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1.
Catheter Cardiovasc Interv ; 97(5): E731-E735, 2021 04 01.
Article in English | MEDLINE | ID: mdl-32473072

ABSTRACT

Postinfarction ventricular septal rupture is a rare and devastating complication of myocardial infarction. Despite attempts at acute surgical and percutaneous defect closure, morbidity and mortality remain high. Herein, we describe a hybrid surgical and catheter-based approach to defect closure in a 63-year-old woman with postinfarction ventricular septal rupture and cardiogenic shock.


Subject(s)
Heart Septal Defects, Ventricular , Myocardial Infarction , Ventricular Septal Rupture , Female , Heart Septal Defects, Ventricular/diagnostic imaging , Heart Septal Defects, Ventricular/surgery , Humans , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/diagnostic imaging , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Treatment Outcome , Ventricular Septal Rupture/diagnostic imaging , Ventricular Septal Rupture/etiology
2.
BMC Public Health ; 20(1): 1094, 2020 Jul 11.
Article in English | MEDLINE | ID: mdl-32652966

ABSTRACT

BACKGROUND: There is limited information about the predictors of multimorbidity (MM) among ethnic minority older adults in Iran. This study aimed to examine the impact of sociodemographic and lifestyle factors on the prevalence of MM, among older Kurdish people living in the Northwest of Iran. METHODS: The current study was conducted in Bukan city located in West Azarbaijan province in the Northwest of Iran. The data for this study was based on the enrolment phase of a longitudinal study on ageing among the Kurdish population aged 50-94 yearswhich was designed according to the elderly component of the PERSIAN Cohort in Iran. Stratified random sampling was used to select people aged 50 + from eight health centres in Bukan from Oct 2017 to Dec 2018. Those who accepted the invitation and completed the baseline questionnaire were included in this study (N = 1493; Response rate 75%). A range of different factors,including sociodemographic and lifestyle factors as well as self-reported chronic conditions, was obtained by trained interviewers. MM was defined as "coexistence of two or more chronic conditions in the same person". We included a list of 36 diseases/conditions in this analysis. Descriptive analysis and logistic regression were performed to compare the prevalence of MM according to different factors. RESULTS: Over a third of the participants (36.6%) had ≥2chronic conditionsand 15.7% had≥3 chronic conditions. Hypertension, diabetes, musculoskeletal conditions, fatty liver, and heart diseases were common chronic conditions. In a fully adjusted logistic regression model, older age (ORadj = 1.92, 95% CI: 1.48-2.48), being female (ORadj = 1.49, 95%CI: 1.14-1.94), living without aspouse (ORadj = 1.81, 95%CI: 1.34-2.44), and inadequate consumption of fruit and vegetables (ORadj = 1.33, 95%CI: 1.06-1.67) were associated with the higher prevalence of MM. CONCLUSION: This study found that the prevalence of MM is relatively high among older Kurdishadults. Sociodemographic differences in the prevalence of MM might be of interest tothe health care system,and the prevalence of common chronic conditions in this study may highlight the need forlifestyle modifications in this community.


Subject(s)
Chronic Disease/epidemiology , Ethnicity/statistics & numerical data , Multimorbidity , Rural Population/statistics & numerical data , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Iran/epidemiology , Logistic Models , Longitudinal Studies , Male , Middle Aged , Minority Groups/statistics & numerical data , Prevalence , Surveys and Questionnaires
3.
J Vasc Surg ; 68(2): 607-610, 2018 08.
Article in English | MEDLINE | ID: mdl-30037677

ABSTRACT

Atherosclerotic innominate artery occlusive disease can lead to cerebral and upper extremity ischemia. Innominate artery angioplasty and stenting can be complicated by stent fractures and restenosis; furthermore, this technique is limited in treatment of innominate artery occlusions. Ministernotomy to the second or third intercostal space can be used instead of conventional full sternotomy for open surgical revascularization of the innominate artery with excellent perioperative and long-term outcomes. This series of three consecutive patients highlights the technique of aorta-innominate artery bypass through ministernotomy.


