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Biomedical subjects

S Saksena

Publications and source records attributed to S Saksena.

At least 145 records · Page 8Linked to original sources
PubMed1992

Long-term multicenter experience with a second-generation implantable pacemaker-defibrillator in patients with malignant ventricular tachyarrhythmias. The Guardian Multicenter Investigators Group.

A second-generation implantable pacemaker-cardioverter-defibrillator was evaluated in 200 patients with sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest. The device permits demand ventricular pacing for bradyarrhythmias and for long QT interval or tachycardia suppression, uses programmable (3 to 30 J) energy shocks for conversion of ventricular tachycardia and ventricular fibrillation and is used with conventional pacing and defibrillation leads. Ventricular tachycardia/fibrillation recognition is based on the ventricular electrogram rate and requires reconfirmation before shock delivery. Two hundred patients (mean age 62 years, mean left ventricular ejection fraction 36%) were enrolled and followed up for 0 to 23 months (mean 12). Epicardial lead system implantation was performed with use of an anterolateral thoracotomy (38%), median sternotomy (26%) and subxiphoid (20%) or subcostal (16%) approach. Perioperative mortality rate was 5.5% (all nonarrhythmic deaths). Implant defibrillation threshold ranged from 3 to 30 J (mean 15), with initial programmed shock energy ranging from 3 to 30 J (mean 22). Ventricular tachycardia/fibrillation sensing threshold ranged from 0.7 to 1.8 mV (median 1) and the tachycardia detection interval from 288 to 416 ms (median 320). Reprogramming of implant variables was necessary for reliable electrographic sensing (54 patients), programmed shock therapy (61 patients) and tachycardia detection rate (63 patients). Device activation for potential shock delivery occurred in 111 patients (55.5%) with actual shock delivery after ventricular tachycardia/fibrillation reconfirmation in 66 patients (33%). During follow-up study, there was a 1% arrhythmia mortality rate, 6.5% cardiac mortality rate and 10.5% total mortality rate. This study demonstrates that the programmable implantable pacemaker-cardioverter-defibrillator is effective in preventing arrhythmic death, yet reduces patient exposure to repeated shock therapy. Reprogramming is usually necessary during follow-up for optimal function.

Adolescent↗
PubMed1992

Survival of implantable cardioverter-defibrillator recipients: role of left ventricular function and its relationship to device use.

The quantitative benefit of ICD therapy in patients with malignant ventricular tachyarrhythmia with different degrees of left ventricular dysfunction is unclear. We evaluated patterns of ICD use and survival in 112 patients with moderate to severe left ventricular dysfunction. Group 1 included 57 patients with moderate left ventricular dysfunction (defined as left ventricular ejection fraction greater than 30%) and group 2 comprised 55 patients with severe left ventricular dysfunction (defined as ejection fraction equal to or less than 30%). The follow-up period ranged from 1 to 78 months. Age, incidence of coronary artery disease, and presenting arrhythmia in the two groups were similar. The mean left ventricular ejection fraction in group 1 was 44.6 +/- 8.2% and in group 2 was 21.6 +/- 6% (p < 0.0001). At 3 years of follow-up 65% of the patients in group 1 and 71% in group 2 (p = NS) had ICD activation for presumed ventricular tachycardia. Survival was calculated by means of actuarial analysis. Arrhythmia or sudden death mortality at 4 years of follow-up was 5% in group 1 and 9% in group 2 (NS). Cardiac mortality was higher in patients with severe left ventricular dysfunction reaching levels of statistical significance at 2 years of follow-up. At 2 years of follow-up it was 12% in group 1 and 40% in group 2 (p = 0.05), and at 4 years of follow-up it was 15% in group 1 and 43% in group 2 (p < 0.01). In both groups there was no difference in cardiac mortality in patients who did and did not have appropriate ICD shocks.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1992

Comparison of clinical benefits and outcome in patients with programmable and nonprogrammable implantable cardioverter defibrillators.

