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Transcatheter extraction of an intracardiac mass is a newer approach that may lead to nonsurgical treatment of complex cardiac masses. We present a case in which thrombectomy devices were combined to extract a right atrial mass, which highlights new frontiers in the treatment of complex transcatheter mass extraction. The combined use of two transcatheter thrombectomy devices (Kong and Godzilla) may provide a powerful addition to the existing armamentarium.
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Cateterismo Cardíaco , Neoplasias Cardíacas , Trombectomia , Humanos , Trombectomia/instrumentação , Resultado do Tratamento , Neoplasias Cardíacas/cirurgia , Neoplasias Cardíacas/diagnóstico por imagem , Cateterismo Cardíaco/instrumentação , Desenho de Equipamento , Masculino , Feminino , Átrios do Coração/cirurgia , Átrios do Coração/diagnóstico por imagem , Cateteres Cardíacos , Ecocardiografia TransesofagianaRESUMO
The foramen ovale serves as an opening between the right and left atria at the site of the fossa ovalis in the fetus during uterine life. During fetal life, it makes it possible for venous blood from the maternal placenta with oxygen and nutrients to bypass the immature fetal lung and get transported to the left side of the heart and onto the systemic circulation. This hole from the right to the left atrium is usually occluded at the time of birth or shortly after birth, due to increased pressures in the left-sided cardiac cavities associated with normal breathing during delivery or shortly afterwards. If the foramen ovale remains open and fails to fuse beyond the first year of life, it is known as a patent foramen ovale (PFO). PFO occurs when, during fetal life, the septum primum and secundum, which develop and overlap normally, fail to fuse at birth. This results in the persistence of communication between the right and left atria. Paradoxical embolism from the right to the left side of the heart can occur through a PFO, causing a cryptogenic stroke or embolic stroke of an undetermined source in an otherwise healthy adult. There was a debate on the long-term benefits of closure. However, data from the randomized evaluation of the recurrent stroke comparing PFO closure to established current standard of care treatment (RESPECT) trial and two randomized trials (patent foramen ovale closure or anticoagulants versus antiplatelet therapy to prevent stroke recurrence (CLOSE) and reduction by dutasteride of prostate cancer events (REDUCE)) have clarified that there is a benefit to closure. In this case report, we describe a patient who presented with cryptogenic stroke, the investigations, imaging modalities for diagnosis of PFO, and procedure for closure. We also describe long-term outcomes and management following closure.
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Mechanical prosthetic valve thrombosis (PVT) is a serious condition that is associated with various life-threatening complications. The utilization of multimodality imaging techniques is critical in identifying this etiology. Its management is complex and often requires repeat surgical valve replacements. Our report describes the case of a 48-year-old female who presented with mechanical mitral valve thrombosis in the setting of subtherapeutic anticoagulation. Due to her complex surgical history, nonsurgical therapeutic options were initially pursued for management. Through shared decision-making and after exhaustion of other alternatives, she was maintained on optimized medical therapy and was scheduled for repeat elective surgery. After compliance with medical therapy and close monitoring, she improved significantly, and her underlying pathology completely resolved, eliminating the need for surgery. This report indicates that the management of mechanical prosthetic valve thrombosis should be individualized and emphasizes the importance of involving a multidisciplinary team of medical and surgical professionals to achieve the best clinical outcomes.
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BACKGROUND: In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world. OBJECTIVES: To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built. METHODS: Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry. RESULTS: The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking. CONCLUSIONS: To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient's personal outcomes with both treatments.
