Implantable defibrillator therapy and mortality in patients with non-ischaemic dilated cardiomyopathy : An updated meta-analysis and effect on Dutch clinical practice by the Task Force of the Dutch Society of Cardiology.

BACKGROUND: Primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with non-ischaemic cardiomyopathy (NICMP) remains controversial. This study sought to assess the benefit of ICD therapy with or without cardiac resynchronisation therapy (CRT) in patients with NICMP. In addition, data were compared with real-world clinical data to perform a risk/benefit analysis. METHODS: Relevant randomised clinical trials (RCTs) published in meta-analyses since DANISH, and in PubMed, EMBASE and Cochrane databases from 2016 to 2020 were identified. The benefit of ICD therapy stratified by CRT use was assessed using random effects meta-analysis techniques. RESULTS: Six RCTs were included in the meta-analysis. Among patients without CRT, ICD use was associated with a 24% reduction in mortality (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.62-0.93; P = 0.008). In contrast, among patients with CRT, a CRT-defibrillator was not associated with reduced mortality (HR: 0.74, 95% CI 0.47-1.16; P = 0.19). For ICD therapy without CRT, absolute risk reduction at 3­years follow-up was 3.7% yielding a number needed to treat of 27. CONCLUSION: ICD use significantly improved survival among patients with NICMP who are not eligible for CRT. Considering CRT, the addition of defibrillator therapy was not significantly associated with mortality benefit compared with CRT pacemaker.

The dialysis procedure as a trigger for atrial fibrillation: new insights in the development of atrial fibrillation in dialysis patients.

AIMS: Atrial fibrillation (AF) is common in dialysis patients and is associated with increased morbidity and mortality. The pathophysiology may be related to common risk factors for both AF and renal disease or to dialysis-specific factors. The purpose of this study was to determine whether and how AF onset relates to the dialysis procedure itself. METHODS: All dialysis patients enrolled in the implantable cardioverter defibrillator-2 (ICD-2) trial until January 2012, who were implanted with an ICD, were included in this study. Using the ICD remote monitoring function, the exact time of onset of all AF episodes was registered. Subsequently, this was linked to the timing of dialysis procedures. RESULTS: For the current study, a total of 40 patients were included, follow-up was 28 ± 16 months, 80% male, 70 ± 8 years old. A total of 428 episodes of AF were monitored in 14 patients. AF onset was more frequent on the days of haemodialysis (HD) (p<0.001) and specifically increased during the dialysis procedure itself (p=0.04). Patients with AF had a larger left atrium (p<0.001) and a higher systolic blood pressure before and after HD (p<0.001). CONCLUSION: This study provides insight in the exact timing of AF onset in relation to the dialysis procedure itself. In HD patients, AF occurred significantly more often on a dialysis day and especially during HD. These findings might help to elucidate some aspects of the pathophysiology of AF in dialysis patients and could facilitate early detection of AF in these high-risk patients.

Remote monitoring and follow-up of cardiovascular implantable electronic devices in the Netherlands : An expert consensus report of the Netherlands Society of Cardiology.

Remote monitoring of cardiac implanted electronic devices (CIED: pacemaker, cardiac resynchronisation therapy device and implantable cardioverter defibrillator) has been developed for technical control and follow-up using transtelephonic data transmission. In addition, automatic or patient-triggered alerts are sent to the cardiologist or allied professional who can respond if necessary with various interventions. The advantage of remote monitoring appears obvious in impending CIED failures and suspected symptoms but is less likely in routine follow-up of CIED. For this follow-up the indications, quality of care, cost-effectiveneness and patient satisfaction have to be determined before remote CIED monitoring can be applied in daily practice. Nevertheless remote CIED monitoring is expanding rapidly in the Netherlands without professional agreements about methodology, responsibilities of all the parties involved and that of the device patient, and reimbursement. The purpose of this consensus document on remote CIED monitoring and follow-up is to lay the base for a nationwide, uniform implementation in the Netherlands. This report describes the technical communication, current indications, benefits and limitations of remote CIED monitoring and follow-up, the role of the patient and device manufacturer, and costs and reimbursement. The view of cardiology experts and of other disciplines in conjunction with literature was incorporated in a preliminary series of recommendations. In addition, an overview of the questions related to remote CIED monitoring that need to be answered is given. This consensus document can be used for future guidelines for the Dutch profession.