Subject(s)
Aorta/surgery , Blood Vessel Prosthesis Implantation/methods , Brachiocephalic Trunk/surgery , Peripheral Arterial Disease/surgery , Sternotomy/methods , Aged , Aorta/diagnostic imaging , Aorta/physiopathology , Brachiocephalic Trunk/diagnostic imaging , Brachiocephalic Trunk/physiopathology , Female , Humans , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Retrospective Studies , Suture Techniques , Treatment Outcome
4.
Eur J Cancer Care (Engl) ; 27(2): e12644, 2018 Mar.
Article in English | MEDLINE | ID: mdl-28145020

ABSTRACT

Across Australia, prostate cancer support groups (PCSG) have emerged to fill a gap in psychosocial care for men and their families. However, an understanding of the triggers and influencers of the PCSG movement is absent. We interviewed 21 SG leaders (19 PC survivors, two partners), of whom six also attended a focus group, about motivations, experiences, past and future challenges in founding and leading PCSGs. Thematic analysis identified four global themes: illness experience; enacting a supportive response; forming a national collective and challenges. Leaders described men's feelings of isolation and neglect by the health system as the impetus for PCSGs to form and give/receive mutual help. Negotiating health care systems was an early challenge. National affiliation enabled leaders to build a united voice in the health system and establish a group identity and collective voice. Affiliation was supported by a symbiotic relationship with tensions between independence, affiliation and governance. Future challenges were group sustainability and inclusiveness. Study findings describe how a grassroots PCSG movement arose consistent with an embodied health movement perspective. Health care organisations who seek to leverage these community resources need to be cognisant of SG values and purpose if they are to negotiate effective partnerships that maximise mutual benefit.


Subject(s)
Patient Advocacy , Prostatic Neoplasms/psychology , Self-Help Groups/organization & administration , Social Support , Survivorship , Adaptation, Psychological , Aged , Aged, 80 and over , Australia , Focus Groups , Humans , Male , Survivors/psychology
5.
Article in English | MEDLINE | ID: mdl-27111695

ABSTRACT

This study describes sources of support utilised by men with localised prostate cancer in the first year after diagnosis and examines characteristics associated with help-seeking for men with unmet needs. A cross-sectional survey of 331 patients from a population-based sample who were in the first year after diagnosis (M = 9.6, SD = 1.9) was conducted to assess sources of support, unmet supportive care needs, domain-specific quality of life and psychological distress. Overall, 82% of men reported unmet supportive care needs. The top five needs were sexuality (58%); prostate cancer-specific (57%); psychological (47%); physical and daily living (41%); and health system and information (31%). Professional support was most often sought from doctors (51%). Across most domains, men who were older (Ps ≤ 0.03), less well educated (Ps ≤ 0.04) and more depressed (Ps ≤ 0.05) were less likely to seek help for unmet needs. Greater sexual help-seeking was related to better sexual function (P = 0.03), higher education (P ≤ 0.03) and less depression (P = 0.05). Unmet supportive care needs are highly prevalent after localised prostate cancer diagnosis with older age, lower education and higher depression apparent barriers to help-seeking. Interventions that link across medicine, nursing and community based peer support may be an accessible approach to meeting these needs. Clinical Trial Registry: Trial Registration: ACTRN12611000392965.


