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INTRODUCTION: Atrioventricular (AV)-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation (AF). We hypothesized that isolation of the AV nodal isolation (AVNI) is associated with a more frequent preservation of an adequate escape rhythm compared to AVNA. METHODS: This retrospective study included 20 patients with therapy-refractory AF being treated with AVNI and 40 historical AVNA-controls. In AVNI the AV-node region was mapped using a 3D mapping system. Ablation was performed around the previously mapped HIS-cloud regions isolating the atrium from the AV-node. In the AVNI group, ablation was performed with irrigated tip ablation catheter in all cases. The two approaches were compared regarding rate of escape rhythm, delta QRS, and procedural data. RESULTS: The number of patients with adequate escape rhythm in AVNI was significantly superior to AVNA immediately postoperative (90% vs. 40%, p < 0.01) and during follow-up (77% vs. 36%, p < 0.05). The median change in QRS width was 0 ms in AVNI versus +26 ms in AVNA (p < 0.01). Thirty percent new bundle branch blocks in AVNA were observed compared to 0% in AVNI (p < 0.01). In the AVNI group, fluoroscopy time and total dose area product were significantly lower (p < 0.01). CONCLUSION: The present study suggests that AV-node isolation using 3D navigation mapping system is a feasible and effective alternative to conventional AVNA. The precise application of radiofrequency lesions preserves a stable AV-junctional rhythm.
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Fibrilación Atrial , Ablación por Catéter , Humanos , Estudios Retrospectivos , Nodo Atrioventricular/cirugía , Ablación por Catéter/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugíaRESUMEN
The remede system is a novel fully implantable transvenous phrenic nerve stimulation (TPNS) device developed to treat central sleep apnea. No information is published on how to explant or replace its leads. An eighty-one year-old had a fractured lead and we removed it over a wire. However, unbreachable resistances occurred with a new lead deployed over the enclosed wire and interventional endovascular techniques were performed to reimplant a new fully functioning system. This first report demonstrates TPNS lead exchange is possible but can be challenging. Interventional maneuvers and techniques, including balloon angioplasty, can facilitate this procedure.
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Terapia por Estimulación Eléctrica , Apnea Central del Sueño , Anciano de 80 o más Años , Humanos , Nervio Frénico , Apnea Central del Sueño/terapia , Resultado del TratamientoRESUMEN
AIMS: Pacing the specific conduction system like the Bundle of His (HB) can lead to more physiologic activation patterns compared to traditional right ventricular apical pacing. The aim of this study was to estimate the feasibility and value of electroanatomical mapping (EAM) for HB pacing during the learning curve and its impact on procedural outcome. METHODS AND RESULTS: Fifteen consecutive patients were treated using EAM of the His bundle region before implantation. Voltage and activation maps of HB potentials were performed. The activation time from His potential to R wave (ECG-reference) was measured and correlated to the HV interval. The atrial and ventricular potentials were blended so the active window could only see the His potential. After completing the activation map, it was transformed into a peak-to-peak voltage map of the HB. With reversed black and white colour scale, the exact point of the maximal His signal amplitude was visualized. Procedural data for the implantation were analysed using this innovative approach. The average total procedural time and fluoroscopy time was 88.2 ± 19.1 min and 10.9 ± 4.5 min, respectively. The 3D mapping time was 18.4 ± 5.1 min. The 13.9 ± 5.1 His potential points were needed in average to complete the map. No periprocedural complications were seen in this cohort. In 86.7% of cases, His bundle pacing was successful. The average threshold for the His bundle stimulation and the R-wave amplitude was 1.62 ± 1 V (@1.0 ms) and 4.8 ± 3.2 mV, respectively. The pacing impedance was 513.5 ± 102.8 Ω. Average paced QRS complex width was 116.9 ± 20.3ms. On average 2.6 ± 1.6 lead positions were targeted to find the optimal pacing site. CONCLUSION: Electroanatomical mapping-guided implantation of His-bundle leads can facilitate the identification of optimal pacing sites and allow to minimize procedure and fluoroscopy times even during the phase of the learning curve.