Integration of data from remote monitoring systems and programmers into the hospital electronic health record system based on international standards.

Remote follow-up of implanted ICDs may offer a solution to the problem of overcrowded outpatient clinics. All major device companies have developed a remote follow-up solution. Data obtained from the remote follow-up systems are stored in a central database system, operated and owned by the device company and accessible for the physician or technician. However, the problem now arises that part of the patient's clinical information is stored in the local electronic health record (EHR) system in the hospital, while another part is only available in the remote monitoring database. This may potentially result in patient safety issues. Ideally all information should become available in the EHR system. IHE (Integrating the Healthcare Enterprise) is an initiative to improve the way computer systems in healthcare share information. To address the requirement of integrating remote monitoring data in the local EHR, the IHE Implantable Device Cardiac Observation (IDCO) profile has been developed. In our hospital, we have implemented the IHE IDCO profile to import data from the remote databases from two device vendors into the departmental Cardiology Information System. Data are exchanged via an HL7/XML communication protocol, as defined in the IHE IDCO profile.

Risk factors and time delay associated with cardiac device infections: Leiden device registry.

AIMS: A nested case-control study of 75 patients with cardiac device infections (CDI) and 75 matched controls was conducted to evaluate time course, risk factors, culture results and frequency of CDI. METHODS AND RESULTS: CDI occurred in 75/3410 (2.2%) device implantation and revision procedures, performed between 2000 and 2007. The time delay between device procedure and infection ranged from 0 to 64 months (mean 14 (SD 16)), 21 patients (28%) had an early infection (<1 month), 26 (35%) a late infection (1-12 months) and 28 (37%) a delayed infection (>12 months). Of interest, 18 (24%) patients presented with an infection >24 months after the device-related procedure. Time delay until infection was significantly shorter when cultures were positive for micro-organisms compared to negative cultures (8 (12) vs 18 (18) months, p = 0.03). Pocket cultures in delayed infections remained more often negative (61% vs 23%, p = 0.01). Independent CDI risk factors were: device revision (odds ratio (OR) 3.67; 95% confidence interval (CI), 1.51 to 8.96), renal dysfunction defined as glomerular filtration rate <60 ml/min (OR 4.64; CI, 1.48 to 14.62) and oral anticoagulation use (OR 2.83; CI 1.20 to 6.68). CONCLUSION: CDI occurred in 2.2% of device procedures, with 24% occurring more than two years after the device-related procedure. Renal dysfunction, device revisions and oral anticoagulation are potent risk factors for CDI.

Cardiac resynchronisation therapy in chronic atrial fibrillation: impact on left atrial size and reversal to sinus rhythm.

OBJECTIVE: To evaluate the impact of long term cardiac resynchronisation therapy (CRT) on left atrial and left ventricular (LV) reverse remodelling and reversal to sinus rhythm (SR) in patients with heart failure with atrial fibrillation (AF). PATIENTS: 74 consecutive patients (age 68 (8) years; 67 men) with advanced heart failure and AF (20 persistent and 54 permanent) were implanted with a CRT device. MAIN OUTCOME MEASURES: Patients were evaluated clinically (New York Heart Association (NYHA) class, quality of life, six minute walk test) and echocardiographically (LV ejection fraction, LV diameters, and left atrial diameters) before and after six months of CRT. Additionally, restoration of SR was evaluated after six months of CRT. RESULTS: NYHA class, quality of life score, six minute walk test, and LV ejection fraction had improved significantly after six months of CRT. In addition, left atrial and LV end diastolic and end systolic diameters had decreased from 59 (9) to 55 (9) mm, from 72 (10) to 67 (10) mm, and from 61 (11) to 56 (11) mm, respectively (all p < 0.01). During implantation 18 of 20 (90%) patients with persistent AF were cardioverted to SR. At follow up 13 of 18 (72%) patients had returned to AF and none had spontaneously reverted to SR; thus, only 5 of 74 (7%) were in SR. CONCLUSION: Six months of CRT resulted in significant clinical benefit with significant left atrial and LV reverse remodelling. Despite these beneficial effects, 93% of patients had not reverted to SR.