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Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Complicações do Diabetes/cirurgia , Revascularização Miocárdica/métodos , Doença Aguda , Adulto , Idoso , Algoritmos , Angina Estável/complicações , Angina Estável/mortalidade , Angina Estável/cirurgia , Ponte de Artéria Coronária , Tomada de Decisões , Feminino , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea , Sistema de Registros , Medição de Risco , Fumar , Resultado do TratamentoRESUMO
Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement (TAVR) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/nonsmokers. A series of multivariable models examined the association between smoking status and outcomes, including 1-year mortality, rehospitalization, mean gradient, and health status (measured by the 12-item Kansas City Cardiomyopathy Questionnaire-Overall Summary Score [KCCQ-OS]) and in-hospital outcomes. A total of 4063 patients (5.6%) were smokers. Smokers presented for TAVR at a younger age (75 [68-81] years versus 83 [77-88] years) but with a greater burden of cardiovascular and lung disease. In adjusted models, smoking was associated with lower in-hospital mortality (relative risk, 0.74; 95% CI, 0.62-0.89 [P=0.001]) but not with in-hospital stroke/transient ischemic attack or myocardial infarction. Smoking status had no association with postdischarge mortality, stroke, myocardial infarction, or heart failure (HF) but was associated with slightly lower 1-year KCCQ-OS scores (2.4-point lower KCCQ-OS; 95% CI, -4.6 to -0.2 [P=0.031]) and higher mean aortic valve gradients (11.1 versus 10.2 mm Hg, P<0.001) in adjusted models. Conclusions The current/recent smoking rate in US patients with TAVR is 5.6% and smokers present at a younger age for TAVR. Smoking was associated with lower in-hospital but similar long-term survival after TAVR, slightly worse long-term health status, and marginally higher mean aortic valve gradients. Further research is needed to understand the effect of smoking cessation on outcomes.
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Estenose da Valva Aórtica/cirurgia , Fumar Cigarros/epidemiologia , Mortalidade , Substituição da Valva Aórtica Transcateter , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/epidemiologia , Doenças Cardiovasculares/epidemiologia , Feminino , Nível de Saúde , Insuficiência Cardíaca/epidemiologia , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Ataque Isquêmico Transitório/epidemiologia , Pneumopatias/epidemiologia , Masculino , Infarto do Miocárdio/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Prognóstico , Modelos de Riscos Proporcionais , Sistema de Registros , Acidente Vascular Cerebral/epidemiologia , Resultado do TratamentoRESUMO
BACKGROUND: Successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can markedly reduce angina symptom burden, but many patients often remain on multiple antianginal medications (AAMs) after the procedure. It is unclear when, or if, AAMs can be de-escalated to prevent adverse effects or limit polypharmacy. We examined the association of de-escalation of AAMs after CTO PCI with long-term health status. METHODS: In a 12-center registry of consecutive CTO PCI patients, health status was assessed at 6â¯months after successful CTO PCI with the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Among patients with technical CTO PCI success, we examined the association of AAM de-escalation with 6-month health status using multivariable models adjusting for revascularization completeness and predicted risk of post-PCI angina (using a validated risk model). We also examined predictors and variability of AAMs de-escalation. RESULTS: Of 669 patients with technical success of CTO PCI, AAMs were de-escalated in 276 (35.9%) patients at 1â¯month. Patients with AAM de-escalation reported similar angina and dyspnea rates at 6â¯months compared with those whose AAMs were reduced (any angina: 22.5% vs 20%, Pâ¯=â¯.43; any dyspnea: 51.8% vs 50.1%, Pâ¯=â¯.40). In a multivariable model adjusting for complete revascularization and predicted risk of post-PCI angina, de-escalation of AAMs at 1â¯month was not associated with an increased risk of angina, dyspnea, or worse health status at 6â¯months. CONCLUSIONS: Among patients with successful CTO PCI, de-escalation of AAMs occurred in about one-third of patients at 1â¯month and was not associated with worse long-term health status.