Subject(s)
Health Services Needs and Demand , Help-Seeking Behavior , Prostatic Neoplasms/physiopathology , Activities of Daily Living , Adult , Aged , Aged, 80 and over , Anxiety/psychology , Cross-Sectional Studies , Depression/psychology , Educational Status , Health Status , Humans , Male , Middle Aged , Peer Group , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/pathology , Prostatic Neoplasms/psychology , Quality of Life , Queensland , Sexual Dysfunction, Physiological , Sexual Dysfunctions, Psychological , Sexuality , Social Support , Stress, Psychological/psychology , Surveys and Questionnaires
6.
Eur J Cancer Care (Engl) ; 25(5): 691-718, 2016 Sep.
Article in English | MEDLINE | ID: mdl-26292029

ABSTRACT

This systematic review describes psychosocial and quality of life (QOL) measures used in psycho-oncology research with cancer patients and caregivers in China. Medline and PsycINFO databases were searched (1980-2014). Studies reviewed met the following criteria: English language; peer-reviewed; sampled Chinese cancer patients/caregivers; developed, validated or assessed psychometric properties of psychosocial or QOL outcome measures; and reported validation data. The review examined characteristics of measures and participants, translation and cultural adaptation processes and psychometric properties of the measures. Ninety five studies met review criteria. Common characteristics of studies reviewed were they: assessed primarily QOL measures, sampled patients with breast, colorectal, or head and neck cancer, and validated existing measures (>80%) originating in North America or Europe. Few studies reported difficulties translating measures. Regarding psychometric properties of the measures >50% of studies reported subscale reliabilities <α = 0.70, <50% reported test-retest reliability, and <30% reported divergent validity. Few reported sensitivity, specificity or responsiveness. Improved accuracy and transparency of reporting for translation, cultural adaptation and psychometric testing of psychosocial measures is needed. Developing support structures for translating and validating psychosocial measures would enable this and ensure Chinese psycho-oncology clinical practice and research keeps pace with international focus on patient reported outcome measures and data management.


Subject(s)
Caregivers/psychology , Neoplasms/psychology , Quality of Life , Adaptation, Psychological , China/ethnology , Fatigue/etiology , Female , Humans , Male , Middle Aged , Neoplasms/ethnology , Pain/etiology , Psychometrics , Social Support , Stress, Psychological/etiology
8.
Aging Ment Health ; 19(7): 571-5, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25847497

ABSTRACT

Since the publication of A Measure of Quality of Life in Early Old Age: The Theory, Development and Properties of a Needs Satisfaction Model (CASP-19) just over 10 years ago, the scale has gone on to be used in a wide variety of studies in over 20 countries across the world and the original paper has become the most highly cited paper for Aging and Mental Health. Therefore it was felt that it was a good time to look back and reflect on the developments in the use of the scale as well as to look forward to what new research is being done and could be done with the measure. To this end we are extremely grateful for the editors for allowing us to bring together a collection of papers that represent cutting edge research using the CASP scale. These papers cover a wide variety of issues, from working conditions to religiosity, from a range of countries, covering Western and Eastern Europe as well as Africa. Each makes an important individual contribution to our understanding of the factors that influence quality of life in later life as well as pointing to the limitations of the measure and future work that can be done in this area.


Subject(s)
Aging/psychology , Psychometrics/instrumentation , Quality of Life/psychology , Surveys and Questionnaires/standards , Biomedical Research/trends , Humans
9.
Lancet ; 381(9860): 73-87, 2013 Jan 05.
Article in English | MEDLINE | ID: mdl-23176802

