RESUMO
Mechanical compression of left ventricular outflow tract (LVOT) was reported to be a leading cause of conduction impairment requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). However, the association between tapered-shape LVOT and PPI after TAVR has not been elucidated. Of 272 consecutive patients treated with SAPIEN 3 in our institute, we retrospectively analyzed the clinical data of 256 patients without previous PPI or bicuspid valve. In-hospital PPI was performed in 20 (7.8%) patients at 8.2 ± 2.9 days after TAVR. Patients requiring PPI had smaller LVOT area (356.3 vs. 399.4 mm2, p ≤ 0.011). Moreover, receiver operating characteristic statistics showed that LVOT area /annulus area possessed significantly higher predictive ability than LVOT area (c-statistic: 0.91 [95% confidence interval [CI]: 0.84-0.95] vs. 0.67 [95% CI: 0.57-0.77], p < 0.001). Multivariable analysis revealed that LVOT area /annulus area (odds ratio [OR]: 1.93 [95% CI: 1.38-2.71]; p < 0.001 per % of decreasing), the difference between membranous septum length and implantation depth (ΔMSID) (OR: 6.82 [95% CI 2.39-19.48]; p < 0.001 per mm of decreasing) and pre-existing complete right bundle branch block (CRBBB) (OR: 32.38 [95% CI2.30-455.63]; p ≤ 0.002) were independently associated with PPI. In our study, tapered-shape LVOT as well as short ΔMSID and pre-existing CRBBB were identified as independent predictors for PPI after TAVR. Higher valve implantation is required to minimize the risk of post-procedural PPI especially for patients with short MS length, pre-procedural CRBBB, or tapered-shape LVOT.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Marca-Passo Artificial , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/etiologia , Bloqueio de Ramo/terapia , Humanos , Estudos Retrospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
At present, underfilling or overfilling the volume of the balloon-expandable transcatheter heart valve (THV) is generally utilized in transcatheter aortic valve implantation (TAVI). However, no research has assessed the clinical impact of filling volume variations of the current-generation SAPIEN 3 THV. We analyzed the clinical data of 331 patients who underwent TAVI with SAPIEN 3 at our institution. Post-procedural echocardiographic and multidetector computed tomography (MDCT) scan data and 3-year prognoses according to each filling volume were assessed. The procedural outcomes and 3-year mortality rates were comparable among the underfilling, nominal filling, and overfilling groups. For all THV sizes, the THV area evaluated on post-procedural MDCT scan increased stepwise along with an elevated filling volume, thereby covering a wide range of native annulus area. Compared with patients in the nominal filling and overfilling groups, those with 23-mm THVs in the underfilling group had a smaller effective orifice area (EOA) (1.38 [IQR: 1.18-1.56] vs. 1.57 [IQR: 1.41-1.84] vs. 1.58 [IQR: 1.45-1.71] cm2, P = 0.02) and a higher mean transvalvular gradient (13.6 [IQR: 11.0-15.7] vs. 12.1 [IQR: 9.0-14.9] vs. 12.0 [IQR: 8.1-14.8] cm2, P = 0.04). In conclusion, by adjusting the filling volume of SAPIEN 3 using THV with limited sizes, continuously distributed native annulus areas were covered. The underfilling implantation technique had a minimal negative effect on the valve function of 23-mm THVs only. In the entire cohort, the filling volume variations did not affect the mid-term prognosis negatively.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Desenho de Prótese , Resultado do TratamentoRESUMO
We experienced a rare case of acute heart failure due to prosthetic valve regurgitation seven years after the transcatheter aortic valve implantation (TAVI). We performed an emergent surgical aortic valve replacement. Intraoperative findings revealed the dehiscence of both sides of the anatomical noncoronary cusp without evident signs of degenerations such as thickening, calcification, or infection. Postoperative course was uneventful, and the patient discharged home 20 days after surgery. Although cause of valve failure was unclear, we are seriously concerned about the increase of similar cases in the future. Application of TAVI especially to younger patients should be avoided until long-term safety is demonstrated.
Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
A 85-year old male with hoarseness due to distal aortic arch aneurysm underwent zone 1 thoracic endovascular aortic repair( TEVAR) with two-debranching at our hospital. Five years after the TEVAR (90 years old), computed tomography( CT) revealed typeâ a endoleak due to migration of proximal end of the graft. Anatomically, additional TEVAR was impossible. To minimize the invasiveness, a two-stage surgery was planned. First, under deep hypothermic circulatory arrest, the ascending aorta was replaced with the brachiocephalic artery reconstruction and insertion of a stented vascular prosthesis distally through partial sternotomy to preserve the debranching bypass. Six days after the surgery, a transcatheter stent graft was placed from the stented vascular prosthesis to the native descending aorta. Postoperative course was uneventful, and CT scan showed no endoleak.
Assuntos
Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso de 80 Anos ou mais , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/cirurgia , Humanos , Masculino , Nonagenários , Resultado do TratamentoRESUMO
BACKGROUND: The effect of multiple prior percutaneous coronary interventions (PCIs) before subsequent coronary artery bypass grafting (CABG) on long-term outcomes has not been well elucidated.MethodsâandâResults:Between 2007 and 2016, 1,154 patients undergoing primary isolated CABG in our institution had no prior PCI (Group N), 225 had a single prior PCI (Group S), and 272 had multiple prior PCIs (Group M). Cumulative incidences of all-cause death, cardiac death and myocardial infarction (MI) at 10 years post-CABG were highest in Group M. After adjusting for confounders, the risk of all-cause death was higher in Group M than in Group N (hazard ratio [HR] 1.45; 95% confidence interval [CI], 1.10-1.91; P<0.01). Between Groups N and S, however, the risk of all-cause death was not different. The risks of cardiac death and MI were likewise higher in Group M than in Group N (HR, 2.39; 95% CI, 1.55-3.71; P<0.01 and HR, 3.65; 95% CI, 1.16-11.5; P=0.03, respectively), but not different between Groups N and S. The risk of repeat revascularization was not different among any of the groups. CONCLUSIONS: Multiple prior PCIs was associated with higher risks of long-term death and cardiovascular events. The incidence of repeat revascularization after CABG was low regardless of the history of single/multiple PCIs.
Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Humanos , Infarto do Miocárdio , Fatores de Risco , Acidente Vascular Cerebral , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND AND AIM OF THE STUDY: Coronary artery fistula (CAF) is a relatively rare cardiac anomaly. We investigated long-term outcomes following surgical repair of CAF in adults. METHODS: We retrospectively investigated 13 consecutive patients undergoing surgical repair of CAF in our institution between 2008 and 2019 (67.3 ± 10.4 years old, 38% male). CAF types were coronary artery-pulmonary artery fistula (77%), coronary artery-coronary sinus fistula (15%), and both (8%). CAFs originated from the left coronary artery (38%), right coronary artery (8%), and bilateral coronary arteries (38%). Pulmonary and systemic flow (Qp/Qs) was measured in seven patients (54%), with a mean value of 1.52. Seven patients underwent surgery for CAFs alone, and others simultaneously underwent surgery for comorbid cardiac diseases. RESULTS: All procedures were conducted under cardiopulmonary bypass. Surgical procedures were direct epicardial ligation of fistula (92%), direct closure of CAF through pulmonary artery incision (38%), direct closure of CAF through coronary sinus incision (8%), or patch closure of CAF through coronary artery incision (8%). Myocardial perfusion scintigraphy showed asymptomatic myocardial ischemia in the right coronary area after surgery in one patient. There were no deaths perioperatively or during follow-up (mean: 66.6 months). There were no coronary or other CAF-related events. CONCLUSIONS: Several anatomical variations in CAF were observed which coexist with cardiac disease. Long-term outcomes following surgical repair were satisfactory, and the concurrent intervention of CAFs during surgery for comorbid cardiac disease is useful to prevent future complications related CAFs in adults.