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Fascículo Atrioventricular , Curva de Aprendizaje , Estimulación Cardíaca Artificial , Electrocardiografía , Fluoroscopía , Humanos , Resultado del TratamientoAsunto(s)
Marcapaso Artificial , Válvula Tricúspide , Humanos , Estimulación Cardíaca Artificial/métodos , Arteria Femoral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
Left ventricular assist devices (LVADs) are an important therapeutic option for patients with end-stage heart failure waiting for heart transplantation or in older patients as definite therapy for heart failure. Interestingly, about 62% of patients receiving LVADs do not have an automatic implantable cardioverter-defibrillator (AICD) at the time of implantation, although these patients have increased risk of being confronted with dangerous arrhythmia. Therefore, an LVAD system including AICD function is a reasonable alternative for such heart failure patients thereby avoiding a second surgical intervention for AICD implantation. In this article, a newly developed system including LVAD and AICD function is introduced, and we also report its first in vitro testing.
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Procedimientos Quirúrgicos Cardiovasculares/instrumentación , Desfibriladores , Corazón Auxiliar , Insuficiencia Cardíaca/cirugía , Humanos , Modelos Cardiovasculares , Diseño de PrótesisRESUMEN
BACKGROUND: Permanent pacemaker implantation (PMI) is associated with increased morbidity after transcatheter aortic valve replacement (TAVR). Cardiac resynchronization-therapy (CRT) is recommended for patients if left ventricular ejection fraction (LVEF) is ≤ 40% and ventricular pacing is expected in favor to sole right ventricular (RV) pacing. Meanwhile, LVEF may recover after TAVR in patients with aortic valve disease and the benefit of CRT is unknown. OBJECTIVE: To analyze the impact of CRT implantation as compared to RV pacing after TAVR. METHODS AND RESULTS: Between 2012 and 2022, 4385 patients (53.1% female, mean age 81 ± 6 years) without prior PMI undergoing TAVR were retrospectively identified in our institutional registry. After stratification of patients in LVEF ≤ 40%, 41-49% and ≥ 50%, Kaplan-Meier analysis revealed significantly different survival rates in each subgroup at 5 years (37.0% vs. 43.5% vs. 55.1%; P ≤ 0.021). At multivariate regression, LVEF and new PMI after TAVR were not relevant for survival. A total of 105 patients with LVEF ≤ 40% received PMI after TAVR (86 patients with RV pacing and 19 with CRT). At 5 years, all-cause mortality was significantly lower in patients with CRT-device as compared to patients without CRT-device (Kaplan Meier estimate of 21.1% vs. 48.8%; HR 0.48, CI 0.204 - 1.128; log rank p = 0.045). In multivariate analysis CRT remained a significant factor for 5-year survival in these patients (HR 0.3, CI 0.095-0.951, p = 0.041). CONCLUSION: In patients undergoing TAVR, PMI did not influence 5-year survival. In patients with LVEF ≤ 40%, CRT-device implantation was associated with improved survival compared to non-CRT-device implantation.
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AIMS: Baroreflex activation therapy (BAT) is an innovative treatment option for advanced heart failure (HFrEF). We analysed patients' BAT acceptance and the outcome of BAT patients compared with HFrEF patients solely treated with a guideline-directed medical therapy (GDMT) and studied effects of sacubitril/valsartan (ARNI). METHODS: In this prospective study, 40 HFrEF patients (71 ± 3 years, 20% female) answered a questionnaire on the acceptance of BAT. Follow-up visits were performed after 3, 6, and 12 months. Primary efficacy endpoints included an improvement in QoL, NYHA class, LVEF, HF hospitalization, NT-proBNP levels, and 6MHWD. RESULTS: Twenty-nine patients (73%) showed interest in BAT. Ten patients (25%) opted for implantation. BAT and BAT + ARNI patients developed an increase in LVEF (BAT +10%, P-value (P) = 0.005*; BAT + ARNI +9%, P = 0.049*), an improved NYHA class (BAT -88%, P = 0.014*, BAT + ARNI -90%, P = 0.037*), QoL (BAT +21%, P = 0.020*, BAT + ARNI +22%, P = 0.012*), and reduced NT-proBNP levels (BAT -24%, P = 0.297, BAT + ARNI -37%, P = 0.297). BAT HF hospitalization rates were lower (50%) compared with control group patients (83%) (P = 0.020*). CONCLUSIONS: Although BAT has generated considerable interest, acceptance appears to be ambivalent. BAT improves outcome with regard to LVEF, NYHA class, QoL, NT-proBNP levels, and HF hospitalization rates. BAT + ARNI resulted in more pronounced effects than ARNI alone.