ABSTRACT

Despite a general acknowledgment that research in children is necessary and ethical, the evidence base for child-specific treatments is still sparse. We investigated children's biomedical and health services research in the UK in relation to training, infrastructure and activity, research evidence, and visibility. We show that excellent opportunities for career researchers exist through a competitive, national integrated academic training programme, but that the number of academic paediatricians has decreased by 18% between 2000 and 2011, falling from 11·3% to 5·9% of the consultant workforce. The potential for rapid delivery of studies in children through the National Health Service (NHS) is not being realised: clinical trainees are poorly equipped with core research skills; most newly appointed consultant paediatricians have little or no research experience; less than 5% of contracted consultant time supports research; less than 2·5% of the 2 million children seen in the NHS every year are recruited to studies; and ten of the 20 UK children's hospitals do not have a clinical research facility. Support through National Institute for Health Research networks is good for studies into drugs, but inconsistent for non-drug research; less than 5% of registered studies involve children and only one children's biomedical research centre has been allocated funding from 2012. Of the UK annual public and charitable biomedical research expenditure of roughly £2·2 billion, about 5% is directed at child health research. The scant evidence base is impeding the development of clinical guidance and policy-less than 20% of the outputs of the National Institute for Health and Clinical Excellence are applicable to children. Paediatric representation on major research boards is weak. Parent and young people's advocacy is fragmented, and their views are insufficiently heeded by regulatory bodies. The strong UK Government commitment to biomedical research has not been translated fully to research for children. The power of research in children to turn the tide of the growing burden of non-communicable, chronic, adult diseases that have their origins in early life, to benefit the health of an ageing population and future generations, and to reduce health-care costs is inadequately recognised. On the basis of our findings, we make several recommendations to improve early-years research, including the formation of multidisciplinary, cross-institutional groups of clinical and non-clinical child health researchers and their access to diagnostic and laboratory facilities suitable for children; a unified Children's Research Network for drug studies and non-drug studies; regulatory assessment of research that is proportionate and based on consistent national criteria; an expansion of research posts; support for parents' and young people's advocacy; collaboration between children's research charities; improved research training for paediatric trainees; and closer integration of child health research with core NHS activities.


Subject(s)
Biomedical Research , Child Welfare , Health Services Research , Child , Humans , Research Support as Topic , United Kingdom
11.
Article in English | MEDLINE | ID: mdl-24725717

ABSTRACT

The majority of patients having surgical intervention for a vascular ring have resolution of their symptoms. However, 5% to 10% of these patients develop recurrent symptoms related either to airway or esophageal compression and may require reoperation. In our series of 300 patients with vascular rings, we performed a reoperation on 26 patients, not all of whom were originally operated on at our institution. The four primary indications for reoperation were Kommerell diverticulum (n = 18), circumflex aorta (n = 2), residual scarring (n = 2), and tracheobronchomalacia requiring aortopexy (n = 4). All patients undergoing reoperation have had preoperative evaluation with bronchoscopy and computed tomographic scanning (CT) with 3-dimensional reconstruction. Patients with dysphagia have had a barium esophagram and esophagoscopy. Patients with a Kommerell diverticulum have undergone resection of the diverticulum and transfer of the left subclavian artery to the left carotid artery. The aortic uncrossing procedure has been used in patients with a circumflex aorta. Aortopexy has been used to treat anterior compression of the trachea by the aorta. Results of these reinterventions have been successful in nearly all cases. Lessons learned from these reoperations can be applied to prevent the need for reoperation by properly selecting the correct initial operation. A dedicated team caring for these children consisting of medical imaging, otolaryngology, cardiovascular-thoracic surgery, and critical care is imperative.


Subject(s)
Aorta, Thoracic , Aortic Diseases/congenital , Aortic Diseases/surgery , Cardiac Surgical Procedures/methods , Diverticulum/congenital , Diverticulum/surgery , Heart Defects, Congenital/surgery , Aortic Diseases/diagnostic imaging , Child , Child, Preschool , Diverticulum/diagnostic imaging , Heart Defects, Congenital/diagnostic imaging , Humans , Imaging, Three-Dimensional , Infant , Reoperation , Tomography, X-Ray Computed
12.
Int J Obes (Lond) ; 37(4): 500-4, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23318718