Assuntos
Fístula Arteriovenosa , Anomalias dos Vasos Coronários , Cardiopatias Congênitas , Fístula Vascular , Adulto , Idoso , Angiografia Coronária , Anomalias dos Vasos Coronários/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Postdilatation after transcatheter heart valve (THV) implantation was associated with larger aortic valve areas in large-scale registries; however, the specific effects of postdilatation are poorly understood. METHODS AND RESULTS: Among a total of 224 consecutive patients who underwent transcatheter aortic valve replacement using SAPIEN 3, 121 patients (54.0%) underwent postdilatation (same contrast volume: N = 101, +1 ml: N = 17, +2 ml: N = 3). THV diameter was assessed (a) during, (b) after implantation, (c) during postdilatation, and (d) after postdilatation by quantitative fluoroscopy. In the overall patients (N = 224), acute recoil was observed from during implantation (23.0 ± 2.0 mm) to after implantation (22.5 ± 2.0 mm, p < .001) with an absolute recoil of 0.52 ± 0.25 mm. After postdilatation (N = 121), THV diameter significantly increased from 22.5 ± 2.0 mm to 22.9 ± 2.1 mm (p < .001), with smaller absolute recoil (0.39 ± 0.21 mm, p < .001). Compared with those who did not undergo postdilatation, patients who underwent postdilatation had larger postprocedural THV area assessed by multi-slice computed tomography (471.4 ± 78.1 mm2 vs. 447.5 ± 76.3 mm2 , p = .02) and larger effective orifice area (EOA) assessed by echocardiography throughout 1 year (at 30 day, 1.66 ± 0.33 cm2 vs. 1.45 ± 0.27 cm2 , p < .001; at 6 month, 1.66 ± 0.33 cm2 vs. 1.44 ± 0.29 cm2 , p < .001; at 1 year, 1.69 ± 0.38 cm2 vs. 1.47 ± 0.30 cm2 , p < .001). CONCLUSIONS: Postdilatation after implantation of the SAPIEN 3 valve produced a larger THV diameter with less acute recoil, followed by larger EOA throughout 1 year. Further studies are needed to evaluate the impact of postdilatation on long-term clinical outcomes.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão/efeitos adversos , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Recuperação de Função Fisiológica , Sistema de Registros , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do TratamentoRESUMO
BACKGROUND: There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan. METHODSâANDâRESULTS: We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69). CONCLUSIONS: These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Feminino , Insuficiência Cardíaca/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Japão , Masculino , Recuperação de Função Fisiológica , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
BACKGROUND: Stereotactic radiosurgery (SRS) has become a primary option for management for both newly diagnosed vestibular schwannomas (VS), as well as VS that enlarge after initial observation. METHODS: A retrospective review of our prospectively maintained data base found 871 patients who underwent Gamma knife® SRS as their initial (primary) management between 1987 and 2008. Follow-up ranged from 1-25 years (median = 5.2 years) Median tumor volume was 0.9 cc (0.02-36) and median margin dose was 13 Gy (12-25). RESULTS: Progression free survival (PFS) after SRS was 97% at 3 years, 95% at 5 years, and 94% at 10 years. Freedom from delayed surgical resection was found in 98.7% of patients. Smaller tumor volume was significantly associated with improved PFS. There were 326 patients with serviceable hearing (Gardner-Robertson 1 or 2) at the time of SRS with audiological follow-up of ≥ 1 year. Serviceable hearing preservation rates after SRS were 89.8% at 1 year, 76.9% at 3 years, 68.4% at 5 years, 62.5% at 7 years, and 51.4% at 10 years. Factors associated with improved serviceable hearing preservation included younger age, Gardner-Robertson grade 1 at SRS, and absence of subjective complaints of dysequilibrium or vertigo (vestibulopathy). Fifty-one patients (5.8%) developed trigeminal neuropathy. Fourteen (1.6%) developed a transient House-Brackmann grade 2 or 3 facial neuropathy. CONCLUSIONS: In this report with extended follow-up, primary SRS achieved tumor growth control in 94% of patients. Optimization of long- term cranial nerve outcomes remains an important achievement of this management strategy for VS.
Assuntos
Neuroma Acústico/radioterapia , Radiocirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neuroma Acústico/diagnóstico , Neuroma Acústico/patologia , Intervalo Livre de Progressão , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
The hemodynamics and outcomes in patients with a small aortic annulus (SAA) after transcatheter aortic valve replacement (TAVR) with a second-generation transcatheter heart valve remain unclear. We investigated whether TAVR with a Sapien XT (Edwards Lifesciences, Irvine, California) influences postprocedural valve hemodynamics and long-term outcome in high-risk SAA patients compared with surgical aortic valve replacement (SAVR).We retrospectively identified 94 SAA patients who underwent aortic valve replacement (TAVR = 35 and SAVR = 59). SAA was defined as an aortic annulus diameter ≤ 20 mm, measured by preprocedural transesophageal echocardiography.The mean age was 80.2 years. The mean Society of Thoracic Surgeons-Predicted Risk of Mortality was 6.8%. The post-procedural peak transvalvular velocity and mean pressure gradient were significantly lower in the TAVR cohort than in the SAVR cohort, whereas the postprocedural aortic valve area was significantly higher in the TAVR cohort. Severe prosthesis-patient mismatch (PPM) occurred less frequently after TAVR than SAVR (TAVR 2.9% versus SAVR 22.0%, P = 0.01). The two-year mortality in SAA patients was similar between the two groups.TAVR with a Sapien XT in SAA patients improved the valve hemodynamics and reduced the incidence of PPM compared with SAVR. TAVR patients had a similar 2-year mortality despite higher risk baseline characteristics. To avoid PPM and the consequent poor outcomes, TAVR can be considered an alternative option to SAVR in high surgical risk patients with SAA.
Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Próteses Valvulares Cardíacas , Hemodinâmica , Humanos , Masculino , Estudos Retrospectivos , Análise de Sobrevida , Resultado do TratamentoRESUMO
Aortic complex rupture is one of the most critical complications associated with transcatheter aortic valve implantation (TAVI). Its incidence is rare, and its mechanism varies by case; therefore, it is difficult to identify the predictors of complex rupture. Herein, we report a clinical case series of aortic complex rupture. Within our cohort, the frequency of complex rupture was 0.8% (4/497 consecutive patients) with an in-hospital mortality of 0. Among these four patients with complex rupture, two underwent emergent thoracotomy and surgical hemostasis without a heart-lung machine and surgical aortic valve replacement, whereas the other two were conservatively managed. The case overview revealed the following similarities: all the patients were elderly, small women; balloon-expandable valves were used; the annulus area was small with heavily calcified leaflet; and aggressive treatment strategy was used (i.e., oversizing and post-dilatation). In such cases, TAVI should be performed with a careful strategy. Once aortic complex rupture occurs, damage can be minimized through cooperation with an institutional heart team and calm management.
Assuntos
Ruptura Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Assistência ao Convalescente , Idoso de 80 Anos ou mais , Ruptura Aórtica/diagnóstico por imagem , Valva Aórtica/patologia , Estenose da Valva Aórtica/patologia , Aortografia/métodos , Calcinose/patologia , Tratamento Conservador/métodos , Feminino , Hemostasia Cirúrgica/métodos , Humanos , Toracotomia/métodos , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate cranial nerve (CN) outcomes after primary stereotactic radiosurgery (SRS) for petroclival, cavernous sinus, and cerebellopontine angle meningiomas. METHODS: From our prospectively maintained database of 2022 meningioma patients who underwent Leksell stereotactic radiosurgery (SRS) during a 30-year interval, we found 98 patients with petroclival, 242 with cavernous sinus, and 55 patients with cerebellopontine angle meningiomas. Primary radiosurgery was performed in 245 patients. Patients included in this report had at least one CN deficit at the time of initial presentation and a minimum of 12 month follow up. Median age at the time of SRS was 58 years. Median follow up was 58 months (range 12-300 months), Median tumor volume treated with SRS was 5.9 cm3 (range 0.5-37.5 cm3), and median margin dose was 13 Gy (range 9-20Gy). RESULTS: Tumor control was achieved in 229 patients (93.5%) at a median follow up of 58 months. Progression free survival rate (PFS) after SRS was 98.7% at 1 year, 96.4% at 3 years, 93.7% at 5 years, and 86.4% at 10 years Overall, 114 of the 245 patients (46.5%) reported improvement of CN function. Patients with CP angle meningiomas demonstrated lower rates of CN improvement compared to petroclival and cavernous sinus meningioma patients. Deterioration of CN function after SRS developed in 24 patients (10%). The rate of deterioration was 2.8% at 1 year, 5.2% at 3 years, and 8% at 10 years. CONCLUSION: Primary SRS provides effective tumor control and favorable rate of improvement of preexisting CN deficit.
