et rétrospective a été menée pour évaluer les patients consécutifs ayant fréquenté un système de santé régional. Le critère d'évaluation principal était le taux de mortalité à 30 jours et à 1 an (2015 à 2019). Les critères d'évaluation secondaires comprenaient le taux de nouveaux sti-mulateurs cardiaques, le taux de réadmission et la durée du séjour (2012 à 2019). Après des régressions logistiques multivariées, nous avons élaboré des modèles d'ajustement selon les groupes de cas pour le taux de mortalité afin d'estimer les risques. Résultats: La proportion de patients qui ont subi une IVAC est passée de 32 % à 53 % (2015 à 2019). Les patients qui ont subi une IVAC transfémorale étaient significativement plus vieux que ceux des autres groupes et présentaient un plus haut taux d'affections concomitantes. Les taux de mortalité de toute cause observés à 30 jours et à 1 an après une IVAC transfémorale ont respectivement diminué de 3,1 % à 0,6 % (P = 0,03) et de 13,6 % à 6,6 % (P = 0,09). Les taux de mortalité pour une CRVA seule et une CRVA combinée à un pontage coronarien étaient faibles et n'ont pas changé de manière significative au fil du temps : les taux de mortalité à 30 jours sont passés de 0,3 % à 1,4 % et de 0,9 % à 3,4 %, respectivement, et les taux de mortalité à 1 an, de 0,9 % à 3,4 % et de 4,7 % à 6,7 %, respectivement. Dans la cohorte ayant subi une IVAC transfémorale, le rapport du taux de mortalité observé par rapport au taux de mortalité attendu à 30 jours et à 1 an a diminué de manière significative, soit de 1,9 (intervalle de confiance [IC] à 95 % : 0,9 à 3,5) à 0,3 (IC à 95 % : 0,1 à 0,8), et de 1,3 (IC à 95 % : 0,9 à 1,7) à 0,7 (IC à 95 % : 0,5 à 0,99), respectivement. Aucune variation n'a été notée quant au taux de mortalité ajusté selon les risques pour une intervention chirurgicale. Conclusions: Les indicateurs consensuels de la qualité fournissent des informations uniques sur la qualité des soins chez les patients traités pour une sténose aortique.

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