ABSTRACT

BACKGROUND: We have previously shown that by term age, preterm infants have elevated intrahepatocellular lipid (IHCL) content and altered regional adiposity, both of which are risk factors for cardiometabolic illness in adult life. Preterm nutritional intake is a plausible determinant of these aberrant trajectories of development. OBJECTIVE: We aimed to establish if macronutritional components of the preterm diet were determinants of IHCL deposition measured at term equivalent age, using (1)H Magnetic Resonance spectroscopy (MRS). METHODS: Prospective observational case-control study in a single UK neonatal unit. (1)H MR spectra were acquired from 18 preterm infants (<32 weeks gestational age at birth) at term age and 31 healthy term infants, who acted as a control group. Neonatal nutritional information was collected from birth to 34(+6) weeks postmenstrual age. RESULTS: IHCL (median, interquartile range) was significantly higher in preterm-at-term infants compared with term-born infants: 0.735, 0-1.46 versus 0.138, 0-0.58; P=0.003. In preterm infants, IHCL was positively correlated with lipid intake in the first week of life (r=0.52, P=0.04). CONCLUSIONS: This study confirms our previous observation of elevated IHCL in preterm infants at term and suggests that early lipid intake may be a determinant. Future work is warranted to establish the clinical relevance and the role of nutritional intervention in attenuating or exacerbating this effect in preterm infants.


Subject(s)
Adiposity , Hepatocytes/metabolism , Infant, Premature/metabolism , Case-Control Studies , Female , Gestational Age , Humans , Infant Nutritional Physiological Phenomena , Infant, Newborn , Infant, Premature/growth & development , Lipid Metabolism , Magnetic Resonance Spectroscopy , Male , Pregnancy , Prenatal Nutritional Physiological Phenomena , Prospective Studies , United Kingdom
13.
Eur J Cancer Care (Engl) ; 22(6): 824-31, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23834328

ABSTRACT

The burden of cancer in China is increasing with future psycho-oncological interventions crucial. A systematic review of psycho-oncology research in China was undertaken to assess quantity, design and target trends over time. Medline, PsycINFO, CINAHL, ProQuest, Web of Science (1999-November Week 4, 2012) were searched. Inclusion criteria were: included cancer patients and/or partners or caregivers from resident Chinese populations (either at least 80% of participants are from China, Hong Kong or Taiwan); assessed psychological adjustment relating to cancer and published in English after 1 January 1999 and prior to 30 November 2012. In all, 208 articles met inclusion criteria. Of these: 52 were cross-sectional descriptive quantitative; 30 were cross-sectional descriptive qualitative; 27 were prospective descriptive quantitative; 2 were prospective descriptive qualitative; 18 assessed interventions; 79 presented instrument validation. Publications increased eightfold from 1999 to 2012. Most studies included patients (n = 195) with 11 articles focusing on caregivers and two on patient-caregiver dyads. The most common cancer studied was breast cancer. The psycho-oncology research effort in China is dramatically increasing. A focus on culturally relevant approaches to underpin the evaluation of empirically derived interventions is warranted; as is direction of efforts to other cancers such as lung and prostate.


Subject(s)
Biomedical Research/trends , Medical Oncology/trends , Neoplasms/psychology , Neoplasms/therapy , Psychology, Medical/trends , Psychotherapy/trends , Biomedical Research/standards , China , Hong Kong , Humans , Research Design , Taiwan
14.
Diabetologia ; 55(11): 3114-27, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22948491

