Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block.

AIMS: To determine whether triventricular (TriV) pacing is feasible and improves CRT response compared to conventional biventricular (BiV) pacing in patients with left bundle branch block (LBBB) and intermediate QRS prolongation (120-150 ms). METHODS AND RESULTS: Between October 2015 and November 2019, 99 patients were recruited from 11 UK centres. Ninety-five patients were randomized 1:1 to receive TriV or BiV pacing systems. The primary endpoint was feasibility of TriV pacing. Secondary endpoints assessed symptomatic and remodelling response to CRT. Baseline characteristics were balanced between groups. In the TriV group, 43/46 (93.5%) patients underwent successful implantation vs. 47/49 (95.9%) in the BiV group. Feasibility of maintaining CRT at 6 months was similar in the TriV vs. BiV group (90.0% vs. 97.7%, P = 0.191). All-cause mortality was similar between TriV vs. BiV groups (4.3% vs. 8.2%, P = 0.678). There were no significant differences in echocardiographic LV volumes or clinical composite scores from baseline to 6-month follow-up between groups. CONCLUSION: Implantation of two LV leads to deliver and maintain TriV pacing at 6 months is feasible without significant complications in the majority of patients. There was no evidence that TriV pacing improves CRT response or provides additional clinical benefit to patients with LBBB and intermediate QRS prolongation and cannot be recommended in this patient group. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT02529410.

A multicenter prospective randomized controlled trial of cardiac resynchronization therapy guided by invasive dP/dt.

BACKGROUND: No periprocedural metric has demonstrated improved cardiac resynchronization therapy (CRT) outcomes in a multicenter setting. OBJECTIVE: We sought to determine if left ventricular (LV) lead placement targeted to the coronary sinus (CS) branch generating the best acute hemodynamic response (AHR) results in improved outcomes at 6 months. METHODS: In this multicenter randomized controlled trial, patients were randomized to guided CRT or conventional CRT. Patients in the guided arm had LV dP/dtmax measured during biventricular (BIV) pacing. Target CS branches were identified and the final LV lead position was the branch with the best AHR and acceptable threshold values. The primary endpoint was the proportion of patients with a reduction in LV end-systolic volume (LVESV) of ≥15% at 6 months. RESULTS: A total of 281 patients were recruited across 12 centers. Mean age was 70.8 ± 10.9 years and 54% had ischemic etiology. Seventy-three percent of patients in the guided arm demonstrated a reduction in LVESV of ≥15% at 6 months vs 60% in the conventional arm (P = .02). Patients with AHR ≥ 10% were more likely to demonstrate a reduction of ESV ≥ 15% (84% of patients with an AHR ≥10% vs 28% with an AHR <10%; P < 0.001). Procedure duration and fluoroscopy times were longer in the pressure wire-guided arm (104 ± 39 minutes vs 142 ± 39 minutes; P < .001 and 20 ±16 minutes vs 28 ± 15 minutes; P = .002). CONCLUSIONS: AHR determined by invasively measuring LV dP/dtmax during BIV pacing predicts reverse remodeling 6 months after CRT. Patients in whom LV dP/dtmax was used to guide LV lead placement demonstrated better rates of reverse remodeling.

Percutaneous Management of Biliary Enteric Anastomotic Strictures: An Institutional Review.