[Cardiac sarcoidosis: improved prognosis through new diagnostic tests and treatment]. / Cardiale sarcoïdose: betere prognose door nieuwe diagnostiek en behandeling.

Cardiac sarcoidosis was diagnosed in 3 patients: 2 men aged 52 and 51 years, respectively, and a woman aged 55 years. Both men had ventricular tachycardia. In the first man, a right-ventricle biopsy revealed a non-caseating granuloma. The second man had active granulomatous cardiac infiltration, according to a gallium scintigram. The first man recovered after receiving immunosuppression, heart-failure medication, and an implantable defibrillator; the second received the same plus radio-frequency catheter ablation, but experienced serious heart failure. The woman was being treated for pulmonary sarcoidosis but complained of progressive cardiac symptoms. She recovered after receiving heart-failure medication, immunosuppression, and a biventricular pacemaker. Sarcoidosis is a multi-system granulomatous disorder of unknown aetiology with cardiac involvement in 20 to 30% of patients, resulting in severe morbidity and mortality. With the help ofgadolinium MRI and positron emission tomography (PET), these conditions can be detected at an earlier stage, which allows for improved evaluation of the efficacy of available therapies. The use of resynchronisation therapy and implantable defibrillators has improved the prognosis of patients with cardiac sarcoidosis.

Comparison of response to cardiac resynchronization therapy in patients with sinus rhythm versus chronic atrial fibrillation.

Cardiac resynchronization therapy (CRT) is a new therapeutic option for patients who have drug-refractory end-stage heart failure. Much information has been obtained from patients who have sinus rhythm, but the use of CRT in patients who have chronic atrial fibrillation (AF) has not been studied extensively. Accordingly, we evaluated the clinical response and long-term survival rate of CRT in patients who had heart failure and chronic AF, and the results were compared with those in patients who had sinus rhythm and who underwent CRT. Sixty patients who had end-stage heart failure (30 had sinus rhythm and 30 had chronic AF), New York Heart Association classes III to IV, left ventricular ejection fraction <35%, QRS interval >120 ms, and a left bundle branch block received a biventricular pacemaker. New York Heart Association class, Minnesota Quality of Life score, and 6-minute walking distance were evaluated at baseline and after 6 months of CRT. Long-term follow-up was

Eligibility for biventricular pacing in patients with an implantable cardioverter defibrillator.

Implantable cardioverter defibrillator (ICD)-therapy prevents sudden death in patients at high risk, but incidence of death due to heart failure remains unaltered. Recent data suggest that biventricular (BV) pacing is useful in patients with heart failure. It is unclear, how many patients with an ICD indication may have an indication for BV pacing. Therefore all patients who received an ICD were analyzed for eligibility of BV pacing using the following criteria: NYHA class III or IV, QRS duration >120 ms, depressed LVEF. Three hundred and ninety consecutive patients received an ICD from June 1996 to March 2001. Underlying disease was ischemic heart disease in 66%. In the 390 patients the mean LVEF was 36+/-17%, 20% were in NYHA class III-IV and 16% were in NYHA class II with an LVEF <30%. Of these 140 patients, 79 had a QRS duration >120 ms. Thus, 79 (20%) patients were eligible for BV pacing in addition to ICD-therapy. Patients who received a BV pacemaker in addition to ICD-therapy had a superior survival, improved in NYHA class and showed a significantly lower hospitalization rate as compared to patients who received an ICD only. Screening for eligibility of BV pacing may be considered in patients with CHF scheduled for ICD implantation.

In the normal rabbit femoral artery increasing arterial wall injury does not lead to increased intimal hyperplasia.