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Angina Pectoris/tratamento farmacológico , Fármacos Cardiovasculares/administração & dosagem , Oclusão Coronária/cirurgia , Nível de Saúde , Intervenção Coronária Percutânea , Idoso , Angina Pectoris/diagnóstico , Angina Pectoris/cirurgia , Bloqueadores dos Canais de Cálcio/administração & dosagem , Distribuição de Qui-Quadrado , Doença Crônica , Oclusão Coronária/complicações , Dispneia/diagnóstico , Dispneia/terapia , Feminino , Inquéritos Epidemiológicos , Humanos , Modelos Logísticos , Masculino , Isquemia Miocárdica/complicações , Nitrocompostos/administração & dosagem , Estudos Prospectivos , Qualidade de Vida , Ranolazina/administração & dosagem , Sistema de Registros , Fatores de TempoRESUMO
Background Prior research has shown that providers may infrequently adjust antianginal medications (AAMs) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patient characteristics associated with AAM titration and the variation in postprocedure AAM management after CTO PCI across hospitals have not been reported. We sought to determine the frequency and potential correlates of AAM escalation and de-escalation after CTO PCI. Methods and Results Using the 12-center OPEN CTO registry (Outcomes, Patient Health Status, and Efficiency iN Chronic Total Occlusion Hybrid Procedures), we assessed AAM use at baseline and 6 months after CTO PCI. Escalation was defined as any addition of a new class of AAM or dose increase, whereas de-escalation was defined as a reduction in the number of AAMs or dose reduction. Angina was assessed 6 months after the index CTO PCI attempt using the Seattle Angina Questionnaire Angina Frequency domain. Potential correlates of AAM escalation (vs no change) or de-escalation (vs no change) were evaluated using multivariable modified Poisson regression models. Adjusted variation across sites was evaluated using median rate ratios. AAMs were escalated in 158 (17.5%), de-escalated in 351 (39.0%), and were unchanged at 6-month follow-up in 392 (43.5%). Patient characteristics associated with escalation included lung disease, ongoing angina, and periprocedural major adverse cardiac and cerebral events (periprocedural myocardial infarction, stroke, death, emergent cardiac surgery, or clinically significant perforation), whereas de-escalation was more frequent among patients taking more AAMs, those treated with complete revascularization, and after treatment of non-CTO lesions at the time of the index procedure. There was minimal variation in either escalation (median rate ratio, 1.11; P=0.36) or de-escalation (median rate ratio, 1.10; P=0.20) compared to no change of AAMs across sites. Conclusions Escalation or de-escalation of AAMs was less common than continuation following CTO PCI, with little variation across sites. Further research is needed to identify patients who may benefit from AAM titration after CTO PCI and develop strategies to adjust these medications in follow-up. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02026466.
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Angina Pectoris/terapia , Fármacos Cardiovasculares/administração & dosagem , Oclusão Coronária/terapia , Intervenção Coronária Percutânea , Idoso , Angina Pectoris/diagnóstico por imagem , Angina Pectoris/fisiopatologia , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/fisiopatologia , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVES: Few studies have evaluated the relationship of diabetes with technical success and periprocedural complications, and no studies have compared patient-reported health status after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in patients with and without diabetes. BACKGROUND: CTOs are more common in patients with diabetes, yet CTO PCI is less often attempted in patients with diabetes than in patients without. The association between diabetes and health status after CTO PCI is unknown. METHODS: In the 12-center OPEN-CTO PCI registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Registry), patients with and without diabetes were assessed for technical success, periprocedural complications, and health status over 1 year following CTO PCI using the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Hierarchical modified Poisson regression was used to examine the independent association between diabetes and technical success, and hierarchical multivariable linear regression was used to assess the association between diabetes and follow-up health status. RESULTS: Diabetes was common (41.2%) and associated with a lower crude rate of technical success (83.5% vs. 88.1%; p = 0.04). After adjustment, there was no significant difference between diabetic and nondiabetic patients (relative risk: 0.96, 95% confidence interval: 0.91 to 1.01). There were no significant differences in complication rates between patients with and without diabetes. Angina burden, quality of life, and overall health status scores were similar between diabetic and nondiabetic patients over 1 year. CONCLUSIONS: Although technical success was lower in patients with diabetes, this reflected lower success among patients with prior bypass surgery, without any significant difference in success rate after adjusting for prior bypass and disease complexity. CTO PCI complication rates are similar in diabetic and nondiabetic patients, and symptom improvement following CTO PCI is robust and of a similar magnitude regardless of diabetes status.