Purpose Stricture formation at the biliary enteric anastomotic site is a common complication due to fibrotic healing. Few therapeutic options are available for biliary-enteric anastomotic site stricture (BES) including new surgical reconstruction or percutaneous transhepatic biliary drainage followed by balloon dilation of BES or stent placement. The purpose of this study is to assess the technical success, complications and reintervention rate of percutaneous transhepatic balloon dilatation (PTBD) of BES after iatrogenic bile duct injuries (BDI). Methods A retrospective review of patients who underwent PTBD for benign resistant BES, previously treated for iatrogenic BDI, from December 2004 to January 2016 was performed. Diagnostic transhepatic cholangiogram was performed to assess the level of obstruction. BES was dilated using 8-12 mm diameter balloons followed by placement of eight to ten Fr internal-external drainage catheters, which were removed after three to six weeks post-PTBD cholangiogram. Follow-up by clinical assessment, liver function tests, and ultrasound was done. Fischer exact test was used to determine if there was a significant association between PTBD sessions and recurrent strictures. Results In total, 37 patients underwent 66 sessions of PTBD, including 10 (27%) males and 27 (73%) females. The mean age was 41.3 years (range 23-70 years). Out of these, 29 (78%) were treated with choledochojejunostomy and eight (22%) with hepaticojejunostomy. 100% technical success was achieved in all the PTBD sessions. Nineteen (51.3%) patients were treated with a single PTBD session. Mean follow-up time was 36 months (range 1-75 months). Eighteen (48.7%) patients needed reintervention, out of these, 11 (29.7%) were symptom-free after second session on three-year follow-up, three (8%) were symptom-free after the third session of PTBD. No significant difference was observed in risk of recurrent strictures after first and second PTBD sessions [18 (48%) vs. 7 (39%); p-value 0.495]. In four (11%) patients, the symptoms persisted and BES recurred even after third session and those were treated by placing metallic stent. In total, three (8.1%) patients got complicated with the stone formation; in two (5%) patients stone was successfully removed percutaneously and in one (3%) patient percutaneous attempt failed so it was followed by surgical removal. Conclusion PTBD is a safe and useful treatment option for benign BES for long-term symptom-free time-period. However, there is no significant difference in developing recurrent BES after PTBD sessions. Few patients with resistant strictures might require stent placement.

Predictors and outcomes of patients requiring repeat transvenous lead extraction of pacemaker and defibrillator leads.

BACKGROUND: A proportion of patients who undergo an initial lead extraction procedure will require a second, repeat extraction. Data regarding this clinical entity are scarce and neither the predisposing risk factors for, nor outcomes from, these procedures have been described previously. We sought to determine the incidence, risk factors, and outcomes of repeat lead extraction. METHODS: A database of extraction procedures from 2001 to 2015 was analyzed. Repeat extraction procedures were identified and the indication for extraction was dichotomized into infection and lead-related problems. Univariate and multivariate analyses were performed to identify predictors of repeat extraction. RESULTS: 807 extraction procedures were identified in 755 patients of whom 6% required a repeat extraction. At multivariate analysis, only suffering a major complication at the initial extraction procedure (odds ratio [OR] 21.5, 95% confidence interval [CI] 2.69-171.92; P < 0.01), complexity of device (cardiac resynchronization devices/implantable cardioverter defibrillators) (OR 2.58, 95% CI 1.2-5.2; P = 0.01), and age (OR 1.02 per year, 95% CI 1.0-1.4; P  =  0.03) were significant predictors of repeat extraction. When repeat extraction was required for infection there was a significant increase in mortality compared with those who did not require a second procedure (36% vs 23%; P  =  0.02). CONCLUSIONS: Repeat lead extraction is required in 6% of cases. Complexity of device, age at extraction, and a major complication at the first extraction were predictors of repeat extraction. Mortality is significantly increased where the repeat procedure is for infection. Clinicians should alert patients to the potential need for further extraction and the increased risks of repeat procedures when indicated for infection.

Endovascular embolisation of visceral artery pseudoaneurysms.

Objective. To evaluate the technical success, safety, and outcome of endovascular embolization procedure in management of visceral artery pseudoaneurysms. Materials and Methods. 46 patients were treated for 53 visceral pseudoaneurysms at our institution. Preliminary diagnostic workup in all cases was performed by contrast enhanced abdominal CT scan and/or duplex ultrasound. In all patients, embolization was performed as per the standard departmental protocol. For data collection, medical records and radiology reports of all patients were retrospectively reviewed. Technical success, safety, and outcome of the procedure were analyzed. Results. Out of 46 patients, 13 were females and 33 were males. Mean patient age was 44.79 ± 13.9 years and mean pseudoaneurysm size was 35 ± 19.5 mm. Technical success rate for endovascular visceral pseudoaneurysm coiling was 93.47% (n = 43). Complication rate was 6.52% (n = 3). Followup was done for a mean duration of 21 ± 1.6 months (0.5-69 months). Complete resolution of symptoms or improvement in clinical condition was seen in 36 patients (80%) out of those 45 in whom procedure was technically successful. Conclusion. Results of embolization of visceral artery pseudoaneurysms with coils at our center showed high success rate and good short term outcome.

Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction.

AIMS: The number of procedures involving upgrade or revision of cardiac implantable electronic devices (CIEDs) is increasing and the risks of adding additional leads are significant. Central venous occlusion in patients with pre-existing devices is often asymptomatic and optimal management of such patients in need of device revision/upgrade is not clear. We sought to assess our use of laser lead extraction in overcoming venous obstruction. METHODS AND RESULTS: Patients in need of device upgrade/revision underwent pre-procedure venography to assess venous patency. In patients with venous occlusion or stenosis severe enough to preclude passage of a hydrophilic guide wire, laser lead extraction with retention of the outer sheath in the vasculature was performed with the aim of maintaining a patent channel through which new leads could be implanted. Data were recorded on a dedicated database and patient outcomes were assessed. Between July 2004 and April 2012, laser lead extractions were performed in 71 patients scheduled for device upgrade/revision who had occluded or functionally obstructed venous anatomy. New leads were successfully implanted across the obstruction in 67 (94%) cases. There were two major complications (infection) and four minor complications with no peri-procedural mortality. Device follow-up was satisfactory in 65 (92%) cases with mean follow-up up to 26 ± 19 months. CONCLUSION: Laser lead extraction is a safe and effective option when managing patients with central venous obstruction in need of CIED revision or upgrade.

Percutaneous extraction of cardiac implantable electronic devices (CIEDs) in octogenarians.

BACKGROUND: As the population receiving cardiac device therapy ages, the number of extraction procedures performed in octogenarians is increasing. This group has more comorbidities and may be at higher risk of such procedures. OBJECTIVES: Document the safety and success of percutaneous lead extraction in octogenarians. METHODS: All extraction cases performed between January 2001 and April 2011 entered into a computer database were analyzed for patient characteristics and indications, extraction technique, procedural success, and complications. Success and complications were classified according to the Heart Rhythm Society consensus statement. Outcomes in octogenarians were compared to younger patients undergoing extraction during the same period. RESULTS: Four hundred and six cases were performed: 72 procedures in octogenarians (mean age 84, range 80-95) and 334 in younger adults (mean age 62, range 20-79). Octogenarians had a greater number of comorbidities per case. Infection was the commonest indication for extraction in both groups. One hundred forty-one leads were extracted in octogenarians and 657 in younger patients. Laser assistance was required in 51.4% of octogenarians versus 49.7% of younger patients. Procedural success was achieved in 71/72 (98.6%) octogenarians versus 329/334 (98.5%) younger patients. No procedural mortality occurred in either group. Overall, complications were more frequent in octogenarians with major and minor complications occurring in 2.8 and 8.3% of octogenarians versus 0.6 and 3.0% of younger patients (P = 0.014). CONCLUSIONS: Procedural success was equally high in octogenarians and younger patients. Percutaneous lead extraction can be performed effectively and safely in octogenarians and is associated with a higher complication rate but no increased mortality.

Multi-site left ventricular pacing as a potential treatment for patients with postero-lateral scar: insights from cardiac magnetic resonance imaging and invasive haemodynamic assessment.