Assuntos
Doenças dos Nervos Cranianos/radioterapia , Neoplasias Meníngeas/radioterapia , Meningioma/radioterapia , Radiocirurgia , Neoplasias da Base do Crânio/radioterapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças dos Nervos Cranianos/complicações , Doenças dos Nervos Cranianos/mortalidade , Nervos Cranianos/efeitos da radiação , Feminino , Seguimentos , Humanos , Masculino , Neoplasias Meníngeas/complicações , Neoplasias Meníngeas/mortalidade , Meningioma/complicações , Meningioma/mortalidade , Pessoa de Meia-Idade , Estudos Prospectivos , Radiocirurgia/efeitos adversos , Dosagem Radioterapêutica , Estudos Retrospectivos , Neoplasias da Base do Crânio/complicações , Neoplasias da Base do Crânio/mortalidade , Resultado do Tratamento , Carga Tumoral , Adulto JovemRESUMO
BACKGROUND: The right gastroepiploic artery (RGEA) is often used for coronary artery bypass grafting (CABG) in Japan. As gastric cancer has a high prevalence in many Asian countries, we investigated problems with surgery for gastric cancer after CABG using the RGEA. METHODS: A total of 860 patients underwent CABG using the RGEA between January 1997 and December 2006. Of these, 13 patients underwent surgery for gastric cancer after CABG. In all cases, the RGEA was harvested by the skeletonization technique, and an antegastric route was used for the anastomosis. RESULTS: Dissection for the No. 6 lymph node was not performed in all cases because of the risk of graft injury. Graft injury during gastric surgery occurred in one patient and post-operative ventricular fibrillation (VF) was observed in two patients. One case of hospital death due to VF and two cases of remote death were encountered. CONCLUSIONS: In planning a resection for gastric cancer following a CABG with a patent RGEA graft, the potential for graft injury must be anticipated. In advanced stages of gastric cancer when the RGEA needs to be resected to dissect the No.6 lymph node, a pre-operative percutaneous coronary intervention or a reoperative CABG may be indicated.
Assuntos
Ponte de Artéria Coronária/métodos , Gastrectomia , Artéria Gastroepiploica/transplante , Neoplasias Gástricas/cirurgia , Idoso , Anastomose Cirúrgica/métodos , Feminino , Artéria Gastroepiploica/lesões , Mortalidade Hospitalar , Humanos , Excisão de Linfonodo , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Complicações Pós-Operatórias , Reoperação , Coleta de Tecidos e Órgãos/métodos , Fibrilação VentricularRESUMO
PURPOSE: Gamma Knife radiosurgery is a highly precise and accurate treatment technique for treating brain diseases with low risk of serious error that nevertheless could potentially be reduced. We applied the AAPM Task Group 100 recommended failure modes and effects analysis (FMEA) tool to develop a risk-based quality management program for Gamma Knife radiosurgery. METHODS: A team consisting of medical physicists, radiation oncologists, neurosurgeons, radiation safety officers, nurses, operating room technologists, and schedulers at our institution and an external physicist expert on Gamma Knife was formed for the FMEA study. A process tree and a failure mode table were created for the Gamma Knife radiosurgery procedures using the Leksell Gamma Knife Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection for failure mode (D) were assigned to each failure mode by 8 professionals on a scale from 1 to 10. An overall risk priority number (RPN) for each failure mode was then calculated from the averaged O, S, and D scores. The coefficient of variation for each O, S, or D score was also calculated. The failure modes identified were prioritized in terms of both the RPN scores and the severity scores. RESULTS: The established process tree for Gamma Knife radiosurgery consists of 10 subprocesses and 53 steps, including a subprocess for frame placement and 11 steps that are directly related to the frame-based nature of the Gamma Knife radiosurgery. Out of the 86 failure modes identified, 40 Gamma Knife specific failure modes were caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the Gamma Knife helmets and plugs, the skull definition tools as well as other features of the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all external beam radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, unsecured plugs/inserts, overlooked target areas, and undetected machine mechanical failure during the morning QA process. CONCLUSIONS: The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process. The results of the present study give us a basis for the development of a risk based quality management program for Gamma Knife radiosurgery.