Technological advances in implantable cardioverter defibrillators (ICDs) have provided a variety of programmable parameters and antitachycardia therapies whose utility and impact on clinical outcome is presently unknown. ICDs have capabilities for cardioversion defibrillation alone (first generation ICDs), or in conjunction with demand ventricular pacing (second generation ICDs), or with demand pacing and antitachycardia pacing (third generation ICDs). We examined the pattern of antitachycardia therapy use and long-term survival in 110 patients with sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). Group I included 62 patients with nonprogrammable first generation ICDs that delivered committed shock therapy after ventricular tachyarrhythmia detection based on electrogram rate and/or morphology was satisfied. Group II included 48 patients with multiprogrammable ICDs (including second and third generation ICDs) that had programmable tachyarrhythmia detection based on rate and tachycardia confirmation prior to delivery of electrical treatment with either programmable shocks and/or, as in the third generation ICDs, antitachycardia pacing. Incidence and patterns of antitachycardia therapy use and long-term survival were compared in the two groups. The incidence of appropriate shocks in patients who completed 1 year of follow-up was significantly greater in group I (30 of 43 patients = 70% vs 11 of 26 patients = 42%; P less than 0.05). In the total follow-up period, a significantly larger proportion of group I patients as compared to group II patients used the shock therapies (46 of 62 patients = 74% vs 25 of 48 patients = 52%; P less than 0.01), with the majority doing so within the first year of implantation (96% and 92%, respectively). Although the frequency of antitachycardia therapy activation was similar, the number of shocks delivered per patient was lower in group II, particularly in the initial 3 months of follow-up (P = 0.06). No clinical variable aided in identifying users from nonusers of antitachycardia therapy. Arrhythmic mortality was virtually eliminated in both groups. Two-year actuarial cardiac survival in the two groups was similar (group I = 78% vs group II = 84%; P greater than 0.2). Survival from cardiac mortality in users and nonusers of antitachycardia therapies was also similar in both groups (P greater than 0.2) and in the total patient group (P greater than 0.2). We conclude that programmable ICDs continue to confer advantages in prevention of sudden death that were observed with nonprogrammable ICDs and can be expected to improve patient tolerance and physician acceptance of device therapy for VT/VF.

Adult↗
PubMed1992

Implantable defibrillators for prevention of sudden death. Technology at a medical and economic crossroad.

Implantable cardioverter-defibrillator therapy is now widely used for the treatment of symptomatic patients with documented or suspected life-threatening VTs. Although sudden death recurrence in ICD recipients is virtually eliminated, the extent of benefit both with respect to cardiac mortality and total survival in this patient population remains to be accurately quantitated, particularly vis-à-vis alternative antiarrhythmic therapies. Advanced device and lead systems can be expected to further improve both patient survival and quality of life after implant. The economic impact of unrestrained proliferation in ICD therapy can be enormous; however, available cost-benefit analyses support judicious use of this therapy with comparable economic impact to other accepted cardiovascular therapies. Such prospective risk stratification becomes economically essential when considering expanding its application to asymptomatic or minimally symptomatic populations at potential risk for future cardiac arrest.

Clinical Trials as Topic↗
PubMed1991

Experience with a third-generation implantable cardioverter-defibrillator.

A Medtronic 7216A pacemaker cardioverter-defibrillator was implanted in 16 patients (mean age 56 years) with sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) and organic heart disease with a mean left ventricular ejection fraction of 33%. Endocardial and epicardial defibrillation shock efficacy was evaluated before or at implant using 1 to 3 shock patterns, i.e., monophasic single, sequential or simultaneous shocks with dual and triple electrode configurations. Endocardial leads used a common right ventricular cathode and dual anodes, whereas epicardial leads used 2 or 3 helical coil patches. VT termination was evaluated using pacing or shock therapy, or both, whereas only shocks were used in VF. Programmable bradycardia pacing, individual zones for VT and VF detection and individualized pacing and shock therapy for VT and VF were used. Monophasic shocks had epicardial defibrillation thresholds ranging from 3 to 18 (mean 10) J and were comparable for sequential and simultaneous shocks (p greater than 0.2). VT detection rates ranged from 340 to 470 ms and VF detection rates from 270 to 330 ms. VT or VF induction, or both, was performed noninvasively in 13 patients after implant and was reproducibly terminated by rapid pacing alone (5 patients), low-energy shocks (2 patients), high-energy shocks (3 patients) and combined therapy (3 patients). Intermediate or high-energy shocks terminated all induced VF episodes. During follow-up (2 to 12 months), there have been 2 noncardiac deaths. Electrical therapy was delivered in 7 patients, for VT (3 patients), VT and VF (3 patients) and indeterminate tachyarrhythmia (1 patient). All VT/VF episodes were successfully terminated, with 78 of 96 (81%) spontaneous VT episodes terminated by pacing. Follow-up reprogramming was required in 5 patients. It is concluded that successful application of individualized electrical therapy prescriptions in patients with VT/VF is feasible. Pacing therapies, which are effective for induced VT, can be reliably used for effective long-term spontaneous VT termination in conjunction with shock therapy and can permit reduced patient exposure to shock therapy. Thus, a programmable hybrid pacemaker cardioverter-defibrillator system provides nonthoracotomy implantation, effective VT/VF termination, demand ventricular pacing and noninvasive modes for arrhythmia induction, event monitoring and clinical trouble-shooting.