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Insuficiencia Cardíaca , Humanos , Femenino , Masculino , Insuficiencia Cardíaca/terapia , Barorreflejo/fisiología , Estudios Prospectivos , Calidad de Vida , Volumen Sistólico/fisiología , Inhibidores Enzimáticos/farmacología , CardiotónicosRESUMEN
Background: Cardiac resynchronization therapy (CRT) by implantation of an endocardial coronary sinus (CS) pacing lead is an established heart failure therapy. The recent European Society of Cardiology (ESC) guidelines on cardiac pacing and CRT recommend conduction system pacing (CSP) as a potential bail-out therapy in patients with previously unsuccessful CS-lead implantation. We present a case in which unsuccessful implantation of a CS pacing and ineffective QRS correction by His-bundle pacing (HBP) was overcome by left-bundle branch pacing (LBBP) to achieve cardiac resynchronization. Case summary: The patient had to undergo revision of a CS lead for CRT due to rising pacing thresholds and pacing impedance. CS-lead implantation was omitted by a stenotic posterolateral CS branch. HBP did not lead to adequate QRS correction. The patient underwent successful LBB lead implantation as bail-out therapy. After LBBP lead implantation electrocardiographic and echocardiographic parameters were evident of effective CRT. Discussion: Conduction system pacing may be an alternative to CS pacing for CRT in heart failure patients, which is endorsed by the current European guidelines. LBBP may overcome limitations of HBP and provide an alternative to other strategies such as surgical implantation of epicardial left-ventricular pacing leads. Further studies are needed to fully clarify the role of LBBP for heart failure treatment.
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BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) is used as an alternative to conventional surgery in high-risk patients. The EuroSCORE quantifies the risk, and patients are selected for this procedure if their predicted mortality is high. The study aim was to evaluate the risk discrimination and calibration of the EuroSCORE, as well as the surgical judgment that is used when selecting the aortic valve replacement (AVR) approach. METHODS: Between 2003 and 2006, a total of 2757 patients underwent isolated, open AVR. The EuroSCORE was compared to the observed in-hospital mortality. A survey among surgeons assessed the relevance of patient-specific factors towards the approach of TAVI versus open AVR. RESULTS: Survivors of AVR had a lower additive EuroSCORE than non-survivors (7.2 +/- 3.34 versus 12.0 +/- 3.34; p < 0.001). The EuroSCORE demonstrated reasonable risk stratification (c-statistic 0.843, p < 0.001). However, none of the 67 non-survivors was correctly predicted (Hosmer-Lemeshow test; p < 0.001), and most patients with a high EuroSCORE survived AVR. The actual mortality was 2.8% as compared to a EuroSCORE-predicted mortality of 12.5 +/- 14.2% (p < 0.001). This poor calibration was worse with higher EuroSCOREs (Cusum test; p < 0.001). Surgeons identified a porcelain aorta as the only factor that warranted TAVI. Most EuroSCORE variables had either no relevance for treatment selection, or prompted open AVR. CONCLUSION: Patient selection for TAVI cannot be based on the EuroSCORE, because it lacks discrimination and center-specific calibration. Thus, individual, surgical judgment that weighs institutional expertise for high-risk patients against a possible reduction of mortality by using interventional techniques, is recommended.
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Insuficiencia de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/epidemiología , Insuficiencia de la Válvula Aórtica/mortalidad , Calibración , Competencia Clínica , Comorbilidad , Enfermedad de la Arteria Coronaria/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Factores de RiesgoRESUMEN
We report the case of an 88-year-old man who developed a mid-left-ventricular (LV) obstruction caused by apical pacing to manage third-degree atrioventricular block. The flow generated by the obstruction was directed toward the LV apex and appeared from late systole to early diastole. The obstruction appeared to result from earlier contraction at the apex compared with the midventricular portion of the LV, which was followed by an also earlier apical relaxation. The obstruction was eliminated by using a second right-ventricular mid-septally attached electrode combined with a sequential septo-apical pacing (septal stimulation 40 ms before apical pacing).