Assuntos
Análise do Modo e do Efeito de Falhas na Assistência à Saúde , Neoplasias/cirurgia , Radiocirurgia/estatística & dados numéricos , Planejamento da Radioterapia Assistida por Computador/métodos , Humanos , Radiocirurgia/métodos , Dosagem Radioterapêutica , Gestão de RiscosRESUMO
As Japan has one of the most rapidly aging populations in the world, transcatheter aortic valve implantation (TAVI) is likely to be performed in increasing numbers of older people. There is little information on either the efficacy or the safety of TAVI in nonagenarians in Asia.From October 2013 to June 2015, 112 consecutive patients underwent TAVI with Edwards SAPIEN XT valves in our institution. We compared 25 patients aged at least 90 years (mean 91.6 ± 1.7 years) with 87 patients aged under 90 years (mean 82.5 ± 6.0 years) at the time of TAVI. All definitions of clinical endpoints and adverse events were based on the Valve Academic Research Consortium 2 definitions.The median follow-up interval was 561.5 days (the first and third quarters, 405.0 and 735.8 days). Nonagenarians had a higher logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), Euro II score, and the Society of Thoracic Surgeons predictive risk of mortality (STS) score, and a prevalence of clinical frailty scale ≥ 4. The rate of device success, and the 30-day and 6-month mortalities were not different between patients aged ≥ 90 years and < 90 years (96.0% versus 92.0%, P = 0.68; both 0%, P = 1.00; 4.0% versus 3.5%, P = 0.32, respectively). At six months, clinical efficacy and time-related valve safety were also similar in the two groups (12.5% versus 13.4%, P = 1.00; 4.5% versus 10.3%, P = 0.68, respectively). The cumulative 1-year mortalities were not significantly different between the two groups (8.4% versus 9.4%, P = 0.94, respectively).TAVI can contribute to acceptable clinical results and benefits in a carefully selected group of nonagenarians in Asia.
Assuntos
Estenose da Valva Aórtica/cirurgia , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Japão/epidemiologia , Masculino , Complicações Pós-Operatórias/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
BACKGROUND: Very limited data exist on the outcomes of transcatheter aortic valve implantation (TAVI) since Japanese marketing approval of the first TAVI device.MethodsâandâResults:The Kyoto University-related hospital Transcatheter Aortic Valve Implantation (K-TAVI) registry includes prospectively collected data from 6 participating hospitals in Japan. We included 302 patients with severe aortic stenosis who underwent TAVI using the SAPIEN XT balloon-expandable valve via transfemoral (TF; n=203, 67%) or transapical (TA; n=99, 33%) approach between October 2013 and September 2015. Device success rate, based on the Valve Academic Research Consortium-2 criteria, was very high in the TF (97.0%) and TA (99.0%) groups. The 30-day mortality rates were 1.5% and 1.0% in the TF and TA groups, respectively. Major complications included stroke (transient or persistent: 2.3%), annulus rupture (1.0%), coronary intervention (1.0%), major vascular complications (1.7%), and permanent pacemaker implantation (5.4%). The procedure times of the post-proctoring period (n=210) were decreased compared with those of the proctoring period (n=89) without affecting the clinical outcomes. The survival rates at 6 and 12 months were 96.9% and 92.5% in the TF group, and 93.9% and 91.8% in the TA group, respectively. CONCLUSIONS: The K-TAVI registry data revealed that the early outcomes of TAVI using the SAPIEN XT were favorable in real-world Japanese patients.
Assuntos
Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Povo Asiático , Intervalo Livre de Doença , Feminino , Humanos , Japão , Masculino , Estudos Prospectivos , Taxa de SobrevidaRESUMO
BACKGROUND: Repeat Gamma Knife stereotactic radiosurgery (GKSR) procedures are becoming common, especially for brain metastases. It is important to identify tumors requiring treatment at repeat GKSR and it can be challenging to distinguish treated tumors, tumor progression and new tumors. Using the image co-registration tool within the Leksell Gamma Plan software, we developed a technique to aid in the identification of tumors needing treatment. OBJECTIVES: The objective was to explore a new co-registration technique to identify tumors requiring treatment at repeat GKSR procedures. METHODS: Ten patients who underwent repeat GKSR for brain metastases were identified. Contrast-enhanced volumetric T1 magnetic resonance images (MRI) from the previous GKSR were co-registered with the new images and the resulting two-color format image was used to evaluate tumor status. RESULTS: Using the co-registered images, tumors were characterized as: resolved, regressed, stable, larger or new. Overall, 13.6% of tumors completely resolved, 26.2% regressed, 13.1% remained stable, while 7.9% progressed. Thirty-nine percent of tumors were new. CONCLUSIONS: The co-registration technique makes clinically relevant changes conspicuous on MRI. It distinguishes between tumors potentially requiring treatment and those that have been treated successfully. It can be used with tumors other than metastases and for evaluating tumor response at follow-up.