Adult↗
PubMed1991

Usefulness of d, I sotalol for suppression of chronic ventricular arrhythmias.

Sotalol is a unique beta-blocking drug, possessing significant class III antiarrhythmic activity. The efficacy and safety of 2 doses of sotalol (320 and 640 mg/day, divided in 2 doses) were compared to placebo in a 6-week randomized, double-blind, multicenter study of 114 patients with chronic ventricular premature complexes (VPCs) at frequencies of greater than or equal to 30/hour. Sotalol significantly reduced VPCs in patients receiving both low (n = 38) and high (n = 39) doses, compared with patients (n = 37) receiving placebo (by 75 and 88%, respectively, vs 10%; p less than 0.001, sotalol vs placebo; p less than 0.05, high vs low dose). The individual efficacy criterion (greater than or equal to 75% VPC reduction) was achieved in 34% of low-dose and 71% of high-dose sotalol versus 6% of placebo-treated patients (p less than 0.003, sotalol vs placebo; p = 0.007, high vs low dose). Repetitive beats were suppressed 25% by placebo (difference not significant), 80% by low-dose (p less than 0.003) and 78% by high-dose sotalol (p less than 0.005). Sotalol decreased heart rate (by 24 to 25%, p less than 0.001) and increased PR (by 4 to 6%, p less than 0.001) and corrected JT intervals (by 12 to 13%, p less than 0.001), but did not change ejection fraction. Proarrhythmia (nonfatal) occurred in 3 sotalol and in 2 placebo patients. Nine discontinued therapy because of adverse effects (1 low dose and 8 high dose, p less than 0.02). In summary, sotalol is an efficacious antiarrhythmic drug for VPC suppression; in lower doses, it is somewhat less effective but better tolerated.

Adult↗
PubMed1990

Management of complications associated with a first-generation endocardial defibrillation lead system for implantable cardioverter-defibrillators.

An automatic cardioverter-defibrillator could be implanted using an endocardial defibrillation lead system (consisting of a tripolar defibrillation electrode catheter in conjunction with an epicostal patch electrode) in 9 of 10 patients with sustained ventricular tachycardia or ventricular fibrillation. Six lead system complications were observed during a follow-up period of 51 +/- 36 weeks. Three catheter electrode conductor fractures occurred and manifested as oversensing and subsequent delivery of inappropriate shocks (1 patient), inability to defibrillate during electrophysiologic testing 3 months after implant (1 patient) and sudden cardiac death (1 patient). Asymptomatic patch electrode conductor fractures were detected on a routine chest roentgenogram in 2 patients. Endocardial defibrillation threshold testing performed at the time of implantation resulted in malfunction of a previously implanted permanent pacemaker pulse generator in 1 patient. Catheter and patch electrode replacement procedures were performed in 3 consenting patients under local anesthesia. Endocardial defibrillation thresholds after lead replacement were comparable to those obtained at time of initial implant. Serial clinical, roentgenographic and electrophysiologic evaluation should be included in follow-up procedures for endocardial defibrillation lead systems. Monitoring for deleterious effects of endocardial defibrillation threshold testing on previously implanted pacemaker systems should be performed at the time of implant and during follow-up. Improved lead designs are necessary for long-term use of endocardial defibrillation electrodes, but replacement procedures are feasible without thoracotomy.

Aged↗
PubMed1990

Efficacy and safety of monophasic and biphasic waveform shocks using a braided endocardial defibrillation lead system.

Endocardial lead systems for implantable cardioverter-defibrillators utilize large (12F) rigid catheters with spring defibrillation electrodes, and lead system failure has been observed during long-term implant. We evaluated a novel flexible 8F braided electrode catheter for pacing and defibrillation in canine experiments. Active fixation and pacing were accomplished using a screw-in distal electrode, and defibrillation pulses were delivered through a braided electrode. Two braided electrode catheters were positioned in the right ventricular apex (6 cm2) and in the superior vena cava-right atrial junction (5 cm2), respectively. An elliptical 13 cm2 surface area patch electrode was positioned along the left lateral cardiac border. Ventricular fibrillation (VF) was induced and monophasic and asymmetric biphasic shocks (leading voltages 260 to 1000 V) were delivered via dual and triple electrode configurations in each animal using a prospective randomized crossover study design. Mean right ventricular pacing threshold was 0.5 +/- 0.2 mA, with a mean electrogram amplitude of 11.1 +/- 2.8 mV during sinus rhythm prior to fibrillation and defibrillation. Two hundred seven VF inductions (mean 30 +/- 4 per animal) were analyzed. The mean defibrillation threshold could be reduced to 8.0 +/- 3.2 joules with biphasic shocks from 12.9 +/- 5.1 joules obtained for monophasic shocks using a dual electrode system (p less than 0.004). Mean shock leading voltage was correspondingly reduced to 488 +/- 100 V from 691 +/- 154 V (p less than 0.0006).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1990

Clinical efficacy of dual electrode systems for endocardial cardioversion of ventricular tachycardia: a prospective randomized crossover trial.