Angioplasty inflicts damage to the arterial wall. We studied whether augmented medial smooth muscle cell necrosis leads to augmented intimal hyperplasia and thus aggravates restenosis. Sixty-three normal femoral arteries of New Zealand White rabbits were overstretched with an angioplasty balloon during either maximal vasoconstriction with phenylephrine (32 arteries) or maximal vasodilation with nitroprusside (31 arteries). After 3 days' survival, medial necrosis was determined as percentage of cross-sectional medial area. In the 3 weeks' survival group, intimal hyperplasia was quantified as its average thickness. The dilation ratios, i.e. balloon diameter divided by arterial diameter at the time of dilation, were significantly higher in the 3 days' and 3 weeks' vasoconstriction groups (VC groups), respectively: 1.96 +/- 0.10 (mean +/- SD) and 2.14 +/- 0.08 in the VC groups versus 1.27 +/- 0.03 and 1.32 +/- 0.05, respectively, in the vasodilation groups (VD groups) (both p < 0.001). Medial necrosis was more extensive in the VC group (64 +/- 5%) than in the VD group (23 +/- 7%, p < 0.001) and proportional to the dilation ratio (r = 0.69, p < 0.01). Intimal hyperplasia, however, was equal in the VC (59 +/- 8 microns) and VD (57 +/- 6 microns, NS) groups and not dependent on dilation ratio (r = 0.10). Thus, extensive medial necrosis produced during balloon dilation in maximally vasoconstricted arteries did not lead to more intimal hyperplasia than when less medial necrosis was induced by balloon dilation during vasodilation.

Thrombogenicity and intimal hyperplasia after conventional and thermal balloon dilation in normal rabbit iliac arteries.

Acute occlusion and restenosis are the major complications of percutaneous transluminal coronary balloon angioplasty. Application of heat during balloon dilation was postulated to reduce these complications. We evaluated thrombogenicity and intimal hyperplasia of normal rabbit iliac arteries after conventional (37 degrees C) and thermal balloon dilation. Thermal dilation was performed with a radio-frequency-heated balloon, provided with three thermocouples attached to the inside of the balloon skin. In a previous in vitro study, thrombogenicity of human subendothelium was increased at 55 degrees C and greatly decreased at temperatures over 70 degrees C. Thermal balloon dilation was therefore performed at 55 and 90 degrees C in vivo. Rabbits survived 2 h for evaluation of platelet adhesion or either 3 or 8 weeks for intimal hyperplasia. Angiograms revealed no occlusions or thrombi after any procedure. Platelet adhesion was quantified on 20 scanning electron microscopic pictures per balloon dilation site and was expressed as the percentage of the luminal surface covered by platelets. Platelet adhesion was similar in all groups, although large thrombi were present in the 90 degrees C group. Intimal hyperplasia was measured morphometrically at regular intervals over the balloon site. After 3 weeks, the average intimal hyperplasia was significantly reduced in the 90 degrees C balloon dilation group, which was mainly due to the absence of intimal hyperplasia in the midpart of these segments. After 8 weeks, intimal hyperplasia was equal in all groups. Thus, in the applied model, platelet coverage was equal after conventional balloon angioplasty and after 55 and 90 degrees C balloon angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS)

Mid-infrared pulsed laser ablation of the arterial wall. Mechanical origin of "acoustic" wall damage and its effect on wall healing.

Pulsed mid-infrared lasers are an alternative to excimer lasers for transluminal angioplasty. The mid-infrared lasers, however, were reported to produce "acoustic" wall damage that might impair the immediate and long-term results. To study the immediate and long-term effects on the arterial wall, 184 craters (1 mm diameter and 1 mm depth) were produced perpendicular to the intimal lining in the thoracic aortas of pigs. Three types of craters were evaluated: Ho-YSGG laser-induced (lambda = 2.09 microns, 2 pulses of 500 microseconds, 0.50 joule/pulse, 50 gm force), mechanically drilled, and "acoustic" craters. "Acoustic" craters were produced by two laser pulses delivered into a saline-filled metal fiber cap, which was placed in a mechanically drilled crater. The metal cap was provided with four outlets for water vapor and isolated "acoustic" from optical and thermal laser effects. The pigs survived 3, 14, and 28 days. Arterial wall damage, medial necrosis, and wall healing were assessed microscopically. At 3 days, laser and "acoustic" craters were accompanied by large tissue ruptures (2.7 +/- 0.9 mm and 2.9 +/- 0.8 mm, respectively, mean +/- standard deviation). These were attributed to large vapor bubbles expanding within the tissue. A zone of medial necrosis was observed adjacent to the laser craters (0.43 +/- 0.15 mm) and to the "acoustic" craters (0.17 +/- 0.14 mm). Neither ruptures nor necrosis was observed with the mechanical craters. At 2 and 4 weeks, the necrotic areas were repopulated with smooth muscle cells and all craters were adequately filled with smooth muscle cells, without any sign of an exaggerated proliferative response. We conclude that within the arterial wall, Ho-YSGG ablation was accompanied by the rapid expansion of a water vapor bubble. The formation of the relatively large vapor bubble is inherent to the use of a mid-infrared laser. The risk of creating dissections clinically, when delivering Ho-YSGG laser pulses, remains to be determined. The present study provided no indication that the arterial wall fissures might affect the restenosis rate unfavorably by promoting myointimal proliferation.