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Bloqueo Atrioventricular/terapia , Estimulación Cardíaca Artificial/efectos adversos , Ventrículos Cardíacos/diagnóstico por imagen , Obstrucción del Flujo Ventricular Externo/etiología , Anciano de 80 o más Años , Bloqueo Atrioventricular/fisiopatología , Ecocardiografía Doppler , Ventrículos Cardíacos/fisiopatología , Humanos , Masculino , Obstrucción del Flujo Ventricular Externo/diagnósticoRESUMEN
BACKGROUND AND AIM OF THE STUDY: Prosthetic heart valve dysfunction impacts on morbidity and quality of life. Although the diagnosis can be made by imaging studies, clinical symptoms commonly precede the diagnostic work-up. The ThromboCheck device analyzes the sound frequency spectra of valve motion, and alterations due to valve dysfunction are observed before overt clinical symptoms develop. The study aim was to determine if the ThromboCheck can be used to monitor the prosthetic valve function of patients at home. METHODS: Between 2003 and 2007, a total of 541 prosthetic heart valve recipients was prospectively enrolled into a double-blind, multi-center study. ThromboCheck devices were used to evaluate the sound frequency phenomena of valve motion. If the sound frequency spectra deviated from baseline, alarm signals were returned to the medical center via telephone, and these prompted evaluation by fluoroscopy and echocardiography. The clinical follow up included questionnaires at regular intervals. RESULTS: The cumulative observation period exceeded 748 patient-years, with a median follow up of 25.2 months per patient (range: 1 to 36 months). Almost all patients used the device at least two to three times per week to evaluate valve function, and the vast majority found it easy to operate. About 135,000 codes were returned to the study centers for further analysis; of these codes, 30 (0.0002%) were alarm signals. On 29 of the 30 occasions, prosthetic valve dysfunction was confirmed by fluoroscopy and echocardiography, yielding positive predictive values and specificities of 97% and 100%, respectively. There was no clinical event in the absence of a ThromboCheck alarm signal. Thrombolysis or increased warfarin-based anticoagulation quickly restored the initial sound frequency spectrum of the prosthetic valve in 16 patients. Another 13 patients were surgically revised; their prosthetic valves revealed significant thrombi upon replacement. By using the ThromboCheck device as part of a surveillance system, 79% of the patients felt safer with regards to prosthetic valve dysfunction. CONCLUSION: Analysis of sound frequency spectra by the ThromboCheck identified prosthetic heart valve dysfunction before clinical symptoms developed, and promoted early therapy. The restoration of valve function normalized the frequency spectra, which may be utilized to guide treatment. These results justify further efforts to introduce the analysis of sound phenomena into routine clinical care after prosthetic valve implantation.
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Válvula Aórtica/fisiología , Prótesis Valvulares Cardíacas , Válvula Mitral/fisiología , Monitoreo Fisiológico/instrumentación , Algoritmos , Válvula Aórtica/cirugía , Método Doble Ciego , Estudios de Seguimiento , Ruidos Cardíacos/fisiología , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Válvula Mitral/cirugía , Monitoreo Fisiológico/métodos , Estudios Prospectivos , Autocuidado , Trombosis/diagnóstico , Trombosis/fisiopatologíaRESUMEN
BACKGROUND AND AIM OF THE STUDY: Depending on the individual risk profile of a patient, disturbances of the functional integrity of mechanical heart valve prostheses occur in up to 2.5% of patients each year. The early phase of prosthetic dysfunction (due to thrombus formation, tissue ingrowth or endocarditis) usually remains undiagnosed, as patients do not present with symptoms in this situation, and imaging techniques (echocardiography, fluoroscopy) demonstrate normal occluder motion. The delay between the onset of prosthetic valve dysfunction and its clinical manifestation may result in complications (e.g. thromboembolism) or extended therapeutic options (e.g. reoperation rather than more intensive anticoagulation). METHODS: A total of 291 patients with mechanical heart valves was allocated to four different sub-groups, and each measured their valve sounds regularly with the 'ThromboCheck' device. Depending on the subgroup, the signals were compared with different reference signals. Patients in whom a suspicious signal was detected were immediately contacted and examined meticulously. RESULTS: Fourteen patients were found to have suspicious signals. In 13 patients, valve dysfunction was confirmed by fluoroscopy, but in four cases neither transthoracic nor transesophageal echocardiography detected abnormal occluder motion or 'musses' adjacent to the prosthesis. Normal valve sounds returned in four patients who underwent thrombolytic therapy. All patients regularly recorded and passed on their signals. Surveys revealed high acceptance and easy handling of the Thrombocheck device. CONCLUSION: Home monitoring of sound pressure measurements of prosthetic valves by digital frequency analysis via a Fast Fourier transformation may detect even very mild alterations of prosthetic valve function. The next evolution of control systems, allowing for registration of flow, frequency spectrum and electrocardiography, opens potential applications for Internet-based, remote monitoring of cardiac patients.