AIMS: Multi-site left ventricular (LV) pacing may be superior to single-site stimulation in correcting dyssynchrony and avoiding areas of myocardial scar. We sought to characterize myocardial scar using cardiac magnetic resonance imaging (CMR). We aimed to quantify the acute haemodynamic response to single-site and multi-site LV stimulation and to relate this to the position of the LV leads in relation to myocardial scar. METHODS: Twenty patients undergoing cardiac resynchronization therapy had implantation of two LV leads. One lead (LV1) was positioned in a postero-lateral vein, the second (LV2) in a separate coronary vein. LV dP/dtmax was recorded using a pressure wire during stimulation at LV1, LV2, and both sites simultaneously (LV1 + 2). Patients were deemed acute responders if ΔLV dP/dtmax was ≥ 10%. Cardiac magnetic resonance imaging was performed to assess dyssynchrony as well as location and burden of scar. Scar anatomy was registered with fluoroscopy to assess LV lead position in relation to scar. RESULTS: LV dP/dtmax increased from 726 ± 161 mmHg/s in intrinsic rhythm to 912 ± 234 mmHg/s with LV1, 837 ± 188 mmHg/s with LV2, and 932 ± 201 mmHg/s with LV1 and LV2. Nine of 19 (47%) were acute responders with LV1 vs. 6/19 (32%) with LV2. Twelve of 19 (63%) were acute responders with simultaneous LV1 + 2. Two of three patients benefitting with multi-site pacing had the LV1 lead positioned in postero-lateral scar. CONCLUSION: Multi-site LV pacing increased acute response by 16% vs. single-site pacing. This was particularly beneficial in patients with postero-lateral scar identified on CMR.

Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy.

OBJECTIVES: We evaluated the relationship between acute hemodynamic response (AHR) and reverse remodeling (RR) in cardiac resynchronization therapy (CRT). BACKGROUND: CRT reduces mortality and morbidity in heart failure patients; however, up to 30% of patients do not derive symptomatic benefit. Higher proportions do not remodel. Multicenter trials have shown echocardiographic techniques are poor at improving response rates. We hypothesized the degree of AHR at implant can predict which patients remodel. METHODS: Thirty-three patients undergoing CRT (21 dilated and 12 ischemic cardiomyopathy) were studied. Left ventricular (LV) volumes were assessed before and after CRT. The AHR (maximum rate of left ventricular pressure [LV-dP/dt(max)]) was assessed at implant with a pressure wire in the LV cavity. Largest percentage rise in LV-dP/dt(max) from baseline (atrial antibradycardia pacing or right ventricular pacing with atrial fibrillation) to dual-chamber pacing (DDD)-LV was used to determine optimal coronary sinus LV lead position. Reverse remodeling was defined as reduction in LV end systolic volume ≥15% at 6 months. RESULTS: The LV-dP/dt(max) increased significantly from baseline (801 ± 194 mm Hg/s to 924 ± 203 mm Hg/s, p < 0.001) with DDD-LV pacing for the optimal LV lead position. The LV end systolic volume decreased from 186 ± 68 ml to 157 ± 68 ml (p < 0.001). Eighteen (56%) patients exhibited RR. There was a significant relationship between percentage rise in LV-dP/dt(max) and RR for DDD-LV pacing (p < 0.001). A similar relationship for AHR and RR in dilated cardiomyopathy and ischemic cardiomyopathy (p = 0.01 and p = 0.006) was seen. CONCLUSIONS: Acute hemodynamic response to LV pacing is useful for predicting which patients are likely to remodel in response to CRT both for dilated cardiomyopathy and ischemic cardiomyopathy. Using AHR has the potential to guide LV lead positioning and improve response rates.

Percutaneous lead and system extraction in patients with cardiac resynchronization therapy (CRT) devices and coronary sinus leads.

BACKGROUND: Cardiac resynchronization therapy (CRT) device and coronary sinus (CS) lead extraction is required due to the occurrence of system infection, malfunction, or upgrade. Published series of CS lead extraction are limited by small sample sizes. We present a 10-year experience of CRT device and CS lead extraction. METHODS: All lead extractions between 2000 and 2010 were entered into a computer database. From these, a cohort of 71 cases involving a CRT device or CS lead was analyzed for procedural method, success, and complications. RESULTS: Sixty coronary sinus leads were extracted in 71 cases (median age 71 years; 90% male) by manual traction/locking stylets (n = 54) or using a laser sheath (n = 6). Procedural success was achieved in 98% of CS leads. A total of 143 non-CS leads were extracted, with laser required in 46% of cases. The mean duration of lead implantation was 35.8 months (range 1-116 months) and 2.86 ± 1.07 leads were extracted per case. CRT extraction case load increased significantly over time. Minor complications occurred in four (5.6%) cases and major complications in one (1.4%) case. There were no intraprocedural deaths, but two deaths occurred within 30 days of extraction. CONCLUSIONS: Our 10-year experience confirms that percutaneous removal of CS leads can be achieved with high procedural success. Our recorded complication rates are no higher than those of non-CS lead extraction series, and should be taken in the context of the frail nature of CRT patients. Ongoing audit of procedure success and complications will be required to further guide best practice in CS lead extraction.