Assuntos
Neoplasias Encefálicas/cirurgia , Neoplasias da Mama/cirurgia , Neoplasias Pulmonares/cirurgia , Radiocirurgia/instrumentação , Idoso , Neoplasias Encefálicas/secundário , Neoplasias da Mama/patologia , Progressão da Doença , Feminino , Humanos , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Radiocirurgia/métodos , Resultado do TratamentoRESUMO
An 80-year-old female patient underwent redo aortic valve replacement for haemolysis caused by moderate paravalvular leakage 1 year after a 21-mm Intuity Elite valve implantation. The elevatorium passed at the segment with paravalvular leakage. The frame was then bent inward using a hook and the peel around the sawing ring was shaved by an elevatorium. After explantation of the Intuity Elite valve, endoscopic examination showed no sign of annular or sub-annular damage. Conventional aortic valve replacement using a biological valve was performed. We introduce a safe alternative technique for explantation of a rapid deployed valve.
RESUMO
Background: Various cardiovascular diseases cause acquired von Willebrand syndrome (AVWS), which is characterized by a decrease in high-molecular-weight (large) von Willebrand factor (VWF) multimers. Mitral regurgitation (MR) has been reported as a cause of AVWS. However, much remains unclear about AVWS associated with MR. Objectives: To evaluate VWF multimers in MR patients and examine their impact on clinical characteristics. Methods: Moderate or severe MR patients (n = 84) were enrolled. VWF parameters such as the VWF large multimer index (VWF-LMI), a quantitative value that represents the amount of VWF large multimers, and clinical data were prospectively analyzed. Results: At baseline, the mean hemoglobin level was 12.9 ± 1.9 g/dL and 58 patients (69.0%) showed loss of VWF large multimers defined as VWF-LMI < 80%. VWF-LMI in patients with degenerative MR was lower than in those with functional MR. VWF-LMI appeared to be restored the day after mitral valve intervention, and the improvement was maintained 1 month after the intervention. Seven patients (8.3%) had a history of bleeding, 6 (7.1%) of whom had gastrointestinal bleeding. Gastrointestinal endoscopy was performed in 23 patients (27.4%) to investigate overt gastrointestinal bleeding, anemia, etc. Angiodysplasia was detected in 2 of the 23 patients (8.7%). Conclusion: Moderate or severe MR is frequently associated with loss of VWF large multimers, and degenerative MR may cause more severe loss compared with functional MR. Mitral valve intervention corrects the loss of VWF large multimers. Gastrointestinal bleeding may be relatively less frequent and hemoglobin level remains stable in MR patients.
RESUMO
Background: Severe aortic stenosis (AS) causes acquired von Willebrand syndrome by the excessive shear stress-dependent cleavage of high molecular weight multimers of von Willebrand factor (VWF). While the current standard diagnostic method is so-called VWF multimer analysis that is western blotting under nonreducing conditions, it remains unclear whether a ratio of VWF Ristocetin co-factor activity (VWF:RCo) to VWF antigen levels (VWF:Ag) of <0.7, which can be measured with an automated coagulation analyzer in clinical laboratories and is used for the diagnosis of hereditary von Willebrand disease. Objectives: To evaluated whether the VWF:RCo/VWF:Ag is useful for the diagnosis of AS-induced acquired von Willebrand syndrome. Methods: VWF:RCo and VWF:Ag were evaluated with the VWF large multimer index as a reference, which represents the percentage of a patient's VWF high molecular weight multimer ratio to that of standard plasma in the VWF multimer analysis. Results: We analyzed 382 patients with AS having transaortic valve maximal pressure gradients of >30 mmHg, 27 patients with peripheral artery disease, and 46 control patients free of cardiovascular disease with osteoarthritis, diabetes, and so on. We assumed a large multimer index of <80% as loss of VWF large multimers since 59.0% of patients with severe AS had the indices of <80%, while no control patients or patients with peripheral artery disease, except for 2 patients, exhibited the indices of <80%. The VWF:RCo/VWF:Ag ratios, measured using an automated blood coagulation analyzer, were correlated with the indices (rs = 0.470, P < .001). When the ratio of <0.7 was used as a cut-off point, the sensitivity and specificity to VWF large multimer indices of <80% were 0.437 and 0.826, respectively. Conclusion: VWF:RCo/VWF:Ag ratios of <0.7 may indicate loss of VWF large multimers with high specificity, but low sensitivity. VWF:RCo/VWF:Ag ratios in patients with AS having a ratio of <0.7 may be useful for monitoring the loss of VWF large multimers during their clinical courses.