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Auscultación Cardíaca/instrumentación , Implantación de Prótesis de Válvulas Cardíacas , Procesamiento de Señales Asistido por Computador/instrumentación , Anciano , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Método Doble Ciego , Ecocardiografía , Ecocardiografía Transesofágica , Femenino , Estudios de Seguimiento , Auscultación Cardíaca/métodos , Ruidos Cardíacos , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Enfermedades de las Válvulas Cardíacas/cirugía , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Válvula Mitral/cirugía , Estudios Prospectivos , Falla de Prótesis , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/fisiopatología , Válvula Pulmonar/cirugía , Reproducibilidad de los Resultados , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/fisiopatología , Válvula Tricúspide/cirugíaRESUMEN
BACKGROUND AND AIMS OF THE STUDY: Optimal management of patients with coronary artery disease and concomitant aortic valve stenosis remains a subject of controversy. In this retrospective study, an attempt was made to identify criteria indicating rapid progression of aortic valve stenosis in patients with coronary artery disease. METHODS: Between 1990 and 1999, 47 patients underwent aortic valve replacement (AVR) after previous coronary artery bypass grafting (CABG) at the authors' institution. The postoperative data, including cardiac catheterization films, were reviewed. RESULTS: Aortic valve disease, mainly aortic stenosis, showed a rapid rate of progression. During a mean interval between CABG and AVR of 5.9 +/- 2.9 years, the mean peak-to-peak pressure gradient across the aortic valve rose from 16.1 +/- 13.8 to 61.4 +/- 23.9 mmHg in patients where presence of calcification and impaired aortic valve motion was found (66.0% of patients had calcified aortic valves; 72.3% had impaired valve motion) at the time of CABG; whereas in those without calcification and/or impaired leaflet motion a mean of 9.2 +/- 0.8 years elapsed before AVR became necessary. CONCLUSION: If a patient must undergo surgery for coronary artery disease, then AVR should be considered not only on the basis of hemodynamic criteria but also with regard to calcification of the aortic valve and its leaflet motion.
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Estenosis de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/fisiopatología , Calcinosis/etiología , Calcinosis/fisiopatología , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/fisiopatología , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Presión Sanguínea/fisiología , Calcinosis/cirugía , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Factores de TiempoRESUMEN
BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate whether: (i) by detection of changing acoustic sound phenomena, minimal changes in prosthetic valve function may be detected earlier than with echocardiography, invasive diagnosis or clinically; (ii) patients can record and pass on signals with a high level of reproducibility from any location via the Internet; and (iii) clinical data evaluation permits conclusions to be drawn on changes in the functional state of a prosthetic replacement valve. METHODS: Simulation studies were carried out using a mock circulation device. Aortic valve replacement (AVR) using extracorporeal circulation was performed in pigs, valve function was artificially disturbed, and valve sounds were recorded. Patients were equipped with briefcase-like devices to record their valve sounds after AVR and to transfer them via the Internet. RESULTS: Simulation studies produced a typical sound spectrum for each tested valve that remained constant under variable conditions. Experiments in animals proved that minimal changes in prosthetic valve function led to a significant change in the sound phenomena. The degree of sensitivity was significantly greater than that in echocardiographic control experiments. All patients in the clinical study regularly recorded and passed on their signals. Surveys revealed high acceptance and easy handling of the compiled devices. Valve dysfunctions were not detected. CONCLUSION: On-line registration of acoustic sound phenomena and ECG seems suited to detect minimal changes in prosthetic function. In particular, the registration of flow, acoustics and ECG envisaged at the next level opens up diverse potential applications for Internet-based, remote monitoring of patients following cardiac surgery or cardiologic treatment.