Relationship between intracardiac impedance and left ventricular contractility in patients undergoing cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) has dramatically improved the symptoms and prognosis of patients with heart failure in large randomized clinical trials. Optimization of device settings may maximize benefit on an individual basis, although the best method for this is not yet established. We evaluated the use of cardiogenic impedance measurements (derived from intracardiac impedance signals) in CRT device optimization, using invasive left ventricular (LV) dP/dtmax as the reference. METHODS AND RESULTS: Seventeen patients underwent invasive haemodynamic assessment using a pressure wire placed in the LV cavity at the time of CRT device implantation. Intracardiac impedance measurements were made at different atrioventricular (AV) and interventricular (VV) delays and compared with LV dP/dtmax. We assessed the performance of patient-specific and generic impedance-based models in predicting acute haemodynamic response to CRT. In two patients, LV catheterization with the pressure wire was unsuccessful and in two patients LV lead delivery was unsuccessful; therefore, data were acquired for 13 out of 17 patients. Left ventricular dP/dtmax was 919±182 mmHg/s at baseline and this increased acutely (by 24%) to 1121±226 mmHg/s as a result of CRT. The patient-specific impedance-based model correctly predicted the optimal haemodynamic response (to within 5% points) for AV and VV delays in 90 and 92% of patients, respectively. CONCLUSION: Cardiogenic impedance measurements are capable of correctly identifying the maximum achievable LV dP/dtmax as measured by invasive haemodynamic assessment. This study suggests that cardiogenic impedance can potentially be used for CRT optimization and may have a role in ambulatory assessment of haemodynamics.

Initial single-center experience of a quadripolar pacing lead for cardiac resynchronization therapy.

BACKGROUND: The Quartet model 1458Q (St. Jude Medical, Sylmar, CA, USA) lead is a quadripolar left ventricular (LV) lead with pace/sense capability from four electrodes (tip and three rings). The lead is capable of pacing in 10 different configurations rather than the three that are available in conventional bipolar pacing leads. We describe a single-center initial experience of the use of this lead in patients undergoing cardiac resynchronization therapy (CRT). METHODS: Twenty-eight patients for a CRT with cardiac defibrillator were implanted between October 2009 and May 2010 with a Quartet lead . Lead position, pacing parameters, stability, complications, and presence of phrenic nerve stimulation (PNS) data were collected at implant and predischarge. Follow-up data were collected at 15 ± 8 weeks for all patients. RESULTS: A Quartet lead was successfully implanted in 96% (27/28) of patients (age 61 ± 15 years; 82% male; ischemic etiology 50%; mean left ventricular [LV] ejection fraction 25 ± 7%; left bundle branch block 68%). PNS was seen at implant in 11 patients (41%) with at least one vector. In eight of these cases (72%), the need for lead repositioning was averted by programming LV pacing utilizing the additional vectors available with the Quartet lead. CONCLUSION: These initial data suggest that pacing with the Quartet lead is associated with a high implant success rate and stable pacing parameters acutely and at short-term follow-up. The 10 LV pacing vectors available with this lead may allow PNS and capture threshold problems to be easily overcome.

Pacemaker and defibrillator lead extraction: predictors of mortality during follow-up.