ABSTRACT

AIMS/HYPOTHESIS: Offspring of diabetic mothers have increased risk of the metabolic syndrome in adulthood. Studies examining BP in offspring of diabetic mothers have conflicting conclusions. We performed a systematic review and meta-analysis of studies reporting offspring BP in children born to diabetic mothers. METHODS: Citations were identified in PubMed. Authors were contacted for additional data. Systolic and diastolic BP in offspring of diabetic mothers and controls were compared. Subgroup analysis of type of maternal diabetes and offspring sex were performed. Fixed-effects models were used, and random-effects models where significant heterogeneity was present. Meta-regression was used to test the relationship between offspring systolic BP and prepregnancy BMI. RESULTS: Fifteen studies were included in the review and 13 in the meta-analysis. Systolic BP was higher in offspring of diabetic mothers (mean difference 1.88 mmHg [95% CI 0.47, 3.28]; p = 0.009). Offspring of mothers with gestational diabetes had similar diastolic BP to controls, but higher systolic BP (1.39 mmHg [95% CI 0.00, 2.77]; p = 0.05); results for type 1 diabetes were inconclusive and there were no separate data available on offspring of type 2 diabetic mothers. Male offspring of diabetic mothers had higher systolic BP (2.01 mmHg [95% CI 0.93, 3.10]; p = 0.0003) and diastolic BP (1.12 mmHg [95% CI 0.36, 1.88]; p = 0.004) than controls; in female offspring there was no difference (systolic: 0.54 mmHg [95% CI -1.83, 2.90], p = 0.66; diastolic: 0.51 mmHg [95% CI -1.07, 2.09], p = 0.52). The correlation between offspring systolic BP and maternal prepregnancy BMI was not significant (p = 0.37). CONCLUSIONS/INTERPRETATION: Offspring of diabetic mothers have higher systolic BP than controls. Differences related to sex and type of maternal diabetes require further investigation.


Subject(s)
Blood Pressure/physiology , Child of Impaired Parents/statistics & numerical data , Diabetes, Gestational/epidemiology , Hypertension/epidemiology , Metabolic Syndrome/epidemiology , Child , Female , Humans , Pregnancy , Risk Factors
15.
Diabetologia ; 54(8): 1957-66, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21626451

ABSTRACT

AIMS/HYPOTHESIS: Offspring of mothers with diabetes are at increased risk of metabolic disorders in later life. Increased offspring BMI is a plausible mediator. We performed a systematic review and meta-analysis of studies examining offspring BMI z score in childhood in relation to maternal diabetes. METHODS: Papers reporting BMI z scores for offspring of diabetic (all types, and pre- and during-pregnancy onset) and non-diabetic mothers were included. Citations were identified in PubMed; bibliographies of relevant articles were hand-searched and authors contacted for additional data where necessary. We compared offspring BMI z score with and without adjustment for maternal pre-pregnancy BMI. We performed fixed effect meta-analysis except where significant heterogeneity called for use of a random effects analysis. RESULTS: Data were available from nine studies. In the diabetic group unadjusted mean offspring BMI z score was 0.28 higher (all diabetic mothers vs controls (95% CI 0.09, 0.47; p = 0.004; nine studies; offspring of diabetic mothers n = 927, controls n = 26,384) and with adjustment for maternal pre-pregnancy BMI, 0.07 higher (95% CI -0.15, 0.28; p = 0.54; three studies; offspring of diabetic mothers n = 244, controls n = 11,206). There was no evidence of a difference in offspring BMI z score in relation to type of diabetes (gestational vs type 1, p = 0.95). CONCLUSIONS/INTERPRETATION: Maternal diabetes is associated with increased offspring BMI z score, although this is no longer apparent after adjustment for maternal pre-pregnancy BMI in the limited number of studies in which this is reported. Causal mediators of the effect of maternal diabetes on offspring outcomes remain to be established; we recommend that future research includes adjustment for maternal pre-pregnancy BMI.


Subject(s)
Body Mass Index , Diabetes, Gestational/physiopathology , Pregnancy in Diabetics/physiopathology , Child , Female , Humans , Pregnancy
16.
Article in English | MEDLINE | ID: mdl-21444042

ABSTRACT

This article was prepared to summarize the points made in a debate that the first author (C.L.B.) had with Dr. Richard Jonas at the American Association for Thoracic Surgery 90th Annual Meeting. The topic of the debate was the optimal surgical approach for functional single-ventricle patients: extracardiac versus intra-atrial lateral tunnel Fontan. My role was to take the viewpoint that the extracardiac Fontan is better. This review summarizes our results at Children's Memorial Hospital (Chicago, IL) with 180 patients undergoing a primary Fontan procedure and 126 patients undergoing an extracardiac Fontan as part of a Fontan conversion. The world literature was reviewed on outcomes following the Fontan procedure, focusing on six main areas supporting the superiority of the extracardiac Fontan: hemodynamics, arrhythmias, applicability to complex anatomy, use of cardiopulmonary bypass, complications of fenestration and thromboembolism, and operative mortality. Based on this review, it is our conclusion that the extracardiac Fontan is the procedure of choice for patients with a functional single ventricle based on a very low operative mortality, a lower incidence of early and late arrhythmias, improved hemodynamics, fewer postoperative complications, and applicability to a wide variety of complex cardiac anatomy.