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Oclusão Coronária/terapia , Diabetes Mellitus , Intervenção Coronária Percutânea , Idoso , Distribuição de Qui-Quadrado , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/epidemiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiologia , Feminino , Nível de Saúde , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Qualidade de Vida , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: People with supraventricular tachycardia (SVT) frequently are symptomatic and present to the emergency department for treatment. Although vagal manoeuvres may terminate SVT, they often fail, and subsequently adenosine or calcium channel antagonists (CCAs) are administered. Both are known to be effective, but both have a significant side effect profile. This is an update of a Cochrane review previously published in 2006. OBJECTIVES: To review all randomised controlled trials (RCTs) that compare effects of adenosine versus CCAs in terminating SVT. SEARCH METHODS: We identified studies by searching CENTRAL, MEDLINE, Embase, and two trial registers in July 2017. We checked bibliographies of identified studies and applied no language restrictions. SELECTION CRITERIA: We planned to include all RCTs that compare adenosine versus a CCA for patients of any age presenting with SVT. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane. Two review authors independently checked results of searches to identify relevant studies and resolved differences by discussion with a third review author. At least two review authors independently assessed each included study and extracted study data. We entered extracted data into Review Manager 5. Primary outcomes were rate of reversion to sinus rhythm and major adverse effects of adenosine and CCAs. Secondary outcomes were rate of recurrence, time to reversion, and minor adverse outcomes. We measured outcomes by calculating odds ratios (ORs) and assessed the quality of primary outcomes using the GRADE approach through the GRADEproGDT website. MAIN RESULTS: We identified two new studies for inclusion in the review update; the review now includes seven trials with 622 participants who presented to an emergency department with SVT. All included studies were RCTs, but only three described the randomisation process, and none had blinded participants, personnel, or outcome assessors to the intervention given. Moderate-quality evidence shows no differences in the number of people reverting to sinus rhythm who were treated with adenosine or CCA (89.7% vs 92.9%; OR 1.51, 95% confidence interval (CI) 0.85 to 2.68; participants = 622; studies = 7; I2 = 36%). Low-quality evidence suggests no appreciable differences in major adverse event rates between CCAs and adenosine. Researchers reported only one case of hypotension in the CCA group and none in the adenosine group (0.66% vs 0%; OR 3.09, 95% CI 0.12 to 76.71; participants = 306; studies = 3; I2 = 0%). Included trials did not report length of stay in hospital nor patient satisfaction. AUTHORS' CONCLUSIONS: Moderate-quality evidence shows no differences in effects of adenosine and calcium channel antagonists for treatment of SVT on reverting to sinus rhythm, and low-quality evidence suggests no appreciable differences in the incidence of hypotension. A study comparing patient experiences and prospectively studied adverse events would provide evidence on which treatment is preferable for management of SVT.
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Adenosina/uso terapêutico , Antiarrítmicos/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Taquicardia Supraventricular/tratamento farmacológico , Adenosina/efeitos adversos , Adulto , Antiarrítmicos/efeitos adversos , Bloqueadores dos Canais de Cálcio/efeitos adversos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Humanos , Hipotensão/induzido quimicamente , Ensaios Clínicos Controlados Aleatórios como Assunto , Verapamil/efeitos adversos , Verapamil/uso terapêuticoRESUMO
OBJECTIVES: To assess patients' perspective about factors associated with stent choice. BACKGROUND: Drug eluting stents (DES) markedly reduce the risk of repeat percutaneous coronary intervention (PCI), but necessitate a longer duration of dual anti-platelet therapy (DAPT) as compared with bare metal stents (BMS). Thus, understanding patients' perspective about factors associated with stent choice is paramount. METHODS: Patients undergoing angiography rated, on a 10-point scale, the importance (1 = not important, 10 = most important) of avoiding repeat revascularization and avoiding the following potential DAPT drawbacks: bleeding/bruising, more pills/day, medication costs and delaying elective surgery. The factor, or group of factors, that was rated highest by each patient was identified. RESULTS: Among 311 patients, repeat revascularization was the single most important consideration to 14.4% of patients, while 20.6% considered avoiding one of the DAPT drawbacks as most important. Most patients (65%) considered avoiding at least one DAPT drawback as important as avoiding repeat revascularization. In no subgroup of patients did more than a quarter of patients prefer avoiding repeat revascularization above all other concerns. Among patients undergoing PCI, more than three quarters received a DES, regardless of their stated preferences (DES use among those most valuing DES benefits, avoiding DAPT drawbacks, or both equally were 78.7%, 86.2%, and 85.6%, respectively, P = 0.56). CONCLUSION: Most patients reported that avoiding DAPT drawbacks was as important as avoiding repeat revascularization. Eliciting patient preferences regarding stent type can enhance shared decision-making and allow physicians to better tailor stent choice to patients' goals and values. TRIAL REGISTRATION: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection (DECIDE-PCI). ClinicalTrials.gov Identifier: NCT02046902. URL: https://clinicaltrials.gov/ct2/show/NCT02046902 © 2017 Wiley Periodicals, Inc.