BACKGROUND: Extraction of cardiac implantable electric devices is an accepted procedure when systems become infected or malfunction. However, there is an associated morbidity and mortality. We report our 5-year experience and identify predictors of mortality, and long-term follow-up. METHODS: We analyzed extraction data from January 2003 to November 2007. Extraction methods used were: locking stylets, telescoping sheaths +/- laser, and femoral work stations. RESULTS: One hundred and eighty-three cases were referred, aged 65 +/- 16 years (range 28-83); 76% were males. Mean implant time was 75 months (range 4-312 months) and indications were: pocket infection (48%), nonfunctioning lead (22%), erosion through skin (18%), endocarditis/septicemia (11%), bilateral superior vena cava thrombosis (0.5%), and painful lead (0.5%). The number of leads extracted were 369, with complete removal in 90.7% and partial in 7.6%. There were no intraoperative deaths but five (2.7%) died within the same admission as their extraction from overwhelming sepsis. Twelve deaths (6.6%) occurred during an average follow-up of 965 days (range 40-1670). Multivariate logistic regression demonstrated that C-reactive protein preprocedure was predictive of acute in-hospital mortality. CONCLUSIONS: Intravascular lead extraction is a safe and efficient method of removing leads. However, there is a subgroup of patients with systemic sepsis with raised inflammatory markers who are at high risk of in-hospital mortality. Long-term follow-up demonstrates mortality which is a marker of the underlying etiology for device implantation, with heart failure patients particularly at risk.

"Cold can for a hot case": use of a coronary sinus shocking lead in association with cold can to achieve successful defibrillation.

Attaining an adequate defibrillation threshold is critical in the functioning of an implantable cardioverter-defibrillator. This is achieved in a majority of implants but in those where this does not occur, reprogramming, lead repositioning, and ultimately placement of a subcutaneous array lead may be necessary.

A shocking lead in the coronary sinus.

Placement of leads into the coronary sinus (CS) is now routinely used for cardiac resynchronization therapy. However, the CS can also be used for the placement of defibrillator shock leads. There is evidence demonstrating that CS leads in situ for the short and medium term can be successfully removed utilizing percutaneous methods. We report a case of CS laser lead extraction where a defibrillator lead had been in place for almost 10 years.

Treatment of inappropriate sinus tachycardia with ivabradine in a patient with postural orthostatic tachycardia syndrome and a dual chamber pacemaker.

We present the case of a 44-year-old woman with postural orthostatic tachycardia syndrome (POTS) and a dual chamber pacemaker. The patient suffered from inappropriate sinus tachycardia that had been resistant to treatment with traditional rate-slowing medications. Ivabradine--the specific sinus node I(f) current inhibitor--was used to successfully lower the heart rate. The patient had no evidence of POTS on repeat autonomic function testing, and there was a corresponding symptomatic benefit. We propose that this class of drugs, the use of which is established as antianginals, should be considered in patients with resistant inappropriate sinus tachycardia.

Extraction of chronic pacemaker and defibrillator leads from the coronary sinus: laser infrequently used but required.

AIMS: Cardiac resynchronization therapy is an accepted treatment for heart failure but it may be necessary to explant these systems along with their leads. The evidence base for coronary sinus (CS) lead extractions is limited. We aimed to evaluate the percutaneous removal of these leads and the utility of laser extraction when necessary. METHODS AND RESULTS: Of 265 patients referred for lead extraction between January 2004 and June 2008, 32 (12.1%) involved CS leads (30 males, mean age 67 years). Mean implantation time was 26.5 +/- 28.7 months (range 1-116 months). Indications for extraction were pocket infection (34.4%), lead malfunction (43.8%), skin erosion (15.6%), and endocarditis (6.2%). Twenty-eight (87.5%) CS leads were removed with manual traction, with laser utilized in four cases (12.5%). No major complications of CS laceration, pericardial effusion, emergency surgery, or death occurred. CONCLUSION: Our experience supports the percutaneous extraction of CS leads as a safe and effective procedure including the utility of laser when necessary.

A case of diaphragmatic pacing with cardiac resynchronization therapy.

Cardiac resynchronization therapy (CRT) is now an accepted treatment for heart failure [McAlister et al. in Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA 2007;297:2502-14.]. In addition to the complications associated with standard pacemaker implants, CRT procedures have their own additional complications such as coronary sinus dissection, diaphragmatic stimulation, and longer implant times. We present a case of CRT implantation which illustrates these problems because of an unusual complication.

Pocket infection related to retained products of pacing.

With the advent of increasing number of implants and more complex pacing systems, referrals for explantations are likely to increase. These procedures have their attendant peri-procedural risks. We report a delayed complication of a system explant, which could have been avoided, and suggest changes in clinical practice that may prevent similar cases.