Subject(s)
Cardiopulmonary Bypass/methods , Fontan Procedure/methods , Heart Defects, Congenital/surgery , Hospital Mortality/trends , Female , Fontan Procedure/mortality , Heart Atria/surgery , Heart Defects, Congenital/diagnosis , Heart Defects, Congenital/mortality , Humans , Infant , Infant, Newborn , Male , Postoperative Complications/mortality , Postoperative Complications/physiopathology , Prognosis , Pulmonary Artery/surgery , Risk Assessment , Survival Rate , Treatment Outcome
17.
JACC Cardiovasc Interv ; 14(8): 830-845, 2021 04 26.
Article in English | MEDLINE | ID: mdl-33888229

ABSTRACT

OBJECTIVES: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves. METHODS: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites. RESULTS: Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation. CONCLUSIONS: At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement-induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Aged , Aged, 80 and over , Cardiac Catheterization , Female , Humans , Male , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Prospective Studies , Retrospective Studies , Treatment Outcome
18.
JACC Cardiovasc Interv ; 14(8): 859-872, 2021 04 26.
Article in English | MEDLINE | ID: mdl-33888231

ABSTRACT

OBJECTIVES: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. METHODS: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. CONCLUSIONS: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.


Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Annuloplasty , Aged , Aged, 80 and over , Cardiac Catheterization/adverse effects , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Prospective Studies , Prosthesis Design , Treatment Outcome
19.
JACC Cardiovasc Interv ; 14(8): 846-858, 2021 04 26.
Article in English | MEDLINE | ID: mdl-33888230

ABSTRACT

OBJECTIVES: The authors report 1-year outcomes of high-risk patients with failed surgical annuloplasty rings undergoing transseptal mitral valve-in-ring (MViR) with the SAPIEN 3 aortic transcatheter heart valve (THV). BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study evaluating transseptal MViR with the SAPIEN 3 aortic THV in high-risk patients with failed surgical annuloplasty rings. METHODS: Prospective enrollment of high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis and failed annuloplasty rings at 13 U.S. sites. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS: Thirty patients were enrolled between January 2016 and October 2017 (median age 71.5 years [interquartile range: 67.0 to 76.8 years], 36.7% women, median Society of Thoracic Surgeons score 7.6% [interquartile range: 5.1% to 11.8%], 76.7% in New York Heart Association functional class III or IV). Technical success was 66.7% (driven primarily by need for a second valve in 6 patients). There was no intraprocedural mortality or conversion to surgery. The primary performance endpoint was achieved in 85.7% of survivors at 30 days (24 of 28) and 89.5% of patients alive at 1 year with echocardiographic data available (17 of 19). All-cause mortality at 30 days was 6.7% and at 1 year was 23.3%. Among survivors at 1-year follow-up, 84.2% were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.0 mm Hg (interquartile range: 4.7 to 7.3 mm Hg), and all had ≤1+ MR. CONCLUSIONS: Transseptal MViR was associated with a 30-day mortality rate lower than predicted by the Society of Thoracic Surgeons score. At 1 year, transseptal MViR was associated with symptom improvement and stable THV performance.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Annuloplasty , Mitral Valve Insufficiency , Aged , Cardiac Catheterization/adverse effects , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Annuloplasty/adverse effects , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Prospective Studies , Prosthesis Design , Treatment Outcome
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