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Acústica , Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Enfermedades de las Válvulas Cardíacas/fisiopatología , Enfermedades de las Válvulas Cardíacas/cirugía , Prótesis Valvulares Cardíacas , Válvula Mitral/fisiopatología , Válvula Mitral/cirugía , Válvula Pulmonar/fisiopatología , Válvula Pulmonar/cirugía , Adulto , Animales , Válvula Aórtica/diagnóstico por imagen , Inteligencia Artificial , Simulación por Computador , Circulación Coronaria/fisiología , Recolección de Datos , Modelos Animales de Enfermedad , Ecocardiografía , Elasticidad , Electrocardiografía , Seguridad de Equipos , Humanos , Internet , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Modelos Cardiovasculares , Válvula Pulmonar/diagnóstico por imagen , Porcinos , Resultado del TratamientoRESUMEN
BACKGROUND: Although prosthetic valves are durable and easy to implant, the need for lifetime warfarin-based anticoagulation restricts their exclusive usage. We investigated if anticoagulation self-management improves outcome in a single-center series. METHODS: Between 1994 and 1998, 765 patients with prosthetic valve replacements were prospectively enrolled and randomized to receive conventional anticoagulation management by their primary physician (group 1, n = 295) or to pursue anticoagulation self-management (group 2, n = 470). A study head office was implemented to coordinate and monitor anticoagulation protocols, international normalized ratios (INR), and adverse events. Patients were instructed on how to obtain and test their own blood samples and to adjust warfarin dosages according to the measured INR (target range, 2.5 to 4). RESULTS: Mean INR values were slightly yet significantly smaller in group 1 than in group 2 (2.8 +/- 0.7 vs 3.0 +/- .6, p < 0.001). Moreover, INR values of patients with conventional INR management were frequently measured outside the INR target range, whereas those with anticoagulation self-management mostly remained within the range (35% vs 21%, p < 0.001). In addition, the scatter of INR values was smaller if self-managed. Freedom from thromboembolism at 3, 12, and 24 months, respectively, was 99%, 95%, and 91% in group 1 compared with 99%, 98%, and 96% in group 2 (p = 0.008). Bleeding events were similar in both groups. Time-related multivariate analysis identified INR self-management and higher INR as independent predictors for better outcome. CONCLUSIONS: Anticoagulation self-management can improve INR profiles up to 2 years after prosthetic valve replacement and reduce adverse events. Current indications of prosthetic rather than biologic valve implantations may be extended if the benefit of INR self-management is shown by future studies with longer follow-up.
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Anticoagulantes/uso terapéutico , Prótesis Valvulares Cardíacas/efectos adversos , Relación Normalizada Internacional , Autocuidado , Tromboembolia/prevención & control , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Tromboembolia/etiologíaRESUMEN
Despite enormous progress concerning material and design, patients with artificial heart valves still face a considerable risk of serious complications (e.g., hemorrhage, thromboemboli, redos) which sum up to 4.9-22.4% for the first 10 postoperative years depending on type and position of the implanted prosthetic valve. Nowadays, technical defects of mechanical valves are negligible and relevant complications are rather a consequence of long-term anticoagulation therapy. To avoid these complications, the authors consider a strict control of both the anticoagulation therapy and the functional integrity of the prosthetic valve to be inevitable. Therefore, with the aim of risk minimization the patient should be enabled to cooperate by means of methods which are easy to handle in his everyday environment. First multicentric results of a new method of early detection of valve dysfunction are presented.
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Análisis de Falla de Equipo/instrumentación , Análisis de Falla de Equipo/métodos , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Falla de Prótesis , Autocuidado/métodos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Autocuidado/instrumentaciónRESUMEN
BACKGROUND: After heart valve replacement, patients are at risk of complications that are linked to irregular oral anticoagulation therapy. Depending on the type and position of the valve, the complication rate is 3% to 6% per patient-year. This study presents clinical results of a device enabling early detection of prosthetic dysfunction by frequency measurements. METHODS: Between November 2003 and March 2006, ThromboCheck devices were handed out to 483 patients after mechanical heart valve replacement from six heart centers. In each case, the devices were calibrated for individual patients early postoperatively. Taking control measurements, the device calculated deviations from calibrated frequency and amplitude ranges using a fast Fourier transform and sent a warning message to the display if any relevant changes occurred. This message was taken as cause to determine morphologic correlations of the disturbance using imaging techniques, for example, echocardiography or fluoroscopy (observation period, 550.7 patient-years; median application period, 15.1 months). RESULTS: Twenty-five true positive, 1 false positive, and no false negative measurements occurred. Eleven patients (44%) received thrombolytic therapy with streptokinase or recombinant tissue-type plasminogen activator, resulting in normalization of the digital frequency analysis. In 4 patients (16%), international normalized ratio levels were adjusted under temporary heparinization therapy. Normalization of the valve sounds were achieved within 3 to 7 days. Seven patients (28%) required reoperation despite lysis therapy. Sensitivity was 100% during the observation period; specificity was 99.8%. CONCLUSIONS: Digital frequency analysis represents a reasonable addition to the monitoring of patients after artificial heart valve replacement to detect prosthesis-related complications early on.