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Técnicas de Apoio para a Decisão , Stents Farmacológicos , Metais , Preferência do Paciente , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/administração & dosagem , Stents , Tomada de Decisão Clínica , Angiografia Coronária , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Estudos Transversais , Custos de Medicamentos , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Missouri , Participação do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/economia , Desenho de Prótese , Retratamento , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Despite guideline recommendations, a significant number of patients with non-ST elevation myocardial infarction (NSTEMI) do not receive dual antiplatelet therapy (DAPT) before angiography "pretreatment." While there may be valid clinical reasons to not pretreat, such as concern for bleeding or multivessel disease warranting coronary artery bypass graft surgery, the degree of variability and factors associated with DAPT pretreatment are unknown. METHODS AND RESULTS: From the multicenter TRIUMPH registry, 1632 NSTEMI patients were not taking DAPT on admission and were included in the study cohort. Among the study patients, only 22% patients received DAPT pretreatment. A multivariable logistic regression model showed that race other than white or black (odds ratio [OR] 0.41, 95% CI 0.21-0.83), hemoglobin level (OR 1.18, 95% CI 1.08-1.29), patients' bleeding risk (assessed with NCDR CathPCI Bleeding Risk Score) (OR 0.85, 95% CI 0.74-0.99), and severe left ventricular dysfunction (OR 0.3, 95% CI 0.13-0.65) were the main predictors of pretreatment with DAPT, whereas likelihood of needing coronary artery bypass graft surgery (GRACE prediction model) was not (OR 1.09, 95% CI 0.88-1.35). Median ORs were calculated to assess variability of receiving DAPT pretreatment across sites after adjustment for patient characteristics. Receiving DAPT pretreatment varied substantially across sites (range 0-100%, mean OR 3.94, P<0.0001). CONCLUSIONS: While deviating from guideline-recommended DAPT pretreatment in patients with NSTEMI was associated with patient factors (eg, bleeding risk), marked variation was present across sites after accounting for patient-level characteristics. This suggests that site-level interventions are needed to improve concordance with current guidelines.
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Infarto do Miocárdio sem Supradesnível do Segmento ST/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Quimioterapia Combinada , Feminino , Fidelidade a Diretrizes , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Sistema de Registros , Medição de Risco , Disfunção Ventricular Esquerda/tratamento farmacológicoRESUMO
We are describing a case of 55-year-old obese female with significant history of uncontrolled rheumatoid arthritis, who recently had decreased her immune-suppression medications. She presented with extensive acral gangrene involving multiple fingers and toes. Clinical picture and laboratory findings were suggestive of vasculitis; however, skin biopsy established diagnosis of calciphylaxis, in settings of normal kidney function. Patient was treated with sodium thiosulfate with gradual improvement in her skin lesions.
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We describe a case of a 40 year old patient with recurrent severe fasting and postprandial symptomatic hypoglycemia that occurred 6 years after gastric bypass surgery. The hypoglycemia was associated with increased insulin and C peptide but all diagnostic modalities for localizing an insulinoma were negative. Medical management failed to control symptoms and the patient underwent subtotal pancreatectomy. Surgical tissue examination confirmed the diagnosis of noninsulinoma pancreatogenous hypoglycaemia syndrome (NIPHS) or nesidioblastosis. Initially after surgery the patient had full remission but after 6 months hypoglycemia recurred. However, this time it was well-controlled with octreotide treatment.