In order to eliminate the need for epicardial electrodes, two large transvenous catheter electrodes or one catheter and one extrathoracic patch electrode have been proposed as alternative electrode configurations for defibrillation and ventricular tachycardia cardioversion by implantable cardioverter/defibrillators. We compared the efficacy and safety of endocardial shocks delivered through these two electrode systems in man in a prospective randomized crossover study. Twelve patients with sustained ventricular tachycardia and heart disease undergoing electrophysiologic study were evaluated. A transvenous tripolar cardioversion electrode catheter with a large distal defibrillation electrode (surface area, 400 mm2) and proximal defibrillation electrode (surface area, 800 mm2) was positioned in the right ventricular apex with a cutaneous patch electrode placed on the cardiac apex. Sustained ventricular tachycardia was induced at electrophysiologic study. Shocks were delivered using two catheter electrodes only (right ventricular cathode and right atrial anode = method I), and one catheter electrode and cutaneous patch (right ventricular cathode and cutaneous apical patch anode = method II). Synchronized monophasic shocks were delivered using three preselected protocols based on ventricular tachycardia cycle length and morphology. Initial shock energies were 25 joules for polymorphic ventricular tachycardia and ventricular fibrillation, 15 joules for monomorphic rapid ventricular tachycardia (cycle length less than or equal to 300 msec), and 5 joules for monomorphic slow ventricular tachycardia (cycle length greater than 300 msec). Ventricular tachycardia was reinduced and shock energies titrated until cardioversion threshold was obtained. Identical ventricular tachycardia episodes were treated with both methods at each energy level.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1990

Current application of implantable cardioverter-defibrillators in the management of malignant ventricular tachyarrhythmias.

Several studies have uniformly demonstrated a marked reduction in expected arrhythmic/sudden death rates in patients with either drug-refractory sustained ventricular tachycardia, ventricular fibrillation or survivors of cardiac arrest following the implantation of cardioverter-defibrillators (ICD). Significant advances in these devices over the past 10 years have permitted programmability and demand pacing. There has been sophistication in tachycardia detection and the characteristics of the delivered electrical therapy. Programs to reconfirm the arrhythmic event, sensing parameters for rate, electrogram amplitude, data storage, interrogation and morphology are available in some devices. Some models will permit both antitachycardia pacing as well as defibrillation functions and choice of shock waveforms as bidirectional and biphasic shocks. Endocardial lead systems using smaller and more flexible electrodes may obliterate the need for thoracotomy. It appears that ICD therapy will form a significant component in antiarrhythmic therapy in the future.

Electric Countershock↗
PubMed1989

Argon laser ablation of malignant ventricular tachycardia associated with coronary artery disease.

The long-term clinical efficacy and safety of intraoperative mapping-guided argon laser ablation alone or in conjunction with standard surgical methods were assessed in 20 consecutive patients with refractory sustained ventricular tachycardia (VT) or ventricular fibrillation. A 15-W argon ion gas laser was used and pulsed laser energy was delivered through a fiberoptic catheter delivery system. Pre- and intraoperative mapping was used to localize the arrhythmogenic tissue. Postoperative clinical, ambulatory electrocardiographic and electrophysiologic evaluations were performed before discharge and at 1 year of follow-up. Thirty-eight VT morphologies were mapped and ablated with laser energy alone (82%), combined laser ablation and mechanical resection (13%) or mechanical resection alone (5%). Concomitant coronary artery bypass surgery was performed in 15 patients and in 1 patient it was performed with mitral value replacement. Postoperative 30-day mortality was 5%. One patient (5%) required postoperative antiarrhythmic drug therapy, and all survivors had suppression of inducible sustained VT at discharge. Mean left ventricular ejection fraction increased from 34 +/- 12% preoperatively to 41 +/- 13% postoperatively (p = 0.001). Efficacy rates for ablation of VT sites associated with anterior myocardial infarction and inferior or posterior myocardial infarction were comparable (100 vs 96%, respectively, p greater than 0.2). At 1-year follow-up no sudden deaths had occurred and total survival rate was 90%. Intraoperative pulsed argon laser ablation alone or in conjunction with standard surgical techniques improves the efficacy of surgical ablation procedures for VT or ventricular fibrillation and reduces the need for additional postoperative antiarrhythmic drug or device therapy.

Aged↗