Origin of arterial wall dissections induced by pulsed excimer and mid-infrared laser ablation in the pig.

To study adjacent tissue damage after delivery of holmium, thulium and excimer laser pulses, porcine thoracic aortas were irradiated in vivo. After 3 days, microscopic analysis of 67 craters produced by all three lasers demonstrated large dissections extending from the craters. The mean diameter of the dissections was smaller for excimer-induced craters (1.38 +/- 0.42 mm; n = 22) than for holmium-induced (2.7 +/- 0.87 mm; n = 22) and thulium-induced (2.37 +/- 0.42 mm; n = 14) craters (p less than 0.01 vs. mid-infrared dissections). In addition, microscopic analysis demonstrated necrosis adjacent to the crater. The lateral necrotic zones of the thulium-induced craters were smaller than the holmium- and excimer-induced necrotic zones (p less than 0.01). To identify the origin of the excessive tissue tearing, laser-saline and laser-tissue interaction were compared in vitro by time-resolved flash photography. In saline solution, the mid-infrared lasers showed bubble formation on a microsecond time scale. The excimer laser produced similar bubbles in the vicinity of tissue. For all three lasers, elevation of the tissue surface was shown during in vitro ablation. Dimension (diameter up to 4 mm) and time course (rise time of 100 to 300 microseconds) of bubble formation and tissue elevation were strikingly similar. Thus, tissue dissections are caused by the expansion of a vapor bubble within the target tissue. Coronary dissections after excimer and mid-infrared laser angioplasty might be related to the forceful bubble expansion.

Early and late arterial healing response to catheter-induced laser, thermal, and mechanical wall damage in the rabbit.

Pulsed lasers are being promoted for laser angioplasty because of their capacity to ablate obstructions without producing adjacent thermal tissue injury. The implicit assumption that thermal injury to the artery is to be avoided was tested. Thermal lesions were produced in the iliac arteries and aorta of normal rabbits by a) electrical spark erosion, b) the metal laser probe, and c) continuous wave neodymium-yttrium aluminum garnet (Nd-YAG) laser energy through the sapphire contact probe. High-energy doses were used to induce substantial damage without perforating the vessel wall. Thermal lesions (n = 77) were compared with mechanical lesions (n = 22) induced by oversized balloon dilation. Medial necrosis was induced by all four injury methods. Provided no extravascular contrast was observed after the injury, all damaged segments were patent after 1 to 56 days. The progression of healing with myointimal proliferation was remarkably similar for all injuries. At 56 days, the neointima measured up to 370 microns. In conclusion, provided no perforation with contrast extravasation occurred, the normal rabbit artery recovered well from transmural thermal injury. The wall healing response is largely nonspecific.

Laser ablation and the need for intra-arterial imaging.

In 48 patients with severe claudication due to a total obstruction of the femoropopliteal artery, percutaneous recanalization was attempted with a 2.2 mm diameter rounded sapphire contact probe in conjunction with a continuous wave Nd:YAG laser. In eight patients the contact probe laser catheter took a subintimal course that could not be redressed. Laser recanalization needs high-resolution diagnostic information on the complex anatomy of the obstruction. Intra-arterial ultrasound imaging may provide the necessary information to evaluate, monitor or guide novel angioplasty techniques. The design of an ultrasound catheter which combines high-resolution diagnostic imaging with steerability, flexibility and controlled ablation is now the major engineering challenge in interventional cardiology.