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Diagnóstico por Computador/instrumentación , Enfermedades de las Válvulas Cardíacas/cirugía , Prótesis Valvulares Cardíacas/efectos adversos , Autocuidado , Método Doble Ciego , Diagnóstico Precoz , Diseño de Equipo , Falla de Equipo , Fibrinolíticos/uso terapéutico , Humanos , Satisfacción del Paciente , Proteínas Recombinantes/uso terapéutico , Reoperación , Sensibilidad y Especificidad , Estreptoquinasa/uso terapéutico , Encuestas y Cuestionarios , Activador de Tejido Plasminógeno/uso terapéuticoRESUMEN
BACKGROUND: Due to increasing life expectancy of patients with heart valve replacement and a limited durability of heart valve bioprostheses, replacement of aortic valve prosthesis becomes necessary in a significant percentage of patients. However, reliable data on mortality and its risk factors in octogenarians after replacement of aortic bioprostheses are limited. PATIENTS AND METHODS: 56 patients aged > or = 80 years who underwent cardiac reoperation of a bioprosthesis due to structural valve deterioration at the authors' heart center between 1991 and 2004 were analyzed retrospectively. To assess predictors of 30-day and 3-year survival, uni- and multivariate Cox regression analyses were performed. RESULTS: 30-day, 1-year, 3-year, and 5-year survival rates were 81.1%, 71.3%, 67.5%, and 50.8%, respectively. Patients with reoperation had an estimated median survival of 5.0 years. Patients who survived their in-hospital stay had a very similar life expectancy compared with the general German population. Postoperative complications such as low cardiac output syndrome and intestinal failure were the only independent predictors of 30-day and 3-year survival (p < 0.001). Postoperative New York Heart Association functional class improved markedly in the study cohort and the majority of survivors was able to live at home. As we cannot offer these patients an alternative effective medical therapy, octogenarians who need their aortic valve prosthesis to be replaced are left in a miserable condition with a poor prognosis, if surgery is denied. Therefore, considering that almost the same criteria are used for younger patients with the emphasis that surgery should not be delayed until they are highly symptomatic, reoperation of the aortic valve in this age group is justified. CONCLUSION: The data demonstrate that it is possible to achieve an acceptable outcome in octogenarians who are in need of a replacement of their aortic valve prosthesis. Early as well as mid-term survival are predominantly influenced by unexpected postoperative complications.
Asunto(s)
Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Factores de Edad , Anciano , Estenosis de la Válvula Aórtica/mortalidad , Femenino , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Complicaciones Posoperatorias , Análisis de Regresión , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Volumen Sistólico , Factores de TiempoRESUMEN
BACKGROUND: Because of increasing life expectancy of patients with heart valve replacement and a limited durability of heart valve bioprostheses, cardiac reoperation becomes necessary in a significant percentage of patients. Reliable data on mortality and risk factors in octogenarians after replacement of aortic valve prostheses are scanty, however. METHODS: We retrospectively analyzed 71 patients aged 80 years and older who underwent cardiac reoperation of the aortic valve (69 bioprostheses, 2 mechanical prostheses) between 1991 and 2004 at our heart center. Survival rate of the study cohort was compared with a control group of octogenarians matched for age, sex, and year of aortic valve replacement. To assess predictors of 30-day survival and 3-year survival, we performed univariate and multivariate analyses. RESULTS: Survival rates at 30 days, 1 year, 3 years and 5 years were 83.6%, 76.1%, 70.8%, and 51.3%, respectively. Results did not differ significantly between the study cohort and the controls. Patients with reoperation had an estimated median survival of 5.6 years. Postoperative complications such as low cardiac output syndrome and intestinal failure were the only independent predictors of 30-day survival (p = 0.020 and p = 0.015, respectively). Low cardiac output, intestinal failure, and diabetes mellitus were independent predictors of 3-year survival (p = 0.001 to 0.033). CONCLUSIONS: Our data demonstrate that it is possible to achieve an acceptable outcome in octogenarians who have reoperation of the aortic valve prosthesis. Early and mid-term survival is predominantly influenced by unexpected postoperative complications and not by preoperative risk factors, with the exception of diabetes mellitus.