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BACKGROUND: Hypertrophic cardiomyopathy (HCM) is a genetic disease with an autosomal-dominant inheritance for which negative inotropes are the most widely used initial therapies. Observational studies and small randomised trials have suggested symptomatic and functional benefits using pacing and several theories have been put forward to explain why. Pacing, although not the primary treatment for HCM, could be beneficial to patients with relative or absolute contraindications to surgery or alcohol ablation. Several randomised controlled trials comparing pacing to other therapeutic modalities have been conducted but no Cochrane-style systematic review has been done. OBJECTIVES: To assess the effects of pacing in drug-refractory or drug-intolerant hypertrophic cardiomyopathy patients. SEARCH METHODS: We searched the following on the 14/4/2010: CENTRAL (The Cochrane Library 2010, Issue 1), MEDLINE OVID (from 1950 onwards ), EMBASE OVID (from 1980 onwards ), Web of Science with Conference Proceedings (from 1970 onwards). No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of either parallel or crossover design that assess the beneficial and harmful effects of pacing for hypertrophic cardiomyopathy were included. When crossover studies were identified, we considered data only from the first phase. DATA COLLECTION AND ANALYSIS: Data from included studies were extracted onto a pre-formed data extraction paper by two authors independently. Data was then entered into Review Manager 5.1 for analysis. Risk of bias was assessed using the guidance provided in the Cochrane Handbook. For dichotomous data, relative risk was calculated; and for continuous data, the mean differences were calculated. Where appropriate data were available, meta-analysis was performed. Where meta-analysis was not possible, a narrative synthesis was written. A QUROUM flow chart was provided to show the flow of papers. MAIN RESULTS: Five studies (reported in 10 papers) were identified. However, three of the five studies provided un-usable data. Thus the data from only two studies (reported in seven papers) with 105 participants were included for this review. There was insufficient data to compare results on all-cause mortality, cost effectiveness, exercise capacity, Quality of life and Peak O2 consumption.When comparing active pacing versus placebo pacing on exercise capacity, one study showed that exercise time decreased from (13.1 ± 4.4) minutes to (12.6 ± 4.3) minutes in the placebo group and increased from (12.1 ± 5.6) minutes to (12.9 ± 4.2) minutes in the treatment group (MD 0.30; 95% CI -1.54 to 2.14). Statistically significant data from the same study showed that left ventricular outflow tract obstruction decreased from (71 ± 32) mm Hg to (52 ± 34) mm Hg in the placebo group and from (70 ± 24) mm Hg to (33 ± 27) mm Hg in the active pacing group (MD -19.00; 95% CI -32.29 to -5.71). This study was also able to show that New York Heart Association (NYHA) functional class decreased from (2.5 ± 0.5) to (2.2 ± 0.6) in the inactive pacing group and decreased from (2.6 ± 0.5) to (1.7 ± 0.7) in the placebo group (MD -0.50; 95% CI -0.78 to -0.22).When comparing active pacing versus trancoronary ablation of septal hypertrophy (TASH), data from one study showed that NYHA functional class decreased from (3.2 ± 0.7) to (1.5 ± 0.5) in the TASH group and decreased from (3.0 ± 0.1) to (1.9 ± 0.6) in the pacemaker group. This study also showed that LV wall thickness remained unchanged in the active pacing group compared to reduction from (22 ± 4) mm to (17 ± 3) mm in the TASH group (MD 0.60; 95% CI -5.65 to 6.85) and that LV outflow tract obstruction decreased from (80 ± 35.5) mm Hg in the TASH group to (49.3 ± 37.7) mm Hg in the pacemaker group. AUTHORS' CONCLUSIONS: Trials published to date lack information on clinically relevant end-points. Existing data is derived from small trials at high risk of bias, which concentrate on physiological measures. Their results are inconclusive. Further large and high quality trials with more appropriate outcomes are warranted.